[Senate Hearing 105-50]
[From the U.S. Government Publishing Office]


                                                 S. Hrg. 105-50, Part 1


 
         CLEAN AIR ACT: OZONE AND PARTICULATE MATTER STANDARDS

=======================================================================

                                HEARINGS

                               BEFORE THE

                            SUBCOMMITTEE ON
        CLEAN AIR, WETLANDS, PRIVATE PROPERTY AND NUCLEAR SAFETY

                                AND THE

                              COMMITTEE ON
                      ENVIRONMENT AND PUBLIC WORKS
                          UNITED STATES SENATE

                       ONE HUNDRED FIFTH CONGRESS

                             FIRST SESSION

                               __________

                        FEBRUARY 5 AND 12, 1997

                                  AND

                    MARCH 3, 1997--OKLAHOMA CITY, OK

                               __________

  Printed for the use of the Committee on Environment and Public Works




                     U.S. GOVERNMENT PRINTING OFFICE
 40-919 cc                  WASHINGTON : 1997
_______________________________________________________________________
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                                 20402




               COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

                       ONE HUNDRED FIFTH CONGRESS

                 JOHN H. CHAFEE, Rhode Island, Chairman
JOHN W. WARNER, Virginia             MAX BAUCUS, Montana
ROBERT SMITH, New Hampshire          DANIEL PATRICK MOYNIHAN, New York
DIRK KEMPTHORNE, Idaho               FRANK R. LAUTENBERG, New Jersey
JAMES M. INHOFE, Oklahoma            HARRY REID, Nevada
CRAIG THOMAS, Wyoming                BOB GRAHAM, Florida
CHRISTOPHER S. BOND, Missouri        JOSEPH I. LIEBERMAN, Connecticut
TIM HUTCHINSON, Arkansas             BARBARA BOXER, California
WAYNE ALLARD, Colorado               RON WYDEN, Oregon
JEFF SESSIONS, Alabama
          Steven J. Shimberg, Staff Director and Chief Counsel
               J. Thomas Sliter, Minority Staff Director

                              ----------                              

  Subcommittee on Clean Air, Wetlands, Private Property, and Nuclear 
                                 Safety

               JAMES M. INHOFE, North Carolina, Chairman

TIM HUTCHINSON, Arkansas             BOB GRAHAM, Florida
WAYNE ALLARD, Colorado               JOSEPH I. LIEBERMAN, Connecticut
JEFF SESSIONS, Alabama               BARBARA BOXER, California

                                  (ii)




                            C O N T E N T S

                              ----------                              
                                                                   Page

                            FEBRUARY 5, 1997
                         REVIEW OF THE SCIENCE

                           OPENING STATEMENTS

Allard, Hon. Wayne, U.S. Senator from the State of Colorado......    14
Baucus, Hon. Max, U.S. Senator from the State of Montana.........     3
Boxer, Hon. Barbara, U.S Senator from the State of California....     6
Chafee, Hon. John H., U.S. Senator from the State of Rhode Island     3
Graham, Hon. Bob, U.S. Senator from the State of Florida.........    15
Hutchinson, Hon. Tim, U.S. Senator from the State of Arkansas....    12
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma...     1
    Article, Epidemiology Faces Its Limits, Science..............    20
Lieberman, Hon. Joseph, U.S. Senator from the State of 
  Connecticut....................................................     9
    Article, Something Is Killing Americans, Riverside (CA) Press 
      Enterprise.................................................    41
Sessions, Hon. Jeff, U.S. Senator from the State of Alabama......     5
Thomas, Hon. Craig, U.S. Senator from the State of Wyoming.......    15

                               WITNESSES

Lippmann, Morton, professor, Institute of Environmental Medicine, 
  New York University............................................    18
    Article, Epidemiological Studies Examining Mortality and 
      Ambient PM, Science........................................   144
    Letter, supplement to CASAC closure documents, from several 
      epidemiologists............................................    27
    Prepared statement...........................................   109
    Responses to additional questions from:
        Senator Baucus...........................................   115
        Senator Boxer............................................   117
        Senator Hutchinson.......................................   115
        Senator Lieberman........................................   116
McClellan, Roger O., president, Chemical Industry Institute of 
  Toxicology.....................................................    59
    Charts:
        Hospital admissions for asthmatics in New York City for 
          ozone scenarios........................................   140
        Sampling fractions for ambient PM distribution...........
          70, 141................................................
        Mortality and PM.........................................   144
    Prepared statement...........................................   134
    Responses to additional questions from:
        Senator Hutchinson.......................................   143
        Senator Lieberman........................................   143
Menzel, Daniel, professor, Department of Community and 
  Environmental Medicine, University of California, Irvine.......    58
    Prepared statement...........................................   127
Schwartz, Joel, associate professor of environmental 
  epidemiology, Harvard University...............................    76
    Prepared statement...........................................   195
Smith, Anne, vice president, Decision Focus Inc..................    75
    Articles:
        How Statistics Can Mislead PM Policy.....................   160
        Real PM Culprit: EPA's Flawed Assumptions, Risk Policy 
          Report.................................................   191
    Prepared statement...........................................   146
    Responses to additional questions from:
        Senator Hutchinson.......................................   152
        Senator Inhofe...........................................   154
Thurston, George, associate professor, Department of 
  Environmental Medicine, New York University School of Medicine.    55
    Prepared statement...........................................   118
    Responses to additional questions from:
        Senator Baucus...........................................   126
        Senator Inhofe...........................................   127
        Senator Lieberman........................................   120
Wolff, George, chairman, Clean Air Scientific Advisory Committee.    16
    Letter, CASAC closure on ozone, to Administrator Carol 
      Browner....................................................
      44, 100....................................................
    Prepared statement...........................................    85
    Responses to additional questions from:
        Senator Boxer............................................   104
        Senator Hutchinson.......................................   102
        Senator Lieberman........................................   108
Wyzga, Ron, business area manager, Air Quality, Health and Risk 
  Studies, Electric Power Research Institute.....................    78
    Prepared statement...........................................   199
    Responses to additional questions from Senator Inhofe........   205

                          ADDITIONAL MATERIAL

Articles:
    Discipline of Epidemiology, Science, September 8, 1995.......    32
    Epidemiology Faces Its Limits, Science, July 14, 1995........    20
        How Statistics Mislead PM Policy, Anne E. Smith and 
          Nathan Y. Chan.........................................   160
    Real PM Culprit: EPA's Flawed Assumptions, Risk Policy Report   191
    Something is Killing Americans, Riverside (CA) Press 
      Enterprise, July 14, 1996..................................    41
Chart, Summary of CASAC Panel Members' Recommendations for 
  Particulate Matter.............................................    48
Letters:
    To EPA Administrator Carol Browner from:
        Clean Air Scientific Advisory Committee..................
          44, 100................................................
        Panel of epidemiologists.................................   100
Statements:
    Association of State and Territorial Health Officials (ASTHO)   208
    Cahill, John, acting commissioner, New York State Department 
      of Environmental Conservation..............................   206
                              ----------                              

                           FEBRUARY 12, 1997
    PROPOSED NEW FEDERAL STANDARDS FOR OZONE AND PARTICULATE MATTER
                           OPENING STATEMENTS

Allard, Hon. Wayne, U.S. Senator from the State of Colorado......   237
Baucus, Hon. Max, U.S. Senator from the State of Montana.........   215
Bond, Hon. Christopher S., U.S. Senator from the State of 
  Missouri.......................................................   254
    Letter, to Administrator Carol Browner, from Senator Domenici   256
Boxer, Hon. Barbara, U.S. Senator from the State of California...   228
Chafee, Hon. John H., U.S. Senator from the State of Rhode Island   213
Hutchinson, Hon. Tim, U.S. Senator from the State of Arkansas....   248
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma...   216
Kempthorne, Hon. Dirk, U.S. Senator from the State of Idaho......   233
Lautenberg, Hon. Frank R., U.S. Senator from the State of New 
  Jersey.........................................................   251
Lieberman, Hon. Joseph I., U.S. Senator from the State of 
  Connecticut....................................................   229
Reid, Hon. Harry, U.S. Senator from the State of Nevada..........   232
Sessions, Hon. Jeff, U.S. Senator from the State of Alabama......   241
Smith, Hon. Robert, U.S. Senator from the State of New Hampshire.   244
Thomas, Hon. Craig, U.S. Senator from the State of Wyoming.......   236
Warner, Hon. John W., U.S. Senator from the Commonwealth of 
  Virginia.......................................................   262
Wyden, Hon. Ron, U.S. Senator from the State of Oregon...........   240

                               WITNESSES

Browner, Hon. Carol M., Administrator, Environmental Protection 
  Agency,........................................................   217
    Memorandum, areas affected by PM10 natural events, 
      Assistant Administrator Mary Nichols.......................   299
    Prepared statement...........................................   276
    Responses to additional questions from:
        Senator Baucus...........................................   316
        Senator Allard...........................................   345
        Senator Boxer............................................   337
        Senator Chafee...........................................   358
        Senator Inhofe...........................................   341
        Senator Lautenberg.......................................   338
        Senator Lieberman........................................   325
        Senator Reid.............................................   348
        Senator Thomas...........................................   293
        Senator Wyden............................................   339
Katzen, Sally, Administrator, Office of Information and 
  Regulatory Affairs, Office of Management and Budget............   271
    Executive Order No. 12866, Principles of Regulation..........   390
    Letter, to Representative Bliley, from OMB...................   386
    Prepared statement...........................................   383
    Responses to additional questions from:
        Senator Boxer............................................   385
        Senator Inhofe...........................................   384

                          ADDITIONAL MATERIAL

Letter, to Hon. Carol M. Browner, EPA Administrator, from Senator 
  Pete V. Domenici...............................................   256
Memorandum, from Mary D. Nichols regarding Areas Affected by 
  PM10 Natural Events.................................   299
Charts supplied by EPA:
    Aggregates of the Mean Health Risk Estimates Expressed as a 
      Percent of Outdoor Children Living in Nine Urban Areas 
      Experiencing Effect One or More Times per Year.............   285
    Cities Studied for PM2.5 Data.....................
      292, 356, 366..............................................
    Costs: Historically Less Than Predicted......................
      291, 357, 367..............................................
    Counties Not Meeting Ozone NAAQS.............................
      368, 379...................................................
    History of Ozone NAAQS Review................................   298
    Hospital Admissions are the Tip of the Iceberg...............
      289, 354, 364..............................................
    Percent of Outdoor Children Estimated to Experience Various 
      Health Effects One or More Times per Year Associated with 
      8- and 1-Hour Ozone Exposures Upon Attaining Alternative...   286
    Smog/Ozone--The Science Calls for Action.....................
      287, 352, 362..............................................
    Soot/Particulate Matter--The Science Calls for Action, Part 1
                                                    288, 353, 361
    Soot/Particulate Matter--The Science Calls for Action, Part 2
                                                    290, 355, 363
    Soot/Particulate Matter--The Science Calls for Action, Part 3   365
Statement, Petroleum Marketers Association of America and the 
  Independent Oil Marketers Association of New England...........   391
                              ----------                              

                 MARCH 3, 1997--OKLAHOMA CITY, OKLAHOMA
                      STATE IMPLEMENTATION ISSUES
                           OPENING STATEMENTS

Hutchinson, Hon. Tim, U.S. Senator from the State of Arkansas....   398
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma...   393
Sessions, Hon. Jeff, U.S. Senator from the State of Alabama......   399
Thomas, Hon. Craig, U.S. Senator from the State of Wyoming.......   397

                               WITNESSES

Grusnick, Richard, Deputy Director, Alabama Department of 
  Environmental Management.......................................   450
    Prepared statement...........................................   505
Hammerschmidt, Ron, Director, Kansas Department of Health and 
  Environment....................................................   445
    Prepared statement...........................................   500
Hays, Hon. Patrick Henry, Mayor, North Little Rock, AR...........   427
    Prepared statement...........................................   499
Hollister, Hon. Nancy, Lieutenant Governor, State of Ohio; 
  accompanied by Bob Hosenburgie, Clean Air Division, Ohio EPA...   405
    Prepared statement...........................................   486
Keating, Hon. Frank, Governor, State of Oklahoma.................   402
    Prepared statement...........................................   485
McBee, Barry R., Chairman, Texas Natural Resource Conservation 
  Commission.....................................................   447
    Draft report, proposed revisions to EPA's PM standard, Texas 
      Natural Resource Commission................................   465
    Prepared statement...........................................   502
Muegge, Hon. Paul, Oklahoma State Senate for the National 
  Conference of State Legislatures...............................   422
    Prepared statement...........................................   490
Savage, Hon. M. Susan, Mayor of Tulsa, OK, for the U.S. 
  Conference on Mayors...........................................   419
    Prepared statement...........................................   489
Schwartz, Hon. Mark, Oklahoma City Council, for the League of 
  Cities.........................................................   424
    Prepared statement...........................................   495
Von Bodungen, Gustave A., on behalf of Dale Givens, Secretary, 
  Louisiana Department of Environmental Quality..................   449
    Prepared statement of Dale Givens............................   504

                          ADDITIONAL MATERIAL

Draft report, proposed revisions to EPA's PM standard, Texas 
  Natural Resource Commission....................................   465
Letters, Metroplan...............................................   475
Statement, Mark S. Coleman, Executive Director, Oklahoma 
  Department of Environmental Quality............................   506




         CLEAN AIR ACT: OZONE AND PARTICULATE MATTER STANDARDS

                              ----------                              


                      WEDNESDAY, FEBRUARY 5, 1997

                             U.S. Senate,  
       Committee on Environment and Public Works,  
                     Subcommittee on Clean Air, Wetlands,  
                       Private Property and Nuclear Safety,
                                                    Washington, DC.

                         REVIEW OF THE SCIENCE

    The subcommittee met, pursuant to notice, at 9:37 a.m., in 
room 406, Senate Dirksen Building, Hon. James M. Inhofe 
(chairman of the subcommittee) presiding.
    Present: Senators Inhofe, Hutchinson, Allard, Sessions, 
Graham, Lieberman, Boxer, and Chafee [ex officio].
    Also present: Senators Baucus and Thomas.

 OPENING STATEMENT OF HON. JAMES M. INHOFE, U.S. SENATOR FROM 
                     THE STATE OF OKLAHOMA

    Senator Inhofe. This hearing will now come to order.
    As the new chairman of the Subcommittee on Clean Air, 
Wetlands, Private Property, and Nuclear Safety of the 
Environment and Public Works Committee, I would like to welcome 
everyone to our first hearing of the 105th Congress. Today's 
hearing will look at the EPA's newly proposed ozone and 
particulate matter standards. I want to impress upon everyone 
that we are here to make sure that we have one thing in common: 
we want good air to breathe. I want it for the people in this 
room, for my kids, and for my grandchildren. That's what this 
is all about.
    It is my intention to run this hearing in a balanced and 
thoughtful manner. The witnesses for this hearing--and this 
will hold for all future hearings--have been carefully selected 
to provide a complete spectrum of diverse viewpoints. In 
particular, we have invited the principal researchers the EPA 
relied upon in their proposal, as well as the chairman of 
CASAC--the Clean Air Scientific Advisory Committee. There are 
21 members of this committee.
    Some of today's witnesses have already been criticized by 
environmental groups for their ties to industry, in particular 
Dr. Wolff, the chairman of CASAC. I want to extend my apologies 
to Dr. Wolff for having his character impugned in this manner. 
I want to make it very clear that he is not testifying today 
because of his occupation, but because he is the appointed 
chairman of the Administrator's Clean Air Scientific Advisory 
Committee.
    The purpose of this hearing is to address the scientific 
questions behind the recent EPA proposals to change the 
national ambient air quality standards for ozone and 
particulate matter. We are not here today to talk about cost/
benefit. We are not here today to talk about impositions on 
lifestyles. These are very significant issues that will be 
addressed in future hearings.
    As the chairman of this subcommittee, I selected the 
science issues to being the oversight process because I believe 
we owe it to the American public to help search for the facts 
and the truth. These are very difficult and complex scientific 
issues and they deserve this separate hearing, apart from other 
considerations, because of the importance science has in 
formulating and administering our Nation's environmental laws 
and policies.
    There are a number of questions about the science that have 
been raised since the EPA first published these proposals. It 
is my hope that today's hearing can begin to answer these 
questions, not only for myself and the committee, but also for 
the American public.
    First matter to determine: There is considerable confusion 
as to what the EPA's Clean Air Scientific Advisory Committee 
recommended and what they did not recommend.
    Second, there are questions about which determinations made 
by the Administrator were based on science and which ones were 
based on policy judgments. While we are not going to question 
those policy judgments today, we need to identify which ones 
were based on science and which ones were not. Is the change 
from a 1-hour standard to an 8-hour standard for ozone 
justified by the available science? I have heard very little 
disagreement there, but I have heard disagreement concerning 
the specific threshold limit set. Was this a science call or 
was it a policy judgment?
    Third, how complete is the scientific body of knowledge 
behind these proposals? If not, then is more time needed to 
conduct the appropriate studies and research?
    Fourth, with a scientific review of the standards required 
every 5 years, are we at a point today where we can say 
definitively that the science requires a change in the 
standards, or are there still too many uncertainties and 
unanswered questions?
    While I applaud the Agency's desire to protect the health 
of the American public, we must be sure that our mutual goal 
will, in fact, become a reality if these proposed regulations 
go into effect. Too often, government officials--both elected 
and appointed--hid behind scientists when proposing policy 
decisions. Congress hides behind science when it tells agencies 
to promulgate regulations based upon the best available 
science, instead of making the difficult policy decisions 
themselves; and administrations also hide behind science by 
substituting scientific statements for policy findings.
    We need to let scientists tell us what the science is, but 
as policymakers and lawmakers, we need to take that science and 
determine what constitutes the best public policy decision.
    Finally, I would like to say that I am pleased that the 
Administrator has agreed to extend the comment period by 60 
days. It is very difficult during the holiday season--and since 
it first came up during the time of Thanksgiving--to 
productively use that period of time. The EPA needs to hear 
from all segments of the public, and this extension will allow 
those people and organizations with fewer resources to spend 
more time analyzing the proposals. This will particularly help 
the States and local governments understand the proposals, 
which is vital since they will be instrumental in the 
implementation of these standards.
    Senator Inhofe. I would now turn to the chairman of the 
parent committee, the Environment and Public Works Committee, 
Senator Chafee.

OPENING STATEMENT OF HON. JOHN H. CHAFEE, U.S. SENATOR FROM THE 
                     STATE OF RHODE ISLAND

    Senator Chafee. Thank you very much, Senator Inhofe. I want 
to commend you for holding these hearings. You have a good list 
of witnesses. You certainly were right when you said this was a 
complicated subject.
    Over the past 25 years our Nation has spent more than $450 
billion to clean our air of life-threatening pollution. This 
effort has been a tremendous success. The most recent report 
card issued by the EPA indicates that pollution levels have 
been reduced by nearly 30 percent, on average, with even 
greater gains made for some of the most serious pollutants, 
namely lead--lead is down 98 percent, probably mostly due to 
the fact that we have gone to unleaded gasoline--and the 
reduction also in carbon monoxide, which is also significant. 
All of these have occurred in some of our most polluted cities.
    In spite of these achievements, EPA has recently proposed 
new regulations that suggest we have a long way to go. These 
new standards for smog and soot are 25 percent to 35 percent 
more stringent than the current levels and would require the 
expenditure of tens of billions of additional dollars.
    Senator Inhofe, in the subcommittee and in the full 
committee, we plan to conduct a thorough review of these 
proposals. Senator Inhofe, as I mentioned, is making an 
excellent start this morning. The scientists, as he pointed 
out, we have with us this morning include the current and past 
chairmen of EPA's Clean Air Scientific Advisory Committee and 
some of the principal investigators whose studies form the 
scientific foundation for these proposed standards.
    I hope that all of the members of the committee on both 
sides come to these hearings with open minds. These are 
extremely complex proposals based on thousands of pages of 
detailed analysis. I want to commend Administrator Carol 
Browner for seeking an extension from the court so that all of 
those affected by these proposals will have more time to review 
and consideration. She will be with us at a hearing next 
Wednesday, February 12, before the full committee. She has 
indicated that EPA stands ready to assist us in any way that it 
can to help us understand these proposals.
    Thank you very much, Mr. Chairman.
    Senator Inhofe. Thank you, Mr. Chairman.
    Next we will hear from the ranking minority member of the 
parent committee, Senator Baucus.

  OPENING STATEMENT OF HON. MAX BAUCUS, U.S. SENATOR FROM THE 
                        STATE OF MONTANA

    Senator Baucus. Thank you, Senator.
    Mr. Chairman, first I want to congratulate you on taking 
over your chairmanship on a very minor, inconsequential issue--
--
    [Laughter.]
    Senator Baucus. I admire your courage for beginning with 
this.
    I am sure, as other Senators have mentioned, the Clean Air 
Act has actually been a huge success for our country. I think 
it may be this committee's most significant accomplishment. 
Since the Act became law in 1970, the population of the United 
States has grown by 25 percent, and the size of our economy has 
doubled. During the same time, our air has actually gotten 
cleaner, even with the increased population and our economy. In 
some cases, a lot cleaner.
    Air pollution from carbon monoxide has fallen by 28 percent 
since 1970, from sulfur dioxide 41 percent, from particulates 
80 percent, lead by 98 percent. A major reason for this success 
has been the program of National Ambient Air Quality Standards. 
That might sound arcane, but the basic idea is very simple. 
Before 1970, we had a Federal air pollution program, but it 
wasn't working. One reason was that air pollution standards 
were determined by balancing public health standards against 
economic policy.
    The principal author of the Clean Air Act, Senator Muskie, 
put it this way:

    The concept of economic feasibility had become an excuse 
for doing nothing, and we agreed that the dangers to health 
from dirty air were sufficiently great that regulations should 
be based on the degree of control needed to protect public 
health.

    So in the Clean Air Act of 1970, Congress remedied that 
defect and established a two-tiered system for setting clean 
air standards.
    In the first step, the EPA establishes national air quality 
standards at the level that is necessary, in the words of the 
statute, to ``protect public health'' with an ``adequate margin 
of safety.'' As the second step, the States write 
implementation plans. When they do, they then have the 
flexibility to consider a variety of factors, including costs. 
A State can, for example, decide that it makes more sense to 
achieve reductions from a few large industrial sources of 
pollution than from a lot of small sources like dry cleaners 
and print shops.
    Over the years, this two-step approach has kept the goal 
focused, unambiguously, on public health. At the same time, it 
has allowed States to consider costs appropriately at a later 
point.
    Furthermore, the Act provides long lead times so that 
States and industries have plenty of time to implement new 
requirements. For example, the proposed standards that we are 
considering today would not go fully into effect, as part of 
enforceable implementation plans, for 12 years. That is 12 
years after these proposed regulations go into effect that 
individuals, companies, corporations would feel the full effect 
of the proposals. If that deadline turns out to be too tight, 
Congress can extend it, as it has before.
    So cost can be taken into account, but only after we have 
established a standard that protects public health. To my mind, 
this system has served our country well. That is not to say 
that establishing a health-based standard is easy. It is not. 
There are not bright lines. There is no magical level above 
which everybody gets sick and below which no one does. Instead, 
the science of air pollution is extremely complex. Like all 
science, it is based on hypothesis and experimentation, risk, 
statistical assumptions, estimates of exposure pathways, and on 
projections from animal studies to humans. It is never 
absolutely certain.
    But we cannot allow the absence of absolute scientific 
certainty to paralyze us. As the saying goes, we can't let 
perfection become the enemy of the good.
    Howard Baker put it well in 1969, when he served in the 
position that Senator Graham now serves in, as the ranking 
member of the Air Pollution Subcommittee. Talking about an 
earlier version of the air standards program, Senator Baker 
said, ``There are those who will challenge any criteria which 
lack final and absolute proof of a direct and causal 
relationship. But responsible public policy cannot wait upon a 
perfect knowledge of the cause and effect.''
    If we cannot achieve perfect knowledge, what should we do? 
How should we decide, in the fact of uncertainty, whether a new 
air quality standard is appropriate? In the end, we have to 
step back, put the slogans and politics behind us, and size it 
up. The question is not whether the science is perfect. The 
question is whether, on balance, in the judgment of the 
mainstream scientific community, the standard will accomplish 
what the law requires, to protect public health with an 
adequate margin of safety.
    If not, the proposed standards should be modified. If so, 
then we should work together to see that the proposed standards 
are implemented reasonably and effectively.
    Mr. Chairman, I commend you for calling this hearing and 
hope that each of us will keep an open mind. This is especially 
important now that EPA has requested 60 more days to consider 
public comments. Some groups may be tempted to use that time to 
build their political case, but that would be a disservice. 
Let's take this time to listen to the physicians, 
toxicologists, and epidemiologists, but not to the spin 
doctors.
    Thank you very much. I particularly thank the committee and 
you, Mr. Chairman, for your indulgence in going over the 5 
minutes.
    Senator Inhofe. Thank you, Senator Baucus.
    I would ask the members of the committee to try to confine 
their remarks to 5 minutes so that we can get to the witnesses 
and get our hearing carried on in a timely fashion.
    I will follow the ``early bird'' rule, as has been the 
custom of this committee, and go now to the first early bird 
who arrived, Senator Sessions.

OPENING STATEMENT OF HON. JEFF SESSIONS, U.S. SENATOR FROM THE 
                        STATE OF ALABAMA

    Senator Sessions. Thank you, Mr. Chairman. I am glad to be 
with you today and appreciate you holding hearings today to 
discuss the science behind the Environmental Protection 
Agency's proposed changes to ozone and particulate matter 
standards. I realize this is an extremely technical issue and I 
am eager to hear testimony from the leading-edge persons in the 
field.
    Like so many of my colleagues, I am concerned about air 
quality in our country and in my home State of Alabama. I 
commend the Environmental Protection Agency for doing a fine 
job in helping to identify the most polluted areas of our 
country and those industry and State officials who have made 
the adjustments--sometimes at great cost--to improve the air we 
breathe. While there is little dispute in some areas that more 
improvement is needed, current efforts have resulted in a much 
higher overall air quality throughout the Nation.
    I understand that today's hearing is focused on science 
because it is only with sound scientific knowledge that we can 
make good decisions. Changing the ozone and particulate matter 
standards is by no means a small proposition. The ramifications 
of enacting new, tighter standards will result in tremendous 
cost economically and socially. Many industries would be forced 
to make costly overhauls of their plants and equipment, which 
could lead to job losses. Likewise, State governments would be 
forced to shift scarce resources to pollution control.
    In short, I want to ensure that the decision to change the 
ozone and particulate matter are based on sound, definitive 
scientific data. History has demonstrated that theory, even 
when supported by some scientific data, cannot be the only 
basis for action. In 1968, Paul Ehrlich, the renowned doctor of 
population studies at Stanford University, wrote a book called 
``The Population Bomb,'' in which he stated, ``The battle to 
feed all humanity is over. In the 1970's and 1980's, hundreds 
of millions of people will starve to death.'' One could easily 
imagine the terrible problems we would be having today had that 
happened. That scientist's predictions--thankfully--were not 
correct.
    Before we act to change ozone and particulate standards, we 
need to identify the problem, understand the underlying science 
behind the problem, and ask what the most appropriate steps, if 
any, are needed to solve the problem. I look forward to working 
with you in that regard.
    Senator Inhofe. Thank you, Senator.
    Next to arrive is the gentlelady from California, Senator 
Boxer.
    Senator Boxer. Thank you very much, Mr. Chairman.
    I want to add my praise to you for having this early 
hearing. I am very hopeful that we on this committee will be 
able to work together to do what prior Senators did before we 
got here. That is to work together so that we protect the 
health and safety of the people of our country. That is indeed, 
in my opinion, a great duty and responsibility, perhaps our 
greatest. We have an Act, the Clean Air Act, that has done 
this.
    I would ask that my entire statement be placed in the 
record and I will try, in 2 minutes, to sum up.
    Senator Inhofe. Without objection, your prepared statement 
will appear in the record.

OPENING STATEMENT OF HON. BARBARA BOXER, U.S. SENATOR FROM THE 
                      STATE OF CALIFORNIA

    Senator Boxer. In my home State, exposure of San Francisco 
Bay Area residents to dangerous levels of ozone has been 
reduced by 93 percent since 1970. It is a success story. Last 
year, the Bay Area became the largest metropolitan area in the 
country to reach attainment of current Federal ozone standards.
    However, my State overall continues to face the most 
challenging and intractable air pollution problems in the 
Nation. Our south coast basin has the most polluted air in the 
country. Although we have seen steady improvement, most parts 
of southern and central California do not meet the current 
Federal ozone standard or the particulate matter standard.
    Air pollution is a very serious problem. For example, 
according to EPA the current average concentration of fine 
particulate matter in southeast Los Angeles may be responsible 
for up to 3,000 deaths annually, and more than 52,000 
incidences of respiratory symptoms, including 1,000 hospital 
admissions.
    Young children constitute the largest group of high risk 
from exposure to air pollutants. They breathe 50 percent more 
air by body weight than the average adult. In California alone, 
there are over 6 million children under the age of 14 and 
approximately 90 percent of them live in areas that fail to 
meet State and Federal standards.
    How are children being affected? Studies show health 
effects ranging from 20 to 60 percent loss of lung capacity. 
Despite this, we hear representatives of industry claim that a 
30 percent loss of lung capacity is not really a health effect 
because it is only temporary. Tell that to a mom whose 
asthmatic child has to stay home or visit the hospital 
emergency room on a regular basis. Tell that to a mom whose 
teenage son suffers from continuous coughing, throat 
irritation, chest pain, and shortness of breath. And what about 
the potential of causing permanent damage? We do have studies 
of lab animals which indicate that long-term exposure to ozone 
causes permanent damage to lungs.
    The Clean Air Act directs the Administrator to set 
standards at levels that, in the judgment of the Administrator, 
protect the public health with an adequate margin of safety. 
This is the law. There is no choice here.
    Health, in my opinion, must continue to be the marker upon 
which standards are based. And those standards must be based on 
science. Once health-based standards are set, cost should play 
an important role in implementation and timetables.
    A lot of serious questions have been raised, Mr. Chairman, 
about the EPA's proposal. Industry is questioning the strength 
of the scientific basis for the proposal. Some think it doesn't 
go far enough. In our search for answers, I think we need to 
look very closely at what the EPA's Clean Air Scientific 
Advisory Committee recommended. I won't go into that now 
because that is what we are going to hear about from the 
witnesses today. But frankly, the recommendations themselves 
are not that complicated. The back-up material is.
    We should keep our eyes on the two areas: the ozone level 
and the particulate matter. We must keep the recommendations in 
mind.
    I look forward to working with you, Mr. Chairman, to answer 
some of these questions. I am hopeful that we can come to this 
on a bipartisan agreement that we can move forward.
    I would particularly like to welcome Dr. Menzel and Dr. 
Wyzga, who have come from California to testify before you.
    Thank you very much.
    [The prepared statement of Senator Boxer follows:]
 Prepared Statement of Hon. Barbara Boxer, U.S. Senator from the State 
                             of California
    Mr. Chairman, I believe that as Senators, we have no greater duty 
and responsibility than to protect the health and safety of the 
American people.
    The Clean Air Act does that and is one of our most successful 
environmental laws. It is also often referred to as one of our most 
complex, comprehensive and far reaching environmental laws.
    Enormous progress has been made in the last 25 years to control and 
reduce air pollution. For example, exposure of San Francisco Bay area 
residents to dangerous levels of ozone has been reduced by 93 percent 
since 1970. Last year, the Bay area became the largest metropolitan 
area in the country to reach attainment of current Federal ozone 
standard.
    However my State of California continues to face the most 
challenging and intractable air pollution problems in the Nation. Our 
South Coast Basin has the most polluted air in the country, and while 
we have seen a steady improvement of air quality, most of Southern and 
Central California does not yet meet the current Federal ozone standard 
or the particulate matter standard.
    Air pollution is a very serious problem. For example, according to 
the EPA, the current annual average concentrations of fine particulate 
matter in Southeast Los Angeles County may be responsible for up to 
3,000 deaths annually, and more then 52,000 incidents of respiratory 
symptoms including 1,000 hospital admissions.
    Even if current Federal standards were achieved, the Environmental 
Protection Agency estimates 300-700 fine particle related deaths and 
more than 40,000 fine particle related health effects.
    Young children constitute the largest group at high risk from 
exposure to air pollutants. They breath 50 percent more air by body 
weight than the average adult. In California alone there are over six 
million children under the age of 14 and approximately ninety percent 
of them live in areas that fail to meet State and Federal standards.
    How are our children being affected? Studies show health effects 
ranging from 20 to 60 percent losses of lung capacity. Despite this, 
representatives of industry claim that a thirty percent loss of lung 
capacity is not really a health effect because it is only a temporary 
reversible loss in lung function. Tell that to a mother whose asthmatic 
child has to stay home or visit the hospital emergency room on a 
regular basis. Tell that to a mother whose teenage son suffers from 
continuous coughing, throat irritations, chest pain and shortness of 
breath.
    And what about the potential of causing permanent damage? We have 
studies of laboratory animals which indicate that long term exposure to 
ozone causes permanent damage to the lungs.
    Mr. Chairman, in 1988 California expressed belief in the need for 
stronger clean air standards when we passed the most stringent ozone 
and particulate matter State standards in the country.
    And let me put this in context--we are committed to continuing to 
make improvements in air quality in a State that is projected to have 
double digit growth in population (18 percent) in the next 10 years. By 
the year 2005, we expect to have 38.2 million people in California--up 
from 32.2 million. We'll have a lot more cars on our highways.
    The Clean Air Act directs the Administrator to set standards at 
levels that in the judgment of the Administer protect the public health 
with an adequate margin of safety. Health must continue to be the 
marker upon which standards are based. And those standards must be 
based on science. Once health-based standards are set, costs should 
play an important role in implementation and timetables.
    A lot of serious questions have been raised about the Environmental 
Protection Agency's proposal. Industry is questioning the strength of 
the scientific basis for the proposal.
    In our search for answers, I think we need to look very closely at 
what the EPA Clean Air Scientific Advisory Committee recommended.
    They reviewed the available science and made a determination that 
there is an adequate scientific basis for the Administrator to revise 
the standards. For both ozone and particulates, the committee approved 
the EPA documents and the recommended specific ranges for new more 
stringent standards. The committee unanimously supported moving from 
the current 1-hour ozone standard to an 8-hour standard; and 19 of 21 
CASAC members supported moving to a fine particle standard for 
particulates.
    As we hear the criticisms of industry, we must constantly keep 
their final recommendation in our minds. We must not let the complexity 
of the debate let us forget them.
    Mr. Chairman, I am going to work aggressively to pursue answers to 
the serious questions that have been raised about the EPA proposal and 
I look forward to working with you, and the other members of this 
subcommittee.
    Mr. Chairman I would like to welcome Dr. Menzel and Dr. Wyzga who 
have come from California to testify before this subcommittee today.
    Thank you.

    Senator Inhofe. Thank you, Senator Boxer.
    Senator Lieberman.

  OPENING STATEMENT OF HON. JOSEPH I. LIEBERMAN, U.S. SENATOR 
                 FROM THE STATE OF CONNECTICUT

    Senator Lieberman. Thank you, Mr. Chairman. Congratulations 
on assuming the chairmanship. I look forward to working with 
you on these important and difficult questions. I totally 
support your thrust, as stated at the outset, that this is all 
about trying to find a basis in science for taking the 
important actions that we are all called on to take.
    I am also going to ask that my statement be included in 
full in the record and see if I can draw more briefly from it.
    Senator Inhofe. Without objection, your prepared statement 
will appear in the record.
    Senator Lieberman. To simply restate that these national 
ambient air quality standards that we are talking about here 
have been a cornerstone of the Clean Air Act since 1970 and 
they are based on a judgment that Congress made--and in a sense 
renewed in the reauthorization in 1990--which is that the 
ozone, particulate matter, and other common pollutant levels 
have to be based on a standard that is adequate to protect 
public health.
    We made a judgment here that the basis of the standard was 
going to be protection of public health with an adequate margin 
of safety. In fact, the standards are designed to ensure that 
sensitive groups--not super-sensitive groups--such as children, 
the elderly, and people with asthma or emphysema, which amounts 
in total to almost one-third of the American people, do not 
suffer adverse health effects as a result of breathing 
unhealthy air.
    The point I want to stress is one that I believe Senator 
Baucus made, which is that while the health standard is the 
basis for these air quality standards, they are not applied 
inflexibly. In fact, the plans that the States adopt are able 
to include specific consideration of cost in deciding how long 
it should take to implement the health-based standard. It can 
also have special allowances for small businesses because of 
the extra dimension of financial difficulty for small 
businesses.
    Areas are given varying times to reach these national 
health-based standards, depending on how difficult the task is. 
I can tell you in my own State, Fairfield County--which has a 
serious problem--is given under our implementation plan 17 
years to come into compliance because of the difficulty in 
doing so. The bottom line is that this approach has been very 
successful.
    Greg Easterbrook, an author, has written on these matters, 
and he said, ``The Clean Air Act isn't perfect, but it ranks as 
one of the most successful, cost-effective government 
initiatives of the modern era.''
    Again, Congress and EPA have been flexible in implementing 
this Act. EPA has recognized that some deadlines have been 
difficult to meet because of air that is brought in from 
outside the State. On two occasions, Congress has extended the 
time-frame for compliance. EPA, as is the case now, has 
constantly worked with advisory committees of industry, 
environmental groups, and others to develop these cost-
effective strategies.
    In response to the new proposed standards--which I gather 
are the first since the late 1970's in the Carter 
Administration and in the second case since 1987 during the 
Reagan Administration. There are some understandable questions 
being raised about the science, but there also seem to me to be 
some questions raised about whether these air quality standards 
should continue to be based on health concerns.
    Mr. Chairman, I want to say very clearly and strongly that 
the basic structure of this system, which is health-based air 
quality standards with cost coming into consideration and a 
very flexible implementation phase, is resoundingly the right 
way to go. For me, in one sense, my conclusion is based on a 
simple proposition which is that people have a right to know, 
by the best available scientific standards, whether they are 
breathing clean air.
    In areas that don't meet the standards, people know they 
are breathing air that presents a risk of their personal 
health. We can at least explain to them why they are not yet 
breathing fully clean air, which is that the cost of controls 
are too expensive, or in some areas it is just impossible to 
achieve the level we want in an early amount of time.
    I am extremely reluctant to change that basic paradigm, 
which I fear some are asking us to do in response to the 
proposed standards for ozone and particulate matter. In other 
words, Mr. Chairman, it is one thing to tell the public, ``You 
won't have clean air for 10 or 15 or 17 years.'' It is quite 
another to tell the public that they can no longer know whether 
the air they breathe is clean or dirty because the air quality 
standards reflect somebody's mixture of cost feasibility and 
health consideration.
    In terms of setting health-based standards, EPA is 
inevitably faced with scientific uncertainties. Over the last 
25 years, the bipartisan policy has been to err on the side of 
caution. Understandably so, when one considers the consequences 
here. But that doesn't mean they are erring on the side of 
caution, that is, acting solely on speculation. It means 
selecting a scientific standard along a continuum of levels 
that would provide varying degrees of public health protection 
and then articulating a rationale from a public health 
perspective for selecting a particular standard.
    Let me say finally, Mr. Chairman, that I am impressed that 
Administrator Browner has relied on a large number of studies 
conducted by different investigators in various locations in 
the United States and worldwide, each possessing distinct 
climates, demographics, and lifestyles. But the conclusions are 
riveting. EPA concludes that 40,000 people are dying 
prematurely every year from exposure to particulate matters, 
even in areas currently meeting the national ambient air 
quality standard. That is to say that 40,000 people would have 
lived longer were it not for particulate air pollution.
    With respect to ozone, EPA concludes that the new standards 
are necessary, particularly to protect approximately 13 million 
kids and 3 million asthmatics.
    Finally, for me the statements by the Administrator in her 
proposed rule present very strong reasons to listen very 
carefully to her arguments for setting new standards. I am 
impressed by what she has to say, but these are big decisions 
with enormous consequences in health and in cost. Therefore, we 
have to be open to comments from a broad range of people.
    That is why I appreciate, Mr. Chairman, the range of 
witnesses you have called today and why I look forward to the 
testimony.
    [The prepared statement of Senator Lieberman follows:]
 Prepared Statement of Hon. Joseph I. Lieberman, U.S. Senator from the 
                          State of Connecticut
    Thank you, Mr. Chairman. I welcome these hearings and look forward 
to working with you in your new position as subcommittee chair.
    The National Ambient Air Quality Standards have been a cornerstone 
of the Clean Air Act since 1970. The law requires EPA to set standards 
to reduce ozone, particulate matter and other common air pollutants at 
levels which are adequate to protect public health with an adequate 
margin of safety. The standards are designed to ensure that sensitive 
groups such as children, the elderly, and people with asthma or 
emphysema--nearly one third of our population--do not suffer adverse 
health effects as a result of breathing unhealthy air.
    After these standards are set, States must develop implementation 
plans to meet them. These plans include specific requirements for 
industry that take cost into account. They can also consider the needs 
of small businesses. Areas are given varying times to reach the 
national standards, depending upon how difficult the task. The 
Fairfield County area of Connecticut, for example, is given 17 years to 
come into compliance.
    This approach has been very successful. Levels of carbon monoxide, 
lead, volatile organic compounds, particulate matter and sulfur dioxide 
have dropped dramatically in the period between 1970 and 1995. As Greg 
Easterbrook has written: ``The Clean Air Act isn't perfect, but it 
ranks as one of the most successful, cost-effective government 
initiatives of the modern era.''
    And both Congress and EPA have been flexible in the implementation 
of the Act. EPA has recognized that certain deadlines are difficult to 
meet because of transported air pollution. On two occasions, Congress 
has extended the timeframe for compliance.
    Currently, EPA is working with an advisory committee of industry, 
environmental groups and other interested parties to develop cost-
effective strategies for implementing the proposed standards. I'm 
confident that many very creative ideas will come out of that process 
and I look forward to its recommendations. That's the history of the 
Clean Air Act--the development of new technologies and innovative 
approaches which greatly reduce the cost of compliance.
    Questions are now being raised about whether or not air quality 
standards should be based solely on health concerns. Mr. Chairman, I 
want to take some time this morning to explain why I strongly believe 
that the fundamental structure of the Clean Air Act--health-based air 
quality standards with costs coming into consideration in the 
implementation phase--is the right one.
    In one sense, the answer is simple. People have the right to know 
whether they are breathing clean air. Today, in areas that don't meet 
the standards for ozone or particulate matter or carbon monoxide, 
people know they are breathing air that presents a risk for public 
health. We can also explain to them why they are not yet breathing 
clean air: costs of controls can be expensive and some areas need time 
to reach the goals.
    I don't want to change that paradigm. If the standards are not 
based solely on public health, some places in our country could be 
meeting the standards and still have unhealthy air. What kind of 
confidence could the public have about such a system? Not very much.
    In other words, Mr. Chairman, it's one thing to tell the public 
that you won't have clean air for 10, 15, or even 17 years because that 
timeframe will allow for implementation of more cost effective 
solutions. It's quite another to tell the public that they can no 
longer know whether the air they breathe is clean or dirty because the 
air quality standard reflects some mixture of cost and health 
considerations. If an area meets an air quality standard, it should 
mean that the air is clean and healthy to breathe. Anything less is 
uninformative at best, deceptive at worst.
    In terms of setting health based standards, EPA is inevitably faced 
with scientific uncertainties. Over the last 25 years, the policy has 
been to err on the side of caution. We must act without scientific 
certitude because our goal, wherever possible, is a serious one: to 
prevent deaths and illnesses. Erring on the side of caution does not, 
of course, mean acting based on speculation. It means selecting a 
standard along a continuum of levels that would provide varying degrees 
of public health protection, and articulating a rationale from a public 
health perspective for selecting one standard and not a lower or higher 
standard.
    Let me comment briefly on the proposals before us. For both of 
these proposed standards, EPA relied on a large number of studies 
conducted by different investigators, in various locations in the U.S. 
and worldwide, each possessing distinct climates, demographics and 
lifestyles.
    With respect to particulate matter, EPA concludes that forty 
thousand people are dying prematurely every year from exposure to 
particulate matter even in areas currently meeting the standard--which 
is to say they would have lived longer were it not for particulate air 
pollution. Such exposure, according to EPA, also leads to tens of 
thousands of cases of chronic bronchitis, and hundreds of thousands of 
incidences of aggravation of asthma and other respiratory symptoms.
    With respect to ozone, EPA concludes that new standards are 
necessary particularly to protect approximately 13 million children and 
three million asthmatics who are not protected by the current standard 
from aggravated respiratory problems that can lead to increased 
hospitalization, illness, days missed from school and work, and other 
restrictions on activity.
    The statements made by Administrator Browner in her proposed rules 
present compelling reasons to listen carefully to the arguments for 
setting new standards for ozone and particulate matter. But these are 
big decisions, and therefore we must be open to comments from a broad a 
range of people as possible. That's why today's hearing is especially 
timely and useful.
    Mr. Chairman, I come from a State where the air quality is among 
the worst in the nation--in significant part as a result of air 
transported from other regions of the country. I have visited St. 
Francis Hospital in Hartford where people are sick because of air 
pollution. And it's not unusual for me to receive a letter similar to 
the one I received in November from a constituent who lives in 
Fairfield, Connecticut. She told me that her sister has pulmonary 
disease and every bit of polluted air is harmful to her health. My 
constituent has no power on her own to protect her sister from 
pollution. But she has the power, under the Constitution, to petition 
us and request that we do what we can to clean up the air and protect 
public health.
    That is a proper role of government. Government exists to protect 
our security. That means defending against threats from abroad. It 
means protecting us from criminals here at home. And it also means 
acting to protect the public from pollution that threatens their 
health, because fighting pollution is a task no individual can 
accomplish without the help of strong laws and adequate enforcement of 
those laws.
    We may never have air that is completely free of contamination. And 
we will never have enough money to do everything we should to clean up 
the air. The question of cost has to come into play in deciding exactly 
how, and how fast, to reach the goal of cleaner, healthier air. But we 
should not let cost compromise that goal, lest we lose sight of who we 
really represent.

    Senator Inhofe. Thank you, Senator Lieberman.
    The next Senator is Senator Hutchinson, one of our new 
members.

OPENING STATEMENT OF HON. TIM HUTCHINSON, U.S. SENATOR FROM THE 
                       STATE OF ARKANSAS

    Senator Hutchinson. Thank you, Mr. Chairman.
    I want to add my appreciation to you for calling the 
hearing today. Certainly, as Senator Lieberman said, this is a 
big decision and it does have enormous consequences. It is a 
huge issue in the State of Arkansas. I have heard from many of 
my constituents about this. I appreciate you calling the 
hearing to discuss the scientific basis behind the EPA's 
proposal to further regulate particulates and ozone.
    I am not a scientist, and this is one of the most 
complicated issues with which I have ever dealt. So this 
hearing is particularly important to my understanding as well 
as the understanding of my colleagues, as I suspect, as well.
    While I do not claim to understand all the intricacies of 
the scientific research, which has been made available to me, I 
have learned a great deal and I hope that some of the issues 
will be explained in more detail today before I make any 
judgments on the science and the regulations which are 
proposed. I want to reiterate that I am withholding judgment 
until I more fully understand the science and perhaps 
understand the reasoning EPA used to determine their proposal.
    One concern I have is the fact that there is no scientific 
evidence that supports a threshold level for regulation of 
ozone. We do not know at what point ozone is at a safe level. 
In addition, as I understand it, there are natural phenomena, 
which could raise ozone levels above even the current levels 
for attainment, and well above the proposed standards. If this 
is the case, it seems possible that certain areas of the 
country could never be in compliance with the Clean Air Act. 
Considering the sanctions that EPA has at its disposal, that is 
a rather daunting possibility.
    Perhaps my greatest concern, however, is the lack of data 
that exists on PM2.5. EPA is recommending that 
particulate matter be regulated at a level that we have not 
even measured. As I understand the science, there are not 
enough monitors in the United States that measure 
PM2.5 to justify setting such a stringent standard. 
Not only can we not measure it, but there is no evidence what 
types of PM2.5 may be the culprit for health 
problems. My concern is that we could conceivably regulate 
particulates that are not even the real problem.
    As I mentioned, I have not yet decided on a position on the 
regulations and I feel very strongly that these questions need 
to be adequately answered before I can make the right decision.
    Mr. Chairman, thank you again for having this hearing. I 
think it shows great insight on your part to convene a hearing 
on the science issues early on so that we can completely 
understand these proposed regulations. I thank you for calling 
the hearing.
    [The prepared statement of Senator Hutchinson follows:]
Prepared Statement of Hon. Tim Hutchinson, U.S. Senator from the State 
                              of Arkansas
    Thank you, Mr. Chairman. I sincerely appreciate the opportunity to 
be here today to discuss the scientific basis behind the EPA's recent 
proposal to further regulate particulates and ozone. I am not a 
scientist and this is one of the most complicated issues with which I 
have ever dealt, so this hearing is particularly important to my 
understanding, as well as the understanding of my colleagues, I 
imagine.
    I am pleased that we have the opportunity to hear from Dr. George 
Wolff and Dr. Morton Lippmann, the current and former chairmen of the 
Clean Air Scientific Advisory Committee, respectively. I trust that 
your expertise in the issues and your knowledge of the process will 
prove extremely beneficial to all the members of the committee, as well 
as the citizens of the United States, as we all try to understand the 
complicated issues we are about to discuss.
    While I do not claim to understand all the intricacies of the 
scientific research, which has been made available to me, I have 
learned a great deal and I hope to have some issues explained in 
detail, before I make any judgments on the science and the regulations 
which are proposed. I want to reiterate that I am withholding judgment 
until I more fully understand the science and perhaps understand the 
reasoning EPA used to determine their proposal.
    One concern I have is the fact that there is no scientific evidence 
that supports a threshold level for regulation of ozone. We do not know 
at what point ozone is at a safe level. In addition, as I understand 
it, there are natural phenomena, which could raise ozone levels above 
even the current levels for attainment, and well above the proposed 
standards. If this is the case, it seems possible that certain areas of 
the country could never be in compliance with the Clean Air Act. 
Considering the sanctions EPA has at its disposal, this seems to be a 
daunting possibility.
    Perhaps my greatest concern, however, is the lack of data that 
exists on PM2.5. EPA is recommending that particulate matter 
be regulated at a level that we have not even measured. As I understand 
the science, there are not enough monitors in the United States that 
measure PM2.5 to justify setting such a stringent standard. 
Not only can we not measure it, but there is no evidence what types of 
PM2.5 may be the culprit for health problems. My fear is 
that we could conceivably regulate particulates that are not even the 
real problem.
    As I mentioned, I have not yet decided on a position on the 
regulations and I feel very strongly that these questions need to be 
adequately answered before I can make a decision. Mr. Chairman, thank 
you for having this hearing. I think it shows great insight on your 
part to convene a hearing on the science issues early on, so we can 
completely understand these proposed regulations.

    Senator Inhofe. Thank you, Senator Hutchinson.
    We will now hear from Senator Allard.

 OPENING STATEMENT OF HON. WAYNE ALLARD, U.S. SENATOR FROM THE 
                       STATE OF COLORADO

    Senator Allard. Thank you, Mr. Chairman.
    I, too, would like to extend my congratulations to you, the 
chairman of this subcommittee. I look forward to working with 
you and the other committee members. I appreciate today's 
hearing and hope that we can clear the air, so to speak, on at 
least the science aspect of these regulations so that we can 
address policy with Administrator Browner next week.
    I think today's hearing will be the most important hearing 
on this issue because it focuses on the science. I hope today 
we can walk away from this hearing having cleared up the 
factual dispute over the science of these regulations. If this 
occurs, then we can either enter into a policy discussion with 
Administrator Browner next week, or we can decide to get out of 
the way and allow the EPA to do their work.
    However, if today's hearing does not clear up whether the 
science is sufficient, next week we will have the opportunity 
to follow up today's discussion with Carol Browner. In any 
event, I look forward to listening and learning from all our 
present and future witnesses because learning is what this 
process is all about.
    Over the past several weeks, I have contacted local elected 
officials in Colorado and also outside scientists. They have 
certainly helped me understand the importance of this issue to 
Colorado and the Nation. I might point out that in Colorado we 
have a special circumstance because of our high altitude. As 
many other States have special geographic considerations, our 
altitude does create some special interest, as far as I'm 
concerned, as to whether it is easier for us to comply or 
whether it is more difficult.
    Mr. Chairman, once again, thank you for calling these 
hearings.
    Senator Inhofe. Thank you, Senator Allard.
    We are very pleased today that we have the entire committee 
present. We will now hear from Senator Graham.

  OPENING STATEMENT OF HON. BOB GRAHAM, U.S. SENATOR FROM THE 
                        STATE OF FLORIDA

    Senator Graham. Mr. Chairman, I do not have an opening 
statement other than to say that I appreciate the fact that we 
are holding this hearing so promptly. Today we will focus on 
the science of the issue and then next week on some of the 
public policy implications. I believe that is the right 
sequence in which we should proceed. I look forward to 
receiving the testimony of this distinguished group this 
morning.
    Senator Inhofe. Thank you, Senator Graham.
    For the information of those here today, Senator Graham is 
the ranking member of this subcommittee.
    I am placing in the record at this point the statement of 
Senator Thomas, a member of the full committee.
    [The prepared statement of Senator Thomas follows:]
Prepared Statement of Hon. Craig Thomas, U.S. Senator from the State of 
                                Wyoming
    Thank you, Mr. Chairman, for holding this hearing today to discuss 
the Environmental Protection Agency's (EPA) proposed rule on 
Particulate Matter (PM) and Ozone. Since the EPA released their 
criteria on November 27, 1996, State and local governments, grass roots 
organizations, small businesses--in addition to many of the nation's 
Governors--have outlined problems and, opposition, to the new 
regulations. Their concerns need to be heard and fully examined before 
any final action occurs on this contentious issue. Furthermore, we need 
to ensure that we are using the best science possible.
    At the outset, I want to compliment the EPA for requesting an 
extension of the comment period an additional 60 days. To quote Senator 
Chafee in his letter to Molly Clark of the American Lung Association, 
``this is the largest single regulatory proposal ever made by EPA.'' 
With that in mind, and with virtually every industry in America 
affected by these new standards, it is imperative that additional time 
be allowed to properly address the impacts these requirements will 
place on the public.
    As we all know, the Clean Air Act (CAA) requires the EPA to 
identify and set standards for pollutants which potentially threaten 
public health. Particulate matter and ozone are two of six pollutants 
for which the EPA has developed National Ambient Air Quality Standards 
(NAAQS). Currently, we have a PM10 standard which regulates 
particles 10 microns in diameter and smaller and an allowable level of 
.12 parts per million cubic feet of ozone. It's important to note that 
according to the EPA's own reports, these pollutants have been 
significantly reduced over the past 10 years and will continue to 
decline as the 1990 Clean Air Act amendments are implemented.
    However, the EPA now wants to regulate particulates of 2.5 microns 
and smaller and initiate a standard of .08 parts per million for ozone. 
I am skeptical that lowering the NAAQS for particulate matter and ozone 
will actually achieve the level of protections stated by the EPA. The 
panelists we will hear from today are experts in the fields of science, 
health and medicine. I look forward to their testimony and views to see 
if in fact the EPA's proposed rule is necessary to protect public 
health.
    Mr. Chairman, one of the most troubling aspects of this process is 
EPA's rush to judgment to implement their proposed PM and ozone 
regulations before we truly know which particulates cause damaging 
health effects. I want to make sure that principles of sound science 
are being applied. As you know, this is a very technical issue and we 
should be confident that the choices we are making will get to the 
heart of protecting public health. Unfortunately, I do not believe that 
has been established. In fact, the EPA's own Clean Air Scientific 
Advisory Committee (CASAC) stated that ``our understanding of the 
health effects of particulates is far from complete.''
    I am also concerned about the geographic areas that will be thrown 
into nonattainment as a result of these standards. The EPA projects 
that 336 counties nationwide will be in nonattainment as a result of 
the new ozone rule and 170 counties will be in nonattainment due to the 
proposed PM2.5 revision. It's no secret that many parts of 
the country are having problems meeting current emissions reductions. 
If these requirements are implemented they could actually postpone 
efforts to achieve attainment status.
    Mr. Chairman, we all want to protect public health and the 
environment. In fact, it was the Bush Administration that passed the 
Clean Air Act amendments of 1990 and a Republican Congress that passed 
the Safe Drinking Water Act, the most environmentally friendly farm 
bill in history and legislation to strengthen food safety laws--all 
last year.
    However, the jury is still out on whether there is sufficient data 
at this time to decide what changes should be made to the PM and ozone 
standards. Nonetheless, it is important to have the best scientific 
data available to us. I compliment the chairman for holding this 
hearing and look forward to hearing from the witnesses that have been 
invited to testify before us today. Thank you.

    Senator Inhofe. I now ask our first panel of witnesses, 
Drs. Lippmann and Wolff, to be seated at the witness table.
    The way we have divided the panelists today is to start 
with two members of CASAC, the Clean Air Scientific Advisory 
Committee. The second panel will be expert scientists in the 
issue of ozone. The third and final panel will consist of 
experts who will focus on the particulate matter issue.
    While they are coming forward and taking their chairs, I 
would like to give you an overview of how we will proceed 
during this public hearing. We have a total of eight witnesses 
who will be testifying today.
    While you listen to testimony that will be given here 
today, you will hear speakers with whom you agree and disagree. 
I would like to ask that those of you who are in the audience 
would not show signs of approval or disapproval. That would be 
nothing but disruptive to our process.
    Each witness will be allocated 5 minutes to give his or her 
opening statement. There will be lights in front of you, green, 
yellow, and red. When you see the yellow light, I would ask you 
to try to conclude your remarks. Of course, when the red light 
comes on, your time has expired.
    Following each of the 5-minute comments by each of the 
witnesses on the panel, I would then ask any member of the 
subcommittee if he or she would like to ask questions. Then we 
will have a round of questions and answers.
    I think we are ready to begin. Let me introduce the members 
of the first panel.
    We have Dr. George Wolff, the chairman of the Environment 
Protection Agency's Clean Air Scientific Advisory Committee, 
and Dr. Morton Lippmann, professor of environmental medicine, 
Institute of Environmental Medicine, New York University.
    We will begin with Dr. Wolff.

   STATEMENT OF GEORGE WOLFF, CHAIRMAN, CLEAN AIR SCIENTIFIC 
           ADVISORY COMMITTEE, GENERAL MOTORS COMPANY

    Dr. Wolff. Thank you, Mr. Chairman, and good morning.
    I am George Wolff, principal scientist for General Motors 
corporate affairs staff. I am here today in my capacity as 
chairman of EPA's Clean Air Scientific Advisory Committee's 
panels that reviewed the scientific basis for EPA's proposed 
changes to the ozone and PM10 standards.
    Mr. Chairman, the debate over EPA's recent proposal to 
revise the standard for ozone and establish a new standard for 
PM2.5, which is particulate matter with a diameter 
less than or equal to 2.5 microns, has complex scientific 
elements. The range of opinions on the reliability of the 
science varies widely.
    CASAC has spent 2 years reviewing the data and studies that 
form the basis of EPA's proposed rules. I have provided for the 
record a detailed analysis of the CASAC review process, which I 
hope will be instructive to the subcommittee in its 
deliberations.
    This morning, I would simply summarize the highlights of 
the panel's findings on both pollutants.
    With respect to ozone, the bottom line is that although the 
ranges of concentrations and allowable exceedances proposed by 
EPA were considerable, there was really no bright line which 
distinguished any of the proposed standards--either the level 
or the number of allowable exceedances--as being more 
protective of public health, including the present standard. 
The weight of evidence indicates that there is no threshold 
concentration for the onset of biological responses due to 
exposure to ozone above background concentrations.
    Based on information now available, it appears that some 
individuals may respond to ozone exposure no matter what the 
level. What this means is that the old paradigm of identifying 
the lowest observable effects level and then providing an 
adequate margin of safety is not possible, either in practice 
or theory. It further means that as a consequence, EPA risk 
assessments must play a key role in identifying an appropriate 
level.
    In reaching the conclusion that there is no bright line in 
terms of public health benefits, we found, for example, that 
the differences of percent of outdoor children responding 
between the present standard and EPA's more stringent 
proposal--that is, 8 hours, one exceedance at .07 parts per 
million--were statistically insignificant for all health 
endpoints. Further, when ozone-aggravated asthma admissions 
were compared to total asthma admissions, the differences 
between the various options were small.
    As a consequence, the panel concluded that the selection of 
a specific level and number of allowable exceedances is a 
policy judgment rather than a decision based on the underlying 
science.
    In summary, the scientific community has made great strides 
in its understanding the health effects of ozone exposure 
because of ongoing research programs. Nevertheless, there are 
still many gaps in our knowledge and large uncertainties in 
many of the risk assessments. The good news is that the 
scientific community may now be in a position to frame the 
important questions that need to be addressed before the next 
ozone review is completed in 5 years.
    Turning to PM, our understanding of the health effects of 
PM is far from complete. Having said that, the panel agreed 
that retaining the annual PM10 standards at their 
current level is appropriate at this time. There was also 
consensus that a new PM2.5 standard be established 
to distinguish between coarse and fine particles.
    However, there was no consensus on the level, averaging 
time, or form of the standard. For example, four panelists 
supported specific ranges near the lower end of EPA's proposal. 
Eight others declined to select a specific range at all. Seven 
selected a level near, at, or above EPA's proposal. Two members 
recommended against the PM2.5 standard.
    At least in part, this diversity of opinion can be 
attributed to the accelerated review schedule. The deadlines 
did not allow adequate time to analyze, integrate, interpret, 
or debate the available data on this very complex issue. Nor 
does the court-ordered deadline recognize that achieving the 
goal of a scientifically defensible standard may require 
interim steps.
    The diversity of opinion among CASAC members underscores 
the many unanswered questions and uncertainties associated with 
establishing causality between PM2.5 and premature 
death. Among these are exposure misclassification, lack of 
understanding of toxicological mechanisms, and the existence of 
possible alternative explanations.
    The panel expressed its desire to avoid being in a similar 
situation when the next PM review cycle is undertaken, and 
therefore urged EPA to implement immediately a targeted 
research program to address these unanswered questions and 
uncertainties. The panel also believed that it is essential 
that EPA obtain long-term PM2.5 measurements.
    Mr. Chairman, that concludes my formal remarks. I will be 
happy to respond to any questions the subcommittee may have.
    Senator Inhofe. Thank you, Dr. Wolff.
    Dr. Lippmann.

   STATEMENT OF MORTON LIPPMANN, INSTITUTE OF ENVIRONMENTAL 
                 MEDICINE, NEW YORK UNIVERSITY

    Dr. Lippmann. Thank you, Mr. Chairman.
    My full statement gives my background. I have personally 
been involved in research on this issue for many decades.
    Senator Inhofe. Without objection, your prepared statement 
will appear in the record.
    Dr. Lippmann. In fact, the size selective standards were 
based largely on my lab work. I have done the physiology and 
deposition studies that support that. I also started the chain 
of studies in the natural setting showing exposure response 
relationships for ozone to children, where there is no question 
that higher exposures produce greater responses. Dr. Thurston 
will later talk about our studies in asthmatic children, which 
show medication usage is directly related to the ozone and 
sulfate levels.
    In my view, the EPA proposals for the revised standards are 
clearly not too strict, since they will permit exposure that 
will cause excess mortality and morbidity. In my view, the EPA 
Administrator has made a prudent public health judgment in her 
selections of the standards.
    The Administrator's decision to proceed with changes in 
both at the same time is a good one because both pollutants 
come from the same sources. They interact and it doesn't make 
sense economically or otherwise to attack the one pollutant and 
not the other.
    CASAC did fully endorse the ranges proposed by staff and 
the Administrator has made her selections within those ranges. 
For ozone the current standard of 120 parts per billion for an 
hour is equivalent to an 8-hour max of 90, based on the third 
highest. So we are essentially only reducing the permissible 
exposure from 90 to 80. The difference is in changing the 
average time to 8-hour from 1-hour, which is in relation to the 
way people respond to ozone. They don't respond immediately. 
The response builds up over successive hours.
    By contrast, the recent air quality guideline exercise by 
the World Health Organization (WHO) in Europe, just completed, 
proposes an 8-hour level of 60 parts per billion, considerably 
more conservative than the EPA proposal.
    For PM, the 50 microgram per cubic meter (mg/m3) 
annual average would be retained without change. But the 24-
hour PM10 is being relaxed because it is now being 
based on multiple exceedances, and not on a single exceedance. 
That is OK, because we don't really believe the coarse 
component, which drives the PM10 concentration, is 
having the effects that the fine particles are. If we don't 
have a standard for fine particles, we don't attack the problem 
that is causing the particulate-related health effects.
    The WHO Europe exercise in air quality guidelines for 
particulate matter say that they can't even establish a 
traditional guideline because there is excess mortality at 
every level. Therefore, they say that the national authorities 
which use these guidelines have to decide how much they can 
tolerate. Less is better, that is, more protective. More means 
more people are affected. CASAC endorsed a range. The EPA 
Administrator has selected something toward the upper side of 
the range on a 24-hour basis.
    She certainly is being prudent. She is heightening the 
standard somewhat, but not going down to what the lowest-
effects level is. The lowest level that is appropriate is 
uncertain because we don't know the compositional factors. The 
next time we do this, the standard should ideally be directed 
at the specific toxic components within the particle mixture. 
But the evidence is absolutely clear that it is the fine 
particles which are most closely related to the mortality and 
the morbidity, and lowering the limits for fine particles a bit 
is a prudent public health judgment.
    I won't go into all the things particles do. Senator 
Lieberman mentioned it, Senator Baucus mentioned it. But to 
save time, I would like to point out that it is misleading to 
talk about the number of communities going out of compliance. 
Many communities, which would be just below the current 
standards, may turn out to be just above the new standards. 
However, the particulate trends are going down. We will have a 
long timeframe for implementation of the new standards. By the 
time the standards are implemented, there won't be that many 
communities who will have to take drastic action. We are 
talking about an incremental reduction in protection, which is 
prudent public policy.
    So CASAC endorsed the ranges proposed by EPA staff. The 
Administrator certainly didn't go to the lower end of the 
range. What we must recognize is that there are major unknowns 
left, and that we will be in the same box 5 years from now 
unless the Agency has more resources to find out what we don't 
know now. Dr. Wolff and I certainly agree entirely--as does 
everyone else in science on this issue--that we need more money 
to find out what the problem is and how we can do a better job 
when the standard cycle comes around again.
    My personal estimate is that we should be spending at least 
$50 million a year, which is small change when compared to the 
health effects benefit, and even to the control costs. Right 
now, we are a bit in the dark, but a judgment call is called 
for by the Administrator because the Act says that she must 
look at these standards periodically. I think she has made a 
prudent judgment call and that we need to get on with it. We 
need to address the unknown and come back to this again in 5 
years.
    Senator Inhofe. Thank you, Dr. Lippmann.
    You say that you need more money. We haven't heard that 
before.
    [Laughter.]
    Senator Inhofe. Dr. Wolff, perhaps you could help me better 
understand the type of science that is being used in these 
studies, particularly the PM studies which apparently were 
epidemiological studies.
    Do epidemiological studies basically examine the 
statistical relationship between health effects or diseases 
with different possible factors versus other studies, such as 
toxicology and physiology, which deal with biological 
mechanisms?
    Dr. Wolff. That is correct. The epidemiological studies are 
based on statistical relationships between two observations.
    Senator Inhofe. So basically statistics versus biological 
mechanisms?
    Dr. Wolff. The toxicological studies are looking for 
biological mechanisms.
    Senator Inhofe. I understand that there is not a biological 
mechanism for PM. Is that true?
    Dr. Wolff. This was a contention of several members that 
were on the CASAC. Most notably, Dr. Mark Utell, who is a chest 
physician, kept reminding us that there was no plausible 
biological mechanism that he could use to explain the 
statistical relationship.
    Senator Inhofe. Those of us--and of course, I guess I speak 
for everyone on this panel who are non-scientists, and laymen, 
so to speak--it is very difficult to understand the risk 
factors shown in these studies. I read an article that was 
given to me by staff in this Science Magazine called 
``Epidemiology Faces Its Limits''.
    Without objection, I would like to enter this article in 
the record.
    [The referenced article follows:]

                     [From Science, July 14, 1995]

                     Epidemiology Faces Its Limits

                            (By Gary Taubes)

    The news about health risks comes thick and fast these days, and it 
seems almost constitutionally contradictory. In January of last year, 
for instance, & Swedish study found a significant association between 
residential radon exposure and lung cancer. A Canadian study did not. 
Three months later, it was pesticide residues. The Journal of the 
National Cancer Institute published a study in April reporting--
contrary to previous, less powerful studies--that the presence of DDT 
metabolites in the bloodstream seemed to have no effect on the risk of 
breast cancer. In October, it was abortions and breast cancer. Maybe 
yes. Maybe no. In January of this year it was electromagnetic fields 
(EMF) from power lines. This time a study of electric utility workers 
in the United States suggested a possible link between EMF and brain 
cancer but--contrary to a study a year ago in Canada and France--no 
link between EMF and leukemia.
    These are not isolated examples of the conflicting nature of 
epidemiologic studies; they're just the latest to hit the newspapers. 
Over the years, such studies have come up with a mind-numbing array of 
potential disease-causing agents, from hair dyes (lymphomas, myelomas, 
and leukemia) to coffee (pancreatic cancer and heart disease) to oral 
contraceptives and other hormone treatments (virtually every disorder 
known to woman). The pendulum swings back and forth, subjecting the 
public to an ``epidemic of anxiety,'' as Lewis Thomas put it over a 
decade ago. Indeed, last July, the New England Journal of Medicine 
(NEJM) published an editorial by editors Marcia Angell and Jerome 
Kassirer asking the pithy question, ``What Should the Public Believe?'' 
Health-conscious Americans, wrote Angell and Kassirer, ``increasingly 
find themselves beset by contradictory advice. No sooner do they learn 
the results of one research study than they hear of one with the 
opposite message.''
    Kassirer and Angell place responsibility on the press for its 
reporting of epidemiology, and even on the public ``for its unrealistic 
expectations'' of what modern medical research can do for their health. 
But many epidemiologists interviewed by Science say the problem also 
lies with the very nature of epidemiologic studies--in particular those 
that try to isolate causes of noninfectious disease, known variously as 
``observational'' or ``risk-factor'' or ``environmental'' epidemiology.
    The predicament of these studies is a simple one: Over the past 50 
years, epidemiologists have succeeded in identifying the more 
conspicuous determinants of noninfectious diseases--smoking, for 
instance, which can increase the risk of developing lung cancer by as 
much as 3000 percent. Now they are left to search for subtler links 
between diseases and environmental causes or lifestyles. And that leads 
to the Catch-22 of modern epidemiology.
    On the one hand, these subtle risks--say, the 30 percent increase 
in the risk of breast cancer from alcohol consumption that some studies 
suggest--may affect such a large segment of the population that they 
have potentially huge impacts on public health. On the other, many 
epidemiologists concede that their studies are so plagued with biases, 
uncertainties, and methodological weaknesses that they may be 
inherently incapable of accurately discerning such weak associations. 
As Michael Thun, the director of analytic epidemiology for the American 
Cancer Society, puts it, ``With epidemiology you can tell a little 
thing from a big thing. What's very hard to do is to tell a little 
thing from nothing at all.'' Agrees Ken Rothman, editor of the journal 
Epidemiology: ``We're pushing the edge of what can be done with 
epidemiology.
    With epidemiology stretched to its limits or beyond, says Dimitrios 
Trichopoulos, head of the epidemiology department at the Harvard School 
of Public Health, studies will inevitably generate false positive and 
false negative results ``with disturbing frequency.'' Most 
epidemiologists are aware of the problem, he adds, ``and tend to avoid 
causal inferences on the basis of isolated studies or even groups of 
studies in the absence of compelling biomedical evidence. However, 
exceptions do occur, and their frequency appears to be increasing.'' As 
Trichopoulos explains, ``Objectively the problems are not more than 
they used to be, but the pressure is greater on the profession, and the 
number who practice it is greater.''
    As a result, journals today are full of studies suggesting that a 
little risk is not nothing at all. The findings are often touted in 
press releases by the journals that publish them or by the researchers' 
institutions, and newspapers and other media often report the claims 
uncritically (see box on p. 166). And so the anxiety pendulum swings at 
an ever more dizzying rate. ``We are fast becoming a nuisance to 
society,'' says Trichopoulos. ``People don't take us seriously anymore, 
and when they do take us seriously, we may unintentionally do more harm 
than good.'' As a solution, epidemiologists interviewed by Science 
could suggest only that the press become more skeptical of 
epidemiologic findings, that epidemiologists become more skeptical 
about their own findings--or both.
                        an observational science
    What drives the epidemiologic quest for risk factors is the strong 
circumstantial evidence that what we eat, drink, breathe, and so on are 
major factors in many devastating illnesses. Rates of heart disease, 
for example, have changed much faster over recent decades than can be 
explained by genetic changes, implicating dietary and environmental 
causes. And the fact that no single cancer affects every population at 
the same rate suggests that factors external to the human body cause 70 
percent to 90 percent of all cancers. In other words, says Richard 
Peto, an Oxford University epidemiologist, ``there are ways in which 
human beings can live whereby those cancers would not arise.'' Only a 
few of these environmental factors are known--cigarette smoke for lung 
cancer, for example, or sunlight for skin cancer--and epidemiology 
seems to provide the best shot at identifying the others.
    The most powerful tool for doing so is the randomized trial, which 
is the standard for studies of new drugs and other medical research: 
Assign subjects at random to test and control groups, alter the 
exposure of the test group to the suspected risk factor, and follow 
both groups to learn the outcome. Often, both the experimenters and the 
subjects are ``blinded''--unaware who is in the test group and who is a 
control. But randomized trials would be prohibitively slow and 
expensive for most risk factors, because they can take years or decades 
to show an effect and hundreds of thousands of individuals may need to 
be followed to detect enough cases of the disease for the results to be 
significant. And randomly subjecting thousands of healthy people to 
pollutants or other possible carcinogens raises obvious ethical 
problems.
    Because the experimental approach is off limits for much of 
epidemiology, researchers resort to observational approaches. In case-
control studies, for example, they select a group of individuals 
afflicted with a particular disorder, then identify a control group 
free of the disorder and compare the two, looking for differences in 
lifestyle, diet, or some environmental factor. Potentially more 
reliable, but also much more costly, are cohort studies, in which 
researchers take a large population--as many as 100,000--and question 
the subjects in detail about their habits and environment. They then 
follow the entire population for years or decades to see who gets sick 
and who doesn't, what diseases they suffer from, and what factors might 
be different between them. Either way, risk-factor epidemiology is ``a 
much duller scalpel'' than randomized trials, says Scott Zeger, a 
biostatistician at the Johns Hopkins School of Mental and Public 
Health.
    What blunts its edge are systematic errors, known in the lingo as 
biases and confounding factors. ``Bias and confounders are the plague 
upon the house of epidemiology,'' says Philip Cole, chair of 
epidemiology at the University of Alabama. They represent anything that 
might lead an epidemiologic study to come up with the wrong answer, to 
postulate the existence of a causal association that does not exist or 
vice versa.
    Confounding factors are the hidden variables in the populations 
being studied, which can easily generate an association that may be 
real but is not what the epidemiologist thinks it is. A ubiquitous 
example is cigarette smoking, which can confound any study looking, for 
instance, at the effects of alcohol on cancer. ``It just so happens,'' 
explains Trichopoulos, ``that people who drink also tend to smoke,'' 
boosting their risk of cancer. As a result, epidemiologists face the 
possibility that any apparent cancer-alcohol link may be spurious. 
Smoking may also have confounded a study Trichopoulos himself co-
authored linking coffee-drinking and pancreatic cancer--a finding that 
has not been replicated. The study, published over a decade ago, 
corrected for smoking, which often accompanies heavy coffee drinking--
but only for smoking during the 5 years before the cancer was 
diagnosed. Trichopoulos now says that he and his colleagues might have 
done better to ask about smoking habits a full 20 years before 
diagnosis.
    Biases are problems within study designs themselves. The process of 
choosing an appropriate population of controls in a case-control study, 
for instance, can easily lead to an apparent difference between cases 
and controls that has nothing to do with what caused the disease. 
``It's often not even theoretically clear who the right comparison 
group is,'' says Harvard epidemiologist Walter Willett. ``And 
sometimes, even if you can design the study so that you have the 
theoretically correct comparison group, you usually don't get everybody 
willing to participate, and the people who do participate in your study 
will be different from the people who don't, often in health-related 
ways.''
    For example, Charles Poole of Boston University has spent several 
years analyzing the results and methodology of a 1988 study of EMF and 
cancer, which found that exposure to relatively high EMF from power 
lines appeared to increase the risk of leukemia and brain cancer in 
children. David Savitz of the University of North Carolina, the study's 
author, selected controls for that study with a common technique known 
as random digit dialing: Researchers take the phone numbers of their 
cases and randomly change the last four digits until they find a 
suitable control. Random digit dialing, however, seems to create ``a 
pronounced bias toward the control group being deficient in persons of 
very low socioeconomic status,'' says Poole. Poor people, it seems, are 
either less likely to be home during the day to answer the phone, less 
likely to want to take part in a study, or less likely to have an 
answering machine and call the researchers back.
    Indeed, the North Carolina researchers reported that their data 
showed that the risk of leukemia and brain cancer rises not just with 
exposure to EMF but also with higher levels of breast-feeding, maternal 
smoking, and traffic density, all of which are markers for poverty. 
This suggests, says Poole, that the study group was poorer than the 
controls, and that some poverty-associated factor other than EMF could 
have resulted in the apparent increase in cancer risk. Nonetheless, the 
study is still cited as supporting the hypothesis that EMF causes 
childhood cancer, although even Savitz concedes that the random dig-it 
dialing problem is ``a legitimate source of uncertainty.''
    Even when such biases can be identified, their magnitude--and 
sometimes even their direction--can be nearly impossible to assess. 
David Thomas, for example, an epidemiologist at the Fred Hutchinson 
Cancer Research Center in Seattle, points to studies analyzing the 
effect of Breast Self-Examination (BSE) on breast cancer mortality 
rates, which, he says, have yielded some ``modest suggestion that there 
might be a beneficial effect'' from BSE. ``You have to ask what 
motivates a woman to practice BSE,'' says Thomas. ``Maybe she has a 
strong family history of breast cancer. If so, she's more likely to get 
breast cancer. That would be an obvious bias,'' which could make BSE 
look less useful than it is. ``Or maybe a woman with a strong family 
history of breast cancer would be afraid to practice BSE. You have no 
way of predicting the direction of the bias. So it would be very 
difficult to interpret your results. You have to go to a randomized 
study to get a reliable answer.''
                            tricks of memory
    Of all the biases that plague the epidemiologic study of risk 
factors, the most pernicious is the difficulty of assessing exposure to 
a particular risk factor. Rothman, for instance, calls it ``a towering 
obstacle.'' When exposure can be measured reliably, a subtle 
association may be credible--as it is in the case of early childbirth 
and a lower risk of breast cancer. The reason is that both cause and 
effect can be measured with some certainty, says Harvard epidemiologist 
Jamie Robins. ``It's easy to know which people got breast cancer, and 
it's easy to know at what age they had kids,'' he says, adding that 
virtually every study on the subject comes to the same conclusion: 
Early childbirth reduces the risk by about 30 percent.
    But epidemiologists are quick to list risk factors for which 
accurate exposure measurements are virtually impossible. Joe Fraumeni, 
director of the epidemiology and biostatistics program at the National 
Cancer Institute (NCI), points to radon: ``When you're studying 
smoking,'' he says, ``that's easy. Just count the number of cigarettes 
and duration and packs per day. But something like radon, how do you 
measure exposure, particularly biologically relevant exposure that has 
taken place in the past?'' Equally uncertain are those risk factors 
recorded only in human memory, such as consumption of coffee or dietary 
fat. Ross Prentice of the University of Washington notes, for example, 
that underweight individuals tend to overreport fat intake on 
questionnaires or in interviews and obese subjects tend to underreport 
it.
    Such recall bias is known to be especially strong, as Willett 
points out, among patients diagnosed with the disease in question or 
among their next of kin. In studies of a possible relationship between 
fat intake and breast cancer, for instance, says Willett, ``people may 
recall their past intake of fat differently if they have just been 
diagnosed with breast cancer than if you pluck them out of a random 
sample, call them up out of the blue over the phone, and ask them what 
their past diet was.''
    Recall bias, for instance, apparently accounts for the conflicting 
findings about oral contraceptive use and breast cancer. Many studies 
have looked for this association over the years, both case-control 
studies and cohort studies. Trichopoulos notes that case-control 
studies have tended to show an association between oral contraceptives 
and breast cancer, while cohort studies have not. Epidemiologists who 
have done cohort studies say the problem is in case-control studies, 
which are thrown off by recall bias--women who are diagnosed with 
breast cancer are more likely to give complete information about 
contraceptive use than women who don't. Those who did case-control 
studies say the bias is in the cohort studies. Cohort studies have to 
rely on impersonal questionnaires because they are so much larger than 
case-control studies, and women are less likely to give complete and 
honest information than they are in the more intimate interviews 
possible in case-control studies. ``The point,'' says Trichopoulos, 
``is which do we believe.''
    It's not just the subjects of studies who are prone to bias; 
epidemiologic studies can be plagued by interviewer bias as well. The 
interviewers are rarely blinded to cases and controls, after all, and 
questionnaires, the traditional measuring instrument of epidemiology, 
are neither peer-reviewed nor published with the eventual papers. ``In 
the laboratory,'' as Yale University clinical epidemiologist Alvin 
Feinstein puts it, ``you have all kinds of procedures for calibrating 
equipment and standardizing measurement procedures. In epidemiology ... 
it's all immensely prey to both the vicissitudes of human memory and 
the biases of the interview.''
                       salvation from statistics?
    With confounders, biases, and measurement errors virtually 
inevitable, many epidemiologists interviewed by Science say that risk-
factor epidemiology is increasingly straying beyond the limits of the 
possible no matter how carefully the studies are done. ``I have trouble 
imagining a system involving a human habit over a prolonged period of 
time that could give you reliable estimates of risk increases that are 
of the order of tens of percent,'' says Harvard epidemiologist Alex 
Walker. Even the sophisticated statistical techniques that have entered 
epidemiologic research over the past 20 years--tools for teasing out 
subtle effects, calculating the theoretical effect of biases, 
correcting for possible confounders, and so on--can't compensate for 
the limitations of the data, says biostatistician Norman Breslow of the 
University of Washington, Seattle.
    ``In the past 30 years,'' he says, ``the methodology has changed a 
lot. Today people are doing much more in the way of mathematical 
modeling of the results of their study, fitting of regression 
equations, regression analysis. But the question remains: What is the 
fundamental quality of the data, and to what extent are there biases in 
the data that cannot be controlled by statistical analysis? One of the 
dangers of having all these fancy mathematical techniques is people 
will think they have been able to control for things that are 
inherently not controllable.''
    Breslow adds that epidemiologist will commonly report that they 
have unveiled a possible causal association between a risk factor and a 
disease because the association is ``statistically significant,'' 
meaning that the error bars--the limits of a 95 percent confidence 
interval--do not include the null result, which is the absence of an 
effect. But, as Breslow explains, such statistical ``confidence'' means 
considerably less than it seems to. The calculation of confidence 
limits only takes into consideration random variation in the data. It 
ignores the systematic errors, the biases and confounders, that will 
almost invariably overwhelm the statistical variation.
    University of California, Los Angeles (UCLA) epidemiologist Sander 
Greenland says most of his colleagues fail to understand this simple 
point. ``What people want to do when they see a 95 percent confidence 
interval,'' he says, ``is say `I bet there's a 95 percent chance the 
true value is in there.' Even if they deny it, you see them behaving 
and discussing their study result as though that's exactly what it 
means. There are certain conditions under which it's not far from the 
truth, but those conditions are generally not satisfied in an 
epidemiologic study.''
                            what to believe?
    So what does it take to make a study worth taking seriously? Over 
the years, epidemiologists have offered up a variety of criteria, the 
most important of which are a very strong association between disease 
and risk factor and a highly plausible biological mechanism. The 
epidemiologists interviewed by Science say they prefer to see both 
before believing the latest study, or even the latest group of studies. 
Many respected epidemiologist. have published erroneous results in the 
past and say it is so easy to be fooled that it is almost impossible to 
believe less-than-stunning results.
    Sir Richard Doll of Oxford University, who once co-authored a study 
erroneously suggesting that women who took the anti-hypertension 
medication reserpine had up to a fourfold increase in their risk of 
breast cancer, suggests that no single epidemiologic study is 
persuasive by itself unless the lower limit of its 95 percent 
confidence level falls above a threefold increased risk. Other 
researchers, such as Harvard's Trichopoulos, opt for a fourfold risk 
increase as the lower limit. Trichopoulos's ill-fated paper on coffee 
consumption and pancreatic cancer had reported a 2.5fold increased 
risk.
    ``As a general rule of thumb,'' says Angell of the New England 
Journal, ``we are looking for a relative risk of three or more before 
accepting a paper for publication!, particularly if it is biologically 
implausible or if it's a brand-new finding.'' Robert Temple, director 
of drug evaluation at the Food and Drug Administration, puts it 
bluntly: ``My basic rule is if the relative risk isn't at least three 
or four, forget it.'' But as John Bailar, an epidemiologist at McGill 
University and former statistical consultant for the NEJM, points out, 
there is no reliable way of identifying the dividing line. ``If you see 
a 10fold relative risk and it's replicated and it's a good study with 
biological backup, like we have with cigarettes and lung cancer, you 
can draw a strong inference,'' he says. ``If it's a 1.5 relative risk, 
and it's only one study and even a very good one, you scratch your chin 
and say maybe.''
    Some epidemiologists say that an association with an increased risk 
of tens of percent might be believed if it shows up consistently in 
many different studies. That's the rationale for meta-analysis--a 
technique for combining many ambiguous studies to see whether they tend 
in the same direction (Science, 3 August 1990, p. 476). But when 
Science asked epidemiologists to identify weak associations that are 
now considered convincing because they show up repeatedly, opinions 
were divided--consistently.
    Take the question of alcohol and breast cancer. More than 50 
studies have been done, and more than 30 have reported that women who 
drink alcohol have a 50 percent increased risk of breast cancer. 
Willett, whose Nurse's Health Study was among those that showed a 
positive association, calls it ``highly probable'' that alcohol 
increases the risk of breast cancer. Among other compelling factors, he 
says, the finding has been ``reproduced in many countries with many 
investigators controlling for lots of confounding variables, and the 
association keeps coming up.'' But Greenland isn't so sure. ``I'd bet 
right now there isn't a consensus. I do know just from talking to 
people that some hold it's a risk factor and others deny it.'' Another 
Boston-based epidemiologist, who prefers to remain anonymous, says 
nobody is convinced of the breast cancer-alcohol connection ``except 
Walt Willett.''
    Another example is long-term oral contraceptive use and breast 
cancer, a link that has been studied for a quarter of a century. Thomas 
of the Fred Hutchinson Cancer Research Center says he did a meta-
analysis in 1991 and found a dozen studies showing a believable 
association in younger women who were long-time users of oral 
contraceptives. ``The bottom line,'' he says, ``is it's taken us over 
20 years of studies before some consistency starts to emerge. Now it's 
fairly clear there's a modest risk.'' But Noel Weiss of the University 
of Washington says he did a similar review of the data that left him 
unconvinced. ``We don't know yet,'' he says. ``There is a small 
increased risk associated with oral contraceptive use , but what that 
represents is unclear.'' Mary Charleson, a Cornell Medical Center 
epidemiologist, calls the association ``questionable.'' Marcia Angell 
calls it ``still controversial.''
    Consistency has a catch, after all, explains David Sackett of 
Oxford University: It is persuasive only if the studies use different 
architectures, methodologies, and subject groups and still come up with 
the same results. If the studies have the same design and ``if there's 
an inherent bias,'' he explains, ``it wouldn't make any difference how 
many times it's replicated. Bias times 12 is still bias.'' What's more, 
the epidemiologists interviewed by Science point out that an apparently 
consistent body of published reports showing a positive association 
between a risk factor and a disease may leave out other, negative 
findings that never saw the light of day.
    ``Authors and investigators are worried that there's a bias against 
negative studies,'' and that they will not be able to get them 
published in the better journals, if at all, says Angell of the NEJM. 
``And so they'll try very hard to convert what is essentially a 
negative study into a positive study by hanging on to very, very small 
risks or seizing on one positive aspect of a study that is by and large 
negative.'' Or, as one National Institute of Environmental Health 
Sciences researcher puts it, asking for anonymity, ``Investigators who 
find an effect get support, and investigators who don't find an effect 
don't get support. When times are tough it becomes extremely difficult 
for investigators to be objective.''
    When asked why they so willingly publish inconclusive research, 
epidemiologists say they have an obligation to make the data public and 
justify the years of work. They also argue that if the link is real, 
the public health effect may be so dramatic that it would be 
irresponsible not to publish it. The University of North Carolina's 
Savitz, for instance, who recently claimed a possible link between EMF 
exposure and a tens of percent increase in the risk of breast cancer, 
says: ``This is minute. . . . But you could make an argument that even 
if this evidence is 1000fold less than for an EMF-leukemia link, it is 
still more important, because the disease is 1000fold more prevalent.''
    One of the more pervasive arguments for publishing weak effects, 
Rothman adds, is that any real effect may be stronger than the reported 
one. Any mismeasurement of exposure, so the argument goes, will only 
serve to reduce the observed size of the association. Once researchers 
learn how to measure exposure correctly, in other words, the actual 
association will turn out to be bigger--and thus more critical to 
public health. That was the case in studies of steelworkers and lung 
cancer decades ago, says Robins. Early studies saw only a weak 
association, but once researchers homed in on coke-oven workers, the 
group most exposed to the carcinogens, the relative risk shot up. None 
of the epidemiologists who spoke to Science could recall any more 
recent parallels, however.
                           an unholy alliance
    There would be few drawbacks to publishing weak, uncertain 
associations if epidemiologists operated in a vacuum, wrote Brian Mac-
Mahon, professor emeritus of epidemiology at Harvard, in an April 1994 
editorial in the Journal of the National Cancer Institute. But they do 
not, he said. ``And, however cautiously the investigator may report his 
conclusions and stress the need for further evaluation,'' he added, 
``much of the press will pay little heed to such cautions. . . . By the 
time the information reaches the public mind, via print or screen, the 
tentative suggestion is likely to be interpreted as a fact.''
    This is what one epidemiologist calls the ``unholy alliance'' 
between epidemiology, the journals, and the lay press. The first one or 
two papers about a suspected association ``spring into the general 
public consciousness in way that does not happen in any other field of 
scientific endeavor,'' says Harvard's Walker. And once a possible link 
is in the public eye, it can be virtually impossible to discredit. As 
far as scientists were concerned, for instance, a 1981 epidemiologic 
study put to rest a suggestion that saccharine can cause bladder 
cancer--one of the few cases in which epidemiology had managed to put 
an end to a suspected association. Yet 14 years later, television 
advertisements for Nutra-Sweet, which contains the artificial sweetener 
aspartame, still tout it as the sweetener that does not have 
saccharine.
    Epidemiologists themselves are at a loss as to how to curb the 
``anxiety of the week'' syndrome. Many, like rothman, simply argue that 
risk factor epidemiology is a young science that will take time to 
mature. Others, like Robins, suggest that barring a major breakthrough 
in the methodological tools of epidemiology, maturity will be hard to 
come by. The pressures to publish inconclusive results and the 
eagerness of the press to publicize them, he and others say, mean that 
the anxiety pendulum, like Foucault's, will continue to swing 
indefinitely (see box on p. 165).
    The FDA's Temple does make one positive suggestion: Although risk-
factor epidemiology will never be as sharp a tool as randomized 
clinical trials, epidemiologists could still benefit by adopting some 
of the scientific practices of those studies. ``The great thing about a 
clinical control trial,'' he says, ``is that, within limits, you don't 
have to believe anybody or trust anybody. The planning for a clinical 
control trial is prospective; they've written the protocol before 
they've done the study, and any deviation that you introduce later is 
completely visible.'' While agencies like the NCI do insist on seeing 
study protocols in risk-factor epidemiology prospectively, this is 
still not standard procedure throughout the field. Without it, says 
Temple, ``you always wonder how many ways they cut the data. It's very 
hard to be reassured, because there are no rules for doing it.''
    In the meantime, UCLA's Greenland has one piece of advice to offer 
what he calls his ``most sensible, level-headed, estimable 
colleagues.'' Remember, he says, ``there is nothing sinful about going 
out and getting evidence, like asking people how much do you drink and 
checking breast cancer records. There's nothing sinful about seeing if 
that evidence correlates. There's nothing sinful about checking for 
confounding variables. The sin comes in believing a causal hypothesis 
is true because your study came up with a positive result, or believing 
the opposite because your study was negative.''
          * * * * *
                       Sizing Up the Cancer Risks
    In the history of epidemiology, only a dozen or so environmental 
agents have ever been repeatedly and strongly linked to human cancer, 
says University of Alabama epidemiologist Philip Cole. Among them are 
cigarette smoke, alcohol, ionizing radiation, a few drugs, a handful of 
occupational carcinogens, such as asbestos, and perhaps three viruses--
hepatitis-B virus, human T cell leukemia virus, and human 
papillomavirus. But every year, epidemiologic papers are published by 
the journal-load, many of them reporting new potential causes of cancer 
in the environment.
    Most are the product of observational epidemiology, in which 
researchers try to compare the lives of people suffering from a disease 
with those of healthy controls. Even its practitioners admit this 
effort is plagued by biases and confounding factors (see main text). As 
a result, most epidemiologists interviewed by Science said they would 
not take seriously a single study reporting a new potential cause of 
cancer unless it reported that exposure to the agent in question 
increased a person's risk by at least a factor of 3--which is to say it 
carries a risk ratio of 3. Even then, they say, skepticism is in order 
unless the study was very large and extremely well done and biological 
data support the hypothesized link. Sander Greenland, a University of 
California, Los Angeles, epidemiologist, says a study reporting a 
twofold increased risk might then be worth taking seriously--``but not 
that seriously.''
    Few of the entries in the following list of potential cancer risks, 
reported in the journals and picked up in the popular press over the 
past 8 years, have come close to fulfilling those criteria. Are these 
dangers real? As the saying goes, you be the judge.
    High-cholesterol diet--risk ratio (rr) 1.65 for rectal cancer in 
men (January 1987)
    Eating yogurt at least once a month--rr 2 for ovarian cancer (July 
1989)
    Smoking more than 100 cigarettes in a lifetime--rr 1.2 for breast 
cancer (February 1990)
    High-fat diet--rr 2 for breast cancer (August 1990)
    Lengthy occupational exposure to dioxin--rr 1.5 for all cancers 
(January 1991)
    Douching once a week--rr 4 for cervical cancer (March 1991)
    Regular use of high-alcohol mouthwash--rr 1.5 for mouth cancer 
(June 1991)
    Use of phenoxy herbicides on lawns--rr 1.3 for malignant lymphoma 
in dogs (September 1991)
    Weighing 3.6 kilograms or more at birth--rr 1.3 for breast cancer 
(October 1992)
    Vasectomy--rr 1.6 for prostate cancer (February 1993)
    Pesticide exposure, indicated by high residues in blood--rr 4 for 
breast cancer (April 1993); contradicted I year later in a larger study 
with one of the same authors.
    Drinking more than 3.3 liters of fluid (particularly chlorinated 
tap water) a day--rr 2--4 for bladder cancer (July 1993)
    Experiencing psychological stress in the workplace--rr 5.5 for 
colorectal cancer (September 1993)
    Diet high in saturated fat--rr 6 for lung cancer in nonsmoking 
women (December 1993)
    Eating more than 20 grams of processed meats (i.e., bologna) a 
day--rr 1.72 for colon cancer (February 1994)
    Eating red meat five or more times a week--rr 2.5 for colon cancer 
(February 1994)
    Occupational exposure to electromagnetic fields--rr 1.38 for breast 
cancer (June 1994)
    Smoking two packs of cigarettes a day--rr 1.74 for fatal breast 
cancer (July 1994)
    Eating red meat twice a day--rr 2 for breast cancer (July 1994)
    Regular cigarette smoking--rr 1.7 for pancreatic cancer (October 
1994)
    Ever having used a sun lamp--rr 1.3 for melanoma (November 1994)
    Abortion--rr 1.5 for breast cancer (November 1994)
    Having shorter or longer than average menstrual cycles--rr 2 for 
breast cancer (December 1994)
    Obesity in men (the heaviest 25 percent of those in the study)--rr 
3 for esophageal cancer (January 1995)
    Consuming olive oil only once a day or less--rr 1.25 for breast 
cancer (January 1995)

    Dr. Lippmann. Mr. Chairman, there were two chest physicians 
on the panel. Dr. Wolff has recommended the views of one. The 
other one did not think that a better mechanistic understanding 
was essential. There are other M.D. epidemiologists on the 
panel, and I wrote a letter with some of them pointing out that 
while we certainly need to know a lot more about mechanism--and 
I am not able to tell you now what all of the mechanisms are--
these M.D. epidemiologists did see a causal connection between 
particles in the air and the effect. We are gaining more 
information as we speak. The evidence is now accumulating to 
show more of a mechanistic basis for this.
    I refer you to the staff paper where the letter that I 
signed with these other epidemiologist members is included as 
Appendix K. It lays out all the details and why we see a causal 
association.
    [The referenced letter follows:]
                                                    March 19, 1996.
Hon. Carol M. Browner, Administrator,
U.S. Environmental Protection Agency,
Washington, DC.

RE: Supplement to the Closure Letter from the Clean Air Scientific 
Advisory Committee

    Dear Ms. Browner: The co-signers of this letter are members of the 
Particulate Matter Criteria Document Review Panel and consultants to 
the Clean Air Scientific Advisory Committee (CASAC) of the Science 
Advisory Board, U.S. EPA. This letter is not being sent as a minority 
report to the CASAC closure letter, but as a supplement to address some 
of the concerns raised in the CASAC letter. We were selected for the 
CASAC review of the Particulate Matter Criteria Document because of our 
combined expertise in the interpretation of epidemiological studies, 
our understanding of the literature on the human health effects of 
particulate air pollution, and our familiarity with the use of air 
monitoring data in analyzing human health effects. As individuals, we 
have been extensively involved in conducting studies of population 
exposure to air pollution and evaluating the human health effects of 
this exposure.
    As noted in the closure letter to you on the draft Air Quality 
Criteria for Particulate Matter from the chair of CASAC, the Panel 
members praised the EPA criteria document for its excellent integrative 
synthesis of the literature. Overall, most panel members concluded that 
the document made a persuasive case that population exposure to 
particulate matter (PM) is casually associated with excess mortality 
and morbidity in the U.S. even at concentrations at and below the 
existing primary air quality standard. While the cosigners of this 
letter are in agreement with this judgment, we are aware that some of 
our Panel colleagues have reservations about this important conclusion. 
Our purpose in the supplementary letter is to make explicit our reasons 
for reaching our conclusion, in order to assist the staff of the 
National Center for Environmental Assessment in addressing the 
reservations of our colleagues. We also intend our comments to aid the 
staff of the Office or Air Quality Planning and Standards in preparing 
the staff paper in support of a revised particulate air quality 
standard.
    The closure letter from the chair of CASAC notes that the concerns 
of Panel members who are not in full agreement with the above 
conclusion fall into three categories:
      1. Uncertainties in the human health risks of particulate air 
pollution, arising from errors in air monitoring from estimating human 
exposure from central monitoring data, and from relating these data to 
excess mortality and morbidity.
      2. Concern that the case for PM2.5 being the best 
available surrogate for the principal causative agent in particulate 
air pollution may be overstated, and that EPA has not adequately 
justified its rejection of other alternative explanations.
      3. Recently published studies that appear to contradict, or at 
least to present a different perspective on, the conclusions reached by 
EPA in its integrative synthesis of the literature.
    Regarding the first of these concerns, the writers of this letter 
wish to make it clear that we are not arguing that PM2.5 is 
the causal agent of the observed excess mortality and morbidity 
associated with particulate air pollution. In our judgment, the studies 
reviewed in the criteria document, specifically those considered in 
Chapter 12 (Epidemiological Studies), are persuasive in demonstrating a 
causal relationship between particulate air pollution, as measured by 
different methods in the various studies, and excess mortality and 
morbidity. However, the evidence does not allow us to conclude that a 
specific physical or chemical component of the particulate mass is 
clearly the responsible causal agent. Our conclusion is analogous to 
making the assertion that cigarette smoke is a cause of lung cancer and 
nonmalignant respiratory disease, even though the specific causal agent 
in cigarette smoke has not been identified among the many chemicals 
known to be present in cigarette smoke.
    The reasons for concluding that particulate air pollution is 
causally related to excess mortality and morbidity have been well 
stated in the integrative synthesis (Chapter 13) of the criteria 
document. For heuristic purposes, we will summarize these reasons here, 
and cite locations in Chapter 13 where supporting sentences and 
paragraphs are presented:
     A large number (2) of epidemiological time-series studies 
have consistently found a statistically significant association between 
daily variation in particulates and total mortality in cities in the 
U.S., Canada, Latin America, the U.K. and continental Europe.
    These findings argue against the associations being attributable to 
statistical sampling variation, i.e. the role of chance (Section 
13.4.1.1).
     The results of these time-series studies cannot be 
attributed to the vagaries of statistical modeling (Section 13.43.2), 
nor to confounding by season or weather (Section 13.4.3.3).
     The results of the time-series studies cannot be 
attributed to other criteria air pollutants. The mortality effect of 
particulates is found whether or not other pollutants are present at 
elevated concentrations, though it is difficult to separate the effects 
of particulates from other pollutants when the latter covary with 
particulates. The most persuasive evidence that the causal agent is 
some component of the airborne particulate mass is in studies of cities 
or seasons where other pollutants are present at very low 
concentrations. Across the range of the 20 studies mentioned above, 
particulate air pollution is the only pollutant that is consistently 
associated with excess daily mortality, and the estimate of its effect 
is relatively stable when adjusted for the presence of co-pollutants. 
There are exceptions to this stability, particularly in those cities 
where particulate and gaseous air pollutants are highly 
intercorrelated. But no monitored air pollutant, other than particulate 
matter, can account for the consistently observed excess mortality in 
these studies (Section 13.4.3.4). Excess morbidity from cardiopulmonary 
diseases has also been observed in a considerable number of studies 
(Section 13.4.1.2), and the morbidity relationship with ambient 
particulate concentrations is stronger overall and more consistent than 
for any other air pollutant.
     There is considerable coherence between the observed 
mortality and morbidity effects of particulate air pollution. Not only 
is excess mortality from cardiovascular and respiratory diseases 
observed, but on days of higher particulates excess hospitalizations 
for cardiovascular and respiratory disease are reported. These 
mortality and morbidity excesses are strongest in populations that 
would be expected to be more susceptible to the effects of air 
pollution, particularly the elderly. The relation of particulates with 
mortality is strongest also for cardiopulmonary diseases rather than 
for other disease categories. On days of high particulates, there is an 
increased proportion of deaths from chronic obstructive pulmonary 
disease, pneumonia, heart disease and deaths among the elderly than on 
days of low particulates. These findings are supportive of a causal 
role for particulate air pollution, since they are health endpoints one 
would most anticipate from exposure by the inhalation route (Section 
13.4.3.5 and Section 13.5.1).
    Given the striking consistency of the above studies, their 
robustness to variations in statistical modeling, the coherence among 
different but closely related health endpoints, and the empirical 
elimination of any alternative explanation for the findings, we 
conclude that a causal interpretation for particulate air pollution 
exposure is reasonable and defensible. This conclusion is further 
supported by longitudinal cohort studies of populations in which a 
geographical gradient in particulate air pollution was associated with 
a corresponding gradient in total mortality, in cardiopulmonary 
mortality and in lung cancer. These studies carefully controlled for 
other individual risk factors for these health endpoints (Section 
13.4.1.1).
    With specific reference to the first category of concern expressed 
by the our Panel colleagues, although population exposure to air 
pollution cannot be perfectly estimated based on central monitoring, 
these inherent errors in exposure estimation are more likely to cause 
an underestimation of the adverse health effects associated with 
pollution exposure, particularly in longitudinal cohort studies where 
individual risk factors and exposures are directly related to health 
effects. Thus the consistent positive findings cannot be attributed to 
exposure measurement error. Furthermore, there is growing evidence that 
fine particles are more uniformly distributed over large geographic 
areas than are coarse particles (Section 13.2.4), that measurements at 
one site give a reasonable estimate of the fine particulate 
concentrations across a city (Section 13.2.6), and that fine particles 
penetrate and have longer lifetimes indoors than coarse particles 
(Section 13.2.6). This evidence supports using ambient measures of fine 
particulates at a central site as an acceptable estimate of the average 
exposure of people in the community (Section 13.2.6). For these 
reasons, we judge that uncertainties arising from air monitoring and 
human exposure estimation do not negate the consistent excess mortality 
and morbidity associations discussed above.
    With regard to the second concern of our Panel colleagues, we 
believe that the case has been made that fine particulates, as measured 
by PM2.5, are the best surrogate currently available for the 
component of particulate air pollution that is associated with excess 
mortality and morbidity. We emphasize once again that we are not 
claiming that PM2.5 is the causal agent, but rather that 
PM2.5 is a better measure, than any alternative metric, of 
the complex in the particulate mass that is causing excess mortality 
and morbidity. Distinguishing between PM10 and 
PM2.5 is difficult, given the high correlation between these 
two pollutants in both time and space. In many studies, either metric 
will provide nearly the same estimate of the exposure-response 
relationship. However, a number of recent re-analyses of mortality and 
morbidity have been performed to address the issue of whether fine or 
coarse particulates (the latter indexed by subtracting PM2.5 
from PM10) more consistently predicts a relationship with 
adverse health effects. These studies, as reviewed in Section 13.4.1.1 
and Tables 13-3, 13-4 and 13-5 of the Criteria Document, conclude that 
excess mortality, hospital admissions for respiratory diseases and 
decreased lung function are more strongly and consistently associated 
with fine rather than with coarse mode particulates. these findings are 
also supported by earlier studies in the U.K. in which British Smoke 
measurements, which primarily reflect the contribution of the fine 
particle mode, were consistently associated with excess mortality. 
Finally, several characteristics of fine mode particles, as opposed to 
the coarse mode, are more consistent with the observed excess mortality 
and morbidity observed in epidemiological studies. As noted earlier, 
these characteristics are: (1) fine particulates are more uniform in 
distribution than the coarse mode across urban areas, (2) fine 
particulates penetrate into indoor environments more completely than 
coarse particles, and (3) fine particulates have a more prolonged 
residence time in indoor air than coarse particles. These points are 
discussed in Section 13.7, Summary and Conclusions. Given that a causal 
association of excess mortality and morbidity with particulate air 
pollution has been established, we concur with staff's judgments that 
fine particulates are the best available surrogate for the population 
exposures associated with these health effects.
    With regard to the third concern of our Panel colleagues, some 
studies have recently been published that are interpreted as 
contradicting the conclusion that particulate air pollution is causally 
associated with excess mortality and morbidity We agree that, in its 
revision of the criteria document, EPA needs to address these apparent 
discrepancies more explicitly, and we offer the following comments to 
assist staff in that task.
    First, the Health Effects Institute (HEI) reanalysis does not 
contradict any of the above conclusions. The HEI analysis conclusively 
demonstrated that the positive findings from the original studies 
selected for reanalysis were replicable, were not an artifact of 
statistical modeling, and were not confounded by idiosyncrasies in the 
method to control for season or weather. The HEI investigators then 
proceeded to apply their statistical modeling procedure to data from 
Philadelphia. They reported moderately high intercorrelations between 
particulates, as measured by total suspended particulate (TSP) 
measurements, and several of the pollutant gases, and, as expected, 
found that under these conditions, they could not attribute the 
observed exposure-response mortality relationships to TSP alone. They 
further observed that the TSP and SO2 effects were not 
independent of one another, and that the TSP effect was stronger in 
some seasons of the year and at some concentrations of SO2, 
while the SO2 effect was stronger in other seasons and at 
some concentrations of TSP. The HEI investigators appropriately 
concluded that, because of the high intercorrelations between 
pollutants in Philadelphia, mortality effects could not be attributed 
solely to particulates. More importantly, in their further report on 
this phase of their study, they concluded that ``insights into the 
effects of individual criteria pollutants can be best gained by 
assessing effects across locations having different pollutant mixes and 
not from regression modeling of data from single locations'' (``Air 
Pollution and Mortality in Philadelphia, 1974-1988'', interim report 
dated February 9, 1996). The EPA Criteria Document undertakes this 
assessment of effects across locations having different pollutant 
mixes, and this assessment was discussed above (in the third bulletted 
paragraph).
    One published reanalysis (Moolgavkar S: Epidemiology 1995; 6:476-
484) of the Philadelphia mortality data set has been interpreted as 
contradicting the findings of the original study (Schwartz J & Dockery 
DW: Am. Rev. Resp Dis 1992; 145:600-604), which concluded that 
particulates were positively associated with variations in daily 
mortality. However, the HEI reanalysis, reported above, confirmed the 
findings of the original study, but more importantly, noted that it was 
not possible in Philadelphia to attribute the mortality effect 
exclusively to particulates or individual gaseous pollutants, due to 
their high intercorrelations, as previously discussed. Separation of 
the effects of these pollutants requires analyses in a variety of 
locations with different pollutant mixes.
    Presentations and papers by Lipfert and Wyzga (Inhalation 
Toxicology 1995; 7:671-689) discuss uncertainties in identifying 
responsible pollutants in epidemiological studies. This article raises 
the important issue of measurement error, but in applying its analysis 
to the Philadelphia data set, it encounters the same problem of 
intercorrelated pollutants and the inability to partition health 
effects exclusively or primarily to one of the pollutants. Similarly, 
the analysis of the Philadelphia data set by Li and Roth (Inhalation 
Toxicology 1995; 7:45-58) purports to show that a panoply of seemingly 
conflicting findings is produced with different modeling strategies, 
but this paper is superseded by the HEI report, which shows 
conclusively that the confounding effect of weather was appropriately 
controlled in the original analysis, and that the original results are 
not an artifact of the modeling strategy.
    Finally, among papers considered as not supporting the main 
conclusion of the EPA criteria document, that of Styer et al. (Environ. 
Health Perspec 1995; 103:490-497) fitted separate regressions to each 
month of the year and found significant particulates effects only in a 
few of the months. But such partitioning of data in small time segments 
is considered to be inappropriate because it results in a significant 
loss of statistical power and thus a loss of sensitivity to the 
moderate relative risk associated with ambient air pollution and a loss 
of ability to separate the effects of one pollutant as opposed to 
another.
    There are several reasons why the mortality and morbidity effects 
of particulate air pollution will not be the same in all cities and at 
all seasons of the year. Therefore, there will not be total agreement 
among all published studies in the magnitude of the adverse effect per 
unit of particulate exposure. The reasons for these variations in 
estimates of the exposure-response relationship are several (as 
discussed in Section 13.4.1.1): (1) the toxicity of particulates likely 
depends on size distribution and chemical composition, and these 
characteristics vary among geographic areas. (2) local populations 
differ in demographic and socioeconomic characteristics, and these 
differences will be likely to modify the health effects of particulate 
exposures. (3) the health status of communities differs among 
geographic areas, and thus the susceptibility of populations to the 
same level of particulate air pollution will vary. (4) average levels 
of copollutants will vary across geographic areas, and these may cause 
small or moderate variations in the particulate effect. In spite of 
these considerations, there is a remarkable consistency in the body of 
epidemiological studies, showing a positive exposure-response 
association between particulates and mortality and morbidity. In our 
judgment, EPA has appropriately synthesized this evidence and drawn a 
responsible public health conclusion, namely, that particulate 
concentrations at current levels are causally associated with excess 
mortality and morbidity. Furthermore, we agree that fine particulates, 
as currently indexed by PM2.5, are the most appropriate 
indicator for the component of the particulate air mass to which these 
adverse effects are attributed. We also agree that some adverse health 
effects may be related to the coarse particulate mode, and that 
therefore it is desirable to consider fine and coarse mode particulates 
as separate candidates for air quality standards. This is the final 
conclusion of Chapter 13 of the Criteria Document, and we hope that our 
discussion will assist the EPA staff in presenting firmer support for 
their conclusion.
            Sincerely,
                                   Morton Lippmann,
     Professor, Nelson Institute of Environmental Medicine,
                                               New York University.

                                          Carl Shy,
           Professor and Chair, Department of Epidemiology,
                       University of North Carolina at Chapel Hill.

                                      Jan Stolwijk,
   Professor, Department of Epidemiology and Public Health,
                                                   Yale University.

                                     Frank Speizer,
                            Professor, Channing Laboratory,
                                            Harvard Medical School.

    Senator Inhofe. Thank you, Dr. Lippmann.
    Let quote from this magazine for the benefit of the 
audience as well as committee members.

    What does it take to make a study worth taking seriously? 
Over the years epidemiologists have offered up a variety of 
criteria, the most important of which are a very strong 
association between disease and risk factor in a highly 
plausible biological mechanism. The epidemiologists interviewed 
by Science say that they prefer to see both before believing 
the latest study, or even the latest group of studies. Many 
respected epidemiologists have published erroneous results in 
the past and say it is so easy to be fooled that it is almost 
impossible to believe less than stunning results.

    In another article, Marsha Engle of the New England Journal 
stated, ``As a general rule of thumb, we are looking for a 
relative risk of three or more.''
    And Robert Temple, who is with the FDA, the director of 
drug evaluation, has stated, ``My basic rule is if the relative 
risk isn't at least three or four, forget it.''
    I would now ask Dr. Wolff this question. I understand in 
the studies the EPA relied on, the relative risk factor for the 
particulate matter studies was right around 1 or 1.2, since 
there is no identifiable biological mechanism--and I don't 
believe there is from what I have studied--and the risk factors 
are so low, in the words of the Science magazine article, are 
these studies ``less than stunning results''?
    Dr. Wolff. Mr. Chairman, there was tremendous diversity of 
opinion on the PM panel. I think part of that diversity of 
opinion was due to the members who considered the article that 
you referred to and essentially none of the studies that had 
been reported on the relationships between PM and mortality 
meet those criteria.
    Senator Inhofe. Unfortunately, my time has expired. I had 
some questions.
    Let me just ask both of you a question.
    Do you think that there was adequate time--having to deal 
with the process--did the panel have enough time to weigh all 
the evidence? Or were deliberations rushed on this?
    Dr. Lippmann.
    Dr. Lippmann. Just a brief note.
    Dr. Trichopoulos, who was cited in that article in 
Science--he said, when you have other information, you don't 
need that large a relative risk. That is in the documentation 
also, and perhaps that should follow in the record.
    As far as time, there is no question that the court-ordered 
deadline made it much more difficult. Dr. Wolff worked 
heroically, as did the EPA staff people, as did many members of 
the committee. So we did have the usual number of review 
sessions.
    It would certainly always be desirable to have more time. 
However, the process did work, and we are always going to be 
left at the end of one of these review processes wishing we had 
more time and more information. But if the Clean Air Act calls 
for the standard to be fully reviewed--it was done. Lots of 
people worked very hard under the tight deadlines to see that 
it was done, but it got done.
    [The referenced article follows:]

        [From Science, Letters to the Editor, September 8, 1995]

                     The Discipline of Epidemiology

                      (By Dimitrios Trichopoulos)

    In the Special News Report ``Epidemiology faces its limits'' (14 
July, p. 164), Gary Taubes assembles a series of quotations from 
ourselves and others about potential methodologic pitfalls in 
epidemiologic studies that might leave readers with the misimpression 
that evidence based on epidemiologic findings is not usually credible.
    A problem does exist with general media reports about single 
scientific studies. Such reports often herald new results without 
describing the scientific context, which can create unnecessary fear 
and confusion. However, this is more an abuse of epidemiologic evidence 
than a problem with epidemiologic research. Taubes seems to perpetuate 
this confusion by listing several media reports of published findings 
and telling the reader ``you be the judge'' (p. 156) when proper 
judging is impossible without substantial additional information. In 
any scientific field, findings of individual studies are usually not 
considered seriously until confirmed by others. Also, in epidemiology, 
as in any other scientific field, more powerful studies need to be 
conducted to evaluate smaller effects, where sources of bias may be 
especially problematic. Often, doing so will require large and long-
term prospective studies with repeated measures of exposure based on 
both questionnaires and biological measurements; a substantial number 
of such studies have commenced over the last 15 years.
    Taubes did not emphasize that what we do know about the prevention 
of cancer and cardiovascular disease has derived largely from 
epidemiologic findings. This knowledge includes not just the many 
adverse effects of cigarette smoking, but also the relation of 
overweight to many diseases, the benefits of increased physical 
activity for cardiovascular disease, the effects of many occupational 
exposures (such as benzene and asbestos), the relation of exogenous 
postmenopausal estrogens to cancer of the uterus, the relation of 
sunlight to all forms of skin cancer, the relation of ionizing 
radiation to many cancers, the adverse effects of many pharmacologic 
agents (for example, DES and thalidomide), and the protective effects 
of high intake of fruits and vegetables against many cancers.
    Epidemiology has also provided important reassurance that many 
aspects of daily life are not major risk factors. For example, the 
relation between coffee consumption and coronary heart disease may not 
be completely settled, but the danger is minimal: The uncertainty is 
whether as much as five cups per day is a weak risk factor or not a 
risk factor at all.\1\ Fear of saccharin carcinogenicity engendered by 
studies in rats was quelled by epidemiologic research. Furthermore, 
epidemiologic studies have provided clear evidence that the incidence 
of several other forms of cancer, including ovarian cancer, is lessened 
as a consequence of using birth control pills.
---------------------------------------------------------------------------
    \1\ S. Greenlang, Epidemiology 4, 366 (1993).
---------------------------------------------------------------------------
    If we wish to continue our progress in understanding the importance 
of lifestyle and environmental risk factors, we have little choice but 
to monitor the occurrence of illness of persons who have and have not 
been exposed to such factors. As Bruce Ames, a molecular biologist at 
the University of California, has noted,\2\ advances in other 
biological sciences can greatly add to the power of epidemiologic 
studies, but cannot replace them. Taubes's report is insightful and 
useful for epidemiologists and nonepidemiologists alike. However, I 
have two objections, one of them of personal nature, the other more 
general.
---------------------------------------------------------------------------
    \2\ B.N. Ames, Science 221, 1256 (1983).
---------------------------------------------------------------------------
    Taubes writes that I have expressed the view that only a fourfold 
risk should be taken seriously. This is correct, but only when the 
finding stands in a biological vacuum or has little or no biomedical 
credibility. We all take seriously small relative risks when there is a 
credible hypothesis in the background. Nobody disputes that the 
prevalence of boys at birth is higher than that of girls (an excess of 
3 percent), that men have a 30 percent higher rate of death compared to 
women of the same age, or that fatality in a car accident is higher 
when the car is smaller.
    The more general issue is that Taubes has omitted a consideration 
that is of a paramount importance in any scientific argument. 
Epidemiology should be evaluated in comparison to other disciplines 
that serve the same objective, that is, to identify the causes of human 
disease and facilitate their prevention. Among these disciplines, only 
epidemiology can document causation without concern about dose-
extrapolation or species variability and with built-in accounting for 
potential modifiers.
    It could be said for epidemiology, with respect to disease etiology 
and prevention, what is frequently said about democracy as a system of 
government: They both have many problems and weaknesses, but they still 
represent the best available approach for the achievement of their 
respective objectives.
                                 ______
                                 

                            (By Jerry Rapp)

    Taubes's excellent article about the proliferation of health-
related messages to the public, and in particular the role of the 
popular press in their promulgation, misses one factor driving this 
process. Research institutions are eager to have the results of health 
risk factor studies performed in their laboratories appear in prominent 
newspapers and news magazines. This is so because individual 
philanthropists like almost nothing better than to support institutions 
whose research efforts have appeared on page one, of, say, the New York 
Times. With the deceleration in government funds available for research 
and the concomitant increased dependence on private, and especially 
individual, funding sources, there will likely be an acceleration of 
these sorts of articles appearing in the popular press. It would 
generate far less confusion if they were just left in the scientific 
literature.
                                 ______
                                 

                         (By Robert W. Miller)

    The limits of epidemiology for environmental studies are well 
covered by Taubes. Genetic epidemiology is quite a different story. 
Clustering of cancer in families has led to the recognition of tumor 
suppressor genes by Alfred G. Knudson Jr. through study of 
retinoblastoma in childhood.\3\ These genes have since been found in 
other cancers of children and some of the commonest cancers of adults. 
Epidemiologic identification of the diverse familial cancers that 
cluster in Li-Fraumeni syndrome led to laboratory research that has 
furthered understanding the role of the p53 gene in carcinogenesis.\4\ 
New clues of the origins of neoplasia are also coming from laboratory 
studies based on cancer clusters in heritable disorders, such as 
ataxia-telangiectasia.\5\ Genetic epidemiology should not suffer guilt 
by association with the downside of its environmental counterpart.
---------------------------------------------------------------------------
    \3\ A.G. Knudson Jr., Proc. Nat'l. Acad. Sci. U.S.A. 68, 820 
(1971).
    \4\ D. Malkin et al., Science 250, 1233 (1990).
    \5\ K. Savitsky et al., ibid., 268, 1749 (1995).
---------------------------------------------------------------------------
                                 ______
                                 

                          (By Alfred J. Saah)

    When critics of epidemiology pay homage at the altar of the 
randomized clinical trial, such trials are made to sound only 
moderately troublesome compared to observational studies, when in fact 
they are often absolutely impractical or absolutely unethical. Examples 
include randomizing women to method of birth control and individuals to 
diet.
    For such research, observational studies are the only recourse if 
you want to work with humans. The future and power of epidemiology rest 
not with simply self-reported data, but with combining such information 
with molecular data on susceptibility. In this way, risk measurements 
reflect characteristics of both host and environment and make targeting 
prevention strategies rational. The challenge will be to use these host 
factors, such as genetic data, in a socially acceptable and nonpunitive 
fashion. Then epidemiology will provide truly meaningful and relevant 
estimates of risk.
                                 ______
                                 

                          (By Gio Batta Gori)

    Most of the epidemiology of multifactorial diseases fails a test of 
method, due to absent experimental randomization and unachievable 
control of biases and confounders. In general, it also fails the 
ultimate test of predictivity, as large randomized experiments designed 
to verify major observational inferences have been thoroughly 
disappointing.\6\ Now, a resounding admission of impotence threatens 
our survival and demands remedial measures.
---------------------------------------------------------------------------
    \6\ M. Susser. Epidemiol. Rev. 7, 147 (1985); L. Werko, Acta Med. 
Scand. 221, 323 (1987); MRFIT Group. J. Am. Med. Assoc. 263, 1795 
(1990).
---------------------------------------------------------------------------
    As other professionals have done, epidemiologists could establish a 
code of good practice, spelling out optimal standards of hypothesis 
formulation, study design, and conduct. Structural uncertainties should 
limit heuristic causal inferences to relative risk or odds ratio values 
above 3 or 4, as Trichopoulos (quoted in the article by Taubes) and 
others before him have concluded.\7\ Although still short of assuring 
verification, this last provision would link with de mimimis 
considerations of ongoing regulatory reform.
---------------------------------------------------------------------------
    \7\ N.E. Breslow and N.E. Day, Statistical Methods in Cancer 
Research, vol. 1. The Analysis of Case-Control Studies International 
Agency for Research on Cancer, Publ. No. 32, Lyon, France, 1980); K.J. 
Rothman, in Cancer Epidemiology and Prevention, D. Schottenfeld and 
J.F. Fraumeni, Eds. (Saunders, Philadelphia, PA, 1982), pp. 15-22, E.L. 
Wynder, Prev. Med. 16, 139 (1987).
---------------------------------------------------------------------------
    Epidemiologist have no choice but to warrant their credibility. We 
owe it to society and to the young entering the profession, who need to 
know honestly whether they can make a difference. Too much of 
epidemiology has become predictable advocacy without secure 
philosophical foundations. A code of good epidemiologic practice would 
be a beginning, perhaps after some soul-searching about the morality of 
provoking public anxieties and policies based on essentially 
unverifiable conjectures.

    Dr. Wolff. The objective of the review is to try to reach 
consensus on the issues. One of the reasons why we couldn't was 
because we were so rushed. Normally, this is a process that 
takes place over a number of years. The PM was compressed in a 
little over a year. I certainly think that it had an adverse 
effect on the process.
    Senator Inhofe. Did CASAC recommend more research?
    Dr. Wolff. CASAC recommended more research.
    Senator Inhofe. Senator Chafee.
    Senator Chafee. Thank you, Mr. Chairman.
    Dr. Lippmann, Dr. Wolff made the following statement 
regarding ozone: there is no bright line, no threshold, the 
scientific community made great strides, but--what do you say 
about that? Do you find a bright line here?
    Dr. Lippmann. No, there is no bright line. There is no 
threshold. My own studies with normal children, asthmatic 
children, healthy people doing their jogging show that the 
higher the ozone the greater the drop in lung function. The 
only thing you can do is to say is that if you are dealing with 
the issue of adversity then greater than 10 percent, or greater 
than 20 percent loss of function is an adverse effect. But you 
can't get away from there being a measurable response at any 
ozone concentration above background.
    The exposure chamber studies show that there is also lung 
inflammation going on while the function is changing. So the 
Administrator is obligated to consider all of the measurable 
responses in making her judgment.
    What can't be disputed is that there is an exposure-
response relationship. If you divide up the cells from the 
chart--as in the example from the staff paper letter to which 
Dr. Wolff referred--you can say there is no significant 
difference between one form of the standard and another because 
of the uncertainty around each of them. But it is indisputable 
that if you lower the permissible exposure you get less 
response in terms of function, hospital admissions for 
cardiopulmonary diseases, and even mortality.
    Senator Chafee. I think a subsequent witness is going to 
have a chart showing New York City hospital admissions. I am 
not going to ask you about that. I will wait.
    Dr. Lippmann. That is kind of the chart I was referring to. 
But you will also hear today from Dr. Thurston, whose research 
is the basis for that chart. I think Dr. Thurston will tell you 
that the chart doesn't necessarily represent what the research 
behind it says.
    Senator Chafee. I don't want to get into the chart yet. It 
is what we say in the trade, a very busy chart.
    [Laughter.]
    Senator Chafee. Dr. Wolff, EPA's proposed standards for 
PM2.5 is a major undertaking. It is my understanding 
that it is probably the largest single regulation EPA has ever 
proposed. I guess my question to you is: do you think the 
science is adequate to support that standard?
    Dr. Wolff. There was no consensus as to what the level 
should be on the committee. The ranges of recommendations 
ranged from the lower end of EPA's recommendations to higher 
than EPA's range.
    Senator Chafee. Higher than the 2.5?
    Dr. Wolff. The upper end of the range for 2.5 was 65 
micrograms per cubic meter. Some of the members recommended a 
level that was higher than that. So I don't think you can say 
that CASAC's conclusions support the level that EPA selected. I 
don't think you could say that CASAC's conclusions support any 
level.
    Senator Chafee. Am I correct that you did not support the 
PM2.5?
    Dr. Wolff. That is not true. I supported a 2.5 standard.
    Senator Chafee. We get into this back and forth on more 
time--which you both testified to that you think more time 
would have been very valuable. Dr. Lippmann has indicated that 
no matter how much time you get, you probably want more. But is 
the science within reach? Do you have that feeling, Dr. Wolff? 
How much longer would it take to get the science that you feel 
would be necessary if we made those scientific studies a high 
priority right now and gave it the money that you think it 
should have?
    Dr. Wolff. Based on our experience with the review, I think 
we can frame the questions that need to be addressed in the 
near term. Unfortunately, we don't have very many measurements 
of PM2.5 right now. We are going to need those 
measurements before we can answer those questions. My own 
personal feeling is that we're talking about a 5-year timeframe 
to find answers to those questions.
    Senator Chafee. Let me see if I understand the answer.
    Did you say 5 years?
    Dr. Wolff. I think we need 5 years before we have answers 
to those questions. It is our hope that we have answers to 
those questions before we begin the next review cycle.
    Senator Chafee. And you nodded in agreement, Dr. Lippmann?
    Dr. Lippmann. Yes, 5 years can answer many of these 
questions. I am sure there will be some that have further 
questions 5 years down the road. But 5 years is a minimum time 
to have a considered, well-designed, well-executed program. Lab 
work and epidemiological studies take a long time to do and a 
long time to analyze. It takes a long time to go through peer 
review. I would say that 5 years is a good timeframe.
    Senator Chafee. I see my time is up. Thank you, Mr. 
Chairman.
    Senator Inhofe. Thank you, Senator Chafee.
    Senator Baucus.
    Senator Baucus. Thank you, Mr. Chairman. I will be very 
brief.
    I would like to establish what CASAC did agree on. If I 
understand it, CASAC agreed with respect to ozone, that there 
should be a change from a 1-hour average to an 8-hour average. 
Is that correct?
    You are both nodding affirmatively.
    Dr. Lippmann. That is correct.
    Dr. Wolff. It was the consensus of the committee.
    Senator Baucus. Again with respect to ozone, I understand 
that the CASAC panel agrees that the studies EPA has collected 
provide an adequate basis for making a decision on the 
standard. Is that correct or not?
    Dr. Lippmann. The studies that EPA selected and winnowed 
through the CASAC process were the right studies to consider. 
We all wish we had more information.
    Senator Baucus. Does it provide an adequate basis for 
making a decision?
    Dr. Lippmann. Yes. The Administrator is required to look at 
the evidence at some given point in time. There was much more 
evidence than we had last time we reviewed ozone when I chaired 
CASAC in the 1980's. We have much more information and a 
judgment call was possible. It wasn't all of the evidence we 
would have liked to have.
    Dr. Wolff. We agree it was the appropriate evidence. It was 
the available evidence. But we did not conclude that it gave us 
a bright line.
    Senator Baucus. I understand.
    Let me move to PM, because I understand your earlier 
testimony, Dr. Wolff--that there is no consensus on the level 
or time, yet there is a consensus on a new 2.5 standard.
    Dr. Wolff. That's correct.
    Senator Baucus. I am sure you agree, Dr. Lippmann?
    Dr. Lippmann. Yes, sir.
    Senator Baucus. The panel did agree that a new 2.5 standard 
is needed?
    Dr. Lippmann. Yes, when you control PM10, what 
industry and everyone else does is control the mass, which is 
driven by the largest particles. So the controls directed at 
PM10 have had very little effect on fine particle 
concentration. We need a fine particle standard in order to 
have controls directed at getting fine particle concentrations 
down.
    Senator Baucus. And with respect to PM10, the 
panel agrees that either a daily or an annual standard should 
be established?
    Dr. Wolff. With PM10?
    Senator Baucus. No, 2.5. I'm sorry.
    Dr. Wolff. Either a 24-hour or annual standard could be 
designed to protect long-term or short-term exposure.
    Senator Baucus. But is it could be? Or should be?
    Dr. Wolff. Could be is the answer.
    Senator Baucus. What is the alternative if not a daily or 
annual? Hourly? What are you going to come up with?
    Dr. Wolff. I think there was consensus that it should 
either be annual or 24-hour.
    Senator Baucus. Is that right, Dr. Lippmann?
    Dr. Lippmann. Either or both. Most of us endorsed both.
    Senator Baucus. Concerning the additional time needed, are 
you saying that 5 years is needed before the EPA should 
promulgate proposed PM standards? What does the 5 years refer 
to?
    Dr. Lippmann. I think we both agree that something will be 
done this round because there is a time clock and the 
Administrator has to take an action. We are saying that we are 
very unhappy that we don't have better information. The 
timeframe for getting that better information is not a month or 
a year. We are not going to get much that will help us in 
another month or another year. Let the clock go around to the 
next cycle and put in place the means to get that information.
    Senator Baucus. But what do we do in the meantime to the 
proposed standards that EPA has promulgated?
    Dr. Wolff. A number of CASAC members expressed the view 
that we should set a PM2.5 standard at this time, 
but at a level that is approximately equivalent in stringency 
to the present PM10 standard. This would allow us to 
begin to collect the data so that we have the data and can make 
a mid-course correction 5 years from now.
    Senator Baucus. What would be the average midpoint of the 
range of the panel with respect to what we should do with 
respect to PM2.5?
    Dr. Lippmann. As Dr. Wolff said, the panel's personal 
preferences span the entire spectrum of the range that EPA 
proposed.
    Senator Baucus. Expand the entire spectrum?
    Dr. Lippmann. That's right. So the Administrator was left 
with having to make her own judgment call.
    Senator Baucus. My question is, What would CASAC's 
recommendation be?
    No, let me ask you personally, what your personal view 
would be on that question.
    Dr. Lippmann.
    Dr. Lippmann. I think what the Administrator has proposed 
is a prudent step in the right direction. My personal 
preference would have been for a somewhat more stringent level. 
But I recognize all the uncertainties that Dr. Wolff gives 
greater importance to and that we can't turn the atmosphere 
around right away. If we are moving in the right direction and 
have to look at it again in 5 years, that is fine.
    Senator Baucus. So even though we have less than perfect 
knowledge, your view is that although it could be more 
stringent, the proposed regulation is very reasonable?
    Dr. Lippmann. That's correct.
    Senator Baucus. Dr. Wolff.
    Dr. Wolff. My personal feeling would be to set the standard 
approximately equivalent to today's PM10 standard 
and then be able to look at it 5 years from now to see if that 
needs to be changed. The reason I would err on the high end is 
because right now there are mechanisms in place that are 
causing PM to decline. PM will decline for the foreseeable 
future, even without new control measures at this point.
    Senator Baucus. But do you personally find the proposed 
regulation reasonable?
    Dr. Wolff. I can't endorse the present proposal based on 
what I have seen.
    Senator Baucus. What would a reasonable person conclude--we 
have a big range here--could an objective scientist find that 
this is reasonable? Would an objective scientist find this 
reasonable?
    Dr. Wolff. I think a reasonable position would be to set 
the standard----
    Senator Baucus. Would an objective scientist find this 
reasonable?
    [Laughter.]
    Dr. Wolff. I would think a reasonable scientist would go a 
little bit higher.
    Dr. Lippmann. I think the choice made is certainly 
reasonable.
    Senator Baucus. And a reasonable scientist would find it 
reasonable?
    Dr. Lippmann. Most of the committee would have found that 
it would be reasonable.
    Senator Baucus. Thank you.
    Senator Inhofe. They are both very reasonable and very 
objective.
    [Laughter.]
    Senator Inhofe. Senator Sessions.
    Senator Sessions. Dr. Wolff, I guess you consider yourself 
a reasonable scientist?
    Dr. Wolff. Yes, I do.
    Senator Sessions. I was a little confused, and perhaps I 
missed something there.
    I believe you indicated to Senator Chafee that you favor 
the 2.5 standard. Then I thought you said that you indicated 
that you would prefer leaving it at 10. Can you explain that 
for us, please?
    Dr. Wolff. Out of the 21 CASAC members, 19 favored the 
creation of a new standard for PM2.5. I was one of 
those 19 who made that recommendation. All 21 members favored 
retention of the current PM10 standard. I was one of 
those as well.
    Senator Sessions. Dr. Lippmann, with regard to the new 
methodology--the 8 hours and all--can you give us your 
impression about how much that eases the implementation or the 
drop?
    Dr. Lippmann. It doesn't. It changes in those areas of the 
country which did have more of a sharper peak of ozone in the 
afternoon. It is a relaxation. For those who tended--like in 
your part of Alabama--to have a broader daily peak, it tends to 
be more restrictive. But 90 ppb on an 8-hour average is about 
the same as 120 ppb for one hour.
    What relaxes it and makes it less likely to cause a 
spurious exceedance, is going from a single exceedance being 
evidence of exceedance to the third highest. So the really 
unusual weather day won't cause a community to go out of 
exceedance. The big advance is not only in changing the hours 
over which you average it, but in looking at multiple 
exceedances. This has been done for both PM2.5 and 
for ozone.
    Senator Sessions. With regard to the Birmingham study, have 
you seen a counter-study that suggested that had humidity been 
factored in that a different result would have occurred on the 
mortality rates?
    Dr. Lippmann. If you look at this literature, which is 
voluminous, there is all kinds of conflicting information. Most 
respected people in this field, having looked at weather, do 
not find that humidity or temperature account for these 
factors. You can, however, find some studies that come to 
different conclusions.
    Senator Sessions. In particular, with regard to the 
Birmingham study, there was a study that said that there would 
be no increase in mortality had they factored in humidity.
    Dr. Lippmann. Yes, there is a published study.
    Senator Sessions. EPA has not been able to have the 
resources or otherwise to study that and to make a definitive 
decision as to which one of those studies might be correct?
    Dr. Lippmann. Yes, that is true, but EPA could not do it 
even if they had resources because it is a matter of flawed 
data in the models. It is hard to make a definitive judgment on 
the basis of one community and two different interpretations of 
data sets. This is a national problem and those issues are best 
addressed by looking not only at Birmingham--not ignoring 
Birmingham--but in a variety of communities to see where the 
dust shakes out.
    Senator Sessions. We are a very high humidity State with 
the highest rainfall in the country. It makes a difference. 
That is a factor which would concern me.
    Dr. Wolff, do all the members of the committee agree that 
the studies that are available to the committee form an 
adequate basis for a decision at this time?
    Dr. Wolff. Are you referring to ozone or PM?
    Senator Sessions. Both.
    Dr. Wolff. The committee agrees that EPA has summarized the 
relevant studies. However, the committee, in the case of ozone, 
believes the science does not give us guidance as to what to 
select for a level. We state that it is strictly a policy 
decision.
    For the PM, there is no agreement among the members as to 
what exactly the science says. So again, there is agreement 
that it is a policy call.
    Senator Sessions. Dr. Wolff, recently a doctor in 
Scientific American dealt with the acid rain question and 
particulate matter in the atmosphere. Are you familiar with 
that article that has come out in the last few months?
    Dr. Wolff. No, I am not.
    Senator Sessions. The article dealt with the impact. It 
sort of deals with unintended consequences of our actions. In 
the December 1996 issue, the conclusion in effect was that the 
reduction in particulate matter in the atmosphere--which is in 
effect a base that neutralizes acid rain--had substantially 
essentially neutralized the effect of our efforts to reduce 
acid rain. That had not been anticipated. As a matter of fact 
the author concluded, ``When we began this work, we certainly 
did not anticipate that reducing one form of pollutants, dust 
particles, could be found to decrease the success or reductions 
or another pollutant, sulfur dioxide.''
    I guess I am saying to you that if we knew within the 
scientific community what kinds of particles caused what kinds 
of medical problems, could we perhaps be more effective and 
make a better case for reduction of those particles as opposed 
to others that may not be harmful?
    Dr. Wolff. There are literally hundreds of different 
chemicals in the atmosphere that form these particles. Many 
people have suggested that maybe it is not the total number of 
particles. Maybe it is some constituent in the particles that 
causes the effects. You are absolutely right that we need more 
information.
    Senator Inhofe. Thank you, Senator Sessions.
    Senator Lieberman.
    Senator Lieberman. Thank you, Mr. Chairman.
    Dr. Wolff and Dr. Lippmann, thank you both for your 
testimony and for your service.
    This is confusing for us to try to understand and so 
important. I just want to clarify something because I was 
confused at the outset--and maybe some of my colleagues were as 
well--we are talking about two different kinds of measurement 
in particulate matter, aren't we? To state it in laymen's 
language, the size of the particles is what we ought to be 
concerned about. I think you said, Dr. Wolff, that 19 out of 
the 21 on CASAC agreed that we ought to go from the 
PM10 standard down to 2.5 to measure finer 
particles, right?
    Dr. Wolff. Let me try to explain this. The PM10 
refers to particles that have a diameter of 10 microns and 
less. So it includes everything from 10 down. PM2.5 
includes all the particles with a diameter of 2.5 microns and 
down. So PM2.5 is a subset of PM10. It is 
finer.
    Senator Lieberman. But we have used the word standard 
interchangeably. I think that is where I got confused.
    On what you just described, then, there was broad consensus 
on CASAC? Where there was disagreement and no consensus was 
what level of those 2.5 particles was acceptable in a unit of 
air. Is that correct?
    Dr. Wolff. That is correct.
    Senator Lieberman. On that there was disagreement, but I 
take it that you felt--and some of the epidemiologists who 
joined you in the letter Dr. Lippmann--that the standard the 
Administrator set was an appropriate standard to protect 
health.
    Dr. Lippmann. Not quite. What we talked about in our letter 
was the plausibility of the association between the inhaled 
fine particles and the health effects. That letter was written 
before the Administrator made her choice of the concentration 
limit.
    Senator Lieberman. So the conclusion of those who wrote the 
letter was what about the plausibility?
    Dr. Lippmann. As compared to Dr. Wolff and some other 
cluster of members on the panel, we were more convinced that 
the fine particles were causally associated with the health 
effects.
    Senator Lieberman. Still on particulate matter as opposed 
to ozone, Dr. Wolff, I have a photocopy of an article of July 
14, 1996, from the Riverside (CA) Press Enterprise about this 
issue. You are quoted in the article as saying,

    Something is killing Americans, but I don't know what. It's 
clear we need some kind of standard to prevent the effects 
we're seeing. The question is: What is it in the particulate 
matter that's doing it? The conclusion we come to is we don't 
know. That's the dilemma.

    Is that a fair quote?
    Dr. Wolff. It was an accurate quote. That was somewhere 
during the middle of the review.
    What was the date on that?
    Senator Lieberman. July 14, 1996.
    [The referenced article follows:]

       [From the Riverside (CA) Press Enterprise, July 14, 1996]

                     Something is Killing Americans

                          (By Gary Polakovic)

    Can the brown haze on the horizon really contain enough poisons to 
kill people?
    Overwhelmingly, scientists who study the problem say yes. Dozens of 
health studies from around the world in the past few years have 
convinced experts smog can be deadly in concentrations common in many 
communities.
    Most experts believe particles are to blame. And there is wide-
spread agreement air quality standards do not protect people from the 
danger.
    ``It's the single biggest public health problem we face today in 
the environment,'' said Daniel B. Menzel, chairman of the Department of 
Community and Environmental Medicine at the University of California, 
Irvine.
    The U.S. Environmental Protection Agency twice reached the same 
conclusion about air pollution in two separate comparative risk reviews 
in 1987 and 1990 that predate the most incriminating particle pollution 
health studies.
    Even industry scientists, skeptical at first, acknowledge a menace 
lurks in the air, although they caution against alarm and have concerns 
about proposals to crack down on smoggy particles.
    ``Something is killing Americans, but I don't know what,'' said 
George T. Wolff, principal scientist at General Motors and chairman of 
EPA's Clean Air Science Advisory Committee. ``It's clear we need some 
kind of standard to prevent the effects we're seeing.
    ``The question is: What is it in the PM (particle matter) that's 
doing it? The conclusion we come to is we don't know. . . . That's the 
dilemma,'' he said.
    Therein lies the rub. It is the questions, not the answers, raised 
by the particle smog health studies that has embroiled scientists in 
debate over how air pollution kills.
    The controversy centers on particle pollution and is reminiscent of 
a similar public health debate a few decades ago.
    ``It's like the debate over cigarette smoking years ago,'' said 
Morton Lippmann, professor of environmental medicine at the New York 
University Medical Center. ``It is real, we just don't know why it is 
happening.''
    For example, scientists do not know which particles in the smog mix 
harm people. Several health studies implicate particulate matter sized 
2.5 microns, called PM2.5. But some scientists say it may be 
particles much smaller.
    Others say it might be a particular particle, such as a metal 
fragment or sulfates. Still others wonder if particles work in concert 
with other pollutants to wreak harm. And a few say it may be impossible 
to distinguish which smog ingredient kills.
    Few laboratory tests have been done to see whether particle-induced 
mortality documented in human populations can be reproduced using 
animals, an important step to provide a cause and effect relationship.
    ``I have no doubt we are seeing mortality, but so far no one has 
been able to identify a biologically plausible mechanism,'' Menzel 
said.
    Michael Kleinmann, toxicologist at the UC Irvine Air Pollution 
Health Effects laboratory, said recent tests at Harvard University and 
UC Irvine have begun to close that gap.
    In an experiment concluded in April, Kleinmann found elderly rats 
breathing very tiny particles and a smidgen of ozone showed 30 percent 
more chemicals inside their lungs capable of destroying lung tissue and 
seriously compromising the animals' respiratory health.
    The uncertainties bother skeptics. Chief among them is Suresh 
Moolgavkar, epidemiologist at the University of Washington and 
professor at the Fred Hutchinson Cancer Research Center in Seattle. He 
acknowledges smog is deadly, but he said more research is needed to 
prove particles are solely responsible for premature death.
    He showed that in Philadelphia gaseous sulfur oxide was associated 
with death during winter and spring while particles seemed to kill in 
summer. Sulfur oxide gas is emitted by coal-fired power plants and 
converts to sulfate, the most abundant particle pollutant in the East.
    ``If two individuals, one who ingested sugar laced with strychnine 
and one who took sugar laced with cyanide, dropped dead, would we blame 
the sugar?'' Moolgavkar said.
    But other scientists dispute those objections.
    In a March 20 letter, four scientists told EPA Administrator Carol 
M. Browner that health studies clearly show ``a causal relationship 
between particulate air pollution . . . and excess mortality and 
morbidity.'' The letter was signed by Lippmann; Carl Shy, chairman of 
the Department of Epidemiology at the University of North Carolina at 
Chapel Hill; Frank Speizer, professor at the Harvard University Medical 
School; and Jan Stolwijk, epidemiology professor at Yale University.
    The four scientists serve on an obscure, 21-member panel called the 
Clean Air Science Advisory Committee, which in May completed a review 
of the scientific evidence and endorsed EPA's recommendation to create 
a new national standard to control ultrafine particles.
    Authors of studies showing deadly effects of particles are also 
troubled by their findings, but for different reasons.
    ``It bugs us,'' said C. Arden Pope III, researcher at Brigham Young 
University. ``We're not out to prove everyone is dying from air 
pollution. We keep asking ourselves, `Is it real?' I was not a believer 
at all. I've tried for 10 years to try and explain away these effects, 
but the bottom line is the phenomenon remains.''
    Jonathon M. Samet, chairman of the epidemiology department at Johns 
Hopkins University in Maryland, said doubts about harm from particles 
have largely been laid to rest. He led an investigation for the 
prestigious Health Effects Institute, which in August validated leading 
studies that conclude particles kill. The institute, funded by industry 
and federal funds, is widely viewed as an objective arbiter of such 
disputes.
    As debate intensifies, Menzel at UC Irvine cautions scientists must 
not lose sight of the big picture: ``We've still got a body count and 
we shouldn't be having that at all.''

    Senator Lieberman. The question I would have--and this is 
our difficulty here--you agree something is killing Americans? 
Premature mortality----
    Dr. Wolff. I don't agree with that today. I don't agree 
that we have the basis to make that statement today.
    We all went through a learning curve, to some degree, 
during this review. Personally myself, I went into the review 
with a very open mind. Along the way, my mind changed. By the 
time we had finished the review, I had more doubts as to 
whether or not the science supported the statistical 
relationship or the causality than I did when I started.
    Senator Lieberman. So did you then conclude, or do you 
know, that there are no premature deaths of Americans due to 
particulate matter?
    Dr. Wolff. I don't think we know.
    Senator Lieberman. So you really question the fundamental 
proposition about health effects in the EPA Administrator's 
report that 40,000 may be dying earlier than they would 
otherwise in this country?
    Dr. Wolff. There are a number of us on the committee who 
question that.
    Senator Chafee. You're talking strictly particulates?
    Senator Lieberman. Yes, just particulates. That is what the 
40,000 premature deaths was related to.
    Dr. Lippmann, I take it that you do not question that there 
are some Americans dying prematurely because of these particles 
in the air?
    Dr. Lippmann. I think more of the committee believes that 
they are.
    Senator Lieberman. And you are in that group?
    Dr. Lippmann. Yes.
    Senator Lieberman. Was there a breakdown--did more of the 
epidemiologists, that is, public health experts on the 
committee, agree that there are premature deaths in America 
caused by particulate matter?
    Dr. Lippmann. Yes.
    [The letter and table referenced in the CASAC report 
follow:]
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[GRAPHIC] [TIFF OMITTED] TH050P1.048

[GRAPHIC] [TIFF OMITTED] TH050P1.049

    Senator Inhofe. Thank you, Senator Lieberman.
    Senator Hutchinson.
    Senator Hutchinson. Thank you, Mr. Chairman. I feel like I 
am getting a crash course in something that is way over my 
head.
    As a layman listening to this, let me restate the issue and 
you tell me if it is a fair characterization. That there is no 
doubt that there was a lot of uncertainty and a lot of 
diversity of opinion. Both of you agree that it would have been 
nice to have more time and more studies. More information would 
be very helpful in determining definitively the causality 
issue. Your differences are that Dr. Lippmann would say that we 
should have the more stringent standard now and do the studies 
and Dr. Wolff would say that until we know and have more 
information and can do those studies we should hold off on the 
most stringent standard?
    Is that a fair characterization of what I have heard?
    Dr. Lippmann. With one exception. It is a very fair 
statement, but I would like to put in the other consideration 
that we don't have to wait now. A decision is called for at 
this point in time with the information we now have. We both 
agree that it is less fully convincing than we would like, but 
a judgment must be made now according to the Clean Air Act. But 
we both agree--and I think we are very close on the issues 
which are uncertain--on the kinds of uncertainties there are. 
We have worked very closely together on identifying the 
research issues. I think we see eye to eye on most of those.
    Senator Hutchinson. While a decision has to be reached, it 
doesn't have to be this decision, the one that has been 
recommended.
    Dr. Lippmann. No.
    Senator Hutchinson. Dr. Wolff, would you respond?
    Dr. Wolff. I think you characterized it accurately. I think 
that there was a spectrum of opinions on the committee----
    Senator Hutchinson. Dr. Wolff, the diversity of opinion 
that you alluded to--I think you said that four members 
supported the level near the low end of the EPA range, eight 
members declined to offer an opinion, seven members supported 
ranges at or above the EPA range, and two members did not think 
a 2.5 standard was needed. Is that accurate?
    Dr. Wolff. That sounds accurate.
    Senator Hutchinson. That is on the PM. On the ozone there 
was a similar spread in diversity of opinion in that three 
members supported .08 PPM with multiple exceedances and three 
members supported .09 PPM with multiple exceedances and so 
forth. There was a big diversity.
    Let me give you a series of questions so that I can let you 
expand.
    Elaborate on the difference of opinion among CASAC. Why was 
there so much diversity? Considering that diversity, how did 
EPA come up with the PM2.5 standard in the first 
place?
    Elaborate on the ozone area and diversity of opinions. Why 
was there so much diversity. How did EPA come up with a 
standard that was the most stringent of all the opinions 
expressed? And did EPA give CASAC any guidance as far as range 
of the standards?
    Dr. Wolff.
    Dr. Wolff. Let me start at the last question first, Did 
they give us any guidance? The answer is yes. They suggested a 
range in their staff paper.
    The diversity of opinion concerning the PM was real. There 
were recommendations all over the place. The reason for that 
diversity was mainly because of all the unanswered questions 
that popped up during the review, the many uncertainties. They 
ranged from a simple thing of saying that EPA has not 
adequately demonstrated that PM2.5 is the culprit. 
Maybe it is PM and maybe it is something else, perhaps a 
constituent of the PM. Maybe it is air pollution because most 
pollutant concentrations are correlated. But then you get two 
other people raising the fact that there is no plausible 
biological mechanism.
    There were concerns that the monitoring--most of these 
studies were done using a single monitor outdoors to represent 
the exposure of all the people in that community. People raised 
the point that 90 percent of the time people spend indoors, so 
how could an outdoor monitor be representative of exposure over 
the whole community.
    They go on from there coming to the biggest doubt that 
Senator Sessions brought up. There are studies that throw in 
humidity and the effect goes away. That is why there was a 
diversity of opinion.
    Senator Hutchinson. Is it fair to say that there is one 
thing that can be agreed upon, that there are still an awful 
lot of unanswered questions. A great deal of information and 
scientific data needs to be gathered before there can be a 
definitive cosmology and----
    Dr. Wolff. Absolutely. We agree on that totally. Like Dr. 
Lippmann said, we have reviewed the Agency's research plans and 
made suggestions. We think we know what needs to be targeted in 
the next 5 years so that we don't go through this again in 5 
years.
    Concerning the ozone, the conclusion was that there was no 
bright line. We had agreement on that. But having said that, 
then some of the members wanted to give their personal 
preference. I didn't. I said it was strictly a policy call 
because I didn't think that a personal preference was a 
scientific opinion. But the personal preferences--and you have 
quoted them correctly--if you took some sort of average of 
them, you would end up selecting .09 with multiple exceedances. 
In the Federal Register notice, EPA acknowledges that. Then 
they say, on the other hand, the environmental groups and 
others are pushing for a .07. So they picked the middle.
    Senator Hutchinson. My time is up.
    Thank you, Mr. Chairman.
    Senator Inhofe. Thank you, Senator Hutchinson.
    Senator Allard.
    Senator Allard. These scientific articles that you 
reviewed--I assume they were refereed and in your opinion the 
panel that refereed them were credible, highly respected 
scientists?
    Dr. Lippmann. These are journal articles, which are 
reviewed in the scientific process. That is traditional. Only 
peer-reviewed journal articles came forward into the docket 
that we were looking at.
    Senator Allard. But when you look at the scientific 
articles, some of these review panels are more tightly 
scrutinized than others, particularly if you are looking at an 
article, for example, that was written--the American Medical 
Journal is a very strictly refereed journal. On the other hand, 
the journal that may have been written for general circulation 
may not have had heavy scrutiny.
    Dr. Lippmann. We are only talking about scientific 
manuscripts. We are not talking about general literature.
    Senator Allard. I know, but I want to be clear on the 
committee is that both of you were comfortable that this was 
good scientific information in these journals and that what 
you're telling this committee is that these written articles--
scientific articles--have been generally recognized by the 
science community as good science.
    Dr. Lippmann. This was the best available science.
    Senator Allard. In the studies that came forward--and we 
were looking at our standard. The average individual sitting in 
this room--would these changes in standards proposed here 
affect the normal person?
    Dr. Lippmann. In all these air standards for all the years 
they have been setting them, following the Act, the focus has 
been on identifying a sensitive segment of the population and 
trying to see if it is a sizable segment, not a single 
individual or a few individuals. Asthmatics as a group is a 
segment which is relevant in this case.
    I am healthy and when the ozone is above the current 
standard, I don't feel bad and perhaps you don't feel bad, but 
there is a sizable number of people--even if a small 
percentage--who is adversely affected.
    Senator Allard. So your response is that a normal person 
would not notice the change in recommended standards?
    Dr. Lippmann. Most people would not notice the change or 
have any impact on their health, but the sensitive segment of 
the population is responsive.
    Senator Allard. You talked about an asthmatic. Is it 10 
percent loss of function, 50 percent loss of function, 25 
percent loss of function? When does that individual begin to 
notice a difference on these changes?
    Dr. Lippmann. The sensory response is not directly related 
to the functional response. In healthy people, you get the 
functional response----
    Senator Allard. Sensory?
    Dr. Lippmann. Do you feel it? Or is it measurable? In other 
words, if I do a respiratory test on you, you may have less 
lung capacity, but you don't feel like you have less lung 
capacity because of your reserve.
    But in our studies of the asthmatic children, the changes 
in lung function are there as they are in healthy children, but 
in asthmatic children they feel it. They get symptoms. They 
require extra medication when the ozone is high. The 
Connecticut River Valley is where we did our most recent study, 
in an area where you send children because it is clean. When 
the ozone was even below the current standards, the symptom 
rate of the children went up, they went to the health clinic 
and asked the physician for more medication.
    We know that is good medical data because the physician had 
to agree that the child not only continued on that baseline 
medication but asked for extra medication on that day and it 
was given to them. We have an exposure response relationship 
for that effect.
    Senator Allard. So that on a particular day when the ozone 
level was observed going up in your particular example, what 
was going on that day that caused the ozone to go up?
    Dr. Lippmann. This is a regional phenomenon. The weather 
pattern sets it up, the high pressure areas--Dr. Wolff, who has 
meteorological background can give you a better technical 
definition. It is a random thing that happens a number of times 
each summer. You get these air masses which cook and develop 
ozone and the associated organic particles that form with the 
ozone.
    Senator Allard. So there could be other factors involved 
rather than just ozone?
    Dr. Lippmann. Yes. In fact, our study showed that the fine 
sulfate particles are also indicative of the response of these 
children.
    Senator Allard. Part of the problem of having a bright line 
with ozone, for example, is not only the effect on a normal 
individual, but the diseased individual with various degrees of 
disease--maybe 30 percent loss of function as opposed to 10 
percent.
    Dr. Lippmann. A 30 percent loss of function wouldn't 
disable you or me, but for an asthmatic child who has less 
capacity, that is a big difference. That is why it is important 
to do these together because the ozone formation process leads 
to hydroxylions, which oxidize the SO2 and make 
acidic fine particles. So you get the organic particles and the 
acidic particles because these things are in the air together. 
The decision by EPA to deal with both pollutants at the same 
time is a very good choice.
    Senator Allard. With your tolerance and that of the 
committee, I would like to ask just one more question.
    In some parts of the country, we have some background 
information that says that particularly in the western parts of 
the United States that the ozone level naturally may occur at 
.075. Would you agree with that?
    Dr. Lippmann. No.
    Senator Allard. It is an EPA staff paper on ozone, EPA 452/
R-96-007, page 20.
    Dr. Lippmann. I can't say it never happened, but that would 
be an unusually high background level. Dr. Wolff I am sure 
would agree.
    Dr. Wolff. Background is normally around .04. But there is 
considerable variability. In a given year, it wouldn't be 
unlikely to see that as high as .07 on a given day.
    Senator Allard. So if we have a normal background that 
could occur at .075, in those parts of the country, how do you 
enforce that?
    Dr. Lippmann. First off, as I said earlier, it is going to 
a multiple exceedance basis. So that rare day won't by itself 
cause an exceedance.
    Senator Allard. Thank you.
    Senator Inhofe. Thank you, Senator Allard.
    Senator Graham.
    Senator Graham. Thank you, Mr. Chairman.
    I would like to ask a few questions that relate to the 
process by which this very significant decision has been made. 
There are obviously important consequences of your scientific 
judgment which include economic consequences and consequences 
on public health. Could you evaluate the degree of exactness, 
certainty of the science, that undergirded this review of ozone 
and particulates in comparison to other scientific issues that 
have come before CASAC and their degree of precision and 
exactitude?
    Dr. Wolff. I think the ozone review was done in a manner 
that was similar to the past reviews in that we were able to 
come to a consensus. I think that is the key. If you can come 
to a consensus, then the level of comfort with the science is 
pretty adequate. We were able to do that with ozone even though 
we concluded that there was no bright line, but that was the 
best science could do. I don't think that we can push the 
science at this point much further.
    For the PM, I think there was a high level of discomfort, 
not with the quality of the science, but because there were 
different interpretations of the science that led to the 
diversity of opinion and no consensus on the committee.
    Dr. Lippmann. This is not a unique kind of review in 
sharing the previous rounds of reviews for the criteria 
pollutants. The process, if anything, improved. The number and 
quality of the available information has improved. It is 
comparable to my experience on other SAB activities. I chaired 
the environmental tobacco smoke review, the risk assessment. I 
am currently chairing the dioxin risk assessment review. These 
are very difficult issues where no manufacturer is coming in 
and asking for an approval and having to submit the proof that 
their product is safe. This is information generated for other 
purposes and interpreted as necessary to make these decisions.
    What makes these decisions different is the implications 
that are involved. We hadn't previously come down to levels 
approaching background. So there is another level of 
complication in this review, which leads to the personal 
preferences being different, recognizing the implications.
    In the past, we were dealing with ranges and levels where 
there was somewhat discomfort or lack of it on the public 
interest side and the industry side because it would be 
expensive. Now we are getting down to levels of concern that 
may not even be feasible in the short run and only gradually 
approached. So I think that is where the difference is, not in 
the process, but in the implications and how that fed back into 
the way individual committee members reacted.
    Senator Graham. But in spite of that schism you just 
described, there was a consensus within the committee on the 
recommendation that went to the Administrator. Is that correct?
    Dr. Lippmann. Yes. We did endorse the ranges put forward by 
the staff paper as a consensus of the committee for both.
    Dr. Wolff. No, we didn't endorse the range for PM.
    Dr. Lippmann. Yes, we did.
    Dr. Wolff. No, we didn't. There were members whose 
recommendations----
    Dr. Lippmann. The personal preferences were different, but 
they endorsed the range.
    Dr. Wolff. No, they didn't.
    Dr. Lippmann. Well, we disagree.
    [Laughter.]
    Senator Graham. Let's ask each to state precisely what your 
understanding of what was or not agreed to.
    Dr. Wolff. The range for the 24-hour PM2.5 value 
that EPA proposed was 18 to 65 micrograms per cubic meter. 
There were a number of members who recommended that it be 75 
micrograms per cubic meter. There were a number of members who 
recommended that there not be a 24-hour standard. So I can't 
say that there was consensus on the range because there were a 
number of members who either favored something higher or didn't 
favor it at all.
    Senator Graham. What number of the members of the committee 
approved the EPA's 18 to 65 range?
    Dr. Wolff. There is a table in the--in fact, we have a 
table here but I don't know if you can see it. It is also a 
table in my written comments. It is on page 7 of the written 
material. The first column is the recommendation for the 24-
hour standard. The range that EPA expressed was 18 to 65. You 
can see that as you go down, there are four people that prefer 
a range that is within the range of EPA's, then a number of 
yeses that simply say that they endorse a 2.5 standard but 
decline to select a range. So we can't say positively one way 
or the other whether they endorse the range or not. Then as we 
go down, we get into some noes, one greater than or equal to 
65, some 75's. It looks to me that of the members who made a 
commitment, the majority of those favored something that was 
above the range or a simple no.
    Senator Graham. Dr. Lippmann, what is your interpretation?
    Dr. Lippmann. I interpret all the yeses to be an 
endorsement of the range. There is no question in my mind about 
that.
    Dr. Wolff. The ``yes'' is not an endorsement of the range. 
I was the one who collected the comments.
    Senator Inhofe. Thank you very much.
    Seeing that there are no further questions, I want to thank 
the first panel very much for coming. Since we went a little 
over our time, we won't have a second round of questioning. If 
there are any further questions of members of the panel or 
committee, we would like to submit them in writing and would 
ask you to respond to both the member who requested and the 
committee.
    Thank you very much.
    Senator Inhofe. I now ask that our second panel, our ozone 
panel, come to the witness table.
    Our second panel is Dr. Daniel Menzel, Community and 
Environmental Medicine, University of California, Irvine; Dr. 
George Thurston, associate professor, Department of 
Environmental Medicine, New York University School of Medicine; 
and Dr. Roger O. McClellan, president, Chemical Industry 
Institute of Toxicology.
    You heard the instructions to the previous panel. If you 
can adhere to the 5-minute comments, your entire statement will 
be submitted, without objection, into the record.
    We will first hear from Dr. Thurston.

 STATEMENT OF GEORGE THURSTON, ASSOCIATE PROFESSOR, DEPARTMENT 
   OF ENVIRONMENTAL MEDICINE, NEW YORK UNIVERSITY SCHOOL OF 
                            MEDICINE

    Dr. Thurston. Thank you.
    The adverse health consequences of breathing ozone at 
levels below the current U.S. national ambient air quality 
standard of 120 parts per billion ppb are serious and well 
documented. This documentation includes impacts demonstrated in 
controlled chamber exposures of humans and animals, and 
observational epidemiology showing consistent associations 
between ozone and adverse impacts across a wide range of human 
health outcomes.
    Observational epidemiology studies have shown compelling 
and consistent evidence of adverse effects by ozone below the 
current United States standard including decreased lung 
function, more frequent asthma symptoms, increased numbers of 
asthma attacks, more frequent emergency department visits, 
additional hospital admissions, and increased numbers of daily 
deaths.
    In my own research, I have found that ozone air pollution 
is associated with increased numbers of respiratory hospital 
admissions in New York City, Buffalo, New York, and Toronto, 
Ontario, even at levels below the current standard of 120 ppb. 
My ozone-hospital admissions results have been confirmed by 
other researchers considering other locales.
    The United States EPA used my New York City asthma results 
in the staff paper--and I guess we will be hearing more about 
them--when estimating the health benefits of lowering the ozone 
standard. However, they failed to consider other respiratory 
admissions affected, such as for pneumonia or bronchitis. Thus, 
considering the published results from various cities, the EPA 
analysis under-predicts the respiratory hospital admission 
benefits of their proposed regulations by about a factor of 
two.
    This month, the results of a study I conducted on the 
effects of air pollution on children at a summer asthma camp in 
Connecticut will be published. This study of a group of about 
50 moderate to severely asthmatic children shows that these 
children experience diminished lung function, increased asthma 
symptoms, and increased use of unscheduled asthma medications 
as ozone pollution levels rise. On the highest ozone days, the 
risk of a child having an asthma attack was found to be 
approximately 40 percent greater than on an average study day, 
with these adverse effects extending to below 120 ppb ozone.
    I might add that this is right near the border of Rhode 
Island. I am sure that this same pollution adversely affected 
children in Rhode Island, my home State.
    More recently, I have found that daily mortality also rises 
after high ozone days in the U.S. cities of New York City, 
Atlanta, Detroit, Chicago, St. Louis, Minneapolis, San 
Francisco, Los Angeles, and Houston, and at ozone levels 
reaching below the current standard. While not yet published, 
these U.S. results are supported by previously published 
results, and by a recent spate of new papers by other 
researchers showing similar associations between ozone and 
human mortality around the globe, including a recent study of 
mortality in London published in the British Medical Journal.
    It is important to keep in mind that the above described 
epidemiology is supported by a large body of knowledge from 
controlled exposure studies that give consistent and/or 
supportive results, and that have demonstrated pathways by 
which ozone can damage the human body when it is breathed. 
Clinical studies have demonstrated decreases in lung function, 
increased frequencies of respiratory symptoms, heightened 
airway responsiveness, and cellular and biochemical evidence of 
lung inflammation in health exercising adults exposed to ozone 
concentrations as low as 80 parts per billion for 6.6 hours. 
Now, clearly, the EPA proposal is based on sound science.
    Airway inflammation is especially a problem for children 
and adults with asthma, as it makes them more susceptible to 
having asthma attacks. For example, recent controlled human 
studies have shown that prior exposure to ozone enhances the 
reactivity of asthmatics to aeroallergens, such as pollens, 
which can trigger asthma attacks.
    In addition, increased inflammation in the lungs can make 
the elderly more susceptible to pneumonia, a major cause of 
illness and death in this age group.
    The EPA has proposed a standard of 80 ppb averaged over an 
8-hour period, rather than the existing 120 limit for the 
highest hour of each day. The switch to an 8-hour average is 
clearly appropriate, based on the scientific evidence that the 
cumulative effects of multiple hours of exposure are worse for 
people than a single peak hour of exposure.
    However, since significant adverse effects are well 
documented down to the 80 ppb level, the EPA proposal provides 
no margin of safety. This is especially true since the proposed 
law will allow several exceedances of this level before a 
violation is cited. Thus, the health evidence would indicate 
that a standard set at 70 ppb ozone averaged over an 8-hour 
period is needed, if any margin of safety is to be provided to 
the public, rather than the 80 recommended by the EPA.
    It is interesting to note what levels other deliberative 
bodies have recommended regarding permissible ozone levels. In 
Canada, the daily 1-hour maximum allowed is 80 ppb of ozone, 
which is roughly equivalent to an 8-hour limit of about 60 ppb 
ozone. In addition, the World Health Organization similarly 
recommended an 8-hour average guideline of 60 ppb for ozone 
over 8 hours. Also, recently the American Conference of 
Governmental Industrial Hygienists have proposed lowering the 
TLV for ozone to 50 ppb over an 8-hour work day for workers 
under heavy exertion. This would indicate that healthy American 
workers need to be protected from levels that would be 
perfectly legal for the rest of us to breathe under the USEPA's 
proposals. The EPA's new proposed ozone limit is weak when 
compared to standards set or recommended by others.
    In conclusion, I would like to reiterate the key messages 
contained in the letter that I and 26 other air pollution 
researchers and physicians sent to President Clinton last 
month. Please listen to the mainstream medical and scientific 
community on this issue. Exposures to ozone and PM air 
pollution have been linked to medically significant adverse 
health effects. The current standards for these pollutants are 
not sufficiently protective of public health.
    Thank you for the opportunity to speak to you.
    Senator Inhofe. Thank you, Dr. Thurston.
    Dr. Menzel.

    STATEMENT OF DANIEL MENZEL, COMMUNITY AND ENVIRONMENTAL 
           MEDICINE, UNIVERSITY OF CALIFORNIA, IRVINE

    Dr. Menzel. Thank you very much, Mr. Chairman.
    My name is Dan Menzel. I am professor and chair of the 
Department of Community and Environmental Medicine, University 
of California at Irvine. I have submitted a written statement 
for the record and I will just summarize some important points 
that I believe are of interest to the committee.
    The committee has asked that I provide my views on the 
ozone standard, and I am pleased to do that. I would also like 
to extend my testimony to include the research effort of EPA 
because it directly affects the standard-setting process. In my 
written testimony I have also stated my views on particulate 
matter standards and research agenda because the two standards 
are interrelated. Particulate matter may be a surrogate for the 
complex mixture of air pollution, including ozone.
    The ozone standard is in need of revision, despite a 
continuing lack of information. Recent human controlled 
exposure studies have shown that some individuals have a 
decrement in respiratory function on inhalation of ozone at the 
current national ambient air quality standard of 120 (ppb). 
Some studies have also shown that changes occur in the 
pulmonary, immune, and defense systems. Recently one of my 
colleagues has shown that ozone-induced changes in cell 
permeability occurs in rats at ozone concentrations near the 
current standard.
    A very large number of experimental animal studies have 
shown that the magnitude of the exposure to ozone--that is, the 
amount of ozone--is more important than the duration of 
exposure in the chronic effects of ozone. Both the human 
exposure pattern and experimental animal studies show that 
chronic exposure to ozone is the most important for adverse 
health effects.
    Despite much work, the risks associated with different 
exposures to ozone are not well known. Much work remains. The 
ozone story is not a closed book.
    The ozone standard should have a shorter averaging time to 
reduce the number of times people are exposed to high peaks of 
ozone. I favor the 8-hour averaging time. We do not have good 
data on how much the risk of lung disease will be reduced by 
reducing the standard from 120 to 90 ppb. In fact, you heard a 
comment that the current standard really is closer to 90 ppb if 
the 8-hour averaging time is implemented.
    It may be that a much greater reduction in the ozone 
standard will be needed in the future. The standard should 
therefore remain at 120 ppb with an 8-hour averaging time and 
let us see whether the ozone standard can be attained with a 
shorter averaging time and what exactly will happen.
    Since the chairman has not heard a request for additional 
money, I thought I would raise this issue and suggest that EPA 
should join with its sister agencies, NIH and NSF, and mount an 
integrated research program. It seems to me that the program 
should develop a comprehensive study for the chronic effects of 
air pollution. Such a program will point out the biological 
mechanism on an integral level. This is again back to the 
plausible biological mechanism as the basis for all studies 
that we should do.
    We should define the dose-response as responsible a 
relationship as precisely as possible. We should seek 
biochemical markers of ozone toxicity in humans for use in 
molecular epidemiology studies. We need to improve the 
extrapolation model of ozone so that a precise estimate of the 
ozone dose can be made for humans in controlled exposures, 
experimental animals, and actual human exposures. We need to 
enhance the risk assessment.
    I would like to discuss a few generic problems that I see 
with EPA's research agenda that are leading to these 
uncertainties in the standard-setting process.
    EPA's research program in the health effects of air 
pollution has suffered so much reduction in funding that it 
should be no surprise that there are major data deficiencies at 
the time of the standard setting. EPA has responded to the lack 
of resources for long-term research by a crisis approach to 
solving long-term problems. Judgments are being made on 
incomplete data and public confidence, in my view, is being 
eroded.
    National programs can solve major problems. We have seen 
this in the AIDS research program. It is a remarkable success. 
Government and scientists have to resist the temptation to tire 
of difficult, long-term problems. We scientists must insist 
that air pollution research deserves the highest priority 
nationally in health research, something we haven't done in the 
past.
    Congress, in my opinion, can help resolve the continuing 
conflict over air pollution health effects by directing and 
empowering through appropriations enough resources so that EPA, 
NIH, and NSF can mount an integrated national program. In my 
view, surely the economic impact of air pollution alone is 
enough to justify such a national program.
    Thank you.
    Senator Inhofe. Thank you, Dr. Menzel.
    Dr. McClellan.

 STATEMENT OF ROGER O. McCLELLAN, PRESIDENT, CHEMICAL INDUSTRY 
                    INSTITUTE OF TOXICOLOGY

    Dr. McClellan. Mr. Chairman and distinguished members of 
the subcommittee, I am pleased to have this opportunity to 
testify at your request on the scientific issues related to the 
proposed new standards. I request that my written testimony be 
included in the record.
    Senator Inhofe. Without objection, your prepared statement 
will appear in the record.
    Dr. McClellan. By way of background, I serve as president 
of the Chemical Industry Institute of Toxicology, a not-for-
profit research organization located in Research Triangle Park, 
NC. The mission of that organization is to develop an improved 
understanding and scientific basis for assessing the human 
health risks of exposure to chemicals.
    The comments I offer today are based on my experience as a 
scientist concerned with the risks of airborne materials and my 
extensive service in advisory roles to numerous public and 
private advisory public organizations that has included service 
on EPA's Science Advisory Board, including service under each 
of the EPA's administrators on a number of committees, 
including serving as chair of the Clean Air Scientific Advisory 
Committee from 1988 to 1992.
    Based on the conversation in the last round, let me digress 
from my written comments and give a little perspective.
    The Clean Air Scientific Advisory Committee reviewed the 
scientific basis for the NAAQS for PM for an extended period of 
time, from 1979 to 1986, before the PM10 standard 
was promulgated in 1987. During the 1980's we had a continuing 
review of the basis for the ozone standard. In fact, we had a 
criteria document prepared and then a supplement to the 
criteria document. Both of the PM and ozone reviews were 
characterized by an iterative pattern of collection of data, 
synthesis, review, identifying research gaps, research, and 
review again. Finally, over a 7-year period we came to a 
closure, yet with a high degree of uncertainty as to the 
adequacy of the PM data for making a regulatory decision. That 
was the basis of promulgating the PM standard in 1987.
    In the case of ozone, we came to a different conclusion. 
There was a divergence of scientific opinion in 1989. We 
related that to the Administrator. Administrator Reilly 
ultimately reaffirmed the existing standard and initiated the 
current process that we are just coming to closure on for 
ozone. Now, we have come together. The degree of uncertainty in 
the ozone picture today, is much less than it was in the late 
1980's. As a result, I think there was a very strong consensus 
on CASAC. We have quite a different situation with regard to 
PM.
    Let me say that there was new scientific information that 
came to bear during the last decade on ozone. This information 
was appropriately reviewed by the EPA in their criteria 
document, reviewed by the staff in their position paper, and I 
think it allowed us to come to a strong consensus that ozone 
was the appropriate indicator in terms of photochemical 
oxidants. It was also appropriate to move to an 8-hour 
averaging time from the 1-hour averaging time. But I hasten to 
add that the 8-hour and 1-hour are relatively closely 
correlated so that even though we didn't have an 8-hour 
standard in the past, we were on the right track. We are on an 
even better track now as we shift to an 8-hour standard.
    We already heard that CASAC had a consensus that there was 
no threshold for ozone, no bright line between adversity and a 
lack of adversity. Based on that, the EPA staff suggested a 
range for an 8-hour averaging time of 0.07 to 0.09 PPM ozone. 
The committee members came down within that range. I personally 
favored a 0.09 PPM standard with an 8-hour averaging time and 
the use of a 3-year average of the annual third highest maximum 
8-hour average.
    My professional opinion was heavily shaped by information 
such as shown in this chart. I would say that the basis of the 
chart is drawn from an excellent piece of work carried out by 
Professor Thurston of NYU, who studied hospital admissions in 
the New York City area and the relationship to ozone levels.
    I would call your attention to the top line. This is simply 
estimated hospital admissions related to asthmatics in the New 
York area. You will see excess admissions for the different 
forms of the standard levels from 0.12 down to 0.07 and 
differing averaging types.
    I call your attention to the fact that these are remarkably 
similar. There are numbers that range from 60 to 240 as 
contrasted to the ``as is'' of 385. Dropping down to the second 
row the values are expressed on a percentage basis. The numbers 
are relatively large; for example, plus 83 percent in terms of 
the present ``as is'', which suggests that we will be reducing 
that as we go to various standards there.
    It is important to look at the third row where we have that 
excess plus the background. This is key because the EPA is 
using a linear model in the background that contributes 680 
cases, more than any of the elevated levels. This ozone 
background is practically impossible to address. So when you 
look at it then as a percentage change compared to the present 
standard, we see very much smaller numbers.
    What I think is very important from a policy standpoint is 
the issue of all asthma admissions. We see these are something 
on the order of 28,000 plus cases. Now when we look at what 
different standards do in terms of the asthma cases, we see 
very small differences.
    To me, this is the kind of risk analysis that points to the 
fact that the ozone standard-setting is really a policy call as 
to which standard you select from the array of possibilities. 
That is the analysis that shaped my opinion on the ozone 
standard.
    Before closing, let me comment briefly on the PM standard. 
I was one of the two individuals on the CASAC who did not 
endorse a PM2.5 standard. My position is that we do 
not have sufficient information today. It is important that we 
understand the nature of this standard. Attached to my 
testimony is a simple graph which shows you that on the 
horizontal dimension we have the size cuts, if you will. On the 
vertical, you will see the level or quantity. My viewpoint is 
that we do not have enough information on the size 
characteristics of material in the air, and we may be very 
likely setting an inappropriate standard that will not yield 
health benefits.
    Senator Inhofe. Thank you, Dr. McClellan.
    I will start the questions. I think I will do it 
differently this time and start with one individual and just 
concentrate on one at a time.
    Dr. Menzel, a lot has been discussed and a lot of emotion 
has been stirred up by the media and the fact that ozone causes 
decreased lung function, with the greatest percentages being a 
decrease of 20 percent in lung capacity.
    Are these cases permanent?
    Dr. Menzel. It is very difficult to say on an individual 
basis whether they are permanent or not. On the other hand, a 
lot of my research has dealt with the question of how permanent 
things would be on a continuous exposure or intermittent 
exposure that would mimic human effects. In those cases, in 
experimental animals where we can see the life term effects, it 
is a permanent, irreversible change.
    Senator Inhofe. If you are experiencing a 20 percent 
decrease in lung function, do you always know it?
    Dr. Menzel. No. As was mentioned by Dr. Lippmann, it is 
very difficult for us to feel changes, unless we are at the 
later stage in life or if we have a preexisting disease such as 
emphysema, bronchitis, or asthma where we have a major decrease 
in lung function to begin with. Then when we are down at that 
low level, any incremental decrease would be appreciated in the 
way people can carry out their lives.
    Senator Inhofe. So there are many causes of this condition?
    Dr. Menzel. Yes, that is the whole problem. It is the 
plausible biological explanation. In the case of ozone, we have 
one for short-term effects. I was the guy who suggested it, but 
I don't believe that my theory, free radical reactions, 
actually applies to the long-term chronic effect.
    Senator Inhofe. Is there a level of ozone where there would 
be no decreased lung function?
    Dr. Menzel. It is very difficult to say yes or no to that 
question, and I don't mean to equivocate. Obviously I am 
critical of existing programs, so I am not afraid to say what I 
think, but the basic problem is that the shape of the ozone 
response relationship is so uncertain that we really cannot 
come to a conclusion. A conservative estimate would be a linear 
dose response saying that at any concentration of ozone there 
is some change. But I don't know whether we can say that with 
any certainty.
    Senator Inhofe. Dr. Thurston, in your Canadian studies that 
you published in May 1994, you state that the ozone is 
responsible for 21 percent of the hospital admissions for 
respiratory complaints.
    Dr. Thurston. During that period, that sounds roughly 
correct.
    Senator Inhofe. You asserted that the study showed an 
increase in hospital admissions during the months of July and 
August for 1986, 1987, and 1988 when the ozone exceeded the 
Canadian ozone standard of 0.08 at that time.
    Could there have been other factors that contributed to 
these admissions, such as heat and humidity?
    Dr. Thurston. Heat and humidity is not a big problem in 
Toronto. It is much cooler there, right on the lake. We did, 
however, consider that in the model. For that matter, when you 
look at asthma, it is cold temperatures that are important to 
asthmatics. When you have cold temperatures, that is when they 
react to temperature. Warmer temperatures would have to get 
well above what you see in Toronto to start having any adverse 
effects.
    Senator Inhofe. Did you control for such things as other 
pollutants?
    Dr. Thurston. Yes, we did look at multiple pollutants. That 
is one of the advantages of that study.
    Senator Inhofe. I was kind of surprised to find out that if 
you controlled for the wealth in your study--apparently there 
is a study that was done that says that for every $10,000 
decrease in median income it had tremendous effects on this, 
such as an 18 percent increase in premature death, 15 percent 
increase in cancer rate, 27 percent increase in lung cancer. It 
is kind of an interesting thing I hadn't thought of.
    Did you control for that?
    Dr. Thurston. That is controlled for in the design. You 
see, each person--in this case, a population is their own 
control--we are following the same population over time. So 
whatever their status and wealth is, certainly, over the months 
we looked at them, it didn't change. What changed was the 
pollution levels. When the pollution levels went up, we found 
that there was a bump in the admissions.
    Dr. McClellan, one of the things I keep running into is 
that we have had significant reductions in ozone levels over 
the last 10 to 20 years, yet we have had significant increases 
in the incidences of asthma among children.
    How would you react to that?
    Dr. McClellan. I think you have characterized it well, 
although I would say that our ozone levels have not gone down 
as much as we would like. But overall we have had very 
significant improvements in air quality, as you all related at 
the opening of the session.
    Why we continue to see an increase in asthma is certainly 
unknown. It is a situation of personal interest to me in that 
one of my children is an asthmatic, yet having grown up in the 
clean air of New Mexico. I know the wide variety of 
circumstances that will trigger an asthma attack for him.
    I think one of our major issues in terms of respiratory 
disease and health today is that we simply do not know what 
causes asthma. We have some interesting speculation and 
hypotheses in terms of issues of indoor air quality. There have 
been suggestions recently related to past immunization 
practices and how they may influence what is going on with 
regard to asthma.
    The actual fact is that I don't think anybody today has 
been able to put forth a convincing basis for why asthma 
continues to go up, but I certainly think that the basis of 
asthma in terms of air pollution simply isn't there. The issue 
of air pollution and air quality triggering asthma attacks is a 
secondary issue.
    Dr. Thurston. Could I comment on that?
    Senator Inhofe. Certainly.
    Dr. Thurston. Yes, I basically agree. That study that was 
mentioned states what we understand now. It does not appear 
that air pollution is causing this epidemic in asthma. However, 
as the number of people who have asthma rises, more and more 
people are there who are especially susceptible to air 
pollution because of asthma. So while air pollution doesn't 
appear to cause new cases of asthma, once people have asthma, 
then air pollution does aggravate their asthma. As I mentioned 
earlier, exposure to ozone increases asthmatics reactivity to 
things they would normally be reactive to, like pollen. A 
physician might see someone come in and do a skin test and 
determine that they had reacted to pollen. They are unaware 
that perhaps yesterday, they were exposed to ozone, which 
increased their sensitivity. That is why they reacted that day, 
as opposed to another day.
    Senator Inhofe. Dr. McClellan, I have one last question.
    Even though this is an ozone panel, you have expertise in 
both PM and ozone. If you were to remove all the pollutants 
covered by this regulation, would you resolve the asthma 
problem?
    Dr. McClellan. No.
    Senator Inhofe. Senator Sessions.
    Senator Sessions. Dr. Thurston, would New York be one of 
the better monitored cities as far as ozone level in the 
atmosphere?
    Dr. Thurston. It could be monitored better. It has a couple 
of stations in the city.
    Senator Sessions. Is that an adequate number of stations 
for a city like New York?
    Dr. Thurston. Ozone happens to be one of the pollutants 
that happens to be widespread. One station is a pretty good 
indicator of levels. Certainly if you know the levels are high 
at one station, they are going to be high at another station, 
and low with low.
    Senator Sessions. There doesn't seem to be a lot of 
divergence across town?
    Dr. Thurston. There is variability spatially within a city, 
depending on what local sources are there and things like that. 
So there is some, but they are highly correlated with one 
another. The absolute levels may differ somewhat. You may get 
an exceedance in one spot and be slightly below the standard in 
another. But a high day is a high day across the city, and a 
low day is a low day across the city.
    Senator Sessions. With regard to your study of asthmatics 
in New York with hospital admissions, do you agree with Dr. 
McClellan that for policymakers the last line there is the best 
numbers to use for an evaluation of the effect of ozone?
    Dr. Thurston. I am not sure I understand the question 
exactly.
    Senator Sessions. There are various numbers, like on line 
two, which are fairly dramatic. Line six shows modest 
variations, at best, as to the ozone level.
    Dr. Thurston. I think that is really an indication that the 
standard being proposed is not that much more stringent than 
the existing standard. It is changing the form somewhat and is 
going down 10 percent, but allowing more exceedances. So that 
would probably be a way you could show the least impact of 
pollution on people's health, if you want to look at it that 
way.
    Senator Sessions. But that would be the most accurate, 
would it not, as to ozone?
    Dr. Thurston. No. I think there are various ways to look at 
this. One of them is the point that if you look, for example, 
at New York or Rhode Island, where they are trying to improve 
the air, but they are in violation--with the new standards of 
8-hour, they would be able to make quicker progress toward 
cleaner air because the air being advected into the State will 
be cleaner to start with because there will be more counties 
upwind that will be cleaned up. I think we as a Nation will be 
able to make faster progress on ozone air pollution and the 
benefit will be more widespread than this would indicate 
because more counties would be influenced with these new 
standards than under the existing standards.
    Senator Sessions. It had the level in the analysis.
    Dr. McClellan, do you think line six is the best analysis 
of the effect of ozone on asthmatic hospital admissions?
    Dr. McClellan. I do. I think what is important for a 
policymaker like Administrator Browner is to focus on total 
asthma admissions, the total problem, and now looking at what 
she has responsibility for, the ozone standard--how does it 
really influence that? I think you look at total asthma 
admissions and you have to say that it is a policy call. The 
variation in values for different potential standards doesn't 
drive you to one of those columns as a standard that is clearly 
more protective of health. It isn't there in that table. It is 
a policy call. You can't use this to say that you are driven to 
set the standard based on the health data.
    Senator Sessions. Dr. Menzel, would you comment on that?
    Dr. Menzel. I agree with what Dr. McClellan has said. 
Perhaps I couched my language a little too academically in my 
statement, because that is basically what I was saying. If we 
try to make an estimate of the difference in the health risk 
for different ozone exposures, we are very uncertain because we 
don't know the nature of the risk relationship to ozone 
declines. Would it decline in the ozone concentration--it is 
very difficult to come to a finite number, or a bright line.
    This discussion centering around asthma brings up the issue 
that I really was hoping that I could encourage you to think 
about. That is that air pollution, although it is a regulatory 
requirement of the Environmental Protection Agency, it is a 
national public health problem. Therefore, it needs to be 
attacked with a national kind of approach. The National 
Institutes of Health really ought to think more about air 
pollution. The National Science Foundation ought to think more 
about the chemistry of air pollution. It isn't EPA's problem. 
It is all of our's problem.
    Senator Sessions. Along that line, you have expressed some 
concern about EPA. In your opinion, have they wisely used the 
resources they have available to them?
    I understand, Mr. Chairman, that appropriations were only 
slightly less than requested last year for EPA.
    Have they wisely used the resources they have to prepare 
for this day that they knew was coming?
    Dr. Menzel. Let me say that EPA is a grossly under-funded 
agency. If you look at what they have been mandated to do by 
the Environmental Protection Act, and then compare that with 
the appropriations they have been able to garner, it is just 
not enough money.
    So what have they done? This is a management decision that 
other administrators have made over the years, which is to go 
from here to here to here to here, shifting resources depending 
on the deadline. I would submit to you that 5 years is really 
not a very adequate time to gather the information we need for 
either ozone or particulate matter. You are really looking at a 
10-year research program.
    Senator Sessions. Dr. McClellan, do you have any comments 
on that?
    Dr. McClellan. I would say the answer to that question is 
that the scientific staff of EPA has done an admirable job with 
the resources they have been allocated. The problem is that the 
dollars allocated to research within the EPA are an 
inappropriate portion of the total budget. EPA cannot label 
itself as a science agency when it spends less than or 
approximately 10 percent of its budget on research.
    Senator Sessions. That is all they spend on research?
    Dr. McClellan. Yes, 90 percent of the dollars go to the 
promulgation of standards, their enforcement, and all the other 
activities. But all of those activities are built on a science 
base that only gets 10 percent of the pie. That is not enough.
    So the problem is that we are still dealing with an Agency 
that is a collection of fiefdoms--air, water, toxics--and we 
need some leadership at the top that says we will have a 
science base underpinning all of this and at long last create 
the science that will lead to science-based standards.
    Senator Sessions. Thank you very much.
    It is my observation that agencies do become bureaucratic 
and fiefdom dominated and that periodically they need to break 
through that and ask themselves what their real mission is. 
Thank you all very much.
    Thank you, Mr. Chairman.
    Senator Inhofe. Thank you, Senator Sessions.
    Senator Lieberman.
    Senator Lieberman. Thank you, Mr. Chairman.
    Dr. McClellan, let me say first--I don't know that you 
meant to personalize this, and I understand the appeal for more 
funding for research because I support it--but it does seem to 
me in the years that Carol Browner has been the Administrator 
of EPA, particularly with regard to these proposed standards, 
that she and we together have tried very hard to be more 
science-based. Maybe we could spend more money on the research, 
but we have asked EPA to do an awful lot of things and they 
have made some research judgments. We could disagree with them, 
but I do think the whole tendency has been to focus it more on 
science.
    Dr. McClellan. Let me say that I certainly would not like 
my remarks to be construed as relating only to Administrator 
Browner. I think the situation has been true from the very 
beginnings of the Agency. It is true whether we have had a 
Republican Administration or a Democratic Administration. We 
tend to take a linear view of the budget process and the budget 
allocation. I think we need to step back and really take a look 
at the bigger picture. That is going to require help from all 
of us, certainly the Congress, the Administrator, and the 
scientific community at large.
    Senator Lieberman. I appreciate that statement. There may 
be disagreement among the panel here and the one before about 
these proposed standards. There is agreement that we would only 
benefit from more investment in research, and the amounts of 
money, relatively speaking concerning the overall Agency budget 
let alone the alleged consequences of various of these 
proposals, is minimal.
    Talking about ozone now, there was a consensus on CASAC 
that going from the .12 to .07 to .09 parts per million of 
ozone was an appropriate range. You said that you decided 
within that range, although you chose .09. Is that correct?
    Dr. McClellan. That is correct. We have two things going 
here. One is the form of the standard going from a 1-hour 
averaging time to an 8-hour. The fact is, in general across the 
country 1-hour and 8-hour are quite closely correlated. As 
several speakers have noted, 120 part per billion 1-hour 
average is roughly the same as 90 part per billion 8-hour 
average. When I looked at it I think the committee was in total 
agreement on the appropriateness of moving toward the 8-hour 
average, as being more health-relevant. Then the EPA staff had 
proposed a range of 70 to 90. I was one of the individuals who 
said that 90 would be appropriate.
    Senator Lieberman. But the CASAC consensus was that the 
range of 70 to 90 was appropriate. Is that correct?
    Dr. McClellan. In fact, in terms of the panel, one 
individual preferred a level of 90 to 100, three were at 90, 
one was at 80 to 90, three were at 80, two said it was a policy 
call, and no individuals on the panel elected to advocate the 
70 part per billion.
    Senator Lieberman. Do I derive from that that a majority of 
those on the panel fell within the 70 to 90 range?
    Dr. McClellan. Yes. We basically said that the science 
doesn't lead you to say one of these numbers more appropriate 
than the others. Basically we said that it was a policy call.
    Senator Lieberman. That is an important point. There was 
the 70 to 90 agreement as an appropriate range. In fact, 
Administrator Browner chose 80, which was a policy call. 
Obviously you disagree with it, but it was within the 
appropriate range. I guess that is the point I was trying to 
make. She didn't reach way outside the range.
    Dr. McClellan. No, that is absolutely correct.
    Senator Lieberman. On the sensitive populations--and I do 
think it is important to clarify that we are talking about 
millions of people here. There are millions of people who have 
asthma. One of my kids has asthma. It is very real for them and 
for all of us who are in their families or who are their 
friends. But I do want to stress something that I think is very 
important.
    Dr. Thurston made a point and I presume the two of you 
would agree. No one here is saying that ozone causes asthma. So 
the increase in asthma in our population--we don't quite 
understand it, but it is not from ozone. Is that right?
    Dr. McClellan. That is correct.
    Dr. Thurston. We don't know what causes the development of 
asthma.
    Dr. McClellan. The causal factor in the increase in asthma 
is simply unknown.
    Senator Lieberman. Maybe you're going to tell me that we 
don't know that it's not caused by this.
    Dr. Menzel. I have written several papers on a theory that 
I proposed that ozone is an underlying cause for pulmonary 
inflammation. Therefore, it is a baseline kind of cause of 
inflammation. So we don't really know what that means in terms 
of the incidents of asthma.
    I would say that we also have to remember that there are 
not only people who are asthmatic. People who have emphysema 
and bronchitis and other kinds of interstitial fibrosis. These 
are all lung diseases.
    Senator Lieberman. You had a very powerful sentence in your 
prepared testimony, Dr. Menzel. Very compelling, controlled 
human exposure experiments suggest that the current ozone 
standard, which is the 120 ppb, may be toxic.
    Dr. Menzel. Yes, that's true. We may be faced with having 
to make major reductions. I think the question of changing the 
frequency may have greater impact than we think.
    Senator Lieberman. My point here--and I think most of you 
would agree--I think we are saying that ozone exacerbates 
asthma for some of those who have it. We are not saying that it 
causes asthma.
    Mr. Chairman, I have one final question.
    Dr. McClellan, am I right in reading that chart to say that 
the new standard proposed by the Administrator would result in 
between a 13 and 44 percent reduction in ozone-related 
admissions?
    [The two referenced charts follow:]
    [GRAPHIC] [TIFF OMITTED] TH050P1.069
    
    [GRAPHIC] [TIFF OMITTED] TH050P1.070
    
    Dr. McClellan. There is actually not a value on there that 
exactly corresponds to what she has proposed. EPA staff here 
could correct me on this, but I think it would be an 8-hour 
three exceedance form at 80. That is not there. But probably 
something in that 10 to 12 percent would be it.
    Senator Lieberman. Again recognizing that we may not be 
able to do anything about background levels of pollution, 
doesn't it make sense to help the people that we have some 
ability to help? In other words, if there is that range of 
hospital admissions resulting from changes in the standards--13 
to 44 percent is what I read in your prepared testimony is a 
significant reduction.
    Dr. McClellan. We can do a lot with statistics and numbers. 
We probably need to go up to the excess admissions line up 
there and take a look at the 120 under the 8-hour five 
exceedance, 80 ppb and say that we are looking at that 120 
versus the 385 as is, versus the 210. But at the same time, 
keep in mind that the background of 28,000 cases out there. One 
of the things we better be doing is making certain that we are 
looking at the real issue: What are the factors that truly 
cause asthma? We need to get away from this single pollutant 
finger-pointing approach to it and look at the fact that today 
environmental diseases are multi-factoral and we should neither 
overstate or understate what the impact of a particular 
standard will do.
    Senator Lieberman. I have one last question, Dr. Thurston.
    Since this chart comes from work you have done, I note in 
your testimony that you have some questions and criticisms 
about the use of this--including EPA's use--because it fails to 
consider hospital admissions for other respiratory effects, 
such as bronchitis or pneumonia. Therefore the risk assessment 
may be understated by a factor of two.
    Can you comment on that?
    Dr. Thurston. This only considers asthma. But in our 
studies we also looked at total respiratory. When you look at 
various cities--not just rely on one city--basically what we 
find is that the total respiratory effect is about double that 
of asthma alone. So you can basically take all these numbers 
and double them. That would give you a better picture.
    Senator Lieberman. Total respiratory effect of ozone?
    Dr. Thurston. Yes.
    You have all seen this before. I am looking at this for the 
first time and it is a little confusing at first. One of the 
things it is missing here is how it varies from our present 
situation. We really don't see what we have from the present 
standard. We are not now meeting the standard.
    It's difficult to make the point without first looking at 
these numbers. Maybe I could respond to it in writing later. 
Could I do that?
    Senator Lieberman. That would be fine.
    Dr. Thurston. The point is that we really have slowed down 
in our progress on ozone. Part of the problem is that we are 
looking at it as a 1-hour peak. Therefore, we have these little 
pockets where we are regulating it. If we go to an 8-hour 
standard, we are going to have a more realistic perspective, 
which is that this is really a national problem that needs to 
be addressed in a national way. If we do that, we are going to 
make progress much more rapidly than we've been making it 
because it is a team effort. Therefore, this new standard would 
get some new credit out of the reductions from ``as is'' down 
to the standard, not just compared to the present standard that 
we are not meeting and this new standard. It is not much of a 
tightening. The big difference is the way it is going to be 
implemented.
    Senator Lieberman. Everybody seems to agree that the move 
to the 8-hour standard is appropriate.
    Thank you, Mr. Chairman.
    Senator Inhofe. Thank you, Senator Lieberman.
    Senator Chafee.
    Senator Chafee. Perhaps the panel could explain this very 
busy chart up there, but let me see if I've got it.
    I don't number the first column, and there are after that 
nine columns. Unfortunately, the numbers aren't under them.
    Let's look in the last column--and I will zero in on you, 
Dr. McClellan. Is this your chart?
    Dr. McClellan. This is a chart which was included in the 
CASAC Committee's closure letter to the Administrator.
    Senator Chafee. You made the mistake of making eye contact 
with me--something we always avoided in law school--so I am 
calling on you.
    [Laughter.]
    Senator Chafee. The total admissions in New York City on an 
annual basis due to asthma is 28,470.
    Dr. McClellan. That is correct.
    Senator Chafee. If you look at the top of that column, that 
column is under excess admissions--if you look way over to the 
left--the excess over what? As I understand, it is excess over 
what there would be if there were no industrial pollution.
    Dr. McClellan. If there were no ozone, a situation that 
cannot occur. It has background ozone in it.
    Senator Chafee. So you would reduce those admissions by 
385, right?
    Dr. McClellan. Yes, but we would still have 680 
attributable to the background ozone, the level which EPA has 
said is background. That is 40 ppb. Above that we have 385 
cases.
    Senator Chafee. Set aside the background because I think 
all of us agree that none of us can do anything about the 
background.
    Dr. McClellan. OK.
    Senator Chafee. I am trying to get clear in mind just what 
we are dealing with.
    If you then go to--I am always staying on that top line--
first what we're saying is that if there were no industrial 
pollution--forget the background--you would reduce the number 
of admissions to hospitals from 28,470 by 385 per year. Now we 
go way back to column one, always staying on the top line. We 
are dealing with excess admissions.
    Because they are not meeting the current--if they met the 
current standards, they would reduce the number of admissions 
by 210.
    Dr. McClellan. They go from 385 down to 210.
    Senator Chafee. We are talking reductions of admissions?
    Dr. McClellan. Your reduction would be the difference 
between 385 and 210.
    Senator Chafee. In other words----
    Dr. McClellan. A lawyer once advised me to never do simple 
arithmetic in a hearing or courtroom. But I will agree that it 
is probably 175.
    [Laughter.]
    Senator Chafee. But now let's go over to what EPA 
recommends, which is the next to last column. Are you with me? 
That is 8H5X. I believe that is what EPA is recommending.
    Dr. McClellan. It is the appropriate number, 80 part per 
billion, 8-hour averaging time, but here it is five exceedances 
and the Agency has recommended three. But it is close.
    Senator Chafee. We can call the next to last column what 
EPA is recommending?
    Dr. McClellan. Right.
    Senator Chafee. If EPA's recommendations went into effect, 
you would find that the excess admissions over perfection would 
be 120. Am I correct?
    Dr. McClellan. That is correct, when that standard was 
attained.
    Senator Chafee. Am I missing something here, or are we 
really dealing in very, very minor improvements to the health 
of the citizens of New York City. There are 28,000 admissions 
currently. If everything were perfect, we would reduce that by 
385 per year.
    Dr. McClellan. I think you have grasped the point.
    Senator Chafee. If EPA's proposed standard went into 
effect, we would reduce those admissions not by 385 but by 120.
    Dr. Thurston.
    Dr. Thurston. The difference would be 385 minus 120, if I 
am understanding this. So the couple hundred you would reduce, 
you would have to multiply that by two if you want to consider 
other people who have respiratory disease. I guess it comes 
down to whether or not you are one of those people as to 
whether it is important.
    Senator Chafee. I think we have to put this in some 
context. It is all right to say that we don't consider 
expenses. But indeed we do. Dr. McClellan is active in water 
matters. When we did the Safe Drinking Water Act we provided 
for the small communities so that they didn't have to meet the 
same standards the large communities did.
    As you recall, we passed that unanimously out of this 
committee and the floor of the Senate. It is now the law. All I 
am trying to do is to get straight in my own mind that for an 
investment of several billion dollars, and in meeting the EPA 
standards, we are reducing the number of admissions over what 
there would be--if there were no problem--by 120. Meanwhile, 
there were 28,000 admissions for asthma.
    Am I on the right track, Dr. Thurston? Where am I going 
wrong?
    Dr. Thurston. I think we are here to get to the truth, and 
that is why I am here.
    The point is that asthma is a big problem and respiratory 
disease is a big problem. We as a Nation have said that we are 
going to protect people from adverse effects of air pollution. 
In other words, there are lots of causes of asthma, and most of 
them we can't do a darned thing about. But this happens to be 
one that we can.
    Senator Chafee. We can do very little about it.
    Dr. Thurston. I am saying that this particular pollutant we 
can do something about. There is a law against these people 
being adversely affected.
    I wish you could have been at that camp with me when the 
children had their asthma attacks. They don't show up in these 
statistics. Children who have asthma attacks don't all end up 
in the hospital, but their effects are very serious.
    Senator Chafee. I certainly will agree and I want to 
associate myself with what the chairman said when he opened the 
meeting here. He said that every single one of us want to 
attain clean air in this Nation. I have 11 grandchildren and 
many of them are in Rhode Island.
    Dr. Thurston. I also have family in Rhode Island.
    Senator Chafee. There is no question that we are concerned. 
But I do get back to what Dr. McClellan said. Will we get the 
``biggest bang for the buck?'' A very expensive undertaking has 
been proposed to meet the new standards suggested by the 
Administrator. From what I see in this chart, you reduce the 
hospital admissions by a tiny percentage of the total 
admissions.
    Dr. McClellan. That's what it says, and these are 
calculations. There are a lot of assumptions built in here. 
There is a linear model of ozone exposure-response that goes 
down to background. But I think the chart is very valuable in 
providing perspective. I think your questions helped illustrate 
the kind of perspective one needs to draw from this and to 
recognize that in setting the standard the Administrator has 
made a policy call. It is not one that is driven to a 
particular answer by the science.
    Senator Chafee. Thank you very much, Mr. Chairman. I know 
we have another panel and I want to hear them.
    Senator Inhofe. We are back on schedule, not due to the 
discipline of the witnesses or the Senators, but that we are 
dropping our numbers.
    [Laughter.]
    Senator Inhofe. Dr. Menzel, did you want one last comment?
    Dr. Menzel. Yes, Mr. Chairman.
    When I made that comment in response to the question about 
whether EPA was doing a good job in husbanding its resources, I 
may have been impolite there. I really did not intend to infer 
that it was personalized with Administrator Browner. I hope the 
committee will understand that. It is the culture that I am 
talking about.
    Senator Inhofe. I thank all three of you for taking time 
out of your schedules to come and testify.
    Senator Inhofe. I would now ask our third panel, which is 
the PM panel--even though we have been transgressing back and 
forth--to come to the table. I would like to welcome Dr. Anne 
Smith, vice president, Decision Focus Incorporated; Dr. Joel 
Schwartz, associate professor of environmental epidemiology, 
Department of Environmental Health, Harvard School of Public 
Health, Harvard University; and Dr. Ron Wyzga, target manager, 
health studies, Electrical Power Research Institute.
    We will start with Dr. Smith.

    STATEMENT OF ANNE SMITH, VICE PRESIDENT, DECISION FOCUS 
                          INCORPORATED

    Dr. Smith. Thank you, Mr. Chairman.
    My name is Dr. Anne Smith. I am a vice president of 
Decision Focus Incorporated. I have 20 years of experience in 
environmental risk assessment and risk management and a Ph.D. 
from Stanford University. I have contributed substantially to a 
number of major air quality policy assessments over the years 
for EPA, the Grand Canyon Visibility Transport Commission, and 
for industry organizations. I am honored to have this 
opportunity to speak with you today. My statement here reflects 
my personal opinions and not those of my company or any other 
group.
    I compare the situation for PM to the classic shell game. I 
think that in trying to control the true culprit with PM, we 
stand the risk of turning over many shells while we try to get 
at the culprit, and yet get no particular benefit from public 
health. I will explain why.
    There are a number of statistical or epidemiology studies 
we have been hearing about. These indicate that as ambient PM 
go up and down, so do health effects. However, when you observe 
two types of data going up and down together, this doesn't 
necessarily mean that we have a causal relationship, even if it 
is statistically significant. For example, if we were to 
discover an association between heat stress mortality and ice 
cream cone sales, we wouldn't conclude that we have a causal 
relationship here, even if it was statistically significant. 
The error in that conclusion would be obvious to us because we 
have a very good understanding of the biological processes for 
heat stress.
    This type of biological understanding does not exist at 
this moment for PM. EPA's peer reviewed criteria document tells 
us that there is no knowledge of the mechanism, no credible 
supporting toxicological evidence, and no compelling argument 
for biological plausibility. It is easy to make big mistakes 
when you are relying on statistical significance alone. Hence, 
the criteria document concludes that ``much caution is 
warranted'' in using these statistical findings for estimating 
risks.
    How much caution? Recently I did some numerical experiments 
to explore the likelihood that several specific types of data 
problems mentioned by EPA could cause significance. To be 
brief, I found plenty of cause for caution on my own.
    The truth is often the opposite of the statistically 
significant result when there are data problems that are found 
in all of these studies. PM may not be causing the mortality at 
all that is being shown in these studies. Other air pollutants, 
such as carbon monoxide or ozone, could be the real culprit as 
well as PM. Presently, there seems to be insufficient 
recognition of the magnitude of this particular uncertainty for 
PM.
    So, what if you could be convinced that there is a fine 
particle effect? Then would a PM2.5 standard be 
sufficient for health protection? No. The shell game analogy 
still applies here.
    Look at what PM2.5 consists of. Unlike any other 
criteria pollutant, PM is made up of many different types of 
components and they are from many different types of sources. 
Even if we believe the problem stems from PM, we still don't 
know which components might be potent, so we don't know which 
sources to control to get at the culprit. Statistical studies 
do not help us narrow down the list of likely culprits. They 
just don't have the relevant data to do that.
    Biological hypotheses exist and they do not help us much 
either in deciding what to control because each one suggests a 
different set of control actions would be necessary to protect 
public health. For example, some think the problem might be 
from a type of particle called the ultra fine. These are about 
100 times smaller than the typical particle accounted for in 
PM2.5. Science tells us that if we want to reduce 
human exposures to ultra fine particles, then we need to apply 
controls to local sources, such as gasoline-fired automobiles.
    But another hypothesis is that there is an effect caused by 
the accumulation of particles in the lungs. If we believe this 
hypothesis, then protection would require controls on only non-
soluble types of particles such as soot and road dust, a 
totally different set of sources.
    There are many more hypotheses about potential culprits. It 
seems unlikely that all of them would be valid. So we don't 
really know what to control. I want to make it clear that this 
is not like the situation with tobacco smoke, where there is a 
single control action--quitting--that is sufficient to control 
all the constituents. Thus we can get certainty that we will 
control the still unknown culprits in tobacco smoke.
    How has EPA communicated these uncertainties to the public? 
Despite clear warnings against it in the criteria document, 
EPA's risk and its benefits estimates use the statistical 
results as if they can be accepted at full face value. In the 
case of the benefits range you have heard from $58 billion to 
$120 billion a year, recognition of uncertainty has devolved 
down to using two point estimates from only two individual 
studies. The benefits range does not reflect the uncertainty in 
whether PM is the causal factor. The benefits range does not 
reflect the uncertainty about which type of fine particle might 
be the culprit and whether those types might be controlled 
under a fine particle standard.
    These and other very significant certainties have simply 
been presumed away. Thus the billions of dollars of benefits 
estimates are much more uncertain than EPA has indicated, and 
in fact could be very small--perhaps even zero.
    I am not suggesting years of delay. I think we could have 
more complete communication to the public of uncertainties, and 
more complete consideration of how alternative approaches to 
regulating could deal with these uncertainties.
    Thank you.
    Senator Inhofe. Thank you, Dr. Smith.
    Dr. Schwartz.

      STATEMENT OF JOEL SCHWARTZ, ASSOCIATE PROFESSOR OF 
         ENVIRONMENTAL EPIDEMIOLOGY, HARVARD UNIVERSITY

    Dr. Schwartz. Thank you, Mr. Chairman. And thank you for 
inviting me.
    I would like to summarize my remarks.
    Senator Inhofe. Without objection, your prepared statement 
will appear in the record.
    Dr. Schwartz. I would like to make several points. First, 
EPA is in fact not out on the science in the proposed 
standards, but actually lags behind the conclusions of many 
governments in western Europe and international scientific 
bodies. The cautions and arguments you have heard put forth 
have all been considered and made before and been considered by 
these bodies in leading to the conclusions that they did. 
Second, there is evidence that fine combustion particles from 
all the major choices are in fact associated with these health 
endpoints. I will explain that. Third, there actually are 
recent toxicological findings which confirm the epidemiology 
findings in considerable detail. Fourth, moving to a 
PM2.5 standard is appropriate and hasn't been made 
before.
    You have heard about the size of these particles. Particles 
less than 2.5 microns are predominantly from combustion--from 
burning things, cars, industrial processes--what we classically 
think of as pollution. The bigger particles are wind-blown 
dust. So the question is, Should we focus our controls on dust, 
or these combustion particles?
    In terms of the scientific consensus, more than a year ago 
the British government's version of CASAC reviewed the evidence 
on particles, concluded that there was a causal association 
with mortality, and recommended that the British government set 
a new particle standard, which is one-third of the current U.S. 
particle standard. They wanted a PM10 level of 50 on 
a 24-hour basis to correspond with 30 at PM2.5.
    Second, as you have already heard from Dr. Lippmann, the 
World Health Organization has developed a criteria document on 
particles. They have concluded that this is a causal 
association after examining all the evidence and have drawn up, 
in fact, dose response relationships that they have recommended 
that people use to estimate how many lives will be saved at 
various different standards. Those folks suggest that indeed 
there are tens of thousands of early deaths that would be 
avoided per year by the proposed EPA standards.
    The Swiss government has just conducted their review and 
has again recommended a standard that is one-third the current 
U.S. standard. These are substantial tightenings.
    Dr. Wolff talked about the 24-hour standard. I think the 
annual average for PM2.5 is actually much more 
important. It seems to me that that was a critical part of the 
staff paper that was approved by CASAC when they voted to 
approve the PM2.5 standard. It was with accepting, 
by their majority vote, the range of 12 to 20. EPA has picked a 
number of 15, which is in the range that has been approved.
    In terms of which particles matter, we have a lot of 
information on this because studies have been done in a lot of 
different places. In the northeast, the dominant source of fine 
particles are in fact sulfates. We see lots of studies showing 
association with fine particles or with particles or with 
sulfates directly. So it appears that sulfates are associated 
with these adverse health effects. They are one of the 
particles that matter.
    On the other hand, in Santa Clara, CA, there essentially 
are no sulfates in the air in the winter. It seems to be wood 
smoke, and they still found results. Other studies have been 
done in places where the dominant source is gasoline or diesel 
engines.
    In terms of toxicology, Dr. Godleski at Harvard has done a 
study exposing animals to concentrated particles from the 
Boston air for 3 days in an average concentration under 100 
micrograms. That is permissible under current EPA standards. 
Little happened to the healthy animals, but 37 percent of the 
bronchitic animals died after 3 days of exposure to permissible 
concentrations of fine particles. So we know that fine 
particles can kill animals at relevant concentrations that are 
seen today when they have illness.
    On the other hand, 10,000 micrograms per cubic meter of 
dust of coarse particles from Mount Saint Helens had no effect 
in epidemiology studies that were done following that eruption. 
So we know that focusing on the fine particles is where we need 
to put our attention.
    Finally, there are other toxicology studies that have taken 
Washington, DC particles, separated into fine and coarse, 
instilled them into the lungs of animals, and there was 
substantial toxicity from the fine particles, but not from the 
coarse particles. This confirms that particles can have a toxic 
effect, which supports the epidemiology, and also suggests that 
it is the small ones that matter. There are also studies using 
data from Mexico City and elsewhere.
    Last, I would like to provide one other piece of evidence. 
This has to do with the issue Dr. Wyzga will raise about 
measurement error in coarse particles. There is also 
measurement error in fine particles, though it is less 
appreciated, because the volatile ones disappear from the 
filters. But if you average your measurements over long periods 
of time, these day-to-day fluctuations tend to average out. I 
have provided you with two pictures at the back of my testimony 
from a study published last year--using data from that study. 
One shows the percent of children in the 24 city studies with 
abnormal lung function, controlling for individual risk 
factors, plotted against the fine particle concentrations in 
those towns.
    Fortunately, the fine particle concentrations and coarse 
particle concentrations didn't correlate that high, so you can 
do the same plot for coarse particles. For the fine particles, 
the percent of children with abnormal lung function triples as 
you go from low to high. For the coarse particles, there is no 
association at all.
    Thank you.
    Senator Inhofe. Thank you, Dr. Schwartz.
    Dr. Wyzga.

  STATEMENT OF RON WYZGA, BUSINESS AREA MANAGER, AIR QUALITY, 
   HEALTH AND RISK STUDIES, ELECTRIC POWER RESEARCH INSTITUTE

    Dr. Wyzga. Thank you.
    I am Dr. Ronald Wyzga. I work at the Electrical Power 
Research Institute in Palo Alto, CA. By training, I have my 
doctorate in biostatistics from the Harvard School of Public 
Health.
    I have undertaken research in this area for many years. I 
am going to give you my personal views, which do not reflect 
those of my institute nor of any of my associates.
    I agree with Joel and others that there are many positive 
studies that show a statistically significant association 
between health endpoints and exposure to particulate levels. I 
have undertaken many of these studies myself, and my institute 
has funded many of these studies. The key question is, Do we 
have enough evidence? Or do we really believe that if we were 
to reduce particulate levels in today's environment, would 
there be public health benefits?
    I think the correct answer to that is that no one really 
knows. Let me tell you why. We have all these positive studies, 
but we have to temper them with several factors.
    First of all, there are negative studies. We need to 
include these and mention these as well.
    Second, recently there have been----
    Senator Chafee. There are negative studies showing that the 
other studies aren't accurate?
    Dr. Wyzga. There are studies that find no association 
between health endpoints and exposure to particulates.
    There is another set of studies that have taken studies 
that were originally positive that have reanalyzed them and 
have come to the conclusion that we cannot say that 
particulates are responsible for those health endpoints. These 
studies have been funded by a wide variety of institutions from 
EPA to private industry. So we are looking at a whole range of 
individuals who have reanalyzed these data sets.
    Third, there is really no one correct way to analyze a data 
set. These are very complex data sets and there are lots of 
different statistical methods that are appropriate that can be 
used to analyze these. Since we can't say what's right, it 
basically gives people a lot of flexibility in the tools they 
use in analyzing a data set. Let me say that even in some 
recent work we have done we use some of these tools and we get 
some remarkably silly results.
    Fourth, we really can't say if it is particulates or some 
other agent in air pollution that is associated with health 
outcomes in these studies. Lots of pollutants occur at the same 
time. It is very difficult to pinpoint which one is causing any 
specific health effects, if it is one pollutant in particular.
    We have a curious disconnect between the personal exposures 
of people to particulates and what is measured with the ambient 
monitor. We need a better understanding of how what we are 
personally exposed to relates to what is measured out there.
    EPA, in its proposal, says that there is no accepted 
biological explanation of the results of the statistical model.
    I firmly believe that when you look at the data, regardless 
of how you look at the existing data, and you compare what we 
know about the health effects of PM10 and the health 
effects of PM2.5, you see absolutely no advantage 
for PM2.5.
    In summary, I see our situation as very much akin to the 
solving of a jigsaw puzzle. We are looking for the picture that 
the puzzle is going to tell us. We have some of the pieces, 
such as positive studies, that are suggesting that there is 
something going on here. But we have some missing pieces; for 
example, the biology. We have other pieces that don't seem to 
fit, the negative studies, the studies that contradict each 
other, the apparent disconnect between personal exposure and 
what is measured at the monitoring station, the fact that it is 
difficult to disentangle the different pollutants. All of these 
pieces are there as we scramble to understand what we can see.
    I don't know if when we look at the finished product--are 
we going to see that there are particulate effects on health? 
Are we going to see that these associations are part of an 
illusion? Or are we going to learn that something completely 
unexpected is occuring, something that we have no knowledge or 
foresight today of what the answer is going to be?
    Senator Inhofe. Thank you, Dr. Wyzga.
    Let me start with Dr. Smith.
    I know I have learned a lot in the last 3 hours. Can you 
explain to me the biological mechanism for PM2.5?
    Dr. Smith. What I have stated comes straight from the 
criteria document. There is no plausible biological mechanism 
that has been----
    Senator Inhofe. Would you say that more studies are needed 
to determine what the mechanism is?
    Dr. Smith. Yes, that's right.
    Senator Inhofe. About how many different substances are 
there at the size of PM2.5?
    Dr. Smith. There are maybe about six different categories 
of different types of chemicals. They all come from quite 
different sources. One of the key categories would be sulfates, 
which come from mainly coal burning. Another key category would 
be nitrates that come from NOX emissions, which come from many 
combustion sources, automobiles, and power plants----
    Senator Inhofe. There are many?
    Dr. Smith. There are many.
    Senator Inhofe. Would it be conceivable that a community 
could protect itself or control a substance such as nitrates 
only to find that 5 years from now or 10 years from now it has 
no effect on the results that we have been looking at today?
    Dr. Smith. Right. That is the essence of what I was trying 
to say.
    Senator Inhofe. Dr. Schwartz, I understand that your 
studies were primarily what the EPA was relying on when they 
came up with their recommendations. Therefore, your testimony 
is very important. I understand that some of your critics--some 
of the scientists who disagree with you--have not been able to 
get access to some of your data.
    I have to say this critically of you, Dr. Schwartz, because 
we have a rule in this committee that we explain to all 
potential witnesses that we want the testimony to be submitted 
48 hours before the appearance, which would have been at 9 
o'clock on Monday. We didn't receive your's until this morning. 
The reason that is significant is that we do take the testimony 
and we read it, our staff reads it, and it gives us an 
opportunity to study it prior to the meeting. It puts us at 
somewhat of a disadvantage.
    Dr. Schwartz. I understand that. First of all, I faxed it 
to the committee yesterday afternoon. I don't know why you 
didn't get it. I gave it to my secretary with the fax numbers. 
In terms of why it was yesterday rather than earlier, I was 
asked rather late in the game to come down here and testify, 
and I didn't have a lot of time to prepare my testimony.
    Senator Inhofe. Dr. Schwartz, you were asked at the same 
time as everyone else. In fact, I believe Dr. Menzel was asked 
after you.
    I only say that because there is a reason for this. I think 
on future committees we are really going to adhere to that.
    On your six-city study--I think this is probably the 
principal research upon which the EPA has made its 
recommendation--at least I have been told that and I saw a 
document here that leads me to believe that--there are so many 
variables. As a general statement, don't you think that a 
scientist's prejudgment can come in by how they weight the 
variables that are out there?
    Dr. Schwartz. I certainly think it is true, as Ron said, 
that different people analyze data differently. That is one of 
the reasons there is a CASAC review process. In the course of 
spending a year in CASAC and a year before that in criteria 
document workshops going over all the issues and how they are 
analyzed, people start to come to some consensus about what is 
appropriate. First of all, my paper went through CASAC review 
and they could have told EPA to ignore it because it wasn't 
appropriate. But also some of the methods I used to control for 
weather and other things were things that were getting 
favorable reviews in the CASAC review process.
    But I would not say that my paper was the basis of the 
decision to go to PM2.5. There are other studies, 
like Dr. Thurston's epidemiology study in Toronto, which also 
shows that coarse mass is not predictive of hospital 
admissions, but the fine particles are, as well as the 
toxicology studies where we see that the coarse particles are 
not toxic to animals' lungs, and the fine ones are.
    Senator Inhofe. It is my understanding that the National 
Institute of Statistical Sciences reexamined your Birmingham 
study and controlled for humidity and got different results. I 
have a few other examples, too.
    I understand that can happen with anyone's study. I 
understand it more now than I did 3 hours ago.
    Dr. Wyzga, you were the last one to testify. I want to go 
back to the first one to testify, Dr. Wolff.
    Senator Inhofe. Senator Chafee.
    Senator Chafee. Sorry to butt in, Mr. Chairman. I really 
have to go, but I wanted to ask one question to Dr. Schwartz.
    You refer to the Godleski study at Harvard. When was that? 
The only reason I am asking is that I believe it is rather 
recent.
    Dr. Schwartz. That was presented last May at the annual 
meeting of the American Scholastic Society, as was the study on 
the fine versus coarse particles from Washington.
    Senator Chafee. Dr. Smith, when you looked at the criteria 
documents, I understand quite clearly that it is a stack of 
documents. Do you know whether the Godleski study was in there?
    Dr. Smith. It was available in abstract form at the time 
the criteria document was published. As far as I know, I have 
not been able to get a hold of anything in any more detail. And 
there are a number of considerations and concerns associated 
with that. But the results were known at the time the criteria 
document was published.
    Senator Chafee. Mr. Chairman, I want to join you in 
saying----
    Dr. Schwartz. Dr. Godleski made a detailed presentation to 
CASAC of the results of that study and went into it in great 
detail and was asked questions.
    Senator Chafee. Mr. Chairman, I want to join with you in 
thanking this panel and the others for coming here. We greatly 
appreciate it. As Senator Hutchinson said, this is a very 
complicated subject. We are all learning and you have greatly 
increased our knowledge.
    Thank you very much.
    Senator Inhofe. Thank you, Mr. Chairman.
    Dr. Wyzga, I know you were here when I was speaking to the 
first witness, Dr. Wolff. I am trying to sort this out and get 
it to something that we understand as people who are not 
scientists.
    You talked about a couple of factors. You had your risk 
factors. I think it was Robert Temple who said that my basic 
rule is that if the relative risk isn't at least three or four, 
forget it. This I understand is somewhere around 1.0 to 1.2 
percent and that there is no identifiable biological mechanism 
for PM.
    We are looking at two very significant bottom line things 
here. Would you comment as to Dr. Wolff's answer and as to 
whether or not you agree with that?
    Dr. Wyzga. Basically what we are talking about here is 
relative risk in the order of 1.05 to 1.07, which is really 
minuscule. What worries me is that given the tools that we have 
and the data we have, are we perhaps even biasing ourselves and 
getting some relatively silly answers?
    One of the things I have done recently is to take some very 
unlike data sets and I am getting very surprising results. If I 
use the same models that relate particulate air pollution to 
health, I can explain the number of deaths each day in San 
Jose, CA, by Philadelphia air pollution mortality data. I can 
take the number of deaths each day in the United States and 
explain those using the same techniques with Philadelphia 
particulate data. I can take the number of births each day in 
the United States and I can explain those with Philadelphia 
total suspended particulate data.
    These results are silly and make absolutely no sense. I 
don't understand them. One of the things I need to do is to try 
to find out why I am getting these silly results. Does it mean 
that we are really doing something inherently wrong? Does it 
mean that somehow Philadelphia particulate data are the key to 
the world? Or does it mean that I just happened to fall upon a 
very strange artifact?
    I don't know, but it is something that really disturbs me, 
particularly when I see these very small relative risks.
    Senator Inhofe. Thank you, Dr. Wyzga.
    Dr. Schwartz. May I respond to that?
    Senator Inhofe. Sure.
    Dr. Schwartz. On the issue of small relative risks, I think 
we have to realize that it is 1.07 and that certainly could be 
a matter of concern to people. That is why it is important to 
try to look at multiple studies as well as at animal studies. 
But it is also important to know that when you look at very 
common health outcomes, that is where you tend to see relative 
risks. You don't see relative risks to dying of heart disease, 
because 40 percent of the population dies of it. It is pretty 
hard to have one risk factor that makes you four times more 
likely than that.
    In fact, the relative risk of having a heart attack for a 
blood pressure of 95 compared to a blood pressure of 85 is 1.1. 
Yet we have one-third of the adult population taking anti-
hypertensive medication because we think it can lower their 
blood pressure by 5 to 10 millimeters and produce that change. 
So it is certainly the case that when we look at common 
outcomes there are plenty of things that have relative risks in 
those ranges.
    Senator Inhofe. I have one last yes or no question to all 
three of you.
    You heard me read the magazine article from Science--and I 
assume that is a credible publication--``Since there is no 
identifiable biological mechanism and the risk factors are so 
low, are these studies less than stunning results?''
    Dr. Smith.
    Dr. Smith. I think I would like to go to EPA's own quote 
from the criteria document, which refers to the same 
circumstances. ``Much caution is warranted in using these 
results.
    Senator Inhofe. Dr. Wyzga.
    Dr. Wyzga. I think these studies raise a concern, but it is 
totally unclear to my mind if the concern is about particulate 
matter or some other pollutant, or some other factor.
    Senator Inhofe. I knew we wouldn't get a one-word answer.
    [Laughter.]
    Senator Inhofe. And I know we won't get it from Dr. 
Schwartz.
    Dr. Schwartz. Given the wealth of studies and the ranges 
that have been reported for different outcomes that the 
conclusions of the World Health Organization panel that these 
are likely causal associations is a warranted one.
    Senator Sessions.
    Senator Sessions. Dr. Schwartz, with regard to the 
Birmingham study, you did not include the humidity in your 
report, did you not?
    Dr. Schwartz. In that study, no. I haven't seen humidity 
being put in lots of other studies. Frankly, I am sure these 
people get a different answer than I do. I am not sure that the 
only difference between our analyses is controlling for 
humidity. I suspect it is due to other things because other 
people I talked to also don't tend to see important effects of 
humidity.
    Senator Sessions. The point is that they used your studies. 
When they just applied and factored in the humidity that was 
present during the days in question, they got no difference and 
no adverse effects from their conclusion of your very own 
study.
    Do you dispute that?
    Dr. Schwartz. I haven't examined in detail what they have 
done. If they tell me that they did something and those are the 
results, I believe them. Then people could look in detail at 
what they did and what I did and decide what they think.
    Senator Sessions. We are all uncertain about a lot of 
things. I guess it would be fair to say that you can't be 
certain whether humidity did or did not have an effect. Is that 
correct?
    Dr. Schwartz. That's correct.
    Senator Sessions. Dr. Smith, you mentioned a cost factor of 
billions of dollars that might be involved in the air. I know 
we aren't supposed to talk about that, but it seems to me that 
we could think in terms of billions of dollars being spent on 
asthma research might save more asthmatics than billions of 
dollars on this.
    Do you have any thoughts on that? Have there been any 
studies on that kind of thing?
    Dr. Smith. I haven't really followed the studies on 
research for asthma, per se, but there is always a question in 
any policy debate as to whether the dollars could be spent more 
effectively in another manner. I have not tried to address 
that. My comments are more aimed at the need to consider 
alternative ways of setting a standard so that we can get a 
higher chance of getting at whatever the culprit is.
    Dr. Wyzga. Could I add one thing to the asthma question?
    Senator Sessions. Yes.
    Dr. Wyzga. One of the things that concerns me is that there 
is general acknowledgement among the community of 
pulmonologists--in fact it is acknowledged in the EPA's 
proposal--that if there is an effect of asthma on asthmatics, 
it is the coarse particles deposited in the upper airways. What 
is curious--and EPA then calculates how many asthmatic attacks 
can be saved and admissions to hospitals--the larger fraction 
would be regulated under PM10. What is proposed is a 
relaxation of PM10. There could be five times as 
many days in which the current PM standard would be violated 
under the new proposal than under the existing ones. So if 
these asthma effects are real, and if we want to protect 
asthmatics, what is being proposed is not the answer.
    Senator Sessions. Dr. Schwartz, you mentioned the ultra 
fine particles. Do you have any feeling that there is any 
distinction between the size of the particles and the adverse 
health effects, whether it might be 1.5 particles that really 
cause the damage rather than the 3.0 particles? Do you have any 
knowledge?
    Dr. Schwartz. That is a good question, Senator.
    I am relatively convinced that the particles larger than 
2.5 microns--which are dust particles basically--are not 
important for most of the health effects. It is possibly 
important for asthma, but even there I am not sure. But for 
everything else, I am relatively convinced that that is not 
what matters. It is really the combustion particles that 
matter.
    Combustion particles are less than 2.5 microns, but mostly 
they are less than 1 micron in size. Ultra fine particles come 
right off the combustion process. You get these very, very 
small particles and then they agglomerate up and tend to get 
bigger. They tend to grow up to things that are around .3 
microns in size, roughly.
    The other major source of particles comes from combustion, 
but it doesn't start out as a particle. Sulfur dioxide will 
come out of a smokestack, power plant, or whatever, travel 
downwind and react in the air to form sulfates, which are 
particles that react with ammonia and you get ammonium sulfate. 
That is a particle. Those tend to be a little bigger. They tend 
to be around .7 microns. But most of them are less than 1 
micron in size.
    I think that yes indeed probably the stuff we are talking 
about is less than 2.5, but it is probably mostly less than 1 
micron.
    The hypothesis has been raised that maybe it is really the 
ultra fines when they are very, very small. That is a 
hypothesis which I am in fact investigating with a group of 
people I am collaborating with in Finland.
    It has the disadvantage that those particles basically 
don't get indoors whereas the sulfate particles do. By the time 
those things get indoors, they have agglomerated up and are 
bigger. So it is hard to see how people are being exposed to 
it.
    Senator Sessions. It is a complicated subject.
    Dr. Schwartz. It is a complicated subject. I am certainly 
looking at it. I am confident it is less than 1 micron. Whether 
it is between .3 and .8, I don't know yet.
    Senator Sessions. Dr. Wyzga.
    Dr. Wyzga. I would agree with Joel with respect to ultra 
fines. I am personally a little skeptical about the hypothesis, 
but it is one that is out there.
    One of the things I have done recently is take every single 
study that has looked at both PM10 and 
PM2.5. If you look at the average pollution level we 
have today, and assume a 10 percent change in the pollution 
level of either PM10 or PM2.5, and 
estimate the benefits of reducing them 10 percent, in no 
study--and we have looked at every one that is out there--do 
you find an advantage for PM2.5. In some studies you 
find advantages for PM10. It is something that I 
really urge the Agency and other scientists to do, to make such 
a table. We have generated it.
    I am now working on a paper that we will be submitting for 
publication based on this work, but I would be happy to submit 
even the preliminary results to this group or any other group 
to show them what we have done.
    Senator Sessions. Then you would conclude that it would be 
unwise for our Nation to undertake a huge national commitment 
to a policy that at this point you feel the data is uncertain 
as to whether we would receive a benefit from it?
    Dr. Wyzga. Yes, sir.
    Senator Sessions. Thank you.
    Senator Inhofe. We thank you very much for coming, all 
three panels. We know how valuable your time is. You have been 
very, very helpful. We appreciate it so much.
    The record will be kept open for members for questions for 
another 48 hours.
    We are recessed.
    [Whereupon, at 1 o'clock p.m., the subcommittee was 
adjourned, to reconvene at the call of the chair.]
    [Additional material submitted for the record follow:]
    Prepared Statement of Dr. George T. Wolff, Chairman, Clean Air 
 Scientific Advisory Committee (CASAC), and Atmospheric Scientist for 
                       the General Motors Company
                         legislative background
    In 1963, the Clean Air Act (CAA) was passed by Congress directing 
the then Department of Health Education and Welfare to prepare 
``Criteria Documents'' which would contain summaries of the scientific 
knowledge on air pollutants arising from widespread sources. The 1970 
CAA required the EPA Administrator to set National Ambient Air Quality 
Standards (NAAQS) for the identified ``criteria'' pollutants and gave 
the Administrator the authority to revise the NAAQS in the future and 
to set additional NAAQS as needed. At that time, 6 air pollutants were 
designated as criteria pollutants: photochemical oxidants (later became 
ozone), sulfur dioxide, non-methane hydrocarbons (later dropped as a 
criteria pollutant category), nitrogen dioxide, carbon monoxide, and 
total suspended particulate (later changed to PM10, which 
includes only particles with an aerodynamic diameter less than or equal 
to 10 microns). In 1971, EPA established NAAQS for all six.
    The absence of a mechanism for a periodic reassessment of the 
initial NAAQS, prompted Congress to add into the 1977 CAA amendments a 
requirement that the NAAQS be reevaluated every 5 years. In addition, 
the 1977 amendments created a new committee--the Clean Air Scientific 
Advisory Committee (CASAC), to review the periodic reevaluations. 
Organizationally, CASAC is housed within EPA's Science Advisory Board 
(SAB)\1\ and functions as one of the ten standing committees of the 
SAB. However, unlike most of the other standing committees of the SAB, 
CASAC reports directly to the EPA Administrator rather than through the 
Executive Committee of the SAB.
    Congress specified a number of responsibilities for CASAC. One was 
to provide independent advice on the scientific and technical aspects 
of issues related to the criteria for air quality standards. The CASAC 
charter\2\ states some of their functions:

          Not later than January 1, 1980, and at five year intervals 
        thereafter, complete a review of the criteria published under 
        section 108 of the Clean Air Act and the national primary and 
        secondary ambient air quality standards and recommend to the 
        Administrator any new national ambient air quality standards or 
        revision of existing criteria and standards as may be 
        appropriate.
          Advise the Administrator of areas where additional knowledge 
        is required concerning the adequacy and basis of existing, new, 
        or revised national ambient air quality standards.
          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 
        activity, and
          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 such 
        national ambient air quality standards.

    Previous activities of CASAC prior to 1985 have been summarized by 
Lippmann.\3\
    Concerning the membership of CASAC, the charter states:

          The Administrator will appoint a chairperson and six members 
        including at least one member of the National Academy of 
        Sciences, one physician, and one person representing State air 
        pollution control agencies for terms up to 4 years. Members 
        shall be persons who have demonstrated high levels of 
        competence, knowledge, and expertise in the scientific/
        technical fields relevant to air pollution and air quality 
        issues.

    For any NAAQS review, a CASAC Panel is constituted to conduct the 
review. A Panel consists of the seven regular members plus a sufficient 
number of consultant members so that the broad spectrum of expertise 
needed to fully assess a particular issue is covered on the Panel. 
These consultants are generally selected from EPA's Science Advisory 
Board (SAB)\1\ or from a pool of about three-hundred consultants 
maintained by the SAB. However, certain issues have required going 
outside of the SAB and the SAB consultant pool to obtain a particular 
expertise. For the ozone NAAQS review, the panel consisted of 15 
individuals including physicians, epidemiologists, toxicologists, 
atmospheric scientists, plant biologists, risk assessment experts and 
an economist. For the PM review, the panel consisted of 21 scientists.
the national ambient air quality standards and the ozone review process
    There are two types of NAAQS: primary and secondary. Primary NAAQS 
are set to protect human public health. Secondary NAAQS are set to 
protect against adverse welfare effects which include protection of 
plants, animals, ecosystems, visibility, etc.
    The major steps in the NAAQS review process are illustrated for 
ozone in Table 1. EPA began drafting the Criteria Document (CD), which 
summarizes all of the relevant science on the sources, chemistry, 
effects, etc. of ozone, in the middle of 1993. Recent Criteria 
Documents have become mammnoth undertakings. The first ozone Criteria 
Document,\4\ published in 1970, summarized the relevant science in 200 
pages. The present Criteria Document\5\ is a three volume set and 
contains over 1500 pages. A draft Criteria Document was sent to the 
CASAC Panel in June of 1994.
    The Staff Paper (SP) contains the Agency's recommendations for the 
range and form of the NAAQS along with the justifications for the 
recommendations that are drawn from material contained in the Criteria 
Document. In the past, the CASAC review of a Criteria Document was 
completed before the Staff Paper was written so that the Staff Paper 
would reflect the science contained in the final Criteria Document. The 
reviews of both the Criteria Document and Staff Paper are iterative 
processes that usually involve two to three revisions to both of the 
documents before CASAC reaches closure, and, in the past, the entire 
process took several years to complete. However, this review was on an 
accelerated schedule because of a previous lawsuit filed by the 
American Lung Association (ALA). In the previous review, CASAC came to 
closure on the Staff Paper in 1989. When EPA failed to complete the 
last two steps listed in Table I by October of 1991, the ALA and other 
plaintiffs filed a suit to compel EPA to complete its review. The U.S. 
District Court for the Eastern District of New York subsequently issued 
an order requiring the EPA Administrator to announce its proposed 
decision by August 1, 1992 and its final decision by March 1, 1993. 
EPA's decision was to retain the existing 1-hour standard of 0.12 ppm, 
but noted that since there were many potentially important new studies 
published since the last Criteria Document was written, they would 
complete the next review of the ozone NAAQS as rapidly as possible. The 
ALA sought judicial review of this decision, but because of EPA's 
intention to complete the review as rapidly as possible, the ALA 
granted EPA a voluntary remand of the petition for review. To 
accomplish the accelerated review, some of the steps listed in Table 1 
were conducted to some extent as parallel tasks rather than sequential 
tasks. In particular, a draft of the Staff Paper\6\ was sent out for 
CASAC review in February of 1995 even though closure on the Criteria 
Document did not occur until November of 1995.
    As shown in Table 1, CASAC reached closure\7\ on the third revision 
of the Criteria Document in 15 months. CASAC also reached closure\8\ in 
November 1995 on the Staff Paper after a nine month review process and 
two Staff Paper revisions. The proposed NAAQS were announced in the 
December 13, 1996 Federal Register. The last step in the process, EPA's 
promulgation, is scheduled to be published in the Federal Register on 
or before June 28, 1997. A public comment period for the December 1996 
notice will close February 18, 1997.
                     history of the ozone standard
    The history of the ozone NAAQS is summarized in Table 2. Additional 
details are contained in the Staff Paper.\6\ In the Staff Paper, EPA 
recommended that the existing 1-hour NAAQS of 0.12 ppm be replaced with 
an 8-hour average NAAQS within the range of 0.07 ppm to 0.09 ppm with 
one to five allowable exceedances per year averaged over a three year 
period. The range of stringency from the most stringent (0.07 ppm with 
1 allowable exceedance) to the least stringent (0.09 ppm with 5 
allowable exceedances) is substantial. In the December 1996, notice, 
EPA proposed an 8-hour NAAQS of 0.08 ppm. To be in attainment, the 
average of the third highest in each year for 3 years could not exceed 
0.08 ppm. At this level, the new NAAQS is significantly more stringent 
than the present 1-hour NAAQS when the resulting number of 
nonattainment areas are considered. With the present NAAQS, 68 
Metropolitan Statistical Areas (MSAs) where ozone was monitored through 
September, 1996 did not meet the standard. This number would jump to 
140 with the new 8-hr NAAQS of 0.08 ppm. However, this does not tell 
the entire story because many of the counties in between MSAs do not 
now have ozone monitors because they meet the present NAAQS. Some of 
these counties would become nonattainment with a more stringent NAAQS.
    As pointed out in the Criteria Document\5\ and the Staff Paper,\6\ 
the 1-hour daily maximum background ozone averages between 0.03 to 0.05 
ppm. This is the average 1-hour maximum ozone that could be expected 
during the summer in the continental U.S. in the absence of sources of 
anthropogenic precursor emissions in the U.S. In rural areas, which 
experience broader ozone peaks than urban areas because of the lack of 
ozone scavenger emissions, the maximum daily 8-hour background ozone 
concentration would be expected to be only slightly less than the 1-
hour maximum background of 0.03-0.05 ppm. Consequently, with an 8-hour 
NAAQS being considered, background ozone becomes a more important 
consideration.
         ozone health effect studies: results and implications
    The ozone review relied mainly on four broad types of health effect 
studies: animal studies, controlled human chamber studies, field 
studies of ambient exposures, and hospital admission studies. The main 
use of the animal studies was to gain insight on the mechanisms by 
which ozone produces biological responses and damage to the respiratory 
system. In the controlled human exposure studies, individuals were 
typically exposed to ozone concentrations slightly above, at, or below 
the present NAAQS for a number of hours (6 hours is the 
most common) while engaged in light to heavy exercise. Before, during 
and after the exposure the individual lung functions (such as FEV1 
which is the maximum volume of air that can be expired in one second) 
are monitored and any symptoms (cough, shortness of breath, chest pain, 
etc.) are noted. These studies have produced two important results. 
First, for one or two hour exposures, decrements in lung function tests 
and symptoms were noted in individuals not engaged in exercise only at 
concentrations greater than three times the present NAAQS. However, 
some exercising individuals experience decreased lung-function test 
performance and symptoms even at concentrations at or below the present 
NAAQS when exposed for multiple hours. This is one of the pieces of 
evidence that suggested a multiple hour (8-hours) NAAQS is a better 
measure of response than a 1-hour standard.
    The field studies consisted of summer camp and adult exercise 
studies. In the summer camp studies, children, engaged in the normal 
physical activities that occur at summer camps, participated in lung 
function testing and the results were compared to the ambient ozone 
concentrations. In the adult exercise studies, lung function tests were 
administered to joggers before and after they ran outdoors and the test 
results were also compared to the ambient ozone concentrations. The 
results of both types of studies showed a small but statistically 
significant relationship between decreased performance on the lung 
function tests with increasing ozone at concentrations at and below the 
present NAAQS. These results are consistent with the controlled chamber 
studies and reinforce the evidence that an 8-hour NAAQS is a better 
measure of response than a 1-hour NAAQS. Furthermore, since the 
relationship between the lung function test results and ozone appears 
to be linear, there may not be a threshold concentration below which 
biological responses will not occur.
    The hospital admission studies examined the relationships between 
daily ozone consistently shown an apparent linear relationship in 
various North American locations between ozone and the admissions, and 
EPA has assumed that this relationship is cause and effect. The 
relationship has been shown to remain even when considering only 
concentrations below the present NAAQS. Thus, there is no evidence of a 
threshold concentration and this reinforces the conclusion from the 
field studies.
          casac's interpretation and recommendations on ozone
    It was the consensus of the CASAC Panel that there only be one 
primary NAAQS, either an 8-hour or a 1-hour NAAQS. Even though an 8-
hour time-frame appeared to be a better measure of response, the Panel 
acknowledged that the same degree of public health protection could be 
achieved with either an 8-hour or a 1-hour NAAQS at the appropriate 
level. It was also the consensus of the Panel that the form of the new 
standard be more robust than the present one. The present standard is 
based on an extreme value statistic which is significantly dependent on 
stochastic processes such as extreme meteorological conditions. The 
result is that areas which are near attainment will randomly flip in 
and out of compliance. A more robust, concentration-based form will 
minimize the ``flip-flops,'' and provide some insulation from the 
impacts of extreme meteorological events.
    The Panel felt that the weight of the health effects evidence 
indicates that there is no threshold concentration for the onset of 
biological responses due to exposure to ozone above background 
concentrations. Based on information now available, it appears that 
ozone may elicit a continuum of biological responses down to background 
concentrations. It is critical to understand that a biological response 
does not necessarily imply an adverse health effect. Nevertheless, this 
means that the paradigm of selecting a standard at the lowest-
observable-effects-level and then providing an ``adequate margin of 
safety'' is not possible. It further means that risk assessments must 
play a central role in identifying an appropriate level.
    To conduct the risk assessments, EPA had to identify the 
populations at risk and the physiological responses of concern, develop 
a model to estimate the exposure of this population to ozone, and 
develop a model to estimate the probability of an adverse physiological 
response to the exposure. EPA selected a small segment of the 
population, ``outdoor children'' and ``outdoor workers,'' particularly 
those with preexisting respiratory disease as the appropriate 
populations with the highest risks. The Panel concurred with the Agency 
that the models selected to estimate exposure and risk were appropriate 
models. However, because of the myriad of assumptions that are made to 
estimate population exposure and risk, large uncertainties exist in the 
model estimates.
    The results of two of the risk analyses are presented in the Staff 
Paper\6\ and are reproduced in Tables 3 and 4. It should be noted that 
the numbers in these Tables differ slightly from the numbers presented 
in the closure letter\8\ which were based on EPA's estimates that were 
in the August 1995 draft of the Staff Paper. The numbers in Tables 3 
and 4 are based on EPA's latest estimates contained in the final June 
1996 Staff Paper. The biggest change is in the total number of asthma 
hospital admissions in Table 5 which is 50% lower than those in the 
closure letter. lie difference is that the closure letter used annual 
admissions, but the numbers in Table 4 are six-month (ozone season) 
numbers. By using a six-month basis for the total admissions, the 
percentage of annual admissions due to ozone exposure is inflated by a 
factor of two.
    The ranges from ten model runs of the risk estimates across nine 
cities for outdoor children are presented in Table 3. Because of the 
large number of stochastic variables used in the exposure model, the 
exposure estimates vary from run to run. However, the ranges presented 
in Tables 3 and 4 are not reflective of all of the uncertainties 
associated with the numerous assumptions that were made to develop the 
estimates.
    Based on the results presented in these and other similar tables 
presented in the Staff Paper and an acknowledgment that all the 
uncertainties cannot be quantified, the CASAC Panel concluded that 
there is no ``bright line'' which distinguishes any of the proposed 
standards (either the level or the number of allowable exceedances) as 
being significantly more protective of public health (this includes the 
present standard). For example, the differences in the percent of 
outdoor children (Table 3) responding between the present standard 
(1H1EX at 0.12 ppm) and the most stringent proposal (8H1EX at 0.07 ppm) 
are small and their ranges overlap for all health endpoints. In Table 
4, the estimates in row 1 suggest considerable differences between the 
several options. However, when ozone-aggravated asthma admissions are 
compared to total asthma admissions (rows 5 and 6), the differences 
between the various options are small.
    The results in Table 4 also raise questions concerning the 
reasonableness of the assumption of a linear relationship between 
admissions and ozone concentrations with no threshold concentration. If 
New York City was just meeting the present NAAQS of 0.12 ppm (1H1EX 
0.12), Table 4 indicates that ozone would be responsible for 890 
admissions per year. However, of that 890, only 210 admissions would be 
due to ozone concentrations above the summer background concentration 
which is taken here to be 0.04 ppm. The majority, 680, or 76.4% of the 
admissions are attributable to ozone exposure when the ozone 
concentrations were less than or equal to the summertime background.
    Nevertheless, the CASAC Panel could see no ``bright line'' to use 
as a guide in selecting the numerical value of an NAAQS. However, some 
of the members did express personal preferences for the level of the 8-
hour NAAQS and they are given below. All the members recommended that 
there be multiple allowable exceedances. Two other members said that 
the selection of a level is strictly a policy decision since the risk 
assessment did not show that any of the NAAQS considered were more 
protective of public health.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                    No. of Members                                             Preference                       
----------------------------------------------------------------------------------------------------------------
1....................................................                                                 0.09-0.10 
3....................................................                                                      0.09 
1....................................................                                                 0.08-0.09 
3....................................................                                                      0.08 
2....................................................                                               policy call 
----------------------------------------------------------------------------------------------------------------

                          perspective on ozone
    Let us examine the individual recommendations of the panel members. 
Of the 15 panel members, ten expressed an opinion on the level of the 
primary NAAQS. Of the five members who did not express an opinion, four 
were plant biologists who were on the panel for their expertise 
regarding the secondary NAAQS issue and they were not expected to 
comment on the primary NAAQS. A fifth panelist, an atmospheric 
scientist, gave the panel guidance on atmospheric issues but chose not 
to participate in the health effects discussions.
    Of the ten who voiced an opinion, all endorsed an 8-hour standard 
and all endorsed multiple exceedances. Three members recommended 0.08 
ppm which is clearly more stringent than the present NAAQS. Three other 
members recommended 0.09 ppm and one member recommended a range of 0.09 
to 0.10 ppm which, with multiple allowable exceedances, ranges from a 
NAAQS equal in stringency to the current NAAQS to a NAAQS less 
stringent to the current NAAQS. Two other members (including the 
author) said it is a policy decision because the science has not shown 
any of the alternatives that are being considered as being more 
protective of public health than any other. The last member supported a 
NAAQS in the ``higher end, the middle to higher end.''
                         the pm review process
    The major steps in the PM NAAQS review process are illustrated in 
Table 5. EPA began drafting the PM Criteria Document\9\, in the middle 
of 1994 Recent Criteria Documents have become mammoth undertakings. The 
first PM Criteria Document,\10\ published in 1969, summarized the 
relevant science in 220 pages. The final version of the present 
Criteria Document is a three volume set containing over 2400 pages.
    The Staff Paper\11\ (Staff Paper) contains the Agency's 
recommendations for the range and form of the NAAQS along with 
justifications that are drawn from material contained in the Criteria 
Document. In the past, the CASAC review of a Criteria Document was 
completed before the Staff Paper was written so that the Staff Paper 
would reflect the science contained in the final Criteria Document (an 
exception to this was the recent ozone review\1\). The reviews of both 
the Criteria Document and Staff Paper are iterative processes that 
usually involve two to three revisions to both of the documents before 
CASAC reaches closure, and, in the past, the entire process took 
several years to complete. However, this review was on an accelerated 
schedule because of a court order resulting from a lawsuit filed by the 
American Lung Association (ALA).
    In February 1994, the ALA filed a suit to compel EPA to complete 
the PM review by December 1995. The U.S. District Court for the 
District of Arizona\12\ subsequently ordered EPA to complete its review 
and propose any revision in the Federal Register by June 30, 1996 with 
final promulgation by January 31, 1997. In addition, the Court adopted 
EPA's projection that the CASAC review of the Criteria Document should 
be completed by the end of August 1995. Further, the Court ordered EPA 
to complete a first draft of the Staff Paper by June 1995 and gave 
CASAC 3 months to complete its review of the Staff Paper. In addition, 
the Court stated: ``The Court excludes from its revised schedule, the 
EPA's provisions for interim CASAC review of various Criteria Document 
and Staff Paper drafts, including participation by CASAC in the 
development of methodologies for assessment of exposure/risk 
analyses.'' As you will see below, however, the review did deviate 
somewhat from this schedule.
    The CASAC Panel members met to discuss the draft of the Criteria 
Document on August 34, 1995, but they could not come to closure. The 
panel felt that the Criteria Document required extensive revisions and 
recommended that it be given the opportunity to review the revised 
draft.\13\ As a result, both EPA and the ALA petitioned the Court and 
were granted an extension allowing CASAC until January 5, 1996 to 
complete its review of the Criteria Document and Staff Paper. CASAC met 
again on December 14-15, 1995 to review the revised draft of the 
Criteria Document and the first draft of the Staff Paper. Again the 
Panel concluded that the Criteria Document did ``not provide an 
adequate review of the available scientific data and relevant studies 
of PM,'' and could not come to closure on either the Criteria Document 
or the Staff Paper.\14\ Again, both EPA and the ALA petitioned the 
Court and were granted an extension allowing CASAC until March 15, 1996 
to complete its review of the Criteria Document and June 15, 1996 to 
complete it review of a revised Staff Paper. At a February 29, 1996, 
the CASAC Panel succumbed to the pressures exerted by the accelerated 
schedule and reluctantly came to closure on the Criteria Document. I 
say reluctantly because in the closure letters it was stated that ``a 
number of members have expressed concern that since we are closing on 
the Criteria Document before we will be able to see the revised 
version, we have no assurance that our comments will be incorporated.'' 
Nevertheless, the Panel closed on the Criteria Document on March 15, 
1996.
    On May 16 and 17, the Panel met for the final time to review the 
revised Staff Paper, and came to closure\16\. The details of this 
review and the CASAC recommendations will be discussed shortly
                      history of the pm standards
    The history of the PM standards is summarized in Table 6. In 1971, 
EPA set annual average and 24-hour NAAQS for total suspended 
particulates (TSP). Total suspended particulates consisted of any PM 
that was collected on the filter of a high volume sampler operating 
within certain EPA specifications. The upper size captured by the high 
volume sampler varied with wind speed and wind direction but was 
generally limited to PM with diameters less than 40 m (the 
width of a human hair is about 70 m). Between 1971 and 1987, 
it was realized that the most important PM, from a health perspective, 
were those that deposited in the deep lung (tracheobronchial or 
pulmonary) region of the of the respiratory system. Maximum PM 
penetration to the deep lung region occurs during oronasal (combined 
nose/mouth breathing) or mouth breathing and deposition is restricted 
to those PM equal to or less than 10 m in diameter. In nasal 
breathing, deep lung deposition is limited to particles less than or 
equal to about 1 m in diameter. Consequently, in 1987, EPA 
replaced the TSP NAAQS with 24-hour and annual PM10 NAAQS 
where PM10 refers to those particles that are equal to or 
less than 10 m in diameter. Operationally PM10 is 
defined by the Federal Reference method and sampler. In terms of 
sampler collection efficiency, the 10 m cut point represents 
the size of the particle that is collected with a 50% collection 
efficiency.
    The PM NAAQS is the only NAAQS that is not chemically specific 
although it is understood that the toxicity of individual particles are 
not equal. Furthermore, it is understood that the potential for 
biological responses varies with particle size. As mentioned above, for 
normal nasal breathing, the particle sizes of concern are generally 1 
m in diameter or less, while for oronasal breathing, particles 
equal to or less than 10 m in diameter are of concern. In 
addition, the sources of the fine particles (PM1.0 or 
PM2.5) are generally different from the sources of the 
coarser particles (particles greater than or equal to 2.5 m in 
diameter. For example particles less than 2.5 m in diameter 
are formed primarily by combustion or secondary chemical reactions in 
the atmosphere whereas particles greater than or equal to 2.5 
m in diameter are formed primarily by mechanical processes 
(construction, demolition, unpaved roads, wind erosion, etc.) For these 
reasons, many have felt that fine and coarse particles should be 
treated as separate pollutants because different control strategies are 
required to address both size ranges. This logic and the health effects 
discussed below are what lead EPA staff to recommend the separate 
PM2.5 and PM10 NAAQS listed in Table 6.
    The proposed PM2.5 NAAQS is considerably more stringent 
than the existing PM10 NAAQS. Based on 1993-95 
PM10 data, there are 41 U.S. counties with monitors not 
meeting either the annual or 24-hr PM10 NAAQS. Under the new 
PM2.5 NAAQS proposals, it is estimated that the 
nonattainment counties would be about 170. However, there are two 
caveats. First, very few places have PM2.5 monitors. 
Consequently PM2.5 data are estimated. The PM2.5 
concentrations were estimated for all counties with PM10 
samplers by multiplying the relatively abundant PM10 data by 
ratios derived from a much more limited PM2.5/
PM10 data base. Second, these estimates only include 
counties with PM10 monitors. It is likely, that there will 
be significant numbers of counties currently without monitors that will 
eventually be found to be out of attainment. As a consequence, the 
actual number of PM nonattainment areas will be substantially higher 
than EPA's estimates.
           pm health effect studies: results and implications
    Although individual PM health effect studies have focused on a 
variety of endpoints, for obvious reasons the epidemiology studies that 
focused on human mortality were the primary focus of this review. 
Consequently, we will only discuss these studies.
    There were two types of PM-mortality studies cited by EPA. The 
first were the short-term, acute mortality studies which compared the 
daily PM and mortality time series in a dozen or so locations around 
the US. After filtering out or accounting for the effects of such 
things as seasonality, day of the week, meteorology, etc. on mortality, 
the remaining statistical relationship between daily PM and daily 
mortality was quantified. Although this relationship varied from 
location to location, the average value was a 4% increase in daily 
deaths for a 50 g/m3 increase in PM10 
concentrations.
    The second type of epidemiological study is the long-term 
prospective cohort studies where the health status of certain groups 
(cohorts) of individuals is followed for a number of years in various 
locations around the country. In these studies, the annual mortality 
rate in a given location is related to the annual average 
PM10 or PM2.5 concentrations after the mortality 
rates have been adjusted for smoking and some other potential 
confounding variables. Of the three studies reported in the literature, 
two show a positive relationship between annual mortality and PM and 
attribute two to three times the number of deaths to PM as the short-
term acute effect studies. The third study shows no PM-mortality 
relationship but EPA dismissed this study for a number of reasons 
including its lower statistical power (smaller sample size). EPA uses 
higher mortality estimates from the two studies to conclude that there 
are premature deaths due to chronic exposure to PM in addition to the 
deaths due to acute exposures identified in the time-series studies.
    In addition, EPA also concluded that the mortality was due to 
PM2.5 rather than the coarse fraction of the 
PM10. As will be discussed below, the evidence for this 
conclusion was ambiguous.
            casac's interpretation and recommendations on pm
    Table 4 summarizes the Panel members' recommendations concerning 
the forms and levels of the primary standards. Although some Panel 
members preferred to have a direct measurement of coarse mode PM 
(PM10-2.5) rather than using PM10 as a surrogate 
for it, there was a consensus that retaining an annual PM10 
NAAQS at the current level is reasonable at this time. A majority of 
the members recommended keeping the present 24-hour PM10 
NAAQS, although those commenting on the form of the standard strongly 
recommended that the form be changed to one that is more robust than 
the current standard to provide some insulation from the impacts of 
extreme meteorological events. Because of the acceptance that 
PM10-2.5 and PM2.5 are different pollutants, 
there was also a consensus that a new PM2.5 NAAQS be 
established, with 19 Panel members endorsing the concept of a 24-hour 
and/or an annual PM2.5 NAAQS. The remaining two Panel 
members did not think any PM2.5 NAAQS was justified. 
However, as indicated in Table 4, there was no consensus on the level, 
averaging time, or form of a PM2.5 NAAQS. At first 
examination of Table 4, the diversity of opinion is obvious and appears 
to defy further characterization. However, the opinions can be 
classified into several broad categories. Four Panel members supported 
specific ranges or levels within or toward the lower end of EPA staff's 
recommended ranges. Seven Panel members supported specific ranges or 
levels near, at, or above the upper end of staff's recommended ranges. 
Two members did not think a PM2.5 NAAQS was warranted at 
all. The remaining eight other Panel members endorsed the concept of a 
PM2.5 NAAQS, but declined to select a specific range or 
level. Consequently, only a minority of the Panel members supported a 
range that includes the present EPA proposals.
    However, most of the members who declined to recommend a range had 
caveats which appear as footnotes in Table 7. The caveats include: 
``recommends a more robust 24-hr. form,'' concerned upper range is too 
low based on national PM2.5/PM10 ratio,'' ``leans 
towards high end of EPA's proposed range,'' ``yes, but decision not 
based on epidemiological studies,'' ``low end of EPA's proposed range 
is inappropriate; desires levels selected to include areas for which 
there is broad public and technical agreement that they have 
PM2.5 pollution problems,'' ``only if EPA has confidence 
that reducing PM2.5 will indeed reduce the components of 
particles responsible for their adverse effects,'' and ``concerned 
lower end of range is too close to background.''
    The diversity of opinion expressed by the Panel members reflected 
the many unanswered questions and large uncertainties associated with 
establishing causality of the association between PM2.5 and 
mortality. Most Panel members were influenced, to varying degrees by 
these unanswered questions and uncertainties. The concerns include but 
are not limited to: (1) the influence of confounding variables, (2) 
measurement errors, (3) the existence of possible alternative 
explanations, (4) the lack of an understanding of toxicological 
mechanisms, (5) the fraction of the daily mortality that is advanced by 
a few days because of pollution, (6) exposure misclassification, (7) 
the shape of the dose-response function, and (8) the use of different 
models in all the studies. Let me expand on these issues.
    The first three concerns are related because they pertain to how 
certain we are that we have identified the correct causative agent. As 
mentioned earlier, PM10 and PM2.5 are not single 
chemical entities. They are composed of four or five major constituents 
and hundreds of trace constituents. Some have suggested that the 
causative agent could be some constituent of the PM rather than the 
total PM or total PM2.5 which would require a control 
strategy targeted at the causative constituent rather than at 
PM10 or PM2.5 in general. Also because many of 
the PM constituents are highly correlated (also with some of the 
gaseous pollutants as well), the regression methodologies used to 
determine association, tend to select those variable with the smallest 
measurement error. For example, PM2.5 and PM10 
are measured much more precisely than the coarse fraction of the 
PM10 (PM10-2.5). Consequently, the slightly 
higher relative risk calculated from the statistical models for 
PM2.5 (versus PM10-2.5) is not proof that 
PM10-2.5 is not the causative agent. Finally, several 
studies including some of the recent reanalyses of original studies 
have included gaseous criteria pollutants in their model and discovered 
that in many cases ozone, sulfur dioxide or carbon monoxide can be as 
important, and in some cases, more important than PM in describing the 
mortality. When the data bases are segregated by season, even more 
confusing results occur as different pollutants are identified for each 
season as being the apparent causative agent. This has led some to 
conclude that it is overall air pollution that is causing the excess 
mortality and that PM is just a surrogate measure. If that is the case, 
it does not necessarily follow that reducing the concentrations of a 
surrogate will result in reduced mortality.
    The fourth issue of concern has caused several of the Panel 
members, including one of the chest physicians to state that there is 
no biologically plausible mechanism that could explain the apparent 
relationship between acute mortality and PM at concentrations that are 
a fraction of the present PM10 NAAQS. This has lead some to 
postulate that the acute mortality is actually a``harvesting'' effect. 
That is, individuals who are terminally ill die somewhat prematurely 
due to the additional stress caused by PM or overall air pollution. 
While this may explain some or most of the acute deaths, it can not 
explain the apparent long-term, chronic deaths attributed to annual PM 
concentrations in the prospective cohort studies. These prospective 
cohort studies suggest that the acute mortality only account for about 
a third to a half of the total deaths attributed to PM. However, all or 
most of this discrepancy vanishes when additional potentially 
confounding variables are included in the cohort studies and historical 
or cumulative rather than concurrent air pollution exposures are 
considered.
    The exposure misclassification concern revolves around the validity 
of the assumption made in all of the acute studies that daily ambient 
PM data collected from a centrally located air monitoring site is 
representative of personal exposure to PM. Results from studies which 
examined this assumption are ambiguous. The shape of the dose-response 
function is also a concern. Because of measurement errors, the present 
statistical methodologies are incapable of detecting the existence of a 
possible threshold concentration below which acute mortality would not 
occur. Finally, there is some concern because the statistical models 
used in the various geographical areas are different. At different 
sites, different combinations of variables, averaging times, methods 
for accounting for seasonality and meteorology, and lag times have been 
used to produce the reported PM-mortality relationships.
    The lack of consensus on many of these issues can be partially 
attributed to the accelerated review schedule. The deadlines did not 
allow adequate time to analyze, integrate, interpret, and debate the 
available data on this very complex issue. Nor did the court-ordered 
schedule recognize that achieving the goal of a scientifically 
defensible NAAQS for PM may require iterative steps to be taken in 
which new data are acquired to fill obvious and critical voids in our 
knowledge. The previous PM NAAQS review took 8 years to complete.
    The Panel was unanimous, however, in its desire to avoid a similar 
situation when the next PM NAAQS review cycle is under way by a future 
CASAC Panel. CASAC strongly recommended that EPA immediately implement 
a targeted research program to address these unanswered questions and 
uncertainties. It is also essential that long-term PM2.5 
measurements are obtained. CASAC volunteered to assist EPA in the 
development of a comprehensive research plan that will address the 
questions which need answers before the next PM review cycle is 
completed.
                              perspective
    Since PM10 measurements became widespread in 1988, 
significant and continuous declines in ambient PM10 
concentrations have been observed throughout the U.S. Nationwide 
PM10 concentrations have declined 22% from 1988 to 1995.\17\ 
The reason for this decline is because of the implementation of 
existing control programs required by the 1990 Clean Air Act Amendments 
that target PM2.5 precursors (VOCs, NOx, and 
SO2), diesel PM emissions and other primary emission 
sources. This trend will continue for the foreseeable future as 
additional measures required by the Amendments are phased in. 
Consequently, there is time to conduct the research recommended by 
CASAC which targets the concerns discussed above. Then appropriate 
PM2.5 NAAQS could be established.
                               references
    \1\ Yosie, T.F. ``The EPA Science Advisory Board,'' Environ. Sci. 
Technol. 1993, 27, 1476-1481.
    \2\ U.S. EPA Science Advisory Board. ``Science Advisory Board FY 
1995 Annual Staff Report,'' EPA-SAB-96-001, U.S. EPA, Washington, DC, 
April 1996.
    \3\ Lippmann M. ``Role of science advisory groups in establishing 
standards for ambient air pollutants,'' Aerosol Sci. Technol. 1987, 6, 
93-114.
    \4\ Public Health Service. ``Air Quality Criteria for Photochemical 
Oxidants,'' U.S. Dept. Health, Education, and Welfare, Washington, DC, 
March 1970.
    \5\ U.S. EPA Office of Research and Development. ``Air Quality 
Criteria for Ozone and Related Photochemical Oxidants,'' EPA/600/AP-93/
004a-c, U.S. EPA, Washington, DC, February 1995.
    \6\ U.S. EPA Office of Air Quality Planning and Standards. ``Review 
of National Ambient Air Quality Standards for Ozone Assessment of 
Scientific and Technical Information OAQPS Staff Paper,'' U.S. EPA, 
Durham, NC, June 1996.
    \7\ Wolff, G.T. ``CASAC Closure on the Air Quality Criteria for 
Ozone and Related Photochemical Oxidants,'' EPA-SAB-CASAC-LTR-96-001, 
U.S. EPA, Washington, DC, November 1995.
    \8\ Wolff, G.T. ``CASAC Closure on the Primary Portion of the Staff 
Paper for Ozone,'' EPA-SAB-CASAC-LTR-96-002, U.S. EPA, Washington, DC, 
November 1995.
    \9\ U.S. EPA Office of Research and Development. ``Air Quality 
Criteria for Particulate Matter,'' EPA/600/P-95/001aF-cF, U.S. EPA, 
Washington, DC, April 1996.
    \10\ Public Health Service. ``Air Quality Criteria for Particulate 
Matter,'' U.S. Dept. Health, Education, and Welfare, Washington, DC, 
January 1969.
    \11\ U.S. EPA Office of Air Quality Planning and Standards. 
``Review of National Ambient Air Quality Standards for Particulate 
Matter, Policy Assessment of Scientific and Technical Information, 
OAQPS Staff Paper,'' EPA-452/R-96-013, U.S. EPA, Research Triangle 
Park, NC, July 1996.
    \12\ American Lung Ass'n v. Browner, 884 F. Supp. 345 (D. Ariz. 
1994).
    \13\ Wolff, G.T. ``Clean Air Scientific Advisory Committee (CASAC) 
Comments on the April 1995 draft Air Quality Criteria for Particulate 
Matter,'' EPA-SAB-CASAC-LTR95-005, U.S. EPA, Washington, DC, August 31, 
1995.
    \14\ Wolff, G.T. ``Clean Air Scientific Advisory Committee (CASAC) 
Comments on the November 1995 Drafts of the Air Quality Criteria for 
Particulate Matter and the Review of National Ambient Air Quality 
Standards for Particulate Matter: Policy Assessment of Scientific and 
Technical Information (OAQPS Staff Paper),'' EPA-SAB-CASAC-LTR-96-003, 
U.S. EPA, Washington, DC, January 5, 1996.
    \15\ Wolff, G.T. ``Closure by the Clear Air Scientific Advisory 
Committee (CASAC) on the Draft Air Quality Criteria for Particulate 
Matter,'' EPA-SAB-CASAC-LTR-96-005, U.S. EPA, Washington, DC, March 15, 
1996.
    \16\ Wolff, G.T. ``Closure by the Clean Air Scientific Advisory 
Committee (CASAC) on the Staff Paper for Particulate Matter,'' EPA-SAB-
CASAC-LTR-96-008, U.S. EPA, Washington, DC, June 13, 1996.
    \17\ U.S. EPA Office of Air Quality Planning and Standards. ``Air 
Quality Trends,'' EPA454/F-95-003, U.S. EPA, Research Triangle Park, 
NC, September, 1995.
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                      U.S. Environmental Protection Agency,
                                 Washington, DC, November 30, 1995.

EPA-SAB-CASAC-LTR-96-002

Hon. Carol M. Browner, Administrator,
U.S. Environmental Protection Agency,
401 M. Street, SW., Washington, DC 20460.

RE: CASAC Closure on the Primary Standard Portion of the Staff Paper 
for Ozone

    Dear Ms. Browner: A Panel of the Clean Air Scientific Advisory 
Committee (CASAC) of EPA's Science Advisory Board (SAB) met on March 
22, 1995, to review a draft of the primary standard part of the 
document entitled Review of National Ambient Air Quality Standards for 
Ozone Assessment of Scientific and Technical Information OAQPS Staff 
Paper. At that time, a draft of the secondary standard portion of the 
document was not completed. At the March meeting, the Panel made 
extensive recommendations for strengthening the document. In August 
1995, a revised Staff Paper, which included a first draft of the 
secondary standard portion was sent to CASAC panel members for review. 
On September 19 and 20, 1995, the Panel met to complete this review. 
The Panel members' comments reflect their satisfaction with the 
improvements made in the scientific quality and completeness of the 
primary standard portion of the Staff Paper. The changes made in that 
portion of the document are consistent with CASAC's recommendations. 
However, the Panel Members provided additional comments to your staff 
at the meeting and subsequently in writing. Although the Panel would 
like to have these comments considered for incorporation in the Staff 
Paper, the Panel did not feel that it was necessary to review another 
revised version and came to closure on the primary standard portion. It 
was the consensus of the Panel that although our understanding of the 
health effects of ozone is far from complete, the document provides an 
adequate scientific basis for making regulatory decisions concerning a 
primary ozone standard.
    The Panel could not come to closure, however, on the secondary 
standard portion of the Staff Paper which was a first draft. To 
facilitate further development of this part of the Staff Paper, the 
Panel members have provided detailed comments to your staff. The Panel 
felt that the suggested revisions were extensive enough to warrant a 
review of the next draft.
    I would like to summarize for you the Panel's recommendations 
concerning the primary standard. It was the consensus of the Panel that 
EPA's selection of ozone as the surrogate for controlling photochemical 
oxidants is correct. It was also the consensus of the Panel that an 8-
hour standard was more appropriate for a human health-based standard 
than a 1-hour standard. The Panel was in unanimous agreement that the 
present 1-hour standard be eliminated and replaced with an 8-hour 
standard.
    The Panel felt that the weight of the health effects evidence 
indicates that there is no threshold concentration for the onset of 
biological responses due to exposure to ozone above background 
concentrations. Based on information now available, it appears that 
ozone may elicit a continuum of biological responses down to background 
concentrations. This means that the paradigm of selecting a standard at 
the lowest-observable-effects-level and then providing an ``adequate 
margin of safety'' is no longer possible. It further means that EPA's 
risk assessments must play a central role in identifying an appropriate 
level.
    To conduct the risk assessments, the Agency had to identify the 
population at risk and the physiological responses of concern, develop 
a model to estimate the exposure of this population to ozone, and 
develop a model to estimate the probability of an adverse physiological 
response to the exposure. The Panel agrees with EPA that the selection 
of ``outdoor children'' and ``outdoor workers,'' particularly those 
with preexisting respiratory disease are the appropriate populations 
with the highest risks. After considerable debate, it was the consensus 
of the Panel that the Agency's criteria for the determination of an 
adverse physiological response was reasonable. Nevertheless, there was 
considerable concern that the criteria for grading physiological and 
clinical responses to ozone was confusing if not misleading. The Panel 
concurs with the Agency that the models selected to estimate exposure 
and risk are appropriate models. However, because of the myriad of 
assumptions that are made to estimate population exposure and risk, 
large uncertainties exist in these estimates.
    The results of two of the risk analyses are presented in Tables VI-
1 and VI-2 in the Staff Paper and are reproduced in the attached 
tables. The ranges of the risk estimates across nine cities for outdoor 
children are presented in Table VI-1. Because of the large number of 
stochastic variables used in the exposure models, the exposure 
estimates vary from run to run. However, the ranges are not reflective 
of all of the uncertainties associated with the numerous assumptions 
that were made to develop the estimates.
    The single estimates presented in Table VI-2 do not reflect any of 
the uncertainties associated with these estimates. (Table VI-2 contains 
only the estimated hospital admissions due to asthma which account for 
over 85 percent of the estimated total hospital admissions due to ozone 
exposure). These uncertainties need to be explicitly articulated in 
order to put the estimates in proper perspective. Nevertheless, based 
on the results presented in these and other similar tables presented in 
the Staff Paper, the Panel concluded that there is no ``bright line'' 
which distinguishes any of the proposed standards (either the level or 
the number of allowable exceedences) as being significantly more 
protective of public health. For example, the differences in the 
percent of outdoor children (Table VI-1) responding between the present 
standard and the most stringent proposal (8H1EX at 0.07 ppm) are small 
and their ranges overlap for all health endpoints. In Table VI-2, the 
estimates in row 1, which appeared in the draft Staff Paper, suggest 
considerable differences between the several options. However, when 
ozone-aggravated asthma admissions are compared to total asthma 
admissions (rows 5 and 6), the differences between the various options 
are small. Consequently, the selection of a specific level and number 
of allowable exceedences is a policy judgment. Although it was the 
consensus of the Panel that the ranges of concentrations and allowable 
exceedences proposed by the Agency were appropriate, a number of Panel 
members expressed ``personal'' preferences for the level and number of 
allowable exceedences. Of the ten panel members who expressed their 
opinions, all ten favored multiple allowable exceedences, three favored 
a level of 0.08 ppm, one favored the mid to upper range (0.08-0.09 
ppm), three favored the upper range (0.09 ppm), one favored a 0.009-
0.10 ppm range with health advisories issued when the 8-hour ozone 
concentration was forecasted to exceed 0.007 ppm, and two just endorsed 
the range presented by the Agency as appropriate and stated that the 
selection should be a policy decision. The members who favored the low 
numbers expressed concern over the evidence for chronic deep lung 
inflammation from the controlled human and animal exposure studies and 
the observations of pain on deep inspiration in some subjects.
    Because there is no apparent threshold for responses and no 
``bright line'' in the risk assessment, a number of panel members 
recommended that an expanded air pollution warning system be initiated 
so that sensitive individuals can take appropriate ``exposure 
avoidance'' behavior. Since many areas of the country already have an 
infrastructure in place to designate ``ozone action days'' when 
voluntary emission reduction measures are put in place, this idea may 
be fairly easy to implement.
    It was also the consensus of the Panel that the form of the 8-hour 
standard be more robust than the present 1-hour standard. The present 
standard is based on an extreme value statistic which is significantly 
dependent on stochastic processes such as extreme meteorological 
conditions. The result is that areas which are near attainment will 
randomly flip in and out of compliance. A more robust, concentration-
based form will minimize the ``flip-flops,'' and provide some 
insulation from the impacts of extreme meteorological events. The Panel 
also endorses the staff recommendation for creating a ``too close to 
call'' category.
    Since the last ozone NAAQS review, the scientific community has 
made great strides in their understanding of the health effects of 
ozone exposure because of ongoing research programs. Panel members were 
very impressed with how much more we understand now as compared to the 
prior round. Nevertheless, there are still many gaps in our knowledge 
and large uncertainties in many of the assessments. For example, there 
is little information available on the frequency of human activity 
patterns involving outdoor physical exercise. Little is also known 
about the possible chronic health impacts of ozone exposure over a 
period of many years. In addition, there is no clear understanding of 
the significance of the inflammatory response inferred from the 
broncholavage data. Panel members stated, however, that the scientific 
community is now in a position to frame the questions that need to be 
better resolved so the uncertainties can be reduced before the next 
ozone review in 5 years. For this reason, it is important that research 
efforts on the health and ecological effects of ozone not be reduced 
because we have come to closure on this review.
    CASAC would appreciate being kept informed of progress on 
establishing a revised or new ozone standard, and plans for research on 
ozone effects. Please do not hesitate to contact me if CASAC can be of 
further assistance in this matter. We look forward to receiving the 
revisions of the secondary standard portion of the Staff Paper.
            Sincerely,
                                       Dr. George T. Wolff,
                    Chair, Clean Air Scientific Advisory Committee.
                                 ______
                                 
Response of Dr. Wolff to an Additional Question from Senator Hutchinson
    Question. Dr. Wolff, please explain the differences between your 
recommendation for a PM standard and the EPA's proposed standard?
    Response. The decision to propose a PM2.5 is consistent 
with the advice CASAC gave to EPA. However, CASAC panel members could 
come to no consensus on the appropriate ranges or levels for 
PM2.5 standards.
    The 21 members of the CASAC PM review panel expressed a tremendous 
diversity of opinion and this is documented in the attached Table that 
is reproduced from CASAC's closure report that was sent to the EPA 
Administrator. The Table was also included in my written comments to 
the Subcommittee. Pertaining to the 24-hour PM2.5 NAAQS, 
only five members recommended a range which included 50 g/
m3 or lower. Four members recommended greater than or equal 
to the top of EPA's range. Four members did not recommend a 24-hour 
NAAQS. The remaining seven members merely endorsed the concept of a 24-
hour PM2.5 NAAQS, but declined to select a value or range. 
Also note from the Table that the diversity of opinion was exhibited by 
the health experts as well as the non-health experts. Clearly, this is 
not an endorsement of a 50 /m3 standard.
    For the annual standard, only two members favored a range that went 
as low as 15 g/m3. Two members favored 20 
g/m3; one chose 20-30 g/m3; two 
chose 25-30 g/m3; and eight did not think an annual 
PM2.5 NAAQS was needed. The remaining six members merely 
endorsed the concept of an annual standard but declined to select a 
value or range. This is not an endorsement of an annual 
PM2.5 NAAQS of is g/m3.
[GRAPHIC] [TIFF OMITTED] TH050P1.103

   Responses by Dr. Wolff to Additional Questions from Senator Boxer

    Question 1a. After its review of the science, did CASAC 
make a determination that there is an adequate scientific basis 
for the Administrator to revise the standards?
    Response. No. CASAC's closure on the Staff Papers simply 
means that the Panels felt that the documents provided an 
adequate scientific basis for making regulatory decisions 
concerning standards. For ozone, the Panel concluded: ``there 
is no `bright line' which distinguishes any of the proposed 
standards (either the level or the number of allowable 
exceedences) as being significantly more protective of public 
health.'' For PM2.5, there was no agreement among 
the Panel members on the level or form of the standard.

    Question 1b. For both ozone and particulates, did CASAC 
approve the EPA documents and the recommended specific ranges 
for new more stringent standards?
    Response. CASAC came to closure on both Criteria Documents 
and Staff Papers. Closure on a Criteria Document simply means 
that CASAC is satisfied that the document provides an adequate 
review of the available scientific data and relevant studies. 
Closure on the Staff Papers means that CASAC is satisfied that 
the document will provide an adequate summary of our present 
understanding of the scientific basis for making regulatory 
decisions concerning the standards. It is not an endorsement of 
EPA's recommendations or the arguments used by EPA to support 
their recommendations.
    For ozone, the Panel did not recommend a more stringent 
standard. ``It was the consensus of the Panel that the ranges 
of concentrations and allowable exceedences proposed by the 
Agency were appropriate,'' but this is not an endorsement for a 
``more stringent standard'' because the range includes 0.09 ppm 
with five allowable exceedances which is less stringent than 
the present 1-hour standard.
    For PM, CASAC did not endorse EPA's recommended range. The 
21 members of the CASAC PM review panel expressed a tremendous 
diversity of opinion and this is documented in the attached 
Table that is reproduced from CASAC's closure report. The Table 
was also included in my written comments to the Subcommittee. 
Pertaining to the 24-hour PM2.5 NAAQS, only five 
members recommended a range that was within EPA's recommended 
range. Four members recommended greater than or equal to the 
top of EPA's range. Four members did not recommend a 24-hour 
NAAQS. The remaining seven members merely endorsed the concept 
of a 24-hour PM2.5 NAAQS, but declined to select a 
value or range (see footnote 2 in the Table). Also note from 
the Table that the diversity of opinion was exhibited by the 
health experts as well as the non-health experts. Clearly, this 
was not an endorsement of EPA's recommended range.
    For the annual standard, four members favored a range or 
value that was within EPA's recommended range. Three members 
favored a higher range and eight did not think an annual 
PM2.5 NAAQS was needed. The remaining six members 
merely endorsed the concept of an annual standard but declined 
to select a value or range. Again, note from the Table that the 
diversity of opinion was exhibited by the health experts as 
well as the non-health experts. Clearly, this also was not an 
endorsement of EPA's recommended range.

    Question 1c. Did CASAC unanimously support moving to an 8-
hour standard for ozone?
    Response. Yes, but this is not an endorsement of a more 
stringent standard.

    Question 1d. Did 19 of 21 CASAC members support moving to a 
fine particulate standard for particulates?
    Response. Yes, but there was no agreement on the level or 
the form of the standard. Those who recommended a level near, 
at, or above EPA's recommended range did so as a means of 
distinguishing between coarse and fine particles in order to 
facilitate research and data collection.

    Question 2. Scientific studies show that healthy adults can 
suffer a temporary loss of lung function of 20 to 60 percent if 
they exercise outside during summer months. In face of this 
evidence, industry representatives claim this is not a health 
effect because it is a temporary and reversible effect. What in 
your personal view, is a health effect?
    Response. The ozone Staff Paper closure letter on page 2 
states: ``After considerable debate, it was the consensus of 
the Panel that the Agency's criteria for the determination of 
an adverse physiological response was reasonable.'' For the 
FEV1.0 lung function test referred to in the 
question, the criteria for being adverse were a 20 percent 
decrease in performance for a healthy individual and a 15 
percent performance decrease for anyone with preexisting 
respiratory illness.
    I am not a physician, so I do not have a personal view.

    Question 3. Some people have suggested that EPA not make 
regulatory decisions unless all the raw data that forms the 
basis of the studies supporting that decision are made publicly 
available. Why should industry be able to obtain access to data 
gathered by public health researchers in order to challenge the 
results, but withhold their own data to public scrutiny?
    Response. This is an important issue. There have been a 
number of studies where researchers have tried to reconstruct 
the original investigators' results, but since the original 
investigators' data are unavailable there is no way to be sure 
the data sets are the same. Nevertheless, these reanalyses 
show, in general, that the original investigators' results can 
be replicated only if an identical model and identical 
assumption are used. Using what the new investigators call 
equally plausible models and assumptions, the PM/mortality 
relationship vanishes. Two of these re-analyses by the Health 
Effects Institute and an EPA-funded study by the National 
Institute for Statistical Sciences question the validity of a 
PM/mortality relationship at concentrations below the standard. 
Therefore it is important for independent investigators to be 
able to re-analyze original data sets.
    In general, most of the data sets can be reasonably 
reconstructed because the mortality, pollution, and 
meteorological data are publicly available. One exception to 
this is the Harvard Six City study which EPA has relied upon 
heavily.
    As far as I am aware, all of the PM epidemiological data 
bases compiled by industry-funding are available to anyone who 
requests them.

    Question 4a. You spent 20 years working for GM is that 
correct?
    Response. Yes. I spent 16 years as an atmospheric science 
researcher for General Motors Research Laboratories before 
becoming chair of CASAC. Prior to that, I was employed by an 
environmental control agency.

    Question 4b. The auto industry has been a major source of 
air pollution for both vehicles and the automotive plants 
themselves--is that correct?
    Response. Yes.

    Question 4c. General Motors and the auto industry have 
historically opposed emission controls. Over the past 4 years 
of CASAC's reviews of the clean air standards have you had 
discussions with anyone in GM or the auto industry about the 
proposed ozone or PM standards?
    Response. GM management and I mutually agreed that I would 
not participate in GM's or AAMA's discussions and activities 
regarding the PM and ozone standards.

    Question 4d. Do you think GM or the industry would be 
adversely affected by a revised ozone or PM standard?
    Response. If the proposed standards are adopted, states 
will need to find significant additional emission reductions. 
All sources that are targeted by a state for additional 
reductions will likely be adversely affected.

    Question 4e. Is it not true that last fall you had a 
briefing for certain selected reporters on this subject held at 
the American Automobile Manufacturers Association offices? In 
that case--were you speaking on behalf of the auto 
manufacturers or on behalf of CASAC?
    Response. As chair of CASAC, the American Automobile 
Manufacturers Association asked me to brief these reporters on 
what was in the CASAC closure letters.

    Question 5. Do your views and assertions reflect the views 
of CASAC as a whole?
    Response. When asked to speak for CASAC, as I have been at 
these hearings, I have an obligation to my colleagues on CASAC 
to portray their views accurately. I try to accurately portray 
the issues where we reached consensus and accurately portray 
the diversity of opinion that CASAC expressed on other issues. 
Consequently, I feel the views and assertions that I make in 
these presentations do reflect those of the CASAC members.

    Question 6. You have said that in the case of ozone, there 
is no statistically significant difference in public health 
risk between the current ozone standard (0.12 ppm over a 1-hour 
period) and the most stringent ozone standard of the range 
recommended by CASAC (0.07 ppm over an 8-hour period). 
According to EPA, there is a statistically significant 
difference which although small, represents tens of thousands 
of people at risk.
    What kind of health effects would there be less of at the 
more stringent 0.07 ppm standard--and why do you believe that 
they are not significant?
    Response. In the closure report to the EPA Administrator, 
CASAC concluded that: ``the weight of the health effects 
evidence indicates that there is no threshold concentration for 
the onset of biological responses due to exposure to ozone 
above background concentrations.'' CASAC then reviewed EPA's 
quantitative risk assessments. Although EPA's analysis showed 
differences among the various standard levels, CASAC stated 
that: ``the ranges are not reflective of all of the 
uncertainties associated with the numerous assumptions that 
were made to develop the estimates.'' As a result CASAC 
concluded: ``there is no `bright line' which distinguishes any 
of the proposed standards (either the level or the number of 
allowable exceedences) as being significantly more protective 
of public health.'' They further state: ``Consequently, the 
selection of a specific level and number of allowable 
exceedences is a policy judgment.'' This means that CASAC felt 
there would not be any demonstrable decrease in the health 
effect endpoints between the two standards.
[GRAPHIC] [TIFF OMITTED] TH050P1.107

 Responses of Dr. Wolff to Additional Questions from Senator Lieberman
    Question 1. The CASAC closure letter on the primary standard 
portion of the Staff Paper for ozone states, ``Although it was the 
consensus of the Panel that the range of concentrations and allowable 
exceedances proposed by the Agency were appropriate, a number of Panel 
members expressed ``personal'' preferences for the level and number of 
allowable exceedances. The Staff Paper proposed a range of 8-hour 
standard concentrations from 0.07 to 0.09 ppm. The Agency proposed to 
set the standard at 0.08 ppm. Isn't it correct that CASAC reached 
consensus that the range proposed by the EPA Staff for the ozone 
standard was appropriate and that the Administrator selected a level 
from within that range?
    Response. The answer is not that simple. One must consider our 
closure report as a whole. In the closure report to the EPA 
Administrator, CASAC concluded that: ``the weight of the health effects 
evidence indicates that there is no threshold concentration for the 
onset of biological responses due to exposure to ozone above background 
concentrations.'' CASAC then reviewed EPA's quantitative risk 
assessments. Although EPA's analysis showed differences among the 
various standard levels, CASAC stated that: ``the ranges are not 
reflective of all of the uncertainties associated with the numerous 
assumptions that were made to develop the estimates.'' As a result 
CASAC concluded: ``there is no ``bright line'' which distinguishes any 
of the proposed standards (either the level or the number of allowable 
exceedences) as being significantly more protective of public health.'' 
They further state: ``Consequently, the selection of a specific level 
and number of allowable exceedences is a policy judgment.'' This means 
that the decisions to select a given level or number of allowable 
exceedances within their proposed ranges cannot be based on science.

    Question 2. In addition to changing the level of the ozone 
standard, EPA changed the form of the standard to make compliance 
easier. Do you agree with EPA's changes in the form of the standard? 
When CASAC's members made their recommendations as to the level of the 
standard, did they take into account these changes in the form of the 
standard?
    Response. First of all the form was not changed to make compliance 
easier. CASAC recommended that the standard be changed to a more robust 
(stable) form so extreme and unusual meteorological events do not cause 
an area, which is close to meeting or has just attained the standard, 
to bounce in and out of attainment year after year. By making the 
standard more robust, it is easier to stay in attainment, but it is 
also more difficult to reach attainment. Even EPA's proposal is still 
not as robust as some of the members would have liked.
[GRAPHIC] [TIFF OMITTED] TH050P1.109

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[GRAPHIC] [TIFF OMITTED] TH050P1.111

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[GRAPHIC] [TIFF OMITTED] TH050P1.114

    Responses of Dr. Lippmann to Additional Questions from Senator 
                               Hutchison
    Question 1. Dr. Lippmann in your statement, you take a very strong 
position that EPA has appropriately synthesized the available evidence 
and drawn a responsible health conclusion that particulate 
concentrations at current levels are causally associated with excess 
mortality and morbidity. You go on to state that you are not claiming 
that the PM2.5 level is the causal agent but that it is the 
best measure of any other metric level. As we have determined, there 
was no unanimous agreement on the particulate standard. Considering 
EPA's proposal completely, as I understand, the only unanimous 
agreement was in ozone, which was to replace the 1 hour exposure 
standard with an 8-hour standard.
    Response. With regard to the proposed PM2.5 standard, 19 
of 21 Panel members agreed that one was needed. The basis was that 
there was a closer association between PM2.5 and excess 
mortality and morbidity than with any other previously used measures of 
fine particle concentration. We do not yet have sufficient monitoring 
data on the concentrations of PM2.5 components to determine 
whether any of them would produce even better degrees of association. 
If future research can establish better associations of this kind, then 
the fine particle standards to be established in the next century can 
be based on them.

    Question 2. If these standards are accepted, can you say 
definitively how quickly the effectiveness can be measured (such as a 
reduction in childhood asthma and mortality rates, due to respiratory 
diseases)?
    Response. With regard to the timeframe for being able to observe 
reductions in adverse health effects due to ozone and fine particles, 
no clear answer is possible at this time. One factor is the timetable 
for implementation of the revised standards. Benefits can only begin to 
occur after airborne concentrations actually come down. For those 
effects which result from periodic peak exposures, such as exacerbation 
of asthma, the frequency should go down in proportion to the reductions 
in exposure. On the other hand, for excess annual mortality and 
baseline reductions in lung capacity, which are attributable to long-
term chronic exposures and the damage they produce, there is likely to 
be a lag of several years, or even decades, before the rates improve.
                                 ______
                                 
 Responses of Dr. Lippmann to Additional Questions from Senator Baucus
    Question 1. You stated that it makes sense to set standards for 
ozone and PM2.5 at the same time. Could you explain why this 
is and what the advantages are of regulating ozone and PM2.5 
together?
    Response. With regard to the advantages of setting standards for 
ozone and PM2.5 at the same time, the main reason is that 
both pollutants are secondary pollutants that form in the atmosphere 
following chemical reactions among gaseous precursors. The gaseous 
precursers come from broadly distributed common sources, especially 
stationary source combusters and motor vehicles, and a common control 
strategy will be needed to reduce them. The photochemical reaction 
sequences that require hydrocarbon vapors, nitrogen dioxide, and 
sunlight lead to ozone formation also lead to the formation of organic 
fine particles and hydroxl ions. The hydroxl ions accelerate the 
transformation of sulfur dioxide and nitrogen oxide vapors from 
combusters into nitric and sulfuric acids and their neutralization 
products, which are also fine particles.

    Question 2. An issue was made over the relative risk factor for the 
PM2.5 studies--whether it was too low to support a 
sufficient degree of scientific certainty. Can you explain the use of 
the relative risk factor and how it applies to the PM2.5 
debate?
    Response. With regard to the relative risk (RR) factors obtained 
from the epidemiological studies based on PM2.5 and 
PM10, the relatively low RR values indicate that only a 
small fraction of the overall population has been affected. However, a 
very small fraction of a very large population can account for large 
numbers of affected people and a relatively large population impact in 
relation to other hazards associated with exposure via air, drinking 
water, foods, etc. Many of the macroepidemiological studies reporting 
RR values at about 1.05 were based on large city populations. Most of 
them indicate statistically significant exposure-response relationships 
and none of the suggested confounding factors has accounted for the 
generally consistent findings.
                                 ______
                                 
    Responses of Dr. Lippmann to Additional Questions from Senator 
                               Lieberman
    Question 1. One of the criticisms of the science of particulate 
matter is that when you look at results from particular cities and add 
different corrections for heat and humidity, or break up the analysis 
of a year's worth of data to look at a specific season or day, the data 
appear to contradict the results from earlier studies. What are the 
dangers of looking at only small portions of an entire data set? Is it 
reasonable that a small subset of the data might be contradictory while 
the weight of evidence suggests that there are severe consequences of 
particulate matter pollution? Has any reevaluation of epidemiological 
studies on particulate matter been performed that contradicts the 
earlier results?
    Response. With regard to the interpretation of diverse 
epidemiological studies in different cities, it is relatively easy to 
find apparent disagreements among the analysts. Some of it derives from 
the limited statistical power of some studies to detect an association 
that is real because of the quality or size of the available data 
bases. Other disagreements arise because of the different modelling 
choices made by the analyst. What is truly remarkable about the 
epidemiological studies with PM is their overwhelming consistency in 
finding small but significant excess risks in studies having the 
statistical power to detect such risks. Some of the analysts who want 
to negate such risks often segregate their data into smaller subsets 
which limits their analytic power, or they use less appropriate models 
or assumptions than the mainstream group of experienced analysts.

    Question 2. Isn't it correct that CASAC heard testimony from a wide 
range of scientists, including Dr. Smith and Dr. Wyzga, and still 
decided that the science was sufficient for EPA to make a regulatory 
decision on setting a standard for fine particles?
    Response. Drs. Smith and Wyzga had ample opportunity to present 
their analyses and findings to CASAC during the various public review 
sessions. They also had the opportunity to interact with the Panel and 
respond to the Panel members questions following their presentations. 
The CASAC consensus followed these discussions.

    Question 3. Did the CASAC panel on which you served in 1989 
conclude that the current ozone standard provides ``little, if any'' 
margin of safety?
    Response. The CASAC panel did, in fact, conclude in 1989, that the 
1-hr, 120 ppb, 1-exceedance standard for ozone provides ``little, if 
any'' margin of safety.

    Question 4. In addition to proposing a level of the 
PM2.5 standard, EPA proposed a form of the standard to make 
compliance easier. When CASAC's members made their recommendations, did 
they take into account these changes in the form of the standard? Is it 
possible to compare directly the personal preferences of CASAC members 
and the level of the standards EPA ultimately proposed?
    Response. When the CASAC members were asked by Dr. Wolff to express 
their personal preferences for a 24 hr PM2.5 standard, they 
had already reached a consensus judgment that a multiple exceedance 
form was desirable. However, they did not, nor could they, know that 
the Administrator would select a 98th percent form, i.e., permitting 7 
daily exceedances in an average year. I believe most members were 
thinking of 3 to 5 permissible exceedances. In any case, there is no 
great difference among these numbers of exceedances in stringency for a 
given numerical concentration limit.

    Question 5. Dr. Wyzga testified that a number of uncertainties make 
attribution of premature death and illness to particulate matter 
exposure difficult. Have you evaluated these issues? Could you comment 
on the nature of these uncertainties? In your view, do they prevent 
attributing premature death and illness to particulate matter 
pollution?
    Response. It is difficult to make a precise attribution of 
premature death and illness to PM because of our limited abilities to 
precisely characterize relevant PM exposures and to make appropriately 
allowances for other causes of mortality and morbidity in large 
populations. Thus, there is uncertainty about the extent of the 
response attributable to PM. On the other hand, the overwhelming 
consistency and coherance of the responses seen in numerous studies in 
cities having different climates and pollution mixtures leaves little 
doubt that PM is causing at least some substantial number of cases of 
excess mortality and morbidity at concentrations below the current 
standard.

    Question 6. Dr. Wyzga also testified that no one knows if the 
proposed particulate standards will lead to improvements in public 
health. What is your view of that conclusion?
    Response. It follows clearly that since current PM exposures are 
causing excess mortality and morbidity, and exhibit no evidence for a 
threshold for such effects, that the proposed standards, which provide 
for some reductions in permissible exposure will lead to proportionate 
improvements in public health.
                                 ______
                                 
  Responses of Dr. Lippmann to Additional Questions from Senator Boxer
    Question 1. Scientific studies show that healthy adults can suffer 
a temporary loss of lung function of 20 to 60 percent if they exercise 
outside during summer months. In the face of this evidence, industry 
representatives claim that this is not a health effect because it is a 
temporary and reversible effect. What in your personal view, is a 
health effect?
    Response. Temporary losses of lung function are a measurable effect 
in natural populations engaged in outdoor recreation at ozone 
concentrations as low as 0.06 ppm. In controlled ozone exposure studies 
at 0.08 ppm lasting 6.6 hours with moderate exercise, some healthy 
adults have function decrements that are greater than 20 percent and by 
common consent, and by CASAC endorsement, such decrements are 
considered adverse responses. Importantly, such chamber exposures also 
produce evidence of lung inflammation and enhanced responsiveness to 
bronchial airway stimulants. While the respiratory function responses 
are no longer detectable the next day, the other, potentially more 
serious responses do not disappear as rapidly. In asthmatic children 
exposed to ozone at a summer camp where concentrations were within the 
current standard, there were more symptoms and extra medication usage 
in proportion to the ozone concentration in the air, as well as reduced 
lung function. Such responses in these children with compromised health 
status is clearly an adverse effect.
    We also know that ozone, at low concentrations results in excess 
emergency room and hospital admissions for respiratory diseases 
conditions. Furthermore several recent papers, not available at the 
time of CASAC closure, document excess mortality associated with peak 
ozone exposures that is independent of PM effects on daily mortality.

    Question 2. Why does the bottom of the recommended range stop at 
0.07 parts per million of ozone? What are the health effects that 
influence your judgment?
    Response. The designation of 0.07 ppm as the lower bound of the 
range was based on the EPA Staff judgment that the effects remaining at 
that level were too small and/or affected too few people to warrant 
considering them adverse from a public health perspective.

    Question 3. On March 20 1996, you and three other members of the 
CASAC panel on Particulate Matter sent a letter to EPA Administrator 
Browner giving additional views on PM. Would you please briefly 
summarize that letter?
    Why did you write the letter? Do you believe that the four of you 
that signed that letter had any special expertise that other members of 
the CASAC panel; did not share?
    Response. The letter that you refer to is available in full as 
Appendix K of the EPA Staff Paper for Ozone. It is available to you in 
abbreviated form in my formal prepared remarks, which I submitted prior 
to the February 5 Hearing.
    We wrote the letter because of our concerns that the CASAC letter, 
which we endorsed as a summary consensus statement on key issues, did 
not provide all of the critical health effect issues and concerns in 
sufficient detail to guide the EPA Staff in the preparation of their 
final version of the Staff Paper. We felt that we, collectively, had 
more relevant direct experience on the interpretation of the air 
pollution epidemiology than most other members who were selected for 
expertise in areas such as ecological effects, meteorology, sampling 
and analyses, clinical medicine, etc.

    Question 4. Some industry experts say we should wait before we set 
a new PM2.5 standard until we conduct research to identify 
the exact causal agent In other words, determine exactly what component 
is causing the premature deaths and illness. Why should we not wait?
    Response. If we wait, we will deny protection against the known 
adverse effects that current exposures within the existing 
PM10 standards are producing. Also, we would not be moving 
against sources of fine particle precursor gases as effectively as we 
could if we have PM2.5 standards.

    Question 5. Industry asserts that human chamber studies of ozone 
are not representative of real exposures because artificially produced 
ozone is used and activities do not represent real world activities. 
Are these assertions correct?
    Response. To the extent that the chamber studies are unrealistic, 
it is because they tend to underestimate the effects produced by ozone 
in natural settings, and because they are largely conducted using 
populations that do not include representatives of the most sensitive 
subpopulations. In my own research on children and adults in natural 
settings, I have seen greater responses to ozone than those reported in 
the controlled exposures in chambers. Healthy children have greater 
functional responses than children in chambers. Many of the healthy 
adults engaged in lunchtime jogging or brisk walks in a rural setting 
self-selected exercise levels greater than those considered very high 
by chamber investigators and had functional decrements after half-hour 
exposures comparable to 2-hour exposures in chambers. In our studies of 
asthmatic camp children, we found comparable functional responses to 
healthy children but for lower breathing rates, and we also found 
asthma exacerbations in terms of more frequent symptoms and increased 
medication usage.

    Question 6. Industry discounts studies showing health effects of 
ozone on children in summer camp because they are exposed not only to 
ozone, but to other pollutants and allergens which may cause which may 
cause the adverse affects.
    Response. In the summer camp studies the children are also exposed 
to other pollutants and allergens. However, their functional responses 
to ozone are not measurably influenced by these other exposures and 
they go up and down with ozone concentrations. Thus, it is only by 
controlling ambient ozone levels that the effects can be reduced.
                                 ______
                                 
    Prepared Statement of Dr. George D. Thurston, Sc.D., Associate 
 Professor, Department of Environmental Medicine, New York University 
                           School of Medicine
    Mister Chairman and members of the Subcommittee, I am George D. 
Thurston, a tenured Associate 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 am also the Director of the National Institute of Environmental 
Health Sciences' (NIEHS) Community Outreach and Education Program at 
NYU. A goal of this program is to provide an impartial scientific 
resource on environmental health issues to decisionmakers, and that is 
my purpose in speaking to you here today.
    Ozone (O3) is a highly irritant gas which is formed in 
our atmosphere in the presence of sunlight from other air pollutants, 
including nitrogen oxides and hydrocarbons. These ``precursor'' 
pollutants, which cause the formation of ozone, are emitted by 
pollution sources including automobiles, electric power plants, and 
industry.
    The adverse health consequences of breathing ozone at levels below 
the current U.S. National Ambient Air Quality Standard (NAAQS) of 120 
parts per billion (ppb) are serious and well documented. This 
documentation includes impacts demonstrated in controlled chamber 
exposures of humans and animals, and observational epidemiology showing 
consistent associations between ozone and adverse impacts across a wide 
range of human health outcomes. The noxious nature of ozone is also 
evidenced by the way it visibly ``eats away'' at materials such as 
rubber, an elastic substance sharing characteristics with human lungs.
    Observational epidemiology studies have shown compelling and 
consistent evidence of adverse effects by ozone below the current U.S. 
standard. These 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. These epidemiologic studies 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 shown confirmatory 
associations between ozone 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 attacks;
     more frequent emergency department visits;
     additional hospital admissions, and;
     increased numbers of daily deaths.
    In my own research, I have found that ozone air pollution is 
associated with increased numbers of respiratory hospital admissions in 
New York City, Buffalo, NY, and Toronto, Ontario, even at levels below 
the current standard of 120 ppb. My ozone-hospital admissions results 
have been confirmed by other researchers considering locales elsewhere 
in the world. The U.S. EPA used my New York City asthma results in 
their ``Staff Paper'' when estimating the health benefits of lowering 
the ozone standard. However, they failed to consider other respiratory 
admissions affected, such as for pneumonia or bronchitis. Thus, 
considering the published results from various cities, the EPA analysis 
underpredicts the respiratory hospital admission benefits of their 
proposed regulations by about a factor of two.
    This month, the results of a study I conducted on the effects of 
air pollution on children at a summer ``asthma'' camp in Connecticut 
will be published. This study of a group of about 50 moderate to 
severely asthmatic children shows that these children experience 
diminished lung function, increased asthma symptoms, and increased use 
of unscheduled asthma medications as ozone pollution levels rise. On 
the highest ozone days, the risk of a child having an asthma attack was 
found to be approximately 40 percent greater than on an average study 
day, with these adverse effects extending to below 120 ppb 
O3.
    More recently, I have found that daily mortality also rises after 
high ozone days in the U.S. cities of New York City, Atlanta, Detroit, 
Chicago, St. Louis, Minneapolis, San Francisco, Los Angeles, and 
Houston, even after accounting for other factors such as season and 
weather, and at ozone levels below the current NAAQS. I find that the 
risk of death rises by about 6 percent on ozone days having a 1-hour 
maximum of ozone that is 100 ppb above the average. While not yet 
published, these U.S. results are supported by previously published 
results, and by a recent spate of new papers by other researchers 
showing similar associations between ozone an4 human mortality around 
the globe. Recently published studies have shown this relationship in: 
London, Amsterdam, and Belgium. In addition, papers recently submitted 
for publication have also shown similar associations between ozone 
exposure and human mortality in both Rotterdam, the Netherlands, and 
Brisbane, Australia.
    It is important to keep in mind that the above described 
epidemiology is supported by a large body of knowledge from controlled 
exposure studies that give consistent and/or supportive results, and 
that have demonstrated pathways by which ozone can damage the human 
body when it is breathed. Clinical studies have demonstrated 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 concentrations as low as 80 parts per billion for 6.6 hours.
    Airway inflammation in the lung is among the serious effects that 
have been demonstrated by controlled human studies of ozone at levels 
typically experienced by most Americans. Airway inflammation is 
especially a problem for children and adults with asthma, as it makes 
them more susceptible to having asthma attacks. For example, recent 
controlled human studies have shown that prior exposure to ozone 
enhances the reactivity of asthmatics to aeroallergens such as pollens, 
which can trigger asthma attacks.
    In addition, increased inflammation in the lungs can make the 
elderly more susceptible to pneumonia, a major cause of illness and 
death in this age group.
    It has been argued that, since the prevalence of asthma has risen 
over the last decade while air pollution levels have not, air pollution 
cannot be affecting asthma. However, this is not correct. This trend 
merely indicates that air pollution probably does not cause' people to 
become asthmatic, but it does not contradict the fact that air 
pollution adversely affects those who already have asthma. Indeed, as 
the asthma ``epidemic'' causes the number of persons with asthma to 
rise, whatever the cause of this ``epidemic'' turns out to be, there is 
a bigger and bigger percentage of the U.S. public who can be severely 
affected by air pollution.
    The EPA has proposed a standard of 80 ppb averaged over an 8-hour 
period, rather than the existing 120 ppb limit for the highest hour of 
each day. The switch to an 8-hour average is clearly appropriate, based 
on the scientific evidence that the cumulative effects of multiple 
hours of exposure are worse for people than a single peak hour of 
exposure. However, since significant adverse effects are well 
documented down to the 80 ppb level, the EPA proposal provides no 
margin of safety. This is especially true since the proposed law will 
allow several exceedances of this level before a violation is cited. 
Thus, the health evidence would indicate that a standard set at 70 ppb 
ozone averaged over an 8 hour period is needed, if any margin of safety 
is to be provided to she public, rather than the 80 ppb recommended by 
the EPA.
    On this subject, it is interesting to note what levels other 
deliberative bodies have recommended regarding permissible ozone 
levels. In Canada, the daily 1-hour maximum allowed is 80 ppb of ozone, 
which is roughly equivalent to an 8 hour limit of about 60 ppb ozone. 
In addition, The World Health Organization (WHO) recently released 
their ``Update and Revision of the Air Quality Guidelines for Europe'', 
and they similarly recommended an 8-hour average guideline of 60 ppb 
for ozone. Also, the American Conference of Governmental Industrial 
Hygienists (ACGIH) has recently proposed lowering the widely' employed 
workplace Threshold Limit Value--Time Weighted Average (TLV-TWA) limit 
for ozone to 50 ppb over an 8-hour work day for workers under heavy 
exertion. This would indicate that healthy American workers need to be 
protected from levels that would be perfectly legal for the rest of us 
to breathe under the US EPA's proposals. The EPA's new proposed ozone 
limit is weak when compared to standards set or recommended by others.
    It is also important to remember that the EPA proposed ozone 
standard is less' stringent than the O3 limit that prevailed 
in the U.S. during the 1970's, before the EPA decided to relax the 
limit to 120 ppb in February, 1979. Until that time, our standard was 
the same as the Canadians: 80 ppb ozone as a daily 1 hour maximum, or 
equivalent to about a limit of 60 ppb when averaged over 8 hours. Thus, 
while the EPA proposal is more stringent than the existing law, it is 
far less restrictive than the law of the land in the U.S. during the 
1970's.
    In conclusion, I would like to reiterate the key messages contained 
in the letter that I and 26 other air pollution researchers and 
physicians sent to President Clinton last month:
     Please listen to the medical and scientific community on 
this issue.
     Exposures to O3 and PM air pollution have been 
linked to medically significant adverse health effects.
     The current NAAQS for these pollutants are not 
sufficiently protective of public health.
    Thank you for the opportunity to speak to you on this important 
issue.
                                 ______
                                 
    Responses of Dr. Thurston to Additional Questions from Senator 
                               Lieberman
    Question 1a. Are hospital admissions the only indicator of adverse 
health effects due to ozone?
    Response. Looking only at the asthma hospital admissions effects of 
ozone gives an extremely narrow insight into the wide scope of adverse 
consequences presently experienced by the public as a result of ozone 
exposure. We know, from published research, that hospital admissions 
resulting from ambient ozone are near the tip of an ``iceberg'' of 
adverse health effects from ozone exposure. Beneath this ``visible'' 
tip of the iceberg are effects not routinely documented, such as 
emergency department visits, asthma attacks, emergency visits to 
private physicians, increased medication use, restricted activity days 
(e.g., work days lost), more frequent respiratory symptoms, diminished 
quality of life (e.g., due to reduced ability to walk up stairs, etc.), 
and other impacts of which we are as yet unaware. For example, as 
detailed later in this response, available studies indicate that, for 
every ozone induced asthma hospital admission recorded, there are 
another 7 persons who became ill enough because of ozone to require a 
visit to the hospital emergency department (ED), and some 700 asthma 
attacks because of ozone. Thus, it would be a serious mistake to think 
that counts of emergency hospital admissions resulting form ozone 
exposure even begin to reflect the much larger scope of the adverse 
human health effects and the medical costs presently being visited upon 
the American people by ozone exposures, especially among children and 
the elderly.
    For example, I recently conducted an epidemiologic study following 
approximately 55 children with moderate to severe asthma attending a 
summer ``asthma camp'' in eastern Connecticut (``Summertime Haze Air 
Pollution and Children with Asthma'', published in the American Journal 
of Respiratory and Critical Care Medicine. 1997. Vol. 155. pp. 654-
660). The results of this study showed that increasing numbers of these 
children experienced debilitating asthma attacks when ozone pollution 
levels increased, as displayed in the attached figure entitled, ``Daily 
Asthma Attacks in Children Increase as Ozone Levels Rise''. However, 
none of these children ended up at the hospital to be ``counted'' as 
hospital admissions. Thus, many asthmatics who suffer attacks just 
suffer in silence, or visit their private doctor, or visit a hospital 
emergency department. However, since they were never formally admitted 
to a hospital, we don't have the statistics to document their 
suffering, so that these impacts are ignored by risk assessments based 
solely on hospital admissions.
[GRAPHIC] [TIFF OMITTED] TH050P1.121

    Question 1b. What are the limitations of the U.S. EPA's 
risk assessment in this regard?
    Response. There are several problems associated with the 
EPA hospital admissions risk assessment discussed at this 
hearing: one has to do with the inherent limitations in all 
such risk assessments; one has to do specifically with EPA's 
narrow focus in this risk assessment case; and one has to do 
with the way the EPA risk assessment results are being used out 
of context.
    First, risk assessment is ultimately, a reductionist 
exercise which considers only the health outcomes and effects 
for which data happen to be available. In epidemiology, which 
provides a key input to risk assessment, we are largely limited 
to ``looking under the lamppost'' for effects. This is because 
the expense of collecting the data required to assess all of 
the potential effects are beyond the allocated research budgets 
of most or all funding sources. As a result, we often look at 
available routinely collected records, such as for mortality 
and hospital admissions. But even these data are limited. Most 
States have only recently started uniform collections of 
hospital admissions records, and many still do not. With 
mortality, the cause of death is poorly reported, and death 
counts are available by county, limiting our ability to conduct 
mortality studies focused on key population subsets or 
locations. More importantly, most of the health outcomes which 
should be considered by risk assessments are not, merely 
because data records for them just don't exist. Thus, the risk 
assessment process is fated to consistently underrepresent the 
scope of the health impacts resulting from environmental 
contaminants.
    In this specific risk assessment case, the EPA OAQPS Ozone 
Staff Paper (EPA-452/R-96-007) asthma hospital admissions risk 
assessment biases the scope of the ozone effects estimates 
downward further, because it presents only a subset of the 
adverse outcomes that we have documented as resulting from 
ozone exposure, and because the most relevant denominator has 
not been used in calculating percentages. Indeed, as I noted in 
my written and oral testimony, even for respiratory hospital 
admissions the numbers used by the EPA underestimate the 
expected ozone cleanup benefits by approximately a factor of 
two, as non-asthma respiratory admissions are ignored. 
Furthermore, there are, as noted above, many additional adverse 
outcomes experienced by the public as a result of ozone 
exposure that are not reflected by hospital admissions.
    Lastly, the EPA hospital admissions risk assessment numbers 
are now being used ``out of context'', which can be misleading. 
In the Staff Paper, it is clearly stated that the EPA risk 
assessment ``does not cover all health effects caused by 
O3 `` and that ``the risk assessment is intended as 
a tool that may, together with other information in this Staff 
Paper and in the CD, aid the Administrator in judging which 
alternative O3 NAAQS provides an adequate margin of 
safety.'' Thus, the original EPA risk assessment was not aimed 
at providing a complete picture of the reductions in effects of 
ozone to be achieved, and should not be interpreted in this 
way.

    Question 1c. Senator Chafee showed you a chart at the 
hearing concerning reductions in hospital admissions due to 
asthma from a changed ozone standard. Can you comment on this 
chart?
    Response. The chart regarding hospital admissions in New 
York City shown at this hearing was based upon Table VI-2 
(revised) entitled ``Estimated Hospital Admissions for 
Asthmatics in the New York City Area'' from the November 30, 
1995 letter ``CASAC Closure on the Air Quality Criteria for 
Ozone and Related Photochemical Oxidants'' from Dr. George T. 
Wolff of General Motors to Carol M. Browner of the U.S. EPA, 
which was itself derived from Table VI.2 of the EPA OAQPS Ozone 
Staff Paper (pg. 158). This chart has several major weaknesses 
as an input to decisionmaking: (i) it embodies only a small 
fraction of the numerous health benefits which can be achieved 
by lowering ambient ozone levels; (ii) comparisons of the 
ozone-related asthma hospital admissions with total annual 
asthma admissions are not the most appropriate way to evaluate 
these estimated ozone health impacts, and; (iii) the validity 
of the EPA ozone proposal, which was based upon an exhaustive 
and comprehensive review of all of the available information 
regarding ozone health effects, should not be evaluated solely 
upon an appraisal of a single study or health outcome, which 
seems to be happening here.
    These chart weaknesses are elaborated upon in more detail 
below.
    (i) The chart presented at the hearing considers only a 
single health outcome, asthma hospital admissions in New York 
City, when we know that ozone induced health effects are being 
experienced elsewhere in the U.S., and that there are a myriad 
of other significant adverse health effects of air pollution 
that are occurring in the public, but are not reflected in this 
table.
    The adverse health effects ignored in the chart include 
both the hospital admissions that occur for causes other than 
asthma, and the effects felt by people who are adversely 
affected, but who never get admitted to the hospital, such as 
those requiring emergency room visits or private physician 
visits, and children experiencing asthma attacks. When these 
other significant adverse effects of ozone are considered, the 
number of people adversely affected rises by many orders of 
magnitude over the numbers indicated in this table.
    Moreover, this table considers only one city (one of the 
few for which suitable asthma admissions data have been 
routinely collected) representing only 8 million of the 
approximately 122 million people in the United States living in 
areas not now in compliance with the proposed ozone standard.
    Thus, the numbers in the hearing chart should not be viewed 
as in any way presenting the full extent of adverse human 
effects from ozone air pollution. Indeed, even for the outcome 
considered, hospital admissions, it is an underrepresentation. 
Looking over the various cities that I have considered, the 
estimated ozone effects on other respiratory categories such as 
pneumonia and bronchitis are of about equal size as those shown 
for asthma, and this does not consider other disease categories 
which have been shown to be adversely affected by air pollution 
in the past (e.g., cardiac admissions). Thus, for hospital 
admissions these numbers are an underestimate of at least a 
factor of two.
    The numbers in the chart presented at the hearing are most 
appropriately viewed as one important signal that significant 
adverse effects are occurring in the general public. It is 
critical that it be recognized that the numbers of people noted 
in the chart are just a small fraction of the total numbers of 
people adversely affected by ozone air pollution who will be 
helped by the proposed new standard, once the myriad of other 
adverse health effects and other locations throughout the U.S. 
that are presently out-of-compliance with the proposed ozone 
standard are considered.
    In order to give the sub-committee some insight as to the 
huge numbers of other effects lurking beneath the surface of 
the table presented, I have made working estimates of the other 
documented adverse impacts of ozone exposure that will also be 
reduced in New York City, once the new standard is met.
    The results of my analysis are presented in the attached 
figure entitled the ``Pyramid of Annual New York City Adverse 
Impacts of Ozone Avoided by the Implementation of the Proposed 
New Standard (vs. ``As Is''). This pyramid is intended to be 
illustrative of the enormous gaps in the table presented at the 
hearing, and is not presented as a peer-reviewed comprehensive 
documentation of all the benefits which would be accrued by 
achieving the EPA's proposed new standard. Please note that the 
figure could not be drawn ``to scale''. If it were drawn ``to 
scale'', the New York City asthma admissions triangle would not 
even be visible, since it accounts for only 0.01 percent of the 
total number of ozone related impacts noted. However, despite 
the fact that it visually overstates the relative size of the 
NYC hospital asthma admissions, and the fact that many ozone 
effects cannot be considered in these calculations due to a 
lack of data, this figure still makes very clear that the New 
York City asthma admissions counts considered in the table 
presented at the hearings represent only a small fraction (far 
less than 1 percent) of the adverse effects of air pollution 
which will be avoided through the implementation of the new 
standard being proposed by the EPA.
[GRAPHIC] [TIFF OMITTED] TH050P1.124

    The starting point of the analysis I used to estimate the 
``pyramid'' of effects noted in the attached figure is the 265 
New York City asthma admissions that will be avoided as a 
result of the implementation of the new standard, as quoted by 
Senator Chafee from top line of the chart (i.e., 385-120 = 265 
admissions). First, as I noted in my written testimony, there 
are also non-asthma respiratory admissions effects. Based upon 
the average ozone impacts derived from my ozone-admissions 
regression results for New York City and Buffalo, this 
indicates that the non-asthma respiratory admissions avoided 
(for causes such as pneumonia and bronchitis) are about 90 
percent of the size of the asthma admissions, or 240/yr. Now, 
based on the fact that New York City hospital records indicate 
that 12.6 percent of pediatric asthma emergency department (ED) 
visits result in an asthma hospital admission (Barton et al, 
1993), it is estimated that the ED visits associated with the 
505 ozone-related respiratory admissions would amount to 
approximately 3,500 ozone-induced ED visits (i.e., 505 x 
1/.126). Furthermore, using the ozone adverse health effect 
coefficients derived from the published literature by the 
Empire State Electric Energy Research Corporation (ESEERCO) in 
the New York State Environmental Externalities Cost Study 
(Oceana Publications, Inc., December, 1995), and ratioing the 
ozone effect coefficients provided in that report with that for 
asthma hospital admissions in New York City (used to get the 
265 admissions), effects for other outcomes were derived, based 
on the original 265 NYC hospital admissions/day estimate. In 
this way, estimated annual effects to be avoided in New York 
City each year were also derived for:
     acute (i.e., daily) mortality,
     asthma attacks,
     Restricted Activity Days (i.e., the total number 
of person-days during which some normal activities were 
curtailed), and
     Acute Respiratory Symptom Days (i.e., the total 
number of person-days during which additional respiratory 
symptoms would be experienced).
    Some may quarrel with the specific coefficients chosen here 
to model the other effects, but the point remains that these 
other effects collectively represent huge multiples of the 
hospital admissions benefits noted for New York City in the 
chart presented at the hearing. Moreover, the categories of 
effects considered in the attached figure are not exhaustive by 
any means, but they still serve to show that the table 
presented at the hearings grossly underestimates the number of 
adverse health events that can be avoided by the meeting the 
proposed standard.
    Note that the numbers in this figure have been corrected to 
avoid double counting of adverse health ``events''. For 
example, the number of hospital admissions has been subtracted 
from the total number emergency department visits, assuming 
that the patients would have first passed through the ED before 
being admitted.
    Note also that this figure can be used to consider other 
cases in the hearing chart as well, since all estimates have 
been scaled to the asthma admissions number. For example, for 
the difference between the existing and the proposed new 
standard cases, the numbers in this figure would all be divided 
by three (=(210-120)/(385-120) = 90/265). However, this 
calculation underestimates the benefits of the new standard, 
since it fails to account for the more rapid progress which 
will no doubt be able to be achieved in New York City under the 
new standard, when upwind counties cleanup. The comparison to 
the ``as is'' case contained in the attached figure is the more 
apt comparison.
    (ii) By using the New York City year-round counts of asthma 
admissions (28,470) as the denominator in its percentage ozone 
effect calculations, even though elevated ozone occurs 
predominantly during the summer months in that city, the chart 
provides percentage changes in admissions to be achieved by the 
control of ozone which may be misleading. Indeed, during the 
months of my study in New York City (June, July, and August) 
upon which the estimates in the table are based, the total 
asthma admissions were only 4,545 (averaged over the two 
summers). Since most of the effects noted by the EPA risk 
assessment would happen during these summer months, a more 
relevant estimate of the percentage reductions achieved would 
therefore be approximately 28,470/4,545 6 times as large as 
indicated by the chart presented at the hearing.
    Thus, again, the information provided in the chart 
presented at the hearing understates the health benefits which 
will be achieved by the implementation of EPA's proposed 
revision to the ozone standard.
    (iii) Senator Chafee's remark during the hearing that this 
chart suggests to him that ``we are dealing in very, very minor 
improvements to the health of the citizens of New York City'' 
indicates to me that the numbers in this narrowly focused chart 
are being overinterpreted and overemphasized. The chart 
represents an analysis of only a single adverse health outcome, 
in a single city, from a single study, selected from an entire 
body of hundreds of studies of a wide range of adverse effects 
that result from exposures to ozone air pollution that have 
been considered by the EPA in setting the newly proposed 
standard.
    Just as the U.S. EPA could not propose an ozone standard to 
the American people based on a single study of a single outcome 
in a single city, no matter how excellent that study, neither 
should we rush to judgment of the EPA's proposed standard on 
such a slender basis. The entire body of evidence available, 
including that in the EPA CD and Staff Paper and that presented 
by witnesses at the EPA public hearings, should be weighed 
before reaching a judgment on the appropriateness of the EPA 
proposal.

    Question 2. One of the arguments for not setting a tougher 
ozone standard is that, while air pollution is dropping, the 
incidence of respiratory disease is increasing. If this is 
true, then air pollution is not causing respiratory disease. 
What is your response to this?
    Response. While this argument sounds logical on the face of 
it, this is not a correct conclusion. That is because the 
increase in asthma incidence over the last decade was driven by 
an unprecedented increase in the underlying prevalence of 
asthma (the number of persons having asthma). According to the 
National Institutes of Health National Asthma Education 
Program, the number of persons in the U.S. with asthma rose by 
29 percent between 1980 and 1987. In the face of this growth in 
the prevalence of asthma, the reduction in asthma attacks 
achieved by the modest reductions in the average ozone levels 
we have been able to achieve in the U.S. in recent years (only 
7 percent between 1985 and 1995, according to the EPA), could 
not possibly offset the dramatic increase in the numbers of new 
people with asthma. Thus, the overall incidence of asthma 
problems has risen, despite our efforts to reduce ozone air 
pollution and its adverse effects on asthmatics.
    Probably the most important thing to derive from this 
discussion, however, is that, as the prevalence of asthma rises 
in our population, then there are more and more people outdoors 
in the summertime who are at risk of adverse impacts from ozone 
air pollution. Unfortunately, most of the factors that 
aggravate the lungs of those with asthma and induce asthma 
attacks cannot be controlled (such as attacks due to breathing 
cold air), but ozone is one of the few known important asthma 
triggers which we can as a Nation do something to control. This 
makes it all the more imperative that we move forward with 
EPA's proposed strengthening of the ozone air quality standard.
                                ------                                


 Response of Dr. Thurston to an Additional Question from Senator Baucus

    Question. One of your studies focused on the impacts of 
ozone on asthmatics. Your Table VI-2 (revised) indicated the 
number of hospitalizations of asthmatics in New York City that 
would be prevented by the implementation of the proposed new 
ozone standard. Is this chart sufficiently indicative of the 
number of serious health effects that would be avoided by 
implementation of the proposed standards? If not, would you 
explain what other health effects would likely be avoided and 
the relative number of people at risk?
    Response. First of all, let me clarify that the chart in 
question, Table VI-2 (revised), while utilizing the results of 
a study I conducted and published, is not my work. The chart 
was developed from work done by the U.S. EPA, and is presented 
in the OAQPS Ozone Staff Paper (EPA-452/R-96-007).
    The chart is not sufficiently indicative of the number of 
serious health effects that would be avoided by the 
implementation of the EPA's proposed new standard. Nor was it 
ever intended to be interpreted as such by the U.S. EPA. Taken 
out of the context of the EPA report's purpose, this chart 
grossly underrepresents the health benefits which will be 
accrued to the American people as a result of the 
implementation of the EPA's proposal.
    As I detail in my response to Senator Lieberman's written 
question, there are many significant adverse health impacts 
occurring throughout the U.S. today as a result of ozone air 
pollution that not considered by this table. These include 
hospital emergency department visits, asthma attacks, emergency 
visits to private physicians, increased asthma medication use, 
restricted activity days (e.g., work days lost), more frequent 
respiratory symptoms, reduced lung function, and diminished 
quality of life (e.g., due to reduced ability to walk up 
stairs, etc.). For example, available studies indicate that, 
for every one ozone induced asthma hospital admission, there 
are another 7 persons who became ill enough because of ozone to 
require a visit to the hospital emergency department (ED), and 
some 700 asthma attacks because of ozone. Clearly, asthma 
hospital admissions resulting from ambient ozone, while 
representing a severe and important health impact, are near the 
tip of an ``iceberg'' of adverse health effects and health care 
costs being borne by the American people every summer, and 
which will be largely avoided if the EPA's proposal is allowed 
to be implemented.
    Indeed, as presented in my response to Senator Lieberman, 
when one broadens the scope of the chart to include the other 
documented health impacts of ozone exposure, and then more 
realistically calculates the total numbers of cases of adverse 
health effects, the asthma hospital admissions noted in Table 
VI-2 (revised) represent only 0.01 percent of the effects that 
will be avoided in New York City by the implementation of the 
EPA proposal.
                                ------                                


 Response of Dr. Thurston to an Additional Question from Senator Inhofe

    Question. In the hearing, you stated that you took personal 
income into account in your Canadian studies. How was this 
accomplished? Did you control for income variances by 
determining the mean income level for hospital admissions, or 
by some other method? How did you obtain this income 
information, through personal interviews or hospital records?
    Response. Because of the time-series design of our Toronto 
study, it was not necessary to actively control for income 
level, since events in a single population were being compared 
over time, rather than an intercomparison of different 
populations. Because an individual's wealth category does not 
vary from day-to-day the way that air pollution levels do, it 
is not necessary to control for this factor in such time-series 
studies. By following the same group of people over time, this 
factor is inherently controlled for by the study design.
    In contrast, it is desirable to control for such factors in 
a cross-sectional study, which intercompares different 
populations at one time, with the various populations 
potentially having differing characteristics. Ah example is the 
cross-sectional study that Dr. Haluk Ozkaynak and I conducted 
when I was a Research Fellow at the Kennedy School of 
Government at Harvard University, and that was published in the 
journal Risk Analysis in 1987 (Volume 7(4): pp. 449-461). This 
study compared city-to-city variations across the U.S. in 
annual mortality versus variations in annual average air 
pollution across these same cities, during the year 1980. In 
this case, we addressed city-to-city variations in economic 
characteristics using two indices of wealth: the percent of the 
population living below the poverty level in each city, and the 
percent of the population with a college degree in each city. 
After statistically controlling for these and other socio-
economic factors across cities, we found that PM2.5 
particles (those less than 2.5 micrometers in diameter) were 
contributing significantly to the annual mortality of 
Americans, accounting for between 3 and 8 percent of all deaths 
at that time (from 60,000 to 160,000 deaths per year). Our 
results also indicated that particles larger than 2.5 
micrometers did not contribute significantly to these mortality 
impacts. This is consistent with the Toronto study you mention, 
which also found that particles larger than 2.5 micrometers in 
diameter did not significantly contribute to the adverse health 
effects found for fine particles (in this case, increased 
hospital admissions). Hence, both of these studies support the 
need for the U.S. EPA to move from the present PM10 
standard to a PM2.5 standard.
    It is also pertinent to this information-gathering hearing 
to mention that, in the U.S. cross-sectional mortality study, 
we also looked at the fine particle mass as a function of 
source category (using elemental tracers of various pollution 
source categories), finding that particles from the metals 
industry (such as the iron and steel industry) and from the 
burning of coal (such as from coal-fired powered plants) were 
indicated to be the most significant contributors to the 
mortality impacts of fine particulate matter.
                                ------                                

 Prepared Statement of Dr. Daniel B. Menzel, Professor, Department of 
     Community and Environmental Medicine, University of California
    My name is Daniel B. Menzel. I am professor and chair of the 
Department of Community and Environmental Medicine, University of 
California at Irvine, Irvine, CA. I have had more than 30 years 
experience in research in air pollution and toxicology. My expertise 
centers in two areas: mechanisms of air pollution toxicity and 
mathematical modeling of toxicology, particularly deposition of air 
pollutants in the respiratory tract. I have served as a senior author 
on multiple EPA Criteria Documents and recently as a Consultant to the 
Clean Air Scientific Advisory Committee examining the Particulate 
Matter Criteria Document and proposed standard.
    The committee has requested that I provide my views on the ozone 
and particulate matter standards, which EPA has published in the 
Federal Register and intends to implement under the Clean Air Act. I am 
pleased to do that and would also like to extend my testimony to 
include the research effort of EPA because it directly affects the 
standard-setting process. I understand that the two standards present 
different problems in terms of the form of the standard, the scientific 
data supporting each standard and the process by which the standard was 
promulgated. In my view, however, there are similarities between the 
two standards that reflect a major deficiency in EPA's efforts. The 
common deficiency is the lack of solid scientific data. EPA is a 
grossly underfunded Agency given the scope of its responsibilities. EPA 
has not done well with its resources by not sustaining research to meet 
the long-term goals of the Agency. Thus, I hope that the committee will 
allow me to express my concerns about the research planning at EPA.
        air pollution is a major long term public health problem
    Air pollution is a worldwide problem. In the United States air 
pollution is of such public health importance that it is critical that 
a national debate be undertaken on the future directions of air 
pollution research and regulation. This committee is providing a very 
valuable forum to the people so that they may learn more about the 
scientific controversy surrounding these two air pollutants and the 
alternative views that exist concerning the future of air pollution 
remediation efforts. I am at the moment writing a review of the 
toxicology of ozone.\1\ This will be the third review of ozone that I 
have written for the scientific literature. Almost 10 years have 
elapsed since my last effort, and I was surprised and saddened to note 
on examining the literature that questions which we raised in the 
review in 1988 still remain unresolved. Much new human data has become 
available on ozone supporting a lower standard and shorter averaging 
time, but the book is far from closed on ozone. I also wrote the first 
part of the health section of the SOx (sulfur oxides) 
Particulate Matter Criteria Document for EPA in 1980. Many of the 
questions raised in that document also remain unanswered. As a 
consultant to the Clean Air Scientific Advisory Committee I assisted in 
the review of the current Particulate Matter Criteria Document. Not 
only were the fundamental questions raised in the original 
SOx Particulate Matter Criteria Document still existent, but 
new important questions arose for which we have no answer. All of these 
experiences suggest to me that a greatly enhanced and invigorated 
research effort in air pollution is needed if we are to make sound, 
reasonable and rational decisions on the implementation of clean air 
standards. If anything, air pollution research is now more important to 
the national public health than ever before.
---------------------------------------------------------------------------
    \1\ Shoaf C.R. and Menzel, D.B. Oxidative damage and toxicity of 
environmental pollutants. In: Cellular Antioxidant Defense Mechanisms. 
(ed., C. K. Chow) CRC Press, Inc, Vol. 1:197-213, 1988.
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    Both the ozone and particulate matter standards have vast 
implications for the quality of life and the economy of the United 
States. It is my opinion that the vast majority of Americans support 
improving and enhancing the quality of their life by eliminating or 
decreasing air pollution. Americans are quite willing to shoulder the 
burden of cleaner air, cleaner water, and cleaner food if they can 
understand clearly the benefits to be gained by these activities. The 
confidence of the American people in the decisions being made on 
environmental issues is critical to the ability of this government to 
govern and implement these decisions. If ever the public loses 
confidence in the environmental strategies promulgated by the Federal 
Government then it will be impossible to carry out large national 
programs designed to eliminate or at least ameliorate the adverse 
effects of air pollution. I am very concerned that the Environmental 
Protection Agency and the Congress maintain the confidence of the U.S. 
public and demonstrate to the public their vigorous support for a 
better quality of life and clean air. Scientific truth is the only 
lasting commodity upon which decisions can be based.
                             generic issues
    From my view the difficulties that we face with both the ozone and 
the particulate matter standard stem from generic issues in toxicology 
which must be addressed in a sound scientific manner. The first of 
these generic issues is a plausible biological mechanism of action for 
the particular pollutant. The second is the nature of the dose response 
relationship. I will address each of these and give examples of how 
they impinge upon the two standards that we are discussing today.
Plausible Biological Mechanisms
    What is a plausible mechanism? We have learned a great deal about 
the quantitative nature of toxic reactions in the last 40 years. It is 
now possible to divide biological reactions to toxicants into several 
categories under which plausible mechanisms have been elucidated. A 
plausible mechanism of action for a toxin places the toxin within the 
context of our knowledge of disease processes. Having a plausible 
mechanism of action increases our confidence that health effects 
observed in animals will occur in humans. Understanding a mechanism of 
action also makes experiments more meaningful and relevant. In this 
forum it is not possible for me to elaborate in greater technical 
detail on how a plausible mechanism influences the experimental design 
and interpretation of the results of experiments. Experimental design 
and the concept of plausible mechanism of action are dealt with in 
standard textbooks of toxicology, such as ``Casserett and Doull's 
Fundamentals of Toxicology''.
    A plausible mechanism of action is critically essential to 
controlled human exposure studies. The extrapolation from animal 
experiments to human exposures as they occur in nature, that is with 
free-living people, depends upon an intermediate link of controlled 
exposures of human volunteers to the toxin. We must have a clear idea 
of a plausible mechanism so that human studies can be developed with 
due care that no harm will ever result to the volunteers who 
courageously commit themselves to these kinds of experiments. In air 
pollution many of the human studies have been very limited because of 
the lack of a clear understanding of a plausible mechanism. 
Investigators have been very reluctant to engage in high level 
exposures of human subjects because they fear that some long-term harm 
will result from their experiments. Clearly, we cannot and will not 
tolerate human experimental studies that result in harm to the 
volunteer. This is simply not ethically acceptable.
Plausible Mechanism of Ozone Toxicity
    One plausible mechanism of action of ozone is the production of 
free radicals by the reaction of ozone with cellular constituents. The 
free radical theory is that which we proposed in 1971.\2\ It is now 
clear that this mechanism of action is too naive and simplistic and 
clearly does not explain the consequences of chronic exposure to ozone. 
Studies with experimental animals clearly show that the results of a 
continuous or intermittent lifetime exposure to ozone are highly 
complex and are not predictable from the free radical hypothesis alone. 
Further experiments are needed with life-term exposures of experimental 
animals using the most modern molecular biology techniques. The complex 
pattern of lifetime ozone exposure must involve multiple signal 
transduction pathways. Simply put, the adverse health effects of 
chronic exposure to ozone are complex and beyond the free radical 
theory which we now recognize as accounting for the brief initial 
contact of ozone with the lung.
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    \2\ Roehm, J.N., Hadley, J.G. and Menzel, D.B. Oxidation of 
Unsaturated Fatty Acids by Ozone and Nitrogen Dioxide: A Common 
Mechanism of Action. Arch. Environ. Health, 23:142-148 1971.
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    Chronic exposure is the critical issue in ozone exposure. EPA 
initiated and was carrying out an excellently conceived and implemented 
research program on the chronic effects of ozone in support of the 
current ozone standard. But this research has stopped and support for 
ozone research by other Federal agencies has stalled. Basic research 
support for ozone by the National Institutes of Health and particularly 
the National Institute of Environmental Health Sciences (NIEHS), has 
fallen away. The scientific community is in error in allowing this to 
have happened.
    Very compelling controlled human exposure experiments suggest that 
the current ozone standard (0.12 ppm) may be toxic. The short term 
exposures under which humans can be safely exposed does not allow us to 
study the chronic effects of ozone exposure. Epidemiologic studies are 
underway in the South Coast Air Basin, particularly those by Professor 
John Peters of the University of Southern California but this study is 
hampered because no quantitative biomarker of ozone health effects has 
been developed.
    We would not be sitting here and engaging in this discussion if 
EPA's chronic ozone study in experimental animals had been carried out. 
Nor would we still have doubts about the ozone standard if ozone 
research had received a high priority in research support by the other 
Federal research agencies such as NIH and NSF.
    In summary, there is a preliminary biologically plausible mechanism 
of action for ozone. The free radical theory is not comprehensive and 
does not explain all of the effects of chronic exposure to ozone. Much 
additional work is needed to understand the chronic effects of ozone.
Particulate Matter
    In contrast to the ozone problem, no plausible biological mechanism 
of action has so far been proposed for particulate matter. It has been 
very difficult to demonstrate toxicity for particulate matter in 
experimental animals. In my laboratory and that of my colleagues at UCI 
we have not been able to show major toxicity with particulate matter at 
potencies approaching the levels reported from epidemologic 
studies.3,4
---------------------------------------------------------------------------
    \3\ Saldiva, P. H., Pope, C. A., Schwartz, J., Dockery, D. W., 
Lichtenfels, A. J., Salge, J. M., Barone, I. & Bohm, G. M. (1995) Air 
pollution and mortality in elderly people: a time-series study in Sao 
Paulo, Brazil. Arch. Environ. Health 50:159-163.
    \4\ Schwartz, J. (1995) Short term fluctuations in air pollution 
and hospital admissions of the elderly for respiratory disease. Thorax 
50: 531-538.
---------------------------------------------------------------------------
    To place this problem in a more global context, urban particulate 
matter is a universal problem. Particulate matter seems to be a common 
result of human concentration in urban areas. To eliminate all of the 
particulate matter in our cities would, in my view, be only possible by 
the elimination of all human activity. Clearly this Draconian approach 
is not reasonable.
    The studies of Schwartz and his colleagues 3,4 have 
challenged our conclusions from experimental animal studies. These 
studies indicate that all particles regardless of their geographic 
origin have the same toxicity. It is well known that the chemical 
composition of the urban particles differ widely between geographic 
areas. For example, in the western US, especially in the South Coast 
Air Basin of Los Angeles and its environs, the chemical processes 
responsible for the formation of particulate matter depend on 
photochemical reactions. Nitric acid is the dominant end product. There 
are very few oxides of sulfur present because of the nature of the 
fossil fuels used in California. On the other hand, in the East Coast 
Corridor the consumption of sulfur-containing fuels is much greater, 
and the chemistry of the reactions leading to the formation of 
particulate matter is not as dependent upon photochemistry as it is 
upon chemical reactions. Sulfuric acid, not nitric acid, is the 
dominant end product present in particulate matter. The chemical nature 
of the particles formed in California are quite different those of the 
East Coast Corridor. Yet the health effects measured by epidemiologic 
techniques suggests that all particles have the same effect despite the 
differences in chemical composition. This is a very troublesome 
problem. One of the basic tenets of toxicology is that the toxicity 
occurs via chemical reaction. How then can the same effect result from 
very different kinds of chemistries? We must conclude that there is no 
plausible mechanism now available for particulate matter which can 
account for the reported results.
Particle Size and Site of Action of Respirable Urban Particles
    The toxicity of particles also depends on the site within the 
respiratory tract where they are deposited. A major advance has been 
the recognition of the dependence of toxicity on the site of 
deposition. The site of deposition in the respiratory tract depends, in 
turn, on the physical size of the particle. By measuring the amount of 
particles within the size range which can be deposited in the human 
lung, EPA adopted a biologically based criterion for its standard 
setting. This concept of defining particulate air pollution in terms of 
the size of particles most likely to be responsible for the adverse 
health effects is referred to as PM10 where 10 refers to 
particles of 10 micrometers aerodynamic mass median diameter or less. 
PM10 is a fairly good surrogate measurement for the amount 
of material that would actually be inhaled and deposited in the human 
respiratory tract. Schwartz and his colleagues extrapolated from 
measured PM10 values. PM10 is a major advance in 
public health policy pioneered by EPA. The PM10 concept 
shifts emphasis to particles of that size which are likely to be the 
most harmful to people. A network of PM10 monitors has been 
constructed in the US and large amounts of data have been accumulated.
    Schwartz and his colleagues went beyond PM10 and 
extrapolated from a very limited set of measurements of 
PM2.5 and PM10 to estimate PM2.5 
values and to relate mortality and morbidity to particulate matter 
exposure smaller than PM10 or particles less than 2.5 
micrometers mass median aerodynamic diameter. Only a few data exist on 
the PM2.5 exposure in our major cities. By shifting from 
PM10 to PM2.5 values, a major difference in the 
regional deposition within the lung of these particles is suggested as 
the site of action. The smaller the particle the more deposition occurs 
in the deeper parts of the lung. By assigning toxicity to particles in 
the PM2.5 range the site of action is also assigned to the 
thoracic region of the lung. Because these PM2.5 values are 
calculated and not measured, it is very difficult to place the heavy 
weight of evidence on this ultrafine particle range as EPA has done in 
its criteria document. Even with a shift in attention to particles of 
this size range, there is still is no plausible mechanism for toxicity. 
Further, some of the CASAC members questioned the potency of the 
particles calculated from the mortality and mobility data. All of this 
underscores the importance of the research program reviewed by CASAC as 
part of the particulate matter standard setting process.
                       dose response relationship
    The dose response relationship is a curve that relates the number 
of individuals responding with an adverse reaction (mortality, 
morbidity or the like) to a certain exposure concentration of the 
chemical. The shape of the dose response curve is important when 
setting standards. All theories of the dose response relationship so 
far indicate that these curves will be non-linear; that is, there will 
be a point at which the probability that a response would occur is very 
unlikely. To put it another way, all theories suggest that there is a 
concentration at which nothing will occur while above that 
concentration adverse effects will occur. The point at which there is 
nothing detectable is the threshold. The dose-response relationship is 
at the heart of the risk assessment. In both the particulate matter and 
ozone standard the dose-response relationship is only poorly 
understood. Consequently, estimates of risk are also uncertain. 
Examples for ozone and particulate matter follow.
The Particulate Matter Dose Response Curve Is Linear Not Curved
    The current assumption of epidemiologic studies is that the 
mortality or morbidity is a linear function passing through zero at 
zero concentration of particles. The dose-response function has no 
point at which no adverse effects occur. The linear dose-response curve 
is in opposition to all of the theories and experimental data derived 
for a host of chemicals acting by a variety of different mechanisms of 
action.
    The epidemiologic basis for a linear relationship between effect 
and dose is very poor. The data are not supported by any kind of a 
generalized theory and are in many cases a default assumption coming 
about because the epidemiologic data are weak. It is very difficult for 
epidemiologists to relate exposure to effect. The methodologies of 
epidemiology at present are insensitive to the concentration or 
exposure effect. This is especially true in ecological studies where 
indirect evidence is used for adverse health effect.
    For example, the epidemiologic studies of particulate matter health 
effects depend upon death certificates and the coincidence of an 
increase in death with an increase in particulate matter exposure. 
These studies again provide no indication of how a person might have 
died from the exposure to particulate matter. The studies only 
associate the death with the exposure to particulate matter. 
Nonetheless, the increases in mortality associated with particulate 
matter are troublesome. If the magnitude of mortality suggested by 
these studies is correct, then we are faced with a major public health 
problem that demands immediate attention.
Time and Intensity Relationships in Ozone Health Effects
    EPA initiated a time and intensity study in cooperation with the 
USSR. This program was well thought out and attacked the question of 
which variable is most important in determining the health effects of 
ozone. From the data that were generated by this study it appears that 
the intensity is the most critical factor rather than the duration of 
exposure for ozone toxicity. These studies of the time and 
concentration effects on ozone toxicity led to the current hypothesis 
upon which the proposed ozone standard is based. If it is correct that 
the magnitude of the exposure is more important, then extremes of 
exposure should be reduced. One strategy to reduce exposure to extreme 
concentrations of ozone is to change the averaging time for the 
standard, making implementation plans stricter for short-term 
excursions. The US-USSR research program to study the time and 
concentration dependency of ozone adverse health effects was very 
productive and was progressing along a track which would, if continued, 
have provided us a great deal of information at this time. 
Unfortunately, EPA chose to reduce and essentially eliminate this line 
of study. Extramural support for the program lagged and ozone in 
general has become an unpopular topic for support by other government 
agencies such as NIEHS.
    Based on the fragmentary information that we have available, I feel 
that it is appropriate to support the EPA proposal of changing the 
averaging time for the ozone standard so that large excursions over 
short time periods will be eliminated or reduced. However, one should 
recognize that changing the averaging time will have a major impact on 
State implementation plans and will have major economic consequences. 
Clearly, understanding the nature of the dose-response relationship is 
very important and affects which alternatives we choose to reduce ozone 
health effects.
Time and Intensity Relationship for Particulate Matter Health Effects 
        Are Unknown
    As stated above, most time and intensity (dose and dose-rate) 
relationships for chemicals follow a simple relationship that the 
product of the dose rate and the time of exposure form a constant. This 
constant is arbitrary and unique for each chemical Epidemiologic 
studies of the increases in mortality associated with increases in 
particulate matter are strictly linear with the amount of particulate 
matter. One reason way this assumption occurs is that a lag period has 
been assumed. The lag period means that the increase in mortality 
occurring 2 to 3 days after an exposure are related to the exposure to 
particulate matter, not earlier or later. The underlying hypothesis is 
that particulate matter toxicity is not immediately evident but occurs 
after this lag period. This very short acting time raises the question 
as to what happens when people are exposed to concentrations of 
particulate matter over the long term. We really have no data on the 
chronic effects in humans of exposure to particulate matter. Chronic 
exposure studies are very difficult to achieve using epidemiologic 
data.
    To my knowledge there are no experimental animal data or controlled 
human studies which relate this kind of lag time to exposure to the 
toxicity of particulate matter. In my laboratory and that of my 
colleagues at UCI we have found that experimental animals such as the 
rat are very insensitive to particulate matter exposures. We have never 
observed potencies equivalent to that proposed for humans based on the 
epidemiologic data. This again raises the question of a plausible 
biological mechanism of action.
                          the research agenda
    It is difficult for scientists such as myself whose livelihood 
depends on experimental research to stand before you and justify 
additional research without seeming to be self-serving. A careful 
study, however, of EPA's support of research in the past is related to 
the missing data in the standard setting process. Sadly, we would not 
be sitting before you if there had been a steady progression of air 
pollution health effects research. EPA's research strategy has been to 
ignore problems until the standard setting cycle is near. Then a 
massive effort is mounted which is expected over 2 or 3 years to result 
in sufficient data to solve the research needs. Regrettably we have 
seen that this strategy does not work. The same questions recur from 
criteria document to criteria document. There are just not enough 
resources put into air pollution health effects research so that we are 
really certain what we're about.
    It is also my opinion that this problem also appears in the low 
esteem with which Congress holds EPA research. I am acutely aware that 
one Congress cannot obligate another Congress and that this 
independence of one Congress from another is fundamental to the 
development of our country. But I think it is time that the Congress in 
its wisdom faced up to the need to make its desire known to its 
successors that support of research for long-term problems in all areas 
of health is essential.
    Air pollution is a long-term problem. From my observations and the 
data in the literature there is no urban area which does not have air 
pollution. We are still dependent on the consumption of fossil fuels 
for energy and the prospects of independence from fossil fuels are far 
into the future. My colleague, F. Sherwood Rowland, received the Nobel 
Prize in Chemistry for his contributions to the global problem of 
depletion of the ozone layer. Dr. Rowland's contributions clearly show 
that this air pollution problem is global. He also was able with his 
colleagues to demonstrate that this was a long-term process. I see no 
way that this is not also true for other kinds of air pollution 
problems.
    As I mentioned above in my current review of the literature of 
ozone I found very little progress had been attained in ozone research 
over the last 10 years. It is essential then that the Congress mandate 
to EPA a sustained basic research effort, Only if EPA clearly is 
committed to a long-term research effort will we solve the problems 
that still exist today as they existed 10 years ago.
    In addition, the Congress should resist any rush to judgment. I am 
deeply concerned over the effects of particulate matter exposure as 
currently revealed by epidemiologic studies. Similarly, I am concerned 
that we have not demonstrated an important increase in a health benefit 
from a small decrease in ozone concentration. Both of these 
alternatives however, are significant commitments on the part of 
society to change the underlying causes of both ozone and particulate 
matter generation in our cities. It is my firm opinion that the U.S. 
public would be willing to engage in whatever is necessary, but they 
will not support any arbitrary change that results in a significant 
economic and personal commitment.
    Our experience in science policy clearly shows that the U.S. 
Government is capable of mounting major efforts to solve major 
problems. No one could have predicted just 5 years ago the remarkable 
success which is being achieved in AIDS treatment. There is a similar 
likelihood that a large-scale problem such as air pollution could be 
better defined and directions for engineering applications clearly 
delineated if we understood more about the biologic aspects of this 
problem. Inventorying pollutants in the atmosphere is undoubtedly an 
important issue, but it does us no good to inventory these pollutants 
in the atmosphere and yet not have a clue as to what their biologic 
activity is. I may sound arbitrary in my opinion that we are in a state 
of great ignorance, but I think that once you listen to the testimony 
of my colleagues here you will come to the regrettable conclusion that 
I am an optimist. I therefore urge the Senate and this committee to 
undertake a new direction in the support of research by EPA and by 
EPA's sister Federal agencies such as the National Institutes of Health 
and in particular the National Institute of Environmental Health 
Sciences. These agencies need to be enabled, directed and empowered, 
indeed mandated, to carry out the long-term large-scale research that 
is necessary to understand much more fully the effects of air pollution 
on the U.S. population.
                              conclusions
The Proposed Ozone Standard
    It is my opinion that we will have achieved only marginal effects 
by decreasing the current ambient air quality standards for ozone from 
120 parts per billion to 90 parts per billion. The nature of the dose 
response relationship is such that it may still be at a linear range 
and thus reduction to much lower levels may be necessary to result in 
the abolition of detectable health effects from ozone. My colleague, 
Robert Wolpert, and I published a simple analysis of different kinds of 
dose response relationships for ozone looking toward this very issue. 
How much would one have to reduce the ozone concentration in the air in 
order to be able to find a detectable advance in public health? Because 
the data are so sparse, a multitude of different kinds of theoretical 
treatments are possible. None of them, however, are sufficiently 
sensitive that one could lead to a clear prediction of a health 
benefit. On the other hand, as I mentioned above, a change in the time 
constant alone is going to have a great benefit. I endorse EPA's 
analysis of the time constant and think that EPA's proposal to a change 
in the averaging time for ozone is likely to be of benefit to the 
public health.
    Still, I think that translating these changes into new State 
implementation plans may be very difficult. To translate both a change 
in the concentration, that is the amount of ozone that is permissible 
in the air and the duration over which it is permissible, will be a 
very difficult task indeed to implement.
    Continued research into the health effects of ozone are urgently 
needed. Further reductions in the ozone standard may be indicated in 
the near future. Because of the economic impact of ozone standards and 
strategies, the highest quality research is needed.
Particulate Matter Standard
    As I have said previously, I do not doubt that the particulate 
matter problem is a very serious problem indeed. We need to place a 
very strong active and progressive research program into place in order 
for us to cope with this problem. It is my view that too little is 
known, In the report of the Clean Air Scientific Advisory Committee to 
Administrator Carol Browner, the committee pointed out that one of the 
areas in which additional research should be undertaken is chronic 
exposure.
    I am not in favor of the use of a PM2.5 standard. A 
viable network of monitoring instruments and sound research supports 
the PM10 standard. The PM2.5 standard has no 
background. There is no existing research quality PM2.5 
network. Without a research quality PM2.5 network it is not 
likely that we will make much progress toward the goal of a new 
particulate matter standard. We lack information on the actual 
PM2.5 in the atmosphere of our cities. We do not know the 
duration of exposure of people to PM2.5. The chemical nature 
of the PM2.5 fraction is poorly known. We lack a plausible 
biological mechanism for particulate matter. We do not know if 
regulation of PM2.5 will be of benefit. A strong aggressive 
long-term research program is essential to address the current data 
deficiencies if we are to convince people that this is a major problem.
Avoid Mistakes Of The Past
    In my comments above I pointed out that the critical data 
deficiencies for ozone and particulate matter are generic and extend to 
the other criteria air pollutants. My criticisms of EPA and of the 
Congress I am sure have not endeared me to either party. My criticisms 
are also directed to me and my scientific colleagues. It is time that 
we faced up to the realities of life. Air pollution is here. Air 
pollution will be with us. Air pollution is a major problem that cannot 
be solved in 5 years.
    EPA needs more resources. All of the health research establishment 
needs more resources to deal with this particular problem. The strategy 
adopted by NIH to deal with major health problems such as AIDS and 
cancer is dependent on ideas generated outside of the government. This 
is not to say that government researchers are not knowledgeable. Rather 
it is simply the recognition that there is great diversity in the 
United States. We have a lot of people working on the same problem, and 
from this diversity we achieve greatness. The Congress should instruct 
the National Institutes of Environmental Health Sciences, NIEHS, and 
EPA to place greater emphasis on air pollution, to seek actively 
support for extramural programs dealing with air pollution, to look for 
the unique idea to encourage the primary review groups that this is a 
programmatic area of importance. Last I would respectfully ask that the 
Congress use the legislative hammer in another way. The Congress can 
have a major impact on the sustainability of research in this area. 
Clearly the Senate recognizes that regulation of air pollutants is a 
major national problem. The Congress should, in my judgment, place a 
burden on the government agencies to carry out the needed long-term 
research. In doing so, the Congress has to realize that it has to 
reallocate resources and that air pollution is a national problem of 
long-term importance requiring additional support.
    Thank you for the opportunity to have addressed you.
                                 ______
                                 
   Prepared Statement of Dr. Roger O. McClellan, President, Chemical 
                    Industry Institute of Toxicology
    Chairmen and distinguished members of the Subcommittee: I am 
pleased to have this opportunity to testify at your request on 
scientific issues related to the new National Ambient Air Quality 
Standards for Ozone and Particulate Matter that the Environmental 
Protection Agency proposes to promulgate under authority of the Clean 
Air Act. I request that this written testimony be included in the 
record as though read in its entirety.
    By way of background, I serve as President of the Chemical Industry 
Institute of Toxicology, a not-for-profit research organization located 
in Research Triangle Park, North Carolina. The institute is supported 
principally by some 30 leading industrial firms and has a mission of 
developing, through the conduct of research, an improved scientific 
basis for understanding and assessing the human health risks of 
exposure to chemicals. This mission is being achieved through the 
conduct of an in-house research program carried out by 160 scientists, 
postdoctoral fellows, and supporting personnel.
    The comments I offer are based on my experience as a scientist 
concerned with the risks of airborne materials and my extensive service 
in advisory roles to numerous public and private organizations. (An 
abbreviated biographical sketch is appended.) My advisory experience 
has included long-term service on the EPA Science Advisory Board. I 
have served under each of the Agency's Administrators on a number of 
committees, previously as chair of its Clean Air Scientific Advisory 
Committee, Environmental Health Committee, Environmental Radiation 
Exposure Advisory Committee, and the Research Strategies Advisory 
Committee and as a member of the Relative Risk Reduction Strategies 
Committee. Most recently, I have served as a member of the Clean Air 
Scientific Advisory Committee Panels considering the National Ambient 
Air Quality Standards for Ozone and Particulate Material. I also served 
on the CASAC panels that earlier reviewed the scientific basis for the 
current National Ambient Air Quality Standards for ozone and 
particulate matter.
      legislative basis for national ambient air quality standards
    The legislative basis for the Clean Air Act is well known to all of 
you. However, I would like to highlight several key points to provide a 
basis for my remarks. The Clean Air Act directs the Administrator of 
the Environmental Protection Agency to identify pollutants which ``may 
be reasonably anticipated to endanger public health and welfare'' and 
to issue air quality criteria for them. These air quality criteria are 
intended to ``accurately reflect the latest scientific knowledge useful 
in indicating the kind and extent of all identifiable effects on public 
health or welfare which may be expected from the presence of [a] 
pollutant in the ambient air. . . .
    For these ``criteria pollutants'' the administrator is directed to 
propose and promulgate ``primary'' and ``secondary'' National Ambient 
Air Quality Standards. In the interest of brevity, I will consider only 
the primary standard setting process in this testimony. The primary 
standard is defined in the Act as one ``the attainment and maintenance 
of which, in the judgment of the Administrator, based on the criteria 
and allowing an adequate margin of safety, [is] requisite to protect 
the public health.'' The legislative history of the Clean Air Act 
indicates that the primary standard is to be set at ``the maximum 
permissible ambient air level . . . which will protect the health of 
any [sensitive] group of the population'' and that for this purpose 
``reference should be made to a representative sample of persons 
comprising the sensitive group rather than to a single person in such a 
group.'' The standard is viewed as sufficient whenever there is ``an 
absence of adverse effects on the health of a statistically related 
sample of persons in sensitive groups from exposure to ambient air.''
    The courts have held that the ``margin of safety'' requirement for 
primary standards was intended to address uncertainties associated with 
inconclusive scientific and technical information available at the time 
of standard setting. And further, it was intended to provide protection 
against hazards that research has not yet identified or whose medical 
significance is a matter of disagreement. In setting a margin of 
safety, the EPA considers such factors as the nature and severity of 
the health effects involved, the size of the sensitive population(s) at 
risk, and the kind and degrees of uncertainties that must be addressed. 
The margin of safety comes into play at the boundary between conclusive 
evidence of adverse effects related to pollutant exposure and levels of 
exposure where there is no conclusive evidence of adverse effects with 
unknown or only partially quantified risks. The selection of a 
particular approach to providing an adequate margin of safety has been 
viewed by the courts as a policy choice left specifically to the 
Administrator's judgment.
    The primary standard is to be set without regard to the cost of its 
implementation.
    A section of the Clean Air Act enacted in 1977 requires that ``not 
later than December 31, 1980, and at 5-year intervals thereafter, the 
Administrator shall complete a thorough review of the criteria 
published under section 108 and the national ambient air quality 
standards . . . and shall make such revisions in such criteria and 
standards and promulgate such new standards as may be appropriate The 
Act requires that an independent scientific review committee be 
appointed to ``complete a review of the criteria . . . and the national 
primary and secondary ambient air quality standards . . . and shall 
recommend to the Administrator any new . . . standards and revisions of 
existing criteria and standards as may be appropriate This function is 
carried out by the Clean Air Scientific Advisory Committee of EPA's 
Science Advisory Board.
    Put in its simplest form, the Clean Air Act requires the 
Administrator to develop criteria and promulgate standards for certain 
air pollutants to protect against adverse effects in the public, 
including sensitive populations, with an adequate margin of safety. As 
clearly implied by the statutory language, levels of pollutant 
exposures can be identified that cause effects, while lower levels of 
exposure will be without effect (i.e., a threshold for response). A 
``margin of safety'' is then used to select a lower level for the 
standard, a level that, if attained, should not result in unacceptable 
risk.
                             ozone standard
    The current primary NAAQS for ozone is set at 0.120 ppm with a 1-
hour averaging time. Attainment of the standard occurs when the 
expected number of days per calendar year with a maximum hourly average 
concentration greater than 0.120 is equal or less than one. 
Operationally, the standard is exceeded if the 0.120 ppm hourly average 
concentration is exceeded a fourth time in a 3-year period.
    In 1993, the EPA Administrator reaffirmed the 0.120 ppm standard 
with a 1-hour averaging time. At the same time, the Agency initiated 
the preparation of an updated criteria document on ozone and made plans 
for preparation of a staff paper for CASAC review of both the criteria 
document and staff paper. The CASAC came to closure on the criteria 
document on November 28, 1995 and on the staff paper on November 30, 
1995.
    The review process for the NAAQS for ozone considered a substantial 
amount of new data published since the last CASAC review was concluded 
in early 1989. The data came from four sources; controlled human 
exposure studies, field studies of children and healthy adults, 
analysis of air quality data and hospital admissions and laboratory 
animal studies.
    The controlled human exposure studies involved individuals engaged 
in light to heavy exercise with exposure to ozone over a range of 
concentrations for 1 to 6.6 hr. Decrements in pulmonary function and 
increases in symptoms of respiratory responses were exposure 
concentration and exposure duration dependent. However, there was 
substantial intergroup variability in response as well interindividual 
variability for repeated exposures. The results of these studies 
support the use of an 8-hour averaging time.
    The field studies of children in summer camp and exercising adults 
took advantage of naturally occurring variations in ambient ozone 
concentrations. Lung function tests were performed in all the 
individuals. A small, but substantially significant, association 
between ozone concentrations and reduced pulmonary function was 
observed for both groups. The relationship between increased ozone and 
decreased function was approximately linear with no clear threshold for 
an absence of effect.
    The hospital admission studies examined the association between 
daily ozone concentrations and daily hospital admissions for 
respiratory effects. Asthmatics were identified as one susceptible 
subpopulation. Linear relationships were observed with increasing ozone 
and increased admissions with no clear evidence of a threshold.
    The animals studied revealed effects that were qualitatively 
similar to those seen in people. The results of a key study with rats 
and mice exposed 5 days per week to ozone at exposure levels of 0.12 
ppm and higher for 2 years suggested that long-term exposure at current 
ambient concentrations of ozone were unlikely to produce serious, 
irreversible changes in the lungs. I found those findings reassuring; 
they reduced my concern for the long-term impact from brief exposures 
that produce reversible effects. Based on consideration of all of the 
data, the EPA staff paper recommended consideration of an 8-hour 
averaging time standard in the range of 0.070 to 0.090 ppm and a 
potential for multiple exceedances.
    Based on the information presented in the ozone criteria document 
and analyzed in the ozone staff paper, the CASAC reached several key 
conclusions:
    (1) Ozone remains an appropriate indicator for use as an indicator 
of photochemical oxidants,
    (2) An 8-hour averaging time standard was more appropriate for a 
human health-based standard than a 1-hour average time,
    (3) ``The weight of the evidence indicates that there is no 
threshold concentration for the onset of biological responses due to 
exposure above background concentrations'' and, thus, ``there is no 
`bright line' which distinguishes any of the proposed standards (either 
the level or the number of allowable exceedances) as being 
significantly more protective of public health.''
    (4) The CASAC Ozone Panel members expressed a range of preferences 
for the level of the standard.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                 No. of Panel Members                                 Preferred Ozone Level (ppm)               
----------------------------------------------------------------------------------------------------------------
1....................................................                                               0.090-0.100 
3....................................................                                                     0.090 
1....................................................                                              0.080--0.090 
3....................................................                                                     0.080 
2....................................................                                                   Policy Call
----------------------------------------------------------------------------------------------------------------


    It is my professional judgment that the primary ozone standard 
should be set at 0.090 ppm with an 8-hour averaging time and the use of 
the 3-year average of the annual third highest maximum of 8-hour 
average ozone concentration to evaluate attainment of the standard. I 
would personally prefer to have some form of averaging of data from 
multiple monitoring sites, when available, rather than using the 
highest monitor to determine attainment of the standard. The use of 
multiple monitors would better reflect population exposure and 
aggregate public health risk.
    My professional opinion on the level and form of the ozone standard 
was shaped by consideration of data such a that shown in Table 1. This 
table is based on a study by Thurston et al. (1992) who examined the 
relationship between ozone levels and hospital admissions. The model 
assumed ozone effects down to a background level of 0.040 ppm. The 
first row on the table (Excess Admissions) was prepared by the EPA 
staff and included in the draft Ozone Staff Paper. It may be noted that 
the excess admissions for various ozone control scenarios included 210 
cases for the present standard to a range of 60 to 240 cases for 
alternative standards. For comparison the present situation (``as is'') 
is estimated to result in about 400 cases. The five lower rows in the 
table were prepared by CASAC Panel members. The second row reporting 
the excess admissions as a percentage change from the present standard 
at first glance appears to suggest considerable difference between the 
several options. However, the other rows are worthy of detailed 
consideration before a final conclusion is drawn.
    The third row includes both the excess admissions due to ozone-
aggravated asthma above the level of the standard and those cases 
related to ozone below the level of the standard down to background. 
The relative effect of the different options now appears to be much 
less, as seen from examining row 4. Let us now turn our attention to 
row 5, all asthma admissions, with a baseline of approximately 30,000 
cases. When this value is compared with that for the various options, 
ozone-aggravated asthma admissions clearly represent only a small 
fraction of the total number of cases and the difference in impact of 
the various options for the ozone standard is small.
    It is especially important to note that 680 asthma admissions per 
year are attributed to background levels of ozone which is assumed to 
be 0.040 ppm of ozone. These calculated cases are a reflection of the 
linear exposure-response models used to calculate the ozone 
attributable cases.
    The primary public health issue relates to the approximately 30,000 
cases of asthma admissions. I can personally identify with these cases 
since one of my children, who grew up in the clean air of New Mexico, 
was and is an asthmatic. My firsthand recollection of his suffering 
from asthma attacks triggered by multiple causes such as animal dander, 
grass pollens, extreme cold air, and heavy exercise left an imprint on 
me. As much as anyone, I would like to better understand what causes 
asthma including the vexing issue of why asthma rates are increasing 
especially when air quality is improving. I have serious reservations 
as to the extent to which ozone exposures are a significant contributor 
to the asthma problem.
    Let me hasten to add that the health impacts of ozone are not 
restricted to effects in asthmatics. However, the table clearly 
illustrates the importance of considering the estimated impacts of 
pollutant exposures within the broader context of other risk factors 
for specific health outcomes. In my opinion, the ultimate concern of 
society is for the aggregate risks from all causes and how best to 
achieve an overall reduction.
    I am personally a strong advocate of comparative risk analyses such 
as detailed above to help guide decisions on important societal issues. 
It is my understanding that the EPA Administrator can use analyses such 
as this in making decisions on the ozone standard although the 
Administrator is prohibited from explicitly considering costs of 
implementing the standard.
    Before leaving the ozone issue, let me note that I believe it is 
unfortunate that the Clean Air Act prohibits the consideration of cost 
in setting the standard. In my opinion, the best interests of society 
would be served if attention could be focused on the ``best buy'' for 
societal actions that will reduce health risks, including those of 
ozone. Further reductions in ozone may not be cost-effective relative 
to other options for reducing risks and improving health.
    The explicit consideration of the cost of achieving the various 
options would be of substantial value in making a decision that is 
likely to have a multibillion-dollar impact on society.
                           particulate matter
    The current particulate matter standard was promulgated in 1987 
when the indicator for particles was changed from Total Suspended 
Partides (TSP) to PM10, the latter referring to particles 
with a mean aerodynamic diameter less than 10m. The 24-hour 
PM10 standard was set at 150 g/m3, with 
no more than one expected exceedance per year, and the annual 
PM10 standard set at 50 g/m3, expected 
arithmetic mean. The PM10 standard is thought to provide a 
more health-protection-relevant metric for controlling exposure than 
the old TSP metric.
    The particulate matter National Ambient Air Quality Standard for 
Particulate Matter is not chemical specific unlike the chemical 
specific standards for other criteria pollutants and most other 
substances regulated by the Environmental Protection Agency. The PM 
standard applies to a broad class of chemically and physically diverse 
substances that exist as discrete particles (liquid droplets or solids) 
over a wide range of sizes. PM is characterized as to its mass within 
given size range.
    Knowledge of the size and origin of particles is, fundamental to 
understanding their potential health effects and, ultimately, the 
establishment of appropriate standards and control strategies. 
Particles in the atmosphere vary widely as to their size and origin. 
The smallest particles arise from condensation of vapor and a 
clustering of individual molecules. These very fine particles grow in 
size and coagulate in the atmosphere to form fine (or accumulation 
mode) particles that are typically less than a micrometer in diameter. 
Other larger or coarse particles typically arise by mechanical 
processes such as the erosion of soil.
    The size of particles influences the dynamics of particles in the 
atmosphere. The finest particles coagulate to become larger particles. 
These particles may be removed from the atmosphere by rain. The largest 
particles may settle out due to gravity. Small and medium size 
particles may be transported long distance by the wind. As a former 
resident of Albuquerque, New Mexico, I can recall that in the spring we 
sometimes had some of Arizona blow through when the winds were from the 
west and Texas and Oklahoma blow through when the winds were from the 
east.
    Scientists studying particles in the atmosphere have appreciated 
the need to better understand particle size and this has led to the 
development of methods for collecting particles and characterizing the 
particles as to size. Just as size influences how particles behave in 
the atmosphere, size also influences their potential for being inhaled, 
deposited in the respiratory tract and causing adverse health effects. 
The concern for how particles of different sizes could affect health 
also influenced the design of air sampling devices.
    Some of the conventions for characterizing particles as to their 
size are illustrated in Figure 1. In particular, note the size 
fractions designated as (1) Total Suspended Particulates (TSP); (2) 
Particulate Matter, 10 microns size (PM10); and (3) 
Particulate Matter, 2.5 micron size
    The TSP sample represents essentially all the particles that can be 
drawn into a high volume sampler. This includes many large, heavy 
particles that have a very low probability of being inhaled and 
reaching the lungs. These particles are clearly a nuisance but are not 
of major health concern.
    Recognition that smaller particles that can be inhaled led to the 
development of methods for collecting smaller particles including the 
PM10 fraction. As an aside, it should be noted that some of 
the smallest of the coarse mode particles are collected in the 
PM2.5 sample. These are collected with devices that will 
collect 50 percent of the particles 10 micrometers in aerodynamic 
diameter. Particles larger than 10 micrometers are collected less 
efficiently, smaller particles are collected more efficiently. The 
PM2.5 fraction is similar except the cutoff is set at 2.5 
micrometers.
    In 1979-1980 EPA was struggling with the issue of developing a 
size-selective PM NAAQS to replace the TSP standard set in 1971. 
Several different size cuts were under consideration and there was a 
flurry of activity to gather field data using new devices including 
some calibrated for PM15, PM10, and 
PM2.5. However, the debate was largely removed from EPA's 
regulatory agency in 1981 when the International Standards Organization 
adopted a 10 micrometer cut point for particles that could penetrate to 
the human thorax (i.e., the trachea, conducting, and pulmonary 
airways). This focused attention on a PM10 standard which 
was formally promulgated in 1987. With promulgation of the of the new 
standard and the need to demonstrate regulatory compliance, there was a 
general shift to PM10 measurements. TSP measurements were 
discontinued and, unfortunately, so were most measurements of 
PM2.5. I have termed this phenomena ``looking under the 
regulatory lamppost.'' In general, after closure on the PM criteria 
document and staff paper in 1986, the level of financial support for 
research on PM dwindled.
    In my opinion, the Agency took appropriate action to move to a 
PM10 indicator in 1987. The use of the PM10 
indicator has been effective in guiding actions to control particulate 
air pollution and minimize the likelihood of adverse health effects 
attributable to particulate air pollution. From 1988 to 1995 there has 
been a 22 percent reduction in the annual mean PM10 
concentrations (see the EPA National Air Quality and Emissions Trends 
Report, 1995). This and a companion document, National Air Pollutant 
Emission Trends, 1990-1994 are excellent references for gaining an 
appreciation of the substantial progress being made in improving air 
quality in the United States. Unfortunately, detailed data are not 
available on trends in PM2.5 and PM1.0 
measurements. However, I suspect substantial reductions have also 
occurred in the concentrations of these smaller particles.
    During the early 1990's reports begun to appear in the literature 
of time series analyses of PM measurements and daily mortality. These 
were retrospective, opportunistic studies of data collected for other 
purposes. These studies frequently used techniques developed originally 
for econometric analyses. The techniques used attempted to account for 
or filter out effects such as season of year, temperature, etc., that 
could influence mortality with the remaining statistical relationship 
between daily PM and daily mortality quantified. Later studies 
attempted to take account of the role of other pollutants such as ozone 
and acid sulfates. A major handicap to the conduct of many of these 
studies was the lack of PM10 data. In many cases, the best 
available data were for TSP. These were then converted or extrapolated 
to PM10 values or, in some cases, even extrapolated to 
PM2.5 values. On average the investigators found about a 4 
percent increase in daily mortality for a 50 g/m3 
increase in PM10 concentration or extrapolated 
PM10 values.
    Unfortunately, only a very few long-term prospective studies of 
cohorts of individuals have been conducted with associated measurements 
of PM and other pollutants. Only rarely have long-term multiyear 
studies been conducted with research quality air pollution measurements 
made rather than depending on regulatory compliance measurements. The 
result is excessive dependence on the old TSP measurements or more 
recently PM10 measurements. Only very limited research has 
been done when both PM10 and PM2.5 have been 
measured and only very recently have some PM1.0 measurements 
been obtained. In the cohort studies mortality rates after adjustment 
for smoking and other confounding variables have been related to the 
PM10 or PM2.5 measurements or extrapolated 
values. EPA used the mortality estimates from two such prospective 
studies to conclude that there are premature deaths due to chronic 
exposure to PM.
    In my opinion, the EPA staff and consulting scientists assisting 
the Agency did an admirable job of compiling all that is currently 
known about the health effects of PM. Unfortunately, the price must now 
be paid for inadequate support of research on the effects of air 
pollution. The data base available today is not sufficient to establish 
a new PM indicator, nor select the level and fond of a new standard.
    The data suggest that high levels of PM as experienced in the past 
are associated with increased morbidity and mortality. However, I must 
note that some investigators have suggested that the effect measured is 
a general air pollution effect with PM measurements serving as a 
surrogate measure of air pollution rather than as a causative agent The 
data are reasonably strong for PM10. Unfortunately, the 
dearth of PM2.5 measurements serve as a serious obstacle to 
rigorously evaluating the association between PM2.5 and 
multiple measures of health for specific populations including those 
that might be especially susceptible. And we have no evaluations of 
possible association health indices and other PM metrics such as 
PM1.0 (that would more accurately reflect particles that 
have been recently formed) or particle size and chemical specific 
metrics traceable to specific types of sources. An absence of data on 
other plausible alternatives and the bright light of the regulatory 
lamppost keeps drawing us back to evaluating associations with 
PM10 and to a lesser extent, PM2.5 It has been 
argued that the only way to get funding for more PM2.5 
measurements is to get a PM2.5 standard. Thus, we are faced 
with the perverse situation of creating a standard to get scientific 
data rather than having a standard developed based on solid scientific 
data. Limited data recently obtained on PM10, 
PM2.5, and PM1.0 size fractions suggest that EPA 
may be making a serious error in proposing a PM2.5 standard 
to control health risks related to fine particles. In the western 
United States where PM2.5 measurements include substantial 
soil dust, the use of a PM2.5 indicator may lead to 
exaggerated estimates of risk. These data strongly suggest that a 
PM1.0 indicator may be more appropriate than the use of a 
PM2.5 indicator.
    The serious shortcomings in the scientific data on PM2.5 
and on PM1.0 led me to not support the promulgation of 
either an annual or a 24-hour PM2.5 standard. I reluctantly 
noted that if EPA was going to propose a PM2.5 standard, I 
would set the 24-hour standard at 75 g/m3 and an 
annual standard at 25 g/m3. These would represent 
levels that would likely not result in misdirected control strategies 
while PM2.5, and hopefully also other PM metrics are 
measured throughout the country. A national strategy to better 
characterize PM air quality would also provide the groundwork for 
development of a cost-effective PM control strategy. And, most 
importantly, there is an urgent need to initiate multiple long-term 
prospective epidemiologic studies to assess if there is currently a PM 
problem and, if so, what specific size or chemical fractions are 
responsible. There is an urgent need for research to establish a 
mechanism-based causal linkage between PM fractions to be regulated and 
human disease.
    To address research needs such as I have outlined in general terms 
will require expenditures on the order of $50 million per year for 5 
years compared to the less than $20 million EPA is expending on PM 
research in 1997. The alternative to making the research investments 
and acquiring information for a science-based standard is to proceed 
blindly with development of standards that will have a multibillion 
dollar impact and may or may not impact positively on human health. I 
urge Congress to provide EPA guidance for immediately initiating the 
expanded research program needed to establish science-based NAAQS for 
PM.
                               reference
Thurston, G.D., Ito, K., Kinney, P.L., and Lippmann, M. (1992). A 
    multi-year study of air pollution and respiratory hospital 
    admissions in three New York State metropolitan areas: results for 
    1988 and 1989 summers. J. Exposure Anal. Environ. Epidemiol. 2:429-
    450.
    [GRAPHIC] [TIFF OMITTED] TH050P1.140
    
    [GRAPHIC] [TIFF OMITTED] TH050P1.141
    
    [GRAPHIC] [TIFF OMITTED] TH050P1.142
    
   Response of Dr. McClellan to an Additional Question from Senator 
                               Hutchinson
    Question. The 1990 Clean Air Act Amendments required the EPA to 
have an independent assessment, which was conducted by the National 
Research Council. I have the report here. The committee on Tropospheric 
Ozone Formation and Measurement was established by the NRC to evaluate 
scientific information relevant to precursors and tropospheric 
formation of ozone and to recommend strategies and priorities for 
addressing the critical gaps in scientific information necessary to 
help address the problem of high ozone concentrations in the lower 
atmosphere. One of the findings in the study suggests that in many 
urban cores and their environs, even if anthropogenic (man made) VOC 
emissions are totally eliminated, a high background concentration of 
reactive biogenic VOCs will remain.
    Further, the Southern Oxidants Study, conducted at North Carolina 
State University, states that ``the complete elimination of 
anthropogenic VOC emissions will decrease peak ozone concentrations in 
Atlanta, but still leave parts of the metropolitan area above the 
present ozone standard under some meteorological conditions.'' This 
statement refers to the current standards, not even the more stringent 
proposed standards.
    With this said, is it possible that even if we eliminate all man-
made ozone, that other areas in the country could still be out of 
attainment for ozone?
    Response. Yes, if a stringent ozone standard of less than 90 part 
per bullion with an 8 hour averaging time is promulgated it is quite 
likely that some areas of the country, such as the south eastern U.S. 
with high background concentrations of reactive biogenic VOCs, will be 
out of attainment. The lower the 8 hour standard is set the higher the 
probability that areas will be in non-attainment and the larger the 
geographic area impacted.
                                 ______
                                 
   Response of Dr. McClellan to an Additional Question from Senator 
                               Lieberman
    Question. In your statement, you express reservations as to the 
extent to which ozone exposures are a significant contributor to the 
asthma problem. But don't you agree that ozone exacerbates the asthma 
problem even if we don't know that ozone causes it?
    Response. Yes, ozone is one of many factors that can trigger 
asthmatic responses in asthmatic individuals. However, there is no 
evidence that ozone is the underlying factor causing the individual to 
be an asthmatic.
[GRAPHIC] [TIFF OMITTED] TH050P1.144

[GRAPHIC] [TIFF OMITTED] TH050P1.145

Prepared Statement of Dr. Anne E. Smith, Vice President, Decision Focus 
                              Incorporated
    My name is Dr. Anne E. Smith. I am a Vice President and Principal 
of Decision Focus Incorporated, a consulting firm with offices in 
Mountain View, CA, Washington, DC, and London, UK. I have 20 years of 
experience in environmental risk assessment and risk management, 
founded on a Ph.D. in economics from Stanford University. I started my 
professional career in the U.S. EPA's Office of Policy, Planning and 
Evaluation in 1977, where I was involved in air quality issues such as 
airborne arsenic regulations and EPA's air cancer policy. Over the 18 
years since, I have contributed to a wide range of major environmental 
science/policy assessments for the U.S. Environmental Protection 
Agency, the National Acid Precipitation Assessment Program, the Grand 
Canyon Visibility Transport Commission, the Electric Power Research 
Institute, the Gas Research Institute, and many others.
    In 1980, I was one of the experts selected by the U.S. 
Environmental Protection Agency's Office of Air Quality Planning and 
Standards to develop methods for assessing risks from criteria air 
pollutants, with a demonstration assessing risks from ambient carbon 
monoxide. I also served the United Nations Economic Commission for 
Europe in preparing a plan for analyzing acid rain control strategies. 
In the late 1980's, I worked closely with the Director of the U.S. 
National Acid Precipitation Assessment Program, advising on methods for 
integrating the scientific research into a comprehensive assessment. 
Recently, I developed the system used by the Grand Canyon Visibility 
Transport Commission to assess alternative policies for managing the 
particle precursors that contribute to impaired visibility in the 
Southwest. I also performed the economic analyses of the Commission's 
recommended visibility management alternatives. In addition to my 
consulting engagements, I have served on a number of expert panels on 
risk assessment, including two committees of the National Academy of 
Sciences, a Keystone Foundation dialog, and two committees of the 
United Nations Environment Programme.
    I am honored to have this opportunity to speak with you today about 
the science supporting the proposed new standards for fine particulate 
matter, PM2.5. My statement reflects my personal opinions, 
and not those of my company or any other group.
    In previous statements on this issue, I have likened the current 
situation for PM to the classic ``Shell Game''--the one where you try 
to guess which of several walnut shells is covering a pea. The proposed 
fine particle standard would force the expenditure of a great deal of 
money to reduce PM from a variety of sources, yet it is far from clear 
that the proposed standard would successfully target the true culprit 
that is causing adverse health impacts. We could turn over many empty 
shells, at great expense, but with little benefit to public health. I 
will explain why.
          what is the evidence of a pm-related health effect?
    There are a number of statistical, or ``epidemiology'', studies 
that seem to indicate that as ambient PM goes up and down, so too do 
the levels of health effects. However, when we observe two types of 
data going up and down together, we should not necessarily conclude 
that there is a causal relationship between the two phenomena. For 
example, if we were to observe such an association between heat stress 
mortality and ice cream cone sales, few people would suggest that one 
is caused by the other. The error in this example is so obvious to us 
because we all have a good understanding of the biological processes 
that result in heat stress. So, when we have statistical evidence of 
the sort that seems to suggest that ambient PM and mortality go up and 
down together, we also want to have scientific data about biological 
processes associated with PM to help us explain why we should believe 
this is a causal relationship and not just a statistical association.
     what does the science tell us about a biological explanation?
    If you review EPA's Criteria Document for PM, you will find that 
EPA concludes that ``no credible supporting toxicologic data are yet 
available.'' \1\ That is, when very high levels of various types of PM 
constituents have been inhaled or otherwise placed in the lungs of 
humans or animals, no one has observed a consistent response of the 
tissues that could be clearly linked to the health effects observed in 
the statistical studies. This inability to elicit significant and 
consistent biological responses to high levels of PM exposure is 
troubling, since you might expect adverse changes to be readily 
observable in laboratory experiments if the health effects were as 
large as the statistics seem to suggest. Toxicological evidence 
suggesting adverse health effects is present for other criteria 
pollutants (e.g., ozone, carbon monoxide, sulfur dioxide, nitrogen 
oxides, etc.).
---------------------------------------------------------------------------
    \1\ USEPA, Air Quality Criteria for Particulate Matter, April 1996, 
p. 13-31.
---------------------------------------------------------------------------
    The inconsistency between the statistics and the toxicology 
findings give us a strong motivation to try to develop a line of 
physiological or medical reasoning to explain whether or not these 
statistical relationships are biologically plausible. Attempts to 
provide such reasoning have been at best speculative. In the peer-
reviewed Criteria Document, EPA suggests that such reasoning is not 
compelling: ``There is . . . a paucity of information . . . that argues 
for the biologic plausibility of the epidemiologic results.'' \2\ Those 
attempts that have been made to construct an argument for biological 
plausibility for mortality (which is what is driving the large benefits 
estimates for the proposed standard) have suggested that the 
susceptible person is very much on the edge of life: for example, ``a 
triggering of a lethal failing of a critical function, such as . . . 
lung fluid balance . . . in [people] already approaching the limits of 
tolerance due to preexisting conditions.'' \3\ Under such 
circumstances, any of a number of air contaminants could have the same 
effect on the person. I don't find these plausibility arguments a 
compelling case for PM alone, because (1) these arguments could be used 
to explain the effects of many other air pollutants or weather 
patterns, while also (2) there are some very good reasons why the 
statistical results could be picking up the effect of one of these 
other possible contributors, as I will now explain.
---------------------------------------------------------------------------
    \2\ USEPA, Air Quality Criteria for Particulate Matter, April 1996, 
p. 13-31.
    \3\ See USEPA, Air Quality Criteria for Particulate Matter, April 
1996, p. 13-51 to 13-57.
---------------------------------------------------------------------------
what are the statistical reasons to doubt that pm is truly causing the 
                          observed mortality?
    We are faced with a situation where statistical results have not 
been corroborated by the rest of the sciences. As every first-year 
statistics student is taught, it is very easy to make big mistakes with 
statistics in this situation. This is why many of the researchers, 
whose findings EPA is using, describe PM as a possible ``surrogate 
for'' or ``correlate of'' a yet-to-be-known specific culprit.\4\
---------------------------------------------------------------------------
    \4\ See for example, Health Effects Institute, Particulate Air 
Pollution and Daily Mortality: Replication and Validation of Selected 
Studies, August 1995, page v.; and abstract of Pope et al., 
``Particulate Air Pollution as a Predictor of Mortality in a 
Prospective Study of U.S. Adults,'' Am. J. Respir. Crit. Care Med., 
Vol. 151, pp. 669-674, 1995.
---------------------------------------------------------------------------
    In statistical studies cited in EPA's Criteria Document, 
researchers looked for patterns of association between PM and 
mortality. The difficulty is that the data to do this contain many 
types of random variations, and the relationships we are looking for 
are probably complex. There are many types of statistical errors that 
one can commit when analyzing data that contain random variations, and 
there are many ways of trying to avoid or minimize statistical errors. 
The Criteria Document describes these statistical errors and the 
potential for misinterpreting statistical results.\5\ Due to these 
potential errors, the Criteria Document states that ``confident 
assignment of . . . variations in health endpoints to specific air 
pollutants may still require additional study'' \6\ and also concludes 
that ``much caution is warranted with regard to derivation or 
extrapolation of quantitative estimates of increased risks . . . based 
on available epidemiology information.'' \7\
---------------------------------------------------------------------------
    \5\ See USEPA, Air Quality Criteria for Particulate Matter, April 
1996, p. 13-51 to 13-57.
    \6\ USEPA, Air Quality Criteria for Particulate Matter, April 1996, 
p. 13-93 to 13-93.
    \7\ USEPA, Air Quality Criteria for Particulate Matter, April 1996, 
p. 13-32.
---------------------------------------------------------------------------
    The question for me has been, How much caution is warranted? 
Recently, I started to explore the likelihood that these errors might 
be large enough to affect the overall qualitative picture of PM risks 
that can emerge from statistical studies. As a result of some numerical 
experiments of my own, I believe that we need to really look much more 
closely at the potential errors in the statistical results than EPA has 
done to date. This is because the PM studies exhibit two distinct types 
of data problems at the same time. It may seem arcane to worry about 
combinations of problems, but the common statistical methods for 
detecting these errors individually don't work when both of the 
following common data problems are present in the same data set:

          (1) Several different pollutants in the data tend to rise and 
        fall with similar patterns (i.e., levels of various pollutants 
        are ``correlated''); and
          (2) There is more difficulty in getting good estimates of 
        people's actual exposures for some of the pollutants than for 
        others (i.e., there are differences in ``measurement errors'').

    These are very common problems for ambient pollution data. They 
both occur to a certain degree in all of the PM studies; they occur 
together. My numerical experiments with these two effects (correlations 
and differential measurement errors) have suggested to me that the 
epidemiological conclusions on PM may not only be subject to 
quantitative inaccuracy, but actually may be at odds with the truth in 
a qualitative sense. In my numerical experiments, a pollutant that was 
constructed to have a perfect relationship with the mortality data 
repeatedly appeared to have no statistically significant relationship. 
A pollutant that was constructed to have no effect on mortality 
repeatedly appeared to have a strong and statistically significant 
effect.\8\
---------------------------------------------------------------------------
    \8\ A briefing on these results could be provided to the 
Subcommittee.
---------------------------------------------------------------------------
    It is not surprising that I could generate such results, since the 
potential for such errors has been proven theoretically.\9\ However, I 
was surprised at how large and consistent the error in the statistical 
conclusions was when I used realistic values for degree of correlation 
and measurement error. If these typical data conditions really can be 
this effective in getting us to draw incorrect conclusions, then it 
means that we could be finding consistent statistical evidence 
implicating fine PM across numerous studies in many locations and over 
different periods of time, even if fine PM were having little or no 
causal effect on mortality at all. One or more other factors may be the 
real cause.
---------------------------------------------------------------------------
    \9\ See, for example, Lipfert, F.W. and R.E. Wyzga, ``Uncertainties 
in Identifying `Responsible' Pollutants in Observational Epidemiology 
Studies,'' Inhalation Toxicology, 1995, Vol. 7, pp. 671-89.
---------------------------------------------------------------------------
    If this potential statistical error cannot be addressed 
satisfactorily, then reduction of uncertainty about the causative role 
of PM10 or PM2.5 should depend very heavily on 
obtaining corroborating scientific evidence of a biological mechanism.
   but what if we decide to believe there is a fine particle effect 
                                anyway?
    I have given you my reasons for skepticism about the statistical 
evidence. But everyone has to draw their own conclusions, and other 
people may be prepared to believe that there really is a significant 
fine particle effect. If we were to have confidence there is a fine 
particle effect, then would we have enough information to set standards 
that are protective of the public health? I think not. The Shell Game 
still applies, and at this point, the existing statistical studies do 
not even pretend to be able to help.
    Why? Look at what PM2.5 consists of. Unlike any other 
criteria pollutant, it is made up of many components, and each 
component is like another shell that may or may not contain the pea. 
Particles come from many types of sources, and for each source, the 
particles consist of very different chemicals and particle sizes. These 
differences may be highly significant for health. Not one of the 
available statistical studies on PM has attempted to unravel the roles 
of all the key types of PM constituents, simply because there are no 
statistically usable data about how these constituents vary in 
different places and at different points in time. As a result, consider 
the effect on these policy-relevant questions:
     Are some specific PM constituents creating a toxic effect, 
while other parts of the PM mix are non-potent? . . . No one yet knows.
     Have we deduced the likely importance of the various 
constituents from biological data? . . . Not yet.
     If we require reductions of fine particles generically, 
can we be confident that the true culprit or culprits will end up being 
controlled? . . . No.
    The true culprit is not known, and better statistical analysis will 
not resolve this uncertainty; only better exposure data will. Better 
laboratory and clinical-level information on health effects will also 
help. Until we have data that can start to reveal the roles of the 
constituents in the PM mix, and the role of PM versus other pollutants, 
we cannot expect to have better answers to these important policy 
questions. Thus, use of current scientific information to set public 
policy amounts to playing a classic ``Shell Game,'' even if you believe 
fine particles cause adverse health effects.
    Let me try to illustrate the dilemma by reviewing some of the 
hypotheses described in the Criteria Document:
     Some toxicological evidence points not to the fine 
particles, but the ultrafine particles (e.g., less than 0.1 m 
in diameter).\10\ This would suggest that regulations should target 
combustion sources that are very close to people, such as automobiles.
---------------------------------------------------------------------------
    \10\ USEPA, Air Quality Criteria for Particulate Matter, April 
1996, p. 13-76 to 13-78.
---------------------------------------------------------------------------
     Another hypothesis relates to how acid the particles 
are.\11\ Acid particles mostly come from sources of SOx and 
NOx, such as power plants.
---------------------------------------------------------------------------
    \11\ USEPA, Air Quality Criteria for Particulate Matter, April 
1996, p. 13-72 to 13-76.
---------------------------------------------------------------------------
     Yet another hypothesis points to long-term accumulation of 
particles in the lungs.\12\ This would suggest controls on those 
particles that are not soluble, such as road dusts, and soot from 
diesel combustion.
---------------------------------------------------------------------------
    \12\ USEPA, Air Quality Criteria for Particulate Matter, April 
1996, p. 13-23.
---------------------------------------------------------------------------
    The list of hypotheses and potential culprits goes on. It seems 
unlikely that all of the hypothesized physiological effects will turn 
out to be equally important. Until we know which of the hypotheses to 
believe, we run the risk of controlling particles that don't 
significantly harm the public health. And, we run the risk of not 
controlling particles that do create a public health hazard. I do not 
have confidence that we will end up controlling the right constituent 
if we set a generic fine particle standard as proposed.
  how has epa communicated about these uncertainties in its risk and 
                         benefits assessments?
    EPA's peer-reviewed Criteria Document for PM describes the pitfalls 
that need to be considered in the use of the statistical findings,\13\ 
and issues warnings about using the statistical results as an actual 
dose-response:
---------------------------------------------------------------------------
    \13\ USEPA, Air Quality Criteria for Particulate Matter, April 
1996, p. 13-51 to 13-57.

          ``There remains much uncertainty . . . regarding the shapes 
        of PM exposure-response relationships, the magnitudes and 
        variabilities of risk estimates for PM, the ability to 
        attribute observed health effects to specific PM constituents . 
        . . and the nature and magnitude of the overall public health 
        risk imposed by ambient PM exposure.'' \14\
---------------------------------------------------------------------------
    \14\ USEPA, Air Quality Criteria for Particulate Matter, April 
1996, p. 13-30.

    Despite these warnings in the peer-reviewed Criteria Document, 
EPA's Staff Paper and its Regulatory Impact Analysis have all used the 
statistically derived estimates as if they give us a reasonable 
approximation of a causal relationship, with no uncertainty other than 
the error bars reported in the single study used for each health 
endpoint. As I have explained above, those statistically derived error 
bars may themselves be unreliable. And, in the case of the benefits 
ranges in the Regulatory Impact Analysis, even the statistical error 
bars have been dropped; uncertainty analysis has devolved to two point 
estimates from two individual studies,\15\ and EPA seems to imply that 
this is the major source of uncertainty in these benefits estimates:
---------------------------------------------------------------------------
    \15\ The estimate of $58 billion is based on ``short-term 
mortality'', using the 1996 Schwartz et al. ``Six Cities'' study. The 
estimate of $119 billion is based on ``long-term mortality'', using the 
1995 Pope et al. Study. No uncertainty of any sort is incorporated into 
any benefits estimates in the Regulatory Impact Analysis other than 
whether short-term or long-term mortality is the relevant health 
endpoint for making benefits estimates.

          ``The uncertainty associated with the benefits estimates are 
        substantial. In particular, benefit estimates vary greatly 
        depending [whether the long-term or short-term mortality study 
        is used to estimate mortality benefits].'' (emphasis 
        added).\16\
---------------------------------------------------------------------------
    \16\ USEPA, Office of Air Quality Planning and Standards, 
Regulatory Impact Analysis for Proposed Particulate Matter National 
Ambient Air Quality Standard, November 4, 1996, p. 10-4.

    Thus, EPA has made several very important presumptions in the risk 
analyses and benefits estimates that it is using to support its 
proposed PM2.5 standards:
     EPA's risk analysis presumes that if the statistical 
indicator or surrogate is controlled, that the actual culprit also will 
be controlled.

          Until we are confident that the statistical association is 
        evidence of causation, this is like the ancient Greek practice 
        of killing the messenger who delivers bad news. For example, 
        ambient levels of PM might simply be correlated with another 
        factor that is the true culprit, such as carbon monoxide or 
        weather. Reducing PM would not produce any health benefits--at 
        the moment it is still only a kind of ``statistical 
        messenger'', telling us that some kind of health effect exists 
        in our environment.

     Even if PM2.5 is a problem, EPA's risk analysis 
also presumes that any action taken to reduce PM2.5 will 
certainly control the specific culprit.

          For example, if organic carbon particles are the culprit, 
        controls on SOx and soot are still assumed to 
        provide health benefits. This is like assuming that we can win 
        the Shell Game no matter what shell we look under.

    There are many other types of uncertainties in the risk analysis 
that EPA's staff also have not incorporated, and which I have described 
in earlier formal written comments to EPA.\17\ Overall, EPA's estimates 
of the benefits of the proposed PM2.5 standards do not 
reflect the real uncertainties that statisticians openly acknowledge in 
their publications, and which EPA describes in its own Criteria 
Document. The $58 to $119 billion per year of benefits that EPA 
estimates we will obtain from the proposed PM2.5 standard 
\18\ is actually like a lottery that we might win--if all of these 
presumptions are correct. At the same time, there is a substantial 
probability that the benefits could be very small, even zero.
---------------------------------------------------------------------------
    \17\ Smith, Anne E., ``Comments on Risk Analysis in EPA's Draft 
Staff Paper for a Particulate Matter National Ambient Air Quality 
Standard'', submitted with the official comments from the Utility Air 
Regulatory Group on the Draft PM Staff Paper, June 6, 1996. (Note: 
Although this reference provides comments on the draft version of the 
Staff Paper, the concerns that it raises remain relevant to the final 
Staff Paper.)
    \18\ USEPA, Regulatory Impact Analysis for Proposed 
PM2.5 Standard, November 1996, table 9.8.
---------------------------------------------------------------------------
             does the nation want to play this shell game?
    This is a valid policy question. Given the large cost of the 
proposed regulation, it deserves an open public debate tempered with a 
willingness to acknowledge the true state of scientific understanding. 
Since the costs of any additional regulation would be undertaken with a 
degree of uncertainty that has the quality of a Shell Game, it is 
essential to good public policy that this decision be informed by 
estimates of risks and benefits that properly reflect the true extent 
of uncertainty that we are facing.
    The state of science leaves a reasonable chance that the proposed 
PM2.5 standard would not generate any significant benefits 
at all. In such a situation, it is also reasonable to consider whether 
there are more effective ways of protecting the public health. I have 
seen no serious discussion from EPA of the merits of regulatory options 
other than a generic PM2.5 standard. The proposed 
PM2.5 standard has not been designed to try to manage the 
uncertainties I have described. It does not account for or suggest the 
relevance of trying to maximize the chances that the most likely 
culprits will be controlled. Why should anyone expect this standard to 
accidentally hit the right target?
    We should try to aim more carefully, with a more thorough 
consideration of the uncertainties, and of alternatives that can 
improve our likelihood of achieving the desired public health benefits. 
I am not suggesting years of delay . . . I am suggesting better risk 
management through a more complete assessment of the uncertainties, and 
a more complete assessment of alternative regulatory approaches.
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     Prepared Statement of Dr. Joel Schwartz, Associate Professor, 
Department of Health, Harvard School of Public Health, Harvard Medical 
                                 School
    I have several points I would like to make today:
    1. EPA is not out in front of the science on the proposed particle 
standard, but rather lags behind a number of governments in Western 
Europe and International Scientific Bodies. The proposed particle 
standard was approved by its own scientific review panel. Following 
those nations in reducing its particle standard will avoid tens of 
thousands of early deaths in the United States.
    2. Substantial evidence exists that fine combustion particles of 
all types are associated with deaths, hospital admissions, and 
respiratory illness.
    3. Despite claims to the contrary, recent toxicological studies 
show that animals exposed to combustion particles in controlled 
conditions exhibit the same effects seen in human epidemiology studies.
    4. The focus on combustion particles, rather than on dust, is 
supported by physiology, toxicology, and epidemiology. This strategy 
avoids costs to control particles which have been shown not to affect 
public health.
    Today, there is a strong scientific consensus that particulate air 
pollution at levels below the current EPA standard are associated with 
substantial increases in mortality and morbidity. Last year, the 
British Government's scientific panel reviewed the epidemiological 
studies of the association between particulate air pollution and daily 
deaths and found they were properly done, consistent across many 
cities, supported by morbidity studies, and concluded that it would be 
imprudent not to consider those associations causal. They recommended 
that the British government set a new particle standard at a level that 
is only one third of the current US standard.\1\ The World Health 
Organization recently convened a panel of international experts to 
develop a particle criteria document. They also concluded that there is 
strong evidence that particulate air pollution below current standards 
is responsible for increased deaths, hospital admissions, and 
illnesses, and published dose-response relationships for countries to 
use in standard setting. These World Health Organization relationships 
predict that the proposed EPA standards will avoid tens of thousands of 
early deaths per year. A Swiss Government scientific review panel has 
likewise recommended a new particle standards be set at a level of one 
third of the current EPA standard. Despite obfuscatory arguments by 
industry-supported scientists, the Clear Air Scientific Advisory Panel 
voted to approve a proposed range of 12 to 20 g/m3 
as an annual average standard for fine particles. The EPA proposal of 
15 g/m3 is in the middle of this range.
---------------------------------------------------------------------------
    \1\ Expert Panel on Air Quality Standards. Particles, Department of 
the Environment. London: HSMO, 1995; p.30.
---------------------------------------------------------------------------
    The reason why so many scientific bodies have reached this 
conclusion is the vast scope of literature indicating that particulate 
air pollution has these effects. For example, studies have shown that 
increases in daily particle levels are followed by increases in daily 
deaths in Amsterdam, Athens, Barcelona, Basel, Berlin, Birmingham, 
Boston, Chicago, Cincinnati, Detroit, Dublin, Erfurt, Eastern 
Tennessee, London, Los Angeles, Lyon, Madison, Milan, Minneapolis, 
Mexico City, New York, Philadelphia, Provo, Rotterdam, Santiago, Santa 
Clara, Steubenville, St. Louis, Sao Paolo, Topeka, Valencia, and 
Zurich. Recent animal studies have corroborated these findings, showing 
toxic effects of fine particles, especially in sick animals.
    Having failed to convince the scientific community and the 
established scientific bodies designated to review the merits of their 
case, industry has launched a lobbying offensive to convince political 
leaders and the general public with the same arguments that failed to 
sway a more technically sophisticated audience.
    One common argument given is that even if particles are causing 
tens of thousands of early deaths per year, we should not regulate them 
because we do not know ``which particles'' to regulate. Absent that 
knowledge, we might waste money regulating the wrong source. I will 
comment on the scientific aspects of this issue. Airborne particles are 
a complex mixture of particles differing by size, chemical composition, 
and structure. Fine particles, which are the focus of this regulation, 
are almost entirely generated by combustion, that is, the burning of 
fuel or other high temperature processes that generate energy, propel 
automobiles, or produce products. Each combustion source, in itself, 
generates a complex mixture of particles. Hence control strategies to 
reduce exposure to fine particles will never focus on a specific 
particle, they will focus on sources. The question becomes, then, 
whether the health effects are due to the types of particles generated 
by one or only a few of the sources, and whether we might waste 
resources regulating sources that have little health impact.
    Fortunately, the vast range of locations where airborne particles 
have been associated with increased deaths and hospital visits allows 
us to examine the association in locations where each of the major 
sources is the predominant source of fine particles. Sulfate particles 
from coal burning power plants predominate in the Northeastern US and 
Canada, and many studies have shown associations between those 
particles and daily deaths and hospital visits. But in Santa Clara CA, 
a winter time study by Fairley showed that particles that were 
predominantly wood smoke, with almost no sulfates, were also associated 
with more deaths, and wood smoke predominates in Spokane and Seattle, 
where particles were associated with increased hospital visits. In Los 
Angeles, Sao Paolo, and Mexico City, the predominant source is 
automobile emissions, in London today it is diesel exhaust, in Erfurt 
Germany and in Dublin it is coal soot, and airborne particles have been 
associated with increased deaths per day in all these locations. The 
epidemiologic data indicates that all of the major sources of airborne 
particles contribute to the excess deaths imposed on the public by 
particulate air pollution.
    In toxicological studies, Godleski of Harvard has shown that 
exposure to either concentrated air particles from the Boston air 
(primarily sulfates from coal burning powerplants) or to resuspended 
fly ash from an oil boiler, killed rats with chronic bronchitis. These 
effects occurred at particle concentrations that were not 
extraordinary, but comparable to concentrations seen in U.S. cities. 
Costa's lab at the US EPA has also shown toxicity using either oil fly 
ash or concentrated particles from air in Washington DC (sulfates from 
coal) or a German city (traffic and industrial pollution).
    EPA has proposed, with CASAC approval, to focus on the fine 
particles due primarily to combustion, rather than windblown dust, in 
tightening the particle standard. Industry critics have also challenged 
this decision. But EPA's focus on true ``pollution'' and not dust is 
supported by a study following the Mount St. Helens eruption, which 
showed very high concentrations (10,000 g/m3) of 
dust had little health effect. A Centers for Disease Control study of a 
dust storm in southeastern Washington State found little impact from an 
episode where particle concentrations exceeded 1000 g/
m3. In contrast, an episode of combustion derived fine 
particles at half those concentrations was associated with a 
substantial increase in daily deaths, hospital admissions, and 
ambulance calls in West Germany in 1985. The great air pollution 
episodes of the mid century (London in 1952, Donora Pa in 1948, and the 
Meuse Valley in Belgium in 1930) were all episodes of combustion 
related fine particles that occurred in stagnant air conditions which 
would result in low dust levels. And the increased deaths from all of 
these episodes are widely agreed to have been causal.
    We also know that it is only the fine particles that can penetrate 
deep into the lung past our primary respiratory defense mechanisms. 
This is important because the studies of daily deaths and particulate 
air pollution show a much larger percent increase in pneumonia deaths 
than of all deaths. Pneumonia is a disease of the lower lung, to which 
fine particles but not coarse particles, penetrate. The increase in 
heart disease deaths also seems more plausibly related to particles 
that penetrate in the breathing region of the lung which is closely 
connected to the heart.
    The animal data also clearly point to the fine particles as much 
more toxic than the coarse particles. When Dreher and coworkers at EPA 
placed fine particles and coarse particles collected from the air in 
Washington, DC in the lungs of animals, they found substantial toxicity 
from the fine particles, but little from the coarse particles. The same 
laboratory has shown that fine combustion particles can induce life-
threatening heart arrhythmia's in animals with chronic lung disease. 
Osornio-Vargas and colleagues at the National Institute of Health 
assessed the toxicity to lung cells of particles sampled from different 
areas of Mexico City. The particles from the northern part of the city, 
which were primarily from combustion were much more toxic than the 
particles from the south, which included much more dust.
    Costa and coworkers have shown that the toxicity of airborne 
particles is related to the concentration of soluble metals on their 
surface, and that coarse particles have much lower concentrations of 
soluble metals than fine combustion particles. This may explain the 
differences in the toxicological data.
    As noted above, Godleski has exposed rats to concentrated fine 
particles from Boston. The exposure averaged less than 100 g/
m3 over a 3-day period, but peaked at 288 g/
m3. While healthy rats were not affected 37 percent of the 
bronchitic rats died following this modest exposure. These results 
agree with the epidemiology studies which show the greatest increases 
in deaths occur in people with chronic lung disease. Even lower 
concentrations of fine particles from Boston air were associated with 
changes in electrocardiograms in healthy dogs. These electrocardiogram 
changes are know risk factors for sudden deaths. Again, the 
epidemiology studies have shown that these deaths are particularly 
affected by airborne particles.
    Epidemiology studies also support the conclusion that the fine 
combustion particles, and not the dust, are responsible for the 
observed health effects. In 1994 Thurston and coworkers at New York 
University reported that coarse particles were not associated with 
hospital admissions for respiratory disease in Toronto, but that fine 
particles were. We reported the same results for daily deaths in six US 
cities last year. Hence the epidemiology is quite consistent with the 
toxicology, and what we know about the penetration of particles of 
different sizes into the lung.
    Industry has argued that these epidemiologic results all derive 
from measurement error. These arguments about measurement error have 
been made consistently by Dr. Lipfert throughout the process of writing 
the EPA criteria document, and its review by CASAC. They represent 
nothing new, were available to CASAC when it approved moving to a fine 
particle standard, and are contradicted by the animal studies. The 
latest version of this argument suggests that we lose some of the 
coarse particles of our current monitors, but the amount varies from 
day to day. This will reduce the correlation of coarse particles with 
mortality. However, fine particles are also lost by current monitoring 
techniques. Because the monitors collect particles for 24 hours and 
then measure them, volatile chemicals on the fine particles often 
escape off the filters before the 24 hour period is up. Hence both 
measures are subject to measurement error, and it is not clear which is 
larger.
    Other studies have looked at the effects of long term average 
exposure to fine versus coarse particles. This is important, because 
averaging over many measurements averages out the measurement error. 
For example, Figure 1 shows data from the 24 City Study, which was 
published last year. The percent of children (aged 8-12) with abnormal 
lung function in each town (after controlling for age, sex, height, and 
weight) is plotted against the mean concentration of fine particles in 
that town. A strong trend is seen, with the percent of children with 
abnormal lung function increasing threefold as you go from the less 
polluted to the most polluted communities. Figure 2 shows the same 
percentages plotted against the concentration of coarse dust particles. 
No evidence of any association is seen.
    In summary, and international scientific consensus has emerged on 
the adverse effects of combustion related particles. This has resulted 
in widespread efforts to tighten airborne particle standards throughout 
the western world. The EPA proposal is not an attempt to push the 
limits, it follows conclusions by other scientific review bodies and 
governments.
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 Prepared Statement of Dr. Ronald E. Wyzga, Business Area Manager for 
    Air Quality, Health, and Risk Studies, Electric Power Research 
                               Institute
    I am Dr. Ron Wyzga. I work for the Electric Power Research 
Institute (EPRI), in Palo Alto, California. The Institute, which is a 
voluntarily funded 501(c) organization operating in public interest by 
electric utilities, is over 20 years old and has an annual budget of 
approximately $500 million. The Environment group is part of EPRI with 
an annual budget of approximately $50 million; this is one of the 
largest privately funded health & environmental research organizations 
in the world. Within the Environment Group, I am responsible for air 
quality research, including research on the health effects of 
particulate air pollution. All EPRI health and environmental research 
is published and made available to the interested public, and 
researchers are encouraged to publish their results in the peer-
reviewed scientific literature. Many of the particulate matter (PM) 
health studies cited in the EPA Criteria Document and Staff paper were 
funded or partially funded by EPRI, including much of the research 
undertaken at the Harvard School of Public Health on this issue.
    Personally I became interested in the topic of PM and health while 
a graduate student at the Harvard School of Public Health. My doctoral 
dissertation in biostatistics covered this topic back in 1971. Since 
then I have been actively engaged in environmental health and 
statistics issues. I have co-authored a book and written over 40 papers 
that have been published in the peer-reviewed scientific literature. I 
have obtained many significant recognitions from my peers. I have 
served on and chaired subcommittees of the National Research Council, 
National Academy of Sciences. I have served or chaired several EPA 
Science Advisory Board Committees. I have also been appointed a Fellow 
of the American Statistical Association. The comments that I present 
today reflect my personal views and judgments as a scientist, who has 
worked in this area for over twenty-five years. These comments should 
not be construed to be the official opinion of my employer or of any 
associate.
    Below I cite several studies and documents. In an effort to achieve 
brevity and avoid technical details, I do not include data or attach 
papers. At times, to be more understandable, I try not to use 
statistical jargon. I have the back-up technical material, which I 
would be happy to share with you if you desire.
                           scientific issues
    Several statistical studies suggest an association between 
particulate matter and health. I have authored some of these; EPRI has 
funded many more. Does this association mean that a reduction in 
particulate matter air pollution will lead to public health benefits? I 
believe the correct answer to this question is that no one knows. We 
have positive studies, but these results are tempered by the following 
issues, which are discussed in more detail below:
    (1) Study results are not consistent. There are several studies 
which fail to find any significant positive association between health 
and particulate matter.
    (2) Re-analyses of the data from existing studies do not support an 
unambiguous particulate matter-health association. The re-analyses by 
independent investigators do not agree with the original investigators' 
conclusions of a significant association between particulate matter and 
health. This is true whether the re-analyses have been funded by public 
(e.g., US EPA) or private entities.
    (3) There is no one correct way to analyze data to determine the 
relationship between health and particulate matter. The results of 
these analyses differ according to the methods used. Hence flexibility 
in choice of analysis can influence the results in a way that 
invalidates commonly used statistical tests.
    (4) It has not been possible in current studies to disentangle the 
effects of particulate matter air pollution from those of other 
pollutants and weather.
    (5) There is an inconsistent relationship between the levels of 
particulate matter that people actually breathe and (a) the measure of 
particulate levels used in air pollution health studies as well as with 
(b) the levels of particulate matter that would be regulated.
    (6) There is no accepted biological explanation for the results of 
the statistical models.
    (7) If there is an association between particulate air pollution 
and health, there is no extant health information that suggests greater 
health effects associated with PM2.5 (particulate matter 
less than 2.5 microns in diameter) than with PM10 
(particulate matter less than 10 microns in diameter).
    (8) To understand any health effects and to manage PM2.5 
concentrations, we need a more accurate definition of PM2.5 
than that to be measured by the proposed Federal reference method.
                       specific scientific issues
    The studies are not consistent. The evidence for particulate air 
pollution health effects comes from epidemiology studies (studies of 
people in the real world), not laboratory or animal studies. Several 
epidemiology studies report no significant relationship between 
particulate matter and public health. There are negative studies; for 
example, studies by Styer et al. of Salt Lake City; Morris of 
Manchester, England; Roth of Prague, The Czech Republic; Burnett et al. 
of ten Canadian cities, and Abbey et al. of California. In addition, 
the recent APHEA study of the European Commission, found no significant 
relationship between PM and mortality in several Eastern European 
cities, where pollution levels were high. Why are these studies 
inconsistent with other studies that report a significant relationship 
between PM and mortality? The methods used in the positive and negative 
studies appear to be reasonable and suggest no obvious error. Is it 
chance or is there some explanation why positive results are found in 
some locations, but not in others?
    Re-analyses of existing studies do not support an unambiguous 
particulate matter-health association. Several studies that have 
reported significant associations between particulate matter and health 
have been re-analyzed. By and large these re-analyses do not reach the 
same conclusions as the original studies. For example, under contract 
to U.S. EPA, Davis et al., at the National Institute of Statistical 
Sciences, re-examined daily mortality and particulate matter 
relationships in Birmingham, Alabama. The Davis et al. analysis tries 
to insure that the effect of hot and humid days is considered in any 
model trying to assess the influence of particulate matter on 
mortality. They conclude: ``When we use the same variables as included 
by Schwartz, we obtain similar results to his. But when we use 
alternative models we obtain different conclusions. In particular, when 
humidity is included among the meteorological variables (it is excluded 
in the analysis by Schwartz), we find that the PM10 effect 
is not statistically significant.'' Roth and Li in a study supported by 
EPRI similarly examined Birmingham mortality data, as well as hospital 
admissions data; they also could find no effect of particulate matter 
on health. The Health Effects Institute, in a project supported by the 
U.S. EPA and the automobile industry, verified the numerical 
correctness of the results of Dockery and Schwartz in Philadelphia, but 
they also tried alternative models in their research project and found 
it impossible to definitively link particulate pollution with increased 
Philadelphia mortality. After application of several models, they 
conclude: ``We caution against using the model coefficients directly to 
estimate the potential consequences of lowering concentrations of the 
individual pollutants through regulatory measures; the pollutant 
concentrations are correlated and the estimates of their effects depend 
on modeling assumptions.''
    In a paper published in the journal Epidemiology, Moolgavkar and 
Luebeck presented an independent analysis of the relationship between 
daily air pollution and mortality in Philadelphia. They conclude: 
``[I]n Philadelphia, each component of air pollution, when considered 
alone, is an important predictor of mortality in at least one season. . 
. . When all pollutants are entered simultaneously into the model, 
however, nitrogen dioxide appears to emerge as the most important 
pollutant.'' In a second study Moolgavkar and his colleagues also 
``failed to replicate findings'' of the study of the relationship 
between daily deaths and particulate air pollution in Steubenville, 
Ohio.
    EPRI has recently sponsored a re-analysis of the relationship 
between daily respiratory hospital admissions and air pollution in 
Detroit. Joel Schwartz of Harvard had previously analyzed these data 
and found a statistically significant association between hospital 
admissions and particulate air pollution. He was kind enough to send 
his data to a group of statisticians at Stanford University. When they 
applied the same model as Schwartz, they obtained similar results. When 
they incorporated the potential influences of day of week into the 
model, particulate matter was no longer a significant predictor of 
hospital admissions. This is potentially important because hospital 
admissions vary by day of week. If they go down on weekends and 
pollution is lower on weekends, and if an investigator did not consider 
``day of week'' in the model, then the investigator could wrongly 
attribute the effects of weekend behavior to pollution.
    Can we say which analysis is the correct one for each of these data 
sets? By and large there is no best way to analyze the data. Each 
individual may have his or her favorite method, but in reality we are 
addressing a complex statistical issue for which there is no one 
correct way to analyze the data. Our problem is that different methods 
give different results. We cannot know which result to believe, but it 
is important to know that these differences occur.
    Could the methods chosen to analyze the data influence the results? 
It is clear that the different models can give different results. None 
of the models fits the data well; hence it is not possible to decide 
which model is best. There is no one correct way to analyze a data set. 
Hence an investigator has considerable freedom in the choice of his/her 
model. There are different ways to address the seasonal nature of the 
data; i.e., the patterns due to the fact that there are more health 
effects, such as deaths, in winter than in summer. An investigator can 
choose weather factors and the other pollutants he or she may place in 
a model. The investigator can decide whether to relate today's 
pollution with today's mortality, or yesterday's pollution with today's 
mortality or the average of the last 5 day's pollution with mortality. 
All of the above and more have been considered. Then there is the model 
construct itself; it could be linear, log-linear, or Poisson. Often an 
investigator may choose one method over another in order to ensure that 
all public health considerations are unearthed so that the public 
health can be protected at all costs. This has been a rationale for 
considering only one pollutant when others are equally likely to 
influence a health response; in their papers authors indicate that a 
specific variable was chosen because it maximizes the association 
between an air pollution variable and a health response. This may be 
``conservative'', but it does not provide an accurate estimate of 
effect or association.
    Usually we use a 5 percent level of significance in empirical 
research; that means that we accept that there is no effect when the 
chance of a positive result occurring is only one in twenty. However, 
the additional flexibility in model choice noted above alters the level 
of significance in statistical tests, making it more likely that the 
investigator will estimate a positive effect when none in fact occurs.
    There may be other factors associated with the complicated data 
sets with which we work. The data are complex time series data, and we 
have little detailed understanding of these data sets. The models we 
apply are relatively simple models. We assume they are adequate for our 
data. In an effort to test this, Lipfert & Wyzga undertook some initial 
analyses to determine how these models performed with unrelated data 
sets; e.g., pollution variables for one city and unrelated health data 
for a distant city.
    Our results are preliminary, but indicate some surprising 
significant relationships such as a statistically significant 
relationship between air pollution in one city and health impacts in a 
distant city. These provocative findings need to be resolved. It may be 
premature to suggest that they impact our evaluation of the current 
science, but it would be irresponsible not to investigate these 
findings further. I hope to clarify these results within the next 3 
months.
    Then there is the issue of pressures to emphasize positive studies. 
This is best described by the following quote from the July, 14, 1995 
issue of Science, entitled, ``Epidemiology Faces Its Limits.'' The 
article states ``Authors and investigators are worried that there's a 
bias against negative studies,'' and that they will not be able to get 
them published in the better journals, if at all, says [Marcia] Angell 
[Executive Editor] of the NEJM [New England Journal of Medicine]. ``And 
so they'll try very hard to convert what is essentially a negative 
study into a positive study by hanging on to very, very small risks and 
seizing on one positive aspect of a study that is by and large 
negative.'' Or, as one National Institute of Environmental Health 
Sciences Researcher puts it, asking for anonymity, ``Investigators who 
find an effect get support, and investigators who don't find an effect 
don't get support.'''
    Could PM be serving as an index for other pollution? If we 
regulated PM, would we achieve the health improvements we want? In 
other words can we disentangle the health effects of particulate matter 
from those of other pollutants and weather? To a limited extent we can, 
but we are hampered by two issues. All pollutants may be associated 
with health effects. Second, most urban pollutants are present at the 
same time. In addition, weather conditions can cause many pollutants to 
concentrate in an area at the same time, including those pollutants 
that are not measured. In fact weather conditions are often correlated 
with pollution as well.
    Hence it is difficult to disentangle any effects of various 
pollutants and to indicate which pollutant may be associated with a 
given health effect. The Health Effects Institute and the Moolgavkar 
and Luebeck quotes above address this problem. In addition, in a paper 
Lipfert and Wyzga published in the Journal of the Air and Waste 
Management Association, we examined many published studies that had 
looked at the relationship between daily mortality and various 
pollutants. We found that if a study had chosen to focus upon sulfur 
dioxide or nitrogen dioxide instead of particulate matter, that study 
found similar effects on daily mortality as did those studies that 
focused upon particulate matter. A focus upon carbon monoxide indicated 
somewhat larger effects than particulate matter, and a focus upon ozone 
gave somewhat smaller effects. Given the high correlation between the 
various air pollutants, an obvious conclusion is that if an 
investigator had elected to study another pollutant instead of 
particulate air pollution, he/she might well have concluded that the 
other pollutant was the pollutant of concern.
    Disentangling the various air pollutants is complicated because of 
statistical considerations. Lipfert and Wyzga have shown, and it is now 
widely accepted, that until one has an understanding of how well the 
measured pollution data represent the levels to which people are 
actually exposed, it is not possible to separate out the effects 
associated with various pollutants. The EPA Criteria document states, 
``Measurement error in pollutants or other covariates may also bias the 
results, . . . and the most poorly measured exposure covariate is 
usually the one that is driven toward no effect.'' Measurement error is 
caused by the fact that the amount of pollution measured by the monitor 
is not the same as that to which a person is exposed. This could be 
caused by inaccuracies in the instrument. It could be due to the fact 
that the monitor is not located in the same area of a city as an 
impacted individual, or it could be due to the fact that people spend 
most of their time indoors where pollution exposures may be very 
different from what is measured at a monitor.
    Is there any relationship between the concentration of particulate 
matter in the air people actually breathe with the levels used in air 
pollution health studies? We know very little about what pollution 
levels people are actually exposed to; we know even less about how the 
actual exposures of people to particulate matter relate to the levels 
measured at outdoor monitors, which can be very distant from people's 
homes. Available data show no consistent relationship between the 
levels of particulate matter people actually breathe and the levels 
measured at outdoor monitors. This is also true when we ask whether 
personal exposure data track outdoor levels over time. In addressing 
this issue in its Criteria Document, EPA depends upon a study of seven 
elderly Japanese living in non-smoking, non-carpeted, ``typical'', 
Japanese homes in Japan. For this group, there was a good relationship 
between personal exposures and ambient measures of PM10. The 
relevancy of this data set to Americans is, however, unclear. Other 
studies do not demonstrate as good a relationship between the air 
actually breathed and that measured at the monitors. A study in 
Phillipsburg, NJ looked at the relationship between personal (actual) 
exposures to PM10 and outdoor measures for 14 individuals. 
For the group as a whole, the personal exposures tended to increase 
with outdoor levels, but the results are not consistent across 
individuals. For some people a reduction in outdoor levels in 
PM10 would have no effect on the PM10 levels 
where people breathe. A study in Azusa, California compared the actual 
exposures and outdoor levels of ten people to PM2.5 and 
PM10 for periods of 7 days. The results were not consistent. 
For half of these people, the actual exposures to PM2.5 
decreased when outdoor levels of PM2.5 increased. No 
individual showed a striking positive relationship between personal 
exposures and outdoor levels.
    Some studies have looked at people who might be more susceptible to 
air pollution. A group at the Gage Research Institute at the University 
of Toronto studied 21 asthmatics for both winter and summer periods for 
a total of about 20 days each. A correlation co-efficient of 1.0 would 
mean perfect concordance; a correlation co-efficient of 0.0 would 
indicate absolutely no association between the two. The average 
correlation coefficient across subject between actual exposures to 
PM2.1 and measured outdoor levels was 0.11; (i.e., outdoor 
measures would explain about 1 percent of the variation in personal 
exposures.) This result suggests that changes in the outdoor levels of 
fine particulate matter (PM2.1) would have negligible impact 
on the asthmatics' actual exposures. EPRI sponsored a study of 
asthmatics in Uniontown, PA. Our contractors from the Harvard School of 
Public Health measured the personal exposures and ambient levels of 
sulfates, a component of particulate matter, and found good agreement 
between personal exposure and outdoor levels. Unfortunately this study 
did not consider particulate matter as a whole.
    We are currently supporting a study at Harvard School of Public 
Health of people with chronic obstructive pulmonary disease (COPD). We 
hope to understand the relationship between actual exposures of 
particulate matter (both PM10 and PM2.5) and 
outdoor levels. The first part of the study was undertaken in Nashville 
and showed absolutely no relationship between these two measures for 
the ten people studied. We are currently repeating that study in 
Boston.
    Why do actual exposures differ from levels measured at monitors? 
First of all, people spend little time in the vicinity of the monitor, 
which may not be in a very representative location. If an individual 
lives in the suburbs, and the monitor is in the center of the city, the 
monitor may not provide a good indication of the pollution level to 
which the individual is exposed. Second people, especially susceptible 
individuals, spend considerable time indoors, where some particulate 
matter may not be able to penetrate and where other sources besides 
outdoor air pollution can have considerable influence on a person's 
actual exposure to particulate matter. Sources of indoor particulate 
matter include passive cigarette smoke, vacuuming, dusting, pet dander, 
fireplaces and woodstoves, hairsprays, etc., etc. For this reason 
personal exposures to particulate matter are often higher than outdoor 
levels because when we move, we generate a cloud a fine particulate 
matter around us, not too unlike that generated by the PigPen character 
in the Peanuts comic strip.
    Is there any biological explanation for the results we see from 
these models? In its proposed decision to promulgate particulate matter 
standards, EPA states, ``it is generally recognized that an 
understanding of biological mechanisms that could explain the reported 
associations has not yet emerged.''
    Is there any reason to believe that PM2.5 is of greater 
health concern than PM10? There is no health evidence that 
PM2.5 presents a greater concern than PM10. In a 
recently published paper Lipfert and Wyzga reviewed 30 published papers 
(all that they could find as of that date) that examined the 
association between mortality and particulate air pollution. Some of 
these studies used PM10 as a measure of particulate air 
pollution; others used PM2.5. We compared the results of the 
studies that used PM10 to those that used PM2.5. 
The differences in estimated effects between the two particulate 
measures was small; if anything, the literature suggested greater 
effects were associated with PM10.
    There are a few studies that consider both PM10 and 
PM2.5. If we consider the estimated effects of 
PM10 and PM2.5 in a head-to-head comparison in 
these studies, we find little difference between the two indices. Where 
there is a difference, the estimated health effects of PM10 
appear to be greater. For example, in Table 13-5 of EPA's Criteria 
document, EPA summarizes the results of the Harvard 6-City Study. The 
table presents the estimated changes in relative risk for increased 
chronic mortality in adults. The higher the number, the greater the 
estimate of increased risk. For PM10 or PM15, it 
is 1.42; for PM2.5, it is 1.31. Lipfert and Wyzga compared 
the PM10 and PM2.5 results for all existing 
studies and found the estimated health effects of PM2.5 to 
be less than or equal to the estimated effects of PM10.
    Why then does the EPA say that there is need for a PM2.5 
standard to protect public health? The basis for this argument is a 
paper based upon the Harvard 6-city study. That paper estimates the 
association between daily mortality and PM2.5, 
PM10, and the difference between PM10 and 
PM2.5. EPA refers to the latter as the ``coarse fraction''. 
That study finds the strongest association between daily mortality and 
PM2.5 and the weakest association between daily mortality 
and the ``coarse fraction''. In our opinion the analysis is flawed, 
however, because of the measurement error issue. In a paper recently 
accepted by the Journal of the Air and Waste Management Association, 
Lipfert and Wyzga show that the comparisons between PM2.5 
and the ``coarse fraction'' are inappropriate without any correction 
for the difference in measurement error. There are at least two types 
of measurement error present in the data collected. First of all, an 
earlier paper by the Harvard investigators noted that the device used 
created inaccuracies averaging 43 percent for the ``coarse fraction''. 
Second since PM2.5 is more spatially uniform than is the 
``coarse fraction'', the readings from a single monitor in a large 
geographic region (up to nine counties) will be much more 
representative for PM2.5 than for the ``coarse fraction.'' 
These two factors will bias downward the estimated impact of the coarse 
fraction. Our conclusion in this paper is: ``In the specific study 
(Schwartz et. al, 1996) that we considered in detail, which employed a 
single monitor in each of six large metropolitan areas, we conclude 
that virtually nothing can be inferred about the true causal nature of 
daily mortality, the actual responses to these agents, or the shapes of 
the true response functions. Given the strong bias in favor of 
PM2.5 resulting from lower instrument errors, less spatial 
variability, the treatment of missing data, and the near significance 
of coarse particles in spite of these handicaps, the most prudent 
conclusion from this study would have been that there is no apparent 
significant difference in mortality associations by particle size.''
    How accurately can we measure PM2.5? A new standard, 
such as PM2.5, requires defining the substance, 
PM2.5, to be controlled. This is defined by the levels 
measured through an official reference method. For PM2.5 
this method is prescribed along with the proposed standard. Field 
testing of the reference method began late last fall. We too have been 
testing a suite of methods at the sites selected by EPA and/or State 
agencies. Our suite includes samplers that work on the same principle 
as the reference method. Test results are being analyzed by several 
groups; neither EPA nor our results have been published yet.
    Our initial results indicate that in some cities the reference 
method would not capture a substantial portion of the fine particulate 
constituents, especially those that are likely to evaporate during the 
measurement process. These results are consistent with theoretical 
expectation. Therefore, we predict that the reference method is likely 
to provide incorrect and incomplete information from the standpoint of 
characterizing and managing any potentially harmful constituents of 
particles. Instead promising newer technologies ought to be considered.
               scientific issues for the annual standard
    How strong is the evidence for that standard? The studies and 
issues I have discussed previously relate both to the daily and annual 
standards. Evidence to support changes in the annual standards come 
from a different type of study. Differences in the health of various 
communities are compared with differences in the air quality for these 
communities. Attempts are made to adjust for other factors (e.g., 
demographic or socio-economic factors) that may explain the health 
differences among communities. It is important that all potentially 
relevant factors be included in the analyses. This is particularly true 
for factors which vary regionally as does air pollution. These factors 
include regional differences in diet, lifestyle, and climate. Omitting 
such a factor from statistical analysis can shift the blame onto air 
pollution. These factors are referred to as confounding factors.
    These studies have improved recently with the study of defined 
cohorts for which we have some individual characteristics, such as 
smoking history. The ability of these studies to control for non-air 
pollution factors is however, limited by the information collected. EPA 
cites two of these studies as providing support for their proposed 
annual standard for PM2.5.
    The first study was based on differences in cohort survival rates 
among the cities studied in the Harvard Six Cities study. EPRI was a 
funder of this study. This study is confounded by the failure to 
account for known lifestyle differences across the six cities. For 
example, EPRI-supported research has shown that differences in the 
fraction of the elderly population with sedentary lifestyles in each 
area can account for most of the differences in mortality among the 
study cities; moreover, the predicted effect of this lifestyle factor 
matches almost perfectly the relationship estimated in an independent 
California study by Breslow and Enstrom.
    The second study also did not consider lifestyle factors; in 
addition, this study only evaluated mortality relationships with 
respect to sulfate and fine particles and did not test whether similar 
results might have been found for any other pollutants.
    Neither of these studies considered the fact that the evaluation of 
chronic health effects must consider the typically long latency periods 
of such diseases and the air pollution histories of the cities being 
studied. Typically, the dirtiest cities have already improved greatly; 
hence chronic health effects could be due to the past dirty air, which 
initiated the process, the end result of which we see today.
                              conclusions
    Would the changes in the proposed particulate standards lead to 
improvements in public health? No one knows. The results of positive 
statistical studies must be balanced by the following issues:
    (1) not all studies find a significant positive association between 
particulate matter and health;
    (2) re-analyses of existing studies, by a wide range of scientists, 
do not support the conclusions of the original studies that there is a 
significant association between particulate matter and health;
    (3) the choice of method to analyze data can influence the results;
    (4) it is very difficult and often impossible to determine which 
specific pollutant may be related to health consequences; is it 
particulate air pollution or some other factor;
    (5) there is an inconsistent relationship between the particulate 
levels in the air we actually breathe and that measured at monitors;
    (6) we have no biological explanation for the results of the 
statistical models;
    (7) if there is an association between particulate air pollution 
and health, there is no health information available that suggests 
greater health effects associated with PM2.5 than with 
PM10; and
    (8) to understand any health effects and to manage PM2.5 
concentrations, we need a more accurate definition of PM2.5 
than that of the proposed Federal reference method.
    It is clear that we are dealing with a very complicated situation; 
the findings to date raise the specter of an important public health 
issue, yet there remain many unanswered questions before we can 
confidently conclude that these effects are real and we know how to 
improve the public health. We clearly need to work together if we are 
to resolve these questions. We need to pool our resources, share our 
knowledge and data to resolve these questions. It is fortunate that we 
as a society have already committed to reducing air pollution and 
pollution levels are in decline.
    Let's continue to work together.
                                 ______
                                 
   Responses of Dr. Wyzga to Additional Questions from Senator Inhofe
    Question 1. EPA has emphasized studies that support their proposal; 
are there either old or new studies that come to the opposite 
conclusion?
    Response. There are many studies that do not demonstrate a 
consistent statistically significant association between air pollution 
and health. I cited several such studies in my statement, such as the 
studies of Styer et al. of Salt Lake City; Morris of Manchester, 
England; Roth of Prague, the Czech Republic; Burnett et al. of ten 
Canadian cities; and Abbey et al. of California. Reanalyses of existing 
studies also raise questions about the unambiguous association between 
health response and exposure to particulate pollution. These studies 
include Davis et al. of Birmingham, AL; Roth and Li of Birmingham, AL; 
Health Effects Institute of Philadelphia; Moolgavkar et al. of 
Philadelphia and of Steubenville, Ohio; and an EPRI reanalysis of 
Detroit.
    In addition, there are several recent studies that come to a 
similar conclusion: Bacharova et al. of Bratislava, the Slovak 
Republic; Balleser et al. of Valencia, Spain; Ponce de Leon et al., of 
London; Schouten et al. of ten Dutch cities; and Wojtyniak et al. of 
four Polish cities.
    There are two important factors to consider in this context. First 
of all, many negative studies don't get published. Journals are less 
likely to publish negative results than positive studies; hence there 
may be several studies with negative findings that have not been 
published, and we are therefore not aware of them.
    The second point is one that I made in my statement. In every case 
where the data from a positive study have been re-analyzed, the re-
analysis does not support an unambiguous statistically significant 
association between health and particulate matter. This is of concern 
because several key data sets are not available for re-analysis; hence 
it is unclear whether the results from these studies would remain the 
same if alternative, yet equally valid, statistical methods were 
applied to `them.

    Question 2. You mentioned the finding of statistical associations 
that clearly make no sense, that draw on similar techniques and some of 
the data used in EPA's studies; can you elaborate?
    Response. The most common type of study considered by EPA is one in 
which daily levels of a health index, such as hospital admissions or 
deaths, are related to daily levels in particulate air pollution, after 
adjusting for other factors such as day of week, weather, time of year, 
or other pollutants. In the past Fred Lipfert of Brookhaven National 
Laboratory and I have examined many such data sets. We decided to look 
at relationships between pollution in one city and health indices in 
distant areas to see whether or not the methods used would provide 
similar results. One would not expect any association between these two 
presumably unrelated data sets; an association could occur only because 
of chance or because there of an artifact in the methods used to 
analyze such data sets. If the association occurs over several data 
sets, chance is not the likely explanation; rather we must conclude 
that there are serious concerns about the methods we are using to 
analyze the data.
    We have related the following data sets and found statistically 
significant associations between:
     daily deaths in Santa Clara County (San Jose, CA) and 
daily air pollution (ozone) in Philadelphia;
     daily hospital admissions in Toronto and daily particulate 
levels in Philadelphia;
     daily deaths in the U.S. and daily particulate levels in 
Philadelphia;
     the number of daily births in the U.S. and daily 
Philadelphia particulate levels.
    We tried to relate daily Philadelphia particulate levels to random 
numbers, such as lottery results, but we could not find any unexpected 
associations. This result suggests that there may be some inherent 
property of the time series data sets that is not properly considered 
in the analyses to date. We are investigating this issue at present 
with additional statistical experts, who specialize in analyzing data 
sets such as these.
    We have not yet analyzed the relationship between demographic 
indices and particulate levels for cities other than Philadelphia.
    This result merits immediate resolution because if the methods used 
to date are shown to introduce spurious associations between daily 
particulate levels and daily health indices, then the many studies 
cited by EPA and others are meaningless.

    Question 3. Have you studied what happens on the days before and 
after peak air pollution episodes? Do your models account for the net 
effects?
    Response. During the severe pollution episodes before 1965 in 
London and elsewhere, if was clear from looking at the data that 
mortality increased shortly after these episodes. See my answer to your 
fourth question. When we look at the data plots, however, for the 
studies undertaken today at contemporary air quality levels, no such 
relationship is apparent. Pollution peaks are rarely followed by 
visible increases in any health index. If pollution were an important 
culprit, we would expect to see some signal in the health data. We do 
not. The model results appear to be influenced more by the temperate 
changes in pollution, an issue which also raises the possibility of 
some artifact being present in the methodology.
    We have on occasion looked at the relationship between deaths on 1 
day and pollution on subsequent days (i.e., the deaths precede the 
pollution), and we find some significant associations although this is 
not an issue that we nor anyone else, as far we know, have examined 
rigorously.
    We have examined the net effects of pollution on mortality over 
several days in Philadelphia. In models where we can find an effect of 
particulate air pollution, we find that the net effect is zero after 
several days.

    Question 4. How do the present peak periods of air pollution 
compare with those experiences in London during the 1950's and 1960's? 
Do we see the same kinds of health responses?
    Response. Air pollution levels during the London episodes of the 
1950's and 1960's were much higher, as much as a factor of ten higher, 
than episodes seen in the contemporary U.S.. We have dramatically 
deceased our pollution levels in the past thirty years, and this is 
true for fine particles as well as for larger particles. One speaker at 
the hearing gave the impression that polluters choose to control the 
larger particles selectively because their higher masses give a 
``bigger bang for the buck''. The big gains in control of particulates 
have come from controlling combustion and manufacturing sources 
involving fine particles, by switching to cleaner fuels and installing 
particulate collectors. In recent decades, fine particles have been 
reduced by about 6 percent per year in New York, Philadelphia, St. 
Louis and Steubenville, Ohio, and we have every reason to believe that 
this trend will continue in response to clean air regulations already 
in force. Larger particles associated with road dust, agricultural 
sources, etc., are harder to control; hence further reductions of these 
particles may be more problematic.
    In London, health responses to high pollution levels were obvious 
from looking at the data; this is not the case with recent studies. See 
answer to question 3. A curious finding, however, is that when the same 
models are applied to the London data during the high episode period 
and to contemporary data sets when pollution levels are much lower, we 
see similar results; i.e., the relative risks of air pollution has not 
changed despite the fact that pollution levels have declined 
dramatically. This result is difficult to explain. It could be due to 
the fact that we're controlling the wrong pollutants; it could be due 
to artifacts in the models and methods (See my answer to your second 
question.); or it could be that we respond to relative changes in the 
level of pollution rather than to absolute pollution levels. Any of 
these explanations would have significant implications on how we 
regulate and control air pollution.
                                addendum
    I have one additional comment to make about an issue that was 
raised at the hearing. The recent experiment of John Godleski was 
mentioned. In these experiments, Dr. Godleski exposed compromised rats 
to Boston air in which particulates were concentrated by a fact of 
thirty for 6 hours a day for 3 days. Concentrations reached about 300 
g/m3. The rats had previously been exposed to very 
high levels of sulfur dioxide to induce bronchitis-like conditions. 
After 3 days of exposure a significant fraction of the rats died. At 
the hearing, the statement was made that the average concentration of 
particulate exposure was 100 g/m3, a concentration 
on occasion found in U.S. cities. I believe that this statement is 
misleading. Rats were exposed at about 300 g/m3 for 
6 hours, which could result in a 24-hour average concentration less 
than 100 g/m3, but we have no reason to average the 
exposure. Averaging the exposure without justification is equivalent to 
saying that standing 6 hours in a pool of water 10 feet deep is the 
same as standing in a pool of water 3 feet deep for 24 hours.
    The experiments of Dr. Godleski are important and need to be 
resolved and understood, but they should not be misinterpreted.
                                 ______
                                 
     Statement of John Cahill, Acting Commissioner, New York State 
                Department of Environmental Conservation
    Good Morning. My name is John Cahill, and I am Acting Commissioner 
of the New York State Department of Environmental Conservation. I 
appreciate this opportunity to present New York's perspective on the 
proposed amendments to the National Ambient Air Quality Standards for 
ozone and particulate matter.
    As you are aware, Section 7409 of the Federal Clean Air Act 
requires that the U.S. Environmental Protection Agency establish 
National Ambient Air Quality Standards for criteria pollutants which 
``are requisite to protect the public health,'' and review these 
standards on 5-year intervals. Based on such a review, EPA has now 
proposed 4 revisions to the standards for both ozone and particulate 
matter. While we are encouraged with the efforts of EPA to meet these 
requirements of the Clean Air Act, and support efforts to ensure that 
the air quality standards are protective of the public health, we have 
several comments to make regarding EPA's proposed revisions.
    In its 1991 report ``Rethinking the Ozone Problem in Urban and 
Regional Air Pollution,'' the National Research Council identified 
several shortcomings in EPA's existing strategy to reduce 
concentrations of tropospheric ozone. In its report, which was mandated 
by the Clean Air Act, the Council suggested that the existing 
monitoring tends to measure transient ``spikes'' in ozone 
concentrations rather than baseline or average levels, and is overly 
sensitive to weather fluctuations. Both of the problems, the report 
concluded, could be traced to the fact that the existing ozone standard 
looked at concentrations on a peak 1-hour basis. We are therefore 
supportive of EPA's proposal to amend the ozone standard to an 8-hour 
interval.
    Over the years, New York has had some success in meeting the 
existing ozone standard of 0.12 parts per million. Most of upstate New 
York, which had been in non-attainment with the standard, has recently 
experienced several years of ``clean data.'' Even the New York City 
metropolitan area has shown a marked reductions in ozone levels. The 
region exceeded the standard only two times during the 1996 ozone 
season, compared to 38 times in 1980. While we will support any 
standard that is based on strong scientific evidence, we are concerned 
about the impact a revision to the ozone standard will have on New 
York's efforts to meet Federal air quality goals, especially without 
dramatic improvements in the quality of air entering the State.
    For instance a revision of the standard to 0.07 ppm, the more 
stringent scenario in the EPA proposal, could cause most of the upstate 
region to be once again designated as non-attainment. There is evidence 
that baseline levels of ozone could reach as high as 0.06 ppm, 
therefore making a standard of 0.07 ppm virtually impossible to attain. 
As previously stated, we support setting the standard at a level which 
is protective of the public health, but setting it so low that it could 
conceivably never be attained, even under the best of circumstances, 
would benefit no one. Literally billions of dollars would be spent 
chasing an unattainable goal.
    It is difficult to ascertain just how the upstate region of New 
York would fare if the standard were set at a level of 0.08 ppm. 
Available data from the last 3 years indicate that much of upstate New 
York is currently hovering around the 0.08 level. This makes it vital 
that EPA use real-world monitoring data for the coming years, rather 
than modeled predictions based on previous data, when making its 
attainment designations. EPA should also require affected States to 
install monitoring networks with sufficient density to provide robust 
data and high confidence in the designations it does make. In this 
manner, improvements made in the upstate region in the next 3 years 
will be included when making an attainment determination. We further 
support EPA's proposal to require measurements to be taken to two 
decimal points (0.08) rather than three (0.080).
    Another concern relating to the proposed amendments involves 
modifications to the existing designation levels that would be needed 
as a result. Currently, the five levels of ozone non-attainment, 
ranging from marginal to extreme, and the associated control strategies 
are set forth in the Clean Air Act. Any changes made to the existing 
standard will require corresponding modifications to these designations 
as well and, therefore, the control strategies a given area would have 
to implement. It is our understanding that these amendments would be 
made by EPA in a rulemaking. We therefore feel it is vital that there 
be sufficient opportunity for the States and other interested parties 
to participate in drafting such regulations, and to review and comment 
on any future changes to the non-attainment designations before they 
are implemented.
    While there may be some uncertainty regarding how the proposed 
amendments to the ozone standards will affect upstate New York, it is 
likely that certain segments of the Midwest would be reclassified as 
non-attainment if the new standards are implemented. New York State has 
repeatedly expressed concern that it will never be able to meet even 
the existing ozone standard so long as the air entering the State at 
its western and southern boundaries already exceeds that standard. As a 
member of the Ozone Transport Commission, New York has enacted several 
control measures beyond those required by the Federal Clean Air Act in 
an effort to attain the ozone standard. We have also actively 
participated in the Ozone Transport Assessment Group, consisting of the 
37 States east of the Rocky Mountains, in hopes of achieving 
significant reductions in the long-range transport of ozone and its 
precursors. Regardless of the final outcome of the proposed amendments 
to the ozone and particulate matter standards, it is crucial to New 
York's attainment strategy that the large sources of ozone precursors 
located in the Midwest and Southeast be required to install the same 
level of controls currently required in the Northeast. In this manner, 
the air quality of the entire region will improve, and the Northeast 
will be able to compete on equal footing with the Midwest as the 
electric generation industry is deregulated. We further support EPA's 
position that the negotiations and rulemakings regarding long-range 
transport of ozone precursors now underway should not be postponed as 
the revisions to the air quality standards are considered.
    As with the ozone standard, we are concerned about the 
environmental and public health impacts of long-range transport of fine 
particulates. In a recent report, the American Lung Association 
estimated that inhalation of particulates is responsible for some 
60,000 premature deaths in America every year. Epidemiological evidence 
suggests that fine particulates pose an immediate risk to the health 
and well being of our citizens. The same contaminants that are largely 
responsible for fine particulates are also significant contributors to 
both ozone formation and the acidic deposition that continues to plague 
the forests and water bodies of the Northeast. Reductions in emissions 
in the OTAG region that lead to these particulates will therefore pay 
off fourfold, resulting in decreases in acidic deposition and ozone as 
well as the direct reductions in particulate matter, which in turn will 
help improve visibility throughout the region.
    As with the proposed changes to the ozone standard, it is important 
that EPA base any redesignation for the particulate matter standards on 
observed, real-world data rather than on computer modeling. EPA will 
also soon need to propose and finalize specifications for the equipment 
used to monitor fine particulates. From our recent experience in 
designing and installing monitors in New York City, it is clear that 
there will be considerable additional expense associated with the 
monitoring network needed to determine compliance with the new 
standards. As Federal funding for compliance with the requirements of 
the Clean Air Act continues to dwindle, EPA must be cognizant of the 
substantial increase in resources that will be needed to meet the 
monitoring requirements of both the ozone and particulate standards.
    In conclusion, New York fully supports the efforts of EPA to set 
new standards for ozone and particulates, provided that they have a 
scientific basis and are attainable. We feel that an 8-hour ozone 
standard is preferable to a current 1-hour standard, both to reduce the 
impact of weather fluctuations, and to provide an accurate assessment 
of the true effectiveness of control strategies by measuring average 
ozone levels rather than worst case, transient events. We also feel 
that EPA and Congress should be cognizant of the costs these new 
standards will impose on the States when considering funding levels for 
grants under Section 105 of the Act. The Department will be submitting 
more detailed comments before the close of the public comment period. 
Thank you again for providing me with this opportunity to present our 
viewpoints on this matter.
                                 ______
                                 
Statement of the Association of State and Territorial Health Officials 
                                (ASTHO)
    The Association of State and Territorial Health Officials (ASTHO) 
is pleased to present its views on the U.S. Environmental Protection 
Agency's (EPA's) proposed rules regarding the National Ambient Air 
Quality Standards (NAAQS) for particulate matter (PM) and ozone, the 
Agency's interim implementation policy, and its proposed surveillance 
methods for particulates. 61 Federal Register 65637, 65715, 65751 and 
65780 (December 13, 1996). ASTHO represents the public health agencies 
of each of the U.S. States and territories and its members are the 
chief executive officers of the health department of every U.S. State, 
territory and possession. ASTHO engages in a wide range of legislative, 
scientific, educational and programmatic activities to improve public 
health. Because human health effects are the foundation of the proposed 
revisions to the NAAQS, ASTHO and its members are vitally concerned 
that any proposed revisions to the NAAQS have a sound scientific 
foundation and promote a beneficial national public health policy.
                      summary and recommendations
    ASTHO believes that EPA's proposed NAAQS for fine particulates and 
ozone will result in far fewer cases of adverse respiratory effects, 
but in the absence of demonstrated thresholds for adverse health 
effects, they will not fully protect the public. Exposure to 20 to 30 
micrograms per cubic meter of fine particulates have shown adverse 
health effects, and argue for the NAAQS to be set lower than that 
level. Adverse health effects from ozone are also reported at 0.08 ppm 
in prolonged exposure with moderate exertion, leaving little apparent 
``adequate margin of safety'' in any proposed standard.
    Since the standards will not fully protect the public, the Agency 
should develop a system to warn the public about high levels of 
particulates in the atmosphere, similar to warnings now given about 
ozone levels. Such warnings about both particulates and ozone would 
allow individuals to take measures to protect themselves against these 
potential health hazards.
    EPA reviewed 86 studies of human health and particulate matter and 
185 studies of ozone and human health as the basis for the proposed 
standards. The Agency has presented a wealth of evidence that ozone 
produces human health effects at the current NAAQS, and sufficient 
evidence that particulate matter, including fine particulates, may 
present a danger to public health. Thus, ASTHO believes that the 
Agency's decision to move forward with new standards is justified on 
public health grounds.
    ASTHO believes that the proposed PM2.5 standard should 
supplement, not replace, the existing PM10 standard. Coarse 
particles are also likely to cause adverse health effects, and people 
should be as protected as possible against exposure to them as well.
    EPA's proposed 24 hour average measurement standard for 
particulates ignores the highest daily exposures, and could result in 
an additional week or so each year of daily exceedences without 
violating the standard. Sensitive populations could needlessly suffer 
additional episodes of illness or death when exposed to these short 
term, high particle levels.
                           particulate matter
    EPA reviewed 86 health studies of human health and particulate 
matter as part of the foundation for the proposed revision to the 
NAAQS. ASTHO believes that the Agency's effort in reviewing the 
scientific data has been thorough, and that the scientific evidence is 
sufficient to generate concern that particulate matter, including fine 
particulates, may presently be a danger to public health. While some 
may have criticized the relative lack of data regarding exposure to 
fine particulates, the uncertainties regarding the composition of 
particulate matter, or the confounding influence of sulfur oxides and 
other pollutants, the existing data supports the Agency's proposed 
action. Additional studies that EPA did not explicitly cite, and which 
estimated the concentration of fine particles through impaired 
visibility corrected for humidity, also support the Agency's action to 
regulate fine particles.
    Consequently, ASTHO agrees that EPA should regulate 
PM2.5 as well as the present PM10. The Agency 
stated in its summary that studies consistently find adverse health 
effects at exposure concentrations between 20 and 30 micrograms per 
cubic meter, and find mortality effects above 30 micrograms per cubic 
meter. Such findings argue for NAAQS set lower than levels at which 
effects become apparent if the standards are to protect human health 
with an adequate margin of safety.
    Moreover, ASTHO believes that the PM2.5 standard should 
supplement, not replace, the existing standards for PM10. 
Coarse particles are likely to cause adverse effects as well as fine 
particles, and full implementation of a new NAAQS may take a decade or 
more. The coarse particles are more common in the western states than 
in the east, and eliminating the present standard would leave people 
living in the west relatively less protected. Even if the existing 
standard were eventually phased out, people should not be left with 
less protection during any period of transition.
    EPA has also proposed to rescind the current 24 hour 
PM10 standard or to retain it at its current 150 micrograms 
per cubic meter, a level that EPA openly acknowledges would not protect 
public health. Virtually all recent studies of mortality and morbidity 
have used PM10 as the principal, if not the only, 
measurement of particulate matter. While PM10 may be a proxy 
for fine particles, coarse particles may also be important in 
determining health outcomes. The current state of the science cannot 
distinguish effectively between the impacts of fine and coarse 
particles in the vast majority of epidemiological studies of 
PM10, especially where health outcomes affect the airways. 
Significant quantities of both fine and coarse particles can easily 
penetrate the bronchial tree and deposit in the airways. Several 
studies in which the coarse fraction either dominated PM mass or in 
which PM2.5 was measured concurrently with PM10 
or PM15, found that coarse particles were associated with 
adverse lower respiratory outcomes.
    Epidemiological data indicate that exposures to low concentrations 
of ambient PM10 have been linked consistently with airway 
related diseases. These studies do not show clearly, however, whether 
the relationship is stronger for coarse or fine particles, or whether 
the associations are roughly equal. Public health efforts, then, should 
continue to focus on reducing exposure to a pollutant indicator, 
PM10, that is linked to airway conditions such as asthma and 
bronchitis. Thus, ASTHO believes that a PM10 standard should 
be retained in addition to putting the new PM2.5 standard in 
place. The weight of scientific evidence, however, supports lowering 
the current 24 hour PM10 standard to protect public health.
    ASTHO encourages EPA and other Federal agencies to continue to 
pursue and sponsor additional research on the public health 
implications of ambient PM2.5. Such research should include 
epidemiological investigations of potentially susceptible 
subpopulations, the relative strength of human health effects due to 
exposure to specific particle sizes, indoor penetration of both fine 
and coarse particles, biological mechanisms of action, and health 
effects due to PM composition.
    ASTHO is concerned that the Agency's proposed criteria for 
attaining standard for fine particulates may not protect public health 
sufficiently. EPA proposes that 24 hour attainment would be measured by 
taking the 98th percentile of daily averages over 3 years. Such a 
standard, of course, ignores the highest daily averages, and could mean 
an additional week or so of daily exceedences without being in 
violation of the standard. Sensitive populations could suffer 
additional illness or death when exposed to high particle levels during 
these allowed short term excursions above the standard. The Agency 
should remember that epidemiological studies show that health effects 
are associated with short duration, high concentration episodes.
    In addition, measured particle concentrations would be averaged 
over several monitors in the area being monitored. Depending where the 
monitors are placed, such an averaging protocol would leave some people 
overexposed. For instance, if one monitor is placed in an area that 
routinely has high particulate concentrations and others are placed in 
more pristine areas, people living in the area of high concentration 
would be left less protected than others.
    The topography of western states places this area at greater health 
risk under the monitoring protocol. The measurement protocol would work 
best in a terrain that is relatively flat and that facilitates 
atmospheric mixing. The west, however, is often characterized by deep 
mountain valleys and temperature inversions that prevent such mixing. 
Tall buildings in urban areas can create ``urban canyons'' which 
inhibit air mixing as well. The result can be radically different 
concentrations in areas that are relatively close together. Average 
measurements of individual exposures under theses circumstance could 
easily be misleading.
    While ASTHO agrees that EPA should try to limit public exposure to 
fine particulates, we also recognize that because no threshold exposure 
has been identified, some individuals will remain unprotected by EPA's 
NAAQS for fine particulates.
    For this reason, ASTHO believes that the Agency should develop a 
system to warn people about ambient particulate levels so that 
sensitive individuals can take measures to protect themselves. Such a 
system would require daily measurements to acquire sufficient data to 
make predictions accurately, and could be modeled after the ozone 
reports routinely given in weather reports and forecasts.
    In areas without PM monitoring, particulate concentrations could be 
modeled and predicted based on the visibility impairment each day in a 
defined geographic area. That visibility impairment would then need to 
be corrected for the humidity each day in that area. Such a modeling 
effort would require an advance over the present state-of-the-art, but 
ASTHO believes that such an effort, when successful, would act to 
protect public health. It would be similar to the turbidity criteria 
currently used to issue ``boil water'' alerts for drinking water.
                                 ozone
    In its review of 185 studies, EPA has presented a wealth of 
evidence that human exposure to ozone produces adverse health effects 
at the current NAAQS. In fact, studies show that adverse effects occur 
during prolonged exposure to ozone along with moderate exertion at 
least down to the new proposed 0.08 ppm level. Consequently, little 
``adequate margin of safety'' would seem to exist for acute effects at 
this, or any other, level that the Agency has proposed as a possible 
new standard. The 0.08 ppm proposed standard, if expressed as a long 
term annual average would, however, approximate estimated background 
exposure and would be virtually indistinguishable from background risk 
for chronic, but as yet unknown, human health effects.
    The Agency should recognize publicly that any of the proposed new 
NAAQS for ozone will not completely protect the public from acute 
health effects because no threshold has been shown to exist. Many 
people will still be placed at health risk no matter which NAAQS the 
Agency chooses, especially people with preexisting conditions that make 
them especially susceptible to respiratory effects.
    ASTHO believes that EPA should act to ensure that the public is 
aware that it will not be completely protected from health effects 
related to ozone exposure with the adoption of new standards, and that 
susceptible individuals must continue to protect themselves from 
exposure to this substance.




         CLEAN AIR ACT: OZONE AND PARTICULATE MATTER STANDARDS

                              ----------                              


                      WEDNESDAY, FEBRUARY 12, 1997

                                       U.S. Senate,
                 Committee on Environment and Public Works,
                                                    Washington, DC.

    PROPOSED NEW FEDERAL STANDARDS FOR OZONE AND PARTICULATE MATTER

    The committee met, pursuant to notice, at 9:30 a.m. in room 
406, Senate Dirksen Building, Hon. John H. Chafee (chairman of 
the committee) presiding.
    Present: Senators Chafee, Smith, Kempthorne, Inhofe, 
Thomas, Bond, Allard, Sessions, Baucus, Hutchinson, Lautenberg, 
Lieberman, Reid, Boxer, Warner, and Wyden.

OPENING STATEMENT OF HON. JOHN H. CHAFEE, U.S. SENATOR FROM THE 
                     STATE OF RHODE ISLAND

    Senator Chafee. I want to welcome you all to the 
Environment and Public Works Committee, and we want to welcome 
Administrator Browner here today and those accompanying her.
    This is the way we're going to do the opening statements. I 
will make an opening statement, then the ranking member, 
Senator Baucus, will make an opening statement, or be available 
for one, if he wishes, the chairman of the subcommittee and the 
ranking member of the subcommittee. But that's all we want to 
have for opening statements. If people want to include their 
statements in the record, obviously, that would be fine, and if 
they wish to give their opening statement during their 
questioning period, that's fine too. But we've got a lot to do 
today, and so that is the way we will proceed.
    The purpose of our hearing is to review the national 
ambient air quality standards for ozone and particulate matter 
that EPA published last November. These are very complex and 
far-reaching proposals. After careful review, I am concerned 
that they may be too far-reaching.
    Let me illustrate: it is possible to push too far and too 
fast. Consider the history of the Safe Drinking Water Act. I 
believe everyone now agrees that the 1986 Amendments to the 
Safe Drinking Water Act went too far. Many of us on this 
committee were here at that time. That legislation overloaded 
the States and community water systems regulated under the law.
    The problems with the drinking water program were created 
by Congress, not by EPA. The 1986 drinking water bill was based 
on the best of intentions. I am sure that if we reviewed the 
testimony at that time supporting the legislation--we were 
working on it from 1984, 1985 and 1986--you will see statements 
very similar to those you will hear today. Children are at risk 
of adverse health effects because they are exposed to toxic 
pollutants. We could avoid disease outbreaks and hospital costs 
by improving control technologies. A large number of Americans 
die prematurely each year because of contaminants that could be 
reduced.
    The 1986 drinking water amendments responded to those 
public health concerns. Congress had the best of intentions, 
but we overloaded the system. As the 104th Congress opened, the 
Safe Drinking Water Act was cited in hearings all across the 
Capitol as the best example of what went wrong with the Federal 
Government.
    With the hard work of Senator Kempthorne, Senator Baucus, 
Senator Reid, and all the members of this committee and the 
support of EPA, we reformed that law last year, as 
Administrator Browner remembers. We got rid of the overload. It 
is back on the right course now, but it was an experience, I 
believe, we should keep in mind. Even in the name of public 
health, it is possible to press too far too fast.
    Now, I would like to contrast that with another statute 
that we passed, the ban on chlorofluorocarbons. Destruction of 
the ozone layer is about as serious an environmental problem as 
you can imagine. It is a worldwide threat that will take a 
century or more to correct. I suppose there are some at the 
beginning when the first scientific papers were published in 
the early 1970's who thought we ought to ban all CFCs 
immediately, but we didn't take that course. Under the 
leadership, first, of Lee Thomas, Administrator Lee Thomas, and 
later of Administrator Bill Reilly, we took a more incremental 
approach.
    We moved step by step, starting with a freeze, then we had 
a reduction. There was a tax to discourage use, and eventually 
we achieved a ban on all CFCs. At first we didn't address all 
of the ozone depleting chemicals, but the list grew as we went 
on. The control program advanced quickly but only as it was 
supported by good science and wide public support. In fact, 
many of the decisions made by the EPA along the way were 
immediately endorsed by scientists of chemical companies that 
manufacture the CFCs. People knew that improving the science 
was the key to getting rid of CFCs. Improving the science 
became a high priority. That is an experience to keep in mind, 
and I think it is well that we remember that. It is possible to 
make rapid progress in even the most difficult environmental 
problems with science serving as the foundation for public 
consensus.
    Now, how do those experiences affect us today? I think it 
is appropriate to ask whether the proposed standards for ozone 
and particulate matter are the right measures or if they go too 
far, if they overload the Clean Air Act.
    Frankly, there is reason to be worried about how the Clean 
Air Act is functioning. Although the EPA has done a good job on 
the acid rain and stratospheric protection provisions of the 
1990 Amendments, the ozone non-attainment program has fallen 
far behind schedule, and these two new proposed standards, 
among the very largest regulations ever issued by the EPA, 
would be piled on top.
    Apparently, some are of the opinion that concerns about 
overloading the system cannot be considered when these 
standards are set. According to this view, we must wait for the 
implementation phase to determine whether we have gone too far. 
I hope that is not what the Clean Air Act says. If it is, I 
think we put the tremendous achievements of the Act in 
jeopardy. Surely, we can find a way to work together to address 
the important public health concerns that the newest science 
indicates might be caused by air pollution without providing 
fuel for another round of attacks on our environmental laws.
    Now, we'll turn to Senator Baucus for his opening 
statement.

  OPENING STATEMENT OF HON. MAX BAUCUS, U.S. SENATOR FROM THE 
                        STATE OF MONTANA

    Senator Baucus. Thank you, very much, Mr. Chairman.
    First, I appreciate your statement here. I think it is 
important to remind us all of where we are in this process.
    Last week the subcommittee heard testimony from scientists, 
and I think a fair summary of that statement from the 
scientists is that there is a significant problem with the 
ozone, and there is an agreed upon range within which the EPA 
should adopt a standard. The particulates--as I recall the 
testimony, it was agreed that there is a significant problem 
with particulates, but there is some dispute among the CASAC 
members as to exactly what that standard should be. In fact, 
the CASAC panel itself did not recommend a particular standard.
    I think it is also important to remind ourselves, at least 
in this instance, that we are not considering any statutory 
changes to the Clean Air Act. Rather, we are here at the 
beginning of a fairly long process to help the Administration 
and the EPA determine what the proper ozone and particulate 
standards should be.
    This is, again, the beginning of a very long process. The 
EPA has not yet proposed its final regulations. We don't even 
know what the final regulations are going to be, and I think it 
is important for us at the beginning of this process to keep an 
open mind and not rush to judgment as to whether the initial 
proposed standards are proper or not.
    Later on this year, perhaps this summer, the EPA will issue 
its final regulation after listening to all the comments. Then 
there is a long process, which looks at the cost side of it, 
with the development of State implementation plans which decide 
how the standards should be achieved. By then, of course, we 
may see new technologies to alleviate the problems in 
implementing the standards.
    I want to contrast this process with the Safe Drinking 
Water Act Amendments. The Safe Drinking Water Amendments in 
1986 were passed, I think almost unanimously, by this Congress, 
and signed by President Reagan. But those were statutory 
changes. The law provided for new tight standards to protect 
drinking water in our country. It is true that in retrospect 
the statutory standards were a bit too tight, particularly for 
small systems, and they imposed monitoring requirements 
demanding expensive technology to have to then be implemented, 
and the Congress did look at the many hearings and move to 
change the statutory provisions, as provided by the Safe 
Drinking Water Act.
    Senator Kempthorne, myself and others worked very hard on 
that, and I compliment them. So the analogy of the Safe 
Drinking Water Act is really apt. Really we are talking here 
about advice and clearing the air, so to speak, on what the 
proper regulation ultimately should be. I urge all of us not to 
undermine the process and not to rush to judgment. We should 
ask open-minded questions about how the EPA arrived at this 
standard, how many people they think are going to be harmed 
without the standard and how that might change with the 
proposed new standard. There are still a lot of questions. I 
think it is unwise to rush to judgment and criticize a proposed 
standard before it is even promulgated. We don't even know what 
the standard is yet.
    Thank you.
    Senator Chafee. Thank you very much, Senator.
    Senator Inhofe, who is the chairman of the subcommittee, 
and then when Senator Graham gets here, we'll hear his opening 
statement and that will end the opening statements.

 OPENING STATEMENT OF HON. JAMES M. INHOFE, U.S. SENATOR FROM 
                     THE STATE OF OKLAHOMA

    Senator Inhofe. Thank you, Mr. Chairman.
     I'll submit the longer statement for the record.
    First, I want to say that everybody in this room--
Administrator Browner, and Senator Thomas, all of us want clean 
air, we want safe air.
    A week ago today, the clean air subcommittee held a hearing 
to hear from the scientific community on this issue. I don't 
think there is anyone up here at this table who would hold 
himself or herself out to be an expert in these areas so we 
have to rely on experts, and that was the reason for the Clean 
Air Scientific Advisory Committee to be written into the 
statutes, and the Administrator has to rely on them also.
    So we had all these people, and if there was one overall 
theme that we learned last week at the hearing, it was that 
there is a lack of scientific consensus about the judgments 
made by the EPA in issuing the regulations.
    In addition, some of the important points would include, 
and I'll name six real quickly.
    More time is needed--and this is eight scientists that came 
to this conclusion--No. 1, more time is needed to conduct 
additional research; No. 2, the EPA's decision was based on a 
policy call, not a scientific consensus; No. 3, there is no 
obvious bright line separately a level at which ozone and PM 
become dangerous for health effects; No. 4, the PM studies were 
based on statistical association--and this is very significant 
because I think they all said there are no biological 
mechanisms here, and that is what you would be looking for in 
order to justify the promulgation of more stringent rules; No. 
5, there is inconclusive evidence regarding the particulate 
matter size and the possible health effects; and, No. 6, 
different researchers are producing different inconsistent 
results from the research on particulate matter. We had that 
come up in this committee where other researchers came and 
refuted some of the accusations that were made by some of the 
previous scientists, Dr. Schwartz.
    The Washington Post said that no one succeeded in 
accomplishing what 15 senators and scientists purportedly set 
out to do yesterday, resolving the scientific questions behind 
the Federal Government's latest proposed clean air standards. 
The Washington Times scientists yesterday said the available 
research wasn't enough to determine whether the plan would do 
what it is intended to do, but they disagreed on the potential 
benefits.
    In my State of Oklahoma, a statement appeared in the Daily 
Oklahoman; it said, ``Senators can't find clean air in the 
haze.'' So I think later on, when we have more time, we can 
talk about some of the specific statements that were made by 
Dr. Wolff, who is the chairman of CASAC, and Dr. Lippmann, who 
serves on CASAC, and their job is, of course, to advise the EPA 
on the scientific issues.
    Now, what I would like to do--I agree with Senator Baucus, 
who says we don't want to rush to judgment on this. There is 
too much yet that we need to determine, and I don't want to use 
a threat of a court order, as an excuse to go in and exercise 
bad policy. I am not a lawyer, but I've spent a lot of time 
looking at the imposition of legal mandates. My conclusion is 
that you don't have to change the current standard. The court 
order doesn't require a change unless scientific evidence is 
there, and also there is nothing magical about 5 years. We 
should find out, and do something or do nothing now, and find 
out 3 years from now. We have conducted the studies and talked 
about it a week ago today that there is nothing to keep us from 
going in at that point and being in full compliance with the 
court order.
    So I look forward to hearing from you, Mr. Chairman.
    Senator Chafee. Well, thank you very much, Senator Inhofe.
    The ranking member of the Subcommittee is Senator Graham, 
and he is not here----
    Senator Baucus. He'll be coming later.
    Senator Chafee. All right, so we will proceed with Ms. 
Browner. We welcome you, Madam Administrator and look forward 
to your testimony.
    Now, I notice--I think it is 27 pages long, isn't it?
    Administrator Browner. I would like to submit for the 
record the 27-page length testimony, and, if I might, just 
provide a summary of that in my opening comments.
    Senator Chafee. We greet that with applause.

  STATEMENT OF CAROL M. BROWNER, ADMINISTRATOR, ENVIRONMENTAL 
   PROTECTION AGENCY, WASHINGTON, DC.; ACCOMPANIED BY: MARY 
  NICHOLS, ASSISTANT ADMINISTRATOR FOR AIR AND RADIATION AND 
   ROBERT HUGGETT, ASSISTANT ADMINISTRATOR FOR RESEARCH AND 
                          DEVELOPMENT

    Administrator Browner. Thank you, Mr. Chairman.
    Mr. Chairman, Senator Baucus, members of the committee, 
good morning, and thank you for the opportunity to testify on 
the EPA's proposed revisions to the national ambient air 
quality standards for particulate matter and ozone, better 
known as soot and smog.
    Appearing with me today will be EPA's assistant 
administrator for Air and Radiation, Mary Nichols, and our 
assistant administrator for Research and Development, Dr. 
Robert Huggett.
    Mr. Chairman, let me begin by saluting both you and Senator 
Baucus for your long-standing and steadfast leadership on 
environmental issues. As you know, it was a spirit of 
bipartisanship that launched the Clean Air Act under President 
Richard Nixon more than a quarter century ago, and it was that 
same bipartisan spirit with this committee in the lead that 
resulted in the strengthening of the Act under President Bush 
in 1990.
    Today, under President Clinton the commitment to clean air 
remains strong. Thanks to your leadership and to the success of 
the Clean Air Act many millions of Americans are breathing 
healthier air. Millions of our children are protected from the 
harmful effects of breathing polluted air. Make no mistake--the 
Clean Air Act has worked for America. It has helped protect the 
public health and it has done so without holding us back.
    Since 1970 emissions of the six major air pollutants have 
dropped by 29 percent while the population has grown by 28 
percent, and the Gross Domestic Product has nearly doubled, 
economic growth and cleaner air. Now that is a level of 
progress we can all be proud of, which brings us to today's 
question: where do we go from here? Do we rest on our laurels? 
Do we stand back? Do we say that because we are making progress 
there is no need to revisit our standards, no need to reassess 
them in light of new scientific findings, no need to ensure 
that they are adequate to protect the health of the American 
people?
    Wisely, the Clean Air Act since its inception does not 
allow us to make that choice, to simply stand still. The Act 
contemplates the march of technology. It envisions that science 
will come up with better ways to understand the health effects 
of the air we breathe, and that the standards of the 1970's 
might not be right for the 21st century.
    The Act includes language directing the EPA to review the 
public health standards for major air pollutants at least every 
5 years in order to ensure that they reflect the best, the 
current science. It also lays out a specific procedure to 
obtain the best available current science, and, if needed, 
revise the standards.
    This is to ensure that we never get to a point where the 
Government tells the American people their air is healthy to 
breath when in fact the scientific community knows it is not 
healthy.
    As you know, the EPA is now under a court ordered deadline 
to fulfill this obligation, and to publish a final decision on 
revisions to the particulate matter standards by mid-July. One 
of the accomplishments of this proposal of which I am the most 
proud is the fact that for the first time we are simultaneously 
proposing air quality standards for more than one pollutant. We 
do this largely for the purpose of allowing State, local 
governments and industry to develop common sense, cost-
effective strategies for meeting those standards and to provide 
the American public with the most accurate information about 
the quality of the air they breath.
    In accordance with the law, the EPA has asked an 
independent panel of scientists and technical experts from 
academia, research institutes, public health organizations and 
industry to review our work and the underlying health studies 
and to make recommendations. That panel, known as the Clean Air 
Scientific Advisory Committee, or CASAC, over a 4-year period 
conducted 11 meetings, all open to the public, a total of 124 
hours of public discussion. Panel members reviewed thousands of 
pages of materials prepared by EPA and integrating the best 
available science. The EPA has held further public meetings at 
which hundreds of representatives from industry, State, local 
governments, organizations, as well as members of the public 
have offered their views.
    I can safely say that this has been the most extensive 
scientific review and public outreach process ever conducted by 
the EPA for public health standards. Over the course of this 
process we looked at more than 5,000 scientific studies of the 
health effects of smog and soot.
    Mr. Chairman, this stack of papers is the bibliography of 
more than--a list of more than 250 scientific studies covering 
more than 10 years of analysis focusing on the human health 
effects of polluted air. These are the ones that CASAC agreed 
should be the basis for a public health standard. Page after 
page, study after study, every single one of these studies in 
this bibliography was peer reviewed. It was published in a 
scientific journal before it was even considered by the EPA, 
before it was presented to CASAC, which then literally engaged 
in another peer review. This is literally peer review, of peer 
review, of peer review. There are included here 185 studies on 
ozone, 86 studies on particulate matter, literally study after 
study indicating that our current air standards are not 
adequately protecting the public's health and that they should 
be strengthened.
    After a thorough review of this evidence, the conclusion of 
the independent panel is that the most recent scientific 
information provides sufficient evidence that serious health 
effects are occurring in children, the elderly and other 
sensitive populations at particulate matter in ozone 
concentrations at, and below, existing standards. Clearly, the 
science calls for action--action to protect millions of 
Americans and especially millions of our children from harmful 
air pollution.
    In a most compelling way, the science leads us to the new 
stronger standards that EPA proposes for smog and soot. For 
smog we propose to change the standards from .12 parts per 
million of ozone measured over 1 hour to a standard of .08 
parts per million measured over 8 hours. In effect, the .12 1-
hour standard is roughly equivalent to .09 when measured over 8 
hours. Thus, to provide the needed measure of public health 
protection that the science and the law calls for, we propose 
to change the concentration from .09 to .08.
    As the chart to my left indicates, Mr. Chairman, this new 
ozone standard, if adopted, would protect nearly 50 million 
more Americans from the adverse health effects of smog----
    Senator Chafee. Madam Administrator, when you refer to the 
chart, I wonder if you could have someone point to the 
significant--first of all, I find it hard to read that chart; 
and, second, if somebody could point to something significant 
that you are dealing with that pertains to your testimony, that 
would be helpful, at least it would be helpful for me.
    Administrator Browner. I apologize. What the chart shows--
to put it out as simply as we can--the first column are the 
numbers of people protected under the current standard, the 
.12, which is roughly equivalent to a .09 at 8 hours. The other 
column, the second column, shows you under the proposed 
standard, which we now invite public comment on, the number of 
people who would be protected.
    Senator Chafee. That's the column to the right, way over to 
the right?
    Administrator Browner. Way over to the right, exactly.
    Senator Baucus. Could you read those so that everybody 
knows what the numbers are?
    Senator Boxer. Could you tell us what the difference is in 
total of the number of people--more people that would be 
protected with the proposed standard because we can't see the 
numbers?
    Administrator Browner. Oh, I apologize. It is--under the 
proposed .08 8-hours the protections speak to 122 million 
Americans, and what that is is a combination of the numbers 
that have been broken out--the number of children protected, 
which is 33 million--again, this is just on ozone; this is just 
on smog, not on the fine particles--the asthmatics protected, 
the people with respiratory diseases protected and then a total 
number of Americans who would be protected.
    Senator Boxer. What is the difference from the current----
    Administrator Browner. A difference of 48 million 
Americans.
    Senator Boxer. Thank you.
    Administrator Browner. If I might, Mr. Chairman, continue.
    In setting the standards and proposing the standards, the 
law requires us to provide what is called an adequate margin of 
safety. Certainly, there is no more appropriate application of 
that requirement than to ensure that our children simply by 
playing outdoors are not doing irreversible damage to their 
health. I think it is important to remember that children are 
among the most vulnerable to polluted air. They breathe in 50 
percent more air per pound of body weight than do adults. 
They're small; their bodies are different. They are growing, 
and they react differently to pollutants. Many children spend a 
great deal of time outdoors during the summer when ground level 
ozone is at its most severe.
    For PM, for the particulate matter, we would maintain our 
current standard on the larger or coarser particles, and we 
would propose a new standard on smaller particles, those at or 
below 2.5 micrometers in diameter. That is what the current, 
best available science has determined is damaging to human 
health.
    Again, the law requires us to provide an adequate margin of 
safety in protecting the public's health.
    Now, hopefully, you can see this next chart. That is 
bigger.
    Senator Chafee. That's progress. I would get your chart 
makers in the future to use the full chart.
    Administrator Browner. When you strengthen the PM standard 
in the way that the EPA proposes, you can see this chart 
displays what happens. Each year 20,000 fewer premature deaths, 
250,000 fewer cases of aggravated asthma, 250,000 fewer 
incidents of acute respiratory problems, and in children 60,000 
fewer cases of bronchitis, 9,000 fewer hospital admissions. 
Taken together, these proposed standards for smog and soot 
would increase the total number of Americans protected to 
133,000 million, including 40 million children.
    Mr. Chairman, let me just say--and I know you recognize 
this--it is a tough issue. It is certainly one of the toughest 
I have faced in my 4 years at the EPA, but I do believe that 
the American people want us to follow the law. It is a law that 
has served us well for 25 years. They want us to protect the 
public health and do so with the latest, best available 
science.
    The best current, peer reviewed, fully debated scientific 
conclusions are that too many Americans are not being protected 
by the current standards for these pollutants. Based on all we 
have seen to date, we believe there is quite literally no other 
alternative but to propose to strengthen the public health 
standards.
    That doesn't mean there is no role for the practicality of 
attaining these standards. There is such a role, and it is 
appropriate when we move to the implementation phase of the 
law. We are now in the public health phase of the Clean Air 
Act.
    In that case, as we look at industry-by-industry, state-by-
state, community-by-community how best to reduce the harmful 
levels of pollution, it is certainly appropriate to consider 
cost, and I want to assure you that if these new standards are 
adopted, the EPA will work with all who are affected--State 
governments, local governments, community leaders, businesses, 
large and small, to find the common sense, cost-effective 
strategies.
    For my part, I have written to all 50 of the Nation's 
Governors encouraging them to participate in the current 
standard-setting process, and should the revised standards be 
adopted, inviting them to work with the EPA on finding the 
solutions, on finding the ways to meet the public health 
standards.
    I believe this Nation, and particularly its industries, can 
rise to the challenge. You, yourself, Mr. Chairman, cited our 
experience with chlorofluorocarbons. That is a great example of 
the industry doing far more than they ever thought they could 
do on the front end, of this country setting a bold public 
health goal and industry rising to the challenge. That is a 
story often told in the history of the Clean Air Act. We have 
done it, and we can do it again.
    I am also aware that these proposed standards are 
controversial and that not everyone is happy with them. I would 
remind this committee, as I am sure you all know, that we are 
still in a period of public comment. We take seriously our 
obligation to carefully consider all of the comments before we 
make a final decision.
    Finally, let me express my concern about the direction of 
the public debate. This is a vital issue of tremendous 
importance to millions of Americans, families and community 
after community. It is not about backyard barbecues or lawn 
mowers. It is not, as was heard on the radio this morning, 
about banning fireworks on the 4th of July.
    Mr. Chairman, this is about whether our children will be 
able to go outside on the 4th of July and enjoy those 
fireworks. It is about finding ways in which we can all work 
together to ensure that the air we breathe is healthy, and that 
our standards protect the greatest possible number of 
Americans.
    Over the history of the Clean Air Act, the goal is, and has 
always been, quite simply clean air--nothing in that has ever 
changed. What has changed is science, which is forever bringing 
advancements and innovations to improve the quality of our 
lives. Science now tells us that our air pollution standards 
are not adequate to protect our health.
    Let us listen to the science, let us respond as we have 
before, let us work together toward common ground to improve 
the quality of air and to protect the health of our citizens. 
Let us do it for our children.
    Thank you.
    Senator Chafee. Thank you very much, Madam Administrator.
    I would like to direct my first question to particulates, 
and it seems to me from the testimony we had the other day that 
this is an area where there are significant savings. I think in 
the prior--while you have here 20,000, I guess, I think the 
Lung Association says something like 60,000. I thought the EPA 
had come up with something like 40,000.
    Administrator Browner. If I might explain, Mr. Chairman, 
the health estimates in terms of the number of premature deaths 
range from 40,000 to 60,000. The acid rain program, which the 
EPA, as you mentioned, is in the process of successfully 
implementing, will speak to some of the problems, the health 
problems, in this category so that the protections are in fact 
40,000 premature deaths--20,000 because of this proposal, 
20,000 because of the work that we're doing under acid rain.
    Senator Chafee. Well, whatever it is, it is significant, 
certainly far greater than it seems we've been promised under 
what you're dealing with in the ozone, and you are familiar 
with that New York City chart that came actually from the 
scientists that were here the other day where they talk of in 
New York City, under the proposed regulations, the number of 
hospital admissions for asthma attacks would be 28,000 and 
would be reduced by something like 160 admissions.
    But the point I'm making is it seems to me where we can 
really get a lot more for our investment is in the 
particulates, but we had--the scientists, both the chairman and 
the former chairman of the Advisory Board, both said that 5 
years more science was required for them to determine exactly 
which particulates to deal with, and that during that time the 
monitoring stations would be built, and they would feel far 
more comfortable, and indeed they recommended--they said five 
more years.
    Now what do you say about that?
    Administrator Browner. Mr. Chairman, you raise, I think, a 
number of very important questions.
    First, I would like to speak to the chart you referenced 
about hospital admissions. That is in fact a chart that is in 
EPA documents and has been made public over a long period of 
time. What is important to understand about hospital admissions 
is they are just the tip of the iceberg. They are one way, one 
measurement of the public health effect. You don't merely seek 
in proposing to strengthen standards to deal with hospital 
admissions. As this chart shows, for every hospital admission, 
there is in fact five-plus emergency or out-patient visits to 
the hospital. There are 20-plus doctor visits, there are 100-
plus asthma attacks. That is the protections that you seek to 
provide. It is not, I think, appropriate to merely look at the 
tip of the iceberg. That is one fact that has to be looked at. 
You should look at all the facts.
    Senator Chafee. Yes, but you use a base. You use something 
as a base, and what you've used is a base in your own 
testimony, and the chart you submitted was hospital admissions, 
and you can work out a ratio there. In other words, here I am 
just quoting your own figures--``under the proposal, there 
would be 28,205 admissions a year in the New York City area and 
that would be reduced by 120.''
    Now, presumably, the same percentages would apply right 
down to non-hospital admissions and attacks, but my real point 
is here from your own testimony you're really making savings or 
prolonging life, whether it is 40,000, or 60,000--I guess you 
say the figure you're using is 40,000--and that is a big 
figure.
    But, getting back to my--the two leading scientists who 
were here before us, the chairman and the former chairman of 
CASAC, said ``we need more study on this.''
    Administrator Browner. Can I explain something about the 
science here because I think this is extremely important?
    First of all, CASAC in their letter of closure to the 
Agency said, and we can give you a quote, that ``an adequate 
basis for regulatory action does exist.'' They said that. All 
the scientific community, I think, would agree that further 
scientific understanding of the how is important, but that 
doesn't change the scientific recognition of cause and effect, 
and let me be more specific here. What the science shows is 
when 2.5 reaches certain levels in outdoor air hospital 
admissions go up, respiratory illnesses go up, deaths go up. 
You have a cause and you have an effect.
    Now the science is still looking at the how, what happens, 
what exactly happens, but the effect is very clear. 2.5 reaches 
certain levels, people become ill, and unfortunately some 
number, a large number of people die. This is not dissimilar to 
the discussion over the last 20-plus years in this country when 
it came to smoking and lung cancer. We knew and the science 
showed us very early on that if people smoked, there was a high 
likelihood they would get lung cancer--that we knew. We 
couldn't tell--today we can't even tell you every single 
scientific step in the process, physiological and 
epidemiological step in the process. It doesn't change the fact 
that when you measure 2.5 in the air, people become sick, and I 
don't think it changes the need for action that you cannot 
explicitly spell out the how. You have a cause, you have an 
effect. That is what the law envisions, and that is what we 
seek to protect against, which is that effect--those premature 
deaths, those aggravated asthmas, those respiratory illnesses.
    Senator Chafee. Thank you very much. My time is up.
    Senator Baucus.
    Senator Baucus. Thank you, Mr. Chairman.
    Secretary Browner, the CASAC Committee said that the 
acceptable range for new standards in the ozone is between 70 
and 90 parts per billion, and essentially it is a policy call 
as to what the new standards should be.
    My question to you is what factors determine your policy 
call, not only with health effects, but obviously you have to 
look down the road and think about costs, think about 
practicality, even though technically States with their State 
implementation plans the more directly affect the cost side of 
this?
    What were the considerations that led you to come to this 
policy decision, the policy recommendation, of what the ozone 
standard should be, and how did you reach it? What did you 
weigh and what was your final decision? How did you reach that 
decision? We know what your decision was but how did you reach 
it?
    Administrator Browner. Quite simply, the science, the 
number of people affected, the number of people that would be 
protected and the requirement in the law that we set a standard 
with an adequate margin of safety.
    What the science shows is far too many people are suffering 
adverse health effects under the current standards. I think it 
is important to understand that CASAC is made up, as I said 
earlier, and I think as you all know, of a variety of experts. 
Dr. Wolff is an industry representative. The medical health 
experts on CASAC, of which there were four on the ozone panel--
there are atmospheric experts, there are other types of 
experts--but there were four health experts. Three of the four 
health experts said .08. The final health expert, the fourth 
one said .08 to .09.
    So it was the science, it was the people affected, the 
health effects they experienced and the medical experts--those 
people who have committed their lives to studying the human 
health side of this saying .08.
    Senator Baucus. Did you look at anything beside the health 
policy, anything else? Did you look only at the science, what 
those health scientists said, anything beside health?
    Administrator Browner. We are driven by the science in this 
case. That is what the law requires and that is what we did.
    We did do a cost-benefit analysis. The law is very clear. 
The interpretations of the law over the last 25 years are very 
clear. This is a public health decision. It is not a cost-
benefit decision. So we make our proposal based on the science, 
the health effects, the medical experts and the law.
    Senator Baucus. But, obviously, the more people that need 
more protection the higher the standard. So if you were looking 
only at health effects, you would have a tighter standard.
    Administrator Browner. There are--obviously, those who have 
suggested that you could go to .07, you could go to .06. Where 
the science takes us is to .08, and that is why we propose it. 
When you look at--and CASAC did discuss a full range, as you 
said yourself, and the medical health experts, after that 
discussion, three out of four said .08, and that, for me, was 
very, very compelling science.
    Senator Baucus. If you look at a curve, the number of 
people protected moved from, say, 9.9--.09 to .08 is 
significant, but when you move from .08 to .07, the number, the 
proportionate number of people protected falls off 
significantly.
    Administrator Browner. I mean, there are changes in the 
number of people you are protecting. The scientific uncertainty 
as you get down to the extreme become greater.
    Senator Baucus. Is that one reason why you came up with 
.08? That is my question.
    Administrator Browner. The science takes us to .08, 
exactly, as you said.
    Senator Baucus. OK, my second question deals with the 
Regulatory Flexibility Act. As you know, the law that Congress 
passed recently says that agencies must do a regulatory 
flexibility analysis of major regulations, and the EPA has 
concluded that this is not a major regulation for the purposes 
of the Act--namely, that, first of all, it's the States that 
implement this, which is a bit legalistic in my judgment, and, 
second, there is a problem historically because the EPA does 
not do an analysis of State implementation plans anyway once 
they come back.
    As you know, several Senators have written you letters and 
are quite concerned about this--that is, the position of the 
EPA. It seems a bit legalistic, and, as I understand it, the 
EPA has revised its view on how it's going to approach this 
under the Regulatory Flexibility Act.
    Could you tell us where you are with respect to that Act's 
provisions and this proposed regulation?
    Administrator Browner. The Small Business Regulatory 
Flexibility Act, we believe that we are complying with the 
intent of that law. What that law requires is really two 
things--one is to work with the small business community, and 
we are doing that. We are working through the Small Business 
Administration to bring in small businesses, to meet with them, 
to look at how when you move to an implementation phase--again, 
we're on a public health phase, but when you move to an 
implementation phase to begin to build that dialog, to begin to 
build that relationship so that we can find the cost-effective 
solutions.
    Senator Baucus. I guess it's important at some phase in 
this analysis that you look at the affect on small business.
    Administrator Browner. We have, and, in fact, in the cost-
benefit analysis we do speak to that, and we are, as I said, 
working with the SBA and small businesses to ensure that they 
are part of the very important dialog that would be necessary 
for any implementation.
    Senator Baucus. We will be watching that, and I appreciate 
that.
    Thank you.
    Senator Chafee. Senator Inhofe.
    Senator Inhofe. Thank you, Mr. Chairman.
    Well, let me go back to what we were talking about before 
and touch on a couple of things that Senator Baucus was trying 
to penetrate there.
    Drs. Wolff and Lippmann a week ago today--let me go ahead 
and read the quotes of Dr. Lippmann. He said,

    Five years to answer many of these questions. I'm sure 
there will be some that will have further questions 5 years 
down the road, but 5 years is the minimum time to have a 
considered, well-designed, well-executed program of lab work in 
epidemiological studies. It takes a long time to do it, a long 
time to analyze it. It takes a long time to go through peer 
review work. I would say that 5 years is a good timeframe.

    Then Dr. Wolff, who is the chairman of CASAC, said,

    Based on our experience with peer review, I think we can 
frame the questions that need to be addressed in the near term, 
but, unfortunately, we don't have very many measurements of 
PM2.5 right now. We're going to need those 
measurements so that we can answer those questions.

     Senator Baucus. Is your microphone on? I'm sorry.
    Senator Inhofe. Again, he concludes, Dr. Wolff, ``My own 
personal feeling is that we're talking about a 5-year timeframe 
to find answers to these questions.'' Now I also have found, 
Administrator Browner, in reading statements--I guess it was a 
deposition in the law that we have been quoted so often--you 
said,

    The schedule developed by the EPA is based on the Agency's 
detailed consideration of each task necessary to review, and, 
if appropriate, revise the criteria and the national ambient 
air quality standards for particulate matter and a rigorous 
assessment of the minimum amount of time needed to accomplish 
these tasks. The EPA schedule provides for notice of proposed 
rulemaking by September 1, 1997, and final action to be 
December 1, 1998. Any shorter timetable would require the EPA 
to reach conclusions on critical scientific and policy issues 
with enormous consequences for society before it has had 
adequate opportunity to collect and evaluate the pertinent 
scientific data. In short, it would force the Agency to take 
procedural or analytical shortcuts that could jeopardize the 
EPA's ability to make scientifically sound and legally 
defensible decisions in the current review.

     And just the other day when you were requesting $26.4 
million during the budget process, which I guess was in the 
President's budget, you said,

    To reduce a great uncertainty about PM's health effects, 
the EPA will continue its efforts to identify the mechanisms by 
which particles affect human health. It will launch research 
into these areas.

    Now are you weighing the relationship effects and PM 
exposure; two, determining the amount and size of particles 
inhaled and retained in your lungs; and, three, investigating 
biological mechanisms by which PM concentrations in outdoor air 
may induce health effects, and, in doing so, evaluating 
potential links between PM exposure and health effects?
    Now, during the last committee meeting, we talked about 
that--the fact that you have to have either a reasonable, 
statistical connection or the biological mechanism, and in this 
case you have neither.
    Let me finish here, first. It is my understanding--I asked 
them to give it to me but they didn't have it--but it is my 
understanding also that the Flexibility Act to which Senator 
Baucus refers requires you to--and it refers to small entities, 
which is individuals, as well as businesses--to advise them of 
the consequences of proposed changes in rulemaking. So, I have 
felt--and, Ms. Nichols, I have read your very complicated 3-
page letter and have concluded that I didn't agree with your 
conclusions.
    [Laughter.]
    Administrator Browner. Senator, you raise a number of 
points, and I will try and respond to all of them.
    The first document I think you are quoting from is a 
document that was filed in a legal proceeding more than 3 or 4 
years ago--I'm not sure--and if you actually have the date, 
that might be helpful.
    Senator Inhofe. Yes, it is proceeding before the court in 
1994.
    Administrator Browner. Right, and at that point, just to 
refresh everyone's memory, there was litigation file by the 
American Lung Association because of their frustration that, 
unfortunately, the EPA had not been able to complete the 
requirements of the Clean Air Act to do a 5-year review. They 
went to court and they said to a judge, ``Force them to do 
this.'' It is something that I agreed that we should do, and 
then we, working with the judge, working with CASAC, laid out a 
schedule that everyone has agreed to, and we have been adhering 
to that schedule. Those pleadings were filed before an 
agreement was reached on a schedule, and they were filed 4 
years ago, and I think that is important to keep in mind here. 
They are not pleadings filed in the last 1, or 2, or 3 weeks. 
They were filed several years ago.
    Senator Inhofe. But you said final action by December 1, 
1998. Any shorter timetable would require the EPA to reach 
conclusions on critical scientific and policy issues without 
the scientific data.
    Administrator Browner. As is often the case in litigation, 
parties make their arguments. You reach a resolution and then 
you abide by the judge's order. That is what we are doing here. 
In no way does our desire to abide by a Federal judge's order 
suggest that we have not done the kind of detailed analysis 
envisioned by the Clean Air Act or that CASAC did not do their 
job.
    CASAC gave us their letter of closure. They were very clear 
in terms of 19 of the 20 member said that we needed to set a 
2.5, that we needed to focus our energies on 2.5, which I think 
is the second issue that you raised, this sense, again, that 
somehow or another there is a lack of science. This argument of 
the science has been around now for several months, and if I 
might just take a moment to explain the science, Mr. Chairman, 
that we have on 2.5. I think that could be very helpful to the 
committee. I know that the Senator's time is up, but I think 
this is an important question that we keep coming to the edge 
of, and if I might have a few minutes to actually explain the 
body of science that exists----
    Senator Inhofe. That is up to the chairman, but if you come 
to the conclusion that adequate scientific data is there, that 
contradicts what was stated by both Dr. Lippmann and Dr. Wolff.
    Administrator Browner. I have to beg to differ here, if I 
might.
    Senator Chafee. We've got a big crowd here today, and we 
want to keep everybody to their time.
    Administrator Browner. There are studies of literally 
hundreds of thousands of Americans. There are studies in more 
than 51 cities where the air was being measured, the amount of 
the fine particles, the 2.5 particles was in fact measured, and 
then the health effects recorded.
    For people to suggest we have no 2.5 measurements, to 
suggest there are not health studies, is absolutely, positively 
not accurate. There are literally health records on hundreds of 
thousands of Americans, what happened to them when the air 
contained 2.5 at particular levels. It is a compelling body of 
science, and it shows there is a cause, 2.5, and there is an 
effect--hospital admissions, premature deaths--where all of us 
agree the science must now turn its attention is the how. The 
fact that you don't completely understand the how should not 
prevent us from providing the protection, from addressing the 
effects. It didn't prevent us in the case of lead poisoning. We 
couldn't tell you how children lost I.Q. points when we made 
the decision as a country to take lead out of our gasoline. We 
had a cause--it was lead in gasoline; we had an effect--it was 
children suffering, I.Q. points being lost--and we made the 
decision. It is only today, almost 20 years later, that we can 
tell you with any precision--and there are still studies going 
on as to how. The same is true here.
    Senator Inhofe. A statistical association----
    Administrator Browner. It's not a statistical association. 
It is not----
    Senator Chafee. We've got to move on.
    Senator Lautenberg.
    Senator Baucus. He's not here.
    Senator Chafee. Senator Lieberman.
    Senator Lieberman. Thank you, Mr. Chairman.
    My colleague from California, Senator Boxer, has to leave 
and I have agreed to yield her 30 seconds.

OPENING STATEMENT OF HON. BARBARA BOXER, U.S. SENATOR FROM THE 
                      STATE OF CALIFORNIA

    Senator Boxer. Thank you, I will speak fast.
    Administrator Browner, that is the best presentation that I 
have ever heard on the need to continue our quest for the 
cleanest possible air. I am particularly taken by the numbers 
of particularly the children who will be helped, and I do think 
that those who say, ``just stay home on bad air days,'' they're 
surrendering. I will not surrender. My State has too much at 
stake, and I just wanted to make it clear that as we move on, I 
will work with you and the members of this committee to find 
out the science to move us forward, and I want to thank my 
colleague.
    [The prepared statement of Senator Boxer follows.]
    Statement of Hon. Barbara Boxer, U.S. Senator from the State of 
                               California
    Thank you, Mr. Chairman, for calling this important hearing today.
     Enormous progress has been made in the last twenty-five years to 
control and reduce air pollution and we must stay on the course of 
progress.
    My state of California has a great deal at stake because our air in 
certain areas continues to be polluted. People feel the adverse impacts 
of that.
    There are those who suggest that our children and adults with 
asthma should just stay home on bad air days.
    Staying home and not going outdoors is not a remedy. It is 
surrender, and I don't believe in surrender. We must act.
    The Clean Air Act directs the Administrator to set standards at 
levels that in the judgment of the Administer protect the public health 
with an adequate margin of safety. That is her directive; that is her 
job. It is not to count votes in the Congress and then set the standard 
or to take a poll and then set the standard. She must set the standard 
at levels that protect the public with an adequate margin of safety. 
Health must continue or to be the marker upon which standards are 
based. And those standards must be based on science. Once health-based 
standards are set, then costs should play an important role in 
implementation and timetables.
    Let me just say this about the cost issue. The debate over 
environmental regulations has continuously pitted the environment 
against industry, in an argument over whether the benefits of higher 
environmental standards are worth the costs they impose on our economy. 
I believe this is a phony debate because unfortunately in calculating 
these costs we never factor in the amount of money we save with higher 
environmental standards.
    A recent article in The Washington Post on a study released by the 
World Resources Institute states, ``When an investment is made or to 
reduce pollution two things happen: A cost is incurred, and other costs 
are averted. The fact that only the incurred cost is counted in 
measuring productivity means that environmental regulation lowers 
productivity not in reality, but by definition.''
    We must keep that in mind.
    Mr. Chairman, I am going or to work aggressively or to pursue 
answers or to the serious questions that have been raised about the EPA 
proposal and I look forward or to working with you, Administrator 
Browner, as well as this committee.
    Thank you.

    Administrator Browner. Thank you.

  OPENING STATEMENT OF HON. JOSEPH I. LIEBERMAN, U.S. SENATOR 
                 FROM THE STATE OF CONNECTICUT

    Senator Lieberman. Thank you.
    Thank you, Administrator Browner.
    Since we didn't have time for an opening statement, I'm 
going to mostly talk and maybe ask you one question toward the 
end because I think this is critically important. I think it is 
very important to restate what you have stated, which is that 
in promulgating these standards, you are doing your job as we 
in Congress have defined it. This is not some personal lark you 
are off on.
    Administrator Browner. That's true.
    Senator Lieberman. You have been ordered by the statute, 
which was adopted by Congress to come back every 5 years and 
ask what science technology, public health experience tells us 
about the impact of dirty air on the health of the American 
people, and you have done that because the standard adopted in 
this law, as you corrected pointed out, on a bipartisan basis, 
starting under President Nixon, taking a significant step 
forward under President Bush--and I was in that room, in the 
Senate Majority Leader Mitchell's Office with Bill Reilly, with 
Boyd and Gray, with a whole group of people from the 
Administration, Senator Chafee and others, both parties; 
Senator Baucus, obviously, negotiating this--this is all about 
health. And, as you correctly stated, the second phase of this 
when you begin to implement it, is what is the practicality? 
What is the cost? How do we do that?
    As I said last week at the subcommittee hearing, Fairfield 
County, CT, southwestern Connecticut, has some of the dirtiest 
air in America. A lot of it has to do with air blowing up from 
other States. A standard that is health-based has been set for 
Fairfield County, but in the interest of reasonable unfair 
implementation, that county has 17 years to reach that 
standard. So the question before us, I think--and what Senator 
Baucus has correctly described as an early stage of the process 
here, and let's not reach premature judgment--is, is your 
fulfillment of the job we've given you being done in a 
reasonable manner? In other words, do the health statistics and 
experience show us that unless we adjust the standard, as you 
say, a lot of people are going to get sick and some are going 
to die earlier than they would otherwise die unless we make 
this change. We can come back and decide what is appropriate 
and what's fair in terms of implementation, but if we determine 
that you've got a scientific basis, as most of CASAC did, for 
these standards that you put before us based on all those 
studies, then we've got to ask ourselves, what is our 
obligation?
    Are we going to tell the American people the truth or are 
we not going to tell them the truth? Now, that is the process 
that we're involved in, and I don't think any of us have been 
far enough into it to reach a conclusion.
    I do want to say about Senator Chafee's statement this 
morning, his statement in the press this morning, and I say 
this respectfully because I have enormous respect for Senator 
Chafee, I was very disappointed to read those statements. 
``With the tighter standards, you're going to find to revolt 
against the Clean Air Act,'' Senator Chafee told reporters.
    I don't see it. There may be a revolt among the regulated 
industries that fear the cost of this. I understand that, and 
that is something we have to consider as we go forward, but a 
revolt among the American people based on the fact that we're 
trying to find a rational basis for protecting their health--I 
don't see it. Overloading the horse, getting the whole program 
in jeopardy, this is a program that has broad support among the 
American people.
    We were talking--I think it was Ms. Nichols and I. I did a 
show with a radio talk show host--this was about 3 or 4 years 
ago--and he wanted to talk about the Clean Air Act, and he 
said, ``You know, I am a conservative. I'm a conservative 
Republican, but let me tell you this. If there is one thing my 
government should do for me and my family, it is to make sure 
that we breathe clean air and drink clean water,'' and I think 
that is what this is all about.
    Now, the yellow light is on. My question is let's go to the 
most unsettling of the conclusions you've reached. What is the 
basis for concluding that the particulate matter standards 
you're proposing will prevent 20,000 premature deaths annually?
    Administrator Browner. If I might put a chart up showing 
you the human health effects peer reviewed, published 
scientific studies that have been done. As I said before, 
literally hundreds of thousands of people have been studied, 
what happens when 2.5 reaches certain levels of concentration 
in the air. What it shows, what each and every study shows are 
large numbers of people affected. I mean, these studies--the 
base of knowledge we have on 2.5 is extremely large. You can 
see how many people were studied in each of these instances----
    Senator Lieberman. Ms. Browner, if you could give some 
numbers because I don't think members of the committee can read 
that.
    Administrator Browner. In the one study involved 
approximately 2.3 million people; another study, 2.4; another 
study, more than a half million. I mean, the numbers go on and 
on. They cover a large number of cities, an excess of 51 cities 
are measuring 2.5, and what it shows you are extreme effects--
deaths, premature deaths, respiratory illness, aggravated 
asthma. The standard that we proposed in keeping with the 
requirements of the law are designed to guard against and to 
prevent those premature deaths. Because it is death, because it 
is so severe, we do it with a margin of safety, as the law 
directs us to.
    If I might, Senator, just take a moment to go back to a 
point you made in your comments. I think inherent in all of our 
environmental statutes is the public's right to know, which is 
something I have worked very hard to honor over the last 4 
years. Most particularly I think the Clean Air Act spoke to the 
public's right to know when it ordered a 5-year review. It 
didn't want--I think the Congress didn't want, three Presidents 
who all signed this provision, didn't want a situation of the 
American public not knowing the quality of their air. So not 
only do we do this because it is where the science takes us, we 
do it because we believe the public has an absolute right to 
know. Moreover, as I think you pointed out, there is no rush to 
judgment here. This is 10 years of science. We have been about 
this process in one way or another for more than 10 years now.
    Senator Lieberman. Thank you.
    Senator Chafee. I knew there was trouble ahead when Senator 
Lieberman started off by saying he had the greatest respect for 
me. I was braced for that shoe to drop.
    [Laughter.]
    Senator Chafee. I would point out that probably the most 
cost-effective and effective step that we could take in the 
United States of America to deal with dirty air is to have 
inspection and maintenance of our vehicles, and we had that in 
the law. When we talk about revolt, there is the perfect 
example. State after State, including California, repealed 
statutes they passed dealing with inspection and maintenance. 
So did my State of Rhode Island. I think Connecticut--somebody 
told me that Connecticut and Oregon were the only two that 
didn't repeal it, and they went through with their inspection 
and maintenance.
     But there is the perfect example of what my concern is, 
and it isn't something to be taken lightly. Everything in the 
Clean Air Act is written in concrete, it's going to stay there 
forever--not at all. If you press this thing too far too fast, 
there are going to be steps taken by the American public, as we 
saw in that inspection and maintenance, which was very sad to 
see take place.
    Administrator Browner. Mr. Chairman----
    Senator Chafee. We've got a tremendous--we've got a big 
group here, and if you want----
    Senator Lieberman. Let her make this one comment.
    Administrator Browner. One minute, thank you, Mr. Chairman.
    Just briefly, when I came to the EPA, I recognized that you 
couldn't apply a one-size-fits-all solution to local air 
pollution problems, that you had to work in partnerships with 
States and local government to find what made the most sense 
for them, and we developed a long menu of options that 
Governors, mayors, communities can choose to reduce their air 
pollution.
    It is true--if you do a simple cost-benefit analysis, 
getting your car inspected will turn out to be the cheapest way 
to clean up the air. That is true. That is what a cost-benefit 
analysis will tell you--$500 a ton as opposed to something on 
the order of $2,000 to $10,000 a ton for any other solution out 
there today.
    But we recognize for some communities, quite frankly, they 
wanted to make a different choice, and we provided the 
flexibility to design the programs. I think it is important to 
understand when given the flexibility, many communities did 
choose to have automobiles inspected. They did choose to say to 
their citizens, ``help us, spend 20 minutes every other year, 
maintain your car, get it inspected,'' and in fact--I don't 
like to disagree with you, Mr. Chairman. I have the utmost 
respect----
    Senator Chafee. Oh, here we go again. I think I'm going to 
cut you off.
    [Laughter.]
    Administrator Browner. But California does have a tailpipe 
inspection program, with all due respect, and I think 
Connecticut also has such a program in place.
    Senator Chafee. I said Connecticut did--Connecticut and 
Oregon.
    Administrator Browner. I apologize.
    Senator Chafee. Senator Kempthorne.
    Senator Kempthorne. Mr. Chairman, thank you very much.
    Senator Reid. Senator Kempthorne, would you yield just for 
15 seconds?
    Senator Kempthorne. Senator Reid, do you have the utmost 
respect for me?
    [Laughter.]
    Senator Reid. I'm sorry. Thank you very much, Senator 
Kempthorne.
    Mr. Chairman, I have been called to a Capitol meeting, and 
I ask unanimous consent that my full statement, together with a 
series of questions, be allowed to be inserted in the record 
and that the Administrator would answer those at her 
convenience.
    Administrator Browner. Certainly.
    Senator Chafee. Fine, and there will perhaps be other 
questions submitted.
    Thank you for coming, Senator Reid.
    [The prepared statement of Senator Reid follows:]
  Statement of Hon. Harry Reid, U.S. Senator from the State of Nevada
    Thank you, Mr. Chairman. I appreciate you scheduling today's 
hearing on EPA's proposed regulations on ozone and fine particles. This 
issue has received a great deal of public attention and I believe it is 
very important that we examine very closely the arguments both for and 
against this proposal.
    The Clean Air Act is a cornerstone of this nation's environmental 
protection program and one of the crowning achievements of this 
committee. Like most members, I am pleased that while our nation's 
population has grown, our air, in most instances, has started to get 
cleaner. Nationwide, air pollution from carbon monoxide, lead, 
particulates, and sulfur dioxide are down significantly.
    In my home state of Nevada, home to the fastest growing city in the 
United States, Las Vegas, the maximum levels of carbon monoxide have 
fallen 35 percent in the last 10 years. So-called unhealthy days have 
fallen from more than 50 per year to less than 10.
    Does this mean the air in Las Vegas is perfect. No. Far from it.
    What it means is that we are making progress.
    That progress is a direct result of previous Congresses and the EPA 
showing leadership when faced with a lack of absolute scientific 
certainty.
    We are faced with a similar lack of certainty today. However, it is 
important that EPA and the scientific community clearly demonstrate 
that these new standards are justified. The processes we have in place 
to set national air pollution control policy has served this nation 
very well. It can be a long and difficult process, but it is one that 
has allowed is to make real progress during the last 27 years. Today's 
hearing is an attempt to make sure that the next steps proposed by EPA 
are ones that will net us continued progress.
    With that said, Ms. Browner, I join with my colleagues in welcoming 
you here today. Before getting to the big question of the day, I have 
one small item to discuss. My state's Governor, Bob Miller, is 
currently chairman of the National Governor's Association. In that 
capacity, he wrote to you recently requesting that you extend the 
comment period on these regulations to allow all of the states and 
municipalities adequate time to review and comment on the regulations.
    I thank you for asking the court for just such an extension last 
week. I understand they have granted a three-week extension of both the 
comment period and the final promulgation date for the particulate 
matter rule. I am sure the extra time will help the folks we are 
expecting to help us implement these rules understand them a little 
better. Again, thank you.
    Ms. Browner, although all of us sitting up here are going to ask it 
a slightly different way, it seems to me that the bottom line reads: 
``Is what you are doing necessary to protect public health with an 
adequate amount of safety?''
    We have heard a great deal in recent weeks about the role of the 
Clean Air Scientific Advisory Committee and what they did and did not 
say. We have also heard many conflicting views about where science 
stops and where policy decisions start.
    It is my hope that you will be able to shed some light on these 
issues.
    Additionally, I am a Westerner. I also represent the fastest 
growing state in what is perhaps the fastest growing region in the 
nation. We are often concerned that the federal government, in setting 
national policies, adopts a one-size-fits-all approach that does suit 
the needs of the states, localities, and people living in the West. In 
your remarks, or as a follow-up, I would like for you to address how, 
if at all, you have incorporated the unique concerns of Western states 
into your proposal.
    I think I speak for the whole committee when I say that, when all 
is said and done, we are hoping to see strong factual and scientific 
conclusions leading to reasonable policy judgments by you and the rest 
of the professionals at EPA we have charged with making just these 
sorts of hard decisions. Thank you, Mr. Chairman.

    Senator Chafee. All right, Senator Kempthorne.

 OPENING STATEMENT OF HON. DIRK KEMPTHORNE, U.S. SENATOR FROM 
                       THE STATE OF IDAHO

    Senator Kempthorne. Mr. Chairman, thank you very much.
    Madam Administrator, I would hope that the EPA will re-
evaluate the economic impacts of the proposed standards under 
both the Unfunded Mandates Act and the Small Business 
Regulatory Enforcement Fairness Act.
    While the Clean Air Act requires standards to be set 
without regard to cost, it does not prohibit the EPA from 
identifying and assessing the real life impacts of the proposed 
regulation. Both the Unfunded Mandates Act and the Small 
Business Regulatory Enforcement Fairness Act are based on the 
principle that the public has a right to know, which I am 
delighted to see you're a staunch advocate of. A regulating 
agency should know as well the costs of regulation, even when 
those costs are not specifically factored into the regulation 
itself.
    The EPA should undertake an analysis of those costs under 
the unfunded mandates law, after all because that is good 
responsible government.
    My question is will you do so?
    Administrator Browner. We agree with you, and in fact we 
have done a cost-benefit analysis on these proposals. As you 
point out, the statute requires us to make a public health 
decision, not a cost-benefit decision. But because I believe, 
as do you, that it is an important part of the debate, an 
important part of the discussion, we did in fact conduct and 
made available to the public a cost-benefit analysis. I think 
something on the order of 2,400 copies of this analysis, which 
is quite long, have been requested and delivered to members of 
the public. It is on the Internet and anyone can access it.
    I think the question perhaps that you raise is the question 
of unfunded mandates and what the law actually requires in 
terms of cost effectiveness termination unless the law 
prohibits, and, as I think the courts have rightfully 
interpreted, the section of the Clean Air Act that speaks to 
public health, it is a public health decision and not a cost-
benefit decision. We did do the study, and it is publicly 
available. I think it is extremely important to understand that 
when you conclude the public health phase and begin the 
implementation phase, cost benefit is front and center. You use 
cost benefit to make judgments in terms of should it be this 
industry that reduces their pollution or another industry. What 
is the cost?
    The final thing, if I might, Senator, just point out is 
that this issue of cost and benefits under the Clean Air Act 
has been an issue for many, many, many, many years, and every 
single time the Congress, every single time the EPA joining 
with the Congress has sought to tighten the public health 
standards under the Clean Air Act, we have heard from some in 
the industry that the cost would be prohibited. The facts are 
actually different. In each and every instance the cost of 
reducing pollution under the Clean Air Act has proven to be far 
less than anyone suggested on the front end, and the benefits 
far greater.
    We have a study right now under peer review that shows the 
benefits under the Clean Air Act for a 20-year period 45 times 
greater than the cost. There is a good history here of industry 
rising to the occasion.
    Senator Kempthorne. OK, and I appreciate very much that 
you're doing the cost-benefit analysis. As you know, that was a 
critical part of the Safe Drinking Water Act, and we worked on 
that together.
    My question, in addition to the cost benefit though is, 
have you determined the costs to the States and the local 
communities that must implement these new standards?
    Administrator Browner. You're asking me a question in terms 
of what it cost then to write a plan? Is that the question 
you're asking? I apologize----
    Senator Kempthorne. Whatever the requirements are that you 
would place on to the governments, what is the cost for them to 
implement?
    Administrator Browner. We are looking at the cost. I think 
what you're asking is there is--obviously, what States do is 
they develop a plan to reduce pollution, to meet a public 
health standard. The actual number of staff people involved, 
the work they do, is a cost we are now looking at with the 
States, and it will be in the next updated cost benefit 
analysis. As we get more information in during the public 
comment period, we do, obviously, revisit these documents and 
make improvements, and we are doing that.
    Senator Kempthorne. And too I would like to visit those 
documents too.
    Administrator Browner. OK.
    Senator Kempthorne. So would you make available then what 
is the cost to States and local governments to implement 
monitoring devices, etcetera, so that we know what is the cost, 
and also what is the cost to business? It follows the concept 
of the Unfunded Mandates Act, which has been now made the law 
of the land.
    Administrator Browner. Right, we agree. What we could do 
this afternoon is deliver to your office the cost-benefit 
analysis as it now stands. Again, this is available on the 
Internet to the American people. Many people have accessed it, 
and then as we conclude the public comment period and make 
improvements based on new knowledge we have received, we will 
also make that available to the committee.
    Senator Kempthorne. OK, my time is up, but just so that we 
have an understanding, the cost benefit is one report; the 
actual cost, another report.
    Administrator Browner. The way I think we are approaching 
this, and we can talk to your staff about it just to make sure 
we have an understanding, is that we are I think developing one 
document that speaks to all of the issues, but we'll work with 
your staff.
    Senator Kempthorne. All right, thank you very much.
    [The prepared statement of Senator Kempthorne follows:]
Statement of Hon. Dirk Kempthorne, U.S. Senator from the State of Idaho
    I want to thank you, Mr. Chairman, and the chairman of the Clean 
Air Subcommittee, for holding this hearing on EPA's proposed new air 
quality standards for ozone and particulate matter, for surely there is 
no more important issue to all of us than breathing clean and healthy 
air.
    It seems self-evident, but I believe that it is a point worth 
emphasizing--All of us here today, Republican and Democrat alike, are 
committed to protecting our environment, our air, our water and our 
natural resources. This is not, and should not be a partisan issue.
    No one wants to see children suffer from asthma or miss school 
because of pollution in the air. No one wants to see tens of thousands 
of Americans die prematurely because of air pollution. So, should we 
have the most stringent air quality standards necessary to protect 
public health? Of course.
    But, in Administrator Browner's own words, our air quality 
standards must be based on ``the very best science to do what is 
necessary to protect public health in common-sense, cost-effective 
ways.'' That is a goal that we certainly all share.
    After reviewing EPA's proposed standards, however, I am concerned 
that we don't yet have ``the very best science'' to ensure that the 
standards will address the real health risks, if any, that may be posed 
by ozone and very fine particulate matter. It is troubling that only 
two of the ten members of the independent scientific review committee, 
CASAC supported EPA's proposed standard for ozone. It is equally 
troubling when the CASAC panel also could not reach a consensus on what 
standard would be appropriate for PM2.5 because there were 
``many unanswered questions and uncertainties regarding the issue of 
causality.''
    And yet, EPA appears prepared to proceed to finalize new standards 
on an expedited schedule, not because it has the ``very best science,'' 
or clear evidence of significant health benefits to be gained, but 
because of a lawsuit and a court-ordered deadline.
    At the very least, it seems that EPA's action is premature. While I 
recognize that under the current law, EPA is required to set air 
quality standards at a level that will ensure public health protection 
with an adequate margin of safety, without regard to cost, the record 
here suggests that EPA does not have the scientific information that is 
necessary to ensure that its standards will, in fact, ensure public 
health protection. For example, CASAC's review of EPA's proposed 
standard for PM2.5 demonstrates that we need better science 
on very fine particulate matter and specifically which small 
particulates cause health problems. Without better scientific 
knowledge, we could find ourselves in the position of forcing 
communities and businesses to spend hundreds of millions and even 
billions of dollars without ever addressing the real health threats. 
Similarly, CASAC's failure to support EPA's proposed ozone standard 
suggests that the scientific basis for lowering the ozone standard is 
at best questionable.
    These new standards, if finalized, will impose substantial new 
costs and burdens on states and local governments, communities, small 
and large businesses, and even individual citizens. Before the Agency 
rushes to finalize any new standards, I believe that it must address 
concerns that have been raised regarding whether there is sufficient 
science to proceed with these rulemakings at this point, or whether 
further studies are needed to ensure that the goals of the Clean Air 
Act are met.
    I would hope that EPA will also reevaluate the economic impacts of 
its proposed standards under both the Unfunded Mandates Act and the 
Small Business Regulatory Enforcement Fairness Act. While the Clean Air 
Act requires standards to be set without regard to cost, it does not 
prohibit EPA from identifying and assessing the real-life impacts of a 
proposed regulation. Both the Unfunded Mandates Act and the Small 
Business Regulatory Enforcement Fairness Act are based on the principle 
that the public has a right to know, and a regulating agency should 
know, the costs of regulation, even when those costs are not 
specifically factored into the regulation itself. EPA should undertake 
an analysis of those costs under the Unfunded Mandates law; after all, 
that's just good, responsible government.
    I look forward to hearing Administrator Browner's testimony this 
morning and I hope that she will address these issues.

    Senator Chafee. Senator Allard.
    Just so that everybody will know where they stand on the 
early bird, next we'll be followed by Senator Wyden, Senator 
Sessions, Senator Smith, Senator Boxer, and Senator Thomas.
    [The prepared statement of Senator Thomas follows:]
 Statement of Hon. Craig Thomas, U.S. Senator from the State of Wyoming
    Thank you, Mr. Chairman, for holding this hearing to continue our 
discussion of the EPA's proposed rule for Particulate Matter (PM) and 
Ozone. I certainly agree with you that what we are considering today is 
quite possibly the largest, most important regulatory action undertaken 
since the creation of the Clean Air Act. It is a pleasure to have EPA 
Administrator Carol Browner with us and I look forward to her comments 
and testimony.
    If there was one consensus reached in last week's hearing on the 
science behind these proposed regulations, it's that there is no 
consensus. Dr. George Wolff, the current chairman of the EPA's Clean 
Air Scientific Advisory Committee (CASAC), stated that the court-
ordered deadline did not allow enough time for members of the panel to 
adequately examine this complex issue. Dr. Morton Lippmann, Professor 
of Environmental Medicine at New York University Medical Center and, 
former CASAC chairman, also stated that more time is needed to conduct 
additional research. At one point, both scientists were bickering back 
and forth about what ``was'' and what ``was not'' agreed to by the 
panel of scientists.
    In the Clinton Administration's budget request for Fiscal Year 
1998, the EPA is seeking $26.4 million for--and I am quoting here--
``research to reduce the great uncertainly about PM's health effects.'' 
If we are not absolutely sure about which particles we should be 
regulating, should we really be seeking to impose new standards? Is 
there a rush to judgment? The request goes on to state that EPA ``will 
launch research into three areas: (1) evaluating the relationship 
between the health effects and PM exposures; (2) determining the amount 
and size of particles inhaled and retained in the lungs; and (3) 
investigating biological mechanisms by which PM concentrations in 
outdoor air may induce health effects and, in doing so, evaluating 
potential links between PM exposures and health effects.'' I think this 
clearly demonstrates the EPA's need for more time and scientific 
research to study this controversial issue.
    This is not about new standards for backyard cookouts or gas 
powered lawnmowers. Instead, it's about possibly implementing a 
standard based on inexact science and inconclusive evidence. If we can 
effectively end health risks for people and children we should do it. 
But we shouldn't step off this cliff merely because we hope and 
theorize that these new standards will offer us the results we want.
    CASAC stated that ``our understanding of the health effects for 
ozone is far from complete.'' The members also documented that ``there 
was no scientific consensus on the level, averaging time, or form of a 
PM2.5 National Ambient Air Quality Standard (NAAQS).'' With 
all of this ambiguity, and a lack of scientific data--which was 
documented by the experts who testified last week--it seems that EPA's 
decision to set new standards for PM and ozone was a judgment call, not 
a result of sound scientific evidence.
    Mr. Chairman, it is paramount that principles of sound science are 
being applied. As we all know, this is a very technical issue and we 
need to be confident that the choices we are making will get to the 
heart of protecting public health. I am concerned, however, that we are 
about to go down a regulatory road before we truly know which 
pollutants are causing health effects.
    No one is rejecting the notion that we need to continue to look for 
ways to improve and protect public health. However, that concept needs 
to be balanced with the best available, peer-reviewed science. It ends 
up building support for whatever measures we take because folks will 
have the confidence that the sacrifices they are making are really 
worth something.
    Mr. Chairman, we all want to protect public health and the 
environment. Folks in Wyoming enjoy clean air and take pride in living 
in a state where current NAAQS are being met. However, if these 
proposed regulations are implemented, Wyoming could get caught up in a 
major sweep and be required to implement standards that may actually 
yield few health benefits. Again, I compliment the chairman for holding 
this hearing and look forward to hearing from our two witnesses.

    Senator Chafee. Senator Allard.

 OPENING STATEMENT OF HON. WAYNE ALLARD, U.S. SENATOR FROM THE 
                       STATE OF COLORADO

    Senator Allard. Thank you, Mr. Chairman.
    I would like to request that my remarks be made a part of 
the record.
    Senator Chafee. Absolutely.
    [The prepared statement of Senator Allard follows:]
Statement of Hon. Wayne Allard, U.S. Senator from the State of Colorado
    Thank you Mr. Chairman. I'm pleased to have Administrator Browner 
with us today to go over this important and complicated issue. Last 
week in my opening statement I expressed the hope that we could settle 
the science in this area so we could discuss the policy with Ms. 
Browner.
    Unfortunately, that didn't happen, and in fact, there may be more 
questions about the science now than before that hearing. So today 
instead of discussing policy I hope Ms. Browner is prepared to help us 
with the science that led her to believe these regulations were 
necessary.
    In particular she should be able to tell us why the CASAC panel was 
so divided on the PM issue. To some it would appear that instead of 
taking sound science EPA is merely taking sides. For example, last week 
the Clean Air Subcommittee was treated to an exchange between two 
prominent scientists who serve on the CASAC panel. This exchange 
basically devolved into a ``yes-this-is-true-no-that-is-not-true'' 
debate. Unfortunately, this type of exchange could lead to a perception 
that science has less to do with these regulations than ideological 
viewpoints. While I don't believe that is true, I do believe we need to 
move very cautiously to ensure that cynicism doesn't become widespread; 
because if that becomes the case more people will take the view of one 
individual who commented that, ``It's apparent from this regulation 
that the EPA doesn't want us driving our cars across the bridge to the 
21st century.''
    Thank you Mr. Chairman.

    Senator Allard. I also have some questions that I would 
like to submit for Ms. Browner to respond to, if she would 
please.
    Administrator Browner. Certainly.
    Senator Allard. In the meantime, I will cover, hopefully, 
some rather fundamental issues here for the committee.
    You used the words,
    ``There would be 133 million people helped with these 
rules''----
    Administrator Browner. Protected.
    Senator Allard. Protected with these rules and regulations. 
The testimony that we had earlier from your advisory council 
with Senator Inhofe stated that this scientific data was 
directed toward those people who are suffering from some type 
of disease disorder. They had asthma--you mentioned this here--
they had asthma or you talked about special risk populations, 
such as children, and then you made in your statement, ``There 
is a 133 million people that would be helped.''
    There's 260 million people in the United States, so I'm 
curious as to how you came up with 133 million.
    Administrator Browner. Well----
    Senator Allard. If you look at your neighbor, they have 
asthma, their child or--I mean, where do you come up with 133 
million? I looked in your testimony and I didn't see that 
written in your testimony.
    Administrator Browner. First of all, healthy people, non-
asthmatics, can experience and do experience, the science shows 
that they experience, under certain levels of pollution adverse 
health effects----
    Senator Allard. That is correct, certain levels of 
pollution, but what you talk about for ozone and for 
particulate matter--in the previous panel I asked them the 
question, well, how about normal people? Will these affect 
normal people? They didn't think that they did. They said that 
these are figures that are directed at people that show signs 
of disease or have some disease----
    Administrator Browner. With all respect, many of the 
studies focused on quote normal people in the real world. It 
looked at what happened to the child.
    Senator Allard. OK, well, then let me--then you mention 133 
million. How come--if only half of the population is affected, 
how come the other half isn't?
    Administrator Browner. Because, fortunately, for half of 
the American people they are living in a place where the air 
already meets a cleaner standard. They are fortunate to live in 
a place where the levels of pollution do not exceed what the 
science shows us in terms of cost and health effects.
    Senator Allard. Well, I just have to tell you as one member 
of this committee in listening to your figures, you seem to 
start out with somewhat of a good scientific basis, and then 
all of a sudden you begin extending your argument and all of a 
sudden you sort of exaggerate your figures--that's the 
impression I get--in your presentation.
    So I'm trying to size down----
    Administrator Browner. Well, let----
    Senator Allard. Just a minute, if you would please.
    Administrator Browner. OK, I apologize.
    Senator Allard. I'm trying to size down what the real 
problem is and where we can really make a difference.
    Now, I'm thinking as a legislature, a senator from the 
western part of the United States, and you have asked local 
governments to implement the Clean Air Act, the clean air 
standards. Will local governments have an opportunity to tell 
Federal agencies what they need to do to comply with this?
    Administrator Browner. There is a process which will, as 
you move into the implementation phase, through--we have a 
panel we use--and I want to get the name right--a Local 
Government Advisory Committee. I personally meet with them 
regularly. We talk about drinking water frequently, and 
hopefully we will talk about it less now that we have a new 
law. But that will be one mechanism for soliciting the input of 
local government, one of many.
    Senator Allard. The input of local government, but I'm 
talking about the implementation of the Clean Air Act.
    Administrator Browner. That's what I'm saying, right.
    Senator Allard. So if the Forest Service, or BLM, decides 
to have a natural burn on forest that increases particulate 
matter, concentration in the air, and it has an impact on the 
total effect because this hangs around States like Colorado not 
for a week, or 2 weeks. It will hang around for 1 to 1\1/2\ 
months during the fire season, and this is going to have an 
impact on what happens in those communities.
    So local communities somehow or another are going to tell 
the Federal Government, the forest or the BLM that you can't 
cause the fire to burn because it does have an impact on our 
standards, on particulate matter?
    Administrator Browner. There are many processes already in 
place and others that will be added to ensure that all of the 
parties with an interest on the implementation side are part of 
the discussions. For example, you raised other Federal 
agencies--an appropriate question. There is a process, the 
interagency process. In fact, Ms. Sally Katzen is here from the 
White Office with authority for managing that process. We are 
in dialog with other Federal agencies.
    Senator Allard. You know, you talk around it but you don't 
really answer my question.
    Administrator Browner. What is the question?
    Senator Allard. The fact is, the point I want to make 
before this committee, is you have one agency out here--two 
agencies--that are doing things that impact ambient air quality 
and somehow or another they get excluded--they don't get 
considered in the process because what they are doing has an 
impact on local governments, and in particular in my part of 
the country, the Grand Canyon Visibility Project, it has an 
impact, and you need to recognize that.
    My time has expired. I have a red light on there, and I 
would like to have more time to visit with you on these issues.
    Administrator Browner. Senator, we do recognize the impact 
that the Federal Government may have on local communities. In 
fact, the Federal Government complies with drinking water 
standards where they operate facilities. We comply with waste 
water standards, we comply with MPDES. No one is suggesting 
that the Federal Government sits outside or the actions of the 
Federal Government in community after community sit outside the 
pollution standards.
    Senator Allard. Mr. Chairman, I keep getting the last--are 
you an attorney? You keep working for the last word.
    Administrator Browner. Well, with all due respect, I think 
I have a right to respond.
    Senator Allard. Well, listen----
    Administrator Browner. I don't have the right to respond? 
I'm sorry.
    Senator Allard. You do have a right to respond, but I just 
want to make sure that you give local governments and States 
the right to talk about what some of these Federal policies are 
having on air quality. In your response to me you talked about 
clean water--we're talking about clean air, and we're talking 
about the impact of national burn on ambient air qualities in 
the States in the western parts of this country, and how it's 
going to affect those local communities.
    I think that the Federal Government needs to be a partner 
in that. We need to do something about it, but they need to be 
a partner in it.
    Administrator Browner. We agree. With all due respect, we 
agree, and, in fact, as I tried to explain, we have processes 
in place to ensure that that happens both at the local 
government level and with the Federal agencies. If there is 
advice that this committee would like to offer, or you would 
like to offer, in terms of other processes, we would be more 
than happy to consider those.
    Senator Chafee. On a high note, with all due respect, we 
agree.
    Administrator Browner. We agree, that's what we're saying--
we agree.
    Senator Allard. But you haven't----
    Senator Chafee. All right. My father once told me never 
argue with analogies.
    [Laughter.]
    Senator Chafee. We'll now move on to Senator Wyden.

  OPENING STATEMENT OF HON. RON WYDEN, U.S. SENATOR FROM THE 
                        STATE OF OREGON

    Senator Wyden. Thank you, Mr. Chairman, and Ms. Browner.
    To me this debate shouldn't come down to just the question 
of your health or your money. Our country made the wise 
judgment years ago. The Clean Air Act was going to be based on 
health standards. I don't think the country wants it changed. I 
would fight changing it. I think there are legislators on both 
sides of the aisle who don't want to see that compromised.
    At the same time, I can list three or four specific 
concrete ways that once we keep the health foundation, we can 
look at ways to hold down costs. For example, in my area we 
like to give credit to parts of the country that have done the 
heavy lifting and are making progress. For example, and I want 
to be very specific on this, because I think it is important to 
find a way to come together after we have made the judgment 
that we want a health standard to look at ways to hold down 
these costs.
    For example, we've got communities in Oregon that are very 
concerned that they've got to spend their time on paperwork 
getting officially reclassified as in compliance with 1990 
standards rather than just bringing you the data showing that 
they are making the progress and moving on.
    Can we start that discussion with some of those things and 
begin to bring people together around that point?
    Administrator Browner. I agree, and, in fact, the question 
of redesignation is one that Ms. Nichols and her office has 
focused a great deal of energy on. We are now expediting those 
applications for redesignation. I think we have been able to 
reduce the time significantly from--unfortunately, it was 
taking years but we now have it down to months.
    Senator I know you appreciate the fact that there is a 
process. It is not simply the EPA and the States saying yea or 
nay. There is a public comment and a public right to know 
mechanism embodied in a redesignation decision, and that does 
take a chunk of time in there, but I think the fact that we 
have been able to reduce it literally from years to months is 
an indication of our willingness to work with communities.
    Senator Wyden. What are your thoughts about expanding, for 
example, the trading of credit as another way, again, to bring 
people together as we look at an Act that has a health 
standard?
    Administrator Browner. We would agree that emissions credit 
trading programs have been very, very successful. As I've said 
in answering some other questions, the history of the Clean Air 
Act is that the estimates of costs on the front end turn out to 
be much greater than the reality of the costs on the back end, 
and I just want to show you a chart.
    We looked at three fairly significant decisions under the 
Clean Air Act. We looked at what people said it would cost us 
to solve the acid rain problem in the country and what it has 
actually cost us. The estimates on the front end range from 
$1,000 to $1,500 per ton. Today, you can buy a credit for $78 
on the Chicago Board of Trade. We looked at what it cost to 
produce a cleaner car. When we went to Detroit and said, ``Make 
us a cleaner car,'' they said, ``It's going to cost something 
on the order of $1,500.'' That car is on the road today and it 
is costing between $60 and $100 a car.
    Over and over again industry rises to the occasion. The 
cost of actually providing cleaner air comes down significantly 
from the estimates, and, equally important, the benefits of 
clean air are far greater than we could have ever estimated or 
guessed on the front end.
     Now, I would also tell you there is a process. We are 
using a Federal Advisory Committee process to look at other 
streamlinings, other innovations, that we can make in the 
implementation of the law. What can we do to respond more 
quickly, to turn around the kinds of answers that the Federal 
Government and State governments need from us. We have a 
process underway.
    Senator Wyden. I've got my warning light on, and let me see 
if I can wrap it up this way.
    I would like to submit to you, Ms. Browner, because you 
have been responsive to our State in the past and we've worked 
closely together about four or five specific suggestions in 
this area. I think it is important for us to talk about how to 
deal with regional differences. I think that it is important 
that we talk about how this is integrated in the whole debate 
about energy policy and energy deregulation.
    My only concern is for those of us who feel strongly about 
keeping those health-based clean air standards. It is critical, 
in my view, to not make the discussions about implementation 
some kind of afterthought and just something that is going to 
be discussed another day. We're going to keep the guts of this 
Act. We're going to fight those who try to compromise it, but, 
at the same time, I think every step along the way we want to 
be looking at these kinds of ideas, and we will furnish them 
for the record in writing, and look forward to pursuing them 
with you.
    Thank you, Mr. Chairman.
    Senator Chafee. Thank you, Senator.
    Senator Sessions.

OPENING STATEMENT OF HON. JEFF SESSIONS, U.S. SENATOR FROM THE 
                        STATE OF ALABAMA

    Senator Sessions. Thank you very much.
    Administrator Browner, I think you are a great advocate for 
the position that you're taking. We have a little different 
perspective in the sense that we have to represent the people 
of our States, and we have to be sure that what we are asking 
them to sacrifice to do is actually going to get the kind of 
benefit and advantage that you predict that it will.
    In that regard, I have some concern about the numbers. 
Senator Allard asked about the number of children protected, 
the number of people protected, and I think he said 133 
million. But if you have that chart there of the smog and 
ozone, I think we had an agreement from all the scientists that 
were here last time that the present level of ozone and present 
levels for particulate matter are not really adversely 
affecting the health of healthy people. The focus has been on 
those who are sensitive in some way.
    Isn't that a fact?
    Administrator Browner. We can show you, I think, what CASAC 
said, if I might, just paraphrase what the scientists said, 
which is it is true. The current levels provide some level of 
protection, but they leave too many people at risk. There are 
too many premature deaths, there are too many aggravated 
asthmas, there are too many respiratory illnesses. That is what 
the science, the human health effect science shows us. It is 
not to say that all the work we've done hasn't been great and 
hasn't been necessary, but the science now shows us that we 
again need to take another step. We need to add another layer 
of bricks.
    Senator Sessions. But we can go further. I will respect 
that, and I think we can go further, and we need to do that as 
we are able and as the science supports it.
    But I was just looking at this figure. It has dawned on me 
that all the total protected Americans means is that that is 
the number--122 million people--who live in the areas of this 
country that will now be under some control if this law goes 
into effect, these regulations go into effect. That is what you 
mean, and I would just suggest to you that that overstates in 
the minds of most of us when I first saw it the real benefits 
that we might be getting from these new standards.
    Wouldn't you agree?
    Administrator Browner. I think it is important to think 
about this in the real world, and what the science now shows us 
is that far too many people under current levels of pollution 
are experiencing aggravated asthma. They are having more 
attacks. We make the decision and we propose the decision based 
on the science and the recognition that too many people are 
suffering and that the law requires a level of public health 
protection.
    I mean, I don't think anyone--and I don't want to say that 
you're suggesting this--but I don't think anyone would find it 
acceptable for us to sort of say, ``OK, for the children out 
there who are experiencing asthma attacks because of polluted 
air, aggravated asthma attacks, don't go outside, or hold your 
breath when you walk home.'' I mean, that is not a solution. I 
mean, we have to look at where the science takes us, and the 
science shows that a lot of people, a lot of people, do 
experience effects.
    It also--when you propose to strengthen the standards, when 
you propose to tighten the standards, it is also important--and 
I would be the first to admit this--to recognize that we 
continue to preserve the health of some number of children. I 
mean, we can't ignore the fact that some number of healthy 
children will without taking action become ill and preventing 
them from becoming ill in the first instance has always been 
part of what the Clean Air Act envisioned.
    Senator Sessions. I just want to try to get a little more 
clarity in what we're talking about.
    We know that ozone has been falling because of regulations 
this government has imposed consistently for a long time. We 
also know that asthma attacks are going up, and we don't know 
why that is true. It is certainly not because ozone is 
increasing. There is something else that is causing the 
increase in asthma attacks of which we don't know, and that to 
me points out some of the problem.
    All this 122 million figure says is that is how many people 
live in areas that are now under these new standards. It can be 
nothing else, the way I would calculate it.
    Another thing on the standards and science of it, again, 
I'm not a scientist. The commissions have studied it, but I 
notice that Dr. Schwartz of Harvard, who supports your 
standards, the first line virtually in his statement to the 
committee was that on the proposed particulate standard the EPA 
is not out in front on the science and lags behind the rest of 
the world in data on that.
    Would you agree with that?
    Administrator Browner. I have not seen that particular 
statement. I would be more than happy to take a look at it.
    Senator Sessions. This is what he said.

    The EPA is not out in front of the science on the proposed 
particulate standards, but rather lags behind a number of 
governments in Western Europe and international scientific 
bodies.

    Administrator Browner. What my colleagues who were at the 
hearing say Dr. Schwartz was saying is that the EPA and the 
United States lags behind in terms of the public health 
protections that other places have tighter standards.
    Senator Sessions. I'm reading his written statement. It 
says, ``The EPA is not out in front of the science on the 
proposed particulate standards.''
    Administrator Browner. As I hear you say that, what he is 
saying is we haven't gone beyond where the science takes us, 
but we are following where the science takes us, which is what 
the law requires of us, best current science. I mean, we can, 
obviously, all check with him, but my sense is what he is 
saying, based on what you are reading is that the EPA is 
following the science, which is what we are required to do.
    Senator Sessions. Well, I just think when we know a new 
period is coming up, a new 5-year report and analysis has to be 
made, the EPA does need to be out in front in developing and 
ensuring that scientific research is done so that when we get 
to that point, we can make the most rational decisions that are 
possible.
    Administrator Browner. That is why, obviously, the 
scientific work is ongoing and why, as I think Senator Inhofe 
noted, the EPA budget does include dollars for ongoing 
scientific analysis. That would be appropriate.
    [The prepared statement of Senator Sessions follows:]
Statement of the Hon. Jeff B. Sessions, U.S. Senator from the State of 
                                Alabama
    I would like to thank Senator Chafee for holding this hearing today 
to discuss the EPA's proposed changes to the Ozone and Particulate 
matter standards. I would also like to thank EPA administrator Carol 
Browner for appearing before this committee and to express my 
commendation to all who have done so much to identify and help solve 
air pollution problems. In partnership with cities, states and 
industry, we have seen the national levels of both ozone and 
particulate matter decrease significantly in recent years.
    We hear many arguments on both sides of the issue concerning the 
increased health benefits, or lack thereof, for families and children. 
As a father of three, I want to find an answer to this health problem 
and support those parents and dedicated health professionals who are 
working for the cleanest possible air. However, the recent hearing held 
before the Clean Air subcommittee with a panel of scientists who advise 
the EPA, raise questions as to whether the proposed new standards for 
ozone and particulate matter will be the best way to better health.
    Testimony from that hearing showed that the proposed new ozone 
standard will have only a minimal impact on the number of hospital 
admissions, leaving the bulk of those who suffer still looking for an 
answer.
    Testimony from that hearing also illustrated a lack of scientific 
data to support proposed changes to the particulate matter standards.
    In addition, dialogue from that hearing served to demonstrate the 
disagreement within the scientific community regarding changes to those 
standards, relative to the health merits such a change might bring. One 
study on particulate matter conducted by Dr. Joel Schwartz of Harvard 
University, in Birmingham, Alabama, showed that an increase in PM 
concentrations adversely affected health and caused increased premature 
death among those who were elderly or had serious health problems. 
However, a study by Davis and Jackson, of the National Institute of 
Statistical Science, using the same data, noted that when you added one 
more factor, humidity--the causality between mortality and increased 
levels of particulate matter became ``statistically insignificant''--
casting serious doubt as to whether or not particulate matter or some 
other factor may have been at play.
    Certainly, there appears to be no clear consensus from the 
scientific community regarding the benefits of imposing these 
standards. Dr. Morton Lippmann, former chairman, and the current 
chairman of the EPA's Clean Air Scientific Advisory Committee, Dr. 
George Wolff, both expressed serious disagreement over the science used 
as the basis for establishing new standards for particulate matter and 
ozone. One issue they did seem to agree upon however, was the need for 
the scientific community to have more time to collect and analyze data, 
and to weigh the health benefits such changes may or may not bring. 
Further, Dr. Schwartz, who testified in favor of the new standards, 
flatly stated that the EPA ``lags behind'' in the scientific analysis 
of this issue.
    The EPA is currently working under a court order to complete its 
review of particulate matter standards. As the former Attorney General 
for the State of Alabama, I have witnessed many instances when groups 
have filed lawsuits and used court orders a tool to help push through 
their agenda. It is important to note that the court order does not 
require the EPA to consider ozone standards but only to review the 
current standard for particulate matter. It does not require the Agency 
to impose new standards.
    In conclusion, I am in support of policy decisions based on sound 
science which will have a positive health impact on the families and 
children of this nation. If we are unsure about what is causing the 
increase in respiratory ailments, and the science appears to be 
inconclusive, then let's direct our efforts into promptly conducting 
the studies that will give us that information--then act.
    Thank you, Mr. Chairman, for this opportunity to learn more about 
how and why these new standards have been proposed. I look forward to 
learning more about this issue from today's witnesses.

    Senator Chafee. Thank you, Senator Sessions.
    Senator Smith.

 OPENING STATEMENT OF HON. ROBERT SMITH, U.S. SENATOR FROM THE 
                     STATE OF NEW HAMPSHIRE

    Senator Smith. Thank you, Mr. Chairman.
    Good morning, Administrator Browner. I have a statement 
that I would like to enter into the record, Mr. Chairman, and 
beyond that, I would just make a comment.
    I heard your comments regarding the backyard barbecues on 
the way into work this morning. I heard an ad that certain 
members of the Senate and the House were willingly rolling 
back--willingly wanting to roll back standards for clean air so 
that children could get sick. So I think I am just as outraged 
by that ad, whoever ran it. I don't even remember who it was.
    Administrator Browner. I would agree.
    Senator Smith. I just want to ask one question for 
clarification on the Executive Summary, National Air Quality 
and Emissions Trends Report.
    Administrator Browner. It is our Trends Report, I believe?
    Senator Smith. Right, and in that report there is a chart 
that lists each of the six items, and it says, ``air quality 
percent change.'' This is from 1986 to 1995. ``Carbon monoxide 
minus 37 percent, lead minus 78, nitrogen oxygen minus 14, 
ozone minus 6, PM10 minus 22, and sulphur dioxide 
minus 37.''
    We still have not reached full attainment on the 1990 Act. 
Is that correct?
    Administrator Browner. The States have adopted their 
implementation plans. They are putting--the plans are there 
that bring us into attainment and the steps are being taken. 
Similarly, we have worked with industry to develop the new 
technologies, the new solutions, and those are now being 
installed.
    It is true from the time you make a decision, from the time 
you adopt a plan and you develop a technology, there is then a 
period of time that plays out for the implementation.
    Senator Smith. Do we have any idea once it's fully 
implemented how much those numbers would change? I would assume 
they would go up slightly if the Act were to be fully 
implemented.
    Administrator Browner. I'm trying to remember that 
particular chart. That chart may well be what the public health 
protections, the current public health standards for the six 
most commonly pollutants get you when full implementation is 
achieved. I apologize--I can go back and look at that chart.
    Senator Smith. All right, if it is--let's assume for the 
sake of argument that it is full implementation. Does that 
figure remain--if we didn't do anything except maintain the 
current standards, let's say, if we made no changes, we just 
stayed where we are, do those figures remain static or do they 
change?
    Administrator Browner. They can change. Whether or not they 
will change we will only know at the time. Obviously, you have 
changes in the economy, you have changes in different 
industrial sectors, so you can have changes in terms of the 
gross numbers.
    It might be helpful, Senator, for me to just explain one 
thing for a moment. The law very specifically told the EPA to 
focus on the six most commonly found air pollutants--those are 
the six you read. You might want to know that in the last 4 
years we did our 5-year reviews not just on particulate and 
ozone, but we also did them on carbon monoxide, sulphur dioxide 
and nitrogen dioxide, and in all of those we retained the 
current standards on.
    Senator Smith. My point is that is a good track record. 
That is a very positive statement for what the Clean Air Act 
has accomplished. My question is simply do those figures remain 
constant or will they change if you didn't do anything except 
maintain where we are? If we looked at this 5 years from now, 
would ozone be minus six or would it be minus 11? I mean, does 
anyone have any idea?
    Administrator Browner. I think they essentially stay the 
same. Here is the trouble we're having----
    Senator Smith. I want to ask one question----
    Administrator Browner.--one growth does occur but 
technology continues to improve. So you get some increase 
because of growth but you get a decrease because of technology. 
They will remain essentially the same, and our requirement is 
to make sure that if keeping them the same is adequately 
protecting the public's health. What we found in most instances 
is yes; in two we found no.
    Senator Smith. One final question regarding the northeast. 
As you know, there are certain areas of the country that are in 
non-compliance, in many cases through no fault of their own or 
not entirely through their own fault.
    I'm concerned that more stringent standards could leave an 
area like the Northeast in non-compliance for even longer 
periods of time, which is beyond our capability to correct. Are 
these standards going to enhance that problem?
    Administrator Browner. I think in fact it is the opposite, 
which is a more stringent public health standard reduces 
overall pollution which is better for your State and for many 
other States. If we take the steps to reduce the generation of 
pollution based on protecting the health of the American 
people, it will be better particularly, I think, for your 
State.
    Senator Smith. Except for the fact in a State like New 
Hampshire if we drove all electric cars, we still couldn't keep 
in compliance.
    Administrator Browner. Well, one of the things that we have 
learned over the last 20 years in implementing the Clean Air 
Act is that much air pollution is really a regional phenomenon, 
and, for example, we have a process underway--your State is 
engaged in it and many of the States here are in fact engaged 
in looking at how to deal with the regional problems, 
recognizing that you cannot simply address this on a State-by-
State basis. Some of your pollution may in fact be coming from 
somewhere else.
    Senator Smith. My time is up, but when you are in non-
attainment--the point is when you are in non-attainment, you 
are in non-attainment, and you are expected to get into the 
attainment category, and you may not be able to do it, and I 
respect what you are trying to do and say on the other areas 
where the causes of the problems are whether it be, you know, 
the midwest or wherever. But the point is if these standards 
are stacked on top of the others in the areas of non-attainment 
where we cannot do anything about it really, that complicates 
the problem for those regions.
    Administrator Browner. What strengthening or tightening the 
standard would do is in fact require those other areas to do 
their fair share and thereby improve the quality of your 
citizen's air.
    I want to say something more generally about ozone. If you 
look at the areas that today might not be able to meet a 
tougher standard, the standard we've proposed, 70 percent of 
those areas would be able to meet a tougher standard through 
currently available or about to be available solutions.
    Let me explain what I mean. Cleaner gasoline is being used 
in many cities to reduce air pollution. It could be used in 
more cities. It's available; we don't need to do anything else. 
It's been designed and it's being sold. Next year because of 
some very good work done by Mary Nichols and her colleagues in 
the Air Office, the cars that are sold in this country will 
have a little $10 device inside. You won't even know it's 
there. It's called an on board canister and it reduces air 
pollution. As more and more cars are sold with this new air 
pollution device, the pollution levels come down. So if you 
look at those sorts of things--and we have many more of these 
cleaner small engines, cleaner diesel engines, cleaner train 
engines, they're in the pipeline and they're coming. There are 
technologies that are being developed, are developed, about to 
be implemented.
    When you take into account just what we know, not what our 
minds can dream of, but what we know, 70 percent of the areas 
that might not today meet a tougher public health standard 
would be able to do so through available common sense cost-
effective solutions.
    [The prepared statement of Senator Smith follows:]
    Statement of Hon. Bob Smith, U.S. Senator from the State of New 
                               Hampshire
    Thank you, Mr. Chairman, for holding this hearing today on what is 
certainly a complex and controversial issue--EPA's proposal to tighten 
the ozone and particulate matter standards under the Clean Air Act.
    I believe it is incumbent upon this committee and Congress as a 
whole to carefully and thoughtfully examine this far-reaching proposal 
to ensure that sound scientific principles have been adhered to, and 
that the entire scope of costs and benefits has been evaluated. I'm 
interested in seeing that we adopt good public policy, not expedient 
public policy. I care deeply about protecting human health, but we must 
consider the full ramifications of our actions.
    From the subcommittee hearing last week, there was consensus that 
the Clean Air Scientific Advisory Committee did not have adequate time 
to deliberate; that another 5 years would be needed to develop adequate 
data on fine particles; and that the court-ordered deadline perhaps 
forced premature recommendations. Of course, we need to be concerned 
about the health effects of these air pollutants and we are taking 
steps now to reduce them. But, we must ensure that any tightening of 
these standards is done using sound science.
    While much of southern New Hampshire does not currently meet air 
quality standards of ozone, a significant portion of the ozone problem 
in this part of New Hampshire is due to the transport of air pollutants 
from outside the state. New Hampshire's utilities have made great 
strides in reducing emissions within the state and reformulated 
gasoline has been introduced in our non-attainment areas, but it's 
still not enough. Consequently, I have been a strong supporter of 
taking steps to improve New Hampshire's air quality by addressing the 
air transport problem using cost-effective, market-based approaches.
    While EPA's proposal is only in draft stage and these standards are 
not due to be finalized until this Summer, I am concerned about the 
potential for new non-attainment areas to be created as a result of 
these standards, particularly since much of New Hampshire's air 
problems come from outside our borders.
    I am also concerned, like Senator Chafee, that this standard 
setting process could produce a backlash against the Clean Air Act. EPA 
recently produced the Clean Air Trends Report that clearly shows what 
great progress we are making in cleaning up the air in this country--
and we will continue to make progress even in absence of these 
standards. For example, the acid rain reduction program is just getting 
into high gear. The trends report shows a 37 percent reduction in 
sulfur dioxide and that means a 37 percent reduction in particulate 
matter since sulfur dioxide is converted to fine particles.
    In conclusion, Mr. Chairman, we must proceed carefully with regard 
to the new standards. It is important to remember that every solution 
creates new problems so we need to ensure that the public health is 
protected in the best way possible--not the most expedient and popular 
way possible. We only need to recall the asbestos fiasco a number of 
years ago when Congress mandated that asbestos be removed from schools 
only to find out later that we had released more asbestos into the air 
and exposed more children to it, while costing school districts 
millions in removal and remediation costs. In short, we made a mistake 
and had to come back and fix it. I don't want that to happen with these 
rules.
    Thank you, Mr. Chairman, and I look forward to hearing 
Administrator Browner's testimony and the opportunity to ask questions.

    Senator Chafee. Thank you, Senator.
    Senator Hutchinson.

OPENING STATEMENT OF HON. TIM HUTCHINSON, U.S. SENATOR FROM THE 
                       STATE OF ARKANSAS

    Senator Hutchinson. Thank you, Mr. Chairman.
    Administrator Browner, with all due respect and great 
appreciate for the conviction and the sincerity and passion 
with which you've made, I sincerely question the certainty that 
these new proposed air standards--based upon what we heard last 
week in the hearing from scientists, based upon my own study 
and reading, the certainty that these new proposed standards 
are following best science, I think that certainty and that 
dogmatism is greatly exaggerated.
    But I want to pick up on one phrase you've used. In one of 
your answers you said, ``The practicality of attaining these 
standards.'' So let me just make a few points, and then I'll 
ask you to respond.
    I understand that during CASAC's deliberations several 
members indicated that there was a need to mandate the 
collection of monitoring data that would allow for a better 
characterization of PM2.5. There is relatively 
little information regarding actual levels of PM2.5. 
In fact, the EPA's criteria document states, and I'm quoting, 
``No credible supporting toxicological data are yet available 
for PM2.5.'' There are thousands of monitors that 
measure PM10 because that is the current standard 
that States have to live by to be in attainment, but there are 
relatively few monitors in the United States that have the 
ability to measure PM2.5.
    As I understand the EPA's PM2.5 proposal--I can 
see new charts coming up immediately--the new 2.5 proposal 
would set new annual average and 24-hour average standards 
based on a 3-year rolling average of these values in an area. 
If I am correct in my understanding, it would take about 5 
years before States could realistically determine non-
attainment areas. I say 5 years because there are currently no 
monitoring networks for PM2.5. They would have to be 
developed--could take up to a year. Once the monitoring begins, 
enough data must be collected to determine non-attainment.
    Because the EPA has proposed standards involving 3-year 
averages, at least 3 years worth of data would be necessary to 
determine which areas are non-attainment. Then after these 3 
years the data would have to go through a quality control 
process, which is required by the EPA and may take about a year 
to ensure that all the readings are valid.
    So we have a 4- to 5-year time period before adequate data 
would be available on PM2.5. However, it would seem 
that the Governors would have to submit a list of non-
attainment areas at about the same time that they would just be 
getting a monitoring network fully operational.
    According to the Clean Air Act, 1 year after the EPA sets 
the clean air standard Governors must submit a list of non-
attainment areas in their States. Two to 3 years after the 
standard is promulgated, the EPA must designate non-attainment 
areas based on those submitted lists.
    Administrator Browner. OK, now----
    Senator Hutchinson. Let me--I've been waiting a long time 
for my 5 minutes.
    Once the State is designated non-attainment, the State must 
submit a State implementation plan in 3 years showing how it 
will attain the standard. But here is the point--if you compare 
the time line required by the law under the Clean Air Act and 
the realistic time line to determine non-attainment areas for 
PM2.5, there seems to be a conflict between the 
availability of data on ambient PM2.5 concentrations 
and the rigorous legal deadlines that are set in the Clean Air 
Act.
    Now I have a series of questions while the light is still 
green. How can the Governors make valid judgments about an 
area's non-attainment status without 3-years of valid 
PM2.5 data?
    Administrator Browner. They are----
    Senator Hutchinson. Let me finish.
    Administrator Browner. Oh, I'm sorry. Do you want me to 
respond as you go along?
    Senator Hutchinson. Let me finish.
    Administrator Browner. I've got to write them down. Hold 
on.
    Senator Hutchinson. How can they make valid judgments about 
an area's non-attainment status without having the 3-year's 
valid PM2.5 data? How can they possibly provide 
meaningful lists of areas for non-attainment designation 1 year 
after you promulgate PM2.5 standard when no 
monitoring network or ambient data exist for PM2.5 
today? And have any regulations or guidance been developed for 
setting up such a network, given that PM2.5 differs 
from PM10, obviously?
    So to me it looks like a long time to do the monitoring. 
Wouldn't it be appropriate to wait until we have that data to 
make that kind of imposition upon the Governors?
    I'm done.
    Administrator Browner. You have done a great summary of a 
very lengthy portion of the Clean Air Act, and let me try and 
step back for just a moment, if I might.
    I think there are two questions here. First, did we have--
did the scientific community have 2.5 information when they did 
their health effect studies? That's one question, and then the 
second question is what has to happen--what are the steps, as 
you very nicely set out--that flow from a public health 
decision in terms of implementation, in terms of monitoring 
networks?
    Let me begin with did the scientists have the 2.5 
information? What we have up here, Mr. Chairman, and members of 
the committee, is a map of all the cities in the United States 
where 2.5 is being measured.
    Senator Hutchinson. How many is that? Is that less than 50?
    Administrator Browner. It's 51 cities where----
    Senator Hutchinson. 51 as opposed to thousands.
    Administrator Browner. If I might just--the point is, and 
I'm speaking to the first question, there is a lot of data 
about what happens when people breathe 2.5 particles. That's 
what this shows, that there is 2.5 being measured.
    Now in terms of developing and implementation programs, you 
are exactly right. The EPA will set guidelines in terms of what 
is the monitoring network. In fact, we are now taking comment 
on what is called a Federal Referenced Method, and just like we 
do for lead, like we do for ozone, like we do for 
PM10, an entire network will be put in place, as it 
should be.
    Based then on that network, which we anticipate we can get 
up and running in the timeframe envisioned by the Clean Air 
Act, Governors, based on the facts that they receive----
    Senator Hutchinson. How long is that?
    Administrator Browner. We're starting now, actually. The 
work is being started now.
    Senator Hutchinson. Will it take a year to get the network 
up?
    Administrator Browner. What the law envisions, just to make 
this clear, is that a Governor not have to make a final set of 
decisions without the network. I think that's the question 
you're going to.
    Senator Hutchinson. It's more than that. Is there an 
estimate of how long it will take to get the monitoring network 
up?
    Administrator Browner. It takes--about 2 to 3 years.
    Senator Hutchinson. Two to 3 years.
    Senator Chafee. Now, folks, we are running over a bit here. 
If you can answer Senator Hutchinson's question, and then we'll 
move on.
    Administrator Browner. It takes about 2 to 3 years to fully 
install the network, and we are beginning the process now.
    Senator Chafee. Did you have a balance of a question that 
he asked that you have not answered?
    Administrator Browner. Yes, but----
    Senator Hutchinson. Mr. Chairman, I just want to say I 
think if you look at the time line as to what you're going to 
be requiring of the Governors, and what the requirements of the 
Clean Air Act are, there is a big conflict in what they're 
going to be able to do practically.
    Administrator Browner. If we might respond, this is a very 
detailed question for the record with specificity. If I might 
say, there is a long history under the Clean Air Act of how 
this relationship and public health standards and the work of 
the EPA and the States evolved, and no Governor would be 
required to do anything until he or she had the appropriate 
data base. That is what the Federal Referenced Method gives 
you, and that is what we are now working on.
    [The prepared statement of Senator Hutchinson follows:]
    Statement of Hon. Tim Hutchison, U.S. Senator from the State of 
                                Arkansas
    Thank you, Mr. Chairman. I am, once again extremely pleased to have 
this hearing today. The more I understand about this issue, the more I 
realize there is to learn.
    Last week at the science hearing, I learned how much difference in 
opinion there is, even among the CASAC scientists, regarding the 
findings of CASAC and what should be done about those findings.
    It is obvious how difficult and complex these issues are to 
understand, but the fact that there was such division among the 
scientists was very surprising. One of the points you continuously 
stressed in your testimony during the Arizona court case was the need 
for time to do studies so that you could make ``scientifically sound'' 
decisions for PM2.5.
    I completely agree and I am sure there is nobody in the United 
States who doesn't want these studies to be based on sound scientific 
principles. If we are going to implement these standards, it is 
important to understand the science behind the problem so we can 
eliminate the problem.
    Unfortunately, based on the fact that there is very little data on 
PM2.5, it does not seem that your decision is based on 
science that is scientifically sound. It seems that your decision was 
based more on pressure to make a decision than on sound scientific 
principles. I look forward to your response on this issue.
    Regarding ozone, I am alarmed by a couple studies that indicate 
that there is a possibility that, even if we eliminate all man-made 
Volatile Organic Compounds (VOCs), some areas of the country could 
never be in attainment.
    Another concern I have is the fact that there is no scientific 
evidence that supports a threshold level for regulation of ozone. In 
other words, we do not know if there is any level, including the 
naturally occurring background level, that ozone is safe.
    I am concerned with the fact that I have heard claims that ozone 
causes asthma, yet we heard from Dr. Thurston and others last week that 
this is not the case. Ozone simply does not cause asthma, yet these 
scare tactics have sent fear throughout the United States.
    I am interested in the truth behind the problem of air pollution. I 
want to know that we are doing the right thing that will save lives, 
yet there seems to be little in the science that supports these 
standards.
    Sure, there are scientists that will support these standards, but 
there are scientists, even scientists on CASAC, the committee EPA 
appoints to study ozone, that will dispute these claims.
    We need to know all the facts before making such a huge decision. I 
know we all are interested in learning all the facts in the science, as 
well as the facts in the decision. For these reasons I look forward to 
this hearing.
    Thank you Mr. Chairman.

    Senator Chafee. Thank you.
    Thank you, Senator.
    Senator Lautenberg.

  OPENING STATEMENT OF HON. FRANK R. LAUTENBERG, U.S. SENATOR 
                  FROM THE STATE OF NEW JERSEY

    Senator Lautenberg. Thank you, Mr. Chairman, and I 
apologize to the Administrator for not having here through her 
testimony. I hope that what I'm going to ask about hasn't 
already been discussed.
    There is an EPA study that suggests the benefits of air 
pollution controls far outweigh the costs. The study reveals 
that for every dollar that is spent on pollution controls since 
1970, the country has gained $45 in health and environmental 
benefits, and, of course, that includes doctor's visits, 
hospitalization, work time lost.
    If we tighten the standards that we're now talking about, 
can you see it yielding similar benefits, similar cost-
effectiveness?
    Administrator Browner. When we look at the two standards 
taken together in terms of the public health protections that 
they will provide, the cost of meeting those standards, what we 
find is on balance the benefits will exceed the cost, as has 
been the history under the Clean Air Act.
    Senator Lautenberg. Are we talking about similar 
proportions?
    Administrator Browner. The range is not as large as the 
historical range, but I would like to caution----
    Senator Lautenberg. It need not be, of course.
    Administrator Browner. Well, I think it is important to 
just explain to people when you do a cost benefit at this point 
in the process, there is a speculative nature to it. Until you 
actually sit down industry-by-industry and figure out exactly 
which one can most cost effectively be used to reduce how much 
pollution, you're dealing with ranges, and they can be fairly 
broad ranges.
    Once we complete a public health phase, we then move into 
an implementation phase, which can make a more precise judgment 
in terms of cost and benefits, as the law requires.
    Senator Lautenberg. Now because part of what we are 
required to answer is the industrial response--it says, you 
know, the cost far outweighs any benefits, etcetera--and I 
don't know how that argument ever really gets solved until 
there is a historical performance to judge it by. So I would 
hope that we can establish the fact that the costs, though 
dispersed among lots of people, lots of places, can be easily 
justified if we are willing to take the risk with some of 
these, or at least develop as much information as we can to 
make the case.
    Administrator Browner. That is certainly what our cost-
benefit analysis now shows. It is 10 to 20 times greater in 
terms of the benefits exceeding the cost.
    Senator Lautenberg. And, again, if you've discussed this, 
please let me know. The existing Clean Air Act, did you discuss 
in your testimony why it is that these aren't really 
competitive decisions, that one need not render the clean air 
less effective if we proceed with the new standards for ozone 
and PM?
    Administrator Browner. I spoke briefly to the Clean Air 
Act. I might add that I believe, and I think many people 
believe, that the public health requirement of the Clean Air 
Act, which has been a part of the law now for 25 years, was one 
of the most important steps taken by this Nation, and it has 
resulted in dramatic improvements in our air quality and it 
gives us a framework to continue the task, to make sure that 
we're providing the public health protections to the American 
people.
    Senator Lautenberg. It seems to me that there is--I would 
use the word assault, but that perhaps is a little enraging so 
I won't use that word--but there is a challenge to the fact 
that you've linked PM and the ozone standard together.
    What are the benefits by addressing both of these at one 
time?
    Administrator Browner. Well, I think it is, one, important 
to understand that many of the sources of the pollution will be 
identical, that it is the same sources that generate ozone 
problems, the same sources that generate the fine particle 
problem. So by working these two standards together, these 
public health protections, it will allow us in the 
implementation phase to find the more cost-effective solutions 
to work with industries so they have to make one round of 
adjustments, not two rounds of adjustments.
    I think it is also important to understand that the health 
effects can be similar, that while they are separate 
pollutants, separate sometimes precursors, they can in fact 
result in very similar health effects. So in terms of what it 
is that we seek to do for the American people, managing them 
together makes a lot of sense.
    Finally, I might point out that while everyone is aware of 
the fact and makes reference to the fact that we are subject to 
litigation in the case of the fine particles, there was in fact 
litigation on ozone. And, as we explained to the American 
people in a Federal Register notice 4 years ago now, that we 
avoided a court-imposed deadline because we promised--in a 
Federal Register notice we promised a Federal judge that we 
would get the job of ozone done by mid-1997. There is a whole 
notice laid out and the steps we would go through, and what the 
judge in that case said to the litigants who wanted the judge 
to impose an order is,

    The government has come forward. They are owning up to 
their responsibility. They are making a public commitment. I'm 
going to allow them to hold to their word, but, quite frankly, 
if they engage in unreasonable delay, you, the litigant, have 
every right to come back to me.

    We made a promise to the American people, and we want to 
honor that.
    Senator Lautenberg. Thanks, Mr. Chairman.
    [The prepared statement of Senator Lautenberg follows:]
 Statement of Hon. Frank R. Lautenberg, U.S. Senator from the State of 
                               New Jersey
    Thank you, Chairman Chafee. I want to welcome Administrator Browner 
to our hearing, and to commend you for your outstanding leadership at 
the Environmental Protection Agency. We are all fortunate that you will 
be staying on in President Clinton's second term.
    We are here today to discuss the EPA's proposed rule for ozone and 
fine particulate matter.
    My views on this, Mr. Chairman, are colored by the air that 
overhangs my state. New Jersey has a real problem with air pollution. 
In fact, all but two counties already fail to comply with existing 
standards. New Jerseyans therefore have a special interest in making 
sure that we do everything possible to improve air quality.
    My views on the proposed rule also are shaped by my deep concerns 
about the serious health consequences of air pollution.
    Ozone is a major problem in my state. And there seems to be a 
strong correlation between high ozone levels and asthma. Emergency room 
visits for asthma in Central New Jersey occurred 28 percent more 
frequently when ozone levels were above 60 parts per million. And I 
would note that 60 parts per million is only half of the current 
standard.
    EPA is proposing to strengthen that standard, and there are sound 
health reasons to do so. Some critics of EPA's proposal recognize that 
the present standard is insufficient to protect many of those who work 
or exercise outdoors. But some of these same critics are resisting 
tougher standards. Instead, incredibly, they propose that Americans 
simply spend more time indoors when ozone levels increase.
    It's the ostrich approach to air pollution. But it makes no sense 
for humans.
    Let me point out that EPA's proposed rule is supported not only by 
environmentalists. It's also strongly supported by the largest utility 
in my state. Like many companies in the Northeast, this utility has 
invested substantial sums to comply with present ozone rules. Yet its 
competitors in other states have not. Meanwhile, pollution from those 
other states regularly drifts into the Northeast. The end result is not 
only dirty air in New Jersey, but an uneven playing field that puts 
Northeastern businesses at a significant competitive disadvantage.
    I also want to emphasize that as we evaluate EPA's proposed 
standards, the real question should be whether the proposals are 
sufficient to protect public health with an adequate margin of safety. 
The purpose of these standards is to establish the levels above which 
public health is threatened. They only set a goal. And EPA's proposal 
would give states time to reach that goal.
    The establishment of these goals should be made without regard to 
the costs of implementation. After all, we're talking about protecting 
our families and our children from serious health consequences. And who 
among us is ready to put a price on the life of a child?
    Having said that, EPA's proposal does not ignore the financial 
implications of tougher standards. To the contrary, we can adjust 
implementation schedules, if compliance is economically impractical.
    But the question before us today is not how long those schedules 
should be. The question is what standard is needed to protect our 
children. And when it comes to protecting children, in my view, we 
cannot and must not compromise.
    Again, I want to thank Administrator Browner for her leadership, 
and I look forward to hearing her testimony.

    Senator Chafee. Thank you, Senator.
    Senator Bond.

  OPENING STATEMENT OF HON. CHRISTOPHER S. BOND, U.S. SENATOR 
                   FROM THE STATE OF MISSOURI

    Senator Bond. Thank you, Mr. Chairman.
    Madam Administrator, last year in the appropriations 
process in which you and I engaged at your request I included 
$18.8 million for research on particulate matter. We were 
advised that scientists have concluded that the current data 
did not adequately demonstrate causality or provide sufficient 
information to establish a specific new control strategy.
    I would like to know what you have been able to do with 
that $18.8 million and what results you have.
    Administrator Browner. We are in fact using that money--it 
was money we requested to help us better understand how to make 
the decisions that flow from the public health standards, and, 
if I might ask Dr. Huggett to explain some of the specifics.
    Mr. Huggett. With the money appropriated in 1997, we have 
research going on in mechanism and dose. We have research going 
on for better methods in epidemiology. In the exposure area we 
have exposure modeling work going on. We have exposure 
assessment research----
    Senator Bond. Excuse me, Madam Administrator. There is an 
ongoing study. You, obviously--you have not received the final 
results. Is that correct? I trust that you will advise this 
committee and the appropriating committee, but, basically, you 
do not have the final details on it.
    I believe there were some questions asked earlier, Madam 
Administrator, about something called the Small Business 
Regulatory Enforcement Fairness Act. You will recall that that 
not only passed the Small Business Committee unanimously, but 
it passed the Senate unanimously and was adopted without 
dissent in the House and signed into law by the President.
    Now some time ago the former ranking member of the Small 
Business Committee, Dale Bumpers, and I wrote to you personally 
as Administrator to ask about your compliance with the 
provisions in that law and the Regulatory Flexibility Act in 
the promulgation of the new NAAQS.
    I have today received a letter dated February 11, signed by 
an Assistant Administrator For Air And Radiation. In that 
letter I think the operative point is, ``In a nutshell, we 
believe that the proposed NAAQS,'' N-A-A-Q-S, ``are not 
susceptible to regulatory flexibility analysis, as prescribed 
by the RFA because the NAAQS do not impose regulatory 
requirements on small entities. Instead, State plans 
implementing the NAAQS establish State regulations that may 
apply to small entities.''
    Now, we wrote to you--this is the Assistant Administrator. 
Is this your answer? Is this the position that you take?
    Administrator Browner. Yes.
    Senator Bond. Now are you familiar with the Regulatory 
Flexibility Act?
    Administrator Browner. Yes, I am.
    Senator Bond. You notice in section 603 it says that ``such 
analysis shall describe the impact of the proposed rule on 
small entities.''
    Now, are you and Ms. Nichols telling us that there are no 
impacts on small entities from this?
    Administrator Browner. We are in a public health phase of 
the Clean Air Act. We are doing the outreach to small business, 
which I think is envisioned by this law, which we support.
    In terms of the detailed regulatory analysis, that can only 
flow once we actually move into the implementation phase 
because it is there that you begin to really understand which 
precise businesses might have to take steps. To do it now would 
be to do it at a very, very gross level, quite frankly, without 
the kinds of specificity that I think the law rightly 
envisioned. It is absolutely positively something that we think 
is important. It is something we will do, and we are not 
ignoring the intent of the law in terms of working with small 
businesses. That has begun, that is ongoing.
    Senator Bond. Madam Administrator, excuse me. Before my 
time expires, I have to say that I believe you are ignoring the 
letter of the law by claiming there is no impact. You're saying 
that if I went out bear hunting and pointed a gun and pulled 
the trigger at a bear and the bear fell dead, it would be the 
bullet that had the impact on the bear. And you would say that 
I, pointing the gun and pulling the trigger, had no impact.
    I believe that that is just dead wrong.
    I would like to submit for the record, and, Ms. Browner, 
for your response a letter from Senator Domenici, which states 
in essence if this in fact is the EPA's position, I can tell 
you unequivocally that the EPA is simply wrong.
    [The letter follows:]
    [GRAPHIC] [TIFF OMITTED] TH050P1.256
    
    [GRAPHIC] [TIFF OMITTED] TH050P1.257
    
    I authored the bill that was ultimately included in CERCLA. 
I would also include statements by the Governor of Missouri who 
says to move the target at this point would upset a fragile 
coalition and would have immense consequences. There are many 
other letters, which I will submit for the record which outline 
the extreme distress that the State Governor in Missouri and 
local officials, mayors and others have because the EPA has not 
gone through the process established by law. I would expect 
that while you make good faith efforts to talk to small 
business, there are specific requirements that must be followed 
that you have not followed.
    Administrator Browner. As we complete this process and 
begin the complicated implementation phase, we couldn't agree 
with you more for the need to do this kind of analysis. I mean, 
maybe I could go back to your analogy of the bear. The problem, 
quite frankly, right now is we don't know which bear and we 
won't know that until we move into the implementation phase, 
and then we have to analyze bear by bear.
    [Laughter.]
    Senator Bond. We say that before you pick out a bear, there 
are certain responsibilities.
    Administrator Browner. We agree. That's what we're saying--
we agree.
    Senator Bond. You haven't--you've already set it in motion.
    Administrator Browner. Yes, but----
    Senator Chafee. All right, all right. My father once told 
me to never argue with analogies.
    [Laughter.]
    Senator Chafee. Now we're going to go another round, and 
I'm delighted that some of the Senators are still here.
    Madam Administrator, this is not a dispute over costs, and 
you keep coming back to that, but as far as I'm concerned, it 
isn't. I've been involved in the 20 years that I've been on 
this committee with every major environmental law that there 
is--clean air, clean water, endangered species, the CFCs, you 
name them, and drinking water. And you are absolutely right 
that the dire predictions about costs have not been realized 
and that the programs came in at less than that.
    But what this discussion is about, as far as I am 
concerned, is effectiveness, and I don't think it is adequate 
to just say we can't consider anything except health. If a 
proposal causes great difficulty with minor improvements, which 
I believe your ozone proposal does, then I think we ought to 
proceed with caution and a few alternatives. Clearly, the 
control of particulates from your own testimony, whether you 
take the Lung Association at 60,000 lives extended or you take 
your own at 40,000, is, I believe, the correct way to go 
especially since we haven't even met in great sections of the 
country the 1990 standards on ozone.
    I would like to pursue that a little bit, if you might. In 
my State if we closed all businesses down and did nothing but 
farming, we would still be in non-attainment, and you recognize 
that and these plans to achieve the attainment under the 1990 
Act were due in 1994. As the deadline approached, many areas 
couldn't make it so then you created or there was created the 
Ozone Transport Assessment Group, the so-called OTAG, and that 
was meant to come up with the solution to this problem. They 
have been working since May 1995. Recently, their work has 
fallen behind in schedule, and so now what is your answer to 
our problem?
    Now, on top of all of this, you tighten up the standards 
when we in the East--and I can just speak particularly of my 
own State--on even meeting the 1990 standards, and your OTAG 
Group seems to be falling apart.
    Administrator Browner. Well, in fact, I think OTAG is 
something that has great potential, has begun to deliver on 
that potential.
    Senator Chafee. We hope it has, 37 States.
    Administrator Browner. Thirty-seven States. It is not easy. 
It is not easy to bring together a diverse range of views, to 
sit in a room, and, quite frankly, do what we've all been 
talking about here, which is find the cost-effective common 
sense solution. That is what they're doing--they're 
prioritizing what are the steps to reduce the air pollution and 
recognizing, and I think this is particularly true, Mr. 
Chairman, for your State, that the lion's share of your problem 
may not in fact originate in your State. It is coming from 
somewhere else, and other people will have to take a series of 
actions not only to improve their air quality but to improve 
the air quality of the people of Rhode Island, the people of 
Connecticut and other Northeast States.
    You, I think, make an extremely good point with respect to 
the particle standard, the proposal we make there. Those are 
very real, unfortunately, permanent effects. It is death that 
we are talking about--20,000, 40,000, 60,000--those are large 
numbers of people whose lives are cut short because of certain 
levels of pollution.
    In the case of ozone, we're not talking about death, but I 
think we would all agree for the child who experiences asthma, 
who can't play outdoors, for the individual who works outdoors 
and can't go to work on a particular day, for that individual 
those are equally troubling health effects. It is not death, 
but it is no less troubling.
    Senator Chafee. Madam Administrator, let's concede all of 
that, but the problem is we're not even meeting the 1990 
standards, and on top of this, you pile another layer which 
isn't going to be met, and I hardly think that increases the 
respect of the law.
    Administrator Browner. While it is true that we are still 
working in a number of areas to reduce pollution to meet the 
current health standards, it is also true that every single 
thing that is being done in any community by any industry to 
reduce pollution would be done, would be important to be done, 
even if you tighten the standards. It doesn't change. You're 
building--it's a set of building blocks, and what we are doing 
now is putting in place a layer that give us one level of 
protection. What the science shows us is that's not adequate so 
we'll have to add another block. It is not without its 
challenges. I'm the first to admit that.
    Senator Chafee. Well, that is not really quite accurate. My 
time is up, and I'll just be very brief here. You're saying, 
``Don't worry, that we'll add new standards but in your attempt 
to achieve the old standards, you're really working toward 
achieving the new standards too.''
    Administrator Browner. Correct.
    Senator Chafee. The States are required to submit the so-
called State Implementation Plans, SIPS, and in that the delete 
a series of--and with great trouble in arriving at these SIPS, 
in devising them they go through a lot of trouble.
    Now what you're saying is, ``Well, that is not going to do 
the trick. The SIPS are fine. They might achieve the 1990 
standards, but forget them,'' I presume you're saying.
    Administrator Browner. No, we're not saying that. Mr. 
Chairman, that is not what we're saying at all. We have--the 
EPA has invested a huge amount of effort and energy in 
developing these SIPS, as have States and local governments, as 
has industry. No one is suggesting that any step that has been 
taken or is about to be taken is a step that shouldn't be 
taken. It is all contributing to cleaner air. The science now 
shows us we need another step on top of, not in place of, but 
on top of.
    Senator Chafee. Senator Baucus.
    Senator Baucus. Thank you, Mr. Chairman.
    Administrator, obviously, these proposed regulations raise 
lots of questions. Could you outline for us please the various 
steps along the way before a company, a person, an industry, 
small business would actually feel the effects of any proposed 
regulations? I mean, first of all, we're in a comment period, 
which means there could be adjustments, and changes, and 
negotiations. You get new data, new information. Then there is 
a different period of time within which I think you get data. 
Then there is another period of time involved with the SIPS.
    Could you just outline for all of us the different steps 
and what can be done and what considerations or what 
adjustments, if any, can be made during each of the steps 
before an entity actually feels the effects of this?
    Administrator Browner. I think it is fair to say that it is 
a very lengthy process. It involves large numbers of parties 
with all of the safeguards envisioned in any administrative 
process in terms of public comment, rulemaking----
    Senator Baucus. Could you outline what they are? Could you 
outline each step?
    Administrator Browner. In the case of--there are two ways 
generally that we will improve air quality. One is through 
national standards on industry, particular industries.
    Senator Baucus. I'm talking about these regulations.
    Administrator Browner. There are two things that will flow 
from the public health standards. One is work with large 
industries, businesses across the country and a set of 
standards to reduce their pollution.
    Anything we do with respect to any individual industry, 
with respect to any type of any sector of the economy, 
business, all of that is subject to cost benefit with public 
review and comment, to propose standards with public review and 
comment, and it is a many year process. It would be our strong 
hope that some industries, as they have done before, will come 
to the table and sit with us in formulating that. That is one 
phase.
    Senator Baucus. Yes, but correct me if I'm wrong because we 
don't have much time here, but essentially, first of all, there 
is a period within which you would take comments for the final 
regulation, and the final regulation could be different from 
the post regulation?
    Administrator Browner. Yes, correct.
    Senator Baucus. All of us should keep that in mind. It 
could be different; it may not be the same.
    Administrator Browner. It could be.
    Senator Baucus. Second, as I understand it, the EPA then 
over a period of time--I think it is a couple or 3 years--
collects data and tries to determine which areas may or may not 
be in attainment. Is that correct?
    Administrator Browner. That is a separate--that is the 
other side of the equation, which is we work on parallel 
tracks. One with businesses, industry; the other is working 
with States and local government to develop the additional 
tools, the additional steps they will take. That is also a 
many, many year process with public comment.
    Senator Baucus. Right, roughly how many years? Roughly, how 
many years?
    Ms. Nichols. In the case of ozone, if the standard is 
changed in June 1997, the EPA would designate roughly 2 years 
after that, State plans would be due 3 years after that. In 
2002 the initial attainment date for the revised standard under 
the current law is 5 years after designation, so that takes you 
to 2004. There is an extension possible based on the severity 
of the problem and availability of control measures, which gets 
you to 2010, and potentially to 2011, if there is an additional 
1-year extension.
    Administrator Browner. And that's for the State plans, just 
to be clear.
    Senator Baucus. Correct, and I understand it, State plans 
then can be very complex, very different visions for different 
entities. It's your point that one size should not fit all.
    Administrator Browner. Right.
    Senator Baucus. So there is time within which to work this 
out.
    Administrator Browner. There will be huge debate, I don't 
doubt, about each component.
    Senator Baucus. And during the time not only health effects 
in sum total, but also the cost considerations are very 
significantly considered. It's a balance, basically, in many 
respects.
    I know this point has been made before, I think, in my 
absence, but the main point is time after time again whenever 
cost estimates are made it turns out that the actual cost is 
much less than the estimated cost.
    Administrator Browner. Yes.
    Senator Baucus. One example that comes to my mind is in the 
Clean Air Act Amendments, particularly SO2 credits. 
I mean, we, according to our best judgment, back in 1989 or 
1990 thought that it would be $1,500 per ton. That is my 
recollection.
    Administrator Browner. Yes, that is correct.
    Senator Baucus. You agree--$1,500 per ton. That was the 
best estimate of what SO2 credits would cost.
    What does it cost today?
    Administrator Browner. We're going to show you a chart we 
actually have. Today on the Chicago Board of Trade you can buy 
acid rain credit for $78, and that is per ton.
    Senator Baucus. Per ton. And has that dropped quickly?
    Administrator Browner. In fact, it has. The estimates, 
obviously, date back to the debate, which was more than 10 
years ago. In 1990 the EPA had an estimate which was a little 
bit lower than the industry. It was $800 to $400, and today it 
is $78.
    Actually, since they went on sale it has been roughly in 
the $78 range. They went on sale, what, 2 years ago now that 
they've been for sale. So it did drop rather quickly.
    Senator Baucus. This may not be accurate, but I was told 
years ago when the original Clean Air Act was passed, the 
Congress asked the automobile industry to come up with 
catalytic converters. The industry said, ``No, it can't be 
done. It is impossible. We don't have catalytic converters. 
It's too costly and it can't be done.''
    Congress decided, well, go ahead and make catalytic 
converters, and my understanding is that not only did we come 
up with the catalytic converters, but it forced the industry to 
go back and redesign their exhaust systems and found that after 
the catalytic converters were designed, the cost of the exhaust 
systems were actually considerably less than they were in the 
first place.
    Administrator Browner. That is absolutely right.
    Senator Baucus. That doesn't always happen, of course. I'm 
not saying that is necessarily going to happen here, but I do 
think it is fair to say that given the imagination and 
creativity that people have, and because we're basically a 
bottom line culture--that is, balance sheets and income 
statements--that people are pretty creative in finding less 
expensive ways to achieve their goals and their results.
    So that is, obviously, why initial costs always overstate 
the actual costs.
    Thank you.
    Administrator Browner. You're exactly right, Senator 
Baucus, and I think that is one of the greatest stories of the 
Clean Air Act over its 25 years is the fact that we have been 
able to reduce air pollution for far less than we projected, 
and the benefits have been far greater. We have a study right 
now on a 20-year period. It is in scientific peer review, and 
we will release it when that peer review is completed. But what 
it shows is that the cost of cleaner air over 20 years, that 
the benefits have exceeded the costs 45 times.
    Senator Baucus. Is that in the record?
    Administrator Browner. We will give you that. It is a draft 
study. As I said, we are in the final phases of peer review. We 
will go ahead and provide you with the draft, and then when the 
peer review is completed, obviously, with that document.
    Senator Baucus. Thank you, Mr. Chairman.
    Senator Chafee. Thank you, Senator.
    Senator Warner.

OPENING STATEMENT OF HON. JOHN W. WARNER, U.S. SENATOR FROM THE 
                    COMMONWEALTH OF VIRGINIA

    Senator Warner. Thank you, Mr. Chairman.
    Welcome, Madam Administrator. I just want to talk a little 
bit about philosophy. I have found that the American people 
want to obey the law--your law, whatever. It seems to me that 
you're moving ahead to establish public policy and put that 
into law when you acknowledge here today that there is going to 
be 30 percent of the community--several in my State--which 
cannot under any knowledgeable means today meet the 
requirements.
    So with one hand we're putting the law into effect knowing 
that 30 percent of the people--that is, 30 percent of the 
community and the people in those communities--can't meet that 
law. Somehow to me that is just the wrong way to go about 
government generally.
    As a side bar over here, those communities are anxious to 
participate in the yearly allocation of highway funds, and 
there is the question put on their right to get those highway 
funds because they can't meet the attainment you've 
established.
    That may have well been covered, Mr. Chairman, earlier 
today, but it's a question that I'm struggling with.
    Administrator Browner. No, that is a good question. I think 
it is a very, very appropriate question. If you look at the 
history of the Clean Air Act, and the chairman himself made a 
reference to CFCs and chlorofluorocarbons. When the Congress 
made what was a very bold public health decision to say, 
``Let's get rid of them,'' we didn't know what the replacement 
would be. We didn't know. The science hadn't yet advanced 
enough to develop a substitute; the technology wasn't there. 
But industry did rise to the occasion, and they did it for less 
money and in a shorter period of time than anyone anticipated, 
and today we in fact are seeing improvements in the upper 
ozone. The hole is shrinking because of that.
    I actually think it is very good news that we could provide 
more Americans with a level of public health protections, 
cleaner air--70 percent of the areas through existing 
technologies--and that the challenge is far smaller than it has 
been previously under the Clean Air Act. I think the thing that 
I take my greatest hope from is not just CFCs, or acid rain, or 
cleaner cars where we've done it, and we've done in less time 
and more cost effectively, it's the city of Los Angeles.
    When I came to my job at the EPA over 4 years ago, there 
wasn't a plan for the city of Los Angeles to meet public health 
air standards currently the law. It didn't exist, but we sat 
down, the city sat down, the State sat down, the businesses sat 
down, environmentalists sat down, and we have a plan today. If 
we can do it for Los Angeles, I don't doubt that we can do it 
for any part of this country and give the American people the 
benefits of cleaner air. It is not without its challenges, but 
it is a challenge we have risen to before, and I know we can do 
it again.
    Senator Warner. Well, that may well be the case. Certainly, 
we've seen that connection with our automobiles. I think the 
industry has made some bold accomplishments there.
    Administrator Browner. Yes.
    Senator Warner. But when you talk about ozone, that is a 
pretty tough one to deal with, and I have one community--I'm 
very privileged to have it here in northern Virginia, which is 
the infrastructure within much of the Federal Government, and 
if we call took the subway tomorrow, put the cars in the garage 
and took the subway, and walked across the bridges--it's good 
exercise--if we all stopped everything, still we can't meet it. 
To suddenly say to those folks that have been struggling for 
years, ``I know you have differences with my Governor, but 
we've worked to try, and it's hopeless. Therefore, you're just 
going to go ahead and be in violation of the law,'' and there 
could be a question of whether or not I can direct some of the 
highway funds to that community, which desperately funds to try 
and break the gridlock, the lost hours of waiting for these 
commuter lines and the like--that's what they're looking for.
    Administrator Browner. We certainly agree and have been 
engaged in a process which the chairman referred to with the 
Northeast States and then expanding to all the States east of 
the Mississippi with the fact that a lot of the pollution 
problems, particularly the northeast States are dealing with, 
they're not generating; that we have to look on a regional 
basis.
    By following the science, strengthening the public health 
protections and then working to secure the implementation, you 
will see a set of actions required that not necessarily have to 
be undertaken by your State, but in other parts of the country 
that will benefit your air quality. I mean, there's, I think, 
some amount of fairness here, that some people have done quite 
a bit and others, quite frankly, have not done enough. What 
this does is it gives you a mechanism for ensuring that 
everyone is doing their part for cleaner air, that all industry 
is honoring their responsibility to reduce their pollution 
levels.
    Senator Warner. Well, with all due respect, you and I have 
a different approach as to how to effect important changes in 
America, whether it's in this area or other areas. But I still 
continue to adhere to the principle that our citizens want to 
obey the law. It's the responsibility of the Congress to enact 
those laws, which they can achieve, and they understand. And, 
in this instance, I think we fall seriously short.
    Thank you, Mr. Chairman.
    Senator Chafee. Thank you, Senator.
    Senator Lieberman.
    Senator Lieberman. Thank you, Mr. Chairman.
    Administrator Browner, Senator Warner's statement frames 
the choice we have, it seems to me, and it frames it in this 
way. Incidentally, when it comes to obeying the law, you're 
obeying the law. The law orders you to come before us and do 
exactly what you're doing today, which is to tell us what we 
have to do to achieve clean air that protects people's health 
with an adequate margin of safety.
    Now Senator Warner raises an interesting and important 
question. Why would we want to promulgate a standard that we 
know that 30 percent of the communities in his State can't 
meet? Well, what's the choice? The choice is to hold back and 
not tell them what we think science says will protect their 
health, and, as you've said over and over again today, there is 
a second phase to this, and that is the implementation phase 
and that's where 30 percent of the Virginians--and we've 
already it, as I've said in Fairfield County. The EPA gave 
Fairfield County 17 years to meet the standard in that part of 
Connecticut.
    I should follow Senator Chafee's warning about analogies, 
but I can't resist letting Senator Bond's bear sleep in the 
woods, if I might say so myself.
    [Laughter.]
    Senator Lieberman. What we're talking about at this phase 
with your order might be a regulation describing how the gun is 
manufactured, or maybe some general rules about hunting. In the 
next phase we're going to do some studies about what the hunter 
is likely to shoot at, and whether there are any bears in those 
woods that are going to be endangered.
    I worked very closely with Senator Bond on the Small 
Business Fairness Enforcement Act. It's an important piece of 
legislation, and you can't tell us now--you're dealing with 
health here. You're not dealing with what is going to be 
required to achieve it in the second phase. You'll get to the 
flexibility with 30 percent of the communities in Virginia and 
with small business.
    Second, Senator Smith referred to the ads about kids 
suffering and the ads about people not being able to barbecue. 
We're all around here experienced enough to know that people 
can overstate on either side of an issue.
    However, there is a difference here. It seems to me that 
you've got science-based statistics that suggest that kids' 
health will be affected by dirty air if change is not made. As 
far as I know--and this is the momentous question I want to ask 
you--the order you are proposing will not prohibit me or any 
other American from barbecuing if it goes into effect or of 
mowing our lawn?
    Administrator Browner. You are free to barbecue. You are 
free to mow your lawn, and, moreover, to enjoy the 4th of July 
fireworks.
    Senator Lieberman. OK, I presume that that does not mean 
that you are not in negotiations or conversations with people 
who are in the business of manufacturing products for 
barbecuing or lawn mowing to try to encourage them to do it in 
a way that is less adverse to our health.
    Administrator Browner. Well, in fact, we have had a very 
successful project with small engine manufacturers, everything 
from the little engines people use on their fishing boats to 
lawn mowers, and we have through an agreed process been able to 
reach a design for a cleaner, small engine that is extremely 
important in terms of air quality. And people today can go to 
their local hardware store and buy a cleaner, small engine lawn 
mower.
    Senator Lieberman. Let me come to the ozone standards 
because we've talked a lot about this, and this is important. I 
do want to say, again, and I'm going to not use the word 
respectfully because I got chastised for it, although I do want 
to say to the chairman that I will respect him even as the 
morning ends. I still do respect the chairman, notwithstanding 
his request that I not state that respect.
    Whether or not the old standards are being adhered to or 
met is not the question that the statute forces you to report 
to us. It is what is the best health right now.
    Administrator Browner. Correct.
    Senator Lieberman. The numbers on the chart are a big 
confusing, and they may have overstated it, but as I look at 
it, I look at the children protected, and you're telling us 
that 13 million more children will be protected under the 
proposed standard; that three million more asthmatics will be 
protected, and that three million more people with respiratory 
diseases will be protected.
    Now that is 19 million people. That's not any small 
subgroup of super-sensitive people. That's a lot of people and 
a lot of families being protected.
    On the question of what's an adverse health effect, how did 
EPA determine, for instance in the case of ozone, what 
constitutes an adverse health effect? There's been a certain 
sense here that you're being a little bit--you're reaching too 
far. I mean, as one of our colleagues said at one point, ``You 
know, if a child is out there and maybe they're asthmatic, they 
ought not to be out there on certain days of the year.''
    Is that what we're talking about?
    Administrator Browner. The studies for ozone cover--there 
are a variety of different scientific studies that are done, 
including putting people in what are called inhalation chambers 
and having them breathe polluted air at a whole variety of 
levels and then measuring the health effects.
    Senator Lieberman. These are normal kids or kids with 
asthma?
    Administrator Browner. They're healthy people. You put them 
in a chamber, and they breathe polluted air. Obviously, we 
don't do this where death is an issue. No scientist is going to 
find somebody----
    Senator Lieberman. A good decision.
    [Laughter.]
    Administrator Browner. But in the case of ozone, there are 
a set of inhalation studies that have been done from .09, to 
.08, .07, .06, on down, and then you measure the health 
effects, and then what you see when you display all of the 
studies, including the inhalation, is that by proposing a .08 
8-hour standard, the number of health effects you can protect 
against.
    Senator Lieberman. Thank you.
    Senator Chafee. Senator Warner.
    Senator Warner. I should be very brief, Mr. Chairman.
    When we talk about projection, 30 percent of the 
communities will be in non-attainment. Under other 
calculations, it's a far higher number of communities, and I'm 
just going to read you an example.
    For example, in Albany, NY, MSA, there are six counties. 
Only three of these six counties have monitors, so EPA predicts 
that of the three counties two will be proposed new standing 
and one county will not.
    Administrator Browner. Senator, if you might just help me 
understand. Are you speaking to ozone or fine particle?
    Senator Warner. We're talking about the proposed .08. 
That's what----
    Administrator Browner. OK, I just want to make sure I 
understood because there are two different issues.
    Senator Warner. Sure.
    So how are you treating these MSA's? That's what I'm 
talking about.
    Administrator Browner. The question----
    Senator Warner. In other words, it looks like only 30 
percent, when in reality, I think I can show you some 
calculations that's much higher than 30 percent.
    Administrator Browner. If I might just step back and 
explain how this portion of the law works in sort of real life.
    Under the Clean Air Act, lines are drawn on maps around 
areas and then decisions are made as to whether or not the air 
within that area is meeting a public health standard. That is 
what the MSA refers to. For a variety of reasons, we have now 
learned that how you draw those lines should perhaps be 
different. An example would be in an urban area, you have large 
numbers of people driving in every day. They live in a suburban 
area, but they're contributing to the urban population. So when 
you want to develop solutions to reduce the pollution, you 
don't look just small, but you look more broadly.
    We are suggesting and we are taking comments on changing 
how you draw the lines. The most important reason being that we 
think that would give greater flexibility to local and State 
governments to find better solutions. It is better based on our 
current knowledge of how pollution actually operates, and so 
what would happen is there would be the need in some areas 
because you would change how you draw the line to more 
accurately reflect how pollution operates to add some 
monitoring stations. That could very well be required, and that 
can be easily done.
    Senator Warner. Well, you're counting the greater 
metropolitan Washington area as one of the 30 percent. To me 
that's wrong because you've got at least----
    Administrator Browner. No, we're not. That's not how we're 
doing that.
    Senator Warner. The law requires the non-attainment areas 
to be measured according to the MSA.
    Administrator Browner. Right, and because of our 
recognition that the MSAs may not have been the best mechanism 
to allow you to find the common sense pollution solutions, we 
are taking comments on whether or not that should be adjusted.
    Senator Warner. Well, this is the list, I think, under your 
structure of 30 percent, so to speak----
    Administrator Browner. I don't know what list that is.
    Senator Warner. This is the EPA Projected Ozone Non-
Attainment Cities In 2007. My point is I think you can run a 
calculation where there is a lot higher number. Thirty percent 
is something I take respectfully--that's it, and what you're 
doing is not just isolating only 30 percent over here, but it 
is a much higher number.
    Administrator Browner. If it would be helpful, we would be 
more than happy to provide for the record the analysis we did 
that brings us to that statement. That might be helpful.
    Senator Warner. I thank you.
    Administrator Browner. Thank you.
    Senator Chafee. Thank you, Senator Warner.
    I've just got a couple of more questions. Do the other 
Senators have questions?
    [No response.]
    Senator Chafee. You have chosen .08 for your ozone 
standard. Yet, at .07 you would achieve better results, and I 
suppose you could go right down to the background levels, which 
are, what, something like .04 or .05.
    So you've portrayed the position you've taken as one of 
looking after the health of children and others, and, yet, why 
didn't you go down to .07?
    Administrator Browner. Because when we looked at the 
science, what we saw in terms of sort of the real world 
studies, the camp kids studies, the hospital admission studies, 
is that the health effects and the health effects you would 
want to protect against can be--that you can do that at .08.
    I have to say in addition to those scientific studies, in 
addition to the fact that that is where the science took us, 
equally important to me is the fact that on the independent 
peer review panel, the four medical health experts, three of 
them said .08 and the fourth one said .08 to .09. They 
specifically discussed these issues of .07, .08, .09, and we 
have health studies at .06----
    Senator Chafee. I think they also said it's a policy 
judgment. Am I correct?
    Administrator Browner. It is, as any decision we make, a 
decision that has to be informed by the science, by the 
evidence, and this is where the science took me. That is true. 
The science took me----
    Senator Chafee. In other words, we don't have the so-called 
bright line that we had--well, when we were doing the CFCs, for 
example. Step over this line and when you've reached this line, 
you've now achieved a protection of health. You go over it, and 
you won't achieve anything more. That's not the situation here. 
You've chosen the .08, but it could be .07, and, as we've 
mentioned, it probably could go right down to background 
levels.
    Administrator Browner. I mean, I think it is a hard 
comparison to make. There is no natural background level for 
chlorofluorocarbons. That is a man-made chemical that is being 
put into air.
    I mean, it is true and it has been recognized--in fact, 
Senator Muskie spoke very eloquently during the debate on the 
1977 amendments to the issue of no bright line, no threshold. I 
mean, it has been recognized in this work for decades now that 
there are natural background levels of ozone, and there may 
very well be some small number of people who do experience some 
small number of effects, even at a background level.
    The .08 that we propose and that we take comment on is 
where the science took us in terms of the health effects that 
we thought were the most troubling, that the medical experts 
thought were the most troubling, that we should be protecting 
against.
    Senator Chafee. Final question, as I've indicated here, I 
think where you're going to do your real achievements is on the 
particulates and the 2.5, which I applaud you for choosing. I'm 
worried about the monitoring stations, and this gets back to 
Mr. Huggett.
    The cost of installing those I think the--how many were 
going to be required across the country?
    Administrator Browner. Actually, this is not Dr. Huggett's 
issue. This would actually be the Air Office issue. Why don't I 
have her explain how these monitoring systems are put in place, 
and we have them already for a lot of other pollutants. So this 
is something we're very familiar with.
    Senator Chafee. But I think these are quite different, as I 
understand these monitoring ones for the particulates, but go 
ahead, Ms. Nichols.
    Ms. Nichols. I would just say that we put out for proposal 
at the same time we put out the ozone and particulate matter 
standard proposals a proposed PM monitoring regulation. The 
structure of the program is that the EPA approves the 
monitoring system. We approve a reference method, and then we 
approve a plan for deploying the monitoring devices.
    It is a phased plan that is being proposed here. This year 
we're actually beginning the deploying of the first 70 
monitoring stations around the country.
    Senator Chafee. How many do you envision across the 
country?
    Ms. Nichols. Ultimately, we will probably end up with 
several hundred monitoring stations. There is still some debate 
about the exact number in places.
    Senator Chafee. That's what I thought. I'm informed that 
there are 1,400 PM10 stations, but this would, 
obviously, be for a finer particle than the PM10's.
    So, in any event, I hope you get on with that, and if you 
require more money, I hope--obviously, this is something where 
the States are going to require some assistance--I would hope 
you would include that in your budget and make a real effort 
for it.
    Ms. Nichols. We would agree.
    Senator Chafee. I think that is what Senator Bond was 
talking about when he gave you that money last year. It was for 
this.
    Administrator Browner. That is correct.
    Senator Chafee. Any other questions.
    Senator Baucus. Madam Administrator, you said it's the 
science that led you to the policy decision of .08.
    What is it in the science that led you to that conclusion?
    Administrator Browner. It's the number of people whose 
health are affected. It's the number of aggravated asthma, 
respiratory illnesses. It's the fact that far too many people 
when the pollution is at that level are experiencing real 
effects.
    Senator Baucus. But, again, at a tighter standard more 
would be protected.
    Administrator Browner. Right, and by tightening the 
standard, as we propose to do, we would be providing protection 
to 133 million Americans.
    Senator Baucus. Why not .07?
    Administrator Browner. When you look at the science, when 
the health experts looked at the science, they felt that .08 
gave the level of protection that the law envisioned, that that 
is where the science took them.
    Senator Baucus. Doesn't it really get no more to the point 
that, as you said earlier, there is no bright line, and that 
we're talking here not about exact science but about sound 
science?
    Administrator Browner. I think----
    Senator Baucus. That, as I understand it, the number of 
people affected from .08 to .07 is much less than the number of 
people affected from .09 to .08.
    The main point I'm trying to make here is that when we talk 
about science, we're talking about sound science. We're not 
talking about perfect science or exact science. We're trying to 
do the best we can in making some judgment calls here because 
there is no perfect science in these areas.
    Administrator Browner. Well, science continues to move on. 
I think what is----
    Senator Baucus. There are differences of opinions and 
views.
    Administrator Browner. There will always be differences of 
opinions. I think what is very important here----
    Senator Baucus. People look at different data. When they 
conduct experiments, data sometimes happens to be different.
    Administrator Browner. Well, that is why you have a CASAC 
process. That is why the law directed us to engage in a public 
review of the science.
    In closing, if I might just say, Senator Baucus, Mr. 
Chairman, 250 plus peer reviewed scientific published studies--
that is clear and convincing. I believe it is compelling. We 
have never had anything of this magnitude when it comes to 
making a public health decision for the people of this country.
    Senator Baucus. What you're saying is this is a study much 
more extensively than other standards?
    Administrator Browner. Absolutely. We've never had----
    Senator Baucus. How much more? Can you quantify it?
    Administrator Browner. You know, we could go through sort 
of proposal by proposal----
    Senator Baucus. Ten percent more, 10 times more?
    Administrator Browner. In some instances, it could be 10, 
20, 30 times more, quite frankly. You have more than 10 years 
of scientific study that shapes the proposal we make. It is 
where the science takes us; it is overwhelming.
    Thank you.
    Senator Chafee. Well, that maybe also, Madam Administrator, 
but when you got to the final cut, as it were, the top review, 
the big leaguers, if you would, the CASAC Group, they weren't--
they didn't have unanimity. I consider unanimity--they had 19 
members and in some they had 17 out of 19. That is pretty darn 
good. I'm not going to argue with that, but there are other 
ones where they couldn't agree on the period, for example, with 
the particulates whether it be annual, or daily, or they 
couldn't agree on the level. So they were all over the lot----
    Senator Baucus. Mr. Chairman, with ozone they did agree on 
the range because that is a policy decision.
    Administrator Browner. Yes.
    Senator Baucus. They did agree.
    Senator Chafee. That's right, on the range they did agree.
    Senator Baucus. Also on particulates they agreed that the 
standards should be separate--of what it should be.
    Senator Chafee. That's right, but my point is that you've 
got a stack of studies this high, peer reviewed, splendid, but 
when the final peer review--that's what CASAC is--comes in, 
there was wide disagreement.
    Administrator Browner. With all due respect----
    Senator Chafee. That's going to be the motto of this 
hearing.
    [Laughter.]
    Administrator Browner. I have to say that anytime you can 
get 19 of 21 scientists, that is huge, No. 1.
    Senator Chafee. I conceded that. I didn't argue.
    Administrator Browner. No. 2, when three of four health 
experts can all agree on .08, that is huge. It is rare that we 
have that kind of scientific agreement when we make decisions. 
What we have here is a process, and a body of scientists that, 
I think, is compelling and leads us to propose to strengthen 
these standards for the American people.
    Senator Chafee. OK, fine. Thank you very much, Madam 
Administrator.
    Now if Ms. Katzen can come up, who has waited patiently, or 
maybe impatiently, we'll take your testimony.

STATEMENT OF SALLY KATZEN, ADMINISTRATOR, OFFICE OF INFORMATION 
   AND REGULATORY AFFAIRS, OFFICE OF MANAGEMENT AND BUDGET, 
                         WASHINGTON, DC

    Administrator Katzen. Thank you very much, Mr. Chairman, 
and members of the committee.
    I am pleased to be here this morning. I found it quite 
illuminating to sit through this morning's discussion of the 
EPA's proposal to revise the ozone and particulate matter 
ambient air quality standards. As has been commented on a 
number of times today, these proposals have sparked 
extraordinary interest from a wide variety of affected groups--
environmentalists and health professionals, who view these 
standards as a necessary and important step to improving air 
quality; State and local governments, who have the front line 
responsibility for implementing these standards; and industry 
and other entities who will have to take the steps necessary so 
that areas will comply with whatever standards are adopted.
    The interests and concerns that have been expressed range 
from the health effects to be ameliorated by these standards 
and the scientific support and other scientific policy issues 
underlying these standards, to the administrative and other 
practical means by which these standards will be implemented, 
to the economic effects in complying with these standards, 
including the costs that will be incurred as people change 
their conduct to implement them.
    Questions have also been raised about OMB's review of these 
proposed rules, focusing particularly on the logistics of how 
and when OMB carried out its responsibilities.
    I am here today because it is my office that is responsible 
under Executive Order 12866 for reviewing executive branch 
regulatory proposals, and we in fact did review the EPA 
proposals that are the subject of this morning's hearing.
    This morning the EPA Administrator presented extensive 
testimony and answered a wide range of questions about the 
Agency's basis for the proposed standards. The Agency should 
take the lead, for it has the statutory authority and bears the 
responsibility for developing substantive regulatory standards. 
Executive Order 12866 specifically recognizes the primacy of 
Federal agencies in the regulatory decisionmaking process.
    OMB's role under the Executive order is to provide 
dispassionate, objective review of the Agency's work. Our task 
is to ensure that the regulatory agency asks the right 
questions, considers the relevant scientific and other data, 
employs sound analysis, and balances the competing concerns in 
a reasonable, practical way.
    In addition, for proposed rules--and the rules under 
discussion today are proposed rules--it is important that the 
regulatory agency present its proposal and justification for it 
in a way that assures informed, meaningful input from the 
public.
    Executive Order 12866 sets forth a number of principles 
generally applicable to regulatory decisionmaking. The 
Executive order was, however, purposefully qualified to apply--
and I am quoting--``to the extent permitted by law.'' That 
qualification is particularly important in this case. As has 
been mentioned many times this morning, under the Clean Air 
Act, the EPA Administrator is to set air quality standards that 
protect public health with an adequate margin of safety. It is 
a health-based determination, and the EPA Administrator is not 
to consider economic factors at this stage of the rulemaking 
proceeding.
    Now, having said this, Executive Order 12866 nonetheless 
requires agencies to prepare economic analyses for proposed and 
final rules, and to submit them to OMB for review even if 
economic considerations are not the determinant factor, or even 
a secondary or tertiary factor. Where, here, a statute 
prohibits the consideration of economic factors, such analysis 
is still important because it helps inform the Administration, 
the Congress, and most importantly, the American people of the 
benefits and the costs of regulatory activity.
    In fact, as has been mentioned this morning, the EPA 
prepared extensive cost-benefit analyses--over 3 inches of 
materials--which accompanied the proposed standards when we 
received them at OMB. We thought it was particularly important 
that the EPA prepare these economic analyses even at the 
standard-setting stage. For while the standards are health-
based and may not reflect economic considerations, they are not 
self-executing. Instead, the EPA must follow these standards 
with regulations to implement them, and in this implementation 
phase, as Administrator Browner has said, costs should, and 
will, play a very significant role. Preparing the benefit cost 
analyses during the standard-setting phase will ensure that 
those addressing the implementation phase--the EPA, its 
Advisory Committees, the State and local governments who are 
responsible for implementing these standards--have the best 
information possible as they set about their work.
    Let me now briefly mention the specifics of OMB's review of 
these proposed standards, and, hopefully, touch on the 
questions that have been raised.
    First, before we received the proposed rules, our staff 
attended a number of meetings at which the EPA explained in 
general terms the methodology it was using in its analysis of 
these rules--the data it was relying on, the assumptions and 
models used. In addition, the EPA and my office hosted a number 
of interagency meetings with the EPA staff to brief other 
Federal agencies on the general issues that the EPA would be 
considering in this rulemaking process.
    Second, the EPA submitted the package of proposals to OMB 
on November 4, 1996. We had to work quickly because of a court- 
ordered deadline of November 29, 1996. This put a strain on 
both my office and the EPA staff as we went about our work.
    During these 3 weeks, I know that my staff worked 
intensely, often late into the evenings and on weekends. We 
gave this matter top priority, putting aside or postponing 
temporarily other responsibilities to focus our attention on 
these standards.
    We were able to identify a number of issues that we thought 
required further work, and while the court-ordered deadline 
precluded full discussion and resolution of those issues with 
the EPA, we have been advised by the Agency that some of these 
issues will in fact be analyzed as part of the economic 
analyses that will be provided to us as part of the package for 
our review of the final standards.
    At the final rule stage, we will continue our obligations 
for review of these rules under the Executive order. There are 
important policy issues that need to be considered, and, as at 
the proposed stage, we expect that many of the affected parties 
will want to meet with us and share their views. We welcome 
those meetings, as it will give us a better idea of the issues 
on which we should focus as we do our work.
    Thank you very much for opportunity to be here and to 
answer any questions you may have.
    Senator Chafee. Thank you very much, Ms. Katzen.
    I want to take this opportunity to thank you for the 
excellent testimony you gave maybe just a year ago--against the 
so-called regulatory reform legislation, which I was very much 
against and was pleased that it didn't pass, although I'm not 
sure that it's not still alive out there somewhere. Like 
Lazarus, it might be back.
    I'm curious to know what your review reveals about the 
feasibility of these standards, and I'm not talking about cost 
and benefits but whether there are strategies available to meet 
the standards. My understanding is that the cost estimates 
couldn't be completed because measures that would attain the 
standards couldn't be identified.
    Am I correct in that?
    Administrator Katzen. I would put it slightly differently. 
We do not do our own estimate. What we do is review the EPA's 
estimates of the benefits and the costs. The EPA benefit-cost 
analysis was based on known strategies and technology, to avoid 
speculation.
    As you heard this morning in testimony regarding the 
timetable, it may be many years before these standards will 
actually have to be implemented, and there may well be 
technological breakthroughs that would lower the costs, but we 
don't know that now. It would be equally difficult to speculate 
on where bringing into compliance would be on the current cost 
curve, assuming there are no technological breakthroughs, 
because such an assumption would be inconsistent with past 
experience.
    So what the EPA did in this instance was look at the areas 
of the country--locality by locality--to determine, based on 
known strategies and technology, the costs. This produced what 
we have in the cost-benefit analysis here. What was missing was 
the residual non-attainment areas where, based on known 
technology, they could not now say what the cost would be of 
reaching full attainment.
    This is one of the areas on which the EPA is doing more 
work as we proceed toward the final rule stage, namely, in 
looking at the residual non-attainment areas.
    Senator Chafee. Well, that is a pretty significant section 
of the country. For example, where I come from is not in 
attainment.
    Administrator Katzen. That is correct, but what the EPA was 
thinking--and I think Administrator Browner touched on it this 
morning--is that as part of the implementation phase, they will 
be looking to the Federal Advisory Committee and the OTAG, 
which will be recommending, we understand, various strategies 
that may have a very helpful effect on the air quality in your 
State by imposing more restraint on areas that are not now 
subject to existing controls.
    With those strategies and policies in place, it then will 
be possible to determine what the real costs will be, but until 
they are determined, it is difficult at best to estimate the 
costs. Such an estimate, if it were simply an extrapolation of 
the path of the known cost curve, would I think, would be very 
misleading to the American public about what is at stake here.
    Senator Chafee. Let's just deal for a moment with the ozone 
standard.
    As I understand it, the EPA has two estimates for the ozone 
standard. Am I correct in that? One is the so-called local 
strategy and the other is the regional strategy, which, 
apparently, is based on a more cost-effective approach.
    Am I correct in what I'm saying, and do these cost 
estimates vary very much?
    Administrator Katzen. I can't give you the specific cost 
estimates specifically of the two different strategies right 
now. We looked at ranges of costs for both the ozone and the 
particulate matter standards, and wanted to make sure that they 
were broken out specifically for each so that we could look at 
them one at a time.
    One of the areas that we want to do further work on is the 
interrelationship between the two because it will be very 
important as we look at each of these standards to determine 
how full compliance with one would affect particulate matter 
and how full compliance with particulate matter would affect 
the ozone attainment.
    So work on the interrelationship is part and parcel of the 
work that is being done now and would fit into the types of 
different strategies that they're looking at.
    Senator Chafee. OK, well, thank you very much. I'm sorry 
that you had to wait so long, and, thus, we lost some of our 
Senators. But we might have follow-up questions, and if you 
could answer those, we would appreciate it.
    Administrator Katzen. I would be happy to answer them to 
them to the best of my ability.
    Senator Chafee. Thank you.
    Administrator Katzen. Thank you very much.
    Senator Chafee. I must say trying to use the acronym of 
your office makes for awkwardness.
    Administrator Katzen. I've gotten used to OIRA.
    Senator Chafee. Where are you from?
    Administrator Katzen. I'm from Pittsburgh, PA.
    Senator Chafee. Oh, I don't mean----
    [Laughter.]
    Senator Chafee. In the Supreme Court the judge asked a 
lawyer, ``How did you get here?'' He said, ``I came by the 
Pennsylvania Railroad.'' He really meant what court did you 
come up through.
    So I'm just--how do you pronounce it? In my State we're 
blessed with having the Naval Underwater Warfare Center, which 
is very, very important. It employs some 2,500 civilians and is 
extremely important, but the acronym of the name is NUWC, which 
I find a little difficult, N-U-W-C. And you are OIRA, 
pronounced how?
    Administrator Katzen. OIRA.
    Senator Chafee. OIRA.
    Administrator Katzen. OIRA.
    Senator Chafee. Well, best wishes to everybody down at OIRA 
and thanks for coming.
    [Laughter.]
    Administrator Katzen. We need them. Thank you.
    Senator Chafee. That concludes the hearing.
    [Whereupon, at 12:30 p.m., the committee was adjourned, to 
reconvene at the call of the chair.]
   Statement of Carol M. Browner, Administrator, U.S. Environmental 
                           Protection Agency
    Mr. Chairman, members of the committee, I want to thank you for 
inviting me to discuss the Environmental Protection Agency's proposed 
revisions to the national ambient air quality standards for particulate 
matter and ozone.
    On these two pollutants, over the past three and a half years, EPA 
has conducted one of its most thorough and extensive scientific reviews 
ever. That review is the basis for the new, more stringent standards 
for particulate matter and ozone that we have proposed in order to 
fulfill the mandate of the Clean Air Act.
    On average, an adult breathes in about 13,000 liters of air each 
day. Children breathe in 50 percent more air per pound of body weight 
than do adults.
    For 26 years, the Clean Air Act has promised American adults and 
American children that they will be protected from the harmful effects 
of dirty air--based on best available science. Thus far, when you 
consider how the country has grown since the Act was first passed, it 
has been a tremendous success. Since 1970, while the U.S. population is 
up 28 percent, vehicle miles travelled are up 116 percent and the gross 
domestic product has expanded by 99 percent, emissions of the six major 
pollutants or their precursors have dropped by 29 percent.
    The Clinton Administration views protecting public health and the 
environment as one of its highest priorities. We have prided ourselves 
on protecting the most vulnerable among us--especially our children--
from the harmful effects of pollution. When it comes to the Clean Air 
Act, I take very seriously the responsibility the Congress gave me to 
set air quality standards that ``protect public health with an adequate 
margin of safety''--based on the best science available.
    Mr. Chairman, the best available, current science tells me that the 
current standards for particulate matter and ozone are not adequate, 
and I have therefore proposed new standards that I believe, based on 
our assessment of the science, are required to protect the health of 
the American people.
    The standard-setting process includes extensive scientific peer 
review from experts outside of EPA and the Federal Government. Under 
the law, we are not to take costs into consideration when setting these 
standards. This has been the case through six Presidential 
administrations and 14 Congresses, and has been reviewed by the courts. 
We believe that approach remains appropriate. However, once we revise 
any given air quality standard, it is both appropriate and, indeed, 
critical that we work with states, local governments, industry and 
others to develop the most cost-effective, common-sense strategies and 
programs possible to meet those new standards.
    I want to make it clear that at this point we have only proposed 
revisions to the two standards. We take very seriously our obligation 
to carefully consider all public comments on these proposals before 
making a final decision. We want to hear from small businesses, 
industry, state and local governments, and other citizens like the 
elderly, children, doctors and people with asthma. While we have 
proposed specific levels for each pollutant, we are also asking for 
comment on a wide range of alternative options. I want to assure you 
here today that I will not make a final decision until comments on all 
of those alternative options have been carefully considered. EPA went 
to the court and requested a 60-day extension for the public comment 
period and the deadline for taking final action on the particulate 
matter standards. Two days ago, the court granted EPA an extension 
until March 12, 1997 for the public comment period and until July 19, 
1997 for issuing a final decision. We intend to extend the schedule for 
ozone accordingly.
    This morning I would like to describe for you the basis for my 
recent decisions to propose revisions to the particulate matter and 
ozone standards. I would also like to discuss some of the innovative 
approaches we are undertaking to ensure that any newly revised standard 
would be met in the most cost-effective way possible.
                               background
    The Clean Air Act directs EPA to identify and set national 
standards for certain air pollutants that cause adverse effects to 
public health and the environment. EPA has set national air quality 
standards for six common air pollutants--ground-level ozone (smog), 
particulate matter (measured as PM10, or particles 10 
micrometers or smaller in size), carbon monoxide, lead, sulfur dioxide, 
and nitrogen dioxide.
    For each of these pollutants, EPA sets what are known as ``primary 
standards'' to protect public health and ``secondary standards'' to 
protect the public welfare, including the environment, crops, 
vegetation, wildlife, buildings and monuments, visibility, etc.
    Under the Clean Air Act, Congress directs EPA to review these 
standards for each of the six pollutants every 5 years. The purpose of 
these reviews is to determine whether the scientific research available 
since the last review of a standard indicates a need to revise that 
standard. The ultimate purpose is to ensure that we are continuing to 
provide adequate protection of public health and the environment. Since 
EPA originally set the national air quality standards (most were set in 
1971), only two of EPA's reviews of these standards have resulted in 
revised primary standards--in 1979, EPA revised the ozone standard to 
be less stringent; and in 1987, EPA revised the particulate matter 
standard to focus on smaller particles (those less than 10 micrometers 
in diameter), instead of all sizes of suspended particles.
    By the early 1990's, thousands of new studies had been published on 
the effects of ozone and there was an emerging body of epidemiological 
studies showing significant health effects associated with particulate 
matter. EPA was sued by the American Lung Association to review and 
make decisions on both the ozone and particulate matter standards. I 
directed my staff to conduct accelerated reviews of both standards. In 
March 1993, I completed a review of the ozone national ambient air 
quality standards (NAAQS) with my decision not to revise the NAAQS, and 
to accelerate the next review in light of emerging information. Soon 
afterwards, in February 1994, I issued a Federal Register notice 
committing the Agency to meeting an accelerated schedule for analyzing 
all of the scientific studies that had become available since EPA 
completed its last review of the ozone standards. The scientific 
analysis and review for both pollutants are completed and EPA proposed 
revisions to the two standards late last year. We expect to announce 
final decision on both pollutants by July 19, 1997.
    I would like to make one final point on this matter. Although the 
reviews for both the ozone and particulate matter standards have been 
accelerated, I gave them very high priority and focused the necessary 
resources on them to ensure that we conducted an exhaustive and open 
review of the science. The criteria documents alone were six inches 
thick for particulate matter and three inches thick for ozone. I am 
satisfied that our decisionmaking process on ozone and particulate 
matter has been thorough, complete and, as I will describe, based on 
extensive peer-reviewed science.
   extensive scientific review process used to review the ozone and 
           particulate matter national air quality standards
     EPA undertakes an extensive scientific and technical assessment 
process during the standard review for each air pollutant. This 
includes developing (1) a ``criteria document'' which reflects the 
latest scientific knowledge on the kind and extent of all identifiable 
effects on public health or welfare of the pollutant, and (2) a 
detailed scientific and technical assessment, known as a ``staff 
paper.'' Using information in the criteria document, the staff paper 
arrays a range of policy alternatives based on the scientific evidence 
and makes recommendations to me. Both of these documents go through 
extensive public and external scientific peer review.
    Our Office of Research and Development is responsible for compiling 
the ``criteria document.'' These are comprehensive assessments that 
include thousands of studies that have been published in peer review 
journals. My Office of Research and Development holds a series of peer 
review workshops on draft chapters of the criteria document. Once the 
entire document has been completed in draft form, it is further 
reviewed by the public and the Clean Air Scientific Advisory Committee, 
or CASAC.
    Established by Congress, the CASAC is a panel of science experts 
external to EPA. During the review for each air pollutant, the panel is 
augmented with additional scientific and technical consultants who have 
expertise related to that pollutant and its effects. In total, there 
were 21 scientists and technical experts from academia, research 
institutes, public health organizations and industry who reviewed the 
particulate matter criteria document and staff paper and 16 who 
reviewed the ozone criteria document and staff paper. The CASAC reviews 
were chaired by George Wolff, an atmospheric scientist from General 
Motors. CASAC meetings are open to the public.
    The CASAC panel reviews the draft criteria documents and the key 
underlying studies and makes recommendations for revisions to the 
criteria document. Industry, state and local agencies, and other 
members of the public also submit extensive comments on the draft 
criteria documents. My staff then revises the document and submits it 
for another review by the CASAC and the public. This process sometimes 
repeats itself two or three times until the CASAC sends EPA what is 
known as a ``closure'' letter, pronouncing the criteria document as 
adequate to be used as a basis for a decision on whether or not a given 
standard should be revised.
    Staff in my Office of Air and Radiation also develops a ``staff 
paper.'' The purpose of the staff paper is to identify the most policy-
relevant information contained in the criteria document and the 
critical elements that the EPA staff believes should be considered in 
the review of the standards. The staff paper typically includes 
quantitative exposure and risk analyses. This document also includes 
staff recommendations of ranges of alternative standards that should be 
considered in any decision I may make on revising a standard. Like the 
criteria document, this draft staff paper is subject to review by the 
public and the CASAC panel. And like the criteria document, the staff 
paper often undergoes two or more reviews--where the scientific panel 
recommends changes and my staff responds to those recommendations--
before the CASAC issues a letter of ``closure'' on it as well. At that 
point the staff paper, along with the criteria document, is ready for 
me to use in making my decision as to whether it is appropriate to 
propose any revisions to the standards.
    public involvement in the ozone and particulate matter decisions
    Throughout the three and a half year process of developing our 
proposed standards, we have been committed to analyzing the science in 
an open public forum and ensuring broad public input. Back in February 
1994, we published in the Federal Register the schedule we intended to 
follow for the review of the ozone standard which identified the 
opportunities for public comment and public meetings.
    Each meeting held with the CASAC on criteria documents and staff 
papers is open to the public. In fact, we have held 11 CASAC meetings 
totaling more than 124 hours of public discussion on the ozone and 
particulate matter criteria documents and staff papers. All of these 
meetings were announced in the Federal Register and open to the general 
public. In addition to the public meetings and the public review and 
comment on the criteria documents and staff papers, the public has 
several other opportunities to provide input to a decision on the ozone 
and particulate matter standard revisions.
    In June 1996, EPA published in the Federal Register an Advance 
Notice of Proposed Rulemaking describing the key issues under 
consideration and timeframes for decisions on the two standards. In 
July 1996, we held national public meetings in Philadelphia and St. 
Louis, where we presented these key issues and options we were 
considering on the two standards and received extensive comments from 
the public. About 100 representatives of industry, state and local 
governments, and members of the public people provided comments at 
those meetings.
    In my announcement of the proposed revisions last November, I 
encouraged broad public participation in the comment process in order 
to obtain the best information available for determining the 
appropriate final standards. We have established a virtually 
unprecedented system for the public to provide their comments. In 
addition to the normal docketing process for receipt of public 
comments, we have established a national toll-free telephone hotline 
(1-888-TELL-EPA) to encourage the broadest amount of public comment 
possible. Over the past 2 months it has received hundreds of calls from 
the public. Several key documents have been made available over the 
Internet. We have also established a system for people to submit their 
comments via E-mail over the Internet. Again, our goal here is to 
ensure that we allow for the broadest array of public comment possible.
    We also held 2 days of public hearings on the proposed standard 
revisions in each of three cities--Salt Lake City, Chicago and Boston. 
In addition, we held a day-long public hearing in Durham, North 
Carolina on our associated proposal for air quality monitoring for 
particulate matter. At these hearings, more than 400 citizens and 
organizations provided testimony about their views of our proposed 
standards.
    We have taken other steps to expand the public discourse on these 
matters. We have held two national satellite telecasts broadcast around 
the Nation to answer questions on the standards from officials from 
state and local governments, industries and other groups. We are also 
working with the Air and Waste Management Association, a national 
organization of industry, government and other air pollution control 
experts, to hold public meetings on the new standards at more than ten 
different locations. Beyond that, I have instructed my Regional 
Administrators to hold public forums around the Nation to discuss the 
issues associated with any possible revision to these air quality 
standards. My regional office staff are also participating in hearings 
that states such as California, Texas and Washington are holding on 
these proposed standard revisions.
    In response to requests from a number of interested parties, EPA 
went to the court and requested an extension of the public comment 
period and the date for a final decision to provide greater opportunity 
for public input into these decisions. As I have already mentioned, the 
court granted us an additional 3 weeks.
      rationale for epa's proposed revision of the ozone standards
    Since the mid-1980's, there have been more than 3,000 scientific 
studies published that are relevant to our understanding of the health 
and environmental effects associated with ground-level ozone. These 
peer-reviewed studies were published in independent scientific journals 
and included controlled human exposure studies, epidemiological field 
studies involving millions of people (including studies tracking 
children in summer camps), and animal toxicological studies. Taken as a 
whole, the evidence indicates that, at levels below the current 
standard, ozone affects not only people with impaired respiratory 
systems, such as asthmatics, but healthy children and adults as well. 
Indeed, one of the groups most exposed to ozone are children who play 
outdoors during the summer ozone season.
    Certain key studies, for example, showed that some moderately 
exercising individuals exposed for 6 to 8 hours at levels as low as 
0.08 parts per million (ppm) (the current ozone standard is set at 0.12 
ppm and focuses on 1-hour exposures) experienced serious health effects 
such as decreased lung function, respiratory symptoms, and lung 
inflammation. Other recent studies also provide evidence of an 
association between elevated ozone levels and increases in hospital 
admissions. Animal studies demonstrate impairment of lung defense 
mechanisms and suggest that repeated exposure to ozone over time might 
lead to permanent structural damage in the lungs, though these effects 
have not been corroborated in humans.
    As a result of these and other studies, EPA's staff paper 
recommended that the current ozone standard be revised from the current 
1-hour form (that focuses on the highest ``peak'' hour in a given day) 
to an 8-hour standard (that focuses on the highest 8 hours in a given 
day). It also recommended setting an 8-hour standard in the range of 
0.07 ppm to 0.09 ppm, with multiple exceedances (between one and five 
per year).
    The CASAC panel reviewed the scientific evidence and the EPA staff 
paper and was unanimous in its support of eliminating the 1-hour 
standard and replacing it with an 8-hour standard. While I do not base 
my decisions on the views of any individual CASAC member (as a group 
they bring a range of expertise to the process), it is instructive to 
note the views of the individual members on these matters. While ten of 
the 16 CASAC members who reviewed the ozone staff paper expressed their 
preferences as to the level of the standard, all believe it is 
ultimately a policy decision for EPA to make. All ten favored a 
multiple exceedance form. Three favored a level of 0.08 ppm; one 
favored a level of either 0.08 or 0.09 ppm; three favored the upper end 
of the range (0.09 ppm); one favored a 0.09-0.10 range with health 
advisories when a 0.07 level was forecast to be exceeded; and two just 
endorsed the range presented by EPA as appropriate.
    Consistent with the advice of the CASAC scientists and the EPA 
staff paper, we proposed a new 8-hour standard at 0.08 ppm, with a form 
that allows for multiple exceedances, by taking the third highest 
reading each year and averaging those readings over 3 years. We are 
asking for comments on a number of alternative options, ranging from 8-
hour levels of 0.07 to 0.09 ppm to an option that would retain the 
existing standard. Just as a point of reference, based on our most 
recent analysis of children outdoors, when measuring the exposures and 
risks of concern, as well as the number of areas of the country that 
would be in ``nonattainment'' status, the current 1-hour ozone standard 
of 0.12 ppm is roughly equivalent to a 0.09 ppm 8-hour standard with 
approximately two to three exceedances.
    We considered a number of complex public health factors in reaching 
the decision on the level and form proposed. The quantitative risk 
assessments that we performed indicated differences in risk to the 
public among the various levels within the recommended ranges, but they 
did not by themselves provide a clear break point for a decision.\1\ 
The risk assessments did, however, point to clear differences among the 
various standard levels under consideration. These differences indicate 
that hundreds of thousands of children are not protected under the 
current standard but would be under EPA's ozone proposal.
---------------------------------------------------------------------------
    \1\ CASAC itself agreed that there are a continuum of effects--even 
down to background--and that there is no ``bright line'' distinguishing 
any of the proposed standards as being significantly more protective of 
public health.
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    Also, consistent with EPA's prior decisions over the years, it was 
my view that setting an appropriate air quality standard for a 
pollutant for which there is no discernible threshold means that 
factors such as the nature and severity of the health effects involved, 
and the nature and size of the sensitive populations exposed are very 
important. As a result, I paid particular attention to the health-based 
concerns reflected in the independent scientific advice and gave great 
weight to the advice of the health professionals on the CASAC. To me, 
this is particularly important given the fact that one of the key 
sensitive populations being protected would be children. The decision 
to propose at the 0.08 ppm level reflects this, because, though it is 
in the middle of the range recommended for consideration by CASAC and 
the EPA staff paper, as a policy choice it reflects the lowest level 
recommended by individual CASAC panel members and it is the lowest 
level tested and shown to cause effects in controlled human-exposure 
health studies.
    Finally, air quality comparisons have indicated that meeting a 0.08 
ppm, third highest concentration, 8-hour standard (as proposed by EPA) 
would also likely result in nearly all areas not experiencing days with 
peak 8-hour concentrations above the upper end of the range (0.09 ppm) 
referred to in the CASAC and the EPA staff paper. Given the 
uncertainties associated with this kind of complex health decision, we 
believe that an appropriate goal is to reduce the number of people 
exposed to ozone concentrations that are above the highest level 
recommended by any of the members of the CASAC panel. The form of the 
standard we proposed (third highest daily maximum 8-hour average) 
appears to do the best job of meeting that goal, while staying 
consistent with the advice of the CASAC as a group, as well as the 
personal views of individual members.
    It is also important to note that ozone causes damage to vegetation 
including:
     interfering with the ability of plants to produce and 
store food, so that growth, reproduction and overall plant growth are 
compromised;
     weakening sensitive vegetation, making plants more 
susceptible to disease, pests, and environmental stresses; and
     reducing yields of economically important crops like 
soybeans, kidney beans, wheat and cotton.
    Nitrogen oxides is one of the key pollutants that causes ozone. 
Controlling these pollutants also reduces the formation of nitrates 
that contributes to fish kills and algae blooms in sensitive waterways, 
such as the Chesapeake Bay.
    As part of its review of the ozone science, the CASAC panel 
unanimously advised that EPA set a secondary standard more stringent 
than the current standard in order to protect vegetation from the 
effects of ozone. However, agreement on the level and form of the 
secondary standard was not reached.
    rationale for epa's proposed revision to the particulate matter 
                               standards
    For particulate matter standard review, EPA assessed hundreds of 
peer reviewed scientific research studies, including numerous 
community-based epidemiological studies. Many of these community-based 
health studies show associations between particulate matter (known as 
PM) and serious health effects. These include premature death of tens 
of thousands of elderly people or others with heart and/or respiratory 
problems each year. Other health effects associated with exposure to 
particles include aggravation of respiratory and cardiovascular 
disease, including more frequent and serious attacks of asthma in 
children. The results of these health effects have been significantly 
increased numbers of missed work and school days, as well as increased 
hospital visits, illnesses, and other respiratory problems.
    The recent health studies and a large body of atmospheric chemistry 
and exposure data have focused attention on the need to address the two 
major subfractions of PM10--``fine'' and ``coarse'' fraction 
particles--with separate programs to protect public health. The health 
studies have indicated a need to continue to stay focused on the 
relatively larger particles or ``coarse'' fraction that are a 
significant component of PM10 and are controlled under the 
current standards. We continue to see adverse health effects from 
exposures to such coarse particles above the levels of the current 
standards. As a result, CASAC scientists were unanimous that existing 
PM10 standards be maintained for the purpose of continuing 
to control the effects of exposure to coarse particles.
    However, a number of the new health and atmospheric science studies 
have highlighted significant health concerns with regard to the smaller 
``fine'' particles, those at or below 2.5 micrometers in diameter. 
These particles are so small that several thousand of them could fit on 
the type-written period at the end of a sentence. In the simplest of 
terms, fine particles are of health concern because they can remain in 
the air for long periods both indoors and outdoors contributing to 
exposures and can easily penetrate and be absorbed in the deepest 
recesses of the lungs. These fine particles can be formed in the air 
from sulfur or nitrogen gases that result from fuel combustion and can 
be transported many hundreds of miles. They can also be emitted 
directly into the air from sources such as diesel buses and some 
industrial processes. These fine particles not only cause serious 
health effects, but they also are a major reason for visibility 
impairment in the United States in places such as national parks that 
are valued for their scenic views and recreational opportunities. For 
example, visibility in the eastern United States should naturally be 
about 90 miles, but has been reduced to under 25 miles.
    EPA analyzed peer-reviewed studies involving more than five and a 
half million people that directly related effects of ``fine'' particle 
concentrations to human health. For example, one study of premature 
mortality tracked almost 300,000 people over the age of 30 in 50 U.S. 
cities.
    Based on the health evidence reviewed, the EPA staff paper 
recommended that EPA consider adding ``fine particle'' or 
PM2.5 standards, measured both annually and over 24 hours. 
The staff paper also recommended maintaining the current annual and/or 
24-hour PM10 standards to protect against coarse fraction 
exposures, but in a more stable form for the 24-hour standard. This 
more stable form would be less sensitive to extreme weather conditions.
    When CASAC reviewed the staff paper, 19 out of 21 panel members 
recommended establishment of new standards (daily and/or annual) for 
PM2.5. They also agreed with the retention of the current 
annual PM10 standards and consideration of retention of the 
24-hour PM10 standard in a more stable form.
    Regarding the appropriate levels for PM2.5, staff 
recommended consideration of a range for the 24-hour standard of 
between 20 and 65 micrograms per cubic meter (g/m3) 
and an annual standard to range from 12.5 to 20 g/
m3. Individual members of CASAC expressed a range of 
opinions about the levels and averaging times for the standards based 
on a variety of reasons. Four panel members supported specific ranges 
or levels within or toward the lower end of the ranges recommended in 
the EPA staff paper. Seven panel members recommended ranges or levels 
near, at or above the upper end of the ranges specified in the EPA 
staff paper. Eight other panel members declined to select a specific 
range or level.
    Consistent with the advice of the EPA staff paper and CASAC 
scientists, in November last year I proposed adding new standards for 
PM2.5. Specifically, based on public health considerations, 
I proposed an annual standard of 15 g/m3 and a 24-
hour standard of 50 g/m3. In terms of the relative 
protection afforded, this proposal is approximately in the lower 
portion of the ranges or options recommended by those CASAC panel 
members who chose to express their opinions on specific levels. 
However, taking into account the form of the standard proposed by EPA, 
we understand that the proposal would fall into the lower to middle 
portion of the ranges or options. In order to ensure the broadest 
possible consideration of alternatives, I also asked for comment on 
options both more and less protective than the levels I proposed.
    Also consistent with the advice of the EPA staff paper and CASAC 
scientists, I proposed to retain the current annual PM10 
standard and to retain the current 24-hour PM10 standard, 
but with a more stable form. I also requested comment on whether the 
addition of a fine particle standard and the maintenance of an annual 
PM10 standard means that we should revoke the current 24-
hour PM10 standard.
    As has been the case throughout the 25-year history of 
environmental standard setting, uncertainty has played an important 
role in decisionmaking on the particulate matter standards. 
Specifically, the uncertainty about the exact mechanism causing the 
observed health effects has led some to argue that not enough is known 
to set new or revised standards. In this case, however, because of the 
strong consistency and coherence across the large number of 
epidemiological studies conducted in many different locations, the 
seriousness and magnitude of the health risks, and/or the fundamental 
differences between ``fine'' and ``coarse'' fraction particles, the 
CASAC scientists and the experts in my Agency clearly believed that 
``no action'' was an inappropriate response. The question then became 
one of how best to deal with uncertainty--that is, how best to balance 
the uncertainties with the need to protect public health.
    Given the nature and severity of the adverse health effects, I 
chose to meet the Congressional requirement of providing the public 
with an ``adequate margin of safety,'' by proposing PM2.5 
standards within the ranges recommended in the EPA staff paper and 
commented upon in the CASAC closure letter. I believe the levels chosen 
reflect the independent, scientific advice given me about the 
relationship between the observed adverse health effects and high 
levels of fine particle pollution. That advice led to a proposed 
decision toward the lower end of the range of levels for the annual 
standard which is designed to address widespread exposures and toward 
the middle of the range for the 24-hour standard, which would serve as 
a backstop for seasonal or localized effects.
    One final note on particulate matter. Some have suggested we need 
more research before decisions are made about these standards. I 
strongly support the need for continued scientific research on this and 
other air pollutants as a high priority. However, as we pursue this 
research, we must simultaneously take all appropriate steps to protect 
public health. We believe that tens of thousands of people each year 
are at risk from fine particles and I believe we need to move ahead 
with strategies to control these pollutants.
  finding common sense, cost-effective strategies for implementing a 
                      revised ozone or pm standard
    Throughout the 25-year history of the Clean Air Act and air quality 
management in the United States, national ambient air quality standards 
have been established based on an assessment of the science concerning 
the effects of air pollution on public health and welfare. Costs of 
meeting the standards and related factors have never been considered in 
setting the national ambient air quality standards themselves. As you 
can see from the description of the process I went through to choose a 
proposed level on ozone and particulate matter, the focus has been 
entirely on health, risk, exposure and damage to the environment.
    I continue to believe that this is entirely appropriate. Sensitive 
populations like children, the elderly and asthmatics deserve to be 
protected from the harmful effects of air pollution. And the American 
public deserves to know whether the air in its cities and counties is 
unsafe or not; that question should never be confused with the separate 
issues of how long it may take or how much it may cost to reduce 
pollution to safe levels. Indeed, to allow costs and related factors to 
influence the determination of what levels protect public health would 
be to mislead the American public in a very fundamental way.
    While cost-benefit analysis is a tool that can be helpful in 
developing strategies to implement our nation's air quality standards, 
we believe it is inappropriate for use to set the standards themselves. 
In many cases, cost-benefit analysis has overstated costs. In addition, 
many kinds of benefits are virtually impossible to quantify--how do I 
put a dollar value on reductions in a child's lung function or the 
premature aging of lungs or increased susceptibility to respiratory 
infection? Very often I cannot set a value and these types of health 
benefits are, in effect, counted as zero.
    At the same time, both EPA and industry have historically tended to 
overstate costs of air pollution control programs. In many cases, 
industry finds cheaper, more innovative ways of meeting standards than 
anything EPA estimates. For example, during the 1990 debates on the 
Clean Air Act's acid rain program, industry initially projected the 
costs of an emission allowance (the authorization to emit one ton of 
sulfur dioxide) to be approximately $1,500, while EPA projected those 
same costs to be $450 to $600. Today those allowances are selling for 
less than $100.
    Another example involves EPA's regulations in the 1970's and 1980's 
to reduce emissions of smog-forming volatile organic compounds from 
coating and printing operations. Industry developed powder coatings and 
ultraviolet light-cured coatings that not only reduced emissions to the 
EPA-required levels, but essentially eliminated emissions altogether. 
In addition to saving industry the high cost of equipment for the 
collection and destruction of volatile organic compounds, these 
coatings provide for faster production, improved efficiency, reduction 
in energy costs and frequently improved performance. The coating 
industry has since developed new export markets. The combination of the 
Clean Air Act and the European goal of zero emissions of volatile 
organic compounds is driving the industry to develop new techniques. 
Although the coating industry as a whole predicts growth of two to 3 
percent, the powder and UV-cured coatings are growing much faster to 
meet the needs of customers to reduce emissions of volatile organic 
compounds.
    On the other hand, the Clean Air Act has always allowed that costs 
and feasibility of meeting standards be taken into account in devising 
effective emission control strategies and in setting deadlines for 
cities and counties to comply with air quality standards. This is 
certainly the case for any revision we might make to either the ozone 
or the particulate matter standards. This process has worked well. In 
fact, our preliminary studies indicate that from 1970 to 1990 
implementation of the Act's requirements has resulted in significant 
monetizable benefits many times the direct costs for that same period.
    If we ultimately determine that public health is better served by 
revising one or both of these standards, the Clean Air Act gives us the 
responsibility to devise new strategies and deadlines for attaining the 
revised standards. In doing so, we are determined to develop the most 
cost-effective, innovative implementation strategies possible, and to 
ensure a smooth transition from current efforts.
    To meet this goal, we have used the Federal Advisory Committee Act 
to establish a Subcommittee for Ozone, Particulate Matter and Regional 
Haze Implementation Programs. It is composed of almost sixty members of 
state and local agencies, industry, small business, environmental 
groups, other Federal agencies and other groups and includes five 
working groups comprised of another 100 or so members of these same 
kinds of organizations.
    The Subcommittee and the various workgroups have been meeting 
regularly for well over a year working to hammer out innovative 
strategies for EPA to consider in implementing any revised standards. 
Members from industry, state governments and others are putting forward 
position papers advocating innovative ways to meet air quality 
standards. It is our belief that results from this Subcommittee process 
will lead us to propose innovative approaches for implementing any new 
standards. The Subcommittee will continue to meet over the next year to 
help develop cost-effective, common-sense implementation programs.
    The issues being addressed by the Subcommittee include:
     What will be the new deadlines for meeting any new 
standards? [If EPA tightens a standard, it has the authority to 
establish deadlines of up to 10 years--with the possibility of 
additional extensions--beyond the date an area is designated 
``nonattainment.'']
     What will be the size of the area considered 
``nonattainment?'' If it revises an air quality standard, EPA has the 
ability to change the size of the affected nonattainment areas and 
focus control efforts on those areas that are causing the pollution 
problems, not just the downwind areas that are monitoring unhealthy 
air.
     How do we address the problem of the pollutants that form 
ozone and/or fine particles being transported hundreds of miles and 
contributing to nonattainment problems in downwind areas?
     What kinds of control strategies are appropriate for 
various nonattainment areas? Can we use the experience of the past 
several years to target those control strategies that are the most 
cost-effective?
     How can we promote innovative, market-based air pollution 
control strategies?
    The implementation of these new standards is likely to focus on 
sources like trucks, buses, power plants and cleaner fuels. In some 
areas, as with the current standards, our analysis shows that reaching 
the standards will present substantial challenges. All of the air 
pollution control programs we are pursuing to meet the current ozone 
and particulate matter standards, as well as programs to implement 
other sections of the Clean Air Act, will help meet any revised 
standards. For example, the sulfur dioxide reductions achieved by the 
acid rain program will greatly help reduce levels of fine particles, 
particularly in the eastern United States. Cleaner technology in power 
plants would also greatly reduce the nitrogen oxides that help form 
ozone across the eastern United States. In fact, we believe that under 
certain comprehensive control strategies, more than 70 percent of the 
counties that could become nonattainment areas under a new ozone 
standard would be brought back into attainment as a result of a program 
to reduce nitrogen oxides from power plants and a large number of other 
sources. Programs under--way to reduce emissions from cars, trucks, and 
buses will also help meet a revised particulate matter or ozone 
standard.
    I intend to announce our proposals on implementation of the 
proposed new standards in phases that correspond to the Federal 
Advisory Committee Act Subcommittee's schedule for deliberating on 
various aspects of the program. I expect to propose the first phase of 
that program at the same time that I announce our final decision on 
revisions to the ozone and particulate matter standards.
    In announcing the proposed ozone and particulate matter standards 
last November, I directed my Office of Air and Radiation to further 
expand the membership of the Federal Advisory Subcommittee to include 
more representation from small business and local governments. Also, in 
conjunction with the Small Business Administration and the Office of 
Management and Budget, we are holding meetings with representatives of 
small businesses and small governments to obtain their input and views 
on our proposed standards.
    There is one last point I would like to make on this matter. 
Critics of the proposals have been saying that meeting these proposed 
standards means widespread carpooling and the elimination of backyard 
barbecues, among other lifestyle changes. The broad national strategy 
is being developed by EPA, as I have described, with extensive input 
from industry, small business, state and local governments and others. 
While the ultimate decisions as to what programs are needed to meet air 
quality standards are up to the state and local governments, I would 
like to state categorically that there will not be any new Federal 
mandates eliminating backyard barbecues or requiring carpooling. These 
kinds of claims are merely scare tactics designed to shift the debate 
away from the critical, complex public health issues we are attempting 
to address.
                              conclusions
    Mr. Chairman, I commend you for holding these hearings. The issues 
we are discussing today are critical to the state of the Nation's 
public health and environment. It is imperative that the American 
public understand these important issues. In that regard, I am 
disappointed that some have chosen to distort this important discussion 
by raising distracting and misleading pseudo issues like ``junk 
science'' and ``banning backyard barbecues.'' I am hopeful that this 
and other hearings and public forums will help focus the national 
debate on the real health and environmental policy implications of 
these national air quality standards.
    In the Clean Air Act, the Congress has given me the responsibility 
to review every 5 years the most recent science to determine whether 
revisions to national air quality standards are warranted. In doing so, 
the law tells me to protect the public health with an adequate margin 
of safety.
    We are constantly reviewing the science associated with these 
standards, but we do not often propose revisions to them. I have done 
so in the case of ozone and particulate matter because of compelling 
new scientific evidence. For the past three and a half years we have 
targeted our resources to conduct a thorough, intensive review of this 
scientific evidence. The scope and depth of this review process has 
been based on unprecedented external peer review activities.
    Given the sensitive populations affected by these pollutants--
children, asthmatics, the elderly--as well as possible effects on 
outdoor workers and other healthy adults, it was my judgment that it 
was appropriate to propose standards that tended to fall in the lower 
end of the range of protection supported by my independent science 
advisors and recommended by experts in my technical offices. Based on 
the record before the Agency at the time of proposal, including the 
advice and recommendations of the CASAC panels, I concluded--subject to 
further consideration based on public comments--that the proposed 
standards were both necessary and sufficient to protect the public 
health, including sensitive populations, with an adequate margin of 
safety.
    At the same time, I recognize that the proposed standards involve 
issues of great complexity and I look forward to receiving a broad 
range of comments from all affected and interested parties. As I have 
described, we have gone to unprecedented lengths to provide the public 
with opportunities to express their views on the proposed standards. We 
have also expressly requested comments on options (including 
alternative levels and forms of the standards) that are both more 
protective and less protective than the levels we proposed.
    Mr. Chairman, this concludes my written statement. I will be happy 
to answer any questions that you might have.
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 Responses by Carol Browner to Additional Questions from Senator Thomas
    Question 1. After reading your testimony, you seem very confident 
that the science supports taking action on particulate matter. You 
mentioned several times about how important it is to have the best 
science available to us and to use that science in determining new 
standards. If you are so confident about this, I am curious as to why 
the EPA's own budget request for Fiscal Year 1998 points out the need 
for more money--and I quote--to research ``the great uncertainty about 
PM and health effects''?
     That sounds to me like the EPA is admitting they don't 
know enough at this point about which particulates cause health 
effects. Why are you seeking $26 million for health effects research if 
you are certain the current science says you should regulate 
PM2.5?
    Answer. Taking action to protect public health in light of the most 
recent scientific information available is not inconsistent with 
earmarking substantial resources to improve our scientific 
understanding for future reviews. Indeed, this responsible public 
health policy and research approach flows directly from the 
requirements of the Clean Air Act. The Act directs EPA to establish 
national ambient air quality standards (NAAQS) that protect public 
health with an adequate margin of safety, based on the most recent 
scientific criteria. These criteria address air pollution that ``may 
reasonably be anticipated to endanger public health'' [Clean Air Act, 
section 108(a)(1)(A)]. Yet, the Act also requires that the criteria and 
standards be reviewed every 5 years. If Congress intended that 
standards should only be established after all appropriate scientific 
research had been completed and all significant uncertainties resolved, 
there would be no need for these periodic reviews to update the 
science. In fact, it has long been the practice of the Clean Air 
Scientific Advisory Committee (CASAC) and the Agency to develop and 
review research needs at the conclusion of each criteria and standards 
review.
    The courts have held that the margin of safety requirement for 
primary standards was intended to address uncertainties associated with 
inconclusive scientific and technical information available at the time 
of standard setting. It was also intended to provide a reasonable 
degree of protection against hazards that research has not yet 
identified. Both kinds of uncertainties are components of the risk 
associated with pollution at levels below those at which human health 
effects can be said to occur with reasonable scientific certainty. 
Thus, the Act requires the Administrator not only to prevent pollution 
levels that have been demonstrated to be harmful but also to prevent 
lower pollutant levels that she finds may pose an unacceptable risk of 
harm, even if the risk is not precisely identified as to nature or 
degree.
    In the case of particulate matter (PM), the Administrator has 
responded to the health risks revealed in the most recent scientific 
assessment by proposing new standards for fine particles, while 
pursuing a vigorous research program to reduce the scientific 
uncertainties. She believes that this reflects a prudent and 
responsible public health policy that is soundly based on the available 
scientific information. This approach is exactly what was recommended 
by her independent scientific advisors. The strongest consensus from 
the CASAC was its near-unanimous support for maintaining 
PM10 standards and establishing new standards for 
PM2.5, and for continuing a comprehensive research program 
to improve our scientific understanding of the key issues.
    If new standards are set, it would take several years to put a 
program in place to implement them with a series of measures over time. 
The effort to conduct monitoring and develop control programs will 
undoubtedly reveal additional scientific and technical information 
needs. The research done over the next few years could be of 
significant benefit in improving new control programs, and contribute 
much to the next criteria and standards review. A delay in establishing 
these standards would add several years to the time when significant 
health benefits can be realized, potentially resulting in tens of 
thousands of additional premature deaths and even larger numbers of 
individuals with air pollution-related illness and symptoms.
    Whether the standards are set for PM10 only or also 
include PM2.5, there are unavoidable uncertainties at 
present with respect to the relative risk presented by various 
components of particulate matter. The Administrator places greater 
weight on the need to adequately control air pollution that is 
responsible for adverse effects than on the possibility we might also 
be controlling some component that may not be related to such effects. 
EPA believes that moving forward simultaneously on both health 
protection and research is the most appropriate approach, one that is 
consistent with both the philosophy and practice of establishing and 
reviewing ambient standards under the Clean Air Act.

    Question 2. I noted with interest that the Administration and you 
responded to the concerns of the nation's Governors by asking the court 
for a 60-day extension of the public comment period and issuance of the 
final rule for particulate matter. You stated: ``it is critical for the 
American people to have a thorough, fair and informed public debate on 
the EPA proposal. To this end I recognize additional time is needed to 
responsibly assess and comment on our proposal.'' As you know, on 
Monday the court granted EPA a 3-week extension of the two standards.
     What is the significance of three additional weeks?
     Given the Governors have to implement the ozone and 
particulate rules and have asked for a longer extension of the comment 
period--and given that you are only constrained by the court with 
regard to the particulate rule--if the nation's Governors asked for a 
longer extension of the public comment period for the ozone rule would 
you grant such an extension?
     Are you letting the court drive the ozone timetable in a 
de facto manner?
    Answer. The significance of the three additional weeks is that they 
represent the Court's view of how much additional time was appropriate 
for public comment on the PM proposal, and of course, that they do 
allow additional time for interested parties to prepare comments. For 
the reasons discussed in the proposal notices, EPA stated its intent to 
review and, as appropriate, modify both standards on a similar 
schedule. Work on review of the ozone standard has been ongoing since 
1992, predating the March 9, 1993 Federal Register notice that formally 
concluded the last review of the ozone standards. In that notice, which 
announced a decision not to revise the standards at that time, the 
Administrator announced her commitment to expedite the next review in 
light of new scientific evidence on the effects of ozone on human 
health that had not as yet been thoroughly peer reviewed. A number of 
public peer review meetings were held on the new studies and on draft 
chapters of the Criteria Document throughout 1993. In a February 1994 
Federal Register notice, the Administrator announced a schedule for 
completion of the scientific assessment and review of the standards, 
including opportunities for public comment--this schedule called for 
proposal by the summer of 1996 and a final decision as to whether to 
revise the ozone standards by the summer of 1997.
    Since that time there have been five public meetings of the CASAC 
to review both the Criteria Document and EPA's Staff Paper. The EPA 
staff has also regularly briefed staff of the National Governors 
Association (NGA) and the States both prior to proposal and after 
proposal on what the science was showing. In addition, after proposal 
EPA briefed NGA and State staff on the proposed standards and the 
rationale for them. Numerous public meetings have also been held both 
prior to and after proposal to further inform the public on the science 
and EPA's proposals.
    The Administrator believes there has been ample time for all 
parties to understand the science and to develop comments on the EPA's 
proposals. The Administrator is not letting the Court drive the ozone 
schedule. In fact, she chose to delay the proposal of the ozone 
standard and to place it on the same schedule as the particulate matter 
standard because of the benefits for developing integrated 
implementation strategies. The rationale for this decision was 
presented in an Advanced Notice of Proposed Rulemaking, published in 
the Federal Register on June 12, 1996. That delay in effect provided an 
additional 5 months for interested parties to review EPA's assessments 
of the scientific and technical information bearing on whether the 
ozone standard should be revised, as well as staff and CASAC advice and 
recommendations on that issue, in preparation for the development of 
comments on the ozone proposal itself. The attached timeline highlights 
the pre-proposal activities discussed above.
    As discussed in the proposal notice, important common factors 
between the two pollutants have been identified that have a significant 
bearing on the implementation of the ozone and particulate matter 
standards. Similar sources emit both pollutants (or their precursors) 
and both are formed under similar atmospheric conditions by precursor 
gases (e.g., nitrogen oxides, volatile organic compounds). These 
similarities provide opportunities for optimizing integrated strategies 
for reducing emissions that contribute to both ozone and fine particle 
pollution in the most cost-effective, efficient and flexible manner 
possible. As you note, the States and Governors have a significant role 
to play in implementing these standards. It is for this reason that EPA 
has established a Federal advisory committee, the FACA Subcommittee on 
Integrated Implementation of the Ozone and PM NAAQS and the Regional 
Haze Program under the Clean Air Act Advisory Committee (CAAAC), to 
advise on the development of an implementation approach that is 
flexible and allows for joint planning, as appropriate, to address 
these pollutants as well as the regional haze problem. The EPA has 
repeatedly demonstrated its willingness to work with the Governors and 
States to develop common sense approaches to addressing air pollution 
problems. This is best exemplified by EPA's substantial support to the 
37 states currently working together in the Ozone Transport Assessment 
Group. As we go forward in developing our implementation policies, 
there will be significant opportunities for the Governors and States to 
participate and provide input.

    Question 3. In the West we often have severe forest fires and brush 
fires during the dry summer months. The amount of particulate matter 
being emitted into the atmosphere by these fires is significant. Is it 
not possible that events like the Yellowstone fires of 1988 could put 
many cities out of attainment for particulate matter?
     How would the EPA separate out health effects from forest 
fires as compared to other contaminants?
     Has the EPA taken into account the unique geological, 
climatic and ecological differences in the Western States?
    Answer. EPA has initiated several actions to address issues related 
to implementing the proposed standards in Western States. An ad hoc 
group has been formed under the FACA Subcommittee on Integrated 
Implementation to discuss issues peculiar to Western States. Also, a 
separate work group has been established under the Subcommittee to 
recommend approaches to issues directly related to planning for and 
minimizing the adverse health effects of wildland fires (both 
prescribed and unplanned wildfires). The work group includes 
representatives from Federal and State agencies that manage land and 
conduct prescribed burns.
    In the past, forest fires have caused the current PM10 
air quality standards to be exceeded, but they have not caused an area 
to be designated nonattainment. The current 24-hour PM10 
standard must be exceeded more than once per year on average in an area 
to cause nonattainment. Furthermore, EPA recently issued a policy 
statement applicable to areas affected by natural events such as 
wildfires. A copy of the policy is attached. The policy allows states 
to discount PM10 air quality data that results from natural 
events in certain circumstances provided that a plan is implemented to 
increase public awareness and minimize the health impacts of such 
events.
    Episodic events such as forest fires would have even less influence 
on attainment of the proposed 24-hour PM standards. The EPA proposed to 
specify the form of the 24-hour standards to allow exceedances on 2 
percent of monitored days. That proposal would allow the standards to 
be exceeded on average about 7 days per year with every-day monitoring.
    Mass concentration measurements of particulate matter from many 
sources have been related to serious health effects in scientific 
studies; as a result, EPA's proposed standards rely on measurements 
using the Federal Reference Method to collect particles of certain 
sizes (e.g., PM2.5 and PM10) that come from a 
wide variety of sources. Thus, the health effects from exposures to 
particulate matter from various sources would not be differentiated. 
However, in determining how best to implement these standards, States 
and local governments would have flexibility in deciding how to control 
various sources in the most cost-effective manner.

    Question 4. We hear a lot of talk about protecting children and 
people at risk, such as the elderly. I completely understand the need 
to protect these groups and find it hard to believe that any of us 
would want to harm children or people who have a hard time breathing. 
That's simply ludicrous. We also hear a great deal of discussion about 
risk assessment and prioritizing risks. Isn't it true that most 
people--young and old--spend more time indoors being exposed to indoor 
air pollution?
     In EPA's own publication The Inside Story: A Guide to 
Indoor Air Quality (April 1995) it states: ``A growing body of 
scientific evidence suggests that the air within homes and other 
buildings can be more seriously polluted than outdoor air, even in the 
largest most industrialized cities. Thus, for many people, the risks to 
health may be greater to exposure to air pollution indoors than 
outdoors.''
     In EPA's recent report on air quality, it's documented 
that over the past 25 years, major air pollutants have decreased 
nationally by almost 30 percent. Wouldn't you agree that if we are 
truly concerned about priorities and sound public policy, we should be 
addressing indoor air pollution, since outdoor air pollution has 
declined and will continue to do so?
    Answer. It is true that most people spend more time indoors than 
outdoors; this was a key consideration in evaluating the risk posed by 
particulate matter and ozone. EPA agrees that it is sound public policy 
to address all major environmental threats to public health. We also 
agree that indoor air pollution is of significant concern and, as noted 
below, EPA has been taking responsible steps to address this concern. 
However, we also believe it is important to fulfill the Clean Air Act 
mandate to revise the ambient air quality standards, as appropriate, to 
protect public health with a margin of safety, the issue that is at 
hand in this review.
    EPA is proud that, through the cooperative effort of States, 
industry, the Federal Government, and the public, the country has made 
great strides to improve outdoor ambient air quality. However, based on 
the record at the time of proposal, EPA's review of the most recent 
scientific information indicates that the current standards are not 
protective enough for ozone and PM. The Clean Air Act requires EPA to 
review the standards and any new scientific information for exactly 
this purpose--to determine if our national air quality standards are 
the correct ones. The most recent scientific information provides 
consistent and coherent evidence that serious health effects are 
occurring in children, the elderly, and other sensitive populations at 
PM and ozone concentrations at and below our existing standards.
    All of the programs being implemented today to meet the existing 
ozone and PM standards will help meet both the current standards and 
any new or revised standards. By building implementation strategies for 
new standards around key existing control programs, we are working to 
build on the momentum of the nation's ongoing control efforts in order 
to provide public health protection as effectively and efficiently as 
possible--revising these standards will do nothing to slow this 
progress.
    For 26 years, the Clean Air Act has promised American adults and 
children that they will be protected from the harmful effects of dirty 
air--based on the best available science. The Act requires that 
national air quality standards ``are requisite to protect the public 
health,'' including sensitive populations such as children at risk from 
the harmful effects of pollution. EPA's proposed ozone standard would 
increase protection for an estimated 122 million Americans from harmful 
ozone exposures, including 33 million children, 7 million asthmatics, 
and 8 million people with other respiratory diseases.
    As part of this review of the ozone standard, EPA conducted a 
state-of-the-art exposure assessment looking at the at-risk population 
exposures to tropospheric ozone, including children and people who work 
for their living out of doors. Children tend to spend more time 
outdoors than adults. Because children engaged in outdoor playing have 
increased respiration rates, they may experience higher exposures to 
ozone and other air pollution. Although residing in air conditioned 
buildings may provide some protection from indoor ozone exposures, not 
everyone can afford air conditioning and many people and children are 
outside (or have the windows open) on summer days when ozone levels may 
be high.
    With regard to particulate matter, outdoor air pollution can be a 
major source of indoor pollution. In a non-smoking household, for 
instance, particles from outdoor sources contribute on average as much 
as 76 percent of the PM2.5 measured indoors (Source: 
Ozkaynak et al., 1993a, Criteria Document p. 7-38). Among the 
population's most sensitive to the effects of particulate matter are 
the elderly, who typically spend more time indoors than the norm. This 
is one of the reasons it is critical to revise the standards to focus 
on fine particles, which not only readily penetrate to the indoor 
environment but remain suspended in the indoor air for substantially 
longer periods than do larger particles.
    With respect to promoting good indoor air quality, it is important 
to remember that outdoor air establishes the base pollutant 
concentration indoors; indoor sources add to that base to create indoor 
conditions. One of the keys to good indoor air quality is clean outdoor 
ambient air, since the technique most frequently used to control indoor 
air quality is ventilation with outdoor air.
    EPA is currently addressing indoor air pollution through voluntary 
measures, including the development and dissemination of guidance to 
the owners and operators of commercial buildings and schools, to 
consumers, home owners and building occupants, and to other influential 
audiences such as public and environmental health advocates, and 
building design and construction professionals, about the most 
effective ways to prevent indoor air problems from occurring, and 
resolve them if they do. Working with over 650 affiliates of national 
organizations such as the American Lung Association, the Consumer 
Federation of America, and the National Association of Counties, EPA 
will be raising awareness about indoor air quality problems and 
encouraging actions to prevent or resolve them in communities across 
the nation. More than 20,000 copies of guidance material EPA published 
in 1995 for schools wishing to prevent or solve indoor air quality 
problems (``Indoor Air Quality Tools for Schools'') will have been 
distributed to American schools, and some 1,500 schools are expected to 
implement our recommendations this year. The ``Building Air Quality 
Guide'' for commercial building owners and managers that EPA published 
in 1991 has become the standard of care for proper building 
maintenance. A multi-year study to characterize the condition of the 
indoor environment in a representative sample of office buildings 
across the country is well underway; 70 building profiles and occupant 
perception questionnaires, out of 100 buildings planned for inclusion 
in the study, will have been completed by the end of this fiscal year. 
Our public outreach and education efforts continue to be a cornerstone 
of our indoor air quality program, with clearinghouses and hotlines 
responding to some 60,000 inquiries per year and distributing more than 
1 million information documents annually.
    In short, we believe we are taking appropriate steps to ensure 
Americans enjoy clean, healthy air both in the outdoor environment and 
indoors.

    Question 5. What costs will state and local communities have to 
incur to comply with the new standards? What will the costs be to 
implement the new monitoring plans that states will be required to have 
in place?
    Answer. Sample estimates of the potential control costs to local 
government agencies associated with the proposed new particulate matter 
standard were provided in the November 1996 particulate matter 
regulatory impact analysis (RIA). These estimates are based on 
assumptions regarding how State and local government agencies will 
implement control measures to achieve any new standards. Potentially 
significant costs to county governments were estimated for 10 percent 
of the small sample of county governments that were assessed. The 
estimated control costs to State and local government agencies 
associated with the proposed new ozone standard were not estimated in 
the November 1996 ozone RIA, but are expected to be insignificant since 
few ozone precursor control measures that were identified in the RIA 
are directly controlled or owned by State and local governments.
    Administrative costs were not estimated in the November 1996 ozone 
and particulate matter RIAs but are expected to be very small relative 
to total control costs. The revised ozone/particulate matter RIA to be 
completed in July 1997 will include estimates of administrative costs.
    The EPA's proposed monitoring regulations for PM2.5 
require a new PM2.5 monitoring network which is currently 
estimated to cost a total of $70.8 million for 1200 stations. Our 
current projection is that States and EPA will share the cost of 
phasing this network in over the next 4 years. Because we are proposing 
to maintain PM10 standards, with modest revisions, we 
project gradual offsets from the current PM10 monitoring 
program. We are currently developing interim PM program guidance which 
continues much of the PM10 program while transitioning to 
the PM2.5 program. Of the estimated $70.8 million cost for 
the PM2.5 network, $4.2 million has been acquired from 
offsets from the current PM10 monitoring program. The 
remainder, $66.6 million, will be needed in new funding from fiscal 
year 98 through the year 2000 to support this new NAAQS monitoring 
network. Essentially, all of these new costs will be incurred during 
1998 to 2000. EPA will provide 60 percent of this burden through the 
Federal 105 Grant funds and assumes that the other 40 percent of this 
burden would be provided by State and local agencies.
    The initial samplers would be allocated to provide geographic 
coverage with added initial emphasis on high population, high potential 
PM2.5 pollution areas and high ozone areas. All new samplers 
will include both Federal Reference Method monitors, special purpose 
monitors, and continuous PM analyzers. In addition, special monitoring 
studies are needed with an emphasis on designing adequate networks to 
lay the ground work for future strategy development.
    The table below outlines the current strategy for phasing in the 
PM2.5 monitors and phasing-out of some of the 
PM10 monitors. The table identifies the number of 
PM10 and PM2.5 sites and the estimated total cost 
of the PM10 and PM2.5 monitoring networks.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                  Approximate No. of Operational Sites                                      Estimated National PM Cost [In millions of  
---------------------------------------------------------------------------------------------------------                    dollars]                   
                                                                                                         -----------------------------------------------
                                                               Year            PM10           PM2.5*           PM10            PM2.5           Total    
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.......................................................            1997            1600             200            15.9             4.2            20.1
1.......................................................            1998            1400             600            12.6            18.6            29.9
2.......................................................            1999            1000            1000             9.8            24.0            33.8
3.......................................................            2000             600            1200             6.7            24.0            30.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Totals include approximate number of sites operating at the end of the year.                                                                          

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 Responses by Carol Browner to Additional Questions from Senator Baucus
    Question 1. What level of tropospheric ozone does EPA consider to 
be due to background concentrations?
    Answer. As defined (with CASAC concurrence) in this review, 
background ozone concentrations are those that would be observed in the 
U.S. in the absence of anthropogenic emissions of VOCs and 
NOx in North America.
    Background ozone concentrations will vary by geographic location, 
time of day, weather, altitude and season. Analyses of air quality 
values at remote sites are the basis for developing estimates of ozone 
concentrations attributable to background sources (see answer to 
Question 2 below). Such analyses produced an estimated range of daily 
1-hour maximum ozone values near sea level of 0.03 to 0.05 ppm during 
the ozone season. Because the distribution of ozone air quality values 
at remote sites is relatively flat, a reasonable estimate of the 8-hour 
daily maximum ozone background during the summer season is also 0.03 to 
0.05 ppm. These analyses also show that 1- and 8-hour ozone background 
concentrations will typically be much lower than 0.05 ppm. These 
estimates of background levels of ozone were carefully assessed during 
the development of the ozone Staff Paper and were explicitly agreed 
upon by CASAC.

    Question 2. Are all background concentrations due to naturally 
occurring ozone precursors? If not, what level of background 
concentrations would be the result of naturally occurring ozone 
precursors? What else contributes to background concentrations?
    Answer. As defined in this review, background concentrations 
include contributions both from natural sources and from ``global'' 
sources of anthropogenic emissions.
    The natural component of background concentrations originates from 
three sources: the intrusion of ozone to ground level from the 
stratosphere, the photochemically initiated oxidation of biogenic and 
geogenic methane and carbon monoxide, and the photochemically initiated 
oxidation of biogenic VOCs. The magnitude of the natural component of 
background ozone concentrations cannot be precisely determined because 
of the role of long-range transport of anthropogenic precursors and/or 
ozone.
    The ``global'' component includes the global transport of non-North 
American emissions of ozone precursors that are uncontrollable by 
emission control strategies in North America.

    Question 3. Some areas in the US have experienced days when rural 
concentrations have been measured at levels at or above 70 ppb. How is 
it determined that ozone measurements are due to background 
concentrations? What rural areas in the country have experienced 
concentrations in excess of 50 ppb? Will any area in the U.S. be 
designated as nonattainment due purely to background levels under the 
proposed standards?
    Answer. Remote areas, used to estimate background ozone 
concentrations, are generally removed from the influence of urban area 
emission sources. Rural areas, on the other hand, are areas that 
typically have no large local emission sources, but could well be 
affected by regional transport of controllable anthropogenic precursors 
and/or ozone from urban area sources. Ozone concentrations measured at 
rural sites usually consist of both locally produced or transported 
background ozone, and ozone or ozone precursors resulting from near or 
long-range transport from urban areas.
    It is true that at rural sites 1-hour ozone concentrations can 
exceed 70 ppb (0.07 ppm). The Staff Paper makes it clear that the 
component consisting of background ozone is only a fraction of rural 
ozone concentrations, which are clearly increased by human activity 
throughout the U.S.
    Based on assessments of air quality values at remote sites, 
background concentrations of ozone alone will not cause any area to 
fail to meet the standard. To the extent that rural areas experience 
transport of anthropogenic precursors and/or ozone, such concentrations 
would be reduced by national implementation strategies designed to 
address transport. The FACA Subcommittee on Integrated Implementation 
is examining the issue of rural transport areas and may make specific 
recommendations regarding how to handle program development for these 
areas. At this point in time, the general direction these discussions 
have taken is to recognize that areas which measure violations of the 
ozone NAAQS may or may not be responsible for the violations. With this 
in mind, the FACA Subcommittee is considering how to structure an 
implementation program that recognizes this reality.

    Question 4. The EPA recently completed the Supplemental Ozone 
Exposure and Health Risk Analysis. Please explain the reason for this 
new analysis and the implications for the proposed ozone standard.
    Answer. The EPA's proposal notice and Staff Paper cited ozone 
exposure and health risk estimates for ``outdoor children'' associated 
with just meeting the current 0.12 ppm, 1-expected exceedance standard 
and several alternative 1- and 5-expected exceedance, 8-hour standards. 
The methods used in the exposure and risk analyses and the selection of 
alternative standards to be analyzed were reviewed with the CASAC 
during the period from December 1993 through March 1994. Given the 
early selection of options to be analyzed, EPA indicated that 
additional alternatives might be analyzed later in the process. In 
conjunction with the decision to propose and take comment on various 
concentration-based forms of an 8-hour standard, EPA staff initiated 
efforts to develop supplemental exposure and risk estimates 
specifically for the proposed standard, alternative 8-hour standards, 
and the current 0.12 ppm, 1-hr standard.
    Several technical revisions were made in preparing the supplemental 
analyses based on what was learned during the development and review of 
the original and supplemental analyses. The revised exposure and risk 
estimates and technical support documents describing the methods and 
results were placed in the public rulemaking docket on February 12, 
1997. The availability of the supplemental reports was announced in the 
Federal Register notice extending the public comment period. EPA is 
continuing its work on the supplemental analysis and evaluating public 
comments received on it.
    While the absolute magnitude of the exposure and risk estimates 
have changed, the relative degree of protection provided by the 
proposed 8-hour standard and the patterns observed across alternative 
standards are similar to those in the estimates available prior to 
proposal, and the proposed standard is still estimated to result in 
important improvements in public health. The supplemental analyses also 
more clearly show that the proposed 8-hour standard provides a more 
consistent target for public health protection, given the city-to-city 
variability observed in air quality patterns, relative to the existing 
1-hour standard. It also is important to note that quantitative 
exposure and risk estimates are just one of many factors the Agency 
considered in developing the proposal. Other considerations include: 
(1) evaluation of the scientific evidence for a range of effects, (2) 
CASAC recommendations and experts' views on alternative standards to 
protect public health, (3) evaluation of population groups particularly 
at risk, (4) estimates of exposures of concern, and (5) air quality 
comparisons for cities upon attaining alternative standards. Thus, 
while the supplemental analyses estimate somewhat higher peak exposures 
of concern and lower risks of adverse effects upon attaining the 
proposed and current standards, they do not substantively change the 
basis for the proposed standard.

    Question 5. Does EPA consider a ``biological response'' to be the 
same as an ``adverse health effect?''
    Answer. No. All individuals frequently experience biological 
responses to a variety of environmental stresses (e.g., heat, cold, 
pollens, solar radiation, air pollutants), most of which are 
sufficiently transient and mild as to not adversely affect an 
individual's health. Distinguishing between measurable biological 
responses and adverse health effects is often a central issue in the 
review of a NAAQS, and was, in fact, a central issue in the current 
review of the ozone NAAQS.
    As discussed in the Federal Register preamble (61 FR 65772-65773), 
in making judgments as to when ozone-related responses become 
significant enough that they should be regarded as adverse to the 
health of individuals in sensitive populations, the Administrator has 
looked to guidelines published by the American Thoracic Society (ATS) 
and the advice of CASAC. While recognizing that perceptions of 
``medical significance'' and ``normal activity'' may differ among 
physicians, lung physiologists, and experimental subjects, the ATS 
(1985) defined adverse respiratory health effects as ``medically 
significant physiologic or pathologic changes generally evidenced by 
one or more of the following: (1) interference with the normal activity 
of the affected person or persons, (2) episodic respiratory illness, 
(3) incapacitating illness, (4) permanent respiratory injury, and/or 
(5) progressive respiratory dysfunction.''
    Application of these guidelines to particular health effects 
related to ambient ozone (O3) exposures involves judgments 
about which medical experts on the CASAC panel and public commenters 
have expressed a diversity of views. To help frame such judgments, the 
EPA staff defined gradations of individual functional responses (e.g., 
decrements in forced expiratory volume in 1 second (FEV1), increased 
airway responsiveness) and symptomatic responses (e.g., aggravated 
cough, chest pain, wheeze), together with judgments as to the potential 
impact on individuals experiencing varying degrees of severity of these 
responses. These gradations and impacts, summarized below, are 
discussed in the Criteria Document (Chapter 9) and Staff Paper (section 
V.F, Table V-4a, 4b, 4c for individuals with impaired respiratory 
systems and Table V-5a, 5b, 5c for healthy individuals) and incorporate 
significant input from the CASAC panel of medical experts. The CASAC 
panel expressed a consensus view that the ``criteria for the 
determination of an adverse physiological response was reasonable'' 
(Wolff, 1995b).
    More specifically, for individuals with impaired respiratory 
systems, small functional responses (e.g., FEV1 decrements 
of 3 percent to 10 percent, increased nonspecific bronchial 
responsiveness <100 percent, lasting less than 4 hours) and/or mild 
symptomatic responses (e.g., cough with deep breath, discomfort just 
noticeable on exercise or deep breath, lasting less than 4 hours) would 
likely interfere with normal activity for relatively few such 
individuals and would likely result in the use of normal medication as 
needed. Moderate functional responses (e.g., FEV1 decrements 
>10 percent but <20 percent, increased nonspecific bronchial 
responsiveness 300 percent, lasting up to 24 hours) and/or 
moderate symptomatic responses (frequent spontaneous cough, marked 
discomfort on exercise or deep breath, wheeze accompanied by shortness 
of breath, lasting up to 24 hours) would likely interfere with normal 
activity for many such individuals and would likely result in 
additional or more frequent use of medication. Large functional 
responses (e.g., FEV1 decrements 20 percent, 
increased nonspecific bronchial responsiveness >300 percent, lasting 
longer than 24 hours) and/or severe symptomatic responses (e.g., 
persistent uncontrollable cough, severe discomfort on exercise or deep 
breath, persistent wheeze accompanied by shortness of breath, lasting 
longer than 24 hours) would likely interfere with normal activity for 
most such individuals and would likely increase the likelihood of 
seeking medical treatment or visiting an emergency room.
    For active healthy individuals, it is judged that moderate levels 
of functional responses (e.g., FEV1 decrements >10 percent 
but >20 percent lasting up to 24 hours) and/or moderate symptomatic 
responses (e.g., frequent spontaneous cough, marked discomfort on 
exercise or deep breath, lasting up to 24 hours) would likely interfere 
with normal activity for relatively few individuals in the at-risk 
populations of concern (active children and outdoor workers). Further, 
it is judged that large functional responses (e.g., FEV1 
decrements >20 percent lasting longer than 24 hours) and/or severe 
symptomatic responses (e.g., persistent uncontrollable cough, severe 
discomfort on exercise or deep breath, lasting longer than 24 hours) 
would likely interfere with normal activity for many such individuals.
    In judging the extent to which such impacts represent effects that 
should be regarded as adverse to the health status of individuals, an 
additional factor that the Administrator has considered is whether such 
effects are experienced repeatedly by an individual during the course 
of a year or only on a single occasion. While some experts would judge 
single occurrences of moderate responses to be a ``nuisance,'' 
especially for healthy individuals, a more general consensus that such 
moderate responses may be adverse emerges as the frequency of 
occurrence increases. Thus, the Administrator agrees with the judgments 
presented in the Staff Paper that repeated occurrences of moderate 
responses, even in otherwise healthy individuals, may be considered to 
be adverse since they could well set the stage for more serious 
illness.

    Question 6. What specific public health considerations form the 
basis for your selection of the 8-hour, 80 ppb, 3rd maximum exceedance 
standard?
    Answer. Taken as a whole, the scientific evidence evaluated in the 
EPA's Criteria Document and summarized in the Staff Paper indicates 
that, at levels below the current standard, O3 affects not 
only people with impaired respiratory systems, such as asthmatics, but 
healthy children and adults as well. The consensus of the CASAC Panel 
was that these documents provide an adequate scientific basis for 
making regulatory decisions on the standard.
    The key controlled human exposure studies identified in this review 
showed that some moderately exercising healthy individuals exposed for 
6 to 8 hours at O3 levels as low as 0.08 ppm experienced 
transient health effects such as decreased lung function as measured by 
FEV1, respiratory symptoms, and lung inflammation; and lead 
to concern that these exposures when repeated can lead to long term 
effects. Summer camp studies also provide extensive and reliable 
evidence of decreased lung function as measured by FEV1 in 
children and adolescents engaged in typical outdoor activities. Other 
recent studies provide evidence of an association between elevated 
O3 levels and increases in hospital admissions and emergency 
room visits, which signal significantly larger increases in doctor's 
visits, school absences, and lost work days. Further, animal studies 
demonstrate impairment of lung defense mechanisms and suggest that 
repeated exposure to O3 over time might lead to permanent 
structural damage in the lungs, though these effects have not been 
corroborated in humans.
    Based on this evidence, the CASAC Panel was in unanimous agreement 
that the present 1-hour standard should be eliminated and replaced with 
an 8-hour standard to focus on those exposures that are of most 
concern. The CASAC Panel also endorsed the range of 8-hour average 
concentrations (0.07 to 0.09 ppm) that EPA staff recommended for 
consideration. Further, the CASAC panel favored changing the form of 
the standard to one that allowed for multiple exceedances. Thus, 
CASAC's evaluation of the evidence is consistent with that of EPA, 
namely that all three major elements of the current O3 
standard should be revised, including the averaging time, the level, 
and the form.
    In reaching a decision on the specific level and form for an 8-hour 
standard, EPA considered a number of complex and interrelated public 
health factors. The quantitative assessments of exposures to ozone at 
levels of concern and of the risk of experiencing various effects 
indicated differences in public health protection among the various 
levels and forms considered, but they did not by themselves provide a 
clear break point for a decision. The quantitative assessments do, 
however, indicate that, under EPA's proposed standard, there will be 
hundreds of thousands of times where children will experience fewer 
incidences of significant decreases in lung function and aggravated 
respiratory symptoms.
    Also, consistent with EPA's prior decisions over the years, when 
setting an air quality standard for a pollutant for which there is no 
discernible threshold, factors such as the nature and severity of the 
health effects involved, and the nature and size of the at-risk 
populations exposed are important considerations. Thus, EPA paid 
particular attention to the health-based concerns reflected in the 
independent scientific advice. The Administrator also gave significant 
consideration to the advice of the human health professionals on the 
CASAC Panel. Of the four human health experts on the CASAC Panel, three 
favored a level of 0.08 ppm and the other favored a level of either 
0.08 or 0.09 ppm. No Panel member favored a standard level of 0.07 ppm; 
three others favored 0.09 ppm, and one favored either 0.09 or 0.10 ppm 
combined with new public health advisories when O3 
concentrations are at or above 0.07 ppm. Thus, the proposed level of 
0.08 ppm reflects the lowest level recommended by individual CASAC 
members; it also reflects the Administrator's consideration of the 
recommendations of the human health experts on the CASAC panel; and it 
is the lowest level tested and shown to cause adverse health effects in 
controlled human-exposure health studies.
    Finally, given the uncertainties associated with this kind of 
complex health decision, EPA has also looked at the reduction in people 
exposed to ozone concentrations that are above the highest level 
recommended by any member of the CASAC panel (i.e., 0.09 ppm). Recent 
air quality data indicate that meeting a 0.08 ppm third-highest 
concentration standard (as proposed by EPA) would result in all but 1 
percent of areas avoiding days with peak 8-hour concentrations above 
the 0.09 ppm level. By comparison, a standard set at the upper end of 
the range of concentrations (5th highest) would result in 17 percent of 
areas exceeding the 0.09 level.

    Question 7. How do the health benefits for the proposed ozone 
standard compare to the other alternatives for which EPA is taking 
comment?
    Answer. The EPA's risk analyses show that under the proposed 
standard of 0.08 ppm, there would be hundreds of thousands of times 
when children will experience fewer incidences of significant decreases 
in lung function and aggravated respiratory symptoms. While the 
differences in the percentages of children affected may be small, they 
represent hundreds of thousands of children. The risk analyses 
indicate, for example, that compared to meeting the current ozone 
standard, meeting the proposed ozone standard would reduce the risk of 
children experiencing over a million significant cases of reduced lung 
function (i.e., FEV115 to 20 percent and greater) 
and hundreds of thousands of respiratory symptoms (e.g., aggravated 
cough, chest pain). Furthermore, there would be a decreased risk of 
lung inflammation and hospital admissions for respiratory causes. EPA 
has identified information compiled by the Centers for Disease Control 
and the U.S. Department of Health and Human Services, and assessments 
prepared by New York State (Rowe et al., 1995) and Dr. George Thurston 
(Thurston et al., 1997) indicating that other related effects such as 
emergency room visits, doctor visits, lost work days, and school 
absences would also be reduced. While larger health benefits are 
estimated for the lower alternative 8-hour standard of 0.07 ppm, the 
uncertainties in these estimates increase significantly at lower 
exposure levels, and no CASAC members judged that the additional health 
benefits estimated for such a standard were a sufficient basis to set a 
standard at this level.

    Question 8. Why does EPA use the decreased lung function of 15 
percent FEV and 20 percent FEV as an indicator of adverse health 
effects? How does that translate into numbers of people likely to 
suffer health effects such as cough and chest pain?
    Answer. As discussed in the response to Question 5, decreased lung 
function is one of many health endpoints used as an indicator of 
adverse health effects. Decreased lung function of 15 percent is the 
midpoint of the range defined as moderate, and greater than 20 percent 
(up to 50 percent or more) is defined as large.
    There is only a weak association between decreased lung function as 
measured by FEV decrements and respiratory symptoms, and thus changes 
in lung functions do not readily translate into numbers of people 
likely to suffer health effects such as aggravated cough or chest pain. 
Respiratory symptoms, which can act as early warning signals, do not 
always accompany decreases in lung functions, particularly in children. 
Such an absence of symptoms can result in children continuing outdoor 
activity longer than they would if they experienced such symptoms. This 
can translate into continued exposure of active children outdoors when 
ozone levels are high, and potentially can result in greater decreases 
in lung function, greater risk of repeated lung inflammation, increased 
risk of hospital admissions and emergency room visits for respiratory 
causes.

    Question 9. Is there a conflict in the time-line between complying 
with the current and proposed standards for ozone? I understand the 
OTAG SIP call is scheduled for this summer. How will this be handled? 
Will there be a similar conflict between current PM standards and those 
proposed? What type of technical and economic resources will be 
available to the states?
    Answer. At the same time EPA proposed the NAAQS, it also proposed 
an Interim Implementation Policy. The purpose of this proposed policy 
is to provide guidance to State and local agencies during the time 
period between promulgation of any final NAAQS and approval of the 
State Implementation Plans for revised NAAQS. The principles upon which 
this policy was based were negotiated with a group of stakeholders 
(State, industry, and environmental groups) and accepted by the FACA 
Subcommittee on Integrated Implementation. This proposed policy 
recognized the existence of OTAG and was structured to include any 
final OTAG actions. While there is no PM equivalent to OTAG, the policy 
recognizes the need to continue implementation of the current 
PM10 program and to coordinate those activities with the 
proposed development of a PM2.5 program.
    It should also be noted that there is no conflict between the 
actions being taken to achieve the current ozone and PM standards and 
any future actions to achieve the proposed standards. To address the 
problems of ozone and PM, especially fine PM, it will take a 
combination of regional and local strategies to reduce air pollution. 
Regional strategies to reduce nitrogen oxides and sulfur dioxide will 
help to significantly reduce the background levels of ozone and fine 
PM. These efforts will bring many nonattainment areas into attainment. 
For other areas, local control measures on nitrogen oxides, volatile 
organic compounds, sulfur dioxide, and PM will be necessary to achieve 
the proposed standards. The exact mix of which pollutants and sources 
need controls will vary from area to area depending on the nature of 
the problem in each area.
    The OTAG SIP call scheduled for this summer will focus on the 
regional part of the problem and is critical to the attaining of either 
the current or the proposed ozone standard. This call is critical to 
continued progress in cleaning the air as we move to the implementation 
of any new standards. The same is true for efforts to achieve the 
current PM10 standard. These efforts are essential to 
address the coarse fraction of particulate matter, which continues to 
be of significant concern. Indeed, in some cases, these measures also 
address the fine PM as well. These actions are not in conflict with 
achieving any new PM standards. Moreover, they are consistent with 
achieving the PM10 standards which EPA has proposed to 
retain in some form.
    The EPA has dedicated significant resources to assisting the States 
and local areas in developing their implementation strategies for 
achieving the current ozone and PM standards, and we will continue to 
provide this assistance in the future. In fact, we are pursuing ideas 
with the FACA Subcommittee on Integrated Implementation to improve and 
harmonize the efforts of the States and local areas in addressing the 
regional nature of the ozone and PM problems.

    Question 10. How many PM2.5 monitors currently are in 
operation and at what locations? How many additional monitors will be 
necessary to provide adequate data to designate? How long does EPA 
anticipate it will take to place monitors and collect adequate data?
    Answer. Currently there are approximately 200 sites with operating 
PM2.5 instruments, the majority of which are in the Western 
US. It has not yet been determined whether or not these monitors will 
be equivalent to the Federal Reference Method (FRM) monitors. We are 
currently canvassing the Regions and States to determine the exact 
number and location of each of these sites. Seventy-two of these 
PM2.5 monitoring sites are operated by the National Park 
Service with support from EPA and located in National Park and 
Wilderness areas. It has not yet been determined whether or not these 
National Park Service monitors will be equivalent to the Federal 
Reference Method monitors, since the FRM has just been proposed. Beyond 
the monitors currently in place, the PM2.5 monitoring 
program is being phased in over a 3-year period with a complete network 
of approximately 1200 sites expected in the year 2000. We would expect 
to have significant data on fine particles for several hundred sites by 
the end of 1999. A full 3 years of data for all sites would, of course, 
not be available until the end of 2002.

    Question 11. On what peer-reviewed research does EPA base its 
selection of 50 g/m3 and 15 g/
m3?
    Answer. In developing proposed PM2.5 standards, the 
Administrator believed that the suite of standards could be most 
effectively and efficiently defined by treating the annual standard as 
the generally controlling standard for lowering both short- and long-
term PM2.5 concentrations. Therefore the full range of 
short- and long-term community epidemiological studies of the health 
effects of particulate matter were considered in developing the 
proposed annual standard. Of the more than 80 such studies identified 
in the Criteria Document and Staff Paper, the Administrator placed 
greatest weight on those epidemiological studies reporting associations 
between health effects and direct measures of fine particles, most 
notably those recent studies conducted in North America. As noted in 
the preamble (61 FR 65660), the studies most directly useful in 
selecting the levels of the annual and 24-hour PM2.5 
standards are those studies specifically reporting significant 
associations between adverse health effects and PM2.5 which 
are included in Tables V-12 and V-13 of the Staff Paper (attached). Not 
only were all of these studies subjected to peer review in the 
scientific literature, but EPA's assessments of these studies in the 
Criteria Document and Staff Paper were also subjected to additional 
expert peer review by CASAC as well as public review.
    The proposed level of 15 g/m3 for the annual 
PM2.5 standard reflects primarily (1) the evidence from 
studies in which fine particles were directly measured showing serious 
health effects at levels below those allowed by the current standard; 
(2) the recognition that while no thresholds have been discerned, 
uncertainties in the evidence of effects increase markedly as the PM 
concentrations decrease; (3) the annual mean concentrations in cities 
in which serious health effects are associated with short-term 
exposures range from about 16 to 21 g/m3; and (4) 
the annual means in cities in which serious health effects are 
associated with long-term exposures, which in one study average about 
18 g/m3, with increased risk being suggested by the 
data at annual means of about 15 g/m3.
    Consistent with the rationale outlined above, the proposed 24-hour 
standard is intended as a ``backstop'' to protect against extremely 
high peak days, localized ``hot spots,'' and risks arising from 
seasonal emissions not adequately controlled by an annual standard. The 
proposed level of 50 g/m3 for the 24-hour 
PM2.5 standard reflects primarily (1) consideration of the 
combined effects of both PM2.5 standards; (2) the importance 
of protecting against peak short-term exposures that might not be 
controlled by the proposed annual standard; and (3) 24-hour 
concentrations (98th percentile values) in cities in which serious 
health effects are associated with short-term exposures to fine 
particles range from about 35 to 90 g/m3, with most 
above 40 to above 50 g/m3.

    Question 12. On what specific projected health benefits does EPA 
base its selection of a 24-hour standard of 50 g/
m3? Its selection of an annual standard of 15 g/
m3?
    Answer. For the particulate matter standard review, EPA assessed 
hundreds of peer reviewed scientific research studies, including 
numerous community-based epidemiological studies. Many of these 
community-based health studies show associations between particulate 
matter and serious health effects. These include premature death of 
elderly people or others with heart and/or respiratory problems each 
year. Other health effects associated with exposure to particles 
include aggravation of respiratory and cardiovascular disease, 
including more frequent and serious attacks of asthma in children. The 
results of these health effects have been significantly increased 
numbers of missed work and school days, as well as increased hospital 
visits, illnesses, and other respiratory problems.
    The EPA's risk assessment produced quantitative estimates of the 
potential benefits of attaining the proposed standards in two cities. 
These risk assessments provided useful insights in selecting the 
averaging times, forms, and levels of the proposed standards, 
particularly in regard to weighing the uncertainties in potential 
benefits for standards at lower concentrations. However, as outlined in 
response to Question 11 above, the proposed standard levels were based 
on a consideration of the health effects literature, and not on 
estimated national benefits associated with alternative standard 
levels.
    The EPA has, however, calculated a potential range of projected 
incremental benefits for partial implementation of the proposed 
PM2.5 standards for the Regulatory Impact Analysis. These 
analyses indicate that the incremental benefits of the proposed 
PM2.5 standards--over both the current PM10 
standards and full implementation of the Clean Air Act Amendment 
requirements--would include health improvements ranging as high as tens 
of thousands fewer premature deaths each year, about ten thousand fewer 
respiratory-related hospital admissions each year, hundreds of 
thousands fewer incidences each year of aggravated asthma and 
respiratory symptoms, and tens of thousands fewer cases each year of 
chronic bronchitis.

    Question 13. Does the Federal Government have to comply with SIPs--
especially with regard to particulate matter--when it undertakes 
prescribed burns? How about with its wildfire management program?
    Answer. Section 176 of the Act requires that the activities of 
Federal agencies, such as prescribed burns, conform to approved SIPs. A 
Federal agency conforms to a SIP when it adheres to the SIP's purpose 
of eliminating or reducing the severity and number of violations of the 
NAAQS, when it does not delay timely attainment of the NAAQS, and when 
it does not cause or contribute to any new violations in any area. 
Federal agencies can conform to SIPs by working with State air 
regulatory agencies to include projected PM emissions from their 
prescribed burn plans in the SIP.
    Wildfires are by definition unplanned, unwanted fires that require 
appropriate suppression. The act of suppressing a wildfire and its 
smoke (PM emissions) is basically conforming to a SIP's purpose. 
Furthermore, EPA issued a policy statement on May 30, 1996 regarding 
areas affected by natural events such as wildfires. A copy of the 
policy is attached. The policy allows states to discount 
PM10 air quality data that results from natural events in 
certain circumstances provided that a plan is implemented to increase 
public awareness and minimize the health impacts of such events.

    Question 14. What is the historic role of the scientific community 
in the NAAQS review process? In addition to the CASAC process, how does 
the scientific community interact with EPA to set the standards?
    Answer. The scientific community has historically played a key role 
in the NAAQS review process. The first step in the process is an 
extensive scientific and technical assessment which includes developing 
a ``Criteria Document'' reflecting the latest scientific knowledge on 
the kind and extent of all identifiable effects of the pollutant on 
public health or welfare. This Criteria Document draws entirely on the 
research conducted by the scientific community and published in the 
peer-reviewed scientific literature. Building on the evaluation of this 
literature in the Criteria Document is a further detailed scientific 
and technical assessment, known as a ``Staff Paper.'' The Staff Paper 
identifies and evaluates the implications for decisionmaking of the key 
information in the Criteria Document; it also arrays a range of 
alternatives based on the scientific evidence and makes recommendations 
to the Administrator. As discussed below, both of these documents go 
through extensive public and external scientific peer review.
    Criteria Documents are comprehensive assessments that typically 
examine thousands of studies that have been published in peer review 
journals. Teams of scientific experts both within and outside EPA 
prepare draft chapters of a Criteria Document based on exhaustive 
reviews of the relevant scientific literature. The EPA then holds a 
series of national and international peer review workshops at which 
other scientific experts review the draft chapters and suggest 
appropriate revisions. Once the entire document has been completed in 
draft form, it is further reviewed by the public and by CASAC. 
Established by Congress specifically to advise EPA on review and 
revision of NAAQS, the CASAC is a panel of independent science experts 
external to EPA. During the review for each air pollutant, the CASAC 
panel is augmented with additional scientific and technical consultants 
who have expertise related to that pollutant and its effects. In total, 
there were 21 scientists and technical experts from academia, research 
institutes, public health organizations and industry who were on the 
CASAC review panel for the particulate matter Criteria Document and 
Staff Paper and 16 who were on the CASAC review panel for the ozone 
Criteria Document and Staff Paper.
    The CASAC panel reviews the draft Criteria Document and the key 
underlying studies and makes recommendations for revisions to the 
Criteria Document. Scientists and other representatives from industry, 
State and local agencies, and members of the public also submit 
extensive comments on the draft Criteria Documents. EPA revises the 
document and submits it for another review by the CASAC and the public. 
This process is often repeated two or three times until the CASAC sends 
EPA what is known as a ``closure'' letter, indicating that the Criteria 
Document provides an adequate basis for a decision on whether or not a 
given standard should be revised.
    Staff Papers identify the most policy-relevant information 
contained in the Criteria Document and the critical elements that the 
EPA staff believes should be considered in the review of the standards. 
The Staff Paper typically includes quantitative exposure and risk 
analyses. This document also includes staff recommendations of ranges 
of alternative standards that the staff believes should be considered 
in any Agency decision on revising a standard. Like the Criteria 
Document, this draft Staff Paper is subject to review by the public and 
the CASAC panel. And like the Criteria Document, the Staff Paper often 
undergoes two or more reviews--where the scientific panel recommends 
changes and EPA responds to those recommendations--before the CASAC 
issues a letter of ``closure'' on it as well. At that point the Staff 
Paper, along with the Criteria Document, is used as the basis for 
Agency decisions as to whether it is appropriate to propose any 
revisions to the standards. Scientists from other Federal agencies also 
provide review and comment to EPA prior to the publication of proposed 
decisions.
    During the public comment period on the proposed decisions, the 
scientific community as well as private citizens and other affected 
groups, such as members of industry and State and local regulatory 
agencies, have the opportunity to provide EPA with their views on the 
proposal. EPA has gone to unprecedented lengths to encourage and 
facilitate comments through numerous public meetings and hearings, 
national satellite broadcasts, and toll-free telephone hotlines and 
special E-mail addresses. EPA reviews and considers comments from the 
scientific community and the public before reaching a final decision. A 
notice of the final decision is then prepared.

    Question 15. EPA received an appropriation [of] $18.8 million for 
PM research. What is the status of that research?
    Answer. Using 1997 PM research resources (a total of $19,051,400 
and 89.0 work years), EPA is continuing and expanding efforts to:
     ``understand the potential health effects associated with 
fine PM;''
     focus on field studies and methods used to better 
characterize the airborne fine particles people are exposed to in major 
regions of the country and produce the means to model and measure them;
     analyze new statistical and epidemiological PM studies to 
determine their relevance to the PM NAAQS, which will either facilitate 
application of the current PM NAAQS or improve the data base for the 
next PM NAAQS update;
     allow for accurate estimates of emission rates from 
fugitive, stationary, and mobile sources by understanding the specific 
composition of the constituents emitted and improving techniques to 
prevent or capture particles of all sizes, which will allow for 
successful implementation of current and future PM NAAQS; and
     provide consultation and support so risk assessments by 
state, Regional, and international air pollution control offices will 
be done with less uncertainty.

    Question 16. Seventeen of the 21 CASAC PM panel members voted to 
``close'' on the PM Staff Paper. Has CASAC used this term consistently 
throughout its history of reviewing NAAQS? What is the accepted meaning 
of the term closure? In addition, the panel voted strongly in support 
of establishing a standard to control PM2.5. Is it unusual 
for CASAC to call for more research? Is this call for more research 
inconsistent with CASAC's advise to establish a PM2.5 
standard? Does EPA need more time to conduct further research before 
setting new standards?
    Answer. In a report of the CASAC (``Setting Ambient Air Quality 
Standards: Improving the Process,'' September 1981), the Criteria 
Document closure process was described:
    Closure represents a sense of the committee determination upon the 
scientific adequacy of a Criteria Document for regulatory purposes at a 
specific point in time, based upon the information currently available. 
Closure is intended to supplement other forms of channeling advice such 
as transcripts, individual notes, and official committee minutes. The 
overall purpose of closure, therefore, is to ensure that the committee 
has given explicit written advice concerning a Criteria Document so 
that in the future the committee's position will not be misunderstood. 
Embodied within the concept of closure is that, when necessary, 
individual committee members can submit written minority reports if 
they disagree with all or part of the full committee report. A sense of 
the committee report would be signed by the chairman.
    With specific regard to the particulate matter review, the closure 
letter to the Administrator for the PM Staff Paper, dated June 13, 
1996, noted that although our understanding of the health effects of PM 
is far from complete, the Staff Paper provides ``an adequate summary of 
our present understanding of the scientific basis for making regulatory 
decisions concerning PM standards.''
    When CASAC reviewed the Staff Paper, 19 out of 21 panel members 
recommended establishment of new standards (daily and/or annual) for 
PM2.5. They also agreed with the retention of the current 
annual PM10 standards and consideration of retention of the 
24-hour PM10 standard in a more stable form. The EPA's 
proposal to add new standards for PM2.5, based on public 
health considerations, is consistent with the advice of the CASAC 
scientists.
    There is no inconsistency in recommending action to protect public 
health in light of the most recent comprehensive assessment of the 
available scientific information, while at the same time calling for 
substantial resources to improve our scientific understanding for 
future reviews. It indeed has been the practice of the CASAC and the 
Agency to develop research needs at the conclusion of each criteria and 
standards review. This responsible public health policy and research 
approach flows directly from the requirements of the Clean Air Act. The 
Act directs EPA to establish standards that protect public health with 
an adequate margin of safety, based on the most recent scientific 
criteria. These criteria are to address air pollution that ``may 
reasonably be anticipated to endanger public health.'' Yet the Act also 
requires that the criteria and standards be reviewed every 5 years. If 
Congress intended that standards be established only after all 
appropriate scientific research had been completed and all significant 
uncertainties addressed, there would be no need for these periodic 
reviews to update the science.
    In the case of particulate matter, the Administrator has responded 
to the health risks revealed in the most recent scientific assessment 
by proposing new standards for fine particles, while pursuing a 
vigorous research program to reduce the scientific uncertainties. She 
believes that this reflects a prudent and responsible public health 
policy that is soundly based on the available scientific information. 
This approach is strongly supported by the Agency's science advisors. 
Clearly the strongest consensus from the CASAC was in their near-
unanimous support for maintaining PM10 standards and 
establishing new standards for PM2.5, and for mounting a 
comprehensive research program to improve our scientific understanding 
of the key issues.
    It will take several years to put an implementation program in 
place for any new standards. The effort to conduct monitoring and 
develop control programs will undoubtably reveal additional scientific 
and technical information needs. The research done over the next few 
years could be of significant benefit in improving these ongoing 
programs, as well as improving the quality of the next criteria and 
standards review. A delay in establishing these standards would add 
several years to the time when significant health benefits can be 
realized, resulting in potentially tens of thousands of additional 
premature deaths and even larger numbers of individuals with air 
pollution related illness and symptoms.

    Question 17. What is the division of costs between State and 
Federal Government and private industry?
    Answer. Governmental costs were not separately estimated in EPA's 
Regulatory Impact Analyses (RIAs). EPA believes, however, that it is 
reasonable to expect that the share of control costs borne by private 
industry will be considerably larger than those borne by the state and 
Federal Governments. Administrative costs were not assessed in the 
initial RIAs, and thus, a detailed breakout of these costs is not 
available. Administrative costs, however, are expected to be only a 
small fraction of total implementation costs. Administrative cost 
estimates will be provided in the revised RIAs to be completed in July 
1997.

    Question 18. Did EPA consider the benefits associated with any 
reduction in health care costs as a result of implementation of the 
proposed standards?
    Answer. No. Costs and monetized benefits are not considered by EPA 
in developing the proposed primary standards. The EPA based its 
proposed decisions on the ozone and particulate matter standards on a 
thorough review, in the Criteria Document, of the latest scientific 
information on known and potential human health effects associated with 
exposure to these pollutants at levels typically found in the ambient 
air. These decisions also take into account the Staff Paper 
assessments, including risk and exposure analyses, CASAC advice and 
recommendations, and public comments received during the development of 
these documents. In general, the best scientific studies for these 
pollutants presented health benefits in terms of the effects 
themselves, and not on health costs avoided.
    However, pursuant to Executive Order 12866, the Agency performed 
Regulatory Impact Analyses (RIA) which calculated the health benefits 
associated with the proposed standards. Numerous health benefit 
categories were quantified in the RIA including health care cost 
savings from reduced hospital admissions.
                                 ______
                                 
    Responses by Carol Browner to Additional Questions from Senator 
                               Lieberman
    Question 1. What is your basis for selecting the levels for the 
particulate matter daily and annual proposed standards?
    Answer. In developing proposed PM2.5 standards, the 
Administrator believed that the suite of standards could be most 
effectively and efficiently defined by treating the annual standard as 
the generally controlling standard for lowering both short- and long-
term PM2.5 concentrations. Therefore the full range of 
short- and long-term community epidemiological studies of the health 
effects of particulate matter were considered in developing the 
proposed annual standard. Of the more than 80 such studies identified 
in the Criteria Document and Staff Paper, the Administrator placed 
greatest weight on those epidemiological studies reporting associations 
between health effects and direct measures of fine particles, most 
notably those recent studies conducted in North America. As noted in 
the preamble (61 FR 65660), the studies most directly useful in 
selecting the levels of the annual and 24-hour standards are summarized 
in Tables V-12 and V-13 of the Staff Paper (attached). Not only were 
all of these studies subjected to peer review in the scientific 
literature, but EPA's assessments of these studies in the Criteria 
Document and Staff Paper were also subjected to additional expert peer 
review by CASAC as well as public review.
    The proposed level of 15 g/m3 for the annual 
PM2.5 standard reflects primarily (1) the evidence from 
studies in which fine particles were directly measured showing serious 
health effects at levels below those allowed by the current standard; 
(2) the recognition that while no thresholds have been discerned, 
uncertainties in the evidence of effects increase markedly as the PM 
concentrations decrease; (3) the annual mean concentrations in cities 
in which serious health effects are associated with short-term 
exposures range from about 16 to 21 g/m3; and (4) 
the annual means in cities in which serious health effects are 
associated with long-term exposures, which in one study average about 
18 g/m3, with increased risk being suggested by the 
data at annual means of about 15 g/m3.
    Consistent with the rationale outlined above, the proposed 24-hour 
standard is intended as a ``backstop'' to protect against extremely 
high peak days, localized ``hot spots,'' and risks arising from 
seasonal emissions not adequately controlled by an annual standard. The 
proposed level of 50 g/m3 for the 24-hour 
PM2.5 standard reflects primarily (1) consideration of the 
combined effects of both PM2.5 standards; (2) the importance 
of protecting against peak short-term exposures that might not be 
controlled by the proposed annual standard; and (3) 24-hour 
concentrations (98th percentile values) in cities in which serious 
health effects are associated with short-term exposures to fine 
particles range from about 35 to 90 g/m3, with most 
above 40 to 50 g/m3.

    Question 2. What is your basis for selecting an ozone standard at 
0.08 ppm with three exceedances, rather than a 0.07 or 0.09 ppm 
standard?
    Answer. Taken as a whole, the scientific evidence evaluated in the 
EPA's Criteria Document and summarized in the Staff Paper indicates 
that, at levels below the current standard, O3 affects not 
only people with impaired respiratory systems, such as asthmatics, but 
healthy children and adults as well. The consensus of the CASAC Panel 
was that these documents provide an adequate scientific basis for 
making regulatory decisions on the standard.
    The key controlled human exposure studies identified in this review 
showed that some moderately exercising healthy individuals exposed for 
6 to 8 hours at O3 levels as low as 0.08 ppm experienced 
transient health effects such as decreased lung function as measured by 
FEV1, respiratory symptoms, and lung inflammation; and lead 
to concern that these exposures when repeated can lead to long term 
effects. Summer camp studies also provide extensive and reliable 
evidence of decreased lung function as measured by FEV1 in 
children and adolescents engaged in typical outdoor activities. Other 
recent studies provide evidence of an association between elevated 
O3 levels and increases in hospital admissions and emergency 
room visits, which signal significantly larger increases in doctor's 
visits, school absences, and lost work days. Further, animal studies 
demonstrate impairment of lung defense mechanisms and suggest that 
repeated exposure to O3 over time might lead to permanent 
structural damage in the lungs, though these effects have not been 
corroborated in humans.
    Based on this evidence, the CASAC Panel was in unanimous agreement 
that the present 1-hour standard should be eliminated and replaced with 
an 8-hour standard to focus on those exposures that are of most 
concern. The CASAC Panel also viewed as appropriate the range of 8-hour 
average concentrations (0.07 to 0.09 ppm) that EPA recommended for 
consideration. Further, the CASAC panel favored changing the form of 
the standard to one that allowed for multiple exceedances. Thus, 
CASAC's evaluation of the evidence is consistent with that of EPA, 
namely that all three major elements of the current O3 
standard should be revised, including the averaging time, the level, 
and the form.
    In reaching a decision on the specific level and form for an 8-hour 
standard, EPA considered a number of complex public health factors. The 
quantitative assessments of exposures to levels of concern and of the 
risk of experiencing various effects indicated differences in public 
health protection among the various levels and forms considered, but 
they did not by themselves provide a clear break point for a decision. 
The quantitative assessments do, however, indicate that, under EPA's 
proposed standard, there will be hundreds of thousands of times when 
children will experience fewer incidences of significant decreases in 
lung function and aggravated respiratory symptoms.
    Also, consistent with EPA's prior decisions over the years, when 
setting an air quality standard for a pollutant for which there is no 
discernible threshold, factors such as the nature and severity of the 
health effects involved, and the nature and size of the at-risk 
populations exposed are important considerations. Thus, EPA paid 
particular attention to the health-based concerns reflected in the 
independent scientific advice. The Administrator also gave significant 
consideration to the advice of the human health professionals on the 
CASAC Panel. Of the four human health experts on the CASAC Panel, three 
favored a level of 0.08 ppm and the other favored a level of either 
0.08 or 0.09 ppm. No Panel member favored a standard level of 0.07 ppm; 
three others favored 0.09 ppm, and one favored either 0.09 or 0.10 ppm 
combined with new public health advisories when O3 
concentrations are at or above 0.07 ppm. Thus, the proposed level of 
0.08 ppm reflects the lowest level recommended by individual CASAC 
members; it also reflects the Administrator's consideration of the 
recommendations of the human health experts on the CASAC Panel; and it 
is the lowest level tested and shown to cause adverse health effects in 
controlled human-exposure health studies.
    Finally, given the uncertainties associated with this kind of 
complex health decision, EPA has also looked at the reduction in people 
exposed to ozone concentrations that are above the highest level 
recommended by any member of the CASAC panel (i.e., 0.09 ppm). Recent 
air quality data indicate that meeting a 0.08 ppm third-highest 
concentration standard (as proposed by EPA) would result in all but 1 
percent of areas avoiding days with peak 8-hour concentrations above 
the 0.09 ppm level. By comparison, a standard set at the upper end of 
the range of concentrations (5th highest) would result in 17 percent of 
areas exceeding the 0.09 level.

    Question 3. EPA's Regulatory Impact Analysis (RIA) for ozone 
included only the most rudimentary treatment of innovative regional and 
market-based strategies that likely would provide cost-effective 
approaches to meet the new standard. For particulate matter the RIA did 
not include any of these flexible approaches. Were the results of the 
Ozone Transport Commission included in the ozone RIA? Why weren't these 
types of innovative strategies considered to a greater extent in the 
RIAs for both pollutants?
    Answer. The November 1996 ozone and particulate matter RIAs 
provided a limited assessment of regional and market-based strategies. 
The ozone RIA assessed the impacts associated with a regional 
NOx cap on utility and large industrial boiler emissions as 
well as a national low emission vehicle program. This strategy was 
originally proposed by the Ozone Transport Commission. It was employed 
in the ozone RIA on a broad geographic scale as a reasonable proxy for 
a future regional NOx implementation strategy. The 
particulate matter RIA assessed the impact of a regional SOx 
cap strategy, but only in a sensitivity analysis.
    A more complete assessment of regional and market-based strategies 
was not performed because of uncertainties regarding the specific 
implementation strategies that may be employed to attain the proposed 
new standards and because of modeling limitations. It should be noted, 
however, that even under the current standards, the Agency has begun to 
emphasize strategies that use the marketplace to reduce costs, that 
utilize national strategies where they make sense, and that look to 
regional and other cooperative approaches, so as to maximize 
efficiencies and minimize costs throughout the air quality management 
system. Specific to the new standards, EPA has established a formal 
advisory subcommittee under the Federal Advisory Committee Act to 
develop innovative, flexible, practical and cost-effective 
implementation strategies. This FACA Subcommittee operates under the 
CAAAC, EPA will consider any recommendations received through this 
process in proposing specific implementation strategies. Future RIAs 
will assess these proposed regional and market-based strategies in 
detail. To the extent that more cost-effective implementation 
strategies will be identified, the cost estimates for partial 
attainment presented in the November 1996 ozone and PM RIAs may be 
overstated.
    Question 4. One concern that has been expressed is that 
implementing a proposed new ozone standard could have a negative effect 
on making progress under the Clean Air Act. In other words, some 
contend that the current structure may be thrown into some disarray 
because areas will spend time planning rather than accomplishing 
emission reductions. What is your reaction to these concerns? Will any 
of the work now being done by the Ozone Transport Commission on 
developing region-wide strategies to control pollution be put on hold 
by the new standards?
    Answer. The Administrator shares the concerns that we not sacrifice 
continued progress in reducing ozone as we move forward to implement 
any new standards. It is for this reason that EPA has conditioned the 
revocation of the current ozone standard for an existing nonattainment 
area on its determination that each State Implementation Plan provides 
for the achievement of a new standard. In addition, EPA has proposed a 
policy to ensure that the progress made in the current program 
continues until the effective date of EPA approval of an area's SIP to 
attain the new NAAQS. The efforts currently underway throughout the 
country, including in the OTC and the Ozone Transport Assessment Group 
(OTAG), to achieve the current ozone standard support achievement of 
the proposed standard. Therefore, there is no reason for delays in 
implementing the measures already planned by States or measures that 
will be identified shortly through the OTAG work. The OTAG will be 
recommending regional control strategies in the next few months. In 
order to support OTAG and ensure the necessary regional reductions will 
be implemented, EPA intends to issue SIP calls within a specified 
timeframe to the relevant States. These actions will ensure that we 
continue to make progress in cleaning the air as we move forward in 
developing implementation strategies for any new standards. In fact, 
the regional emission reductions will pay benefits in terms of improved 
air quality to many local areas and may be the only reductions they 
need to achieve the proposed standards.

    Question 5. Is your decision to set PM2.5 standards 
inconsistent with the need for further research in the area of health 
effects of particulate matter and with EPA's research agenda in this 
area?
    Answer. Taking action to protect public health in light of the most 
recent scientific information available is not inconsistent with 
earmarking substantial resources to improve our scientific 
understanding for future reviews. Indeed, this responsible public 
health policy and research approach flows directly from the 
requirements of the Clean Air Act. The Act directs EPA to establish 
standards that protect public health with an adequate margin of safety, 
based on the most recent scientific criteria. These criteria address 
air pollution that ``may reasonably be anticipated to endanger public 
health.'' Yet the Act also requires that the criteria and standards be 
reviewed every 5 years. If Congress intended that standards should only 
be established after all appropriate scientific research had been 
completed and all significant uncertainties addressed, there would be 
no need for these periodic reviews to update the science.
    In the case of particulate matter, the Administrator has responded 
to the health risks revealed in the most recent scientific assessment 
by recommended establishing new standards for fine particles, while 
pursuing a vigorous research program to reduce the scientific 
uncertainties. She believes that this reflects a prudent and 
responsible public health policy that is soundly based on the available 
scientific information. This approach is strongly supported by the 
Agency's science advisors. Clearly the strongest consensus from the 
CASAC was in support of maintaining PM10 standards and 
establishing new standards for PM2.5 and for mounting a 
comprehensive research program.
    While the research done over the next few years will improve the 
quality of the next criteria and standards review, a delay in 
establishing new standards would add several years to the time when 
significant health benefits can be realized, resulting in potentially 
tens of thousands of additional premature deaths and even larger 
numbers of individuals with air pollution related illness and symptoms. 
EPA believes that moving simultaneously on both health protection and 
research is the most appropriate approach, one that is consistent with 
both the philosophy and practice of establishing ambient standards 
under the Clean Air Act.

    Question 6. In our last hearing, we heard testimony suggesting that 
EPA should first identify the component of particulate matter that is 
causing the problem before proposing a new standard for fine 
particulates. Some witnesses suggested that we might pursue the wrong 
control strategies if we do not wait for this information. Please 
comment on these concerns.
    Answer. The question of which pollutant components to regulate has 
been a significant concern for particulate matter since the inception 
of the first particulate matter controls. Other ambient pollutants 
(e.g., nitrogen dioxide or carbon monoxide) are uniquely defined as 
individual chemicals, whether or not they serve as proxies for a larger 
class of substances (e.g., ozone as an index of photochemical 
oxidants). The act of defining general particulate matter as a 
regulated pollutant raises the spectrum of a host of particulate 
materials of varying composition, size, and other physicochemical 
properties, not all of which are likely to produce identical effects.
    Nevertheless, both our past and present regulatory experience with 
particulate matter controls and each successive review of the standards 
has resulted in a reaffirmation of the appropriateness of retaining 
standards that control particles as a group, rather than eliminating 
such standards and waiting for scientific research to develop 
information needed to identify more precise limits for the literally 
thousands of particle components that might or might not be responsible 
for observed health effects. Each such decision recognized the 
possibility that potentially less harmful particles might be included 
in the mix that was regulated, but concluded that the known or 
anticipated health and environmental benefits of controlling general 
particles was of paramount concern.
    The governmental response to one of the first great air pollution 
disasters, the 1952 London episode, is instructive. Although scientists 
did not (and still do not) know the mechanisms by which thousands of 
individuals died nor which particulate and gaseous pollutants were most 
likely responsible, a program to reduce the use of ``smoky'' coal was 
instituted that, by all accounts, was a success in greatly reducing the 
impact of air pollution on health. The government also embarked on 
research to study these effects, which ultimately revealed that effects 
could occur at much lower concentrations.
    These British studies formed the principal basis of the original 
U.S. particulate matter standards. Each CASAC review of these standards 
(Friedlander, 1982; Lippmann, 1986; Wolff, 1996) has recognized the 
continued need to control ``general'' particulate matter. The major 
refinements that have been recommended through the course of these 
reviews have been to improve the measurement of particulate matter by 
defining scientifically based size classes (i.e., moving from TSP to 
PM10 and PM2.5) that permit more effective and 
efficient regulation of those fractions most likely to present 
significant risks to health and the environment.
    During the most recent review, EPA examined the available data to 
determine whether the available evidence would tend to support 
inclusion or exclusion of any other physical or chemical classes of 
particulate matter, for example sulfates, nitrates, or ultra-fine 
particles. This review concluded, with CASAC agreement, that the 
available data continue to support the retention of PM10 as 
a measure of particulate matter. Further, based on an examination of 
the risk posed by the components of PM10, the Criteria 
Document concluded it would be most appropriate to ``consider fine and 
coarse mode particles as separate subclasses of pollutants.'' (U.S. 
EPA, 1996a, p. 13-94). The examination of component classes found that, 
while both fine and coarse particles can produce health effects, the 
fine fraction appears to contain more of the substances potentially 
linked to the kinds of effects observed in the recent epidemiological 
studies. However, the available scientific information does not rule 
out any one of these components as contributing to fine particle 
effects. Indeed, it is reasonable to anticipate that no single 
component will prove to be responsible for all of the effects of 
particulate matter. The consistent epidemiological findings across 
geographical areas (and particulate composition) supports this view. 
Nineteen of twenty-one CASAC members agreed with the EPA staff 
recommendation to add standards for PM2.5 as a separate 
pollutant class.
    Whether the standards are set for PM10 only or also 
include PM2.5, there are unavoidable uncertainties at 
present with respect to the relative risk presented by various 
components of particulate matter. In this regard, the Administrator 
places greater weight on the concern that by failing to act now, we 
would not be controlling adequately those components of air pollution 
that are responsible for adverse effects than on the possibility we 
might also be controlling some component that may not be related to 
such effects. PM2.5 encompasses all of the potential agents 
of concern in the fine fraction, including sulfates, acids, transition 
metals, organics, and ultrafine particles, and includes most of the 
aggregate surface area and particle number in the entire distribution 
of atmospheric particles. Subject to consideration of public comments, 
the Administrator believes that movement to develop control programs 
for fine particles at this time would clearly serve to reduce the risk 
of those particle components most likely to present significant health 
risks.

    Question 7. Please discuss the activities of the Federal advisory 
committee that is helping EPA devise cost-effective ways to implement 
the proposed standards. Is the committee considering market-based 
solutions where appropriate?
    Answer. The FACA Subcommittee for the Integrated Implementation of 
the Ozone and PM NAAQS and the Regional Haze Program was established in 
September 1995. Since that time the Subcommittee has held public 
meetings approximately every 2 months. There are six workgroups under 
the Subcommittee which meet on a more frequent basis. The Subcommittee 
currently consists of about 75 members and is intended to have balanced 
representation from State and local agencies, tribal organizations, 
environmental groups, industry, lawyers/consultants, scientific/
academic institutions and other Federal agencies. EPA recently took 
steps to increase the membership of the Subcommittee with particular 
emphasis on adding additional representatives from small businesses.
    The EPA's charge to the Subcommittee was to address innovative, 
cost effective, and creative approaches when making recommendations on 
ways to implement new/revised ozone and PM NAAQS. While costs are not 
considered in the standard setting process, they are being examined in 
the development of programs to implement new or revised standards. In 
the development of these programs, control strategies can be harmonized 
to take advantage of multi-pollutant control technologies as well as 
the efficiency of implementing all necessary controls at one time. 
Additionally, the Subcommittee is examining market-based emissions 
trading and other economic incentive approaches for achieving emission 
reductions at a lower overall cost to the economy. These approaches are 
currently being discussed by the Subcommittee as part of the Phase II 
strategy in the coming year. Phase II of the implementation strategy, 
which will address control strategies, including market-based programs 
and economic incentives, is currently scheduled for proposal in mid-
1998.

    Question 8. Another concern that has been expressed about the new 
PM2.5 standard and the change in the form of the 
PM10 standard is that some of the control strategies 
implemented for PM10 during the last several years will be 
wasted. What is your response to this criticism?
    Answer. The EPA is soliciting public comment on whether to revise 
the form of the PM10 standard to a more robust form, as 
recommended by EPA staff and some CASAC members. If the Administrator 
were ultimately to choose that course, we do not believe that actions 
taken to date to implement the current standard would be wasted. EPA's 
current proposal continues the evolution of PM regulation toward more 
effective and efficient protection of public health. As noted in the 
response to Question 6 above, the last time PM standards were revised, 
in 1987, EPA replaced its PM standards measured in terms of ``total 
suspended particulate matter'' (TSP) with PM10 standards 
that excluded particles larger than 10 micrometers. This change 
improved health protection afforded by PM standards, but did not 
invalidate the benefits afforded by implementing the previous TSP 
standards. Indeed, EPA's recent draft study of costs and benefits of 
the Clean Air Act found billions of dollars of benefits from 
implementing the former TSP standards. Similarly, EPA believes the 
addition of PM2.5 standards will increase the overall health 
and welfare protection provided by the particulate matter standards 
with respect to fine particles. In this case, however, EPA and CASAC 
both concluded that control of larger PM10 particles (termed 
``coarse fraction particles'') should continue and remains essential to 
protecting public health.
    The nature of the controls needed to meet PM10 and 
PM2.5 standards varies from region to region. For many non-
attainment areas in California and the Pacific Northwest, for example, 
the PM10 standards have prompted significant fine particle 
control by addressing woodsmoke and photochemically derived particles 
that are significant contributors to PM10. Clearly, such 
controls would continue to be needed under the proposed new 
PM2.5 standards. In a number of areas, control of industrial 
sources to meet the PM10 standards have reduced both fine 
and coarse particles and would continue. Under EPA's proposed 
revisions, the need for additional controls in some areas significantly 
affected by short-term excursions of naturally derived coarse particles 
(e.g., unpaved roads, dust storms) could be reduced, consistent with 
EPA's assessment of the health effects evidence. EPA believes, however, 
that the vast majority of controls put into place under the current 
PM10 standards have produced significant public health and 
welfare benefits, and would continue to do so under the proposed shift 
toward fine particle standards. EPA believes that the proposed revised 
standards will, however, provide significant additional benefits by 
focusing additional controls on fine particles that are the source of 
significant PM exposures in large regions of the Eastern U.S. that are 
attaining the current standards.
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 Responses by Carol Browner to Additional Questions from Senator Boxer
    Question 1. As you may know, last Congress I introduced a bill 
entitled The Children's Environmental Protection Act. Among other 
things, my legislation would require EPA to set all health and safety 
standards at levels that protect our children and other sensitive 
subpopulations. Last September you announced that the Clinton 
Administration shared this goal and I am pleased that in announcing 
these proposed standards, and in your testimony, you indicated that 
these standards are intended to accomplish this goal.
    Do you believe that you could make a decision to promulgate air 
quality standards equivalent to current standards which still meet the 
goals of protecting children and sensitive subpopulations?
    Answer. Based on the record before the Agency at the time of 
proposal, including the advice and recommendations of the CASAC panels, 
the Administrator concluded--subject to further consideration based on 
public comments--that the proposed standards were requisite to protect 
the public health, including sensitive populations, with an adequate 
margin of safety. Given the at risk populations affected by these 
pollutants--children, asthmatics, the elderly--as well as possible 
effects on outdoor workers and other healthy adults, it was the 
Administrator's judgment that it was appropriate to propose standards 
that tended to fall in the lower end of the range of protection 
supported by my independent science advisors and recommended by experts 
in my technical offices.
    Specifically, with regard to particulate matter, because of the 
consistency and coherence across the large number of epidemiological 
studies conducted in many different locations, the seriousness and 
magnitude of the health risks, and the fundamental differences between 
``fine'' and ``coarse'' fraction particles, the CASAC scientists and 
the Agency clearly believed that ``no action'' was an inappropriate 
response to protect children, asthmatics, and the elderly.
    With regard to ozone, the decision to propose the 0.08 ppm ozone 
standard with a 3rd-highest daily maximum 8-hour average (averaged over 
a 3-year period) was based upon the scientific information contained in 
the ozone Criteria Document, the analyses and staff recommendations in 
the ozone Staff Paper, and the scientific discussions and advice of the 
CASAC. The CASAC members unanimously recognized the need for replacing 
the current 1-hour standard with an 8-hour standard, and eight members 
offered personal views as to the appropriate level of an 8-hour 
standard. Of the four human health experts on the CASAC Panel, three 
favored a level of 0.08 ppm and the other favored a level of either 
0.08 or 0.09 ppm. No Panel member favored a standard level of 0.07 ppm; 
three others favored 0.09 ppm, and one favored either 0.09 or 0.10 ppm 
combined with new public health advisories when O3 
concentrations are at or above 0.07 ppm.
    In 1989, when the CASAC chairman wrote to the Administrator about 
the scientific basis for the current ozone primary standard, it was 
recognized that maintaining the 1-hour standard at 0.12 ppm would 
provide ``little or no margin of safety.'' Since 1989, numerous new 
scientific investigations have demonstrated health effects associated 
with longer-term averaging times at levels as low as 0.08 ppm.
    Weighing all of this information and the staff and CASAC 
recommendations in the context of the analyses conducted to assess the 
health risks to sensitive subpopulations, the EPA chose the proposed 
standard as providing better protection than an 8-hour standard of 0.09 
ppm, which by some metrics would be approximately equivalent to the 
current 1-hour standard.

    Question 2. Do you believe that the current research and data 
regarding the impact of air pollution on children understates the 
impact on children? Please explain.
    Answer. Perhaps. Many of the health endpoints (e.g., lung 
inflammation, airway reactivity, childhood asthma) which have been 
reported in current human health studies have not been analyzed in 
terms of public health risk associated with exposure to ambient ozone 
levels. There are also numerous health endpoints (e.g., accelerated 
aging of lung tissue, lung scar tissue, increased susceptibility to 
respiratory infection) which have been observed in animal toxicology 
studies but have not yet been fully extrapolated to human health 
effects data due to differences in species sensitivity and dosimetry. 
For example, there is a lack of adequate information on the possibility 
that repeated airway inflammation in children could lead to later 
development of chronic respiratory disease and impaired development of 
lung tissue. All of these limitations could contribute to understating 
the impact of ambient ozone exposures on children.

    Question 3. Some have suggested delaying one of the two standards. 
Aren't the strategies for compliance with the ozone and particulate 
matter standards similar? Therefore, isn't it more economically 
efficient to promulgate the rules simultaneously?
    Answer. In its proposal, EPA concluded that the effects and control 
of each are in many instances linked and will be affected by the other. 
For this reason, EPA stated in the proposal its intent to review and, 
as appropriate, modify both standards on a similar schedule. First, the 
same atmospheric chemical processes form both pollutants. Many of the 
atmospheric chemical reactions which form ozone are also responsible 
for production of PM2.5. Second, many of the precursors for 
ozone and PM2.5 come from common sources. For example, 
nitrogen oxides from fossil fuel fired power plants are ozone 
precursors. These same power plants also emit sulfur dioxide which is a 
PM2.5 precursor. Control decisions affecting any power plant 
would be more efficient if they are made with a full appreciation of 
all the obligations the plant may be facing as opposed to a piecemeal 
approach. Finally, the Regional Haze Program will benefit from the 
joint implementation of the PM2.5 and ozone NAAQS because, 
again, many of the ozone and PM2.5 precursors are primary 
causes of visibility impairment.
                                 ______
                                 
    Responses by Carol Browner to Additional Questions from Senator 
                               Lautenberg
    Question 1. I understand that EPA estimates children will 
experience 1.5 to 2 million fewer incidents of significant decreases in 
lung under the new standards for ozone. Why are children affected by 
ozone more than adults, and is there any data that indicates whether 
these affected children experience any problems in later life as a 
result of decreased lung function in childhood?
    Answer. Exposure analyses indicate that during the summertime when 
ozone levels are higher, children spend more time outdoors engaged in 
active behaviors which increase total ozone breathed and resulting 
health impacts. Because children often do not experience ozone-induced 
respiratory symptoms (e.g., cough, chest pain), which act as early 
warning signals, they may continue to play outdoors even when ambient 
ozone levels are higher and may cause adverse health effects. Although 
children will experience reductions in FEV1 (reduced lung 
function) when exposed to higher ambient ozone concentrations, these 
effects tend to be transient and are not believed to cause problems 
later in life. However, health effects such as repeated lung 
inflammation, centriacinar lesions, and lung tissue damage may result 
in problems as children grow older. When repeated over a season or over 
many seasons, these effects may lead to irreversible damage and/or 
accelerated aging of the lungs, and may limit full development of lung 
tissue. Such effects have been observed in controlled-exposure animal 
toxicology studies but have not been confirmed to date in human health 
effects studies.

    Question 2. One of the benefits of the tighter ozone standard which 
the Regulatory Impact Analysis didn't consider is the reduction of 
toxic air pollution. The Clean Air Act has led to a significant 
reduction in certain cancer-causing chemicals, known as Volatile 
Organic Compounds. For example, benzene has been reduced by 30 percent. 
Under your proposed new standard, do you agree that these types of 
carcinogens would be further reduced? Shouldn't that reduction have 
been included in the cost-benefit analysis performed as part of the 
Regulatory Impact Analysis?
    Answer. Various benefit categories associated with the newly 
proposed ozone standard could not be monetized in the November 1996 
Regulatory Impact Analysis (RIA). One example is the benefits 
associated with reductions of toxic air pollutants beyond those that 
occur as a result of existing requirements. Reductions in ambient ozone 
concentrations are achieved through reductions in emissions of volatile 
organic compounds (VOCs) and/or reductions in nitrogen oxides. In 
addition to contributing to ozone formation, some VOCs are carcinogens 
or can potentially cause a wide range of adverse health effects. In 
addition, the same types of chemical reactions in the atmosphere that 
create ozone can also create toxic air pollutants. The benefits 
associated with reduced cancer and other health impacts from air 
toxics, however, could not be monetized in the RIA because of data and 
time limitations.
    Numerous other benefit categories, such as reduced nitrogen 
deposition in estuaries, reduced damage to urban ornamentals, reduced 
lung function effects, etc. could not be monetized in the November 1996 
RIA. Also, the benefits of particulate matter reductions accruing from 
controls designed to reduce ozone concentrations could not be assessed. 
Work is underway to monetize and include additional ozone reduction 
benefit categories (including the benefits associated with reductions 
in some toxic air pollutants) in the revised RIA scheduled for 
completion July 1997.

    Question 3. Opponents have claimed that CASAC advisors could not 
agree on the appropriate standards to recommend for clean air. But 
CASAC unanimously supported moving to an 8-hour standard for ozone and 
19 of 21 members supported moving to a fine particle standard for 
particulates. In what areas were there any disagreements among CASAC 
members?
    Answer. CASAC reached consensus that the Staff Papers for both 
ozone and PM provide an adequate summary of our present understanding 
of the scientific basis for making regulatory decisions concerning the 
two standards. With regard to ozone, the CASAC members unanimously 
agreed that the 1-hour primary ozone standard should be replaced with 
an 8-hour standard and that a secondary standard more stringent than 
the current standard was needed to protect vegetation. Furthermore, 
they agreed that the form of the primary standard should be changed 
from the current one-expected-exceedance form to one which allowed for 
multiple exceedances. There was a diversity of personal opinion on the 
appropriate level for the ozone primary standard. Of the four clinical 
human health experts on the panel, three supported a level of 0.08 ppm, 
and one supported a level of either 0.08 or 0.09 ppm. Of the other four 
panel members who offered personal views, three recommended that the 
level be set at 0.09 ppm and one member supported a range from 0.09 to 
0.10 ppm but with public health advisories beginning at 0.07 ppm.
    With regard to PM, there was a clear consensus on CASAC that a new 
PM2.5 standard should be established, with 19 of 21 members 
endorsing the concept of a 24 hour and/or an annual PM2.5 
standard. There was less consensus on specific standard levels among 
members expressing personal opinions on the matter. Eight panel members 
supported staff recommendations for PM2.5 standards, but 
expressed no opinion on selecting specific levels. Of the 11 who 
offered opinions, 6 supported levels within the ranges recommended by 
EPA staff, with the other 5 supporting levels above that range. EPA 
proposed standards that are in the lower to middle part of the range 
recommended by those CASAC members who chose to express their opinions.
    A majority of CASAC members recommended that, while adding the fine 
particle standard, EPA should keep the present PM10 24-hour 
standard at least as an option to be considered. EPA proposed keeping 
that standard, as well as an option that would eliminate it. Those 
CASAC panel members who commented on the issue recommended that EPA 
change the form of the PM10 standard to one that is more 
``robust'' or flexible than the current form; EPA proposed such a form.
    There was also CASAC consensus on the staff's recommendations 
regarding the secondary effects of PM; i.e., that EPA not establish a 
separate national secondary standard for protecting visibility but 
pursue a separate regional haze program, and that there was an 
inadequate basis for establishing a secondary NAAQS to reduce soiling 
and material damage effects.
                                 ______
                                 
 Responses by Carol Browner to Additional Questions from Senator Wyden
    Question 1. After Congress passed the 1990 Clean Air Act, a number 
of areas in Oregon were designated non-attainment and the levels of 
particulate pollution in the Klamath Falls area were among the worst in 
the entire country. Today there is not a single area in Oregon that is 
not meeting air quality standards. As EPA goes forward with 
implementation of its proposals to change the current standards, will 
EPA give any special recognition to the areas--including those in 
Oregon--that have made progress in meeting the current standards? Will 
the areas that have made progress be given greater flexibility, for 
example, in implementing the new standards or will they (be) treated 
the same as other areas that made little or no progress in improving 
their air quality over the last 7 years?
    Answer. EPA is aware of the accomplishments of Oregon nonattainment 
areas in meeting the PM10 NAAQS. In fact, EPA publicly 
acknowledged the specific accomplishments of Klamath Falls in the 
Agency's National Air Quality Emissions Trends Report for 1991. While 
public recognition is important, under the Clean Air Act, the formal 
method for recognition of these accomplishments is to redesignate 
existing nonattainment areas to attainment. Consistent with Clean Air 
Act requirements, EPA is ready to work with Oregon to complete the 
formal process of recognizing these accomplishments by redesignating 
these areas to attainment once such a request is received.
    With respect to the proposed PM2.5 standard, all areas 
of the country would be implementing this new standard for the first 
time. The Agency has proposed an Interim Implementation Policy to deal 
with current PM10 nonattainment areas. Since the Agency is 
proposing to retain a PM10 NAAQS, those areas which did not 
make progress under the current PM10 NAAQS will still be 
obligated to attain the PM10 NAAQS. At the same time, the 
Agency is concerned about implementation of the proposed standards for 
PM2.5 and ozone and has formed the Subcommittee for the 
Integrated Implementation of the Ozone and Particulate Matter NAAQS and 
the Regional Haze Program. This Subcommittee, which was formed under 
the Federal Advisory Committee Act, and has representation from the 
State of Oregon as well as other stakeholders, is charged with 
providing advice and recommendations to the Agency. The emphasis of 
this effort is the development of innovative control strategies to 
achieve maximum flexibility and cost-effectiveness in the attainment of 
the NAAQS and achievement of regional haze requirements. This should 
help all areas of the country attain the proposed PM2.5 
NAAQS in the most cost effective and flexible manner possible.

    Question 2. Shouldn't areas that have data to show that they're 
making progress in meeting the current air quality standards focus 
their resources on meeting the new standards--on actually improving the 
air quality--rather than having to expend resources completing the 
paperwork needed to get officially reclassified as in compliance with 
the 1990 standards? If an area has monitoring data to show it is 
complying with current standards, what can EPA do to maximize the use 
of scarce resources to meet the new standards the Agency is proposing, 
rather than spending time and money on what is essentially a paperwork 
exercise?
    Answer. Actions being taken to achieve the current ozone and PM 
standards are steps in the right direction toward achieving any new 
standards and EPA will continue to push for States and local areas to 
make progress in cleaning their air under the current standards as they 
move forward to implementing new standards. We agree that time should 
not be wasted on unnecessary paperwork but rather on real environmental 
improvements. This is why the Subcommittee on Integrated Implementation 
was initiated to focus on how to streamline and simplify the 
implementation process and the transition to new standards to minimize 
the impact on all parties concerned. The Interim Implementation Policy 
proposed for public comment on December 13 is the first step in this 
process. As we move forward to finalize that policy, we will be trying 
to balance the need for ensuring continued progress and moving to 
implementing new standards. We will keep your specific concerns in mind 
as we finalize this policy.

    Question 3. How does EPA propose to account for regional 
differences in background levels of PM2.5 when establishing 
the annual concentration level for this pollutant and in implementing 
the new standard for this pollutant?
    Answer. In the review, EPA concluded that background concentrations 
vary from the Eastern to the Western U.S. (``Background'' is defined in 
the Staff Paper as the distribution of PM concentrations that would be 
observed in the U.S. in the absence of anthropogenic emissions of PM 
and precursor emissions of VOC, NOx, and SOx in 
North America. Background is thus distinguished from regional 
background, which refers to PM concentrations of both natural and 
anthropogenic sources which may be transported from one region to 
another.) Accordingly, EPA estimated ranges of annual average 
concentrations for natural background PM2.5 in the Eastern 
and Western U.S. of 2-5 g/m3 and 1-4 g/
m3, respectively. (It is important to note that the data 
used to establish the high end of these ranges reflect the estimated 
effects of background and anthropogenic emissions from within North 
America and therefore provide estimates of the upper bounds.) The 
proposed PM2.5 annual standard of 15 g/
m3 is well above these estimated natural background levels.
    With respect to implementation of the standard, background levels 
of PM2.5 are considered in the development of State 
Implementation Plans (SIPs) which are designed to produce attainment of 
the NAAQS. As a part of this planning process, States would explicitly 
include the background concentrations of PM2.5 in their area 
when designing control strategies. This level of background would 
affect the control strategies; e.g., as a general matter, in areas 
where the background is high, the control strategies are more stringent 
than in areas where the background is low. At the same time, if there 
are programs to reduce regional or national background levels, the 
States are allowed to account for this in designing control strategies. 
For example, the implementation of the Acid Deposition Program will 
reduce regional background concentrations of PM2.5. 
Therefore, States are allowed to account for these changes in 
background when they develop their SIP control strategies; i.e., the 
overall effect of the implementation of the Acid Deposition program 
will be to reduce the stringency of State-developed control strategies 
for PM2.5.

    Question 4. You state in your testimony that one of the areas the 
new standards will likely focus on is emissions from power plants. As 
you know, there are currently efforts underway both in Congress and the 
States to restructure the electric power industry. These efforts could 
dramatically transform our nation's electric power system. EPA is 
developing its implementation strategy over the next few months, 
without knowing how electricity restructuring may affect the industry 
in the future. How will EPA's implementation strategy for power plants 
provide flexibility to accommodate the changes that may occur in the 
electric power industry? Will you build in opportunities for periodic 
revisions of the strategy to reflect significant changes in the 
electric power industry and in other industries?
    Answer. The EPA is very aware of current efforts to restructure our 
nation's electric power system. We are already performing sophisticated 
modeling efforts to assess the impact of restructuring on the industry 
and on air quality in the future. Results from these modeling efforts 
will assist us in designing our implementation strategy for attaining 
the newly proposed ozone and particulate matter national ambient air 
quality standards.
    Over the next few years, the Agency will be developing an 
implementation strategy for attaining the new air quality standards. We 
have not yet finalized a strategy for achieving emission reductions 
from power plants. We are seriously exploring, however, a flexible 
market-based emissions trading strategy to achieve the NOx 
and SOx emission reductions (beyond those achieved via Title 
IV, the acid rain program of the Clean Air Act Amendments) needed to 
attain the proposed new standards. Such a strategy would provide 
maximum flexibility to achieve emission reductions at minimum costs and 
to accommodate changes that may occur in the electric power industry in 
the future. To the extent feasible, we will build in flexibility and 
opportunities for implementation program revisions should adjustments 
be required as a result of significant changes in the electric power 
industry.

    Question 5. You state in your testimony that ``sulphur dioxide 
reductions achieved by the acid rain program will greatly help reduce 
levels of fine particulates.'' Can greater use of emissions trading 
under the acid rain program also contribute to a reduction in fine 
particulate pollution and, if so, what will EPA do to increase 
emissions trading to help reduce particulate pollution?
    Answer. Yes, particularly in the Eastern United States, additional 
sulphur dioxide emission reductions achieved through an emissions 
trading program can reduce ambient levels of fine particle 
concentrations significantly. The acid rain trading program has proven 
to be an extremely cost-effective strategy for achieving substantial 
SOx emission reductions and for achieving subsequent fine 
particulate concentration reductions.
    Primarily to reduce fine particle concentrations, EPA has been 
exploring options for expanding the acid rain SOx trading 
program. In particular, through the Agency's Clean Air Power 
Initiative, EPA held a number of meetings with interested stakeholders 
to improve air pollution control efforts involving the power industry. 
Through these meetings, various options for expanding the acid rain 
trading program were developed.
    EPA also has established a formal advisory committee under the 
Federal Advisory Committee Act to develop innovative, flexible, 
practical, and cost-effective implementation strategies to attain the 
new proposed ozone and particulate matter standards. Recently, the 
possibility of expanding the acid rain trading program to help 
attainment of the proposed particulate standard has been an issue of 
discussion among various interest groups represented within this 
committee.
    Finally, the Agency is assessing the costs and benefits associated 
with expanding the acid rain trading program within an updated version 
of the Regulatory Impact Analysis (RIA) for the proposed particulate 
matter standard. The revised RIA will be completed July 1997.
                                 ______
                                 
 Responses by Carol Browner to Additional Questions from Senator Inhofe
    Question 1. Ms. Browner, before the committee you stated that the 
PM studies showed a definite cause and effect. During the previous 
Science hearing the absence of a biological mechanism was verified by 
experts. In the CASAC closure letter dated June 13th, the panel stated:

          ``The diversity of opinion also reflects the many unanswered 
        questions and uncertainties associated with establishing 
        causality of the association between PM2.5 and 
        mortality. * * * ''
          Is it your position that epidemiological studies, without a 
        biological mechanism establish causality? What criteria does 
        the Agency use in establishing causality? Since your finding of 
        causality contradicts the scientific experts and the CASAC 
        panel, what did you rely on for your findings?

    Answer. As the Criteria Document points out, the interpretation of 
epidemiologic data as an aid to inferring causal relationships between 
presumed causal agents and associated effects has long been addressed 
by several expert committees or deliberative bodies faced with 
evaluation of controversial biomedical issues (Page 12-3). Criteria for 
determining causality developed by these bodies are outlined in Chapter 
12 of the Criteria Document. No single criterion is sufficient by 
itself, and it is not necessary that all criteria be fulfilled in order 
to support a determination of causality. While biological plausibility 
is one of the criteria, a full understanding of biological mechanisms 
is not. In her testimony as well as in the PM Federal Register Notice, 
the Administrator notes the distinction between having strong evidence 
of a cause/effect relationship and understanding how the relationship 
works at the level of biological mechanism. Numerous public policy 
judgments, from occupational guidelines and standards to the Surgeon 
General's 1964 decision on smoking, have been based primarily on 
epidemiological results, without an understanding of underlying 
biological mechanisms. In making such judgments, we cannot ignore 
epidemiological associations, especially when they provide consistent 
and coherent results across different cities, with different mixes of 
copollutants, and conducted by different researchers.
    The Administrator bases her conclusions with respect to the 
likelihood of a causal relationship between air pollution containing 
particulate matter and health effects across a range of concentrations 
squarely on the comprehensive assessment of the evidence contained in 
the Criteria Document that was peer reviewed and approved for use in 
standard setting by her science advisors. It is important to note that 
the CASAC found that this Criteria Document reflected the ``best ever 
example of a true integrative summary of the state of knowledge about 
the health effects and the various available indices of PM exposure'' 
(Wolff, 1996).
    With respect to the body of particulate matter epidemiologic data, 
both past and present criteria reviews leave little doubt about 
causality in regard to increased mortality and illness in relation to 
very high historic concentrations of particle-laden air pollutant 
mixtures (Criteria Document, pages 12-29), even though there is no 
accepted biological mechanism that explains these widely accepted 
conclusions. There is less consensus, however, with respect to how to 
interpret more recent studies, which suggest that these clearly 
demonstrated effects extend to concentrations well below those 
permitted by current air quality standards. The PM Federal Register 
Preamble summarizes the Criteria Document and Staff Paper assessments 
of a number of specific issues that have been raised regarding the 
adequacy and strength of the individual epidemiologic studies at 61 FR 
65644-65648. The Criteria Document finds these studies have ``clearly 
substantiated associations'' of serious health effects with ``exposures 
to ambient levels of PM found in contemporary U.S. urban air sheds even 
at concentrations below current U.S. PM standards.'' The Criteria 
Document evaluation of other possible explanations for the reported PM 
epidemiology results (e.g., effects of weather, other co-pollutants, 
choice of statistical models, exposure misclassification) finally 
concludes that ``the reported associations of PM exposure and effects 
are valid.''

    Question 2. The relative risk factor for PM2.5 was 
established at or around 1.17. What other major rulemakings has the 
Agency undertaken with a relative risk factor in this range?
    Answer. The relative risk of 1.17 referred to by the question 
appears in one of two long-term cohort studies and reflects the 
increase in risk of total mortality in populations living in the most 
polluted and least polluted cities studied. The corresponding relative 
risk for the most sensitive populations in these studies, those with 
cardiopulmonary diseases, is somewhat higher, in the range of 1.3 to 
1.4. While relative risks of this magnitude are smaller than 
epidemiologists find in studies of occupational exposures and risks 
such as smoking, they are nevertheless quite significant from a public 
health perspective. Taken at face value, these long-term studies 
suggest that the lives of several tens of thousands of Americans may be 
shortened by up to 2 years or more. Even taking into account the 
recognized uncertainties associated with such estimates, these risk 
estimates rank particulate matter as one of the most significant public 
health issues EPA has ever addressed. Moreover, unlike some estimates 
of environmental risk, these estimates are based directly on 
epidemiological data on human mortality, not on an extrapolation from 
high-dose laboratory animal data.

    Question 3. The committee has heard conflicting figures describing 
the number of PM2.5 studies, from hundreds, to 65, to 6. In 
an EPA reply to my written request for a list of all studies which 
examined PM2.5, I received a list of 28 studies. Of these 7 
were found not to be statistically significant, 4 found no association, 
and only six found significant association. If this is the case would 
you please provide a breakdown and explanation for the remaining 
studies the EPA has characterized as supporting the proposed 
regulations. How many other studies are there? What aspect of 
PM2.5 did they study? If they did not examine 
PM2.5, how are they relevant to this process? How many of 
these studies ``found significant association'' and how many were 
deemed ``not to be statistically significant'' or ``found no 
association?''
    Answer. The tabulation of record for studies considered by EPA is 
the Criteria Document and Staff Paper. There are literally thousands of 
studies on PM-related health effects, animal toxicology, controlled 
human studies, visibility impairment, soiling and nuisance, atmospheric 
chemistry and related topics referenced in the Criteria Document. In 
considering the question of which studies of particulate matter were of 
most significance to determining the potential health effects of 
particles at concentrations that extend to below those allowed by the 
current standards, EPA relied principally on the significant body of 
mostly recent community epidemiologic studies. As noted in the 
Preamble, of the more than 80 such PM studies that evaluated short-term 
concentrations of particulate matter and health that are summarized in 
Tables 12-2 and 12-8 to 12-13 of the Criteria Document (65 FR 65646), 
more than 60 reported positive, statistically significant associations. 
Tables 12-16, 12-21, and 12-22 summarize an additional 11 studies of 
long-term PM concentrations and health. Nine of these studies reported 
one or more statistically significant associations between particulate 
matter and health indicators. As discussed in the preamble and in the 
response to question 1 above, these long- and short-term studies were 
examined both individually and collectively in addressing the 
consistency and coherence of the evidence, ultimately supporting the 
Criteria Document conclusion that PM effects associations are real and 
suggesting a likely causal relationship. They are, therefore, directly 
relevant to the process, although in a more qualitative fashion.
    These studies used a variety of indicators of particulate matter, 
including PM10, PM2.5, Total Suspended Particles 
(TSP), sulfates, hydrogen ion, British Smoke, and more. All of these 
indicators either contain or are themselves constituents of fine 
particles. Not all of these indicators are, however, readily useable 
for making the best quantitative estimates of risk. Therefore, the 
Criteria Document identified a more limited subset of these studies as 
most useful for making quantitative estimates of effects associated 
with thoracic particles (<10 um) and fine particles. This refined list 
of studies and related effects estimates are provided in Chapter 13 of 
the Criteria Document in Tables 13-3 to 13-5 (attached).
    Your earlier request to Mary Nichols focused on studies that 
actually measured PM2.5 and fine particle components. 
Because neither the Criteria Document nor the Staff Paper listed in one 
place all studies using fine particle indicators, EPA staff prepared a 
separate summary drawn from these documents in response to discussions 
with your staff. This summary was provided to your staff on February 11 
and to you in the February 1997 letter from Mary Nichols. In examining 
this summary, however, we found a somewhat different breakdown than 
that stated in your question:
     ``The total number of studies in the summary was 32, of 
which 23 were short-term and 9 long-term;''
     Twenty-one studies had one or more significant 
associations between fine particle indicators and health endpoints;
     Seven studies found a positive result that was either not 
significant or could not be clearly distinguished; and
     Four studies found no association.
    In response to your original question about which of these studies 
were most directly useful in establishing the proposed annual 
PM2.5 standard, six studies were highlighted in the summary 
provided. None of these studies relied on British Smoke or other 
optical indicators; these less certain indicators were not used for 
quantitative purposes for this proposal, even though such studies did 
form the principal basis for the current PM10 standards. 
Only studies that actually measured fine particle mass were relied on 
directly for deciding upon the precise level to propose. All six of 
these studies showed a statistically significant association between 
fine particle mass and effects. Five measured PM2.5, and one 
measured PM2.1. The five studies directly measuring 
PM2.5 are the same ones included on the Chart used by the 
Administrator in her recent Senate testimony. Air quality information 
from other PM2.5 studies noted in the summary provided 
supplemental support in deciding on what levels to propose for the 
PM2.5 standards.

    Question 4. During the Science Hearing Dr. Schwartz stated:

          ``I am relatively convinced that the particles larger than 
        2.5 microns are not important for most of the health effects. 
        It is really the combustion particles that matter. Combustion 
        particles are less than 2.5 microns, but mostly they are less 
        than 1 micron in size. Ultra fine particles come right off the 
        combustion process. You get these very, very small particles 
        and then they agglomerate up and tend to get bigger. They tend 
        to grow up to things that are around .3 microns, roughly.''
          Has the Agency ruled out the ultra fine particles as a health 
        risk? Is it possible they are a more significant threat than 
        PM2.5?

    Answer. ``Combustion particles'' include directly emitted 
``ultrafine'' (<0.1 m) particles that quickly aggregate into 
larger sizes as well as particles that form in the air from reaction of 
gases such as sulfur dioxide. Both the Criteria Document and the Staff 
Paper examine the potential contribution of directly emitted ultrafine 
particles to the observed effects of particulate matter. The Criteria 
Document points out that such ultrafine aerosols (<0.1 m) are 
a class of fine particles that have the potential to cause toxic injury 
to the respiratory tract as seen in several animal studies (p. 13-76). 
The Staff Paper assessment includes the following evaluation of 
potential risk:

          ``Because of their short lifetime, it is unclear that 
        unaggregated ultrafine particles make up any significant 
        fraction of the mass of fine particles or of PM10, 
        other than in the vicinity of significant sources of ultrafine 
        particles. The relationship between ultrafine numbers (or mass) 
        and the mass of fine or thoracic [PM10] particles 
        found in typical community air pollution has not been 
        established. Although the Criteria Document provides little 
        direct information, it might be expected that penetration and 
        persistence of unaggregated ultrafine particles to indoor 
        environments would be limited. For these reasons, it is 
        questionable whether ultrafine aerosols could be playing a 
        major role in the reported epidemiologic associations between 
        the measured mass of fine or PM10 particles and 
        health effects in sensitive populations'' (Staff Paper, p. V-
        72-73).

    In summary, given their much longer atmospheric lifetime and 
broader dispersion from source regions, the larger fine particles 
appear to be of greater risk to public health. Because of the potential 
toxicity of ultrafine particles and the opportunity for exposure near 
combustion sources, however, they represent an area where additional 
research is necessary. In any event, strategies that control fine 
particles will focus new attention on both directly emitted and 
atmospherically formed ultrafine particles.

    Question 5. Who will determine the implementation steps for these 
regulations? Based on past experience, what percentage would be 
determined by the States and local governments, and what would be 
mandated by the EPA in order to bring a nonattainment area into 
compliance? To what extent would States have flexibility to regulate 
implementation procedures? Will the Agency deem any particular 
procedure as mandatory, or to the contrary will the Agency prohibit a 
specific implementation procedure, such as barbecuing?
    Answer. Under the Clean Air Act, EPA has responsibility to set the 
national ambient air quality standards (NAAQS). After the NAAQS are 
established, the Clean Air Act outlines the process and requirements 
for the development of State Implementation Plans (SIPs). The States 
take the primary role in developing SIPs in accordance with the process 
and substantive requirements of the Act. The purpose of the SIP is to 
outline the specific emission reduction measures a State will implement 
to bring about attainment and maintenance of the NAAQS. In order to 
facilitate the development of approvable SIPs, EPA provides the States 
and local governments with the necessary technical tools and 
implementation guidance.
    In developing SIPs, the States and local governments, within the 
constraints of the Clean Air Act, have the responsibility and 
flexibility to make specific choices as to which sources or source 
categories to regulate or not regulate. In some cases, the Act 
specifies more specific control programs such as Reasonably Available 
Control Technology (RACT) and New Source Review (NSR). The Act may also 
specify more general requirements for reasonable further progress or an 
attainment demonstration. EPA has historically not interpreted these 
more general control requirements to mandate specific control measures. 
EPA's role is to review and approve or disapprove SIPs based on the 
requirements of the Clean Air Act. Finally, under the Clean Air Act, 
EPA has a duty to develop and implement certain national emission 
control programs, such as those for motor vehicles and acid deposition. 
While these actions contribute to attainment of the NAAQS and may have 
been adopted (in whole or in part) to facilitate attainment, they are 
not specifically intended to bring about attainment of the NAAQS.
                                 ______
                                 
 Responses by Carol Browner to Additional Questions from Senator Allard
    Question 1. Ms. Browner, I would like to ask you to respond to a 
quote from last week's hearing. The quote is, `` * * * in a paper 
Lipfert and Wyzga published in the Journal of the Air and Waste 
Management Association, we examined many published studies that had 
looked at the relationship between daily mortality and various 
pollutants. We found that if a study had chosen to focus upon sulfur 
dioxide or nitrogen dioxide instead of particulate matter, that study 
found similar effects on daily mortality as did those studies that 
focused on particulate matter. A focus upon carbon monixde indicated 
somewhat larger effects than particulate matter, and a focus on ozone 
gave somewhat smaller effects.'' If in fact this is true, how can we be 
certain the regulations you have proposed will protect human health 
when in fact you may have identified the wrong pollutant? How do we 
know that we won't mandate the expenditure of billions of dollars only 
to have identified the wrong cause of mortality?
    Answer. The conclusions reflected in the quote are not wholly 
supported by the Lipfert and Wyzga (1995) paper referenced. For 
example, in comparing their measure of risk among pollutants, the 
authors base their conclusions on 41 instances showing associations 
between measures of particulate matter and mortality, but found only 3 
such cases for carbon monoxide. This is hardly a basis for any 
conclusion about the relative size of carbon monoxide effects. In fact, 
the ``larger'' value referred to for carbon monoxide is driven by a 
single study in Sao Paulo, Brazil. In that study, when PM and carbon 
monoxide are entered together into the analyses simultaneously with 
other pollutants, the PM risk measure (elasticity) is stable, while 
that for carbon monoxide drops by more than a factor of 5, and is only 
\1/4\ that for PM. As Lipfert and Wyzga (1995) state in their paper 
``In examining the joint regressions, we noted instances where 
SO2, CO, and O3 contributions were less in the 
joint regressions than in separate regressions.''
    The issue highlighted here, that of the potential effects of co-
pollutants is, nevertheless, an important one. Because different air 
pollutants are often correlated with each other over time, and multiple 
air pollutants may contribute individually or collectively to health 
effects, it is important to examine particulate matter effects studies 
to assess the potential for what is termed ``confounding'' and 
``effects modification'' by co-occurring pollutants. The Lipfert and 
Wyzga (1995) paper is a limited review of the literature, that was 
fully evaluated in EPA's and CASAC's scientific review and cited in the 
Criteria Document, the Staff Paper, and the PM Federal Register Notice. 
Unlike this single paper, the Criteria Document contains a 
comprehensive, thorough, and more recent review of the PM health 
effects literature, particularly with respect to the specific issue of 
the effects of co-pollutants. The treatment of multiple pollutants in 
individual studies is dealt with most cogently on pages 12-329 to 12-
344 of the Criteria Document. The findings as summarized in the 
integrative synthesis of PM effects are as follows:

          ``Confounding by co-pollutants sometimes cannot be avoided. 
        In studies where sensitivity analyses demonstrate that 
        including other pollutants in the model cause little change in 
        either the RR [relative risk] estimate for PM or the width of 
        the confidence interval for the PM effect, one may conclude 
        that the model is not seriously confounded by co-pollutants. 
        Some studies of PM related mortality or morbidity have shown 
        the specific relative risk estimates for PM only in the 
        respective models to be little changed by inclusion of other 
        co-pollutants in the model, suggesting little confounding in 
        those cases. On the other hand, in those analyses where the RR 
        estimate for PM was notably diminished by inclusion of other 
        co-pollutants in the model (indicative of some confounding), 
        the PM effect typically still remains statistically 
        significant, although reduced. Since a number of mortality and 
        morbidity studies have shown that the PM effect on health is 
        not sensitive to other pollutants, we may conclude that 
        findings regarding the PM effects are valid'' (Criteria 
        Document, p 13-57).

    As noted in the Criteria Document, it is reasonable to expect that 
co-pollutants present in some study areas might modify (either increase 
or decrease) the apparent effects of PM by atmospheric interactions or 
by interactive effects on sensitive subpoulations. Moreover, the 
possibility of exposure misclassification for gaseous pollutants such 
as carbon monoxide or sulfur dioxide could modify their apparent 
significance relative to PM. Another way to examine this issue is to 
compare study results from multiple areas with varying degrees of co-
pollutant concentrations. If such PM confounding or effects 
modification was occurring to an appreciable degree, the associations 
with PM would be expected to be consistently high in areas with high 
co-pollutant concentrations, and consistently low in areas with low co-
pollutant concentrations. However, EPA's examination of reported 
PM10--mortality associations as a function of the varying 
levels of co-pollutants in study areas found that consistent effects 
estimates were observed across wide ranges of co-pollutant 
concentrations (Staff Paper, Figures V-3a, V-3b). In essence, the PM 
effects estimates were similar in vastly different geographic locations 
with high and low concentrations of pollutants such as sulfur dioxide, 
nitrogen dioxide, ozone, and carbon monoxide and varying climactic 
conditions. This consistency and coherence of the PM health effects 
data further support a significant contribution of PM, alone or in 
combination with other pollutants, to the observed increases in 
mortality and morbidity (Criteria Document, page 13-1).
    Based on the most comprehensive assessment of available scientific 
evidence, the Administrator believes that her proposal, in combination 
with existing standards and programs, will result in regulating the 
correct pollutants, and that strategies that reduce fine particulate 
matter will materially reduce the risk of adverse health effects.

    Question 2. Are you arguing that there is a completely accurate 
relationship between PM people breathe with the levels used in air 
pollution health studies?
    Answer. The PM to which people are exposed is composed of particles 
from outdoor sources (e.g., industrial sources, cars, diesel engines) 
and indoor sources (e.g., cigarette smoke, cooking). The exposure to 
particles of outdoor origin is the part of exposure that is relevant to 
the national ambient air quality standards.
    As noted in the preamble to the proposal (61 FR 65645) one 
difficulty in interpreting the epidemiological studies, particularly 
for quantitative purposes, is the uncertainty and possible bias 
introduced by the use of outdoor monitors to estimate a population-
level index of exposure.
    The Staff Paper and Criteria Document conclude that central ambient 
monitoring can be a useful, if imprecise, index for representing the 
average exposure of people in a community to PM of outdoor origin. In 
addition, the documents conclude that measurements of daily variations 
of ambient PM concentration have a plausible linkage to the daily 
variations of human exposures to PM from ambient sources for the 
populations represented by the ambient monitoring stations. 
Furthermore, this linkage will be better for indicators of fine 
particles than for indicators of fine plus coarse particles (i.e., 
PM10 or TSP). Thus, it is reasonable to use a representative 
central ambient monitor or spatially averaged group of monitors to 
represent the mean community exposure to particles from outdoor 
sources.

    Question 3. Would you concede that the science in this area is not 
as well developed as it should be (Phillipsburg and Azusa, monitored v. 
personal exposure)? If not would you concede that there is a difference 
of opinion in the mainstream scientific community?
    Answer. Both the Staff Paper and the proposal preamble point out 
that a comprehensive treatment of the potential influences of exposure 
misclassification and measurement error is an important research need. 
The uncertainties regarding human exposure do not invalidate the 
associations reported in the literature. The available evidence on the 
consistency of the PM effects relationships in multiple urban locations 
with widely varying indoor/outdoor conditions and a variety of 
monitoring approaches makes it less likely that the observed findings 
are an artifact of errors in measurement of pollution or of exposure.
    Furthermore, in a supplemental letter (Lippmann et al., 1996), four 
of the CASAC health scientists stated:

          * * * although population exposure to air pollution cannot be 
        perfectly estimated based on central monitoring, these inherent 
        errors in exposure estimation are more likely to cause an 
        underestimation of the adverse health effects associated with 
        pollution exposure, particularly in longitudinal [day-to-day] 
        cohort studies where individual risk factors and exposures are 
        directly related to health effects. Thus the consistent 
        positive findings cannot be attributed to exposure measurement 
        error. Furthermore, there is growing evidence that fine 
        particles are more uniformly distributed over large geographic 
        areas than are coarse particles ([Criteria Document,] Section 
        13.2.4), that measurements at one site give a reasonable 
        estimate of the fine particulate concentrations across a city 
        ([Criteria Document,] Section 13.2.6), and that fine particles 
        penetrate and have longer lifetimes indoors than coarse 
        particles ([Criteria Document,] Section 13.2.6). This evidence 
        supports using ambient measures of fine particles at a central 
        site as an acceptable estimate of the average exposure of 
        people in the community ([Criteria Document,] Section 13.2.6). 
        For those reasons, we judge that uncertainties arising from air 
        monitoring and human exposure estimation do not negate the 
        consistent excess mortality and morbidity associations. * * * 

    Question 4. As you know the Denver Metro Area has not had an ozone 
violation since 1987. About 1 year ago Denver submitted an Ozone 
Maintenance plan to have them redesignated as an ozone attainment area. 
Obviously, we would like to have Denver in attainment with the old 
standards before any new standards come out. Further, since the Federal 
Register notice does not give an implementation date we would like to 
know that EPA will put Denver in attainment before these regulations go 
into place, will you talk to Region VIII about this?
    Answer. EPA places a high priority on redesignation requests to 
attainment and is working diligently to redesignate Denver to 
attainment for ozone before a final decision on the new ozone NAAQS.
    Although the Colorado Air Quality Commission took action on the 
maintenance plan nearly a year ago, Colorado law requires that all such 
rules undergo a legislative review before being forwarded by the 
Governor to EPA. Therefore, the redesignation package was not received 
by EPA until late summer 1996. Upon EPA's receiving the package and 
reviewing it, we discovered that it did not include a complete 
technical support document to justify the redesignation. We have not 
yet received the complete information from the State, but we are 
proceeding to review the package before us, awaiting the additional 
information. Hopefully, this delay will not adversely affect 
approvability before the final decision is made on the ozone NAAQS.
    In the meantime, EPA will do everything possible to expedite the 
review.

    Question 5. Finally, on an issue completely unrelated to this 
hearing, but important none the less, is the issue of State Self 
Audits. As you know Colorado has a self-audit law and I believe the 
state is being sued by an environmental organization over that law. I 
understand they [are] pressuring EPA to also oppose this form of state 
law. Does EPA have a position on this issue? If you are not prepared to 
answer here I understand but please reply in writing.
    Answer. The EPA issued its final audit policy, ``Incentives for 
Self-Policing: Discovery, Disclosure, Correction and Prevention of 
Violations,'' on December 22, 1995. The policy encourages self-policing 
violations discovered through environmental audits or compliance 
management programs. The policy protects the public's right to know the 
nature of the problems disclosed by regulated entities under the 
policy, and it preserves the Agency's ability to recover any 
significant economic benefit gained by the violator. As of January 
1997, 105 companies had disclosed violations at more than 350 
facilities under the policy, proving that environmental auditing can be 
encouraged without blanket amnesties or audit privileges.
    The EPA has worked with states in their efforts to craft policies 
and laws that offer incentives for environmental auditing but that do 
not impair state enforcement authority under delegated programs. 
Federal laws and regulations establish clear standards that states must 
meet to obtain approval to administer Federal environmental programs. 
The Agency supports state audit laws that neither impair the minimum 
requirements for adequate enforcement authority nor create evidentiary 
privileges that limit access to evidence of civil violations or 
criminal misconduct. Nevertheless, the Agency questions state audit 
immunity/privilege laws that place restrictions on the state's ability 
to obtain penalties and injunctive relief for violations of Federal 
program requirements, or obtain information that may be needed to 
determine compliance status. In analyzing the impact of such state 
audit laws, the EPA stands ready to consult with state officials to 
ensure the adequacy of enforcement authority in delegated state 
programs. In working with the states, the EPA relies on a policy 
document issued February 14, 1997, ``Statement of Principles, Effect of 
State Audit Immunity/Privilege Laws on Enforcement Authority for State 
Programs,'' which articulates the minimum requirements for adequate 
enforcement and information gathering authority for the purpose of 
approving or delegating programs in states with audit privilege or 
immunity laws.
    EPA Region 8 is currently analyzing the petition to revoke 
Colorado's authority to administer the Clean Water Act and will 
coordinate a response with EPA Headquarters. The petition was filed 
January 29, 1997, by a coalition of public interest groups, including 
the Sierra Club, the Western Colorado Congress, the Oil Chemical and 
Atomic Workers Union, and the High Country Citizens Alliance. The 
petitioners claim that the Colorado audit privilege and immunity law 
has impaired the state's ability to adequately enforce the NPDES 
program and has eliminated sufficient opportunities for public 
participation. In assessing the petition, the EPA will consider the 
factors outlined in the Statement of Principles. EPA may consult the 
Colorado Attorney General or other state officials if clarification is 
needed as to the effect of the audit law.
  Responses by Carol Browner to Additional Questions from Senator Reid
    Question 1. Given that we all agree that overall air quality has 
been improving in the U.S. in recent years, it has been argued to me 
that EPA is moving the goal post on this issue. Much of the Nation is 
not currently in attainment of either the current ozone standard, the 
existing PM10 standard or both. Might it not be a better use 
of the nation's resources to focus on attaining the current standards 
before we tighten them?
    Answer. We also are proud of the accomplishments to date under the 
Clean Air Act in improving air quality in the U.S. EPA is not ``moving 
the goal post'' but rather is attempting to maintain the goal of the 
CAA since its original enactment in 1970: setting national ambient air 
quality standards which protect public health with an adequate margin 
of safety and protect public welfare from known or anticipated adverse 
effects. Based on the recent review of the science and consistent with 
the recommendations of the CASAC, the Administrator has concluded, 
subject to public review and comment, that the current standards for 
PM10 and ozone do not meet the goal of the CAA and therefore 
has proposed revised standards for ozone and PM10 and new 
standards for PM2.5.
    While we share your concern about the cost of achieving these 
standards, it is important to note that EPA's recent draft study of the 
costs and benefits of the Clean Air Act found billions of dollars of 
benefits from implementing the former Total Suspended Particulate 
Matter (TSP) standards. Our concern about the costs has led us to work 
with States, environmental groups, industry, small business 
representatives, and academia through our FACA Committee to develop 
more flexible, cost-effective strategies for achieving these standards. 
We believe, as has been demonstrated in the past, that the public 
health can be protected at lower costs than are anticipated either at 
the time of setting a standard or passage of environmental legislation.
    Question 2. Local and state air quality control personnel have 
expressed concerns to me about the cost of implementing these 
regulations, and particularly of developing a PM2.5 
monitoring network. Although this is an implementation issue, how does 
EPA intend to distribute the financial burden of implementing the 
standards and developing the required monitoring network?
    Answer. It is currently estimated that EPA's proposed monitoring 
regulations for PM2.5 will cost $70.8 million for 1200 
stations. EPA will provide 60 percent of this burden though the Federal 
105 Grant funds, with the other 40 percent of the costs provided by 
State and local agencies. The Federal share will be provided by a 
combination of new and reprogrammed funding requested in the fiscal 
year 1998 budget. Within existing monitoring programs, we plan to shift 
emphasis away from certain criteria pollutants (for which we have 
successfully reduced ambient levels) and toward PM2.5 
monitoring. Examples include a reduction of monitoring sites for sulfur 
dioxide, lead, carbon monoide and nitrogen dioxide, as well as 
PM10. While EPA is shifting resources and requesting new 
funding for PM2.5, we foresee the States proportionally 
sharing the costs of developing the PM2.5 monitoring 
network.
    The initial samplers would be allocated to provide geographic 
coverage with added initial emphasis on high population, high potential 
PM2.5 pollution areas and high ozone areas. All new samplers 
will include both Federal Reference Method monitors, special purpose 
monitors and continuous PM analyzers. In addition, special monitoring 
studies are needed with emphasis on designing adequate networks to lay 
the ground work for future strategy development. Because we are 
proposing to maintain PM10 standards, with modest revisions, 
we project gradual offsets from the current PM10 monitoring 
program. We are currently developing interim PM program guidance which 
continues much of the PM10 program while transitioning to 
the PM2.5 program.
    The table below outlines the current strategy for phasing in the 
PM2.5 monitors and phasing-out of some of the 
PM10 monitors. The table identifies the number of 
PM10 and PM2.5 sites and the estimated total cost 
of the PM10 and PM2.5 program.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                  Approximate No. of Operational Sites                                      Estimated National PM Cost [In millions of  
---------------------------------------------------------------------------------------------------------                    dollars]                   
                                                                                                         -----------------------------------------------
                                                               Year            PM10           PM2.5*           PM10            PM2.5           Total    
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.......................................................            1997            1600             200            15.9             4.2            20.1
1.......................................................            1998            1400             600            12.6            18.6            29.9
2.......................................................            1999            1000            1000             9.8            24.0            33.8
3.......................................................            2000             600            1200             6.7            24.0            30.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Totals include approximate number of sites operating at the end of the year.                                                                          


    Question 3. Realizing that costs cannot be considered in modifying 
the national ambient air quality standards. However, the initial 
analysis the Agency has done on changing the ozone standard seems to 
indicate that costs outstrip benefits by a comfortable margin. Again, 
realizing that there are only so many resources that can be aimed at 
these problems, is the ozone control program really the one that will 
give us the greatest environmental ``bang for the buck''?
    Answer. The Clean Air Act requires EPA to set standards that 
protect the public health with an adequate margin of safety and protect 
the public welfare from known or anticipated adverse effects without 
consideration of costs. For 26 years, the Clean Air Act has promised 
American adults and American children that they will be protected from 
the harmful effects of dirty air. EPA believes that the public has a 
right to know if the air quality in their area is unhealthy on a 
particular day. This information allows them to take personal actions 
to protect their health or the health of their family if they are at 
risk.
    Concerning the costs and benefits associated with achieving the 
proposed ozone standard, it is important to note that those estimates 
reflect only the monetized costs and benefits. There are many benefits 
likely to be associated with the standard that we are not able to 
monetize such as reduction of the following endpoints: chronic 
respiratory damage, premature aging of lungs, susceptibility to 
respiratory infection/impairment of respiratory tract defense 
mechanisms, cancer and other health effects caused by toxic pollutants 
(ozone and PM controls will reduce toxics), alteration of airway 
responsiveness, incidence of significant changes in pulmonary function, 
reduced acute inflammation and respiratory cell damage, nitrogen 
deposition in sensitive estuaries (like Chesapeake Bay), impacts on 
national parks, non-commercial forests, and ecosystems, impacts on 
growth and survivability of tree seedlings, materials damage (e.g., 
dirt on buildings), mortality/morbidity from lower fine particle levels 
from ozone controls, visibility impairment resulting from ozone 
controls, and damage to urban ornamentals (e.g., grass, flowers, trees, 
shrubs) from ozone controls. Despite the existence of all of these 
currently non-monetized benefit categories, the partial attainment 
monetized benefit estimates presented in the Agency's Regulatory Impact 
Analysis ranged as high as the lower bound of associated costs.
    We formed the FACA Subcommittee for the Integrated Implementation 
of the Ozone and Particulate Matter NAAQS and the Regional Haze Program 
to look at ways to achieve all of these standards in the most cost-
effective manner. Nitrogen oxides and organic compounds can contribute 
to all three types of air quality problems and by looking for 
opportunities of multiple benefits from controlling different sources 
of these pollutants, the air quality problems can be addressed more 
efficiently. In addition, the Subcommittee is also investigating how 
market-based strategies can be used to further reduce the cost of 
achieving the standards.

    Question 4. Again, skipping ahead to implementation. I have been 
very impressed with the recent success of several air programs that 
promote regional solutions, flexibility and market mechanisms to 
promote more cost-effective compliance. The Acid Rain Program, in 
particular, comes to mind. Do you anticipate an implementation plan for 
the new ozone and PM2.5 standards that will encourage such 
flexibility?
    Answer. Yes. In fact, EPA expects that the continued implementation 
of the Acid Rain Program will play a major role in the attainment of 
the PM2.5 NAAQS. In addition to this, in September, 1995, 
EPA formed the Subcommittee for the Integrated Implementation of the 
Ozone and Particulate Matter NAAQS and the Regional Haze program under 
the Federal Advisory Committee Act. This Subcommittee was charged with 
the goal of developing innovative control strategies that integrate 
ozone, PM and regional haze considerations. The ultimate goal of this 
effort is to produce approaches which achieve maximum flexibility and 
cost effectiveness in the attainment of the NAAQS and in achievement of 
regional haze requirements. The Subcommittee is actively exploring a 
number of flexible approaches based on regional solutions and market 
mechanisms. This includes the use of economic incentives and broad-
based market trading mechanisms to bring about attainment of the NAAQS 
and achievement of regional haze requirements.

    Question 5. You are planning to spend $18 [million] this year for 
PM2.5 research and the budget request suggests that you plan 
to spend $24 million in next year. Please explain how any findings 
unearthed by this research will impact the implementation of these 
regulations.
    Answer. It will take several years to put an implementation program 
in place for the new standards. The effort to conduct monitoring and 
develop control programs will reveal additional scientific and 
technical information needs. The research done over the next few years, 
including that conducted through this and next years budgets, could be 
of significant benefit in improving these ongoing programs, as well as 
improving the quality of the next criteria and standards review. One 
category of our fiscal year 1997 and 1998 research is directed toward 
producing data and tools useful in guiding implementation strategies. 
This component of the research includes:
     determining source contributions to ambient PM 
concentrations and the availability, performance, and cost of risk 
management options to meet ambient PM standards;
     understanding the atmospheric chemistry of PM to support 
fate and transport modeling used in implementation; and ``development 
and evaluation of improved particle measurement methods to characterize 
atmospheric PM.
     The other major component of the research program will 
focus on health effects, including potential mechanisms, population 
exposures, and advances in community studies. This information will 
support the next review of the standards, which will occur before final 
implementation plans are due.

    Question 6. In recent years, EPA's efforts on particulate matter 
have focused on smaller and smaller particles, which has led to the 
current call for a PM2.5 standard. All of this seems to 
suggest that the Agency no longer believes that PM10 is the 
threat it once was. Why not just repeal the standard?
    Answer. While EPA recommendations for general particle standards 
have progressed toward smaller size particle standards, the most 
current review by EPA and CASAC make it quite clear that the 1987 
establishment of PM10 as an indicator for particulate matter 
was a wise decision. As noted in the preamble, ``The recent information 
on human particle dosimetry contained in the Criteria Document provides 
no basis for changing 10 m as the appropriate cut point for 
particles capable of penetrating to the thoracic regions (61 FR 
65654).'' More specifically, the CASAC advised the Administrator that 
``there is a consensus that retaining an annual PM10 NAAQS * 
* * is reasonable at this time'' (Wolff, 1996). While EPA believes 
there is strong scientific evidence suggesting that new fine particle 
standards should be established, there is also a clear need to retain 
PM10 standards, at or near the level established in 1987, to 
provide complete protection of pubic health against all particle 
fractions of concern to public health.

    Question 7. There has been some confusion about the health effects 
of ozone. Does ozone cause asthma? Or does it just make it worse for 
those who already have it?
    Answer. Ozone has been shown to aggravate the symptoms and 
underlying physiological responses (e.g., lung inflammation) which are 
associated with asthma. Epidemiological studies have reported an 
association between ambient ozone concentrations and hospital 
admissions/emergency room visits for respiratory causes. Clinical 
research has provided evidence of greater reductions in lung function 
for asthmatics than for healthy individuals. Increased airway 
reactivity has been demonstrated in both healthy and asthmatic 
individuals following exposure to ozone. And, ozone exposures of human 
subjects have been reported to increase indicators of pulmonary 
inflammation, which could precede development or worsening of an asthma 
event. Thus, taken as a whole, research supports the contention that 
while ozone has not been seen to cause asthma, it contributes to health 
effects which worsen asthma.

    Question 8. As you know, the Intermodal Surface Transportation 
Efficiency Act is up for reauthorization this year. With the 
possibility of so many additional communities falling into non-
attainment, has EPA had any interaction with the Department of 
Transportation about issues of attainment, conformity, and the 
allocation of resources under ISTEA? If yes, please describe.
    Answer. Yes. While developing the Administration's proposal, the 
Department of Transportation (DOT) consulted with EPA on issues 
pertaining to how the proposed standards would be addressed in the 
Congestion Mitigation and Air Quality Improvement Program (CMAQ). In 
the Administration's proposal, newly designated areas that might result 
from the proposed standards would be eligible for funds under CMAQ 
after those areas had made a SIP submittal to EPA. These areas would be 
included in the apportionment formula for calculating CMAQ.

    Question 9. Please provide copies of the large easel charts used by 
the Administrator at the hearing.
    Answer. Copies of the large easel charts used by the Administrator 
are attached.
    [Attachments for the Record to Question 9 follow:]
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 Responses by Carol Browner to Additional Questions from Senator Chafee

    Question 1. During your testimony before the committee on 
February 12, you referred to several charts and figures. Please 
provide a copy of each of these charts for the hearing record. 
Please explain the meaning and source of each statistic used in 
each chart or figure including a citation to any study from 
which a statistic was drawn.
    Answer. Attached are the charts and figures used by 
Administrator Browner in her testimony. The meaning and source 
of the statistics presented in these charts and figures, as 
well as specific citations, are included as endnotes on the 
charts and figures.

    Question 2. One of the charts used in your testimony was 
entitled ``Smog/Ozone: The Science Calls for Action.'' This 
chart (attached) purports to show the number of people in 
various groups that would be ``protected'' by the current 
standard for ozone and by the standard you have proposed. In 
the context of this chart what does the term ``protected'' 
mean?
    Answer. The numbers of people ``protected,'' as summarized 
in the referenced chart (attached), are the numbers of people 
in the listed groups who live in areas that are not projected 
to meet the current and proposed ozone standards (based on 1993 
to 1995 air quality data). People in these areas would receive 
increased protection from the standards since they will breathe 
cleaner air as a result of control measures. As these areas 
reach attainment with the standards, the level of protection 
would increase.

    Question 3. What are the adverse health effects experienced 
by ``people with respiratory diseases'' as the result of 
exposure to ozone?
    Answer. ``People with respiratory diseases'' are generally 
subject to the array of adverse health effects related to ozone 
exposures discussed in the preamble to the proposed ozone NAAQS 
(especially pages 65719-65723). These adverse effects include 
decreased lung function; increased respiratory symptoms and 
related increases in medication use and/or medical treatment; 
increased airway responsiveness, which can lead to increased 
medical treatment or to more persistent alterations in airway 
responsiveness, particularly for individuals with impaired 
respiratory systems; increased susceptibility to respiratory 
infection; increased hospital admissions and emergency room 
visits; and in response to repeated exposures, repeated 
inflammation of the lung and potential long-term effects that 
may, over a lifetime, result in chronic respiratory damage.
    More specifically, for individuals with respiratory 
diseases, lung function and symptomatic effects most clearly 
become adverse at the moderate or greater level of severity. 
Moderate functional responses (e.g., Forced Expiratory Volume 
in 1 second or FEV1 decrements >10 percent but <20 
percent, increased nonspecific bronchial responsiveness 
300 percent, lasting up to 24 hours) and/or moderate 
symptomatic responses (frequent spontaneous cough, marked 
discomfort on exercise or deep breath, wheeze accompanied by 
shortness of breath, lasting up to 24 hours) would likely 
interfere with normal activity for many such individuals and 
would likely result in additional or more frequent use of 
medication. Large functional responses (e.g., FEV1 
decrements 20 percent, increased nonspecific 
bronchial responsiveness >300 percent, lasting longer than 24 
hours) and/or severe symptomatic responses (e.g., persistent 
uncontrollable cough, severe discomfort on exercise or deep 
breath, persistent wheeze accompanied by shortness of breath, 
lasting longer than 24 hours) would likely interfere with 
normal activity for most such individuals and would increase 
the likelihood of their seeking medical treatment or visiting 
emergency rooms.

    Question 4. If the term ``protected'' means living in a 
area that would be designated nonattainment under the current 
or proposed standard, please indicate how these population 
estimates were made, including the year for which the estimates 
are made and a list of the areas that would be in nonattainment 
for each of the standards.
    Answer. The total population estimates in the chart 
referenced in Question 2 (entitled ``Smog/Ozone: The Science 
Calls for Action'') were computed using 1990 U.S. Census data 
and ambient ozone air quality data from EPA's Aerometric 
Information Retrieval System (AIRS), the national repository 
for monitoring data collected by state and local air pollution 
agencies. Air quality data for the years 1993 through 1995 were 
used (the three most recent years with complete, quality-
assured monitoring data). Based on these data, Table Q-4 lists 
the counties, and the population in the counties, that failed 
to meet the three standards referenced in the chart: the 
current 1-hour, 0.12 ppm, 1 exceedance standard, and the 0.09 
ppm and 0.08 ppm average annual third highest daily maximum 8-
hour concentration standards. The determination as to whether a 
county fails to meet an alternative standard in this analysis 
was made using the rounding convention used for the current 
standard; i.e., fractional parts of the design value 
concentration of 0.005 or greater round up. Of the more than 
3000 counties in this country, a total of 561 counties, 
representing approximately two-thirds of the nation's total 
population had complete monitoring data used in this analysis.
    The 1990 U.S. Census data were used to estimate both total 
population and the number of children, 18 years of age and 
younger, living in the counties that failed to meet the 
referenced alternative standards. The estimated number of 
asthmatic individuals living in counties that failed to meet 
each alternative standard was calculated by multiplying the 
total population living in the counties by the rate of asthma 
cases in the U.S., obtained from the National Center for Health 
Statistics document titled ``Current Estimates From the 
National Health Interview Survey, 1994.'' Similarly, the 
estimated number of individuals with respiratory diseases 
living in counties that failed to meet each alternative 
standard was calculated by multiplying the total population 
living in the counties by the case rate for chronic obstructive 
pulmonary disease (COPD), which includes chronic bronchitis and 
emphysema, obtained from the same 1994 National Health 
Interview Survey.

    Question 5. The Clean Air Scientific Advisory Committee 
(CASAC) concluded from a review of all the science that 
biological responses to ozone may be expected down to 
background levels. On that basis, please indicate (using the 
same methodology used to prepare the chart referred to in 
question 2) the number of people in each group who would be 
``protected'' if you had proposed each of the following 
standards: 0.08 ppm, 8-hour, 1 exceedance; 0.07 ppm, 8-hour, 1 
exceedance; 0.04 ppm, 8-hour, 1 exceedance. How many additional 
people in each group could be protected if you eliminated the 
rounding convention that is associated with your proposed 
standard?
    Answer. Table Q-5 provides a summary of the number of 
people in each group who live in counties that failed to meet 
the three alternative ozone standards listed in Question 5, as 
well as the three discussed in the response to Question 4. The 
Table presents results obtained both by using the current 
rounding convention, as described in answer to Question 4, and 
by eliminating the current rounding convention, by rounding up 
at 0.001 ppm rather than 0.005 ppm. Note that for your 
requested alternative of 0.04 ppm, the Table simply shows the 
total population of the counties. There is no reliable evidence 
regarding adverse health effects at this level.

    Question 6. How many people in each group have been left 
``unprotected'' by the standard you have proposed? Is it the 
additional number that could have been ``protected'' had you 
proposed a standard in the current form allowing 1 exceedance 
per year? Is it the additional number that could have been 
``protected'' had you proposed a standard at the low end of the 
range (0.07 ppm) that CASAC voted as acceptable? Or is it the 
number of additional people that could have been ``protected'' 
had you followed the science indicating that ozone causes 
biological responses down to background levels (assuming 
background is 0.04 ppm)?
    Answer. In addition to those people who would be directly 
protected by implementation measures designed to meet the 
proposed standard, as discussed in answer to question 11 above, 
EPA anticipates that additional people would be protected 
through indirect, regional measures as a result of a shift to 
broader regional control strategies likely to be incorporated 
in new implementation plans designed to bring the country into 
attainment with the proposed standard. Thus, it is difficult to 
estimate how many more people may actually breathe cleaner air 
as a result of the proposed standard or any other new 8-hour 
standard that would trigger such regional strategies. There are 
approximately 17 million more people (including approximately 4 
million children, 1 million asthmatics, and 1 million people 
with respiratory diseases) who live in areas that are projected 
not to meet a 0.08 ppm, 1-expected-exceedance, 8-hour standard 
as compared to the proposed standard.
    While there was a consensus on the CASAC ozone panel that 
the range of consideration could reasonably include an 8-hour 
standard set at 0.07 ppm, neither the staff nor CASAC has 
indicated that each level within the range would necessarily be 
an appropriate choice or meet the statutory requirements. In 
selecting the proposed standard, the Administrator gave great 
weight to the individual views of the panel members, none of 
whom supported the need for a standard at the 0.07 ppm level. 
Nor does EPA believe at this time (pending review of public 
comments) that any additional improvements in air quality that 
would result from a standard at this level are necessary to 
protect sensitive populations with an adequate margin of safety 
from adverse effects associated with exposure to ozone.
    With regard to any consideration of a standard set at the 
estimated background level of 0.04 ppm, it is very important to 
take into account the distinction that the EPA and CASAC have 
both drawn between ``biological responses'' and ``adverse 
effects.'' Since NAAQS are not intended to protect people from 
any and all biological responses, without regard to the nature 
and severity of such responses, it would be totally 
inappropriate to characterize the science as suggesting a need 
for protection of public health at this background level.

    Question 7. Considering the case made by the presentation 
of this chart--that more people can be ``protected'' (live in 
nonattainment areas)--if you tighten the standard, what is the 
reason for not ``protecting'' those who could have been 
``protected'' with the more stringent alternatives--
alternatives that are in keeping with CASAC's vote on an 
acceptable range or the underlying science?
    Answer. As discussed above in answer to question 6, EPA 
recognizes that more people would be directly protected by a 
standard with the same averaging time (8 hours) and level (0.08 
ppm) as the proposed standard, but with a 1-expected-exceedance 
form. In considering the selection of the form of an 8-hour 
standard, EPA gave great weight to the advice of CASAC. It was, 
in fact, ``the consensus of the [CASAC ozone] Panel that the 
form of the 8-hour standard be more robust than the present 1-
hour standard'' (Wolff, 1995), with all ten panel members who 
expressed their opinions on this issue, including the human 
health experts, favoring a form that allowed for multiple 
exceedances. More specifically, the panel endorsed a 
concentration-based form (e.g., the proposed 3rd-highest daily 
maximum 8-hour average concentration). Such a form has the 
effect of insulating areas from the impacts of extreme 
meteorological events that result in instability in areas' 
attainment status and, thus, in control programs designed to 
bring about long-term improvements in air quality. Thus, in 
selecting the proposed standard, including the specific 
averaging time, level, and form, EPA sought to base its 
decision on the entire range of scientific and technical 
information that the Clean Air Act specifically identifies as 
being part of the criteria on which standards are to be based 
(including ``those variable factors (including atmospheric 
conditions) which of themselves or in combination with other 
factors may alter the effects on public health or welfare of 
such air pollutant'' [Clean Air Act, section 108(a)(2)(A)]), as 
well as the advice of the independent scientific advisory 
committee specifically chartered by the Clean Air Act to 
provide advice and recommendations to the Administrator on 
NAAQS decisions.
    [Attachments to Questions 1, 4, and 5 (From Set 1) From 
Senator Chafee follow:]
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    Question 8. Section 109(b)(1) of the Clean Air Act requires you to 
promulgate national ambient air quality standards ``the attainment and 
maintenance of which in the judgment of the Administrator, based on 
such criteria and allowing an adequate margin of safety, are requisite 
to protect public health.'' Do the standards you have proposed provide 
an adequate margin of safety? Please identify the margin of safety that 
is provided.
    Answer. Based on the record before the Agency at the time of 
proposal, including the advice and recommendations of the CASAC panels, 
the Administrator concluded--subject to further consideration based on 
public comments--that the proposed standards were requisite to protect 
the public health with an adequate margin of safety. The Administrator 
will of course re-examine that conclusion in light of public comments 
in making her final decision.
    In selecting primary standards that provide an adequate margin of 
safety, the Agency is seeking to prevent pollution levels that pose an 
unacceptable risk of harm. In selecting the proposed standards, the 
Administrator did not follow what might be called a two-step process, 
involving an initial determination of a ``safe'' or ``protective'' 
level, followed by the addition of a discrete margin of safety to that 
level. Instead, consistent with EPA's decisions over the years, the 
Administrator considered in the course of her analysis such factors as 
the nature and severity of the health effects involved, the size of the 
sensitive population(s) at risk, and the kind and nature of 
uncertainties that must be addressed. As EPA indicated in revising the 
standards for particulate matter in 1987 (52 FR 24641, July 1, 1987):

          In the absence of clearly identified thresholds for health 
        effects, the selection of a standard that provides an adequate 
        margin of safety requires an exercise of informed judgment by 
        the Administrator. The level selected will depend on the 
        expected incidence and severity of the potential effects and on 
        the size of the population at risk, as well as on the degree of 
        scientific certainty that the effects will in fact occur at any 
        given level of pollution. For example, if a suspected but 
        uncertain health effect is severe and the size of the 
        population at risk is large, a more cautious approach will be 
        appropriate than would be if the effect were less troubling or 
        the exposed population smaller.

    This approach is consistent with the advice and recommendations of 
CASAC on the current review of the standards for ozone and particulate 
matter, as well as its advice from previous reviews. It is also 
consistent with judicial decisions specifically interpreting the margin 
of safety requirement in section 109(b)(1) of the Act. In upholding 
EPA's national air quality standards for lead, for example, the U.S. 
Court of Appeals for the District of Columbia Circuit stated:

          Adding the margin of safety at the end of the analysis is one 
        approach, but it is not the only possible method. Indeed, the 
        Administrator considered this approach but decided against it 
        because of complications raised by multiple sources of lead 
        exposure. The choice between these possible approaches is a 
        policy choice of the type that Congress specifically left to 
        the Administrator's judgment. This court must allow him the 
        discretion to determine which approach will best fulfill the 
        goals of the Act.

    Lead Industries Association v. EPA, 647 F.2d 1130, 1161-62 (D.C. 
Cir.), cert. denied 449 U.S. 1042 (1980) (footnotes and citations 
omitted). See also Natural Resources Defense Council v. Administrator, 
902 F.2d 962, 973-74 (D.C. Cir. 1990) (PM NAAQS), vacated, in part, 
dismissed, 921 F.2d 326 (D.C. Cir.), certs. dismissed, 498 U.S. 1075, 
cert. denied, 498 U.S. 1082 (1991); American Petroleum Institute v. 
Costle, 665 F.2d 1176, 1186-87 (D.C. Cir. 1981) (ozone NAAQS), cert. 
denied, 455 U.S. 1034 (1982).
    In summary, the Agency's approach to providing an adequate margin 
of safety in the proposed standards for ozone and particulate matter 
did not involve the addition of a specific increment of protection at 
the end of the analytic process. Rather, the considerations that go 
into selecting a standard that provides an adequate margin of safety 
were taken into account as appropriate at various stages of the 
analytic process, both by the CASAC in offering its advice to the 
Administrator and by the Administrator in selecting the specific 
standards that she proposed.

    Question 9. In your testimony on February 12, you stated, ``The 
standards that we proposed in keeping with the requirements of the law 
are designed to guard against and prevent those premature deaths. 
Because it is death, because it is so severe, we do it with a margin of 
safety, as the law directs us to.'' Would the standard for fine 
particulate matter that you have proposed eliminate all premature 
deaths that may be expected to be caused by exposure to this pollutant 
or would some premature deaths continue as the result of breathing air 
that met the standards you have proposed?
    Answer. The Administrator has based her proposal on a full 
evaluation of peer reviewed scientific information on the known and 
potential effects of PM, not on the results of a national assessment of 
the potential number of premature deaths at alternative levels. EPA's 
assessment of the science, consistent with the advice of CASAC, 
concludes that the current information base does not enable us to 
demonstrate or quantify adverse effects at levels below our proposed 
standards with any degree of reasonable certainty. That assessment of 
the recent scientific literature does find a consistent and coherent 
set of studies that indicate clear relationships between PM and health 
effects at concentrations below those permitted by the current PM 
standards. Nevertheless, as the preamble recognizes, key uncertainties 
and related issues increasingly call into question the likelihood of 
PM-related effects as PM2.5 concentrations decrease below 
the mean values in areas where effects have been observed and/or as 
such concentrations approach background levels (61 FR 65659). These 
uncertainties and unanswered questions, particularly with respect to 
biological mechanisms, have led some to suggest PM2.5 
standards at levels higher than those proposed. By contrast, the 
Administrator proposed to include a greater margin of safety, in part 
because the potential effects are so severe. As detailed in the 
preamble, this led to proposal of an annual PM2.5 standard 
at a level below the lowest mean values in areas where such 
associations were clearly observed.
    Based on the record before the Agency at the time of proposal, the 
Administrator concluded that it is neither demonstrated nor likely that 
significant adverse health effects would occur at PM2.5 
concentrations below those levels that would result from attainment of 
the proposed standards. Consistent with other NAAQS decisions, however, 
the margin of safety inherent in the approach taken by the 
Administrator does not result in a standard with zero risk. If the key 
uncertainties inherent in the epidemiological data base at the lowest 
range of concentrations examined are discounted, quantitative estimates 
can be made of potential effects at concentrations that extend to the 
lowest levels measured in the studies. Although such estimates may be 
consistent with the study results, they reflect only one of several 
possible outcomes, especially at such lower concentrations. Even at 
concentrations where the evidence for the existence of PM effects is 
stronger, the quantitative certainty to be accorded such risk estimates 
is unclear. Because the scientific evidence does not demonstrate 
whether or not any increased mortality is occurring at such lower 
concentrations, such estimates should be viewed with caution.

    Question 10. If premature deaths and numbers of other serious 
adverse health effects would be caused by fine particulate pollution at 
ambient levels in compliance with the standard you have proposed, how 
does the standard provide a margin of safety?
    Answer. See responses to Questions 8 and 9 above.

    Question 11. Although the Staff Paper stated that no studies 
relying on human data indicate premature deaths from exposure to ozone 
pollution at ambient levels, the draft Regulatory Impact Analysis 
released with the proposed standard did include avoided deaths among 
the benefits estimated for the proposed ozone standard. Please provide 
the foundation for this estimated benefit. What studies did you rely on 
to make the estimates? How many deaths are caused by ozone exposures at 
what levels? Would deaths be caused by ambient ozone levels below the 
standard you have proposed? How many deaths at each level of the 
following levels: current standard; proposed standard; .07 ppm, 8-hour, 
1 exceedance; and background (.04 ppm)?
    Answer. Although the Staff Paper noted a number of epidemiologic 
studies cited in the Criteria Document that suggested a possible 
association of ozone with mortality, both the Criteria Document and the 
Staff Paper pointed out flaws and limitations in the available 
literature. The Criteria Document and Staff Paper ultimately concluded 
``that although an association between ambient O3 exposure 
in areas with very high O3 levels and daily mortality has 
been suggested, the strength of any such association remains unclear at 
this time'' (Staff Paper, p. 42). Accordingly, the potential 
association between ozone and mortality does not form a principal basis 
for the proposed ozone standard.
    The current draft Ozone Regulatory Impact Analysis (RIA) reflects 
an analytical attempt to quantify all of the known and potential 
benefits of reducing ozone. As noted in the RIA, a number of such 
benefit categories cannot be quantified with available information. In 
an attempt to capture a full range of potential benefits of reducing 
ozone, including more uncertain and speculative benefits for inclusion 
in upper bound estimates, the RIA staff examined the ozone mortality 
issue. This examination includes several peer reviewed studies that 
have appeared in the literature since publication of the Criteria 
Document. Given the inherent uncertainties involved in such estimates, 
they were used only in expressing an upper bound benefits estimate; the 
lower bound for ozone mortality benefits was zero.
    The ozone RIA is not the only benefits assessment to take this 
approach. A study sponsored by the Economic Commission for Europe 
(EFTEC Ltd, 1996) provided a range of estimates for ozone-mortality 
based on earlier studies contained in the Ozone Criteria Document. In 
addition to these, the RIA analysis also examined more recently 
published multi-pollutant community studies addressing ozone mortality 
that were evaluated in the Particulate Matter Criteria Document. As 
noted on page IX-6 of the RIA, these include studies in several U.S. 
and Canadian cities. While these studies found some evidence of 
association between ozone and mortality, the relative strength and 
consistency for the underlying relationship varied. The available 
studies, taken together, were judged to provide sufficient support for 
a potential relationship to warrant inclusion in an upper bound 
estimate for the benefits analyses. Because benefit functions from one 
of these studies (Moolgovkar et al., 1995) were readily available 
without further analyses, the staff chose to use those functions to 
derive an estimate for use in the upper bound of the range of benefit 
estimates.
    Ozone mortality is an instance where there are reasonable 
probabilities that the effect is nonexistent or that the effect could 
be significant. In this case, we believe it would be premature to set 
an air quality standard based on this evidence, but we also believe 
that an RIA estimate of benefits should reflect an ``expected value'' 
together with a range of possible outcomes. Therefore, for the RIA that 
is to be issued in July with the final NAAQS decisions, we are 
exploring statistical methodologies to evaluate all known studies that 
examined this effect (about a dozen), most of which have appeared since 
the closure of the ozone Criteria Document, to calculate the ``expected 
value'' and range of possible outcomes.

    Question 12. Would the proposed ozone standard eliminate all of the 
premature deaths that might be expected to be caused by exposure to 
ozone in the ambient outdoor air?
    Answer. As noted in answer to Question 11 above, EPA's assessment 
of the scientific evidence does not provide a basis to link a specific 
number of ozone-related premature deaths to a specific level of an 
ozone standard.

    Question 13. Would the proposed ozone standard eliminate all of the 
adverse health effects that would be caused by exposure to ozone in the 
ambient outdoor air?
    Answer. Attainment of the proposed ozone standard would not 
guarantee elimination of all adverse health effects associated with 
ambient ozone exposure for all individuals in the population. In the 
absence of a discernible threshold, it is not possible to select a 
level below which absolutely no effects are likely to occur. As 
discussed in response to Question 14, however, not all biological 
responses are adverse health effects. Moreover, legislative history of 
the Clean Air Act, past EPA decisions on NAAQS, and judicial decisions 
have made it clear that the primary standards are intended to protect 
the most sensitive population groups as a whole and not necessarily the 
most sensitive or most exposed individual. As discussed in the proposal 
notice (61 FR 65727), the Administrator's task becomes one of 
attempting to select a standard level that will reduce risks 
sufficiently to protect public health with an adequate margin of 
safety, since setting a zero-risk standard is neither possible nor 
required by the Act.

    Question 14. If premature deaths or other adverse health effects 
would be caused by exposure to ozone at ambient levels below the 
standard you have proposed, how does the standard provide a margin of 
safety?
    Answer. As noted in answer to Question 11 above, EPA's assessment 
of the scientific evidence does not provide any basis to suggest a 
significant risk of premature mortality in areas meeting the proposed 
ozone standard. With respect to other health effects of ozone, a key 
question is what constitutes an adverse effect. Some biological 
responses vary in degree, depending on the magnitude of exposure or 
other factors. Determining at what point such effects become so 
significant that they should be regarded as adverse within the meaning 
of the Act is a matter of informed judgment that must be exercised by 
the Administrator. To help inform such judgments, EPA seeks the advice 
and recommendations of the CASAC as well as other medical experts.
    As discussed above in answer to Question 8, NAAQS are set at a 
level which provides an adequate margin of safety to protect against 
pollution levels that may pose an unacceptable risk of harm. In making 
such determinations, EPA recognizes that none of the options would 
provide a risk-free standard. For example, in establishing the lead 
NAAQS in 1978, EPA clearly indicated that the standard level was based 
on preventing ``most children'' in the United States from exceeding the 
target blood lead level (43 FR 46246, October 5, 1978). In considering 
what standard level will provide an adequate margin of safety, the 
Administrator takes into account such factors as the nature and 
severity of the effect, the size of the sensitive population, and the 
likelihood and magnitude of exposure and associated health risk. In the 
case of ozone, estimates of the extent to which ambient ozone exposures 
cause effects below 0.08 ppm are based either (1) on extrapolation of 
exposure-response relationships to levels below those tested for lung 
function and respiratory symptom responses or (2) on observations of 
associations in community epidemiology or field studies, where exposure 
to ozone occurs with other pollutants and is not as precisely known. As 
a result, in contrast to the health effects clearly shown in controlled 
human exposure studies at levels down to 0.08 ppm ozone, there is 
increasing uncertainty about the number of individuals affected and the 
magnitude of the effects at levels below 0.08 ppm.
    Based on the record at the time of proposal and the considerations 
discussed above, it was the Administrator's view that the proposed 
standard was requisite to protect public health with an adequate margin 
of safety. The Administrator also recognized at the time of proposal 
that there was a diversity of views on the significance of the various 
health effects associated with ozone exposure and the selection of an 
appropriate policy response in the face of scientific uncertainties. 
Accordingly, in the proposal notice, the Agency solicited comment on 
alternative 8-hour standards both more stringent and less stringent 
than the proposed 8-hour standard. In reaching a final decision on the 
ozone standards, the Administrator will have to decide, after a careful 
review of the public comments, what ozone standard will protect public 
health with an adequate margin of safety.
                                 ______
                                 
     Prepared Statement of Sally Katzen, Administrator, Office of 
  Information and Regulatory Affairs, Office of Management and Budget
    Mr. Chairman, members of this committee, I am pleased to be here 
today to discuss EPA's recent proposals revising the ozone and 
particulate matter (PM) ambient air quality standards (NAAQS). These 
EPA proposals have sparked extraordinary interest from a wide variety 
of affected groups--environmentalists and health professionals, who 
view these standards as a necessary and important step to improving air 
quality; State and local governments, who have the front-line 
responsibility for implementing these standards; and industry and other 
entities, who will have to take the steps necessary so that areas 
comply with the proposed standards. The interests and concerns that 
have been expressed range from the health effects to be ameliorated by 
these standards--and the scientific support and other science policy 
issues underlying these standards--to the administrative and other 
practical means by which these standards will be implemented, to the 
economic effects of complying with these standards--the costs incurred 
by those who will have to change their conduct to implement these 
standards.
    At least in my experience as Administrator of OMB's Office of 
Information and Regulatory Affairs (OIRA), there is more public 
interest in these two proposals than in any other recent rulemakings. 
And I am acutely aware of the interest and questions that have been 
raised about OMB's review of these proposed rules--from the simple 
logistics of how and when we did the review, to the substance of what 
we thought of the proposed rules and the accompanying regulatory 
analyses that EPA prepared.
    The EPA Administrator has prepared extensive testimony, describing 
in detail the Agency's basis for the proposed environmental standards. 
The regulatory agency has the statutory authority and bears the 
responsibility for developing substantive regulatory standards. 
Executive Order No. 12866 specifically recognizes the primacy of 
Federal agencies in the regulatory decisionmaking process.
    OIRA's role under the Executive Order is to provide dispassionate, 
objective review of the Agency's work. Our task is to assure that the 
regulatory agency asks the right questions, considers the relevant 
scientific and other data, employs sound analysis, and balances the 
competing concerns in a reasonable, practical way. In addition, for 
proposed rules, it is important that the regulatory agency presents its 
proposal, and the justification for it, in a way that assures informed, 
meaningful input from the public.
    E.O. 12866 sets forth a number of principles generally applicable 
to regulatory decisionmaking. It was, however, purposefully qualified 
to apply ``to the extent permitted by law.'' That qualification is 
particularly important in this case. Under the Clean Air Act (CAA), the 
EPA Administrator is to set air quality standards that ``protect public 
health with an adequate margin of safety.'' Indeed, the EPA 
Administrator is not to consider economic factors in determining the 
appropriate standards.
    Having said this, E.O. 12866 nonetheless requires agencies to 
prepare economic analyses for proposed and final rules and to submit 
them to OIRA for review, even if economic considerations cannot be a 
determining factor--or even a secondary or tertiary factor--in 
formulating the proposal. Where a statute prohibits the consideration 
of economic factors, such analysis is still important because it helps 
to inform the Administration, Congress, and the public of the benefits 
and costs of regulatory actions.
    In fact, EPA prepared extensive benefit-cost analyses--over three 
inches of material--for these proposed standards. These analyses are 
based on ambitious and sophisticated modeling efforts using inventories 
of known emissions sources in which the Agency attempted to identify, 
locality by locality, the most efficient set of control measures for 
attaining the standards, the costs of these measures, and the extent of 
air quality benefits that would be achieved. Projected air quality 
improvements served as the basis for an assessment of potential health 
benefits, which were monetized by assigning dollar values to each 
health outcome.
    It was particularly important that EPA prepared these economic 
analyses for these standards. While the standards themselves are 
health-based, and may not reflect economic considerations, they are not 
self-executing. Instead, EPA must follow-up these standards with 
regulations to implement them. In the ordinary course, this would 
include: specifying how one would determine whether localities are, or 
are not, in attainment; the timing for achieving attainment; guidance 
on control strategies to achieve attainment; etc. In this 
implementation phase, costs should and will play a very significant 
role. Preparing the benefit-cost analyses during the standard-setting 
phase will ensure that those addressing the implementation issues--EPA, 
its advisory committees, the State and local governments who are 
responsible for implementing these standards, and all those affected by 
the standards--have the best information available.
    Let me now discuss briefly the specifics of OMB's review of these 
proposed standards. Before we received the proposed rules, OIRA staff 
had attended a number of meetings at which EPA explained in general 
terms the methodology it was using in its analysis of these rules 
(e.g., data, assumptions, models, etc.). In addition, EPA and OIRA 
staff had hosted a number of interagency meetings with EPA staff 
briefing other Federal agencies on the general issues surrounding EPA's 
review of ozone and particulate matter standards.
    EPA submitted the proposed rules on November 4, 1996. We had to 
work quickly because of a court-ordered deadline to issue the 
particulate matter standard by November 29, 1996. Although there was no 
court-ordered deadline for the ozone standard, EPA thought it important 
to publish the two proposals simultaneously. This would allow the 
regulated community and other interested entities to evaluate each of 
the proposals with the other in mind, and to consider how the two 
proposals would interact.
    During these 3 weeks available for review, my staff worked 
intensively, often late into the evenings and weekends. We gave this 
matter top priority, putting aside or postponing other 
responsibilities. We were able to identify a number of issues that 
require further work, and while the court-ordered deadline precluded 
full discussion and resolution of these issues with EPA, we have been 
advised by EPA that some of these issues will be analyzed as part of 
the economic analyses that will be provided to us as part of the 
package for our review of the final standards.
    At the final rule stage, we will fulfill our obligations for review 
of these rules under the Executive Order. There are important policy 
issues that need to be considered. And, as at the proposed stage, we 
expect that many affected parties will want to meet with us and share 
their views to assure that we give careful consideration to the 
relevant issues.
    Thank you for the opportunity to comment. I welcome any questions.
                                 ______
                                 
 Responses by Sally Katzen to Additional Questions from Senator Inhofe
    Question 1. I understand the OMB review process for the proposed 
regulations was very short this fall, approximately 3 weeks. How long 
do you normally spend on such a renew, and what steps did you shorten 
during your review? Where there any documents that you didn't have time 
to study and review during the process?
    Answer. Under Executive Order 12866, OIRA generally has up to 90 
days for its review of proposed rules; our most recent statistics 
indicate that the average time for review is roughly 45 days. With 
respect to these proposed rules, as I indicated in my testimony, even 
before receiving the proposed rules, OIRA staff had attended a number 
of meetings at which EPA explained in general terms the methodology it 
was using in its analyses of these rules. Once we received these draft 
proposals, OIRA staff worked intensively, often late into the evenings 
and on weekends. We gave this matter top priority, putting aside or 
postponing other responsibilities.
    As a result of this review, we were able to identify a number of 
issues that required further work. While the court-ordered deadline 
precluded full analysis of these issues with EPA, we have been advised 
that these issues will be analyzed as part of the package for our 
review of the final standards.

    Question 2. How much time will you need to adequately review the 
final rule, given that this is perhaps the largest environmental 
regulation ever?
    Answer. As noted in response to the previous question, we have 
essentially continued our review of these rulemakings since the 
publication of the proposed standard, and have already begun to focus 
on the final rule packages. Given that these are very significant 
environmental regulations--highly visible and controversial--and that 
the court has been unwilling to grant an extension of time, we are 
prepared to devote all available resources in the time allotted.

    Question 3. Did you have enough time to adequately perform a cost/
benefit analysis? Did you follow the Clinton Executive Order for Cost 
Benefit Analysis for Major Rulemakings?
    Answer. Under Executive Order 12866, it is the Agency that has the 
responsibility to provide an assessment of benefits and costs of 
economically significant rules (see section 6(a)(3)(C)), and it is OIRA 
that has the responsibility to provide meaningful oversight so that the 
Agency's regulatory action is consistent with applicable law, the 
President's priorities, and the regulatory principles set forth in the 
Executive Order (see section 6(b)). The ``Cost Benefit Analysis'' 
document referred to in your question is not an Executive Order but 
rather what we characterize as a ``best practices'' document, entitled 
``Economic Analysis of Federal Regulation under Executive Order 
12866,'' that was prepared by an interagency group and released by OMB 
on January 11, 1996.
    In a letter dated December 16, 1996, the Honorable Thomas J. 
Bliley, Jr., Chairman, House Committee of Commerce, asked our views of 
whether, and to what extent, EPA's economic analyses followed the 
significant technical requirements for economic analysis set forth in 
the ``best practices'' document. I have attached a copy of my January 
15, 1997, response to the chairman. The relevant material is at pages 4 
to 6.
    Question 4. How do you know the potential impacts without knowing 
which counties might be in noncompliance? What potential difficulties 
are there in analyzing impacts without monitoring data available? Was 
there additional data that would have made your review more productive?
    Answer. EPA projected the number of non-attainment areas using 
existing data on particulate matter levels for particles that are less 
than 10 microns in size (PM10) in counties across the Nation 
and estimates of particulate matter levels for particles that are less 
than 2.5 microns in size (PM2.5) that typically comprise a 
given level of PM10. As a part of our review, we requested 
that EPA present the extent of the uncertainty of its estimates. In the 
absence of better data on PM2.5 levels in these counties, 
EPA's analysis of the extent of noncompliance will necessarily be 
limited to the analysis in the current Economic Analyses.

    Question 5. Are there scientific uncertainties involved with these 
proposals? Does your office believe more data or research might be 
warranted?
    Answer. As I pointed out in my January 15, 1997, response to 
Chairman Bliley, EPA frankly acknowledged that there is substantial 
scientific uncertainty in the risk analyses on which the benefits are 
based. For my discussion of this issue, see page 6 of the attachments.
    As a general matter, the amount of research data should be 
commensurate with the significance of the decision. Given the sweeping 
scope of these two proposed standards, more data or research would most 
likely be useful, particularly for the particulate matter standard. On 
the other hand, it should be recognized that, depending on the risks, 
social policies, and equity concerns involved, an agency has the 
responsibility to decide, despite uncertainties, what sound public 
policy requires to be done now.
                                 ______
                                 
  Responses by Sally Katzen to Additional Questions from Senator Boxer
    Question 1. What about all of the effects that cannot be monitored? 
How do you ensure that they are not ignored in the evaluation process?
    Answer. In Executive Order 12866, President Clinton set forth the 
regulatory philosophy and principles of regulation that he wanted his 
Administration to follow in developing its regulations. He stated:

          In deciding whether and how to regulate, agencies should 
        assess all costs and benefits of available regulatory 
        alternatives, including the alternative of not regulating. 
        Costs and benefits shall be understood to include both 
        quantifiable measures (to the fullest extent that these can be 
        usefully estimated) and qualitative measures of costs and 
        benefits that are difficult to quantify, but nevertheless 
        essential to consider. (Sec 1(a)). (Emphasis added.)

    The President placed the responsibility for taking these principles 
into consideration not only on the rulemaking agencies, but also on the 
Office of Information and Regulatory Affairs (OIRA) in OMB. In our 
``best practices'' document for performing economic analyses, we 
reiterated the importance of including in economic analyses both those 
benefits that can be readily quantified, as well as those that are 
difficult to quantify and should be assessed in a qualitative manner.

    Question 2. How does OMB take into account the ``cost of delay?'' 
Suppose we waited three more years to revise the standard-the best 
scientific estimate seems to be that 60,000 additional lives would be 
lost. Isn't that a powerful argument for making a decision soon?
    Answer. As a general matter, if an agency has reasonable confidence 
that a rulemaking would improve the health or safety of the American 
public, and if the rule otherwise satisfies applicable legal and policy 
standards, then the agency should move promptly to complete the 
rulemaking and begin to realize the intended benefits. Given the 
assumption posited in your question, there would be considerable 
benefits associated with earlier implementation of the standard.
                                 ______
                                 

                 letter submitted for the record by omb

                          Executive Office of the President
                            Office of Management and Budget
                                  Washington, DC, January 15, 1997.

The Honorable Thomas J. Bliley, Jr.
Chairman, Committee on Commerce
U.S. House of Representatives
    Dear Mr. Chairman: This is in response to your letter of December 
16, 1996, regarding the Office of Information and Regulatory Affairs' 
(OIRA) review of the Environmental Protection Agency's (EPA) recently 
proposed revisions of the National Ambient Air Quality Standards 
(NAAQS) for ozone and particulate matter.
    You asked for my response to four specific questions.
    Question 1. According to section 6(b)(2)(B) of the Executive Order, 
the Office of Information and Regulatory Affairs (OIRA) is supposed to 
have up to 90 days to review ``significant regulatory actions.'' This 
period of time is generally believed to be necessary to analyze complex 
draft regulations. Yet, it appears that OIRA had only about 3 weeks to 
review these very important rules despite advance knowledge of a 
judicial deadline of November 29, 1996 for Agency action.
    Question 1a. Please explain why these draft proposed regulations 
were not submitted to OIRA at a substantially earlier date in order to 
provide OIRA with a 90-day review period as contemplated in the 
Executive Order.
    Answer. Questions about the timing of EPA's submission of the 
proposed rules to OIRA can best be responded to by EPA.

    Question 1b. Please explain what efforts you made to ensure the 
submission of these proposed rules to OMB in time for a normal 
regulatory review as envisioned in the Executive Order.
    Answer. We originally expected EPA to submit the proposals in early 
September. As it became apparent that submittal of the proposals would 
slip, I made a number of requests to EPA to submit these proposals as 
soon as possible so as to provide OMB and other Federal agencies with 
time to properly review them.

    Question 1c. Given the short amount of time available to OIRA for 
review prior to the judicial deadline, please explain the extent to 
which OIRA was kept informed by EPA prior to formal submission of the 
various draft rules for OMB review, particularly with respect to (i) 
data, assumptions, models and analytic methods which were to be the 
foundation of the regulatory analysis; and (ii) the alternative 
standards under consideration.
    Answer. A number of meetings were held over an extended period of 
time with EPA explaining in general terms the methodology it was using 
in its analysis of these two rules (e.g., data, assumptions, models, 
etc.). In addition, EPA and OIRA staff hosted a number of interagency 
meetings with EPA staff briefing other Federal agencies on the general 
issues surrounding EPA's review of the ozone and particulate matter 
NAAQS.

    Question 1d. The presence of an inflexible judicial deadline 
appears to have substantially curtailed OIRA's review of these 
important rules. Please explain whether, and to what extent, you 
believe that the judicial deadline adversely affected OIRA's ability to 
perform its regulatory review responsibilities under the Executive 
Order.
    Answer. During our discussions with EPA staff before the Agency 
submitted the proposals, we identified a number of issues that were not 
resolved in the draft proposals submitted to OMB for review in early 
November. The abbreviated period of review required an intensified 
effort on our part and on the part of other agencies and EPA, and 
several issues were not able to be fully analyzed prior to publication 
of the proposals. We have been advised by EPA that these issues will be 
analyzed as a part of the Economic Analyses for the final rules.

    Question 2. Section 1(b) of the Executive Order sets forth a number 
of analytic and decisionmaking principles that the Administration uses 
to guide regulatory decisionmaking. Please explain the extent to which, 
in your view, these proposed regulations satisfied each of the 
principles set forth in this subsection of the Executive Order.
    Answer. Executive Order No. 12866 establishes 12 general Principles 
of Regulation'' that agencies should follow. (See the attached list of 
principles from the Executive Order.) A discussion of these principles 
as they apply to these proposals follows. We note that EPA will be 
preparing final Economic Analyses in response to comments on the 
proposals from the public and from other Federal agencies. These final 
Analyses will be available for Congress to refer to during its review 
process after promulgation of the standards.
    (Nos. 1, 2, 12) EPA clearly identified the problem that it intends 
to address and the significance of this problem. Ozone and particulate 
matter air pollution is a problem of ``market failure. Private markets 
fail to achieve optimal levels of pollution control because the 
benefits of pollution control do not primarily accrue to those who must 
pay the costs to control pollution. This classic economic problem of 
``enternalities'' is described clearly in the Economic Analysis. This 
problem is not caused by existing regulations. EPA clearly defined and 
described the proposed standards.
    (Nos. 1, 4, 7) The Clean Air Act (CAA) requires EPA to review NAAQS 
every 5 years to ensure that they are protective of human health and 
the environment. As part of this process, EPA has completed 
comprehensive assessments of the peer-reviewed scientific literature on 
the public health and welfare (e.g., visibility and vegetation damage) 
effects of concern associated with these pollutants. These assessments 
were reviewed by the Clean Air Scientific Advisory Committee (CASAC), 
an independent review panel established by statute, with an opportunity 
for public comment during the Committee's review. While CASAC was 
concerned about scientific uncertainties that exist with regard to 
these effects and the lack of adequate research on fine particles, it 
concluded that EPA's assessments provide an adequate scientific basis 
for the Administrator to make policy decisions regarding revisions to 
the existing standards.
    (No. 3, 5, 8, 11) NAAQS are set to protect public health with an 
adequate margin of safety and to protect public welfare from the 
adverse effects of the pollutants of concern. Under the law, EPA is not 
allowed to consider costs and other economic factors in setting health-
based NAAQS. EPA and OMB are, of course, very concerned about the 
economic impacts of meeting any new standards and agree that Congress 
and the public should be fully informed as to the estimated costs and 
benefits that may result from their implementation. EPA's Economic 
Analyses were prepared under Executive Order No. 12866 in order to 
inform the public about the expected benefits and costs of these 
standards as well as to guide implementation efforts to attain these 
standards in a cost-effective manner.
    EPA has not proposed any specific compliance strategy or a specific 
set of control measures for complying with the new standards at this 
lime; instead, it has indicated that it intends to propose an 
implementation strategy at a later date that incorporates 
recommendations from a subcommittee of the Clean Air Act Advisory 
Committee. The specific purpose of this subcommittee is to advise EPA 
on ways to develop innovative, flexible, practical, and cost-effective 
implementation standards to attain the proposed standard. Regarding 
distributional impacts, EPA has tailored the proposed standards to 
provide additional protection for sensitive subpopulations (e.g., 
outdoor exercising children, asthmatics, and the elderly). The analyses 
for these proposals did not address the distributional and equity 
effects of the rule.
    (No. 9) EPA states in the preambles to both rules that the proposed 
revisions to the standards ``will not in themselves impose any new 
expenditures on [state and local] governments'' and thus EPA has not 
performed any analysis of effects on such governments. EPA recognizes 
that any corresponding revisions to associated State Implementation 
Plan requirements and air quality surveillance requirements may require 
additional expenditures. EPA has advised us that these effects will be 
addressed at the time such revisions are proposed and consultations 
with State and local governments will be conducted at that time.
    (No. 6, 10) EPA has found it difficult to assess fully the costs 
and benefits of the proposed rules. Application of all known control 
measures would be insufficient to achieve compliance with the current 
ozone NAAQS in four metropolitan areas, and in 50 counties for the 
current PM NAAQS. The number of such ``residual nonattainment areas'' 
would increase significantly under the proposed standards. The cost 
estimates EPA presents in its Economic Analyses represent this 
``partial attainment'' scenario based on currently identified measures 
with known costs that EPA considers likely to be implemented. EPA 
believes that new, cost-effective measures for reducing emissions of 
fine particles, NOX, and VOCs will be developed in the 
future and will ultimately allow the residual nonattainment areas to 
come into compliance, but it has not estimated the costs of these as 
yet unknown measures. EPA also calculated benefits for the partial 
attainment scenario and found monetized benefits to be greater than 
costs for the proposed PM standard and less than costs for the proposed 
ozone standard.
    There is also a potential overlap between control strategies to 
address ozone and particulates. For this reason, EPA intends to combine 
the implementation of the two standards to allow for efficient measures 
to reduce both particulates and ozone precursors simultaneously. 
However, EPA has not analyzed the extent to which the adoption of one 
of the two standards might reduce the benefits and costs of the other 
standard.

    Question 3. Section 6(a)(3)(C) of the Executive Order sets forth 
certain requirements for the analysis of costs and benefits of 
``significant regulatory actions.'' On January 11, 1996, OMB published 
a guidance document entitled ``Economic Analysis of Regulations Under 
Executive Order 12866,'' to guide agencies' fulfillment of these 
analytic requirements. This document describes the elements that 
agencies should include and the economic methods and practices that 
agencies should use in performing economic analyses under the Executive 
Order.
    (a) Please explain whether, and to what extent, EPA's economic 
analysis meets or fails to meet each of the significant technical 
requirements for economic analysis set forth in OMB's guidance 
document, entitled ``Economic Analysis of Federal Regulations Under 
Executive Order 12866.''
    (b) Please identify any and all technical errors in EPA's economic 
analysis discovered during OIRA's review which had, or may yet have, a 
material effect on the public's complete and clear understanding of the 
risks, costs, and benefits of these proposed rules.
    Answer. The ``Economic Analysis of Federal Regulations Under 
Executive Order No 12866'' lists three basic components of the 
prepublication ``Best Practices'' analysis of Federal regulations: a 
statement of need for the proposed action, an examination of 
alternative approaches, and an analysis of benefits and costs. The 
document includes a number of general principles and technical 
suggestions for each of these components; it is not intended to serve 
as a formulistic checklist.
Statement of need for the proposed action
    The Best Practices document suggests two general topics that should 
be discussed: the market failure, if any, that the regulation is 
designed to correct, and the appropriateness of solutions other than 
Federal regulation, such as market mechanisms or state and local 
regulation. As discussed in response to question 2 above, EPA provided 
a discussion of the market failure which gives rise to the need for air 
quality standards. The CAA mandates Federal standards to address this 
problem and sets specific health-based criteria for standard-setting.
Examination of alternative approaches
    The Best Practices document lists several different types of 
alternatives which should be considered where appropriate, including 
performance oriented standards, alternative levels of stringency, 
alternative effective dates of compliance, and informational measures.
    Air quality standards are by their very nature performance 
standards. The Economic Analyses considered several different levels of 
stringency for both the ozone and PM proposals, but they did not 
evaluate some of the other types of alternatives listed above. For 
example, the current proposals do not include implementation schedules 
for attainment of the new standards OMB has been advised that this 
issue will be addressed at the implementation stage. Finally, in the 
ozone proposal, EPA discussed the communication of public health 
information as a complement to the NAAQS, but did not consider or 
evaluate such an approach as an alternative to progressively more 
stringent NAAQS.
Analysis of benefits and costs
    The Agency conducted extensive analyses of the costs and benefits 
of the proposed standards. These included sophisticated modeling 
efforts based on inventories of known emissions sources in which the 
Agency attempted to identify, locality by locality, the most efficient 
set of control measures to attain the standards, the costs of these 
measures, and the resulting air quality improvements. These projected 
improvements then served as the basis for an assessment of potential 
health benefits, which were monetized by assigning dollar values to 
each health outcome. While these analyses were consistent with the Best 
Practices document and produced much useful information, there were 
several areas where additional work would have been productive; EPA has 
advised us that these areas. noted below, will be addressed in the 
Economic Analyses accompanying the final rules.
    EPA's analytic baseline is compliance with the current NAAQS in 
2007. For the ozone NAAQS, EPA did not disaggregate the cost of the 
control measures to meet the baseline. For the particulate standard, 
the 2007 baseline control measures and the associated costs were not 
presented. Finally, neither standard included adoption of the other in 
its baseline. which could result in an overstatement of benefits and 
costs of both rules.
    EPA evaluated several alternative standards of differing stringency 
in its analysis of both NAAQS. In its ozone analysis, however, EPA 
presented an analysis of two options that ``bracket'' its proposed 
option, but not the proposed option itself. EPA prepared no 
quantitative analysis of the projected costs and benefits of its 
proposed ``SUM06'' secondary standard.
    EPA frankly acknowledged that there is substantial scientific 
uncertainty in the risk analyses on which the benefits estimates are 
based. However, the analyses did not fully reflect the ranges of 
uncertainties associated with various assumptions and ad hoc 
adjustments in the models. In the case of fine particles, for example, 
the uncertainty attributable to the lack of an identified biological 
mechanism for the health effects of concern and the possibility of a 
threshold concentration below which there are no adverse effects were 
not reflected in the range of estimated benefits. For analyses as 
complex as these, it is difficult to document fully all assumptions. 
Nevertheless, there are several areas where additional clarification 
and sensitivity analyses would be helpful. For example, a large share 
of the estimated benefits are due to--and sensitive to--assumptions 
about improvements in air quality during off-peak periods, the periods 
in which most cumulative low-level exposure occurs. For the ozone 
standard, the basis of this ``rollback'' assumption is not clear, nor 
has the Agency performed a sensitivity analysis, as it did for the 
particulate matter rollback assumptions.
    As suggested in the Best Practices document, the analyses discussed 
several categories of benefits that have not been quantified or 
monetized. These include prevention of various respiratory symptoms; 
benefits to ecosystems, including plants and sensitive water bodies; 
prevention of materials damage and visibility improvements. In addition 
to monetized costs, there were also costs that have not been monetized. 
These include the administrative costs to states and local governments 
to plan and implement air quality programs. Finally, the analyses were 
presented in terms of annual benefits and costs, and neither costs nor 
benefits are discounted.

    Question 4. According to press accounts summarizing EPA's recent 
announcements, the proposed new standards will result in costs to 
society of approximately $6.5 to $8.5 billion per year and annual 
benefits to society of $120 billion. Others have suggested that these 
figures may not be reliable. Based on OIRA's independent and objective 
analysis, please provide OIRA's best professional estimate of the 
expected costs and benefits of each of these proposed regulations 
presuming that each is fully implemented as proposed.
    Answer. OIRA has not prepared its own estimate of the likely 
benefits and costs of attaining these proposals. We note, however, the 
following. As to costs, the estimate of approximately $6 to $8.5 
billion per year is a combined estimate for both the ozone and 
particulate matter NAAQS EPA estimated costs of $0.6 billion to $2.5 
billion per year for the proposed ozone NAAQS and $6 billion per year 
for the proposed particulate matter NAAQS. Each of these estimates is 
for partial attainment. EPA did not estimate the costs of full 
attainment because it is not possible to estimate the costs of the as 
yet unknown measures that will be required to allow residual 
nonattainment areas to come into compliance.
    As to benefits, the estimate of the benefits to society of $120 
billion per year is a combined estimate for both the ozone and 
particulate matter NAAQS. EPA estimated benefits for partial attainment 
of the ozone NAAQS of approximately $30 million per year, with a range 
from $10 million to $1,200 million per year, and it estimated benefits 
for partial attainment of the particulate matter NAAQS of $60 billion 
to $120 billion per year.
    As reported in the Economic Analyses for the proposals, there are a 
variety of ways in which these estimates may overstate or understate 
the benefits and costs of these proposals, including factoring in 
nonquantifiable costs and benefits, uncertainties, and efficiencies.
            Sincerely,

                                              Sally Katzen,
                                                     Administrator.
                                 ______
                                 

                               ATTACHMENT

                        principles of regulation
                       executive order no. 12866
    (1) Each agency shall identify the problem that it intends to 
address (including, where applicable, the failures of private markets 
or public institutions that warrant new agency action) as well as 
assess the significance of that problem.
    (2) Each agency shall examine whether existing regulations (or 
other law) have created, or contributed to, the problem that a new 
regulation is intended to correct and whether those regulations (or 
other law) should be modified to achieve the intended goal of 
regulation more effectively.
    (3) Each agency shall identify and assess available alternatives to 
direct regulation, including providing economic incentives to encourage 
the desired behavior, such as user fees or marketable permits, or 
providing information upon which choices can be made by the public.
    (4) In setting regulatory priorities each agency shall consider, to 
the extent reasonable, the degree and nature of the risks posed by 
various substances or activities within its jurisdiction.
    (5) When an agency determines that a regulation is the best 
available method of achieving the regulatory objective, it shall design 
its regulations in the most cost-effective manner to achieve the 
regulatory objective. In doing so, each agency shall consider 
incentives for innovation, consistency, predictability, the costs of 
enforcement and compliance (to the government, regulated entities, and 
the public), flexibility, distributive impacts, and equity.
    (6) Each agency shall assess both the costs and the benefits of the 
intended regulation and, recognizing that some costs and benefits are 
difficult to quantify, propose or adopt a regulation only upon a 
reasoned determination that the benefits of the intended regulation 
justify its costs.
    (7) Each agency shall base its decisions on the best reasonably 
obtainable scientific, technical, economic, and other information 
concerning the need for, and consequences of, the intended regulation.
    (8) Each agency shall identify and assess alternative forms of 
regulation and shall, to the extent feasible, specify performance 
objectives, rather than specifying the behavior or manner of compliance 
that regulated entities must adopt.
    (9) Wherever feasible, agencies shall seek views of appropriate 
State, local, and tribal officials before imposing regulatory 
requirements that might significantly or uniquely affect those 
governmental entities. Each agency shall assess the effects of Federal 
regulations on State, local, and tribal governments, including 
specifically the availability of resources to carry out those mandates, 
and seek to minimize those burdens that uniquely or significantly 
affect such governmental entities, consistent with achieving regulatory 
objectives. In addition, as appropriate, agencies shall seek to 
harmonize Federal regulatory actions with related State, local, and 
tribal regulatory and other governmental functions.
    (10) Each agency shall avoid regulations that are inconsistent, 
incompatible, or duplicative with its other regulations or those of 
other Federal agencies.
    (11) Each agency shall tailor its regulations to impose the least 
burden on society, including individuals, businesses of differing 
sizes, and other entities (including small communities and governmental 
entities), consistent with obtaining the regulatory objectives, taking 
into account, among other things, and to the extent practicable, the 
costs of cumulative regulations.
    (12) Each agency shall draft its regulations to be simple and easy 
to understand with the goal of minimizing the potential for uncertainty 
and litigation arising from such uncertainty.
                               __________
  Statement of the Petroleum Marketers Association of America and the 
          Independent Oil Marketers Association of New England
    My name is Joseph Tomaino. I am President of the Independent Oil 
Marketers Association of New England (IOMA) and I am testifying for 
both that Association and the Petroleum Marketers Association of 
America. These Associations represent almost 10,000 independent 
petroleum marketers. Nearly 90 percent of these marketers are small 
businesses and it is on their behalf that I offer my testimony.
    We are opposed to the EPA proposal to alter the Ozone and 
Particulate Matter Air Quality Standards.
    EPA is moving quickly down the path to the holy grail of many a 
regulatory rule writer: the unreachable standard. The billions spent by 
business, industry and consumers to meet the requirements of the 1990 
amendments to the Clean Air Act have been successful. They have been so 
successful that the environmental bureaucracy appears to be in a frenzy 
to move the goal posts before the public can recognize the absurdity of 
an added wave of Draconian transportation controls and restrictions on 
industrial expansion. The lowering of these standards will have a 
profound effect on the small businesses that we represent as well as 
other businesses and consumers throughout the country. These proposals 
will stymie the growth that is so essential to our national economy and 
America's workers.
    First, we are concerned that the establishment of the proposed 
standard is only marginally linked to public health. Second, we believe 
that EPA has not allowed sufficient time for comment on this proposal 
and has denied small business the opportunities afforded by the Small 
Business Regulatory Flexibility Act to fully participate in the 
preparation of the proposal. Third, EPA has not measured the likely 
costs of this proposal and their impact on the economy.
    The same group of scientific advisors that EPA is relying upon as 
the basis for its severe ozone restriction has acknowledged that 
``there is no 'bright line' which distinguishes any of the proposed 
ozone standards * * * as being significantly more protective of public 
health''. More importantly they have highlighted the rush to judgment 
nature of EPA's proposal by conceding at ``there are still many gaps in 
our knowledge and large uncertainties in many of the assessments''.
    The scientific case for a change in the particulate matter standard 
is equally shaky. Recently, the highly respected Health Effects 
Institute of Cambridge (directed by former MA DEP Commissioner, Daniel 
Greenbaum) questioned (through a team of scientists at John Hopkins 
University) the proposed particulate standard change on the grounds 
that EPA has failed to establish an unambiguous scientific basis for 
its health effect claims linked directly to articulates. Add to this 
the fact that the Harvard School of Public Health, the principle source 
of data for EPA's decision to further restrict particulate matter, has 
steadfastly refused to disclose lost of the raw data for its 
conclusions in the six cities study to the general scientific 
community. Even though several of the studies in question were 
commissioned by EPA, the Federal agency claims it is helpless to force 
Harvard to share its raw data. Recently, we hear that HSPH, perhaps as 
a result of pressure from the scientific community, is ``negotiating'' 
with the Health Effects Institute to turn over more raw data later this 
month or perhaps in February. As we all now, the deadline for comment 
on these proposals is February 18th.
    The small business community is forced to assume that EPA, who paid 
for this research with public money and now relies upon these studies 
to justify its particulates proposal, has tacitly permitted, if not 
encouraged, Harvard to withhold its raw data from full scientific peer 
review.
    In May, 1994 the Clean Air Scientific Advisory Committee asked EPA 
to take the lead in questing that the particulate researchers make 
available the ``primary data sets'' so that a broad spectrum of 
researchers could validate the analysis. Apparently, this 1994 request, 
by the agency's own scientific advisory committee, fell on deaf ears.
    This proposal has been referred to as the biggest air quality 
restrictions ever proposed by EPA. will lead to the reclassification of 
many cities into non-attainment that were not classified as such by 
Congress during their 1990 deliberations on the Clean Air Act. During 
consideration of Clean Air Act, Congress and the President established 
a multi-tier system for classifying cities as to their non-attainment 
status for ozone and established appropriate control measures. This 
proposal would dramatically alter the way control measures are 
established and applied.
    Allowing interested parties a mere 60 days to comment on such a 
sweeping proposal is unconscionable. EPA argues that the appearance of 
haste is due to the fact that they are proceeding under court order. 
However, EPA's media messages generally neglect to point out at the 
Federal court order does not in any way involve the ozone standard.
    Congress clearly anticipated that the EPA would provide sufficient 
time for small business to comment and work with the agency on 
proposals that would affect their business. Separating a proposal that 
will lead to a requirement that states and locals impose control 
measures on industry under Federal law and then claiming such a 
proposal does not impose costs on industry is at best a mythical 
separation.
    Some analysts have estimated that the proposed new standards would 
result in over 800 on-attainment areas triggering automatic 
environmental controls. Non-attainment classification would require 
state and local governments to impose additional pollution control 
measures.
    Independent petroleum marketing companies have already expended 
tremendous resources to stall vapor recovery systems and distribute 
reformulated gasoline and multiple types of diesel fuel. The cost of 
compliance with the additional Federal and state controls made 
necessary by this proposal's lower standards will have a devastating 
impact on these independent motor fuel marketers. We can anticipate a 
further reformulation of gasoline and diesel fuel, an expansion of fuel 
programs to off road use vehicles and engines and additional 
requirements for vapor recovery at retail outlets. The result will be 
increased refining and marketing costs that must be passed on to 
consumers and businesses.
    Based upon the shaky scientific foundation for the proposal, 
insufficient time provided for comment and input and the astronomical 
implementation costs we urge EPA to reaffirm the existing standards for 
ozone and particulate matter. At the very least, the agency should not 
rush a conclusion. The ozone issue is not subject to court order and 
therefore need not be rushed. While the particulate matter standard is 
subject to court order, the agency should simply petition the court for 
additional time.
    Thank you for this opportunity to testify.



         CLEAN AIR ACT: OZONE AND PARTICULATE MATTER STANDARDS

                              ----------                              


                         MONDAY, MARCH 3, 1997

                             U.S. Senate,  
       Committee on Environment and Public Works,  
             Subcommittee on Clean Air, Wetlands, Private  
                               Property and Nuclear Safety,
                                                  Oklahoma City, OK

                      STATE IMPLEMENTATION ISSUES

    The subcommittee met, pursuant to notice, at 11 a.m. at 
Oklahoma City Community College, 777 South May Road, Oklahoma 
City, OK, Hon. James M. Inhofe (chairman of the subcommittee) 
presiding.
    Present: Senators Inhofe, Hutchinson, and Sessions.
    Also present: Senator Thomas.

 OPENING STATEMENT OF HON. JAMES M. INHOFE, U.S. SENATOR FROM 
                     THE STATE OF OKLAHOMA

    Senator Inhofe. The meeting will to come to order.
    Before we start welcoming our panelists we'll make a few 
comments.
    I'd first like to thank the Oklahoma City Community College 
for generously letting us use your resources here. This is a 
great facility. It's close and convenient to the Will Rogers 
Airport. And I think now that we'd all agree it's one of the 
finest institutions around. We're very, very proud of being--we 
thank you very much for allowing us to be here.
    Let me welcome everyone to today's subcommittee hearing, 
certainly welcome Governor Hollister and Governor Keating. I 
would like to introduce my colleagues: Craig Thomas, is the 
U.S. Senator from Wyoming; Tim Hutchinson is the U.S. Senator, 
our neighbor over here to the East from Arkansas; Senator Jeff 
Sessions is from Alabama. I appreciate very much all of you 
coming along with all of the witnesses.
    Today the subcommittee is holding its third hearing on this 
subject. The name of this subcommittee is the Subcommittee On 
Clean Air, Property Rights, Wetlands and Nuclear Safety. It's a 
subcommittee of the Environment and the Public Works Committee, 
I'm the chairman of this subcommittee.
    This is the third hearing we've had concerning the EPA's 
proposed changes in the National Ambient Air Quality Standards 
for ozone and particulate matter.
    The purpose of this hearing today is to hear from State and 
local governments to determine how they would be affected.
    Last December, we found out about these proposed changes by 
the Administration, this actually happened right during the 
Thanksgiving holidays, and some of it went unnoticed.
    I went around the State of Oklahoma and convened 21 
meetings in 21 counties. We felt that they might have to go out 
of attainment if this were to be passed, so we had a chance to 
talk to a number of people at that time. Now we've progressed 
and the comment period has been delayed a little bit and we're 
into it hot and heavy.
    I believe it's important to ensure that everyone, here in 
Oklahoma and around the country, has clean air to breathe. The 
one thing that we all agree, every witness that's going to be 
here today and all of those in the room, is that we do want 
clean air.
    I think the changes in our national clean air policy must 
be carefully considered regarding science and the impact it 
will have on our citizens.
    Our first hearing was the scientific hearing. We invited 
some of the members of CASAC--the Clean Air Science Advisory 
Committee, which is a committee set up by statute to make 
recommendations to the EPA as to the science behind proposed 
changes and regulations. There are 21 scientists. We had our 
first hearing from these scientists. Some were for and some 
were against it, but the one thing that they all agreed on is 
that this is premature, that there is no scientific 
justification for making changes today and to relate certain PM 
standards or PM types as to affecting respiratory illnesses.
    The one thing they all agreed unanimously on is that they 
needed at least 5 more years before they can make a 
determination that these standards should be adopted.
    At the second hearing we heard from Carol Browner, the 
Administrator of the EPA. She defended her proposals even to 
the point of contradicting her own science experts. Since that 
hearing we have discovered the EPA has even tried to censor 
other Federal agencies that disagree with them, specifically 
the President's own Office of Management and Budget.
    Congressman Tom Bliley from the State of Virginia 
discovered a memo from the EPA to the OMB instructing them to 
remove language from their analysis that contradicted what the 
EPA believes.
    Specifically, the EPA wrote the OMB, ``As written, the 
OMB's response could very well damage--be damaging to the PM 
and ozone National Ambient Air Quality Standards effort. Thus, 
we strongly recommend that OMB employ language much more 
similar to language previously submitted by the EPA to the 
OMB.''
    Now, I have to state to the witnesses here and those in 
attendance, this is the first time that I can recall any agency 
that's proposing changes in standards to try to influence a 
report out of the OMB.
    We're going to address this when we get back to Washington, 
but for today's purposes I think you should be aware of it.
    Today's hearing is to talk to people in the community, 
people in the State as to how they would be affected under this 
proposed--the two proposed rule changes in both particulate 
matter and ozone standards.
    Besides the obvious effect on local communities, States, 
the proposed regulations would have a direct impact because the 
States and local governments will be expected to implement the 
procedures.
    I have been disturbed that Carol Browner, the Administrator 
of the EPA, has consistently made statements that--it's scare 
tactics when you talk about car pooling and about when you can 
barbecue and having inspectors come into the State and tell us 
what we can do. She claims that that's not going to happen.
    She bases that claim on the fact that the States will be 
doing this. They will be responsible for doing it. We'll just 
be telling them what to do and, therefore, if they do that it's 
the States making those impositions.
    I would suggest, however, that out in California where none 
of the communities, very few of the communities are in 
compliance they have done such things as mandated car pooling, 
has restricted the time of day that you can burn fires and cook 
on your patio. So, I don't think that's completely out of the 
realm of possibility even here in the State of Oklahoma and the 
other States that are here today.
    The last thing I want to mention is we passed two laws last 
year, one that would stop unfunded mandates and the other was 
called the Small Business Regulatory Flexibility Act.
    I can remember when I was mayor of Tulsa, I'm sure the 
mayors who are here today would agree with this, that the one 
thing that concerns us the most is unfunded mandates.
    In other words, the Federal Government coming in, telling 
us things that we must do but not sending the funding. This is 
something that the Government's been good at, so we passed a 
law saying that you can't do that anymore.
    Well, the EPA is contending that that doesn't apply. If 
there are mandates those mandates will come from the States 
and, therefore, it's not the Federal Government making that 
mandate.
    They also say that in the Small Business Regulatory 
Flexibility Act, which was passed so that any change in 
regulation would have to determine what effects it has on small 
entities, it's called--small entities are defined as small 
businesses and individuals.
    The EPA is contending that there are no effects on small 
business or on individuals because if there are changes then it 
will be the States who are responsible for that and not the 
Federal Government.
    So, I think we have an impasse here in the way that we're 
interpreting the intent of the unfunded mandates law in the 
Small Business Regulatory Flexibility Act.
    Last, I would say that we're going to have these major 
impacts, and we've had a chance to really spend some time and 
we have an excellent group of people here today to--as 
witnesses.
    [The prepared statement of Senator Inhofe follows:]
Prepared Statement of Hon. James Inhofe, U.S. Senator from the State of 
                                Oklahoma
    The hearing will now come to order.
    I would like to welcome everyone to today's subcommittee hearing, 
particularly my colleagues Senator's Jeff Sessions of Alabama, Tim 
Hutchinson of Arkansas, and Craig Thomas of Wyoming. I would also like 
to thank in advance our witnesses today and welcome everyone to 
Oklahoma City.
    Today's hearing is the third in a series of hearings examining the 
EPA's proposed changes to the National Ambient Air Quality Standards 
for ozone and particulate matter. The purpose of the hearing today is 
to receive testimony from State and local government officials on how 
the proposed changes would effect their States and communities. Last 
December, I traveled around Oklahoma conducting 21 meetings with 
different civic groups, Chambers of Commerce, and concerned citizens in 
areas which would be in nonattainment under the EPA proposals. I did 
this to alert everyone to these regulations and begin the process of 
obtaining feedback from the State. Today we continue that process by 
hearing from elected officials.
    I believe it is important to ensure that everyone, here in Oklahoma 
and around the country, has clean air to breathe. But I think that 
changes to our national clean air policy must be carefully considered 
regarding the science behind the changes and the impacts on our 
citizens. These proposals to tighten the rules are coming at the same 
time that the EPA has reported that the quality of our air has been 
improving over the last 20 years. Our air is cleaner today than it was 
just 5 years ago. Is it right to tighten the rules even more, or should 
we continue to let the measures we have in place improve our air before 
we act?
    Our first hearing, held in Washington, DC, examined the scientific 
issues behind the EPA's proposal. We heard from a balanced panel of 
scientific experts expressing a broad range of opinions. Probably the 
most important fact to come out of that hearing was a clear call for 
more time by the scientific community to study the issues behind the 
proposals. Even the most outspoken supporter of the Agency's proposal 
admitted that we need at least 5 more years before we can understand 
all of the issues in the proposal.
    At the second hearing, we heard from Carol Browner, the 
Administrator of the EPA. She defended her proposals, even to the point 
of contradicting her own science experts. Since that hearing we have 
discovered that the EPA has even tried to censor other Federal Agencies 
that disagree with them, specifically the President's own Office of 
Management and Budget regarding the economic analysis required by law.
    Congressman Bliley of Virginia discovered a memo from the EPA to 
OMB instructing them to remove language from their analysis that 
contradicted what the EPA believed. Specifically, EPA wrote to OMB, 
``As written, the OMB's response could be very damaging to the PM and 
Ozone NAAQS effort. Thus we strongly recommend that the OMB employ 
language much more similar to language previously submitted by the EPA 
to the OMB.''
    However, these discoveries have not stopped the rhetoric coming 
from her Office. But these are issues that my subcommittee will 
investigate further back in Washington, DC.
    Today's hearing will concentrate on the effects these regulations 
would have on communities across the Nation if they are enacted as 
proposed. Oklahoma City was selected for this hearing because it is a 
community that has been in attainment under the current rules but would 
be thrown into nonattainment based upon its average ozone levels of 
.085 parts per million. The current rule is .12 parts per million and 
under the EPA's proposal, the level would be dropped to .08. Under the 
proposal, hundreds of counties across Oklahoma and the Nation would be 
in nonattainment for either ozone or PM, with many communities failing 
the standards for both.
    Besides the obvious effect on local communities and States, these 
proposed regulations would have a direct impact because the States and 
local governments will be expected to implement procedures to reach 
attainment. States will be forced to rewrite their State Implementation 
Plans to account for the changes in the standards and local communities 
will need to adopt new strategies to control emissions. Carol Browner 
has been highly critical to claims that these regulations would outlaw 
barbecues and force car pooling. She swears that these proposals will 
not result in these controls. But what she fails to mention is that the 
actual implementation steps would be decided at the local level, and 
that communities in California have previously considered such limits. 
Now they may be forced to implement them because of the stricter 
controls. While I do not expect any of today's witnesses to explain how 
they would meet the new standards, I am extremely interested in whether 
they would be able to meet them, and what the standards would in 
essence require.
    In addition, I hope the witnesses can address how these proposals 
would impact their resources and whether this is the best use for their 
resources. Besides the demands other programs place on your limited 
funds, are these issues even the most important environmental concerns 
facing your communities? Too often in Washington, every bureaucrat 
believes that the problem they work with requires the spending of 
unlimited funds and deserves priority over everything else.
    I hold the position that these proposed regulations violate 
recently passed legislation. Specifically the Unfunded Mandates Law and 
the Small Business Regulatory Flexibility Act.
    Carol Browner has stated that these regulations are not an unfunded 
mandate because the implemented steps will be required by the States, 
not the Federal Government. She also believes that the proposals will 
not impact small businesses, because the States will be the ones to 
impact the businesses, not her. So I would also like to hear if you, as 
Governors, Mayors, State Senators and Councilmen will have the 
flexibility not to impact State resources and small businesses, or will 
the EPA be requiring you to act. When I was the Mayor of Tulsa, I would 
have considered this to be another example of Federal intrusion into 
local matters. I am extremely interested in hearing what our witnesses 
have to say about these matters.

    Senator Inhofe. What I would like to do is--we have plenty 
of time, I'm not going to try to adhere to a real tight time 
schedule, but let's say if you folks who are witnesses would 
submit your entire testimony in writing it will get into the 
record and we'll have the benefit of that, but you might hold 
your remarks down to 5 or 10 minutes if at all possible.
    We'll time it at, what, 7\1/2\ minutes and that will give 
you an idea. But we're not pressed for time today so we'll go 
ahead and on with the show.
    First of all, one of my close personal friends, the 
Honorable Frank Keating, Governor of the State of Oklahoma. My 
next door neighbor for years in Tulsa and someone I'm very 
proud to have as my Governor.
    Governor Keating.
    Governor Keating. Thank you Senator Inhofe.
    Mr. Chairman, and members of the subcommittee, we are 
obviously very honored to have you in Oklahoma to give you an 
opportunity to hear our concerns.
    Senator Inhofe. Let me interrupt for just a minute, 
Governor Keating. I goofed, I should have asked for opening 
statements from the other Senators. So, just remember where you 
are and I'll come right back to it.
    Governor Keating. It's always easy to welcome people.
    Senator Inhofe. Let's start off over here on the left side 
with Senator Thomas from Wyoming.

 OPENING STATEMENT OF HON. CRAIG THOMAS, U.S. SENATOR FROM THE 
                        STATE OF WYOMING

    Senator Thomas. Thank you. I'll be very brief, you've 
covered it very well.
    First of all, let me thank you for holding this hearing. I 
think it's extremely important and important that we get out to 
the country to talk about these kinds of issues so that 
everyone knows about it.
    I'm from Wyoming so we have a little advantage of being 
west of you, Governor, and the wind sort of comes your way so 
that's always helpful.
    We--I guess the main thing that I've discovered over these 
two hearings is the uncertainty. Everyone whose come, all the 
scientists, all the people who really study it are very 
uncertain, so I think that's what we deal with.
    Then it's been caught up in this emotional thing. Of 
course, when you talk about health and children and all those 
things you try to balance that out with the cost, that becomes 
very difficult. Carol Browner, of course, has done that 
specifically and intentionally and so it makes it very tough.
    We ought to understand, of course, as you have, Jim, that 
everybody is concerned about health. What we need to do is find 
the best way to balance the health and what we do in order to 
make a living.
    So, I'm delighted to be here today. I think we do need to 
give some great thought to this so that we can preserve our 
jobs, we can preserve our economy and at the same time do the 
best we can on health and I think we can do the two things 
together. I'll submit my statements in the record.
    Senator Inhofe. Very good. Next we hear from Senator Jim 
Hutchinson, who is actually from Fayetteville, AR, so they have 
a lot of the same problems we have along our adjoining border.

OPENING STATEMENT OF HON. TIM HUTCHINSON, U.S. SENATOR FROM THE 
                       STATE OF ARKANSAS

    Senator Hutchinson. Thank you, Mr. Chairman. I also want to 
thank you for calling the hearing today. It's good to be in 
Oklahoma City.
    I know Oklahoma City is a city that is familiar with 
tragedy and disaster. Unfortunately, we had our own tragedy in 
Arkansas over the weekend with 24 fatalities and 14 tornadoes 
and 9 different counties that have now been declared a disaster 
area.
    Governor Huckaby, I know, would have liked to have been 
here today. He is with James Lee Witt with FEMA in Arkansas 
today and so my heart goes out to all those. We visited a lot 
of them in the hospital yesterday.
    But the President may be flying to Arkansas tomorrow so I 
felt it was important to be here. I think the importance of 
this subject was that it was important to continue to come here 
and to hear testimony today.
    I thank you for calling the hearing on the very important 
subject of these proposed EPA's clean air standards and giving 
us an opportunity to hear most directly from those who are 
going to be responsible for implementing the standards, the 
States and the local governments.
    I think also, Mr. Chairman, it's a highly symbolic, 
important symbolic gesture to have this hearing in the heart of 
America.
    Sometimes Washington forgets that any law, any regulation, 
any proposal that's implemented has far-reaching effects that 
cannot be measured from a hearing room on Capitol Hill. While 
it was important for us to have the hearings in Washington, 
this is even more important, I think, to be here in Oklahoma 
City.
    For the last month we've had two hearings, which have 
helped me to understand, if nothing else, how complex these 
standards are.
    The first hearing we heard from leading scientists on the 
issue, in my opinion, learned exactly how little evidence there 
is to justify setting such stringent standards.
    One thing there was agreement on and that was that more 
time is needed. In fact, I think most of the scientists that we 
heard testify said that 5 years was really needed whether they 
favored implementing the more stringent standards now or 
waiting; they agreed that more scientific study was needed, 
more monitoring, more data accumulation, both ozone and 
particulates. The EPA has chosen the radical and severe 
recommendations of the scientists.
    The scientists, experts in their field, presented 
contradictory testimony and could only agree on one thing, that 
they strongly disagreed with each other.
    So while some of the scientists felt strongly that the 
proposal was warranted just as many thought the proposals were 
not warranted at all.
    So, I think, as we listen to the testimony today I will be 
very interested in hearing how this is going to impact our 
local governments, our State governments and this mandate 
that's imposed how it's going to impact business and industry, 
how it's going to impact the opportunity for economic 
development in our States. We're all most of all concerned 
about health and safety.
    But when you have limited dollars, both public and private, 
we have to make some decisions and whether or not the proposed 
standards are the best way to ensure the health and safety of 
the American people I think is very, very much in question.
    So, I look forward to the testimony today and, Mr. 
Chairman, I thank you for calling the hearing. I would ask that 
my entire statement be included in the record.
    Senator Inhofe. It will be included in the record and I 
appreciate you coming very much.
    Incidentally, I believe this is the largest number of U.S. 
Senators we ever had in a field hearing in Oklahoma so I do 
appreciate all of you coming.
    Senator Jeff Sessions, a new member of the U.S. Senate from 
the State of Alabama.

OPENING STATEMENT OF HON. JEFF SESSIONS, U.S. SENATOR FROM THE 
                        STATE OF ALABAMA

    Senator Sessions. Thank you, Jim, I appreciate being with 
you and being able to share in this hearing.
    I think the single most productive hearing that I've been 
in in my short tenure in Washington was your first hearing that 
you called that deals specifically with the science of our 
clean air.
    You were correct in that and we didn't talk about emotional 
issues. We dealt with would these new standards really help 
people's health. We found that there was serious disagreement 
about that among the experts and I congratulate you for going 
right to the heart of that matter and I also congratulate you 
for bringing us to the heart of America to meet with the people 
who will have to implement the regulations that will be agreed 
upon and passed by Washington.
    It is not the Washington crowd that will have to live with 
it, it's the people in the cities and towns and counties 
throughout America.
    They made a lot of progress. Ozone levels are falling in 
America and the air is getting cleaner. We are making progress.
    I've talked to several people this morning involved in the 
efforts by whole teams of people to identify in their 
communities ways to get their communities into attainment of 
standards and they worked hard at it and it's really depressing 
to them now to have new standards to be dumped on them and some 
of them feel like they may not ever be able to meet and 
question whether or not they can be met.
    So, we need to deal with this question. We need to have the 
cleanest air. We need to have the most care we possibly can for 
our citizens. We need to make sure that our health is not being 
damaged by the air that we breathe but we need to do it in a 
sound and efficient way identifying the best and healthiest way 
to do that.
    We'll be hearing from Governors who--and county 
commissioners and State people who will be dealing with honest 
questions about are they going to have to mandate expensive 
vehicle inspections. Are they going to have to mandate car 
pooling. What will they do? That's one of the things I want to 
ask, what can you do to even make modest reductions in ozone 
standards.
    I won't say anymore. I'll submit my remarks for the record.
    [The prepared statement of Senator Sessions follows:]
  Prepared Statement of Hon. Jeff B. Sessions, U.S. Senator from the 
                            State of Alabama
    I would like to thank Senator Inhofe for holding this hearing today 
to discuss the proposed changes to the National Ambient Air Quality 
Standards for ozone and particulate matter. Holding this hearing in 
Oklahoma City with a panel of witnesses from State and local 
governments gets to the heart of the problem with implementing the 
EPA's new standards--it is not the Washington bureaucrats who would 
bear the expense of trying to comply with new standards:
     it is the Governor who must restrict the building of new 
highways
     it is the Mayor who will have to force the citizens of his 
city to car pool
     it is the State Environmental Director who will have to 
recommend policies to deter economic development
     and most importantly, it is the people, like the family in 
Alabama who may be pushed into poverty because jobs have been lost or 
because of the high cost of compliance in the soon to be named ``non-
attainment'' areas.
    Under Senator Inhofe's leadership, we held two hearings in 
Washington on the issue of the EPA's proposed standards. During the 
first of those hearings we heard from members of the EPA's own Clean 
Air Scientific Advisory Board, which is a panel of scientists who 
advise the EPA in proposing standards for air quality. The testimony 
from those scientists proved that they could agree on only one issue--
that the scientific basis for implementing new standards for ozone and 
particulate matter was incomplete. During the second hearing we heard 
from the Administrator of the EPA who provided Members of this 
committee a ``sales pitch'' for much tougher standards. I have to say 
that I was disappointed that we did not use that time to wrestle with 
the complex issues we are facing.
    The testimony from the EPA scientists showed that high 
concentrations of ozone can have an effect, although a temporary one, 
on the lung function of healthy individuals and can aggravate the lungs 
of those with existing respiratory ailments. The good news is that 
ozone levels have been falling for years. Still many States are still 
struggling to bring their areas into compliance with the existing 
standards, and I commend the tremendous progress they have made.
    What we must determine is whether the EPA's proposed standard for 
ozone goes too far, too fast as Chairman Chafee fears, requiring a 
level close to that which occurs naturally while failing to achieve 
real health benefits for the people who must bear the burden of 
compliance. During the hearing we heard testimony from Dr. Roger 
McClellan, former chairman of the EPA's Scientific Advisory Committee. 
We learned that if New York city was to attain the current standards, 
there would still be some 28,295 people admitted to the hospital each 
year for asthma. If the new standards were imposed, that number would 
drop by 120 individuals or three tenths of 1 percent. I am not 
suggesting that we ignore the suffering of those 120 people who might 
be protected, but I do question whether imposing stricter standards for 
the entire Nation is the most cost-effective way to solve the asthma 
problem.
    The scientific basis for imposing the tighter standards for 
particulate matter was also discussed during the first Clean Air 
Committee hearing. During that hearing, Dr. Joel Schwartz, a member of 
the EPA's Scientific Advisory Board, testified that he had found a 
``causal relationship'' between the level of particulate matter in the 
air and premature deaths and hospitalization. He had conducted a study 
in Birmingham, AL, in 1993 using data collected between August 1985 and 
December 1988 to support his claim. A study conducted by the National 
Institute of Statistical Sciences, a group who actually receives 
funding from the EPA and the National Science Foundation, used the 
exact same data Dr. Schwartz used for his study with one additional 
variable--humidity. The National Institute of Statistical Sciences 
study concluded that, and I am quoting now, ``when humidity is included 
among meteorological variables, we find that the particulate effect is 
not statistically significant.'' Is this the type of science the EPA is 
relying on to justify a tightening of the clean air standards? 
Testimony this committee has heard certainly suggests it is.
    When I asked Dr. Schwartz about this published re-evaluation of his 
study, he was aware of it. He admitted to me that he couldn't be sure 
if humidity did or did not have an effect his conclusions.
    As a father of three, I know and care deeply about children--I will 
not support any policy which will put mine or any other child in harm's 
way. What we must determine is whether there is compelling evidence to 
suggest a tightening of the standards would have significant health 
benefit for children or anyone else. I must say that I thought the EPA 
Administrator's testimony at the Clean Air Committee's second hearing 
was not about the scientific findings her Agency is charged with 
gathering, but an emotional appeal to support a policy decision to 
propose tighter standards.
    For example, one chart the EPA Administrator presented to the 
committee regarding the proposed changes to ozone standards showed that 
74 million Americans are protected by the current standards for ozone. 
Under the new standards, she claimed an additional 33 million children 
would be protected, an additional 7 million asthmatics would be 
protected, and an additional 8 million people suffering from 
respiratory diseases would be protected for a total of 48 million more 
Americans ``protected'' by the new standards or a grand total of 122 
million for both the current and proposed standards. Apparently, the 
EPA Administrator believes the population of this country is comprised 
only of children, asthmatics, and people suffering from respiratory 
diseases because the number she uses just happens to correspond exactly 
with the 1990 census data regarding the TOTAL population of areas 
currently in non-attainment plus the 48 million additional people who 
live the areas which would fall into non-attainment under the proposed 
standards (I would like to submit the EPA chart and 1990 census data 
for the record). Any person testifying before Congress, but especially 
a Cabinet level official, should come prepared to discuss seriously 
these important issues. A promotional effort is not what I am looking 
for. I want to be sure we are doing the right thing before asking the 
American economy and American people to absorb the huge costs these new 
standards would bring. The plain fact is that these regulations could 
cost jobs and make us less competitive in the world.
    I am in support of reasonable policies, based on sound science 
which will protect public health. The testimony which has been provided 
before this committee so far makes me afraid that the proposed 
standards put forth by the EPA do not represent a reasonable policy 
decision, are based on inconclusive science, and cannot be shown to 
have any real health benefits for our citizens. Implementation of these 
new standards will definitely have an impact on the people of this 
Nation, however, it will lead to lost jobs, lost competitiveness in a 
world market and additional health problems for those children and 
families who are pushed into poverty.
    Thank you. I look forward to hearing the testimony of our witnesses 
today who will be on the ``front line'' of trying to comply with the 
proposed standards if they are implemented.

    Senator Sessions. Again, I want to say how much I 
appreciate your leadership and the leadership Oklahoma has 
provided to the U.S. Senate. You have clearly two of the finest 
Senators Washington has. It's been a delight to get to know 
them and my respect for them is unbounded.
    I also am delighted to see that your Governor, Frank 
Keating, and I were U.S. attorneys together in the early 
1980's, I've known him throughout the years and our last 
opportunity to get together was in my hometown of Mobile less 
than a year ago when he and Kathy were there to speak to the 
Salvation Army, that was a wonderful thing for you to do and I 
enjoyed the breakfast together. Frank, it's good to see you 
again.
    Senator Inhofe. Thank you very much, Senator Sessions.
    Governor Keating.

  STATEMENT OF HON. FRANK KEATING, GOVERNOR, STATE OF OKLAHOMA

    Governor Keating. Mr. Chairman, Senator Inhofe and members 
of the subcommittee, it is an honor for me to represent my 
fellow Oklahomans in this hearing because it is important that 
our elected officials and appointed officials, our citizens, 
have the opportunity to review their concerns and their hopes 
with members of this subcommittee.
    I'm especially pleased to see Senator Inhofe is the 
subcommittee chairman. Senator Inhofe, as the mayor of Tulsa, 
was very sensitive to the issues of clean air. As mayor I know 
he told us to turn off our two-cycle mowers and take the bus 
when I was the vice chairman of the transit authority some 
years ago there and we as a community and we as a State have 
been very sensitive to clean air issues.
    I believe Senator Sessions, as a former U.S. attorney, has 
been promoted to glory and I know, Senator Tim Hutchinson, your 
brother Asa who was U.S. attorney with me as well, also now is 
a distinguished member of the Congress and a great compliment 
to both States and obviously to both families.
    Mr. Chairman, I want to apologize, after I complete my 
informal remarks and present to you a formal statement, which I 
hope would be made a part of the record, I have to go to honor 
a friend of yours, Jim Pilsticker, who is the head of Arrow 
Trucking in Tulsa for his role through the Fish and Wildlife 
Service of creating natural habitat in Oklahoma for migratory 
waterfowl and migratory song birds and eagles, this is a 
statement of how sensitive we are to our habitat, how very 
proud we are of the fact that we have tremendous recreational 
opportunities in Oklahoma. We do not have any desire as to soil 
our nest. We want our State to be as pristine as it can be but 
also as prosperous as it can be.
    And for me to join Mr. Pilsticker to be honored in this 
section of the country as the person who has done most to 
encourage the development of waterfowl habitat is a statement 
of our interest in the environment as a State and certainly as 
a leadership community.
    The issue, Mr. Chairman, obviously before us is are the 
proposed increased standards on ozone and fine particles 
suggested by the Environmental Protection Agency necessary.
    My testimony today, as I've indicated, is formally 
presented that I would ask to be made a part of the committee 
record, but informally and formally I'm here as Governor of the 
State of Oklahoma as well as chairman of Interstate Oil and Gas 
Compact Commission representing some 26 States, and also as a 
representative of the National Governors Association 
representing our 50 State Governors.
    In each capacity I have a strong and a lifetime commitment 
to clean air standards that protect the public health.
    However, I think all of us ask the question, and must ask 
the question, are these standards, these rigid standards issued 
without full regard for the totality of scientific evidence.
    The results of these standards in Oklahoma will be--are 
very clear and I think will be very damaging. Oklahoma City, 
Tulsa, and Lawton and some other areas, all of which we are 
growing, as a developing State we're very interested in 
bringing new jobs and new industry to Oklahoma but these three 
cities, with tremendous difficulty, have become containment--or 
attainment cities, would fall out of attainment with the 
Federal Clean Air Act.
    Existing implementation plans would have to be revised, in 
our judgment at great cost, and they would have a negative 
effect on economic growth, something that is very important to 
us, a State that needs to keep its per capita personal income 
and encourage high value, high wage jobs, not only to maintain 
their presence here but to expand and to locate here.
    Oklahoma is proud of its progress to date in assuring clean 
air and the health protection of our citizens.
    However, these proposed new standards are the toughest in 
history, as the members of this subcommittee know. They will 
have enormous impact on the economy and our ability in Oklahoma 
to create jobs.
    Communities forced into non-attainment would be at a huge 
disadvantage in competing for new business in industry and 
jobs. This is especially true, as I know Senator Thomas 
humorously noted, we're a State that there is not a lot in some 
sections of our State to separate us from a lot of other 
States. We have a large agricultural population.
    In this section of the State and West have a wind that 
blows from other places and we're very concerned about the 
impact that these standards would have on our agricultural 
economy, our ability to grow the foodstuffs that provide to the 
tables and for the tables of the rest of America.
    Also our ability, in Tulsa particularly, to expand and to 
provide the income level for the State to provide the education 
level that our people so desperately need.
    An example, of course, is here, Oklahoma City Community 
College cannot be unless we have the jobs and the taxpayers to 
make it be and we cannot expect to have the jobs and the 
taxpayers if we have an arbitrary set of standards that shuts 
down, and I want to emphasize that, Mr. Chairman, literally 
shuts down our ability to expand businesses and to attract new 
business to our State.
    We also believe that this will have a profound negative 
impact on the oil and gas industry, which is the second largest 
employer in the State of Oklahoma, one that has provided us a 
tremendous depth to our economy and prosperity.
    The non-attaining communities would also face increased 
regulation and the possible withholding of Federal highway 
funds.
    We are in the legislature, as I speak, and there are 
members of the legislature present, in the process of trying to 
dramatically expand our State's transportation infrastructure. 
We expect to spend a great deal of money this year in doing 
that. These kinds of things are very worrisome to us because, 
obviously, if we can't do this we shortchange our prospects for 
our young people and we drive them out of the State.
    Also, if we can't do this we shortchange the ability of our 
cities to expand and to grow and to create the tax revenue to 
payoff the bonds necessary to build highways.
    The National Governors Association and the Interstate Oil 
and Gas Compact Commission have asked for extended hearings. 
The EPA, Environmental Protection Agency, has complied and 
we're grateful for that, but they should have taken these 
objections even more seriously and gone back to square one to 
re-examine the standards.
    The scientific credibility gap, Mr. Chairman, that you 
noticed, I think is true. The EPA's own clear air scientific 
advisory committee has failed to agree on the impact, if any, 
fine particulate matter has on respiratory health.
    The current ground level ozone levels before the new 
standards are very close to natural levels. Is the EPA seeking 
to go nature one better?
    The scientific advisory committee took no stand on the 
proposed new ozone levels and the raw data has not been made 
public.
    How can we be asked to make a decision that would cost so 
much when the scientific evidence for that decision is shaky at 
best or uncertain at best and locked in some ones else's files.
    The Competitive Enterprise Institute shows that 72 percent 
think that State and local government should set pollution 
levels and criteria and 65 percent of our public think that 
State and local governments do a better job of protecting the 
environment than the Federal Government.
    As I've noted, Mr. Chairman, and members of the 
subcommittee, we have no desire to soil our nest. We want a 
viable prosperous successful but clean and environmental 
friendly State and we think we can do that, thank you, with 
very definite and close attention to the science and to the 
needs of our public, the health needs of our public.
    What we need, Mr. Chairman, is a true partnership among 
Federal, State, and local and industrial concerns to assure a 
safe and clean environment with due regard for the needs of the 
economy. Instead, we propose to be receiving mandates based 
upon questionable science and driven by unelected officials in 
Washington.
    The IOGCC position is that the new standards would have a 
serious and negative impact on the industries ability to meet 
our petroleum requirements.
    Congress should recall that most oil and gas producers are 
small businesses, hence the standards must be reviewed, in our 
view, under the provisions of the Small Business Regulatory 
Enforcement and Fairness Act as the chairman noted.
    The National Governors Association's position is that a 
cost-benefit analysis must be applied to any new regulation. 
The EPA should be required to certify that all new regulations 
will produce benefits that justify their costs and that the EPA 
and Congress should consider all possible alternatives with an 
emphasis on non-regulatory and innovative approaches.
    In summary, Mr. Chairman, first the proposed new clean air 
standards would have a very debilitating effect on State and 
local governments, on communities and our efforts in Oklahoma 
to encourage economic growth and new jobs.
    Second, the scientific evidence supporting the standards is 
shaky at best and remains a matter of debate among scientists 
and I cannot imagine us applying onerous standards, expensive 
standards if we don't have some kind of common denominator with 
respect to scientific evidence.
    And, third, there is no evidence that the standards would 
significantly benefit the public health.
    On those grounds I oppose the proposed standards, urge 
their rejection and appreciate your being here to listen to the 
concerns of my fellow citizens.
    Senator Inhofe. Thank you, Governor Keating.
    Let me ask you a question. You have to go to this other 
event, normally we'd hear from both of the witnesses then ask 
questions. Do you have time to do that or should we start with 
you?
    Governor Keating. I'm happy to hear my friend from Ohio.
    Governor Voinovich I know is speaking with--through 
Governor Hollister here and it's always an honor to have people 
from Ohio, we need their sales tax revenue, but I'm happy to 
listen to Governor Hollister's testimony.
    Senator Inhofe. Well, Governor Hollister, we appreciate 
very much your coming. I think I mentioned to you that I was on 
a radio talk show this morning in Ohio and they all love you 
dearly there.
    They also mentioned that Governor Voinovich has led the way 
in this subject area and so he regretted he couldn't be here 
but we're most appreciative that you are here with us today and 
we're anxious to hear your testimony.

 STATEMENT OF HON. NANCY HOLLISTER, LIEUTENANT GOVERNOR, STATE 
 OF OHIO; ACCOMPANIED BY BOB HOSENBURGIE, CLEAN AIR DIVISION, 
                            OHIO EPA

    Lieutenant Governor Hollister. Yes, Senator Inhofe.
    Mr. Chairman, thank you very much. I appreciate the 
invitation and I too appreciate all of you as U.S. Senators 
taking the time to have the field hearing to listen to those of 
us in the States that have, I think, some very serious stories 
to tell.
    Governor Keating, I'm delighted to be in Oklahoma, and I 
appreciate your hospitality.
    As you all know, I represent the other part of the heart of 
the Midwest in the United States, the great State of Ohio. I'm 
delighted to be here today because Ohio has a story to tell.
    In listening to your opening statements and Governor 
Keating's well-put remarks, I would agree with everything that 
has been said that this issue is not about clean air.
    Because for almost the last 30 years every State in this 
country has made clean air and clean water part of their 
process, part of the government at every level in the State 
level as well as the local level and that substantial progress 
has indeed occurred not only in Ohio but throughout the country 
in trying to meet attainment standards, in trying to deal with 
the situations that apply to the environment.
    But the issue, as it has been appropriately stated, the 
issue is proposed changes to the standards by U.S. EPA and that 
this proposal will, in essence, reduce ozone smog levels by an 
additional one-third and limit particulate matter for the first 
time ever.
    In short, in my opinion, representing the State of Ohio, 
the proposed standards are draconian. They are not based on 
sound science and they will indeed be cost prohibitive for all.
    But I'd like to take a moment and look at the State of Ohio 
and what we have been able to accomplish yet as our 
environmental concerns have progressed.
    That since the passage of the Clean Air Act, Ohio has seen 
peak ozone levels drop 25 percent overall and in some instances 
up to 50 percent in some of our major urban areas. Since 1972, 
Ohio industries and businesses have spent more than $5 billion 
on capital costs to control pollutants.
    In 1993, all seven major metropolitan areas in the State of 
Ohio were in some form of noncompliance. Today we have only one 
metropolitan area that remains in noncompliance and they're 
within .03 of a point of being in compliance. We have only two 
counties out of 88 in the State of Ohio that are not in 
compliance with existing particulate matter and they too are 
very close to attainment. So, we have worked very hard in Ohio 
to comply with the standards that have been put in place.
    What have we done as a State, and I think that was a very 
appropriate question, Senator Sessions, that you asked, and 
that in Ohio we have put E-Check.
    Now, let me tell you, if you don't have E-Check in Oklahoma 
you would find that E-Check is one of the most disastrous words 
you will ever hear. It has been a major sore point for 
constituents in the State of Ohio.
    E-Check right now, even passing 4 million Ohioians who pay 
$19.50 to have their emissions checked on their automobile. If 
they do not pass this test they cannot get their vehicle 
registration and would have had any number of problems.
    Some of our sister States, in Pennsylvania, is examining 
their whole E-Check program. The State of Michigan has, in 
effect, suspended their program because of the problems.
    Additionally, in Ohio we have put vapor control systems on 
gasoline pumps in selected areas throughout the State, again, 
trying to address this problem.
    We have numerous industrial controls and voluntary 
compliance programs throughout the State of Ohio. In fact, the 
communities are very great being involved in this. Chambers of 
Commerce in every urban area put out alerts, are in contact 
with their business and industry saying, you know, what are 
your emission levels, make sure you check them, it appears we 
could be in noncompliance.
    So, we have a system in place through local government, 
local chambers, with State government in Ohio EPA to always 
look to attaining the standards.
    You know, Federal reports have shown that through 1995 Ohio 
public utilities spent $3.7 billion on air pollution controls. 
That is more than the combined expenditures of New York, New 
Hampshire, New Jersey, Vermont, Massachusetts, Maryland, Maine, 
Delaware, Connecticut, and Rhode Island. So we feel that we are 
truly doing our part.
    The impact, if these standards are imposed, what would 
happen to the State of Ohio is in effect all seven of our major 
metropolitan areas would fail the new ozone standards. And that 
21 counties, more than any other State in this county, would 
fail the new particulate matter standards. In total, we have 88 
counties and by EPA estimates, and I have a map here that shows 
it very dramatically in the red 52 counties would be non-
attainment, noncompliance. In the blue areas that's uncertain. 
We could be looking at an entire State in non-attainment.
    This is not an urban and a rural issue. This is an issue 
that faces everyone whether you live in a major metropolitan 
area or a small rural county. I'm from southern Ohio. My 
county's population is 62,000. They will be non-attainment.
    We have small counties like in Noble County with 11,000 
population, they will be non-attainment. In addition to the 
cities of Cleveland and Toledo and Cincinnati and Youngstown 
and Columbus. So we have a very serious situation and a 
devastating economic impact facing the State of Ohio.
    When I look at the particulate matters standards, 
PM2.5 will become something that we're all very 
familiar with, that there is no State or national monitoring 
network in place now. In fact, equipment necessary to do this 
to the standard that U.S. EPA wants does not exist at this 
point in time. It's been appropriately pointed out, there is no 
data available on the health risk.
    I would also mention for the record that President Clinton 
in his budget proposal to Congress has placed $26 million to 
study the issue of particulate matter and how it relates to 
health benefits. That clearly points the facts are not 
established on health risk and particulate matter.
    The consequences to the State of Ohio we will have an 
expansion of the dreaded E-Check and that we will have the 
opportunity to put in place mandatory clean fuel, and I say 
that somewhat facetiously, because it looks as though mandatory 
clean fuel could cost an additional 10 cents per gallon and 
that there will be more controls, more restrictions on business 
and industry.
    Additionally, we anticipate that there will have to be a 
reformulation on consumer products, whether that's how long it 
takes paint to dry or aerosol containers.
    Our Department of Development has identified 17,500 
manufacturing facilities in our State that cover over 900,000 
jobs. This is 80 percent of our manufacturing work force. It is 
anticipated that all of these companies would be located in 
non-attainment areas in the State of Ohio and the cost to try 
and comply would be prohibitive. And that Ohio EPA estimates 
that only partial compliance cost would be $760 million 
annually, that is outrageous.
    From my personal perspective, when I look at this issue on 
the national level it is also a global issue because what is 
driving U.S. EPA. What promulgated them to reach the point to 
put these standards in place that are so prohibitive to States 
in this country.
    From my concern it's something that you need to be very 
aware of because climate control is a global conversation. We 
have treaties in place. We have discussions taking place right 
now in Geneva. We have an article called the Berlin mandate, 
which, quite frankly, puts us in a no win situation because we 
have representatives of the U.S. Government signing treaties in 
Europe that binds us to limiting further our emission controls 
while excluding developing countries and I have a problem with 
that. This is a discussion that needs to be--have a check and 
balance with the U.S. Congress.
    I would also like to reinforce what Governor Keating has 
said and what you all have mentioned, that you have a window of 
opportunity as U.S. Senators to examine this issue because I 
truly believe that U.S. EPA will proceed, they will put these 
measures in place and you have a 60 day window of opportunity 
to rescind these measures, to make a comment. On behalf of the 
State of Ohio I would urge you to do so. Thank you.
    Senator Inhofe. Thank you, Governor Hollister.
    Governor Keating, I had an experience the other day when I 
was doing these 21 meetings around the State, one was in Sand 
Springs, and one of our valued industries, Sheffield Steel, I 
know you've visited them many times, was there, they now are 
operating three shifts a day 7 days a week.
    One of the things California experienced is that some of 
the companies that have been operating at that kind of an 
accelerated program are cut back, it was mandated they be cut 
back to--in one case it was 4 days a week one shift a day.
    Now, one of the many things that you have done very, very 
well, and I think you followed the lead of our former beloved 
Governor and U.S. Senator Dewey Bartlett, is in your industrial 
recruiting effort where you actually go in to the CEO and sit 
down and talk about what we have in Oklahoma.
    I'd have to ask you if these standards are lowered at the 
number of counties in Oklahoma that even the EPA agrees would 
come out of attainment what would you tell those CEOs when you 
go in to sit down in their offices?
    Governor Keating. Well, and--Senator, that is a challenge 
because those of us who are Governors who not only visit CEOs 
of companies within the United States but also companies 
without the United States want to talk about our productivity 
levels, our educated work force, the tax structure, the 
regulatory structure, but if they think that there is something 
out here, a mist, if you will, that will negatively impact 
their ability to expand or to locate they will not do it.
    I mean money and jobs are very fungible. If they think that 
as a result of something they can't control and that I can't 
control that they will be discouraged from being successful in 
my State they will not come. The reality is a developing State 
like Oklahoma cannot have that happen.
    You know, it's one thing for us to catch up with California 
or to catch up with Connecticut in terms of income. They have 
an infrastructure in place we don't have. We have to catch up 
sensitive to our environment but we have to catch up.
    It would be catastrophic for our ability to keep our young 
people in Oklahoma, to expand our job base, to increase the per 
capita income of our people if I couldn't answer that question 
with any kind of sense or fact.
    Right now to say that these are issues outside of my 
control, no matter how hard we work as a State, and we have 
worked as a State, you know as mayor of Tulsa how hard we 
worked to make our State pristine, it doesn't matter.
    Someone who has never been here will tell us what we can or 
cannot do. That is, in my judgment, anti-Federal and it 
certainly is completely contrary to the ability of our--the 
opportunity for our ability to grow.
    Senator Inhofe. Governor Hollister, what would your posture 
be?
    Lieutenant Governor Hollister. I would agree with Governor 
Keating. And we experience this right now.
    When any company is looking at Ohio as a place to locate 
one of the first questions that's asked is what is your 
attainment or non-attainment status. And you don't even further 
the conversation. That's the end of the conversation. You may 
never even know that they're looking at your State. Or if you 
have an existing industry that wants to expand their expansion 
plans are automatically limited by the amount of the emissions 
they put in the air.
    So--and I would agree with his comments that it is a very 
frustrating situation to have to deal with a set of standards 
that as a State government or local government you have no say 
in, that someone else made the decision for you and try to 
explain that a Federal action leads to State consequences.
    Senator Inhofe. I use the Sheffield Steel example, but 
there are many others around. I use it as an example also 
because when they showed me how they're operating; they're at 
three shifts a day and the number of people that they employ in 
northeastern Oklahoma, they made the statement that if this 
happens and if they are cut down in terms of the numbers of 
shifts a day they wouldn't be able to find a place in the 
United States that they could move to. This would cause them to 
have to look elsewhere, overseas.
    Lieutenant Governor Hollister. Oh, absolutely.
    Senator Inhofe. I also want to say that it sounds like I'm 
being very negative about Carol Browner, she happens to be one 
of my favorite people. You know, you can--one of the things 
that you can do in Washington is you can truly like somebody 
and disagree with them and that's the relationship that we 
have. She's been in my office many times and we've had many 
conversations.
    But I am very critical of her interpretation of the two 
laws that I described in my opening remarks, the unfunded 
mandate law as well as well as the flexibility laws that were 
passed.
    The response that she gave, Governor Keating, that this is 
not an unfunded mandate to the States, such as the State of 
Oklahoma, because the States are going to have to make the 
determination as to what they're going to do to come into 
compliance if the standards are lowered. That this is--that 
there is no responsibility under the flexibility law for the 
Federal Government to explain what's going to happen to ``small 
entities'' because the States will be doing that.
    What's your interpretation of that response?
    Governor Keating. Well, that's the only response she could 
give to you. I mean the reality is this is a tremendous 
potential burden on us. The State will have to pay in lost 
wages and lost development opportunities and, of course, we'll 
have to pay to comply for those operations that we are involved 
with, but the private sector, of course, that fuels the engine 
that keeps us alive will have to pay big time.
    I think that any time the Government proposes to do 
something it makes abundant good sense to say, well, how much 
is this going to cost, will this really do the things that we 
propose to do.
    As I know all of the membership of this subcommittee said 
at the outset of your presentations, we want clean air, we want 
clear water, but, you know, there is a level beyond which an 
enormous additional investment does not provide and enormous 
additional benefit and that is the line that needs to be found.
    We want appropriate scientific evidence to find that line 
and all of us as a people will lock arms together to go up to 
that line. But right now when there is confusion and 
disagreement within the scientific community and we are asking 
a developing State like Oklahoma to expend enormous resources 
to kill our ability to grow and to prosper I think it is simply 
not in the best interest of the country and certainly not in 
the best interest of Oklahoma.
    Senator Inhofe. Thank you. Governor Hollister, you used a 
couple of figures, one was that the President has in his budget 
$26 million.
    Are you aware that last year we had in our budget $28.8 
million for the express purpose of studying this to see what 
scientific basis there is for making changes and that money 
wasn't spent for that purpose, Instead they come out with these 
recommendations.
    The other thing that I wanted to mention, did I hear you 
correctly, tell me again about the $3.5 billion.
    Lieutenant Governor Hollister. We have our utilities--our 
public utilities in the State of Ohio have spent on emission 
control, pollutant control devices, $3.5 billion through 1995 
and this impacts our coal industry.
    We're talking about trying to comply with the standards, we 
have lost over 12,000 jobs in the State of Ohio in our coal 
industry as a direct result of the last standards that 
implemented and we did comply, but the expenditure was $3.5 
billion.
    Senator Inhofe. Well, you know, if it was $3.5 billion 
would you say that the EPA's estimate as to what this cost 
would be nationwide, $6 billion might be a little conservative?
    Lieutenant Governor Hollister. We think it's very 
conservative. Because we estimate partial compliance being at 
$670 million.
    Senator Inhofe. Thank you. Senator Thomas.
    Senator Thomas. Thank you. Let me pursue just a little bit, 
as the chairman said, when we ask about the cost EPA says, 
well, we're not creating the costs it's the States as they put 
in their State implementation program.
    Somebody, I think it was our friend from Missouri, said it 
was like someone shooting a bear then blaming the bullet.
    Do you--will you have flexibility as to the way that you 
can adhere to these regulations enough to reduce the cost?
    She indicated you could do different things in the State to 
alleviate the cost. How do you react to that?
    Governor Keating. I mean obviously Lt. Governor Hollister 
will jump in and perhaps have a little finer point, but the 
reality is we probably all are going to have to do it in much 
the same way because all of us are first world economies. All 
of us have--you know, many of us have coal mining operations. 
We have agricultural operations. We have industrial operations 
of various sorts and, of course, we have service industries, 
but we'll all have to do it in about the same way.
    It's just that incremental additional benefit that is 
enormous cost that we question. As we were all growing up we 
competed against 49 other States, you know, now we're competing 
against 49 other States and 140 other countries. This is--we 
must do this right or don't do it because it is going to be 
expensive.
    If we make sure that the expense is justified, is worthy of 
our investment, it really will have a profound positive impact 
on public health, then that's something we can debate but when 
the scientific community is uncertain, there's some that say it 
really won't have much impact. To have us have to do it 
virtually in the same way at an enormous cost and assurance 
that we will not have the job growth and the income growth we 
need to provide for our youngsters.
    Lieutenant Governor Hollister. I would concur with the 
Governor. I think that the interesting conversation or the 
explanation that they just simply propose standards and the 
responsibility therefore is ours and therefore the 
responsibility is not at the Federal level it is double speak 
and, indeed, is it the bullet, the gun or the bear.
    But from Ohio's perspective, you know, you've got latitude 
in any number of standards, as it has been explained to me, 
that's not the problem. The problem is, the bottom line is you 
still have to implement them.
    In implementing changes or increasing emission controls on 
any given factory or plant or we're going to move into other 
dimensions now too it seems, it's going to cost money to do so. 
And to make that kind of an expenditure, as the Governor 
pointed out, without sound science makes no sense.
    Governor Keating. Senator, if I may say this, and I 
apologize, I've got to go, but how do you do this in an 
agricultural economy consistent with the most modern 
technology. I mean how do you not turn the earth.
    Last year we had a very severe drought. We had to turn the 
earth. Obviously there are particulates that will go into the 
air as a result of that. You've got to turn the earth. You 
can't, you know, not do that. I don't care how modern your 
technology, you have to plant seeds, you have to harvest corn, 
you have to harvest wheat, you have to harvest cotton, those 
products in our State there are only certain ways you can do 
it.
    What it will do, it seems to me, is reduce the amount of 
harvesting done, reduce the amount of planting done, reduce the 
amount of expenditure and investment in the agricultural 
sector, which, of course, will dramatically raise food prices 
for what purpose, that's what worries us, where is all this 
leading us.
    Lieutenant Governor Hollister. I think the other point, 
even to comment on what the Governor said, we're looking at 
major highway construction in Ohio, may have to stop or be 
carefully monitored.
    When you're talking about increasing Oklahoma's 
infrastructure system you're going to face the same problem 
that even highway construction will come under some sort of 
monitoring especially when it comes to particulate matter, very 
difficult situation.
    Senator Thomas. We had a little trouble with forest fires, 
they sort of mess up the air around town.
    Senator Inhofe. Senator Thomas, if I could interrupt you 
for just a moment.
    Since Governor Keating has to leave there was one question 
that Senator Sessions had of you before you left and then I'd 
ask Governor Hollister if you could remain. Thank you.
    Senator Sessions. Governor Keating, I think one thing that 
we need to not lose sight of is the fact that the reaction of 
the Governors as a whole, not just the two of you, but the 
whole Governors conference is it fair to say is very concerned 
about these standards and are very troubled that they may hurt 
the economy of this country?
    Governor Keating. Well, Senator Sessions, that is not a 
partisan issue. Democrats and Republicans alike, the NGA, as 
you know, represents both parties as well as the Independent 
Governor, the Governor King of Maine, and all of us are 
concerned with the science, with the dynamics, with the 
results, with the economic costs, with the impact on our States 
to grow.
    Of course, once again, with people that we can't get hold 
of who will make these decisions, will force us to do things 
without any responsibility or any response. We find that very 
troubling.
    That is from the National Governors Association, people of 
both parties, both concerned with where this is leading us.
    Senator Sessions. And the Unfunded Mandate Act that passed, 
what, 2 years ago, you felt would give you protection for this 
very kind of thing; is that correct?
    Governor Keating. Absolutely. I think that it does apply. I 
don't care how nicely you might want to lawyer this language, 
the fact is this is something that's going to cost us. The 
issue, of course is, does it make sense? Is it cost effective? 
Will it contribute to public health and safety? And if the 
answer is we don't know then why are we doing it.
    Senator Sessions. Well, it's easy for somebody to get the 
credit or to pass a rule to say cleanup the air and walk away 
and you have to do the job.
    Governor Keating. That's correct.
    Senator Sessions. That's good--that's the kind of problem I 
think we're dealing with at the most basic level.
    Governor Keating. Yes, sir.
    Senator Sessions. Some people, you know, and I don't know 
all the answers and I'm learning but I can see where the 
dynamics lie and it's going to--the burden is going to fall on 
the States and the localities.
    Governor Keating. Right.
    Senator Inhofe. Governor Keating, thank you very much. I 
know you do have to leave and I appreciate your coming by and 
spending this time with us.
    Governor Keating. Thanks, Mr. Chairman. I told Lt. Governor 
Hollister, I apologized to her to have to take all these 
questions but, I'm sorry, I do have to go to this luncheon.
    Senator Inhofe. I have a feeling she can handle it.
    Governor Keating. I think she can too.
    Senator Inhofe. Thank you, Frank.
    Senator Thomas, did you want to say something?
    Senator Thomas. I just have one more. I guess I missed--we 
hear a lot of discussion from the New England States, you 
alluded to it in your statement, that they're concerned about 
the interstate movement of pollution and that they are being 
affected by the coal fire generation in the midwest. How do you 
react to that?
    Lieutenant Governor Hollister. That is a statement that's 
been repeated often. In the last several years a group has been 
put together, in fact it's nationwide--the OTC, the Ozone 
Transportation Group--to study this issue.
    According to initial scientific data, the State of Ohio's 
airborne pollutants stay within a hundred mile radius. Indeed, 
airborne particulate matter from Ohio could be drawn in a 
circle with a hundred mile radius. That area's air is what we 
would have to concentrate on for environmental control, not the 
New England States.
    So, to learn these facts was very heartening because we 
toss around words. We talk about, even from the New England 
States, saying, well, those of you, the old industrial States 
are polluting us. And how is that? Never has there been sound 
science to say that's actually happening.
    So, the OTC group are the formation of those groups, 
multiple States have been very, very helpful because we feel 
very strongly that within a 100 mile radius is where you look 
for airborne particles, not 500 miles or 800 miles.
    Senator Inhofe. Thank you, Senator Thomas. Senator 
Hutchinson.
    Senator Hutchinson. Governor Hollister, thank you for your 
testimony. I notice that what Governor Keating and yourself 
both focus a great deal upon is the disincentive that would be 
created for investment for business and industry for the very 
real competitive disadvantage that many States would be placed 
at and, of course, I guess Ohio's procedures being more 
developed than Oklahoma or Arkansas.
    This is a huge issue in the State of Arkansas, a State that 
has for many years not experienced great economic growth. We've 
not seen per capita income increase like we would like and not 
seen the jobs created and now that's happening. And to many of 
us, as we look at economic growth in Arkansas, we see that 
being jeopardized by these kinds of very onerous and not 
justifiable standards.
    But one other, I think, concern that has not been raised 
about what might happen is the impact upon ISTEA funds.
    I serve--our committee in fact will be reauthorizing the 
Intermodal Surface Transportation Efficiency Act, the Highway 
Funding Bill and Highway Policy and one of the conditions, of 
course, that EPA has the right, if they find a State out of 
attainment, to withhold those transportation funds from the 
State and that in Arkansas would also be very devastating, as 
I'm sure it would impact----
    Lieutenant Governor Hollister. It would be in Ohio also, 
Senator, it would be very detrimental.
    Senator Hutchinson. One of the--when we had Administrator 
Browner, one of the areas that I questioned her was regarding 
the time table for establishing sufficient PM2.5 
data and comparing that to the timetable that the Clean Air Act 
would require Governors to act and for them to comply, and she 
agreed that it would really take about 5 years for the 
monitoring network and for everything necessary to be in place.
    But when you read the Clean Air Act the law requires that a 
year after a regulation is promulgated Governors must submit a 
list of non-attainment areas in their State.
    I remember Administrator Browner brought this very 
impressive looking chart that demonstrated the monitors that 
currently exist to monitor PM2.5. While there are 
thousands of monitors for PM10 there were a grand 
total of 51 monitors nationwide for PM2.5.
    So to promulgate a standard this year without even having a 
network in place to monitor that data would seem to be almost 
impossible, putting the States in almost an impossible 
situation.
    Now, you gave a number of statistics and I'm really 
curious, the 2 counties out of 88 are out of compliance 
currently, so you said very well.
    Lieutenant Governor Hollister. Yes.
    Senator Hutchinson. That if these new standards were 
imposed 21 counties----
    Lieutenant Governor Hollister. Twenty-one counties, that 
would be more than any other State.
    Senator Inhofe. Out of 88?
    Lieutenant Governor Hollister. Out of 88.
    Senator Hutchinson. Out of 88. And how $760 million annual 
cost, 17,500 businesses and 900,000 jobs would be located in 
the non-attainment area, is that----
    Lieutenant Governor Hollister. That's 80 percent of our 
manufacturing work force that are located in major urban areas, 
which would fall into non-attainment.
    And what--you start almost splitting hairs because you're 
talking about particulate matter attainment, you're talking 
about ozone attainment and we break all of that down in the 
State of Ohio, but what it comes down to is that 52 counties, 
and that is a very conservative estimate, would be non-
attainment either for ozone and/or particulate.
    Senator Hutchinson. How, without these monitors, how could 
you--how did you arrive at--are these just pretty rough 
estimates or do you feel comfortable, how----
    Lieutenant Governor Hollister. These are estimates from 
U.S. EPA as well as Ohio EPA evaluating their data.
    Again, that's part of the frustration. When we're talking, 
and I showed you the map, these are just preliminary estimates, 
they're very conservative, and that's sort of a baseline and we 
anticipated it to be much worse than that but it's a place to 
start. They're called hardcore guesstimates.
    Senator Hutchinson. Hardcore guesstimates.
    Lieutenant Governor Hollister. That's what we're dealing 
with.
    Senator Hutchinson. The requirement is that within a year 
when the regulation is promulgated the Governors must submit a 
list of non-attainment areas in their State. Without the 2.5 
monitoring network in place would it even be possible for you 
to provide that information within a year?
    Lieutenant Governor Hollister. I think it would be very 
difficult to do and I think each State has a very active 
environmental protection agency. And, again, we would be 
putting forth our best guesstimate.
    I have with me Bob Hosenburgie, who is the head of our 
Clean Air Division for Ohio EPA and he might want to address 
that specifically if that's permissible, sir.
    Senator Inhofe. That would be, yes.
    Lieutenant Governor Hollister. Bob.
    Mr. Hosenburgie. Thank you, Mr. Chairman and members of the 
committee.
    The specific item you hit upon, in Ohio, although we have 
an extensive monitoring network, we do not operate any monitors 
for PM2.5. Specifically because U.S. EPA has not 
approved a methodology to do so. We did not want to invest the 
money in monitors to attempt to measure PM2.5 to 
only later find out that's it's not the approved methodology 
and that those--that that equipment would not be useful 
anymore.
    So, you are correct in that I do not know how we would 
present to U.S. EPA information within a year as to what areas 
would be in attainment or not attainment because in fact the 
data does not exist.
    And to just further explain. The 21 counties are based on 
U.S. EPA's proposal, the data that they gave out and they also 
say that it's subject to significant uncertainty.
    Senator Hutchinson. So, within a year you're not certain 
that you could with any degree of confidence even come up with 
a list of non-attainment areas much less a plan as to how to 
control and mitigate the new standards?
    Mr. Hosenburgie. Yes, that is correct. And the other thing, 
just go back to a bit of the history in the development of the 
PM10 standard where we are today, we used to have 
total suspended particulates and now we are PM10.
    We had 2 or 3 years of monitoring PM10 before we 
had to submit those designations to U.S. EPA. We're allowed to 
do monitoring and had monitoring in place so that when EPA 
changed from total suspended particulates to PM10 we 
had some data base and something real to submit those and 
fulfill the requirements in the Act.
    Lieutenant Governor Hollister. And we have no data base 
now.
    Mr. Hosenburgie. That is correct.
    Senator Hutchinson. Well, it seems to me what EPA is 
proposing to do is to propose a new standard, a more stringent 
standard, that cannot--you cannot physically--you cannot--the 
States could not possibly comply simply because the monitoring 
network is not in place and the data is not available. Is that 
fair?
    Lieutenant Governor Hollister. Yes, that's an accurate 
statement. One other thing, and I don't have the figures in 
front of me, we have a number of areas in this country that are 
in noncompliance right now, they are non-attainment, and the 
U.S. EPA has admitted that for all practical purposes it's 
almost impossible for them to reach an attainment status. What 
are those folks going to do when this type of regulation is put 
in place let alone those of us who are almost in a 100 percent 
compliance.
    Senator Hutchinson. But you have two counties----
    Lieutenant Governor Hollister. And now we have two--we are 
so close with those two. I mean we're working very closely with 
the communities. Everyone is involved in trying to put it over 
the top and make sure that we're OK.
    Senator Hutchinson. Would you agree that it would make a 
lot more sense, since Administrator Browner acknowledges that 
it will take 5 years for that monitoring network and for 
everything to be in place for the States to comply, that to go 
ahead and to begin to work toward the more stringent monitoring 
network, accumulate the data, build a scientific case, if such 
a case can be built for the more rigid standards, before the 
new regulations are imposed upon----
    Lieutenant Governor Hollister. Oh, absolutely. It's called 
common sense.
    Senator Inhofe. Thank you, Senator.
    Let's keep in mind, however, when you say common sense, 
we're dealing with Washington.
    Senator Sessions.
    Senator Sessions. Well, I hear how much Oklahoma has done. 
I know Alabama has worked real hard on this project, what Jim 
did in Tulsa and how much community involvement you've had in 
the whole State of Ohio to make these major improvements in 
your air quality.
    Let me ask you, do you think this--having these--now just 
as you're reaching that goal, to have these huge higher 
standards in place, empaneled, would that--what kind of impact 
would it have on the enthusiasm of the people whose been 
working, and their view----
    Lieutenant Governor Hollister. Senator, I invite you at any 
time or I'll be glad to send you the clips from individuals who 
are dealing with E-Check right now. They are most unhappy with 
this. Any number of problems. And trying to put these programs 
in place to address some of the issues we've been discussing.
    I define progress as steps forward and these new standards 
are not progress. They are steps backward.
    I qualify that by saying, again, that there isn't any State 
that isn't environmentally conscious and they've been putting 
things in place and working with local government to continue 
to make a better environment, that just makes good sense for 
quality of life and for productivity and selling your State. To 
me these standards are a step backwards.
    Ohio is an old industrial State. Seven years ago when you 
talked about Ohio the word rust belt was attached to the State 
of Ohio. We have worked so hard, not only to be in compliance 
with the Clean Air Act, but to improve our industrial 
commercial base. As Governor Voinovich is fond of saying, the 
rust is off the belt. For us to go backward is something that 
we will absolutely fight.
    Senator Sessions. Well, I just had a conversation recently 
with a very successful businessman who said when I up the 
standards, when I up the bar for my company we have a plan and 
we know how we're going to get there before we ask our people 
to do it otherwise it's depressing to everybody when you have a 
standard and there's no real way to get there.
    I do, I know that every year older and less efficient cars 
are going off the market, which is good, and not being used, 
but in Alabama we're a poor State. We've got a lot of people 
that go to work with cars that may not meet those standards and 
it's going to fall disproportionately on the poor people of 
America. In Alabama if they've got to have checks and spend 
$200 and $300 on a car that may not be worth $300 to get it up 
and that does worry me some.
    Let me ask you this. I was thinking about these numbers, 
you mentioned $5 billion had already been spent in Ohio?
    Lieutenant Governor Hollister. Yes.
    Senator Sessions. That--in those kind of figures, Jim, I 
think it's rather odd that EPA has spent--hasn't spent the $26 
million that it would take to tell what these things may play 
on to be.
    I had the opportunity on an airplane a few weeks ago to sit 
right next to the air quality scientist for the Tennessee 
Valley Authority. I asked him what would it do to them and he 
told me that it would cost $1 billion for TVA to meet these new 
standards, and Craven Crowell, the Administrator of TVA told me 
the same thing. So, the figures of $6 to $8 billion used by TVA 
that it would cost to get in compliance nationally appear to be 
really far below reality.
    I will not pursue the matter anymore other than to ask you 
one more thing. If an area is not in compliance and a new 
business wants to build there, or an old business wants to 
expand and it has only modest but some modest increase in 
particulate or ozone emissions, do you know exactly what would 
have to be done before they could build?
    Lieutenant Governor Hollister. I know that would certainly 
be a point of discussion and I would ask Mr. Hosenburgie to 
address the particulars.
    Mr. Hosenburgie. Mr. Chairman, Senator Sessions, the--there 
are something that is both in the Clean Air Act and U.S. EPA 
regulation, it's called the Emission Offset Policy.
    What it requires is that if it's something called either a 
major new source going in or a major modification, what has to 
happen is that company has to find emission reductions 
equivalent to or a little greater than what it projects it will 
put out after it expands.
    So, it has to go around shopping for emission reductions 
from other companies and obtain those before it can build. That 
is always a significant hurdle.
    Going back to some of the previous questions. Many times in 
dealing with new companies having to come in the first thing 
they ask for when they come in to meet with our agency where 
are the non-attainment areas. They just frankly say we won't go 
there. And we'll say, well, maybe we'll help you look for the 
offsets. And they say, no, don't bother, we just do not want to 
build in a non-attainment area.
    Senator Sessions. This puts a major detriment on the entire 
non-attainment area for economic growth, I don't think there's 
any doubt about that.
    Lieutenant Governor Hollister. Oh, absolutely.
    Senator Sessions. Thank you, Mr. Chairman.
    Senator Inhofe. Thank you. Let me just add one comment. I 
think it was Senator Hutchinson who brought up this whole idea 
of ISTEA and its effect. We happened to have Rodney Slater, the 
newly appointed Secretary of Transportation in before our 
committee just this last week and we asked him the same 
question.
    I think as to what kind of costs would be involved in terms 
of non-attainment States, and obviously--it became obvious to 
us that the amount of money that is being appropriated wouldn't 
come close to meeting those costs.
    Any other questions for Senator Hollister?
    Well, thank you very much Senator Hollister--I'm sorry, 
Governor Hollister, I appreciate very much your coming. I do 
know that your Governor is the, I think, the chairman of the--
--
    Lieutenant Governor Hollister. He's the incoming chairman 
of the National Governors Association and feels very strongly 
about this issue.
    Senator Inhofe. I know he does, I had occasion to be with 
him on such a panel in Washington and I think everything that 
you have said he would agree with.
    Lieutenant Governor Hollister. Thank you.
    Senator Inhofe. Thank you very much.
    We're going to have seventh-inning stretches between the 
panels so if anyone wants to stand up we'll take about a 3 or 4 
minute recess while I introduce the next panel.
    I'd like to make a comment, however, that we have three 
Governors who said that they want to submit their testimony, 
and they are Governor Nelson of Nebraska, Governor Schafer of 
North Dakota and Governor Huckaby from Arkansas.
    I would also suggest for the witnesses who just testified 
and those who will be testifying in a few minutes, that we may 
have questions that we will submit and request that you answer 
those questions in writing.
    We'd now ask that our next panel come forward. Our second 
panel is the Oklahoma State Senator Paul Muegge on behalf of 
the National Conference of State Legislatures. I'll let Senator 
Muegge explain what he does with that Conference of State 
Legislatures.
    Mayor Susan Savage, my mayor of my city, Tulsa, OK. She'll 
be speaking on behalf of the U.S. Conference of Mayors. I 
believe that Mayor Savage is the chairman of the Energy and 
Environment Committee for the U.S. Conference of Mayors. We 
appreciate very much your speaking in their behalf.
    We'll ask you when you're responding to questions whether 
you're speaking for yourself or for the association.
    We have Mark Schwartz of Oklahoma City and he'll be 
speaking on behalf of the League of Cities. I believe, Mark, 
you are the chairman of a comparable committee with the League 
of Cities, we'll let you identify that committee, if you would.
    Mayor Patrick Henry Hays of North Little Rock, AR. I was 
riding in from the airport with Mayor Hays and I commented that 
I tell my friends in the U.S. Senate quite frequently, if you 
really want to know what a hard job is you become mayor of a 
city, that's a hard job.
    Senator Thomas. Mr. Chairman, you've got a lot of faith in 
this seventh inning stretch, so many escape when----
    Senator Inhofe. Well, they did, didn't they. They wouldn't 
do that in Wyoming, would they?
    Senator Thomas. Of course not.
    Senator Inhofe. The last time I was in Wyoming at one of 
these hearings I found that their attention span up there was a 
little shorter even than ours.
    [Recess.]
    Senator Inhofe. Since our last two panels have four 
witnesses each we're going to ask that we try to follow some 
type of a time element here, let's say 6 minutes for each 
opening statement and maybe 5 minutes for each round of 
questioning and see how the time goes. Don't feel badly if you 
have to go a little bit over.
    However, your entire statement will be submitted for the 
record.

STATEMENT OF HON. M. SUSAN SAVAGE, MAYOR OF TULSA, OK, FOR THE 
                   U.S. CONFERENCE ON MAYORS

    Ms. Savage. Senator, I know we've not officially reconvened 
here but on behalf of your city of Tulsa I want to present to 
you a centennial pin as Tulsa is celebrating its 100th 
anniversary this year because we don't want you to forget 
Tulsa.
    Senator Inhofe. We won't. Thank you very much.
    A lot of people get a little confused about that, Susan, 
because they say, wait a minute, how can you have your 
centennial when Oklahoma didn't become a State until 1907. We 
had to explain to them when I was mayor of Tulsa.
    Ms. Savage. You have to explain this. But Tulsa was 
progressive even then.
    Senator Inhofe. It was progressive even then and you 
might----
    Ms. Savage. It just took the rest of the State a while to 
catch up.
    Senator Inhofe. Do you want to share with them what Tulsa 
means and----
    Senator Hutchinson. Was it at that time, Senator, mayor of 
the Nation of Tulsa perhaps.
    Ms. Savage. It was Tulsie Town, which was settled by the--
Tulsa was settled by the Creek Nation, Muskogee Creek Nation in 
the 1800's actually about 50 years before we were incorporated 
as a municipality.
    As the Senator knows, the actual incorporation occurred in 
Muskogee, OK, which was at that time Indian Territory in 1898. 
We cannot find Tulsa's actual original articles of 
incorporation.
    We are told that--we thought they were in Muskogee, then we 
thought perhaps they were in Oklahoma City and we thought--were 
told they might be in Fort Worth or in Dallas. We've since been 
told that perhaps they burned but I've had a couple of people I 
know from Muskogee say, don't worry, if you need some new ones 
we can get you some that represent any age possible.
    So, there's a lot of folk lore but we're having a wonderful 
year of celebration which brings together our Creek heritage as 
well as the very diverse nations in Tulsa.
    Senator Inhofe. Well, then why don't we say that Mayor 
Savage and myself as a former mayor of Tulsa, invite everyone 
to come and celebrate our centennial with us in Tulsa.
    Ms. Savage. Thank you.
    Senator Inhofe. We're very pleased to have this. Mayor 
Savage, I think your dual role here in energy and environment 
for the U.S. Conference of Mayors is significant. I know you've 
attended panels throughout the country and we appreciate your 
making your time available for us today.
    Ms. Savage. Appreciate the invitation. Thank you.
    Are you ready for me to start?
    Senator Inhofe. Yes, ma'am.
    Ms. Savage. One of the things I've found in this job I 
suddenly have to wear glasses to read so let me don these and 
begin.
    I'm very, very pleased on behalf of the Conference of 
Mayors as well as the city of Tulsa, and I will try my best, 
Senator, to keep in mind that I am here on behalf of the 
Conference of Mayors to address this Senate subcommittee and 
wish to welcome those of you to this wonderful State.
    There is a tremendous amount of documentation. I just 
learned, Senator, from your aide, Mr. Edwards, that our 
documentation did arrive. There was some question but it has 
arrived for everyone to receive.
    The primary responsibility of any mayor is to protect the 
public health and safety of the citizens in our community.
    While air quality is most certainly an important public 
health issue the proposed new air quality standards encompass 
far more than just a debate about the levels of ozone and 
particulate matter that we will determine to be acceptable in 
our air. The outcome of this discussion will speak volumes 
about the livability of our cities well into the future.
    Clean air is a laudable, responsible goal. Governments, 
industry, and citizens have an obligation to ensure that the 
air we breathe is clean and safe across this country.
    Yet, the discussion of the proposed new air quality 
standards is being held in isolation from the discussion of any 
implementation plans for the new standard raising many 
questions for the leaders of our cities. Will communities be 
held to a more severe standard for pollution which originates 
in and is transported from other areas.
    Will communities be held responsible for the hydrocarbon 
emissions of those automobiles driving into or through an urban 
area on a daily or just a periodic basis? How can communities 
mitigate the effects of unfavorable weather patterns which 
contribute to the ozone levels due to high temperatures or a 
lack of wind?
    In fact, in Tulsa where the air quality has continued to 
improve we often say that Tulsa doesn't have an ozone problem. 
We have a weather problem on some days.
    The discussion of the proposed new air quality standards is 
being held without consideration of the many significant and 
substantial policy decisions this committee in fact will face 
this year in its deliberations on the reauthorization of ISTEA, 
brownfields, Superfund, the future of Congestion Mitigation Air 
Quality funds and other significant environmental policy issues 
which dramatically impact the livability of our cities and for 
which well coordinated policy goals need to be articulated and 
pursued.
    Talk to any mayor of any size city and what you hear is the 
same, years of federally imposed mandates to meet uniformly 
applied environmental standards have contributed to urban 
sprawl, creating a greater reliance upon the automobile, while 
at the same time reductions in public transit operating dollars 
and the proposed elimination of the Congestion Mitigation Air 
Quality funds remove a central tool for our communities who 
work to improve air quality.
    In fact, cities like Tulsa, which has made enormous strides 
toward cleaner air and remained in compliance with air quality 
standards since 1990, are penalized by receiving fewer CMAQ 
dollars than other cities which have not taken such pro-active 
positions, measures or who went into attainment after 1990.
    Let me give you one quick example. Victor Ash, who is the 
mayor of Knoxville, TN, former Conference president, has been 
working with me very closely on behalf of the Conference on 
this issue.
    Knoxville recently reached attainment, is now in a 
maintenance position, they received $1.2 million in CMAQ, Tulsa 
just received $400,000. We're not in maintenance we're just in 
attainment.
    Mayors across the country whose cities are currently in 
attainment and who have worked to maintain that status, need to 
understand the purpose and the value of being redesignated into 
non-attainment, which would be the effect if the standard as 
proposed is promulgated. It is unclear how this causes an 
improvement in air quality.
    There are currently more than 500 counties nationwide with 
monitoring stations, 11 percent are now in non-attainment. With 
this new proposed standard 70 percent would immediately go into 
non-attainment, which includes Tulsa and Oklahoma County.
    A health benefit analysis is the basis for the 
recommendation to change the standard, yet the lack of 
inclusion of an implementation strategy, no commitment to 
adequate funding for impacted communities, and no definitive 
knowledge about the precursors of ozone impede progress toward 
the creation of effective local responses and supportable 
community consensus which blames the goal of clean air with 
responsible business growth.
    Other pressing matters need to be addressed as part of this 
discussion, even if the rules for implementation evolve 
subsequent to the promulgation of the standard. As a group of 
diverse communities, cities question the wisdom of putting the 
two standards, ozone and particulate matter, in the same 
category. While their effects may be similar in the health 
based data, the available technology to monitor the two 
pollutants vastly different.
    The country is ill-prepared to monitor for 2.50 particulate 
matters since few monitors exist. Additionally, there are no 
guidelines for their placement and evaluation, leaving 
community leaders unable to construct a workable strategy.
    In the materials released from the Environmental Protection 
Agency there has been mention of development and implementation 
of innovative technologies.
    Cities are interested in being part of any initiative which 
involves new technology. At the same time we would like to see 
the agency acknowledge and credit some of the effective 
pollution reduction methods which use little or no technology 
but are based on public awareness and leadership commitment.
    For example, Tulsa's nationally recognized ozone alert 
program or voluntary alternatives to commute program and 
voluntary lowering of the re-vapor pressure, which our industry 
has undertaken.
    Cities has more questions than answers about the proposed 
new standard at this point. Have other measures to improve our 
air quality been examined as we as a nation strive to improve 
air quality? Does the focus on a more stringent standard 
provide the impetus necessary to generate the public and 
private support to provide a desirable air quality? We 
encourage further research to explain the origins of precursors 
for ozone.
    I see I'm running a little bit short on time so let me skip 
to one additional point and then we can, perhaps, cover more in 
the question period.
    In Tulsa we created the first--the Nation's first Flexible 
Attainment Region, or FAR agreement, in partnership with the 
EPA, which is the model being used by other communities for 
environmental regulation.
    The FAR allows an area to custom design programs to improve 
air quality when there is a violation of the standard and to 
add more measures as they are necessary, without redesignation 
to non-attainment. These partnerships should be encouraged to 
local--to ensure local responses to air quality concerns. They 
make sense, provide flexibility and enable us to move from the 
cookie cutter approach to environmental regulation and to work 
with our State governments and our local leaders to make the 
decisions about what works in our own communities.
    Mayors care deeply about the health and safety of their 
citizens. We are prepared to be part of a process which results 
in progressive, sensible environmental policy which can be 
achieved. In a well coordinated effort we want to construct an 
air quality solution we can defend to our citizens. There 
remains much work to be done on this.
    Thank you very much.
    Senator Inhofe. Thank you, Mayor Savage. You are to be 
commended on the FAR program. I think that was an effort where 
a lot of levels of Government worked together and it makes 
sense.
    Ms. Savage. Thank you.
    Senator Inhofe. Senator Muegge, would you identify the--
there is a group that you're working in within the, I believe, 
the Council of State Legislators.

 STATEMENT OF HON. PAUL MUEGGE, OKLAHOMA STATE SENATE, FOR THE 
           NATIONAL CONFERENCE OF STATE LEGISLATURES

    Mr. Muegge. Yes, I will address that in my remarks.
    Chairman Inhofe, we appreciate you bringing this committee 
to Oklahoma and welcome the other members of the committee to 
the State of Oklahoma to listen to our concerns about this 
issue.
    I will be testifying on behalf of the National Conference 
of State Legislatures. I serve presently on the Agriculture and 
International Development Committee of the National Conference 
of State Legislatures. I am chairman of the Senate Agriculture 
Committee here in the State of Oklahoma and also serve as vice 
chair of the Energy Environmental Resources and Regulatory 
Affairs Committee here in the State Senate.
    I appreciate the opportunity to join you today to discuss 
the proposed changes to the National Ambient Air Quality 
Standards for particulate matter and ozones.
    The National Conference of State Legislatures, NCSL, is the 
bipartisan organization that represents the Nation's 7,541 
State Legislators. We assess Federal legislation and regulation 
to ensure that State and Federal responsibilities are 
appropriately sorted out. We further work to remove impediments 
to successful implementation of Federal law and regulations. 
Also, NCSL serves as the key resource for State lawmakers for 
information and analysis of Federal legislative and regulatory 
action on environmental and other issues.
    NCSL is a strong supporter of the principles underlying the 
Clean Air Act Amendments of 1990. NCSL has repeatedly and 
forcefully stated its view that the Federal Government should 
implement and maintain an environmentally sensitive and cost 
effective clean air policy that establishes minimal national 
ambient air quality standards in cooperation and consultation 
with the States and with local governments.
    NCSL supports minimum Federal standards for ambient 
particulate matter and ozone. Protection of human health and 
the preservation of the environment are a top priority for our 
States. NCSL urges EPA to proceed diligently with full 
implementation of the Clean Air Act to achieve healthy air 
quality for the public and the environment. Specifically, NCSL 
believes that both stationary and mobile sources must reduce 
emissions of ozone and particulate matter precursors, nitrogen 
oxide, and volatile organic compounds.
    NCSL does not process scientific or technical expertise 
required to evaluate and comment on the specific standards set 
out in the proper rules. NCSL believes it would be imprudent to 
make educated, but not expert, guesses regarding the support or 
opposition to the proposed standards.
    However, NCSL has serious concerns relating to the process 
of the promulgation of the proposed rules to the revised 
standards for ozone and particulate matter. The concerns result 
largely from the failure of the U.S. Environmental Agency to 
comply with Federal law and Presidential Executive orders on 
unfunded mandate relief. The concerns do not focus on the new 
standards or the underlying science that is the basis for the 
new standards. NCSL refrains from commenting on the content of 
the proposed rules of the new particulate standards and revised 
ozone standards.
    My testimony will focus solely on the process by which EPA 
developed the rules and its failure to comply with provisions 
of the Unfunded Mandate Reform Act of 1995 and two Presidential 
Executive orders.
    NCSL asserts that in order to adhere to the provisions of 
the Unfunded Mandates Law and Executive Orders 12866 and 12875, 
EPA is required to:
    No. 1, assess the full cost of State compliance with the 
revised standards;
    No. 2, disclose all Federal resources available to States 
for compliance activities;
    No. 3, identify and assess all alternatives to the proposed 
revisions and select the least burdensome and most cost 
effective options; and
    No. 4, consult and work closely with the State and local 
governments during promulgation and implementation of any 
revised standards.
    NCSL also requests that the EPA provide full funding 
federally and complete guidance for the State implementation.
    And also that they publish detailed explanations of the 
reasons for revising the standards.
    NCSL makes these recommendation as an organization with a 
commitment to the Clean Air Act. NCSL believes the Clean Air 
Amendments of 1990 address important air quality issues and are 
essential to protecting public health and environment.
    At the same time, in order to meet the goals of the Clean 
Air Act, Congress and the EPA must fulfill their 
responsibilities to provide financial and technical assistance 
to the States. Moreover, EPA has a legal and ethical obligation 
to meet the requirements of the unfunded mandates and Executive 
Orders 12866 and 12875.
    Thank you.
    Senator Inhofe. Thank you, Mr. Muegge.
    Mr. Schwartz is one of the individuals who has an abundance 
of knowledge in this area. He attended a couple of the meetings 
that we had around the State and I appreciate very much you 
bringing that expertise to those meetings as well as to this 
meeting.

STATEMENT OF HON. MARK SCHWARTZ, OKLAHOMA CITY COUNCIL, FOR THE 
                        LEAGUE OF CITIES

    Mr. Schwartz. Thank you, Mr. Chairman.
    Let me, again, welcome you and the other Senators on the 
behalf of the city of Oklahoma City.
    Senator Hutchinson, let me express my condolences for the 
losses in your State this weekend.
    As I told Senator Thomas, I've been to Gillette and it has 
great air there and I love the State.
    I am here, Mr. Chairman, both as council member from 
Oklahoma City but I am testifying as the president of the 
National League of Cities on behalf of the 16,000 cities and 
towns across the Nation that we represent regarding EPA's 
proposed new standards for ozone and particulate matter. I 
formally chaired the NLC Energy and Environment Committee a 
number of years ago.
    I would refer you to a copy of the National League of 
Cities resolution of December 1996, which is attached to my 
full statement which has been submitted to the committee.
    We are an organization that developed policy resolution 
very quickly after the proposals came out in December during 
our annual meeting in San Antonio.
    I would concur with many of the statements we've heard from 
Governor Keating and Mayor Savage that as municipal officials 
that we concur with initiatives to protect health in our 
cities. We care about the communities and the people who live 
there. We want to be able to assure our citizens that the air 
they breathe, the water they drink and the rivers, lakes and 
streams in which they play meet the highest and safe as 
possible health standards in this country that we can provide 
as local officials.
    I can bring little to the debate about smog and soot as a 
scientist. However, we do have appropriate standing to raise 
significant concerns about the process by which they were 
developed and are being proposed as well as the potential for 
imposing exceedingly costly new Federal mandates on the 
citizens of this country that may yield few, if any, benefits.
    There are a number of areas that I would like to address 
today, Mr. Chairman. First I think there's an issue of 
credibility. Many of the State implementation plans developed 
as a result of the 1990 Clean Air Act Amendments are just now 
being implemented. NLC played a very big role in the amendments 
for the 1990 Act.
    The plans have not been in effect long enough to determine 
their impact. The implication, at least for the uninitiated, 
that what is currently being required is meaningless or futile. 
If significant additional resources are to be committed to 
further reductions in pollutants, there must also be adequate 
assurances that these investments will yield at a minimum 
appreciable health benefits.
    We are also troubled by the absence of adequate and basic 
information with respect to PM2.5. It would seem 
appropriate to us that before issuing a new set of requirements 
it might be helpful to know where it is a problem, how 
extensive is the problem and whether it's the pollutant or is 
it a subset or constituent of the pollutant that in fact is 
causing the problem.
    In connection with science, it appears clear from the 
recent reporting and from testimony given at your recent 
hearing, that there is a significant disagreement with the 
adequacy of the science on which the proposed standards are 
based.
    We're concerned that we may be moving toward requirements 
to regulate naturally occurring phenomena, such as windborne 
sand from beaches and deserts, or pollen from natural 
vegetation.
    It is very incredible and frustrating to me, and Mr. 
Chairman, you referred to this earlier, when you read the Clean 
Air Science Advisory Committee's letter with respect to 
particulate matter 2.5 submitted to Administrator Browner last 
June 13 that it states, ``The deadlines did not allow adequate 
time to analyze, integrate, interpret and debate the available 
data on a very complex issue.'' I think that says a whole 
bunch.
    In regard to public support of public health issues, many 
municipalities have made Herculean efforts to come into 
compliance with the NAAQS and Oklahoma City and Tulsa are very 
proud to say that this State is an attainment State.
    But to learn now that instead of some recognition for the 
accomplishment for these efforts that we find out that the 
efforts might have been inadequate, inappropriate or 
ineffective is quite dismaying for those cities that are not in 
attainment yet, there are those you heard in Ohio, they are 
working so hard and diligently to get there.
    So, if we're being told the investments we've made have 
proven to be futile taxpayers will not continue to fund these 
issues if it doesn't mean anything and I hear 5 years from now 
that, no, these standards weren't good enough.
    There are some inconsistencies with other laws, ISTEA was 
mentioned earlier, and I would like to direct my attention to 
one issue that as we face more stringent controls on emissions 
causing air pollution, many of which are generated by stop and 
go rush hour traffic, we are simultaneously hearing proposals 
which would cut mass transit operating funds, which provides a 
virtually guaranteed method of reducing the proximate cause of 
the pollutants.
    Equally seriously, there are those in Congress who in 
proposing changes to ISTEA would remove the Congestion 
Mitigation Air Quality program, which I believe is a mistake 
and I--and this is but one inconsistency in terms of the ISTEA 
issues and other statutes.
    Finally, municipal officials are very concerned about being 
required to comply with Federal standards where there are few 
or no tools available to attain such compliance or when there 
is no body of knowledge on how to achieve compliance given the 
significant unknowns, where, how much, from what sources.
    With respect to particulate matter of 2.5 we're concerned 
about the deadlines and the consequences of failure to meet 
them in however many areas may be out of compliance.
    Despite Administrator Browner's assurances in her recent 
testimony before your committee that 70 percent of the 
potential non-attainment areas can come into compliance with 
the proposed new standards by using existing technology and 
strategies, the National League of Cities question the validity 
of that assumption. Furthermore, we are very concerned about 
the other 30 percent. We're an organization that represents all 
the cities and towns in this country, not just a percentage of 
them.
    Recommendations. First, we don't believe the Courts ought 
to be forcing decisions related to complex scientific matters. 
We believe Congress should overturn the Court's deadline in 
order to give EPA and the scientific community adequate time to 
draw sound scientific conclusions about further reductions in 
air emissions.
    Second, if the Clean Air Act requires EPA to review air 
pollution standards every 5 years the funding to comply with 
this requirement should be provided. If these funds were not 
available because of limited Federal resources or alternative 
national priorities then this requirement should be changed 
accordingly.
    Third, if indeed as Administrator Browner indicated in your 
recent hearings, over 200 scientific studies support the need 
for tighter controls on specific air emissions then EPA has 
done a poor job of publicizing, explaining or demonstrating the 
adequacy of the scientific basis for their proposals. We either 
need more and better science or more and better explanations of 
the science that exists is valid.
    Fourth, the impact of the proposed requirements on existing 
State implementation plans that have only recently been 
approved needs to be assessed.
    Finally, Mr. Chairman, we need better information about the 
pervasiveness of PM2.5 before proposals are 
finalized, how many PM2.5 non-attainments there are, 
where they're located, how significant is the problem in these 
areas. It is difficult to accept the premise that a problem 
exists for there is little information about where it exists.
    Thank you, Mr. Chairman and the committee, for this 
opportunity to testify today.
    Senator Inhofe. Thank you, Mr. Schwartz.
    And last on the panel we'll hear from the Honorable Mayor 
of North Little Rock, AR, Patrick Henry Hays.
    Who could vote against a guy with a name like Patrick Henry 
Hays?

STATEMENT OF HON. PATRICK HENRY HAYS, MAYOR, NORTH LITTLE ROCK, 
                               AR

    Mr. Hays. So far, Mr. Chairman, it has worked.
    Senator Inhofe. Just kidding.
    Mr. Hays. I was re-elected for a third term last November 
and I hope that that's something, you know, a total attribute 
in terms of the public's support.
    But I am happy to be here and happy that you have given us 
an opportunity to come to Oklahoma City.
    I want to certainly compliment two of my colleagues, I know 
Mr. Schwartz and Ms. Savage who I had a chance to work with in 
local government matters over the last several years, Susan 
through the U.S. Conference of Mayors and Mark through the 
National League of Cities.
    Also I certainly want to compliment our Senator as I had 
served in the State Legislature with your colleague in the 
House side of our State Legislature, Mr. Hutchinson, Tim was 
certainly an able legislator in the House and we certainly 
compliment both him and your activities as you go about trying 
to determine what makes sense for the country.
    I am the mayor of the third largest city in Arkansas, North 
Little Rock, with approximately 65,000 people.
    However, I'm here representing Metroplan, which is a 
council of governments composed of 22 member governments in 
addition to the Arkansas Highway and Transportation Department 
along with Central Arkansas Transit, which is our metropolitan 
transit authority.
    We represent over 550,000 residents, the largest area in 
Arkansas, metropolitan area in Arkansas, with somewhere in the 
neighborhood of 300,000 jobs that are represented in that area.
    And let me posture, although I'm speaking for Metroplan, I 
certainly want to include Crittenden County and West Memphis in 
the two areas that at least at present in Arkansas would be 
challenged by these new regulations.
    While particulate matter is still somewhat up in the air, 
because there literally has been no monitoring, and I've heard 
these comments by others at the panel, my city is the only area 
in which ozone monitors occur. We have one monitor at the North 
Little Rock airport and another in an area that is in close 
proximity to literally the largest diesel electric locomotive 
repair facility in the country, Union Pacific has its shop in 
that area.
    As such part of my concern, and I'd like to certainly 
submit the information that I've provided for the record and it 
goes into a little bit different direction, or not different 
direction but additional direction that I want to comment on.
    Some of the things that I'm real concerned about is the 
fairness of the monitoring system. With those two monitors that 
essentially cover that entire geographic area in Central 
Arkansas one is located in close proximity to the airport, the 
other to that diesel repair facility and how accurate, is my 
concern, that whatever monitoring goes on whether that 
monitoring is certainly accurate in terms of the reflection 
that it may have.
    I think even with our concern about the ozone limitation 
we're very concerned about where that's going to lead and what 
that may do.
    I think we all recognize that perception becomes reality 
and the perception that you are a non-attainment area, not 
knowing exactly what details may have to go into the 
formulating of a plan and the implementation of that plan.
    As transportation has been the backbone of my community, we 
begin our history as the end of the line, so to speak, of rail 
coming from Memphis to St. Louis. And as such, with the 
confluence of Interstate 30 and I-40 transportation has 
continued to remain a strong part of our community.
    I think I could also mention that West Memphis, as its 
confluence of 200 State systems also, perhaps, has some of the 
same problems.
    We have been improving over the last several years and I 
think mainly we think that improvement has been attributed to 
perhaps mild summers in addition to a turnover of the fleet in 
terms of the national standards that Detroit has, perhaps, been 
assisting us with.
    So our concern is very strong and it is very valid but 
there's one other point that I'd like to make as a mayor. We 
sit here and look to Washington and I think the unfunded 
mandate legislation, which was adopted, was a compliment to the 
Congress and recognizing that more and more things are being 
heaped more and more on our shoulders without the funds to 
address those problems, clean air, welfare reform.
    As I mentioned a little earlier on the plane, the 
restructuring of the electric industry, clean water, storm 
water drainage, the solid waste, you know, more and more things 
are being put on us and I think we all know, as a revolt of the 
constituencies have occurred a number of times, there doesn't 
seem to be anybody that's coordinating all these burdens that 
are being placed on the average Joe in the street, or Jane in 
the street, as we are trying to be the floor where there are no 
cracks.
    People has talked about welfare reform, how people are 
going to fall through the cracks. Well, those are the cracks 
that we have to shore up and receive the quality of life 
problems that are dealt with as Washington deals with spreading 
its one cookie cutter size fits all over the country.
    And I think without--what I've heard more and more said 
here is that there appears to be no one that agrees that the 
standards ought to stay the same. That the proposed standards 
by EPA are not supported by at least anyone at this table and 
the comments that I've heard, Mr. Chairman, from your table 
that no one supports those, and so I guess it's going to be 
kind of interesting and exciting and comforting, I guess in 
many respects, to see that this window of opportunity, as you 
go back to Washington, either through carrying the big 
legislative stick or certainly encouraging your colleagues to 
adopt legislation that would give us some relief in terms of 
where we might be going, not only with what our topic is here 
but also look at the overall impact that our citizens are 
having to face in all of these other areas that are being 
addressed by the Congress.
    I compliment you. I certainly want to thank my Senator for 
giving me the opportunity in coming here and speaking not only 
for myself. Mayor Dailey, who was supposed to be here from 
Little Rock, as many might realize, is dealing with some deaths 
and severe damage that occurred in his city, so on behalf of 
all of us from Arkansas, both from the central part of the 
State as well Crittenden County and West Memphis, we look 
forward to that window of opportunity, that you are going to 
carry back on our behalf to Washington, opening in a way that 
will provide us some relief. Thank you very much.
    Senator Inhofe. Thank you, Mayor Hays.
    Mayor Savage, in your written testimony you brought up the 
question the fairness issue, and I'm glad you did. It seems 
like cities such as Tulsa and Oklahoma City are always required 
to do more than places like New York and Los Angeles even 
though those cities will probably never come into compliance 
with current regulations.
    You've cited, and this is, I believe a quote, you said, 
``The health benefit analysis is based--is the basis for the 
recommended changes.'' You also stated that there is, ``No 
definitive knowledge about the precursors to ozone.''
    Are you suggesting that the science is clear on particulate 
matter but not on ozone?
    Ms. Savage. I would suggest that the science on ozone is 
more extensive than it is on particulate matter, as this 
committee knows far better than I, the differences of opinion 
on the validity of the science has been well documented.
    To say, and I think Mayor Hays said it well and Councilman 
Schwartz said it well, we at the local level are somewhat 
confused about exactly what it is anyone is trying to 
accomplish.
    In thinking through the purpose of our session here today, 
it occurred to me from the Conference of Mayors, because we 
have cities the size of Chicago and Los Angeles who are 
currently not in attainment, to North Little Rock and Oklahoma 
City and Tulsa who are in attainment and so we all share the 
goal of clean air. However, the manner in which we arrive to 
that goal sometimes may be different.
    The point becomes there's a concern about the health of our 
citizens. There is a concern about the impact of this type of 
very stringent proposed regulation on our local economies. 
There is clearly a concern that I try to convey about whose 
responsibility is this and how do we impose the regulation on 
the governmental entity to clean the air when you can't really 
capture what you're trying to clean.
    So, I don't want to ramble, Senator, but there is certainly 
a body of knowledge which--a little bit of which I have seen, 
that says there are definite health impact to ozone. The 
particulate matter we know is much less studied.
    Senator Inhofe. Let me ask you just briefly, you heard the 
question I asked Governor Keating about recruiting industry and 
of course you had great accomplishments in this area too, one 
of which is Westinghouse. It's my understanding that 
Westinghouse in Tulsa is expanding largely because of our 
attainment status. Would you agree with that?
    Ms. Savage. We have been the beneficiary of a recent 
manufacturing location in Tulsa and the company would not have 
located there had we been in non-attainment we were told and 
they were expanding and growing jobs, so we're very fortunate.
    Senator Inhofe. Senator Muegge, you commented that you're 
in the Ag Committee. Well, you know, I've visited extensively 
with people from the Oklahoma Farmers Union, the Farm Bureau 
and other groups and they're very much concerned about this. Do 
you want to make a comment as to how the adoption of these 
proposals might affect adversely the ag community?
    Mr. Muegge. Yes, I'm wearing two hats here today, I'll put 
on my agriculture hat.
    As you well know, what happened a year ago we had a severe 
drought and all across Texas and Kansas and Oklahoma why we had 
many, many days where we had a lot of particulate matter in the 
air.
    Of course, if this would come at a time to Oklahoma City it 
could place them in a non-attainment situation immediately and, 
of course, we would be the cause of that.
    There's no way that we can manage our farming operations to 
deal with this kind of a hazardous situation that occurs 
naturally in our farming operations, particularly when we're at 
the vagaries of nature. So this is--would place a heavy burden 
upon not only those of us out in the country that are trying to 
make a living struggling with agriculture, we could impact 
cities as well.
    Senator Inhofe. You know, coming over here we came over in 
a small plane, I had a couple of staff people with me and I 
pointed down right outside of Bristow where a farmer was out in 
his field and just looking at that we take for granted a lot of 
the freedoms that we have today and yet we have been told of 
kinds of stories as to what regulations would go into, 
particularly in the ag community, and there is a great concern. 
It really isn't talked about as much as it should be.
    Mr. Schwartz, it was kind of interesting, you brought out 
the 70 percent and the 30 percent. Tell us a little bit more 
about what would be expected of the 30 percent.
    Mr. Schwartz. Well, I think the real problem, Mr. Chairman, 
is those 30 percent are never going to get there from Point A 
to B anyhow. I mean the reality is there if you can't meet 
today's standards the likelihood of meeting under the proposed 
standards is probably next to impossible.
    If anything, you know, there are--there have been, 
interestingly enough, the variations provided under the act for 
ozone in terms of under severity of issues, but that, of 
course, does not apply to particulate matter so you've got 
whole other world to deal with.
    I think you're looking at cities that probably see receding 
economic development because what--they're going to flee, and 
that has been the issue, that they have gone from areas where 
they couldn't get those credits for air emissions and they go 
to other areas of the country and putting everybody across a 
level playing field where nobody can have economic development 
does not help the country in terms of a global economy.
    Senator Inhofe. Mayor Hays, you brought up in your written 
testimony the effect on ISTEA and I've commented several times 
I have a great deal of respect for Rodney Slater, I know you 
know him well, and when he was testifying before us he really 
wasn't clear as to what types in a budget request of money 
should be requested because everything is so ambiguous right 
now.
    Would you have any advice for Secretary Slater on what he 
should ask for in terms of an appropriation to take care of 
this contingency?
    Mr. Hays. Mr. Chairman, I always would have advice for a 
cabinet member, now whether or not it would be any that he 
might take I don't know, but the whole gamut of what we're 
trying to do here is to try to improve the health of our 
citizens.
    Without reliable information, I think Governor Keating, if 
I remember correctly, commented about how can you do anything 
other than try to make sense and it doesn't make any sense to 
go forward in trying to develop plans to spend resources to 
scare literally new employers from either bringing their 
companies into your area or adding to their work force unless 
you have some reliable data to act on. I think that's one of 
the biggest concerns that we all have right now that that's 
just an impossibility.
    Senator Inhofe. It is. My time is up. Let me just ask you a 
yes or no question, we'll start with you, Mayor Hays, and just 
run down the table.
    Would you consider if these proposed standards went into 
effect to be an unfunded mandate?
    Mr. Hays. Yes, I would.
    Senator Inhofe. Mr. Schwartz.
    Mr. Schwartz. Most likely it would be.
    Ms. Savage. Yes.
    Mr. Muegge. Yes.
    Senator Inhofe. Thank you very much. Senator Thomas.
    Senator Thomas. Thank you. Let me read you something. This 
is not an unfunded mandate but is very similar. This is a 
letter from the Assistant Administrator. As you know, new and 
revised NAAQS are based on air quality criteria issued under 
section 8 of the Act set at levels sufficient to protect public 
health and public welfare from the adverse effects. Once the 
standard is set or revised the States are primarily responsible 
for ensuring attainment and maintenance of it under section 110 
and part of the States develop and States implement plans 
covering under this framework the potential or revised standard 
if adopted would not establish any requirements. Therefore, the 
rulemaking is not susceptible to regulatory flexibility or 
unfunded mandates as prescribed. They establish no requirements 
applicable to small entities.
    So, what they say is that the standard does not do it it's 
the States implementing that causes it and so that's a fun 
thing to live with.
    At any rate, we'll expect you guys from Arkansas to do a 
great deal with this.
    Mr. Hays. We'll be happy to carry the load Senator.
    Senator Thomas. I don't quite understand, Mayor Savage, you 
talked about the cities activity. This is transferred to the 
State to implement, is it not, what is the legal statutory 
responsibility of the city?
    Ms. Savage. Senator, were you referencing the comment I 
made regarding our flexible attainment region, our FAR 
agreement that we've negotiated with the EPA?
    Senator Thomas. Not particularly but you talk about the 
things that you have to do with the city. What is that a result 
of, the State's implementation program?
    Ms. Savage. It's a combination things. We went several 
years ago to the Environmental Protection Agency because Tulsa 
has been be in attainment since 1990.
    Subsequent to that and because of our ozone alert program, 
which has been modeled by cities across the country, we went to 
the EPA to say, wait just a minute, we're doing these 
activities, industry is producing gasoline which has a lower 
re-vapor pressure voluntarily. We're paying for free bus rides 
on days with a high ozone alert or probably exceeding our 
standard, we're doing that voluntarily as a community yet we 
receive no credit. Communities in non-attainment who are 
working toward attainment who do the same things receive 
credit. We need to be in balance here. We need the same credit.
    We negotiated a flexible attainment region agreement with 
the EPA, with our State Department of Environmental Quality, 
with our Chamber of Commerce, with our metropolitan planning 
organization, with the city of Tulsa, with Tulsa County, to 
give us a framework in which we would say if Tulsa exceeds the 
number of allowed occurrences within a set period of time then 
we will agree to do--and it's prescriptive, a variety of 
different things.
    We went to the State legislature last year and passed a gas 
tax--or excuse me, a gas cap law that would require if we 
violate the standards for us to, as communities, to be able to 
implement a more stringent type of gasoline cap.
    Now, I use that way of example because Oklahoma City has 
negotiated a FAR agreement that's a little bit different. It 
allows a community to work with the State organization, with 
the business community and with the Federal Government in a 
partnership model to address any environmental concerns.
    It makes sense. It enables to us to really be the guides of 
our own destiny and to continue to be responsive in trying to 
clean up the air.
    Senator Thomas. The State has the primacy, does it not, in 
Oklahoma to enforce these----
    Ms. Savage. Yes, there's a State implementation plan and 
they are partners.
    Senator Thomas. So, do you measure by cities? The city is 
not the unit that you measure, is it?
    Ms. Savage. Well, it's on a county basis.
    Senator Thomas. You do it by counties or----
    Ms. Savage. It's a county basis. The Tulsa area, our 
council of government's area is comprised of five different 
counties, now they're not all members of this agreement.
    So the point becomes, it's kind of complicated to explain, 
but it is a way to take the goal of cleaner air and to make 
everybody responsible for that occurrence.
    Senator Thomas. You were talking about monitoring 
equipment, I think, Mayor. Do the cities do their own 
monitoring?
    Ms. Savage. City-County Health.
    Mr. Hays. In Arkansas we don't. The Department of Pollution 
Control and Ecology, if I'm not mistaken, is the one that has 
monitoring authority.
    Senator Thomas. State entity?
    Mr. Hays. That's correct, that's a State agency.
    Senator Thomas. And that's true also in Oklahoma?
    Ms. Savage. City-County Health Department. City-County 
Health Departments do it. We also have issues of the placement 
of our stations. We exceed often--not often, but when we do 
exceed it's most likely near our airports.
    Senator Inhofe. Let me interrupt just a minute. We're in 
kind of an unusual situation. In Tulsa our city and county 
lines are very close to the same.
    Senator Thomas. I see. Well, you should move that one away 
from the airport.
    Ms. Savage. Well, we thought about big fans out there on 
days when the air doesn't move and I made the statement earlier 
that, you know, we don't feel we have a serious air problem in 
Tulsa it's a weather problem. Typically, and the Senator knows 
this, on days where there's high humidity, no wind, it captures 
the particulate matter and the ozone in the air and it doesn't 
disperse.
    We have issues of transport, which is another concern of 
cities like Oklahoma City and Tulsa. We started our southern 
most monitoring station on ozone--high ozone risk days many 
times at .05. Well, we're already well on our way to the top 
level of the standard.
    So, we have a lot of issues and I make the point again, we 
all want clean air but there are more questions than there are 
answers today in what has been proposed.
    Senator Thomas. So, if I understand it correctly--well, let 
me ask you this very briefly, what would you like to see 
happen, are you for withdrawing these, are you for more time, 
do you have--the legislatures or municipalities, do you have a 
suggestion, in a sentence what would you do?
    Mr. Schwartz. The National League of Cities is very 
definite in its resolution that Congress override these 
proposed regulations and then take the appropriate time to 
study and if there are appreciable health benefits find a 
reasonable way to do it but we don't know that yet.
    Ms. Savage. The Conference of Mayors would concur with that 
general approach and add to it that as we discuss environmental 
issues we need to look at Federal coordination among some of 
these policy issues.
    How are we going to clean up the air and address 
transportation because, you know, I mentioned urban sprawl and 
it has happened for us, and part of that involves the cutbacks 
in areas of public transit. So some of those policy goals need 
to be examined and better coordinated.
    Mr. Hays. We, in our metropolitan area within the framework 
of what EPA is considering, very briefly, we supported the AR 
concentration basis standard because we felt it was more 
aggressively associated with the reality of the problems. The 
conventional rounding method where they round down, we support 
retention of that.
    We do not support their average third highest daily maximum 
set at eight parts per million. We believe the 8-hour ozone 
standard would afford protection over the current standard for 
persons at risk either at the third highest daily set at 0.09 
parts per million or the fifth highest set at 0.08 parts per 
million was the recommendation that comes from our Council of 
Government.
    So, essentially, I think over all we're hopeful that 
there's little or no change unless there is--absent scientific 
information, but if there is within the parameters those are 
our recommendations.
    Senator Thomas. Legislature.
    Mr. Muegge. Presently, probably as we speak, why the Senate 
should have passed on a concurrent resolution with the House to 
request that these proposed rules be delayed and a further 
study be considered.
    Senator Thomas. Thank you, sir.
    Ms. Savage. I will offer, Senator, one point that I think 
you will find occurring among the municipalities and local 
governments, and Mayor Hays referenced it as the 8 hour 
averaging. I think these hour readings where you have a spike 
in the afternoon and potentially it exceeds and violates the 
air quality standards because of what happens between 2 p.m. 
and 3 p.m. seems to be a little silly.
    Senator Thomas. Sure. Thank you.
    Senator Inhofe. Thank you. Senator Muegge, I'd like to ask 
you to submit for the record the resolution as it is worded and 
the votes, how it comes out too.
    Mr. Muegge. I will take care of that.
    Senator Inhofe. Senator Hutchinson.
    Senator Hutchinson. Thank you, Mr. Chairman. And I thank 
the panel for your contribution.
    I especially want to welcome Mayor Hays, who I had the 
opportunity to serve with in the Arkansas legislature and I'm 
glad to get to visit with my colleague again and we appreciate 
your testimony.
    And also, Mr. Chairman, I would like to acknowledge the 
presence of Mr. Allen McVey, who is representing Governor 
Huckaby from Arkansas, and Becky Keogh, who is with the 
Department of Pollution Control and Ecology, who is 
representing the State of Arkansas as well today.
    I would ask unanimous consent to have entered into the 
record a letter from Governor Huckaby to Carol Browner asking 
for delay in implementation of these proposed rules.
    Senator Inhofe. Without objection.
    Senator Hutchinson. And a resolution from the Arkansas 
House of Representatives asking also that until further 
scientific health science data is available that those 
standards be delayed.
    Senator Inhofe. Without objection.
    Senator Hutchinson. I'm going to hand--let me hand them to 
you in just a moment, Mr. Chairman, but in Governor Huckaby's 
letter, Mr. Schwartz, I want to ask--I want to read this and 
then ask you to respond to it.
    Environmental Protection Agency, he writes, has identified 
one area in Arkansas, Crittenden County, as an area of possibly 
subject to redesignation to non-attainment with revised ozone 
standards.
    The case of Crittenden County, which is West Memphis, AR, 
the ozone levels are primarily due to the proximity to Memphis, 
TN, and a large number of transportation vehicles which travel 
along the interstate highway corridors through the area.
    Control of emissions from the primary sources are not 
possible within the areas to be designated. Expensive local 
control agents will have marginal to no gain in air quality 
somehow multi-state sources can be addressed under the proposed 
rule.
    I don't know who I want to toss that out to but it would 
seem to me that in border cities, where clearly in this case 
where you have a smaller urban area like West Memphis, AR, 
adjacent to a large metropolitan area like Memphis, TN, and 
where it's clear that the--being out of attainment is primarily 
because of--it mentions in another area that no matter what 
they do in West Memphis they're still going to be out 
attainment.
    How does the proposed rules suggest that be handled?
    Mr. Schwartz. Well, Mr. Chairman and members, Senator, I 
tell you, I find it real frustrating in terms of the ability 
for me--to put me in a position where I might have to, or West 
Memphis, may have to go and start suing one another under 
regulations because it came from here.
    I think part of the difficulty, as Senator Muegge has said, 
not all the council and State legislators have made up their 
mind yet in terms of where this rule should go.
    NLC has but I know that the Governors are split on both 
sides of the issue, on both sides of the aisle that is, 
Republicans and Democrats have different positions on this 
depending upon where you are. It is a very regional issue.
    To put people in the position where we can go to the 
government and say, my friend Pat here is a good friend but, 
Mayor, I'm sorry, we're going to be suing you because you're 
sending over. Well--or we are sending to you. It makes it very 
difficult particularly when there are other methods to do 
things.
    Now, down in this part of the country, as you well know, we 
can drive cars more than we have mass transit. However, we have 
made great strides in terms of mass transit in Oklahoma City 
and in Tulsa and other regional areas, not to the extent of 
subways in the major cities, but I would suggest that we need 
to keep enhancing those issues. We have done that in Oklahoma 
City and Tulsa with the use of compressed natural gas in our 
buses instead of all being diesel, which contributes to those 
pollutants.
    I think it is terrible to put areas, regions, cities, and 
States to fight one another. I think it is a mistake to do that 
and it only opens up the door to greater frustration and 
Washington is going to be saying, go out there, children, and 
settle this amongst yourselves.
    Senator Hutchinson. This proposed rule really invites more 
of that?
    Mr. Schwartz. Absolutely.
    Ms. Savage. It also misses the point. I think we have 
substantial issues. Transport, we know they're real but it 
doesn't get us to how we address that, it just puts us in a 
fight with one another, which is not productive. So, just to 
listen to what you've described, I would say it substantially 
misses the point.
    Mr. Hays. Senator, if I could add one point. We had a 
meeting in Executive Committee of the Arkansas Municipal League 
last week and one of the issues that came up there's 
legislation or a bill that was filed to remove the authority to 
prohibit open burning, the back yard type of burning by DPC&E.
    I spoke against that legislation because it would add--
potentially add particulates to the air. One of the smaller 
mayors in Arkansas came up and said, well, I'm kind of angry at 
this body because, you know, you all always run over us when 
it's a rural or urban issue and the discussion went around to 
the fact that we just really didn't think that all of us 
understood that because, for example, if this legislation--or 
this rule is made firm and we became non-attainment, it's my 
understanding that there's a 60 mile radius around the area of 
non-attainment that would govern it and if you look at 
Crittenden County and look at Pulaski County, you're literally 
looking at everything up and down I-40 from, you know, Little 
Rock, North Little Rock to Memphis and that encompasses a large 
rural area, as I know the Senator is aware.
    So, you know, in many instances, although it seems to pit 
one against the other, whether it be geography and States or 
whether it be urban versus rural that is not the case. There 
would be a lot of rural area that would be encompassed 
particularly as Arkansas is somewhat of a State in a geographic 
square, more or less, and the amount of territory that that 
would take up in Arkansas. So, we've got a lot of educating to 
do. I don't think that the general public is aware of what 
lurks out there.
    Senator Hutchinson. Mayor Hays, while you're talking I have 
a threefold question. You in your testimony addressed the issue 
of ISTEA funding and how that might be impacted and I would 
like you to speak to that, the investment in job creation, a 
problem of this rule, what it will do to States like Arkansas.
    And, third, I had a letter from a company that serves 
Arkansas concerning electric rates and the impact. I know that 
North Little Rock has municipal power but this company 
estimated that electric rates would go up 8 percent to the 
residential customer in order to comply with these new 
standards.
    What would it do, do you have any idea what it would do in 
North Little Rock?
    Mr. Hays. Let me just try to be very brief. I know ISTEA 
has been addressed with somewhat of a question mark, although 
certainly significant increases in the cost.
    There's one other aspect that I'd like to point out and 
that is if there is a non-attainment area within the State some 
funds that have a quasi label to them that are currently going 
to the, for example, the Arkansas Highway and Transportation 
Department, $5,000,000 to be precise, would have to be 
redirected toward those non-attainment areas, specifically 
programs that would address the ability to attain or reach an 
attainment status.
    So, whereas there is some discretion within, at least as 
our State goes, the Arkansas Highway and Transportation 
Department, not only would the cost accelerate but also some of 
the funds that are currently being allocated would have to be 
reallocated within the distribution formula to----
    Senator Hutchinson. But it's five million that is currently 
going into road construction that would be diverted into 
mitigation?
    Mr. Hays. Could be. Could very well be. You have to be in 
compliance with the plan that would then be developed in order 
to try to address the non-attainment status so it would be----
    Well, and I'll give you a partial example that, you know, 
some of those discretionary funds could go toward completing 71 
up in the northwest part of our State and now they have to be 
directed toward Crittenden County or central Arkansas in order 
to meet our non-attainment status.
    You know, whether that would be a valid effort to attain it 
or not, again, is certainly up to this body as well as EPA.
    Job reduction, as I mentioned a little earlier. North 
Little Rock, Central Arkansas, in the confluence of 
transportation, with both water, Mayor Savage and I are on an 
informal committee of the Arkansas River navigation communities 
and are very proud of that transportation thoroughfare that 
Senator McClellan, along with Senator Kerr, I believe of this 
State, helped complete. But to try to be brief, transportation 
is really the life blood--or strong life blood of our area. And 
to the extent that companies would relocate or not locate or 
not increase could be very vital to the economic wellbeing.
    We've been at 3.5 percent unemployment for a number of--
well, 3 years plus. We can see this certainly as a wet blanket 
that would be thrown around that.
    Electric rates, you know, the cost of doing business there 
are no small numbers in utilities, particularly electricity, 
the livelihood of companies that come into your area. Wright 
Video, which is one of the largest production facilities that 
has come to Central Arkansas, almost a thousand employees now 
and growing, their key cost ingredient is electricity. Anything 
that would affect that would affect their livelihood and as 
such so would our livelihood be affected. So, the impact would 
be catastrophic if reasons didn't meet the road in an 
appropriate way.
    Senator Thomas. Could I just be a Devil's advocate for a 
minute?
    When you talk about jobs and investment are you talking 
about world competition or if everyone in the country is 
covered by the same thing what difference would it make?
    Mr. Hays. Senator, I think we all realize now that we no 
longer complete with--I know northwest Arkansas and central 
Arkansas used to be at each other's odds in trying to divide up 
the legislative pie. I think we more realize now that we are 
competing with economic regions, whether they cross State 
boundaries or national boundaries, and literally we are--we're 
not competing so much as a nation anymore--I mean as a State or 
city as we are with those regional economic areas but 
worldwide.
    More and more that worldwide competition, you know, is 
going to be between central Arkansas and central South Africa 
so we can't say that we can roll up our borders and go home 
anymore. I think that's just being naive.
    Senator Thomas. I don't want to be confused, I'm not for 
that either, but I hear that question, you know, they say, 
well, you're going to treat everybody equally bad what 
difference does it make.
    Ms. Savage. I would add to what Mayor Hays has said is that 
as we are different regions of the country we have different 
air quality issues with which we must address and I think a 
standard that applies uniformly to everyone across the country 
doesn't make any sense.
    Senator Inhofe. Thank you, Senator Hutchinson.
    Senator Sessions.
    Senator Sessions. Thank you. Mr. Chairman, I'm delighted 
that you chose to have this meeting in Oklahoma. I thought 
maybe it was a parochial interest but--and I know we have two 
good Senators here, but look at the leadership that you've put 
together here.
    We have Mayor Savage and she is on the Environment 
Committee of the U.S. Conference of Mayors and is speaking for 
them. You have Oklahoma City Councilman, Mr. Schwartz, 
president of the National League of Cities. We have Mr. Hays, 
who represents 22 governmental agencies. And Mr. Muegge is 
speaking for and on behalf of the National Conference of State 
Legislatures. This is a remarkable group you've assembled and 
it is, I think, as public policy centers, remarkable that--and 
the Governors we had previously are all very troubled by these 
regulations and I think we have to raise questions.
    I also note among Oklahomans my legislative director, Rick 
Derwin, is an Oklahoman. I don't know if his parents are here. 
Are they here? They might be. Rick is a dynamo and I wish he 
could have been with us today.
    So, I'm impressed with the backgrounds and I'm impressed 
with the unanimity of the concern. I think any of us who have 
the ability to pass laws or control the imposition of 
regulations that can cause billions and billions of dollars of 
costs need to be listening to the people who do that.
    One of the things that was interesting to me, last week I 
had occasion to have dinner with three of Jefferson County, 
that's Birmingham, Alabama primarily, of county commissioners 
and they were talking about they were endeavoring to get out 
and reach attainment under the old standards.
    They made remarkable progress, Birmingham has over the 
years, just tremendous progress. It used to be so bad but it's 
just almost in attainment now. They talk about--they were 
considering reformulating gasoline.
    Have any of you considered that and have you learned that 
that may be not only not a benefit but a detriment?
    Ms. Savage. Senator, we do it. In Tulsa our industries do 
it as part of our ozone alert effort. They do it voluntarily. 
They do it understanding that there's no incentive from a cost 
standpoint to do it. It is just good public policy to keep 
Tulsa in attainment.
    They voluntarily each year have lowered the re-vapor 
pressure of the gasoline produced and sold in Tulsa so that 
we--because 70 percent of our ozone problem relates to 
hydrocarbon emissions from automobiles then to sell a product 
with a lower re-vapor pressure helps to address that, they've 
done that voluntarily.
    And I--while at the start of my formal comments I did not 
have time to say I think one of the strategies, perhaps, that 
would be of tremendous benefit to communities and to industry 
is to work from an incentive based approach rather than a 
punitive approach because I think those industries who have 
stepped forward in Tulsa to say we understand air quality is 
our concern, there's a business cost to it. While we don't have 
any--there's no business benefit in the short term. In the long 
term we all benefit from cleaner air. So we've done it. We do 
it on an annual basis. We stay in attainment because of the 
industrial support that we have from our community.
    Senator Sessions. Well, I think that was encouraged by EPA 
and was a source of real encouragement but recent reports, 
including a pretty in-depth article in the Wall Street Journal 
has indicated that reformulated gasolines produces formaldehyde 
in the atmosphere.
    We've had a number of health complaints about people who 
breathe the fumes and my county commissioners were saying I 
wish EPA would tell us whether that really would help or not. I 
hate to commit to a program and then find out it's really not 
productive.
    Ms. Savage. I probably need to correct something. When you 
say reformulated gasoline I jumped right into lower re-vapor 
pressure and I know those are two different things but the 
point becomes we are trying a variety of strategies voluntarily 
to see what works.
    We all keep coming back to the same point of discussion 
here that the science is still pretty new in terms of the 
technologies which can help us.
    We're all for more research and more innovative technology 
and will work with the Federal Government to explore different 
options because I think that's to our benefit to do so. So, it 
does get frustrating.
    I think you hear some of that here because we're trying to 
stay within this arbitrary set of regulations yet we don't 
exactly know what works the best. I mean if everyone goes in 
their house and stays inside we're probably going to be OK on 
those poor days but that's not very practical either.
    Mr. Schwartz. Senator Sessions, I might--and I guess 
Oklahoma City could be in a position from say, well, OK, we 
currently clean our streets with street sweepers because it 
helps us. One, it's a livable city issue, but it also avoids 
issues when you get the storm water runoff, which helps us 
there. Now, if I've got street sweepers out there it's going to 
kick up all this particulate matter.
    You take the street sweepers, take the landfills in this 
country and every day, under EPA rules, daily cover has to take 
place at landfills. PM10 does apply I think 
currently to the landfills but it would go to 2.5 and somehow 
the rules always get over to air quality standards as well, 
building roads, et cetera, et cetera.
    In essence, you know, we've got Washington who tells my 
colleagues in the State what to do, and the State and 
Washington tells us what to do and we have no one else but the 
taxpayers. There's only, as you all are debating and 
discovering in Washington, there's only so much money. There's 
only so much money and I think we need to make sure that we use 
our taxpayer's money as wisely as we can.
    To put us in a position where we start conflicting with 
other laws that we have to comply with, such as storm water 
runoff, you know, you've got to understand the vast majority of 
local officials who will become very educated and are very 
dedicated people, out of the 16,000 in this country most of us 
make next to nothing and do it as a volunteer and the issue is 
you've got educated people who are trying to work hard because 
the burden has become incredible. When the Unfunded Mandate 
Bill was passed NCL supported it and so everybody passed it and 
they kept on sponsoring that. Where are you going to put us?
    You know, it reaches a point where people are just going to 
throw their hands up in the air when there's no science and no 
appreciable benefit.
    Senator Sessions. One of the things you mentioned about 
dust. Scientific American had an article I read just by chance 
earlier this year, and it analyzed particulate matter and acid 
rain and what it discovered was the 1990 Clean Air Act, which 
has done some great things, has reduced particulate matter but 
the particulate matter from burning and the other things act as 
a base and tends to neutralize acid rain. We've gotten little 
or no improvement in the acid rain, in some areas perhaps 
worse, because there's a--and so there's a doctrine of 
unintended consequences that we have to keep in mind and that's 
why good science is crucial.
    We don't know whether one particulate--maybe it's the 
particles from burning of leaves that causes the problem and 
not the particles from diesel, gasoline, or vice versa. We have 
no idea which particle it is that may be causing the health--
and I think it is important to note that none of the ozone or 
particulate studies that we've seen indicate that these are 
carcinogens and none indicate that they are damaging, so far as 
I understand, to healthy individuals but can exacerbate health 
conditions in those who are sensitive to matters. So, we just 
need to know what we're dealing with I think.
    I would only make one more point to confirm what you're 
saying. It looks to me like we have a county of 13,000 about 50 
miles from Birmingham that's out of compliance with about 
13,000 people or so and it's because of Jefferson County, 
Birmingham, and nothing that they could ever do is going to get 
that county in compliance.
    Senator Inhofe. Thank you, Senator Sessions. We have time 
for a second line of questioning if it's brief, and we'll 
adhere to 2 minutes.
    During our hearing in Washington when Carol Browner was 
there she talked about the fact that it would take between 3 to 
5 years to really analyze and determine which PM's would be--
are the real villains here and another 3 to 5 years to 
designate non-attainment areas.
    Of course, CASAC, the scientific group testified in their 
hearing that it would be 5 years before we really know which, 
if any, of the PM's and at which level were hazardous to the 
health or to respiratory illness.
    I'm going to read the resolves that Senator Hutchinson 
mentioned that was passed by the Arkansas State Legislature 
then I'll ask each one of you just kind of yes or no do you 
agree with it starting with Mayor Hays.
    Be it resolved that due to remaining uncertainties and the 
lack of causality between PM2.5 and adverse health 
effects that EPA should abandon its current consideration of 
PM2.5 standard until more information, including 
sound science and cost effectiveness data are available.
    Mayor Hays.
    Mr. Hays. Very briefly. Yes, to that answer and on both of 
the resolutions that I brought, not only from my city, which is 
attached to my testimony, as well as the resolution adopted by 
the Metroplan, the Council of Governors both speak to that 
issue, agree with the Arkansas Legislature and I think you 
could probably safely say that there's unanimity at least in 
all three of those, those two bodies that I represent with the 
Arkansas----
    Senator Inhofe. I was asking this question really in your 
capacity as an elected official as opposed to standing for it 
in an organization.
    Mr. Hays. Absolutely.
    Senator Inhofe. Mr. Schwartz.
    Mr. Schwartz. I concur, yes, sir.
    Senator Inhofe. Mayor.
    Ms. Savage. Yes.
    Mr. Muegge. I would concur. I would like to make a remark, 
Senator Inhofe. I think that in our Nation what we've done in 
the past is we've always identified a problem and a crisis and 
we've attacked that with vigor. We had unlimited resources and 
we ran out there and solved that problem.
    I don't think we're going to have those kind of resources 
anymore. I think what we've got to do is look at any issue 
comprehensively and make sure we know what the consequences are 
and understand from the very beginning that we can't resolve 
all of the problems, all of the issues that we have facing us, 
particularly government can't do that. So, I think that's a new 
order that we need to very seriously look at and make sure that 
our citizens understand what the costs are and what the 
benefits are.
    Senator Inhofe. Thank you very much.
    Senator Thomas, do you have any remaining questions?
    Senator Thomas. Just I guess I would like to say, I'm 
looking to you, Mayor, how do we--how would you handle this 
business of having uniform standards?
    I think you objected to the idea that you applied the 
standards everywhere.
    Ms. Savage. Well, if I were in charge of writing the 
standard----
    Senator Thomas. Let's pretend you are.
    Ms. Savage. I would promulgate standards in a general way 
and then work with, on a regional basis, to address specific 
concerns. We know in our area for the air quality problems we 
have what they are. We have some ideas about how to address 
them and we do a number of things.
    But I think if you talk to any community or any region you 
will hear essentially the same thing, that I don't want to be 
held to the same standard that Chicago is, for example, because 
we have very, very different environmental issues.
    So, I would seek a formula. I don't presume to offer one, 
I'm sorry, but I'll work on that, Senator, that is--that 
provides a way in which we have the flexibility but we're also 
asked to perform, to demonstrate, to create innovative 
solutions which we can use within--in partnership with 
governments and business.
    So I think the standards sometimes get--we get hung up in 
the numbers and they seem to be rather arbitrary.
    Senator Thomas. That's kind of the pattern of central 
government, I'm afraid.
    Mr. Hays. Senator, if I could, briefly, you know, and this 
may sound a little bit radical, but I would have no standards 
but what I would do from a congressional standpoint is focus as 
much energy and resources that I could toward research and 
understanding of what the problem is and to that extent I would 
publicize that information, you know, as the local community, 
then it would be my responsibility to decide along--I say mine, 
it's not individually but certainly as a community, to decide 
how we could address that.
    Public safety is one that we took a real leadership role in 
Arkansas. That was something that was threatening the health 
and safety of our community as it is certainly in many areas 
nationwide. We took very active and aggressive steps to reach 
that.
    If we understand what the problems are, those of us that 
are local officials, along with those who live in our community 
have been--have been very proactive in trying to address those. 
Again, I think what we've found here and continuing to find is 
that we don't really know how serious, if we have a problem, 
and if so how serious it is.
    Senator Inhofe. Senator Hutchinson.
    Senator Hutchinson. Just following up on what Mayor Hays 
said. If we could take all of the resources that will be 
necessary to enforce these new proposed standards and apply 
that to the kind of research to obtain the data to answer the 
kind of questions that Senator Sessions asked a minute ago 
about causality. I think if we're really concerned about the 
health and safety of boys and girls in the United States that 
would be far more productive use of our limited resources.
    Just to touch base, Mayor Savage, I think you said Tulsa 
doesn't have an ozone problem they've got a weather problem. I 
kind of like that.
    Ms. Savage. Well, I'm the mayor.
    Senator Hutchinson. There were two studies found that if we 
control all man made volatile organic compounds, one of the 
components necessary to create ozone, that still there will be 
natural phenomena which will raise areas out of attainment for 
ozone. So, even Mother Nature cannot comply with the EPA if in 
fact that's the case.
    So, do you have any suggestions? I think Senator Thomas was 
pretty much on target, that if we could find the kind of 
flexibility, find a means of providing the flexibility for 
local governments and for States without the one-size-fits-all 
and the kind of regional differences that we will have gone a 
long ways.
    Ms. Savage. I would maybe summarize what my colleagues here 
have said, that we're all concerned about air quality. We want 
to work toward cleaner air. We want to do that in a manner that 
fits our communities.
    I think increasing our flexibility, being able to average 
the measurements over an extended period of time rather than 
arbitrary measurements on an hourly basis makes some sense.
    Having the opportunity to really extend the ability to have 
more research in this area that some technology which actually 
may make sense for communities and for business to me seems a 
tremendously good investment.
    So, as we all work toward this, the message from the mayors 
would be don't hit us so hard that we can't get up again and 
give us the flexibility, give us an opportunity to work 
together on these kinds of things and I think you're going to 
find we'll be pretty successful at it.
    Senator Hutchinson. Mr. Chairman, if I could ask one other 
thing. I think I heard Mayor Hays and I think Mayor Savage also 
that one of the problems was the location of these monitoring. 
How is that determined? We've got them at an airport. We've got 
it by a diesel--how are those monitors----
    Mr. Hays. I just found out yesterday, or day before 
yesterday, Senator, where mine were located. For a county 
they're both in my city, exactly where, DCP&E made that 
selection, and so the burden of the entire central part of the 
Arkansas rests on my city's shoulders and I'm not sure exactly 
why that is done.
    Ms. Savage. I think you're going to hear from some State 
folks here, you can ask them that question, they're the ones 
who do that.
    Senator Hutchinson. I will do that. Thank you very much.
    Mr. Hays. Senator, may I ask, was the written testimony, 
Mr. Chairman, that we have submitted, was that all of which 
made a part of this record?
    Senator Inhofe. Yes. Your entire statement will be 
submitted and will be a part of the record and will be used.
    Senator Sessions, do you have any further questions?
    Senator Sessions. I will just ask if anyone would want to 
comment on the concern that it places us in the competitive 
world market. Do you know of any companies, we have a lot of 
paper companies in Alabama, for example, they also have plants 
all over the world, they're building them in South America, in 
Canada, and places like that.
    If we are--do you think that these regulations strictly 
enforced when other nations are not enforcing such regulations 
will continue to drive American industry at even faster rates 
out of our country to other countries?
    Mr. Hays. Just a quick observation. I think that--and, 
again, I want to come back to the scientific data. I think that 
if we have some clear evidence that a certain level of ozone or 
a certain level of particulate are adversely effecting the 
health of our citizens, then I think that's the responsibility 
that we want to shoulder.
    Senator Sessions. I agree 100 percent.
    Mr. Hays. So, regardless of whether that puts us at a 
disadvantage internationally is something that I'm going to try 
to support and do all I can to see that it's achieved.
    It comes back to that line of what is adversely affecting 
the health and safety of those citizens that I'm responsible 
for.
    Ms. Savage. Senator, I would add to that by saying, and 
Senator Inhofe made a reference to Whirlpool, but we also have 
Hiltie Corporation, which is an international company who has a 
presence in Tulsa. Loughton, which is an international 
corporation which has a presence in Tulsa. Both of whom are 
undertaking or recently have undertaken expansions in our 
community, both of whom went two or three steps beyond what 
they needed to do under existing environmental regulations, 
they just felt it was the responsible thing to do.
    I'd like to be able to--and we can do it on a community 
leadership basis, to say these are great companies, look what 
they're doing, they're helping to clean up our environment, but 
there are a whole bunch who aren't as well and I think there 
needs to be some way to, perhaps, hammer on some of those 
offenders but overall I think our approach has been more 
punitive and it should be just in the policies overall. I would 
like to see us move to more of an incentive base for 
communities who really are working with their businesses to 
clean up the environment, cleanup the air, cleanup the water, 
provide for environmental mitigation as well as job growth. I 
think the two are very compatible and we ought to be developing 
policies that would support that.
    Senator Sessions. I'll just say that this panel today, 
we've focussed primarily on the question of what the 
implementation burden would be, we're asking you who will be 
there. We've had committee hearings on science and health and 
we need to do some more. I think it is--science at this point 
on health questions are inconclusive. But it is--I think it's 
appropriate that we do consider what you will have to go 
through if these regulations go forward.
    Ms. Savage. Thank you.
    Senator Inhofe. Thank you, Senator Sessions.
    I want to extend to each one of you our appreciation for 
coming today and spending so much time with us.
    It is very meaningful and it's kind of nice when you get 
out of Washington you talk to real people and you find out what 
real people are thinking.
    Thank you very much.
    Ms. Savage. Thank you, Senator.
    Mr. Hays. We know that that window of opportunity will be 
opened and that a breath of fresh air will blow back to 
Washington.
    Senator Inhofe. Good for you. Patrick Henry Hays, thank 
you.
    Before the next panel comes up, it will be our final panel, 
that will leave 1 hour for that panel. We're going to take a 5-
minute break for any reason and look forward to introducing the 
next panel.
    [Recess.]
    Senator Inhofe. We'll now introduce our last panel. Our 
last panel is from some surrounding States. We have Dr. Ron 
Hammerschmidt, director of the Kansas Department of Health and 
Environment. I will make a statement, since all of you are 
wondering, he's not related to any of the Arkansas 
Hammerschmidts; Barry McBee, chairman of the Texas Natural 
Resource Conservation Commission. Gus Von--help me with that.
    Mr. Von Bodungen. Von Bodungen.
    Senator Inhofe. All right. He is here from the State of 
Louisiana Department of Environmental Quality. I have to say 
that I shared with him the experience that we had when our 
Super Fund cleanup was taking place in his hometown of Baton 
Rouge, it was when Oxy U.S.A had the spill, and they had a plan 
to do it in about 2 years and the EPA came in and said, no, we 
want to do it under our supervision, which would have been 
about 9 years, I think we ultimately prevailed on that.
    We also will hear from Richard Grusnick, deputy director of 
the Alabama Department of Environmental Management.
    We will be adhering to a 5-minute rule on opening 
statements. Your entire statement will be submitted to the 
record and we'll start over here with Dr. Hammerschmidt.

STATEMENT OF RON HAMMERSCHMIDT, DIRECTOR, KANSAS DEPARTMENT OF 
                     HEALTH AND ENVIRONMENT

    Mr. Hammerschmidt. Thank you, Mr. Chairman and members of 
the committee.
    I'm happy to be here today to provide you with some 
comments on the standards.
    Our department has a critical interest in the proposals for 
these standards because we serve a dual role.
    We're both responsible for developing and implementing 
statewide protection programs and with public health and we're 
also the implementing agency for these rules as they're 
proposed.
    On this basis we're going to talk today primarily, however, 
about implementing perspective of our agency and not get in too 
much of the health effects research.
    The State of Kansas is proud of our air quality and 
recognizes the importance of clean air to the health of our 
citizens, its environment and its economy.
    Kansas is currently in attainment for all ambient air 
quality standards statewide. Our past successes can be 
attributed to the ability of local, State, and even Federal 
Government agencies across our State to work effectively with 
the affected business interests, special interest groups, and 
the general public. These relationships are critical to any 
success that we might have.
    Although many questions remain relative to technical 
requirements and implementation costs, our fundamental concerns 
lie in two areas.
    The first is the shortage of information and apparent 
inconsistencies in that information about the particulate 2.5 
standard. The particles of greatest concern in the 2.5 that are 
being distinguished from the coarse particles currently 
regulated is based upon their characteristic differences, i.e., 
they're combustion related, they might be soluble chemicals, 
chemically reactive, et cetera, and that they originate from 
different sources than the secondary--the larger particulate.
    However, information as to the source of the 
PM2.5 indicates that there is a significant overlap 
between fine and coarse fractions in the many sources of 
fugitive dust, which includes paved roads, unpaved roads and 
windblown dust that you've heard about today.
    This confusion is exacerbated by lack of 2.5 data in rural 
States. As a result, we think the fugitive dust component of 
PM2.5 emissions in rural States may represent a 
source of exposure that's not intended to be implicated as a 
target of concern by the health studies completed in primarily 
the larger urban areas of our State of the United States.
    It is apparent to us that adequate study has not been 
completed of any of these sources in rural areas. Because of 
our concerns we will be providing additional comments.
    Our second major area of concern involves the potential 
impact of the proposed revisions to the ozone standards on 
primarily Kansas City.
    Historically, ozone has been a concern in the metropolitan 
area. This is a five county area that goes across State lines, 
two counties in Kansas and three counties in Missouri.
    It was declared non-attainment in the late 1970's and 
remained as such until 1992 when we managed to achieve 
attainment status with a redesignation.
    In order to gain that status two States of Kansas and 
Missouri were required to demonstrate compliance with the 
existing standards.
    I would note that that has been a joint effort between the 
two States, between the local municipal governments, between 
local county governments and also the Mid-America Regional 
Council, which is a forum for determining how we can best work 
on these issues together.
    We had a violation in 1995 at, of course, one of our 
stations located by an airport, as everybody seems to. These 
exceedances have resulted in a violation and we have been 
working in recent months through an organized local regional 
air quality forum consisting of a broad coalition to come up 
with a way to avoid further violation and maintain our 
attainment status.
    They have made a number of recommendations related to 
emission control, transportation management and air related 
public education compounds in the Kansas City area. Forum 
members have arrived at a fairly clear consensus.
    As you might well expect, we are also working some 
resolutions through our legislature and will be happy to 
provide those to the committee when they're finally adopted.
    State and local governments are also currently reviewing 
plans based upon this air quality forum's recommendation.
    Although we continue to progress in the Kansas City area 
under our current plans, the proposed revision of the .08 parts 
per million would result in a return of our Kansas City area to 
non-attainment status and we would have to deal with our 
maintenance program under there.
    In addition, we might note that the recommended level would 
have exceedences beyond the Kansas City area. In fact, in a 
research project conducted in a small rural county in the 
western part of our State with 4,800 residents we did have 
measurements that would exceed the proposed standard. So, it 
isn't just a large urban problem.
    What we would recommend, and we intend to also formalize 
these in our comments on the current standard, is that EPA take 
some more time to review what they propose and, perhaps, 
consider some of the many things that have been discussed here 
today that I won't, in the interest of time, go through again.
    The depth of the impacts of both the .08 parts per million 
standard and the PM2.5 do bear further examination. 
And with that I'll be happy to answer any questions.
    Senator Inhofe. Thank you, Dr. Hammerschmidt.
    Let me ask if Becky Keogh would come up. Becky, can you 
come up here?
    And, Becky, if you could maybe pull that chair up behind 
Dr. Hammerschmidt in case there are some questions that would 
be directed to you. We won't recognize you for opening 
statements, I know you're not prepared for that, but we may ask 
some questions.
    Becky is the deputy director of the Arkansas Department of 
Pollution Control and Ecology. We're glad to have you here 
today Becky.
    Mr. McBee.

 STATEMENT OF BARRY R. McBEE, CHAIRMAN, TEXAS NATURAL RESOURCE 
                    CONSERVATION COMMISSION

    Mr. McBee. Thank you, Mr. Chairman, Senators, for the 
invitation to come and speak to you today about this important 
issue for Oklahoma, for Texas, for all of our States and 
particularly to come and speak as one who will be tasked, as 
you have noticed, EPA with the implementation of whatever 
standards are finally given to us.
    I have provided written testimony for the record, this will 
be a brief version of that. Let me also note, out of an 
abundance of caution for the record, that these are my personal 
views as the chairman of my agency. We have a three-person body 
that governs my agency and we have no official agency position 
as of yet. We will develop that and vote on that later on this 
week.
    As has been said many times here today, I know everyone in 
this room supports clean air. The good news in the State of 
Texas is that ozone levels are in fact dropping, showing that 
our standards and our controls are having an impact.
    So it was that we in Texas waited, like my colleagues here, 
along with the other States, for these new EPA standards to be 
announced, hopeful that they would be a clear mandate that 
would be fully supported by the scientific community. That is 
not what has happened.
    These proposals from EPA have not established a bright line 
for the standards. In my opinion, there have to be bright lines 
for standards such as these. I, as an environmental policymaker 
in a State with 18 million people and with literally billions 
of dollars at stake, without a bright line we will be forced to 
make decisions in the midst of a gray area of science, an area 
that, as we've touched on today, everyone agrees, seemingly, 
that not much is certain and there's a great deal that we do 
not know. We don't have bright lines with these standards. At 
best we have dim lines.
    Now, so it's not as surprising as the finding of Truman 
Bliley, noted by Chairman Inhofe, we too were surprised 
recently by a recent action of EPA. Some of you or your staff 
may be familiar with this.
    There was a recent study that has been sponsored by EPA, a 
study that we in Texas were not notified about until it had 
been posted on the internet, that has in our minds created even 
more uncertainties about replacing the 1 hour ozone standard 
with the proposed 8 hour standard.
    This study seems to suggest that the 1 hour standard would 
be more protective for children in at least two areas of our 
Nation, in Los Angeles and the city of Houston.
    And as I have noted, that has contributed to this 
atmosphere of uncertainty about the entire process. It appears 
that truly we do not know as much as we even thought we knew 
about ozone and we, in fact, do need to know more.
    So, because of this we believe the EPA proposals on ozone 
and particulate matter should be separated, they should be 
decoupled.
    In light of this new study alone we believe it is not good 
public policy to act now to change the ozone standard. EPA was 
compelled to move forward on a change to the particulate 
standard. Now, that is not the case, as you well know, for 
ozone. If more research is needed on ozone, as it appears there 
may be, we should do that now instead of prematurely altering 
the standard which, once again, is working in the State of 
Texas.
    This EPA study also points to another problem. If research 
shows that different areas of the State of Texas should have 
different standards to protect their citizens then how is it 
that EPA can still maintain that one-size-fits-all for the 
entire country.
    This study I've noted has pointed out that what may be good 
for Dallas/Fort Worth may not be good for the city of Houston. 
We believe in the State of Texas we should not be called upon 
then to adopt a separate State standard in addition to a 
Federal standard that will not fix the problem that EPA has 
identified.
    We believe it is increasingly clear in our Nation that one 
size does not fit all and that it may be time for a flexible 
regional approach to clean air and to air quality standard, an 
approach that is being explored in Texas in certain 
communities.
    Now, we note, if, however, EPA does choose to move forward, 
and I will echo the concern of Governor Hollister that was out 
and interventioned by you and your colleagues in Congress, EPA 
will in fact move forward on this standard.
    Let me touch on the proposal itself. EPA proposed an 8-hour 
standard with .08 parts per million level proposing that some 
how that is the bright line for the Nation. Let me tell you, in 
my view that line is in the wrong place.
    There is, I think, a growing consensus, if not almost a 
universal consensus, on the wisdom of an 8-hour standard. You 
heard the prior panel touch on that. But there is no consensus 
on the right level for the standard.
    EPA chose .08 even though the range of .08, 2.09 or higher 
was recommended by more of its own clean air science advisory 
committee and we believe there is no toxicological study which 
shows more health protection from a level of .09 than one of 
.08.
    Let me also just touch on the particulate matter standard 
in closing. There we have gone from ozone's dim line to no line 
at all. There are very few data on fine particulate matter and 
based on what EPA is proposing, absolutely no data from 
monitoring in the State of Texas.
    There does appear to be a growing body of evidence that 
there could be heath effects from fine particulate matter. But 
CASAC, which expressed concern about those health effects, was 
not even close to a consensus on a standard. It expressed 
indeed some legitimate concerns and some unanswered questions.
    So, what we have to do instead of setting a premature 
standard is to speed up dramatically the Federal research 
efforts, which CASAC and the Western Governors Association, 
joined by my Governor, George W. Bush, called for, and only 
after that research is concluded decide on a standard, if any.
    In closing, it should not be too much to ask, I believe, 
for government, especially given the potential effects on 
family, on business and industry, on lifestyle and the 
staggering cost of these regulations to adopt standards that 
are both clear and based on sound and compelling science. With 
so much at stake, the Federal Government is not doing its job 
if these standards are not clear and if they do not have that 
basis and, sadly, they do not.
    Senator Inhofe. Thank you very much.
    Mr. Von Bodungen.

STATEMENT OF GUSTAVE A. VON BODUNGEN, ON BEHALF OF DALE GIVENS, 
    SECRETARY, LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY

    Mr. Von Bodungen. Thank you. I'm representing Dale Givens, 
the Secretary of the Louisiana Department of Environmental 
Quality today, and I also would like to thank the committee for 
the opportunity to comment on these proposed regulations.
    Louisiana, in partnership with EPA has been very successful 
in improving air quality through the implementation of the 
Clean Air Act.
    Today Louisiana meets five of the six National Ambient Air 
Quality Standards for criteria pollutants with only ozone 
remaining.
    Our ozone non-attainment parishes have decreased from 20 to 
5. We have met our obligations under the 1990 amendments of the 
Clean Air Act, completing all required emission reductions. We 
have submitted the required ozone attainment demonstration 
plan.
    As required by the Clean Air Act, complete implementation 
of the attainment plan will be accomplished in 1999. At that 
time, we expect to be in full compliance with the present ozone 
standard. Already, as a result of substantial emission 
reductions in place, air monitoring data show marked decreases 
in ozone. Louisiana is on a successful course for cleaner air.
    Louisiana supports the establishment of NAAQS which are 
necessary to protect human health and which are based on sound 
technical and scientific data.
    In the setting of the standards, the EPA has stated that it 
cannot consider economic or technological feasibility of 
attaining the standard. We have therefore concentrated our 
review of the proposal based on the underlying health science 
including the EPA staff paper and the independent scientific 
advisory reports.
    Based on our study of these documents, Louisiana supports 
the EPA position that an 8-hour standard is more appropriate 
for a human health-based standard than the present 1 hour 
standard. Louisiana also agrees that the form of the standard 
should be concentration based.
    The EPA's staff paper recommends .09 PPM as the upper level 
of an 8-hour standard that would reduce estimated exposures of 
the at-risk population sufficiently to provide some margin of 
safety against pulmonary inflammation and increased 
susceptibility to pulmonary infection.
    Louisiana supports a level of the standard set at .09 parts 
per million as the 3 year average of the annual third highest 
maximum 8 hour average ozone concentration.
    As we appreciate the underlying science for setting the new 
standard, little or no public health benefit would be gained by 
setting the standard at .08 parts per million, that the EPA has 
proposed, rather than .09.
    In addition, Louisiana favors the proposal made by a number 
of CASAC members for an expanded air pollution warning system 
that could be implemented for sensitive individuals who could 
then take appropriate exposure avoidance action. CASAC pointed 
out to the EPA that this idea would be easy to implement since 
many areas of the country already have an infrastructure in 
place to designate ozone action days when voluntary emission 
reduction measures can be taken. Tulsa, OK, everybody's 
example, has such a program in place.
    For a number of years the Baton Rouge area has operated a 
program to apply administrative controls on industrial 
emissions to industrial sources during periods when ozone 
levels are expected to be elevated.
    Efforts to develop a community ozone action day program 
were begun last summer in Baton Rouge. This effort is expected 
to continue this summer and is supported by the public.
    These are our initial comments regarding the primary 
standard being proposed for ozone. We are continuing to review 
the entire proposed set of changes which includes the secondary 
standard for ozone, the changes to the particulate matter 
standard and the implementation proposal for both pollutants.
    Due to the large volume of documentation associated with 
these proposals, it will take time to properly review them and 
the support documentation in order to provide additional 
comments.
    Thank you again for the opportunity to comment today.
    Senator Inhofe. Thank you very much.
    Mr. Grusnick.

    STATEMENT OF RICHARD GRUSNICK, DEPUTY DIRECTOR, ALABAMA 
             DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

    Mr. Grusnick. Mr. Chairman, like the rest of the panel, I 
appreciate the opportunity to offer testimony today on the 
implication of EPA's proposal of the standards have on State 
and local government.
    There are two basic points I'd like to make today. The 
first is tightening the standards would divert regulatory 
resources from the areas with the most serious air quality 
problems.
    The second point I'd like to make is given the difficulty 
and resistance encountered in identifying and implementing 
measures to meet the current standard, the credibility of all 
levels of government will ultimately decline if the proposed 
standards are adopted.
    The only current non-attainment area in Alabama is the 
Birmingham area which includes Jefferson and Shelby counties.
    Birmingham was designated a marginal to least severe ozone 
non-attainment area pursuant to the Clean Air Act amendments of 
1990.
    A significant amount of the air regulatory resources in 
Alabama have been focused in this area by developing and 
enforcing regulations dealing with smaller types of industries 
that we don't regulate in the remainder of the State and in 
focusing on improvements in the transportation system.
    This makes sense, we're focusing the regulatory efforts and 
associated increased costs in the area of the State with the 
worst air quality where the benefits would be greatest. This 
focusing of resources would decrease if the proposed standards 
were adopted.
    Under the current range of proposed standards, the number 
of non-attainment counties in Alabama would increase from two 
to somewhere between eight and all sixty-seven counties, with 
the most likely scenario including a minimum of 20 counties 
being designated non-attainment.
    It's not realistic to expect that resources available to 
the regulatory agencies to be expanded to the level necessary 
to implement these non-attainment programs with the same level 
of oversight and detail and thoughtfulness that exists with the 
current programs.
    This will mean that resources will be diverted from the 
areas with the most severe air quality problems to implement 
the requirements of the newly designated less severely 
impacted, less densely populated non-attainment areas.
    Given the reality of limited resources, I question whether 
establishing a tighter standard will actually result in the 
most effective use of the State's regulatory resources to 
provide the maximum benefits from cleaner air in Alabama.
    I also have reservations about the continued credibility of 
efforts to improve air quality. The days of easy choices have 
passed. This is evidenced by the 10 years it took Congress to 
pass--to reauthorize the Clean Air Act with the 1990 amendments 
and the challenges already faced in implementing its 
provisions.
    No longer are requiring controls on large industry and the 
manufacture of lower emitting new vehicles adequate to satisfy 
the air quality mandates of the existing law. Small businesses 
are now required to reduce their emissions and lifestyle 
changes are necessary in some areas.
    I have seen presentations by representatives of other more 
challenged States which indicate emission reductions in excess 
of 70 percent will be required to meet the current standard. 
Couple this with the fact that transportation sources are 
generally responsible for half the emissions and the problem is 
obvious.
    Many of the more severely impacted areas have been unable 
to develop plans to meet the current standard using any 
politically or socially acceptable strategy.
    Investigations into long range transport have also failed 
to identify a strategy which would allow the current standard 
to be achieved throughout the eastern United States.
    From a practical perspective, I think it is reasonable to 
question whether raising the target when the current one is 
already too high to hit in many instances is the logical thing 
to do.
    In addition, many of the measures recently implemented have 
met with strong opposition. In the more severely impacted areas 
smaller businesses have been regulated, automobiles have their 
emissions tested, and certain types of new industrial growth 
continues to be essentially precluded by the emission offset 
requirements.
    Tightening the air quality standard would significantly 
expand the number of areas subject to these requirements and 
may undermine the support for continued air quality 
improvement. This is especially likely since these requirements 
will impact more rural areas which have historically or 
traditionally been viewed as having good air quality.
    It should also be noted, and I think this is important, 
that continued improvement in air quality will occur even 
absent a revision to the standards since the aggressive 
requirements of the Clean Air Act amendments of 1990 have not 
been fully implemented. They contain many far reaching emission 
reduction provisions and, again, many of them have not been 
fully implemented.
    Perhaps continued evaluation of the disputed health effects 
studies would be reasonable as we continue to implement the 
blueprint for improving air quality established by Congress in 
the 1990 amendments.
    In summary, adoption of the proposed standards would most 
likely result in diverting regulatory resources from the most 
impacted areas and a loss of government credibility all the 
while air quality improvements will continue to be realized as 
a result of the 1990 amendments.
    Thank you.
    Senator Inhofe. Thank you, Mr. Grusnick. We will have now 
one round of questions at 7 minutes apiece, which will put us 
right up to the 3 o'clock news conference that we'll be having 
in the Oklahoma Room. So, anyone who is interested in attending 
that would certainly be welcome to do so.
    Let me go ahead and start here. Dr. Hammerschmidt, you 
mentioned that your State legislatures are taking up a 
resolution; is that correct?
    Mr. Hammerschmidt. Yes, it is.
    Senator Inhofe. When will that be?
    Mr. Hammerschmidt. Well, we just had turn around yesterday 
so I would imagine it's going to be a couple of weeks before 
they get----
    Senator Inhofe. That would be ample time and we would ask 
that you would send that to us for our record.
    Dr. Hammerschmidt, Kansas City, I assume is--I think the 
portion of Kansas City that is Kansas was actually out of 
compliance at one time and then came within compliance; is that 
correct?
    Mr. Hammerschmidt. Well, actually we've never separated the 
two. It's just always been the metropolitan Kansas City air 
shed, which is the five counties.
    Senator Inhofe. All right, fine. But they were found to be 
out of compliance and then you do the fine work that you did 
and the people in Kansas City did and you came within 
compliance.
    If these regulations were to go through, it's my 
understanding you would now be out of compliance again?
    Mr. Hammerschmidt. That's correct.
    Senator Inhofe. What more can you do? You've done a lot so 
far, but what more could you do if that should happen?
    Mr. Hammerschmidt. What we have been able to do so far has 
been primarily to work with the industrial sector within the 
area to reduce their emissions.
    We are currently, as I mentioned, we've had a violation and 
had a plan developed. We are looking at implementing this 
summer some public education. We're looking at implementing 
some of the free riding, free mass transportation ridership, 
those type of things.
    The one thing there's not consensus on at this point is the 
imposition of an inspection and maintenance program for 
vehicles and that's one that remains reasonably contentious, 
both politically and within the city.
    In a big picture, it appears to us that in order to get 
into some of these lessor levels that we're going to have to 
move more away from the industrial sector and move more into 
things that effect individuals, such as inspection and 
maintenance program and that type of thing.
    Senator Inhofe. Do you have any idea what--have you 
quantified the cost if that should happen?
    Mr. Hammerschmidt. No, we have not. We've--I guess our hope 
has been to find a way to improve the air quality without 
having to go to inspection and maintenance.
    Senator Inhofe. Mr. McBee, I want you to know I'm not one 
of those who have said that our problems in Oklahoma are due to 
the prevailing south winds.
    Mr. McBee. Thank you, Senator.
    Senator Inhofe. I notice that in your statement and in your 
oral statement you repeated it, that recently you gave studies, 
just last month, I think, shows that the 8-hour standard for 
Houston would be worse for public health than the current 1 
hour standard, and that's the first time we've heard that. 
Could you kind of elaborate a little bit on that?
    Mr. McBee. This is an update on part of the risk analysis 
that was done by EPA. It was done, I think, after they had 
promulgated these standards and it shows, at least at first 
blush, we are continuing to analyze it, that again in Los 
Angeles and in Houston that the existing 1-hour standard 
provides greater protection, particularly for children, than 
the 8-hour standard would.
    It has caused us, as we determined the State's position on 
these proposals, to step back and replace the data that's part 
of the uncertainty that we face. In fact, increased 
uncertainties.
    We believe we knew a great deal about ozone, perhaps we do 
not know as much as we once thought. So, we would assert that 
it's time for EPA to step aside, delay this proposal and focus 
on that study and any other studies that are in the pipeline. 
This is not a single isolated incident, perhaps, to make sure 
that we, in fact, do know and that they in fact do know enough 
to go forward.
    Senator Inhofe. Ms. Keogh, you heard the testimony and the 
comments made by Mayor Hays. Do you find yourself in agreement 
from your standpoint as deputy director of the Arkansas 
Department of Pollution Control and Ecology to be in 
substantial agreement with Mayor Hays?
    Ms. Keogh. Yes. I appreciate the opportunity to participate 
today even though I didn't have written comments prepared.
    Generally I think my comments wouldn't be different and 
would reflect many of the same statements that the individuals 
made as well as Mayor Hays.
    I attended the meetings where those resolutions that he 
presented in his comments were passed and participated in those 
discussions.
    The impacts in Arkansas I think have been discussed, you 
know, in two areas. I agree that as a State agency and as a 
professional in this field it's very important that the burden 
of demonstrating the impacts of these regulations not be left 
to the State agencies, but be brought forward to the public 
when the proposal is made. I think that's very important from a 
professional standpoint and, as they mentioned, for our own 
credibility in terms of implementing other regulatory programs 
within the State.
    Senator Inhofe. Well, let me ask you this question, and 
maybe you also, Mr. Grusnick. You've stated, all of you have 
stated, and it has been an incontrovertible fact, that our air 
is getting cleaner from the efforts that we have made in the 
past.
    The thing that disturbs me, I guess, from the hearing we 
had where Carol Browner was there, that she is making the 
American public believe that our air will get dirtier if these 
regulations do not get enacted. Would any of you want to 
comment on that?
    Mr. Grusnick. Well, again, I think Congress did--again, it 
took 10 years to amend the law last time, and there was some 
fairly aggressive things. Phase two of the acid rain 
provisions, for example, have not yet kicked in. That's where 
the lion's share of the reduction in oxygen oxide and sulphur 
oxide emissions are going to come. Both of those, oxygen oxide 
is implicated with ozone and the small particles, as is sulphur 
oxide with the small particles, so we have that.
    We have the fleet turnover in automobiles that will 
continue absent anything. Generally the improvements in the 
transportation system. Increased efficiency of vehicles. 
There's other regulations that EPA will have to adopt to 
control the hazardous air pollutants. So, there's a built in 
continued improvement for some period of time that in my 
judgment removes the sense of urgency to change the standard 
right now.
    Mr. Von Bodungen. I'd like to echo that and I think you've 
made an excellent point. We've been fighting this ozone 
standard for over 20 years. I've been in this area since 1970, 
and I've been the head of it since 1976 and this is an 
extremely stringent existing standard, it's very stringent.
    The feeling is, as you listen to the proposal, we're going 
to take some kind of quantum leap, when we can't even meet the 
present standard, although in a lot of cases we are showing a 
lot of improvement. As Richard said, there's still a lot of 
things in the pipeline that are coming down.
    A significant amount of the country is serious ozone non-
attainment and the compliance deadline for those type of States 
is 1999. So, we're looking for more improvements under the 
existing standard.
    Senator Inhofe. Well, you know, one of the things that 
bothers me, I guess, I noticed a lot of masks when we came in 
here today, and of course in Washington they made a big issue 
out of that and the media loves it, in spite of the fact that 
we have made dramatic progress in cleaning up the air in 
America yet the incidents of various respiratory diseases has 
gone up, which would leave someone to doubt that it was related 
directly to that. If the air is getting cleaner why are those 
increasing. Do any of you have any thoughts along those lines?
    Mr. McBee. Well, I think part of the body of evidence that 
does tell you that incidents, for example, of asthma is going 
up, is attributable to things, perhaps, such as indoor air 
pollution and not outdoor air quality and then some other just 
living condition factors.
    I mean I know in the city of Houston intensive studies have 
been done in certain areas that are, for example, lower income 
housing areas and they find a higher incidence there also which 
may be attributable simply to the conditions in which people 
live within their homes and not the outside air that, in fact, 
they are breathing.
    Mr. Von Bodungen. I think that there is a dramatic under 
estimation of the impact of indoor air pollution.
    I can't remember the last time I was in a building where 
you could open the windows.
    Senator Inhofe. Well, you know, I just think it's a great 
disservice to a lot of people with respiratory problems to make 
them believe something that is not scientifically proven. I 
find this to be very offensive because I certainly feel sorry 
for these people.
    My time is up. You heard me read the resolution that was 
passed by the State of Arkansas. I'd just like to have you run 
down to see if you agree with the sentiments expressed in that 
resolution. Mr. Grusnick.
    Mr. Grusnick. Yes, I do.
    Mr. Von Bodungen. Yes.
    Mr. McBee. Yes, Senator.
    Mr. Hammerschmidt. Yes.
    Ms. Keogh. Yes, I do.
    Senator Inhofe. Thank you very much. Senator Thomas.
    Senator Thomas. Mr. McBee, where would you go for good 
science?
    Mr. McBee. Well, I think it may be a question of--science--
I don't seek to impugn the science that has been done 
particularly on the particulate side or on the ozone side.
    I mean I will note though that there's the vast difference 
weight. I think EPA was looking at about a thousand studies in 
terms of ozone and that drove them to the 8-hour standard. 
Again, there's concurrence that that's probably the right move.
    They're looking at less than 200 studies on fine 
particulates. So, I think it is just simply the weight of the 
evidence not that we're going to the wrong place. We simply 
have not taken enough time. We have not studied the issue 
sufficiently and so thoroughly as we need to.
    We simply need to, as noted by Senator Inhofe, continue to 
go forward expending some of the funds that's been dedicated 
for this purpose, EPA has chosen not to, apparently, yet 
expend.
    Senator Thomas. EPA, according to their reports have been 
studying these things now for 4 or 5 years. I guess sometimes I 
wonder--we talk a lot about peer review for science and so on, 
in many things, not just this one, and I'm sort of anxious to 
know how we can feel more comfortable with the science of some 
of these things.
    Dr. Hammerschmidt, is the move from 10 in the particles to 
2, is that a big step?
    Mr. Hammerschmidt. I think the answer to that is obviously 
yes, because we are talking about going to a much finer 
particulate.
    We're also, it's been mentioned a couple of times by other 
panelists, that we don't even have the monitoring stations 
designed to do that. We also don't even have the methodology 
approved as to how we're even going to gather much less 
evaluate it, so it is a big step.
    We think that when we do--and I don't like the word good 
science as much as complete science. If we get the complete 
science in we think there might be a big difference between the 
fine--the PM2.5 that you see in a bus barn or in the 
middle of--in an urban area that you see in a rural area where 
you're largely getting dust and different type of particles 
from an unpaved road.
    So, we think there is a need for more complete science and 
the direct answer to your question is, yes, it is a big jump 
from the PM10 to the PM2.5.
    Senator Thomas. Someone mentioned difficulty in rural 
areas. Is this because most of that pollution is natural 
pollution and there isn't much you can do to control it?
    Mr. Hammerschmidt. Well, it's different because I've lived 
by unpaved roads and I imagine many of the people here have 
and, you know, you get a lot of dust and it tends to be very 
fine dust depending on what the roads are made out of.
    That is different than a small particle that's the direct 
result of combustion, you know, diesel fuel versus road dust.
    Some of the effects may be the same, some maybe not. Again, 
that's where we need to get more of a health study to look at 
that.
    Senator Thomas. EPA, as I recall, backed away from 
something awhile back on fugitive dust, took the right step, 
then replaced it with this which is probably more difficult.
    How would you go about regional differential in terms of--I 
mean the results you want--just because you live one place and 
I live another you shouldn't ought to have to live with any 
less quality air than I. How do you do regional things?
    Mr. McBee. Well, I think the first and foremost is to set 
good standards nationally. There may need to be a minimum 
baseline nationally. I think that is, again, we find error in 
what EPA has done in trying to set these minimum baselines. We 
do not know enough today.
    I think within that then allow communities, and I harken to 
what Mayor Hays said, allow those local elected officials, the 
local leaders, to within some range really deal with the 
priorities what they want to address first.
    The city of Houston and the State of Texas is really 
embarking on that effort now to look at ozones, to look at 
nitrogen oxide, to look at, perhaps, even some of the critical 
pollutants such as benzene, and try to craft their own more 
regionalized approach to deal with what they believe are the 
most pressing problems today, pressing problems that are 
decided upon by the local community, not by those in Washington 
sitting at EPA.
    I think within some minimum protection for people all 
across this Nation there are ways to in fact find these sorts 
of regional approaches and we need to explore that.
    Senator Thomas. Mr. Grusnick, I think your observation was 
a good one in that as we move up and have moved up and have 
generally good air everywhere now you can put your resources 
where they're most needed. This, I suppose, will spread those 
resources out again over the whole scope of things.
    Mr. Grusnick. That's exactly right. I guess in Alabama we 
have the two counties that are non-attainment for ozone now, if 
the standard was .08, as proposed, we'd go eight counties be 
non-attainment. One of them would have a population of 14,000 
people. If it went to .07, which is the lower end, it would be 
67 counties that would have--all 67 counties would be non-
attainment.
    So, yes, you know, one approach we could take is to sit 
here and say, look, if you're going to change these standards 
you need to give us sufficient resources so that we can do the 
quality job we've done in other areas throughout--I think 
that's, given the direction government's going right now, I 
think that's an unrealistic assessment.
    So if you take the other tack and say you're going to have 
limited resources where can those best be spent. I'd prefer to 
coax them in the areas that do have the worst air quality and 
the highest population densities also.
    Senator Thomas. I certainly subscribe to this idea of 
flexibility and also responsibility for doing it. Thank you Mr. 
Chairman.
    Senator Inhofe. Senator Hutchinson.
    Senator Hutchinson. Thank you. Let me get this question out 
of the way. I'll address this to Mr. McBee and then I don't 
know who it ought to go to, but how are these monitoring sites 
determined, is it different from State to State? We've got 
monitoring sites next to airports. How is it determined?
    Mr. McBee. They are chosen, I believe, with a scientific 
basis trying to find the worst case possible.
    We as a State agency put----
    Senator Hutchinson. These are consciously put by airports.
    Mr. McBee. I believe they are. I think there is some 
credence to doing that. But we seek to--we seek, as a State 
agency, what we think will really produce the result, if you 
will, in concurrence with the EPA, we work with them in terms 
of the siting of these particular monitors.
    I think on the belief that if we are identifying the areas 
of greatest concern, and obviously the air elsewhere within the 
community is going to be better than that.
    Given our existing system, this is one of the flaws in the 
existing system, where we are looking at a single monitor for a 
single hour, and that's the right approach, but if we move 
toward averaging not only over a temporal average over an 8-
hour period but perhaps spacial averaging, averaging all the 
monitors within an area, something that we as a commission 
support, that will give us a true better picture of air 
quality. We site monitors today based on the existing system, 
which I think is a flawed system.
    Senator Hutchinson. Ms. Keogh, in Arkansas, same thing?
    Ms. Keogh. As I understand it from our staff, I wasn't 
there when they were located, we worked within specific 
guidelines or criteria that EPA established in selecting the 
location.
    I agree with Mr. McBee that those standards may not be 
applicable under the proposed averaging.
    We also, I guess the locations--once--this is 
representative of many things, working with EPA is, that kind 
of once the State obligates or agrees within those guidelines 
to place something or, in fact, like in North Little Rock, have 
two monitors, then what we find is that it's difficult to 
remove one of those monitors or to move it to a different 
location within the EPA system.
    I believe Mark Coleman mentioned to me briefly that he was 
successful in moving one by having a garbage truck back up and 
hit it. That was obviously an accident and not intentional. 
But, you know, I hope we don't have to go to that extent if we 
find there is justification to move a monitor.
    Senator Hutchinson. Dr. Hammerschmidt, walk me through, if 
these standards on PM should be adopted, what process would you 
go through to get an area out of attainment into attainment and 
what kind of resources are we talking about, what kind of 
timeframe are we talking about, what happens?
    Mr. Hammerschmidt. OK. Senator, the first thing we'd have 
to do is the monumental task of going around and finding all 
the areas that were non-attainment.
    In other words, with the new methodology and the new 
sampling procedure, if you will, we'd have to go around to 
those areas that we felt were most likely to go into non-
attainment and that's about----
    Senator Hutchinson. You don't have monitoring equipment to 
do that currently?
    Mr. Hammerschmidt. We have no monitors within the State of 
Kansas that would monitor for PM2.5. I doubt if 
there's very many States that do.
    We have quite a network of PM10 monitors but 
that data is not useful unless you do an extrapolation.
    Senator Hutchinson. Do you have any idea how long it would 
take to do that?
    Mr. Hammerschmidt. Oh, golly, it's going to take a couple 
of years to get through that whole process just to--you've got 
to get through the four season changes, et cetera, et cetera.
    We would fight the battle with monitor locations, you know, 
do you put a monitor on the edge of one of the smaller towns, 
do you put it in the middle of a busy intersection, where do 
you put a particulate monitor.
    Senator Hutchinson. Next to the airport.
    Mr. Hammerschmidt. Well, actually where you don't want to 
put it is probably next to the quarry. But--or next to any kind 
of road because lots of people don't realize how much dirt 
there is on a road.
    Senator Hutchinson. We've used a couple of years, then what 
happens?
    Mr. Hammerschmidt. What we would then have to do if it was 
an urban area, like a Kansas City area where we think a lot of 
the PM2.5 is going to be due to dust coming off of 
paved streets. There's a lot of dirt on a paved street, believe 
it or not.
    Then you're going to have to start looking at this issue of 
what do you do to control that dust. Do you do wet 
applications? Do you keep the roads wet--how do you keep that 
dust down?
    In another application, say a smaller town where you might 
have unpaved roads, you've got the option, obviously, of paving 
some of them, which is not cheap.
    Then you get into the issue that was cited earlier, what if 
you have an agricultural area located immediately next to an 
area that's non-attainment and you get a nice midwest breeze, 
you know, 40 or 50 mile an hour breeze when they happen to be 
doing the tilling in the spring prior to planting and you're 
going to get a lot of dust then.
    Senator Hutchinson. Excuse me, Dr. Hammerschmidt, what 
you're talking about are various steps you would take then to--
--
    Mr. Hammerschmidt. Right.
    Senator Hutchinson [continuing]. To mitigate the 
containment?
    Mr. Hammerschmidt. Right.
    Senator Hutchinson. Does everybody agree on the process, is 
this the steps you'd----
    Mr. McBee. Senator, I might add, we have looked at the cost 
in Texas, that's going to be a $1.5 million to $2.5 million a 
year on top of our existing monitoring costs with no offer from 
EPA to pay those costs.
    Mr. Hammerschmidt. Once you get the monitoring and the 
mitigation done you would then say--you'd have a plan developed 
and you'd say this is our plan and we've met it. And that's a--
in Kansas City it took us from the mid-1970's clear up to 1992 
to get just the ozone attainment taken care of.
    Senator Hutchinson. What does EPA do during this multi-
year, 5 years or so process that you're going through, are you 
out of--can they at that point start enforcing ISTEA funds or 
whatever enforcement mechanisms they might want to use?
    Mr. McBee. There's a possibility of that. There's been 
discussions, I think, in terms of the implementation policy of 
these standards to allow time.
    Although, we are troubled by some comments we're beginning 
to hear from EPA that they may move, even with the scarcity of 
data today about PM2.5, to begin to declare areas as 
attainment or non-attainment. And that tells you--a very 
disturbing thought that--very little we know, as you've heard 
extensively here today, they would begin to make those 
decisions and potentially move to enforce some of the penalties 
under the Clean Air Act.
    Mr. Hammerschmidt. One thing we're particularly concerned 
about is that they have decoupled the setting of the standards 
from the--from any discussion of these implementation policies 
and procedures that they might use. They will not discuss it.
    Senator Hutchinson. So, we're really in the dark on exactly 
what process might be--or what they may require or what 
enforcement may take place if you're out of compliance. Does 
anybody else want to comment on that before I move on to my 
next--OK.
    Mr. McBee, you mentioned lifestyle and whether it would 
impact it. We've heard a lot about concerning the barbecuing 
and so forth. EPA says, and I think correctly, that this 
standard would not ban barbecues, camp fires, lawn mowing, and 
so forth.
    But if an area was very close, or was very badly out of 
attainment, could that not be the end result from what the 
State or local municipalities would have to do to enforce some 
of those kinds of lifestyle changes?
    Mr. McBee. Senator, eventually I think it could be. I'm not 
here to tell you that barbecues will be banned in Texas under 
these standards or I won't be able to go home.
    Senator Hutchinson. There would be a wholesale revolt; 
wouldn't there?
    Mr. McBee. There would be.
    Senator Sessions. You don't have any barbecue in Texas; do 
you?
    Mr. McBee. If you do look at areas of the country, 
limitations such as that in terms of use of fireplaces, in 
terms of use of barbecues, consumer equipment, I mean those 
things have been talked about and in fact put into place. So, 
it's not out of the realm of possibility.
    Senator Hutchinson. I have to quit; don't I?
    Senator Inhofe. No, don't quit.
    Senator Hutchinson. Just one more thing, very simple here. 
If EPA tells us that their proposed standards could have 
nothing to do with cost-benefit analysis, but their mandate 
says health only is what they're to be looking at, and they 
say, therefore, we're going to go from 10 to 2.5 on PM out of 
health--for health reasons. Why not even more rigid standards? 
I mean if going from 10 to 2.5 means better health, and that's 
their only mandate, and they're not going to consider the cost 
to industry, the cost to the taxpayers, the costs to local 
government, or any other factors, then why not make it even 
more rigid.
    Can anybody explain to me how--why 2.5?
    Mr. McBee. I don't think they can. And I think that is part 
of the fallacy of their argument that they are simply setting 
standards, cost is not a factor. That would be true if there 
were a bright line. There is no bright line and so they have, 
therefore, entered into a policymaking determination and within 
that determination cost must be taken into account, I believe, 
both as a matter of law and certainly as a matter of good 
public policy.
    Senator Hutchinson. So, it's arbitrary but there is costs, 
they really are considering what that cost is going to be they 
go--I mean--it's unreasonable.
    Mr. Von Bodungen. I think if they would have ignored that 
they would have said .07 instead of .08. That will give you an 
example, they didn't do it themselves.
    Ms. Keogh. Yes, I believe they had data submitted to them 
that even finer particulate matter would create additional 
health, you know, impact. So, you know, I agree with you, there 
obviously is some policymaking going on.
    What the basis of that is is not clear to other State 
agencies and that's what, you know, really concerns me as being 
the implementing agency for these standards obviously, as we 
have today, to some extent we'll take the heat on that and I 
think we, again, have to be able to provide, you know, credible 
justification.
    Senator Hutchinson. Thank you, Mr. Chairman.
    Senator Inhofe. Thank you, Senator Hutchinson.
    Senator Sessions.
    Senator Sessions. Those fine and ultra fine particles, 
someone has even suggested it may be the ones that are really 
causing the health consequences may be smaller than 2.5. Do you 
think that's possible?
    I mean we don't have the science right now to show whether 
it's a 2.4 or 2.5 or 1.0 that may be the triggering particle 
that cause the health consequences, whatever that is.
    Mr. Grusnick, we've been talking about improving the air, I 
know you've been involved in the State of Alabama in air 
quality since 1972.
    Mr. Grusnick. Yes.
    Senator Sessions. You've seen the whole history of it, I 
suppose?
    Mr. Grusnick. I like to tell people I've had 26 years of 
experience and they said, no, you've had 1 year experience 26 
times. So, I hope they're wrong.
    Senator Sessions. Just one question. Tell us about 
Birmingham. What have you observed that they've accomplished 
since--in those 26 years?
    Mr. Grusnick. Well, while I grew up in Birmingham in the 
pre-1970's and it had about, on some rankings, the third worst 
air quality in the country primarily due to particulate 
emissions from industrial sources. That's back when being an 
air pollution regulatory was fun, going to the big industries, 
say make them cleanup my air and, you know, you really got a 
lot of support for that.
    By regulating about 55 companies back then we made dramatic 
air quality improvements. We measure levels three times the 
Federal standard. We've not measured a violation of the 
particulate standard in the past 10 years.
    So, there was a lot less ambiguity about how much should 
you spend to get what level of improvement. Most of these folks 
didn't have controls back then.
    You know, every time we've had a debate about clean air 
over the years there's been this issue it's going to cost so 
much, it's going to be impossible to make--take this step and 
this sort of thing. As it turned out a lot of the predictions 
about it being impossible to do turned out not to be correct.
    But I think we are really getting to the point now where 
there's more credibility, where maybe it's just--maybe there 
really is a wolf out there that people are hollering about.
    You know, again, you've done most of the subject in with 
the very large industries. We're getting down to the smaller 
business people now.
    I'll give you some idea. In Birmingham we've had to go 
through a couple of iterations in adopting new regulations for 
sources there to reduce hydrocarbon emissions to hopefully meet 
the ozone standard.
    In 1979 we adopted some regs that got us 6,000 tons per 
year reduction by regulating 14 sources. That resulted in 450 
tons per year emission reduction for each we regulated.
    In 1985 we got a 12--some more regulations, 1,200 tons per 
year reduction in emission--excuse me, 10,000 tons per year 
reduction with 1,200 sources regulated, eight tons per new 
source regulated.
    So, the more people you impact with new regulations I think 
the more people pay the cost as opposed to get the benefits.
    I think that's one of the things that's causing some of the 
resentment for government regulation now is that we're getting 
into the bowels of society, if you will.
    Senator Sessions. Dr. Hammerschmidt, on--one of the things 
that was said, I believe in the hearings when Ms. Browner was 
there, was that .09 would be equivalent to the present .12 
standard since it was on an 8-hour basis rather than the 1 hour 
basis.
    I believe you and others suggested you don't agree with 
that, that .09 would in fact be a higher standard than the 
present standard?
    Mr. Hammerschmidt. I believe so.
    Senator Sessions. Of course, .08 would be an even higher 
standard. So, it's a significant move on ozone also. Any 
disagreement with that?
    One of the things that was commented, we talk about 
budgetary concerns, and perhaps we do need to spend on the 
science, but one of the comments by one of the scientists who 
served on the EPA board was, and he was very critical of them, 
they had only spent 10 percent of their budget on dealing with 
these kind of studies when we knew we was facing this 5 year 
cycle.
    Do any of you have any comment on whether--on that comment, 
any thoughts or observations?
    Mr. McBee. Well, I think one of the roles that EPA today 
plays, and must continue to play, is to be, I think, the 
scientific body for us. We don't have those resources at the 
State level usually to engage in these sorts of studies.
    So, when they are instructed and they're given the 
opportunity to spend these dollars I believe they really have 
the obligation and the responsibility to spend them and spend 
them wisely.
    They don't do any of us, as State regulators or the people 
of this country, a service by not expending the funds that are 
given to them for that purpose.
    Senator Sessions. Mr. Chairman, on the comments, I think 
some have mentioned today that EPA is under a Court ordered 
deadline. They asked for some additional time, the Judge only 
gave them 21 days.
    But I think it's important to note that the deadline is not 
to impose these standards. The deadline is merely to evaluate 
and set new standards if they need to be set.
    So, the Court--I've seen this over and over and over again, 
that our governmental agencies say they've got to do something 
that's unpopular because they've been made to do so by the 
Courts and that is not the case in this circumstance.
    Mr. Von Bodungen. I'd like to comment a little bit there. I 
agree with Mr. McBee that these two should be separated because 
one of them is being driven by a Court--one time line driven by 
a Court suit but the other one isn't.
    Frankly, it's a very tough cycle. Five years is just too 
tight to do good science and to really get into the study. You 
can't rush to judgment on these type of things. You want to 
make sure you do the right thing.
    Mr. McBee. If you break apart these numbers in terms of the 
cost of the ozone versus the particulate standard and the 
benefits, those numbers are dramatically different, 
particularly the ozone standard, that there may not be an 
appreciable benefit in terms of financial--a financial benefit 
to the country in terms of cost to the industry for regulation 
versus avoiding costs in terms of health care costs. There may 
actually be a real cost as we read the numbers to the ozone 
standards.
    Ms. Keogh. I guess from our perspective in Arkansas what I 
would prefer to see, I guess, when EPA reviews things like this 
that they come back with recommendations, they don't 
necessarily have to adjust the standards.
    I think we would all agree that there may be health data 
that indicates a possible problem and that perhaps the common 
sense and scientific thing to do is to go establish real life 
monitoring data. That may be the more appropriate 
recommendation as opposed to actually starting to adjust 
numerical standards.
    Senator Sessions. Mr. Chairman, I'm not sure I have it 
straight, being new to this area, but it seems to me is it 60 
days--they have 60 days notice to the world that these 
standards are going to be imposed. It seems to me that is--is 
that----
    Senator Inhofe. Well, first of all, the 60-day comment 
period was extended by 21 days. However, if you recall, we 
passed in the last session of the legislature the Flexibility 
Act, which gives Congress veto power over the regulators. So, 
that we as--in our committee, the committee that we all sit on, 
decide that we disagree with these we can go ahead, have our 
meeting, take it to the House and the Senate all in the same 
day but then of course we'd be subject to, perhaps, a 
Presidential veto, in which case then you have to come up with 
two-thirds.
    So, as it is right now, the timing goes into June before we 
would have the opportunity to invoke the provisions of the 
Bill. Incidentally, Don Nickles, who was the author of that 
Bill that passed in 1994. So, that's kind of the time line.
    Senator Sessions. Well, my only thought was 6 months or so 
might be good to--if you really wanted your comments and the 
comments from the science, the EPA, environmental management 
agencies in the States, 6 months or even more may be an 
appropriate time as a matter of policy.
    If you were writing the law would you ask for that much 
time or more? Anybody disagree with that?
    I just think that would be a natural way to do it unless we 
were in an emergency situation.
    I guess that's all. Thank you, Mr. Chairman.
    Senator Inhofe. Any further comments?
    Well, first of all let me thank the witnesses for appearing 
today.
    We will be having a news conference in just a few minutes 
in the Oklahoma Room, it's scheduled for 3 o'clock, we'd invite 
the witnesses, any witnesses from any panel who are still here 
to join us.
    This hearing is going to be recessed, not adjourned, we're 
going to hold it open for 3 weeks so that we can get documents, 
such as we discussed, Dr. Hammerschmidt, that can be entered as 
part of the record.
    Today we heard from officials from seven States, included 
the national representatives from the U.S. Conference of 
Mayors, League of Cities, National Conference of State 
Legislatures.
    Briefly, I put down six, what I consider to be results that 
everyone agreed to. No. 1, that the cost is far greater than 
the EPA estimate. In fact, the $3.5 billion for Ohio alone 
would certainly verify that.
    Agreement that the EPA violated unfunded mandates. Non-
attainment status affects competition, jobs and makes it hard 
to attract business. Implementation steps would affect small 
businesses. Create lifestyle changes.
    No. 5, the States have no monitoring systems, in fact, 
don't know how to implement one for particulate matter.
    And, last, States and cities are not convinced that the 
science is sound. In fact, they believe more research is 
needed, which is exactly what the panel said, the scientific 
panel that is statutorily obligated to advise the EPA.
    So, again, I appreciate very much your coming. And more 
than anything the 35 people that endured 4 hours. Now you know 
what life is like in Washington.
    Particularly my colleagues, Senator Thomas, who had to 
catch a flight, Senator Hutchinson and Senator Sessions for 
coming and using up this day of no votes to help us out here in 
Oklahoma determine how real people think.
    We are recessed.
    [Whereupon, the subcommittee was adjourned, to reconvene at 
the call of the chair.]
    [Additional material submitted for the record follows:]
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Statement of Governor Frank Keating, Oklahoma, and Chairman, Interstate 
                     Oil and Gas Compact Commission
    Mr. Chairman, thank you for the opportunity to testify on an issue 
that is of great importance to the citizens of Oklahoma and the Nation. 
The comments I make today are given on behalf of the State of Oklahoma 
and as chairman of the Interstate Oil and Gas Compact Commission 
(IOGCC), an organization representing the Governors of 29 oil and gas 
producing States. I have also been asked to submit the National 
Governors' Association viewpoints, which attached to the written 
portion of my testimony.
    Along with the Governors of our Nation's other 49 States, I have a 
strong commitment to clean air standards that protect public health, 
and believe the needs of Americans who suffer from respiratory ailments 
must be addressed. At the same time, the other Governors and I 
recognize that the U.S. Environmental Protection Agency's current 
proposal on ozone and particulate matter standards would have 
significant costs and impact the ability of States and local officials 
to meet other urgent priorities. A balance must be reached between the 
need to protect public health and the danger of unnecessary, overly 
expensive regulation.
    The issue before us today goes beyond whether tightening of Federal 
air quality standards for ozone and fine particles is necessary. I 
question whether the Environmental Protection Agency should impose such 
potentially devastating standards without providing data that clearly 
support the change.
    The proposed change in Federal standards for ozone probably would 
cause Oklahoma City and Tulsa, and possibly Lawton and several other 
more rural areas, to fall into non-attainment with the Clean Air Act. 
This is despite the countless hours and millions of dollars spent by 
our State and local governments, businesses and citizens to comply with 
current Federal standards.
    In fact, Oklahoma can be proud of the accomplishments we have made 
in cleaning the air of our State. Our Department of Environmental 
Quality and local entities have done an excellent job of coordinating 
efforts, and the progress is impressive. Our pollution level 
measurements statewide have declined significantly. Nationally, air 
pollution has declined over the past 10 years, even while the 
population has increased.
    EPA is now seeking to enact the toughest air quality standards in 
our Nation's history, with enormous economic and employment 
consequences. Our scientists, and many scientists who advise the EPA on 
this matter, question whether the scientific evidence supports this 
proposal. Oklahoma's larger cities, which are right now competing for 
new businesses and industries, would find recruitment of new employers 
difficult or impossible with the threat of noncompliance with Federal 
air standards hanging over their heads. The effect on Oklahoma's 
largest economic contributors, including the oil and gas industry, 
would be profound.
    Expressing a concern about inadequate time for State governments 
and citizens to respond to these sweeping new regulations, the 
Interstate Oil and Gas Compact Commission and the National Governors' 
Association called on the EPA to extend the public comment period on 
this proposal. We are pleased that the EPA responded to this request, 
but ``back to the drawing board'' might be the more appropriate 
response of EPA at this point.
    In addition to the substantial resources States must commit to 
developing new State Implementation Plans for these new standards and 
the chilling effect on business growth and investment, communities in 
nonattainment of Clean Air standards would be subject to significantly 
increased regulations. States would be threatened with the withholding 
of Federal highway funds for nonattainment areas if they fail to 
implement regulatory action.
    As Governor, I also note the lack of public demand for these new 
standards. The Oklahoma Department of Environmental Quality has 
indicated that overwhelming public support in the form of significant 
individual lifestyle changes and sacrifices, would be needed to help 
these cities attain the proposed Federal standards.
    More significantly, whether these new standards would afford 
significant health benefits is a matter of great debate. As the 
Governor of this State, I care very deeply about the health of its 
citizens. Oklahoma's environmental experts at Department of 
Environmental Quality have reviewed the proposal and are concerned that 
the available scientific studies indicate these new standards may not 
offer the additional health benefits claimed by the EPA.
    The EPA's research does not take into account major scientific 
uncertainties. The scientific community--even the EPA's own Clean Air 
Scientific Advisory Committee--is not in agreement as what impact, if 
any, fine particulate matter may have on human health at these levels 
of exposure. The data are weak at best.
    Ozone research is another scientific ``gray area.'' Current ground 
level ozone standards--before these new standards are enacted--are 
already near the level at which ozone occurs naturally. Increasing 
these already tight standards may or may not have any benefit, and 
certainly would carry a heavy cost.
    There are no answers from the EPA on concerns regarding the 
validity of the scientific basis for these proposed standards. Although 
the Clean Air Scientific Advisory Committee approved the documents upon 
which the standards are based, they were highly critical of the 
particulate matter scientific documents and remained neutral on the 
ozone documents. In fact, the committee said ``There is no bright line 
which distinguishes any of the proposed standards as being 
significantly more protective of public health.''
    Another element of this rush to judgment I find shocking is that 
nobody, outside of the researchers who performed the studies upon which 
EPA is basing this proposal, has apparently been given access to the 
raw data. His is not proper public policy.
    I support measures that provide reasonable environmental and health 
protection, but in this case I believe the Environmental Protection 
Agency simply has not finished its homework. Rather than taking the 
stance that ``we are all in this together'' and using innovative non-
regulatory approaches to help communities continue to achieve 
environmental goals--as the States have done--the EPA has adopted the 
familiar command-and-control approach.
    A recent survey commissioned by the Competitive Enterprise 
Institute indicated 72 percent of the 1,000 people surveyed believe 
that State or local governments should determine what air pollution 
control measures are used. In addition, 65 percent believed that State 
or local government would do better at environmental protection than 
the Federal Government.
    I agree. Since 1935 the Interstate Oil and Gas Compact Commission 
has acted to protect the fundamental rights of States to regulate their 
resources and make determinations that affect the health and safety of 
their citizens. Federal agency interference time and again has given us 
the type of environmental policy we see proposed today--short-sighted 
bureaucratic decisions driven by political rhetoric rather than sound 
science.
    The chilling effect these proposed standards would have on the 
domestic petroleum industry would be far-reaching. These restrictions 
would significantly impede the ability of oil and gas producers to 
provide the energy the United States needs. As the majority of oil and 
gas operators in the IOGCC States are small business men and women, I 
urge Congress to carefully review EPA's proposed standards under the 
new Small Business Regulatory Enforcement and Fairness Act.
    Unless the Environmental Protection Agency can meet its 
responsibility of providing clear and compelling evidence that there is 
a need to impose these more stringent standards and justification for 
the financial burden that would result, I would stand in opposition to 
them.
                                 ______
                                 
Prepared Statement of Lieutenant Governor Nancy P. Hollister, State of 
                                  Ohio
    Mr. Chairman, members of the committee, I am Nancy Hollister, 
Lieutenant Governor for the State of Ohio. I appreciate the opportunity 
to speak to you about what I believe to be the most significant 
environmental policy issue facing Ohio today: U.S. EPA's proposal to 
tighten the national standards for ozone and particulate matter.
    First, I would like to share some background information with you 
about U.S. EPA's proposal impact on Ohio and give you a sense of what 
our State faces if these new standards are finalized as presented. 
While expansion of the controversial vehicle emission testing program 
will probably cause the most call to elected officials, I believe it is 
important for this committee to understand that the ramifications of 
this proposal are far broader and potentially far costlier than just 
expanding automobile testing.
    Under the Federal Clean Air Act, U.S. EPA set health-based 
standards for six major pollutants: sulfur dioxide, nitrogen dioxide, 
carbon monoxide, particulate matter, ozone and lead. The Clean Air Act 
requires U.S. EPA to re-evaluate these standards every 5 years. As 
recently as 1993, U.S. EPA announced that revisions to the ozone 
standard were not appropriate.
    Ohio has worked hard to meet the current ozone standard. In 1993, 
there were four major metropolitan areas in Ohio designated as 
``moderate'' nonattainment for ozone (Cleveland-Akron, Dayton, 
Cincinnati and Toledo) and three areas designated as ``marginal'' 
nonattainment (Columbus, Youngstown, and Canton). Ohio Implemented an 
aggressive program to reduce the emissions that cause ozone, including 
enhanced auto emission testing in 14 counties; industrial controls; and 
mandatory vapor recovery systems on gasoline pump nozzles. Thanks to 
these and other voluntary efforts, today, only four of 88 counties in 
the State in the Cincinnati area remains nonattainment for ozone.
    U.S. EPA's recent proposal makes the ozone standard more stringent 
and changes in the way we measure violations of the standard. U.S. 
EPA's proposal to tighten the ozone standard would send not only the 
seven urban areas I just mentioned back into nonattainment, but we 
predict that a total of at least 32 additional counties would also face 
nonattainment status. In fact, based on the previous 3 years readings, 
every single air monitor in Ohio would show exceedances of the new 
standard. I am the former Mayor of the city of Marietta. Marietta is 
located in the southeastern Ohio and has a population of 15,026 in a 
county with a total population of 62,254. The Ohio Environmental 
Protection Agency operates an ozone monitor in the city of Marietta and 
the monitor does not meet the proposed standards, which would mean even 
areas with these small populations would face nonattainment status and 
the subsequent control strategies. For these nonattainment areas, this 
would mean expansion of vehicle emission testing; mandatory clean 
fuels; additional controls on industries and utilities; reformulated 
consumer products such as paint and aerosols; and higher prices for 
lawn mowers and leaf blowers with cleaner burning engines. Mandatory 
car-pooling and restrictions on barbecue grills have also been 
mentioned as possible ozone control measures, but I hope we don't have 
the resort to that in Ohio.
    Another large concern for Ohio is the effect of the nonattainment 
designation on industrial growth. Since virtually every urban area in 
Ohio will be nonattainment, the ability for these areas to attract new 
or expansion of existing industry will be greatly diminished. One only 
needs to look at the construction of many of the new automobile 
assembly plants in the Midwest to see that the majority were 
constructed in attainment areas outside of the cities further 
contributing to urban sprawl. U.S. EPA actions will only further 
accelerate the trend of urban sprawl.
    The proposed Federal particulate standard is another subject of 
debate in Ohio. Current regulations apply to particles that are 10 
microns and smaller. There are only two counties in Ohio Jefferson and 
Cuyahoga that don't attain the current PM10 standard. The 
existing PM10 standard for larger particles will still be in 
effect, however, this rulemaking actually relaxes the PM10 
standard. In addition, U.S. EPA is proposing to create a standard that 
will regulate a new pollutant very fine particles known as 
PM2.5.
    Unfortunately, I can't offer the same details about the scope of 
the nonattainment area for PM2.5. There is no State or 
national air monitoring network for PM2.5. U.S. EPA 
estimated that 21 Ohio counties would not attain the standard for the 
finer particulates. And if you're thinking that only urban areas would 
be affected, listen to some of the counties on U.S. EPA's list for 
particulates: Noble County, with a population of about 11,000; Wyandot 
County, population 22,000; and Sandusky County, population 62,000. 
Quiet honestly, we have no idea how U.S. EPA came up with that list; we 
do know they admit that the list is subject to ``significant 
uncertainty.''
    It is possible that many of the control programs we would implement 
to comply with the new ozone standard could help with meeting the fine 
particulate standard. It appears that coal-fired utilities may be 
affected the most, but because we know so little about the makeup of 
PM2.5, we may have to start regulating a universe of 
activities that we haven't even considered yet. However, all activities 
that contribute to the generation of fine dust are potential sources 
needing control including road dust, woodburning fireplaces, 
agricultural activities and virtually all manufacturing processes. Our 
preliminary estimate is that compliance cost for the new particulate 
standard will be on the order of $2 billion.
    U.S. EPA's decision to combine the ozone and particulate standard 
review into one rulemaking is significant. While we believe there are 
problems with the scientific basis behind the changes to both 
standards, U.S. EPA's own documents show that the costs of meeting the 
new ozone standard may exceed the benefits expected. U.S. EPA appears 
to be relying on benefits from the new particulate standard to justify 
the cost of the ozone standard. Not only do I believe that U.S. EPA 
seriously underestimated the cost of attaining both standards, but our 
review of this proposal raises serious doubts about the projected 
health benefits.
    Let me briefly explain the problems we've identified with each 
proposed standard. I'll start with ozone. We agree with U.S. EPA's 
science advisors that the more stringent ozone standard will not 
significantly improve public health. One of the principle health 
studies that U.S. EPA used to calculate health benefits found that if 
compliance with the proposed ozone standard is achieved, there would be 
a reduction of less than 1 percent in the hospital visits per year in 
the New York City area for asthma related illnesses.
    Furthermore, U.S. EPA recognizes that some area in this country 
have been unable to achieve the existing ozone standard and still more 
areas would find it impossible to achieve the new standard. In fact, 
EPA estimates that 53 million people would end up living in areas where 
attaining the new ozone standard and thus realizing all of the health 
benefits would be virtually impossible. We believe that it may be even 
worse: even more areas than projected won't be able to comply with the 
ozone standard. We would need a major program to control emissions for 
utilities and other combustion sources through the entire eastern 
United States, and Ohio would have to implement every conceivable 
control measure from enhanced automobile testing to controls on 
industry and more expensive fuels. Even then, many of Ohio's urban 
areas may not be able to attain the proposed ozone standard.
    While my primary concern with U.S. EPA's proposed ozone standard is 
the lake of public health benefit, I also want to draw your attention 
to plans in U.S. EPA's cost estimates. U.S. EPA estimated the national 
cost of partial attainment to be as much as $.6 billion annually. 
However, U.S. EPA assumed that States like Ohio would already be 
spending billions of dollars in new controls to help the Northeast 
States in the Ozone Transport Commission to meet the existing ozone 
standard, so the costs of those controls were not included in the 
estimate for the revised ozone standard. We estimate the cost for Ohio, 
alone, for partial attainment to be $.76 billion per year.
    I also wanted to address direct cost to State and local government 
of U.S. EPA's proposal. There are many universities, health and 
correctional facilities that burn coal in boilers to supply heat or 
power. In Ohio, we estimate that there are approximately 13 such 
facilities with 34 boilers that would be subject to the new standards. 
Under the U.S. EPA proposal for ozone, it is likely that nitrogen 
oxides emissions will need to be reduced. For fine particulate, 
increased collection of particulate matter will be necessary. For this 
type of installation, we estimate the capital cost for a typical 
facility to be $700,000, not including operating cost. Although faced 
with these additional costs, many facilities will choose to convert to 
higher priced natural gas. This wastes valuable capital that was 
expended on the original installation and will increase operating 
costs. These are real costs that will be expended on additional 
controls instead of these resources being directed to the main function 
of these institutions.
    Let me now turn to the particulate standard. I can summarized my 
concerns about U.S. EPA's proposal to create a fine particulate 
standard with three words: lack of data. As I mentioned earlier, U.S. 
EPA is relying on projected health benefits of the proposed particulate 
standard to justify the cost of both standards. There have been a 
number of scientific studies which show a link between air pollution 
and significant respiratory and cardiovascular-related effects. 
However, U.S. EPA has not been able to establish a direct link between 
fine particulate and those health problems. I am concerned that we may 
spend billions of dollars to comply with a new particulate standard in 
Ohio only to find after more scientific research that we were going 
after the wrong pollutant. The public soon loses faith in government's 
credibility when public health scares turns out to be unjustified. Even 
U.S. EPA recognizes the need for more research for particulate matter. 
The President's budget for Federal fiscal year 1998 requests $26.4 
million, a 37 percent increase, to fund studies to determine the link 
between particulate matter and health effects. This request is 
indicative to the weakness of the current proposal and that U.S. EPA 
should await the results of this effort before promulgating a new 
standard. I would urge U.S. EPA to develop a comprehensive program that 
includes further scientific research on health effects, additional 
monitoring of air quality and allow for adequate time for public review 
and comment on the health effects research before proceeding with a 
change to this standard.
    I hope I have given you sense of the problem we see with U.S. EPA's 
proposal. I would like to conclude with some thoughts about immediate 
and long-term solutions to improving the air quality standard setting 
process in this country.
    The short-term problem is that U.S. EPA gave interested parties 
only 60 days to comment on this proposal. Ohio did all it could to 
fully understand the impact of this rule, but 60 days is just not 
enough time to thoroughly review more than 1,000 pages of rules plus 
thousand of technical supporting documents. Governor George Voinovich 
of Ohio and a number of other elected officials requests additional 
time to review the proposal, and U.S. EPA requested from the Federal 
court with jurisdiction over this case for the additional time. 
Unfortunately, the judge only allowed an additional 21 days, which 
remains an insufficient time. Many of Ohio's State departments are 
preparing formal responses to U.S. EPA's dockets on this matter. When 
they are finalized, I would also like to submit a set to your record.
    In the long run, I believe States will find relief only through 
congressional action. William Ruckelshaus, a former U.S. EPA 
Administration official, has said the Clean Air Act created ``an 
impossible standard of perfection.'' I do not advocate a rollback of 
the public health protections many of our environmental laws have 
produced. However, 30 years of science and experience has taught us 
that a ``zero risk'' standard is not possible. The Clean Air Act needs 
to be updated to reflect this knowledge and to create a regulatory 
system which maximizes public resources for maximum public benefit.
    In addition to developing more reasonable goals for setting clean 
are standards, Congress also needs to incorporate a requirement that a 
comprehensive, cost-benefit analysis be made part of the standard 
setting process. Today, the Clean Air Act does not allow U.S. EPA to 
consider cost when setting standards. The only reason U.S. EPA has done 
any type of cost benefit analysis with this rulemaking is because 
Congress passed the Small Business Regulatory Enforcement and Fairness 
Act last year requiring such an analysis on major rules which affect 
small businesses. By U.S. EPA's own estimate, the cost of compliance 
with these standards is on the order of $6-8 billion a year. That 
raises the estimated cost of the entire Clean Air Act Amendments of 
1990 by almost a third.
    I would be happy to answer any questions you may have. Thank you.
                                 ______
                                 
         Prepared Statement of Mayor M. Susan Savage, Tulsa, OK
    Thank you for this opportunity to address the Senate Subcommittee 
on Clean Air, Wetlands, Private Property and Nuclear Safety today. I am 
here to speak on behalf of the Nation's mayors and especially as chair 
of the Energy and Environment Committee for the U.S. Conference of 
Mayors.
    The primary responsibility of a mayor is to protect the public 
health and safety of the citizens in our communities. However, proposed 
new air quality standards encompass far more than just a debate about 
the levels of ozone and particulate matter that we will determine to be 
acceptable in our air. The outcome of this discussion will speak 
volumes about the livability of our cities well into the future.
    Clean air is a laudable, responsible goal. Governments, industry, 
and citizens have an obligation to ensure that the air we breathe is 
clean and safe across this country. Yet, the discussion of the proposed 
new air quality standards is being held in isolation from the 
discussion of any implementation plans for the new standard. Will 
communities be held to a more severe standard for the pollution which 
originates in and is transported from other areas? Will communities be 
held responsible for the hydrocarbon emissions of those automobiles 
driving into or through an urban area on a daily or periodic basis? How 
can communities mitigate the effects of unfavorable weather patterns 
which contribute to the ozone levels due to high temperatures or a lack 
of wind?
    This discussion of the proposed new air quality standards is being 
held without consideration of the significant and substantial policy 
decisions this committee will face this year in its deliberations on 
the reauthorization of ISTEA, Brownfields, Superfund, the future of 
Congestion Mitigation Air Quality funds and other significant 
environmental policy issues which dramatically impact the liveability 
of cities and for which well coordinated policy goals need to be 
articulated and pursued.
    Talk to any mayor of any sized city and what you hear is the same--
years of federally imposed mandates to meet uniformly applied 
environmental standards have contributed to urban sprawl, creating a 
greater reliance upon the automobile while at the same time, reductions 
in public transit operating dollars and the proposed elimination of the 
Congestion Mitigation Air Quality funds remove essential tools for 
communities who work to improve air quality.
    In fact, cities like Tulsa, which has made enormous strides toward 
cleaner air and remained in compliance with air quality standards, are 
penalized by receiving fewer CMAQ dollars than other cities which have 
not taken proactive positions and find themselves in non-attainment.
    Mayors across the country whose cities are currently in attainment 
and who I have worked to maintain that status, need to understand the 
purpose and the value of being redesignated into non-attainment. It is 
unclear how this causes an improvement in air quality. A health benefit 
analysis is the basis for the recommendation to change the standard, 
yet the lack of inclusion of an implementation strategy, no commitment 
to adequate funding for impacted communities, and definitive knowledge 
about the precursors of ozone impede progress toward the creation of 
effective, local responses.
    Other pressing matters need to be addressed, even if the rules for 
implementation evolve subsequent to the promulgation of the standard. 
As a group of diverse communities, we question the wisdom of putting 
the two standards, ozone and particulate matter in the same category. 
While their effects may be similar in the health based data, the 
available technology to monitor the two pollutants is vastly different. 
The country is ill-prepared to monitor for .25 particulate matter since 
few monitors exist. Additionally, there are no guidelines for their 
placement and evaluation, leaving community leaders unable to construct 
a workable strategy.
    In the materials released from the Environmental Protection Agency 
there has been mention of development and implementation of innovative 
technologies. Cities are interested in being part of any initiative 
which involves new technology. At the same time we would like to see 
the Agency acknowledge and credit some of the effective pollution 
reduction methods which use little or no technology but are based on 
public awareness and leadership commitment.
    Have other measures to improve air quality been examined as we as a 
Nation strive to improve air quality? Does the focus on a more 
difficult standard provide the impetus needed to generate the public 
and private support needed to provide a desirable air quality? We 
encourage further research to explain the origin of the precursors for 
ozone. The sources of background ozone, which come from biogenic 
sources, will seriously affect any community's mitigation strategies.
    The definition of nonattainment and its implications is another 
issue we would like to explore further. With the prospect of so many 
potential new nonattainment areas, there exists the possibility to 
create new locally designed programs and strategies without adding the 
burden of punitive economic measures. Nonattainment could be a measure 
at which further implementation begins; it need not be not a threat to 
economic development. Incentives, rather than punitive measures ought 
to be afforded to communities and industries which produce and burn 
cleaner fuels.
    Tulsa is ready to use the new health advisory system described by 
EPA to encourage at risk individuals to stay indoors when high ozone is 
anticipated. Our Ozone Alert! alternate commute program is premised on 
the availability of information reaching 250 large companies before 4 
p.m. on the day before the air quality is predicted to be poor. That 
information network is augmented by media announcements which begin 
during the afternoon commute and are carried on television in the 
evening. The addition of specific pollution information would be very 
little extra trouble and provide a most beneficial service. This 
service should be included in a State Implementation Plan.
    In Tulsa, we created the Nation's first Flexible Attainment Region 
or FAR in partnership with the EPA. The FAR allows an area to custom-
design programs to improve air quality when there is a violation of the 
standard and to add more measures as they are necessary without 
redesignation to nonattainment. These partnerships should be encouraged 
to ensure local responses to air quality concerns. Local leaders are 
best positioned to make the decisions which work in their communities.
    Mayors care deeply about the health and safety of their citizens. 
We believe that we can work cooperatively with State and Federal 
officials to find the best strategies to improve air quality for all 
Americans.
                                 ______
                                 
Prepared Statement of State Senator Paul Muegge, Oklahoma, on Behalf of 
             the National Conference of State Legislatures
    NCSL is a strong supporter of the principles underlying the Clean 
Air Act. NCSL repeatedly and forcefully asserts that the U.S. 
Environmental Protection Agency (EPA) should work with State and local 
officials to implement and maintain an environmentally sensitive and 
cost-effective clean air policy. Setting minimum national ambient air 
quality standards that protect human health and preserve the 
environment should be a top priority.
    While advocating clean air policy, NCSL also vehemently supports 
the Unfunded Mandates Reform Act and Executive Orders 12866 and 12875. 
NCSL has serious concerns about the failure of EPA to comply with the 
Unfunded Mandates Law and the executive orders during the rulemaking 
process to revise the air quality standards for particulate matter and 
ozone. Clearly, Congress and the President intended EPA to comply with 
these policies by considering cost during all rulemaking actions.
    NCSL asserts that EPA is required to adhere to the following 
provisions of the Unfunded Mandates Law and Executive Orders 12866 and 
12875:
    1. EPA is required to assess the full cost of State and local 
compliance with the revised standards.
    2. EPA is required to disclose all Federal resources available to 
States for compliance activities.
    3. EPA is required to assess alternatives and select the least 
burdensome and most cost-effective option.
    4. EPA is required to work with elected State and local officials 
during promulgation of the standards.
    In addition, NCSL makes the following points regarding EPA's 
regulatory action to revise the National Ambient Air Quality Standards 
for particulate matter and ozone:
    1. Section 105 of the Clean Air Act is the main source of Federal 
assistance for State air quality programs, including implementation of 
new air quality standards. Section 105 authorizes State grants that may 
cover up to three-fifths of the cost of implementing State plans. 
Because EPA determined that the proposed rules are ``significant 
regulatory actions,'' meaning that the total annual cost of compliance 
will be in excess of $100 million, EPA must explain why its budget 
request for Section 105 grants for fiscal year 1998 was only $157 
million, merely $4 million more than estimated fiscal year 1997 
outlays.
    2. EPA must demonstrate to the satisfaction of Federal, State and 
local officials as well as to the public that revised standards are 
necessary and that the new standards will provide the utmost protection 
of public health and the environment. NCSL fears that the controversy 
surrounding the revisions may arouse enough public opposition to 
ultimately reverse EPA's decision. If the revisions are rescinded after 
finalization, States may have begun to comply by entering into 
contractual and financial commitments. It would be difficult and 
expensive for States to withdraw from such commitments.
    To clarify, NCSL has expertise on the rulemaking process. NCSL does 
not possess the scientific or technical expertise required to determine 
``unhealthy'' levels of ambient ozone and particulate matter. 
Therefore, NCSL believes it would be imprudent to make educated, but 
not expert, guesses regarding the support for or opposition to the 
standards contained in the proposed rules.
                                 ______
                                 
    Mr. Chairman and members of the subcommittee, I am Senator Paul 
Muegge from the State of Oklahoma testifying before you on behalf of 
the National Conference of State Legislatures. I appreciate the 
opportunity to join you today to discuss the proposed changes to the 
National Ambient Air Quality Standards for particulate matter and 
ozone.
    The National Conference of State Legislatures (NCSL) is the 
bipartisan organization that represents the nation's 7,541 State 
legislators. We assess Federal legislation and regulation to ensure 
that State and Federal responsibilities are appropriately sorted out. 
We further work to remove impediments to successful implementation of 
Federal law and regulation. Also, NCSL serves as the key resource for 
State lawmakers for information and analysis of Federal legislative and 
regulatory actions on environmental and other issues.
    NCSL is a strong supporter of the principles underlying the Clean 
Air Act Amendments of 1990. NCSL has repeatedly and forcefully stated 
its view that the Federal Government should implement and maintain an 
environmentally sensitive and cost-effective clean air policy that 
establishes minimum national ambient air quality standards in 
cooperation and consultation with State and local governments.
    NCSL supports minimum Federal standards for ambient particulate 
matter and ozone. Protection of human health and preservation of the 
environment are a top priority for States. NCSL urges EPA to proceed 
diligently with full implementation of the Clean Air Act to achieve 
healthy air quality for the public and the environment. Specifically, 
NCSL believes that both stationary and mobile sources must reduce 
emissions of ozone and particulate matter precursors, nitrogen oxide 
(NOx) and volatile organic compound (VOC).
    NCSL does not possess the scientific or technical expertise 
required to evaluate and comment on the specific standards set out in 
the proposed rules. NCSL believes it would be imprudent to make 
educated, but not expert, guesses regarding the support or opposition 
to the proposed standards.
    However, NCSL has serious concerns related to the process of 
promulgation of the proposed rules to revise the standards for ozone 
and particulate matter. The concerns result largely from the failure of 
the U.S. Environmental Protection Agency (EPA) to comply with Federal 
law and Presidential executive orders on unfunded mandate relief. The 
concerns do not focus on the new standards or the underlying science 
that is the basis for the new standards. NCSL refrains from commenting 
on the content of the proposed rules for new particulate matter 
standards and revised ozone standards.
    My testimony will focus solely on the process by which EPA 
developed the rules and its failure to comply with provisions of the 
Unfunded Mandate Reform Act of 1995 and two Presidential executive 
orders. NCSL asserts that in order to adhere to provisions of the 
Unfunded Mandates Law and Executive Orders 12866 and 12875, EPA is 
required to:
    1. Assess the full cost of State compliance with the revised 
standards.
    2. Disclose all Federal resources available to States for 
compliance activities.
    3. Identify and assess all alternatives to the proposed revisions 
and select the least burdensome and most cost-effective option.
    4. Consult and work closely with State and local governments during 
promulgation and implementation of the revised standards.
    5. Provide full Federal funding and complete guidance for State 
implementation.
    6. Publish detailed explanations of the reasons for revising the 
standards.
    NCSL makes these recommendations as an organization with a 
commitment to the Clean Air Act. NCSL believes the Clean Air Act 
Amendments of 1990 address important air quality issues and are 
essential to protecting public health and the environment. At the same 
time, in order to meet the goals of the Clean Air Act, Congress and the 
EPA must fulfill their responsibilities to provide financial and 
technical assistance to States. Moreover, EPA has a legal and ethical 
obligation to meet the requirements of UMRA and Executive Orders 12866 
and 12875.
                the unfunded mandate reform act of 1995
    The Unfunded Mandate Reform Act (UMRA) is a historic piece of 
legislation that recognizes the threat to our constitutional system of 
federalism represented by Federal legislation that imposes costs and 
requirements on State and local governments without regard to their 
ability to comply. Among others, the purposes of the Act are ``to 
promote informed and deliberate decisions, by Congress on the 
appropriateness of Federal mandates in any particular instance.''
    EPA is obligated by law to adhere to UMRA during promulgation of 
revisions to ozone and particulate matter standards. With the enactment 
of UMRA, Congress promised States relief from the burden of unfunded 
mandates and further promised States that Federal agencies would work 
cooperatively with them to develop regulatory alternatives that are 
less expensive and more cost-effective. Congress understood that 
Federal mandate relief efforts will preserve the financial viability of 
State governments, thus ensuring successful implementation of Federal 
laws and regulations.
    Title II of UMRA requires Federal agencies to prepare and consider 
estimates of the budgetary impact of regulations containing unfunded 
Federal mandates on State, local and tribal governments, unless 
otherwise prohibited by Federal law. Congress imposed this requirement 
on Federal agencies in order to generate the data necessary for 
informed congressional decisions on regulatory and appropriations 
issues. NCSL believes that the aggregate economic burden of the 
proposed air quality standards are great enough to trigger further 
congressional action to reduce the burden on the States, either by 
increasing appropriations or relieving regulatory burdens. Furthermore, 
UMRA requires EPA to generate estimates of mandate costs in order to 
develop less burdensome regulatory alternatives.
                    executive orders 12866 and 12875
    President Clinton issued Executive Order 19866 ``Regulatory 
Planning and Review'' in September, 1993, in response to States' 
concern of being overwhelmed by the cumulative effect of unfunded 
mandates. The intent of 12866 is to establish ``a regulatory system 
that protects and improves health, safety, and well-being of the 
American public and the environment, and improves the performance of 
the economy without imposing unacceptable or unreasonable costs on 
society.''
    The President issued Executive Order 12875 ``Enhancing the 
Intergovernmental Partnership'' in October 1993 as a supplement to 
12866. Under 12875, Federal agencies are specifically directed to 
reduce unfunded mandates on State, local and tribal governments and 
increase their flexibility in complying with Federal regulations.
    The orders demonstrate the Administration's commitment to relieving 
the economic burden of unfunded Federal mandates on the States. Though 
EPA partially complied with Executive Order 12866 by submitting 
information to OMB, EPA has an obligation to fully comply with 
Executive Orders 12866 and 12875 by adopting the most cost-effective 
options when promulgating the proposed changes to the national air 
quality standards for ozone and particulate matter.
    In response to the proposed changes to the national ambient air 
quality standard for particulate matter and ozone, NCSL asserts that 
EPA is required to strictly adhere to the following provisions of UMRA 
and Executive Orders 12866 and 12875:
1. EPA must assess the full cost of State and local compliance with 
        regulatory actions to revise the national ambient air quality 
        standards for particulate matter and ozone. [UMRA Section 201 
        and Executive Order 12866 Section 1(b)(3)]
    UMRA and Executive Order 12866 require EPA to estimate the 
aggregate economic impact that the revised standards will have on 
State, local and tribal governments. If the estimated aggregate annual 
expenditures of the rule is $100 million or more, the rule is 
considered a ``significant regulatory action'' that triggers 
requirements to complete and publish with the rule the following in-
depth analysis:
    1. Qualitative and quantitative assessment of the anticipated costs 
and benefits of the mandate;
    2. Analysis of Federal financial assistance and other Federal 
resources available to State, local, and tribal governments;
    3. Estimates of future compliance costs;
    4. Analysis of any disproportionate budgetary effects on any 
regions, States, localities and tribes;
    5. Estimates of the effects on the national economy;
    6. Reports of EPA's prior consultation with elected State, local 
and tribal officials;
    7. Summary of submitted comments from the various levels of 
government; and
    8. EPA's evaluation of those comments.
    EPA produced regulatory impact analyses, pursuant to Executive 
Order 12866, that assess the costs, economic impacts and benefits 
associated with implementation of the revised standards. Though the 
revised standards are ``significant regulatory actions,'' EPA claims, 
in the regulatory impact section of the proposed rules, that it does 
not have to comply with UMRA because ``it is inconsistent with 
applicable law.'' EPA has failed to produce most of the required in-
depth analyses listed above, specifically numbers two through eight, 
and failed to publish, as part of the proposed rule in the Federal 
Register, any of the analyses.
    Estimates of how much money State, local and tribal governments 
will need to spend to comply with the revised air quality standards are 
critical. The President of the United States as well as Members of 
Congress have a need to know how much the revised standards will cost 
the States in order to make informed executive and legislative 
decisions regarding, not merely the Clean Air Act, but also the 
imposition of new mandates in other areas. Decisions by the President 
and Congress pertaining to funding of current and future mandates 
depend on accurate information from Federal agencies regarding the 
financial burden on States and localities.
    EPA's estimate must contain all costs associated with changing the 
air quality standards. This estimate should account for the costs of 
enactment of State authorizing legislation, promulgation of State 
regulations, development of new State air quality plans, construction 
of pollution control measures, and installation of monitoring stations.
    Furthermore, estimates must account for the new, more stringent air 
quality programs that would be required in many States. Many areas have 
already employed efficient and effective air pollution control 
measures, such as HOV lanes and public transportation programs. In an 
attempt to reduce pollution levels even lower, some States may have to 
use expensive, inefficient, and potentially unpopular measures, such as 
the employer commute option program.
2. EPA must disclose all Federal resources available to State and local 
        governments that may be used to cover the cost of implementing 
        and achieving the revised standards. [UMRA Section 202]
    UMRA requires EPA to disclose all Federal funding and other 
resources available to States for implementation of the revised 
standards. Executive Order 12875 Section 1(a) takes this concept one 
step further by prohibiting EPA from imposing new standards that are 
not required by law unless there are Federal funds available to cover 
the costs or, EPA can submit to OMB documentation of consultation with 
State officials and data supporting the need for the mandate. According 
to both proposed rules, EPA submitted documentation to OMB in partial 
compliance with Executive Order 12866, but neither rule contained 
notice of EPA compliance with Executive Order 12875. Again, NCSL 
asserts that EPA must fully comply with both Executive Orders 12866 and 
12875.
3. EPA must select the least burdensome and most cost-effective option 
        that will achieve the same level of public health protection. 
        [UMRA Section 205 and Executive Order 12866 Section 1(b)(3) and 
        Section 1(b)(6)]
    UMRA and Executive Order 12866 require EPA to assess and consider 
all options and to adopt the least expensive and most cost-effective 
alternative for achieving the intended goal of the proposed rules. In 
addition, Executive Order 12866 requires EPA to prepare a cost-benefit 
analysis to demonstrate that the benefits justify the costs of the 
proposed rule. NCSL asserts that EPA's failure to consider cost during 
the proposed rulemaking process was in violation of UMRA and both 
Executive Orders. Congress and the President clearly intended to 
require EPA to consider cost issues and implementation problems when 
setting revised standards.
    NCSL disputes claims by EPA that it is prohibited from considering 
the cost of attaining revised national air quality standards. UMRA 
requires Federal agencies, including the EPA, to assess the economic 
impact of their regulatory actions on State, local and tribal 
governments, as well as the private sector. Absent a clear statement by 
Congress that it intended to exempt Clean Air Act regulations from the 
coverage of the Unfunded Mandates Reform Act, the EPA may not presume 
that it is prohibited from considering the cost of attaining revised 
national ambient air quality standards. UMRA, Title I, Section 4 
clearly lists the categories of Federal law that are excluded from its 
coverage. The Clean Air Act is not one of the listed exclusions.
    Furthermore, NCSL challenges EPA's assertion in testimony before 
the Senate Committee on Environment and Public Works that actions 
during the public health phase are completely independent from actions 
during the implementation phase. NCSL also disputes EPA's claim that 
the revised standards, in themselves, would not impose any additional 
cost or mandates. NCSL strongly believes that the chosen standard 
closely relates to the cost of implementation. Because the cost varies 
for different standards, NCSL asserts that the EPA must fully comply 
with UMRA and Executive Order 12866 by considering cost when adopting 
revised standards. Furthermore, EPA must adopt standards that are more 
cost-effective, more attainable, more acceptable to the public and more 
likely to be implemented successfully.
4. EPA must furnish State legislators with opportunities to provide 
        meaningful input during development and implementation of any 
        changes to the national ambient air quality standards. [UMRA, 
        Sec. 204; Executive Order 12866, Sec. 1(b)(9); and Executive 
        Order 12875, Sec. 1(b)]
    UMRA and Executive Orders 12866 and 12875 require EPA to consult 
and work with State legislators to reach a mutual understanding about 
how to further improve air quality without imposing such burdensome 
costs or unpopular control measures that the process breaks down. NCSL 
lauds EPA's coordination of the Clean Air Act Advisory Committee to 
fulfill this intergovernmental dialog requirement. Listed among the 
members of the committee was a State senator from Maryland. NCSL 
understands that the State senator participates in advisory committee 
meetings and is content with the efforts that EPA is making to continue 
regular dialog with the advisory committee.
    Though EPA has fulfilled this obligation to date, NCSL would like 
to stress the importance and legal obligation of EPA to continue 
working with State legislators during promulgation of the revised 
standards. State legislators must draft, consider and enact enabling 
legislation to authorize new or amended State programs, including those 
required by Federal law or regulation. Without enabling legislation, 
State agencies have no authority to administer State programs. In 
addition, State legislators are solely responsible for appropriating 
State funds that pay for State programs. State legislators, therefore, 
must not be dictated to, but rather must be made full partners in the 
process of defining and implementing mutual goals.
    The States have a wealth of experience in implementing control 
programs. State legislators, similarly, have expertise in crafting 
environmental programs in ways that are sensitive to local values and 
conditions. NCSL encourages Congress and the EPA to pay particular 
attention to the voices of that expertise and experience. EPA should 
establish a regular process for communication with State legislators 
and should develop a working group of legislators to become more 
actively involved in the implementation process.
    In addition to specific provisions discussed above, UMRA and 
Executive Orders 12866 and 12875 contain overall principles that 
Federal agencies should follow during promulgation of Federal 
regulations that impose unfunded mandates on States. NCSL asserts that 
EPA should adhere to those principles as follows:
5. EPA should provide full Federal funding, complete technical guidance 
        and maximum flexibility to States for compliance with the 
        revised standards.
    The imposition of new air quality standards without additional 
Federal funds contradicts the commitment of the Administration and 
Congress to reduce the burden of unfunded mandates on States. NCSL 
believes that States must have full financial and complete technical 
assistance to ensure attainment of the new standards, and to cover in 
part the cost of new mandates on States.
    NCSL understands that Clean Air Act, Section 105 is the main source 
of Federal assistance for State air quality programs, including 
implementation of new national ambient air quality standards. Section 
105 authorizes EPA to provide States with grants that cover up to 
three-fifths of the cost of implementing State plans. Because EPA 
determined that the proposed rules are ``significant regulatory 
actions,'' meaning that the total annual cost of compliance will be in 
excess of $100 million each, NCSL seeks an explanation of why the 
budget request by EPA for Section 105 grants for fiscal year 1998 was 
only $157 million, merely $4 million more than estimated fiscal year 
1997 outlays. According to EPA estimates, $4 million in additional 
funding will not be enough to cover the costs associated with these 
revised regulations.
    If EPA imposes new standards for ozone and particulate matter 
without providing accompanying financial and technical assistance, 
States will face a significant financial burden. If the challenge 
presented by this unfunded mandate burden cannot be met, States may 
face expensive and economically restrictive offset sanctions. The 
sanctioned area would experience additional economic hardship caused by 
the need to offset any new emission sources by twice as much reduction 
in other sources. This has the potential to significantly stunt 
economic growth. The depressive effects on local economies coupled with 
increasing cost of compliance may accelerate a downward spiral of non-
compliance. Widespread non-compliance may undermine public support for 
the Clean Air Act and breed increased public cynicism about the 
government's ability to effectively administer programs.
    6. EPA should publish detailed explanations of why the specific 
revisions are necessary and provide scientific evidence to support the 
estimated benefits to public health.
    EPA must demonstrate to the satisfaction of Federal, State and 
local officials as well as to the public that revised standards are 
necessary and that the new standards will increase protection of public 
health and the environment. NCSL fears that the controversy surrounding 
the revisions may arouse enough public opposition to ultimately reverse 
EPA's decision. If the revisions are rescinded after finalization, 
States may have entered into commitments, such as purchasing testing 
equipment or contracting for more public transit. It would be difficult 
and expensive for States to withdraw from contracts if the final 
revisions are rescinded.
    In recent years, there have been cases where EPA has imposed a 
mandate on regulated entities and then, after a public outcry, 
retracted the mandate. In some cases, the regulated entities had 
complied with the mandate by entering into contractual and financial 
commitments based on the imposed mandate. These regulated entities were 
left with few options once the mandate had been rescinded: either pay 
large penalties to withdraw from legal and financial commitments or 
contend with an outraged public.
    A classic example of this problem, as discussed above, is the 
mandate that required States to include IM-240 testing equipment as 
part of the enhanced inspection and maintenance program. Some States 
complied by including this technology in their air quality plan. These 
States bought land and financially committed to buy the expensive IM-
240 equipment. Public opposition, fueled by expectations of long lines 
and costly inspections, convinced many States and finally the EPA to 
abandon the costly testing equipment. States now have the flexibility 
to choose the most efficient and effective technology for their 
enhanced inspection and maintenance program.
    Rather than repeat the IM-240 fiasco, EPA is better advised to 
comply with UMRA and Executive Orders 12866 and 12875 in order to deal 
upfront with the cost and implementation problems.
    Once again, NCSL asserts that EPA is required to strictly adhere to 
the provisions and principles of UMRA and Executive Orders 12866 and 
12875 while promulgating revisions to the national ambient air quality 
standard for particulate matter and ozone. Clearly Congress and the 
President intended EPA to comply with these edicts by estimating and 
considering cost during its rulemaking actions. The burden of unfunded 
mandates on State, local and tribal government has become too great. 
Congress and the President recognized the looming threat of rampant 
unfunded mandates and have directed Federal agencies to ameliorate the 
problem.
    Mr. Chairman and members of the subcommittee, thank you for the 
opportunity to share the views of the National Conference of State 
Legislatures regarding the proposed revisions to the National Ambient 
Air Quality Standards for particulate matter and ozone.
                                 ______
                                 
 Prepared Statement of Mark Schwartz, Councilmember, Oklahoma City, OK
    Mr. Chairman, members of the Subcommittee: I am Mark Schwartz, 
Councilmember from Oklahoma City and President of the National League 
of Cities. I am here today to testify on behalf of NLC and the 16,000 
cities and towns across the Nation we represent on EPA'S proposed new 
standards for ozone and particulate matter. I would like to ask if I 
may submit, for the record, a copy of NLC's resolution on the proposed 
changes to the National Ambient Air Quality Standards adopted last 
December at our annual meeting.
    Municipal elected officials support Federal initiatives designed to 
protect public health and the environment. NLC was an active and 
supportive participant in the debate on, and enactment of, the 1990 
Clean Air Act Amendments. As local elected officials we care about our 
communities and the people--including our own families--who live there. 
We are not solely discussing economic development and attracting 
industry and jobs. None of us want to be out of compliance with Federal 
standards. We want to be able to assure our citizens that the air they 
breathe, the water they drink, and the rivers, lakes and streams in 
which they play, meet the highest and safest possible public health 
standards. And, local governments are willing to make every effort 
possible to obtain the necessary resources to achieve these objective. 
We, as local elected officials can bring little to the smog and soot 
debate as scientists or epidemiologists. So while we cannot challenge 
with impeccable credentials the adequacy of the science on which these 
proposed new standards are based, we do believe we have the appropriate 
standing to raise significant concerns about the process by which they 
were developed and are being proposed, as well as the potential for 
imposing exceedingly costly new Federal mandates on the citizens of 
this country that may yield few, if any, benefits.
    From the municipal perspective, there are four areas of concern:
     credibility as to

          the current air quality standards, and
          the adequacy of the science on which requirements are 
        based;
          continued public financial support for Clean Air Act 
        initiatives

     inconsistency among statutes that have overlapping 
impacts;
     unattainable objectives; and,
     a process--or lack of one--that fosters unhelpful judicial 
interventions.
                              credibility
Current NAAQS
    Many of the State Implementation Plans developed as a result of the 
1990 Clean Air Act Amendments are just now being implemented. The 
implementation strategies incorporated in these plans have not been in 
effect long enough to determine their impact. We need answers to 
questions about the validity and impacts of the requirements now 
imposed on our States, local governments, and businesses if yet another 
set of requirements will overlay the existing ones. The implication--at 
least for the uninitiated--is that what is currently being required is 
meaningless or futile. If significant additional resources are to be 
committed to further reductions in pollutants, there must also be 
adequate assurances that these investments will yield (at a minimum) 
commensurate, or (at a maximum) appreciable health benefits.
    We are also troubled by the absence of adequate and basic 
information with respect to PM2.5. It would seem appropriate 
to us that before issuing a new set of requirements, it might be 
helpful to know where it is a problem, the pervasiveness of the problem 
and, whether it is the pollutant or a subset of the pollutant that is 
the cause of the problem.
Science
    It is clear from recent reporting, and from testimony given at your 
recent hearings, that there is significant disagreement about the 
adequacy of the science on which the proposed new standards are based. 
While we might agree with Administrator Browner that demonstrable 
``cause and effect'' justifies action, the very existence of the 
scientific controversy raises questions in our minds about whether the 
``cause and effect'' are indeed sufficiently certain to justify action. 
We find it inexplicable that as the Nation's air quality improves, the 
incidence and/or severity of asthma increases. Logic would indicate it 
should be the reverse. We are concerned that we may be moving toward 
requirements to regulate naturally occurring phenomena, such as wind-
borne sand from beaches and deserts, or pollen from natural vegetation.
Public Support
    With respect to continued public support, many municipalities have 
made Herculean efforts to come into compliance with the National 
Ambient Air Quality Standards. To learn now that instead of some 
recognition of accomplishment, these efforts were inadequate, 
inappropriate, or ineffective is dismaying.
    As you well know, many States and even more local governments face 
voter imposed constraints on our ability to raise revenues. Sooner or 
later our constituents will object to financing the implementation of 
Federal mandates designed to accomplish specific objectives if, after 
the fact, these investments prove to be futile. It is not just our 
credibility that is at stake; the Federal Government has a similar 
interest in assuring the wise use of our limited resources.
                             inconsistency
    Your committee was responsive to NLC's concerns about the 
inconsistencies between requirements in the Clean Air Act (required 
reductions in vehicle miles traveled) and provisions in the highway 
legislation in effect at the time which allocated resources based on 
increases in VMTs. In developing and enacting the Intermodal Surface 
Transportation Efficiency Act (ISTEA), these conflicting objectives 
were addressed. Now we are faced with an Administration seeking to 
impose more stringent controls on emissions causing air pollution--many 
of which are generated by stop/go rush hour traffic--while 
simultaneously proposing significant cuts in transit funding which 
provides a virtually guaranteed method for reducing the proximate cause 
of these self-same pollutants! Equally seriously, many in Congress are 
proposing changes to ISTEA which would remove the Congestion Mitigation 
Air Quality program. That is but one inconsistency.
    Another example: the Nation's larger municipalities--and soon the 
preponderance of all other cities, towns and counties--are, or will be, 
required to comply with stormwater management measures to prevent, 
eliminate or reduce pollutants in urban run-off. One method to 
accomplish this objective is street sweeping. Will clean air 
requirements prevent municipalities from implementing such activities 
because street sweeping raises air-borne dust, thus reducing their 
ability to meet the Federal stormwater mandate?
                        unattainable objectives
    One of our major concerns is the increasing intrusion of the 
Federal Government into decisions with respect to local land use 
planning, and the distinctly anti-growth bias of many Federal 
environmental mandates. Less than 10 percent of the land area of this 
Nation is urbanized; our population is growing at a reasonable pace of 
about 1 percent per year. If we can neither build housing, office 
space, industrial facilities in undeveloped areas, nor restore or 
rehabilitate such facilities in developed areas, how do we accommodate 
our growing population? Environmental mandates are not, nor should they 
be, the means for determining national growth policy. If we, as a 
Nation, are ready to abandon the restoration and revitalization of our 
cities, or to control population growth, that should be attained openly 
and honestly.
    Municipal officials are also concerned about being required to 
comply with Federal standards when there are few or no tools available 
to attain such compliance or when there is no body of knowledge about 
how to achieve compliance. This committee addressed many these concerns 
in the 1990 Clean Air Act Amendments by creating classes of 
nonattainment based on the severity of the air pollution problem, 
alternative requirements based on the degree of pollution, and varying 
timeframes for attaining compliance based on the complexity of the 
problems being addressed.
    Nonattainment designations based on severity of the air quality 
problem, however, apply only to ozone, not to particulate matter. Given 
the significant unknowns (where, how much, from what sources) with 
respect to PM2.5, we are concerned about deadlines and the 
consequences of failure to meet them in however many areas may be out 
of compliance.
    Despite Administrator Browner's assurances in her recent testimony 
before your committee that 70 percent of the potential nonattainment 
areas can come into compliance with the proposed new standards by using 
existing technology and strategies, we question the validity of this 
assumption and furthermore, are concerned about the remaining 30 
percent.
                         judicial intervention
    As public officials, I must say we find it peculiar that, more 
often than not, EPA complies with its legal deadlines, obligations and 
requirements only in response to lawsuits and court orders. In some 
respects, we empathize with EPA; they too must deal with ``unfunded 
Federal mandates.'' However, we too have inadequate resources to 
accomplish all that is required of us. I cannot imagine a circumstance 
in which a municipality could simply ignore a legislated requirement 
for almost 20 years without consequence.
    Court driven decisions, with unrealistic deadlines, on complex 
environmental issues are not helpful. It is incredibly frustrating to 
read the Clean Air Science Advisory Committee's letter with respect to 
PM2.5 which says, ``. . . the deadlines did not allow 
adequate time to analyze, integrate, interpret, and debate the 
available data on a very complex issue.'' (see CASAC letter to 
Administrator Browner dated June 13, 1996, page 3).
                            recommendations
    First, we do not believe the courts should be permitted to force 
decisions on complex scientific matters. At a minimum, Congress should 
overturn the court's deadline giving EPA and the scientific community 
adequate time to draw sound scientific conclusion about further 
reductions in air emissions.
    Second, EPA should be required to obey the laws applicable to the 
agency just like everyone else. But, Congress must also assure they 
have the resources to do so. If the Clean Air Act requires EPA to 
review air pollution standards every 5 years, the funding to comply 
with this requirement should be provided. If these funds are 
unavailable--because of limited Federal resources or alternative 
national priorities--then this requirement should be changed 
accordingly.
    Third, if indeed, as Administrator Browner indicated in your recent 
hearings, over 200 scientific studies support the need for tighter 
controls on specific air emissions, then EPA has done a poor job of 
publicizing, explaining or demonstrating the adequacy of the scientific 
basis for their proposals. No one expects unanimity on complex science, 
but the American people need far better assurances than they have now 
that the scientific basis for these proposals is sound. We either need 
more and better science, or more and better explanations that the 
science that exists is valid.
    Fourth, before moving forward with ever more stringent 
requirements, the impact of implementing new requirements in the State 
implementation plans that have only recently been approved needs to be 
assessed. No new standards should be imposed until such assessment has 
occurred.
    And finally, we need better information about the pervasiveness of 
PM2.5 before proposals are finalized. How many 
PM2.5 non-attainment areas are there; where are they 
located; and how significant is the problem in these areas. It is 
difficult to accept that a problem exists if there is little 
information about where it exists.
    Mr. Chairman, members of the Committee; thank you for the 
opportunity to testify on this important issue to the nation's cities 
and towns. I would be happy to answer any questions I can.
                                 ______
                                 
                          RESOLUTION--No. 97-7
              proposed changes in clean air act standards
    Whereas, the U.S. Environmental Protection Agency has proposed new 
standards for ozone and particulate matter; and
    Whereas, these new standards could have a significant impact on 
local governments, substantially expanding the number of areas out of 
compliance with the National Ambient Air Quality Standards; and
    Whereas, full implementation of the existing standards for ozone 
has not yet been fully completed; and
    Whereas, EPA is proposing significant new monitoring requirements 
to determine whether and where there is a problem with respect to the 
proposed new standard for particulate matter; and
    Whereas, there is scientific uncertainty as to whether particulate 
matter (regulated at 2.5 microns) or a constituent comprising 
PM2.5 (sulfur dioxide, nitrogen oxide, volatile organic 
compounds) is a health risk; and
    Whereas, court-ordered deadlines to resolve issues involving 
complex scientific matters are inappropriate; and
    Whereas, because of the court ordered deadline, the comment period 
of these proposals will be limited to sixty days from publication in 
the Federal Register;
    Now Therefore Be It Resolved, That the National League of Cities 
calls on the U.S. Congress to:

         Lreaffirm the existing standard for ozone to allow 
        sufficient time to assess the impact of the current pollution 
        control programs before imposing more stringent requirements;
         Loverturn the court-ordered deadlines for the issuance 
        of new standards for particulate matter; and
         Lrequire EPA to conduct adequate and appropriate 
        monitoring and scientific research to assure that any new 
        standards for particulate matter are based on sound scientific 
        information.

    Be It Further Resolved, That NLC urges Congress to ensure that EPA 
has adequate time to consider all relevant evidence in revising air 
standards and that the Agency not be forced to promulgate new and 
costly standards prematurely because of arbitrary court-ordered 
deadlines.
                                 ______
                                 
 Prepared Statement of Mayor Patrick Henry Hays, North Little Rock, AR
    I am pleased to be on this panel. My name is Patrick Henry Hays. I 
am Mayor of the city of North Little Rock, Arkansas. Mayor Jim Dailey 
of Little Rock was originally slated to be here, but circumstances 
prevented him from attending. He extends his warm regards end sincere 
interest in this topic of vital interest to all in central Arkansas.
    If I may, I would first like to say a few words about North Little 
Rock, our regional planning agency and the central Arkansas area, which 
I am here representing. North Little Rock is located across from Little 
Rock on the Arkansas River. We are a community of approximately 65,000 
persons and a destination for many others who work or shop in our city. 
The air quality monitors that are used to determine violations of the 
ozone standard in central Arkansas are located in North Little Rock.
    North Little Rock is a member of Metroplan, which is a council of 
local governments and the designated metropolitan planning 
organization, or MPO, for the Little Rock-North Little Rock 
Metropolitan Statistical Area (MSA). Metroplan has twenty-two (22) 
member governments, plus the Arkansas State Highway and Transportation 
Department (AHTD), and the Central Arkansas transit Authority (CATA). 
Metroplan is an example of the cooperative spirit that has developed in 
central Arkansas among elected officials and other community leaders in 
the area.
    Little Rock is the State Capital and located approximately in the 
geographic center of the State. Our region is also located at the 
center of the State's transportation and distribution network. It is 
the largest metropolitan area in the State, with over 550,000 residents 
and over 300,000 workers. Our economy is healthy and growing. 
Employment in the four-county area is concentrated in the services (29 
percent), trade (24 percent), and government (19 percent) sectors. 
During the 5-year period between 1990 and 1995, total MSA population 
grew by 5.3 percent, while employment increased 11.3 percent.
    Now regarding the air quality in central Arkansas, we have been in 
attainment of all national ambient air quality standards (NAAQS) since 
1983. However, there have been several exceedances of the ozone 
standard, although these have been such rare events that our attainment 
status has remained unchanged. Even without the control measures that 
could have accompanied nonattainment, we have seen a general reduction 
in our ozone levels during the last 10 years. We mainly attribute this 
to turnover in the vehicle fleet, wherein newer cleaner vehicles have 
gradually replaced older more polluting vehicles. Somewhat milder 
summer temperatures may have also helped to improve our air quality in 
recent years. Violations of the particulate matter standards have not 
even been an issue, since the PM10 standards were adopted in 
1987. In recognition of our clean air status, approximately one and 
one-half years ago an areawide coalition of alternative fuel and clean 
air stakeholders was put together, which led to our designation by the 
U. S. Department of Energy as the Central Arkansas Clean Cities Area. 
Data and charts illustrating the air quality history of central 
Arkansas are attached to my written statement.
    Since EPA proposed changes to the ozone and particulate matter 
standards, at least two sets of comments have been adopted by community 
leaders in our area.
    On February 24, 1997, the North Little Rock City Council adopted a 
resolution urging Congress to retain the existing national ambient air 
quality standards for ozone and particulate matter. We indicated that 
the impact of the current standards and control programs should be 
assessed before imposing more stringent requirements. Our resolution 
also urged Congress to overturn the court-ordered deadlines for 
promulgation of new particulate matter standards, and indicated that 
BPA should first institute adequate and appropriate monitoring of fine 
particulates before promulgating any new standards for 
PM2.5. A copy of the resolution is attached to my written 
statement.
    Last week, on February 26, 1997, the Metroplan Board of Directors 
unanimously approved comments regarding EPA's proposed air quality 
standards for both ozone and fine particulate matter. While Metroplan's 
comments are attached to my written statement, I would like to briefly 
summarize them here.
    With respect to the proposed ozone standard the Metroplan Board's 
comments indicate that:
     We can support an 8-hour concentration based standard, 
because it is more directly associated with the health effects cited in 
exposure studies and there is scientific agreement on this issue.
     The conventional rounding convention should be maintained 
with respect to determining violations, due to the same data accuracy 
concerns that CPA has cited in their proposals.
     We do not support EPA's proposal to use the average third-
highest daily maximum, set at 0.08 parts per million, because the Clean 
Air Scientific Advisory Committee could not achieve a consensus on 
either the appropriate level or form for an 8-hour standard.
     We believe that an 8-hour ozone standard would afford 
improved protection over the current standard for persons at risk if 
based on either the third-highest daily maximum set at 0.09 parts per 
million or the fifth-highest daily maximum set 0.08 parts per million.
    With respect to the proposed PM-2.5 standards the Metroplan Board's 
comments indicate that:
     At present, there is no monitoring program for PM-2.5 and 
very little data regarding the extent and sources of PM-2.5. This is 
problematic for a variety of reasons. For example, if natural sources 
are a major component of PM-2.5, controlling man-made sources may not 
be an effective approach. In addition, what if all metropolitan areas 
or large agricultural districts or national forests were designated in 
nonattainment of the PM-2.5 standards?
     Nonattainment of the proposed PM-2.5 standards could 
severely impact metropolitan areas, due to the connection between the 
Clean Air Act Amendments and ISTEA. For example, areas designated in 
nonattainment would have limitations on the type of transportation 
projects that could be implemented. MPOs would also have to prove 
``conformity'' with the State Implementation Plan (SIP) for air quality 
control, before most projects would be approved by EPA. This would 
result in more project delays and increase both MPO and project costs. 
In addition, limited or reduced Federal funding for public transit 
conflicts with more restrictive air quality standards, in that transit 
may be one of the major strategies for reducing emissions from mobile 
sources.
    For these reasons, we think that fine particulates should be 
monitored by all States for a period of up to 3 years without 
regulation consequences to determine the extent and sources of PM-2.5. 
Afterwards, the standards should be subject to another public comment 
period. This decision on fine particulate standards should not be made 
without better data and understanding of the likely consequences.
    In conclusion, it is fair to say that we are concerned about the 
consequences to our State and regional economies, if EPA's proposed 
changes are allowed to go into effect. The possibility exists that 
central Arkansas and West Memphis could be designated in nonattainment 
of the proposed ozone or particulate matter standards. Currently, 
businesses are attracted to central Arkansas and to our State, partly 
because we are in attainment of the clean air standards. If our clean 
air status changes our ability to attract new industry could be 
undermined, and perhaps, even some existing industry and jobs could be 
lost as well.
    I ask that my written statement and attachments be placed in the 
official record of this hearing. I will attempt to respond to any 
questions you may have. Thank you!
                                 ______
                                 
 Prepared Statement of Ronald F. Hammerschmidt, Director, Division of 
        Environment, Kansas Department of Health and Environment
    We are pleased with the opportunity to provide comment on the 
revisions proposed by the U.S. Environmental Protection Agency (EPA) to 
the National Ambient Air Quality Standards (NAAQS) for ozone and 
particulate matter. The Kansas Department of Health and Environment has 
a critical interest in the proposals both as an agency responsible for 
implementing many of the air quality programs affected by the 
proposals, as well as the state-level agency in Kansas responsible for 
developing and implementing statewide programs designed to protect the 
public health in our State. It goes without saying, that the protection 
of the health of the citizens of Kansas is of paramount importance to 
our agency and our State. On this basis, our comments are presented 
primarily from the perspective of an implementing agency. The health 
effects research referenced by the EPA has not been the subject of 
critical review by our agency.
    The State of Kansas is proud of its air quality and recognizes the 
importance of clean air to the health of its citizens, its environment, 
and its economy. Kansas is currently attainment for all ambient air 
quality standards statewide. Past successes are attributed to the 
ability of local, State, and Federal Government agencies across the 
State to work effectively with affected business interests, special 
interest groups, and the general public to promote improvements in air 
quality. These relationships are critical to continued success in our 
air quality programs.
    Although many questions remain relative to the technical 
requirements and implementations costs for these complex proposals, our 
most fundamental concerns lie in two areas.
    The first of these involves the shortage of information and 
apparent inconsistencies in that information which is available on the 
characteristics and origins of the particles targeted by the proposal 
to establish a new fine particle particulate matter (PM2.5) 
standard. The particles of greatest concern are being distinguished 
from the coarse particles currently regulated on the basis that they 
are characteristically different (e.g., combustion-related, soluble, 
chemically-reactive, etc.) and that they originate from different 
sources including processes that result in the formation of secondary 
particles from gaseous precursors. However, emission information 
pertaining to the sources of primary PM2.5 particles 
indicates that a significant overlap occurs between the fine and coarse 
fractions of many sources of fugitive dust; including paved roads, 
unpaved roads, and windblown dust. This confusion has been exacerbated 
by the lack of PM2.5 air monitoring data in rural States. As 
a result, the fugitive dust component of PM2.5 emissions in 
the rural areas of the United States may represent a source of exposure 
not intended to be implicated as a target of concern by the health 
studies completed primarily in the larger urban areas of the United 
States. It seems apparent that adequate study has not been completed of 
the sources and health implications of exposure to PM2.5 
particles in rural areas. Because of these concerns, our agency will be 
providing comment to EPA that additional speciated air monitoring 
information be collected to assess the role of fugitive dust in the 
PM2.5 standard proposal and to more accurately characterize 
the particles of concern. Ideally, this information would be available 
prior to final decisionmaking on the new particulate matter standard.
    Our second major area of concern involves the potential impact of 
the proposed revision to the ozone standard in Kansas City. 
Historically, ozone has been a concern in Kansas primarily in the 
metropolitan area of Kansas City. A five-county area in Kansas City 
(including Johnson and Wyandotte counties in Kansas) was declared an 
ozone nonattainment area in the late 1970's and remained as such until 
1992 when the area was federally-approved for redesignation to 
attainment. In order to gain attainment status, the States of Kansas 
and Missouri were required to demonstrate to EPA that compliance with 
the standard could be maintained into the future and a long-term 
maintenance plan was approved. Hot weather conditions experienced 
during the summer of 1995 resulted in a total of nine exceedances of 
the standard spread across four of the six ozone monitoring sites 
maintained throughout the five-county area. These exceedances resulted 
in a regulatory violation at one of the monitoring locations. The 
resulting violation triggered implementation of contingency provisions 
in the maintenance plan designed to respond to future findings of air 
quality problems. This response was organized through a regional air 
quality forum consisting of a broad coalition of interested parties 
including State, local, and Federal Government representatives, local 
businesses, environmental groups, and members of the public. A series 
of recommendations for enhancements to the emission control, 
transportation management, and air-related public education programs in 
Kansas City emerged from this group. These recommendations include 
actions above those required as the minimum in the maintenance plan 
approved for the area. Forum members arrived at a clear consensus that 
continued progress to prevent further air quality problems in Kansas 
City was in the best interest of the city now and in the future. State 
and local governments (including the regional planning organization) 
are currently preparing plans and adopting regulations to implement the 
recommendations of the Kansas City air quality forum.
    Although air quality progress continues in Kansas City under its 
current maintenance plan, the proposed revision to a 0.08 ppm (eight-
hour average, third high) standard will result in the return of the 
Kansas City area to nonattainment status. By way of comparison to the 
existing standard, the excursions during 1995 resulted in a total of 3 
days of air quality problems. If the revision proposed had been in 
effect in 1995, the area would have experienced a total of 17 air 
quality problem days. Compliance with such a standard will be very 
difficult. If the lower range proposed (0.07 ppm, 8-hour average, first 
high) had been in effect, a total of 31 problem days would have 
occurred. Even the highest range proposed (0.09 ppm, 8-hour average, 
fifth high) would have increased the number of problem days in 1995 
from three to seven even though the 0.09 ppm proposal is presented as 
being roughly equivalent to the current standard.
    While we believe the scientific advisers to EPA, and the EPA 
itself, should be applauded for openly acknowledging their difficulties 
in arriving at a single, discrete level for a revised ozone standard, 
the differences in the impact to implementing agencies (and associated 
health implications) between a 0.07 ppm standard and a 0.09 ppm 
standard are pronounced in Kansas. The lower range proposed (0.07 ppm, 
8-hour average, first high) has been exceeded in far western Kansas in 
a rural community with a population of 4,800 residents.
    Despite the wide range of numerical options presented in the 
proposal, the recommended level of 0.08 ppm (third high) creates a 
discrete regulatory compliance level that will have significant impact 
in Kansas City. As noted previously, the attainment status of the area 
would most certainly return to nonattainment at a time during which a 
broad community effort was encouraging additional air quality control 
measures well above the minimum required under the area's maintenance 
plan. The current impetus for these actions has been the community 
consensus to make a ``clean'' city cleaner. Upon return to a 
nonattainment status, there is great concern that the impetus will 
change to one that attempts to make a ``dirty'' city cleaner. This 
shift from a community process to a regulatory process may reduce the 
value of community involvement in the implementation of air quality 
initiatives when faced with new regulatory agency mandates. We have 
deep concerns that this change will polarize affected interests and 
delay further progress in Kansas City. Delays in actual air quality 
improvements may also occur as a result of implementing agencies having 
to begin a new, extended planning process including modeling and 
attainment plan development. The timeframe for developing a new 
attainment plan will be long in comparison to the much shorter 
timeframe involved in continuing progress under the maintenance 
process. The depth of the impacts of the proposed 0.08 ppm standard in 
Kansas City has prompted our agency to prepare comments for submittal 
to EPA that encourages retention of the existing standard until the 
attainment/nonattainment designation process can be reformed. Such 
reforms would recognize the uncertainties involved in establishing a 
discrete ozone compliance level and the value of establishing a tiered 
regulatory approach.
    Again, we appreciate the opportunity to bring this information 
before the Subcommittee.
                                 ______
                                 
Prepared Statement of Barry R. McBee, Chairman, Texas Natural Resource 
                        Conservation Commission
    Thank you very much for inviting me here today to offer testimony 
on this vitally important issue for Oklahoma, for Texas and for all of 
our States.
    For the record I need to clearly express that these are my personal 
comments as chairman of the State's environmental agency, but not yet 
the official agency policy--a policy that will be voted on and 
finalized later next week.
    Also for purposes of the record it is important to note that we in 
Texas felt it was important to solicit public input on these new 
proposed standards. In January and February we held nine public 
meetings across the State and heard from hundreds of citizens. In 
total, we received more than 2,200 comments.
    Everyone in this room supports clean air. The good news is that 
ozone levels in our State are dropping and our standards and controls 
are having the desired impact. We in Texas, while making progress, have 
been waiting like other States for these new EPA standards to be 
announced, hopeful that they would be a clear mandate fully supported 
by the scientific community. That is not what happened.
    It should not be too much to ask government, especially given the 
potential effects on families, business and industry and lifestyles and 
the staggering cost of many regulations, to adopt standards that are 
both clear and based on sound and complete science. With so much at 
stake, the Federal Government simply is not doing its job if these 
standards are not clear and not built on that basis.
    Sadly, however, these proposals from EPA have not established the 
``bright line'' about where the standards should be. And, in my 
opinion, there have to be bright lines for these standards. Instead, 
I--as an environmental policymaker in a State in which more than 18 
million people live, and with untold billions of dollars at stake--am 
forced to make decisions in the midst of a gray area of science, where 
everyone agrees that nothing is certain and not enough is known. We 
don't have bright lines. At best we have only dim ones. We have 
educated guesswork--and for our citizens that is clearly not enough.
    Some of you may be familiar with a recent study sponsored by EPA--a 
study which Texas was not notified about before it appeared on the 
Internet--that has increased the uncertainty about replacing the 1-hour 
ozone standard with an 8-hour standard. The study seems to suggest that 
the 1-hour standard would be more protective than the 8-hour standard 
in two cities, Houston and Los Angeles.
    This has contributed to the atmosphere of confusion which already 
exists about this whole process. It clearly points out that we do not 
know as much as we think we do about ozone. Surprisingly, we do not 
know enough even about the two cities with the worst problems in the 
country. We have to know more.
    Because of this, the EPA proposals on ozone and particulate matter 
should be separated. And in light of this new EPA study alone, it is 
not good public policy to act now to change the ozone standard. EPA was 
compelled by the courts to move on the particulate standard. That is 
not the case for ozone, but EPA chose to proceed at the same time. If 
more research is needed on ozone, we should do that now instead of 
prematurely altering a standard which, I will remind you, is working in 
Texas.
    And yet another compelling reason to separate the issues is the 
cost to society of these new ozone standards which E.P.A.'s own studies 
have indicated will be significant.
    This EPA study also points out another problem. If research shows 
that different areas of Texas should have different standards to 
protect their citizens, how can EPA still maintain that ``one size fits 
all?'' EPA in this study itself has pointed out that what is good for 
Dallas/Fort Worth may not be good for Houston--and the State of Texas 
should not therefore be forced to enact a State standard on top of the 
Federal standard to fix what EPA refuses to fix. It should be clear 
that one size may not fit all, and that it may be time for a flexible, 
regional approach to clean air and air standards. It should be possible 
under EPA guidance for regions to select controls, based on research, 
that will do the most to clean up their air.
    If, however, the EPA decides to move forward with its ozone 
proposal with a level of .08 ppm--perceiving that somehow as the bright 
line for the Nation--please let me tell you that the line is in the 
wrong place. There is no consensus. EPA chose .08 even though the range 
of .08 to .09 ppm or higher was recommended by more of EPA's own Clean 
Air Science Advisory Committee members who expressed an opinion on a 
specific standard. And there is no toxicological study which shows more 
health protection from a .09 level than one of .08.
    Given that, setting the allowable ozone level thus becomes a matter 
of public policy. And I believe the right policy decision is one that 
does not, as the .08 proposal does, boost the number of nonattainment 
areas in Texas from four to nine--more than any other State. That 
standard might not ever be attained by some areas, regardless of the 
level of controls. And all of this in the context of EPA's admission 
that we don't know what we thought we knew about ozone in the Houston 
area.
    As I mentioned earlier, the levels of ozone in our State have seen 
a general decline. We can point to hard data, for example, that show 
ozone levels in the Dallas/Fort Worth nonattainment area are decreasing 
and that specific controls are working. But if the standard is changed 
in midstream, at what cost to DFW and other areas do we do so? And do 
we know that the new standard--given the uncertainties from studies 
like the one I've mentioned, from ongoing studies about ozone transport 
and other issues--will work better in DFW or any area in Texas? We do 
not.
    On other aspects of the ozone proposal, I do believe that those 
areas that have worked hard for flexible attainment region status--
including Tulsa, and two areas in my State, Corpus Christi and 
Longview/Tyler/Marshall, should be given time to let their strategies 
work.
    In reference to the interim implementation policy proposal we 
support the following points: spatial averaging; the need for greater 
communication of ozone highs, especially to populations sensitive to 
ozone; and the need to have incentives for early emission reductions. 
And one final point, we need agreement that there is no need to keep 
working on the premise of a 1-hour standard if this will be changing, 
so we should refocus our resources toward a new standard.
    As for particulate matter, we have gone from ozone's dim line to no 
line at all. There are very few data on fine particulate matter and, 
based on what EPA is proposing, absolutely no data from monitoring in 
Texas. There does appear to be a growing body of evidence that there 
could be long-term health effects from fine particulate matter. But 
CASAC, which expressed concern about potential health effects, was not 
even close to a consensus on a standard; it expressed instead 
legitimate concerns and unanswered questions. What we have to do 
instead of setting a premature standard is to speed up dramatically the 
Federal research efforts, which CASAC and the Western Governors 
Association have called for, and only after that research has concluded 
decide on a standard, if any.
    Also, I would ask members of this Committee to press for review of 
these proposals under the Small Business Regulatory Enforcement 
Fairness Act (SBREFA). Although EPA may say that the proper time for 
this review is at implementation of these standards, if and when that 
happens, that will not work. The standard will be implemented not by 
EPA but by the 50 States and at different paces.
    Finally, in this time when our citizens expect fiscal 
responsibility and reject incomplete science, we should very carefully 
consider any legislation which does not require a very formal and 
careful assessment of actual costs compared to proven benefits. As in 
the case of these standards, citizens have every right to expect a 
bright line about sound science and costs vs. benefits, not educated 
guesswork.
                                 ______
                                 
 Prepared Statement of J. Dale Givens, Secretary, Louisiana Department 
                        of Environmental Quality
    Good afternoon. My name is J. Dale Givens and I am the Secretary of 
the Louisiana Department of Environmental Quality. Thank you for 
allowing me the opportunity to provide testimony on the proposed 
changes to the National Ambient Air Quality Standards for ozone and 
particulate matter.
    Louisiana, in partnership with the Environmental Protection Agency 
(EPA) has been very successful in improving air quality through the 
implementation of the Clean Air Act. Today Louisiana meets five of the 
six National Ambient Air Quality Standards (NAAQS) for criteria 
pollutants with only ozone remaining. Our ozone nonattainment parishes 
have decreased from 20 to 5. We have met our obligations under the 1990 
amendments of the Clean Air Act (CAA), completing all required emission 
reductions. We have submitted the required ozone attainment 
demonstration plan. As required by the CAA, complete implementation of 
the attainment plan will be accomplished in 1999. At that time, we 
expect to be in full compliance with the present ozone standard. 
Already, as a result of substantial emission reductions in place, air 
monitoring data show marked decreases in ozone. Louisiana is on a 
successful course for cleaner air.
    Louisiana supports the establishment of National Ambient Air 
Quality Standards (NAAQS) which are necessary to protect human health 
and which are based on sound technical and scientific data. In the 
setting of the standards, the EPA has stated that it cannot consider 
economic or technological feasibility of attaining the standard. We 
have therefore concentrated our review of the proposal based on the 
underlying health science including the EPA staff paper and the 
independent scientific advisory reports. Based on our study of these 
documents, Louisiana supports the EPA position that an 8-hour standard 
is more appropriate for a human health-based standard than the present 
1-hour standard. Louisiana also agrees that the form of the standard 
should be concentration based.
    The EPA's staff paper recommends 0.09 ppm as the upper level of an 
8 hour standard that would reduce estimated exposures of the at risk 
populations sufficiently to provide some margin of safety against 
pulmonary inflammation and increased susceptibility to pulmonary 
infection. Louisiana supports a level of the standard set at 0.09 ppm 
as the 3 year average of the annual third highest maximum 8 hour 
average ozone concentration. As we appreciate the underlying science 
for setting the new standard, little or no public health benefit would 
be gained by setting the standard at 0.08 ppm rather than 0.09 ppm.
    In addition, Louisiana favors the proposal made by a number of 
CASAC members for an expanded air pollution warning system which could 
be implemented for sensitive individuals who could then take 
appropriate exposure avoidance action. CASAC pointed out to the EPA 
that this idea would be easy to implement since many areas of the 
country already have an infrastructure in place to designate ozone 
action days when voluntary emission reduction measures can be taken. 
Tulsa Oklahoma already has such a program in place. For a number of 
years the Baton Rouge area has operated a program to apply 
administrative emission controls to industrial sources during periods 
when ozone levels are expected to be elevated. Efforts to develop a 
community ozone action day program were begun last summer in Baton 
Rouge. This effort is expected to continue this summer and is supported 
by the public.
    These are our initial comments regarding the primary standard being 
proposed for ozone. We are continuing to review the entire proposed set 
of changes which includes the secondary standard for ozone, the changes 
to the particulate matter standard and the implementation proposal for 
both pollutants. Due to the large volume of documentation associated 
with these proposals, it will take time to properly review them and the 
support documentation in order to provide additional comments.
    Thank you for the opportunity to comment and your attention to the 
concerns of Louisiana.
                                 ______
                                 
  Prepared Statement of Richard E. Grusnick, Deputy Director, Alabama 
                 Department of Environmental Management
    Mr. Chairman and members of the subcommittee, good morning. My name 
is Richard Grusnick and I am deputy director of the Alabama Department 
of Environmental Management, the agency charged with administering the 
major environmental laws in Alabama. Prior to assuming my current 
duties, I was chief of the department's air division and have been 
involved in Alabama's program to regulate air pollution since its 
inception in 1972.
    I appreciate the opportunity to appear before this subcommittee 
today as it conducts oversight hearings on EPA's recent proposal to 
revise the air quality standards for ozone and particulate matter and 
the effect these proposals may have on State and local governments. 
There are two basic points I wish to make today. These are:
    1. Tightening the standards would divert regulatory resources from 
the areas with the most serious air quality problems.
    2. Given the difficulty and resistance encountered in identifying 
and implementing the measures required to meet the current air quality 
standards, the credibility of all levels of government may ultimately 
decline if the proposed standards are adopted.
    The only current nonattainment area in Alabama is the Birmingham 
area which includes Jefferson and Shelby counties. Birmingham was 
designated a marginal ozone nonattainment area pursuant to the Clean 
Air Act amendments of 1990. A significant amount of the air regulatory 
resources in the State have been focused in this area by developing and 
enforcing regulations dealing with smaller sources than are regulated 
in the remainder of the State and by working with the transportation 
planning agencies to ensure that transportation improvement plans 
conform with the air quality goals in this largest metropolitan area of 
the State. This makes sense--focus the regulatory efforts and 
associated increased costs in the area of the State with the worst air 
quality where the benefits would be greatest. This focusing of 
resources would decrease if the proposed standards were adopted.
    Under the range of proposed standards, the number of nonattainment 
counties in Alabama would increase from two to somewhere between eight 
and all sixty seven counties, with the most likely scenario including a 
minimum of 20 counties. It is not realistic to expect that resources 
available to the regulatory effort would increase to correspond with 
the increased workload of developing the necessary plans, regulations 
and implementing the requirements in each of the counties. This would 
mean that resources would have to be diverted from the areas with the 
most severe air quality problems to implement the requirements in the 
newly designated, less severely impacted, less densely populated 
nonattainment areas. Given the reality of limited resources, I question 
whether establishing a tighter standard will actually result in the 
most effective use of State resources to provide the maximum benefits 
from cleaner air in Alabama.
    I also have reservations about the continued credibility of efforts 
to improve air quality. The days of easy choices have passed. This was 
evidenced by the 10 years it took Congress to reauthorize the Clean Air 
Act with the 1990 amendments and the challenges already faced in 
implementing its provisions. No longer are requiring controls on large 
industry and the manufacture of lower emitting new vehicles adequate to 
satisfy the air quality mandates of the existing law. Small businesses 
are now required to reduce their emissions and lifestyle changes are 
necessary in some areas. I have seen presentations by representatives 
of other, more challenged States which indicate emission reductions in 
excess of 70 percent will be required to meet the current standard. 
Couple this with the fact that transportation sources are generally 
responsible for half the emissions and the problem is obvious. Many of 
the more severely impacted areas have been unable to develop plans to 
meet the current standard using any politically or socially acceptable 
strategy. Investigations into long range transport have also failed to 
identify a strategy which would allow the current standard to be 
achieved throughout the eastern U.S. From a practical perspective, I 
think it is reasonable to question ``raising the target'' when the 
current one is already too high to hit in many instances.
    In addition, many of the measures recently implemented have met 
with strong opposition. In the more severely impacted areas smaller 
businesses have been regulated, automobiles now have their emissions 
tested, and certain types of new industrial growth continues to be 
essentially precluded by the emissions ``offset'' requirements. 
Tightening the air quality standard would significantly expand the 
number of areas subject to these requirements and may undermine the 
support for continued air quality improvement. This is especially 
likely since these requirements will impact more rural areas which have 
traditionally been viewed as having good air quality.
    It should also be noted that continued improvement in air quality 
will occur even absent a revision to the standards since the aggressive 
requirements of the Clean Air Act amendments of 1990 contain many far 
reaching emission reduction provisions which have not yet been fully 
implemented. Many of these provisions will result in significant 
reductions in the emissions of pollutants responsible for ozone and 
fine particulate matter. Perhaps continued evaluation of the disputed 
health effects studies would be reasonable as we continue to implement 
the blueprint for improving air quality established by Congress in the 
1990 amendments.
    In summary, adoption of the proposed standards would most likely 
result in:
     diverting regulatory resources from the most impacted 
areas; and
     a loss of government credibility.
    All the while air quality improvements will continue to be realized 
as a result of the 1990 amendments.
                                 ______
                                 
  Prepared Statement of Mark S. Coleman, Executive Director, Oklahoma 
                  Department of Environmental Quality
    Thank you for the opportunity to testify on issues that are of 
great importance to the citizens of Oklahoma and the Nation. On behalf 
of the citizens of the State of Oklahoma, I wish to submit the 
following remarks: Under the current Ambient Air Quality Standards, the 
entire State of Oklahoma is considered to be in attainment status. In 
many respects our State has been an innovator in the field of air 
pollution control. Oklahoma was the first State to institute ozone and 
carbon monoxide alert programs. These programs were further enhanced by 
the adoption of the flexible attainment region program for the 
metropolitan areas of our State. The programs have become 
``blueprints'' for numerous other areas of the country. Industry, the 
general public, as well as government have striven to maintain our 
clean air status, and we are justifiably proud of these efforts. These 
advances have come at no small effort on the part of our citizenry. 
Many changes have been made on a voluntary basis which have maintained 
the clean air we currently enjoy. With many of the effects of the 1990 
Clean Air Act amendments unclear and yet to be realized, it would seem 
imprudent to make wholesale changes at this date.
    However, if the standards are to be changed, the existing body of 
scientific data seem to indicate that the standard for ozone should be 
set on an 8-hour basis, which for the majority of the country is more 
protective of human health. For those areas where this may not be the 
case, the secondary standard set at current levels should be 
maintained. The numerical level of the standard could be set at a level 
close to that of the current standard until such time as the scientific 
evidence demonstrates a level which meets the ``bright line'' test. 
Such a strategy would allow for the protection of those who are exposed 
over a long period of time and would allow for the further collection 
of scientific data upon which to base changes to the ozone standard. 
The actual statistical treatment of the data should allow for the 
atmospheric abnormalities which occur frequently during the ozone 
season.
    The new proposal for the particulate standard needs to be looked at 
in the light of the actions that are available to the agency. The 
preponderance of scientific data seem to indicate that these smaller 
particles are more dangerous to human health than those we currently 
regulate. It appears that much of the data upon which the conclusions 
were based are data which has been extrapolated from other data sets 
developed from larger particles. Since one of the actions available to 
the agency is to reaffirm the current standard and mandate the 
collection of actual data upon which decisions can be made, perhaps 
that option should be pursued. The shortage of reliable consistent, 
quality assured data about these small particles and their origins is 
of the utmost importance before we move forward with the standard 
setting process. Since these particles are not well understood, and 
since there is evidence which indicates that there is some overlap 
between fine and course fractions further research must be undertaken 
to describe the interactions between the particles and their gaseous 
precursors.
    It seems apparent that the research necessary to understand the 
public health impacts, the sources of these particles and the 
implications of exposure to the various levels of fine particles needs 
further refinement. Since the particles in question, are of various 
species, we strongly recommend further collection of speciated data to 
characterize the particles of concern.
    While we understand the process EPA and it's advisors have 
undertaken, the record of these deliberations themselves indicate that 
there is not a strong body of evidence which leads us to a single 
discrete level at which to set either standard. The advisory body as 
well as the EPA staff are to be commended for their efforts. However, 
in the light of the costs associated with the setting of either of the 
proposed standards as well as the impact on the implementing agencies, 
we have grave concerns that actions which are not well founded nor 
based on clear and compelling scientific data may actually cause a 
backsliding in Oklahoma's support of Air Quality improvements. Again, 
thank you for the opportunity to testify.