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QUALITY SCIENCE FOR QUALITY AIR 

HEARING 

BEFORE THE

SUBCOMMITTEE ON ENERGY AND 

ENVIRONMENT 

COMMITTEE ON SCIENCE, SPACE, AND 

TECHNOLOGY 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

TUESDAY, OCTOBER 4, 2011 

Serial No. 112–41 

Printed for the use of the Committee on Science, Space, and Technology 

( 

Available via the World Wide Web: http://science.house.gov 
(II) 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

HON. RALPH M. HALL, Texas, Chair 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

LAMAR S. SMITH, Texas 

DANA ROHRABACHER, California 

ROSCOE G. BARTLETT, Maryland 

FRANK D. LUCAS, Oklahoma 

JUDY BIGGERT, Illinois 

W. TODD AKIN, Missouri 

RANDY NEUGEBAUER, Texas 

MICHAEL T. MCCAUL, Texas 

PAUL C. BROUN, Georgia 

SANDY ADAMS, Florida 

BENJAMIN QUAYLE, Arizona 

CHARLES J. ‘‘CHUCK’’ FLEISCHMANN, 

Tennessee 

E. SCOTT RIGELL, Virginia 

STEVEN M. PALAZZO, Mississippi 

MO BROOKS, Alabama 

ANDY HARRIS, Maryland 

RANDY HULTGREN, Illinois 

CHIP CRAVAACK, Minnesota 

LARRY BUCSHON, Indiana 

DAN BENISHEK, Michigan 

VACANCY 

EDDIE BERNICE JOHNSON, Texas 

JERRY F. COSTELLO, Illinois 

LYNN C. WOOLSEY, California 

ZOE LOFGREN, California 

BRAD MILLER, North Carolina 

DANIEL LIPINSKI, Illinois 

GABRIELLE GIFFORDS, Arizona 

DONNA F. EDWARDS, Maryland 

MARCIA L. FUDGE, Ohio 

BEN R. LUJA ́ N, New Mexico 

PAUL D. TONKO, New York 

JERRY MCNERNEY, California 

JOHN P. SARBANES, Maryland 

TERRI A. SEWELL, Alabama 

FREDERICA S. WILSON, Florida 

HANSEN CLARKE, Michigan 

VACANCY 

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT

HON. ANDY HARRIS, Maryland, Chair 

DANA ROHRABACHER, California 

ROSCOE G. BARTLETT, Maryland 

FRANK D. LUCAS, Oklahoma 

JUDY BIGGERT, Illinois 

W. TODD AKIN, Missouri 

RANDY NEUGEBAUER, Texas 

PAUL C. BROUN, Georgia 

CHARLES J. ‘‘CHUCK’’ FLEISCHMANN, 

Tennessee 

RALPH M. HALL, Texas 

BRAD MILLER, North Carolina 

LYNN C. WOOLSEY, California 

BEN R. LUJA ́ N, New Mexico 

PAUL D. TONKO, New York 

ZOE LOFGREN, California 

JERRY MCNERNEY, California 

EDDIE BERNICE JOHNSON, Texas 
(III) 

C O N T E N T S 

Tuesday, October 4, 2011 

Page 

Witness List ............................................................................................................. 2 

Hearing Charter ...................................................................................................... 3 

Opening Statements 

Statement by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment, Committee on Science, Space, and Technology, U.S. 

House of Representatives .................................................................................... 6 

Written Statement ............................................................................................ 7 

Statement by Representative Brad Miller, Ranking Minority Member, Subcommittee on Energy and Environment, Committee on Science, Space, and 

Technology, U.S. House of Representatives ....................................................... 8 

Written Statement ............................................................................................ 10 

Witnesses: 

Dr. Roger O. McClellan, Advisor, Toxicology and Human Health Risk Analysis 

Oral Statement ................................................................................................. 12 

Written Statement ............................................................................................ 14 

Dr. George Thurston, Professor, New York University School of Medicine 

Oral Statement ................................................................................................. 19 

Written Statement ............................................................................................ 20 

Dr. Michael Honeycutt, Chief Toxicologist, Texas Commission on Environmental Quality 

Oral Statement ................................................................................................. 26 

Written Statement ............................................................................................ 27 

Dr. Robert F. Phalen, Professor of Medicine, and Co-Director, Air Pollution 

Health Effects Laboratory, University of California, Irvine 

Oral Statement ................................................................................................. 36 

Written Statement ............................................................................................ 38 

Dr. Anne E. Smith, Senior Vice President, Nera Economic Consulting 

Oral Statement ................................................................................................. 39 

Written Statement ............................................................................................ 40 

Mr. J. Edward Cichanowicz, Consultant 

Oral Statement ................................................................................................. 51 

Written Statement ............................................................................................ 53 

Discussion 61 

Appendix 1: Answers to Post-Hearing Questions 

Dr. Roger O. McClellan, Advisor, Toxicology and Human Health Risk Analysis ......................................................................................................................... 82 

Dr. George Thurston, Professor, New York University School of Medicine ........ 92 

Dr. Michael Honeycutt, Chief Toxicologist, Texas Commission on Environmental Quality ..................................................................................................... 96 

Dr. Robert F. Phalen, Professor of Medicine, and Co-Director, Air Pollution 

Health Effects Laboratory, University of California, Irvine ............................. 110 

Dr. Anne E. Smith, Senior Vice President, Nera Economic Consulting ............. 112 
Page

IV 

Mr. J. Edward Cichanowicz, Consultant ............................................................... 118 

Appendix 2: Additional Material for the Record 

Reprint of article by Dr. Roger O. McClellan, Advisor, Toxicology and Human 

Health Risk Analysis: ′′Role of Science and Judgment in Setting National 

Ambient Air Quality Standards: How Low Is Low Enough?′′, Air Quality 

and Atmospheric Health (published online 01 June 2011). .............................. 122 

Letter from Dr. Roger O. McClellan, DVM, MMS, Dsc (Honorary) to Honorable Lisa P. Jackson, Administrator, U.S. Environmental Protection Agency, May 6, 2011. .................................................................................................... 138 

Memo from Honorable Cass R. Sunstein, Administrator, Office of Management and Budget, Office of Information and Regulatory Affairs, September 

2, 2011. .................................................................................................................. 143 
(1) 

QUALITY SCIENCE FOR QUALITY AIR 

TUESDAY, OCTOBER 4, 2011 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT, 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY, 

Washington, DC. 

The Subcommittee met, pursuant to call, at 10:04 a.m., in Room 

2318 of the Rayburn House Office Building, Hon. Andy Harris 

[Chairman of the Subcommittee] presiding. 
2 
3 

1 For the first time, during the 1997 revision of the PM NAAQS, EPA established separate 

standards for fine particulate matter (smaller than 2.5 micrometers or PM2.5) and coarse particulate matter (smaller than 10 micrometers or PM10). 

HEARING CHARTER

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT 

U.S. HOUSE OF REPRESENTATIVES 

Quality Science for Quality Air 

TUESDAY, OCTOBER 4, 2011

10:00 A.M.–12:00 P.M. 2318 RAYBURN HOUSE OFFICE BUILDING

Purpose 

On Tuesday, October 4, 2011, the Subcommittee on Energy and Environment of 

the Committee on Science, Space, and Technology held a hearing to examine the Environmental Protection Agency’s (EPA) process for setting standards under the 

Clean Air Act including (1) the role of scientific advice from the Clean Air Scientific 

Advisory Committee (CASAC) and similar bodies, (2) the economic underpinnings of 

EPA’s Regulatory Impact Analyses, and (3) the assumptions, models, and data used 

in projecting compliance, technological standards necessary to achieve compliance, 

and environmental benefits associated with proposed and finalized rules. 

Witnesses 

• Dr. Roger O. McClellan, Advisor, Toxicology and Human Health Risk Analysis 

• Dr. George Thurston, Professor, New York University School of Medicine 

• Dr. Michael Honeycutt, Chief Toxicologist, Texas Commission on Environmental Quality 

• Dr. Robert F. Phalen, Professor of Medicine and Co-Director, Air Pollution 

Health Effects Laboratory, University of California, Irvine 

• Dr. Anne E. Smith, Senior Vice President, NERA Economic Consulting 

• Mr. J. Edward Cichanowicz, Consultant. 

Background 

Originally passed in 1963, the Clean Air Act underwent significant amendments 

in 1970, 1977, and 1990. The CAA provided the EPA the statutory authority to regulate air pollution to address public health and welfare concerns. Under the CAA 

statutory framework, the Agency is required to set goals of reducing emissions from 

both stationary and mobile sources. 

National Ambient Air Quality Standards 

The foundation of the CAA is based primarily on the concept of nationwide air 

quality goals and the development of individual state plans to meet those goals. 

EPA has identified six ‘‘criteria pollutants’’ that are most prevalent and necessary 

to the protection of public health and welfare for National Ambient Air Quality 

Standards (NAAQS): sulfur dioxide (SO2), particulate matter (PM), 1 nitrogen oxides 

(NOχ), carbon monoxide (CO), ozone (O3), and lead (Pb). For each of these pollutants, EPA established a ‘‘primary’’ standard at a level designed to protect the public 

health within an ‘‘adequate margin of safety.’’ In addition, the statute allows EPA 

to set a secondary NAAQS to protect public welfare. At this point, EPA has not set 

secondary standards at different levels than the primary standards. 

The standards themselves are not directly enforceable. Rather, NAAQS establish 

ceilings for concentrations of criteria pollutants in ambient air. States are required 

to develop their own State Implementation Plans (SIPs) which outline the measures 

the State will take to meet the reduction required by the standard (attain) or stay 

in compliance with the standard (maintain). For example, a SIP may include emission limits for power plants, refineries and manufacturing facilities within the state, 
4 

2 Lead Industries Assn., Inc. v. EPA, 647 F.2d 1130, 1148 (CADC 1980) and Whitman v. 

American Trucking (February 2001). 3 http://yosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/CASAC. 4 http://republicans.energycommerce.house.gov/Media/file/Letters/112th/030811inhofe.pdf. 5 http://epw.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore¥id=d55fa42f7c41-456e-893f-2963eb26e07e. 6 CAA 112(d)(2). 

or fuel specifications for emission reductions from mobile sources. SIPs must be approved by EPA. If EPA determines that a SIP will not be able to attain or maintain 

the NAAQS concentrations, EPA can require States to abide by a Federal Implementation Plan (FIP) until such time that the State develops an approvable SIP. 

Further, if a State fails to submit a SIP, fails to submit an adequate SIP, or fails 

to implement a SIP, certain sanctions may be imposed; for example, the State may 

be banned from receiving Federal highway grants. 

Under the CAA, each NAAQS must go through a review every five years in order 

to ensure the standards were protecting public health according to the most recent 

scientific findings. After a scientific assessment and receipt of expert advice, the Administrator uses his or her own judgment to determine whether or not and to what 

extent an NAAQS is to be revised. Several Supreme Court cases 2 limited the ability of EPA to take cost into consideration when setting the NAAQS. However, EPA 

still prepares a Regulatory Impact Assessment (RIA) that details the Agency’s expected costs and benefits. 

Clean Air Scientific Advisory Committee 

NAAQS reviews also include a scientific assessment phase in which EPA assesses 

the scientific and technical data and provides opportunities for public and expert review of relevant staff documents. EPA then provides these documents to the Clean 

Air Scientific Advisory Committee (CASAC) for review and feedback. CASAC typically provides the Administrator of the EPA with a recommended concentration 

range for a particular NAAQS that it believes the scientific literature justifies. 

According to the EPA, CASAC ‘‘provides independent advice to the EPA Administrator on the technical bases for EPA’s national ambient air quality standards. Established in 1977 under the Clean Air Act (CAA) Amendments of 1977 (see 42 

U.S.C. § 7409(d)(2)), CASAC also addresses research related to air quality, sources 

of air pollution, and the strategies to attain and maintain air quality standards and 

to prevent significant deterioration of air quality.’’ 3

In providing this advice, CASAC comments on EPA staff documents and responds 

to charge questions from EPA staff. CASAC is comprised of seven permanent members that are supplemented by more than a dozen additional scientists that are appointed to join them for individual NAAQS reviews. 

In recent months, several Members of Congress 4 have raised questions regarding 

the objectivity and independence of the CASAC in providing this scientific advice 

to EPA. 5

Hazardous Air Pollutants 

The CAA distinguishes between two types of pollutants: aforementioned criteria 

pollutants (e.g., NOχ, SO2, PM, etc.) and hazardous air pollutants (HAPs). HAPs 

theoretically pose similar public health concerns as criteria pollutants but are much 

less ubiquitous; therefore, a different standard setting regime was established. The 

National Emission Standards for Hazardous Air Pollutants (NESHAPs) was established to deal with these nonconventional pollutants. The 1990 amendments required HAPs regulations to consider cost and technological feasibility. Further, the 

statute directed EPA to develop standards by industrial source category (e.g., acid 

gases) rather than focus on individual pollutants. 

Maximum Achievable Control Technology 

The mandating of NESHAPs by the 1990 CAAA set the course for the rapid development of technology-based standards for all major and industrial source categories 

that emit HAPs. These standards are known as Maximum Achievable Control Technologies, or MACT. MACT standards are to be based on the ‘‘maximum degree of 

reductions and emissions deemed achievable for the category or subcategory, the 

EPA administrator, taking into consideration the cost of achieving the reduction, 

any non-air-quality health and environmental impacts and energy requirements, determines is achievable for new or existing sources.’’ 6
5 

Scientific Inputs for Standard Setting Under the Clean Air Act 

Throughout the development of both NAAQS and NESHAP standards, EPA is required to provide scientific justification for the regulations. The initial inputs include information regarding the effects of pollutants on public health and welfare. 

EPA must provide information that demonstrates that criteria pollutants or HAPs 

within the ambient air at current concentrations constitute a threat to public 

health. The health risk is estimated through a scientific assessment, and the public 

and expert advice is provided to EPA. The Court has ruled that EPA may not take 

cost into account when establishing NAAQS levels, though Executive Orders have 

required that such costs must still be analyzed through a regulatory impact assessment. For MACT, EPA must take cost into account, and may not set a standard 

that protects the public health to a level that has no risk of health effects. Finally, 

EPA is required for the MACT to conduct a technological feasibility analysis to determine if the technology to reduce emissions of pollutants is available and cost effective. Again, although EPA is not required to conduct a similar analysis in the 

case of NAAQS levels, the Agency still does a technical assessment when developing 

the regulatory impact assessment. 

The results of these scientific inputs: health, risk, cost and technology, provide the 

basis and necessary justification for EPA to move forward with setting a standard 

or making an existing standard more stringent. The Science, Space, and Technology 

Committee will examine the process by which the quality of the scientific inputs affects the overall justification for regulation, and the importance of that process in 

ensuring that only appropriate and necessary rules are promulgated. 

Relevant Current Proposed and Finalized (but under review) Rules 

The following regulations pertain to the aforementioned Clean Air Act authorities: 

• National Emission Standards for Hazardous Air Pollutants from Coal- and Oilfired Electric Utility Steam Generating Units and Standards of Performance for 

Electric Utility Steam Generating Units; 

• National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, and Institutional Boilers; 

• National Emission Standards for Hazardous Air Pollutants for Major Sources: 

Industrial, Commercial & Institutional Boilers and Process Heaters; 

• Portland Cement Manufacturing NESHAP and NSPS; 

• Review of the Primary National Ambient Air Quality Standard for Sulfur Dioxide; 

• Review of the Primary National Ambient Air Quality Standard for Ozone; 

• Review of the Primary National Ambient Air Quality Standard for Particulate 

Matter; 

• Review of the Primary National Ambient Air Quality Standard for Lead; 

• Cross-State Air Pollution Rule. 
6 

Chairman HARRIS. The Subcommittee on Energy and Environment will come to order. 

Good morning. Welcome to today’s hearing entitled ‘‘Quality 

Science for Quality Air.’’ In front of you are packets containing the 

written testimony, biographies and Truth in Testimony disclosures 

for today’s witness panel. I recognize myself for five minutes for an 

opening statement. 

I thank our witnesses for being here today to provide their expertise on the process for incorporating quality science into Clean Air 

Act standards. In the debate over EPA issues, it can often seem 

like two ships passing in the night: one side talking about jobs, the 

other discussing children’s health. This hearing is designed to provide context to this conversation and to examine the science and 

technology assumptions behind air quality standards. 

It is important to note at the outset that overall air quality in 

the United States is excellent. By any objective metric, air quality 

and related human health has improved dramatically, and the levels of every major air pollutant have plummeted over the last three 

decades. Most of America meets increasingly stringent EPA standards. 

Despite these improvements, the unprecedented pace of EPA’s 

Clean Air Act agenda requires us to ask two basic questions: are 

we using common sense in establishing environmental standards, 

and how low is low enough? 

Unfortunately, whether it is the Cross-State Air Pollution Rule, 

National Ambient Air Quality Standards for ozone or fine particulate matter, or the so-called utility MACT rules, these questions 

are being ignored and EPA is moving ahead promulgating major, 

job-destroying regulations on the basis of shaky, and often secret, 

science. 

Now, both as a physician and the Chairman of a Subcommittee 

overseeing what is supposed to be science at EPA, I was alarmed 

to hear Administrator Lisa Jackson explain two weeks ago that 

particulate matter ‘‘does not make you sick. It is directly causal to 

dying sooner than you should’’ and that ‘‘if we could reduce particulate matter to healthy levels, it would have the same impact as 

finding a cure for cancer.’’ 

Now two weeks ago, Assistant Administrator Gina McCarthy had 

a hard time explaining how the Cross-State Air Pollution Rule 

would avoid ‘‘up to 34,000 deaths’’ at a committee hearing in this 

room. Given the imprecise justification for those 34,000 avoided 

deaths, the Administrator’s claim of 572,000 avoided deaths, which 

is the number who die from cancer each year, is patently ridiculous. 

I would hope that, of all people, members of the President’s Cabinet would be responsible enough to ensure any public health claims 

are grounded in science, not hyperbole, and if our current air is 

such a threat to human health that it is killing hundreds of thousands of people each year, I am very interested to review the information that the Agency relies on in establishing this relationship. 

Accordingly, I have asked EPA to make the federally funded data 

sets and associated science upon which these health claims appear 

to be based publicly available. But because the EPA is not transparent with the sources of their data, from what we have seen so 
7 

far, EPA seems to rely on making statistical hay out of minor associations between pollutants and premature mortality. This is not 

quality science; this is press-release science in which public relations is considered more important than an honest, transparent, 

scientific discussion of environmental outcomes and human health. 

One glaring example is the EPA’s justification of these major 

Clean Air Act regulations on the basis of double-counting the 

health benefits of lower particulate matter levels. Without these coincidental co-benefits, none of these rules would have passed a simple cost-benefit analysis. 

Just last week, EPA’s Inspector General released a report highlighting the agency’s inability to follow basic peer review and scientific integrity guidelines in developing its endangerment finding 

on carbon dioxide. I am concerned that similar problems plague 

EPA’s Science Advisory Board and the Clean Air Scientific Advisory Committee, or CASAC. We are not seeking to denigrate the 

participating scientists, but there are questions raised by the IG 

that need to be asked about the independence of these bodies. In 

many cases, these panels suffer from little turnover, financial conflicts, a lack of balance and transparency, and, perhaps most importantly, panelists that are peer reviewing their own work. 

There are also a number of signs that this EPA is underestimating the time and cost to install pollution control technology 

that is required. For example, there is no power plant in America 

that can meet the three requirements proposed by EPA in the Utility MACT Rule. 

I am pleased that the House of Representatives has begun pushing back against this job-killing regulatory agenda through legislation like the recently passed TRAIN Act, and I hope that the recommendations of our panelists today will help guide our oversight 

of EPA science going forward. 

[The prepared statement of Mr. Harris follows:] 

PREPARED STATEMENT OF SUBCOMMITTEE CHAIRMAN ANDY HARRIS

The hearing will come to order. I thank our witnesses for being here today to provide their expertise on the process for incorporating quality science into Clean Air 

Act standards. 

In the debate over EPA issues, it can often seem like two ships passing in the 

night: one side talking about jobs, and the other discussing children’s health. This 

hearing is designed to provide context to this conversation and to examine the 

science and technology assumptions behind air quality standards. 

It is important to note at the outset that overall air quality in the United States 

is excellent. By any objective metric, air quality and related human health has improved dramatically, and the levels of every major air pollutant have plummeted 

over the last three decades. Most of America meets increasingly-stringent EPA 

standards. 

Despite these improvements, the unprecedented pace of EPA’s Clean Air Act agenda requires us to ask two basic questions: ‘‘Are we using common sense in establishing environmental standards?’’ and ‘‘How low is low enough?’’ 

Unfortunately, whether it is the Cross-State Air Pollution Rule, National Ambient 

Air Quality Standards for ozone or fine particulate matter, or the so-called utility 

MACT rules, these questions are being ignored and EPA is moving ahead promulgating major, job-destroying regulations on the basis of shaky (and often secret) 

science. 

Both as a physician and the Chairman of a Subcommittee overseeing what is supposed to be science at EPA, I was alarmed to hear Administrator Lisa Jackson explain two weeks ago that particulate matter ‘‘does not make you sick. It is directly 

causal to dying sooner than you should’’ and that ‘‘if we could reduce particulate 

matter to healthy levels, it would have the same impact as finding a cure for cancer.’’ 
8 

Two weeks ago, Assistant Administrator Gina McCarthy had a hard time explaining 

how the Cross-State Air Pollution Rule would avoid ‘‘up to 34,000 deaths.’’ Given 

the imprecise justification for 34,000 avoided deaths, the Administrator’s claim of 

572,000 avoided deaths is patently ridiculous. 

I would hope that, of all people, members of the President’s cabinet would be responsible enough to ensure any public health claims are grounded in science, not 

hyperbole, and if our current air is such a threat to human health that it is killing 

hundreds of thousands of people each year, I am very interested to review the information that the Agency relies on in establishing this relationship. Accordingly, I 

have asked EPA to make the federally-funded data sets and associated science upon 

which these health claims appear to be based publicly available. 

Because the EPA is not transparent with the sources of their data, from what we 

have seen so far, EPA seems to rely on making statistical hay out of minor associations between pollutants and premature mortality. This is not quality science; this 

is press release science in which public relations is considered more important 

than an honest and transparent discussion of environmental outcomes and human 

health. One glaring example is EPA’s justification of these major Clean Air Act regulations on the basis of double-counting from the health benefits of lower particulate 

matter levels. Without these coincidental co-benefits, none of these rules would have 

passed a simple cost-benefit analysis. 

Just last week, EPA’s Inspector General released a report highlighting the Agency’s inability to follow basic peer review and scientific integrity guidelines in developing its endangerment finding on carbon dioxide. I am concerned that similar problems plague EPA’s Science Advisory Board and the Clean Air Scientific Advisory 

Committee or CASAC. We are not seeking to denigrate the participating scientists, 

but there are questions raised by the IG that need to be asked about the independence of these bodies. In many cases, these panels suffer from little turnover, financial conflicts, a lack of balance and transparency, and, perhaps most importantly, 

panelists that are peer reviewing their own work. 

There are also a number of signs that this EPA is underestimating the time and 

cost to install pollution control technology that is required. For example, there is 

no power plant in America that can meet the three requirements proposed by EPA 

in the utility MACT rule. 

I am pleased that the House of Representatives has begun pushing back against 

this job-killing, regulatory agenda through legislation like the recently-passed 

TRAIN Act, and I hope that the recommendations of our panelists today will help 

guide our oversight of EPA science going forward. 

Chairman HARRIS. The chair now recognizes Mr. Miller for an 

opening statement. 

Mr. MILLER. Thank you, Mr. Chairman. I appreciate your holding this hearing. The EPA does have before us the need, often court 

imposed, to issue new and updated regulations, and we should review what those regulations are based on and what we really get 

out of them, but the Clean Air Act’s history speaks for itself. It is 

not just the EPA’s own estimates. Those estimates have been 

broadly supported by public health experts, neutral experts, those 

who truly do not have a financial ax to grind, who are not employed by the industry, either directly or as consultants or as experts or whatever else. EPA’s own estimates are that in the first 

20 years of the Clean Air Act, the Clean Air Act has prevented 

more than 200,000 premature deaths and almost 700,000 cases of 

chronic bronchitis, and the benefits continue to grow and grow. The 

Chairman said correctly the air quality is much better in the 

United States. That is because we have had the Clean Air Act in 

effect for 40 years. It has not been because of the benevolence of 

industry. It has been because there has been an Act in place that 

has been enforced by the Environmental Protection Agency, in 

some instances, kicking and screaming, but still enforced, enforced 

if not by the Agency at least by the courts requiring the Agency 

to follow the law. 
9 

And the blame for these regulations for the effect on jobs is not 

really something we can attribute to the industry because there are 

many in the industry that support the regulations and think that 

they need to be tougher than they are, and many have advocated 

for that. But politicians have learned that there is a political value 

in creating a villain, creating a demon, and they have made the 

EPA their demon, so there is no room between their image of the 

EPA as a rogue agency that is enforcing the Clean Air Act, signed 

by President Nixon, later strengthened by President Bush. So demonizing the EPA by making specious claims that their regulations 

kill jobs also without any particularly well-grounded basis while ignoring all the benefits for public health and the economy is another 

cynical effort to gain votes and get Americans to vote against their 

own self-interest. Americans aren’t buying it. Polls show that 

Americans understand the importance of the EPA and understand 

the importance of environmental protection, support clean air and 

water, and do not believe that pollution and damage to the public 

health is the price that we have to pay for prosperity. 

But in this Congress we have seen an unrelenting attack on environmental protection. There have been 136 votes so far, all to 

ratchet back environmental protections, the most extreme example, 

the TRAIN Act, and nobody opposes transparency. I have pushed— 

for four years as Chairman of the Science Committee’s Subcommittee on Oversight, I have pushed hard for transparency and 

we should have that, but we also know that the arguments about 

process are usually driven by folks who are not happy with the result of the process, and if you don’t like the result, you almost 

never like the process. 

The Inspector General did criticize, it is true, some of the processes of the EPA but also said that the EPA’s processes that they 

did use complied with the statute, and they said that there was no 

reason to think that the result would have been any different if the 

processes had been different. I think we should continuously improve the processes. Process does matter. But the characterization 

of the Inspector General’s report is simply not correct. 

So with significant progress over the last 40 years, I think we 

should look at how to build on that, continuing to improve the 

quality of our air, recognizing the importance of that to a strong 

economy. Premature deaths cost our economy. People having bronchitis and not being able to go to work cost our economy. Stronger 

environmental protections also push industry to develop new technologies and have in fact increased jobs in various areas. 

So we have proven time and again that worker productivity improves better if there is clean air. Agricultural yield is improved if 

there’s clean air. There is a reduction in mortality and illness and 

other economic and public health benefits that far outweighs the 

cost of compliance. Of course, we should consider the costs of compliance but we should also include the effect on the public health 

as well. 

Thank you, and I yield back. 

[The prepared statement of Mr. Miller follows:] 
10 

PREPARED STATEMENT OF RANKING MEMBER BRAD MILLER

I want to thank Chairman Harris for holding a hearing to discuss the science underpinning the 40-year-old landmark legislation, the Clean Air Act. While I disagree 

with some of the opinions of my colleagues and the witnesses, I understand the timing and motivations behind this hearing. As we look forward to the EPA issuing 

new and updated pollution regulations, it is worth reminding ourselves of what they 

are based on and what we get out of them. In that regard, the Clean Air Act’s history of protecting public health speaks for itself. 

In the four decades since it was signed, the Clean Air Act has saved hundreds 

of thousands of lives. Even in its first 20 years—as emissions reductions were just 

beginning—EPA figures show that the Clean Air Act prevented more than 200,000 

premature deaths and almost 700,000 cases of chronic bronchitis. 

And these benefits to the public will continue to grow. The EPA projects that by 

2020, the Clean Air Act will prevent roughly 230,000 deaths, 200,000 cases of heart 

disease, and 2.4 million asthma flare-ups every year. These will have a real economic effect by keeping children and adults out of the hospital and saving the nation from 22.4 million missed school and work days per year, providing upwards of 

$2 trillion in economic benefits by 2020. These benefits would far exceed the original 

costs by 30 to 1. That’s not a bad investment by any standard. 

The Clean Air Act is hardly the economy-killer that so many claim. Over the last 

20 years, while emissions of the six principal air pollutants were reduced by an additional 41 percent, the Nation’s Gross Domestic Product has increased by more 

than 64 percent. And we not only got cleaner air, but entirely new technology sectors to boot. In fact, GDP has risen by more than 200 percent since the Act was 

signed 40 years ago, and this is in spite of the doomsday prophesies of widespread 

economic disruption and industrial collapse that some said would result from environmental regulations. These claims have been proven wrong time and again, and 

we should expect to look back and regard the alarmism of today as no different. 

To be fair, the blame for misguiding the public on the costs and benefits of regulations cannot be laid solely at the feet of industry that in the end exists to turn a 

profit. In fact, ‘‘industry’’ is hardly uniform in its regard for environmental regulations, with many industrial stakeholders clearly advocating in favor of the new regulations. It depends on how they have invested. And even those on the losing end 

of EPA’s regulations are often complaining about the process or timeline, knowing 

that the eventual regulation will be the same. 

Unfortunately, there is a more troubling force at play here as politicians have discovered the distinct political value of vilifying the EPA. To them, there is no middle 

ground, and no room for negotiation or compromise with this ‘‘rogue agency.’’ In politicizing the issue—sometimes far beyond the comfort level of the industries they 

profess to champion—there also seems to be no limit to the hysterics. In a recent 

hearing on the EPA’s transport ruIe before this Committee, a witness actuaIly stated that the rule will ‘‘jeopardize the lives of our most medically fragile citizens.’’ 

Demonizing environmental safeguards and the EPA by making specious claims 

that regulations kill jobs—and even people—while completely ignoring the proven 

positive effects they have on public health and the economy, is another cynical ploy 

to get Americans to vote against their own self-interest. 

Thankfully, poll after poll shows that the public believes that EPA should protect 

their right to clean air and water more than they believe that pollution is the price 

they must pay for economic security. 

In this Congress, it seems we have seen every assault possible on environmental 

protections such as the Clean Air Act, taking 136 anti-environmental votes in the 

House thus far. Before the recess, the House passed the so-called TRAlN Act, a 

piece of legislation that would derail efforts to curb emissions of dangerous pollutants such as soot, mercury, dioxins and acid gases. Of course, nobody would argue 

against having ‘‘transparency’’ in our regulatory processes, but that is not really 

what these bills are about. They are about politics first, and buying time for polluters who must otherwise be dragged kicking and screaming into environmental 

compliance, while more forward-looking firms are deprived of making a return on 

their investments in cleaner technology. 

Efforts such as the TRAIN Act and the paralysis-by-analysis it would impose are 

themselves anything but transparent or comprehensive. It adds another layer of bureaucracy, essentially for the purpose of weighing industry’ s cost of compliance, 

without considering the benefits for public health and the creation of new jobs. It 

also removes any provision to ensure that such safeguards will ever take effect, delaying them indefinitely. It is designed to ignore the overwhelming evidence that 

saving Americans’ lives is far cheaper than saving polluters’ dollars. 
11 

No regulatory process is ever going to make everyone happy because someone 

must always change, but we should certainly look for ways to make the processes 

more efficient and transparent. Instead of making doomsday claims that never hold 

up and scaring the American public into forgoing their own rights to a cleaner environment, we need to trust in the EPA’s reliable, established scientific processes for 

characterizing the effects of emissions on public health and evaluating the costs and 

benefits of new technologies. We should acknowledge that we did not get 40 years 

of dramatic pollution reductions with strong economic growth because EPA’s scientific processes are not tried and true. Put simply, they work. 

And speaking of process, I am disappointed that we do not have before us an EPA 

witness nor one from the Science Advisory Board. If we’re going to talk about them, 

they ought to be here to defend themselves. That’s just fundamental fairness. 

Quoting Republican President Nixon who first signed into law the 1970 Clean Air 

Act, ‘‘I think that 1970 will be known as the year of the beginning, in which we 

really began to move on the problems of clean air and clean water and open spaces 

for the future generations of America.’’ 

Although significant progress has been made in the past 40 years, it is our job 

now to build upon this legacy and ensure that we continue to improve our environmental quality while fostering a strong economy. This is not science fiction; it is our 

history. In the U.S., a healthy environment and strong economy are not mutually 

exclusive. Stricter pollutions limits force us to push the envelope of scientific innovation and create new technologies. And, as it has been proven many times over, improved worker productivity, increased agricultural yield, reduction in mortality and 

illness, and other economic and public health benefits far outweigh the costs of compliance. 

Thank you, and I yield back. 

Chairman HARRIS. Thank you very much, Mr. Miller. 

If there are Members who wish to submit additional opening 

statements, your statements will be added to the record at this 

point. 

At this time I would like to introduce our witness panel. Our 

first witness, Dr. Roger McClellan, is an advisor to public and private organizations on issues concerned with air quality, utilizing 

his extensive experience in comparative medicine, toxicology, aerosol science and risk analysis. He was also formerly the Chair of 

EPA’s Clean Air Science Advisory Committee. 

Our next witness will be Dr. George Thurston, who is a Professor 

at the NYU School of Medicine. Dr. Thurston conducts research 

into the human health effects of air pollution. He has been published widely in the scientific literature and was a consultant to 

EPA’s Clean Air Science Advisory Committee’s Panel on Nitrogen 

Oxides. 

Next, we have Dr. Michael Honeycutt, Chief Toxicologist at the 

Texas Commission on Environmental Quality. Dr. Honeycutt is the 

Director of the Toxicology Division there and an Adjunct Professor 

at Texas A&M University and has published numerous articles in 

the peer-reviewed literature. 

Dr. Robert Phalen, Professor of Medicine and Co-Director of the 

Air Pollution Health Effects Laboratory, University of California, 

Irvine, will be the next witness. Dr. Phalen has over 30 years of 

experience with inhalation studies of hazardous materials. He is 

also a member of EPA’s Clean Air Science Advisory Committee 

Panel on Particulate Matter. 

Next, we have Dr. Anne Smith, Senior Vice President at NERA 

Economic Consulting. Dr. Smith is an economist and decision analyst specializing in energy and environmental markets and compliance planning. Before joining NERA, Dr. Smith headed the Climate 

and Sustainability Group at Charles River Associates. 
12 

Finally, we have Mr. J. Edward Cichanowicz, an experienced engineering consultant. He provides consulting services for utility industry clients in developing and implementing environmental control strategies to meet the mandates of the EPA and state and local 

regulatory agencies. Mr. Cichanowicz specializes in the technical 

feasibility, cost and risk of adopting both mature and evolving technologies. 

Now, as our witnesses should know, spoken testimony is limited 

to five minutes each after which the Members of the Committee 

will have five minutes each to ask questions, and we do have a 

copy of your written testimony. 

I now recognize our first witness, Dr. Roger McClellan, an advisor on toxicology and human health risk analysis. Dr. McClellan. 

STATEMENT OF DR. ROGER O. MCCLELLAN, 

ADVISOR, TOXICOLOGY AND HUMAN HEALTH RISK ANALYSIS 

Dr. MCCLELLAN. Good morning, distinguished Members of the 

Subcommittee. Thank you for the invitation to present my views 

and the role of science in informing policy judgments on the setting 

of National Ambient Air Quality Standards. I ask that my written 

testimony be entered in the record as though read in its entirety. 

Let me summarize it. 

What I hope my comments will convey is how low is low enough 

requires context. It is not an abstract question. For more than five 

decades, I have been contributing to the development of the science 

needed to address important societal issues concerned with air 

quality. I am proud to have served on many EPA advisory committees under the Administrations of both parties. I have served on 

numerous Clean Air Scientific Advisory Committee panels and 

chaired CASAC from 1988 to 1992. I served on the panels that advised on the 1997 ozone standard, the 2006 particulate matter 

standard. I did not serve on the ozone panel that advised on the 

2008 ozone standard. However, I did offer comments to the Administrator and CASAC. 

In March 2008, then-Administrator Johnson revised the ozone 

standard using the policy judgment exclusively delegated to the 

EPA Administrator in the Clean Air Act. He retained ozone as an 

indicator, the averaging time of eight hours, the statistical form, 

the standard attained when the fourth highest eight-hour average 

is less than the numerical level of the standard, and he reduced the 

concentration allowed from 84 to 75 parts per billion. In announcing his decision, he noted that he depended on the science to inform his decision and noted that the advice provided by the Clean 

Air Scientific Advisory Committee was in fact a blend of science 

and the committee’s own personal policy preferences. 

In January 2010, EPA Administrator Jackson formally announced a fast-track reconsideration proposal to set the standard 

in the range of 70 to 60 PPB. This in my opinion was the beginning 

of a serious misadventure and waste of resources. In my opinion, 

her decision was discretionary, arbitrary, capricious and without 

precedent. With the decision, she was expressing a personal opinion. If I had been in office 22 months earlier, I would have made 

a different policy choice. She wrapped herself in the cloak of 

science saying I will follow the advice of CASAC. In taking this 
13 

course, she abdicated the specific and exclusive authority delegated 

to the EPA Administrator by the Clean Air Act. 

In January 2011, she asked CASAC to elaborate on the basis of 

their recommended range. CASAC Chair Jonathan Samet wisely 

noted the decision as to an adequate margin of safety to protect 

public health was inherently a blend of science and policy. 

After repeatedly missing self-imposed deadlines, Administrator 

Jackson sent a proposed final rule to OMB in mid-summer. On 

September 2, 2011, Administrator Cass Sunstein of the OMB Office 

of Information and Regulatory Affairs advised Administrator Jackson her proposed rule was not mandatory, said it was discretionary, it would produce needless uncertainty and was being offered even while the next five-year review cycle was proceeding in 

an orderly fashion to conclude in March 2013, and he noted that 

her rule was not based on the latest science as called for by the 

Clean Air Act, and most importantly, the President had indicated 

he has made it clear he does not support finalizing the rule at this 

time. 

I applaud the common sense decision of Administrator Sunstein 

and President Obama. It is unfortunate that the President and his 

appointees did not have a discussion in 2009 that could have avoided this serious misadventure. 

Looking to the current review, I urge EPA and CASAC to carefully heed the thoughtful advice of Supreme Court Justice Stephen 

Breyer, who offered the view that a comparative health view was 

appropriate in setting the standards. I urge the Administrator to 

recognize that even when all U.S. manmade precursor emissions 

are eliminated, ambient ozone concentrations expressed as the 

maximum eight-hour average are just below 60 PPB. These background levels should be considered in making policy judgments on 

setting the standard. 

I think the Administrator and CASAC should be cognizant of the 

very weak signal for air pollution impacting public health currently. We have made great progress. And keep in mind, the substantial adverse health signal associated with socioeconomic status. 

Employment and jobs do matter. 

Frequently we hear about the relative risks associated with air 

pollution expressed as a few percent over a baseline. My view is, 

we ought to be concerned more with the science of the baseline. 

What can we do to drive down those baseline risks? Future research should focus on that, and keep in mind, a big number in 

terms of relative risk, the relative risk of unemployment, lower socioeconomic status. That is not a couple of percent, that is 100 percent looking at the lowest quartile versus the upper quartile. 

Thank you for the opportunity to testify, and I look forward to 

addressing your questions later, including the process used by 

CASAC. 

[The prepared statement of Dr. McClellan follows:] 
14 

PREPARED STATEMENT OF DR. ROGER O. MCCLELLAN, ADVISOR, TOXICOLOGY AND

HUMAN HEALTH RISK ANALYSIS

Major Points of Testimony of Roger O. McClellan—October 4, 2011 

• Clean Air Act is primary National Statute governing air quality issues in the 

U.S.A. The CAA requires the Administrator of the U.S. EPA to establish primary (health-based) and secondary (welfare-based) National Ambient Air Quality Standards for six criteria pollutants with science-based criteria to be reviewed every five years. 

• Primary NAAQS are to be established by the EPA Administrator based on the 

‘‘latest scientific knowledge’’ at levels ‘‘requisite to protect public health’’ while 

‘‘allowing an adequate margin of safety’’ without considering the cost of implementing the standard. 

• In March 2008, then-Administrator Stephen Johnson revised the Ozone NAAQS 

as required by the CAA using the scientific record based largely on papers published in 2005 and earlier to inform his policy judgments. He retained (a) ozone 

as the indicator for photochemical oxidants, (b) the averaging time of eight 

hours, (c) the statistical form (the standard is attained when the fourth highest 

eight-hour average value over a three-year period does not exceed the numerical 

level of the standard, and (d) reduced the level from 84 ppb to 75 ppb. In announcing his decision he noted that the Clean Air Scientific Advisory Committee had recommended the standard be set in the range of 60 to 70 ppb, advice based on a blend of science and their policy judgment. 

• In January 2010, Administrator Lisa Jackson announced that she was going to 

‘‘reconsider’’ Administrator Johnson’s policy decision and set the standard in the 

range of 60 to 70 ppb. She based this discretionary, arbitrary and capricious action on (a) her personal opinion that if she had been in office 22 months earlier 

she would have made a different policy choice, and (b) wrapped herself in a 

‘‘cloak of science’’ saying I will follow the advice of CASAC. With this proposal 

she abdicated the specific and exclusive authority delegated to the EPA Administrator to make the policy judgments inherent in setting the NAAQS. 

• On September 2, 2011, Administrator Cass Sunstein of the Office of Information 

and Regulatory Affairs/OMB advised Administrator Jackson that her proposed 

final rule was: (a) not mandatory, produced needless uncertainty, and that her 

Agency was already proceeding with five-year review cycle set to conclude in 

March 2013, (b) that her proposed final rule was not based on the latest science, 

and (c) the President had instructed Mr. Sunstein to return the rule to her— 

‘‘He has made it clear that he does not support finalizing the rule at this time.’’ 

• I applaud the actions of Administrator Sunstein and the President. My only regret is they did not have this ‘‘common sense’’ discussion with Administrator 

Jackson in early 2009. It would have avoided the misuse of the substantial EPA 

resources spent on this misadventure during 2009–2011. 

• Building on recent experience in revising the NAAQS for Ozone and PM2.5, I 

will comment on the NAAQS setting process and the role of CASAC. 

• I will emphasize that the language of the CAA and the efforts of narrowly focused advocacy groups may not be promoting, but rather damaging, public 

health. 

• I urge the Congress to refocus the Nation’s effort on public health revising the 

Clean Air Act, to allow consideration of costs in setting NAAQS, as part of an 

omnibus legislative package—‘‘Promoting Public Health’’ that recognizes a 

healthy economy with people employed is the cornerstone of a healthy population. 

Good morning, Mr. Chairman and Members of the Subcommittee. Thank you for 

the invitation to present my views on the role of science in informing policy judgments on the setting of National Ambient Air Quality Standards. 

Since 1999, I have served as an advisor to public and private organizations on 

issues related to air quality in the ambient environment and workplace, drawing on 

more than 50 years of experience in comparative medicine, toxicology, aerosol 

science, and risk analysis. Prior to 1999, I provided scientific leadership for two organizations—the Chemical Industry Institute of Toxicology (1988–1999) in Research 

Triangle Park, NC, and the Lovelace Inhalation Toxicology Research Institute 

(1966–1988) in Albuquerque, NM. Both organizations, under my leadership, earned 

an international reputation for developing scientific information undergirding occupational and environmental health standards. 
15 

The testimony I offer today also draws on my experience serving on numerous scientific advisory committees. This has included service on many EPA Scientific Advisory Committees from the origin of the Agency, including the Clean Air Scientific 

Advisory Committee (CASAC), which I chaired from 1988 to 1992, and on CASAC 

Panels that have considered all the criteria pollutants at various times. I served on 

the CASAC Panel that advised on the 2006 revision of the Particulate Matter 

MAAQS. I served on the CASAC Ozone Panel that reviewed the basis for the 

NAAQS promulgated in 1997. I did not serve on the most recent CASAC Ozone 

Panel. However, I closely followed the current NAAQS Ozone review process from 

its inception in September 2000 to present. The testimony I offer today reflects my 

own views on that review process and the science used to inform the policy judgments made in revising the NAAQS for Ozone. Attachment 2 is a reprint of a recent 

paper I authored entitled ‘‘Role of Science and Judgment in Setting National Ambient Air Quality Standards: How low is low enough?’’, Air Quality and Atmospheric 

Health (published online: 01 June 2011). 

EPA Administrator Johnson’s March 2008 Decision 

This morning I would like to comment on the role of science and judgment in the 

‘‘Final Rule for the National Ambient Air Quality Standard for Ozone’’ announced 

on March 12, 2008, by EPA Administrator Stephen Johnson. That Final Rule revises the 1997 Standard and concludes a process begun in September 2000. 

Throughout the review process, there was debate over the numerical level of a revised standard. In my view, much of the debate was premature and focused on the 

outcome desired by various parties—a lowering of the ozone standard—even before 

the review of the science was complete. That resulted in a blurring of the boundary 

between the role of science and judgment in the setting of the standard. 

As I will discuss later, Administrator Lisa Jackson took advantage of the CASAC’s 

blended science and policy advice to initiate in January 2010 reconsideration of the 

March 2008 decision of then-Administrator Johnson. 

As required by a Court Decree, the EPA published a Proposed Rule on July 11, 

2007, and requested public comments on anticipated action in issuing a Final Rule 

for the ozone standard. Release of the Proposed Rule intensified the debate over the 

numerical level of the standard and continued to blur the distinction between 

science and judgment in the setting of the standard. Numerous comments were submitted to the official ozone docket. I submitted my personal comments to the ozone 

docket and also joined with nine of my scientific colleagues in submitting a document—‘‘Critical Considerations in Evaluating Scientific Evidence of Health Effects 

of Ambient Ozone’’ to the Docket. The debate over the numerical level of the standard continues even today as evidenced by this Hearing. 

Much of the debate failed to acknowledge that the setting of the standard involves 

policy judgments informed by science. The debate has included repeated reference 

to the Clean Air Scientific Advisory Committee (CASAC) Ozone Panel recommendation that the primary standard be set within a specific narrow numerical range, i.e., 

0.060–0.070 ppm. In my opinion, the CASAC Ozone Panel moved from the science 

arena into the policy arena in advocating an upper bright line value of 0.070 ppm 

for the primary standard. That value represents the personal judgment of the Ozone 

Panel Members, not just their interpretation of the science. It is my opinion, the 

CASAC Ozone Panel never adequately communicated the extent to which the recommendations they communicated to the Administrator represented both their interpretation of the science and their personal policy judgments on the numerical 

level of the standard. 

The EPA Administrator, under the authority of the Clean Air Act, has the exclusive responsibility and authority for making policy judgments, informed by science, 

in setting the ozone standard. Supreme Court Justice Stephen Breyer, in the landmark case Whitman v. American Trucking Association (531 U.S. 457, 2001), offered 

‘‘common sense’’ guidance for setting the standards for criteria pollutants such as 

ozone (Attachment 3). Justice Breyer expressed the opinion that while the Administrator cannot consider cost in setting air quality standards for the criteria pollutants, the EPA Administrator need not set standards at zero risk. He advised the 

Administrator to use judgment in a ‘‘comparative health’’ context when ‘‘deciding 

what risks are acceptable in the world in which we live.’’ 

In short, Justice Breyer recognized that everyday life carries with it a variety of 

risks. Justice Breyer’s opinion provides ‘‘common sense’’ guidance for deciding how 

low is low enough in setting air quality standards—the numerical level of the standard and the associated acceptable risk level, even if not specifically articulated, are 

policy judgments that should be informed by science. In my opinion, the Administrator could have made a policy judgment, informed by science, with selection of a 

numerical value for the ozone primary standard as high as the 1997 primary stand-
16 

ard of 0.08 ppm. His selection of a lower value was consistent with the original advice of his own staff—0.075 ppm up to a level slightly below the current standard. 

In my own comments to the Ozone Docket, I reviewed the science available on 

the health effects of ozone. In my comments, I noted the substantial uncertainty and 

variability in the findings of an increase in common health effects with ozone exposure in the range of the current standard and below. These scientific uncertainties 

were also detailed in the comments I and nine of my colleagues submitted to the 

Docket. Both sets of comments also emphasized that the selection of any specific numerical standard is a policy judgment informed by science. 

The CASAC Ozone Panel, in proposing a bright line upper limit of 0.070 ppm, offered their collective judgment on, in the words of Justice Breyer—‘‘what risks are 

acceptable in the world in which we live.’’ The CASAC was advancing their collective policy choice; it should not be postured as being exclusively science based. 

Science alone can never provide a basis for deciding how low is low enough; policy 

judgments are always required in deciding ‘‘what risks are acceptable.’’ Any specific 

numerical value for the Standard has an associated implied ‘‘acceptable risk value,’’ 

even if the level of acceptable risk has not been explicitly stated. 

The CASAC Ozone Panel’s letter to the Administrator dated April 7, 2008, commenting on the Final Rule, continues to suggest that somehow science and scientists 

alone can establish the appropriate numerical level of the NAAQS for ozone. In that 

letter, the CASAC Ozone Panel again failed to clarify the distinction between their 

interpretations of the science and their policy judgment in offering an opinion on 

the numerical level of the ozone standard. The Panel should have clearly acknowledged that the numerical level they have advocated reflects their personal policy 

preferences. Likewise, in arguing for ‘‘further lowering the national ambient ozone 

standards,’’ the Panel fails to acknowledge that this is a collective wish that goes 

well beyond considering just the available scientific information. How low is low 

enough for the ozone standard is ultimately a policy judgment informed by scientific 

information and analysis. The Clean Air Act clearly specifies that the EPA Administrator has the exclusive authority and responsibility for using judgment in the setting of the standard. 

Without question, the Administrator, in setting the standard, should consider scientific advice received from many parties, including the special advice provided by 

the Clean Air Scientific Advisory Committee. However, it is clear that the Clean Air 

Act calls for an Advisory Committee and not a Clean Air Standard Setting Committee. This places a special responsibility on the Committee to distinguish between 

their scientific advice and their personal policy judgments as to the numerical level 

of the Standard. 

It is noteworthy that the March 2008 Final Rule states—‘‘the Administrator observes that he reaches a different policy judgment than the CASAC Panel based on 

apparently placing different weight in two areas:—’’ The Final Rule goes on to detail 

these differences. The Rule goes on to state—‘‘and fully considering the scientific 

and policy views of CASAC, the Administrator has decided to revise the level of the 

primary eight-hour O3 standard to 0.075 ppm.’’ Without question, the Final Rule 

clearly acknowledges that the CASAC Ozone Panel offered both their scientific and 

policy views. It is unfortunate that the CASAC Ozone Panel did not make this important distinction in its communications to the Administrator in their public statements on the Final Rule. 

Administrator Jackson’s Misadventure 

During 2009 there were rumors that the President Obama/Administrator Lisa 

Jackson Administration was going to ‘‘fast track’’ a ‘‘reconsideration’’ of the March 

2008 Ozone NAAQS issued by then-Administrator Stephen Johnson. Thus, it was 

not surprising when Administrator Jackson on January 19, 2010, announced a proposed ‘‘reconsideration’’ Ozone NAAQS to be based on the record used to set the 

standard in March 2008. This included the science used for the March 2008 policy 

decisions, scientific papers which had been published primarily in 2005 or earlier. 

By initiating the ‘‘reconsideration’’ action, Administrator Jackson was in essence 

saying—‘‘if I had been in office in March 2008 (nearly a year before being appointed 

and confirmed), I would have made a different policy judgment call.’’ In my opinion, 

Administrator Jackson’s action was totally discretionary, arbitrary, capricious and 

without precedent. I know of many NAAQS that have been revised by EPA Administrators in accordance with the Clean Air Act and using EPA’s now well-established 

formal rulemaking process. I know of no NAAQS established by a previous Administrator that has been ‘‘reconsidered’’ by a new Administrator based on the old and 

aging record. 
17 

In announcing the ‘‘reconsideration’’ proposal (EPA, 2010) Administrator Jackson 

put on the ‘‘cloak of science’’ and said that she would set the ‘‘reconsideration’’ 

standard in the range of 60 to 70 ppb following the advice of the CASAC Ozone 

Panel. In taking this course, she ignored the documented record of previous Administrator Johnson who noted that the advice of the CASAC Panel was a blend of 

science and policy. In the fall of 2008, the EPA was already initiating action on the 

next review of the Ozone NAAQS (Martin, 2008). In initiating the next review, it 

was noted that the CASAC advice on the previous review was ‘‘a mixture of scientific and policy considerations.’’ By proceeding with the ‘‘reconsideration’’ proposal 

based exclusively on the advice of the CASAC Panel, Administrator Jackson abdicated her responsibilities under the Clean Air Act to use her judgment in the setting 

of NAAQS. 

The ‘‘fast track’’ reconsideration proposal turned out to be on a slow track with 

the target date for release of the final rule repeatedly revised. My suspicion was 

that Administrator Jackson and her senior advisors were continually spinning the 

‘‘Ozone Science Kaleidoscope’’ in an attempt to have the science justify a specific numerical level. Indeed, in January 2011, Administrator Jackson went back to CASAC 

and asked for yet another opinion on the setting of the ozone NAAQS. The CASAC 

Panel had a difficult time dealing with this serious question for several reasons. 

First, the CASAC members found it difficult to offer an opinion on the old science 

since many of them were already involved in reviewing the new science that would 

inform policy judgments on potential revision of an Ozone NAAQS in March 2013. 

Second, the CASAC Panel meetings were actually teleconferences. With about 20 

‘‘official’’ participants such teleconferences are much like a ‘‘Tower of Babylon.’’ The 

third issue was the challenge of separating the Panel members’ views of the science 

from their personal policy preferences. The CASAC Chair, Dr. Jonathan Samet, 

wisely offered the following summary comment to Administrator Jackson in his letter dated March 30, 2011. Dr. Samet wisely noted that establishing a margin of 

safety was apparently a blend of science and policy. I offered comments to Administrator Jackson on Comments on EPA-CASAC-11-004 Clean Air Scientific Advisory 

Committee (CASAC) Response to Charge Questions on the Reconsideration of the 

2008 Ozone National Ambient Air Quality Standards (Attachment 4). 

Apparently Administrator Jackson and her senior advisors spun the ‘‘Ozone 

Science Kaleidoscope’’ without a firm endorsement of CASAC and in mid-summer 

sent forward a final rule for review by OMB’s Office of Information and Regulatory 

Affairs. Administrator Jackson has testified that she had proposed 70 ppb. I have 

seen no indication as to specifics of a revised Secondary Standard. It is important 

to recognize that the CASAC Ozone Panel (Henderson, 2008) in a letter dated April 

7, 2008, based on a meeting scheduled even before then Administrator Johnson had 

issued a final rule protested both the Primary and Secondary Standard. They also 

expressed their displeasure with the involvement of then-President Bush and Susan 

Dudley, who then headed OMB’s Office of Information and Regulatory Affairs. Such 

involvement was not a surprise to students of the history of the NAAQS process. 

President Clinton conferred with the EPA Administrator Carol Browner on the 

Ozone and Particulate Matter NAAQS revisions in 1997. 

The misadventure of Administrator Jackson with the ‘‘reconsideration’’ Ozone 

NAAQS was brought to a close on September 2, 2011. The legal basis for the decision to abandon the ‘‘reconsideration’’ proposal is contained in a memo from Cass 

Sunstein, Administrator of the Office of Information and Regulating Affairs within 

OMB (Sunstein, 2011) (Attachment 5). In his memo, he notes the proposed final rule 

was (a) not mandatory and produced needless uncertainty and that his Agency was 

already proceeding with the next review that should be concluded in March 2013, 

(b) her proposed final rule was not based on the latest science, recall the record is 

largely based on pre-2006 scientific publications, and (c) the President had advised 

Mr. Sunstein to return the proposal to Administrator Jackson—‘‘He has made it 

clear that he does not support finalizing the rule at this time.’’ 

I applaud the actions of Mr. Sunstein and President Obama for making a sound 

common sense decision. My only regret is that the key parties had not conferred in 

early 2009 and never have launched this misadventure that wasted valuable EPA 

resources and those of many other interested parties. In this time of crisis, the 

scarce resources could have been used better on other endeavors. The really good 

news is that a potential precedent setting actions did not take place. It is hard to 

imagine the uncertainty and chaos that would occur if every change in Presidential 

Administration were to be accompanied by a new EPA Administrator that would 

‘‘reconsider’’ the policy judgments of the previous EPA Administrator. 
18 

The Wrong Scientific and Policy Focus 

Remarkable progress has been made in improving air quality in the United States 

during the last four decades using the various regulatory tools provided by the 

Clean Air Act including the establishment of NAAQS. Clean air is automatically 

equated with better health. Every lowering of a NAAQS for each of the criteria pollutants has been justified on the basis of health benefits. 

It has been argued by some that a linear relationship, without a threshold, exists 

between ambient concentrations of criteria pollutants and increased risk of morbidity and mortality over and above the baseline morbidity or mortality rate. Some 

scientists have argued that the absence of a threshold and a linear concentrationresponse relationship extends to background concentrations. Using that logic, which 

I do not necessarily agree with, it can be argued that health benefits result from 

every reduction in concentration, even reductions in background. With this flawed 

logic and a prohibition in considering cost in setting NAAQS the answer to how low 

is low enough becomes zero. That is hardly realistic and certainly does not meet the 

common sense comparative health approach advanced by Supreme Court Justice 

Breyer. 

In my view, the USA is reaching a point of diminishing returns in setting the 

NAAQS at lower and lower concentrations with each review and treating each reduction as a success story for public health. In examining this viewpoint, it is important to remember that each NAAQS is a federal goal. The achievement of the goals 

is by and large left to the States through the development of State Implementation 

Plans and their actual implementation and, finally, to actions on the part of private 

firms and the public. 

In my opinion, this approach is flawed in that it fails to recognize any untoward 

consequences of setting lower standards and attempting to attain them. I submit the 

untoward consequences may be substantial. Let me illustrate by discussing health 

impacts using a common metric-all-cause mortality. Major population studies have 

suggested that a 1 μg/m3 increase in particulate matter—2.5 micron size causes a 

0.5% increase in mortality. You may not recognize the 0.5% value because it is usually expressed as 2.5% increase per 5 μg/m3 of PM2.5. In reality, 5 to 10 μg/m3 is 

the background level for PM2.5 in most areas in the U.S.A. Does it make sense to 

talk about a 5 μg/m3 change in PM2.5? In my opinion, No! Thus, I use a more realistic 1 μg/m3 change. 

Some population studies suggest a 0.24% change in mortality for a 5 ppb change 

in eight-hour ozone concentration. Again, you may not recognize the value because 

it has frequently been presented as 3.6% for a 75 ppb change in eight-hour ozone. 

This is hardly a realistic presentation recognizing background levels for the eighthour highest ozone concentrations approaches 60 ppb, the level simulated by models 

when all man-made ozone precursors are shut off. I view a 5 ppb shift in ozone as 

being more realistic. 

Let me now turn to a real risk factor—socioeconomic status (SES). The ratio of 

the mortality rate for all-cause mortality for men in the lowest quartile of SES over 

the top quartile was found to be 2.02 by Steenland et al. (2004). In other words, 

a doubling of the mortality rate by dropping from the top quartile to the bottom 

quartile. Put another way, moving to the second quartile from the lowest quartile 

reduced the ratio to 1.69 and a move from the second to the third quartile reduced 

the ratio to 1.25. Socioeconomic status matters—employment and jobs matter. If the 

U.S. wants to improve the health of the Americans, we need to create employment— 

JOBS. 

Setting aside the issue of socioeconomic status, does it make sense to keep pursuing risk factors that only contribute marginally to our overall burden of disease? 

I think the answer is No! Recognizing the small estimated burden of disease attributed to air pollution, it would appear to make more sense to pursue what are the 

major factors that contribute to the baseline incidence of disease. For example, there 

is appropriate increasing concern for rising asthma rates. However, when it is recognized that air pollution decreased substantially while asthma rates increased, it 

would appear that the focus on air pollution and asthma is misdirected. 

A Path Forward 

I am increasingly concerned that our policy for advancing public health is being 

driven by advocacy groups with narrow interests. Perhaps it is time for all the advocacy groups to step back and ask what can be done to further improve the health 

of all Americans. A starting point is to recognize that the steady progress made in 

improving the health of Americans over the last half century has been driven by 

a strong economy that provided jobs and improving income. Perhaps the answer to 
19 

the question of how low is low enough for each of the NAAQS is low enough for 

now. I suggest it is appropriate for time out on moving the goal posts. 

I urge the Congress to refocus the nation’s effort on public health revising the 

Clean Air Act, to allow consideration of costs in setting NAAQS, as part of an omnibus legislative package—‘‘Promoting Public Health’’ that recognizes a healthy economy with people employed is the cornerstone of a healthy population. 

References 

McClellan, R. O. Comments on National Ambient Air Quality Standards for 

Ozone: Proposed Rule, Federal Register, Vol. 72, No. 132/Wednesday, July 11, 2007, 

pp 37818–37919, Docket ID No. EPA-HQ-OAR-2005-0172, submitted October 9, 

2007. 

Brauer, M., Frampton, M.W., Koutrakis, P., McClellan, R.O., McDonnell, W.F., 

Moolgavkar, S., North, D. W., Smith, A.E., Smith, R.L., Utell, M.J. Critical Considerations in Evaluating Scientific Evidence of Health Effects of Ambient Ozone. Comments on National Ambient Air Quality Standards for Ozone: Proposed Rule, Federal Register, Vol. 72, No. 132/Wednesday, July 11, 2007, pp 37818–37919, Docket 

ID No. EPA-HQ-OAR-2005-0172, submitted October 9, 2007. 

McClellan, R.O., ‘‘Written Statement for Consideration by the Clean Air Scientific 

Advisory Committee (CASAC) Ozone Review Panel’’ at the Panel’s Teleconference 

Meeting on February 18, 2011 (Prepared on February 7, 2011). 

Chairman HARRIS. Thank you very much, Dr. McClellan. 

I now recognize our second witness, Dr. George Thurston, a Professor at New York University School of Medicine. Dr. Thurston. 

STATEMENT OF DR. GEORGE THURSTON, 

PROFESSOR, NEW YORK UNIVERSITY SCHOOL OF MEDICINE 

Dr. THURSTON. Good morning. 

The evidence is clear, as Mr. Miller was saying, the adverse 

health consequences of breathing polluted air are well documented 

in the published medical and scientific literature, even at levels we 

experience today. This human evidence includes impacts revealed 

by epidemiologic studies, natural experiments and controlled chamber exposure experiments, also including consistent associations between air pollution exposure and increases in risk of adverse 

health impacts across a wide range of human health outcomes including illness and death. 

These effects of air pollution include decreased lung function, the 

ability of a person to breathe air in and out freely, more frequent 

asthma symptoms, increased numbers of asthma and heart attacks, 

more frequent emergency department visits, additional hospital admissions, and increased numbers of premature deaths, which, by 

the way, all have a huge economic impact. 

One of the air pollutants most carefully studied is fine particulate matter, or PM2.5, which are particles that are so small that 

they can become lodged deep in the lung when they are breathed 

in and they can cause a variety of health problems. For example, 

two of the larger cohort studies of air pollution and death, the Harvard Six Cities study and the American Cancer Society study, both 

of which I was involved in, have demonstrated greater risk of premature death in more polluted cities as compared to studies with 

cleaner air as demonstrated in figure one of my testimony that I 

submitted. 

Another major air pollution health threat is ozone, as Mr. 

McClellan was discussing. Ozone is a highly irritant gas that is 

formed in our atmosphere in the presence of sunlight and other 

precursor air pollutants such as nitrogen oxides and hydrocarbons 
20 

that come from trucks and buses and cars and power plants and 

various pollution sources. In my own research, I found that ozone 

air pollution is associated with increased numbers of respiratory 

hospital admissions and death. But these effects of ozone are only 

the tip of the iceberg of adverse health effects associated with this 

pollutant. Ozone is especially a problem for children with asthma. 

My own asthma camp study results have shown that children have 

more asthma attacks on higher ozone air pollution days in the 

summer. The air pollution health effects associated indicated by epidemiological studies are supported by a large body of data from 

controlled human exposure studies giving consistent results and 

demonstrating pathways by which air pollution can damage the 

human body when it is breathed. 

It has also been well shown that reducing pollution in the air can 

result in health benefits for the public. For example, Arden Pope 

conducted a compelling study of the period during the winter of 

1986 and 1987 when the Geneva steel mill in Utah Valley shut 

down during a strike. The PM levels dropped dramatically and the 

hospital admissions in the valley showed the same pattern as the 

air pollution, decreasing dramatically during the strike as shown 

again in my written testimony. When pollution levels diminish, the 

health of the general public improves. 

A recent follow-up analysis of a Harvard Six Cities study has 

also shown that mortality is decreased as PM2.5 pollution decreases 

over time, as shown in figure three of my written testimony. Thus, 

recent research shows lowering of air pollution levels in the air is 

an effective way to improve public health. 

As to the role of CASAC, the setting of the National Ambient Air 

Quality Standards, or NAAQS, is an essential mandate of the 

Clean Air Act. The Clean Air Science Advisory Committee was authorized by Congress to provide the EPA Administrator with independent advice on the setting of the NAAQS. This process has 

worked well and has led to the application of sound science to the 

setting of the U.S. NAAQS standards to protect the health of the 

American people. 

In conclusion, the science is sound and the results are clear. 

Cleaning our air reduces air pollution and health impacts, lowers 

our health care costs and saves lives. With the independent advice 

of CASAC, the EPA’s regulatory control of ambient air pollution 

has led to reductions in both air pollutant exposures and health 

risks to the American people. This has caused the public to enjoy 

associated health benefits including decreased asthma attacks, 

fewer hospital admissions, fewer heart attacks, and increased 

length and quality of life. 

Thank you for this opportunity to testify on this important issue. 

[The prepared statement of Dr. Thurston follows:] 

PREPARED STATEMENT OF DR. GEORGE THURSTON, 

PROFESSOR, NEW YORK UNIVERSITY SCHOOL OF MEDICINE

I am George Thurston, a tenured Professor of Environmental Medicine at the New 

York University (NYU) School of Medicine. My scientific research involves investigations of the human health effects of air pollution. I have served on the U.S. EPA’s 

Clean Air Science Advisory Committee (CASAC) Panel, and have been a contributing author to EPA’s Integrated Science Assessment (ISA) documents. 
21 

I am also a member of the National Institute of Environmental Health Sciences’ 

(NIEHS) Center at the NYU Institute of Environmental Medicine. One goal of this 

Center is to provide an impartial scientific resource on environmental health issues 

to the public and decision makers, and that is my purpose in speaking to you at 

this hearing. 

The adverse health consequences of breathing polluted air are well documented 

in the published medical and scientific literature. During the past decades, medical 

research examining air pollution and public health has shown that air pollution 

causes a host of serious adverse human health effects. The human evidence includes 

impacts revealed by epidemiologic studies, natural experiments and controlled 

chamber exposures, all showing consistent associations between air pollution and increases in adverse health impacts across a wide range of human health outcomes, 

including illness and death. 

Epidemiological Evidence of Air Pollution Effects on Health 

Observational epidemiology studies provide the most compelling and consistent 

evidence of the adverse effects of air pollution. ‘‘Epidemiology’’ is literally ‘‘the study 

of epidemics,’’ but includes all statistical investigations of human health and potentially causal factors of good or ill health. In the case of air pollution, such studies 

follow people as they undergo varying real-life exposures to pollution over time, or 

from one place to another, and then statistically intercompare the health impacts 

that occur in these populations when higher (versus lower) exposures to pollution 

are experienced. In such studies, risks are often reported in terms of a Relative Risk 

(RR) of illness, wherein a RR=1.0 is an indication of no change in risk after exposure, while a RR>1.0 indicates an increase in health problems after pollution exposure, and that such exposure is damaging to health. 

These epidemiological investigations are of two types: (1) population-based studies, in which an entire city’s population might be considered in the analysis; and 

(2) cohort studies, in which selected individuals, such as a group of asthmatics, are 

considered. Both of these types of epidemiologic studies have confirmed associations 

between air pollution exposures and increasing numbers of adverse impacts, including: 

• decreased lung function (a measure of our ability to breathe freely); 

• more frequent asthma symptoms; 

• increased numbers of asthma and heart attacks; 

• more frequent emergency department visits; 

• additional hospital admissions; and 

• increased numbers of premature deaths. 

The fact that the effects of air pollution have been shown so consistently for so 

many health endpoints, and in so many places, indicates these associations to be 

causal. 

Particulate Matter Air Pollution 

One of the air pollutants most carefully studied is particulate matter (PM). Fine 

particles (PM2.5), such as those that result from power plants and diesel trucks, defeat the defensive mechanisms of the lung, and can become lodged deep in the lung 

where they can cause a variety of health problems. New evidence indicates that 

short-term exposures to air pollution cause both respiratory and cardiac effects, including more heart attacks. In addition, my own research indicates that long-term 

exposure to fine particles increases premature mortality, and such exposures in the 

general population have been estimated to take years from the life expectancy of 

people living in our most polluted cities, relative to those living in cleaner cities 

(e.g., see Brunekreef, 1997). 

PM2.5 air pollution may be emitted directly from tailpipes and smokestacks 

(known as ‘‘primary’’ particulate matter), but much PM2.5 that we breathe comes 

from the conversion of gaseous pollution emissions, such as sulfur dioxide, in the 

atmosphere to form ‘‘secondary’’ PM2.5. 

The hazards of PM air pollution have become particularly clear in the past two 

decades of research. Two of the largest studies on air pollution and death, the Harvard Six Cities Study, published in 1993, followed by the American Cancer Society 

(ACS) Study report in 1995, have demonstrated greater risk of premature death in 

higher PM cities compared to cities with cleaner air. The Harvard Six Cities study 

monitored air pollution and tracked mortality in six U.S. cities and discovered a 25 

percent increased risk of death in the most polluted city (Dockery et al., 1993). Simi-
22 

larly, the ACS study examined half a million people in over 150 metropolitan areas 

throughout the United States and found a 17 percent increase in risk of mortality 

between the city with the least PM and the city with the highest levels of this pollution (Pope et al., 1995). The results of these two landmark studies were challenged 

by industry, resulting in an independent reanalysis by the Health Effects Institute 

(HEI)-funded by industry and EPA. HEI found the results to be robust, and confirmed the relationships documented by the original investigators (Krewski et al., 

2002). 

More recent follow-up analyses of the Harvard and ACS studies have now considered longer records of time, and have confirmed and extended the conclusions from 

these two major studies. Indeed, a recent National Institute of Environmental 

Health Sciences (NIEHS)-funded extension of the ACS study, of which I was Principal Investigator, strengthens the original conclusions of the ACS study and, importantly, now links increased risk of lung cancer to long-term exposure to particulate 

matter (Pope et al., 2002), as shown in Figure 1. 

Ozone Air Pollution 

Another major air pollution health threat, ozone (O3), is a highly irritant gas that 

is formed in our atmosphere in the presence of sunlight from other ‘‘precursor’’ air 

pollutants, including nitrogen oxides and hydrocarbons. These precursor pollutants 

are emitted by pollution sources including automobiles, electric power plants, and 

industry. 

In my own research, I have found that ozone air pollution is associated with increased numbers of respiratory hospital admissions in U.S. and Canadian cities. But 

these effects of ozone are only the ‘‘tip of the iceberg’’ of adverse effects associated 

with this pollutant, and they are best viewed as indicators of the much broader 

spectrum of adverse health effects being experienced by the public today as a result 

of air pollution exposures, such as more restricted activity days and doctors’ visits. 

Airway inflammation induced by ozone is especially a problem for children and 

adults with asthma, as it makes them more susceptible to having asthma attacks. 

My own asthma camp results have shown that children have more asthma attacks 

on high ozone days in the summer (Thurston et al., 1997). In addition, recent controlled human studies have indicated that prior exposure to ozone enhances the reactivity of asthmatics to aeroallergens, such as pollens, which can trigger asthma 

attacks. In addition, the increased inflammation and diminished immune system 
23 

ozone effects in the lung can make the elderly more susceptible to pneumonia, a 

major cause of illness and death in this age group. 

Controlled Exposure Studies 

The air pollution—health effects associations indicated by epidemiologic studies 

are supported by a large body of data from controlled exposure studies giving consistent and/or supportive results, and demonstrating pathways by which ozone can 

damage the human body when it is breathed. For example, clinical studies have 

demonstrated ozone-related decreases in lung function, increased frequencies of respiratory symptoms, heightened airway hyper-responsiveness, and cellular and biochemical evidence of lung inflammation in healthy exercising adults exposed to 

ozone. Similarly, animal exposures to combustion-related PM2.5 have been shown to 

have significant adverse effects on the lung, including diminished respiratory defense mechanisms, opening the lung to illness from other causes. 

The Benefits of Cleaner Air 

Most published studies evaluate whether rising air pollution levels worsen health, 

but it has also been shown that reducing pollution in the air can result in health 

benefits to the public. For example, Pope (1989) conducted a compelling study clearly showing that, when pollution levels diminish, the health of the general public improves. He investigated a period during the winter of 1986–87 when the Geneva 

Steel mill in the Utah Valley shut down during a strike. The PM levels dropped 

dramatically in that strike-year winter, as opposed to the winters preceding and following when the steel mill was in operation. As shown in Figure 2 below, hospital 

admissions in the valley showed the same pattern as the PM air pollution, decreasing dramatically during the strike. As a control, Pope also examined the pollution 

and hospital admissions records in nearby Cache Valley, where the mill’s pollution 

was not a factor, and no such drop in respiratory admissions was seen, showing that 

the drop in admissions in the Utah Valley was not due to some cause other than 

the reduction in the air pollution levels. 

A more recent study considers a broadly relevant case showing the benefits of 

cleaner air. During the Atlanta Summer Olympics of 1996, traffic-related ozone and 

PM declined significantly as a result of the alternative mass transportation strategy 

implemented to reduce road traffic during the Games (Friedman et al., 2001). These 

improvements were correlated with changes in the rate of children’s hospital admissions. Compared to a baseline period, traffic-related ozone and PM levels declined 

by 28% and 16%, respectively. Concentrations of both PM and ozone also rose noticeably after the end of the Olympics. The study showed a significant reduction in 

asthma events associated with these pollution improvements. This study indicates 

that improvements in acute air pollution can provide immediate public health benefits. 

Furthermore, a recent follow-up analysis of the Harvard Six Cities Study discussed earlier (Dockery et al., 1993) has shown that mortality was decreased by lowering pollution (Laden et al., 2006). An extended analysis of the Harvard Six Cities 

Study (to include follow-up through 1990) has now shown that reductions in long- 
24 

term ambient PM pollution results in concomitant reductions in the health risks associated with PM. As shown in Figure 3, large reductions in PM at Harvard study 

cities have resulted in likewise large reductions in the relative risk (RR) of mortality 

in those cities: Steubenville, OH (S), Harriman, TN (H), St. Louis, MO (L), and Watertown, MA (W). The authors found that, for each decrease of 1 μg/m3 in averge 

PM2.5, the overall death rate from causes such as cardiovascular disease, respiratory 

illness and lung cancer decreased by some 3 percent, while also extending the lives 

of study subjects. Thus, although we still carry very large health risks in the United 

States from our present levels of air pollution, amounting to tens of thousands of 

premature deaths per year, recent research shows that the lowering of air pollution 

levels in the air is an effective way to improve public health. 

The evidence is clear and consistent: air pollution is adversely affecting the health 

and lives of Americans across our Nation. There is a coherence between the epidemiologic study associations and experimental study results, validating that there 

is indeed a cause-effect relationship between air pollution and adverse human 

health effects. The importance of these health effects relationships is made all the 

more imperative by the fact that virtually every American is directly impacted by 

this pollution. Cleaning the air causes improvements in public health, saving lives 

and improving the quality of life of all Americans. 

The Role of CASAC 

The setting of the National Ambient Air Quality Standards (NAAQS) is an essential mandate of the Clean Air Act. These NAAQS apply to ‘‘criteria’’ air pollutants 

that, in the words of the legislation, ‘‘endanger public health or welfare.’’ At present, 

six pollutants are designated as criteria pollutants. The Clean Air Science Advisory 

Committee (CASAC) was authorized by the Congress in 1977 to aid the EPA Administrator in the setting of these NAAQS. Its members are derived largely from academia and from private sector research institutes, and are appointed by the EPA 

Administrator. CASAC’s role is primarily to review the agency’s work in the process 

of setting each NAAQS, which are each reviewed on an every-five-year schedule, 

and then to provide the EPA Administrator with independent advice on the interpretation of agency documents for the setting of the NAAQS. Most notably, CASAC 

reviews the agency’s Integrated Science Assessment (ISA) and the Risk and Exposure Assessment (REA) that summarize the science and the policy analyses, respectively. The assessment of these pollutants individually during the CAAA approach, 

potentially missing effects of synergisms among the various air pollutants, combined 
25 

with the fact that not all potential health impacts can be quantified in the REA 

process, has likely caused the EPA to underestimate the total benefits of pollution 

reductions when viewed on an individual pollutant-by-pollutant basis. Despite these 

facts, the EPA’s REA and RIA (Regulatory Impact Analysis) analyses have consistently indicated that the valuation of the health benefits of cleaner air, such as fewer 

hospital admissions and deaths, far outweigh the costs of applying emission controls 

to reduce air pollution. 

Based upon the EPA ISAs, REAs, and CASAC independent expert advice on the 

setting of the NAAQS (usually provided as a range of possible standards), the EPA 

Administrator proposes an updated standard for each pollutant that can be the 

same, more stringent, or less stringent than the existing NAAQS standard for a criteria air pollutant. This process has generally worked well in the past, and has led 

to the application of sound science to the setting of the U.S. NAAQS standards to 

protect the health of the American public. 

Conclusions 

• The science is sound and the results are clear: cleaning our air reduces air pollution health impacts, lowers our health care costs, and saves lives. 

• With the independent advice of CASAC, as stipulated by the Congress, the 

EPA’s regulatory control of ambient air pollutants has led to reductions in both 

air pollutant exposures and health risks to the American people. This has 

caused the public to enjoy associated health benefits, including decreased asthma attacks, fewer hospital admissions, fewer heart attacks, and increased 

length and quality of life. 

Thank you for the opportunity to testify on this important issue. 

References 

Brunekreef B. (1997) Air pollution and life expectancy: is there a relation? Occup 

Environ Med. Nov; 54(11): 781–4. 

Dockery DW, Pope CA 3rd, Xu X, Spengler JD, Ware JH, Fay ME, Ferris BG Jr, 

Speizer FE. (1993) An association between air pollution and mortality in six U.S. 

cities. N Engl J Med. Dec 9; 329(24):1753–9. 

Krewski, D. et al. (2000) Reanalysis of the Harvard Six Cities Study and the 

American Cancer Society Study of Particulate Air Pollution and Mortality: Investigators’ Report Part I: Replication and Validation. Health Effects Institute, Cambridge, MA. 

Laden F, Schwartz J, Speizer FE, Dockery DW. (2006) Reduction in fine particulate air pollution and mortality: Extended follow-up of the Harvard Six Cities study. 

Am J Respir Crit Care Med., Mar 15; 173(6):667–72. 

Pope CA 3rd. (1989). Respiratory disease associated with community air pollution 

and a steelmill, Utah Valley. Am J Public Health. 1989 May; 79(5):623–8. 

Pope CA 3rd, Thun MJ, Namboodiri MM, Dockery DW, Evans JS, Speizer FE, 

Heath CW Jr. Particulate air pollution as a predictor of mortality in a prospective 

study of U.S. adults. Am JRespir Crit Care Med. 1995 Mar; 151(3 Pt 1): 669–74. 

Pope CA III, Burnett RT, Thun MJ, Calle EE, Krewski D, Ito K, and Thurston, 

GD. (2002). Lung Cancer, Cardiopulmonary Mortality and Long-Term Exposure to 

Fine Particulate Air Pollution. Journal of the American Medical Association (JAMA). 

March 6, 2002, Vol. 287, No. 9, pp. 1132–1141. 

Thurston, G. D., Lippmann, M., Scott, M.B., and; Fine, J.M. Summertime haze 

air pollution and children with asthma. Am. J. Respir. and Crit. Care Med. 155:654– 

660 (1997). 

Chairman HARRIS. Thank you very much, Dr. Thurston. 

I now recognize our next witnesses, Dr. Michael Honeycutt, Chief 

Toxicologist for the Texas Commission on Environmental Quality. 

Dr. Honeycutt. 
26 

STATEMENT OF DR. MICHAEL HONEYCUTT, 

CHIEF TOXICOLOGIST, TEXAS COMMISSION ON 

ENVIRONMENTAL QUALITY 

Dr. HONEYCUTT. Good morning, Mr. Chairman and Members of 

the Committee. I have submitted more detailed written comments 

on the science behind the ozone and PM NAAQS and the Utility 

MACT, but I will touch on the highlights right now. 

Regarding ozone, I would first like to talk about the concept of 

personal exposure. As regulators, we set health protective standards for chemicals in outdoor air and we measure those pollutants 

at outdoor monitors. However, it is a well-established fact that we 

are not exposed to ozone concentrations at concentrations measured 

at outdoor monitors. This is because Americans spend on average 

90 percent of our time indoors, especially on hot days when ozone 

levels are at their highest. Because ozone is formed in sunlight, 

ozone concentrations are always much lower indoors than outdoors 

and in fact are practically zero in air conditioned buildings. Keeping that in mind, I want to talk briefly about the ecological epidemiology studies that EPA is using as the primary basis for the 

ozone NAAQS. 

Ecological epidemiology studies are exploratory studies designed 

to look for correlations. They are supposed to be followed up by 

more rigorous epidemiology studies to see if the correlations are 

real. These studies are not supposed to be used quantitatively and 

they are certainly not rigorous enough to set environmental policy. 

Statisticians can run data through elegant models to try to find 

statistically significant correlations but the output of those models 

is only as good as the input, and any researcher worth their salt 

will tell you that correlation is not causation. 

With the ozone NAAQS, EPA has set environmental policy based 

on these ecological epidemiology studies. Specifically, the studies 

gathered death certificates for people who died from non-accidental 

causes including cancer, liver disease or any other disease. The assumption is that breathing ozone made them die earlier than they 

would have otherwise. The researchers correlated the outdoor 

ozone levels, usually from the highest monitor in the city, with various time periods just before the time of death for these thousands 

of people. Using the highest monitor or even an average value in 

the city is not scientific since ozone levels can vary tremendously 

across a city. These studies did not look at whether the people who 

died were actually outdoors for eight hours just prior to their death 

to actually breathe that ozone. Even if we assume that these ill 

people spent eight hours outdoors just before they died, were they 

near the monitor the EPA assumed they were? Were they exposed 

to other pollutants during the day? Did they take their medications 

that day? There are a whole host of common sense questions that 

go unanswered in these studies. Simply put, these studies cannot 

tell us if ozone caused these deaths or if these people died prematurely, much less tell us what level of ozone caused their premature death. 

EPA also used clinical studies conducted by Professor William 

Adams, formerly from USC, in setting the ozone NAAQS. EPA reanalyzed his data inappropriately and called the mild effects he observed adverse. 
27 

Turning to the Utility MACT, EPA themselves determined that 

the rule will not have an effect on mercury levels in fish in America’s watersheds. EPA continues to overstate the health risk of 

lower IQ and heart disease from mercury while ignoring the very 

well-demonstrated health benefits of eating seafood. EPA used a 

study known as the Faroe Island study to set their safe level for 

mercury where the mothers ate whale meat and blubber contaminated with PCBs in addition to eating the fish. The Faroe Island 

infants ingested 600 times EPA safe dose of PCBs. I will say it 

again: 600 times EPA safe level. The effects EPA attributed to mercury can more justifiably be attributed to the PCBs. A similar 

study in the Seychelles Islands that did not include PCB exposures 

was essentially negative. EPA ignores the fact that Japanese eat 

10 times more fish than Americans do and have higher levels of 

mercury in their blood but they have lower rates of coronary heart 

disease and they have high scores on their IQ tests. Methyl mercury is a toxic chemical but scientific data overwhelmingly do not 

support EPA’s position on the risk of mercury. In fact, EPA may 

have the most conservative safe level for mercury in the world. The 

FDA, the ATSDR, the World Health Organization and Canada all 

have set a higher safe level for mercury, and EPA still uses decadeold data whenever they say that six percent of the women in the 

United States have unsafe levels of mercury in their blood. Newer 

data time and time again clearly shows this isn’t the case. 

Thank you for the opportunity to testify. 

[The prepared statement of Mr. Honeycutt follows:] 

PREPARED STATEMENT OF DR. MICHAEL HONEYCUTT, CHIEF TOXICOLOGIST, TEXAS COMMISSION ON ENVIRONMENTAL QUALITY

Main Conclusions 

On behalf of the Texas Commission on Environmental Quality (TCEQ), I disagree 

with the United States Environmental Protection Agency’s (EPA) proposed range of 

values for the eight-hour ozone and PM standards because of uncertainties relating 

ambient concentrations to personal exposures and limitations of the epidemiological 

and clinical studies used as the basis of the revisions. The TCEQ strongly recommends that EPA use robust scientific data as the basis for the ozone and PM 

standards and Utility MACT, and more meaningful consideration of risk management issues in its final policy decisions. 

The roles of uncertainty and bias in EPA’s assessments have been severely 

downplayed and should be reexamined. This is particularly true in EPA’s analysis 

of personal exposure. For ozone, EPA relies on studies that estimate personal exposure (the amount of ozone a person actually breathes) by using ambient monitoring 

data, which oversimplifies personal exposure by assuming that ambient monitoring 

data accurately reflects personal exposure. Further, EPA doesn’t acknowledge or account for this potential overestimate in their standard calculations. Also, it is essential that EPA clearly discuss the uncertainties associated with adverse health effects 

reported in both ecological epidemiology and clinical studies. These uncertainties 

should also be clearly communicated in publicly accessible documents in consideration of new standards. 

EPA should be more critical and conscientious in its selection of studies they use 

to calculate proposed numerical standards. Specifically, EPA should consider ecological epidemiology studies in a more broad, supportive context, rather than as the primary basis for calculating air quality standards. Ecological epidemiology studies are 

not scientifically rigorous enough to draw conclusions about the cause of health effects identified in the studies for ozone or any other pollutant and are not suitable 

for policy decisions. As with all observational studies, the results may provide valid 

areas for further inquiry and be informative, but should not be considered conclusory. EPA’s criteria for the selection of key studies should emphasize not only statistical significance but also biological significance of the observed adverse health ef-
28 

fects Furthermore, EPA should focus on the entire weight of evidence of more robust 

epidemiology and toxicology studies for the basis of its policy decisions. 

Finally, EPA should avoid unnecessary regulation that will not improve human 

health. EPA’s own analysis demonstrates that the Utility MACT will not have an 

effect on mercury levels in fish in U.S. watersheds. EPA’s claims of mercury causing 

lower IQ and heart disease scares the public into avoiding seafood. EPA ignores the 

fact that Japanese eat 10 times more fish than Americans do and have higher levels 

of mercury in their blood, but have lower rates of coronary heart disease and high 

scores on their IQ tests. To claim that a policy decision is ‘‘based on the science’’ 

without putting those decisions in appropriate context with real world implications 

is not just a misuse of science but causes harm to the public. It is a disservice to 

her citizens when government exaggerates, misstates or misleads the public about 

the ‘‘real’’ risk of environmental effects. 

Ozone NAAQS 

Ecological Epidemiology Studies 

EPA used ecological epidemiology studies, also known as time-series analyses, as 

the primary basis of the most recent proposed ozone standard. Ecological epidemiology studies are observational studies designed to look for correlations. To accomplish this they examine the relationships between exposure and disease at a population level rather than on an individual level. These types of studies are intended 

to be followed up by more rigorous epidemiology studies to determine if the correlations are real. While ecological epidemiology studies are useful in evaluating potential associations between health effects and ambient exposures to environmental 

pollutants, they are severely limited due to their study design. Policy conclusions 

should not be based on ecological epidemiology studies for the following reasons: 

• 1. Ecological epidemiology studies are not designed to determine if ozone caused 

the health effects evaluated. The assumption that ozone caused all evaluated 

health effects, including aggravation of asthma and premature mortality, in ecological epidemiology studies is not well-grounded in science. Ecological epidemiology studies do not collect data on when, how long, and how much exposure 

occurred; if exposure occurred before the health effects; or if it makes biological 

sense that the chemical could cause the effect. In other words, the study designs 

are incomplete. Scientists agree that the incomplete study design does not provide enough information to determine the actual cause of studied effects. Ecological epidemiology studies are not supposed to be used quantitatively and they 

certainly are not rigorous enough to set environmental policy. 

• 2. Lack of personal exposure data severely limits the utility of ecological epidemiology studies. The issue of limited or entire absence of personal exposure data 

is significant. Personal exposure is a measurement of the amount of an air pollutant that a person actually breathes. In the case of air pollutants like ozone, 

ecological epidemiology studies rely on ambient monitoring data as a surrogate 

for personal exposure for percentages of people with a health issue in an area 

(i.e., census tract, county, or state). However, it is very unlikely that people 

would ever be exposed to those pollutants at concentrations measured at outdoor monitors for very long. This is partly because the average American spends 

90% of his/her time indoors, especially during the heat of the summer when 

ozone concentrations tend to be at their highest. Ozone concentrations in most 

buildings are characteristically low, due to the reactive nature of ozone, the 

tendency of ozone to deposit on surfaces, and the ventilation systems inside 

buildings (McClellan et al., 2009). Other additional factors such as time spent 

outdoors, outdoor activity level, and weather (especially temperature and relative humidity) can dramatically change the potential for ozone exposure and 

the resultant estimate of risk. Therefore, ambient ozone concentrations alone do 

not adequately characterize, and easily overestimate, personal exposures 

(Sarnat et al., 2006). This position is shared by the National Academies of 

Science (NAS 2008) and the Clean Air Science Advisory Committee (CASAC 

2006). That ecological epidemiology studies continue to derive inconsistent and 

vastly differing conclusions about the adverse effects of ozone is perhaps evidence of this fact. 

• 3. Ecological epidemiology studies frequently do not take into account the heterogeneity of regional air pollution and oversimplify their exposure analysis by re-
29 

1 Many ecological epidemiology studies do not look at the area immediately around a monitor 

but rather at a conglomeration of several cities. For example, Bell and Dominici (2008) looked 

at communities, which they defined as a county or contiguous counties. 2 EPA acknowledges the variance in ozone concentrations across a region within its state implementation planning (SIP) process by its requirements to have multiple monitors within a 

populated region and its requirement to further analyze unmonitored areas during the planning 

process. 

lating health effects to only ozone. In most ecological epidemiology studies, 1 exposure is estimated to be either some statistical representation (e.g., average or 

weighted average) of several air monitors or concentrations at the monitor with 

the highest readings. This assumption oversimplifies outdoor exposure because 

concentrations vary across a given area. 2 Moreover, few studies fully account 

for simultaneous exposure to multiple other pollutants, such as particulate matter, nitrogen dioxide, and sulfur dioxide. The ratios of these pollutants can vary 

tremendously from region to region, making it difficult to determine which effects are related to which pollutants. This complication blurs the association between health effects and ozone exposure, as documented in recent studies. Furthermore, it has been documented in studies that the association between ozone 

and health effects is confounded by temperature and relative humidity (which 

alone can cause physical stress), and population characteristics, such as age, 

health status, socioeconomic status, and exercise. 

• 4. Ecological epidemiology studies have considerable uncertainty in their identification of health effects. To determine prevalence of a health issue, epidemiologists frequently use readily available information, including hospital admissions 

records and death certificates, or participant surveys. In some of the ecological 

epidemiology studies EPA used for the proposed ozone standard, death certificates for thousands of people who died at a hospital from any non-accidental 

cause were compared to outdoor ozone levels from up to three days before the 

person died. Because of the broad selection criteria, it is highly likely that many 

of these people died due to non-respiratory health issues unrelated to ozone exposure. This problem is compounded when paired with the lack of personal exposure data, making it impossible to know if decedents were actually well 

enough to be outdoors in the days preceding their deaths. In this case, patient 

history records from physicians would be more reliable than hospital admission 

records or death certificates for determining the presence and severity of any 

health effects potentially caused or aggravated by ozone exposure. EPA could 

better serve the public trust to recognize the limitations on the information and 

data used and to fully consider these limitations when making policy decisions. 

• 5. Additional statistical analysis (time-series and multi-city time-series studies) 

further complicates the interpretation of ecological epidemiology studies. The 

shortcomings of ecological epidemiology studies are compounded when researchers perform time-series studies, which try to correlate health effects collected 

from epidemiology studies and ambient ozone concentrations measured during 

the hours and days leading up to their hospital visit or death. Some studies 

compare even broader sets of data from multiple cities averaged over multiple 

years. In addition to the issues regarding uncertainty in the original ecological 

epidemiology study discussed previously, this additional analysis fails to take 

into account: 

• The high degree of variability between cities, seasons, and years; 

• The effect of other pollutants that contribute or cause the same effects; 

• The inconsistent ambient air sample collection period between cities; 

• Socioeconomic factors such as age, access to health care, etc., and 

• Mortality differences among cities. 

In addition, further analysis of time-series data indicates the studies are highly 

influenced by the type of statistical model used (often, the model showing the most 

health effects) and publication bias (studies showing effects are more likely to get 

published than those showing no effects). Due to the substantial uncertainty in 

these studies, policy decisions should not be based on these studies and EPA should 

revise its study selection criteria to use studies of higher scientific quality. 

• 6. Results of ecological epidemiology studies are inconsistent and it remains unclear if ozone is truly related to increased health effects. Ecological epidemiology 

studies have provided vastly different conclusions regarding the effects of ozone 

on the population, with studies showing significant adverse effects, no effects, 

or even protective effects of ozone. In particular, one reanalysis of an ecological 
30 

3 FEV1 is a measure of the forced expiratory volume during the first second of an active exhalation. This measurement is used to assess lung function and is often used in epidemiological 

or controlled clinical studies. The measurement is accomplished by having a subject inhale deeply and then exhale quickly. A significant reduction in FEV1 may be indicative of impaired ventilation. 

epidemiology study frequently cited by EPA identified only six out of 95 cities 

evaluated with a significant correlation of mortality and ozone (Smith et al., 

2009). Furthermore, although it has been repeatedly hypothesized that ozone is 

a potent inducer of asthma attacks, Texas Inpatient Hospital Discharge data on 

the numbers of hospital visits for asthma between 1999 and 2001 actually 

showed that people were more likely to visit the hospital for asthma during 

winter when ozone is at its lowest than they were in the summer when ozone 

concentrations are high. In a relative risk sense, cold weather and pet dander 

are more potent inducers of asthma hospital visits than ozone. Furthermore, results from a four-year (2000–2003) air quality study conducted by Texas A&M 

University and Driscoll Children’s Hospital indicate hospital admissions to be 

weakly correlated with ambient daily maximum ozone levels. 

Clinical Studies 

Clinical studies expose humans to a known concentration of ozone for a known 

period of time and monitor their health. Although these studies do not have the significant limitations of ecological epidemiology studies, there is confusion among scientists and regulators about whether subtle clinical changes documented in the 

studies represent adverse effects. In its ozone reassessment, EPA failed to consider 

key recommendations regarding this issue and conducted a reanalysis of clinical 

data that was not scientifically appropriate. 

• 1. EPA should rely on biological, not just statistical, significance in identifying 

an adverse health effect in clinical studies. Ambiguity exists in defining what 

constitutes an adverse effect on exposure to air pollution. Clinical studies evaluating health effects due to ozone exposure have mainly focused on decreases in 

lung function as measured by forced expiratory volume in one second (FEV1) 3 and other similar measures. Daily normal activities, exercise, and diurnal 

variations can themselves cause changes in the FEV1. Within a single day, 

FEV1 in normal subjects can vary by over 5% (Pellegrino et al., 2005) and be 

as high as 17.6% (Medarov et al., 2008). Therefore, controlled exposure studies 

must properly account for normal changes by including filtered air (FA) exposures and a range of concentrations and exposure durations. The American Thoracic Society (ATS) recommends a comprehensive description of ‘‘adverse’’ effects by combining the loss of lung function in conjunction with respiratory 

symptoms, such as cough and discomfort while breathing (ATS 2000). Further, 

OEHHA, the TCEQ, and jointly the ATS and the European Respiratory Society 

(ERS) consider decrements in FEV1 of TM % as ‘‘mild,’’ not ‘‘adverse.’’ However, 

in its reevaluation of the Adams (2006) study, EPA identified FEV1 decrements 

of only 2.8% to be adverse effects. According to the sources listed previously and 

Adams himself, the decrements in the Adams (2006) study at 0.06 ppm are not 

of biological significance, even though they may be of statistical significance. 

Therefore, it is also prudent that the EPA justify the importance of key study 

results to indicate not just statistical significance, but also biological significance before labeling the result as an adverse effect. 

• 2. EPA’s reanalysis of Adams (2006) data is not scientifically appropriate and 

should not be included as part of the final ozone policy decision. In addition to 

the issue of whether or not the decrease in FEV1 was adverse, the EPA also 

conducted a highly contentious statistical reanalysis of the Adams (2006) data 

to show statistical significance in the absence of the effect (Brown 2007, Brown 

2008). Dr. Adams himself disagreed with the EPA’s reanalysis and statistical 

reinterpretation of his study during a teleconference on March 5, 2007, and in 

written comments to the EPA during the 2007 comment period. EPA’s reanalysis was also criticized by other statisticians and scientists, as stated in comments submitted to EPA by Drs. RL Smith and JE Goodman. The TCEQ concurs with Dr. Adams’ peer-reviewed results. 

• 3. EPA should consider more recent studies as part of the ozone weight of evidence. Recent clinical studies (Kim et al., 2011; Schelegle et al., 2009) of ozone 

exposure at concentrations lower than 0.08 ppm have further confirmed the 

Adams (2006) results, showing no adverse effects at 0.06 ppm. When compared 

to filtered air, Schelegle et al. (2009) reported statistically significant mean per-
31 

4 In fact, EPA has provided no data to illustrate lives saved under previous standards. All 

estimates of lives saved are projections, not factual. 

cent change in FEV1 at 0.07 ppm (5.34%) and Kim et al. (2001) reported statistically significant mean percent change in FEV1 at 0.06 ppm (1.71%), these are 

not only within in the range of intra-individual variability but are also substantially less than the 20% decrease identified as adverse. 

• 4. EPA needs to emphasize the importance of having realistic controls for clinical 

studies. Many of the clinical studies use filtered air (no ozone) for the control 

groups (Schelegle et al., 2009; Kim et al., 2011), which creates an unrealistic 

scenario as the natural background ozone concentration in the atmosphere is 

around 0.04 ppm (Last et al., 2010). In its analysis of the clinical studies, EPA 

has not adjusted for this background factor and has not provided any justification for not doing so. Not adjusting for background can result in overestimating 

the severity of the observed effects as ‘‘adverse effects,’’ when in fact the effects 

were ‘‘not adverse.’’ Based on the clinical studies, it can be inferred that the 

weight of evidence at the lower range of exposure levels (i.e, 0.06–0.07 ppm) is 

weak and inconclusive. Thus, I can conclude that the clinical studies used to 

justify the lower end of the proposed range do not support lowering the ozone 

standard below the present NAAQS of 0.075 ppm (Adams 2002 and 2006; 

Schelegle et al., 2009; Kim et al., 2011). Further, these studies are conservative 

since they do not consider personal exposure. 

Differing Roles of Policy and Science 

EPA’s recent attempts at using science to justify policy decisions are particularly 

troubling. In its reconsideration of the ozone standard, EPA attempts to establish 

a health basis as the need for a new, reduced standard. However, the assumption 

that the reduced standard would prevent up to 12,000 deaths is based on dubious 

studies and the use of such an analysis signals an unfortunate shift in the roles of 

scientists and risk managers. 

• 1. The basis of the theoretical number of lives saved is meaningless and unrealistic. EPA relied on studies that took mortality data from ecological epidemiology studies to calculate the number of theoretical deaths that would be avoided with a lower standard. Not only do these studies suffer from the severe limitations described above, but theoretical lives saved estimates are also meaningless from a scientific and practical standpoint. It is not possible to verify either 

the current number of deaths due to ozone exposure or the future change in 

deaths if the standard is lowered because there is still no conclusive evidence 

that ozone causes mortality at ambient concentrations. 4 There is no guarantee 

of increased life expectancy or degree of confidence in this estimation, since 

some degree of risk is present in all aspects of daily life. 

• 2. EPA misuses scientific studies to justify policy decisions. Scientific studies 

should be just one aspect of responsible policymaking. Rigorous scientific studies 

focus on expanding the knowledge of how a chemical interacts with the body 

at different tested doses. However, even the most extensive studies are not able 

to define an acceptably safe level of a chemical. In the specific case of ozone, 

scientific studies have still been unable to clearly identify human risk at current ambient levels and have certainly not shown if 0.065 ppm ozone is substantially more protective than 0.08 ppm. Determining what level of risk is acceptable is and should remain a decision for risk managers, not scientists. 

Responsible risk managers and policymakers consider science as one of many aspects to be considered in setting policy. Science cannot determine practical issues, 

such as the feasibility of implementation and to what extent society would accept 

the trade-offs associated with the standard. For example, an overly restrictive 

health-based standard might be more detrimental to public health if it forces an industry out of business due to the cost of compliance and its employees are unable 

to find work to support their families. Studies have consistently indicated that poverty is a much better predictor for premature mortality than exposure to environmental pollutants. Public officials with a broader perspective of potential policy implications are better equipped to evaluate these important aspects. 
32 

PM NAAQS 

The Proposed PM Standard 

EPA has proposed a new particulate matter (PM) standard that is twice as stringent as the current standard. Attainability of the proposed standard, especially in 

rural and agricultural areas, is impractical and even EPA staff acknowledges that 

the available scientific evidence supports the effectiveness of the current standard 

in protecting public health. There is no scientific basis supporting a reduction in the 

current standard, let alone a two-fold reduction. 

• 1. EPA based the proposed PM standard on an ecological epidemiology study. 

EPA used a study by Zanobetti and Schwartz (2009), which is an ecological epidemiology study, as a basis for the proposed PM standard. This ecological epidemiology study concludes that exposure to coarse PM is ‘‘suggestive’’ of a causal 

relationship with adverse effects. As stated above, ecological epidemiology studies are incomplete studies plagued with limitations and should not be used as 

the basis for policy conclusions. 

• 2. EPA assumes all PM composition is equal. Not all PM is created equally; 

however, EPA makes the assumption that it is. Coarse PM is produced by surface abrasion or suspension of biological material and fragments of living 

things. Because of this, PM in urban and industrial areas is likely to be vastly 

different from PM in rural and agricultural areas. Urban and industrial PM is 

expected to be enriched with pollutants; pollutants that are inherently more 

toxic than the dust predominantly found in agricultural operations and arid 

rural areas. EPA didn’t take this scientific fact into consideration when they developed their proposed PM standard. When they assume all PM composition is 

the same, they ignore the fact that agricultural and rural areas will likely exceed the standard due to natural occurrences rather than man-made sources. 

• 3. PM composition varies greatly by geographic regions. The PM data EPA used 

in their assessment for the proposed PM standard were not uniformly distributed across the United States or even within counties. Therefore, potential differences in PM composition may be reflected in the EPA estimates. Geographic 

variability is also strongly influenced by region-specific sources, meteorology 

(e.g., wind speed and direction), and topographical conditions (e.g., trees, mountains). When PM composition differs geographically, the conclusions drawn may 

not apply equally to all parts of a geographic region. 

Utility MACT 

Mercury and the Utility MACT 

EPA has proposed a National Emission Standards for Hazardous Air Pollutants 

(NESHAP) rule for coal- and oil-fired electric utility steam generating units (EGU). 

This proposed NESHAP rule (the Utility MACT) would establish maximum achievable control technology (MACT) emission limits for certain hazardous air pollutants 

(HAP), including mercury. In EPA’s analysis for mercury, they state ‘‘if U.S. EGU 

impacts to watersheds included in the risk assessment were zeroed out, for a significant majority of those watersheds, total exposure would still exceed (and in most 

cases, significantly exceed) the RfD [Reference Dose].’’ In EPA’s own words they are 

admitting control of U.S. EGU mercury emissions will not have an effect on mercury 

levels in fish in U.S. watersheds; however, they still insist on the necessity to require these controls. Concurrent with the Utility MACT, the EPA’s National-Scale 

Mercury Risk Assessment Supporting the Appropriate and Necessary Finding for 

EGUs (mercury risk assessment) was released for public comment and review by 

EPA’s Science Advisory Board Mercury Review Panel. Currently, the Mercury Review Panel’s support for the mercury risk assessment is contingent upon development of a revised document that addresses numerous issues. The Panel’s comments 

to EPA on the mercury risk assessment were finalized in September 2011, illustrating the limited time allowed for review and revisions of such an important document whose purpose was to determine whether a public health hazard is associated 

with U.S. EGU emissions. One could easily conclude that the Panel’s input was 

merely a formality and was not intended to be seriously considered, much like EPA 

treats input from the States. 
33 

5 In December 2000, EPA issued a ‘‘regulatory determination’’ under the Clean Air Act (CAA) 

that it is ‘‘apppropriate and necessary’’ to regulate mercury emissions from coal-based power 

plants and nickel emissions from oil-based power plants. This regulatory determination listed 

coal- and oil-based EGUs as a source category under section 112(c) of the CAA, the first step 

to setting MACT standards. On January 30, 2004, EPA proposed to remove EGUs from the 112 

list based on a finding that it was neither appropriate nor necessary to regulate EGUs under 

this section of the CAA. On March 29, 2005, EPA issued a final revision of the appropriate and 

necessary finding for coal- and oil-fired EGUs and removed such units from the 112 list. The 

removal of EGUs from the 112 list was challeneged in court. On February 8, 2008, the court 

determined that EPA violated the CAA by removing EGUs from the 112 list. As a result, EGUs 

remain a CAA section 112(C) listed source category according to EPA. The basis of the court 

ruling was that EPA did not follow the requirements of 112(C)(9) in removing EGUs from the 

112 list. As such, the court did not reach a determination on the merits of the case. 

• The EPA 2000 appropriate and necessary finding estimates were inaccurate. 5

The risk analysis estimates of hazard quotients due to U.S. EGU-attributable 

emissions of mercury have already decreased significantly between the 2005 

and 2016 scenarios, mainly due to PM controls. In fact, 2010 levels of mercury 

emissions are already at levels predicted for 2016. In addition, the 2000 appropriate and necessary finding was based on estimates that U.S. utility mercury 

emissions would increase from 46 tons in 1990 to approximately 60 tons in 

2010. In reality, emissions were reduced to 29 tons in 2010. 

• U.S. EGU mercury emissions are insignificant compared to other sources. The 

Utility MACT preamble states that on average, U.S. EGUs are estimated to 

contribute only 2% to total mercury deposition in the U.S. Therefore, any health 

benefits related to mercury reductions would pose an insignificant change in the 

overall risk from mercury from all sources. Only in combinations of the worstcase watersheds with fish consumption rates (e.g., 95th and 99th percentile fish 

consumption rates paired with the 95th and 99th percentile watersheds) did estimates of U.S. EGU-attributable hazard quotients (HQs) exceed 1.5 (EPA considered an HQ>1.5 to represent a potential public health hazard). U.S. EGUs 

contributed insignificantly to the total risks posed by other sources of mercury; 

thus, regardless of this regulation, risk from mercury deposition will remain 

from sources other than U.S. EGUs. 

Mercury is a global pollutant. It travels beyond boundaries of states and continents. EPA modeling estimates that, on average, 83% of the mercury deposited in 

the U.S. originates from international sources, excluding Canada; the remaining 

17% comes from U.S. and Canadian sources. As such, control strategies related to 

EGUs may not affect change in fish tissue concentrations of mercury. According to 

EPA (2007), ‘‘The mix of long-distance and local sources makes it difficult in some 

water bodies to achieve water quality standards for mercury.’’ 

• EPA uses a worst-case scenario for risk and does not characterize risk for realistic U.S. populations. EPA should have characterized risk for the more realistic 

general recreational angler population to provide perspective and information to 

that population. Instead, the EPA’s mercury assessment is essentially a worstcase scenario that focuses on subsistence fishing populations and may overestimate risk for the majority of the U.S. population. EPA’s own Science Advisory 

Board Mercury Review Panel states ‘‘There is scant evidence documenting the 

prevalence or extent of subsistence fishing in the United States.’’ 

• EPA states that about seven percent of women of child-bearing age are exposed 

to mercury at a level capable of causing adverse effects in the developing fetus. Several well-conducted studies examining effects of mercury on children have 

been conducted, including the Seychelles Child Development Study (Seychelles) 

and the Faroe Island Study (Faroe). A blood mercury No Effect Level (NEL) of 

85 parts per billion (ppb) was observed in the Seychelles study. Interestingly, 

this study also observed positive improvements on IQ as mercury levels increased; a phenomenon likely due to nutrients such as omega-3 fatty acids and 

selenium from high fish consumption. A blood mercury NEL of 58 ppb was observed in the Faroe study; however, these residents also consumed large quantities of whale meat and blubber that contained unsafe (according to EPA) levels of polychlorinated biphenyls (PCBs). Since neither study found effects below 

58 ppb blood mercury levels, one would only expect to find health effects in children whose mothers had mercury levels higher than 58 ppb in their blood. 

EPA’s safe level (the RfD) is set to prevent blood mercury levels exceeding 5.8 

ppb, 10 times lower than the NEL of 58 ppb from the Faroe study. 

Data from the Centers for Disease Control’s (CDC’s) National Health and Nutrition Examination Survey (NHANES), 2003–2008, show the mean blood mercury 

level for pregnant women is 0.69 ppb (well below EPA’s safe blood mercury level) 
34 

(Jones et al., 2010). Although some individuals have blood mercury levels greater 

than EPA’s safe blood mercury level, none have blood mercury levels above the 

Faroe study NEL of 58 ppb, and therefore adverse health effects would not be expected in their children. A 2005 study conducted by Texas Department of State 

Health Services (DSHS 2005) determined that even when subsistence fishers are 

eating fish from Caddo Lake with elevated mercury, women of child-bearing years 

did not have blood mercury levels greater than the EPA’s safe blood mercury level. 

On comparing U.S. blood mercury levels to other countries, both the United Kingdom (UK) and Japan median blood mercury levels are higher. Using EPA’s RfD to 

describe Japan’s data, 66% of Japanese women are exposed to levels above EPA’s 

safe blood level. From this the claim could be made (falsely) that 66% of Japanese 

children are born at risk for adverse effects. On the contrary, the Japanese population consumes 10 times more fish than the U.S. population but only shows positive 

outcomes; they have lower rates of coronary heart disease and high IQ scores. EPA 

is causing unnecessary alarm in the public with their assertions that 7% of women 

of child-bearing age are exposed to mercury at a level capable of causing adverse 

effects in the developing fetus when the evidence clearly shows this statement to 

be false and misleading. 

• EPA uses an RfD that is more conservative than most other Agencies (U.S. and 

World). The Agency for Toxic Substances and Disease Registry (ATSDR) and 

the U.S. Food and Drug Administration (FDA) both have established safe levels 

three-fold higher than EPA’s conservative RfD. The World Health Organization 

(WHO) recommends a level that is two times higher than EPA’s RfD; Health 

Canada uses a value similar to the WHO recommended value. The TCEQ 

agrees with ATSDR and FDA that it is more appropriate to use a study that 

reflects U.S. fish consumption (e.g., saltwater fish such as tuna) rather than a 

study based entirely on consumption of saltwater fish and mammals (e.g., 

whale). 

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Texas Department of State Health Services (DSHS). Health Consultation: Mercury Exposure Investigation Caddo Lake Area—Harrison County Texas. Agency for 

Toxic Substances and Disease Registry (2005). Available online at: http:// 

www.atsdr.cdc.gov/HAC/pha/CaddoLake/CaddoLakeHC.pdf. 

Weil, M, Bressler, J, Parsons, P, Bolla, K, Glass, T, and Schwartz, B 2005. Blood 

Mercury Levels and Neurobehavioral Function. JAMA. 2005;293(15):1875–1882. 

Zanobetti A, Schwartz J (2009). The effect of fine and coarse particulate air pollution on mortality: A national analysis. Environ Health Perspect., 117: 1–40. 

Chairman HARRIS. Thank you very much, Dr. Honeycutt. 

I now recognize Dr. Robert Phalen, Professor of Medicine, and 

Co-Director of the Air Pollution Health Effects Laboratory, for five 

minutes to present his testimony. Dr. Phalen. 

STATEMENT OF DR. ROBERT F. PHALEN, 

PROFESSOR OF MEDICINE, AND CO-DIRECTOR, 

AIR POLLUTION HEALTH EFFECTS LABORATORY, 

UNIVERSITY OF CALIFORNIA, IRVINE 

Dr. PHALEN. Chairman Harris, Mr. Miller, thank you for this opportunity. 

My participation in the Clean Air Scientific Advisory Committee 

on Particulate Matter was interesting and stimulating. Everyone 

involved—the members of CASAC, the EPA staff and public presenters—was qualified, efficient and dedicated. But we are here to 

find, and I think all of us agree, to find possible ways to improve 

the CASAC process of incorporating good science. Therefore, I will 

present seven points for you to consider that are my observations 

as a result of my participation in the CASAC Particulate Matter 

subcommittee. 

One, the EPA mandate is too restrictive. It does not allow the 

full competence of the EPA to be used in protecting public health. 

They are required to evaluate pollutants one by one, and pushing 

one pollutant way down can raise the risks from other factors, including unemployment. The EPA also has to err on the side of increased safety, and if you overdo this, you actually increase the 

overall risk to public health. 
37 

Two, linear incrementalism. This is where CASAC is only allowed to comment on questions that are supplied by EPA, and each 

of these comments seems to lead step by step to an inevitable conclusion. Therefore, the committee can’t really express their concerns and their doubts along the way. 

Three, the definition of particulate matter just by weighing it, 

and not taking the composition into account, to me is very poor 

science mainly because some areas of the country have more toxic 

particulate matter than others. And by setting one standard nationwide that adequately protects maybe two or three cities, you 

are punishing major industries, including agriculture, and you are 

punishing areas where the particulate matter has a different, less 

toxic composition. 

Four, the current risk assessment process is very seriously 

flawed, as it is based on ‘‘individual pollutants.’’ In 2009, the National Academy of Sciences at EPA’s request looked at risk assessment and said in reality the risks are not the just risks of the pollutant, the risks are the risks of the ‘‘decision’’ about that pollutant. 

For example, if you lower a particle standard, it is going to affect 

agriculture, it is going to affect the price of gas, and it is going to 

affect small businesses in particular. The National Academy said 

the risk assessment has to be on the decision itself because that 

is what the public lives with. So the decision itself and all of its 

important health consequences have to be taken into account in the 

risk assessment. 

Five, the public commenters that make presentations to CASAC 

were eloquent and well reasoned in their presentations, but 

CASAC did not even discuss them or weigh their comments and 

that was a shame. So the feedback from industry, interested scientists, and the American Lung Association, for example, were not 

effectively taken into account by CASAC. 

Six, the subcommittee that I was on did not adequately inform 

the Administrator on the pitfalls, the scientific limitations, and 

even the adverse health consequences that would flow from a more 

stringent regulation. Not understanding the feasibility of compliance, the economic hardships and unintended adverse consequences places the Administrator in an embarrassing position of 

possibly having to issue a standard that might do more harm than 

good to public health. 

Number seven, the final, and I think this is the most important, 

the public is not going to be adequately informed about the adverse 

effects (i.e., unintended consequences) associated with new standards. They (the public) are informed about the benefits but not the 

adverse side of the coin. ‘‘Informed consent’’ is a fundamental ethical principle that has to be applied when you make decisions that 

will affect people’s lives. Informed consent must include, and elucidate, the adverse consequences that flow from a standard or decision. CASAC was not allowed to discuss any of the adverse consequences associated with setting new standards. But the public 

must live with all the consequences of the new standard. 

In sum, the current process is very elegant, it is very highly 

evolved, and it is very efficient for getting scientists involved. But 

in my opinion, it is seriously flawed, it is narrowly focused, and it 

is even ethically questionable. 
38 

It is important to reiterate that no one is really to blame because 

all of the people that were involved, in my opinion, performed their 

tasks enthusiastically and competently. Thank you. 

[The prepared statement of Dr. Phalen follows:] 

PREPARED STATEMENT OF DR. ROBERT F. PHALEN, 

PROFESSOR OF MEDICINE, AND CO-DIRECTOR, 

AIR POLLUTION HEALTH EFFECTS LABORATORY, 

UNIVERSITY OF CALIFORNIA, IRVINE

My participation in the CASAC subcommittee on Particulate Matter (CASAC-PM) 

was stimulating and enlightening. Everyone involved, committee members, EPA 

staff, and public presenters, were well-qualified, efficient, and dedicated. But we are 

here, in part, to explore possible improvements in the process, so I will summarize 

some of my personal observations to that end. Many of the problems arose from the 

outdated mandate that the U.S. EPA had to follow. 

• 1. The mandate is too restrictive, and does not allow the full competence of the 

EPA to be used in protecting public health. Evaluating air pollutants one by one 

can lead to air standards that do not make sense given the complexities of air 

chemistry (e.g., suppression of one pollutant can cause the mixture to have increased toxicity). The mandate to err on the side of increased safety can also 

be a disservice to public health. And the policy to set nationwide standards can 

place unreasonable burdens on some industries and some regions of the U.S. 

• 2. Linear incrementalism, in which CASAC only comments on each step in a 

long process, can lead to conclusions that do not pass a ‘‘common-sense criterion.’’ The questions posed to CASAC-PM appeared to be restrictive, carefully 

crafted, and led to inevitable conclusions. 

• 3. Defining particulate matter by aerodynamic mass fractions, with composition 

not taken into account, is poor science in my opinion, and it punishes some regions and industries. Furthermore, it does not apply to ultrafine particles (the 

count can be quite large without having any appreciable mass). 

• 4. The current risk assessment process is seriously flawed. It is based on individual mass fractions and can lead to regulations that do not serve public 

health. The 2009 National Academy of Sciences Report (National Research 

Council, ‘‘Science and Decisions: Advancing Risk Assessment,’’ The National 

Academy Press, Washington, DC, 2009) advises that the ‘‘decision’’ to set a 

standard, not the ‘‘pollutant,’’ is what must undergo risk assessment. The public 

must live with all of the relevant consequences of an air standard, not just selected effects of the substance under consideration (the general economy, jobs, 

and costs of goods and services have dominant impacts on public health, but 

they are not even considered by CASAC). 

• 5. The public comments were not weighed and discussed by CASAC-PM in spite 

of the fact that most were well-reasoned and relevant. If the agenda included 

time for discussion of public comments and formal acceptance or rejection of 

their recommendations, the process might be improved. 

• 6. The CASAC-PM subcommittee did not adequately inform the EPA Administrator on the pitfalls, scientific limitations, and even the range of adverse health 

consequences associated with the recommended PM standards. Not understanding the feasibility, economic hardships, and unintended adverse health 

consequences can place the Administrator in the embarassing position of 

issuing a standard that may harm public health. 

• 7. The public will not be adequately informed about the adverse effects associated with new standards. ‘‘Informed consent’’ is a fundamental ethical principle 

that should be applied to mandates, including air standards. Informed consent 

must include, and elucidate, the adverse consequences that flow from a decision. 

CASAC-PM was not allowed to adequately discuss the adverse consequences associated with air standards. 

In sum, the current process, although elegant and efficient, in my opinion is 

flawed, narrow, and possibly ethically questionable. 

It is important to reiterate that all of the people involved performed their tasks 

enthusiastically and competently. Thank you for this opportunity to provide what 

I hope are constructive comments. 

Chairman HARRIS. Thank you very much, Dr. Phalen. 
39 

I now recognize Dr. Anne Smith, Senior Vice President at NERA 

Economic Consulting, for five minutes. Dr. Smith. 

STATEMENT OF DR. ANNE E. SMITH, 

SENIOR VICE PRESIDENT, NERA ECONOMIC CONSULTING 

Dr. SMITH. Mr. Chairman, Members of the Committee, thank you 

for inviting me. I am Anne Smith. My statements today reflect my 

own opinions and not those of my company, NERA Economic Consulting. 

EPA is relying on benefit estimates, the so-called co-benefits from 

ambient PM2.5 reductions to claim that the rules that are not intended to address PM2.5 at all have benefits larger than their costs. 

For instance, for the ozone reconsideration, up to 91 percent of the 

estimated benefits were not from reductions in ozone risk but from 

EPA’s predictions of coincidental PM2.5 reductions under that rule. 

Ozone benefits alone always fell short of their costs by tens of billions of dollars per year. 

For the Ozone Utility MACT Rule, EPA claims this air toxics 

rule will save up to 17,000 lives per year and many other respiratory and heart ailments but all of those purported benefits are 

due to PM2.5, not to air toxics. Over 99.99 percent of the Utility 

MACT Rule’s estimated benefits are due to PM2.5 co-benefits and 

not the air toxics that are its purpose. 

EPA has developed a habit since 1996 of relying on PM2.5 co-benefits to create a benefit-cost case for its non-PM rulemakings. PM2.5

co-benefits were the driving factor in all but two of the 24 non-PM 

air rules which EPA quantified any benefits for at all as you can 

see listed here in this figure with the Xs in the first column, and 

EPA’s co-benefits habit has really taken over since 2009. Claims of 

PM2.5 mortality co-benefits now account for over 99.9 percent of the 

benefits in all of the RIAs since 2009 except the ozone reconsideration, as you can see in the last column of the table. 

Where did all these PM co-benefits come from? How could they 

be increasing in importance even though ambient 2.5 is declining 

to the levels that EPA deems safe? This is how. In 2009, EPA 

changed the assumption that in one fell swoop nearly quadrupled 

its estimates of the number of U.S. deaths due to PM2.5. EPA decided to calculate risks from PM2.5 exposures that occur far below 

the level it deems safe under the PM2.5 NAAQS. Prior to this 

change, EPA was assuming that less than four percent of all current U.S. deaths were due to PM2.5, and after this change it is assuming that 13 percent of all current deaths in the United States 

are due to PM2.5. All of these newly calculated PM2.5 risks come 

from the most non-credible source of risk calculation. By assuming 

that a unit of exposure to PM2.5 at concentrations well below any 

epidemiological studies will increase your risk of death by just as 

much as a unit of exposure at the much higher PM2.5 levels that 

statisticians have observed correlations for. This new assumption is 

scientifically dubious but its lack of realism shows in how it has 

driven the underlying estimate of PM-related deaths in the United 

States to implausible levels. EPA’s new PM risk estimates now 

imply that 25 percent of all deaths nationwide were due to PM2.5

as recently as 1980, 25 percent. EPA projects PM2.5 will be almost 

entirely in the safe range, that is, in attainment with the PM 
40 

NAAQS, after the Cross-State Air Pollution Rule is implemented in 

2014. But EPA is also assuming there will still be about 250,000 

deaths per year due to PM2.5 after that and it keeps tapping into 

this implausible estimate of a reservoir of PM benefits to come up 

with the very large co-benefits estimates for its new rules, and the 

Utility MACT is a shining example. The 17,000 lives that EPA 

claims it would save in 2016 are taken from that highly dubious 

pool. Effectively, all of those 17,000 deaths are from exposures to 

PM that according to the EPA ambient standard are safe. About 

4,000 of those 17,000 deaths, if believed to really exist, will be prevented anyway if EPA tightens its PM2.5 standard down to 11 

micrograms per cubic meter as it appears to be poised to do this 

year. The Utility MACT should not be credited with those benefits. 

They belong on the PM NAAQS benefits ledger. But the remaining 

13,000 of those deaths should not be counted at all because they 

are from exposures that are already below 11 micrograms per cubic 

meter, which EPA does not consider to be risks that are believable 

enough to set a PM NAAQS standard that would stop them. So in 

sum, EPA’s use of highly dubious co-benefits gives it a shield to 

justify a complex web of rules. 

The fact that EPA does not just use its streamlined regulatory 

option, which is to set a PM2.5 NAAQS, hints at the degree to 

which it realizes that those co-benefits calculations do not reflect 

true public health risk but also it is just bad policy. A complex web 

of non-PM rules cannot possibly be a cost-effective path to addressing a nation’s clean air needs, and no one disputes that these rules 

do have significant costs that need to be streamlined to the maximum extent possible. 

Thank you very much. 

[The prepared statement of Dr. Smith follows:] 

PREPARED STATEMENT OF DR. ANNE E. SMITH, 

SENIOR VICE PRESIDENT, NERA ECONOMIC CONSULTING

Mr. Chairman and Members of the Committee, thank you for your invitation to 

participate in today’s hearing. I am Anne E. Smith, and I am a Senior Vice President of NERA Economic Consulting. I am a specialist in environmental risk assessment and integrated assessment to support environmental policy decisions, which 

was a core element of my Ph.D. thesis at Stanford University in economics and decision sciences. I have performed work in the area of air quality cost and benefits 

analysis and risk assessment over the past 30 years, including as an economist in 

the USEPA’s Office of Policy, Planning, and Evaluation, as a consultant to the 

USEPA Air Office, and in many consulting engagements since then for government 

and private sector clients globally. I have also served as a member of several committees of the National Academy of Sciences focusing on risk assessment and riskbased decision making. I have been deeply involved in assessment of the evidence 

on risks from ambient fine particulate matter (PM2.5) since EPA first turned to the 

task of identifying an appropriate National Ambient Air Quality Standard (NAAQS) 

for PM2.5 over 15 years ago. I have also analyzed costs, risks and benefits of many 

other key U.S. air policies, including ozone, regional haze, mercury and other air 

toxics, NO2, SO2, and greenhouse gases. I thank you for the opportunity to share 

my perspective today on the economic underpinnings of EPA’s policy analyses for 

setting air quality standards. My written and oral testimonies reflect my own opinions, and do not represent any position of my company, NERA Economic Consulting. 

The Chairman has asked me to describe my work analyzing major Clean Air Act 

regulations including National Ambient Air Quality Standards (NAAQS) and National Emission Standards for Hazardous Air Pollutants (NESHAPs), and to discuss 

any trends I have identified in EPA’s analyses of such regulations. Although I have 

worked on these issues for over 30 years, I would like to focus my testimony today 

on analyses and research that I have done during 2011. In the past several months, 
41 

I have reviewed and commented on the costs and benefits in EPA’s Regulatory Impact Analysis (RIA) for the reconsideration of the ozone NAAQS. I have also prepared technical comments on the RIA for the proposed NESHAP for electric generating units, which was proposed in May 2011. That rule is commonly called the 

‘‘Utility MACT’’ rule because it would impose maximum achievable control technology (MACT) standards on several categories of air toxics emitted by electricity 

generators. I am presently in the process of reviewing the entire body of RIAs that 

EPA has produced for air quality regulations, to trace the history of some troubling 

patterns that I found in EPA’s ozone and utility MACT RIAs. 

My key findings, which I will explain in more detail below, are: 

• EPA is relying to an extreme degree on coincidental ‘‘co-benefits’’ from PM2.5 reductions to create the impression of benefit-cost justification for many air regulations that are not intended to address PM2.5. 

• In 2009, EPA vastly increased the levels of mortality risks that it attributes to 

PM2.5 simply by starting to assign risks to levels of PM2.5 down to zero exposure, thus ‘‘creating’’ risks from ambient exposures that are well within the safe 

range established by the PM2.5 NAAQS. 

• This single change nearly quadrupled the pool of purported U.S. deaths due 

to PM2.5 that RIAs can now count as ‘‘saved’’ by minor incremental reductions 

in already-low ambient PM2.5 levels projected under new rules. 

• This additional pool of PM2.5-related mortality consists of the most non-credible sort of risk estimate, as it is derived from an assumption that a unit of 

exposure at PM2.5 levels well below any observed in the epidemiological studies poses just as much risk as a unit of exposure at the higher PM2.5 levels 

where associations have been detected. 

• With this change, EPA is now assuming that 13% to 22% of all deaths in the 

Eastern U.S. were due to PM2.5 in 2005, and that 25% of all deaths nationwide were due to PM2.5 as recently as 1980. 

• The decision to inflate the PM2.5 risk estimates by presuming risks continue 

down to zero has its greatest impact on co-benefits estimates because—for rules 

that do not address PM2.5 directly—a much greater share of their incremental 

reduction of PM2.5 will occur in areas that are already in attainment with the 

PM2.5 NAAQS (and thus that have PM2.5 levels that EPA has deemed safe). Yet, 

EPA now attributes about 200,000 more PM2.5-related deaths per year to exposures in those areas. 

• If it were viewed as credible that such large effects exist below the level of the 

PM2.5 NAAQS, the appropriate policy remedy would be to tighten the PM2.5

standard, and not to regulate something else altogether in order to obtain those 

benefits through ‘‘coincidence.’’ 

• Co-benefits from a pollutant that EPA already can and does regulate should not 

be allowed to serve as the predominant benefit in RIA’s for rules that target 

a different public health concern. 

• Otherwise, RIAs will only help drive our nation towards regulatory complexity by creating the false appearance of a benefit-cost justification for regulations that are very costly compared to their own benefits. 

EPA is relying to an extreme degree on coincidental ′′co-benefits′′ from PM2.5 reductions to justify air regulations that are not intended to address PM2.5. 

As EPA releases each of its proposed and final air quality rules, it typically emphasizes that the rule will generate health benefits that exceed its costs. However, 

close inspection of the associated RIAs reveals that a majority of those benefits— 

sometimes all of them—are not from reductions in the pollutant(s) being targeted 

by the new regulation, especially in the case of air regulations that are targeting 

clean air objectives other than PM2.5. For many of those, the bulk of the benefits 

estimates in their RIAs are attributable to reductions in already-low concentrations 

of ambient PM2.5 that EPA has predicted will occur coincidentally as a result of regulation of those non-PM pollutant(s). 

For example: 

• In the Ozone Reconsideration RIA, up to 91% of EPA’s benefits estimate for its 

preferred standard was due to EPA’s predictions of coincidental PM2.5 reduc-
42 

1 The preferred standard that EPA had forwarded to OMB for the Ozone Reconsideration was 

70 ppb. 2 A copy of my full review of the ozone RIA is available at http://www.nera.com/ 

67¥7390.htm. Parts of it are excerpted in the Appendix of this testimony. 3 A copy of my full review of the Utility MACT RIA is available at http://www.nera.com/ 

67¥7412.htm. Parts of it are excerpted in the Appendix of this testimony. 

tions rather than to reductions in ozone risks that were the target of the rule. 1

Not a single one of EPA’s benefits estimates in that RIA exceeded its costs unless PM2.5-mortality co-benefits were added in. By EPA’s own calculations, all 

of the alternative ozone standards had ozone benefits that fell short of their 

costs by billions of dollars per year. 2

• EPA has widely claimed that the Utility MACT rule, which targets air toxics, 

will save up to 17,000 lives per year, 11,000 heart attacks, and numerous other 

respiratory and cardiovascular ailments. But all of those purported health benefits are due to EPA’s predictions of coincidental reductions of PM2.5—which is 

not an air toxic. Of all the air toxics targeted by this rule, EPA has estimated 

benefits for only one—mercury—and EPA’s highest estimate of those mercury 

benefits is only $6 million per year, compared to EPA’s estimate of $10.9 billion 

in costs per year. In the Utility MACT’s RIA, over 99.99% of the benefits that 

EPA has attributed to the rule are due to PM2.5 co-benefits rather than to the 

air toxics that are its purpose. 3

In my ongoing review of all air regulation RIAs, I have identified 28 RIAs released 

since 1996 that were for rules not targeting PM2.5-related health risks. These are 

listed in Table 1 in chronological order. 
43 
44 

4 EPA, Policy Assessment for the Review of the Particulate Matter National Ambient Air Quality Standards. EPA-452/R-11-003. Office of Air Quality Planning and Standards, Research Triangle Park, N.C., April 2011, p. 2–106. (Available at: http://www.epa.gov/ttnnaaqs/standards/ 

pm/data/20110419pmpafinal.pdf.) 5 EPA, Quantitative Health Risk Assessment for Particulate Matter. EPA-452/R-10-005. Office 

of Air Quality Planning and Standards, Research Triangle Park, N.C., June 2010, p. G–2. 

(Available at: http://www.epa.gov/ttn/naaqs/standards/pm/data/ 

PM¥RA¥FINAL¥June¥2010.pdf.) 6 EPA, Regulatory Impact Analysis (RIA) for the Final Transport Rule, Docket ID No. EPAHQ-OAR≥2009-0491, p. 3. (Available at http://www.epa.gov/airtransport/pdfs/FinalRIA.pdf.) 

Table 1 shows that in 22 of those 28 RIAs, I found that a majority of the total 

benefits were due to PM2.5 mortality co-benefits. In fact, PM2.5 co-benefits were the 

only benefits, or accounted for more than 99.9% of the quantified benefits in 13 of 

those 22. Of the remaining six, four did not quantify health benefits at all (yet most 

of those discussed PM2.5 co-benefits qualitatively as well as direct benefits of the 

rule’s targeted pollutants). This leaves just two of the 28 RIAs that were not specifically targeting ambient PM2.5 yet did not find that most or all of the quantified benefits were actually co-benefits due to PM2.5. Overall: 

• PM2.5 health-related co-benefits have been relied on to create the benefit-cost 

case for regulations that were actually intended to address mercury, a host of 

other air toxics, ozone, regional haze, lead, NO2, and SO2. 

• The trend towards almost complete reliance on PM2.5-related health co-benefits 

has grown over time. 

In 2009, EPA changed its RIA calculations to vastly increase the levels of PM2.5 cobenefits that it can attribute to non-PM2.5 rules. 

As noted above, EPA has been increasingly relying on PM2.5 co-benefits to produce 

a benefit-cost case for a host of non-PM2.5 rules. However, in my review of RIAs, 

I also realized that EPA made a move in 2009 that greatly increased those co-benefits estimates —and did so in a way that I consider to have no scientific credibility. 

The co-benefits that EPA estimates for rules that are not targeting ambient PM2.5

are calculated from very small changes in PM2.5 concentrations that are already well 

below the safe level established by the PM2.5 NAAQS. This is because those co-benefits are supposed to be computed only for incremental improvements beyond existing 

regulations, such as the existing PM2.5 NAAQS. The PM2.5 NAAQS imposes a maximum annual average ambient concentration of 15 μg/m3, which the EPA Administrator deemed to protect the public health with an adequate margin of safety in 

2006. That NAAQS is under review now, and EPA staff (with CASAC’s concurrence) 

has stated that the lowest level that it may be revised to is 11 μg/m3. 4 Nevertheless, 

in 2009, EPA suddenly started to calculate PM2.5 risks in its RIAs down to the lowest level its air quality models predict, which can be as low as 4 or 5 μg/m3. This 

results in risks being attributed to exposures that are far below the level of PM2.5

deemed safe. As I will show, those increased risk estimates are very large. EPA is 

using those greatly inflated risk estimates to justify a wide range of regulations 

other than PM2.5, even though it is not prepared to argue that those risks are credible enough to justify action in the form of an even-tighter PM2.5 NAAQS. 

Risk Estimates Have Been Nearly Quadrupled. This decision by EPA to calculate risks down to the lowest level that its models project, rather than just to the 

lowest measured level (LML) in the epidemiological study that serves as the basis 

for its risk relationship greatly increased EPA’s estimates of PM2.5 co-benefits in its 

RIAs. This large inflationary effect can be observed just by comparing EPA’s baseline 2005 risk estimates in its 2010 PM2.5 Quantitative Health Risk Assessment for 

PM2.5—which does not extrapolate below the LML—to those in its post-2009 RIAs 

which do extrapolate below the LML. The former is being used the current review 

of the PM2.5 NAAQS mentioned above, and in it, EPA estimates 88,000 deaths were 

due to PM2.5 in 2005 based on an epidemiological study by Laden et al. 5 In its concurrent RIAs, however, EPA estimates fully 320,000 deaths due to PM2.5 for the 

same year, the same estimated air quality, and using the same Laden et al. study. 6

The former is 4% of total annual U.S. deaths of 2.4 million and the latter is 13% 

of 2.4 million annual U.S. deaths. Notably, EPA is now using both of these contradictory estimates of baseline PM2.5-related deaths simultaneously in different regulatory 

proceedings—EPA is using the smaller number of baseline deaths in its CASAC-reviewed risk analyses for the PM2.5 NAAQS review, and it is using the larger number 

of baseline deaths in its RIAs that are generating the large co-benefits for non-PM2.5
45 

7 EPA, Regulatory Impact Analysis (RIA) for the Final Transport Rule, Docket ID No. EPAHQ-OAR-2009-0491, p. 1. (Available at http://www.epa.gov/airtransport/pdfs/FinalRIA.pdf.) 8 The benefits of the Utility MACT rule are calculated after having modeled full implementation of the proposed Clean Air Transport Rule, which was the proposed version of the final 

CSAPR. It is thus fairly similar to an analysis of benefits after accounting for the reductions 

expected from CSAPR. 

regulations, such as for air toxics regulations and for non-PM NAAQS, such as 

ozone. 

Thus, with this single change in its RIA calculations, EPA has caused the estimate of total PM2.5-related deaths to nearly quadruple, from 88,000 to 320,000. In 

effect, in 2009, EPA quietly ‘‘created’’ an additional reservoir of 232,000 PM2.5-related deaths that it could continue to tap into in its future RIAs as co-benefits for 

the many non-PM clean air regulations that it will be proposing and promulgating 

in the future. The RIAs for the proposed Utility MACT and the Ozone Reconsideration are recent RIAs that benefited from the dramatic inflation of EPA’s estimates 

of total PM2.5 risks, as I will show next. 

Inflated Co-Benefits Estimates Are Being Calculated for Small Changes in 

Exposure to PM2.5 that EPA Deems Safe. The Cross-State Air Pollution Rule 

(CSAPR) that was promulgated in July 2011 is intended to help bring the nation 

into compliance with the present PM2.5 NAAQS. The RIA for the CSAPR reports 

that in 2014 it will save up to 34,000 lives that would otherwise end prematurely 

due to PM2.5 exposures, as compared to premature deaths in a baseline that did not 

even include CAIR. 7 One can think of this as a reduction from the 320,000 underlying deaths associated with 2005 levels of PM2.5. Even if we assume that control 

measures between 2005 and 2014 additional to those of CSAPR would double the 

estimated lives saved that EPA attributes to CSAPR alone, EPA is estimating that 

there still will remain some 250,000 deaths due to PM2.5 even after CSAPR has been 

implemented in 2014. It is from this remaining reservoir of ‘‘premature deaths’’ (still 

nearly 10% of all U.S. deaths per year!) that EPA finds the 17,000 lives that it purports would be ‘‘saved’’ as a co-benefit of the Utility MACT, when it comes into effect 

in 2015 and mandates reductions of acid gases. 8 When placed in the context of such 

a huge pool of lives that still ‘‘could be saved’’ if PM2.5 were to be 100% eradicated, 

it becomes apparent that the 17,000 lives of ‘‘co-benefits’’ is a small percentage 

change that reflects the small difference in PM2.5 exposures offered by the Utility 

MACT. The RIA for the Utility MACT confirms that it provides not only a small 

percentage risk reduction, but that its comes from very low exposures, as Figure 1, 

copied from Figure 6-15 of the Utility MACT RIA, shows. 
46 

10 See Utility MACT RIA, p. 4–5, (at http://www.epa.gov/ttnecas1/regdata/RIAs/ 

ToxicsRuleRIA.pdf.) 11 11 Some might argue that these PM2.5 benefits will appear sooner because the Proposed 

Utility MACT Rule will be fully implemented by 2016, while full implementation of a tightened 

Figure 1 shows that effectively all of the Utility MACT’s purported PM2.5 co-benefits are due to reductions in exposures to PM2.5 that are already below the annual 

NAAQS standard of 15 μg/m3. This fact can be inferred from the figure in the following way. The blue S-shaped curve in Figure 1 indicates on the vertical axis the 

percent of the RIA’s PM2.5 co-benefits estimate that is attributable to baseline PM2.5

exposures at or below the PM2.5 concentration on the horizontal axis. This is known 

as a ‘‘cumulative distribution.’’ The point on the horizontal axis where the S-shaped 

curve just reaches 100% indicates the level of baseline PM2.5 at or below which all 

(i.e., ‘‘100%’’) of the estimated PM2.5 co-benefits occur. I have added a vertical dotted 

red line to Figure 1 at the level of the current annual NAAQS (i.e., at 15 μg/m3 on the horizontal axis). As one can see, the vertical reading on the blue S-shaped curve 

is about 100% at 15 μg/m3, which means that about 100% of EPA’s estimated PM2.5

co-benefits from the Utility MACT would be based on reductions in annual average 

PM2.5 exposures that are already below the health-protective level of the current 

standard. Not only are most of the benefits occurring at very low PM2.5 exposures 

to start with, but RIA also tells us that they are due to very small exposure 

changes. The changes in exposure are only 0.7 μg/m3 on average, and do not exceed 

1.49 μg/m3 in any location. 10

EPA is presently considering whether to tighten the PM2.5 NAAQS, with a Proposed Rule expected later in 2011. EPA is considering a range of possible alternative 

annual standards that extends as low as 11 μg/m3. If EPA revises the NAAQS to 

the lowest of those levels, the RIA’s figure also tells us that 20% of the co-benefits 

being attributed to the Utility MACT (i.e., those that occur in locations where prerule PM2.5 is above 11 μg/m3) are going to occur anyway, as a result of NAAQS attainment. 11 They therefore are inappropriate to count as co-benefits of the Proposed 
47 

PM2.5 NAAQS will be several years later. However, that difference is only temporary, and many 

have argued that the accelerated time frame for implementation of the Utility MACT rule will 

be far more disruptive than EPA’s cost analysis indicates due to its exceedingly rapid implementation. Thus, making a point that these could be considered valid temporary co-benefits for the 

years 2016 through perhaps 2020 only raises the question of whether that accelerated time 

frame is reasonable and justifiable. 12 See pp. 14–16 of my technical comments on the Utility MACT (at: http://www.nera.com/ 

67¥7412.htm). 

Rule for air toxics—they should be counted as the direct benefits of the new PM2.5

standard. Moreover, the remaining 80% of the Utility MACT’s PM2.5 co-benefits are 

for reductions in PM2.5 exposures that will still be deemed safe by EPA. 

The Additional PM2.5 Benefits Estimates Are Not Scientifically Credible. 

The significant inflation in PM2.5 health benefits that EPA has introduced into its 

RIA calculations since 2009 is accomplished by adding in benefits of the least credible sort because most of that increase is due to benefits estimates below—often far 

below—the levels of PM2.5 that have been observed in the scientific studies that 

form the basis of the PM2.5 health effects literature. Thus, overnight in 2009, in the 

course of preparing RIAs that are not subject to public peer review, EPA dramatically escalated its estimates of benefits for all of its RIAs. This had the most profound impact on its estimates of benefits in the vast swath of the U.S. that has 

PM2.5 concentrations below 10μg/m3: small changes in modeled PM2.5 in these areas 

used to contribute nothing to the total estimated benefits of a regulation, but they 

now contribute as much as 70% of the co-benefits estimates (as can be seen in the 

case of the co-benefits in the Utility MACT RIA from Figure 1). EPA accomplished 

this enormous benefits inflation without changing the epidemiological studies it relies on, but by altering a much more obscure assumption in its risk analysis calculations, the use of the ‘‘LML.’’ 

One associated and interesting effect of this benefits inflation, however, is the degree to which it makes the total number of deaths attributed to PM2.5 implausible. 

EPA’s presumption that fully 320,000 deaths in the U.S. were ‘‘due to PM2.5’’ in 

2005 represents over 13% of all deaths in the U.S. on average. And behind that average is the presumption that in large expanses of the Eastern U.S., between 16% 

and 22% of all deaths in 2005 were ‘‘due to PM2.5.’’ By extension (although EPA has 

not reported this calculation), EPA’s estimates imply that about 25% of all deaths 

nationwide were due to PM2.5 as recently as 1980. 12 These fundamental assumptions that underpin EPA’s co-benefits calculations stretch the bounds of credibility, 

and thus undercut the credibility of all the co-benefits estimates themselves. 

The simple reason why these new baseline risks are so large—implausibly large 

in my view—is that EPA assumes in its risk analysis calculations that there is no 

tapering off of relative risk as PM2.5 exposure approaches zero. For years there has 

been a debate about whether the concentration-response relationship can truly be 

linear down to zero, but this debate has been focused on questions of statistical 

power and on basic principles of toxicology. The implication of the linear-to-zero/nothreshold assumption has never been debated in terms of its implication that an implausible proportion of total deaths in the U.S. would be due to PM2.5—but perhaps 

now it should be debated that way too. 

The decision to inflate the PM2.5 risks by presuming risks continue down to zero has 

its greatest impact on co-benefits estimates. 

The vast increase in total deaths that EPA now attributes to PM2.5 exposures (i.e., 

the increase from 88,000 to 320,000 for the year 2005) has a greater inflationary 

effect on estimates of co-benefits from rules that do not address PM2.5 risks directly 

than it does on the direct benefits of rules to steer ambient PM2.5 into attainment 

of its NAAQS. In rules not targeting ambient PM2.5 directly, the changes in PM2.5

are only coincidental and presumably incremental to attainment of the PM2.5

NAAQS. Such changes are most likely to occur in areas that are either already in 

attainment or will be pushed into attainment by rules implementing the PM2.5

NAAQS. In fact, coincidental and incremental reductions of PM2.5 that could qualify 

as co-benefits from a non-PM rule must occur in locations that are already in attainment with the PM2.5 NAAQS, or else those benefits are being double-counted, because they have already or soon will be counted as the direct benefits of the PM2.5

NAAQS itself. Hence, by inflating its PM2.5 benefits estimates with additional risk 

estimates of the least credible form, EPA has enhanced its ability to justify nonPM2.5 regulations through PM2.5 co-benefits. The practice of basing the benefit-cost 

case for new rules almost solely on co-benefits rather than on direct benefits is troubling to start with, but this recent change in EPA’s RIA benefits estimation methods 
48 

13 13 For a more complete discussion of these points, see my technical comments on the Utility 

MACT RIA, pp. 19–20, pp. 35–36, and Appendix C, available at http://www.nera.com/ 

67¥7412.htm. 

now causes the bulk of the co-benefits that it estimates to be quite suspect from a 

scientific basis. 

If it were viewed as credible that such large effects exist below the level of the PM2.5

NAAQS, the appropriate policy remedy would be to tighten the PM2.5 standard, 

and not to regulate something else altogether in order to obtain those benefits 

through ‘‘coincidence.’’ 

There remain many reasons to continue to have doubts about the causality in the 

presumed relationship between ambient PM2.5 and mortality. These calculations 

continue to rely solely on statistical associations with little to no clinical evidence 

to support the causal interpretation of these correlations. Despite many efforts to 

provide statistical controls, the ability to tease out other explanations based on phenomena that are correlated with variations in ambient PM2.5 levels remains elusive. 

Alternative explanatory factors may include traffic, noise, and even socioeconomic 

conditions that have not been possible to characterize fully with statistically useful 

data. Tighter controls on PM2.5 may therefore not produce the benefits that EPA calculates even for reductions from levels of PM2.5 that are in the ranges of concentrations that have been measured in the epidemiological studies. But to also assume 

that the presumed causal relationship remains in effect with equivalent potency 

down to essentially zero concentration levels is simply inappropriate scientifically. 13

EPA and CASAC have not shown any willingness to argue for setting a PM2.5

standard at those very low levels that have not yet been studied, even though there 

is a complete and thoroughly effective mechanism in the Clean Air Act that gives 

the Administrator the ability to protect the public health from such exposures if 

they really do pose risks as large as EPA assumes in its RIAs. EPA therefore should 

not continue its practice of reporting that regulations that do not address ambient 

PM2.5 will have benefits that exceed their costs based on estimates of PM2.5 risks 

that EPA is not prepared to directly reduce through the PM2.5 NAAQS. 

Co-benefits from a pollutant that EPA already regulates should not be allowed to 

serve as the predominant benefit in an RIA for a rule that targets a different 

public health concern. 

EPA’s use of co-benefits in its RIAs scares the public into believing that people 

would be dying in droves were it not for implementation of new rules on pollutants 

for which EPA has not actually identified any current public health risk. It gives 

EPA a shield to justify building a complex web of many different rules, when EPA 

could provide almost all of those purported health-protective benefits with just a single rule: the PM2.5 NAAQS. That EPA does not take this simple, streamlined approach hints at the degree to which it realizes that its co-benefits calculations do 

not reflect true public health risks. But also, it is just bad policy to promote the 

goal of further PM2.5 risk reductions by way of expanding MACT rules for mercury, 

acid gases, metallic air toxics and by way of striving to attain tighter NAAQS for 

ozone, lead, SO2 and NOχ. This cannot possibly result in a cost-effective path to addressing a nation’s clean air needs. 

Appendix 

More Details From My Technical Comments on the Utility MACT and Ozone RIAs 

I have described and discussed the key trends of concern that I have observed in 

my review of many RIAs, but I also would like to also provide the summaries of 

the specific issues that I found in the two RIAs for which I have written full technical comments. I believe that a recap of my summaries for those two individual 

RIAs may help illustrate the depth of the problems that are created by EPA’s reliance on PM2.5 co-benefits as the central feature of its benefits analyses for clean air 

rules that are not purposefully reducing PM2.5-related health risks. 

Summary of Key Findings From My Review of the Proposed Utility MACT Rule 

This section is excerpted from my Technical Comments on the Regulatory Impact 

Analysis Supporting EPA’s Proposed Rule for Utility MACT and Revised NSPS (76 

FR 24976) which was entered into the Utility MACT docket as part of comments 
49 

14 Stated in a more readable format, the range of benefits estimated for the air toxics is $500,000 per year to $6 million per year. The Utility MACT RIA’s summary Table 1-3 incorrectly states the lower bound, and I am reporting the values from RIA Chapter 5 (Table 5-7), 

and in the Proposed Rule (at 24979). 15 15 Utility MACT RIA, p. 4–5. To put this in context, the annual average standard (i.e., 

the level protective of public health with an adequate margin of safety) is 15 μg/m3, about 20 

times larger. Even the maximum decrease in PM2.5 projected under the Proposed Utility MACT 

Rule is only 1.49 μg/m3 (ibid.). 

submitted by the Utility Air Regulatory Group (UARG). The full comments can be 

downloaded from http://www.nera.com/67¥7412.htm. 

• Although EPA reports that the Proposed Rule will produce annual benefits 

ranging from $53 billion to $140 billion, these benefits have nothing to do with 

air toxics at all. 

• EPA’s estimates of the direct benefits due to reduction of the air toxics that are 

the specific purpose of this rulemaking range from only $0.0005 billion to 

$0.006 billion per year 14—less than .01% of EPA’s total benefits estimate—and 

this is due to reduction of just one of the HAPs, mercury (Hg). EPA concluded 

it had no basis for estimating benefits from reduction of any of the other EGU 

HAPs. 

• Effectively all of the $53 billion to $140 billion of estimated benefits is due to 

‘‘co-benefits’’ from coincidental reductions of fine particulate matter (PM2.5), a 

pollutant that is separately and independently regulated under the Clean Air 

Act (CAA) as a criteria pollutant. 

• The PM2.5 co-benefits lack credibility because almost all of that dollar value 

comes from exposures that are so low that EPA deems them safe and is expected to continue to deem them safe after completing its review of the current 

PM2.5 health standard this year. Further, the reductions in exposure levels are 

very small, averaging only 0.7 μg/m3 in annual average concentrations. 15

• The PM2.5 co-benefits also lack credibility because of a long list of well-documented technical problems with the way EPA chooses to calculate actual health 

risks from statistical associations that have not been reliably shown to reflect 

causal relationships. These causality questions are particularly pronounced with 

respect to individual PM2.5 constituents such as sulfate, which is almost the 

only constituent accounting for the Proposed Rule’s co-benefits. 

• Prima facie evidence of the non-credibility of EPA’s co-benefits estimates exists 

in EPA’s baseline estimates of risk in this RIA: deaths that were ‘‘due to’’ ambient PM2.5 exposures exceeded 20% in areas of the U.S. in 2005. These co-benefits assumptions also imply that over 40% of deaths were due to PM2.5 in parts 

of the U.S. during the period 1979–1983 when PM2.5 concentrations were approximately double those for 2005. These surprisingly high assumptions about 

baseline risk, which in my opinion stretch the bounds of plausibility, are the 

result of a single assumption change in 2009 in EPA’s RIAs to extrapolate risks 

below the ambient PM2.5 levels that have been studied, to as low as background 

(i.e., nearly zero). 

• RIAs are not subject to peer review by EPA’s Clean Air Scientific Advisory 

Committee (CASAC) or to a public comment period. 

• EPA has not made this assumption change in any of the risk analyses supporting its current review of the PM2.5 health standard, which are subject to 

CASAC review. 

• The PM2.5 co-benefits estimates are virtually all tied to attainment of the Proposed Rule’s MACT for acid gases, which is the one MACT category in this Proposed Rule for which EPA has not offered any evidence of health risk. 

• Given that almost all of the co-benefits are solely attributable to the acid gas 

MACT portion of the Proposed Rule, there is no cost-benefit case for the remainder of the HAPs control requirements in the rule, whether their estimated cobenefits are included or not. 

In light of the above points, which are further elaborated in the rest of my comments, I conclude that the lower bound of the PM2.5 co-benefits should be zero, and 

that EPA’s upper bound PM2.5 co-benefits estimate is just not credible. EPA has not 

even quantified any benefits for the HAPs themselves, other than a tiny benefit 

from Hg reduction. 

More importantly, I conclude that EPA’s argument that there is a strong cost-benefit justification for the Proposed Rule is inappropriate because it is based solely on 

a preponderance of co-benefits from a pollutant that is already regulated, and not 
50 

an air toxic. Moreover, the estimate is almost entirely derived from changes in very 

low concentrations that EPA has deemed adequately protect the public health. In the 

meantime, EPA has not been able to quantify, or even clearly identify, any meaningful amount of direct benefits from the reductions in air toxics that this rule mandates. The maximum ratio of direct benefits to costs for all three MACT groupings 

is 0.0006-to-1, with a net loss of about $10.9 billion per year. Each individual MACT 

grouping appears to impose a net benefit-cost loss on the basis of its direct benefits 

only, and two of those groupings appear to impose net losses even if their share of 

the upper bound estimates of co-benefits is included in the net benefit calculation. 

Summary of Key Findings From My Review of the Ozone Reconsideration RIA 

This section contains excerpts from the beginning and end of my report, ‘‘Summary and Critique of the Benefits Estimates in the RIA for the Ozone NAAQS Reconsideration,’’ which was prepared for the American Petroleum Institute. The full 

report can be downloaded from http://www.nera.com/67¥7390.htm. 

The excerpts below have been modified to fit the current document’s figure numbering. 

EPA’s statements on health benefits from lowering the Ozone NAAQS grossly 

misrepresent what EPA is actually estimating as the potential benefits of reducing 

public exposures to ozone. If based on ozone benefits alone, not one of EPA’s estimates of the benefits of reducing ozone to a tighter alternative ozone standard is 

as large as the costs of attaining that respective ozone standard—all cost more than 

the ozone benefits they might provide. 

EPA’s estimates of ozone benefits are less than their costs despite the fact that 

EPA has now escalated those benefits by always including benefits due to ozonerelated mortality. EPA’s science advisors (CASAC) found no ‘‘causal’’ link established between ozone and mortality during their deliberations, but EPA now presumes, as part of the reconsideration, a causal link between ozone and mortality 

risk. Despite this change that is unsupported by CASAC, EPA’s net benefits estimates for ozone standards tighter than 0.075 ppm are all still deeply negative. 

The only way EPA finds benefits greater than costs for a tighter ozone standard 

is to add in health gains from concomitant reductions in PM2.5 that may occur while 

reducing ozone precursors—‘‘co-benefits’’ that have nothing to do with ozone exposures. Thus, EPA’s claim that tightening the Ozone NAAQS has greater benefits 

than costs has nothing to do with reducing risks from ozone. EPA also has inflated 

the magnitude of these co-benefits as part of the reconsideration through several 

specious assumption changes. The Agency’s inflated co-benefits assumptions during 

this reconsideration represent a change compared to those assumed in the original 

Ozone NAAQS review ending in 2008. Even with both ozone mortality benefits and 

PM2.5 mortality co-benefits, a large fraction of EPA’s net benefits estimates are negative. 

Figure 2 illustrates the Supplemental RIA’s estimates of the net benefits of each 

of the alternative ozone standards (relative to the standard of 0.084 ppm) when no 

PM2.5 co-benefits are included. Even using the highest estimate of ozone mortality 

benefit in the RIA combined with the lowest EPA cost estimate, the estimated net 

benefits of the 0.075 ppm standard are about ¥$4.5 billion relative to the 0.084 

ppm standard while the yet-tighter alternative standards (i.e., 0.070 through 0.055 

ppm) have estimated net benefits ranging from ¥$8.8 billion to ¥$12.7 billion. If 

one treats the ozone-mortality association as non-causal, EPA estimates that the 

current ozone standard of 0.075 ppm would have net benefits of ¥$7.5 billion and 

the yet-tighter alternative standards of 0.070 through 0.055 ppm would range from 

¥$18.8 billion to ¥$76.7 billion. In fact, if there is no causal relationship between 

ozone and mortality risk, the net benefits estimates for standards tighter than 0.075 

ppm remain negative even with the inclusion of the highest of EPA’s PM2.5 mortality 

and morbidity co-benefits and using the low end of its cost range. 
51 

Chairman HARRIS. Thank you, Dr. Smith. 

And I now recognize our final witness, Mr. J. Edward 

Cichanowicz, for five minutes to present his testimony. Mr. 

Cichanowicz. 

STATEMENT OF MR. J. EDWARD CICHANOWICZ, CONSULTANT 

Mr. CICHANOWICZ. Thank you. Good morning, Mr. Chairman, 

Members of the Committee. This morning I would like to summarize my opinion on the time that it takes to design and install environmental controls, and then I would also like to present a few 

graphics that convey the size of this equipment and how it fits into 

a power plant. 

I will discuss three types of equipment: flue gas desulfurization 

scrubbers that remove sulfur dioxide, catalytic converters that remove nitrogen oxides, and a fabric filter, or baghouse, that removes 

particulate matter. Experience with this equipment in the last 10 

years demonstrates that the timeline for most projects starting all 

the way from conceptual design including permitting and picking 

the right contractor and through commercial operation is more 

than 40 months for scrubbers and catalytic converters. Fabric filters will require less time. 

The mandates of the Cross-State Air Pollution Rule and the Utility MACT are based on EPA’s assumption of a much shorter time 

frame, less than 30 months. Notably, others within EPA agree with 

the estimates of near 40 months. Specifically, in a rulemaking addressing the retrofit of best available control technology to reduce 

NOx at a power station in New Mexico, EPA staff conducted their 

own survey and concluded that 37 months on average was required 

to retrofit catalytic converters. In summary, the mandates for the 
52 

Cross-State Air Pollution Rule and the Utility MACT presume an 

installation time that is not supported by recent experience. 

If I could ask you to turn your attention to the graphics, I would 

like to show first a power station. This is a satellite image from a 

power station that is in Georgia. The reason why it is important 

is that they have already retrofit or are in the process of retrofitting the controls that we have just talked about. They have done 

it in response to a state mandate, and what we are going to do is 

look at the layout of the equipment as originally designed, and 

then we are going to walk around the unit and see what kinds of 

things have been put in and where they have been put. First, I will 

call your attention to the original equipment as designed, and that 

is denoted by the blue callouts. On the top, you see the boiler house 

and below it the initial original particulate collectors. The boiler 

house is indicated by the red rectangle and it contains, as you 

would guess, the boiler and the steam turbine and a lot of the fuel 

handling equipment. Right below it is the original particulate control device, and you will see it has its own stack. The first thing 

we will do is look and see what happens when we install a catalytic 

converter. This station is so big that it actually has two parallel 

flow paths so it is kind of like having two environmental control 

systems on one site, and what you see in the green is one of the 

two catalytic reactors being retrofit. At the time of the image, that 

construction was almost complete on one and was starting on the 

second. It is important to know that these catalytic converters are 

basically hung off the back of the boiler house so they are a couple 

hundred feet in the air. They are quite large devices. 

As you continue to walk around the station, we see first one of 

the fabric filters that has been retrofit. Now, the good news for this 

site is that there is actually room to put one. The bad news is, it 

is not real close to the original equipment so you can see the fair 

amount of ductwork that had to be configured to tie it into the existing equipment. 

As we continue to walk around, we see the location for the scrubber. It is being constructed within the green circle, and again, there 

is space for it, it just isn’t very close to the balance of plant equipment and you need the additional ductwork. Also please note, there 

is an additional stack that is being constructed. For the type of 

scrubbers that most people prefer, they essentially saturate the gas 

with water, and what that means is that when the gas goes up the 

stack, it basically rains inside the stack and so you kind of have 

to build a new stack to tolerate those set of conditions. And then 

finally, the second of the two fabric filters is shoehorned in, and 

again, there is space for it, it just has to be configured within the 

site. 

The next graphic or the only other graphic I will show is an absorber tower for a scrubber. First, I will call your attention to the 

red circle in the lower right. That is the standard reference person, 

and it gives you an idea of how large the equipment is. The gas 

enters on the lower right, proceeds vertically upward and then 

exits through the top to the left. The reason why these devices are 

so big is that the speed of the gas has to be slowed down to about 

anywhere from four to seven miles per hour. We have to mix other 

chemicals with it and we also have to make sure there is enough 
53 

residence time for the reactions to take place. If you will note on 

the top of the tower, there is a series of nozzles that spray an alkaline material. 

Let me give you an idea of how much water is there. If you were 

to, say, stumble into a monsoon on the Pacific Rim, you might have 

a rainfall of 15 to 20 inches of rain per hour. Within that scrubber, 

it is generated 80 to 100 inches of rain per hour. So the point is, 

it is a very powerful spray and it sets up an engineered set of really perfect conditions that are intended to annihilate almost anything coming out in the gas, and for many cases, they do so. 

So in summary, the reason why these devices take the time that 

they do is that they are complex, engineered systems. Their design 

needs to be thought out and they need to be constructed with precision. 

Thank you. 

[The prepared statement of Mr. Cichanowicz follows:] 

PREPARED STATEMENT OF MR. J. EDWARD CICHANOWICZ, CONSULTANT

Summary 

The U.S. Environmental Protection Agency (EPA) states that planning, designing, 

and constructing state-of-the-art emission control systems can be accomplished in 

less than 30 months. EPA made such claims when publishing its Cross State Air 

Pollution Rule (CSAPR) this summer and when proposing National Emissions 

Standards for Hazardous Air Pollutants for electric generating units (the Utility 

MACT proposal) last spring. 

Contrary to EPA’s claims, however, the ‘‘start to finish’’ times for this equipment—flue gas desulfurization (FGD) ‘‘scrubbers’’ to reduce sulfur dioxide (SO2); selective catalytic reduction (SCR) catalytic reactors to reduce nitrogen oxides (NOχ); 

and fabric filters to remove particulate matter—will be much more than 30 months. 

The most recent experience shows retrofits of FGD and SCR systems will typically 

take between 40 and 50 months. 

There are two key reasons why it takes this long to plan, permit, fabricate, and 

install these control systems. First, the equipment is large and must be configured 

to fit into often-crowded plant sites. Second, these are not off-the-shelf designs; each 

must be custom-tailored to the site and coal. The problems are compounded when 

several control technologies are retrofit simultaneously at one plant site. For example, in order to comply with the CSAPR and the Utility MACT rule as proposed, 

owners may need to install FGD scrubbers and SCR catalytic converters at their 

plant sites at about the same time they are installing fabric filters to reduce mercury and other pollutants targeted by the proposed Utility MACT rule. 

Few ‘‘short cuts’’ are available to significantly reduce this schedule by more than 

a few months. I do not concur with EPA’s statement in the CSAPR rulemaking that 

years can be carved off the ‘‘start-to-finish’’ times of FGD and SCR systems by fast 

tracking design and procurement processes. And there is a downside to fast tracking 

these kinds of projects: it could compromise the quality of design or construction of 

the equipment, forcing plant operators for decades to use control systems that are 

ill-suited or otherwise not optimal for their sites. 

Similarly, EPA has no basis to predicate the feasibility of its very tight Utility 

MACT compliance deadlines on principally one methodology: injecting specially prepared powders or sorbents into power plant gas streams to remove mercury and 

other pollutants such as hydrogen chloride. These sorbents will work in some instances, but not across the board as envisioned by EPA to achieve the targeted reductions. And where the use of sorbents does not achieve the very low emission limits proposed by EPA, owners will have to retrofit fabric filters to meet the proposed 

Utility MACT rule. EPA predicts as much as half of the generating inventory in the 

U.S. will have to do so. Under the best of circumstances, it would be difficult (if not 

impossible) to retrofit fabric filter controls at so many sites in the short MACT compliance timeframe. The challenge becomes even greater, though, if owners must install fabric filters at roughly the same time they are installing FGD and SCR systems to comply with the CSAPR. 
54 

Introduction 

Chairman Hall, Ranking Member Johnson, and Members of the Subcommittee, 

thank you for the opportunity to speak with you today. I will provide an overview 

of the factors that affect the retrofit of environmental control technologies to coalfired power stations for the purpose of meeting the mandates of the Cross State Air 

Pollution Rule (CSAPR) and the National Emissions Standards for Hazardous Air 

Pollutants (i.e., Utility MACT), particularly factors that influence the timing of installation. 

The power industry in the last 10 years has successfully retrofit state-of-the-art 

environmental controls to a large fraction of generating units. Consequently, much 

of the power delivered into today’s markets is generated by units equipped with effective environmental controls. The industry will continue to strive to meet future 

environmental mandates. However, as I will describe, the type of equipment that 

must be retrofit is exceedingly large in size, can be very complex, and can require 

special engineering and preparation tasks. To do this right simply takes time. Further, we have learned from experience what happens when the design or fabrication 

of a control technology is rushed, or is not optimized or properly designed for a given 

site and fuel. The outcome is never good. 

Based on my years of experience advising power generation equipment owners in 

the retrofit of environmental control technology, I believe that typically between 40 

and 50 months will be required to retrofit control options to meet the mandates of 

the CSAPR and the Utility MACT. It may be possible to reduce a few months from 

the schedule by fast tracking design and procurement, and using so-called ‘‘lean’’ 

construction methods, but in general it will not be possible to achieve this outcome 

in less than 30 months. Further, a result of fast tracking these duties could be a 

compromise in the quality of design or construction of this equipment. Operators 

would be forced for decades to use equipment that is not optimal for the site, 

orotherwise ill-suited. 

Description of Environmental Controls 

The industry selects from a suite of environmental controls those appropriate for 

a given task: removing sulfur dioxide (SO2), nitrogen oxides (NOχ), particulate matter, and trace species commonly referred to as hazardous air pollutants (HAPS). 

HAPS include mercury and acid gases such as hydrogen chloride. There are two distinguishing features of environmental controls for power plant effluent gases—first, 

the equipment is very large, and second, there is no one-size-fits-all design. Most 

equipment represents a custom design tailored to the characteristics of a particular 

site, and coal. 

Exhibits 1–3 depict three of the key control technologies utilized. Exhibit 1 depicts 

a flue gas desulfurization (FGD) process that removes SO2. Exhibit 2 depicts a selective catalytic reduction (SCR) module to reduce NOχ; this module is basically a catalytic converter for a power station. Exhibit 3 depicts a fabric filter or baghouse, 

which filters out particulate matter. As will be discussed subsequently, the fabric 

filter device is important not only to control particulate matter, but also to contribute to limiting emissions of HAPS. Each of Exhibits 1–3 is meant to convey the 

large equipment size that is necessary to process the volume of gaseous combustion 

products. The equipment must be of large flow cross-section to reduce the velocity 

or speed of the gas to very low levels, to allow mixing of chemical reagents, and to 

provide time for reactions to take place to completion. For example, the speed of the 

gas in the FGD absorber tower is typically 5–10 feet per second—or about 3–7 

mph—necessitating a large reactor. 

The vessel size becomes problematic when it must be fit into an existing crowded 

site. It is the challenge of fitting these vessels into crowded sites, all of which differ 

in almost limitless ways, which can require a protracted design and installation effort. Exhibit 4 presents a plant layout—in my opinion of intermediate difficulty— 

containing this equipment, showing how environmental controls can be arranged. 

Some sites can be open and offer less challenge, but a notable number of units will 

face space limits. 

In summary, the retrofit of environmental controls—all utilizing large vessels or 

reaction chambers, some with chemical and byproduct support plants—requires custom design, shop fabrication, and installation that take a lot of time. 

Timeline for Equipment Installation 

The ‘‘start-to-end’’ time line to install these control systems includes many steps 

above and beyond just the work to prepare a detailed design and install the equipment. A discussion of the key steps required and a summary of recent experience 
55 

is insightful. A detailed description of the key steps and recent relevant experience 

is presented in a report submitted to EPA on October 1, 2010 (a copy of which is 

attached to these comments), as part of comments to the rulemaking process. I’ll 

summarize both topics. 

Ten Steps: Project Initiation to Completion 

The complete scope of activities to retrofit environmental controls can require as 

many as 10 separate steps, each of which will vary by project. Several of these steps 

can be conducted in parallel, but most require some sequence—at least some portion 

of one activity must be completed before the next is started. The 10 steps, including 

the range of time (in months) for execution, are: 

• Conceptual Design and Preparing a Specification. What you want to build must 

be described in a way bidders can use to derive a design (6–12 months). 

• Identification of Qualified Bidders. Potential contractors are to be identified; 

this process is typically conducted in parallel with the preceding (one month). 

• Solicitation and Review of Bids and Contractor Selection. Onsite ‘‘walkdowns’’ 

are essential to acquaint bidders with the project. Evaluating capabilities is 

key; cost alone is not the determining factor in contractor selection (3–5 

months). 

• Negotiating Contract Terms and Conditions. Acceptable terms and conditions 

for labor and material, including escalation, are negotiated in advance (1–5 

months). 

• Securing Construction, Operating Permits. Permits—issued by local regulatory 

agencies and public utilities commissions—are required before construction can 

begin. Some preliminary design must be completed to define equipment and estimate emissions. Opening a storage site for byproduct material is most challenging (4 months–4 years). 

• Finalizing Design. Producing engineering drawings is key, with detailed estimates of media emissions, to enable equipment purchase and fabrication (15– 

45 months). 

• Mobilizing the Workforce. Identifying and securing the services of the mobile, 

specialized workforce has been rate-limiting for some projects (1–3 months). 

• Construction. Includes soil, foundation, and structural preparatory work; fabricating, transporting, and erecting equipment. This is the most protracted onsite 

activity (25–40 months). 

• Process Tie-In (1–3 months) and Process Start-Up (1–3 months) are the final 

steps. 

Each of these steps is essential, although some can be expeditiously conducted depending on the site. For example, where an owner has negotiated a long-term strategic agreement with one supplier, the steps of contractor selection, evaluation, and 

contract negotiation for any project may take less time. However, getting the longterm agreement in place at the start is a lengthy process. 

Projected time lines that do not consider each of these steps may not reflect the 

true ‘‘start’’ date, and will not be accurate. 

Recent Experience and Lessons Learned 

The power industry, working with the community of equipment suppliers, has extensive experience retrofitting environmental control technology to generating units. 

Most recently, a significant fraction of the generating inventory was retrofit with 

FGD scrubbers and SCR catalytic converters over the time period of 2008 through 

2010. Specifically, a total of 123 generating units were retrofit with FGD, and a 

total of 40 units were retrofit with SCR catalytic converters from 2008 through 

2010. 

During the past two years, I have been involved with or had the opportunity to 

review retrofit projects for 22 FGD scrubbers and 14 SCR catalytic converters. As 

I described in the previously referenced October 1, 2010, report that was submitted 

to EPA, the time required to execute each retrofit—from ‘‘start-to-finish’’—varied between units and sites. For FGD retrofits, completing all duties for the least complex 

projects—those that retrofit a single FGD process at a single site—took from 40 to 

64 months, with the average of projects being 48 months. The shortest of these 

schedules—40 months—was incurred for a unit that applied the process design from 

a near-identical ‘‘sister’’ unit, and was able to construct several critical facilities in 
56 

parallel. The retrofit of multiple FGD equipment to more complex sites can require 

more time. 

For SCR catalytic converters, the complete scope of duties for the least complex 

projects required from 28 to 46 months, with an intermediate project taking 40 

months. The shortest of these schedules—28 months—was achieved as the subject 

unit was on the ‘‘end’’ of a row, providing improved access for cranes and other 

heavy fabrication equipment. Similar to FGD, the retrofit of SCR equipment to more 

complex sites with multiple units requires more time, up to 60 months. 

Some within EPA appear to agree it will typically take more than 21 (or even 30) 

months to install SCR. In an unrelated rulemaking to establish Best Available Retrofit Technology (BART) to limit NOχ emissions from the San Juan Generating Station (SJGS) in New Mexico, EPA determined recently (on August 22, 2011), that on 

average it takes 37 months to retrofit an SCR system on an existing unit. And EPA 

determined that it would be reasonable for the owners of SJGS to have five years 

to undertake and complete the SCR retrofit at SJGS. 

In summary, under the best conditions, an FGD scrubber will require at least 40 

months to retrofit, with most applications between 40 and 50 months. For SCR, 

under the best conditions an SCR catalytic reactor will require 28 months, with 

most applications averaging 44 months. 

Compliance Timing: ‘‘Logjam’’ of Events 2012 to 2015 

The emissions reductions provisions of the CSAPR and the Utility MACT require 

control technologies to be installed and operational at almost the same time—January 1 of 2014 for the CSAPR, and January 1 of 2015 for the Utility MACT rule. 

Given the time required to prudently design and install control equipment, it is not 

possible for operators affected by these regulations to meet these deadlines. This becomes clear with a further elaboration of the needs of each mandate. 

2014 Mandates of the Cross State Air Pollutant Rule (CSAPR) 

The CSAPR requires affected companies in the so-called ‘‘Group 1’’ states to 

achieve the mandated SO2 reductions by January 1 of 2014. The amount of generating capacity, and the number of FGD scrubbers that need to be installed to 

achieve this compliance, has been projected by EPA as part of the Agency’s analysis 

in support of the rule. 

EPA’s initial estimates of technology retrofit for the CSAPR, as first published in 

2010, projected that 85 units generating 25 GW of capacity would retrofit FGD to 

comply with the 2014 mandate. In the final proposal for the CSAPR in July of 2011, 

EPA revised downward the estimates of FGD to 39 units generating 17.4 GW of capacity. The basis of EPA’s downward revision appears to be a consequence of altering the modeling details and lowering the projected load growth. Based on the typical FGD ‘‘start-to-finish’’ scope discussed of 40 to 50 months, any owners that must 

comply would already have had to start—and in fact should be more than one year 

into these efforts. Given the date of the final release of the CSAPR—less than 60 

days ago on July 7 of 2010—the timing presumes owners started engineering well 

in advance of finalizing EPA’s rule. 

EPA’s rationale in proposing the 2014 date is not only that a 27-month time line 

is typical for FGD, but also that owners can start work without risk prior to the 

promulgation of a final regulation. This is not the case. Historically, there have been 

instances where owners have quickly and proactively responded to a pending rule, 

only to witness the rule being changed or delayed. As a result, construction is terminated, or acquired SO2 allowances cannot be utilized. The owner must absorb any 

‘‘sunk’’ costs for equipment or allowance purchase. 

2015 Mandates of the Utility MACT Rule 

Perhaps more challenging is the schedule presented by the National Emissions 

Standards for Hazardous Air Pollutants (NESCHAPS)—the Utility MACT mandate. 

Compliance strategies for this proposed rule—scheduled to be finalized by the end 

of this year—are uncertain. The control technologies discussed in this testimony so 

far—the FGD scrubber, the SCR catalytic converter, and the fabric filter—can contribute in ways both large and small to MACT compliance. Owners of generating 

units are investigating how to best utilize these technologies for MACT, recognizing 

the degree of control required for both mercury and hydrogen chloride is at or beyond the capabilities of these controls in most applications. 

However, EPA is predicating success—timely compliance with the MACT—based 

principally on one methodology. This method entails injecting into the gas one or 

more specialty powder(s), referred to as sorbents, to remove mercury and hydrogen 
57 

chloride. One class of sorbents, known as activated carbon, is intended to remove 

mercury from combustion products. A second class of sorbents—actually a family of 

materials derived from the mineral trona—is intended to remove acid gases, such 

as hydrogen chloride. EPA believes any shortcomings in sorbent performance can be 

compensated by retrofitting fabric filters to 166 GW of capacity—more than half of 

the national inventory of units in 2015. 

Regarding mercury, experience with activated carbon in demonstration tests suggests this sorbent will be successful on many units. However, as noted in an August 

2011 report addressing mercury control technology (a copy of which is attached to 

this testimony) for the proposed Utility MACT rule, there may be an equal population of units that will not meet the targeted mercury limit. There may also be 

units where the carbon sorbent induces operating problems, or increases the emissions of particulate matter. 

Regarding control of ‘‘acid gases’’ such as hydrogen chloride, the uncertainty is far 

greater. EPA, to its credit, developed an extensive database of emissions of HAPS 

species from power generation equipment. Regrettably, certain elements of the database were either ignored or not properly utilized. EPA’s proposed hydrogen chloride 

limits presume that sodium sorbents can be a sole means to comply—despite the 

fact that of the 11 units in EPA’s database using this approach, there are only two 

units with data suggesting such success. EPA predicted in a March 17, 2011, document that 56 GW of capacity would deploy this sodium-based sorbent approach. It 

is hard to believe the design for so many commercial systems can be successfully 

scaled, and equipment installed, on such limited experience. 

For both the mercury and hydrogen chloride MACT mandates, EPA’s ‘‘backstop’’ 

approach is broad application of fabric filters to 166 GW of capacity. Again, it is 

hard to believe that such capacity can be retrofit with both sorbent injection systems 

and fabric filters, and successfully operate as predicted, in slightly more than three 

years. Furthermore, the proposed fabric filter retrofits are to be achieved at the 

same time the technologies for CSAPR are being deployed. Such a schedule would 

stretch supply sources in 2013 and, in my opinion, well into 2014 as the FGD units 

are delayed. Although the task of installing any single fabric filter collector may be 

less onerous than a FGD or a SCR catalytic converter, many of the steps are still 

the same. 

Review of Key Uncertainties 

In summary, several key uncertainties behind the proposed mandates in 2014 and 

2015 should be considered: 

Equipment Installation Timeline: EPA’s assumed time line for equipment installation—based on experience gathered from 2008 through 2010—is unrealistic. 

The FGD and SCR installations completed prior to 2010 were mandated five years 

prior to the compliance date. As EPA hasnoted in CSAPR rulemaking documents, 

some large system owners initiated work prior to 2005, but in response to incentives 

to acquire SO2 allowances. Owners had a financial incentive to deploy technology 

early—and not a disincentive of putting capital at risk, which is the present case. 

Capability of Sorbent Injection for Hg Control. The use of activated carbon 

sorbent to remove mercury has been demonstrated to meet the proposed MACT mercury limit for several categories of generating units. However, an equal number of 

generating units could be at risk to meet the proposed MACT limit using activated 

carbon sorbents, unless a fabric filter is retrofit. 

Capability of Sodium-Based Sorbents to Remove Hydrogen Chloride to 

the MACT Limit. Sodium-derived sorbents have been used to remove acid gases 

such as hydrogen chloride, but there is limited experience in achieving the low levels mandated by the MACT. At this time there are only two operating units with 

data suggesting this option can potentially meet the proposed Utility MACT rule. 

Capability to Broadly Retrofit Fabric Filters. EPA’s analysis of complying 

with the MACT is predicated on the ability to successfully retrofit 166 GW of generating capacity with fabric filter controls by January of 2015. As noted in an analysis 

that I co-authored and submitted in July of 2011 as comments to MACT (a copy 

of which is attached to this testimony), it is unlikely this amount of fabric filter control technology can be retrofit by January of 2015. Successfully retrofitting fabric 

filters to this capacity alone would be a challenge, much less conducting this work 

contemporaneous with FGD scrubber retrofit for the CSAPR. 
58 
59 
60 
61 

Chairman HARRIS. Thank you very much, Mr. Cichanowicz. 

And what we will do now is, we will start with five minutes of 

questions, a five-minute round of questions, and I recognize myself 

for the first five minutes. 

Dr. Phalen, let me just ask you a question just to elaborate a little bit about your testimony because what you imply is that the decisions made by CASAC are made—or I should say the advice is 

not made as to the entirety of the decisions and the other potential 

ramifications of that decision. Rather, it goes to a very specific 

question that is asked without taking the entire context. Is that 

correct? 

Dr. PHALEN. Yes, sir, that is correct. And when you look at such 

isolation of an issue, it causes trouble everywhere else. 

Chairman HARRIS. Sure, so that when you have—for instance, 

there is a study from Stony Brook University earlier this year that 

found that people who experienced a period of unemployment were 

more than 60 percent more likely to experience premature mortality. So you have some co-factor there, and in this case, everybody 

agrees, I think that if you lose your health insurance, you are more 

likely to have premature mortality. I mean, I think probably there 

is uniform agreement on that. If you don’t have a job, you are more 

likely not to have health insurance. Therefore, you can connect 

something that reduces the number of jobs to actually an adverse 

health effect. Is that what you are talking about when you are saying that the panel should be allowed to make statements regarding 

the entirety of a decision? 

Dr. PHALEN. Affirmative, Mr. Chairman. 

Chairman HARRIS. Okay. Thank you very much. 
62 

Dr. McClellan, you stated in your testimony that CASAC specifically said that it was a science and policy judgment when these 

standards are being suggested. Now, I am a little puzzled by that. 

How are you making policy judgments without science? I mean, is 

that what is happening at EPA, that in fact, you are infusing policy 

into these decisions that are not based on science or without a scientific background? 

Dr. MCCLELLAN. In the CASAC review of the science in the two 

recent cases, the PM2.5 and then the ozone, they chose to set a 

bright line. They said in the case of the PM2.5 that the Administrator should set the annual standard and higher than 14 

micrograms per cubic meter. The Administrator renewed it at 15 

and they stamped their feet and said you didn’t follow our advice. 

Anybody knows that 14 is one integer less than 15 but to suggest 

that the science was so compelling that 14 was acceptable, 15 was 

not, that is a blending of policy and science. In the case of ozone, 

they said 60 to 70 PPb. They tried to sort of justify it by saying 

well, we gave you a range. I don’t presume to say that they would 

have stamped their feet if you had gone below 60 but they stamped 

their feet when the Administrator set it at 75 PPb. They actually 

had scheduled a meeting before the formal rule was announced, 

and at that meeting protested and said no, we told you 70 PPb, you 

set it at 75 PPb. Their advice was a blend of science and their personal policy preferences. There is no scientific methodology that 

can tell you this is where the standard should be set. That represents a policy choice exclusively delegated to the Administrator 

of EPA. 

Chairman HARRIS. Thank you. Thank you very much. 

Dr. THURSTON. I would like to respond to that. 

Chairman HARRIS. Well, I have a question for you, Dr. Thurston, 

because I only have about a minute left. Dr. Thurston, two questions. One is, one of your graphs kind of presumes that there are 

linear effects and some of the science assumes that there is a linear 

effect of increasing and decreasing exposure but we know from carcinogens, for instance, specifically that is likely not true, that at 

some low levels, you know, an effect seeing a reducing carcinogens 

at a higher level may not have the same effect on mortality as reducing the amounts at a lower level. So would you agree that the 

science about linearity of effect of air pollutants is not clear? 

Dr. THURSTON. Well, I would say the evidence we have is consistent, or certainly not inconsistent with a linear effect, and I 

think that, you know—— 

Chairman HARRIS. Right. Okay. Thanks. I just need a very simple answer because I have one more question. 

Dr. THURSTON. But you mentioned figure one does show the association going down to seven micrograms per cubic meter, well 

below the standard. 

Chairman HARRIS. I know, and it has a bunch of lines. I understand that. 

Dr. THURSTON. But in response to Dr. Smith’s comment—— 

Chairman HARRIS. I have to ask this question because this puzzles me. 

Dr. THURSTON. Go look at figure one. 
63 

Chairman HARRIS. In the past 20 years, and I have observed this 

being a physician even in the operating room, the incidence of asthma has clearly increased. The incidence and prevalence of asthma 

in the population has clearly increased in the past several decades. 

Would you agree with that? 

Dr. THURSTON. Yes. It is a multifactoral disease. 

Chairman HARRIS. Has air pollution clearly decreased significantly in the past several decades? 

Dr. THURSTON. Yes, but it is not the only cause of asthma. 

Chairman HARRIS. These are very complicated interactions; 

aren’t you afraid that we simplify them too much when we make 

statements as were made by the Assistant Air Quality Administrator here that hundreds of thousands of asthma episodes are 

going to be avoided if we change these standards when in fact 

there are hundreds of thousands more episodes since the last time 

we changed these standards? 

Dr. THURSTON. I think it raises a good point, that there is a 

whole pyramid of effects that are not measured by the system. In 

other words, I can’t answer that question because we don’t have 

good records of those hospital—you know, the asthma exacerbations, and that is not considered by the process, so we are really 

underestimating the benefits of clean air and the process the EPA 

is using today, and that is a good example. 

Chairman HARRIS. Thank you. And Dr. Thurston, by the same 

logic, I would say we may be overestimating the benefits by the 

very same example of the poor data we have. 

Anyway, I recognize Mr. Miller for five minutes. 

Mr. MILLER. Thank you, Mr. Chairman. This hearing is about 

process, but the process of the Committee I think also bears some 

scrutiny. It is very strange for the EPA’s processes to be the subject 

of this Committee’s hearing and for the EPA not to be present. I 

think most Americans understand fundamental fairness is that if 

you are going to be criticized in public, that you should be there 

to defend yourself, but the EPA has not been invited today, and in 

past hearings when they have been criticized, they have not been 

called to testify. 

There was a book about a famous singer of the last generation. 

I will not say his name although all of you know who I am talking 

about, because I think he denied this and his family denied this, 

but according to the book, the singer as a young man would go to 

bars, have too much to drink, get in fights, but then after he became famous and as a middle-aged man he would continue to go 

to bars and get in fights but the fights would be different. He 

would have his bodyguards hold the person he was in the fight 

with so he could punch them. This hearing does seem like one of 

those fights. The EPA is being punched and cannot punch back. 

Fundamental fairness does require that they be here and they are 

not. 

Also, the Chairman used the term ‘‘financial conflicts’’ to describe 

those involved in EPA decision-making, and I think that is something we should be concerned about. I think members of this Committee and the American people are entitled to know what financial interest anyone has who is involved in any process of government. That is why I criticize the Committee’s change in rules at 
64 

the beginning of this Congress to require much less in financial disclosure; the Truth in Testimony forms require all that a witness 

disclose is that they are being paid to testify at the hearing without 

any other disclosure of what their financial interests are, and we 

have had again and again witnesses whose entire livelihood comes 

from the industries whose interests are very much the subject of 

Committee hearings, and all we see on the financial disclosure 

forms are that they are not being paid to attend, they are simply 

public-spirited citizens. 

Just to pick on one of you, Mr. Cichanowicz, your information 

available on the Internet about you does say that you—and actually in the introduction it says that you do primarily work for utility industry clients. It does appear from the Internet that your clients have included Edison Electric, Midwest Ozone Group, American Coalition for Clean Coal Electricity, American Public Power 

Association, the National Rural Electric Cooperative Association. 

Mr. Cichanowicz, what percentage of your income comes from the 

utility industry? 

Mr. CICHANOWICZ. Probably 75 percent. 

Mr. MILLER. Okay. Do you not think the American people and 

the members of this Committee ought to know that in evaluating 

your testimony? 

Mr. CICHANOWICZ. It is evident, isn’t it? I mean, in my resume—— 

Mr. MILLER. Well, we had to ask about it. It was not available 

in the regular course of things. It is something that I have had to 

use my time to ask about today. 

Dr. Thurston, it seems like you could barely get a word out in 

response to Dr. McClellan’s statements and the questioning. Do you 

want to elaborate upon what you said earlier? 

Dr. THURSTON. Well, you know, I did want to just point out that 

first of all, I don’t remember any foot stamping in the CASAC process. But the fact is that the reason why there was a problem, this 

was the first time that the Administrator in many years of CASAC, 

that I know of, that the Administrator did not follow the advice of 

CASAC, and that is really what this whole problem was about, and 

that is why, of course, Administrator Jackson then went ahead and 

she said well, okay, the last Administrator wouldn’t follow CASAC, 

but I will go back to the tradition of following CASAC, and that is 

really in a nutshell what happened there. 

Mr. MILLER. Okay. I will yield back the little bit of time I have 

left. 

Chairman HARRIS. Thank you. 

I recognize the gentleman from California, Mr. Rohrabacher, for 

five minutes. 

Mr. ROHRABACHER. Thank you very much, Mr. Chairman. 

Let me just note that the personal attack on our witness was obnoxious and not reflective of higher standards that I have had here 

and you have also had, to my colleague from North Carolina. This 

type of personal attack is not acceptable. The fact is, every witness 

we ever have has some contact with the people that they are expert 

with. 

Mr. MILLER. Will the gentleman yield? 
65 

Mr. ROHRABACHER. No, not yet. The fact is, is that people who 

are expert tend to have worked in the industry in which they are 

expert, and the fact is that when you confront someone’s arguments, you confront someone’s arguments with better arguments or 

you challenge what they are saying by suggesting there is another 

explanation. That is totally within the area of acceptability with 

these kind of hearings. Just simply trying to dismiss someone on 

a personal level because of the way he has earned his living is just 

absolutely unacceptable to me. Anyway, let me go on with my questions now. 

Mr. MILLER. Will the gentleman now yield? 

Mr. ROHRABACHER. Yes, I will. Go right ahead. 

Mr. MILLER. Okay. Mr. Rohrabacher, do you not think the American people are entitled to know if a witness has financial interest, 

if they are employed by an industry whose interests are at stake 

in the hearing? I did not attack him personally but I said that—— 

Mr. ROHRABACHER. Let me just—— 

Mr. MILLER. And those were the questions I asked at our organizational meeting, why does our form not require the same law as 

it has in the past. 

Mr. ROHRABACHER. Reclaiming my time. The fact is, is that this 

witness’s background, his financial background is open in his resume. He stated that very clearly, and he is not hiding anything, 

and your line of questioning, which I might add, questioning the 

process rather than the arguments, which called into question our 

Chairman’s integrity was unacceptable as well, and this is just the 

type of thing that we see time and time again. It is the global 

warming approach as well, dismiss your opponents, do not confront 

their arguments, challenge them on their integrity rather than 

challenging the positions that they have taken. This is not acceptable, and that is one of the reasons we are having this hearing 

today is because the EPA may be suffering from that same type of 

mindset which is not consistent with good science and is not consistent with finding the truth. 

Dr. Thurston, you had some things you wanted to say, you wanted to confront, I would be happy to grant you time—you didn’t feel 

you had the time to confront some of the things, the points the 

Chairman was making. Go right ahead. 

Dr. THURSTON. Well, thank you. Well, I did get a few of those 

comments in anyway, but I was trying to refer to Dr. Smith’s testimony saying that, well, below the ambient—the NAAQS standards, 

that there is probably no proof that there were any benefits. But 

figure one of my testimony is from a study that I was principal investigator of, and there is the indications that the benefits do keep 

going down well below the standard to levels about seven 

micrograms per meter cubed. And the only reason probably we 

can’t show below that is we have no place in the country that is 

cleaner than that, that has a metropolitan area with enough people 

to study. 

Mr. ROHRABACHER. Thank you very much. 

Dr. McClellan, do you have something to say about that? 

Dr. MCCLELLAN. Well, again, that is a failure to place the science 

in context. If we examine the Thurston graph very closely, it shows 

confidence intervals around each one of those curves, and I think 
66 

you would be very hard pressed to suggest that there is even statistical significance in terms of those effects as we go down at that 

lower portion of the curve. What you are arguing, Dr. Thurston, is 

that the answer to how low is low enough is zero. I am saying that 

you have to have context in terms of making those decisions. I look 

forward to having an Administrator of the EPA who will make 

those policy judgments and not rely exclusively upon scientists who 

draw a bright line. 

Mr. ROHRABACHER. And Dr. Phalen, did you have something to 

comment on that as well? 

Dr. PHALEN. No, sir. 

Mr. ROHRABACHER. Okay. Thank you very much. 

I would just like to note, Dr. Phalen does come from the University of California at Irvine and we are very proud of the work that 

you do there and very proud of the work that the university is engaged in. 

Dr. PHALEN. We are very proud of you as well. 

Mr. ROHRABACHER. Thank you. God bless. 

Chairman HARRIS. Thank you very much, Mr. Rohrabacher. 

I now recognize the gentleman from California, Mr. McNerney. 

Mr. MCNERNEY. Thank you, Mr. Chairman, and I thank the witnesses for coming in today. 

Dr. Honeycutt, I was pretty intrigued by your quote that correlation is not causation. There is some truth to that. 

My question is going to be directed to Dr. Thurston. Dr. Thurston, how do scientists, in your opinion, determine causal relationships between pollution and adverse health effects? What is the 

right way to go about doing that? 

Dr. THURSTON. Well, as you pointed out, correlation does not necessarily mean cause and effect, but when you start to look at a 

broad-based knowledge base, you know, as I pointed out in my testimony, and basically we use the principles of Austin Hill that he 

developed to look at cigarette smoke. Back in the 1960s there were 

many of those who said well, really you can’t prove that cigarettes 

cause lung cancer, and so we went through many decades before 

people really accepted the fact that cigarette smoke and smoking 

cigarettes causes lung cancer. Believe it or not, people denied that 

for decades, and based on these same arguments that sometimes 

you hear about air pollution. So then he developed a whole series 

of things where you look for coherence between different endpoints, 

you look for a time sequence, you look for natural experiments like 

Dr. Pope’s experiment, well, study, where he followed the fact that 

when there was a strike and the pollution levels went down, the 

hospital admissions for children also went down, and then when 

the pollution—when the plant started up again, the pollution went 

up, the hospital admissions went back up again the following year. 

Mr. MCNERNEY. So, I mean, there is no yellow brick road for 

science. You have to look at it—— 

Dr. THURSTON. Well, you have to look at all the evidence, and 

one study is not enough, and you need to look at many studies and 

many different types of studies, and we have done that, and the 

evidence is clear that air pollution, increasing pollution causes increased adverse health effects. And decreasing pollution causes decreased health impacts and better public health. 
67 

Mr. MCNERNEY. I agree, but that is not what I hear from all the 

witnesses here. 

Dr. Honeycutt, do you think that the Clean Air Act is worth enforcing, and if so, who should enforce it? 

Dr. HONEYCUTT. Excellent question, sir. It goes back to what Dr. 

McClellan said. It is how low is low enough. What Dr. Thurston is 

saying is absolutely correct. But those levels that they were talking 

about are extremely high levels. There is no doubt that, you know, 

getting air pollution out of the milligram-per-cubic-meter range 

into the microgram-per-cubic-meter range has been a great benefit. 

But now we have reached the point of diminishing returns. You 

know, lowering the standard a microgram per cubic meter or two 

or a part per billion or two, that is in the statistical noise of health 

effects. You are not going to be able to see to measure those health 

effects, but they are going to cost billions of dollars to get. So the 

question now flips back to you. I mean, do you think that is worth 

the investment? It is not up to me as a scientist to make that call. 

Mr. MCNERNEY. Well, I don’t have enough scientific knowledge 

to understand how much one or two micromeasurements is going 

to make a difference. Is that within the realm, Dr. Thurston, of 

causality? Can we make determinations on those small differences? 

Dr. THURSTON. Well, sure. You know, I think that we do studies 

where we look at different places and look at the same place over 

time and are able to discern those differences. You need enough 

power, which is one of the quandaries we have is that the places 

where the people live tend to be the more polluted places, and the 

less polluted places don’t have as many people, so then it becomes 

more difficult to study at the lower levels. 

But I did want to pick up on something that Dr. Phalen pointed 

out, which is that the components of the pollution are important, 

and in fact, the most recent studies are showing that if you look 

at the components, like from traffic and from coal plants and from 

oil plants, and start looking at the various pieces and adding them 

up, you actually see larger effects than just looking at particulate 

matter in general where you just weigh it, and our studies have 

started to show this, and some of them we have published doing 

work for the Health Effects Institute and right now—— 

Mr. MCNERNEY. So there is room for more science here? 

Dr. THURSTON. There is, but what I am saying is, we are probably underestimating the benefits of clean air, and perhaps we 

should be looking at these—and I am agreeing with Bob here that 

we should be starting to look at more of the constituents, the way 

we did with lead. We looked at lead in particulate matter and controlled that. Maybe we have to start looking at the components because right now we are underestimating, I think, the benefits of 

clean air. 

Mr. MCNERNEY. Thank you. I didn’t expect you to end that 

quickly. 

I just spoke to a friend of mine from Iowa who I grew up with 

who has COPD and he said that just goes with being a farmer in 

Iowa, the dust that you breathe in, and so Dr. Smith mentioned, 

well, what is in the particles makes a difference, and I agree with 

that. I mean, if the dust particle has plutonium in it, that is a lot 

different than just having dust, but just the size of the particle by 
68 

itself makes a difference and has to be taken into consideration if 

we want people to remain healthy and don’t want to have to pay 

continually increasing health costs for our seniors. 

I yield back. 

Dr. THURSTON. But I don’t think that COPD should be a part of 

doing a job. I remember in the past people used to say well, when 

they smelled pollution, that was the smell of money, and you know, 

in reality, we have been able to run our businesses and clean up 

the air and, you know, our GNP has been rising at the same time 

the pollution levels were going down, so they are not really as 

closely linked as you might have been led to believe today. There 

are health benefits and also economic benefits of cleaning the air. 

I am guessing here, and one should never guess, but I am guessing 

that some of the equipment that was put on those plants were 

made right here in America, and we can have a lot of jobs and 

make a lot of money selling that pollution control equipment, saving lives around the world and making money, creating jobs cleaning the air. So I think that, you know, you have to look at the 

whole picture. 

Mr. MCNERNEY. Thank you. 

Chairman HARRIS. Thank you very much. I couldn’t agree more, 

you have to look at the whole picture. 

I recognize the distinguished gentleman from Florida, the Chairman, Mr. Hall—I am sorry, from Texas. 

Chairman HALL. I will move anytime. 

Mr. Harris, I won’t ask any questions. I just want to make a 

comment here that I probably shouldn’t make. You offered me the 

chance to ask three EPA witnesses a couple of weeks ago or so, and 

I said I wouldn’t believe any of them under oath, and I was with 

one of them later at a party and I wished I hadn’t said that. So 

I might say some things that I want to take back, but when Gina 

McCarthy came before our Committee and remarked about people 

that were out of work, she said ‘‘We are not in the business of creating jobs.’’ I think that is an insult to every person and every 

breadwinner that has been a breadwinner and had to look into the 

face of his children and tell them why he couldn’t and his wife and 

tell her why he couldn’t send her children back to school next year 

because he didn’t have a job. He had no job, very little hope and 

a whole lot of heartbreak. I think that is the kind of testimony we 

are getting from them. She didn’t use any science when she gave 

us that really smart aleck remark that hurt a lot of people. 

And Mr. Miller, the great lawyer who came here, I think, because he is a great attorney, but I understand he had the right to 

ask for a witness. I don’t know if he did or not but if he didn’t, he 

could always appeal to me, and of course, I would have told him 

to go back to you. I think he had an opportunity to have a witness 

if he wanted, and he threw the skunk into the jury box and then 

left. I didn’t get a chance to tell him that in person. 

Chairman HARRIS. Would the Chairman yield? 

Chairman HALL. I have high regard for Mr. Miller, a minimum 

high regard for him. 

Chairman HARRIS. Thank you. Would the Chairman yield? 

Chairman HALL. Yes, I yield the rest of my time to you. 

Chairman HARRIS. Thank you very much, Mr. Chairman. 
69 

Yes, I would like to respond to that. As you know, Mr. Chairman, 

the minority always has the opportunity to invite any witness they 

would like. They clearly could have invited someone from EPA. We 

extended an invitation to the current Chair of CASAC and they 

weren’t able to attend. I mean, the bottom line is, we tried. You 

know, we can’t drag them in, as you know, Mr. Chairman, but we 

tried. 

In response to the consults don’t disclose enough information, 

this was an astounding line of attack on this panel of witnesses. 

Every expert in the field has financial paths back somewhere, everyone. Look, I was an expert on obstetric anesthesiology and fetal 

physiology. I got money from the NIH. Clearly, I had an interest 

in that research being done because I got funding, supported my 

salary. I suspect Dr. Thurston gets funding for it. I suspect that 

you could easily presume all that from reading anyone’s biography 

that is submitted to this panel. I just wanted to point for the record 

those biographies are part of the record. They are made part of the 

record. They were supplied to the minority. Nothing was hidden at 

all, just so we clear the air on that, if you pardon the pun. 

Now, Dr. Thurston, I have got to ask you a question here, because, you know, it is always comfortable to assume well, you 

know, if you got a little bit of something that is bad, then if you 

have more, it must be worse, and if you have less, it must be better. Let us take mercury because I think Dr. Honeycutt—I mean, 

the science behind mercury is fascinating because I had read this 

but had forgot about it years ago, that, you know, the EPA’s blood 

level for safety is 10 times less than what the Faroe study showed 

is safe based on epidemiology, and in fact there is evidence that as 

you increase exposure to mercury because you also increase exposure to the other fatty acids that are obtained in those same fish 

that in fact you could have an improvement in neurologic development. Now, that flies in the face of examining mercury by itself 

and saying well, you know, 58 is good, 5.8 must be better. Well, 

that is not true. That is just not what the scientific—so although 

it is attractive to say that—I mean, would you agree that that is 

one of the stories of the mercury standards? 

Dr. THURSTON. Well, I can’t profess to be an expert on the toxicity of mercury. 

Chairman HARRIS. Do you disagree with Dr. Honeycutt’s testimony? I mean, you are—I don’t know. I guess—so you are not an 

expert in other air pollutants besides particulate matter? 

Dr. THURSTON. Well, no, but mercury is a toxic metal, and I have 

not spent my time studying it, but it is true, you know, when you 

look at metals, each one is unique and you really have to look at 

that one. Like fluoride is—— 

Chairman HARRIS. Sure. Let me just—and I hate to interrupt 

you but—— 

Dr. THURSTON [continuing]. Is a nutrient at low levels, and toxic 

at high levels. 

Chairman HARRIS. So just like when we look at particulate matter, PM2.5, I mean, there are numerous different things that can be 

a particulate matter of that size, some of which may be less toxic, 

some of which may be much more toxic, but the EPA doesn’t distinguish, does it? It says this is the level for any particle of that size. 
70 

Dr. THURSTON. It has been a process. They started out originally 

collecting all particles in the air, total suspended particulate matter, and then we moved to PM2.5, which are particles small enough 

to pass the trachea. In other words, they said with the particles 

that you can’t even breathe, we are not going to monitor those, and 

then now we have gone to PM2.5, which are very fine particles that 

get deepest in the lung, and we monitor that most closely, although 

we are still looking at the other particles that can get into other 

parts of the lung, the PM2.5 minus PM2.5 or the coarse particles, 

that is something that is being investigated and indirectly can be 

controlled through PM2.5 standards. But that is under consideration by CASAC and EPA what the coarse particle standards 

should be. 

But then the next step is to, as you say, to go to what the composition is, and what I am telling you is, when we have started 

doing that, what we are finding is, the sum of the parts is greater 

than that whole. So it is not an exact measure of the toxic pollutant but by being so we have uncertainty and the estimates, therefore it is reducing. 

But I did want to comment—— 

Chairman HARRIS. Dr. Thurston, we are way, way over. 

Dr. THURSTON. I know, but you brought my name up—— 

Chairman HARRIS. If we have a second round, you will get it, 

okay? 

Dr. THURSTON [continuing]. Vested interest. I have never taken 

money from vested interests. That is an important distinction here. 

Chairman HARRIS. You don’t consider government funding a 

vested interest? I think the American public would disagree with 

you. 

Chairman HALL. Mr. Chairman, my time is expired. 

Chairman HARRIS. Thank you for yielding back the balance of 

your time, Mr. Chairman. 

I recognize the gentlewoman from California, Ms. Woolsey, for 

five minutes, and you can take extra. 

Ms. WOOLSEY. Thank you, thank you. 

Mr. Cichanowicz, I was going to call you witness number six 

until I realized I could say your name. I was taken by your graph 

chart picture of how difficult you thought it was for the utilities to 

put in control devices. Do you have any kind of picture or graph 

or comparison that tracks the results of not taking care of our 

clean air, of what happens when our air is poor, when our kids are 

getting asthma, when our workers are unproductive because they 

have got respiratory disease, because of the cumulative impact of 

not just your industry but all industries and cars and people and 

airplanes, the effect this is having and the cost to our health care 

system? How does that compare with putting some control devices 

into some of the utilities? Do you have anything like that? 

Mr. CICHANOWICZ. Those issues are out of my skill set. 

Ms. WOOLSEY. Well, see, we ought to have that because the 

check and the balance of this whole thing is not just about an industry, it is about the people and the costs of keeping people 

healthy in the United States of America, and clean air is a huge, 

huge part of that. So I just wanted to say that. 
71 

So Dr. Thurston, okay, CASAC got a lot of criticism. As I was 

coming in I heard a lot of CASAC this, CASAC that. You were part 

of CASAC? 

Dr. THURSTON. I have served on a panel, yes. 

Ms. WOOLSEY. You served on the panel. You know, there were 

public forums. What did the public say when they came before the 

commission? Is it a commission? 

Dr. THURSTON. Well, it’s a committee. You know, there is a public comment period but that is usually people like the American 

Lung Association come forward, and they are obviously very supportive of cleaner air because they are trying to prevent lung disease. 

Ms. WOOLSEY. Well, then aren’t they trying to destroy business 

around the country by saying things like that? 

Dr. THURSTON. I am unaware of that agenda. No, they want to 

clean air and bring better health to people, and decrease our health 

care costs. In other words, if you clean the air, fewer people will 

go to see their doctors, fewer people will have to end up going to 

the emergency room, fewer people will have to check into a hospital, and you actually lower your health care costs when those 

events are fewer. And if we don’t control the air, then obviously we 

are increasing the health care costs relative to what they would be. 

Ms. WOOLSEY. And isn’t the cost of health care also a burden on 

business? 

Dr. THURSTON. Yes. 

Ms. WOOLSEY. So I mean, doesn’t that offset the cost of—— 

Dr. THURSTON. And the American people, yes, and that is something that I think is worthy of spending time trying to reduce. 

Ms. WOOLSEY. That is clear. 

Okay, now, all of you, many utilities have already installed control devices. If EPA hadn’t had those regulations or if they pulled 

back on the regulations, what kind of incentives will there be for 

them to make these changes? I mean, why would they do it? Are 

they going to do it? Mr. Cichanowicz, is the utility industry going 

to live up to good-faith effort in this regard? 

Mr. CICHANOWICZ. The issue I came to discuss was the time it 

takes to deploy technology. I don’t think the topic of whether you 

do it or not is separate. All I am saying is the time that it takes 

and the schedule. That is what is key in my testimony and that 

is what is key in trying to put these systems in. 

Ms. WOOLSEY. Okay. How about you, Dr. Smith? Do you have 

any idea what would happen if we didn’t have these regulations? 

Dr. SMITH. There are air quality standards that are in place and 

those air quality standards will cause power plants to put these 

controls in if there are in areas where there is nonattainment. My 

point was that the regulations need to be considered on the merits 

of their own benefits and their own costs, and there are a significant number of regulations that are going into place that don’t 

have benefits anything close to their costs. 

Ms. WOOLSEY. Well, costs within the industry, not costs for the 

heath care costs in the country. 

Dr. SMITH. Costs compared to their benefits. The benefits include 

the health care costs, and those are part of the whole cost-benefit 

framework. 
72 

Ms. WOOLSEY. Dr. Phalen? 

Dr. PHALEN. Yes, ma’am. Thank you. That is an excellent question. My experience in California has been that utilities such as 

Southern California Edison have supported the research, and I 

have seen some of the strongest advocates for clean air as employees of industry. 

Ms. WOOLSEY. Except for Mr. Rohrabacher, aren’t we Californians considered the kooks of the world, that we do things because 

they are the right thing to do and we won’t have any business in 

our state even though it is the eighth economy in the world and 

all that because we do have these regulations? 

Dr. PHALEN. EPA’s national air standards are called NAAQS, 

and for a while California’s were called CAAQS. 

Ms. WOOLSEY. But ours work. 

Dr. PHALEN. But I am firmly against there being a war between 

industry and the public or industry and regulators. I would like to 

see a comprehensive evaluation of public health because we know 

industry is important to public health and we know clean air, as 

you aptly pointed out, is important to public health. So I see the 

need to cooperate rather than battle, because whoever wins—— 

Ms. WOOLSEY. I agree with you totally, and Dr. Honeycutt, if 

they let me, I will come back to you, but I am going to ask Dr. 

Thurston a question. 

Chairman HARRIS. Yes, we will have one abbreviated second 

round. Is that okay? 

Ms. WOOLSEY. I know, but I am not supposed to be here after 

this. 

Chairman HARRIS. I will give you 30 more seconds. 

Ms. WOOLSEY. Thirty-one seconds? 

Chairman HARRIS. Thirty more. 

Ms. WOOLSEY. Thirty more seconds. So Dr. Thurston, is not— 

don’t you come to the Science Committee thinking that science is 

what we are supposed to rely on for our information, and—— 

Dr. THURSTON. Yes. 

Ms. WOOLSEY [continuing]. Doesn’t it seem kind of counterproductive that we might think we should have a study on what 

happens to health care overall? Isn’t there a worry that then the 

scientist will come to us and say oh, my gosh, what do we need to 

do with our air and then this committee will say oh, well, but we 

don’t want to believe that science. 

Dr. THURSTON. Well, it is about sound science, and that is the 

role of CASAC, to make sure that sound science is leading the EPA 

in their decision making, but you have to remember that after this 

the OMB, Office of Management and Budget, does a thorough analysis, economic analysis, that has been required since the Clinton 

Administration to show that the economic benefits outweigh the 

economic costs, and they would not have any of these regulations— 

don’t worry about the fact of the benefits, because they are going 

to far outweigh the costs or the regulations are not going to go forward. That is the way it works. So, you know, we have also got to 

consider that there is another process that follows the Administrator’s decision, which is that by OMB that does these economic analyses and does consider the costs, and the benefits have always outweighed of clean air. There is something like—you know, it ranges 
73 

depending on the decision but a good rule of thumb is maybe what 

Benjamin Franklin said: An ounce of prevention is worth a pound 

of cure. And oftentimes we see about a 16-to-one valuation of the 

benefits to the costs. 

Chairman HARRIS. Thank you very much, Ms. Woolsey. 

We have enough time since we are here until noon to have a second round of questioning for five minutes, and I will recognize myself for the first second round here. 

Let me just ask Mr. Cichanowicz, because you are an expert in 

these systems and installing. What percent of these pollution reduction systems have been installed in the past 30 years as opposed to before then? 

Mr. CICHANOWICZ. Well, the bulk of them have been installed—— 

Chairman HARRIS. Close to 100 percent? 

Mr. CICHANOWICZ. Yes. 

Chairman HARRIS. Okay. When was the last time we had an unemployment rate of nine percent. Was it 30 years ago? So we have 

never had to install pollution control of this magnitude and cost 

during a period of recession like we have right now. Would that be 

correct? I mean, on the order of magnitude of what we are talking 

about. 

Mr. CICHANOWICZ. I believe so. 

Chairman HARRIS. Those are just facts, I mean, and we can discuss facts. We have not had an unemployment rate of 9.1 percent 

since the early 1980s, and almost 100 percent of these pollution 

controls that we are talking about have had to be installed in periods when we have not had unemployment. So the point to making 

this decision in a vacuum of jobs. Now, if we have a 16-to-one benefit, I know how to solve our debt problem: spend $1 trillion on air 

pollution reduction and we solve our national debt because we have 

a $16 trillion benefit. It is ridiculous on the surface to believe there 

is a standard of 16 to one, every dollar you spend on this you get 

$16 worth of benefit. It is patently ridiculous on the surface. That 

is my editorial comment. 

Dr. Smith, let us get to mercury because we just had a hearing 

about these mercury standards, and my understanding based on today’s testimony how this decision was made in your testimony almost none of the benefit claimed from that mercury standard—the 

heart attacks, the asthma, you know, you hear the whole litany, 

same litany over and over for every single one we have a hearing 

on this. None of them really come from mercury, do they? They all 

come from the co-benefit or the double counting of the particulate 

matter. Is that right? 

Dr. SMITH. Six million dollars of the benefits out of the $150 billion comes from mercury—— 

Chairman HARRIS. That is close enough to nothing. Okay. 

Dr. SMITH [continuing]. Change of 511 IQ points in total aggregate across some 30,000—anyway, a large number of children. 

Chairman HARRIS. And Dr. Smith, if I might just interrupt, that 

would presume that the Faroe study is inaccurate and that in fact 

by lowering mercury exposure you absolutely get a reduction. 

Dr. SMITH. It is presuming that as you reduce the tiny bits of reduction in mercury and get tiny IQ benefit increases. 
74 

Chairman HARRIS. Could you just briefly, because I have about 

two minutes left, just go by this double counting deal again? Because it always amazed me, the testimony was always the same. 

The EPA would come in and say yes, if we do this rule, we get 

34,000 less deaths, 150,000 less asthma attacks, 15,000 less heart 

attacks, and we kept on hearing the same thing over and over 

whether it was ozone or mercury or whatever. I am thinking this 

is pretty amazing because when I went to school, I didn’t think 

mercury caused heart attacks. So could you go through this double 

counting for the Committee once again? 

Dr. SMITH. If I can just take the Utility MACT that has 17,000 

deaths. As I was saying, 4,000 of those are due to exposures to PM 

that are between 11 micrograms per cubic meter and 15 

micrograms per cubic meter. All 4,000 of those are due to attainment of the current safe standard for PM, but if EPA tightens the 

standard down as low as 11, which it is considering doing, those 

are benefits from the PM standard if those occur. All the rest, if 

EPA does not tighten the standard below 11, it is saying that all 

the rest of the benefits, the other 13,000 of them that is in that 

co-benefits case, aren’t really credible enough in order to protect 

the public health from them. Otherwise EPA should just set the 

PM standard lower, and EPA is not prepared to do that. It said it 

is not prepared to go below 11, and that indicates the degree to 

which those extra 13,000 are just not credible. 

Chairman HARRIS. And you also, I think, in your testimony mentioned not only that but that it counts them in one case but not 

the other. It uses the old standard for the PM when it considers 

PM deaths but the new standard when it looks at all the other 

ones. Was that in your testimony also, in your written testimony? 

Dr. SMITH. Well, what is happening here is, they are putting the 

cart before the horse. They count the benefits by putting them into 

co-benefits for a MACT that has no benefits of its own. And then 

later it doesn’t really have them perhaps to count again for the PM 

rule but it doesn’t need them because they have still got that huge 

reservoir to keep counting up against in order to justify the PM 

rule, so basically taking benefits from the rich, which are the PM 

benefits, and spreading it all around to the other regulations that 

don’t have any benefits of their own to create a complex web of regulation, when in fact the right way to do this and the cost-effective 

way to do this for our society is to go after the problem directly and 

decide where to set the PM standard. 

Chairman HARRIS. Thank you very much, Dr. Smith. 

The gentleman from California, Mr. McNerney, is recognized. 

Dr. THURSTON. I would like to respond to that, if I could. 

Chairman HARRIS. If Mr. McNerney agrees, you will be more 

than welcome if he yields time to you. 

Mr. MCNERNEY. Thank you, Mr. Chairman. 

I just want to say a word or two about the controversy that was 

brought up with Mr. Miller’s questioning. It has become standard 

for vested interests to bring pseudoscientists forward that are paid 

for by vested interests to perpetuate the status quo that started as 

Dr. Thurston brought out on smoking. It is being brought out on 

global warming. We are seeing it brought out now. So I think it is 

perfectly appropriate to try to understand what the witnesses’ in-
75 

terests are and how it is being paid for. So I think he was perfectly 

justified in those questions, and I didn’t take those as an attack on 

any particular witness. 

The thing I want to ask about is to follow up with Lynn 

Woolsey’s question about the benefits or the pollution equipment 

that has already been installed in power plants and the benefits of 

that installation, and I think Dr. Thurston sort of hit it on the 

head. Developing technology to clean up our air quality is an important economic driver. For example, how many people were employed when that equipment was put in the power plants there 

that you are discussing? We employed probably thousands of people 

or more putting in that equipment, and the United States developed that equipment, and now we are able to sell that to other 

countries. So no, I don’t buy the argument that this is entirely detrimental to our economy to have clean air. I think the opposite is 

absolutely true. So one of the things I would like to point out is 

the cap and trade that was employed to reduce sulfur dioxide in 

New England and the northeastern states, the cost was a fraction 

of what the industry was predicting it would be. The benefits were 

enormous. We developed technology that put us ahead of the curve. 

So I would like Dr. Thurston to respond to that. 

Dr. THURSTON. I certainly agree. I wanted to bring up the point, 

though, that, you know, there seems to be—you know, in Dr. 

Smith’s testimony, she started saying well, we can’t—shouldn’t 

take credit for the things that happen at the same time. In other 

words, when you go to clean up, let us say, mercury, you put on 

control equipment which also captures particulate matter. Well, 

certainly, they are going to be controlled and they would not otherwise be controlled. There are many power plants in the United 

States. Because of the way the Clean Air Act was written by Congress, the assumption was that older plants would go out of service 

and they were grandfathered in, and there are many plants, coalfired power plants, that are spewing pollution virtually uncontrolled relative to the technology we have today, and I think what 

is happening here is that this rule, by putting on proper particulate 

matter controls and vapor controls, is closing the loophole on these 

really gross emitting—they are the low-hanging fruit of air pollution in the United States, these power plants. In other words, this 

is the biggest bang for our buck that we can get. If we are going 

to control air pollution, I do think cleaning up these coal-fired 

power plants that have been operating under this grandfather 

clause is a really efficient way to clean up our air and get the 

health benefits that would accrue, and they certainly can because 

they are not going to happen anyway. 

Mr. MCNERNEY. Are we going to create jobs implementing this 

low-hanging fruit that Dr. Thurston is referring to? 

Mr. CICHANOWICZ. It certainly takes people to build and design 

the power plants, yes. 

Mr. MCNERNEY. Thank you. 

I think I will yield back. 

Chairman HARRIS. Thank you very much. 

I now recognize the gentleman from California, Mr. Rohrabacher. 

Mr. ROHRABACHER. Thank you very much. 
76 

Just to get on with our little discussion as to what standards we 

should have here in dealing with one another on a civil and honest 

basis, I think it is really more important to try to challenge witnesses based on the arguments that they are presenting, rather, 

the facts that they have and their suppositions they are making 

rather than trying to discredit them and dismiss them and perhaps 

smear them as people who lack integrity in terms of what they are 

saying. I found that to be more important and the best way to go. 

I have very strong opinions, and I certainly don’t challenge someone’s integrity, and I would not think of asking Dr. Thurston, well, 

how many grants have you gotten from the EPA to do your studies, 

blah, blah, blah. I wouldn’t think about that. I think about what 

is he saying, what is he arguing, and this idea that we are trying 

to discredit witnesses rather than confront what they say and challenge them is out of line. 

Dr. THURSTON. May I respond to that? 

Mr. ROHRABACHER. No, you can’t. You don’t run this hearing, 

and I have a very limited amount of time, but I will at the end give 

you a chance to comment on my comments. 

Let me just note, I disagree totally with the idea that the American people were smoking because somebody told them a lie and 

would not testify in Congress that smoking causes cancer. My 

brother died of cancer. I was after him for years to quit smoking. 

He knew exactly what he was doing. He was addicted to nicotine, 

all right? And he couldn’t break the habit along with other people. 

We all know that. It wasn’t that they don’t know and didn’t know, 

and so I deny that supposition. 

Dr. Thurston, would you like to comment on that? No? Okay. 

Dr. THURSTON. Well, I mean, I will just say that there was a controversy at the time for decades where the cigarette—maybe you 

knew and your brother knew, but the cigarette companies certainly 

did not admit that their product caused those effects. 

Mr. ROHRABACHER. Let me just note, I think the idea that the 

American people didn’t know that cigarette smoking was harmful 

to their health is not something that I believe is the case. 

Now, we are talking about the benefits of cleaner air, and let us 

just note that obviously breathing cleaner air is an important—is 

something good for your health if that cleaner air is above—is already above the threshold of being unhealthy or being healthy if 

you are going to—in other words, what is the air at right now? If 

you breathe more air in and it is above the threshold that will 

make you unhealthy, then it will not have that impact of being 

healthy. I think that is the point that we have heard made here. 

And one last thing. Mr. Chairman, I ask the kids from my district every time they come in to see me, and I see every child that 

I can from my district, and I always ask them when I come in the 

classroom, how many of you think that the air in southern California was better when I went to high school there 45 years ago 

or is it better today, and 90 percent of these kids, maybe 95 percent, say the air pollution in southern California is so much worse 

today than it was when you were in school, how lucky you were 

to live at a time when you are not being poisoned by these terrible 

people in industry, and in fact, it is just the opposite. It is 180 degrees the opposite. The air in southern California is so much better 
77 

now than when I was their age and yet they are being lied to and 

they are being scared to death and they are being—and the people 

who are trying to put it in perspective are having their arguments 

dismissed and having their credibility challenged rather than their 

arguments being challenged. So I would hope that we have a little 

more honest discussion, we don’t try to frighten people into behavior that will destroy our economy and put people out of work and 

cause a lot more anxiety. 

One last point: I have 10 seconds. I do believe in cleaner air, obviously. We should all believe in cleaner air. I would hope that we 

develop the small modular nuclear reactors that the nuclear industry, which has been opposed by these very same environmentalists 

over the years, I would hope that we can get together and support 

nuclear energy as a solution which we all can agree upon. Thank 

you very much. 

Chairman HARRIS. Thank you very much, Mr. Rohrabacher. 

The gentlewoman from California is back, so Ms. Woolsey, you 

are recognized for five minutes. 

Ms. WOOLSEY. Thank you, Mr. Chairman. 

Dr. Thurston, as you have heard, many members of the majority 

party have stated that EPA develops regulations based upon faulty 

scientific evidence, and could you explain to us how the science 

that underpins EPA regulations is peer reviewed and the importance of peer-reviewed science? 

Dr. THURSTON. Well, certainly. I did want to respond, if I 

could—— 

Ms. WOOLSEY. You may. Go ahead. Use my time. 

Dr. THURSTON. The Congressman wouldn’t ask me about whether 

I am funded by EPA for research, when in fact, that is what the 

form asks. It asks, have you had federal support. It does ask that 

but it does not ask, do you have funding from any vested interest, 

and I do think that it is a valid thing to get a balanced picture of 

the full information. In other words, consider the source, and to 

have not only where people get their funding from the government 

but where they get their funding from other places as well so, you 

know, have equal opportunity of information gathering. And right 

now, the form did ask where have you gotten your funding from 

the government, but not where I have gotten it from, from industry 

or vested interests. 

Anyway, but in terms of the question of the peer-reviewed 

science, yes, you know, it is very important, the process that EPA 

goes through where they have their staff along with experts that 

they hire, mostly from the academic community, and they go 

through the literature and they evaluate the reports that are out 

there, and using peer-reviewed things, things that are published in 

the literature where the peers of these people have reviewed it, not 

just a report that has been put out by an interest group or by the 

government. It has to be a peer-reviewed document, and then that 

is looked at collectively and the whole picture for various health 

outcomes and they evaluate each health outcome in terms of 

whether, you know, it is inconclusive or conclusive or suggestive 

that there are effects, so they go through and they rank out the effects and see what they think is really well supported and conclusive, and then based on those things—— 
78 

Ms. WOOLSEY. Do things change because of their review? I 

mean—— 

Dr. THURSTON. Well, that is why they do the review every five 

years. Science is constantly changing, and one of the things that 

we do find is that as we clean the air, more and more people are 

living in cleaner air, as the Congressman pointed out, although 

there are parts of California that have gotten worse—the central 

valley of California. You know, L.A. has improved, but the central 

valley of California has gotten worse in the recent years as it has 

become developed. It used to be an agricultural area. Now it is well 

developed. And so the pollution levels are actually rising in California in some places, but the question—well, I have lost my train 

of thought here. But, you know, the science does change over time, 

and generally, as I was saying, the pollution levels as they go 

down, we are able to have more people living in cleaner areas, so 

we are able to study that. If you don’t have any people living in 

clean areas, you can’t study it. I mean, part of the reason why we 

don’t see effects at very low levels, or unable to show them definitively, is because we don’t have enough people living in clean air. 

If we have cleaner air, then we will be able to test that hypothesis, 

and that is one of the limiting things. But over time we are learning more and more, and we are learning about more health outcomes. Neonatal and pregnant mother exposures is an active area 

of interest that we are finding more and more evidence that suggests that exposures to mothers and young infants are very important to future health, not only their health at the time but future 

health throughout their life, so and it is the California children’s 

health study that is following children over time and learning more 

and more about what childhood exposure affect. So it is a learning 

process, and as time progresses, we learn new things, and so that 

is why the standards get evaluated. 

But I must point out that the standards don’t always go down. 

They have gone up based on this assessment. During the Carter 

Administration, the ozone standard was actually increased, and so 

CASAC does not always recommend, as Dr. McClellan might sort 

of imply, that we always are lowering and lowering. In fact, there 

is a history of CASAC when the evidence did not support the 

present standard saying it should be higher. So there is a record 

going both ways on this. 

Ms. WOOLSEY. Okay. I have 16 seconds. Is there anything you 

want to say that you didn’t get to say in your testimony or in your 

answers? 

Dr. THURSTON. Well, I did appreciate the point that was made 

by the Congressman that as you breathe more air, you get more 

effects, and we have found that exercising adults, if you go out on 

a polluted day and exercise, that increases the adverse health effects. And so the advice is always, well, stay indoors on these high 

air pollution days and don’t exercise. But Americans should exercise more, so I think what we really have to work toward is getting 

cleaner air so that we can exercise every day, not just on the nonpolluted days. 

Ms. WOOLSEY. Thank you very much. 

Chairman HARRIS. Thank you very much, and before we adjourn, 

I want to thank the witnesses for their valuable testimony and the 
79 

Members for their questions. I know there were issues about potential conflicts of interest. You know, it is worthy to note that of the 

seven CASAC members now, five of them receive funding from the 

EPA, and we have to decide whether that in fact is a vested interest that may affect the members of the CASAC. 

Anyway, the members of the Subcommittee may have additional 

questions for the witnesses, and we ask you to respond to those in 

writing. The record will remain open for two weeks for additional 

comments from the Members. 

Again, I want to thank you all for a very informative hearing. 

The witnesses are excused and the hearing is now adjourned. 

[Whereupon, at 11:51 a.m., the Subcommittee was adjourned.] 

(81) 

Appendix 

ANSWERS TO POST-HEARING QUESTIONS
82 

ANSWERS TO POST-HEARING QUESTIONS

Responses by Dr. Roger O. McClellan, 

Advisor, Toxicology and Human Health Risk Analysis 

Questions submitted by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment 

Q1. During the hearing, Dr. Thurston stated that ‘‘there is a history of CASAC when 

the evidence did not support the present standard, saying it should be higher.’’ 

Q1a. In your view and experience with CASAC, is Dr. Thurston correct that there 

is a history of recommending less stringent standards? 

A1a. The quote attributed to Dr. Thurston is correct. Unfortunately, he did not specifically identify the situation to which he was referring. If he had done so his quote 

would likely have conveyed a different picture. My experience with the setting of 

National Ambient Air Quality Standards (NAAQS) goes to the early 1970s and predates the Clean Air Act Amendment of 1977 which called for the EPA Administrator 

to seek the advice of a committee of scientists, a committee which is now known 

as the Clean Air Scientific Advisory Committee (CASAC). 

The situation that Dr. Thurston refers to is probably based on the actions of an 

ad hoc Sub-Committee of EPA’s Science Advisory Board chaired by the late Dr. 

James Whittenberger that advised on the revision of the Ozone NAAQS that occurred in 1979. The Whittenberger Subcommittee pre-dated the organization of 

CASAC. The original NAAQS for Ozone set in 1971 had a one-hour averaging time 

and was set at 0.08 ppm measured as photochemical oxidants. The Whittenberger 

Subcommittee advised that the numerical level for the one-hour averaging time be 

increased to 0.12 ppm measured as ozone. It was the opinion of the ad hoc Committee that with the change in the measurement method, the numerical level should 

be changed to provide equivalent health protection. The standard with the new indicator, ozone instead of photochemical oxidants, and set at 0.12 ppm ozone averaged 

over one hour was issued on February 8, 1979. The point at which the Standard 

was attained was also revised to ‘‘When the expected number of days per calendar 

year with maximum hourly average concentrations above 0.12 ppm is equal to or 

less than one.’’ A complete exposition on the matter by Dr. Thurston would have 

conveyed a different impression than his ‘‘sound bite’’ statement. I think his statement is misleading. 

Q1b. What motivates members of CASAC to recommend a lower or higher standard? 

A1b. In responding to this question it is important to provide some background information on what has been referred to as CASAC. The Clean Air Act specifies that 

a committee to provide advice on the setting of the NAAQS shall consist of seven 

individuals. Further, it specifies that one individual shall be a member of the National Academy of Science. This has been broadly interpreted to mean an individual 

who is a member of the National Academy of Sciences, National Academy of Engineering or the Institute of Medicine. The Act also specifies that one member shall 

be a physician and one member shall represent State air pollution control agencies. 

The CASAC members are appointed by the EPA Administrator for a two-year 

term that may be renewed for a second two-year term. The EPA Science Advisory 

Board website described an orderly and transparent process for making appointments to advisory committees. In actual practice the selection process is conducted 

behind closed doors by the EPA Science Advisory Board staff. It is not known to 

what extent personnel from the EPA’s Office of Air Quality Planning and Standards 

participate in the selection process or other EPA officials from outside of the Science 

Advisory Board office, including the Administrator’s senior science and policy advisors. 

In actual practice, the seven members of CASAC rarely meet, deliberate or offer 

written advice solely as a seven-person committee. Most often, the seven CASAC 

members are supplemented by an additional six to 15 individuals who are appointed 

as consultants for a specific review, i.e., the CASAC Ozone Review Panel served 

through the review that concluded in March 2008 or the Particulate Matter Review 

Panel that served through the review that concluded in October 2006. The EPA and 

many others regularly refer to the CASAC Panels as though they were the sevenperson CASAC. It is necessary to carefully review minutes or letters related to 

CASAC activities to discern whether the functions were carried out by CASAC or 

a specific CASAC Panel consisting of both official Committee members or CASAC 

augmented by consultants. 
83 

Let me now turn to the question of what motivates CASAC members and consultants. First, I can only relate that my service as Chair of CASAC (1988–1992) and 

as a member of numerous CASAC Panels was motivated by a desire to serve the 

public by offering advice to the EPA Administrator on scientific matters of air quality of which I was knowledgeable and which I recognized were of enormous scientific 

and societal importance. I always viewed the scientific advice I and my colleagues 

offered as being of substantial value to the EPA Administrator in making difficult 

policy decisions informed by the relevant science. 

I suspect many CASAC members and consultants were motivated in the same 

manner as I was motivated. In other cases, and especially over the last several decades, it is my impression that some CASAC members and consultants have also 

been strongly motivated by a desire to have scientific publications they authored 

used in the setting of the NAAQS and, in some cases, a desire to see that more 

stringent standards were set. In my opinion, during some reviews a strong anti-industry bias has been evident. In some cases, individuals use the ‘‘cigarette industry’’ 

and how knowledge of the health risks of cigarette smoking developed over the decades as being prototypical of ‘‘all industry.’’ In some cases, the view has been expressed that if standards are set lower, industry will find a way to meet them. In 

my opinion, posturing these complex issues as science versus industry is totally inappropriate. The issue is really how can the science and the settings of NAAQS best 

serve Society as a whole. 

It is also important to recognize that a substantial ‘‘clean air research enterprise’’ 

has developed, especially over the past two decades. Many individuals are motivated 

to see the research aspects of the enterprise continued with sustained and, perhaps, 

even increased funding. Thus, some like to point to the science used in the setting 

of the various NAAQS as justifying both past as well as additional future research 

support. The research endeavors in many ways have shifted from the conduct of 

‘‘issue-resolving’’ research to ‘‘issue-perpetuating’’ research to be continued through 

a career of current investigators and their trainees. 

I have a personal concern that the focus on air pollution, at current levels in the 

USA, may in a perverse way be negatively impacting on our efforts as a society to 

have a positive overall impact on public health. It can be argued that for a number 

of health endpoints air quality accounts for less than 10% of the attributable risk. 

Would we as a society achieve greater progress by focusing attention on the 90% 

or more of attributable risk related to other risk factors? I think so. My concern is 

that a narrow focus on a single risk factor, air quality may be misguided. Concern 

over asthma is a great example. There is no question that asthma rates in children, 

especially in inner cities and minorities, have been increasing in recent years. At 

the same time air quality has been dramatically improved. In my view it does not 

make sense to keep trumpeting air pollution as a major concern for influencing 

asthma and to continue to sponsor research on the link between air pollution and 

asthma. I think our scarce national resources, both dollars and scientific expertise, 

would yield a better return by focusing on what causes the disease rather than on 

a single risk factor—air quality. 

Q2. There was some discussion about the independence and impartiality of CASAC 

during the hearing. You previously served as the Chair of CASAC, as well as 

on individual panels. 

Q2a. What are the major strengths and weaknesses of the current CASAC process? 

A2a. The major strength of the NAAQS setting process, including the role of 

CASAC, is that it should provide an orderly process for the periodic review of the 

science under-girding the policy judgments that must be made in the setting of the 

four elements of each NAAQS [(a) the indicator, (b) averaging time, (c) numerical 

level and (d) statistical form)]. I have several concerns with the NAAQS process as 

it has evolved, especially during the past two decades. I am very concerned that 

some individuals have overstated the role of science in the process and understated 

the role of the EPA Administrator in making the ultimate policy judgments required 

to set NAAQS. In my opinion, the best contemporary science should inform all the 

policy judgments that are inherent in the setting of each NAAQS. 

However, scientists and others should appreciate that there is no scientific methodology for specifying the precise level, averaging time and statistical form of each 

NAAQS. When scientists state these either as specific numbers or ranges they are 

offering advice that is a blend of science and their own personal preference for a 

policy outcome. In stating a range of numerical levels, the highest value in the 

range has a dominant role in any further deliberations. In essence, the CASAC 

Panel or CASAC is saying ‘‘thou shall not set the NAAQS higher than the upper 

value in the range.’’ The lower end of the range is most likely a statement of the 
84 

policy preference of some individuals on the CASAC Panel. By specifying an upperbound numerical level for the NAAQS below the existing NAAQS, the CASAC has 

clearly offered a policy judgment that the standard must be lowered. This is a policy 

judgment exclusively reserved by the Clean Air Act to the EPA Administrator. 

The CASAC Panel review of the Ozone Reconsideration NAAQS serves to illustrate the point I have made. The CASAC Ozone Panel Chair, Dr. Jonathan Samet, 

in his March 30, 2011, letter to EPA Administrator Lisa Jackson, stated that establishing a margin of safety was inherently a blend of science and policy. It follows 

then that identifying a numerical ceiling for the Ozone NAAQS of 70 ppb (eighthour average) is a blending of science and policy preferences. 

Q2b. EPA often cites the public health benefits in its Regulatory Impact Analyses to 

argue for more stringent standards. Does CASAC or any other scientific body 

review these analyses? 

A2b. The Regulatory Impact Analyses are typically released to the Public after the 

Administrator’s decision on each NAAQS is released. This is done allegedly so that 

costs of achieving the NAAQS do not influence the Administrator’s decisions on each 

NAAQS in keeping with the Supreme Court decision in the case of Whitman v. 

American Trucking Associations. In actual practice, I suspect the Administrator is 

very knowledgeable of the contents of the Regulatory Impact Analysis when the 

final proposed NAAQS is sent to the Office of Information and Regulatory Impact 

Analysis, Office of Management and Budget for review before the final rule is released. 

To the best of my knowledge, the Regulatory Impact Analyses are not routinely 

reviewed by CASAC or any other scientific committee. I suspect that EPA would 

argue that each Regulatory Impact Analyses is conducted using the basic methodology recommended by various National Research Council/National Academy of 

Science Committees and various EPA Science Advisory Board Committees. I think 

the Regulatory Impact Analyses would benefit from critical review by a Committee 

that included scientists and engineers as well as economists. In my opinion, a conceptual review of the approach used to develop regulatory impact analyses is not 

adequate. There is a clear need for critical review of multiple Regulatory Impact 

Analyses to understand the strengths and weaknesses of how the Analyses are conducted and how the results are presented. 

In my view, the Agency and society at large would benefit from having several 

teams, working at arm’s length from the Agency, prepare Regulatory Impact Analyses using what they view as best practices. It would be of interest to compare the 

results of the analyses prepared by the different teams. The current Regulatory Impact Analyses have had, for several decades, primary input from a single EPA contractor. A key consideration in comparing analyses prepared by different teams is 

how they address issues of uncertainty. In my opinion, EPA’s analyses typically understate the uncertainties and systematically overestimate the monetized health 

benefits of the NAAQS. This issue for the Ozone NAAQS has been clearly illustrated 

by Dr. Anne Smith in her testimony. 

Q2c. What recommendations do you have for improving the CASAC process and ensuring that panels are independent, transparent, balanced, and impartial? 

A2c. I offer multiple recommendations for improving the CASAC process: 

• (a) There is a need to critically evaluate the process by which CASAC members 

and consultants are appointed. The appointment process should recognize that 

biases originate in many ways. The current EPA view appears to be view biases 

as originating with employment by or serving as a consultant to industry. I 

argue that academic scientists who are supported by funding from the EPA, 

NIH and other government agencies also bring their biases to the advisory 

table; this needs to be recognized. I argue that the biases are reflected in multiple ways (i.e., biases toward seeing specific papers authored by the member 

or consultant and close colleagues cited and used, biases toward noting the need 

for more research) and, most importantly, the existence of a strong anti-industry bias. 

• (b) The committee process can be improved in multiple ways. As a starting 

point, the CASAC Panels should maximize the use of face-to-face meetings held 

in public view and minimize the use of teleconferences. 

• (c) CASAC Panel meetings should be of sufficient length (including multiple 

meetings if necessary) to allow adequate time to discuss the report at hand and 

elaboration on the strengths and weaknesses of the material prepared by the 

Agency and its consultants. 
85 

• (d) All reports presented to CASAC Panels should have the authors of each section identified, not merely a listing of numerous contributors at the front of the 

Report. 

• (e) Sufficient time should be set aside during CASAC Panel meetings for interested parties to provide oral comments, to complement previously submitted 

written comments, on each document. The current practice of allowing each 

commentor three to five minutes for oral comments should be abandoned. The 

Committee Chair needs to clearly acknowledge the value of public comments. 

All too often in the past decade, public comments have been dismissed as an 

obligation for the CASAC Panel to hear in the shortest possible time and for 

the EPA staff to deal with. 

• (f) All deliberations of major issues should be carried out in public open meetings. The practice that has developed in recent decades of having key discussions and the drafting of key conclusions carried out by two or three designated 

‘‘lead’’ authors outside of public view should be discontinued. Alternatively, key 

conclusions and recommendations should be drawn from the ‘‘provisional’’ written comments prepared by individual CASAC members and consultants and 

made available for public consideration at least two weeks prior to any scheduled meeting. 

• (g) Letters from the CASAC Panel Chair to the EPA Administrator should, in 

general, be much shorter, summarizing key conclusions and recommendations 

with the comments of individual Panel members attached as an Appendix. This 

approach would require each Panel member to clearly articulate their views on 

key issues and recommendations in their written comments. This approach will 

allow for a range of opinions on the science to emerge and avoid the common 

practice of hiding behind the ‘‘consensus’’ opinion of the Panel. In my opinion, 

consensus defined as (a) general agreement, (b) the judgment arrived at by most 

of those concerned, or (c) group solidarity in sentiment and belief is best used 

by religious, fraternal or other social groups. In my view, excess emphasis on 

reaching consensus views on complex scientific issues can obscure underlying 

uncertainties and ambiguities in data and conclusions. It is my view that 

CASAC should focus on the science and avoid offering judgments that are inherently statements of a desired policy outcome. 

Recommendations from CASAC with regard to specific numerical levels and forms 

of the Standard should always be identified as a blend of science and policy (See 

Samet letter of March 30, 2011, to Administrator Jackson). To the extent feasible, 

Panel members should attempt to differentiate between their views on the science 

and their personal policy preference as outcomes. It is crucial that the CASAC never 

preclude the Administrator’s policy option of reaffirming the existing NAAQS. 

Science should always inform the policy judgments made in the setting of each 

NAAQS, but the science should not be framed as though it dictates a specific numerical outcome or lower. 

Q3. The Federal Advisory Committee Act requires that panels be ‘‘fairly balanced in 

terms of points of view,’’ and General Services Administration regulations guiding FACA implementation (41 CFR 102–3.60) require agencies to, in establishing 

advisory committees, ‘‘ensure that, in the selection of members for the advisory 

committee, the agency will consider a cross-section of those directly affected, interested, and qualified, as appropriate to the nature and functions of the advisory committee.’’ In your view, is EPA CASAC membership ‘‘fairly balanced in 

terms of points of view,’’ and is an appropriate ‘‘cross-section of those directly 

affected, interested, and qualified’’ represented on the Committee? 

A3. As I discussed in my answers above, I do not believe the membership of 

CASAC or recent CASAC Panels have been ‘‘fairly balanced in terms of points of 

view’’ and have not included a ‘‘cross-section of those directly affected, interested, 

and qualified.’’ To the contrary, the membership has been excessively dominated by 

scientists that to a large extent have developed the scientific information contained 

in the documents. In some cases, the individuals have already offered opinions as 

to how the science should be used to set NAAQS, a more stringent standard based 

on their science. 

In my opinion, a strong argument can be made for excluding, or at least limiting, 

the portion of individuals from this class (authors of key input) that serve on a specific panel. The subject matter being reviewed should be presented in a manner that 

would allow broadly knowledgeable scientists to offer a scientific view on the material and its use in Standard setting without the scientist having been directly involved in developing the science under consideration. I have advanced the view elsewhere in these comments that the estimated portion of risk for specific diseases 
86 

linked to air pollution is sufficiently small that greater societal benefits might be 

gained by looking more broadly at other factors influencing the risk of these diseases. This broader view is likely to come from scientists including medical practitioners who can look beyond ‘‘air pollution’’ as the dominant risk factor for the disease of concern. The focus needs to be on improving the health of society, not single 

risk factors. 

Q4. Guidance from both OMB and the National Academies indicates that peer reviewers should not review work products that they were involved in. It appears, 

however, that 22 of the 25 members of the 2008 ozone reconsideration CASAC 

panel were reviewing EPA documents that specifically cited their work. Is this 

appropriate, and if not, what recommendations do you have to better account for 

and avoid such situations? 

A4. I do not take exception to this statement as fact. To be blunt, a ‘‘clean air research enterprise’’ has been created over the past several decades. The ‘‘enterprise’’ 

wants to be sustained and it wants to be heard and to have influence. One measure 

of success expressed by some individuals is whether the NAAQS. On the positive 

side, substantial new scientific information has been developed. However, the approach has become excessively narrow focusing many times on a single risk factor, 

a specific pollutant, or a broad class of risk factors, air pollution. In my opinion, the 

utility of this narrow approach may be reaching the point of diminishing returns. 

I am personally convinced the time has come for CASAC members and consultants 

to be selected based on a broader health orientation with limited participation of 

individuals whose focus is on single risk factors (pollutants or air pollution in general). 

Q5. Several witnesses mentioned significant health effects and premature mortality 

associated with socioeconomic status, joblessness, and other economic factors. 

Q5a. Please describe the recent literature that suggests a correlation between socioeconomic status and health outcomes. 

A5a. In my opinion, recent EPA documents have been seriously deficient in not explicitly acknowledging that the diseases of concern arise from multiple risk factors 

and that specific air pollutants, and air pollution in general, is not the major causative factor. Supreme Court Justice Stephen Breyer in Whitman v. American Trucking Associations noted the importance of using a ‘‘comparative health’’ orientation 

in deciding how low is low enough in setting NAAQS. I have been disappointed that 

EPA and CASAC have not followed up on this excellent advice. 

It is my view, drawing heavily on the opinion of Justice Breyer, that the EPA Administrator should take a broad view of multiple factors when making policy decisions, informed by science, on the level (with or given statistical form) of a specific 

criteria pollutant that will be protective of public health with an adequate margin 

of safety. In my opinion, this should definitely include consideration of background 

levels of the pollutant arising from non-anthropogenic sources including spatial and 

temporal dimensions. 

Two papers come immediately to mind with regard to the role of socioeconomic 

factors on health. The recent paper, ‘‘Losing Life and Livelihood: A Systematic Review and Meta-Analysis of Unemployment and All-Cause Mortality,’’ [D.J. Roelf, E. 

Shor, K.W. Davidson and J.E. Schwartz, Social Science and Medicine 72: 840–854 

(2011)] provides a comprehensive review of the health impacts of unemployment. 

The finding that ‘‘the risk death was 63% higher among those who experienced unemployment than among those who did not, after adjustment for age and other covariates’’ is sobering in view of current unemployment in the United States and 

around the world. The 63% increase in all cause mortality stands in stark contrast 

to the increased risk of less than 10% estimated for air pollution. 

An earlier paper, ‘‘All-Cause and Cause-Specific Mortality by Socioeconomic Status Among Employed Persons in 27 U.S. States, 1984–1997,’’ [K. Steenland, S. Hu 

and J. Walker, Am. J. Public Health 94: 1037–1042 (2004)] compares the impact of 

socioeconomic status on multiple health outcomes. A key statistic is the Mortality 

Rate Ratio which is the ratio of the lowest quartile of socioeconomic status over the 

top quartile of socioeconomic status. In short, a comparison of the poorest one-quarter of the population with the one-quarter most well off. The ratio for all-cause mortality for men was 2.02 and for women it was 1.29. These increases of 102% and 

29%, like the 63% increases estimated by Roelf et al. for unemployment, are sobering. Heart disease has been increasingly cited as being of concern for particulate 

matter. Steenland et al. found that the Mortality Rate Ratio for socioeconomic status was 1.88 for men and 1.84 for women. These increases associated with socio-
87 

economic status of 88% and 84% are substantially greater than those observed for 

particulate matter. 

In my paper, ‘‘Role of Science and Judgment in Setting Ambient Air Quality 

Standards: How Low is Low Enough?’’ [R.O. McClellan, Air Quality and Atmospheric Health, published online 01 June 2011], I express the view that socioeconomic impacts should be considered by the Administrator as context for setting 

the NAAQS. It would be appropriate for papers such as those by Roelf et al. (2011) 

and Steenland et al. (2004) to be discussed within the EPA’s various documents undergirding each NAAQS and in the Regulatory Impact Analyses. It would certainly 

be appropriate for CASAC to review these papers and comment on their scientific 

quality. In my opinion, the scientific methodology and quality of these papers are 

certainly equivalent to that found in the various papers that focus on air pollution 

as a risk factor. 

In a few instances, those papers such as the reanalysis conducted by Krewski et 

al. [Krewski, D., M. Jerrett, R.I. Burnett, R. Ma, F. Hughes, Y. Shi, M.C. Turner, 

A.C. Pope III, G. Thurston, F.E. Calle, M.I. Thun, ‘‘Extended Follow-Up and Spatial 

Analysis of the American Cancer Society Study Linking Particulate Air Pollution 

and Mortality,’’ Health Effects Institute, Cambridge, MA, Report No. 140] with support from the Health Effects Institute, factors such as socioeconomic status are examined as risk factors. Many times the results for the covariate such as socioeconomic status are not reported. Krewski et al. (2009) did include the results in 

their report to the Health Effects Institute. Not surprisingly, the relative risks of 

socioeconomic status are greater than for the individual pollutants. Unfortunately, 

these results are not highlighted and directly compared to the results for individual 

air pollutants. In short, these important contextual findings are buried in the reports and never surface in the EPA’s documents reviewed by CASAC. 

I have suggested, only partially tongue in cheek, that the CASAC review process 

might be strengthened if the CASAC Panels were to include several unemployed 

and several underemployed scientists. My view is that personal experience with socioeconomic impacts might help CASAC Panels fully appreciate the enormous impact of their advice and the need to draw a clear line between comments on the 

science and any personal ideological preferences for tightening the NAAQS. 

There should be no argument that a healthy population is dependent on a healthy 

economy—jobs do count! The offering of scientific advice that will inform policy judgments on the setting of NAAQS clearly carries with it substantial responsibility. 

Q5b. In your view, does EPA or CASAC adequately take these regulatory consequences into account? 

A5b. To the best of my knowledge, the EPA has never in any documentation related to the setting of NAAQS taken account of the impact of socioeconomic status 

or unemployment on the health of the U.S. population. Moreover, the EPA has not 

in any documentation related to the setting of NAAQS clearly acknowledged that 

other risk factors have a substantially greater impact on the health endpoints under 

consideration than does the specific criteria pollutant or air pollution in general. I 

am not aware that CASAC has ever advised EPA to take account of the role of socioeconomic factors, unemployment or other risk factors influencing the health 

endpoints under consideration. In developing the documentation for setting the 

NAAQS, EPA has ‘‘blinders’’ on with regard to providing any context for the policy 

judgments that must be made in setting the NAAQS. Likewise, CASAC has had a 

similar narrow focus as though the setting of the specific NAAQS was the only concern. Indeed, the EPA and CASAC have even given credence to the use of the results from use of a single pollutant models when the results of the use of multipollutants models showed diminished effects from the specific criteria pollutant 

under consideration. The EPA and CASAC regularly use the language of the Clean 

Air Act and the Supreme Court decision in Whitman v. American Trucking Associations (2001) to keep a narrow focus on setting the NAAQS under consideration, leaving the impression that providing context for policy judgments would detract from 

the setting of the NAAQS. Indeed, recent CASAC letters that advise that the 

NAAQS must be set at some specific level lower than the current NAAQS appear 

to have the goal of assuring the NAAQS will be lowered. 

Q6. You discussed the President’s decision to withdraw EPA’s proposed reconsideration of the ozone standard. What principles from that decision should be applied to other EPA standards? 

A6. I applauded President Obama’s decision directing EPA to not proceed with setting of the ‘‘reconsideration; Ozone NAAQS. It was the right ‘‘common sense’’ decision. It is unfortunate the President did not have a conversation with EPA Adminis-
88 

trator Jackson in early 2009 indicating the need for using common sense in the setting of NAAQS as well as all other regulatory decisions. 

The OIRA/OMB memorandum signed by Cass Sunstein that undergirded the 

President’s decision emphasized several points: 

• (a) Decisions on each NAAQS must use the latest science to inform the policy 

judgments inherent in setting each NAAQS. 

• (b) Decisions on each NAAQS should take account of other related regulatory 

actions. In this specific case in considering the potential for developing a ‘‘reconsideration’’ Ozone NAAQS, Administrator Jackson should have recognized that 

setting of the Ozone NAAQS in March 2008 had already triggered the next review. In short, the memo emphasizes the need be efficient in use of resources 

and avoid needless efforts. 

• (c) Be respectful of the guidance in the Clean Air Act for periodic review of each 

NAAQS. A corollary is to avoid arbitrary and capricious deviations from that 

schedule. 

• (d) Remember to consider context in taking regulatory actions including the setting of the NAAQS. In this specific instance, the President pointed to the need 

for considering the current dire state of the economy that among other factors 

requires predictable regulatory actions. I can only assume the President sought 

legal counsel in deciding that the language the Clean Air Act provided latitude 

for the decisions of OIAR/OMB and his own actions. 

I think these four principles offer a sound foundation for future EPA actions in 

reviewing and setting NAAQS and making other regulatory decisions. 

Q7. Dr. Phalen and Dr. Thurston both mentioned the role of particulate matter constituents in determining health effects, as opposed to particulate matter mass. 

In your view, what is the validity of developing regulations or estimating regulatory health benefits based upon particulate matter mass? 

Q7a. Has your research or research by others been able to identify and rank the relative toxicities of the known components of PM2.5? 

A7a. In my opinion, the use of a particulate matter mass based metric based on 

particle size, i.e., Total Suspended Particulate Matter, PM2.5 and PM2.5 was appropriate at the time each of those indicators was adopted. The science available at the 

time informed the policy decision to use them. However, even when initially adopted 

it was recognized that these were relatively crude indicators of the potential toxicity 

of particulate matter. In short, they provided blunt tools for guiding development 

and implementation of particulate matter control strategies. However, the science 

available today clearly indicates that not all particulate matter has equal toxicity 

potency irrespective of the chemical compositions. It is crucial to recognize this 

range of potency, especially when EPA with CASAC concurrence has moved toward 

lower and lower standards as though all Particulate Matter being regulated was as 

potent as the most potent particulate matter studied. There is clearly both a temporal and spatial pattern to particulate matter potency. For example, the strongest 

signals of a particulate matter causing morbidity and mortality are in the Northeast 

USA while it appears that particulate matter levels in California have not resulted 

in statistically significant increases in health risks. 

In my opinion, a strong case can be made for reaffirming the particulate matter 

NAAQS put in place in 2006 and offering guidance for imposing more stringent particulate matter standards only when there is clear evidence linking an increase in 

adverse health effects to (a) specific chemical composition on a size selection basis 

(b) or to particulate matter emitted from specific sources. A PM2.5 NAAQS based 

only on mass and set at lower and lower levels is not consistent with current scientific knowledge. 

Q7b. Could you provide your ranking of the toxicity of PM2.5 components on either 

a qualitative or quantitative basis? 

A7b. It is not possible in the limited time and space available to provide a complete 

response to this broad and important question. Suffice it to note that the several 

EPA documents that undergirded the 1997 and 2006 revisions of the NAAQS for 

particulate material and the current review described the substantial spatial variability in the composition of particulate matter in the several size ranges. For example, the most recent Integrated Science Assessment for Particulate Matter (December 15, 2009) notes that the contribution of sulfate in the east (16 to 46% of particulate matter, 2.5 m exposures) is substantially greater than in the west (about 4%) 

while motor vehicle emissions and secondary nitrate are greater sources of exposure 

in the west (about 9%) as compared to the east (about 4%). Previous documents 
89 

have shown as much as a thousandfold difference in the concentration of specific 

elements (such as vanadium, nickel and lead) in particulate matter samples from 

across the USA. The same EPA documents report the results of toxicity assays with 

both ambient particulate matter and specific aerosols such as Carbon Black. Many 

of these studies have yielded negative results. I would speculate that the differences 

in toxic potency for aerosols (in the PM2.5 size range) are at least as great as the 

acknowledged difference in the potency of PM2.5 versus PM2.5 aerosols. 

The simple fact is that EPA, in company with CASAC, seems to have a focus on 

using a ‘‘one size fits all’’ approach in creating a NAAQS for Particulate Matter, 2.5 

μ, and driving the standard to lower and lower concentrations. In my opinion, if 

CASAC were doing its job it would have urged a ‘‘time out’’ and asked—does the 

current approach make scientific sense? I do not think it does, and from Dr. Robert 

Phalen’s testimony it is clear that he does not think the current exclusive focus on 

a mass-based NAAQS for PM2.5 is appropriate. Likewise, it appears that Dr. George 

Thurston might agree. I submit that a more scientifically sound approach to promoting public health would be for the EPA to look at complementary (a) PM 

NAAQS and (b) source specific standards based on the potency of actual emissions 

from different sources. The National Ambient Air Quality Standards are not the 

only tool EPA has in the Clean Air Act tool box! 

A serious problem with EPA and CASAC’s approach to evaluating scientific evidence is the current excessive emphasis on ‘‘causality.’’ With this approach, causality is evaluated exclusively based on PM2.5 mass; all the studies are placed in 

the same bin. Indeed, one can argue that the approach is directed at having an increasing number of health endpoints identified as causally related to PM2.5 exposure, irrespective of the levels of exposure. It is disappointing that CASAC did not 

offer EPA scientific advice to use the ‘‘causality’’ approach to evaluating key individual constituents in particulate matter. 

Q8. Both ozone and particulate matter occur naturally. Could you describe the role 

of background levels of ozone and particulate matter in setting standards for 

these pollutants? Have EPA and CASAC properly accounted for these background levels in establishing regulations or estimating health benefits? 

A8. The EPA has not acted in a consistent, science-based manner in dealing with 

background levels of any criteria pollutants including ozone and particulate matter. 

Some CASAC Panel members and consultants have urged that greater attention be 

given to background levels. Other individuals have expressed the view that background levels of ozone should not be considered in the setting of the ozone NAAQS, 

that background should only be considered during implementation of the NAAQS. 

I strongly disagree with that view. 

In my opinion, the EPA needs to do a much better job of creating a scientifically 

sound understanding of the spatial and temporal dimensions of background levels 

for all criteria pollutants, especially for ozone and particulate matter, and then 

using that scientific information to inform policy decisions in the setting of NAAQS. 

I note the need for acknowledging spatial and temporal dimensions. I make this 

point because there are clear differences in ozone background across the USA; one 

size does not fit all. A failure to acknowledge those differences in the setting of 

NAAQS can penalize certain areas of the USA with naturally occurring higher levels of background ozone. 

The temporal pattern of ozone background levels is also very important. This was 

ignored by EPA and CASAC in the setting of the March 2008 ozone NAAQS. In that 

case, EPA did a very poor job of characterizing what it called ‘‘policy relevant’’ background ozone. EPA understated the background levels of ozone, especially as they 

would occur with an eight-hour averaging time and a standard set at about the 98th 

percentile for exceedances. The result was to substantially overstate the potential 

benefits of reducing the level of the Standard (see testimony of Dr. Anne Smith). 

These points were emphasized in a report I provided to EPA in October 2007 as part 

of the public comment process. This is a very specific example of how EPA and 

CASAC regularly ignore public comments that do not support their position, a lower 

NAAQS. 

The issue of background levels for PM2.5 is also important, especially as regards 

the 24-hour averaging time standard. The Particulate Matter Integrated Science Assessment (2009) noted that Policy Relevant Background levels, levels in the absence 

of U.S. anthropogenic sources, had a maximum daily range of 3.1 to 20 μg/m3 with 

a peak of 63 μg/m3 at the nine National Parks across the USA. It is hoped that the 

EPA Administrator will consider these levels when making a policy decision to reaffirm or revise the NAAQS for PM2.5. 
90 

Q9. As you know, influential studies based on data from the American Cancer Society and the Harvard Six Cities Study provide the basis for major EPA regulations and determines how EPA develops its ‘‘deaths avoided’’ estimates for particulate matter. These data sets were developed with government funds, but are 

not publicly available so they can be analyzed by other scientists. Do you support 

making this and similar federally-funded highly influential scientific data and 

information transparent and publicly available so they can be analyzed by other 

scientists? Do you support making this and similar federally-funded highly influential scientific data and information transparent and publicly available? 

A9. It is my understanding that the Harvard Six Cities Study, initiated by the late 

Professor Ben Ferris, was funded largely by grants from the National Institutes of 

Health with perhaps some limited supplemental funding from the EPA. The study 

also made substantial use of air monitoring data collected with support from the 

EPA. Individuals in six different studies were enrolled in the study with the explicit 

understanding that it was being conducted to evaluate the health effects of air pollution. Thus, it is correct that this study was funded largely by U.S. government 

funds. The Harvard University investigators have indicated in the past that individuals enrolled in the study with the understanding that their identities would not 

be revealed and, thus, one basis for not releasing the data to other investigators is 

that the identity of specific subjects might become known. 

The American Cancer Society (ACS) studies present quite a different situation. It 

is my understanding that the ACS cohort of individuals from across the USA were 

enrolled for the purpose of conducting studies to better understand the occurrence 

of cancer in the population. It is my understanding that individuals self-enrolled 

and, thus, it was not a random sample from the U.S. population and is not likely 

a representative sample of the U.S. population. The study, from its beginnings, has 

been managed and funded by the ACS. The survival of the enrollees has been followed using National Death Records. It is my understanding that what is known 

about each enrollee is based on what they provided at the time of self-enrollment, 

including place of residence and the matched information at death including when 

and where they died. Obviously, information about each individual’s place of residence, life style, occupation, etc., between time of enrollment and death is unknown. 

The ACS very closely controls access to the ACS data. 

Decades ago I urged that these extraordinarily valuable data sets that have a pivotal role in EPA’s setting of NAAQS should be made available to other investigators 

for evaluation. I expressed this view not out of concern for Harvard University investigators to conduct the studies in a competent manner, but rather related to a 

view that different analytical teams with varied scientific backgrounds might identify alternative approaches to analyzing the data sets. After much negotiation the 

Health Effects Institute (HEI), jointly funded largely by the EPA and the automotive industry, would sponsor a ‘‘re-analysis’’ of the Harvard Six Cities Study and 

ACS Study data sets. I was pleased that their re-analysis was conducted. I was very 

disappointed that a second or third team of analysts were not funded to do parallel 

analyses. 

By and large, the single re-analysis did verify the core findings of the original 

analyses. Most importantly, the re-analysis revealed additional information over and 

above that of the original analyses. 

It is my personal opinion that any research study conducted with U.S. government funding should, at some reasonable time interval, have provision for the data 

(stripped of personal identifiers) to be released for evaluation by other competent 

investigators. This only seems reasonable as an approach to realizing the best return on the expenditure of U.S. government funds. It is obvious that such an approach will pose many logistical challenges. I am confident the hurdles can be overcome if there is a will to serve the public good. 

My own personal preference is to require that a procedure be established that will 

require that for any study results to be used by the EPA in the setting of NAAQS 

or other standards, the base data from the study be made available (stripped of any 

personal identifying information) for further analysis by the EPA or other interested 

parties. It is important to recognize that decisions with multi-billion dollar impacts 

(both benefits and costs) are being based on the analysis of these very large and 

complex data sets. Critics of my proposal will likely argue that the standard peer 

review process used by prestigious scientific journals should be sufficient to assure 

the quality of the analyses of the original investigators. I am a strong proponent 

of peer review and fully recognize both its strengths and weaknesses. A comparison 

of the peer review process used by HEI in conducting the re-analyses of the Harvard 

Six Cities Study and the ACS Study with the original peer review given the original 

publications should be sufficient to convince skeptics if the need for something be-
91 

yond the usual peer review when policy decisions informed by science are used to 

set NAAQS that have enormous impact on society. 
92 

Responses by Dr. George Thurston, Professor, 

New York University School of Medicine 

Questions submitted by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment 

Q1. Do recent studies report an association between particulate matter and mortality 

in all cities and areas of the U.S.? 

Q1a. If not, how do you account for this fact that PM is associated with mortality 

in some cities, but not in others? 

Q1b. Similarly, are there cities and areas of the U.S. where no association between 

ozone and acute mortality are reported? If so, what explains this lack of an association? 

A1a–b. While there is a nationwide association found between exposure to air pollution and mortality (e.g., see Pope et al., 2002; Bell et al., 2004; Dominici et al., 

2005), there is not always enough statistical power to detect such a size of effect 

in single cities, due to lower population size (and therefore in numbers of observations) in smaller cities. Thus, the most consistent air pollution–health effects relationships are usually found in large cities, such as New York and Los Angeles, 

where there are sufficient numbers of people to provide enough statistical power to 

discern, in a single city, the air pollution effect that is also seen overall nationwide. 

As I stated in the hearing on October 4, 2011: ‘‘You need enough power, which 

is one of the quandaries we have is that the places where the people live tend to 

be the more polluted places, and the less polluted places don’t have as many people, 

so then it becomes more difficult to study at the lower levels.’’ And then, again, later 

in the hearing, I also stated: ‘‘part of the reason why we don’t see effects at very 

low levels, or unable to show them definitively, is because we don’t have enough 

people living in clean air. If we have cleaner air, then we will be able to test that 

hypothesis.’’ 

Q2. You wrote in 2009 that access to vital ‘‘records that have informed . . . pivotal 

research has recently been curtailed sharply, threatening the continuation of the 

type of research necessary to support future standard setting.’’ You have been a 

co-author on influential studies based on data from the American Cancer Society 

and the Harvard Six Cities Study. These data provide the basis for major EPA 

regulations and determine how EPA gets their ‘‘deaths avoided’’ estimates. These 

data sets are not publicly available so they can be analyzed by all scientists. Do 

you support making these data sets transparent and open to outside scrutiny if 

they are being used to justify regulatory decisions? 

A2. While making data available for independent scientists to analyze is an important goal, a major complication is the countervailing priority of protection of patient 

and/or study subject privacy. To resolve these two important countervailing concerns, these two particular data sets have been released to an independent body 

(The Health Effects Institute), and their respective results and findings validated 

independently (see Krewski et al., 2003). 

Q3. In both your previous work and your testimony, you have indicated substantial 

differences in the effects of components of particulate matter, such as PM from 

Seattle and PM in Detroit. You have stated that ‘‘PM composition has an appreciable influence on the health effects attributable to PM’’ and that ‘‘we should 

be starting to look at more of the constituents.’’ 

Q3a. If these constituents are the critical determinant of health effects, does it make 

sense to develop regulations or to estimate regulatory health benefits based 

upon particulate matter mass? 

Q3b. Have you considered how EPA might develop some type of toxicity-weighted 

NAAQS? 

Q3c. Has your research or research by others been able to identify and rank the relative toxicities of the known components of PM2.5? 

Q3d. Could you provide your opinion as to the appropriate ranking of PM2.5 constituents by toxicity on either a qualitative or quantitative basis? 

Q3e. You mentioned the 1989 Pope study about PM and health effects. How did the 

composition of PM vary between strike and non-strike days? 

A3a–e. (3a.) Since the evidence links PM2.5 mass with health effects, it is important 

to continue to regulate that, but other constituent-specific regulations can also be 
93 

set, as done in the past with lead (Pb) in particulate matter. This could potentially 

allow regulations for PM2.5 control to be more efficiently focused on controlling the 

particulate matter with the greatest toxicity, rather than merely those contributing 

the greatest mass. (3b.) As noted above, it might take the form of regulating PM2.5

constituents, as has previously been the case with lead (Pb). (3c.) That goal is the 

subject of ongoing research by me and others in my field of research. (3d.) I don’t 

think it is possible to quantitatively rank the toxicity of PM constituents at this 

time, and it likely varies from health endpoint to health endpoint, but generally 

speaking we have found that the particulate matter air pollution from fossil fuel 

combustion is among the most strongly associated with adverse health effects, including mortality. (3e.) This has been investigated in depth by intramural researchers at the U.S. EPA. They have discovered that: 

• ‘‘the 1986/1988 (Utah) extracts contained more sulfate, cationic salts (i.e., calcium, potassium, magnesium), and certain metals (i.e., copper, zinc, iron, lead, 

strontium, arsenic, manganese, nickel). Although total metal content was (3/4) 

1% of the extracts by mass, the greater quantity detected in the 1986 and 1988 

extracts suggests metals may be important determinants of the pulmonary toxicity observed.’’ (Dye et al., 2001). 

Moreover, these U.S. EPA scientists were also able to replicate key biological effects of this PM using a mixture of such metals, reporting: 

• ‘‘The parallel epithelial injury induced by the extracts and their surrogate Zn 

∂ Cu ∂ V mixtures suggests that these metals are mediating the acute airway 

epithelial effects observed; however, metal interactions appear to play a critical 

role in the overall cellular effects induced by the PM-derived extracts. These experimental findings are in good accord with epidemiologic reports of adverse airway and respiratory health effects in Utah Valley residents.’’ (Pagan et al., 

2003) 

In related research by this group of U.S. EPA investigators, it has been found that 

the co-presence of sulfates, such as sulfuric acid, can make these transition metals 

more ‘‘bio-available’’ to cells in the body, and therefore more damaging. Thus, the 

co-presence of acidic sulfates in such metals containing particles makes them even 

more potent at damaging the lung (e.g., Gavett et al., 1997). This conclusion is also 

supported by studies of human respiratory cells (e.g., Veronesi et al., 1999), and by 

the conclusions of a recent report from the Committee on the Medical Effects of Air 

Pollutants (COMEAP, 2009). 

Q4. Figure 3 in your written testimony appears to indicate that relative risk for 

PM2.5 drops below 1.0 at 14 micrograms per cubic meter (μg/m3) with no data 

for PM2.5 levels lower than 13 μg/m3. In your oral testimony you referred to this 

graph as an indicator that premature deaths due to PM2.5 occurred well below 

the NAAQS. 

Q4a. Could you explain if this graph or any related study would support EPA’s calculating PM2.5-related death down to the lowest measured value of approximately 4 μg/m3? 

Q4b. In light of your testimony about the ‘‘independent expert advice’’ provided by 

CASAC, why have they failed to recommend a NAAQS down to this lowest 

measured value? 

Q4c. This figure shows that much of the data is consistent with a threshold (relative 

risk of 1.0 or below) at about 15 μg/m3. In your mind, what relative risk would 

suggest a causal relationship? 

A4a. The graph is not inconsistent with EPA’s assumption, and is consistent in 

that effects are suggested to extend well below the present long-term standard for 

PM2.5. 

A4b. There are different health outcomes to consider, and differing strengths of association for the various outcomes at various concentration levels. Also, the setting 

of a standard is a different process from that used for a risk analysis, so they are 

not necessarily going to agree on levels of applicability. 

A4c. This question is based upon a misinterpretation of Figure 3. The relative risks 

(RRs) provided in that graph are relative to the mean long-term PM2.5 concentration 

in the study (about 15 μg/m3), so the fact that the RRs go below 1.0 only means 

that, as the concentration goes below the mean, the risk of mortality is proportionally reduced from the mean risk. It does not mean there are no effects below 15 

μg/m3. Instead, it means that there are mortality risks of PM2.5 exposure to con-
94 

centrations below 15 μg/m3, but they are smaller than if the concentration were 15 

μg/m3. Thus, this would indicate that there are PM2.5 mortality risk benefits of reducing PM2.5 that extend below 15 μg/m3. 

As I stated on the day of the hearing: ‘‘there is the indication that the benefits 

do keep going down well below the standard to levels about seven micrograms per 

meter cubed. And the only reason probably we can’t show below that (concentration) 

is that we have no place in the country that is cleaner than that, that has a metropolitan area with enough people to study.’’ 

Q5. You discussed the value of peer review in ensuring that scientific information 

is ‘‘not just a report that has been put out by an interest group or by the government.’’ Would you support EPA’s Regulatory Impact Analyses being subjected to 

peer review by CASAC or another body? 

A5. Proper peer review is an important aspect of scientific research evaluation, so 

I strongly support that occurring for all scientific research. U.S. EPA RIAs are public documents that already undergo a significant amount of scrutiny under the 

present process. It is also important to note that the RIAs are not research, per se, 

but instead they are documents that rely on published, peer-reviewed literature. 

Moreover, I am uncertain whether the legislative authority for the U.S. EPA RIA 

allows for that process to occur under CASAC, in the case of such a regulatory document that is required, not by the Clean Air Act, but by a separate Executive Order. 

If such a review were deemed to be in the purview of CASAC, I also am also uncertain whether CASAC presently has the proper external environmental economist 

expertise to review such an economic document. For example, the EPA’s recent Air 

Toxics Rule RIA reportedly examines changes in employment in the directly regulated industry (utilities), and the increased demand for labor directly stemming from 

the construction and installation of pollution abatement and control (PAC) equipment resulting from this regulation (see Bivens et al., 2011, attached to this letter 

for inclusion in the record), which is not, to my knowledge, a topic covered by the 

present expertise of EPA’s CASAC. Thus, I see possible legal and logistical barriers 

to this proposed additional RIA peer review. 

References 

Bell ML, McDermott A, Zeger SL, Samet JM, Dominici F. 2004. Ozone and shortterm mortality in 95 US urban communities, 1987–2000. JAMA. 2004 Nov 17;292 

(19):2372–8. 

Bivens, J. (2011). A lifesaver, not a job killer: EPA’s proposed ‘‘air toxics rule’’ is 

no threat to job growth. Briefing paper #312. Economic Policy Institute, Washington, 

DC. 

COMEAP. (2009). Long-term exposure to air pollution: effect on mortality. London: Committee on the Medical Effects of Air Pollutants (COMEAP), Department of 

Health. 

Dominici F, McDermott A, Daniels M, Zeger SL, Samet JM. 2005. Revised analyses of the National Morbidity, Mortality, and Air Pollution Study: mortality among 

residents of 90 cities. J Toxicol Environ Health A. 2005 Jul 9–23;68(13–14):1071– 

92. 

Dye JA, Lehmann JR, McGee JK, Winsett DW, Ledbetter AD, Everitt JI, Ghio 

AJ, Costa DL. Acute pulmonary toxicity of particulate matter filter extracts in rats: 

coherence with epidemiologic studies in Utah Valley residents. Environ Health 

Perspect. 2001 Jun;109 Suppl 3:395–403. 

Gavett SH, Madison SL, Dreher KL, Winsett DW, McGee JK, Costa DL. (1997) 

Metal and sulfate composition of residual oil fly ash determines airway 

hyperreactivity and lung injury in rats. Environ Res. 1997 Feb;72(2):162–72. 

Krewski D, Burnett RT, Goldberg MS, Hoover BK, Siemiatycki J, Jerrett M, 

Abrahamowicz M, White WH. 2003. Overview of the reanalysis of the Harvard Six 

Cities Study and American Cancer Society Study of Particulate Air Pollution and 

Mortality. J Toxicol Environ Health A. 2003 Aug 22–Oct 10;66(16–19):1507–51. 

Pagan I, Costa DL, McGee JK, Richards JH, Dye JA. 2003. Metals mimic airway 

epithelial injury induced by in vitro exposure to Utah Valley ambient particulate 

matter extracts. J Toxicol Environ Health A. 2003 Jun 27;66(12):1087–112. 

Pope, CA III, Burnett, RT, Thun, MJ, Calle, EE, Krewski, D, Ito, K, and Thurston, GD. Lung cancer, cardiopulmonary mortality and long-term exposure to fine 

particulate air pollution. J. Am. Med. Assoc. (JAMA) 287(9):1132–1141 (2002). 
95 

Veronesi B, Oortgiesen M, Carter JD, Devlin RB. (1999). Particulate matter initiates inflammatory cytokine release by activation of capsaicin and acid receptors in 

a human bronchial epithelial cell line. Toxicol Appl Pharmacol. 1999 Jan 

1;154(1):106–15. 
96 

Responses by Dr. Michael Honeycutt, Chief Toxicologist, 

Texas Commission on Environmental Quality 

Questions submitted by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment 

Q1. During the hearing, there was some discussion about the independence and impartiality of CASAC. You have frequently been involved in the CASAC process 

and you were on EPA’s ‘‘short list’’ for the most recent particulate matter panel. 

Q1a. What are the major strengths and weaknesses of the current CASAC process? 

Q1b. EPA often cites the public health benefits in its Regulatory Impact Analyses to 

argue for more stringent standards. Does CASAC review these analyses? 

Q1c. What recommendations do you have for improving the CASAC process and ensuring that panels are independent, transparent, balanced, and impartial? 

A1. This question appears to have been meant for Dr. Thurston, but I will also 

address it. 

Strengths 

• Formed from non-EPA scientists, engineers, and economists and other social scientists recognized as experts in their fields. 

• Should have a wide range of representation from academia, industry, federal, 

state, and tribal governments, research institutes and non-governmental organizations. 

• Chartered to: 

• Review the criteria and standards promulgated by EPA, and provide other related scientific and technical advice; 

• Recommend to the EPA Administrator any new NAAQS and revisions of existing criteria and standards as may be appropriate; 

• Advise the EPA Administrator of areas in which additional knowledge is required to appraise the adequacy and basis of existing, new, or revised 

NAAQS; 

• Describe the research efforts necessary to provide the required information; 

• Advise the Administrator on the relative contribution to air pollution concentrations of natural as well as anthropogenic (human-caused) activity; 

• Advise the Administrator of any adverse public health, welfare, social, economic, or energy effects which may result from various strategies for attainment and maintenance of NAAQS. 

• Chartered Member Composition: 

• At least one member of the NAS; 

• At least one physician; 

• At least one person representing State air pollution control agencies. 

Weaknesses 

• Members recommended by EPA staff and appointed by EPA Administrator. 

• Financial and administrative support given solely by EPA. 

• There are only seven chartered members. 

• Current Chartered Member Composition: 

• None of the current members appears to be a member of the NAS—a charter 

requirement; 

• While there are two members with an M.D., neither appears to be practicing 

physicians; 

• One member represents the eight northeastern states through a non-profit 

organization, accounting for approximately 14% (one out of seven members)— 

most states and tribes are not represented; 

• Academia is represented by approximately 57% of the panel (four out of seven 

members); 

• Research organizations represent approximately 29% (two out of seven members); 

• Industry, federal and tribal governments, and non-governmental organizations have 0% representation on the current panel. 
97 

A1a. It does not appear that the CASAC panel reviews EPS’s Regulatory Impact 

Analyses. 

A1b. Appointed membership to the CASAC panel should be an impartial and transparent process that allows for a balanced representation for all interested parties. 

To achieve this, it would be advisable to have the membership appointed by neutral 

parties. It is a conflict of interest for a person to pick the members of the review 

committee that will review their work. 

A1c. I believe the CASAC review process should not be run by EPA. It should be 

run either by another federal organization such as the Council on Environmental 

Quality or by an independent group such as the NAS. The review panels should be 

broader than they currently are, with multiple experts in each subject area with 

varied and balanced views. For example, the ozone CASAC should consist of, at a 

minimum, two epidemiologists, two toxicologists, two human health risk assessors, 

two practicing physicians (e.g., pulmonologists), two atmospheric chemists, and two 

environmental engineers. These experts should represent a variety of interests, including federal government, state government, academia, industry, and non-governmental organizations. Charge questions should not be so pointed as to lead the peer 

reviewers to a pre-determined conclusion. Of course, peer reviewers should not be 

reviewing their own work as either bias or the perception of bias could influence 

the process. EPA should model their peer reviews after those conducted by Toxicology Excellence for Risk Assessment (www.tera.org), a non-profit group recognized 

worldwide for their independent scientific peer reviews. 

Q2. The Federal Advisory Committee Act requires that panels be ‘‘fairly balanced in 

terms of points of view,’’ and General Services Administration regulations guiding FACA implementation (41 CFR 102–3.60) require agencies to, in establishing 

advisory committees, ‘‘ensure that, in the selection of members for the advisory 

committee, the agency will consider a cross-section of those directly affected, interested, and qualified, as appropriate to the nature and functions of the advisory committee.’’ In your view, is EPA CASAC membership ‘‘fairly balanced in 

terms of points of view,’’ and is an appropriate ‘‘cross-section of those directly 

affected, interested, and qualified’’ represented on the Committee? 

A2. No, the CASAC membership is not fairly balanced and is not an appropriate 

cross-section of those directly affected, interested, and qualified, as noted in the response to question 1. The states and tribes are grossly underrepresented, and no 

CASAC members represent industry. 

Q3. Guidance from both OMB and the National Academies indicates that peer reviewers should not review work products that they were involved in. It appears, 

however, that 22 of the 25 members of the 2008 ozone reconsideration CASAC 

panel were reviewing EPA documents that specifically cited their work. Is this 

appropriate, and if not, what recommendations do you have to better account for 

and avoid such situations? 

A3. It is not appropriate for scientists to peer review their own work; it presents 

a clear conflict of interest. When a panel reviews a document in which a member’s 

work is cited, that member should recuse himself from review of the document. 

Prior to each review, panel and committee members should sign a legally-binding 

document stating their conflicts of interest, which should be made available for 

transparency. 

Q4. In recent testimony before our Committee, EPA Assistant Administrator Gina 

McCarthy stated that the Cross-State Air Pollution Rule would prevent ‘‘up to 

34,000 premature deaths’’ and Administrator Lisa Jackson recently stated before 

another Committee that ‘‘if we could reduce particulate matter to healthy levels, 

it would have the same impact as finding a cure for cancer.’’ Do you agree with 

these statements from the Environmental Protection Agency? In your view, do 

current levels of particulate matter and ozone cause hundreds of thousands of 

premature deaths? 

A4. I do not agree with the statements that Ms. McCarthy and Ms. Jackson made. 

The data that EPA used to base these statements cannot be used scientifically to 

quantitatively ‘‘count lives’’ like EPS did. In my view, current levels of particulate 

matter and ozone do not cause hundreds of thousands of premature deaths. 

EPA relies on studies that take mortality data from ecological epidemiology studies to calculate the number of theoretical deaths that would be avoided with a lower 

standard. Not only do these studies suffer from severe limitations, but estimates of 

theoretical lives saved are also meaningless from a scientific and practical standpoint. It is not possible to verify either the current number of deaths due to expo-
98 

1 1 Health Effects Institute (HEI). 2011. Fine Particles and Health: Which Components Might 

Matter? Fall 2011 Update. Available from: http://pubs.healtheffects.org/getfile.php?u=668. 2 Health Effects Institute (HEI). 2007. The HEI National Particle Component Toxicity 

(NPACT) Initiative: Answering Key Air Pollution Questions. Available from: http:// 

www.healtheffects.org/Pubs/NPACT.pdf. 

sure or the future change in deaths if the standard is lowered. All estimates of lives 

saved are estimates, not factual. There is no guarantee of increased life expectancy 

or degree of confidence in such an estimation, since some degree of risk is present 

in all aspects of daily life. It is impossible to tease out the miniscule risks from low 

levels of air pollution from the overwhelming risks of diet, genetics, smoking, etc. 

Q5. Dr. Phalen and Dr. Thurston both mentioned the role of particulate matter constituents in determining health effects, as opposed to particulate matter mass. 

In your view, does it make sense to develop regulations or to estimate regulatory 

health benefits based upon particulate matter mass? 

Q5a. Has your research or research by others been able to identify and rank the relative toxicities of the known components of PM2.5? 

Q5b. Could you provide your ranking of the toxicity of PM2.5 components on either 

a qualitative or quantitative basis? 

A5. Particulate matter (PM) in the atmosphere contains both primary (i.e., emitted 

directly by sources) and secondary (i.e., formed in the air from combustion processes) components, which can be anthropogenic or natural in origin. PM can contain 

inorganic as well as organic components, including acids (such as nitrates and sulfates), metals, and soil or dust particles. 

In general, the potential for adverse health effects depends on the mass concentration, size, shape, and composition of the particles. Differences in the composition of ambient PM introduce uncertainty into estimates of health effects. EPA uses 

a generic mass concentration of PM for risk (health effects) estimates, in which case 

they assume all varieties of PM have identical potential for toxicity, which we know 

is not the case. The estimates, if based solely on the same PM mass level, may result in over- or underestimates, depending on spatial variability in the PM components. Therefore, PM mass concentration most likely is not the primary factor in 

the reported association. For example, coarse PM (PM2.5) in urban or industrial 

areas is likely to be enriched by anthropogenic pollutants that tend to be inherently 

more toxic than the windblown crustal material which typically dominates coarse 

particle mass in arid rural, agricultural, and mining areas. 

In its 2009 Integrated Science Assessment (ISA) for PM, EPA recognized that epidemiological studies evaluating health effects associated with long- and short-term 

fine particle (PM2.5) exposures have reported heterogeneity in responses both within 

and between cities and geographic regions in the U.S. This heterogeneity may be 

attributed, in part, to differences in the fine particle composition. The ISA concludes 

‘‘that many constituents of PM2.5 can be linked with multiple health effects, and the 

evidence is not yet sufficient to allow differentiation of those constituents or sources 

that are more closely related to specific health outcomes.’’ Many different constituents of the fine particle mixture as well as specific source categories of fine particles 

are linked, at some level, to adverse health effects. 

Furthermore, in the Health Effects Institute (HEI) Research Report 161 (Assessment of the Health Impacts of Particulate Matter Characteristic), Dr. Michelle Bell 

analyzed data on 52 chemical components of PM2.5 and found significant associations of PM2.5 elemental carbon, nickel, and vanadium content with cardiovascular 

hospital admissions, although these components contain relatively low percentages 

of PM2.5 total mass. 1 In summary, it is not appropriate to develop regulations or 

to estimate regulatory health benefits solely based on PM mass without considering 

chemical composition. 

A5a. In a study by Valberg (2004), the chemical components of ambient PM2.5 were 

ranked according to their individual toxicities as a comparison to those using the 

epidemiological PM-mortality ‘‘effect-function’’ (toxicity per unit mass) methodology. 

In addition, the HEI launched a National Particle Component Toxicity (NPACT) Initiative to evaluate the comparative toxicity of specific components of PM in 2009. 2

Specifically, HEI NPACT will examine relationships between PM components and 

health in toxicological studies in 12 locations across the U.S. and companion epidemiological studies in over a hundred cities. The results of these studies could provide information for future PM NAAQS to focus on different PM components. 
99 

3 Peter A. Valberg. 2004. ‘‘Is PM More Toxic Than the Sum of Its Parts? Risk-Assessment 

Toxicity Factors vs. PM-Mortality ‘Effect Functions’.’’ Inhalation Toxicology, 16(suppl. 1):19–29. 

A5b. An example of toxicity rankings of known chemical components in ambient 

PM2.5 can be found in the Valberg (2004) study. 3 The TCEQ has not undertaken 

such a ranking study. 

Q6. In your written testimony you describe the importance of discerning between a 

statistical significance and actual biological significance of a given adverse 

health effect. Is there a plausible biological explanation for all of the NAAQS 

levels endorsed by EPA? Is there a plausible biological explanation for the various health benefits cited by EPA in the accompanying Regulatory Impact Analyses? 

A6. I agree with EPA on the biological bases and regulatory levels for the sulfur 

oxides, nitrogen dioxide, and carbon monoxide NAAQS. I disagree with EPA on their 

biological bases and regulatory levels for the ozone and PM2.5 NAAQS. I mostly 

agree with EPA on their biological basis for the lead NAAQS, although I disagree 

with their regulatory level. I do not think there is a plausible biological explanation 

for the various health benefits cited by EPA in their ozone and PM2.5 NAAQS Regulatory Impact Analyses. 

Q7. Can you provide the Committee an explanation of an ecological epidemiological 

study? How are such studies conducted? What is the value of an ecological epidemiological study compared with a clinical or toxicological study? How are these 

studies used by EPA and CASAC? Are you aware of how EPA or CASAC 

weights the evidence derived from these different studies? 

A7. In most ecological epidemiology studies, researchers gather death certificates 

for a certain time period for people in a particular city who died from non-accidental 

causes, including diseases such as cancer or liver disease. The assumption is that 

breathing ozone made them die earlier than they would have otherwise. For each 

time of death, the researchers find out what the outdoor ozone level was at various 

time periods before the person died. In the case of ozone, for example, suppose a 

90-year old person died of congestive heart failure at noon on a particular day. The 

researchers will find out the eight-hour ozone average for 4 a.m. to noon. Then they 

will back up an hour and find out the eight-hour ozone average for 3 a.m. to 11 

a.m. They will back up another hour, and so on, usually for 36 hours, collecting numerous eight-hour ozone averages that they will then run through various statistical models. They will repeat this process for hundreds to thousands of people, depending on the study. No other patient information is evaluated other than the time 

of death. 

Usually the researchers will use the outdoor ozone readings from the monitor with 

the highest ozone measured in the city. Some studies average the ozone readings 

across the city. Using the highest monitor, or even an average value, in a city is 

unscientific, since ozone levels can vary tremendously across a city, as illustrated 

in the map on the following page. 
100 

The map above is of the Dallas-Fort Worth non-attainment area showing (as a 

typical example) eight-hour ozone concentrations for 1 a.m. to 9 a.m. on September 

19 of this year. Monitored ozone concentrations vary by more than 50% across this 

area, and yet ecological epidemiology studies do not look at the monitor closest to 

where a person actually lived. Using this map as an example, it is scientifically unsound to assume that a person who had, in reality, been exposed to 33 ppb was exposed to 63 ppb. 

These studies did not look at whether those people that died were truly outdoors 

for eight hours just prior to their death to in fact breathe the ozone. It is most likely 

that the 90-year old person in our example was in a hospital or hospice in the days 

preceding their death, where the ozone concentrations were most likely near zero. 

Even if we assumed that these ill people spent eight hours outdoors just before they 

died, were they near the monitor that the researchers assumed they were? Were 

they exposed to other pollutants during that day? Did they take their medications 

that day? There are a whole host of common sense questions that go unanswered 

in these studies. Simply put, ecological epidemiology studies cannot tell us if ozone 

caused these deaths or if these people died prematurely, much less tell us what level 

of ozone caused their premature death. 

These ecological epidemiology studies are the primary studies EPA used to base 

their previously proposed ozone standard. Ecological epidemiology data has very little, if any, value when compared to toxicological or clinical studies. There are ample, 

very well-conducted toxicological and clinical studies on which to base the ozone 

standard. In my opinion, EPA should give ecological epidemiology studies no weight 

at all in deriving a quantitative standard. Toxicological and clinical studies should 

be given the most weight, taking into account mode of action, biological plausibility, 

personal exposure, and what actually constitutes an adverse effect (e.g., a 5% decrement in FEV1 [Forced Expiratory Velocity at one second] is NOT an adverse effect). 

Q8. As you know, influential studies based on data from the American Cancer Society and the Harvard Six Cities Study provide the basis for major EPA regulations and determines how EPA develops its ‘‘deaths avoided’’ estimates for particulate matter. These data sets were developed with government funds, but are 

not publicly available so they can be analyzed by other scientists. Do you support 

making this and similar federally funded highly influential scientific data and 

information transparent and publicly available? 
101 

A8. Yes, I strongly support making these types of data and similar information 

publicly available. The reproducibility of results by independent scientists is of paramount importance in science, and this is a criterion of good science which cannot 

be tested using data not publicly available. This is particularly important and relevant to highly influential data with significant implications for regulation, public 

health, and the economy. Independent scientific analyses may reveal significantly 

disparate results depending upon the methods and assumptions utilized in the analyses and/or that initial conclusions were not adequately scientifically defensible to 

withstand any reasonable level of scientific scrutiny. Any medical privacy concerns 

may be alleviated through appropriate coding of potentially identifying information 

(e.g., names, addresses). The antithesis of governmental transparency is a highly influential government analysis based on hidden data, a predicament for EPA only exacerbated by the fact that the non-publically available datasets were developed 

using taxpayer dollars. Clearly, important underlying data such as these should be 

publically available so that the resulting scientific findings, by EPA or any other entity, may be vetted through additional scientific analyses and peer review. 
102 

4 Philip W. Davidson, et al., 2011. ′′Fish Consumption and prenatal methylmercury exposure: 

Cognitive and Behavioral Outcomes in the Main Cohort at 17 years from the Seychelles Child 

Development Study.′′ Neurotoxicology, In Press. 

Questions submitted by Representative Randy Neugebauer 

Q1. You discussed in your testimony that ‘‘EPA may have the most conservative safe 

level for mercury in the world.’’ Could you provide a comparison of EPA’s reference dose for mercury and the blood mercury concentrations associated with 

health effects? 

A1. The figure below shows levels of mercury in blood associated with health effects from studies done on people in the Faroe Islands and the Seychelles Islands, 

and data from recent surveys of blood mercury concentrations in U.S. women aged 

16–49, as compared to the blood mercury level that EPA’s RfD is set to protect 

against (5.8 ppb). EPA is causing unnecessary alarm in the public by using decadeold data in their assertions that 6% of women of child-bearing age have mercury 

in their blood at a level capable of causing adverse effects in the developing fetus. 

Newer data documenting decreases in blood mercury concentrations over time show 

this statement to be false and misleading. Additionally, adverse effects are associated with much higher blood mercury levels. 

There are no widespread mercury health effects issues in the United States. In 

fact, unwarranted concerns about mercury may be causing women to avoid eating 

fish, which itself could lead to adverse health effects. Researchers from the University of Rochester recently published a 17-year follow-up to the Seychelles study. heir 

conclusions are as follows: ‘‘At age 17 years there was no consistent pattern of adverse associations present between prenatal MeHg (methylmercury) exposure and 

detailed domain specific neurocognitive and behavioral testing. There continues to 

be evidence of improved performance on some endpoints as prenatal MeHg exposure 

increases in the range studied, a finding that appears to reflect the role of beneficial 

nutrients present in fish as demonstrated previously in younger subjects. These 

findings suggest that ocean fish consumption during pregnancy is important for the 

health and development of children and that the benefits are long lasting.’’ 4
103 

Q2. How has air quality in Texas changed over the last 10 and 20 years? Have particulate matter, ozone, and mercury levels increased or decreased? If air quality 

has improved, is this progress due to steps taken by Texas or is this just the result of federal enforcement of Clean Air Act requirements? 

A2. With a vigorous economy, a rich supply of natural resources and a diverse population, Texas continues to see improvement in air quality throughout the state. 

Ambient air monitoring data demonstrate trends of decreasing concentrations over 

time for particulate matter and ozone, and reported mercury emissions have continued to decrease. The strides that Texas has made in reducing emissions, and more 

importantly ambient concentrations of ozone, is more impressive considering the 

population increase (meaning more cars and electricity needs) and Texas’ position 

as an economic engine of the entire country. Texas now has the second largest population in the country, behind California. Between the 2000 and 2010 census, Texas’ 

population increased by 20.6%, which equates to 4,293,741 people. 

Although Texas has some of the most highly industrialized and populated areas 

in the nation, air quality in these and other areas of the state continues to improve 

and is comparable to or better than that of similar areas in other states. The state 

has been especially successful in reducing ozone air pollution. For example, in the 

last 10 years (2000 through 2010), ozone levels in Texas have decreased by 27% 

statewide. By comparison, the rest of the nation averaged only a 14% decrease in 

ozone levels over this same time period. Nitrogen oxides (NO2), a main precursor 

to ozone formation, decreased substantially in Texas from 2000 to 2009. Point source 

NO2 emissions were reduced from 796,247 tons per year (TPY) in 2000 to 336,417 

TPY in 2009, a decrease of 57.75%. In the Houston-Galveston area alone, one of the 

most comprehensively controlled industrialized complexes in the world, over 180,000 

tons of ozone-producing NO2 emissions had been reduced by 2009. This reduction 

equates to more than the total NO3 emitted from all Texas power plants in 2009 

(∼145,000 tons). 

Until 2006, all the PM2.5 monitors in the Houston area had recorded design value 

readings lower than the NAAQS of 15.0 micrograms per cubic meter (μg/m3)—except 

for the Clinton Drive monitor, which is on a heavily traveled road across the street 

from the entrance to the Port of Houston Authority (PHA). To determine the cause 

of the elevated readings at this monitor, the TCEQ funded a series of in-depth studies. The studies concluded that the high readings were confined to a small area near 

the monitor, which is in close proximity to heavy truck traffic at the port entrance, 

unpaved shipyards along the Houston Ship Channel, and railroad tracks that run 

parallel to the road. To remedy the situation, the TCEQ worked in cooperation with 

the PHA, the City of Houston, Harris County, and local industry. Subsequent readings, in 2009, at the Clinton Drive monitor showed an annual average of 12.6 μg/ 

m3 of PM2.5 that translates to a design value of 14.1 μg/m3 for 2007 through 2009. 

On October 8, 2009, the EPA sent a letter to the governor concerning violations of 

the annual PM2.5 standard at the Clinton Drive monitor in Harris County for the 

design value years of 2006 through 2008. On February 4, 2010, the governor submitted to the EPA a recommendation that Harris County remain designated as attainment for the 1997 annual PM2.5 standard of 15 μg/m3. On April 29, 2010, the 

EPA regional administrator signed a letter stating that he concurred with the governor’s recommendation that Harris County remain attainment for PM2.5. 

PM2.5 design values are presented in the figures below to show 10-year trends. 

There are two PM2.5 standards, the 24-hour and an annual. All areas in Texas meet 

both NAAQS and most areas have shown decreases in both design values since 

2002. 
104 

Currently, Texas has one nonattainment area for the PM2.5 NAAQS—El Paso. In 

2010, the El Paso area did not meet the PM2.5 NAAQS. 

The El Paso area typically observes exceedances of the PM2.5 standard, but mostly 

from dust storms created by high winds, and, high winds in El Paso typically qualify 

as an exceptional event. Most likely, the Texas Commission on Environmental Quality (TCEQ) will be petitioning the EPA for an exceptional event, thereby excusing 

the exceedances of the PM2.5 standard. EPA may take up to three years to consider 
105 

TCEQ’s request, which may delay any potential redesignation of the El Paso area 

to attainment. 

In the last 10 to 20 years, air quality in Texas has seen significant improvement, 

especially with ozone. Specifically the one-hour and eight-hour ozone design values 

for two of Texas’ most populated and heavily monitored areas—the Houston-Galveston-Brazoria (HGB) and Dallas-Fort Worth (DFW) areas have decreased significantly. In the early 1990s, the ozone design values in HGB were some of the highest 

in the nation, 220 parts per billion (ppb) for one-hour and 120 for eight-hour. As 

of 2010, they were down to 126 ppb and 84 ppb, respectively. In DFW, the one-hour 

design value was near 150 ppb in the 1990s and by 2010 the area had attained the 

standard; for the eight-hour standard, the area’s design value was as high as 105 

ppb and in 2010 it was at 86 ppb. From 1990 through 2010, the population of each 

area has grown by several million. 
106 

5 EPA. 2011. Draft National Emission Standards for Hazardous Air Pollutants From Coal and 

Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-FuelFired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units. May 3. 

Improvements in air quality are not limited to the HGB and DFW areas. Other 

areas of Texas have also reaped the benefits of improved air quality, including 

Beaumont/Port Arthur, which today is attaining the 1997 eight-hour ozone standard 

and was redesignated attainment by the EPA in 2010. Other areas in Texas with 

regulatory ozone monitors have also shown improvements. Austin, San Antonio, and 

Tyler/Longview have implemented air quality strategies on a voluntary basis that 

are part of the statewide improvements, and have allowed them to remain attainment. The only areas that are designated in nonattainment of the 1997 eight-hour 

ozone standard are the HGB and DFW areas. 

U.S. anthropogenic mercury emissions have decreased, while mercury emissions 

from other parts of the world have increased. 5 According to EPA, the U.S. contribution to global anthropogenic mercury emissions has declined from 10 percent in 

1990 to five percent in 2005, due to reductions in U.S. emissions and increases in 

emissions from other countries. Specifically in the U.S., emissions of mercury for 

coal-fired units above 25 megawatts (MW) decreased from 46 tons in 1990 to an estimated 29 tons in 2010. Mercury is naturally present in coal in trace amounts, which 

is then emitted when the coal is burned. From 2000 to 2010, mercury and mercury 

compound releases to the air in Texas ranged from a minimum of 12,776 pounds 

in 2009 to a maximum of 16,639 pounds in 2000, according to the EPA’s Toxic Release Inventory (TRI). Just using the two endpoints of reporting year 2000 and reporting year 2010, the percent decrease for mercury and mercury compound emissions is 11.3%. Over the last 11 years, the reported emissions have fluctuated from 

year to year, but all are less than reported emissions in 2000. TRI changed the reporting status of mercury and mercury compounds beginning with reporting year 

2000, lowering the threshold reporting criteria for manufacturing and processing 

from 25,000 lbs to 10 lbs. Previous to reporting year 2000, only one facility reported 

air emissions for mercury and mercury compounds. After the change in reporting 

criteria for reporting year 2000, the number of facilities reporting mercury or mercury compounds air emissions has been about 80 each year. 

In Texas, protection of air quality predates the Federal Clean Air Act, and state 

requirements are often more stringent than what is required by the federal statute. 

States are given primary responsibility for ensuring air quality protection under the 

Federal Clean Air Act, with EPA’s role primarily supervisory and secondary to the 

role of the states. States, including Texas, are responsible for developing state im-
107 

plementation plans (SIP) which contain the necessary control strategies for ensuring 

that states attain and maintain the NAAQS. SIPs must also contain major and 

minor permitting programs, and provisions for public participation. These programs 

are developed and managed by the states, with the exception of some states that 

rely on EPA to manage their Prevention of Significant Deterioration (PSD) permitting programs, the programs that permit major sources of air pollutants. Texas has 

been delegated authority to manage its own PSD permitting program from EPA 

(with the exception of greenhouse gas permits), and permits both major and minor 

sources of air pollutants in the state. In Texas, with the exception of certain activities that produce de minimis amounts of air pollution, all stationary sources that 

produce air contaminants must be permitted. Texas has also developed a variety of 

robust rules to set limits on types of air pollution, particularly in the state’s nonattainment areas, to ensure that those areas meet and attain the NAAQS by the 

applicable Federal Clean Air Act deadlines. The following strategies have resulted 

in significant reductions in nitrogen oxides (NOχ) and volatile organic compounds 

(VOC) over the last 10 years in Texas: 

• The NOχ Mass Emission Cap and Trade (MECT) program required an overall 

80% reduction in NOχ emissions from sources in the program and applies to 

most point sources on the Houston-Galveston-Brazoria (HGB) emissions inventory and even some minor sources that are not included in the point source inventory (phased implementation from 2002 to 2008). 

• A comprehensive suite of rules adopted for the Dallas-Fort Worth (DFW) 1997 

eight-hour ozone nonattainment area requiring NOχ reductions from cement 

kilns, power plants, industrial boilers, stationary engines used in the oil and 

gas industry, and many other sources (March 2009 to March 2010). 

• Rules for enhanced monitoring and testing of flares, cooling towers, and other 

sources in the HGB area with highly reactive VOC (HRVOC) emissions known 

to cause rapid formation of ozone (January 2006). 

• Annual and short-term limits on HRVOC emissions for sources in Harris County (January 2007). 

• More stringent requirements for VOC storage tanks in the HGB area to address 

VOC emissions from roof landings on floating roof storage tanks and from flash 

emissions on crude oil and condensate tanks that were found using new technology, like gas-imaging cameras, that allow the operators to observe plumes 

of VOC emissions that would normally not be visible (January 2009). 

While not required by federal regulations, Texas has also adopted regional control 

strategies that required reductions from certain sources in counties outside the nonattainment areas. These controls help improve air quality in areas like DFW by reducing transport of pollution from outside the area. Examples of such regional control strategies include: 

• East and Central Texas Utility Rule (Senate Bill 7): Required NOχ and SO2 reductions from grandfathered power plants in East Texas (2003 to 2005). 

• Regional Cement Kiln Rule: Required NOχ reductions from cement kilns in 

Bexar, Comal, Ellis, Hays, and McLennan counties (2003 to 2005). 

• East Texas Combustion Rule: Requires NOχ reductions from certain stationary 

gas-fired engines in 33 attainment counties east and southeast of DFW, primarily in the oil and gas industry (March 2010). 

In addition to rules that are required for implementation of the NAAQS, Texas 

has also worked to develop innovative permitting mechanisms to allow flexibility 

while requiring sources to control their emissions. Texas has required all major 

sources of air pollution that were uncontrolled under the Federal Clean Air Act, because of grandfathered status, to obtain air quality permits that contain federally 

enforceable emissions limitations. In this way, Texas has gone beyond what is required by the federal statute to ensure that emission sources in the state will have 

control requirements that can be enforced to ensure protection of the state’s air 

quality resources. 

Because of innovative programs for point sources, Texas has seen 58% reduction 

to point source NOχ emissions from 2000 through 2009. The strides that Texas has 

made in reducing emissions and more importantly ambient concentrations of ozone 

is more impressive considering the population increase (meaning more cars and electricity needs) and Texas’ position as an economic engine of the entire country. Texas 

now has the second largest population in the country behind California. Between 

April 1, 2000, and July 1, 2009, Texas population increased by more than 840,000 

people, more than any other state, and its mobile source emissions still decreased. 
108 

The Federal Government has the primary responsibility to regulate mobile sources. 

States have very little ability to effect change in this area. The Texas Legislature, 

however, chose to fund one of the most aggressive, if not the most aggressive, programs to reduce NOχ from mobile sources. The TCEQ has provided over 

$900,000,000 in grants through its Texas Emissions Reduction Plan program to provide financial incentives to upgrade or replace older heavy-duty vehicles, non-road 

equipment, locomotives, marine vessels, and stationary equipment to reduce NOχ

emissions in eligible areas. Over $150,000,000 has been provided through the Drive 

A Clean Machine program to repair gasoline vehicles that fail emission tests and 

replace old vehicles with newer cleaner cars and trucks. Texas also has requirements for cleaner-burning fuel that are more stringent than federal fuel requirements in order to reduce NOχ and VOC emissions (Texas Low Emission Diesel and 

Low Reid Vapor Pressure Gasoline programs). 

Q3. Could you explain the significance of the four-year air quality study conducted 

by Texas A&M University and Driscoll Children’s Hospital on the connection between hospital admissions and ambient ozone levels? 

A3. This study was conducted in the Corpus Christi area and provides Texas-specific data on pediatric asthma patients compared with air quality indicators (e.g., 

ozone). The results of this study are consistent with results of numerous other studies in showing that hospital emissions for respiratory symptoms such as asthma are 

not directly related to ozone levels. As with numerous other studies, more hospital 

admissions occurred on days with an ozone air quality in EPA’s good range than 

on days when air quality for ozone was in EPA’s bad range. Therefore, this suggests 

that air quality indicators like ozone do not predict hospital admissions related to 

respiratory symptoms. 

It is widely known that hospital admissions for asthma are much higher in the 

winter than in the summer. As an example, see the graph below the TCEQ developed for ozone concentrations versus asthma hospital admissions for Dallas County, 

Texas, for 2005 to 2008. 

As can be seen, when ozone levels increase, hospital admissions for asthma decrease and when ozone levels decrease, hospital admissions for asthma increase. 

This phenomenon occurs worldwide. 
109 

Q4. EPA recently released several ‘‘technical adjustments’’ to their Cross-State Air 

Pollution Rule. In the view of the Texas Commission on Environmental Quality, 

are these adjustments sufficient to alleviate the economic and reliability impacts 

of this regulation in Texas? 

A4. The TCEQ believes that Texas should not be included in the CSAPR for PM2.5. 

Texas was not included in the rule for PM2.5 at proposal. The TCEQ has technical 

concerns with the EPA claim that Texas is contributing to the monitor in Granite 

City, Illinois, that we were not allowed an opportunity to comment on. 

The EPA did recently propose on October 6, 2011, revisions to the CSAPR that 

would provide an additional 70,067 tons of SO2 allowances to the Texas CSAPR 

budget and a delay until 2014 for the implementation of the assurance provisions 

limiting interstate trading. Based on TCEQ’s initial review of the EPA’s proposed 

revisions, while the proposal may lessen some of the impact of the CSAPR on some 

Texas utilities it does not address TCEQ’s overall concerns regarding the feasibility 

of such substantial reductions in sulfur dioxide (SO2) emissions in an unprecedented 

short period of time. Even accounting for the additional allowances proposed for 

Texas’ budget, recent SO2 scrubber startups, and announced SO2 scrubber startups 

for 2012, the TCEQ expects that substantial SO2 reductions will still be needed in 

Texas for the 2012 control period. While the 2012 control period is an annual compliance, companies must reduce their SO2 emissions early enough in the year to 

avoid running out of allowance mid-year and being forced to shut down. Companies 

must certify compliance with the CSAPR and there are significant penalties associated with a company’s actual SO2 emissions exceeding the allowances held. Therefore, companies are unlikely to gamble compliance on SO2 allowances becoming 

available at the end of the 2012 control period. The EPA’s intent for delaying the 

assurance provisions until 2014 is to encourage trading in the initial two years of 

the CSAPR program. However, Texas is still limited to trading with Group Two 

states which still does not appear to be a viable trading market for SO2 allowances 

sufficient to address Texas’ concerns. In effect, companies will only have a matter 

of months to achieve the large reductions in SO2 emissions that the EPA is mandating with the CSAPR which leaves some companies with limited options for compliance. The TCEQ will continue reviewing the EPA proposed revisions to the 

CSAPR and plans on submitting comments to the EPA on the proposal. However, 

the TCEQ does not consider the CSAPR as finalized or the proposed revisions to 

the rule to be cost-effective and certainly not the $500 per ton claimed by the EPA. 
110 

Responses by Dr. Robert F. Phalen, Professor of Medicine, and Co-Director, 

Air Pollution Health Effects Laboratory, University of California, Irvine 

Questions submitted by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment 

Q1. During the hearing, Dr. Thurston said that asthma was being exacerbated by 

current levels of air pollution and that ‘‘we are really underestimating the benefits of clean air.’’ In your view, what is the cause of increased asthma rates over 

the last several decades? 

A1. Although I am not an expert on asthma, the fact that asthma is on the increase while air quality has significantly improved implies that other factors are 

dominant. Such factors include: (1) obesity; (2) overmedication of children’s infections; (3) lack of immune challenge to allergens during early childhood; (4) increased 

exposure (after developing asthma) to indoor allergens, e.g., from insect infestations; 

and (5) poverty. 

Q2. Both you and Dr. Thurston mentioned the importance of particulate matter constituents as opposed to mass. 

Q2a. Please discuss the research that shows variability in particulate matter and 

health effects associations. 

Q2b. In light of the importance of particulate matter speciation, does it make sense 

to develop regulations or to estimate regulatory health benefits based upon particulate matter mass? 

Q2c. Did the CASAC particulate matter panel on which you served discuss whether 

it was appropriate to regulate PM on the basis of mass? 

A2a. Numerous studies indicated that PM components, rather than PM mass, are 

resonsible for the health effects. A good example is the study by M.D. Bell et al.; 

Hospital admissions and chemical composition of fine particulate air pollution (Am. 

J. Respir. Crit. Care Med., 179(12):1115–1120, 2009) in which vanadium, elemental 

carbon, and nickel were driving hsopital admissions in persons aged 65 years or 

older. Also relevant is the study of 35,789 elderly Californians for J.E. Enstrom 

(Inhal. Toxicol., 12(14): 803–816, 2005) that found the small risk of fine particles 

found prior to 1982 vanished during the period of 1983–2002. These study examples 

imply that PM mass is a poor indicator of health effects. 

A2b. I believe that it does not make sense to regulate fine particulate mass for 

health purposes. 

A2c. My CASAC-PM panel did discuss the use of PM mass for regulatory purposes. 

The apparent reason for sticking with mass was the lack of enough research to set 

individual component standards. I believe that it was a mistake to continue and propose mass-based standards. 

Q3. During the hearing, there was some discussion about the independence and impartiality of CASAC. You served on the most recent CASAC panel for particulate 

matter. 

Q3a. What are the major strengths and weaknesses of the current CASAC process? 

Q3b. EPA often cites the public health benefits in its Regulatory Impact Analyses to 

argue for more stringent standards. Does CASAC review these analyses? 

Q3c. What recommendations do you have for improving the CASAC process and ensuring that panels are independent, transparent, balanced, and impartial? 

A3a. Please see my submitted testimony on seven weaknesses of the CASAC-PM 

process. 

A3b. The claimed benefits do not take into account offsetting adverse consequences 

that also affect health, such as economic impacts of the proposed new standards. 

A3c. More CASAC representation by experts on the economy, industry, agriculture, 

and overall public health would be helpful. 

Q4. The Federal Advisory Committee Act requires that panels be ‘‘fairly balanced in 

terms of points of view,’’ and General Services Administration regulations guiding FACA implementation (41 CFR 102–3.60) require agencies to, in establishing 

advisory committees, ‘‘ensure that, in the selection of members for the advisory 

committee, the agency will consider a cross-section of those directly affected, in-
111 

terested, and qualified, as appropriate to the nature and functions of the advisory committee.’’ In your view, is EPA CASAC membership ‘‘fairly balanced in 

terms of points of view,’’ and is it an appropriate ‘‘cross-section of those directly 

affected, interested, and qualified’’ represented on the Committee? 

A4. My answer to 3c. above applies here. 

Q5. Guidance from both OMB and the National Academies indicates that peer reviewers should not review work products that they were involved in. It appears, 

however, that 22 of the 25 members of the 2008 ozone reconsideration CASAC 

panel were reviewing EPA documents that specifically cited their work. Is this 

appropriate, and if not, what recommendations do you have to better account for 

and avoid such situations? 

A5. The funding-related and other potential conflicts of interest of CASAC-PM 

members appeared to influence their input, to the detriment of the public good. I 

believe that there is adequate scientific expertise in the U.S. to form a panel of scientists that did not perform the work that is reviewed, or receive substantial support from regulatory agencies that was not balanced by other sources. 

Q6. How much do we know about the relationship between air pollutants like particulate matter and human health effects? Are there areas that need to be studied 

more? 

A6. There are perhaps thousands of studies that relate to the effects of inhaled air 

pollutants. The problem is not so much about a lack of information, but the selection 

of information on the direct effects of individual pollutants without due consideration of the totality of risk factors faced by the public. Driving the levels of individual pollutants down to very small concentrations can have a net harmful effect 

on public health. The logical basis of current PM regulations is weak; the pulic deserves better. 

Q7. As you know, influential studies based on data from the American Cancer Society and the Harvard Six Cities Study provide the basis for major EPA regulations and determine how EPA develops its ‘‘deaths avoided’’ estimates for particulate matter. These data sets were developed with government funds, but are not 

publicly available so they can be analyzed by other scientists. Do you support 

making this and similar federally funded highly influential scientific data and 

information transparent and publicly available? 

A7. I do believe that publically funded research must be transparent and available 

to the public. However, I’m not strongly supportive of requiring such disclosure 

retroactively, except in cases where the data are directly responsible for setting a 

standard. My concern is that retroactive requirements can place an unnecessary 

burden on the research community without additional funding (e.g., for personnel) 

for this potentially large task. 
112 

1 Krewski et al., Reanalysis of the Harvard Six Cities Study and the American Cancer Society 

Study of Particulate Air Pollution and Mortality, Special Report, Health Effects Institute, July 

2000, p. 33 2 The lowest measured level of 7.5 micrograms per cubic meter among the ACS cities was 

for the PM2.5 concentrations that were used in Pope et al. ‘‘Lung Cancer, Cardiopulmonary Mortality, and Long-term Exposure to fine Particulate Air Pollution,’’ JAMA, Vol. 287(9), March 

2002, pp. 11332–1141. 

Responses by Dr. Anne E. Smith, 

Senior Vice President, Nera Economic Consulting 

Questions submitted by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment 

Q1. During the hearing, Dr. Thurston stated that the benefits associated with particulate matter reductions ‘‘keep going down well below the standard to levels 

about seven micrograms per meter cubed.’’ 

Q1a. What does the literature suggest about these effects? 

A1a. The study Dr. Thurston refers to is based on a database first established by 

the American Cancer Society (‘‘ACS’’) in 1982. At the time that the individuals were 

recruited for the ACS study, they had to be at least 30 years old. The average age 

of all the individuals at the time of recruitment was 59 years. The study Dr. Thurston refers to has tracked the survival outcomes of those individuals since 1982, 

thus building up estimates of the average mortality risk at each age level in dozens 

of cities across the U.S. Researchers have then assessed whether a statistical correlation exists between the estimated average mortality risk in each city and the 

cities’ average ambient PM2.5 concentrations, after attempting to control for all the 

other major factors that contribute to mortality risk. With this as background, I will 

explain why Dr. Thurston’s statement that the PM2.5-mortality risk association has 

been observed to levels as low as seven micrograms per cubic meter is not an appropriate indication of what the literature suggests. 

The estimates of differences in mortality risk across cities are built up by following the survival outcomes of the people in each city over many years. This means 

that the observations of their mortality risks at each age, if attributable to air pollution at all, could be a result of exposures they experienced many years in the past, 

or that they accumulated over a long period of time. For example, all of the individuals in the ACS database were exposed to U.S. pollution levels since at least 1952 

(i.e., 30 years before 1982), and the average individual in the database experienced 

U.S. pollution levels dating back to 1923. As researchers using the ACS database 

have stated, ‘‘In the 1950s, levels of air pollution in most North American and European cities were 10 to 50 times higher than those found today.’’ 1 Since the mortality 

risk estimated for each city is based on many years of tracking these people, recent 

average PM2.5 concentrations such as those in 2000, cannot be viewed as indicative 

of the PM2.5 exposure level that most affected their observed survival outcomes. 

Those individuals who had not already died by 2000 would have already lived at 

least 48 years of their lives while being exposed to earlier, higher PM2.5 levels. Yet, 

Dr. Thurston’s statement that the PM2.5-mortality relationship is observed down to 

concentrations as low as seven micrograms per cubic meter is just a statement that 

the lowest annual average PM2.5 concentration reported among the dozens of cities 

in the ACS database was about seven micrograms per cubic meter in the most recent update of the study, i.e., concentrations measured during 1999–2000. 2 It is 

misleading to imply that the estimated mortality-risk relationship has been observed down to that level because PM2.5 levels in that city were higher in the many 

earlier years of the study period during which most of the deaths used to estimate 

each city’s average mortality risk occurred. That is comparable to assuming that recent lower levels of PM2.5. accounted for the health outcomes of people who died as 

much as several decades ago. 

While the lowest level in the cities in the most recent update of the ACS cohort 

study was about 7.5 micrograms per cubic meter, the lowest annual average PM2.5

level at the time that those individuals’ survival outcomes were first being tracked 

(i.e., about 1820) was 10 micrograms per cubic meter, and the levels across all the 

cities ranged from 10 to 38 micrograms per cubic meter, with an average of 20 

micrograms per cubic meter. 

Another problem with Dr. Thurston’s assertion that effects have been observed 

down to about seven micrograms per cubic meter is that an observed statistical 

trend based on a scatter of data across multiple cities cannot be attributed to any 

single city within that dataset—it is an average across all the cities. It is 
113 

unsupportable to assert that the association exists at the lowest measured level because the data establishing that association are sparsest at the ends of the range. 

This makes it impossible to assign statistical confidence to any quantitative estimates of a concentration-response relationship at the extreme ends of the range of 

data. The quantitative estimate of the concentration-response relationship is an average slope based on many data points (as many data points as there are cities in 

the analysis), and the statistical reliability of that average slope estimate weakens 

rapidly for concentrations at the far ends of the range of observations of concentrations in the dataset. 

Q1b. What levels have CASAC and EPA considered in setting ambient standards for 

particulate matter? 

A1b. EPA staff, with CASAC’s concurrence, is only considering tightening the annual PM2.5 standard to a level somewhere between 11 and 13 micrograms per cubic 

meter. This range does not extent lower than 11 micrograms per cubic meter in 

large part because of the lack of statistical confidence that the same magnitude of 

effect exists for cities with PM2.5 concentrations at or near the lower bound of the 

studies. 

Q2. You outlined in your testimony the problems with EPA’s Regulatory Impact 

Analyses, which are used to generate health benefits like premature deaths 

avoided by a regulation. 

Q2a. Are these health estimates peer reviewed by EPA’s Clean Air Scientific Advisory 

Committee or any other body? 

A2a. EPA’s Regulatory Impact Analyses are not reviewed by EPA’s Clean Air Scientific Advisory Committee. They are not subject to public comment and response 

either, because they are not required under the Clean Air Act, but only by an Executive Order. 

Q2b. Last month, President Obama made the decision to withdraw EPA‘s reconsidered ozone standard last month, citing feasibility concerns and the need for the 

‘‘best available science.’’ Prior to that decision, EPA‘s analysis claimed that the 

new standard would prevent 12,000 premature deaths a year. Was this analysis significantly different from the analysis conducted for CSAPR or the Utility MACT? Did EPA rely on particulate matter co-benefits in this analysis as 

well? 

A2b. EPA’s supplemental RIA for the ozone standard reconsideration reported a 

range of estimates of avoided premature deaths for each of five different alternative 

standard levels. These estimates included premature mortality due to ozone and to 

PM2.5. The majority of the avoided premature deaths were due to particulate matter 

co-benefits rather than due to ozone. For example, for the 0.070 ppm alternative 

ozone standard, EPA estimated that ozone-related mortality would be reduced by 

250 to 1,100 deaths per year, while the benefits of coincidental reductions in PM2.5

were estimated to be 430 to 4,200 deaths per year. Both sets of mortality reduction 

estimates were calculated in the same manner as for other RIAs such as CSAPR 

and Utility MACT. 

These coincidental PM2.5-related mortality risk reductions under a regulation that 

is not designed nor intended to reduce PM2.5 are called ‘‘PM2.5 co-benefits.’’ In the 

case of the ozone RIA, the PM2.5 co-benefits were based solely on estimates of reduced NOχ emissions, which EPA projected would cause ambient PM2.5 concentrations to decline too, as a result of efforts to reduce NOχ to attain the tighter ozone 

standard. EPA is reporting PM2.5 co-benefits in nearly all of its air regulation RIAs, 

including the Utility MACT, in which PM2.5 co-benefits accounted for at least 

99.99% of all the benefits of that rule. (In that case, to co-benefits were due solely 

to reductions of SO2 emissions that would come from efforts to reduce acid gases 

required by the Utility MACT.) Thus the entire cost-benefit case for the Utility 

MACT rests on PM2.5 reductions, despite the fact that neither PM2.5 nor its precursor, SO2, are air toxics that are the target and sole purpose of the Utility MACT. 

PM3-related benefits are also calculated in a comparable manner in the CSAPR 

RIA. In the latter case, however, CSAPR is intended specifically to reduce ambient 

PM2.5 (to assist in attainment of the PM2.5 NAAQS) and thus in that RIA, those estimates are categorized as direct benefits, not co-benefits. 

Q3. President Obama recently said that ‘‘I reject the argument that says for the economy to grow, we have to roll back . . . rules that keep our kids from being exposed 

to mercury.’’ What percentage of the benefits claimed in the Utility or Mercury 

MACT comes from mercury? 
114 

A3. Only 0.0004% to 0.011% of the benefits claimed in the Utility MACT comes 

from any air toxic reduction, and all of that is due to just one of the many air toxics 

in that rule, mercury. Stated in dollars, the benefits estimated from mercury in the 

Utility MACT RIA are between $0.5 million and $6 million per year, relative to the 

rule’s estimated annual cost of $10,900 million per year. These small benefits are 

estimated even though the Utility MACT rule is projected to reduce utility mercury 

emissions from 28.7 tons per year to 6.8 tons per year. 

Q4. In calculating costs for Regulatory Impact Analyses, EPA frequently cites singleyear annual costs instead of net present value of cost streams. In your view, is 

this the appropriate approach to estimating regulatory compliance costs? 

A4. Regulatory compliance costs and benefits should be considered on a present 

value basis. EPA’s practice of reporting the costs and benefits for a single year can 

be misleading, especially if the baseline of emissions is declining after the single 

year selected. For example, PM2.5 and SO2, and NOχ can all be expected to keep 

declining after 2015 even if the Utility MACT rule is not imposed because there are 

specific standards already in effect that will take effect between now and 2020. 

However, EPA reports its PM2.5 co-benefits only for 2016, at a point in time where 

PM2.5 emissions should be on a steady decline through 2019 (which is the latest attainment date for the 2006 PM2.5 NAAQS). Thus, there must be a declining trend 

in baseline risks, and hence PM2.5 co-benefits should be much smaller soon after 

2016, yet the annual costs will not decline. Thus, choosing 2016 as the single year 

for reporting the benefits and costs from the Utility MACT gives an overstated impression of the size of the benefits relative to their costs. If a single year is assessed, 

it should be selected as the year in which all other existing regulations are fully 

implemented. At a minimum, EPA should report the trend in annual benefits and 

costs in future years. Nevertheless, a present value of costs and benefits would be 

a more sensible way of addressing this problem, rather than to report costs and benefits only for a single point in time. 

Q5. Your testimony outlined EPA’s reliance on coincidental particulate matter cobenefits to justify a variety of Clean Air Act regulations. Executive Order 12866 

states that each ‘‘agency shall avoid regulations that are inconsistent, incompatible, or duplicative with its other regulations.’’ 

Q5a. Does this reliance on PM co-benefits meet this requirement to avoid duplicative 

regulations? 

A5a. The practice of relying on PM2.5 co-benefits in RIAs for rules that are not addressing PM2.5 directly is inconsistent with the purpose of RIAs. The purpose of 

RIAs is to provide policy makers and the public with an understanding of which 

types of rules are best serving the public interest. RIAs are useful only if they can 

help identify laws and regulations that are not providing benefits in a degree that 

warrants the extra regulatory complexity that they impose on our society. The current reliance on PM2.5 co-benefits is inconsistent and incompatible with this purpose 

because it masks the regulatory burden of new regulations that have few or no direct benefits of their own. At the same time, any PM co-benefits that are deemed 

credible would be gained much more cost effectively by direct regulation of PM2.5

itself, as already provided for by the Clean Air Act. Thus, reliance on co-benefits 

from pollutants that already have regulatory frameworks in place, such as PM2.5, 

allows RIAs to encourage growth in regulations that are unnecessarily duplicative 

of the existing provisions under the Clean Air Act to protect the public health in 

the most cost-effective manner, which is a serious concern if those regulations cannot be justified based on their own direct benefits. 

Q5b. In your view, has EPA provided adequate evidence that it is not counting coincidental and incremental PM2.5 reductions more than once for these various 

regulations? 

A5b. EPA states that it includes all existing regulations in its baseline, but never 

provides sufficient evidence in its reports or associated technical documentation for 

anyone to confirm that point. In addition, double-counting is almost surely occurring 

when multiple regulations are being analyzed simultaneously, rather than in a sequence that actually would allow each RIA’s baseline to account for all other regulations that will be in effect by the time the additional new rule is actually being implemented. Another problem in which double-counting occurs relates to EPA’s practice of reporting benefits for a single year. As I explained in my response to Question 4 above, if the year selected for reporting benefits of a new rule is earlier than 

the year in which another existing rule would be fully implemented, then the benefits reported for the new rule will effectively be overstated because they will be tem-
115 

porary in nature, and a few years later would be the benefits that were originally 

attributed to the existing rule. 

Q5c. What are the problems with taking PM benefits and spreading them around to 

other regulations that have insignificant benefits of their own? 

A5c. The practice of taking PM benefits that should be attributed to PM regulations themselves and spreading them around to other regulations that have insignificant benefits of their own subverts the entire purpose of RIAs, which is to help 

policy makers and the public recognize excessive and non-productive regulatory requirements, and to be informed enough to decide whether certain laws and regulations might be better to reform than to continue. The practice of attributing PM 

benefits to changes in PM exposures that are in attainment with the PM2.5 NAAQS 

also undercuts the motivation of policy analysts and EPA to grapple with whether 

those estimates are credible enough to tighten the PM2.5 NAAQS directly. If they 

are that credible, then the only cost-effective way to address those risks is via their 

direct regulation. Thus the practice of spreading PM benefits around to other regulations also leads to cost-ineffective methods of dealing with the main air quality 

risks that our public health may be facing. 
116 

Questions submitted by Representative Judy Biggert 

Q1. On September 21st, NERA Economic Consulting released a new economic analysis on four major EPA rules affecting electric generating units: the Utility 

MACT; the Cross-State Air Pollution Rule; rules on cooling water intake structures, and the classification of coal combustion residuals as hazardous. What 

did this analysis find about the employment and electricity price impacts of 

these rules? 

A1. NERA’s analysis finds that these regulations will decrease employment and increase electricity rates. On average over the period 2012–2020, when these four regulations are being implemented, NERA estimates 183,000 fewer jobs in each year. 

On average over the period 2012–2020, NERA estimates that electricity rates would 

be 6.5% higher on a national average basis. This electricity rate impact varies significantly by region of the U.S., with a range from 0% to 14%. The largest rate impacts are in regions that rely more extensively on coal-fired generation. A copy of 

the full NERA report on this analysis can be downloaded at http:// 

www.americaspower.org/sites/default/files/ 

NERA¥Four¥Rule¥Report¥Sept¥21.pdf. 

Q2. A recent analysis conducted by EPA found that the Clean Air Act results in $2 

trillion of economic benefits. Do you agree with this analysis? How did EPA arrive at this figure, and what was the role of ‘‘willingness to pay’’ surveys that 

estimate the value of a ‘‘statistical life?’’ 

A2. The EPA analysis mentioned is summarized in an EPA report sometimes referred to as the Second Prospective Benefit-Cost Analysis of the Clean Air Act. This 

analysis attempted to estimate the benefits that will be derived by 2020 as a result 

of the 1990 Clean Air Act Amendments (‘‘CAAA’’). About 90% of the $2 trillion estimate is due to projected reductions in mortality risk from reductions in ambient 

PM2.5 in 2020, relative to what EPA projected ambient PM2.5 concentrations would 

be in 2020 but for the 1990 CAAA. The $2 trillion is not an estimate of financial 

benefits, such as would appear in measures of GDP or average household income. 

Rather, this estimate is intended to reflect the improved ‘‘sense of well-being’’ of the 

U.S. population as a result of EPA’s projected large improvement in mortality risk, 

also known as willingness to pay (‘‘WTP’’). 

The WTP measure that EPA used to value the mortality risk reductions is called 

the value of statistical life (‘‘VSL’’). It is not the value assigned to an individual life. 

Rather, it is a summary statement of the WTP for a very small change in risk of 

dying, such as a change in risk of dying in a given year of one in 10,000. If that 

WTP is found to be an average of $800 across the entire affected population, then 

the VSL would be $8 million, which simply means that for every 10,000 people benefitting from this amount of risk reduction, there would be one less life lost per year, 

and yet the aggregate WTP among those 10,000 affected people would be 10,000 

times $800, or $8 million. Hence, the WTP for this risk reduction would be $8 million per expected life saved, or per ‘‘statistical’’ life saved. One difficulty with the 

estimate of VSL is obtaining a sound estimate of what people are actually willing 

to pay for those small risk reductions. EPA’s VSL estimate is based on a mixture 

of two types of evidence: (1) estimates based on wage data of what workers are willing to give up in annual pay to work in jobs have lower on-the-job death risks and 

(2) direct questionnaires that present a certain hypothetical risk reduction opportunity to survey respondents and ask them to state what they would be willing to 

pay to have that risk reduction. Both of these methods present significant methodological difficulties. The VSL that EPA has used in this study is based on a review 

of 21 wage-risk studies and five WTP survey studies. All but one of the survey studies asked about WTP for changes in job and other accidental risks, rather than 

about disease risk. 

I do not agree with the $2 trillion estimate for several reasons, which are explained in more detail in a paper I co-authored with W. David Montgomery in June 

2011, which can be downloaded from the website of the National Taxpayers Union 

at: http://www.ntu.org/news-and-issues/energy-environment/macro¥vs¥wtp¥v19- 

pdf3.pdf. Three of the primary reasons I consider the $2 trillion estimate to be far 

overstated are: 

• (1) The size of the risk reduction being valued in the EPA analysis is far larger 

than the 1-in-10,000 to 1-in-100,000 risk reductions in the WTP studies from 

which EPA’s VSL assumption is derived. These values for very small risk 

changes cannot be simply linearly increased to represent values for much larger 

risk changes such as 1-in-1,000 to 1-in-100, but the latter are the levels of annual risk change that EPA is attributing to the PM2.5 reductions from the 
117 

CAAA. Due to budget constraints, a valid WTP for these much larger risk 

changes, if it were to be measured, would likely be much smaller. 

• (2) I believe that the mortality risk change that EPA has assumed for each unit 

of change in average annual PM2.5 concentrations is overstated to the point of 

non-credibility. EPA is assuming a range on PM2.5 concentration-response relationships that implies that there is a 25% probability that PM2.5 caused more 

than 25% of all deaths nationwide in the U.S. when ambient concentrations 

were like those that existed in the period around 1980. 

• (3) EPA’s baseline of PM2.5 but for the 1990 CAAA is far too high. EPA assumes 

that no PM2.5 NAAQS standard would have been imposed if the 1990 CAAA had 

not been enacted, which is not a credible assumption. All of the authority necessary to issue the PM2.5 NAAQS and its associated emissions regulations was 

provided in the Clean Air Act of 1977. In fact, the 1990 CAAA did not make 

any changes to Section 109 of the 1977 Clean Air Act, which is what established 

the NAAQS process that exists today. Thus, the PM2.5 baseline in EPA’s analysis is grossly overstated, and thus the $2 trillion of benefits due to reductions 

in PM2.5 ‘‘due to the 1999 CAAA’’ is also grossly overstated. 

Q3. If EPA had not incorporated coincidental particulate matter co-benefits (including health benefits associated with reductions below the National Ambient Air 

Quality Standard), how many EPA Clean Air Act regulations would have 

passed a simple cost-benefit test in the last two years? 

A3. I interpret ‘‘pass a simple cost-benefit test’’ to mean that the estimate of annual benefits exceeds the estimate of annual costs in the year that EPA analyzed 

in its RIA. The concept of ‘‘particulate matter co-benefits’’ only applies to rules that 

do not directly aim to reduce ambient PM2.5. I have identified 13 RIAs released in 

the last two years for emission-reducing rules under the Clean Air Act that do not 

directly aim to reduce ambient PM2.5. 

• Of these 13, two were to reduce greenhouse gases. Both of the greenhouse gas 

rules pass the cost-benefit test without accounting for PM2.5 co-benefits, but 

only because EPA has estimated that these rules will have negative costs, and 

so they would pass the cost-benefit test even with zero direct benefits. 

• The 11 remaining RIAs are for regulations of air toxics (‘‘NESHAP’’), ambient 

air quality standards (‘‘NAAQS’’) and new source performance standards 

(‘‘NSPS’’). Of these 11, not one passes the simple cost-benefit test without incorporating coincidental PM2.5 co-benefits, yet all but two do pass the cost-benefit 

test based on their PM2.5 co-benefits. (One exception is an RIA for a recently 

proposed rule for NSPS and NESHAP for the oil and natural gas industry. That 

RIA discusses PM2.5 co-benefits qualitatively, but does not provide any quantitative estimates; if EPA quantifies its co-benefits in a future draft of the RIA, 

that rule may also pass a cost-benefit test based on PM2.5 co-benefits. The other 

exception is a NESHAP for area sources from industrial boilers. In that case 

the cost lies just a bit higher than the high end of the estimated range of PM2.5

co-benefits.) 
118 
119 

Responses by Mr. J. Edward Cichanowicz, Consultant 

Questions submitted by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment 

Q1. Could you provide the Committee with your estimate of the number of electric 

generating units (EGUs) that will be regulated by the Cross-State Air Pollution 

Rule and the Utility MACT? Could you also provide the number or percentage 

of these units that will require additional air pollution control systems to comply, and the number or percentage of those EGUs that may not be able to acquire and install these systems in time to comply with the rules? 

A1. The Cross-State Air Pollution Rule (CSAPR) will require approximately 60 generating units to retrofit control technology. Approximately half of these units will 

not be able to install the required equipment by the CSAPR mandate. The Utility 

MACT, based on EPA estimates, will require 533 generating units to retrofit fabric 

filter control equipment, with 90 units also requiring ‘‘semi-dry’’ scrubbers. Significantly less than half of these units will be able to comply with the Utility MACT 

mandate. 

In summary, about 600 units—approximately half of the 1,200 generating units 

in the U.S—will be required to retrofit control technology for both the CSAPR and 

the Utility MACT. Less than half of these 600 units will be able to meet the respective CSAPR or Utility MACT compliance mandate. 

Q2. Short of ceasing operations, are there any options available to these non-compliant EGUs under the Clean Air Act that can guarantee these units can come into 

compliance without facing an enforcement by EPA or citizen suits? 

A2. The only option—other than ceasing operation—for non-compliant units is to 

switch the source fuel to natural gas, if adequate supplies and delivery pipeline are 

available. The cost for natural gas (in terms of cost per million Btu of energy content) significantly exceeds the cost of solid fuel (coal), which will proportionally increase generating costs. Further, significant capital investment could be required to 

provide for natural gas access. 

The switch to natural gas is not perceived to be a realistic option on a national 

basis. 

Q3. In your opinion, what about EPA’s assumptions for installation timelines of pollution control equipment is incorrect? If EPA were to fix the timeline problem, 

would you agree with the other technology assumptions they make? 

A3. As noted in my written testimony, EPA’s assumptions about the time required 

to retrofit the key control technologies—24 and 27 months depending on the control 

device—are too optimistic (e.g., presume a shorter schedule than realistic). Recent 

experience shows in most cases these control technologies will require 40–50 

months. As a result, it will not be possible for the complete national inventory of 

generating units to comply with the CSAPR. 

Some of EPA’s key technology assumptions are correct while others are not. Assumptions about the control capability of the selective catalytic reduction (SCR) 

‘‘catalytic reactors’’ for NOχ, and the flue gas desulfurization (FGD) ‘‘scrubbers’’ for 

SO2 are generally accurate. In contrast, EPA assumptions about the control capability of dry sorbent injection (DSI) to remove hydrogen chloride (HCI) are optimistic. These overly optimistic assumptions address the (a) degree of HCI removal 

achievable, (b) availability of the highly specialized sorbent, (c) impact on power 

generation equipment, and (d) other environmental impacts such as solid byproduct 

management. 

Q4. How many power plants are currently utilizing dry sorbent injection (DSI) to 

meet the proposed Utility MACT requirements? How does their real world capture rate compare with EPA’s proposed standard? 

A4. Only two of the total of 28 generating units reported by EPA to apply dry sorbent injection utilize this approach at conditions that reflect the Utility MACT. 

Even these two units—which utilize western coal with low chlorine and high inherent alkalinity—do not reflect the conditions that will be experienced by the national 

inventory of units that must comply with the Utility MACT. 

Q5. According to your testimony, fast-tracking pollution control in the manner advocated by EPA could compromise design quality and equipment construction 

equipment. Should we also be concerned that EPA’s compliance deadlines could 

compromise worker safety? 
120 

1 See Figure 1-2 of ‘‘Feasibility of Retrofitting Fabric Filter Particulate Matter Control Technology to the Electric Generating Unit Inventory as Projected by EPA,’’ July 2011. 

A5. I have spent considerable time at plants during construction activities and 

heavy equipment maintenance. Worker safety should be considered in developing 

plans to fast-track installation, particularly conducting field work that requires relocating or installing material with cranes. 

Q6. EPA has cited instances where pollution controls have been installed in less 

than the 40–50 month timeline cited in your testimony. Is EPA correct to use 

those examples as representative of the entire electricity industry? Is there anything about those examples that make them significantly different than normal 

experience? 

A6. EPA is not correct in citing the examples noted for two reasons. First, the time 

required to complete a project cited by EPA does not include the total start-to-finish 

scope, but reflects only a portion of the work. Specifically, almost without exception, 

EPA estimates ‘‘start’’ time as when contracts for final engineering are awarded. 

EPA ignores the permitting and preliminary engineering steps that require significant time. Also, some of the installations cited by EPA reflect less challenging applications than typically encountered. 

Q7. According to a report by the Clean Energy Group (CEG), a consortium of energy 

companies that stands to profit from EPA’s regulations, the amount of pollution 

controls required to satisfy CSAPR is less than the number of controls that industry installed between 2008 and 2010, proving industry can meet EPA requirements. Is the CEG correct, or are there problems with its analysis? 

A7. Although it is true the number of controls required for the CSAPR is less than 

those retrofit between 2008 and 2010, the CEG ignores the difference in start time. 

In general, much of the work to install the control technologies that were completed 

in 2008 and 2010, as referenced by the CEG, was started in 2005. Many projects 

started prior to 2005. The key difference between the start times and deployment 

dates for these projects is due to the specifics of the Clean Air Interstate Rule 

(CAIR), the relevant mandate for projects installed during the 2008 to 2010 time 

period. Specifically, compared to the CSAPR, the CAIR offered a greater time period 

between when the rule was finalized and when units had to be in compliance. Further, the CAIR contained provisions that offered a financial incentive for owners of 

generating units to deploy control technology early. In contrast, the CSAPR does not 

contain such provisions; in fact, the usual disincentives exist that penalize owners 

for early work for the CSAPR if the rule is not issued in final form as proposed. 

Questions submitted by Representative Judy Biggert 

Q1. The Environmental Protection Agency has claimed that they can provide a oneyear extension for the 2015 Utility MACT compliance date. In your testimony, 

you outline the 10 steps needed to add pollution control equipment to an existing 

power plant. In your view, would a one-year extension provided on a case-bycase basis be sufficient to allow utilities to go through all 10 steps? 

A1. No. The one-year extension would help alleviate, but not eliminate, the significant delay. Analysis that I have conducted for the Utility MACT (described in a reference submitted with my testimony) shows the extension of one year would enable 

only about 50% of the projects to be completed. 1 This same analysis shows that 

a two-year extension is required for about 95% of projects to be completed. 
(121) 

Appendix 2 

ADDITIONAL MATERIAL FOR THE RECORD
122 

ADDITIONAL MATERIAL FOR THE RECORD

REPRINT OF ARTICLE BY DR. ROGER O. MCCLELLAN, ADVISOR, TOXICOLOGY AND

HUMAN HEALTH RISK ANALYSIS: ‘‘ROLE OF SCIENCE AND JUDGMENT IN SETTING

NATIONAL AMBIENT AIR QUALITY STANDARDS: HOW LOW IS LOW ENOUGH?’’, Air 

Quality and Atmospheric Health (published online 01 June 2011). 
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LETTER FROM DR. ROGER O. MCCLELLAN, DVM, MMS, DSC (HONORARY) TO HONORABLE LISA P. JACKSON, ADMINISTRATOR, U.S. ENVIRONMENTAL PROTECTION AGENCY, MAY 6, 2011. 
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MEMO FROM HONORABLE CASS R. SUNSTEIN, ADMINISTRATOR, OFFICE OF MANAGEMENT AND BUDGET, OFFICE OF INFORMATION AND REGULATORY AFFAIRS, SEPTEMBER 2, 2011. 
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Æ