[Senate Hearing 106-968]
[From the U.S. Government Publishing Office]



                                                       S. Hrg. 106-968
 
                      COMPARATIVE RISK ASSESSMENT:
                        SCIENCE ADVISORY BOARD'S
                          RESIDUAL RISK REPORT
=======================================================================

                   HEARING AND INFORMATIONAL MEETING

                               BEFORE THE

                              COMMITTEE ON
                      ENVIRONMENT AND PUBLIC WORKS
                          UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                            OCTOBER 3, 2000

                               __________

                                   ON

HOW THE U.S. ENVIRONMENTAL PROTECTION AGENCY WILL MAKE USE COMPARATIVE 
RISK ASSESSMENT STRATEGIES AND METHODS TO PROTECT THE HEALTH AND SAFETY 
                              OF AMERICANS

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


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               COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

                       ONE HUNDRED SIXTH CONGRESS
                             second session
                   BOB SMITH, New Hampshire, Chairman
JOHN W. WARNER, Virginia             MAX BAUCUS, Montana
JAMES M. INHOFE, Oklahoma            DANIEL PATRICK MOYNIHAN, New York
CRAIG THOMAS, Wyoming                FRANK R. LAUTENBERG, New Jersey
CHRISTOPHER S. BOND, Missouri        HARRY REID, Nevada
GEORGE V. VOINOVICH, Ohio            BOB GRAHAM, Florida
MICHAEL D. CRAPO, Idaho              JOSEPH I. LIEBERMAN, Connecticut
ROBERT F. BENNETT, Utah              BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas          RON WYDEN, Oregon
LINCOLN CHAFEE, Rhode Island
                      Dave Conover, Staff Director
               J. Thomas Sliter, Minority Staff Director

                                  (ii)







  
                            C O N T E N T S

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                                                                   Page

                            OCTOBER 3, 2000
                           OPENING STATEMENTS

Baucus, Hon. Max, U.S. Senator from the State of Montana.........60, 51
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma...     1
Lautenberg, Hon. Frank R., U.S. Senator from the State of New 
  Jersey......................................................... 2, 53
Lieberman, Hon. Joseph I., U.S. Senator from the State of 
  Connecticut....................................................    54
Moynihan, Hon. Daniel Patrick, U.S. Senator from the State of New 
  York........................................................... 7, 52
Smith, Hon. Bob, U.S. Senator from the State of New Hampshire.... 3, 50

                               WITNESSES

Anderson, Elizabeth L., President and CEO, Sciences 
  International, Inc.............................................    29
    Prepared statement...........................................   110
    Responses to additional questions from:
        Senator Baucus...........................................   125
        Senator Smith............................................   122
Brenner, Robert, Principal Deputy Assistant Administrator for Air 
  and Radiation, Environmental Protection Agency.................    42
    Prepared statement...........................................   146
Davies, J. Clarence, Senior Fellow, Center for Risk Management, 
  Resources for the Future.......................................    26
    Prepared statement...........................................   107
    Responses to additional questions from:
        Senator Baucus...........................................   109
        Senator Smith............................................   109
Guerrero, Peter, Director, Environmental Protection Issues, 
  General Accounting Office......................................     9
    Prepared statement...........................................    67
    Responses to additional questions from:
        Senator Baucus...........................................    75
        Senator Smith............................................    73
Hartnett, Katherine, executive director, New Hampshire 
  Comparative Risk Project.......................................    20
    Prepared statement...........................................    86
    Responses to addtional questions from:
        Senator Baucus...........................................    90
        Senator Smith............................................    88
Hopke, Philip, Chair, Residual Risk Subcommittee, Science 
  Advisory Board.................................................    40
    Prepared statement...........................................   150
    Responses to additional questions from:
        Senator Baucus...........................................   153
        Senator Smith............................................   154
Hughes, Lee, Vice President of Corporate Environmental Control, 
  Bayer Corporation..............................................    44
    Prepared statement...........................................   141
    Responses to additional questions from:
        Senator Baucus...........................................   145
        Senator Smith............................................   144
Lippman, Morton, Professor, New York University, chair, Science 
  Advisory Board.................................................    33
    Letters, EPA...............................................132, 135
    Prepared statement...........................................   128
    Responses to additional questions from:
        Senator Baucus...........................................   137
        Senator Smith............................................   133
McGartland, Al, Director, National Center for Environmental 
  Economics, Office of Policy, Economics, and Innovations, 
  Environmental Protection Agency................................     7
    Prepared statement...........................................    55
    Responses to additional questions from:
        Senator Baucus...........................................    65
        Senator Smith............................................    59
Pompili, Michael J., Assistant Health Commissioner, Columbus 
  Health Department, Columbus, OH................................    23
    Prepared statement...........................................    95
    Responses to additional questions from:
        Senator Baucus...........................................   101
        Senator Smith............................................    99
Stadler, Felice, National Policy Coordinator, Clean the Rain 
  Campaign, National Wildlife Federation.........................    38
    Prepared statement...........................................   155
    Responses to additional questions from Senator Smith.........   156

                          ADDITIONAL MATERIAL

Articles:
    Achieving Harmony Among Environment, Economy and Energy......    85
    Air Pollution Panel Backs EPA and Six Cities Study...........    93
    Scientists Question SAB's Criticism of EPA's Residual Risk 
      Program....................................................   140
Letters:
    Environmental Protection Agency............................132, 135
    New Hampshire Comparative Risk Project.......................    86
    Science Advisory Board.......................................   162
Reports:
    New Hampshire Comparative Risk Project.......................    78
    Columbus Community Environmental Management Plan.............    97
    SAB Advisory of Residual Risk of Secondary Lead Smelters.....   164
Statements:
    Biddinger, Dr. Gregory, Exxon-Mobil Company..................   183
    Brown, Dr. Stephen L., Risks of Radiation Chemical Compounds.   186
    Cory-Slechta, Dr. Deborah, Department of Environmental 
      Medicine, University of Rochester..........................   190
    Gentile, Thomas J., New York State Department of 
      Environmental Conservation.................................   191
    Hattis, Dr. Dale, Clark University, Worcester, MA............   197
    McFarland, Michael J., Engineering Department, Utah State 
      University.................................................   201
    Middleton, Paulette, Center for Environmental Sciences and 
      Policy.....................................................   204
    Parris, George E., Ph.D., director, Environmental & 
      Regulatory Affairs, American Wood Preservers Institute.....   158
    Taylor, George E., George Mason University...................   206
    Zimmerman, Dr. Rae, Robert Wagner Graduate of Public Service, 
      New York University........................................   209
  


  COMPARATIVE RISK ASSESSMENT: SCIENCE ADVISORY BOARD'S RESIDUAL RISK 
                                 REPORT

                              ----------                              


                        TUESDAY, OCTOBER 3, 2000

                                       U.S. Senate,
                 Committee on Environment and Public Works,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 9:31 a.m., in 
room 406, Senate Dirksen Building, Hon. Robert C. Smith 
(chairman of the committee) presiding.
    Present: Senators Smith, Inhofe, Moynihan, Lautenberg, and 
Baucus.

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

    Senator Inhofe [assuming the chair]. The committee will 
come to order.
    I thought we would start while waiting for the chairman to 
get here.
    Before doing any opening statements, let me pay a special 
tribute to my good friend Patrick Moynihan. Not many people are 
aware of the fact that he is a Tulsa boy, from Tulsa, OK. In 
fact, one of his roommates in school--what was John's last 
name? John Barry, that is right, John Barry was a very liberal 
Democrat and he is my next-door neighbor.
    Some people accuse me of being a very conservative 
Republican. Finally, he came to me one day. We used to have 
these conversations about you. That was the only thing we 
agreed on, nice things about Patrick Moynihan. He finally came 
to me one day and he said, ``You know, this neighborhood isn't 
big enough for both of us.''
    And he left. So, that was the end of your friend there.
    You know, in Tulsa we have a very well known morning show 
that is heard far beyond the confines of Oklahoma. It is called 
``The Early in the Morning Show.'' He just absolutely worships 
Daniel Patrick Moynihan. In fact, he was after me since the 8 
years I was in the House and the 6 years in the Senate to line 
up an interview. That did finally happen.
    So, even though he was quite young when he left Tulsa, he 
is one that we claim as our own, Daniel Patrick Moynihan.
    Our chairman has just arrived. Chairman Smith, I started 
without you. Let me finalize this comment because I know that 
your family was with the Tulsa Tribune at one time. I ran 
into--and I hadn't seen him for 10 years--Jake Jones on the 
airplane yesterday. You know, the paper is no longer there any 
more. I hadn't seen him in probably 12 years and I ran into him 
on the plane.
    So, anyway, we are very proud of Pat Moynihan to be a 
native Tulsan. He is part of our area.
    Senator Moynihan. You are very generous, sir. I am proud to 
have such an origin.
    Senator Inhofe. Well, if you hadn't been so young, you 
wouldn't have been willing to leave, I am sure.
    Senator Lautenberg. Mr. Chairman.
    Senator Smith [assuming the chair]. Senator Lautenberg.

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

    Senator Lautenberg. May I ask, we have a Transportation 
Conference about ready to start, miracle of miracles, and I did 
want to have just a couple of minutes to talk about my friend 
to my right, and that is often the position. May I have that 
time now?
    Senator Smith. Go ahead.
    Senator Lautenberg. I would ask the involvement of the 
witnesses. Pat Moynihan and I are probably on our--I want to 
say ``last legs,'' but on our last committee, the Environment 
and Public Works Committee. I think it is fair to say that in 
the year that you joined this committee, Senator Moynihan, it 
was called the Committee on Public Works. Then the word, 
``environment'' was added. Is my briefing paper correct?
    Senator Moynihan. I believe, sir, Senator Muskie had just 
added ``environment.''
    Senator Lautenberg. Well, I am sure your influence helped. 
I am awfully glad you did because Senator Moynihan and I are 
from either sister or brother States, however you phrase it. 
The fact of the matter is that we are inextricably linked 
because of the necessity to function together in our region.
    For me, Senator Moynihan, it has been a distinct honor and 
pleasure. We have worked together on some fairly important 
issues that under the jurisdiction of this committee: clean 
water, clean air, trying to make sure that the harbor keeps 
functioning so that we have the depth to accommodate the ships 
that are now plying the harbor waters, but also those in the 
future.
    We dare not stand by and let changing conditions impair our 
economy, whether it is heavier trucks on the highways, which we 
had to accommodate, or changes in our aviation system, we 
stepped up to the plate and did it.
    In the case of dredging in the harbor, it is a phenomenon 
resulting from new technology and larger vessels. So, I 
remember that it was in 1985 that we stood at the top of the 
World Trade Center calling for tougher standards to control air 
toxics. Ultimately, we were able to beat back the 
Administration's efforts to weaken the requirements on 
midwestern power plants that spewed air pollution all over our 
two States.
    Senator Moynihan's conscience, intellect, and integrity 
have made him a fearsome adversary. By the same token, if you 
need a friend and a soldier in the ranks or a partner in duty, 
Pat Moynihan was the person you could call on.
    Pat Moynihan also has the distinction of recognizing the 
tremendous toll of air pollution in terms of acid rain and its 
effect in the Adirondacks and other mountainous and lake areas 
in his beautiful State.
    So, I say that the Senate will be a poorer place as a 
result of the retirement of departure of Pay Moynihan from the 
Senate. One of the things that we hope is that he will continue 
to stay involved in public policy.
    There is such a wealth of experience and information there. 
As I said earlier, also the intellect to support the use of 
that knowledge and that experience, whether it has to do with 
our international relationships or whether it has to do with 
making sure that we pay attention to the needs of our railroads 
and our transportation system or making certain that the water 
that our people drink is safe.
    So, I say this, Senator Moynihan, that is not bottled 
water. I want everybody to know that.
    Thank you, Mr. Chairman, for this opportunity to say these 
few words.
    Senator Moynihan. Mr. Chairman, I would like to thank my 
dear colleagues from Oklahoma and from New Jersey. We have been 
together a long while and we will continue. Thank you.

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

    Senator Smith. Well, I know we are embarrassing you, 
Senator Moynihan, but in reflecting, you have the same 
unfortunate experience that I did in that you assumed the 
chairmanship upon the death of a colleague in the middle of the 
session. Senator Burdick passed away and you assumed the 
chairmanship, as I did when Senator Chafee passed away. So, we 
have, unfortunately, something in common there.
    But I also wanted to remind you of the time that you, not 
long after having assumed that chair and when I was a fairly 
young, in terms of tenure here, Member of the Senate.
    You came to my office after having assumed that 
chairmanship and insisted on coming to my office rather than me 
coming to yours and gave me a great opportunity to have 
significant input into the transportation bill which you were 
then working on. I have never forgotten that.
    You hear oftentimes the expression of people who are both a 
gentleman and a scholar, and you are both. I mean that. It is 
very, I think, well, it is certainly timely but perhaps no 
accident that you are here. This is your last hearing. Yet, it 
is on risk assessment and you have had so much to do with it. I 
have a long litany of things, which I am not going to read, but 
I will put in the record your conversations in that area.
    So, it has been a real pleasure to serve with you.
    Senator Moynihan. Thank you, Mr. Chairman.
    Senator Smith. I appreciate your friendship.
    Senator Moynihan. It will be a pleasure to hear our 
witnesses if you want to get on with it.
    Senator Smith. Senator Lautenberg, this is also your last 
hearing, I believe. It seems like we have had four or five 
``last hearings'' for you.
    Senator Lautenberg. Keep them going.
    Senator Smith. You really enjoy this. But, I did make some 
comments the last time on the record for you.
    Senator Lautenberg. You did. I don't feel deprived, Mr. 
Chairman. I truly appreciated it. I would appreciate one more 
courtesy, and that is, if I could submit my statement on this 
hearing into the record.
    Senator Smith. All members' statements will be submitted 
for the record.
     Senator Baucus has just come in. Why don't we just have 
the first panel come up while Senator Baucus makes a few 
remarks?
    Senator Baucus. Thank you, Mr. Chairman. This is quite a 
day. It is bittersweet. It is a time when we are happy for the 
Senator from New York but we will also sorely miss him.
    Senator Moynihan has been a friend to all of us on the 
committee. He has certainly been a mentor to me. He teaches the 
best way, which is by example, not by telling people what to 
do, but by example, by coaxing out our better angels.
    Senator Moynihan is optimistic. He is positive. He appeals 
to the more noble side of human nature, and again, by example. 
He always encourages us to think a little harder, think a 
little more deeply, think about something that is off the 
beaten path, and listen a little more carefully. He is always 
stressing honor and always stressing civility.
    He elevates our debates in many ways, with his sharp 
intellect, and certainly with his very, very deep, broad grasp 
of public policy, often bringing up historical references that 
help clarify matters a little, put things in perspective, focus 
our minds a bit more.
    Every once in a while, I try to match him, and I try to 
impress him coming up with an historical reference of my own. I 
must say that each time he corrects me.
    I will never forget the moment I told him that it was that 
great statesman, Disraeli, who said that, ``In politics a week 
is a long time.''
    Right away he corrected me and said, ``No. I think that was 
Baldwin.''
    And he was right.
    A few months ago, though, we passed a law naming Foley 
Square Courthouse in New York after Senator Moynihan. I worked 
very hard on this speech. I wanted to use the occasion to 
describe Senator Moynihan's extraordinary contribution to our 
Nation's public architecture. It is well known, both in the 
District of Columbia and New York. I closed by quoting the 
inscription in St. Paul's Cathedral memorializing Sir 
Christopher Wren. The quote is, ``If you would see his 
memorial, look around.''
    Well, I said the same could be said about Pat Moynihan. 
That is, if you look down Pennsylvania Avenue or up to the new 
courthouse you could see his memorial by just looking around.
    Well, the Senator seemed pretty pleased with my remarks and 
he thanked me profusely. He also corrected me in his ever-so-
courteous, gentlemanly, civil way. He said, ``Max, I must note 
that your translation was correct. But the inscription is 
actually in Italian.''
    I was crestfallen. I had tried to come up with something 
that was accurate that would just be the perfect statement that 
would capsulize the Senator. Well, I must say I have done a 
little further research. It is true the inscription marks Sir 
Christopher Wren's resting place. It is also true it is under 
the east end of the church. But my very, very good friend, it 
is hard for me to say this, was slightly off. It is not in 
Italian, but it is in Latin, ``Lector, situation monumentum 
requiris, circumspice.''
    Senator Moynihan. Well, I got that right.
    Senator Baucus. You always have the last word, and always 
accurately and always teaching. I will say no more, except that 
he is one of the most wonderful human beings that I have had 
the pleasure to know and certainly one of the best Senators 
that we have all had the pleasure to work with. Again, just a 
wonderful, wonderful person.
    Senator Moynihan. I am deeply honored, my dear friend.
    Senator Smith. Thank you, Senator Baucus.
    Let me welcome everyone to the hearing this morning on the 
use of comparative risk assessment in setting our environmental 
priorities. We will hear testimony on the Science Advisory 
Board report on EPA's case study analysis of residual risk.
    I think the materials that we received today for the 
hearing show that there is a real interest in using the 
comparative risk assessment to prioritize our resources.
    I am particularly pleased that Ms. Kate Hartnett, the 
executive director of the New Hampshire Comparative Risk 
Project is here today to talk about New Hampshire's experience 
with comparative risk. Her testimony demonstrates the continued 
passion and the innovative spirit that the States and the local 
governments are bringing to environmental protection that 
sometimes we forget.
    This is the third in a series of general oversight hearing 
conducted by the full committee. Our first hearing looked at 
the EPA's proposed budget for fiscal 2001. Our second focused 
on State successes and the need for a new partnership between 
the States and the Federal Government.
    Today's hearing takes us to the next level, beginning the 
process of identifying the tools that we will improve our 
environmental programs with. A comparative risk assessment is 
one of those tools. We all recognize that there are not enough 
resources available to address every environmental threat. I 
think that is the problem, that we forget sometimes that there 
are not enough resources to address every single environmental 
threat that we have. So, we have to prioritize.
    The Federal Government, States, local communities, private 
sector and even the environmental organizations all have to 
target limited resources on the environmental problems that 
present the greatest threat to human health and the 
environment.
    Our focus therefore is and should be on getting the most 
out of our dollars. Comparative risk is the tool that enables 
us to prioritize the risks to human health and the environment 
and target those limited resources on the greatest risk.
    It provides the structure for decisionmakers to do three 
things. No. 1, identify the environmental hazards. No. 2, 
determine whether there are risks posed to human beings or the 
environment. No. 3, characterize and right those risks. Risk 
managers can then use that analysis to achieve greater 
benefits.
    Finally, we will hear how EPA is using comparative risks to 
focus on the right problems and strategies and to what extent 
this approach has led to the development of a results-oriented 
strategic plan, an overview.
    We will hear how many States and local governments are 
already using comparative risk assessment, a public and open 
process that allows cooperation instead of confrontation, 
encourages dialog instead of mandates, and States are setting 
priorities. They are developing partnerships. They are 
achieving real results by using this comparative risk as a 
management tool.
    They are using good science to maximize environmental 
benefits with limited resources. I believe we should encourage 
and promote that. Hopefully, we will hear that this morning 
from the witnesses.
    Let me welcome this morning Mr. Al McGartland, Director of 
the National Center for Environmental Economics, Office of 
Policy, Economics, and Innovations of the Environmental 
Protection Agency. Welcome.
    I would also like to welcome Mr. Peter Guerrero, Director 
of the Environmental Protective Services at GAO. We are glad to 
have you here.
    Senator Baucus, did you have an opening comment?

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

    Senator Baucus. Mr. Chairman, first of all, I really 
appreciate your holding this hearing. It is a very important 
subject that we are going to have to delve into more deeply as 
time proceeds.
    The second, longer statement I would like to include in the 
record.
    I would like to begin that it is always important for this 
committee to look at new tools for improving the way we protect 
public health and the environment. I believe that is a given.
    I believe that risk-based tools such as comparative risk 
assessment can help us. There is not much doubt about that. But 
when we proceed thoughtfully examining comparative risk and 
residual risk, I think we should also clearly understand that 
these are tools, I mean these are mechanisms. They are ways to 
help us achieve our goals.
    It is important for us to realize what these tools can do, 
but also what they cannot do. As with any tool, any mechanism, 
there is always a limitation. In the case of risk assessment, 
one inherent limit is that the science on which it is based 
isn't, and it really never can be complete. That is simply the 
nature of science. Science is an analytic logical pursuit which 
is just that.
    We also have to factor uncertainty into our decisions. We 
also must recognize in addition to science there are other very 
important values, values such as fairness, values such as 
equity which are essential components of any environmental 
decision.
    The bottom line is that tools such as risk assessment can 
certainly help us form our decisions, but they can't by 
themselves tell us what that decision is and what decision to 
make.
    Also, Mr. Chairman, I would like to briefly comment on the 
subject addressed by our last panel this morning, namely the 
status of the residual risk program. I know that some have 
questioned has the ability or the resources to remove residual 
risk from the environment, suggesting that EPA doesn't have 
enough data or does not have the right data or the right 
models.
    I must say, some of those criticisms are frankly correct 
only in part, but those feelings may have more to do with 
inadequate funding and organization than they do with the lack 
of good science. The 1990 amendments to the Clean Air Act, in 
those amendments, the conferees carefully considered the issue 
of residual risk. It was not just thrown in at the last minute.
    We also knew there would be uncertainties associated with 
estimating the risk. That is why we required a report to 
Congress first with any necessary regulation to follow. It is 
also why EPA must consider many factors including costs, energy 
and safety before deciding to issue new regulations.
    So, in conclusion, I want to thank our chairman for holding 
this hearing. It is an extremely important subject. I look 
forward to the testimony.
    Senator Moynihan. Mr. Chairman, may I make a very brief 
remark to continue on what Senator Baucus has said?
    Senator Smith. Surely.

      OPENING STATEMENT OF HON. DANIEL PATRICK MOYNIHAN, 
            U.S. SENATOR FROM THE STATE OF NEW YORK

    Senator Moynihan. We are beginning to see the maturing of 
the whole subject of environmentalism. When I first came on 
this committee nearly a quarter of century ago, with great 
respect, our hearings consisted of earnest young people telling 
us the sky was falling. Well, how did they know? Well, 
everybody knew. Well, everybody didn't know.
    We have almost a quarter of century of gradually building 
into our legislation, as Senator Baucus has said, some 
specifications about learning to measure. Never do anything 
serious about a subject until you learn to measure it. We are 
now doing it. This is advanced mathematics in many cases, but 
it is a mathematics we know. Linking the mathematics with 
actual data is the work we are involved with. I think it is a 
very cheering note with which to take leave of you all.
    Senator Smith. Let me just say to the witnesses, your 
complete statements will be made part of the record. Please try 
to summarize them in 5 minutes.
    We are going to be interrupted around 10 o'clock by a vote. 
So, hopefully, we can get through your statements and perhaps a 
question or two before we get to that point. We will probably 
have to recess for a few minutes during that vote.
    Mr. McGartland.

   STATEMENT OF AL McGARTLAND, DIRECTOR, NATIONAL CENTER FOR 
   ENVIRONMENTAL ECONOMICS, OFFICE OF POLICY, ECONOMICS, AND 
          INNOVATIONS, ENVIRONMENTAL PROTECTION AGENCY

    Mr. McGartland. Mr. Chairman and members of the committee, 
thank you for inviting EPA to provide our views on the use of 
comparative risk assessment. I am honored to be here today.
    In my role as the Director of the National Center for 
Environmental Economics, I provide technical expertise and core 
research to users of comparative risk analysis. As its name 
implies, comparative risk analysis involves the simultaneous 
consideration of a wide range of environmental risks so that 
the seriousness of risk can be characterized relative to one 
another.
    EPA has invested in the development of comparative risk. 
Our bottom line is that comparative risk assessment is an 
important tool to help inform our budget and priority setting 
processes. While it will continue to improve, there are 
difficulties and limitations that must be well understood. It 
is not a white line or a mechanistic solution to our difficult 
priority decisions.
    EPA generally applies comparative risk at the national 
level. State and local governments undertake these studies at a 
smaller geographic scale and we are pleased to see that 
representatives from cities and States have been invited to 
present their perspectives to this committee.
    Recently, private companies and industrial sectors are 
using comparative risk assessment as they incorporate 
environmental management systems into normal operating 
procedures. By ranking the environmental problems associated 
with their operations, businesses can target their protective 
efforts to the worst risk to workers and surrounding 
communities and they can achieve the best results at least 
costs.
    EPA has a growing investment in these studies. Our first 
comparative risk analysis released in 1987 ranked 31 different 
environmental problems in four different classes: cancer risk, 
non-cancer human health risks, ecological risks, and welfare 
effects.
    Later, we asked our Science Advisory Board to review these 
findings and recommend improved methods for assessing and 
comparing these risks. Even more recently, EPA has published a 
detailed national study of the benefits and costs of air 
pollution. The study broke new ground by making extensive use 
of original exposure modeling and risk assessment.
    Finally, our Science Advisory Board recently finished a 
report on integrated decisionmaking incorporating comparative 
risk assessments. We continue to work on additional studies to 
help us in our priority setting and decisionmaking process. In 
fact, EPA now routinely incorporates comparative risk 
assessments in our internal decisions and in our partnerships 
with State, local and tribal governments.
    For example, the performance targets identified in EPA's 
strategic plan reflect the relative priority the Agency will 
place on different environmental problems and programs. 
Comparative risk considerations have been explicitly factored 
into various internal agency-wide budget exercises.
    Furthermore, risk information, when available and relevant, 
is implicitly included in most discretionary decisions made by 
agency program managers, both in setting priorities within 
major programs and allocating resources across programs.
    For example, we are using comparative risk assessments to 
help develop our schedule for controlling source categories of 
toxic air pollutants under Section 112(e) of the Clean Air Act.
    Our EPA State-tribal partnership activities also use 
comparative risk analysis. Between 1990 and 1999 EPA provided 
financial aid, about $1 million per year, to States, 
localities, tribes and watershed organizations to support 
comparative risk projects of their choosing.
    In most cases these projects resulted in a much clearer 
understanding of local environmental challenges and sometimes 
they inspired new environmental initiatives.
    In 1995, EPA and the States jointly entered into the new 
National Environmental Performance Partnership System, or 
NEPPS. Under NEPPS, EPA and the States jointly set priorities 
for actions and comparative risk assessment is one of the 
management tools used by States to determine which programs 
they want to target for improvement.
    NEPPS also gives the States more flexibility in 
administering EPA grant funds. States can now consolidate a 
variety of individual grants into one. In short, greater 
flexibility and comparative risk have come together to 
strengthen traditional partnerships.
    Despite the data and methodological improvements that have 
been made over the last decade, comparative risk assessment 
remains an imperfect tool. EPA does not view comparative risk 
assessment as a white line or a mechanistic way of ordering the 
Agency's priorities for strategy, budgets or actions.
    A number of other factors also have to be considered. For 
example, many Federal laws set timetables and deadlines for EPA 
to take specified actions or accomplish specified goals. EPA 
has an obligation to comply with those legal requirements 
regardless of the extent to which they reduce risk relative to 
other actions we might take.
    Another difficult problem arises in an attempt to include 
human health and ecosystem risks in the same ranking. How do 
you prioritize risks associated with pollutant exposures that 
may cause cancer in humans as compared to degraded water 
quality, say, in the Chesapeake Bay that may deplete oyster 
beds?
    The Science Advisory Board recognized this problem when 
they completed their reducing risk report and they did not 
attempt to include human health and ecological risk in the same 
ranking.
    This is not a complete list of all the factors that enter 
into EPA's priority setting process. Other hard-to-quantify 
considerations like inter-generational equity and environmental 
justice also have to be weighed.
    For our purposes here today, I simply want to emphasize the 
comparative risk assessments for providing EPA with a useful 
mechanism for helping us think about environmental priorities, 
but by themselves, they cannot provide complete answers.
    Thank you very much.
    Senator Smith. Thank you, Mr. McGartland.
    Mr. Guerrero.

STATEMENT OF PETER GUERRERO, DIRECTOR, ENVIRONMENTAL PROTECTION 
               ISSUES, GENERAL ACCOUNTING OFFICE

    Mr. Guerrero. Mr. Chairman, we appreciate the opportunity 
to testify on the challenges that EPA faces in using 
comparative risk assessment to set priorities. My remarks are 
based on GAO's long-standing work in this area from our 1988 
Comprehensive General Management Review of the Agency to our 
more recent efforts by EPA to develop the outcome-oriented 
measures under GPRA.
    In summary, I would like to make two points. First, while 
EPA's priorities should reflect an understanding of the 
relative risks of environmental and public health concerns, 
good data often do not exist to fully characterize these risks.
    In the absence of reliable data, public perceptions of risk 
can influence how EPA determines its priorities and allocates 
resources. EPA's ability to assess risks and establish risk-
based priorities has been hampered by data quality problems, 
including critical data gaps, data bases that are not 
compatible with one another and persistent concerns about the 
accuracy of the Agency's data.
    EPA has taken major steps during the past few years to 
improve its data and to better inform the scientific community 
and public of environmental public health risks, but more needs 
to be done.
    Second, measuring program results or outcomes is critical 
to determine EPA's effectiveness and the extent to which it is 
successfully addressing the most serious environmental 
problems.
    Nevertheless, the Agency has historically relied on 
activity-based output measures, such as the number of 
inspections performed, because of the inherent difficulties in 
establishing sound linkages among program activities and 
environmental improvements in public health.
    Spurred by the requirements of the Results Act, EPA has 
made progress in recent years in measuring the outcomes of its 
efforts, but more progress is needed here as well.
    A short history is helpful for understanding the challenges 
that EPA faces in setting risk-based priorities and measuring 
performance. Since EPA's establishment in 1970, the Federal 
Government has developed a complex system of laws and 
regulations to address environmental problems.
    Over the years as environmental threats were identified, 
the Congress responded by enacting new laws to address each new 
problem. However, these laws were not integrated to provide EPA 
with an overall system for setting priorities to ensure that 
the most important problems were addressed first.
    Compelled by budgetary constraints and a growing list of 
problems, EPA began in the late 1980's to consider whether its 
resources were being spent on the problems that posed the 
greatest risk. The Agency concluded the Nation was devoting 
more resources to the problems that had captured public 
attention than to problems that were lesser known, but 
potentially more serious.
    Subsequently, EPA began incorporating the concept of 
relative risk and environmental risk in its decisionmaking. 
However, establishing risk-based priorities, as I mentioned, 
requires good data and EPA's ability to make these assessments 
is limited by three factors.
    The first factor is the extensive gaps exist in EPA's 
knowledge about environmental and health risks. Let me give 
three examples. EPA's integrated risk information system, which 
is a data base of potential health effects from chronic 
exposure to various substances, lacks basic toxicity data for 
about two-thirds of the known hazardous air pollutants.
    The second example: EPA's national water quality inventory 
does not accurately describe water quality conditions 
nationwide. Only 19 percent of the Nation's rivers and streams 
are assessed for the 1996 inventory, the latest available at 
the time of our review, as were only 6 percent of ocean and 
shoreline waters.
    A third example: Of some 1456 toxic chemicals we recently 
reviewed, actually human exposure data were being collected for 
only 6 percent. For example, of the 475 chemicals that EPA 
identified as in need of testing under TSCA, only 2 percent 
were being measured for human exposure.
    EPA has recognized that it has numerous and significant 
gaps in its data and has initiated several efforts to fill 
these gaps.
    A second challenge facing EPA is incompatible data systems, 
which makes it difficult for EPA to effectively use information 
that it does have to manage risks and set priorities.
    Over the years, EPA has developed and maintained stovepipe 
data systems that make the sharing and integration of data 
difficult. EPA now recognizes that common data definitions and 
formats, known as data standards, are essential to its efforts 
to integrate data from various data bases, including those of 
its State partners.
    In recent years, EPA has undertaken several efforts to 
develop standards for some of the data items in its information 
systems. According to EPA's Reinventing Environmental 
Information Action Plan, six standards will be developed, 
approved by EPA in partnership with the States and in use in 13 
data bases by the end of fiscal year 2003.
    However, EPA recognizes that current data improvement 
efforts are only the first step toward its goal of full data 
integration.
    The third challenge confronting EPA is the data that it 
does have is often not accurate. In various reviews, we and 
others have shown that persistent concerns exist about the 
accuracy of data in many of EPA's information systems.
    While EPA acknowledges that data errors exist, the Agency 
believes that in the aggregate its data are of sufficient 
quality to support its programmatic and regulatory activities. 
However, EPA has not conducted an agency-wide assessment of the 
accuracy of its information systems.
    To address such problems, EPA revised its agency-wide 
quality system in 1998 to expand and clarify requirements for 
how environmental data are to be collected and managed. 
Although the Science Advisory Board recently commended the 
Agency for its development of the system, the Board also found 
the implementation has been uneven.
    Moreover, the Board reported that 75 percent of the States 
authorized to implement EPA environmental programs lacked 
approved quality management plans.
    Finally, Mr. Chairman, I would like to discuss EPA's 
efforts to develop performance-oriented measures. Closely 
linked to EPA's ability to manage risks and set priorities is 
its ability to measure whether what it does is in fact reducing 
environmental health threats.
    EPA has long been aware of the need for environmental 
measures; nevertheless the Agency has made little progress in 
developing measures until the results act mandated their use by 
requiring Federal agencies to report annually on their progress 
in meeting their performance goals.
    Still, of the 364 performance measures that EPA has 
developed, only 19 percent are outcome measures. The rest are 
activity measures such as the number of permits issued or 
inspections undertaken. Developing outcome focus measures will 
require better data, resources and strategies and, most 
importantly, sustained management commitment.
    In conclusion, GAO's work has identified numerous problems 
in the quality of EPA's data and the way the Agency manages it. 
These problems cut across programs and limit the Agency's 
ability to both assess and compare risks and to measure 
environmental results.
    To its credit, EPA has initiated actions to improvement 
information management activities, but while EPA has made 
progress, it does not yet have a long-term strategy to ensure 
the completeness, compatibility and accuracy of its data.
    That concludes my remarks. I would be happy to answer any 
questions you may have.
    Senator Smith. Thank you, Mr. Guerrero.
    I think we are going to have to make an administrative 
decision here to go vote. We are about halfway through the 
vote. So we are going to recess for about 10 minutes. We will 
get back as quickly as possible. We apologize for the 
inconvenience. Thank you.
    [Recess.]
    Senator Smith. The hearing will come back to order. I think 
the other Senators will be back shortly.
    Mr. McGartland, let me just ask you a couple of questions. 
In your opinion, is EPA trying to develop a roadmap for ranking 
these environmental problems as a function of risk?
    Mr. McGartland. The answer to that is yes, and let me 
explain. I mentioned in my remarks the 1987-released study. 
When that was done, that was the first of its kind, I think 
there were a lot of people in the Agency that really thought 
twice about whether this be done or could it be done, even.
    But, as any sort of phenomenon has sort of momentum behind 
it, it has become woven into the fabric of the Agency in many 
ways. So, I would be hard-pressed to find a program manager who 
didn't know the results of the Science Advisory Board studies 
or even the 1987 study and how they have evolved over time. So, 
I think it has become almost a backdrop to how we do business 
within the Agency in terms of thinking about what we should be 
doing next, et cetera.
    Then, I think that each program office is doing this, like 
the Air Office I mentioned earlier and the comprehensive 
benefit cost study that they did. I think they have even gone 
beyond looking at comparative risk, but thinking about the 
risks that are posed and the feasibility and costs associated 
with reducing those risks, you know, sort of looking backward 
and also looking prospectively in to the future.
    Senator Smith. When you look at the way the program offices 
are designed as well as the way the legislation, frankly, is 
designed, the stovepipe that Mr. Guerrero mentioned, it is 
really laid out to compete against the concept of comparative 
risk assessment, isn't it?
    Mr. McGartland. Well, I think comparative risk assessment 
is certainly easier to do with any given media like air or 
water, say, because your expertise and the models that one 
would deploy, the fate and transport models and the scientific 
models within a specific media share a lot of things in common, 
but are different across media.
    I am an analyst, and from an analyst's perspective I think 
you can say a lot more with more certainty about the cost and 
benefits within a specific media rather than making those leaps 
across media.
    I think the other thing that stopped the Agency from just 
thinking about comparative risk is the other attributes of 
risks, like is it an exposed subpopulation? It might be a very, 
very high risk, but the general population might be at low 
risk.
    How do you rank maximum risk compared to total risk or 
aggregate or average risk? How do you think about, as 
mentioned, ecological risk versus human health risks? All those 
issues, including feasibility, I think, curtail or limit the 
ability of the Agency to think of just comparative risk in 
terms of putting its steps forward.
    Senator Smith. Well, I think your critics would say that 
there is not enough of the interaction, that the stovepipe 
concept does in fact exist. You know, in the Clean Air Act, we 
do it here. That is the way the legislation is designed, as 
well.
    If you try to say that more focus should be put on one of 
the stovepipes over another, then you become anti whatever the 
one is you are criticizing rather than pro-comparative risk 
analysis. I mean, if you go to any community, pick any 
community in America and let's just say they have a Superfund 
problem, they have a Clean Air problem. Maybe they have a CSO 
problem, why can't they make the determination what is the most 
immediate threat to them, to their environment, to their health 
and safety?
    That is not happening; is it? I mean it can't be the way we 
have it now. There might be some risk assessment and 
prioritization done within the pipe, but not between the pipes.
    Mr. McGartland. I am not as familiar at the State level 
since mainly my expertise and analysis is generated more toward 
national studies. But I do think, both from an institutional 
point of view, but also from an analytic point of view, it is 
difficult.
    I don't know how to compare sort of Superfund risks to a 
given subpopulation compared to sort of particulate matter.
    Senator Smith. But I think that really is the issue. There 
is no Federal entity, at least that is what some of the 
witnesses have said in their written testimony that are going 
to follow you, or at least one witness said it anyway, there is 
no Federal entity that promotes and directly assists any State 
and local government with risk-based decisionmaking.
    I mean if it is a priority with you to use this comparative 
risk assessment, why not work with the States and local 
communities to do it? Is there any entity within your 
department to do that? There is none that I know of, but the 
question is why not?
    Mr. McGartland. Well, I think I would have to get back to 
that, Senator. My shop is sort of supporting the program 
offices. I would certainly welcome the chance to get back to 
you and the committee on an explanation for that.
    Senator Smith. Yes, I think it would be good to provide at 
least your view on it for the record as to how we might go 
about assisting. I might ask some of the other witnesses what 
their thoughts are on it as well.
    Mr. McGartland. We did, as I mentioned in my remarks--in 
the 1990's we had a program that worked with State and local 
governments to think about comparative risks and to actually 
take them on.
    Senator Smith. Let me ask you, Mr. Guerrero, do you have 
any specific recommendations that you would like to make to 
either of us in the Congress or to the Agency in this regard in 
terms of how we might do better at comparative risk assessment?
    Mr. Guerrero. Mr. Chairman, I think the heart of the 
Agency's ability to do this type of risk comparison and risk 
management depends on the quality of the data. I would want to 
emphasize the key points that we have made that too often data 
are incomplete. When they are available, the accuracy of the 
data is sometimes suspect.
    The systems that EPA has to manage with are incompatible 
with one another. So, there is need for data standardization to 
allow for the integration of information to allow for this type 
of risk management to occur.
    We have made specific recommendations to the Agency to 
correct these three problems. Fundamentally, we feel the Agency 
needs a strategic plan that will set forth a clear 
understanding of where those data gaps are, which ones need to 
be addressed first, that would establish clear milestones for 
taking steps to fill in the gaps and that would identify the 
resources that would be required to deal with that.
    I would say that it is in the resource area that the 
Congress can be of most assistance to the Agency. Data 
collection and data management have always, when push comes to 
shove, gotten the short end of things.
    It is so critical and so fundamental to the Agency's 
ability to set priorities and to manage risk that it is 
important that the Congress work very closely with the Agency 
in making sure it has the resources it needs to do that job.
    Senator Smith. What would you suggest that EPA do to 
develop additional result-oriented assessment?
    Mr. Guerrero. Again, I think the key there is data. This 
year, as we do every year, we looked at their compliance with 
the Results Act. We observed, and program managers told us, 
limited availability of data on environmental conditions and on 
the health effects of pollutants was a major challenge to 
developing outcome goals and measures.
    We also observed that a number of EPA offices were doing a 
better job than others in helping to develop these outcome 
measures and fill in those kinds of data gaps.
    The Office of Enforcement, for example, had done a fairly 
good job. But this was an area that required continued 
attention by the Agency. So, I would say that central to better 
performance management is again having the right data to assess 
conditions and to assess results and make corrections in 
programs to ensure that they achieve their results.
    Senator Smith. Just a final question for you, Mr. 
McGartland. Under Executive Order 12866, EPA prepared detailed 
cost-benefit analysis for all economically significant 
regulations. Under that order EPA was supposed to review 
periodically existing regs that are economically significant to 
determine if they can be made more effective or less 
burdensome.
    How effective has EPA been in carrying out those 
responsibilities?
    Mr. McGartland. I am familiar with only some of those 
efforts, not every one, since I am in the policy office and not 
in individual programs. But I know from the standpoint of the 
Air program, we did a benefit and cost study of the Clean Air 
Act. We did both a retrospective look from 1970 to 1990, and a 
prospective look from 1990 into the 2010 timeframe.
    In the process of carrying out those studies, we looked at 
individual provisions of the laws. In that report we highlight 
where the regulations are that are the biggest net benefit-
producing regs and areas of regulatory programs and which are 
not.
    So, in that sense I think we can take away a pretty 
complete picture in the air quality arena. We are right now 
working with the Water Office on a similar study, which should 
highlight programmatic areas with benefits-cost estimates with 
them.
    Senator Smith. Well, what kind of followup are you doing on 
what you find?
    Mr. McGartland. Well, two things. One is that we are taking 
some of the results from the Clean Air Act study, for example, 
and we are incorporating that in our programmatic priorities. 
For example, in the air toxic side, EPA proposed a budget shift 
to move further away from technology-based standards to more 
risk-based multimedia standards on hazardous pollutants.
    So, I think the study is fairly new and the followup is yet 
to come. The news on the air side was, in general, the net 
benefits were quite large.
    Senator Smith. I have been on this community for 10 years 
and I have seen some movement in the right direction in risk 
assessment. But I will tell you the way I view it and if either 
of you disagree, then defend yourselves.
    In my view, I think the majority of any risk assessment is 
done within each of these stovepipes. I don't see a lot of risk 
assessment being conducted between the pipes. That, I think, is 
the root cause of the problem as far as local communities are 
concerned.
    You are asking local communities to defend themselves 
against EPA perhaps on a Superfund site that, yes, it looks 
ugly, yes we would like to clean it up, but no, it is not 
causing anybody any health problems, it is really not causing 
any significant environmental problems immediately to the 
community or members of the community.
    But, you know, we have other problems. We are not in 
attainment with our clean air or perhaps we have a river that 
is being polluted or whatever and we can't get the resources 
that we need focused on that because we have to worry about a 
Superfund site that we probably don't have the technology to 
clean up and you are telling us we are in non-compliance.
    Unless you are willing at the Federal level to begin to 
look at this and work with the States to move away from this 
stovepipe, we are never going to get there. I think we have to 
get out of the box.
    That is my view. I think there are some within the Agency 
who are talking that way, but I think when you look at the way 
the programs are structured within the EPA, we are not going 
there. Now, maybe in concept we are in our minds, but we are 
not doing it with the way the programs are structured.
    You just basically admitted yourself, you said, ``Well, I 
am more involved with the Federal end.'' Well, we need people 
at the Federal end involved with the State and local end and 
vice-versa or we are never going to understand these things and 
we are never going to get there.
    I think we have to get out of the box and start getting 
into the 21st century here. When we started, and Senator 
Moynihan referred to it, I believe, in his comments, you know, 
in the 1960's and 1970's environmental regulations were out of 
desperation. We needed it. We were polluting the air, the land, 
and the water.
    Now, though, we have made significant progress in that 
regard. I think it behooves us now to take these resources and 
focus them on the most immediate list and work down the list 
and prioritize them the same as you do your household budget. 
You might be planning a vacation, but if your car breaks down, 
then there goes the vacation money. You have to fix the car. We 
make priorities. We make decisions. We are not doing that now.
    We are out there throwing what we think is our unlimited 
dollars at these various problems and seldom prioritizing in a 
way that we could get some of the most immediate health threats 
and environmental problems out of the way.
    I don't think we are ever going to get there if we don't do 
that. We are assuming that we have so many resources that we 
could just do it all. That would be nice. Maybe we will get it 
all at some point. I think before that we need to get to the 
point where we can start the prioritization process and cleanup 
the most serious problems first.
    As I say, in all due respect, I don't think that is 
happening really in terms of the way the programs are 
structured in the EPA.
    Senator Baucus, I was just about to leave this panel, but 
if you have questions, go right ahead.
    Senator Baucus. Well, I would like to followup on the 
resource question. What do we need to do an adequate job? To me 
risk assessment and the threat of risk assessment is a good 
tool. As I mentioned, it makes sense. I am informed and 
certainly GAO has concluded that perhaps we could use more 
resources. But that sort of begs the question in my mind of how 
much is enough.
    Mr. Guerrero. I think the resources have to follow a 
coherent strategy and justification for why those resources are 
needed. The Agency needs to have a strategy that says, these 
are the key areas of data that we need to have to be able to 
set risks and to be able to compare risks and make better 
informed decisions and here is the schedule on which we need to 
develop that to support this type of decisionmaking and here 
are the resources that will be required to fill in those gaps 
and to make our systems more compatible with one another and to 
allow us to answer these kinds of questions.
    So, when we observed there were these barriers standing in 
the way of the Agency using risk management to help set 
priorities, we don't necessarily say, ``Well, it is going to 
take X or Y dollars to do that.'' I think what is key in here 
is the Agency having a good, well-founded plan and strategy for 
what it needs to do to move this process along. That is what is 
missing.
    Senator Baucus. Mr. McGartland, do you agree?
    Mr. McGartland. I think we do need more data clearly. Data 
is very expensive to obtain. I think I mentioned the 
toxicological data we need from animal studies. The majority of 
the chemicals are not yet complete in their risk assessments.
    Without completion of those things, it is hard to do risk 
assessment if we don't have the underlying data base to support 
the toxicology and the epidemiology.
    The Agency recently created Office of Environmental 
Information. It is the first time in the Agency's history we 
have had a centralized environmental information office. I know 
that they have taken on a number of interesting, innovative 
steps, in addition to having a unique facility identifier for 
every facility in the country so that we can link cross-media 
data bases, et cetera.
    Senator Baucus. Having heard Mr. Guerrero suggest we need a 
schedule, do you agree with that?
    Mr. McGartland. I think a schedule would help. I think if 
we have clear needs that have been outlined and conversations 
with GAO and others. We could identify the low-hanging fruit in 
areas where we can't do our business currently.
    Senator Baucus. What would some of those areas be?
    Mr. McGartland. The underlying toxicological data to 
support the risk assessments of the Agency. I think there is 
monitoring data for painting a picture of the current baseline 
of the environment both in the water area and the air area and 
the other media. I think I would probably start with that. As 
an analyst, that is the kind of value that you need to think 
about, benefits and costs and what we are going to buy for 
future regulations.
    Senator Baucus. Mr. Guerrero, could you suggest some 
elements of a schedule or what areas? Can we break this down a 
bit?
    Mr. Gurrero. We didn't make very specific recommendations 
as to specifically which areas. We did observe that there are a 
number of gaps. The EPA's integrated risk information system 
lacks basic toxicity data for two-thirds of the known hazardous 
air pollutants. So this is a key area.
    The limited monitoring of the Nation's waterways to assess 
the quality of lakes, rivers, streams and shorelines is another 
area. We recently issued a report where we observed that for 
some 1450-odd toxic chemicals we reviewed, actual human 
exposure data were being collected for only about 6 percent of 
those.
    So, there certainly is enough information out there from 
the work we have done and from the work the SAB has done to 
help the Agency and guide it in terms of setting these kinds of 
priorities.
    Senator Baucus. Do States collect much data that is 
helpful?
    Mr. Guerrero. Yes, they do. In fact, not only do the States 
collect information but also sometimes information that might 
be valuable could be collected at the local level from public 
health agencies and sometimes it can be collected from other 
Federal agencies.
    Senator Baucus. How reliable is it?
    Mr. Guerrero. Well, that is the key. What is needed here, 
as EPA develops this strategy for producing a more complete 
understanding of environmental conditions and risks, is a 
strategy to identify how it will bring in these other sources 
of information and how we will ensure the reliability of that 
data.
    We do know from the work that we have done that there are 
concerns that some of the State-developed information is not 
that reliable and needs to be improved. The Agency needs to 
work with the States in that regard.
    Senator Baucus. Is there any protocol problem here? You 
know, one State might collect data a certain way----
    Mr. Guerrero. Yes, and the Agency recognizing that, is 
developing data quality standards and will be working with the 
States.
    Senator Baucus. How much variation is there today?
    Mr. Guerrero. There is some variation. The variation 
depends on the results of different frequencies in which 
different States may sample for different water quality 
standards. They may be sampling using different protocols. All 
of these issues need to be addressed in terms of improving data 
quality.
    Senator Baucus. To me it seems like a gargantuan task. For 
example, let us take a very parochial example in my State of 
Montana. I assume the health agencies obtain data with respect 
to infectious diseases. It turns out that is not the problem 
for this one community living in Montana, rather it is 
contamination from an asbestos mine. It is just not an 
infectious disease.
    How do you know what to look for? It is everything. I mean, 
you need a super, super, super computer, it seems to me, of 
some kind. I guess I don't know this very well and I am showing 
my ignorance. But, in theory it is great. I guess as I was 
saying earlier, you just have to know its limitations.
    Mr. Guerrero. Well, we certainly wouldn't recommend that 
the Agency kind of throw a blanket over this issue and try to 
collect everything you could possibly collect. This has to be a 
targeted, focused effort. That is why, again, I come back again 
to what we recommended to the Agency. Who is coming up with a 
strategy? Because it does need to set priorities. It needs to 
identify key areas where information is critical for making the 
major decisions it will have to make over the next few years.
    Senator Baucus. Is anybody working on setting up the 
strategy?
    Mr. Guerrero. Yes. Unfortunately, it is going much slower 
than we would like to see. The Agency tells us now it will be a 
three-phase effort and the first phase will be completed at the 
end of this year.
    So, the good news is yes, the Agency is working on 
developing this kind of strategy which, in our opinion, it 
desperately needs. The bad news is it seems like it is going to 
take a long while to get there.
    Senator Baucus. So, we don't know what the strategy is?
    Mr. Guerrero. We haven't seen it. We don't know it.
    Senator Baucus. So, we have to be as careful as we can to 
comment whether it makes sense or doesn't make sense because 
there isn't one.
    Mr. Guerrero. That is right. What I would urge the Congress 
to do is to continue to oversee the Agency's efforts in this 
area.
    Senator Baucus. Absolutely. Thank you.
    Thank you, Mr. Chairman.
    Senator Smith. I would just say as a final point, does the 
EPA make decisions with data or without data? I mean, that is 
the issue, isn't it? Are you using the data to make your 
decisions or are you not using the data and making decisions 
anyway?
    Mr. McGartland. Well, it is a continuum, of course. There 
is always something in the limit or in the most simplistic 
cases where we lack the capability to estimate benefits or 
risks.
    We can usually get a very good handle or a reasonable 
handle on costs and exposure in some sense from experts and 
what literature exists on the chemical, about the reasonable 
toxicity, relative toxicity of that chemical vis-a-vis other 
chemicals. That would be the limited case in terms of a 
regulatory proposal.
    When we had the benefit of a rich epidemiological database 
or if we actually have human data, et cetera, we are obviously 
on much surer footing when we move forward in quantifying our 
benefits. Probably even on the cost side a dearth of data 
exists.
    The Census Bureau used to do a survey called the Pollution 
Abatement, Control and Expenditure Survey every year, which 
gave it a handle on how much industry was spending on pollution 
abatement. They canceled that survey due to budget cuts or re-
priorities.
    So, we are equally challenged on the cost side and are 
taking steps, I think, to get a handle on that as well.
    Senator Baucus. This, to me, is just so important, the 
resources for the data. My State of Montana, 20 years ago, we 
got a multi-year baseline data EPA appropriation. It is the 
best thing we ever did because we are then in a position to 
know what different actions would have on, say, Flathead Lake, 
MT, in that area, whether it was Forest Service actions or 
Glacier park nearby or Canada with the potential coal power 
plants or coal mines.
    We had the baseline data, so we could measure what the 
effects of some actions on the rivers and lakes would be. I 
just believe firmly, Mr. Chairman, it is foolhardy when this 
Congress prevents agencies from having the funds and the 
resources they need to get this data.
    Some of it is priorities of the Agency, but I must say I 
think some of it is kind of Luddite-like of the way that 
Congress just doesn't want to know. One way you don't want to 
know is just don't give money to let them find out. I strongly 
urge all of us together to help in that regard.
    Senator Smith. Well, we thank the panel. There could be 
questions submitted to you by other members. We will be keeping 
the record open until the close of business Friday for that.
    Thank you, Mr. McGartland and Mr. Guerrero.
    We will call up the next panel please.
    Senator Baucus. Mr. Chairman, I ask consent to have Senator 
Moynihan's full statement included in the record.
    Senator Smith. Without objection.
    Senator Smith. Panel II consists of Ms. Katherine Hartnett, 
executive director of the New Hampshire Comparative Risk 
Project; Mr. Michael J. Pompili, assistant health commissioner, 
Columbus Health Department; J. Clarence Davies, Ph.D., senior 
fellow, Center for Risk Management, Resources for the Future, 
Dr. Elizabeth L. Anderson, president and CEO of Sciences 
International, Inc.; and Dr. Morton Lippman, professor, New 
York University, chair of the Science Advisory Board.
    Welcome to all of you. Your statements will be made part of 
the record and I will just go down the table from left to 
right. We will start with Ms. Hartnett. Since your statements 
will be part of the record, please try to summarize in 4 or 5 
minutes, if you can, please.

   STATEMENT OF KATHERINE HARTNETT, EXECUTIVE DIRECTOR, NEW 
               HAMPSHIRE COMPARATIVE RISK PROJECT

    Ms. Hartnett. Good morning. Thank you very much. I 
apologize for my voice. I think it will last 5 minutes.
    Senator Smith. Excuse me for interrupting you, Ms. 
Hartnett. But we are going to have to slightly modify our usual 
process for hearings because the Minority has invoked what has 
been called the 2-hour rule. Senate Rule 26.5(a) prohibits a 
Senate committee from conducting business for more than 2 hours 
past the time that the Senate begins its daily session, which 
means we can only go until 11:30.
    But Senator Baucus and I have agreed that the rule doesn't 
prohibit the committee from conducting informational meetings 
so we will try to do what we can on the record until 11:30, but 
if the Minority does invoke the rule at 11:30, we will adjourn 
and reconvene briefly for an informational meeting rather than 
an official hearing.
    Should that happen, it would have no impact on the 
witnesses. They would still be allowed to present that 
testimony as well as any additional materials.
    At a later date when the committee is conducting business, 
we will see a unanimous consent order to take the transcript of 
that meeting and put it in as part of the official record.
    I am sorry, Ms. Hartnett, go ahead.
    Ms. Hartnett. Thank you very much. I apologize for my 
voice. I have been talking too much and on too many airplanes 
recently.
    My name is Katherine Hartnett. I am executive director of 
the New Hampshire Comparative Risk Project. It is a public-
private partnership in New Hampshire; very different than some 
of the models we have heard about.
    My job today is to condense 7 years worth of work into 5 
minutes. Fortunately, most is conveyed in this book, which I 
believe everybody has copies. The Comparative Risk Project in 
New Hampshire focused on environmental quality of life and 
hazards to that environmental quality of life as the focus of 
our comparative risk process.
    We identified ``environmental quality of life'' as an 
intersection of healthy people, healthy ecology, and healthy 
economy. After a year of talking about our results, we 
condensed the information down to 26 pages. So, most of the 
actual process that I am going to talk about is contained in 
this book called, ``For our Future: Our Guide to Caring for New 
Hampshire's Environment.''
    The other thing I will observe is that we couldn't agree 
more with Senator Moynihan. What really has happened is that 
there has been a maturing of the environmental movement. In 
fact in New Hampshire we are recognizing the economic root of 
most of the environmental issues that we face. In the next few 
minutes I will describe how we got there.
    We agreed at the beginning of the Comparative Risk Project 
our goal was to maximize environmental protection at minimal 
cost--this was back in 1993. We wanted to separate fear from 
hazard to try to more effectively prioritize actions.
    We looked for solutions that would benefit multiple 
problems. We wanted to design approaches that productively 
engage multiple constituencies and showed results. We recognize 
that everyone has a role in this process.
    The Comparative Risk Project worked. We identified 55 
stakeholders from businesses, environmental organizations, 
public health groups, citizen groups, political leaders, State 
and local government officials. We all gathered in a neutral, 
non-advocacy setting. We worked to identify, to study, and to 
rank identified risks to environmental quality of life.
    We had technical staff that summarized ecological, public 
health and economic information in a consistent format with 
consistent criteria. The group worked by consensus over 8 
daylong sessions. The work was important, so it took a while to 
do. We did rank into an integrated list 55 risks to New 
Hampshire's environmental quality of life as I defined, 
``Healthy people, healthy ecology and healthy economy.''
    We documented the influence of accessible science condensed 
in this Comparative Risk Project report along with explicit 
judgment and individual values in the ranking.
    We basically designed what has been recognized as quite a 
credible process. The diverse participants had three 
requirements: Leave preconceptions at the door, be able to 
listen to others and work collaboratively, and finally to bring 
a sense of humor to difficult discussions.
    It was important for people to set aside what they knew and 
listen to the information from a different perspective. By 
putting environmental quality of life at the center, it allowed 
us to focus on the intersection of having all three things 
together: healthy people, healthy ecology, and healthy economy.
    We have created a continuum of hazard from relatively 
higher to lower. The common vocabulary of the severity, the 
extent, the reversibility, and the uncertainty of individual 
risks helped this group of diverse people come to some 
consensus about how those risks were allocated along the 
continuum of hazard.
    We also recognized the long term, meaning 7- to 10-year 
nature, of the solutions we were talking about.
    Now, basically, what we did when we came up with the list 
of ranked risks, as we began to separate fear from hazard, was 
to recognize that while 4 of the top 10 risks in the integrated 
list were risks to public health, 4 of the top 5 were related 
to threats of air and water quality.
    We then traced those 55 risks back to 11 sources, things 
like energy use, land use, transportation, recreation, food and 
water.
    We identified four key actions to reduce hazard in New 
Hampshire. Those four were: (1) to continue work on improving 
public health in New Hampshire--we found that people were 
living longer healthier lives for a variety of reasons. (2) to 
continue to reduce releases of pollutants. That is thanks to 
everything from NEPA, the Clean Air Act, Clean Water Act, Safe 
Drinking Water Act, RCRA, CERCLA, and SARA. Between 1970 and 
1986, the range of Federal and the equivalent State regulations 
have been successful. After 30 years of regulation, the air, 
water and land are quite clean and the economy never stronger.
    So, in New Hampshire we are focusing now on something 
called ``Minimum Impact Development.'' We are looking at (3) 
how we use land; and (4) how we use energy materials and 
resources.
    In terms of comments to Congress based on our experience, 
we suggest that there may be an opportunity here for Congress 
to take credit for the work it has done to date, that the 
regulations that came during the first generation of 
environmentalists have been successful. Why not take the time 
to celebrate those successes, and to recognize also that the 
current set of environmental hazards we face will probably not 
be solved by any one regulation or group of regulations.
    The challenge today is more difficult. There are not clear 
villains or easy solutions. Everyone is involved, at work, at 
home, and how we recreate. Information and clear understandings 
are essential. Why not take the time to convene annual 
hearings? Ask for consistent information.
    We heard about the important role of data on regional and 
local conditions. Try to incentivize good data. Then work on 
developing an action plan to support the work of State and 
local communities, encouraging community-based solutions 
informed with accessible data and supported by sufficient 
funding.
    Certainly examples that EPA has been involved in a little 
bit out of the ``stovepipe'' or ``box'' might be things such as 
is currently funding my work under the Sustainable Development 
Challenge Grant, or the CARA legislation is another example 
that relates directly to our experience in New Hampshire.
    Also, I must mention the essential role of transportation 
and the question of how we maintain mobility as we grow to 
greater density in the State. It plays a key role in our 
economic activity, and can also then be traced back to a wide 
range of environmental hazards or environmental benefits, 
depending on how we answer those questions.
    So, in short, a key Federal environmental role can be to 
stimulate, requiring consistent regional and local information 
about environmental conditions and trends to assemble a 
national picture and then support a wide variety of actions 
based on those data.
    We would love to see annual deliberations that encourage 
results-oriented environmental quality, use environmental 
indicators as measures of progress, and link agency budgets to 
reducing environmental impacts.
    The key role of getting citizens involved, getting results 
and seeing the effects of Federal support on the ground would 
be a true legacy for the second generation of environmental 
management.
    Thank you.
    Senator Smith. Thank you, Ms. Hartnett.
    Mr. Michael J. Pompili.

STATEMENT OF MICHAEL J. POMPILI, ASSISTANT HEALTH COMMISSIONER, 
            COLUMBUS HEALTH DEPARTMENT, COLUMBUS, OH

    Mr. Pompili. Good morning, Chairman Smith and members of 
the committee. It is an honor to provide testimony to you this 
morning, particularly on a process which I strongly believe in 
and which has been central to several programs which have been 
developed for the Columbus community over the past 10 years.
    Your willingness to discuss the use of comparative risk 
assessment in setting community priorities demonstrates your 
understanding that there are no simple answers to solving 
environmental issues that the impact on our communities and 
that it is critical to involve the stakeholders in the process.
    During the next few minutes of testimony, it is my goal to 
share with you how we have successfully implemented several 
comparative risk processes in Columbus, to identify the central 
themes which have led to the success of these efforts and to 
make some recommendations.
    This all started with a Community Environmental Management 
Plan, which was established through the Columbus Health 
Department in 1992. It is made up of five components. The first 
component was actually based on the Science Advisory Board from 
U.S. EPA. We have established an Environmental Science Advisory 
Committee; we call it ESAC, which is a body of 18 environmental 
scientists, educators and other professionals that report back 
to us on scientific issues.
    The second component was Priorities 1995. It was our 
comparative risk project. It took over 2 years and it is a 
classic example of comparative risk assessment. For this we 
used over 250 community volunteers and they logged over 5,000 
hours to come up with a list of actually 192 recommendations 
for our community.
    They identified the city's most pressing environmental 
problems, analyzed and determined potential risks to citizens, 
ranked these problems in terms of severity and then developed 
potential solutions to these problems.
    The third component is called our Columbus Environmental 
Snapshot. They use key indicators to provide the public with 
status and trend information on the State of Columbus and 
Franklin County environmental issues.
    In creating the snapshot, the objective was to compile 
information already being collected by numerous governmental 
organizations into a single, easy-to-understand and user-
friendly document. The information contained in the snapshot 
represents both an educational resource and a means of gauging 
the success of past environmental efforts including status 
reports on Priorities 1995.
    The fourth component, which we started actually in February 
1998, was the Columbus Community Risk Panel. It is a 35-member 
community designed to help Greater Columbus residents make 
informed decisions about risk.
    The panel, through various initiatives, serves as an 
ongoing research to help develop a more informed citizenry and 
provide the community with accurate information on health and 
quality of life risks. Panel members again include public 
officials, community leaders from government, professional 
groups, public and private business, health care and 
educational organizations and the media.
    A key goal of the panel is to establish connections with 
citizens. This is accomplished through a variety of projects 
including establishment of community computer centers in 
African-American churches, the Neighbor-to-Neighbor Program, 
formation of Community Advisory Panels that bring industrial 
facilities and neighborhood groups together and establishing a 
Web site for risk information.
    The last component is called Project CLEAR, which is a new 
citizen-driven initiative based on the same principles as our 
Priorities 1995 Risk Project. It is designed to address Central 
Ohio's outdoor air quality, particularly issues related to 
ground-level ozone pollution.
    CLEAR's main objective is to involve citizens, businesses, 
local governments, and other organizations in evaluating and 
choosing strategies to improve overall air quality. What is 
particularly unique about Project CLEAR is that it moves beyond 
the public opinion forum into a more public deliberation 
process.
    Three basic principles underlie all the components of the 
Community Environmental Management Plan. First, promoting the 
use of science and scientific information wherever possible, 
second, developed a more informed citizenry on issues of 
community health, environment and quality of life, and finally, 
encouraging public participation in the decisionmaking process.
    These principles have not only led to the success of our 
efforts, but are appropriate at all levels of government, 
local, State and Federal.
    An excellent example of these principles operationalized at 
the State level was when Senator Voinovich, then Governor 
Voinovich, embarked on a comparative risk project for the State 
of Ohio. Similar efforts have been conducted by 25 of the 50 
States as well as at least 12 local communities.
    The process represents a new way of doing things most 
importantly involving the public in meaningful ways.
    So, the question remains, what role can the Federal 
Government play in this effort? The Federal Government's role 
is to establish national priorities. The use of a national 
comparative risk process could provide general direction in 
setting these national priorities, but it is important to 
understand the limitations of a Federal comparative risk 
project.
    A Federal comparative risk project is doomed to fail 
because risks encountered in Florida aren't compared to the 
risks found in Oregon. Instead, it would be most appropriate 
for the Federal Government to support these efforts on a State 
and local level and actively promote the principles of sound 
science and informed citizenry and public participation.
    Specifically, the Federal Government can serve as a 
technical assistance center, both generating data and 
fulfilling the role of information resource. State and local 
communities will vary widely in their ability to successfully 
implement a comparative risk project.
    Federal support and technical guidance may allow for at 
least some degree of consistency and utility of effort. Because 
community participation and buy-in are critical in these types 
of initiatives and central for any behavioral change to occur 
on the part of the individuals, Federal emphasis and support 
for community participation at the local level may also be 
appropriate.
    Shifting from categorical-thinking formulas to community-
thinking formulas will go a long way toward promoting 
involvement.
    Further, it would be helpful for States and local 
communities to look to the Federal Government for funding of 
comparative risk projects or at least linking to the available 
funding for such efforts.
    Some of what I have described is not necessarily a new 
role. At one time the Federal Government funded a U.S. EPA 
office to directly assist State and local folks interested in 
doing this type of work.
    The Regional Statistical Planning Branch of the Office of 
Policy Planning and Evaluation was extremely helpful to us in 
Columbus, providing a $50,000 grant for our project and direct 
technical assistance and project formation and implementation.
    I have heard many other local project directors share these 
sentiments. Unfortunately, the office was disbanded a year or 
so ago and the personnel were reassigned within the Agency. To 
my knowledge, there is no Federal entity that exists concerned 
with promoting and directly assisting State and local 
governments with projects dealing with risk-based 
decisionmaking.
    By recognizing the value of local communities in 
determining their priorities, a further role for the Federal 
Government is flexibility. While Federal standards and 
regulations are often warranted, it is important to allow for 
some tailoring of the effort according to local community's 
needs.
    U.S. EPA's Project XL is a perfect example of this type of 
philosophy. In its current form, however, Project XL is 
somewhat cumbersome and a challenge to negotiate. We are quite 
pleased to have just signed the final agreement for an XL 
Project in Columbus, actually a week ago today an effort which 
took over 3 years to finalize.
    In asking for flexibility, however, local communities need 
to hold themselves accountable and maintain, if not higher, 
standards that those set forth at the Federal level.
    If by your flexibility at the Federal level you are 
demonstrating your trust of the State and local government to 
make sound environmental decisions, we must safeguard this 
trust and work cooperatively with you toward common goals.
    Without a certain level of trust at all levels of 
government, even the most innovative programs are doomed to 
fail.
    In closing, let me once again reiterate the importance of 
public participation and connecting with our citizenry. More 
and more of our citizenry are expressing dissatisfaction or 
disinterest in civic responsibility.
    While they are disengaging from the political process, you 
must fight to have them actively involved in directing 
resources and actions that will impact their own neighborhood 
and their quality of life.
    We must demonstrate government's trust in the ability of 
the residents to make these programs work. I am a very strong 
believer that our citizenry will make the right decisions.
    If they are able to receive information in an 
understandable way, if they are presented with accurate 
portrayals of the existing tradeoffs regarding risks, and if 
the decisionmaking process reinforces the need to consider a 
whole range of options available.
    If these themes maybe woven through the Federal, State and 
local government we may yet see a public which still seeks out 
their civic roles.
    Thank you.
    Senator Smith. Thank you very much, Mr. Pompili.
    Dr. Davies, welcome.

STATEMENT OF J. CLARENCE DAVIES, SENIOR FELLOW, CENTER FOR RISK 
             MANAGEMENT, RESOURCES FOR THE FUTURE.

    Mr. Davies. Thank you, Mr. Chairman. I am pleased and 
honored to be able to share with the committee my views on the 
important subject of comparative risk assessment. My views are 
only my views and do not represent RF's views. Resources for 
the Future is a research institution that doesn't take 
positions on public policy issues.
    Comparative risk assessment is an important analytical tool 
that deserves the attention this committee is giving to it. The 
fundamental goal of most of our environmental programs is to 
reduce or prevent risk, thus identifying and comparing risks is 
a logical starting point for evaluating progress and 
identifying future directions and priorities.
    There are, however, important limitations inherent in the 
use of comparative risk assessment. Most importantly, we have 
no common metric to deal with the diverse kinds of risks that 
government addresses. When I was at EPA, we referred to this as 
the ``How many whales is your grandmother worth'' problem. The 
problem was how do you get some comparability among very 
diverse end points.
    I might say that just dividing health risks from ecological 
risks doesn't solve that problem. Different kinds of health 
risks, different kinds of ecological risks present the same 
problem of how do you get some kind of common measurement to 
compare these things.
    There are answers that can be given to these questions, but 
the answers are heavily dependent on values. Even if scientific 
understanding was perfect and data were complete and accurate, 
the value elements inherent in CRA would prevent comparative 
risk assessment from ever being a purely scientific 
undertaking.
    The science and the data in most cases are woefully 
incomplete. Other witnesses have commented on that. This adds 
further elements of uncertainty and value judgment to 
comparative risk.
    There are different kinds of comparative risk assessment 
and it is important to make some distinctions among them. In 
particular, there is a basic difference between comparing 
individual pollutants or activities and comparing programs.
    Comparing mercury to lead is very different from comparing 
air pollution to water pollution. You use different methods and 
different approaches to do those two different things. That 
doesn't make life any simpler, but it is true.
    This hearing is focused primarily on programmatic 
comparative risk assessment and it is important to keep that in 
mind.
    More generally, the type of comparative risk assessment 
undertaken and the process used to make the comparisons should 
depend on the purpose for which the comparative risk assessment 
is being done. Doing a comparative risk assessment to establish 
research priorities involves quite different considerations 
than doing one to establish enforcement priorities, for 
example. So, the kind of priorities that you are working with 
is a crucial factor.
    In my written statement I talk about various uses of 
comparative risk. I am going to skip over that, but there are a 
number of uses to which comparative risk assessment can be 
employed and they are important and it is an essential tool.
    I do want to talk a bit about the limitations of 
comparative risk assessment. As I noted, the assumptions and 
values that unavoidably enter into both risk assessment and 
comparative risk assessment are major considerations. Risk 
assessment is an odd mixture of science, non-science, and 
comparative risk assessment necessarily suffers from all the 
limitations of risk assessment.
    CRA suffers from additional methodological problems. For 
example, how should the risk reduction effect of current 
efforts be considered? If there were no public program to 
protect drinking water in this country, drinking water would 
rank among the highest risks, as it does in many developing 
countries. However, because we do have protection programs in 
place, the current risks from drinking water in the United 
States are not great.
    In the context of budgeting, for example, how to deal with 
existing efforts poses difficulties for comparative risk. We 
cannot do zero-based budgeting, in a sense, because on a zero-
based budget you would have nothing protecting drinking water 
and that would be a very high risk, but it is a very low risk 
if you just look at the risks at the present time. So, taking 
into account current efforts is a major methodological problem.
    Most importantly, comparative risk assessment deals only 
with risk and risk is only one of several factors that enter 
into most government decisions. Again, other witnesses have 
commented on this, but cost is an obvious factor.
    To the extent that decisions should be based on cost-
benefit analysis, risk is only the benefit side of the 
equation. You somehow have to get cost in there as well.
    Furthermore, you cannot do a cost-benefit analysis of a 
problem, only of a solution. Whereas comparative risk 
assessment deals with problems--air pollution, water pollution, 
cost-benefit deals with solutions--inspecting automobiles, 
installing technology in plants and so on.
    So you are dealing with two different universes of things 
when you deal on the one hand with cost-benefit analysis and on 
the other hand with comparative risk assessment. Getting from 
one type of analysis, comparative risk, to the other, cost-
benefit, is not simple because you are analyzing two distinct 
sets of things.
    Let me note a few other limitations. First, how the 
comparative risk assessment is done can have an important 
effect on the outcome. A paper by my colleague, David Konisky, 
which I would like to submit for the record, demonstrates that 
problem. How broadly you define the categories makes a big 
difference in how you rank the risk.
    Second, how to involve the public. Mr. Pompili is 
absolutely right about the critical importance of involving the 
public. But that means you have to resolve how you combine 
technical scientific information with the information that the 
public brings to bear.
    Then, finally, the data problem, which has been commented 
on extensively. Let me simply say that in terms of the 
committee's tasks, I think the time is long overdue to create a 
Bureau of Environmental Statistics, comparable to the Bureau of 
Labor Statistics or the Center for Health Statistics. We need 
that. There is no such institution in the environmental area. 
It would be a major step forward, both in terms of improving 
the amount and the quality of data. We have no central place to 
look to for environmental statistics and we need one.
    The statutory context makes a big difference. In my written 
testimony I make several comments about it. Let me just second 
the comments you made, Mr. Chairman, with regard to the 
problems of stove piping.
    However, let me say that in my view as long as the statutes 
are drafted in a stovepipe fashion, the Agency cannot organize 
in any other way than by stovepipe. The stovepipe, medium-by-
medium organization is a major impediment to doing comparative 
risk assessment. It is also a major impediment to data 
collection.
    In the long run we need an integrated single environmental 
statute. That is the only way we can overcome the stovepipe 
problem.
    In fact, the United States, in a decade or so is going to 
be one of the few industrialized countries left that doesn't 
have an integrated environmental statute. The Europeans, the 
Scandinavians, a number of countries have already gone in that 
direction of integrated environmental statutes. The United 
States is going to have to face up to that sooner or later.
    Let me conclude by saying that despite its limitations, 
comparative risk assessment is a valuable analytical tool. It 
may be most useful for the questions it raises and as a way of 
initiating a process leading to more transparent and defensible 
decisionmaking. How well it serves these functions will depend 
heavily on whether Congress itself asks for relevant risk 
information and uses the answers in its budgetary, oversight 
and legislative actions.
    Thank you, Mr. Chairman.
    Senator Smith. Thank you very much, Dr. Davies.
    Dr. Anderson, welcome.

STATEMENT OF ELIZABETH L. ANDERSON, PRESIDENT AND CEO, SCIENCES 
                      INTERNATIONAL, INC.

    Ms. Anderson. Good morning. I am pleased to be invited by 
this committee to testify on the important issues of risk 
assessment, particularly as they are involved in two programs 
of focus today: The Comparative Risk Program and the Residual 
Risk Program.
    My name is Elizabeth Anderson. I am president of Sciences 
International, an organization that specializes in the health 
and environmental sciences.
    Previously, I was privileged to be involved in founding and 
directing the first EPA's carcinogen assessment group. 
Subsequently, I also directed the expanded office, the Office 
of Health and Environmental Assessment, where I had the 
opportunity to essentially direct the Agency's central risk 
assessment programs for 10 years.
    I was also the executive director of the committee that 
first adopted risk assessment and risk management as a process 
for regulating environmental toxicants.
    Subsequently, this committee wrote the first agency's risk 
assessment guidelines. I have been involved for many years with 
the Society for Risk Analysis as a founder, past president and 
currently editor-in-chief of the society's flagship journal, 
``Risk Analysis: An International Journal,'' that serves as an 
international focal point for developments in risk analysis.
    Obviously, a principal focus and interest of mine is 
improvement in the sciences supporting risk assessment. Two 
important applications of risk assessment that we are 
discussing today, the comparative risk assessment program and 
EPA's Residual Risk Program are of great importance and must 
rely on the tools of risk assessment.
    In the case of comparative risk, we are comparing human 
health and environmental risk across many programs and many 
media to set priorities to assist informed decisionmaking. In 
the Residual Risk Program the regulatory requirement is to 
assess residual risk in a relatively short period of time 
following the application--that is 8 years after the 
application--of maximum achievable control technologies across 
all of the major industry categories.
    Today, I want to discuss essentially the important progress 
and the importance risk assessment has to these activities. The 
details of my testimony are presented in my written statement, 
which thoroughly explores these topics.
    I will summarize that testimony by focusing on the five 
areas that I have selected as the principal focus for my 
recommendations.
    First, the complexity and cost of conducting risk 
assessments called for by Comparative Risk and the Residual 
Risk Programs is really unprecedented. For example, when we 
think of the Residual Risk Program, we are speaking of 188 
hazardous air pollutants that must be evaluated for 175 source 
categories involving literally thousands of facilities. This 
must be done in a relatively short period of time.
    Even more toxic pollutants and sources must be considered 
in the Comparative Risk Program. The previous experience with 
programs such as this has been limited. Let me just mention 
this because I think it is very important. We are considering 
individual and population risk and ecological risk in multi-
pathway risk assessments across many industries, facilities, 
and pathways.
    The prior experience with these kinds of comprehensive risk 
assessments has been with individual Superfund sites and 
individual facilities that are combustion sources, not these 
comprehensive source categories. So, this is an enormous 
challenge.
    My recommendation is that we must have a thoroughly 
disciplined tiered approach that everyone subscribes to. The 
first tier would certainly employ the best available data, but 
would be recognized as a screening level assessment.
    For those sources that have low risk, obviously, no further 
work needs to be done. For the sources that appear to be posing 
a risk of any concern, the next tier would involve a 
sensitivity analysis to focus on gathering data for the most 
important parameters to express risks more accurately.
    Resources necessary to conduct these risk assessments both 
within EPA and on the part of involved parties needs to be 
recognized. In addition, I see no way that these risk 
assessments can really be refined without a partnership with 
the involved source categories.
    EPA's current draft guidelines for this tiered approach 
really fall far short of specifying this kind of disciplined 
approach and following the steps that I have laid out in my 
testimony. That is, to have the initial upper-bound risks serve 
a screening purpose, but then to very clearly articulate what 
kind of risk assessment steps would follow and under what 
guidelines and when they would be triggered.
    Second, I wanted to identify several policy issues that 
these two programs essentially require for clarification. 
Historically, EPA has limited its risk assessment guidance for 
hazardous air pollutants to carcinogens, inhalation risks, and 
risks to individuals, but has not addressed how judgments will 
be made about multi-pathway risks and how broader population 
risks will be considered.
    Further, language in the 1990 Clean Air Act Amendments for 
residual risks states that environmental risks must also be 
considered, there is some very specific language.
    How these policy issues will be considered under the 
Residual Risk Program must be clearly articulated. There should 
be an opportunity, clearly, for public involvement and comment 
before arriving at final criteria for identifying risks of 
concern.
    Third, emissions data must be substantially improved. 
Historically, EPA has used the readily available emissions data 
that it has. Often these are estimated values rather than more 
precise measured, post-regulatory emission values.
    The risk assessment can be no more accurate than the 
emissions that are used in the dispersion model. I recommend 
that in the second iteration these emissions data be improved. 
Again, I see no way of improving these data without a 
partnership with the organization and facilities that have the 
best emissions information.
    Fourth, the integrated risk system, the IRIS data base, as 
a repository of regulatory toxicity values must be revised. The 
risk assessment forum for which I was the first director, set 
up the IRIS data base and commenced the stewardship program of 
employing information readily available in the Agency to 
establish this data base principally to ensure consistency 
across the regulatory programs and to share information.
    It was really not intended as a direct use for regulatory 
decisions. Since that time the IRIS data base has become not 
only the most important source of regulatory toxicity values 
for all of EPA's programs, but it is widely used by State and 
international programs as well.
    The IRIS files include over 500 chemicals. Many of these 
are woefully out of date. I have discussed a number of these 
issues in my written testimony. My recommendation is that for 
the identified 188 air toxic chemicals, refinements in the 
toxicity issues need to be revisited as a part of the Tier 2 
risk assessment process. The same concept need to be entered 
into refinement for the Comparative Risk Programs.
    I recommend, as everyone else does, that the resources need 
to be committed to EPA to update all of the over 500 chemicals 
in the IRIS file and to maintain this data base in a refined 
and up-to-date status.
    In making this recommendation, however, I recognize that it 
is an almost impossible task. Nevertheless, I think all efforts 
should be made to carry it out. To be totally practical, I 
further recommend that the preface to the IRIS date base be 
restated to recognize reality.
    That is that the data base can probably never be a current 
source of all the latest information in the literature with 
application of the latest risk assessment methodologies 
necessary to assure accuracy in risk assessment for risk 
management decisions.
    Finally, uncertainty and variability analysis must be 
applied more explicitly. Historically, EPA has come to 
recognize the importance of performing variability and 
uncertainty analysis, but to date the Agency has been able to 
do so for a very limited number of parameters used in the risk 
assessment.
    This process needs to be extended to address all parameter 
categories. However limited or precise the uncertainty analysis 
and the variability analysis may be though, it is not clear 
what, if any, role these analysis play in the risk management 
process.
    I recommend that there be clear guidelines developed for 
the use of uncertainty and variability analysis in making 
management decisions. I have suggested some ways of doing this 
in my written testimony.
    Finally, I think risk assessment is an exceedingly valuable 
tool. The underlying sciences have been greatly improved since 
they were first employed in 1976. I believe progress will 
continue and these processes can provide the essential bases 
for risk-based management decisions.
    Thank you.
    Senator Smith. Thank you very much, Dr. Anderson.
    Before turning to you, Dr. Lippman, I am going to have to 
implement the rule. It will not mean that your testimony will 
not be officially received at some point, but it will be 
informational for the purpose of today.
    Because of the Senate Rule 26.5 (a) being called for by the 
Minority, this does prohibit any committee from meeting beyond 
the 2-hours after the Senate goes into session. As I indicated 
earlier, Senator Baucus and I have agreed to adjourn and go 
back to an informational meeting, which I will do in just a 
second.
    At some point in the future we will ask unanimous consent 
of the committee to make this part of the record. So, I would 
just say to the Clerk, just be prepared to make that indication 
when we have the unanimous consent agreement.
    So, at this point I am going to adjourn the hearing.
    [Whereupon, at 11:33 a.m., the committee adjourned, to 
reconvene at the call of the chair.]





  COMPARATIVE RISK ASSESSMENT: SCIENCE ADVISORY BOARD'S RESIDUAL RISK 
                     REPORT--INFORMATIONAL MEETING

                              ----------                              


                        TUESDAY, OCTOBER 3, 2000

                                       U.S. Senate,
                 Committee on Environment and Public Works,
                                                    Washington, DC.
    The committee reconvened outside of the regular order at 
11:33 a.m. in room 406, Senate Dirksen Building.
    Present: Senators Smith, Inhofe, and Baucus.
    Senator Smith. I will now call this informational meeting 
to order.
    Our next witness is Dr. Morton Lippmann, chairman of the 
Science Advisory Board.

 STATEMENT OF MORTON LIPPMANN, PROFESSOR, NEW YORK UNIVERSITY, 
                 CHAIR, SCIENCE ADVISORY BOARD

    Mr. Lippman. Mr. Chairman, I appreciate the opportunity to 
offer information on the scientific basis for the current 
limitations of and opportunities for future improvements in 
quantitative risk assessment as a tool for environmental risk 
management.
    This hearing is focused on the capabilities and limitations 
of current knowledge and technical means of comparative risk 
assessment in the roles of guiding new legislative mandates, 
societal choices and individual decisions based on risk 
avoidance.
    In my remarks I will focus on health risks associated with 
exposure to air-borne chemicals and mixtures thereof in our 
communities.
    In order to determine the extent of any health risk 
existing among members of the population resulting from the 
inhalation of air-borne chemicals, we need to know: (1) the 
concentrations of the agents in the air and for particles, 
their particle size distribution; (2) the unit risk factor, 
that is the number of cases and/or the extent of any adverse 
effects associated with the risk exposure. We may also need to 
know more about the population of concern, such as the 
distributions of ages, preexisting diseases, predisposing 
factors for illness such as smoking, dietary deficiencies or 
excesses and so forth.
    Such direct comparisons can, however, only be made in 
practice with any quantitative reality for a handful of 
chemicals; the so-called criteria air pollutants. Their ambient 
air levels are routinely monitored. Human exposure response 
relationships are reasonably well known.
    For the other hundreds of air-borne chemicals known 
collectively as hazardous air pollutants or air toxics, there 
are neither extensive ambient air concentration data nor unit 
risk factors that do not heavily err on the side of safety, 
which is appropriate for many of their intended uses, but not 
for comparative risk.
    This disparity has resulted from the different control 
philosophies built into the Clean Air Act and maintained by the 
EPA as part of its regulatory strategy.
    Criteria pollutants come from numerous and widespread 
sources, have relatively uniform concentrations across an air 
shed, require State-wide and/or regional air inventories and 
control strategies for source categories such as motor 
vehicles, space heating, power production, et cetera.
    There is also a long history of routine, mostly daily 
measurements throughout the country. By contrast, HAP's sources 
are considered to be definable point sources at fixed 
locations. Downwind concentrations are highly variable, and 
generally drop rapidly with distance from the source.
    The emissions standards for hazardous air pollutants rely 
on technologically-based source controls and are intended to 
limit facility fence line air concentrations to those that 
would not cause an adverse health defect to the most exposed 
individual at the fence line.
    Also, until quite recently, there has been no program for 
routine measurements of air toxics in our communities. That has 
just started up and there are essentially no data yet available 
to analyze.
    Most of the unit risk factors for air toxics are based on 
cancer as the health effect of primary concern. In these 
studies and in studies to assess non-cancer effects, the data 
are derived from controlled exposures in laboratory animals at 
maximally tolerated levels of exposure; it won't kill them 
immediately.
    The translation of the results from these studies, the unit 
risk factors relevant to humans exposed at much, much lower 
levels in the environment is inherently uncertain and has been 
approached conservatively.
    The resulting unit risk factors are generally based on an 
assumption of no threshold and a linear extrapolation to zero 
risk at zero dose. They are generally described in terms of 
them being 95 percent upper bound confidence limits, but this 
descriptor is undoubtedly highly conservative in itself.
    When these conservative unit risk factors are used for the 
prediction of the consequences of human exposure, they are 
multiplied by estimates of predicted air concentrations, which 
are themselves, in the almost universal absence of 
measurements, almost certainly upper-bound estimates from 
dispersion models that apply, really, to the most highly 
exposed individuals in the community.
    Dr. Hopke in Panel III will go into some more of the 
limitations of this approach in the residual risk analysis.
    The resulting estimates of health risk are therefore highly 
conservative, upper bound levels. They are inherently 
incompatible with population impacts estimated for the more 
widely dispersed criteria pollutants. The margins of safety for 
criteria pollutants are generally less than a factor of two, 
rather than multiple orders of magnitude built into the risk 
assessments for air toxins.
    The highly conservative nature of unit risk factors for air 
toxics is well illustrated by a calculation made during work 
done for EPA during preparation of the section 812 (cost-
benefit) Study. It concluded that the imposition of the vinyl 
chloride National Emission Standard for Hazardous Air 
Pollutants (NESHAP) had prevented 6,000 cases of cancer.
    Since the calculated cancer incidence reduction was 
considerably larger than the historic incidence level of this 
cancer overall, it was obvious that the benefit claim for the 
imposition of the NESHAP was grossly exaggerated.
    The National Research Council Committee report on 
strengthening science and peer review at EPA not only 
recommended the position of Deputy Administrator for Science, 
it also concluded that research on risk assessment and risk 
management was not only needed, but needed to be conducted by 
EPA since no other Federal agency had the mandate, need or 
desire to conduct such research.
    Comparative risk assessment is an idea whose time is 
coming. If EPA is provided with appropriate research resources 
to harness the new technical approaches and sophisticated 
research tools now emerging to fill key knowledge gaps, it can 
make comparative risk assessment more useful and feasible in 
the not too distant future.
    If the recommendations in the NRC Strengthening Science at 
EPA Report are adopted, the prospects for such advances will be 
greatly improved. I encourage Congress to consider explicitly 
giving EPA a mission statement that includes the performance of 
a long-term research program focused on health and 
environmental risks as a means of enhancing its capabilities 
for effective and efficient stewardship of its environmental 
responsibilities.
    In closing, I want to thank the committee for the 
invitation to testify on these important issues. I stand ready 
to answer your questions.
    Senator Smith. Thank you, Dr. Lippman.
    Senator Inhofe will be here in a moment. He is going to 
chair the last panel because I have to leave.
    I am only going to ask each of you one question, if you 
could respond as briefly as possible, and then I will have some 
other questions for the record and I think other members may as 
well.
    I think many times we have witnesses here and you get the 
impression that you testify and nobody listens. Congress 
doesn't listen. It is all just a bunch of testimony and it goes 
in the file somewhere. The truth is we do. We get a lot out of 
the hearings when people come here from various disciplines and 
testify before the Congress. It is very helpful to all of us in 
drafting and sometimes in eliminating legislation.
    Let me just start with you, Dr. Lippmann. In listening to 
what you had to say, let me just ask you, here is your chance 
to respond directly and give us some input. The way I read what 
you are saying, you basically are saying between the lines that 
EPA exaggerates risk. Is that true? Is that your position?
    Mr. Lippmann. I would distinguish between criteria 
pollutants and hazardous pollutants in the air environment. For 
criteria pollutants, I don't think so. I think from my 
experience with CASAC committees, EPA has been quite realistic 
in setting NAAQS for PM and ozone that protect the public with 
a very small margin of safety.
    With respect to the very different tradition and ways of 
approaching air toxics, the IRIS values or risk assessment 
numbers have been highly conservative for historically correct 
reasons. Thus, these risks in most cases are grossly 
exaggerated.
    In the absence of sufficient information, it will not be 
conservative in every case because there are uncertainties in 
the risk assessment which the safety factors protect against 
adverse effects. But in most cases, clearly the cancer risks 
and other risks for hazardous air pollutants will end up being 
very much exaggerated. It is not intentional, but because that 
is the nature of the information available and the way in which 
long-standing procedures for risk assessment have been done.
    I think Congress needs to give EPA a more realistic basis, 
mission statement, and organizational framework. The stovepipe 
issues that you raised earlier really hinder its ability to do 
comparative risks or even to want to do them.
    Senator Smith. In moving from that to you, Mr. Davies, you 
said that you felt that you didn't see how we could get there 
with the stovepipe approach.
     Briefly, how would you reorganize those laws? I mean right 
now you do have a series of specific environmental laws, i.e., 
stovepipes. How would you suggest that we reorganize in the way 
of blending these together, if necessary, or what are you 
suggesting we do, just briefly?
    Mr. Davies. I am suggesting that one goes to a single 
integrated environmental statute. I had occasion 12 years ago 
to draft such a statute. I would be happy to make it available 
to the committee.
    Senator Smith. The challenge is accepted. We would like to 
see it.
    In that individual statute you are saying the various 
components of the disciplines, clean air, clean water, 
Superfund, and so forth, would be all within that statute and 
the prioritization would be whose responsibility?
    Mr. Davies. Well, ultimately, the Administrator's, but the 
task would be considerably simplified because you would not 
have individual programs, focused on individual media or 
individual pollutants, defending their turf in the same way 
that you do now.
    So, it would be easier to set priorities across the entire 
range of environmental problems.
    Senator Smith. Thank you. We would like to see that.
    Ms. Hartnett, as you know, I am very familiar with the 
leadership in New Hampshire on many of these proposals, 
especially in risk assessment.
    In your view, does Federal law help you or hinder you to do 
a better job at the State and local level in comparative risk 
assessment?
    Ms. Hartnett. I will answer actually by referencing a 
cartoon that is in the record. It is a very good question. The 
cartoon shows a figure called ``science'' rubbing a bottle. The 
genie comes up and the question is ``Are you a good genie or an 
evil genie?'' The answer is ``yes.'' I would say the same thing 
about the role of the Federal Government. Yes. Seriously, there 
has been a lot of work done, particularly through work in air 
resources to relate the nature of the specific chemicals that 
are regulated to the underlying causes.
    In waste, probably less progress.
    In water, a mixed record, I would say, in New Hampshire.
    Senator Smith. You reminded me of one of Yogi Berra's 
infamous remarks when he said, ``When you come to a fork in the 
road, take it.''
    That is kind of similar to that.
    Let me ask you, Dr. Anderson, essentially the same 
question. As currently organized--as the EPA is currently 
organized, is it capable of meeting the challenges that you 
have identified in conducting appropriate risk assessment?
    Ms. Anderson. I think it is. But there are many other 
elements to be considered. I think it is not necessarily the 
organizational structure that is the difficulty.
    I have mentioned the complexity of the challenge, and it is 
an enormous challenge. Resources are always an element, and I 
have mentioned that as well.
    I think the biggest difficulty is to grasp the significance 
of the advances in the sciences that we are dealing with and 
find a way to realistically employ them. If there is a 
commitment to do so, I believe it can be done. But I think 
there needs to be a very clear prescription for accomplishing 
this.
    I don't necessarily think that the organization of EPA is 
the impediment to this. I think there are clearly many other 
barriers because we are not getting there fast enough.
    I think the concepts that I presented in my written 
testimony for trying to correct what Dr. Lippman said earlier, 
that we have intentionally biased risk assessment to protect 
public health, this was necessary in the early years because 
risk assessment approaches would not have been accepted at all 
had there not been a provision for replacing uncertainty with 
public health protective assumptions. We were moving from the 
zero risk tolerance policy to an acceptance policy. So, we had 
to be sure we didn't underestimate the magnitude of public 
health.
    Having said that, we cannot continue to employ those same 
approaches for serious regulatory decisionmaking. We said this 
in 1976. This isn't something new. Therefore, the emphasis 
needs to be on an iterative process to refine risk assessments, 
and a commitment to following this process.
    Now, whether structure makes this happen or resources make 
this happen or legislation makes this happen, it is probably 
some element of all of these. But I think the focus needs to be 
on the goal and then the way to get there, the implementation 
process, can be more carefully inspected.
    Senator Smith. That is a good answer.
    Finally, Mr. Pompili, you were talking about support and 
technical assistance from the Federal Government and how it 
would be helpful to the States. What other role, other than 
funding, would be appropriate for the Federal Government to 
assist in your risk-based decisionmaking?
    Mr. Pompili. Right now we are in a situation where we are 
starting to work with Region 5. We are taking a look at ozone 
attainment in central Ohio. Now we are using Region 5 a little 
bit for some technical advice as we are going through this 
process.
    The other thing that comes through, and it is kind of scary 
but I have been involved with this from time to time, the data 
that is out there comes across as factual on a local level. 
Basically, with all this information out there, and it is up on 
the Web sites and everywhere else, everybody thinks because it 
is from the EPA, they think this information is always correct.
    If we can get that information to be correct and be 
accurate to what really is going on, it would be very 
beneficial. So, I talk about having technical information from 
the regions to help out and second, also having accurate 
information over the Web that is available on a local level 
would be a lot more beneficial to our decisionmaking process.
    We know from local experiences that in a great many of 
decisionmaking situations the abundance of information causes 
us more trouble on the local level than it helps. Information 
is put out there, as the information is out there, there should 
be an accurate way to distribute data that is useful.
    Senator Smith. Thank you so much for the answers. You have 
been a very good panel, very interesting. I appreciate all of 
you coming here. I know many of you came a long distance. Thank 
you very much for coming and putting up with the little 
interruption we had to have here because of the 2-hour rule.
    I will dismiss this panel and call up Panel III. Panel III 
is Mr. Lee Hughes, the vice president for Corporate 
Environmental Control of the Bayer Corporation; Mr. Robert 
Brenner, Principal Deputy Assistant Administrator for Air and 
Radiation, Environmental Protection Agency; Dr. Philip Hopke, 
chair of the Residual Risk Subcommittee, Science Advisory 
Board; and Ms. Felice Stadler, national policy coordinator of 
the Clean the Rain Campaign, the National Wildlife Federation.
    Welcome to all of you. Since you have one lady, I will 
start on the right side and move down the panel to the left. 
Your complete statements will be made a part of the record. 
Please feel free to summarize in 4 or 5 minutes if you can.
    We will start with you, Ms. Stadler.

STATEMENT OF FELICE STADLER, NATIONAL POLICY COORDINATOR, CLEAN 
        THE RAIN CAMPAIGN, NATIONAL WILDLIFE FEDERATION

    Ms. Stadler. My name is Felice Stadler. I coordinate the 
National Wildlife Federation's National Clean the Rain 
Campaign. The campaign seeks to raise public awareness about 
how toxic air pollution contaminates our lakes and streams and 
advocate for national and local policies to phaseout the 
emissions of mercury and other persistent biocumulate toxics, 
PBTs.
    While we recognize that EPA needs to refine its methodology 
for performing residual risk assessments, we firmly believe 
that the program must be preserved and adequate resources be 
provided to allow the Agency to do the critical assessments 
needed to protect humans and wildlife from actual harm.
    As you are aware, Congress amended the Clean Air Act in 
1990 to establish a more effective program to reduce toxic air 
pollution. Congress required major sources that emit any of 188 
listed toxic air pollutants to make performance standards based 
on the best industry practices to minimize toxic releases.
    Have reductions achieved to date solved the air toxics 
problem in communities and ecosystems throughout the United 
States? Certainly not. People and wildlife continue to be 
exposed to toxic air pollution, which harms their well being.
    For this reason it is vitally important that EPA move to 
the next phase of its national air toxic strategy, the Residual 
Risk Program.
    Now, I will mention three reasons for why we need to do 
this. First, without residual risk, EPA will not be able to 
address the harm posed by the most toxic air pollutants, PBTs 
like mercury and dioxins. PBTs are harmful at extremely low 
levels and uniquely harmful to people and wildlife because they 
become increasingly toxic as they move up the food chain.
    For example, mercury is one million times more toxic in 
fish than in surrounding water. So, when we eat fish we are 
consuming concentrated mercury. Those most vulnerable to the 
effects of PBTs include unborn children, women, low-income 
communities, and communities of color.
    EPA is not required to address the full extent of the harm 
posed by the most toxic compounds through technology standards. 
Therefore, the residual risk program is critical to ensure 
unique risks are appropriately addressed.
    Second, EPA's technology standards do not take into account 
the cumulative risk that occurs when industrial sources are 
concentrated in one area. For example, in Memphis, TN, you can 
see sources of toxic air pollution in every direction: A 
petroleum fueling station, a six-lane highway, a refinery, a 
lead smelter and a factory.
    Less than a block away from these sources there is low-
income housing and a playground. Unfortunately, this picture is 
not unique. Risk-based programs enable EPA to evaluate these 
real life scenarios that are all too common for countless 
citizens.
    Third, Congress and EPA never intended the technology-based 
program to address entirely all toxic emissions from all of its 
sources. Technology-based standards provide the best industry 
can offer at the time they are imposed. But this does not 
translate into being the most stringent or comprehensive 
approach.
    In fact, when EPA issued the proposed Portland Cement Kiln 
rule 2 years ago, EPA announced it would evaluate the need to 
make the standard more stringent to address mercury emissions 
as part of the residual risk phase.
    Without this program, this category of sources and others 
like it would likely never be adequately regulated under the 
Clean Air Act.
    In conclusion, I want to raise the issue of uncertainties 
related to the residual risk program. Every risk assessment 
must contend with uncertainties: Who is exposed? How much they 
are exposed to? The health effects of pollutants.
    Requiring every uncertainty to be addressed before taking 
action would effectively mean no action will be taken. EPA is 
refining its tools to carry out the residual risk program. It 
should be given the opportunity to go forward and implement 
that program. But policy paralysis will be the result if EPA is 
required to address every uncertainty before acting.
    Finally, I would like to close with two recommendations to 
improve how we regulate sources of air toxics. First, the risks 
to people and wildlife from several PBTs are well established. 
Any release of these pollutants causes harm. For that reason 
and international agreements, the United States has committed 
to virtual elimination of these pollutants.
    To properly address the unique risks posed by PBTs, EPA may 
not engage in complicated risk analysis. Instead, it simply 
needs to set a schedule for phasing out the emissions of these 
chemicals from all sources and then apply progressively lower 
emissions standards to meet that goal.
    Second, rather than merely relying on pollution controls to 
solve the Nation's air toxics problem, we urge Congress and the 
Agency to look at solutions that encompass pollution 
prevention. This applies to both the technology-based program 
and the residual risk program.
    EPA has the tendency to assume that all pollution is 
unavoidable and that bolting on technology will solve the 
problem. Instead, it is time for EPA to begin to assess what 
pollution could be avoided altogether and develop policies that 
reflect a commitment to more sustainable and less toxic 
solutions.
    Thank you for the opportunity.
    Senator Smith. Thank you.
    Before I introduce Dr. Hopke, I want to apologize to the 
witnesses. I have to leave. I do have another appointment. 
Senator Inhofe is going to finish chairing the hearing.
    Dr. Hopke, welcome.

 STATEMENT OF PHILIP HOPKE, CHAIR, RESIDUAL RISK SUBCOMMITTEE, 
                     SCIENCE ADVISORY BOARD

    Mr. Hopke. Thank you. Mr. Chairman and members of the 
committee, my name is Dr. Philip Hopke. I am here to discuss 
with you the views of the Residual Risk Subcommittee on the 
residual risk methodology as described in EPA's report to 
Congress, particularly as applied to the secondary lead smelter 
source category.
    I chaired this subcommittee of the EPA's Science Advisory 
Board's Executive Committee. My testimony will try to reflect 
the consensus view of the subcommittee with some added input 
from the Science Advisory Board's Executive Committee, although 
I am speaking for myself.
    In early March the subcommittee conducted a peer-review of 
an Agency draft case study of the residual risk assessment 
methodology applied to secondary lead smelter source category.
    We understand that the Agency plans another iteration 
including additional data collection and analysis before these 
results are considered for use in a regulatory context.
    Review of the seven-volume set of materials focused on 
eight specific questions that are addressed in detail in the 
SAB report that has been submitted to you.
    In short, the subcommittee concludes the Agency developed a 
useful, self-described work in progress. The methodology used 
in this interim work product as far as it currently goes is 
consistent with the methodology described in the report to 
Congress. Further, many of the assumptions used are consistent 
with current methods and practice.
    The case study provides an example of how the approach 
presented in the report might be implemented. However, it also 
raises a number of concerns we provided in the report on this 
document. The major concerns will be highlighted here.
    Because the subcommittee has not seen the full residual 
risk assessment and thus we are unable to comment on the 
complete process, a number of important concerns were 
identified that should be addressed.
    Specifically, this interim analysis does not include the 
following important elements: A full ecosystem risk assessment, 
a health risk assessment that includes population risks, a full 
analysis of uncertainty and variability, a computer model for 
assessing multi-media transport and fate that has been 
adequately evaluated, a clear description of the process and 
how the assessments will be linked to the eventual risk 
management decisions.
    I would like to highlight a couple of these problems to 
illustrate a larger concern that we would like to bring to your 
attention.
    The current analysis for secondary lead smelter was done 
using the multimedia transport and fate model that was 
originally developed as part of the analysis reported in the 
mercury report to Congress. However, it was never fully peer-
reviewed for its use in mercury, and it was then modified for 
use with lead without review of assumptions and coefficients.
    EPA has been developing a new multimedia exposure model, 
the total risk integrated methodology that had undergone an 
initial review by the SAB. It was quite encouraging.
    However, it now appears that completion of this model and 
its use in risk assessment has been slowed so that it may not 
be available in the near term. This delay produces serious 
doubts in any of the assessments that have to be based on a 
temporary model that has not been subjected to careful external 
scrutiny.
    Another of the most serious problems was the inability to 
utilize the available data to test the modeling results. In the 
secondary lead smelter case, fugitive emissions were found to 
produce most of the risk.
    In several of the cases, results presented in the draft 
report were implausible in that the predicted concentrations 
would have produced immediately observable results on the 
effected human and ecological populations.
    In the vicinity of most of these sources, sampling was 
conducted to test compliance with the national ambient air 
quality standard for lead and total suspended particulate. Such 
measurements could be used to test the concentrations at the 
boundaries of these facilities.
    However, the risk analysis could not utilize these ambient 
monitoring data that are available in the air's data base 
because of lack of resources to recover and then organize them. 
An important policy question arises as to how good such 
residual risk assessments need to be.
    It is our understanding that when the form of control 
specified in title III was being considered by Congress a 
decade ago, the expectations for the level of these residual 
risk analysis were quite low.
    The scientific basis of risk assessment has grown 
considerably over the past years and thus the level of 
expectation from the scientific community such as those of us 
who have served on this SAB subcommittee has risen 
considerably.
    Thus, the subcommittee has expressed its concerns regarding 
future assessments. Accordingly, I wish to use this opportunity 
to express our concerns regarding the level of analysis that 
can and should be done to assess residual risk as part of the 
control of hazardous air pollutant emissions.
    The subcommittee believes it is possible to provide more 
quantitative and useful human health and ecological risk 
assessments than is currently envisioned for a reasonable 
investment of additional resources for data collection and some 
additional outside expertise as needed.
    The resulting assessments will be much more credible to 
both the regulated community and those potentially effected.
    I would like to express my gratitude to the members of the 
committee for inviting me and giving me the opportunity to 
deliver the SAB Residual Risk Committee's review message.
    I look forward to your questions.
    Senator Inhofe [assuming the chair.] Thank you, Dr. Hopke.
    Mr. Brenner.

    STATEMENT OF ROBERT BRENNER, PRINCIPAL DEPUTY ASSISTANT 
 ADMINISTRATOR FOR AIR AND RADIATION, ENVIRONMENTAL PROTECTION 
                             AGENCY

    Mr. Brenner. Good afternoon, Senator Inhofe. I welcome the 
opportunity today to discuss the Residual Risk Program, which 
is one component of the Clean Air Act strategy for protecting 
the public from toxic air pollution.
    In the landmark Clean Air Amendments of 1990, Congress 
called for a two-phased approach to reducing toxic air 
emissions from major industrial sources.
    First, EPA is to issue technology-based standards on an 
industry-by-industry basis to ensure that all plants are well 
controlled.
    In the second phase, EPA must assess the remaining risks 
from those industries and, if necessary to protect health and 
the environment, set residual risk standards requiring further 
reductions in toxic emissions.
    A decade later EPA continues to believe that it makes sense 
to evaluate whether MACT standards provide the public with 
adequate health and environmental protection and to take action 
if they do not.
    EPA regularly hears from citizens concerned about whether 
toxics are endangering them. These citizens include minority 
and low-income residents who are often disproportionately 
represented in neighborhoods near industrial sites.
    Although the job will not be easy, EPA, with the aid of the 
scientific community, including the National Academy of 
Sciences, has developed risk assessment methodologies and risk 
management procedures that can help to support reasoned 
decisions on whether to require further emission reductions 
based on the available scientific information and consideration 
of uncertainties.
    When Congress overhauled the Clean Air Act in 1990, it was 
well established that the public is exposed to toxic air 
pollutants such as lead, benzene, dioxin, mercury and chromium. 
It was known that air toxics can cause serious health effects 
such as cancer, neurological damage, miscarriages, birth 
defects or lung damage.
    In response, Congress rewrote the ineffective air toxic 
provisions of the 1970 act and mandated a comprehensive 
strategy to toxic air pollution, including the two-phased 
approach for major industrial sources that I mentioned earlier.
    I am happy to report that the first phase of the program 
which requires dirtier facilities to achieve a level of 
performance already being achieved by cleaner facilities of the 
same type is proving very successful.
    Maximum Achievable Control Technology standards issued to 
date will reduce annual emissions of air toxics by 1.5 million 
tons, many times the reductions achieved by standards issued 
during the 1970 to 1990 period.
    As we work to complete those MACT standards, we are in 
parallel beginning to implement the second phase, the residual 
risk program.
    As Congress directed, we will start with the science. We 
will conduct risk assessments based on available information, 
and credible and relevant scientific studies conducted around 
the world by universities, governments, industry and others.
    Considering all the available health information, the law 
then calls for EPA to make an informed decision whether a 
source category needs to make further reductions to bring toxic 
emissions to a safe level.
    In the time remaining I would like to talk about some of 
the issues that are being raised today. A Science Advisory 
Board panel has reviewed an incomplete EPA case study that 
illustrates methodologies we will use for screening analysis in 
the residual risk program.
    We asked SAB to review this incomplete case study precisely 
because we wanted external reviewers to help us improve our 
methodologies before we finished the study. We are doing just 
that, based on the very good technical comments that we 
received.
    I would like to submit for the record EPA's response to the 
SAB. The SAB expressed general concern about data gaps. In 
response, we are working, for example, to improve the national 
toxic inventory, a repository of air toxics emissions data from 
States.
    We are working with States and cities to expand monitoring 
of ambient air toxics levels. We are developing a new, better 
multi-pathway methodology called TRIM, the Total Risk 
Integrated Methodology, which has received two very favorable 
reviews from the SAB.
    We are also conducting modeling on a national and local 
scale to improve information on the level of air toxics that 
people are exposed to. We disagree with statements by some 
individuals that data gaps make it impossible for EPA to carry 
out the statute.
    The law does not require residual risk decisions to be free 
of uncertainty. For many source categories uncertainties may 
preclude a precise risk estimate. Even so, the body of health 
information often may support a reasoned judgment whether or 
not public health is protected with an ample margin of safety.
    In light of current uncertainties, some may suggest that 
EPA wait for more complete information before attempting to 
assess and address any risks from air toxics remaining after 
MACT.
    The flaw in this approach is that in some cases individuals 
may continue to be exposed to an unsafe level of toxics near 
industrial facilities while we fail to act based on information 
that is available now.
    In the field of environmental protection as in much of 
life, there are few decisions for which we would not like to 
have more information. The reality is that to avoid paralysis, 
we must make reasoned choices based on the information we have.
    If there is not sufficient evidence of a threat, however, 
EPA will not issue a residual risk standard. If toxic emissions 
are unsafe based on the framework provided by Congress, EPA 
will take protective action.
    Thank you, Senator Inhofe, for the opportunity to testify 
here today.
    Senator Inhofe. Thank you, Mr. Brenner.
    Mr. Hughes.

     STATEMENT OF LEE HUGHES, VICE PRESIDENT OF CORPORATE 
            ENVIRONMENTAL CONTROL, BAYER CORPORATION

    Mr. Hughes. Good afternoon, Senator Inhofe. My name is Lee 
Hughes and I am vice president of Corporate Environmental 
Control for Bayer Corporation. I am responsible for the 
environmental matters of Bayer's U.S. operations. This includes 
compliance with the Clean Air Act.
    I am here today representing the American Chemistry 
Council.
    Senator Inhofe. Let me ask, for a moment here, on my time, 
would you elaborate a little more on what the Bayer Corporation 
does for the record.
    Mr. Hughes. The Bayer Corporation is an operation in the 
United States, which is owned by our parent out of West 
Germany. We are a $10 billion operation with 35 facilities 
throughout the United States employing roughly 24,000 employees 
making agricultural chemicals, base chemicals, pharmaceuticals, 
diagnostics equipment, and a pretty multi-service operation.
    Senator Inhofe. Thank you. Welcome.
    Mr. Hughes. I am here today representing the American 
Chemistry Council. The Council represents the leading companies 
engaged in the business of chemistry. The chemical industry 
supported the 1990 Clean Air Act Amendments. For over a decade 
we have worked with EPA in the development of programs that 
continuously make people's lives better, healthier and safer.
    Our industry supports the Clean Air Act's approach for 
regulating air toxics which first requires the application of 
technology-based MACT controls and then it looks at any 
unacceptable residual risks.
    EPA has estimated that our industry has achieved a 90-
percent emission reduction due to our MACT performance. The 
residual risk effort can build on these reductions. If residual 
risk regulations are needed for our industry, they will be due 
in 2003. This means that important decisions about this program 
are being made now.
    We believe the following key principles will ensure a 
successful residual risk program. We must first prioritize real 
and scientifically-validated risks. Second, we must use the 
flexibility provided in the Act to reduce risks in innovative 
and effective ways. Third, we must use high quality and peer-
reviewed models and data.
    These principles are detailed in our written statement. 
However, we are aware of several barriers that could hinder our 
efforts to further reduce risks.
    EPA's Science Advisory Board has highlighted many of them. 
These barriers need your attention. The first barrier is 
outdated health information. The health benchmarks used for 
residual risk must reflect the best scientific information 
available. The IRIS data base, the EPA's primary source of 
health data on hundreds of chemicals is out of date and of 
varying quality. The Commission on Risk Assessment and the 
Science Advisory Board agree IRIS's limitations are certain to 
hinder our ability to identify and then reduce risks.
    What can be done? EPA is trying to increase the pace of 
IRIS reviews and open the process to stakeholders. This process 
both needs to be supported and expedited so that new 
information can be used for residual risk assessments.
    Staff and resources for IRIS must be increased. Our 
association members will spend more than $600 million on health 
and environmental research related to chemical use. The 
residual risk regulations, however, will be due before we and 
EPA can complete our work. That is why Congress must ensure 
that EPA is open to and uses new scientific information in the 
residual risk regulations.
    The next barrier is non-peer review tools. EPA must subject 
the key tools used in this area to a balanced scientific 
review. To ensure they are really reducing risks, we must base 
risk assessments on high quality peer-reviewed science.
    Another barrier is outdated emissions and site information. 
The most recent EPA data on our industry does not reflect 
significant reductions we have already achieved. To correctly 
identify risks we need more current information about emissions 
and facility characteristics. We are voluntarily providing EPA 
with better information, but the task before both EPA and us is 
immense.
    Finally, the statutory clock is running. There will be a 
significant challenge to address these limitations within the 
Act's current deadlines. Adding to this challenge, the Act 
requires compliance with the risk standards within 90 days of 
promulgation. This will be a near impossibility if sources must 
design, procure, and install new technology or change chemical 
processes to incorporate pollution prevention instead of end-
of-pipe controls.
    It won't be long before a deadline is missed. Congress 
should not let this program be carried out by the courts in 
closed-door settlement discussions.
    Again, to achieve success in reducing residual risks we 
must update health benchmarks and use the most current 
scientific information. We must peer-review all key tools, 
obtain better emissions and site information, and continue this 
important oversight of EPA's ability to meet the requirements 
of the Act.
    I reiterate our industry's commitment to work with you, EPA 
and all stakeholders to achieve success.
    Thank you for hearing my testimony today. I would be happy 
to answer any questions.
    Senator Inhofe. Thank you, Mr. Hughes.
    Mr. Hughes, the thing you brought up last is the thing that 
concerns me more than anything else. The EPA began the Residual 
Risk Program by first looking at the lead smelter industry.
    It is my understanding that one of the reasons for that was 
that it is less complicated and there is more data. In other 
words, you would be able to expedite that a little quicker than 
some of the rest of the industrial sectors. Is that accurate?
    Mr. Brenner. Well, it happened to be an industry where we 
had some data that we could begin to look at.
    Senator Inhofe. A running start.
    Mr. Brenner. I am not sure it is the one that had the most 
data available to us.
    Senator Inhofe. All right. On the other industrial sectors, 
have you started those and if so, what is the timeline there?
    Mr. Brenner. We have begun looking at some of the other 
industrial sectors, yes. You have heard we have begun working 
with the chemical industry to begin looking at their sources. 
We have begun looking at coke ovens. The way the act works, the 
first of these analyses is due to be done at the end of next 
year.
    So, we are trying to conduct a series of screening 
assessments to see whether additional controls might----
    Senator Inhofe. That is the 2002 deadline, the first one?
    Mr. Brenner. I think the first one is actually following 
2001 and then there is more following 2002.
    Senator Inhofe. Well, you know, I think it is important to 
talk about this problem today. What I didn't want to happen is 
to wake up 2 years from now and find out, as Mr. Hughes was 
suggesting that we are not getting it done in compliance with 
the laws that we have to live by right now and then end up 
having the courts getting involved in it.
    Even though this has to be very short because of what 
happened on the floor today, and I will make this real quick, 
but I am concerned about what choices we have right now.
    In the second panel, Dr. Lippman said that we should 
continue the MACT Program but put off the Residual Risk Program 
until we can conduct better risk assessments. So, first of all, 
let me see what reaction to Dr. Lippman's statement you might 
have at the table.
    Mr. Hopke. I think we are in a position to conduct 
reasonable residual risk assessments for the purpose of seeing 
whether any of these post-MACT facilities produce an 
unreasonable and unacceptable risk.
    Again, the precision with which we can do that may not be 
the best in terms of setting standards or similar kinds of 
things, but in terms of trying to identify whether there might 
be any real problems to real people living in the vicinity, I 
think we have the basic tools or could have the basic tools in 
place and time with a bit more focus by the Agency.
    I mean, they have been working on TRIM for a while. It was 
our understanding that it had been slowed down to some extent. 
We would like to see that really get rolled out and be ready to 
run.
    When you don't even have enough resources dedicated that 
you cannot poll your own data bases to do reality checks on 
your models, it seems like something is wrong. So, we think 
that it is a process with some reasonable fixes that could 
provide the kinds of information that are going to be needed to 
make the decisions that are necessary.
    Senator Inhofe. Well, Mr. Brenner said that it was 
incomplete when it was given to the Science Advisory Board.
    Mr. Hopke. We understood that. It was a draft.
    Senator Inhofe. Why did you decide to do that instead of 
trying to get it as complete as possible before giving it? What 
constraints were you under?
    Mr. Brenner. The reason we did that was we wanted the Board 
to have an opportunity to look at the methodology before we 
completed the analysis. That way, if we needed to change the 
methodology, make adjustments to it, we could do that before we 
made a final decision on these lead smelters.
    Meanwhile, in parallel, we have been collecting additional 
data to make sure that we have more robust data before we make 
that final decision.
    So, it was an effort to consult with the Science Advisory 
Board as early as possible in the process. It has proved to be 
very valuable.
    Senator Inhofe. So, now you have had that evaluation so you 
have a better indication of where you can go from here. What is 
your timing now?
    Mr. Brenner. Our timing now is to try to continue to 
develop some of the methodologies that will be used, as you 
heard. This TRIM model, for example, the Total Risk Integrated 
Methodology, will be helpful to us in making a final decision 
on lead smelters.
    We are also trying to work to collect additional data, 
talking to the States, talking to the industry, and talking to 
some of the health departments in areas where these smelters 
are located. We want to pull all of that information together 
and sometime next year be able to make a decision as to whether 
we should proceed further in the risk assessment process.
    We always have the opportunity partway through to decide 
well, we have looked at the source category, and based on what 
we found with our initial assessment, there is not enough 
concern about risks to proceed.
    We could decide that we don't need to take additional 
action in that area and we can turn to other source categories 
or we may find there is still cause for concern and then we 
will have to use more sophisticated methodology and data to 
finally make a decision.
    We are hoping to use this screening approach so that in 
many instances we won't have to spend a lot of time with the 
industry. Our initial screen will tell us that there is not a 
significant risk there and we can return to the areas where our 
priority should be greater because there is greater cause for 
concern.
    Senator Inhofe. When Mr. Hughes expressed a concern that 
this end up in the courts, do you all share that concern or 
what thoughts do you have on that?
    Ms. Stadler. I would like to jump back in and respond to 
the first question and then I can address that as well. We are 
definitely not done with the MACT program, with the technology-
based part of the Clean Air Act.
    We would encourage the Agency to continue to invest 
resources to finish that program and to finish it effectively. 
There are still a number of key sources that have not been 
effectively regulated.
    At the same time we want to make sure that the residual 
risk part of the program does proceed and that we don't wait to 
make sure that all these issues are resolved.
    In particular, we would like to see EPA prioritize and 
start looking at some of the rules that they knew initially 
were probably not stringent enough. I gave the example of the 
Portland Cement Kiln Rule.
    In the Federal Register notice, EPA did acknowledge that it 
likely is not an effective rule because it was not regulating 
some key pollutants. We would like to see EPA go back to that.
    In terms of getting things caught up in the courts, we 
definitely agree, we would like to see this process proceed 
swiftly, but also not jeopardize quality. But at the same time 
we don't want to see it get hung up in the courts because then 
things just basically cease to move forward. That would not be 
in the best interests.
    Senator Inhofe. Are there any other thoughts?
    Mr. Hopke. I don't see that getting it into the courts will 
be a productive way of protecting public health.
    Senator Inhofe. The whole idea is to avoid that.
    Mr. Hopke. Yes.
    Mr. Hughes. I guess one comment which maybe goes to the 
source of our concern, is seen by just looking at the 
comparison between that which was done on the lead smelter 
issue dealing with some 20 facilities and probably less 
hazardous air pollutants than we are having to deal with in the 
particular segment of our industry we are currently 
approaching, which will include over 250 facilities, deal with 
100-some chemicals in a lot of different locations.
     You know, it is a concern that we haven't, let us say, 
underestimated the task involved and the complexity involved. 
When moving from somewhat of a smaller look at the risk 
assessment approach and now, how are those same principles 
applied to the larger one?
    We will just need to keep watching that, along with the 
timeframes, to make sure we don't get ourselves in a situation.
    Senator Inhofe. When I first walked in I heard Senator 
Smith--I wasn't sure what context it was in or what question 
was asked. He was talking about appropriating more money.
    Other than pouring more money on this, what role does each 
one of you see Congress playing in this to try to get this 
done? Let me start with you, Ms. Stadler.
    Ms. Stadler. Well, I think playing an oversight role is 
always important if it is a constructive role. I think that 
obviously we need to make sure that the resources are 
available.
    But at the same time I think Congress should support what 
the Agency is doing to implement this program as opposed to 
using the oversight process to stall progress.
    Congress can make sure that things are going on the right 
track, that you get feedback from the Agency in terms of 
whether their resources are adequate, but again, not to use it 
to basically tie the Agency's hands or to become too 
prescriptive in terms of how to move the Agency forward.
    Mr. Hopke. I think one of the things would be to clarify 
just what level of precision and uncertainty in the risk 
assessment is going to be acceptable.
    Again, I think there has been a change in the view of what 
these residual risk assessments would have entailed when the 
law was put in place in 1990 relative to then what Congress had 
asked for from the NAS panel that produced ``Science and 
Judgment'' and now a higher level of expectation in terms of 
the quality of the output product.
    I think some clarification as to how good is good enough to 
make decisions is one of the things that I think we might be 
grappling with here.
    Mr. Brenner. Senator Inhofe, I believe there are two areas 
where we could work closely with the Congress on this set of 
residual risk issues. The first is resources, not to throw 
money at it, but just the fact that we heard from the earlier 
panels that to collect data on these chemicals and to collect 
data on the emissions from the sources of these chemicals is a 
resource intensive task. Unfortunately, given budget 
constraints, we have not been able to provide the resources 
that had been requested in previous years.
    Hopefully, there will be some opportunities to work 
together to address that in the future. Then the second area is 
on this very difficult decision. If we do find source 
categories that pose significant risk, then there is a decision 
as to what level of control might be appropriate, what 
constitutes what is called in the statute ``an ample margin of 
safety?''
    That involves considering risk, the potential for effects 
on sensitive individuals. It also calls for considering costs 
and technology availability. That is the sort of thing, where I 
think as we come to the first few of these categories where 
such a decision may be necessary, we would probably want to 
work with you and your staff to talk through these issues and 
make sure we both understand the set of concerns we would be 
grappling with.
    Mr. Hughes. I think I will just reiterate on the issue of 
resources. Without resources the program can't achieve 
especially the pace that it is expected to achieve. So, 
supplying resources to make sure that can happen, there you are 
talking about financial resources to go to the Agency to make 
sure the programs are funded to where they need to collect data 
and address those issues from that perspective.
    I also think that as we move through the process, I don't 
have one specific identified at the moment, but there may be 
cases where we identify, maybe, some problems or some things 
that need to get fixed.
    If there is a way that we can approach something from a 
more holistic standpoint but we end up getting blocked by a 
piece of legislation. If there is a way that all the 
stakeholders could come to agreement that it is a better 
approach at doing that, support from Congress would be 
necessary to be able to correct some of those inherent things.
    As I said, I don't know or have one specifically at the 
moment, but as we move through this we typically run into some 
things like that.
    Senator Inhofe. What about deadlines? Primarily, Mr. Hopke 
and Mr. Brenner, do we need more time?
    Mr. Hopke. Well, at the level of resources currently being 
allocated, I cannot imagine how they are going to meet the 
deadlines.
    Mr. Brenner. I think it is too soon to say that we are 
going to need more time. We are conducting these screening 
analyses. We are working on collecting the additional data.
    I still believe that by working with the industry groups, 
working with the States, using data that other governments have 
collected the California EPA, that we can move through the 
initial screening assessments rather rapidly and then see how 
many industry categories we need to focus on.
    I think until we have gone through those early stages to 
see how this screening process works, we don't know yet that we 
will need more time.
    Senator Inhofe. Here is what I would like to do and one 
reason we wanted to have this: To avoid a train wreck, now is 
the time to be addressing this thing.
    What I would like to ask you to do, Mr. Brenner--well any 
of you while you are working your way through this--if it 
appears that deadlines have to be changed, that, you know, 
changes have to be made, that we find out about it early enough 
that we can do that before we run out of time.
    That is one of the major concerns that we have on our side 
of the table. So, if you can keep us informed as time goes by 
as to the progress you are making and how much more time you 
might need, if you do need it, we need to know.
    Mr. Brenner. We will certainly do that and then we can 
assess, sometimes as we get closer to the deadlines whether 
more time is needed.
    Senator Inhofe. All right. We are right now at the time 
that we have to quit. I think you know what happened on the 
floor today. There will be questions that we will send you to 
be answered for the record.
    But right now, if there is any last statement you want to 
make, the four of you, if you make it brief, this is your 
chance.
    Thank you very much for coming. We look forward to 
continuing to work with you as we near these deadlines we are 
talking about.
    Thank you.
    [Whereupon, at 12:30 p.m., the committee was adjourned, to 
reconvene at the call of the chair.]
    [Additional statements submitted for the record follow:]
      Statement of Hon. Bob Smith, U.S. Senator from the State of 
                             New Hampshire
    Good morning. I want to welcome everyone to today's hearing on the 
use of Comparative Risk Assessment in setting environmental priorities. 
We will also hear testimony on the Science Advisory Board's report on 
EPA's case study analysis of residual risk.
    I think the excellent materials that we received for today's 
hearing show that there's a real interest in using the comparative risk 
assessment process to prioritize resources. I am particularly pleased 
that Ms. Kate Hartnett, the executive director of the New Hampshire 
Risk Project, is here today to talk about New Hampshire's experience 
with comparative risk. Her testimony demonstrates the continued passion 
and innovative spirit that states and local governments are bringing to 
environmental protection.
    This is the third in a series of general oversight hearings 
conducted by the full committee. Our first oversight hearing looked at 
the EPA's proposed budget for fiscal year 2001. Our second oversight 
hearing focused on State successes and the need for a new partnership 
between the States and the Federal Government. We learned about 
programs that work, and those that don't.
    Today's hearing takes us to the next level--beginning the process 
of identifying the tools that will improve our environmental programs. 
Comparative risk assessment is one of those tools. We all recognize 
that there aren't enough resources available to address every 
environmental threat. The Federal Government, States, local 
communities, the private sector, and even environmental organizations 
all have to target their limited resources on the environmental 
problems that present the greatest threat to human health and the 
environment. Our focus, therefore, is, and should be, on getting the 
biggest bang for the limited bucks.
    Comparative risk is the tool that enables us to prioritize the 
risks to human health and the environment and target our limited 
resources on the greatest risks. It provides the structure for 
decisionmakers to: (1) identify environmental hazards; (2) determine 
whether there are risks posed to humans or the environment; and (3) 
characterize and rank those risks. Risk managers can then use that 
analysis to achieve greater environmental benefits.
    Today, we will hear how EPA is using comparative risk to focus on 
the right problems and strategies; and to what extent this approach has 
led to the development of a results-oriented Strategic Plan.
    We will also hear how many states and local governments are already 
using comparative risk assessments a public and open process that 
allows cooperation, instead of confrontation, and encourages dialog, 
instead of mandates. States are setting priorities, developing 
partnerships, and achieving real results by using comparative risk as a 
management tool. They are using good science to maximize environmental 
benefits with limited resources. I believe we should encourage and 
promote these successful programs.
    I look forward to hearing from the witnesses this morning.
                               __________
  Statement of Hon. Max Baucus, U.S. Senator from the State of Montana
    I would like to begin by thanking our committee Chairman, Senator 
Smith, for holding this hearing. The issues of comparative risk 
assessment and residual risk analysis are not only important, but 
timely.
                      comparative risk assessment
    I believe that it is important for this committee to continue to 
examine tools for improving the ways in which we protect public health 
and the environment.
    We need to always look for new approaches to addressing lingering 
or emerging environmental problems. We must determine which of these 
tools will give us the results, and the efficiencies, that we need.
    And at the same time, we must set environmental priorities more 
effectively than we have in the past so that our efforts, and the money 
that is available, will address the most pressing problems.
    I believe that risk-based tools--such as comparative risk 
assessment--have much to offer in this regard. Because of this, I have 
long been a strong supporter of the use of risk assessment as an 
environmental policy tool.
    For example, I worked hard with Senator John Chafee and other 
members of this committee to find an appropriate role for risk 
assessment when we amended the Safe Drinking Water Act in 1996. I am 
proud of what we came up with. I think we significantly improved that 
law.
    At the same time, however, I have also long believed that we need 
to proceed carefully and thoughtfully as we consider using risk-based 
tools. We need to clearly understand what each tool can do. And what 
each can't. Otherwise, we may end up expecting too much or too little 
of them.
    For example, while I'm a supporter of risk assessment, I often 
think that its most ardent proponents oversell it. They simply gloss 
over inherent limitations to risk assessment, such as the gaps in data 
or scientific understanding, the absence of important analytical 
methods, and the sensitivity of this tool to underlying assumptions.
    We need to be honest about risk assessment. We take its strengths--
and weaknesses--fully into account in each and every application of 
risk assessment.
    Further, it is important to remember that any tool we may decide to 
use to assist in decisionmaking is just that, a tool. There are no 
``silver bullets'' for decisionmaking.
    One of the reasons for this is that, despite when we may hear 
sometimes, the ``science'' we must depend on is, and can never be, 
complete. That's simply the nature of science.
    I recall a speech made by Senator Smith, one he made when he first 
became this committee's chairman, in which he said that we can't deny a 
problem just because the science is uncertain. I couldn't agree more. 
If we waited for scientific certainty, we'd end up deferring action on 
every single environmental problem we face.
    Furthermore, it is critical to recognize that values such as 
fairness, equity and other subjective judgments are essential 
components of any environmental decision.
    A risk assessment may legitimately find that, for most Americans, 
hazardous waste sites pose little risk. But it is equally legitimate, 
from the perspective of fairness or equity, to ask whether this means 
we should decide not to protect the health of the minority of Americans 
who happen to live near these sites.
    The bottom line is that, when used carefully and thoughtfully, 
tools such as risk assessment can be extremely helpful in informing 
environmental policy decisions. But they cannot by themselves make 
these decisions.
                             residual risk
    Before I end, I would like to say a few words about the second part 
of today's hearing, residual risk. I look forward to hearing from our 
last panel about the status of the residual risk program.
    As everyone here knows, we're gradually beginning stage two of the 
ambitious control program for toxic air pollutants that we started in 
1990. The MACT standards are almost all done now and EPA has begun to 
look at reducing the risks to public or environmental health that 
remain after MACT has been applied.
    Some people have questioned whether EPA has the ability or the 
resources to regulate to get rid of ``residual risk.'' They suggest 
that EPA doesn't have enough data or the right data or the right 
models. Some of those criticisms may be partly on the mark, but that 
has a lot more to do with funding than ``science.'' Residual risk was a 
carefully considered provision of the 1990 Amendments and it was not 
adopted lightly. We understood that there would be significant 
uncertainties associated with estimating risk.
    That's why we required a report to Congress first, with any 
necessary regulation to follow. And, that's why EPA has to consider 
costs, energy, safety and other relevant factors, before issuing 
regulations to reduce residual risk.
    I look forward to making this program work and further reducing 
toxic air pollution.
    Again I would like to thank Senator Smith for holding this hearing. 
I hope it provides this committee with an opportunity to learn much 
more about EPA's residual risk analysis, as well as comparative risk 
assessment and what it has to contribute to improving environmental 
decisionmaking.
                               __________
Statement of Hon. Daniel Patrick Moynihan, U.S. Senator from the State 
                              of New York
    Mr. Chairman, fellow members of the committee, I am delighted to be 
here for a hearing on risk assessment, a topic on which I held my very 
first hearing as chairman of this committee in 1992. I am also deeply 
grateful to my friends for their kind words today.
    I remember fondly the many significant accomplishments that we have 
made together on this committee. In 1980, 1982 and 1990 we wrote 
significant legislation to curb acid rain and other air pollution that 
has choked our skies, fowled our waters, and endangered our health. We 
have come a long way to fix these problems, but we still have more to 
do and I hope the committee will continue to focus on air pollution and 
pass legislation next year to address these ongoing threats. In 1986, 
we passed the landmark Water Resources Development Act (WRDA) which 
broke a deadlock that had stalled millions of dollars of civil works 
projects critical to State and local communities. One of my proudest 
achievements is our work on the Intermodal Surface Transportation 
Efficiency Act (ISTEA) of 1991 which has changed the way we view 
transportation policy.
    I have greatly enjoyed my time serving on this committee since I 
was first appointed on February 11, 1977. I began my service on the 
committee under the leadership of Senator Jennings Randolf of West 
Virginia and served as chairman myself in 1992. More recently the 
committee has had a wonderful period of productivity under the sage 
guidance of my beloved friend, the late John H. Chafee. Today, Senator 
Smith serves as a facilitator who conducts the committee's work in a 
fair and open process. I will surely miss this committee, its work, and 
the friends with whom I have had the privilege to serve.
    The matter before us today is one that we cannot take lightly. The 
calculation of risks posed by environmental contaminants and the 
subsequent determination of appropriate regulatory controls is a 
complex exercise that involves not only the lives of our citizens and 
the health of our environment, but the State of our welfare and 
economy. It is quite clear that environmental regulations have 
prevented millions of deaths EPA has estimated that the Clean Air Act 
alone prevents 205,000 cases of premature mortality annually. At the 
same time, Resources for the Future estimates that $160 billion is 
spent annually in the United States for environmental compliance. This 
may not be too much to spend on environmental protection, but it is too 
much to spend unwisely.
    Comparative risk assessment is an example where science must take 
the leading role. Only science can give us the parameters to estimate 
the relative risks posed by varying concentrations of toxic substances. 
However, good science can only be accomplished with adequate resources 
and data. The Science Advisory Board has reported to us that EPA lacks 
the resources and data to adequately address some aspects of risk 
assessment. We must support EPA's request for more research dollars if 
we are to expect EPA to adequately address this issue.
    In conclusion, I have always believed that good science makes good 
policy, and good policy makes good politics. While factors such as 
cost, welfare, and even politics indeed play a role, we must ensure 
that environmental decisions can always be justified by scientific 
research. I thank the committee for the opportunity to discuss this 
issue and, again, I am grateful to my colleagues for their kind words 
today and for their valued friendships throughout the years.
                               __________
 Statement of Hon. Frank R. Lautenberg, U.S. Senator from the State of 
                               New Jersey
    Thank you, Mr. Chairman, for holding a hearing on this important 
topic.
    Congress tends to address environmental problems one at a time. The 
Clean Air Act, the Clean Water Act, and the Resource Conservation and 
Recovery Act are each massive, complex laws, and we rarely take the 
time to examine where these laws intersect. Last week, this committee 
held a hearing on the Streamlined Environmental Reporting and Pollution 
Prevention Act, which I have introduced with Senator Crapo and which, 
Mr. Chairman, I hope we can mark up soon. That bill reduces the 
administrative burdens associated with the piecemeal nature of 
environmental reporting.
    This hearing essentially addresses a similar issue. In this 
hearing, we will discuss whether our current environmental laws are 
focused on the whole forest, or just a few well known trees.
    That may sound like an abstract notion, so let me bring it to life. 
In Toms River, New Jersey, there has been observed a higher than normal 
incidence of certain childhood cancers. It's a terrible situation, and 
one that is likely happening undetected across the country. So what's 
causing it? How do we prevent it? Was it caused by any of the dozens of 
chemicals found in tiny amounts in the water? What about the 
radioactive materials released to the air from the nearby nuclear 
plant? What about the pollution from the cars on the parkway which 
bisects Toms River? What are the greatest environmental risks to this 
community?
    And these are just the questions science can answer. When we as 
policymakers decide how best to prevent environmental risks in this 
community and across the country, we face other questions that have no 
scientific answer: How do we compare the risk of an elderly person's 
premature death to that of a child's asthma attack? How do we compare 
risks to our health risk to those of our grandchildren and their 
children? How do we compare a human health risk to the extinction of an 
animal species? At what point do we decide we know enough about an 
emerging risk to take a precautionary approach? There are no scientific 
answers to these questions--yet we can't decide how best to allocate 
our risk reduction resources without resolving them.
    That all being said, I look forward to the thoughts of our expert 
witnesses on these challenging issues.
    Thank you, Mr. Chairman.
                               __________
     Statement of Hon. Joseph I. Lieberman, U.S. Senator from the 
                          State of Connecticut
    As the 106th Congress draws to a close, I would like to take this 
opportunity to bid farewell to a good friend and a man I deeply 
respect, Senator Frank Lautenberg, who is retiring at the end of this 
Congress.
    During his 18 years in the Senate, he has admirably served his 
constituents in New Jersey but he has also served Americans nationwide. 
With his acute understanding of the issues, his principled nature, and 
his strong, effective leadership, he has stood firm for families. He 
has worked tirelessly to build a strong economy, to better the 
education and mentoring of our children, to rebuild the infrastructure, 
and ensure equal rights and equal opportunity for all Americans. He 
leaves a legacy of legislative success from which the Nation will 
benefit long into the future. Today, however, I would like to pay 
special tribute to his work to preserve our environment.
    In our time together on the Environmental and Public Works 
Committee, Senator Lautenberg has achieved great things. One that 
stands out is the role he played in renewing and improving the 
Superfund program. His insistence that people living near hazardous 
waste sites be protected from health risks motivated him to address the 
broader threat posed by poisons seeping into the earth.
    Senator Lautenberg must also be credited for another noteworthy 
achievement: public access to information about toxic chemicals 
manufactured, used or transported in our communities or released into 
the environment. His leadership was instrumental in the establishment 
of the Toxics Release Inventory, which, as part of the Emergency 
Planning and Community Right-To-Know Act and the Pollution Prevention 
Act, requires a publicly accessible toxic chemical data base to be 
developed and maintained by the Environmental Protection Agency (EPA). 
In great part, because of Senator Lautenberg's vigilance, Americans now 
have access to this valuable source of information that both encourages 
companies to better manage their toxic substances and provides citizens 
with the data necessary with which to challenge violators.
    My colleague's love for the environment did not stop with his work 
to clean up the land. It extended to the air we breathe and the 
waterways that sustain us. As a longtime advocate for clean air, he led 
the fight to include a section in the 1990 Clean Air Act Amendments 
that set specific limits on the allowable levels of specific hazardous 
air pollutants. This was a significant achievement in Congress' efforts 
to improve air quality, since before 1990, EPA had not regulated the 
majority of these chemicals. The language Senator Lautenberg drafted 
left no uncertainty, and we began to remove these toxins from our 
skies.
    For Senator Lautenberg, the quality of indoor air was equally as 
important. He championed the ban on smoking on domestic airline 
flights, an accomplishment that literally allows traveling Americans to 
breathe easier every day.
    He has likewise been a strong advocate of clean coastal areas for 
the safety and enjoyment of our citizens. My friend wrote legislation 
to ban ocean dumping of sewage and to clear beach areas of rubbish. He 
responded to constituent complaints of syringes littering the beaches 
and actively promoted legislation to control medical wastes. And he 
worked to stop offshore oil drilling and to prevent oil spills from 
polluting the water fronts and endangering wildlife.
    Finally, Senator Lautenberg's abiding interest in transportation 
has improved the safety and quality of life for Americans coast to 
coast. He successfully encouraged states to raise the national drinking 
age to 21 and has since sponsored legislation to lower the national 
standard over which a driver is presumed drunk to a blood alcohol level 
of 0.08. He demonstrated particular leadership in the battle to 
authorize and fund a national Intelligent Transportation Systems 
program to reduce traffic congestion and speed motorists to their 
destinations and successfully sought to block the expanded use of the 
larger, triple trailer trucks. This was a special victory, for he felt 
passionately that longer, combination vehicles endangered the lives of 
others on the road. We must also be grateful for the Senator's longtime 
commitment to a passenger rail system and mass transit investment. He 
championed the Boston to D.C. high-speed rail which will open as early 
as Thanksgiving and sponsored legislation for a major Federal 
investment in the development of high-speed rail corridors across the 
Nation.
    Through these and many other efforts, the Senator from New Jersey 
has helped to ensure that Americans live in a cleaner, safer and 
healthier environment. I commend him for his significant and lasting 
accomplishments and thank him for his dedication and leadership. It has 
been an honor to work by his side, and I wish him great happiness in 
his future endeavors.
                               __________
  Statement of Dr. Al McGartland, Assistant Administrator, Office of 
Policy, Economics, and Innovation, U.S. Environmental Protection Agency
                              introduction
    Good morning, Mr. Chairman and members of the committee. I 
appreciate this opportunity to present EPA's views on the value of 
comparative risk assessment, and the extent to which we use this tool 
to attain the Agency's, and the Nation's, public health and 
environmental goals.
    EPA's interest in comparative risk dates from 1987, when we 
produced a groundbreaking report, Unfinished Business, that assessed 
and ranked 31 different environmental programs that we had the legal 
responsibility for managing at the time. That report marked the first 
time in the Agency's history that we attempted a comprehensive, cross-
media, risk-driven comparison and ranking of environmental risk. Then 
in 1990 EPA's Science Advisory Board (SAB) produced Reducing Risk, a 
report that examined strategies for reducing major environmental risks, 
and recommended improved methodologies for assessing and comparing 
risks and risk reduction options in the future.
    Since then, comparative risk assessments have become more widely 
accepted as an input to the priority-setting process. They have been 
conducted by a number of State and local governments, and I am pleased 
to see that representatives from cities and states have been invited to 
present their perspectives to this committee. For its part, EPA has 
made use of this tool in our Agency-wide strategic planning processes, 
in our partnerships with state, local, and tribal governments, and in 
many specific programs, both regulatory and non-regulatory. There is no 
doubt that comparative risk assessment today is helping EPA, other 
levels of government, and the business community prioritize risks, 
target our respective risk reduction efforts, and thus reap more 
environmental benefits for every dollar spent.
    At the same time, I want to emphasize that the usefulness of 
comparative risk assessment is limited. It is not being used by EPA 
today, and most likely never will be used, as a bright-line, 
mechanistic way of ordering the Agency's priorities for either 
strategy, budgets, or actions. A number of other factors also have to 
be considered, and all these relevant factors, including but not 
limited to comparative risk assessment, have to be considered when the 
Agency sets its priorities.
    For example, many Federal environmental laws set timetables and 
deadlines for EPA to take specified actions or accomplish specified 
goals. EPA has an obligation to carry out the laws, which reflect the 
will of an elected Congress and properly reflect considerations beyond 
comparative risk.
    Another difficult problem arises in any attempt to include human 
health and ecological risks in the same ranking. How do you prioritize 
the risks associated with pollutant exposures that may cause cancer in 
humans, as compared to degraded water quality in the Chesapeake Bay 
that may deplete oyster beds? The Science Advisory Board recognized 
this problem when they wrote Reducing Risk, and they did not attempt to 
include human health and ecological risks in the same ranking.
    Community concerns also have to be considered when setting 
environmental priorities. If a community believes that action must be 
taken to solve what it considers to be a pressing environmental 
problem, then EPA has an obligation to respond, even if the problem 
does not rank high on a list of comparative risks.
    Another consideration in setting priorities is the different roles 
that EPA has, depending on the environmental problem being addressed or 
program being implemented. For example, budget needs may differ 
depending on whether a regulatory program is implemented at the Federal 
level or is primarily implemented by the States. As another example, a 
program aimed at reducing risk through public education may have 
different budget needs compared to a program that provides technical 
assistance.
    This is not a complete discussion of all the factors that enter 
into EPA's priority-setting processes. Other hard-to-quantify 
considerations, like intergenerational equity and environmental 
justice, also have to be weighed. For our purposes here today, I simply 
want to emphasize that comparative risk assessment provides a useful 
mechanism for helping us think about environmental priorities, but by 
itself it cannot provide any complete answers.
    comparative risk assessment in strategic planning and budgeting
    An important area in which comparative risk information comes into 
play is in the Agency's planning, priority-setting, and budgeting 
processes. As required by the Government Performance and Results Act 
(GPRA), EPA developed a 5-year Strategic Plan in 1997, Annual 
Performance Plans for Fiscal Years 1999 through 2001, and an Annual 
Performance Report for Fiscal Year 1999. I want to emphasize that EPA 
is one of the few, if not the only, agency to restructure its budget to 
match the goal and objective structure of its Strategic Plan. This 
allows Agency decisionmakers, Congress, and the public to identify the 
resources associated with each of the Agency's goals and objectives, 
and to compare the prospective benefits of these long-term outcomes 
when making judgments about the Agency's proposed priorities and 
funding.
    In setting its strategic goals and objectives and developing 
specific budget proposals to achieve them, the Agency uses the best 
available scientific and economic analysis. The performance targets 
identified in the Strategic Plan, such as the objective of having 95 
percent of the population served by community water systems receive 
water that meets national health standards by 2005, reflect the 
Agency's decisions on the relative priority the Agency will place on 
different environmental problems and programs. In communicating our 
GPRA goals and objectives, annual performance targets, and actual 
performance, the Agency has attempted to characterize for Congress and 
the public the nature of the different health and environmental risks 
that our programs are addressing.
    With regard to annual budgets, comparative risk considerations have 
been explicitly factored into various internal Agency-wide budget 
investment and reduction exercises. As an example, our Office of 
Research and Development uses information on the relative risks 
associated with environmental problems in its annual cross-goal ranking 
used in determining research priorities. Furthermore, it would be fair 
to State that risk information, when available and relevant, is 
implicitly included in most discretionary decisions made by Agency 
program managers, both in setting priorities within major programs and 
allocating resources across programs.
    In recent budget formulation exercises, internal budget guidance 
specifically required that Agency investment proposals characterize 
human and ecological risk reductions. While risk information plays a 
role, GPRA priority-setting and resource allocation decisions are 
generally made on the basis of multiple criteria. Costs and benefits, 
equity, institutional and legal feasibility, statutory mandates and 
other Congressional direction, public values, risk tradeoffs, and 
governmentwide priorities represent some of the factors that enter into 
budget discussions and decisions.
    Many challenges face EPA, Congress, and the interested public in 
better using comparative risk information in environmental priority-
setting and budgeting. Availability of cost and risk data is improving, 
but varies greatly across and within EPA programs. Methodologies for 
assessing risk and benefits are at varying stages of development. 
Finally, the diverse endpoints being addressed by environmental 
programs--such as cancer versus non-cancer health effects, human health 
versus ecological protection, reduction of chronic exposures versus 
prevention of low-probability but high-risk chemical spills and 
accidents make direct comparisons of risks and benefits difficult. As 
we work to improve comparative risk data and tools for use in priority-
setting and budgeting, EPA also will continue to improve the links 
between its budget and its GPRA goals and objectives in order to 
facilitate the ongoing dialog with Congress and stakeholders about our 
priorities.
      comparative risk assessment in epa/state/tribal partnerships
    A strong partnership between EPA and State and tribal governments 
has always been one of the most important and effective aspects of U.S. 
environmental policy. As comparative risk assessments have become more 
sophisticated and useful over time, they have been incorporated into 
the EPA/state/tribal partnership in several fundamental ways.
    For example, from the time that EPA and the SAB first began to 
assess and prioritize relative risks, the Agency has encouraged and 
supported similar processes by states, communities, and Native American 
tribes. Between 1990 and 1999 EPA provided financial and technical 
assistance to states, localities, tribes, and watershed organizations 
to support comparative risk projects of their choosing. EPA provided 
expert advice on the process, developed resource materials, supported 
communications among project directors, and paid for project startup 
costs. EPA required all parties involved to meet general project 
criteria, but the participants decided how they would apply the 
criteria, and they could use comparative risk assessments to meet their 
unique purposes. During the decade of the 1990's EPA provided about one 
million dollars a year to support these comparative risk assessment 
activities.
    In most cases, the projects resulted in a much clearer 
understanding of local environmental challenges, and sometimes they 
inspired new environmental initiatives. The results of EPA-supported 
comparative risk assessments also led to the funding of several 
environmental risk-management initiatives that were already under 
consideration by State and local governments at the time. At EPA we are 
very proud of these accomplishments, and I think the State and local 
representatives you will hear from today will agree.
    As these critical partnerships have evolved over the past decade, 
comparative risk assessments have played an increasingly important 
role. Because of our shared commitment to improving public health and 
environmental quality, in 1995 EPA and the states jointly entered into 
a new National Environmental Performance Partnership System, or NEPPS. 
This stronger, more collaborative partnership emphasizes that EPA and 
the states are mutually dependent on each other in our respective 
efforts to reach our shared environmental goals. Through NEPPS EPA and 
the states jointly set priorities for action, and we work together to 
clarify our roles and responsibilities.
    The centerpiece of NEPPS is Performance Partnership Agreements 
(PPAs) between EPA and individual states. The PPA is the mechanism that 
allows each state, in conjunction with EPA, to set priorities, solve 
problems, and make the most effective use of our collective resources. 
Comparative risk assessment is one of the management tools used by 
states to determine which programs they want to target for improvement 
or strengthening as part of their PPAs. These agreements thus give 
states greater freedom to focus their resources on their highest 
environmental priorities, and comparative risk assessment is one way 
those priorities can be established. However, like EPA, states must 
comply with Federal environmental requirements regardless of their 
considerations of comparative risk.
    Under NEPPS the states also have more flexibility in administering 
EPA grant funds. With our new Performance Partnership Grants (PPGs), 
states now can consolidate a variety of individual grants into one. 
That kind of simplification and consolidation can be driven by 
comparative risk assessment. For example, if a comparative risk 
analysis showed that a particular source of drinking water poses 
relatively high risks, a State could combine funding for drinking water 
and solid waste programs and target it at the program in need of 
supplemental funding. Here again, greater flexibility and comparative 
risk assessment come together to strengthen a traditional partnership.
    Let me give you an example of how this works in practice. 
Delaware's Department of Natural Resources and Environmental Control 
(DNREC) was the first to utilize a so-called ``logic model,'' which 
uses comparative risk assessment to help set priorities. Different 
categories of environmental information were organized to reflect 
environmental conditions, stressors, and pollution sources. The DNREC 
then developed a self-assessment that addressed the department's 
activities and capabilities in relation to this information. The 
subsequent Performance Partnership Agreement contained joint EPA/state 
priorities and initiatives that reflected the environmental and program 
needs identified by the self-assessment. In short, comparative risk 
assessment was one of the primary forces shaping Delaware's PPA.
        comparative risk assessment in epa's regulatory programs
    To some extent, comparative risk assessment is used in many of 
EPA's regulatory programs. I would like to describe three in more 
detail, because that will give you a sense of how comparative risk 
assessment has been integrated into the Agency's more traditional 
activities.
    For example, EPA is using comparative risk assessments to help set 
priorities in its program to control toxic air pollutants. Under 
Section 112(e) of the Clean Air Act, EPA is required to develop a 
Source Category Schedule (SCS) for promulgating Federal emissions 
standards for 174 categories of sources of toxic air emissions. In 
determining scheduling priorities, the law requires EPA to consider 
three criteria: (1) the adverse effects of the different hazardous air 
pollutants; (2) the quantity and location of emissions of each 
pollutant; and (3) the relative efficiency of different groupings of 
source categories or subcategories. To help develop this schedule, EPA 
established a system that combines emissions estimates, health effects 
data, and limited population information in order to generate an 
approximate idea of the comparative risks of the various source 
categories. This system was used in conjunction with other 
considerations, such as work load efficiency and the time needed to 
develop different standards, to establish the Source Category Schedule.
    EPA also has used a form of comparative risk assessment in 
developing our Integrated Urban Air Toxics Strategy under Section 
112(k) of the Clean Air Act. The law requires EPA to identify at least 
30 pollutants that pose the greatest threat to public health in the 
largest number of urban areas. To address this requirement, EPA 
developed a methodology composed of three separate ranking analyses 
that each relied on information relevant to risk assessment, such as 
toxicity, emissions, ambient monitoring, and air quality modeling. We 
integrated the results of the three analyses to obtain the list of 33 
urban hazardous air pollutants that will guide our actions under the 
strategy to protect public health in urban areas.
    As in the air program, many of the priorities in our national water 
program are guided by the principle of addressing the highest risks 
first. For example, the Safe Drinking Water Act of 1996 provides clear 
direction to the Agency to focus on contaminants of greatest risk. 
Consequently, over the last few years EPA has issued a number of 
regulatory actions aimed at controlling high risk contaminants such as 
disinfectants and disinfectant byproducts. We have proposed criteria 
for determining when disinfection is required for underground drinking 
water sources, and proposed added protections for smaller drinking 
water systems. In addition, EPA now is gathering data on the occurrence 
and health effects of other contaminants. These data will help the 
Agency make sound decisions in the future about which drinking water 
contaminants are high-risk and warrant regulation, while also helping 
set priorities for drinking water research, monitoring, and guidance 
development, including health advisories.
           comparative risk assessment in voluntary programs
    Over the past decade, EPA has augmented its traditional regulatory 
programs with a variety of voluntary partnerships that can be targeted 
at either regulated or unregulated pollutants. These programs have 
proven to be remarkably successful, because many businesses have begun 
to realize that there is a strong linkage between economic and 
environmental performance. In most cases, as businesses become 
efficient and reduce or eliminate waste streams, they become more 
profitable. For these and other reasons, many businesses today are 
demonstrating environmental stewardship and improving environmental 
performance in ways that go beyond what government regulations require.
    The growth of voluntary partnership programs in the 1990's occurred 
at the same time that the techniques of comparative risk assessment 
were becoming more sophisticated and more widely applied. As a 
consequence, many voluntary risk-reduction efforts--whether conducted 
by EPA, private businesses, or jointly--include a comparative risk 
component.
    For example, EPA today is trying to find more effective, 
integrated, and comprehensive solutions to the complex environmental 
problems caused by specific industry sectors. At the same time, we want 
to reduce the regulatory burden on those same industry sectors. To meet 
those goals, we have initiated a sectors program that takes a more 
strategic approach to environmental protection. We tailor a set of 
actions--some required by regulation and some voluntary--to address the 
unique environmental issues, needs, and opportunities presented by 
different industries. The strategic design and subsequent 
implementation of these sector programs involve comparative risk 
assessments as part of the priority-setting process.
    When EPA works in partnership with a particular industry sector, we 
jointly design a targeted set of effective actions that achieve 
cleaner, cheaper, smarter environmental results. This priority-setting 
process involves a comparative analysis of the industry's most 
significant environmental impacts and the likely effects of possible 
actions to address those problems. This analysis may not take the form 
of an in-depth, scientific study, but it does involve thorough 
consideration of existing data sources, current environmental 
priorities, and expert stakeholder perspectives. The end result is a 
tailored, sector-specific action plan that, by definition, reflects the 
sector's comparative risk profile.
    For example, EPA's metal finishing sector stewardship program 
started with a comparative assessment of that industry's multiple 
environmental impacts. The stakeholders involved, including EPA and 
industry representatives, reached the common conclusion that the 
greatest environmental stewardship opportunities in this industry 
sector were water and energy conservation, reduced metals loadings, and 
reduced sludge generation. EPA then was able to work with the industry 
and other stakeholders to develop a first-of-its-kind stewardship 
program that set voluntary performance targets for those key 
environmental parameters.
    Many of the innovative ideas developed and tested at EPA over the 
past decade have come together in a new program that the EPA 
Administrator announced on June 26. Called Performance Track, this 
program encourages businesses to do more than the law requires to 
protect human health and the environment. For those businesses that 
show exemplary environmental stewardship, EPA is going to reward them 
with a package of benefits that will include lower costs, streamlined 
administrative operations, and public recognition.
    One of the most important actions that we're requiring of 
Performance Track participants is that they put in place a vigorous 
environmental management system. These management systems will have to 
include several specific components, including a facility-wide 
commitment to pollution prevention, environmental training for all 
employees, and an emergency preparedness program. We'll also expect 
participating companies to set specific performance targets and then 
hit those targets successfully.
    And that's where comparative risk assessment will prove valuable. 
In their environmental management systems companies will have to 
characterize their environmental emissions, assess the health and 
ecological risks they entail, and then set risk-based priorities for 
improving their performance over time. In this sense comparative risk 
assessments lie at the heart of environmental management systems, and 
thus they will play an integral role in EPA's Performance Track 
program.
                               conclusion
    As these examples demonstrate, over the past decade comparative 
risk assessment has emerged as an important priority-setting tool at 
EPA. In most cases, more complete data bases and more sophisticated 
methodologies would lead to more robust results, and so at EPA we're 
continually working to improve our capabilities to conduct comparative 
risk assessments.
    At the same time, I want to emphasize that these assessments will 
never, by themselves, provide an unambiguous, bright-line way of 
ranking the Agency's management priorities. No matter how much data we 
collect or how much further the methodologies evolve, the reality of 
risk reduction will always demand a large measure of judgment related 
to ethics, equity, and economics. Widespread public concerns, for 
example, may raise the profile of a particular risk and necessitate 
early and forceful Agency action, even if the risk is not very high 
when compared to other Agency programs. We sometimes may act to control 
relatively less serious risks if available risk management options are 
cheaper and more effective. And sometimes we have to apply simple human 
judgment when deciding on the relative importance of controlling risks 
to humans versus risks to ecosystems, or risks to current generations 
versus risks to the future.
    In short, when setting priorities for budgets and actions, EPA has 
to consider a range of factors, one of which is comparative risk 
assessment. I believe we are using such assessments well today, and we 
will use them even more effectively in the future. But even as we 
improve their use and effectiveness, we should not lose sight of their 
inherent limitations.
    Thank you very much.
                                 ______
                                 
 Responses of Al McGartland to Additional Questions from Senator Smith
    Question 1. In its report entitled ``Strengthening Science and Peer 
Review at EPA'', the NRC concluded that:

          Scientific knowledge and technical information are essential 
        for determining which environmental problems pose important 
        risks to human health, ecosystems, the quality of life, and the 
        economy. We need scientific information to avoid wastefully 
        targeting inconsequential problems while ignoring greater 
        risks. We need such information to reduce uncertainties in 
        environmental decisionmaking and to help develop cost-effective 
        strategies to reduce risk. We need science to help identify 
        emerging and future environmental problems and to prepare for 
        the inevitable surprises.

    Do you agree? Please explain what EPA actions are being taken in 
that regard.
    Response. We agree that scientific knowledge and technical 
information are essential components in the evaluation of environmental 
problems. As stated in our Strategic Plan, EPA strives to ensure that 
its efforts to reduce environmental risk are based on the best 
available scientific information. In its implementation of the 
Government Performance and Results Act (GPRA), EPA established a 
strategic planning framework comprising 10 strategic goals with 
associated long-term objectives. Goal 8 of that framework, Sound 
Science, emphasizes EPA's commitment to (1) identify the most important 
sources of risk to public health and the environment and thereby guide 
Agency decisions, and (2) anticipate environmental and other changes 
that might portend future environmental risk and integrate futures 
thinking into Agency planning.
    There are many examples of actions EPA has taken to enhance the use 
of sound, credible, and relevant science in Agency decisionmaking. One 
example is the Office of Research and Development (ORD) Strategic Plan, 
which complements the Agency's Strategic Plan and identifies risk-based 
criteria for establishing research priorities. Using these criteria, 
ORD has identified eight high-priority areas where significant levels 
of input will be required for EPA decisionmaking now and in the future. 
These research areas will include issues such as: understanding the 
health risks of exposure to fine particles in air pollution, preserving 
safe drinking water, and research to improve ecological risk 
assessment.
    Because science activities take place throughout EPA, the cross-
agency Science Policy Council is building on the ORD development of 
both an Agency-wide inventory of scientific activities and a 
``Strategic Framework for EPA Science'' in planning EPA scientific and 
research activities that focus on the most important environmental 
risks. Importantly, the technical products that result from these 
efforts are peer reviewed, thereby ensuring the best and most relevant 
science is used in Agency actions and decisions. In the area of 
anticipating future environmental problems, ORD is building upon the 
National Academy of Public Administration report, ``Remembering the 
Future: Applying Foresight Techniques to Research Planning at EPA'' to 
apply the concept of futures in its research planning.
    Additionally, in October 1999, the Administrator created a new 
Office of Environmental Information (OEI) that has central 
responsibility over information management, policy and technology 
because of the growing demand for high-quality environmental 
information. Creating the office was a collaborative process with input 
from a wide range of staff and stakeholders, both internal and external 
to EPA. OEI activities such as strengthening information partnerships, 
enhancing information quality, and communicating the utility of 
environmental information will help the Agency to foster information-
based decisionmaking. We also hope these activities will generate new 
trend and outcome-information to promote adaptive and forward-looking 
environmental management by decisionmakers at all levels.
    These examples illustrate some of the steps that EPA has taken to 
incorporate scientific, technological, and environmental information 
into the environmental decisionmaking process.

    Question 2. Michael J. Pompili, Assistant Health Commissioner, 
Columbus Health Department Columbus, Ohio testified that:

          At one time, the Federal Government funded a U.S. EPA office 
        to directly assist State and local folks interested in doing 
        this type of work. This Regional and Statistical Planning 
        Branch of the Office of Policy, Planning and Evaluation was 
        extremely helpful to us in Columbus providing a $50k grant for 
        our project and direct technical assistance in project 
        formation and implementation. I have heard many other local 
        project directors share these sentiments. Unfortunately, the 
        office was disbanded a year or so ago and its personnel were 
        reassigned within the Agency. To my knowledge, there is now no 
        Federal entity that exists concerned with promoting and 
        directly assisting State and local governments with projects 
        dealing with risk-based decisionmaking.

    Please explain why that office was disbanded and what is EPA doing 
to reinstate support for State and local governments with projects 
dealing with risk-informed decisionmaking.
    Response. The Agency operated a comparative risk program for 
approximately 7 to 8 years. During that time, we made large 
contributions to State and local governments for conducting risk 
assessments. State and local governments have continued to use the 
tools and methods that we shared during that time to set their 
priorities. Two years ago, we shifted our comparative risk staff and 
resources to focus on the Agency's implementation of the President's 
Clean Water Action Plan.
    We continue to encourage our State and local counterparts to 
incorporate risk and other factors into their priority-setting process. 
As part of the National Environmental Performance Partnership System, 
EPA Regional Offices work with our State counterparts in joint planning 
and priority setting. These efforts are based upon an analysis of 
environmental information and State and local conditions to determine 
the environmental problems that deserve the highest attention. 
Environmental information is coupled with risk assessment to identify 
the most significant State and local environmental problems. The State 
Agency and EPA Regional Office then develop work plans to address these 
problems.
    The State/EPA work plans are contained within Performance 
Partnership Agreements or other similar documents outlining the 
priorities, what actions will be taken by which agency, and how State 
assistance grants will be used to accomplish this work. Under current 
guidelines and a proposed new regulation governing State assistance 
grants (the Part 35 rule), EPA and States work together to determine 
comparative risks and set priorities. With a Performance Partnership 
Grant (PPG), a State can combine two or more of 16 different 
categorical grants into a PPG to have funding flexibility to address 
the highest priority risks. States are encouraged to involve the public 
in this process of determining priorities.
    Some of our program offices also offer assistance to communities 
for evaluation of local environmental problems. For example, we have a 
program called the Technical Outreach Services for Communities (TOSC), 
which is a service of the Hazardous Substance Research Centers program 
and the Superfund program. Through the TOSC program, communities have 
access to independent technical advisors through universities. TOSC has 
helped 118 communities understand the issues and solve problems dealing 
with hazardous substance contamination.

    Question 3. Under executive order 12866, EPA prepares detailed 
cost-benefit analyses for all economically significant regulations. 
Under that order, EPA also is to review, periodically, existing 
regulations that are economically significant to determine if they can 
be made more effective or less burdensome. How effective has EPA been 
in carrying out those responsibilities? What would EPA do if a proposed 
regulation did not pass the benefit-cost test?
    Response. (a) How effective has EPA been in carrying out those 
responsibilities? EPA has a strong record of success under the 
``lookback'' provision of Executive Order 12866. In 1995, in response 
to the President's request, EPA conducted a page-by-page review of all 
its regulations and removed over 1200 pages of regulations from the 
Federal Register. Subsequent to that effort, EPA has reached out to the 
regulated community to identify cheaper, cleaner, and smarter ways to 
achieve needed environmental improvements than those codified in 
existing regulations, including those that are deemed economically 
significant. Two of our major initiatives in this direction have taken 
place under the auspices of the Common Sense Initiative and Project XL. 
A sample of recent improvements stemming from our ongoing review of 
existing rules includes:
    Proposal for a Consolidated Air Rule for Chemical Manufacturers.--A 
newly issued rule that consolidates 16 Federal air regulations into a 
single guideline could save the average U.S. chemical plant about 1,700 
hours or $80,000 a year. The regulation, which represents the first 
consolidated rule ever under the Clean Air Act, would afford plant 
managers a choice. The facility managers could opt to comply with the 
consolidated rule or continue operating under the existing 16 rules.
    Streamlined Certification Process for Auto Makers.--A streamlined 
process for certifying that new passenger cars and trucks meet Federal 
standards for air pollution emissions is expected to save automobile 
manufacturers an estimated $55 million a year. Under the proposed 
process, testing would be performed on vehicles actually in use on the 
Nation's highways rather than on brand new vehicles. In addition to 
cutting burden, the new process creates an incentive for manufacturers 
to produce more durable emissions-control equipment and gives EPA 
better date for managing air quality programs.
    Simplified Hazardous Waste Management Requirements.--the Agency 
addressed several barriers that have prevented common-sense practices 
in managing hazardous wastes. Reforms to the 20-year-old program for 
managing polychlorinated biphenyls (PCBs) are expected to produce cost 
savings estimated between $178 million and $736 million each year. 
Another regulatory revision simplifies the cleanup and closure of 
hazardous-waste disposal facilities.
    Compliance Alternatives for Small Drinking Water Systems.--Under 
new flexibility offered under the 1996 amendments to the Safe Drinking 
Water Act, EPA issued regulations to give small-community water systems 
less expensive treatment alternatives to comply with Federal drinking 
water standards in the future. Smaller systems can also request more 
time to achieve compliance and variances from Federal requirements, as 
long as such actions do not threaten public health.
    Lowering the Cost of Lead-Based Paint Disposal.--Based on studies 
showing that lead-based paint debris could be safely placed in ordinary 
landfills (under the Toxic Substances Control Act), EPA proposed that 
this disposal option be provided as an alternative to the traditional, 
but more expensive disposal currently required under hazardous waste 
regulations.
    (b) What would EPA do if a proposed regulation did not pass the 
benefit-cost test? The Agency uses the benefit-cost analyses it 
conducts under Executive Order 12866 as a tool in the decisionmaking 
process. The key goal of the economic analyses is to provide 
policymakers with information on the potential consequences of 
environmental policies. Executive Order 12866 says that Agencies should 
adopt approaches that ``maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity), unless a statute 
requires another regulatory approach.'' However, it is often difficult 
to determine which regulatory options will maximize net benefits 
because quantitative environmental and health effects data (e.g., air 
or water quality, risk factors) are often not available or are sparse. 
This constraint means that many benefits and cost categories cannot be 
expressed in monetary terms, which then constrains the use of benefit-
cost analyses in the public policy decisionmaking process. Thus, a 
strict comparison of monetized benefits and costs should not be used in 
making policy decisions.
    Additionally, economic efficiency should not be the sole criterion 
for developing good public policies because a large number of social 
goals and constraints motivate and shape environmental policy. For 
example, the Agency considers environmental justice issues, statutory 
and judicial mandates, institutional constraints, technical 
feasibility, and enforceability in the regulatory policy process. Even 
the most comprehensive economic analyses are but part of a larger 
policy development process, one in which no individual analytical 
feature or empirical finding dominates. The results of our benefit-cost 
analyses serve as important inputs for this broader policymaking 
process along with other analyses and considerations.

    Question 4. Looking back at the last thirty years, what lessons has 
the Agency learned about improving environmental decisionmaking using: 
(a) an integrated approach, (b) a risk-informed approach, and (c) 
benefit-cost analysis.
    Response. Looking back in time, the Agency has learned much about 
using various approaches to managing environmental problems. Following 
are our experiences with some of these approaches:
    (a) An integrated approach.--There are many complex, high-profile 
issues (e.g., children's health, contaminated sediments) that do not 
easily fit into a single EPA office or a media-specific approach, but 
nevertheless must be addressed because of the significant environmental 
problems they represent. EPA has learned that finding solutions to 
these issues means looking beyond traditional environmental media and 
programmatic boundaries.
    The changing nature of environmental protection with greater 
attention to multiple stressors, cumulative risk, non-regulatory policy 
approaches, globalization, and enhanced public access means that 
science must be integrated across media and programs. EPA has 
established new offices (such as the Office of Children's Health 
Protection) and initiatives (such as the Persistent, Bioaccumulative, 
Toxic chemicals (PBT) Initiative) that recognize the necessity for 
employing an integrated approach. The Office of Research and 
Development's (ORD) Strategic Plan for 2000 identifies ``Integrate 
Environmental Science and Technology to Solve Environmental Problems'' 
as one of ORD's five goals for the coming decade. In addition, the 
Agency is developing an enhanced ``EPA-Wide Inventory of Science 
Activities'' that will facilitate cross-agency science integration.
    Collaboration among technical experts from across the Agency, as 
well as the cross-program/media integration of information, provides 
opportunities for synergism in the scientific process. For example, the 
Agency's highly successful experience over the past several years with 
promoting scientist to scientist meetings on important environmental 
topics bears this out. Efforts to enhance scientific collaboration and 
integration will increase over the coming years. In this way, the 
Agency can carry out its mission with a growing understanding of 
environmental problems in a multimedia context that focuses attention 
on the greatest risks.
    (b) A risk-informed approach.--Agency decisionmakers recognize that 
risk assessment and other scientific information can guide 
decisionmaking at EPA. Scientific inquiry, investigation, and 
information lead to the identification of potential risks to human 
health and the environment, and also point the way toward addressing 
those risks. Risk assessment weighs heavily in Agency decisions and, as 
appropriate, these assessments are joined with other scientific 
information, such as economic data and engineering studies, to provide 
scientific input to Agency decisions.
    Because of the critical role risk assessment plays in environmental 
decisionmaking, EPA has developed a framework for ecological 
assessment, cancer assessment guidelines, and other risk assessment 
tools. These tools promote consistency across the Agency in how risk 
assessments are performed and used in Agency decisions. Research to 
improve human health risk assessment and ecological risk assessment 
represent two of the highest priority research areas of the Agency's 
Office of Research and Development.
    (c) Benefit-cost analysis.--Agency decisionmakers recognize that 
benefit-cost analysis can be a meaningful tool for environmental 
decisionmaking, along with other analyses and considerations. A 
thorough benefit-cost analysis of proposed regulatory alternatives can 
assist the Agency in developing control requirements that achieve the 
highest environmental quality and human health standards at the lowest 
costs. The Agency has learned the importance of developing better ways 
to measure benefits and costs in order to more meaningfully inform 
decisionmakers, the importance of communicating information about 
benefits and cost categories that cannot be monetized, and the 
importance of working to achieve consistency in our economic analyses 
across the Agency.
    Despite the greater use and prominence of benefit-cost analysis in 
the environmental policymaking process, it is still only possible to 
quantify a limited subset of all the important benefits and costs 
associated with regulatory options. In most instances, significant 
benefit categories remain unquantified and unvalued. For example, in 
EPA's Clean Air Act (CAA) Section 812 study, a benefit-cost analysis of 
the entire CAA, some of the numerous unquantified benefits include: 
ecological effects, materials damage, behavioral effects, developmental 
effects, agricultural effects, eutrophication, acid deposition and many 
human health effects. This limitation also affects the Agency's ability 
to assess broad programs or strategic long run plans aimed at informing 
budgeting and planning decisions within public and private agencies. 
Our inability to quantify and value important benefit categories limits 
the contribution that benefit cost analysis can add to the policymaking 
process is necessarily constrained.
    The Agency is taking a number of steps to address these problems. 
An important function of the Agency's newly formed National Center for 
Environmental Economics (NCEE) is to develop data and methods for 
benefit and cost assessments through research aimed at filling priority 
needs common to many programs in the Agency. NCEE is actively 
performing innovative research on new and improved methods and 
incorporating cutting-edge advances in the field. In addition, NCEE 
promotes efforts by academics and EPA staff to improve the means to 
value costs and benefits. NCEE also works to communicate EPA's research 
priorities to economics professionals across the Nation, thereby 
helping to focus their expertise and own resources to better meet EPA's 
needs.
    EPA will soon release its Guidelines for Preparing Economic 
Analyses, which establish a sound scientific framework for performing 
economic analyses of environmental regulations and policies. They 
incorporate recent advances in theoretical and applied work in the 
field of environmental economics, and specifically address the issues 
of valuation of benefits, presentation of uncertainties in analysis, 
and consideration of regulatory alternatives. The Guidelines will help 
ensure that important subjects such as uncertainty, sensitivity 
analysis, timing, and valuation of costs and benefits, are treated 
consistently in all economic analyses prepared to inform at EPA's 
decisionmakers.

    Question 5. Why is the Agency's Strategic Plan still an inherently 
output-oriented plan as opposed to a result-oriented one? Please 
specify EPA actions in that regard.
    Response. The Strategic Plan represents a balance between outcomes 
and outputs. The Agency's Plan covers all the major functions and 
activities of EPA and therefore strikes an appropriate balance between 
the management functions and the environmental results we are trying to 
achieve. Since the issuance of the 1997 Strategic Plan, the Office of 
Chief Financial Officer (OCFO) has also worked closely with EPA's 
program offices through the Annual Plan process and more recently via 
the revision of the Strategic Plan in improving the measurability and 
outcome orientation of the Agency's strategic architecture of goals and 
objectives and performance goals and measures.
    Response. In pursuit of strong outcome orientation of the goals and 
measures, the Agency formed the Performance Measurement Improvement 
Team. The primary objective of this Team is to work with EPA's programs 
in their efforts to increase the general quality and outcome 
orientation of the Agency's performance goals and measures. The Team is 
involved in efforts such as workshops and training sessions, on-going 
analyses of annual goals and measures, and Goal-specific performance 
measurement improvement projects. In addition, our process for revising 
the Plan incorporated numerous opportunities for providing feedback to 
the program offices on their proposed revisions to the strategic 
architecture. Through these processes, we noted substantial improvement 
in the objective statements incorporated in the 2000 Strategic Plan; 
half of the objectives in the Plan are environmental outcome-oriented.
    EPA continues to work both internally and with our partners to 
strengthen the outcome orientation and measurability of the Agency's 
strategic architecture of goals and objectives. For example, two 
significant obstacles that impede EPA's efforts in developing outcome-
oriented metrics are the lack of data on environmental conditions 
(e.g., the current State of public health and the environment) and the 
difficulties associated with establishing a direct relationship between 
these parameters, which are also impacted by many other factors. EPA is 
conducting and funding research to help provide some of the information 
and methodologies necessary to overcome these obstacles. First, we are 
helping to develop and collect baseline data on environmental 
conditions. In collaboration with the states and other Federal 
agencies, we are monitoring and measuring indicators of ecological 
health, such as fish populations and stream concentrations of dissolved 
oxygen. These indicators will allow us to estimate conditions of the 
Nation's ecological resources with known degree of confidence. 
Similarly, the Centers for Disease Control provide estimates of public 
health, and we are working with them to collect data on exposure to 
environmental contaminants to further our understanding of the 
relationships between exposure reductions and improved health.
    These activities will serve as the foundation for outcome-oriented 
performance measures, helping us improve our Strategic Plan to reflect 
the results of our work.

    Question 6. How is the Agency addressing GAO's recommendations 
regarding data gaps, poor quality of available data, and 
inconsistencies in data-bases?
    Response. EPA has recently initiated the first stage of a multi-
phase effort to develop an Agency ``Information Plan.'' The first phase 
will identify broad options for information management by the Agency 
over the next several years and the associated implications. 
Implementation of the plan will transform how the Agency manages its 
information assets (the people, policies, data, and technology) so that 
EPA can better provide integrated, timely, and cost-effective access to 
accurate information to decisionmakers and the public. Phase I of the 
plan will identify strategic choices facing EPA such as the need to 
address current and future information needs. We expect to complete the 
first phase of the Information Plan in December 2000.
    With respect to data quality and inconsistency, EPA is pursuing 
several activities to address these issues. First, the Agency is 
developing a Data Quality Plan to evaluate the life-cycle of data 
collection, management and use in EPA in order to identify those places 
where quality vulnerabilities exist. This information will lead to 
follow-up actions by the program offices responsible for the data and 
information. Second, the Agency has created an ``integrated error 
correction process'' which allows users of the national data systems to 
report known or suspected data errors. In this process, EPA and State 
data stewards research the reported error, make corrections in the data 
bases if appropriate, and report back to the individual on the action 
taken. This process was established in June 2000 and is now active for 
the information systems in EPA's Envirofacts data warehouse; the 
process will be added to additional systems in fiscal year 2001. Third, 
EPA's data standards program is improving the consistency of the 
information collected and used by the Agency. EPA has developed and 
approved the six major data standards in the Reinventing Environmental 
Information program. More recently, we joined with the Environmental 
Council of the States and with representatives of Indian Tribes to 
create the Environmental Data Standards Council, a cooperative effort 
to develop and implement additional data standards. The Council is now 
pursuing the development of four additional data standards. Taken 
together, these actions will lead to the data quality improvements 
sought by all concerned.

    Question 7. Asked by Chairman Smith during hearing on October 3, 
2000. (paraphrased) There is no Federal entity that promotes and 
directly assists any State and local government with risk-based 
decisionmaking. Is there any entity within your Agency to do that?
    Response. As we explained in our answer to Question No. 2, we 
continue to encourage our State and local counterparts to incorporate 
risk and other factors into their priority-setting process. As part of 
the National Environmental Performance Partnership System, EPA Regional 
Offices work with our State counterparts in joint planning and priority 
setting. These efforts are based upon an analysis of environmental 
information and State and local conditions to determine the State and 
local environmental problems that deserve the highest attention. 
Environmental information is coupled with risk assessment to identify 
the most significant environmental problems. The State Agency and EPA 
Regional Office then develop work plans to address these problems.
    The State/EPA work plans are contained within Performance 
Partnership Agreements or other similar documents outlining the 
priorities, what actions will be taken by which agency, and how State 
assistance grants will be used to accomplish this work. Under current 
guidelines and a proposed new regulation governing State assistance 
grants (the Part 35 rule), EPA and States work together to determine 
comparative risks and set priorities. With a Performance Partnership 
Grant (PFG), a State can combine 2 or more of 16 different categorical 
grants into a PPG to have funding flexibility to address the highest 
priority risks. States are encourage to involve the public in this 
process of determining priorities.
    In addition, EPA has developed and updated numerous risk assessment 
guidelines and related documents over the last 15 years. These 
guidelines, addressing such diverse risk assessment issues as 
carcinogenicity, reproductive health, exposure, pollutant mixtures, and 
ecological effects, are published by the Agency following peer review. 
The published guidelines are often used by state, local, and tribal 
governments (as well as the international community) as they consider 
how to develop and use risk assessments for their programs.
                                 ______
                                 
 Responses of Al McGartland to Additional Questions from Senator Baucus
    Question 1. The testimony by GAO cites numerous concerns, including 
data gaps, data base incompatibilities, and data inaccuracy, as well as 
failures in integrating measured outcomes with EPA programs. You 
indicated that the Agency is developing a strategic plan that responds 
to these concerns. Please describe that plan in as much detail as 
possible. When will it be completed and available for review by the 
committee?
    Response. As we responded to Chairman Smith's Question No. 6, EPA 
has recently initiated the first stage of a multi-phase effort to 
develop an Agency ``Information Plan.'' The first phase will identify 
broad options for information management by the Agency over the next 
several years and the associated implications. Implementation of the 
plan will transform how the Agency manages its information assets (the 
people, policies, data, and technology) so that EPA can better provide 
integrated, timely, and cost-effective access to accurate information 
to decisionmakers and the public. Phase I of the plan will identify 
strategic choices facing EPA such as the need to address current and 
future information needs. We expect to complete the first phase of the 
Information Plan in December 2000.
    With respect to data quality and inconsistency, EPA is pursuing 
several activities to address these issues. First, the Agency is 
developing a Data Quality Plan to evaluate the life-cycle of data 
collection, management and use in EPA in order to identify those places 
where quality vulnerabilities exist. This information will lead to 
follow-up actions by the programs responsible for the data and 
information. Second, the Agency has created an ``integrated error 
correction process' which allows users of the national data systems to 
report known or suspected data errors. In this process, EPA and State 
data stewards research the reported error, make corrections in the data 
bases if appropriate, and report back to the individual on the action 
taken. 'this process was established in June 2000 and is now active for 
the information systems in EPA's Envirofacts data warehouse; the 
process will be added to additional systems in fiscal year 2001. Third, 
EPA's data standards program is improving the consistency of the 
information collected and used by the Agency. EPA has developed and 
approved the six major data standards in the Reinventing Environmental 
Information program. More recently, we joined with the Environmental 
Council of the States and with representatives of Indian Tribes to 
create the Environmental Data Standards Council, a cooperative effort 
to develop and implement additional data standards. The Council is now 
pursuing the development of four additional data standards. Taken 
together, these actions will lead to the data quality improvements 
sought by all concerned.

    Question 2. What is the recent history of EPA's requests for 
environmental data collection funding and Congress's appropriation of 
these requested funds?
    Response. Environmental data collection is an activity that is 
vital to the mission of the Agency and supports the goals and 
objectives of our program offices. It is spread throughout EPA's 
overall budget. EPA is working closely with our many partners and 
stakeholders in trying to improve our information collection programs.
    The Agency's data collection is an element of two annual reports 
submitted to OMB: ``Report on Information Technology;'' and ``Capital 
Assets Plan and Justification.'' These reports contain information on 
the amounts budgeted for all aspects of information technology 
including resources directly involved in data collection activities 
managed by various Agency offices.

    Question 3. We heard testimony about the New Hampshire and 
Columbus, Ohio comparative risk projects. Has EPA supported, 
financially, technically, or otherwise, these projects or other similar 
projects on a local, state, or regional level? Hay the Agency used any 
of the results from these projects to help inform national 
environmental priorities?
    Response. The Agency provided financial and technical assistance to 
interested state, local, and tribal governments interested in 
conducting comparative risk processes. The results of the projects were 
used to improve environmental protection at the state, local and tribal 
level. Although the results were not formally used in national priority 
setting, EPA's program offices work directly with our Regional offices 
(who had worked with the States to identify regional priorities) to 
develop the Agency's strategic and annual plans. Additionally, EPA goal 
teams engage in an extensive stakeholder outreach effort when 
developing strategic objectives, and the Agency consults with State 
organizations, such as EGOS, when developing its strategic plan.

    Question 4. What is your reaction to having a national comparative 
risk project performed and then using its results to determine EPA's 
budget and regulatory priorities?
    Response. Comparative risk analyses have become more widely 
accepted as an input to the priority-setting process, and they have 
been conducted by a number of State and local governments. For its 
part, EPA has incorporated this useful tool unto our Agency-wide 
strategic planning processes, into our partnerships with state, local, 
and tribal governments, and into many specific programs, both 
regulatory and non-regulatory. However, EPA is not using comparative 
risk analysis as a brightline, mechanistic way of ordering the Agency's 
priorities for either strategy, budgets, or actions.
    One important limitation of comparative risk analysis is that there 
is no common metric to evaluate the many kinds of risks that could be 
addressed. This lack of a common metric raises many questions that 
cannot be answered by scientific analysis alone. For example, EPA does 
not typically engage in risk comparisons from widely variant activities 
such as the risk from radon exposure compared to actuarially determined 
traffic deaths. How do we incorporate the involuntary versus voluntary 
nature of the exposure? Making comparative risk comparisons is 
difficult even if the risks being compared are environmental in nature. 
How does one compare the asthma problems associated with elevated ozone 
to reproductive effects in ecosystems exposed to endocrine disrupting 
chemicals? How should we compare skin cancer to throat cancer?
    In addition to these comparative risk questions, a number of other 
factors also have to be considered when the Agency sets its priorities: 
Some of these factors, such as meeting statutory mandates and 
responding to public concerns, are identified in our response to 
Question No. 5. Moreover, decisions on some of these factors, such as 
equity and environmental justice, require a degree of judgment that 
cannot be answered through scientific analysis alone.

    Question 5. What are the drawbacks or obstacles to having a 
national comparative risk project performed and then using its results 
to determine how EPA's budget should be allocated?
    Response. Comparative risk assessment is a useful mechanism for 
helping us think about environmental priorities, but comparative risk 
assessment alone cannot provide complete answers. The Agency must 
consider a number of factors, including but not limited to risk, when 
setting its priorities. Some of these factors include statutory 
mandates, community concerns, and the organizational structure of 
various environmental programs. Additionally, a significant problem 
inherent in the use of comparative risk assessment is the lack of a 
common metric.
    Many Federal environmental laws mandate specific actions. The 
environmental statutes also often set timetables and deadlines for EPA 
to take specified actions or accomplish specified goals. EPA has an 
obligation to carry out the laws, which reflect the will of an elected 
Congress and properly reflect considerations beyond comparative risk.
    Community concerns also have to be considered when setting 
environmental priorities. If a community believes that action must be 
taken to solve what it considers to be a pressing environmental 
problem, then EPA has an obligation to respond, even if the problem 
does not seem to rank high on a list of comparative risks.
    Another consideration in setting priorities is the different roles 
that EPA has, depending the environmental problem being addressed or 
program being implemented. For example, budget needs may differ 
depending on whether a regulatory program is implemented at the Federal 
level or is primarily implemented by the States. As another example, a 
program aimed at reducing risk through public education may have 
different budget needs compared to a program that provides technical 
assistance.
    As discussed in Answer #4 above, there is no common metric for 
comparing the different kinds of risks that could be addressed. For 
example, how can human health and ecological risks be incorporated into 
the same risk ranking? How would we prioritize the risks associated 
with pollutant exposures that may cause cancer in humans compared to 
degraded water quality in the Chesapeake Bay that may deplete oyster 
beds? The Science Advisory Board recognized this problem when they 
wrote Reducing Risk and they did not attempt to include human health 
and ecological risks in the same ranking.
    This is not a complete discussion of the issues associated with 
using comparative risk assessment alone to make national budget 
decisions. Other hard-to-quantify considerations, such as distributive 
impacts and environmental justice, also have to be considered. 
Therefore, comparative risk assessment cannot be used as a bright line 
mechanistic way of ordering the Agency's priorities for either 
strategy, budgets, or actions because there is no one analytical method 
that can address all of these issues.

    Question 6. Please describe each of the data collection efforts 
which EPA supports, conducts or uses, to get an accurate picture of the 
Nation's public and environmental health.
    Response. Under the Paperwork Reduction Act, the Agency is required 
to obtain Office of Management and budget approval before it can ask 
the public to submit information or retain records. In general, any 
monitoring, reporting or recordkeeping requirements imposed on non-
Federal respondents will require an Information Collection Request 
(ICR). EPA has about 350 active ICRs. EPA is developing a web-based, 
searchable tool, called the Information Collection Request Inventory 
(ICRI), based on these Information Collection Requests (ICRs). Once 
completed, the inventory will enable EPA and the public to better 
understand the types of information EPA collects, from whom, and the 
cumulative impact of EPA's collection activities. We expect to complete 
the ICR Inventory in the second quarter of fiscal year 2001.
                               __________
  Statement of Peter F. Guerrero, Director, Environmental Protection 
   Issues, Resources, Community, and Economic Development Division, 
                       General Accounting Office
    Mr. Chairman and members of the committee: We appreciate the 
opportunity to discuss our observations on the data that the 
Environmental Protection Agency (EPA) needs to manage its programs more 
effectively. In reports going back to our comprehensive general 
management review of EPA in 1988,\1\ we have identified numerous long-
standing problems in the agency's efforts to collect and use 
environmental data. Drawing from this work, I will discuss today the 
limitations in the data that EPA needs to: (1) set risk-based 
priorities for its programs and (2) develop outcome-oriented measures 
of its programs' results. Our observations are as follows:
---------------------------------------------------------------------------
    \1\ Environmental Protection Agency: Protecting Human Health and 
the Environment Through Improved Management (GAO/RCED-88-101, Aug. 16, 
1988).
---------------------------------------------------------------------------
     EPA's ability to assess risks and establish risk-based 
priorities has been hampered by data quality problems, including 
critical data gaps, data bases that do not operate compatibly with one 
another, and persistent concerns about the accuracy of the data in many 
of EPA's data systems. While EPA's priorities should reflect an 
understanding of relative risk to the environment and public health, 
good data often do not exist to fully characterize risk. In the absence 
of reliable data, public perceptions of risk can influence how EPA 
determines its priorities and allocates resources. EPA has taken major 
steps during the past few years to improve its data and to better 
inform the scientific community and general public of environmental and 
public health risks. To finish this job, the agency will need to expand 
its data improvement initiatives to fill key gaps in its data, take 
advantage of opportunities to develop and implement data standards to 
achieve compatibility among environmental data bases, and ensure the 
accuracy of its data.
     Measuring the results (outcomes) of its programs is 
critical to determining EPA's effectiveness. Nevertheless, the agency 
historically has relied on activity-based output measures, such as the 
number of inspections performed, because of inherent technical 
difficulties in establishing sound linkages among program activities, 
environmental improvements, and public health. Spurred by the 
requirements of the Government Performance and Results Act of 1993 
(Results Act), EPA has made progress in recent years in measuring the 
outcomes of its programs. To ensure future success in developing 
outcome measures, however, EPA will need to make a long-term management 
commitment to overcome major challenges to obtaining the data needed to 
show the results of environmental programs.
                               background
    Since EPA's establishment in 1970, the Federal Government has 
developed a complex system of laws and regulations to address the 
Nation's environmental problems. Over the years, as environmental 
threats were identified, the Congress responded by enacting laws to 
address each problem, incrementally adding to the statutory framework 
that sets EPA's agenda. However, these laws were not coordinated or 
integrated to provide EPA with an overall system for prioritizing 
problems so that the most serious problems can be addressed first.
    Impelled by budgetary constraints and a growing list of 
environmental problems, EPA, in the late 1980's, began to consider 
whether its resources were being spent on the problems that pose the 
greatest risks to public health and the environment. The agency 
concluded that the Nation actually was devoting more resources to 
problems that had captured public attention than to problems that were 
less well known but potentially more serious. Subsequently, EPA began 
incorporating the concept of relative health and environmental risk 
into decisions on environmental priorities and emphasizing the need to 
identify the most serious risks and to keep the public informed about 
the relative seriousness of various environmental problems. To assess 
risks and deal with those likely to do the most harm, EPA has 
recognized that it needs to have adequate environmental and scientific 
data to conduct risk assessments, set standards, and develop 
regulations. It also needs such data to identify and develop measures 
of environmental quality and to assess the effectiveness of its 
programs by linking program activities to changes in environmental 
conditions.
    epa needs better data to establish risk-based program priorities
    Establishing risk-based priorities for EPA's program activities 
requires good data on the use and disposal of thousands of chemicals. 
To assess human exposure to a chemical, EPA needs to know how many 
workers, consumers, and others are exposed; how the exposure occurs; 
and the amount and duration of the exposure. For environmental 
exposure, EPA needs to know whether the chemical is being released to 
the air, water, or land; how much is being released; and how wide an 
area is being affected. EPA's ability to make such assessments is 
limited by: (1) gaps in environmental and health data, (2) data bases 
that do not operate compatibly with one another, and (3) the lack of an 
effective system for ensuring the accuracy of the agency's data. 
Although EPA has implemented several agencywide initiatives to address 
these problems, each of the initiatives has encountered obstacles that 
must be overcome to substantially improve the agency's data.
Extensive Gaps Exist in EPA's Information About the Environment and 
        Health Risks
    Our work over the past few years has shown that very little is 
known about the risks of potential exposure to chemicals and 
environmental conditions for workers, the general public, and plant and 
animal life. For example, we reported the following:
     EPA's Integrated Risk Information System, which is a data 
base of the agency's consensus on the potential health effects of 
chronic exposure to various substances found in the environment, lacks 
basic data on the toxicity of about two-thirds of the known hazardous 
air pollutants.\2\
---------------------------------------------------------------------------
    \2\ Major Management Challenges and Program Risks: Environmental 
Protection Agency (GAO/OCG-99-17, Jan. 1999).
---------------------------------------------------------------------------
     EPA's National Water Quality Inventory does not accurately 
describe water quality conditions nationwide. Only 19 percent of the 
Nation's rivers and streams were assessed for the 1996 Inventory (the 
latest report available at the time of our review), as were 6 percent 
of ocean and other shoreline waters. Pollution of the latter has 
resulted in an increasing number of beach advisories and closures in 
recent years.\3\
---------------------------------------------------------------------------
    \3\ Water Quality: Key EPA and State Decisions Limited by 
Inconsistent and Incomplete Data (GAO/RCED-00-54, Mar. 15, 2000).
---------------------------------------------------------------------------
     Of 1,456 toxic chemicals we recently reviewed, data on 
human exposure were being collected for only about 6 percent. For 
example, of the 476 chemicals that EPA identified as most in need of 
testing under the Toxic Substances Control Act, only 10, or 2 percent, 
were being measured for human exposure. (See table 1.)

     Table 1.--Extent to Which Human Exposure Data Are Collected for
 Potentially Harmful Chemicals Through Surveys of EPA and the Department
                      of Health and Human Services
------------------------------------------------------------------------
                 Priority chemicals                   Chemicals measured
----------------------------------------------------  or being measured
                                             No. in --------------------
            Description of list               list     No.    Percentage
------------------------------------------------------------------------
Chemicals found most often at the national      275       62         23
 Superfund sites and of most potential
 threat to human health...................
EPA's list of toxic of concern in air.....      168       27         16
Chemicals harmful because of their              368       52         14
 persistence in the environment, tendency
 to bioaccumulate in plant or animal
 tissues, and toxicity....................
Pesticides of potential concern as listed       243       32         13
 by EPA's Office of Pesticide Programs and
 the U.S. Department of Agriculture's
 Pesticide Data Program...................
Chemicals that are reported in the Toxic        579       50          9
 Release Inventory; are considered toxic;
 and are used, manufactured, treated,
 transported, or released into the
 environment..............................
Chemicals most in need of testing under         476       10          2
 the Toxic Substances Control Act (Master
 Testing List)............................
------------------------------------------------------------------------
Note: Our analysis was based on human exposure data collected through
  the Department of Health and Human Services' National Health and
  Nutrition Examination Survey or EPA's National Human Exposure
  Assessment Pilot Surveys through 2000.

    EPA has recognized that it has numerous and significant gaps in its 
data and has initiated several efforts to fill at least some of the 
gaps. For example, under its Environmental Monitoring and Assessment 
Program, EPA is working with other Federal agencies to develop 
information that the public, scientists, and the Congress can use to 
evaluate the overall health of the Nation's ecological resources. EPA 
also recently launched its High Production Volume Challenge Program, 
which asked chemical companies to voluntarily generate data on the 
effects of the chemicals they manufacture or import. As of December 
1999, over 400 participants had agreed to make public, before the end 
of 2005, basic hazard data on over 2,000 of 2,800 high-production-
volume chemicals, which are chemicals manufactured or imported into the 
United States in amounts equal to or greater than one million pounds 
per year. Furthermore, EPA's new information office will be responsible 
for encouraging the agency's program offices to reach out to other 
Federal agencies as well as to universities, research institutes, and 
other sources of environmental information for data that EPA does not 
collect but that may exist elsewhere. To date, however, such efforts 
have been hampered by technological limitations imposed by the myriad 
of incompatible information systems in use across the government.
    Moreover, much of the information needed, such as environmental 
monitoring data, will be expensive to obtain. Thus, it will be 
important for EPA to work with the states and industry to reduce the 
reporting burden and to encourage efforts to use data that may already 
have been collected by other Federal agencies or other entities. 
Likewise, as we recommended to EPA in our September 1999 report on its 
information management activities, it will be essential for the agency 
to develop a strategy that prioritizes its requirements for additional 
data and identifies milestones and needed resources. EPA can then use 
this information to support its budget requests.
Incompatible Data Systems Limit the Usefulness of Environmental Data
    Over the years, EPA has developed and maintained ``stovepipe'' data 
systems that are not capable of sharing the enormous amounts of data 
gathered. EPA now recognizes that common data definitions and formats, 
known as data standards, are essential to its efforts to integrate data 
from various data bases, including those of its State partners. EPA 
also considers data standards as key to reducing the reporting burden 
on industry and the states because such standards would permit 
integrated, and thus more efficient, reporting of information to the 
agency. In recent years, EPA has undertaken several efforts to develop 
standards for some of the data items in its information systems. 
According to the Office of Environmental Information, EPA recently 
approved six data standards and expects that all of these standards 
will be implemented in the relevant data systems by fiscal year 2003.
    EPA recognizes that its current data improvement efforts are only 
first steps toward its goal of full data integration. For example, EPA 
has focused primarily on the compatibility of its data with those of 
State environmental agencies, rather than of other Federal agencies and 
nongovernmental sources. In a May 2000 report, we stated that improved 
collaboration among Federal agencies in meeting the needs for human 
exposure data is essential because individual agencies have different 
capacities and skills and separate attempts have fallen short of 
supporting the large efforts that are needed.\4\ EPA's Science Advisory 
Board\5\ has also recommended that EPA do more to link the agency's 
data bases with external data bases. The Board noted that ``answering 
many health-related questions frequently requires linking environmental 
data with census, cancer or birth registry data, or other data systems 
(such as water distribution maps) to determine whether there is a 
relationship between the environmental measures and health.''\6\ EPA 
officials acknowledge the importance of linking EPA's data bases with 
those of other agencies at all levels of government. However, they told 
us that their actions to do so have been limited by resource 
constraints and by the fact that EPA's statutes do not give the agency 
the authority to require that other agencies collect or report data 
using formats compatible with those used by EPA.
---------------------------------------------------------------------------
    \4\ Toxic Chemicals: Long-Term Coordinated Strategy Needed to 
Measure Exposures in Humans (GAO/HEHS-00-80, May 2, 2000).
    \5\ The EPA Science Advisory Board was created by the Congress to 
provide advice to EPA from scientists outside the agency.
    \6\ Science Advisory Board, Review of the Agency-Wide Quality 
Management Program, EPA-SAB-EEC-LTR-98-003 (Washington, D.C.: EPA, July 
24, 1998).
---------------------------------------------------------------------------
Concerns Persist About the Accuracy of EPA's Data
    In various reviews, we and others have identified persistent 
concerns about the accuracy of the data in many of EPA's information 
systems. EPA acknowledges that data errors exist but believes that, in 
the aggregate, its data are of sufficient quality to support its 
programmatic and regulatory decisions. However, EPA has not assessed 
the accuracy of its information systems agencywide, and preventing 
errors and correcting them once they have been identified has proved 
daunting for the agency. For example, in January 1998, an EPA advisory 
council on information management issues described the difficulty of 
correcting errors in EPA's data bases: ``Once an error is stored in one 
or more of the agency's systems, making corrections to all those 
systems is an exercise in frustration and futility. There is no simple 
way to ensure corrections are made to all possible systems.''
    To address such problems, EPA revised its agencywide quality system 
in 1998 to expand and clarify requirements for how environmental data 
are collected and managed. Although the Science Advisory Board recently 
commended the agency for its development of this system, the Board also 
found that its implementation has been uneven within the agency. 
Moreover, the Board reported that more than 75 percent of the states 
authorized to implement EPA's environmental programs lack approved 
quality management plans for all or some of these programs and thus are 
likely to be generating data of unknown quality. We recently reported 
that EPA's National Water Quality Inventory, which EPA uses as a basis 
for measuring progress under the Clean Water Act, does not accurately 
describe water conditions nationwide. While EPA prepares the Inventory 
on the basis of data submitted by the states, the states do not use a 
statistical sampling design that provides a comprehensive picture of 
water quality. The Science Advisory Board has pointed out that EPA 
programs that rely on data of unknown quality are exposing themselves, 
the reliability of their decisions, and their credibility to 
criticisms.
    Correcting errors in the agency's data is an important 
responsibility for the new information office. This office recently 
developed an Internet-based system to identify, track, and resolve 
errors found in national environmental data bases. The system currently 
allows individuals to notify EPA of suspected errors in some of the 
agency's major data bases, and EPA intends to implement the data 
correction system in additional data bases during the next 2 years.
     efforts to develop outcome-oriented performance measures are 
                    constrained by data limitations
    Well-chosen environmental measures inform policymakers, the public, 
and EPA managers about the condition of the environment and provide for 
assessing the potential danger posed by pollution and contamination. 
They also serve to monitor the extent to which EPA's programs 
contribute to environmental improvement and can be used in future 
priority-setting, planning, and budgeting decisions. EPA has been aware 
of the need for environmental measures since the mid-1970's. 
Nevertheless, the agency made little progress in developing such 
measures until the Results Act mandated their use by requiring Federal 
agencies to report annually on their progress in meeting performance 
goals. Under the Results Act, EPA has begun to set goals and measures 
that are intended to help the agency, as well as the Congress and the 
public, assess the environmental results of the agency's activities. 
While EPA has made progress in adopting more measures that reflect the 
environmental or health outcomes of programs, the overwhelming number 
of EPA's measures reflect outputs, such as the number of inspections 
performed or regulations issued, and additional progress is needed.
    EPA considers getting the data needed to measure results its 
biggest challenge in developing outcome-oriented performance measures. 
To date, EPA and the states have made limited progress in developing 
such measures, as these examples indicate:
     Of the 364 measures of performance that EPA has developed 
for use during fiscal year 2000, only 69 (19 percent) are environmental 
outcomes; the other measures reflect program activities, such as the 
number of actions taken to enforce environmental laws. (See table 2)
     Given inherent uncertainties about the results of research 
and development activities, the problem of developing outcome-oriented 
measures is particularly difficult for EPA's science activities. Of 36 
measures related to EPA's strategic goal of ``sound science,'' only 2 
reflect outcomes.

  Table 2.--EPA's Analysis of the Number and Type of Annual Performance
          Measures for Its Strategic Goals for Fiscal Year 2000
------------------------------------------------------------------------
                                               No. of annual performance
                                                        measures
             EPA's strategic goal             --------------------------
                                                Output  Outcome   Total
------------------------------------------------------------------------
Goal 1: Clean Air............................       19       14       33
Goal 2: Clean and safe water.................       65       17       82
Goal 3: Safe food............................       16        1       17
Goal 4: Preventing pollution and reducing           28       14       42
 risk in communities, homes, workplaces, and
 ecosystems..................................
Goal 5: Better waste management, restoration        34        8       42
 of contaminated sites, and emergency
 response....................................
Goal 6: Reduction of global and cross-border        27        7       34
 environmental risks.........................
Goal 7: Expansion of Americans' right to know       28        3       31
 about their environment.....................
Goal 8: Sound science, improved understanding       34        2       36
 of environmental risk and greater innovation
 to address environmental problems...........
Goal 9: A credible deterrent to pollution and       15        3       18
 greater compliance with the law.............
Goal 10: Effective management................       29        0       29
                                              --------------------------
  Total......................................      295       69      364
------------------------------------------------------------------------
Source: GAO's analysis of EPA data.

    In addition to establishing output- and outcome-oriented 
performance measures, EPA has adopted a framework for categorizing its 
performance measures according to the type of outputs or outcomes to be 
achieved. As shown in figure 1, most of the performance measures are 
outputs involving either research and development efforts or actions by 
EPA, states, tribes, or other governmental bodies, such as establishing 
standards for hazardous levels of lead in paint, dust, and soil. The 
other categories represent outcomes, including measures that focus on 
risks to ecology, health, or welfare; pollutants absorbed by the body; 
and concentrations of pollutants in the environment. Over time, EPA 
plans to increase the number of such measures, as it is able to obtain 
better data linking its program activities with changes in 
environmental and health conditions.
[GRAPHIC] [TIFF OMITTED] T1529.001

    Even with better data, it will be a major challenge for EPA to link 
its environmental programs and activities to outcomes. Environmental 
conditions may change because of a number of factors, including 
variables such as the weather or economic activity, many of which are 
beyond the control of EPA and its State partners. Likewise, it may be 
difficult to show the relationship between EPA's annual program 
activities and some outcomes that may not be apparent until many years 
later. For example, current EPA activities to reduce the amount of 
polluting nutrients from fertilizers in the ground may not result in 
improved water quality for a decade or more.
    EPA program officials recognize that they need additional measures 
that show the outcomes of programs, and they have recently taken 
actions that should strengthen the agency's ability to develop them. 
For example, EPA is developing processes and long-term strategies to 
improve the quality of performance measures and link the activities of 
program offices with environmental results. However, substantial 
resources are required to identify and test the potential measures. 
Once the measures are established, gathering and analyzing the data can 
be resource-intensive, and it can take years to show environmental 
improvement.
                              observations
    Our prior work has identified numerous problems in the quality of 
EPA's data and the way that the agency manages its data systems. These 
problems cut across the various programs regulated by EPA and have 
limited the agency's ability to assess risks and measure environmental 
results. To its credit, EPA has initiated actions to improve its 
information management activities. While EPA has made progress, its 
initiatives do not provide a long-term strategy to ensure the 
completeness, compatibility, and accuracy of its data. Furthermore, the 
initiatives have encountered obstacles that highlight the difficulties 
facing EPA as it attempts to improve its information management 
activities.
    As we recommended in our September 1999 report, to substantially 
improve the quality of the data used to set risk-based priorities and 
report on progress toward improving environmental conditions and human 
health, EPA needs to develop a strategy that reflects a long-term 
commitment to resolving data problems. Such a strategy should include 
establishing milestones and identifying the resources necessary to fill 
major data gaps, identify and develop all needed data standards and 
implement them in key data bases, and coordinate the agency's data 
standardization efforts with those of the states, Federal agencies, and 
other organizations. This effort would provide both senior agency 
managers and the Congress with what is now missing--the information 
they need to make the best decisions possible on the costs, benefits, 
and tradeoffs involved in providing scarce resources to meet critical 
data requirements. Although EPA concurred with our recommendation, the 
agency has made little progress toward developing and implementing a 
comprehensive strategy. For example, EPA recently informed us that it 
has not yet completed the first stage of a multi-phase effort to 
develop an information plan for the agency. EPA plans to complete the 
first stage by December 2000, which will identify broad options for 
information management over the next several years.
    Mr. Chairman, I would be happy to respond to any questions that you 
or other members of the committee may have.
                                 ______
                                 
 Responses by Peter Guerrero to Additional Questions from Senator Smith
    Question 1. Please elaborate on how improved data and data 
management can help EPA in developing cost-effective strategies to 
reduce health and environmental risks?
    Response. Scientific knowledge and technical information are 
essential for determining which environmental problems pose important 
risks to human health and the environment. This information is needed 
to avoid wastefully targeting inconsequential problems while ignoring 
greater risks. EPA also needs to be able to identify emerging and 
future environmental problems and to have adequate data to develop 
cost-effective solutions to those problems.

    Question 2. What are some of the major obstacles confronting EPA 
that preclude it from moving faster toward a results-oriented agency?
    Response. EPA considers getting the data needed to measure results 
its biggest challenge in developing results-oriented performance 
measures. To date, EPA has made limited progress in developing such 
measures. For example, of the 364 measures of performance that EPA 
developed for use during fiscal year 2000, only 69 (19 percent) are 
environmental outcomes; the other measures reflect program activities, 
such as the number of actions taken to enforce environmental laws.
    As we stated in our testimony, EPA is limited by gaps in 
environmental and health data, data bases that do not operate 
compatibly with one another, and the lack of an effective system for 
ensuring the accuracy of the agency's data. Different data collection 
and analysis methods among states (which EPA relies upon extensively 
for information) make it difficult to aggregate data and use the 
information to determine environmental outcomes. For example, states do 
not use identical survey methods and criteria to assess water equality. 
EPA officials told us that such inconsistencies from State to State 
make developing national performance goals and measures for water 
quality difficult.
    Even with better data, it will be a major challenge for EPA to link 
its environmental programs and activities to outcomes and move toward a 
results-oriented agency. Environmental conditions may change because of 
a number of factors including variables such ass the weather or 
economic activity, many of which are beyond the control of EPA and its 
State partners. Likewise, it may be difficult to show the relationship 
between EPA's annual program activities and some outcomes that may not 
be apparent until many years later. For example, current EPA activities 
to reduce the amount of polluting nutrients from fertilizers in the 
ground may not result in improved water quality for a decade or more.
    Developing better information to characterize results will require 
additional resources--to fill gaps, conduct monitoring on environmental 
conditions, improve data management and quality, and so forth. Improved 
cooperation among the many parties currently also involved in 
collecting environmental data--states, tribes, local governments, 
industry, other Federal agencies and the public--will also be 
necessary.

    Question 3. In its recently issued report on ``Strengthening 
Science at the U.S. Environmental Protection Agency: Research 
Management and Peer Review Practices (2000)'', the National Academy of 
Sciences stated:

          Scientific knowledge and technical information are essential 
        for determining which environmental problems pose important 
        risks to human health, ecosystems, the quality of life, and the 
        economy. We need scientific information to avoid wastefully 
        targeting inconsequential problems while ignoring greater 
        risks. We need such information to reduce uncertainties in 
        environmental decisionmaking and to help develop cost-effective 
        strategies to reduce risk. We need science to help identify 
        emerging and future environmental problems and to prepare for 
        the inevitable surprises.

    Does GAO agree with the above statement? Please provide GAO's views 
on what role should risk assessment and economic analysis have in EPA's 
decisionmaking. What current attributes in EPA would need to be changed 
to address the above issues?
    Response. Recognizing the fundamental importance of good 
information, both scientific and technical, GAO agrees with the above 
statement and supports EPA's efforts to improve environmental 
information. While both risk assessment and economic analysis are 
important tools for EPA decisionmakers and should be used, they do not 
provide precise answers to policy questions. This is because estimates 
of health risks and economic costs are developed in the face of both 
scientific uncertainties and data limitations, and inevitably include 
assumptions and judgments.
    Recognizing the limitations of both risk assessment and economic 
analysis, we believe that EPA can nonetheless make improvements in how 
it uses both tools in order to assist decisionmakers. The quality of 
risk assessment is dependent upon the data available to perform the 
assessment, which in the past have not been as complete as possible. 
EPA's recent actions to reorganize information activities, develop a 
comprehensive information plan, and implement various other information 
initiatives are steps toward providing higher quality data needed to 
improve the assessments. As we stated in our testimony, however, 
successfully completing these data improvement actions will not be easy 
and will require a long-term commitment and sufficient resources. 
Likewise, EPA needs to take actions to make its economic analyses more 
useful to both agency decisionmakers and the Congress. Chief among 
these actions is improving the presentation and clarity of information 
contained in the economic analyses, such as clearly identifying the 
values of key assumptions as well as the sensitivity of benefit and 
cost estimates to key data uncertainties.

    Question 4. Your statement focused on data quality, availability, 
and management problems. Are there specific recommendations you would 
like to make for either the agency or the Congress in this regard?
    Response. As we recommended last September, EPA's information 
office should develop an action plan detailing the steps the agency 
must take to ensure that its environmental and regulatory data are 
sufficiently complete, compatible, and accurate to meet the agency's 
needs.\1\ This plan should specify the resources that will be required 
to accomplish these tasks. It should also lay out a strategy and 
milestones for ensuring that EPA obtains the data it needs to 
effectively set priorities, assess progress in achieving its goals and 
objectives, and report on its accomplishments in a credible way. Such 
an action plan would also serve the Congress in its funding decisions 
and oversight of agency activities.
---------------------------------------------------------------------------
    \1\ Environmental Information: EPA is Taking Steps to Improve 
Information Management, but Challenges Remain (GAO/RCED-99-261, 
September 1999).
---------------------------------------------------------------------------
    In addition, Federal efforts to collect human exposure data are 
very limited--largely because coordinated, long-term planning at the 
Federal level has been lacking due to sporadic agency commitments to 
human exposure measurement and monitoring. To help meet the gaps in 
exposure data, we recommended that EPA work together with HHS and other 
Federal agencies with environmental health responsibilities to forge a 
strategic approach that would:
     provide a long-term structure to human exposure monitoring 
as an interagency effort,
     establish a mechanism for setting priorities in line with 
agency goals and performance measures,
     clarify agency roles and minimize duplication, and
     help agencies to share expertise.\2\
---------------------------------------------------------------------------
    \2\ Toxic Chemicals: Long-Term Coordinated Strategy Needed to 
Measure Exposures in Humans (GAO/HEHS-00-80, May 2000).
---------------------------------------------------------------------------
    The Results Act, which requires agencies to coordinate their 
research activities, also provides an existing mechanism for 
congressional oversight over Federal efforts to more effectively 
coordinate research. Continued congressional oversight of the Results 
Act, with particular attention to this area, would be helpful.

    Question 5. What is the status of EPA's use of benefit-cost 
analyses in managing environmental risks?
    Response. We have found that EPA and other agencies could make 
improvements that would strengthen the clarity and credibility of their 
economic analyses. For example, some of the economic analyses that GAO 
reviewed did not incorporate the best practices set forth in OMB's 
guidance (e.g., 5 of the 20 analyses reviewed did not discuss 
alternatives to the proposed regulatory action).\3\
---------------------------------------------------------------------------
    \3\ Regulatory Reform: Agencies Could Improve Development, 
Documentation, and Clarity of Regulatory Economic Analyses (GAO/RCED-
98-142, May 1998).
---------------------------------------------------------------------------
    Moreover, in our 1997 review of 23 economic analyses developed by 
EPA in support of air quality regulations under the Clean Air Act, we 
found that these analyses could be made; more useful by increasing 
their clarity and thoroughness.\4\ For example, many of these benefit-
cost analyses did not include executive summaries, which can provide 
easily accessible information for both agency decisionmakers and the 
Congress. Some of the economic analyses did not identify one or more 
key economic assumptions (such as the; discount rate or the dollar 
value assigned to a human life) that can have a significant impact on 
the results of the analysis. Furthermore, in the analyses that 
identified key economic assumptions, the rationale for the values used 
was not always explained. We recommended that the EPA Administrator 
ensure that benefit-cost analyses identify the (1) value, or range of 
values, assigned to key assumptions, along with the rationale for the 
values selected, (2) sensitivity of benefit and cost estimates when 
there are major sources of uncertainty, and (3) regulatory and non-
regulatory alternatives considered, including those not subjected to 
benefit-cost analyses.
---------------------------------------------------------------------------
    \4\ Air Pollution: Information Contained in EPA's Regulatory Impact 
Analyses Can be Made Clearer (GAO/RCED-97-38, April 1997).
---------------------------------------------------------------------------
                               __________
Responses by Peter Guerrero to Additional Questions from Senator Baucus
    Question 1. I appreciate your comments on the lack of environmental 
data. This is a real problem. What is the recent history of EPA 
requests for funding for environmental data collection and Congress' 
appropriation of those requested funds?
    Response. EPA does not have this information readily available. 
However, the agency has assured us that it is currently gathering the 
data needed to answer the question, and we will forward the agency's 
response to you when we receive it.

    Question 2. In testimony from later panels, we heard questions 
being raised about whether risk assessments accurately predict harm to 
public health, such as the incidence of certain types of disease which 
may be caused by exposure to environmental contaminants. Is EPA or any 
other Federal agency collecting national public health data of this 
type so that more accurate national risk assessment work can be 
performed?
    Response. In our recent investigations into toxic chemicals and 
indoor air pollution, we have found that the amount of data collected 
was extremely limited. As we reported in May 2000, Federal and State 
efforts to collect data on human exposure to toxic chemicals are 
limited, despite some recent expansions due to improved technology.\5\ 
Surveys from EPA and the Department of Health and Human Services (HHS) 
together measure in the general population only about 6 percent of the 
more than 1,400 toxic chemicals that were included in our review. Even 
for those chemicals that are measured, information is often 
insufficient to identify smaller population groups at high risk, such 
as children in inner cities and people living in polluted locations who 
may have particularly high exposures. We found that three main barriers 
limit Federal and State agencies' abilities to make more progress: (1) 
Federal and State laboratories often lack the capacity to conduct 
measurements needed to collect human exposure data, (2) there is often 
a lack of information to help set test results in context, and (3) 
coordinated, long-term planning among Federal agencies has been 
lacking, partly because of sporadic agency commitments to do human 
exposure measurement and monitoring. HHS and EPA officials indicated 
that they have been discussing the merits of establishing a coordinated 
interagency human exposure program, but they have not yet formalized or 
agreed upon a long-term strategy.
---------------------------------------------------------------------------
    \5\ Toxic Chemicals: Long-Term Coordinated Strategy Needed to 
Measure Exposures in Humans (GAO/HEHS-00-80, May 2000).
---------------------------------------------------------------------------
    In a separate review, we found that EPA is making progress in its 
efforts to provide communities with more information on releases of 
toxic chemicals, as required by section 312 of the Emergency Planning 
and Community Right-to-Know Act (EPCRA).\6\ Thus far, public use of the 
information has been limited. Much of the information has not been 
computerized to provide easy access and when it has, it is not 
available in regional or national data bases that permit comparisons 
among industries or geographical areas. Further, EPA has not developed 
policies, procedures, and standards to govern key aspects of its 
projects to disseminate information or to assess the data's accuracy.
---------------------------------------------------------------------------
    \6\ Environmental Information: Agencywide Policies and Procedures 
Are Needed for EPA's Information Dissemination (GAO/RCED-98-245, 
September 1998).
---------------------------------------------------------------------------
    In our 1999 review of the status of Federal research activities on 
indoor air pollution, we found that many gaps in knowledge and 
understanding of the problem remain.\7\ These include gaps and 
uncertainties with respect to (1) the identity and the sources of 
pollutants, (2) the mechanisms by which people are exposed to them, (3) 
the health effects resulting from prolonged and intermittent exposure 
to low-level concentrations of chemical and biological pollutants as 
well as complex pollutant mixtures, and (4) the most cost-effective 
strategies for reducing pollutant sources, exposures, and consequent 
health effects.
---------------------------------------------------------------------------
    \7\ Indoor Pollution: Status of Federal Research Activities (GAO/
RCED-99-254, August 1999).

    Question 3a. Clearly, EPA has an important role and a 
responsibility in collecting environmental data. However, states too 
have a role and responsibility in collecting these data. After all, 
they have a considerable stake in protecting public health and the 
environment. How much environmental data collection are the States 
funding themselves?
    Response. We have not independently compiled statistics on the 
amount of data collection being funded by the states. However, a 1999 
joint study by EPA and the Environmental Council of States (EGOS) 
concludes that states are responsible for 83 to 99 percent of the 
environmental pollutant data contained in six key EPA data systems.\8\ 
For example, more than 99 percent of EPA's air data comes from states; 
about 91 percent of EPA's water data comes from states; and more than 
92 percent of EPA's hazardous waste data comes from states. ECOS also 
said that it is not necessarily the EPA demand for information that is 
driving these State efforts. In many cases, states are attempting to 
meet the demands of their own citizens and policymakers.
---------------------------------------------------------------------------
    \8\ U.S. Environmental Protection Agency and Environmental Council 
of States, Environmental Pollutant Reporting Data In EPA's National 
Systems: Data Collection by State Agencies, Sept. 30, 1999.
---------------------------------------------------------------------------
    EGOS reported that states were spending about $12.5 billion in 
fiscal year 1996 (the latest date for which data is available) on 
environmental protection and natural resources, with EPA providing 
about $2.5 billion (20 percent) of this amount. EGOS does not have 
specific information on how much of this is for data collection.

    Question 3b. On their own, are states funding sufficient collection 
of data for them to set risk-based priorities and develop results-
oriented measures of their environmental programs?
    Response. We have not looked at this issue for all types of 
environmental media. However, as noted in our testimony, we recently 
performed a review of water quality data during which we surveyed all 
50 states and the District of Columbia.\9\ All the states and the 
District of Columbia responded to our survey. The results of our survey 
highlighted the need for more comprehensive State monitoring and called 
into question the extent to which unknown and potentially serious 
problems are going undetected. Only six states reported having the 
majority of the data needed to fully assess all their waters. Less than 
half the states have a majority of the data needed to determine if 
waters that have been assessed should be placed on their lists of 
waters that do not meet standards.
---------------------------------------------------------------------------
    \9\ Water Quality: Key EPA and State Decisions Limited by 
Inconsistent and Incomplete Data (GAO/RCED-00-54, March 2000).
---------------------------------------------------------------------------
    We also recently completed a review to determine the extent to 
which State and Federal agencies--in particular the Department of 
Health and Human Services (HHS) and EPA--collect human exposure data on 
potentially harmful chemicals, including data to identify at-risk 
populations.\10\ As mentioned earlier, the review showed that Federal 
efforts to collect human exposure data are limited, measuring in the 
general population only about 6 percent of the chemicals under review. 
At the State level efforts were similarly limited: Almost all State 
officials who we surveyed said they highly valued human exposure data 
for populations within their borders. However, despite this perceived 
value, most officials reported that they were unable to collect human 
exposure data in most of the cases in which they thought it was 
important to do so.
---------------------------------------------------------------------------
    \10\ Toxic Chemicals: Long-Term Coordinated Strategy Needed to 
Measure Exposures in Humans (GAO/HEHS-00-80, May 2000).
---------------------------------------------------------------------------
    Furthermore, ECOS told us that, while states are generally 
collecting the data they need to set risk-based priorities and develop 
results-oriented measures, they may not have enough information to do 
risk assessment. However, according to ECOS, it is clear that states 
have had some success in collecting data needed for risk assessment, 
based on the comparative risk projects undertaken in the 1990's and 
used as input into Performance Partnership Agreements with EPA. A 
number of states have also produced ``State of the Environment'' 
reports, which address environmental performance.

    Question 3c. What is the correct mix between environmental data 
collection funded by the Federal Government and that funded by the 
States?
    Response. We agree with the National Academy of Public 
Administration's 1995 assessment that EPA should focus its activities 
on problems of national, interstate, or intergenerational interest, 
while supporting problem-solving at all levels through technical 
assistance, increased flexibility, and information dissemination.\11\ 
The primary Federal responsibility should be to collect data to 
identify overall trends and emerging issues, to determine risks 
associated with exposure to harmful chemicals, and to fill the gaps in 
existing data needed to set priorities and assess risks. The states, on 
the other hand, must meet the demands of their own citizens and 
policymakers while, at the same time, developing the information needed 
to provide assurance that environmental laws are being properly 
implemented and enforced.
---------------------------------------------------------------------------
    \11\ National Academy of Public Administration Report to Congress, 
Setting Priorities, Getting Results: A New Direction for EPA, April 
1995.

    Question 3d. What, if any, State efforts are underway to 
standardize environmental data collection to improve comparability and 
public health protection?
    Response. In a recent review on EPA's environmental information 
management, we found that EPA and the states have taken initial steps 
to increase data compatibility.\12\ As a part of the 1c398 action plan 
for Reinventing Environmental Information (REI) initiative, EPA and the 
states are developing six data standards to be used in 13 of EPA's 
major data bases. The standards being developed will apply common 
definitions and formats. According to the REI action plan, these six 
standards will be developed, approved by EPA in partnership with the 
states, and in use in the 13 designated data bases by the end of fiscal 
year 2003.
---------------------------------------------------------------------------
    \12\ Environmental Information: EPA Is Taking Steps to Improve 
Information Management, but Challenges Remain (GAO/RCED-99-261, 
September 1999).
---------------------------------------------------------------------------
    The current initiative is limited in terms of the number of 
standards being developed (six), the number of EPA data bases in which 
the standards will initially be used (13), and the amount of data in 
those data bases (only the new data being entered) that will 
incorporate the standards. EPA recognizes that its current effort is 
only a first step toward its goal of full data integration.
    In response to the above question, ECOS emphasized that efforts are 
currently underway to standardize data for the purposes of smoothing 
the flow of data from states to EPA and sharing comparable data between 
and among states. The Data Standards Council (a joint effort of states 
and EPA) is leading the effort. ECOS cautioned, however, that the work 
will improve the comparability of data, but will not eliminate it as a 
problem.
    EPA responded to the question by also describing the work of the 
Data Standards Council and starting that the agency has also initiated 
a new project in partnership with the states, the Information 
Integration Initiative (I-3), this past fall. According to EPA, the 
effort is an enterprise-wide approach to integrating, managing, and 
providing access to environmental information. The agency will work 
closely with the states and other data partners in developing this 
comprehensive data exchange network. In its review of the fiscal year 
2001 budget request, we found that while the concept of information 
integration envisioned by EPA has merit, it is critical that the I-3 
effort be well thought out, and that all prerequisite requirements be 
met before embarking on this major investment. Many of the 
prerequisites, in fact, had not been completed. The Subcommittee on VA, 
HUD, and Independent Agencies, Senate Committee on Appropriations, also 
questioned the requested funding for
I-3 in fiscal year 2001 beyond the amount needed to perform the 
prerequisite steps for ensuring that the investment is prudent and the 
project will be effectively managed.
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                    New Hampshire Comparative Risk Project,
                                     Concord, NH, October 25, 2000.
Bob Smith, Chair and Max Baucus, Ranking Member,
Committee on Environment and Public Works,
U.S. Senate,
Washington, DC.

Attn: Angie Giancarlo

Re: NH Comparative Risk questions

    Dear Senators Smith and Baucus: Thank you for your letter of 
October 11 with follow-up questions to my October 3 testimony before 
your Senate committee. In general, we agree wholeheartedly with Senator 
Moynihan's observation at the October 3 hearing that environmental 
management has ``matured'' over the past 30 years. We offer our 
testimony, and the following comments, with that recognition, confident 
progress can and will continue in this next generation of environmental 
challenges.
    Definitions: Before you read the enclosed answers, please review 
the inside cover of the New Hampshire project guide, For Our Future, 
where we define our goal as protecting ``environmental quality of 
life,'' created by healthy people, healthy ecology, and healthy 
economy.
    Also, on page four of the guide, we define ``New Hampshire 
Environment,'' ``comparative risk,'' ``risk assessment,'' and ``cost-
benefit analysis.'' In the answers below, ``comparative risk'' means 
the collaborative, public, non-governmental process as used in New 
Hampshire. Our process created a voluntary, public-private 
partnership--participants identified hazards to our environmental 
quality of life along a continuum, explicitly incorporating scientific 
information, individual judgment, and personal values, using consistent 
criteria, and a shared vocabulary regarding ``risk.'' Other states, and 
USEPA in Unfinished Business, used a different, internally-based 
comparative risk process, set within a State or Federal agency. 
Traditional ``risk assessment'' is a very different undertaking, where 
a specific individual risk is studied and the harm of exposure 
quantified, often using models. We did not address the specific issue 
of ``residual risk'' in the context discussed by others at the hearing.
                               __________
Statement of Katherine Hartnett, New Hampshire Comparative Risk Project
                                summary
    (1) Thank you--for NEPA, CAA, CWA, SDWA, RCRA, CERCLA, SARA (1970-
1986) and reauthorizations. After 30 years, air, water, land are 
cleaner, economy never stronger.
    (2) Try to condense over 7 years of work into next 5 minutes (as 
locals say, ``sugar down'').
    (3) Fortunately, New Hampshire is small state--44th in area, 42nd 
in population. The good news is, because of small scale, most effective 
leaders try to work together (and it's ``hard to hide''). So, New 
Hampshire is a good scale for an inclusive process.
    (4) The process worked--55 stakeholders, from businesses, 
environmental organizations, public health, citizen groups, political 
leaders, and State and local government officials, gathered in an 
neutral, non-advocacy setting to identify, study, and rank risks. 
Technical staff summarized ecological, public health, and economic 
information in consistent format, with consistent criteria. Group 
worked by consensus, over 8 day-long sessions, to rank 55 risks to New 
Hampshire environmental quality of life (``healthy people, ecology, 
economy''). Documented influence of accessible science, personal 
judgment, and individual values in ranking.
    (5) Bottom line we began to separate fear from environmental 
hazard, and now, to reduce hazard. While four of top ten risks were to 
public health, four of top five were related to threats to air and 
water quality. Traced risks back to 11 sources (i.e., transportation, 
energy use, land use and development, recreation, water and food, 
etc.). Identified four key actions to reduce hazard. Current focus on 
two: (a) sound land use and (b) efficient use of energy, materials, and 
resources.
    (6) Identified transition to next generation of environmental 
management, with changes from:
    ``Us vs. them'' to ``we''
      ``problems'' to ``opportunities'',
     ``illness'' to ``wellness'',
     ``economy vs. environment'' to ``economy = environment'',
     ``environmental threats to humans'' to ``Humans threaten 
environmental quality''\1\ 
---------------------------------------------------------------------------
    \1\NOTE: See attached outline and For Our Future: A Guide to Caring 
for New Hampshire's Environment for more detail. For more info, pls 
contact Katherine Hartnett, Exec Dir. kateharttiac.net
    MESSAGE: Comparative risk process worked at NH scale. After 30 
years of successful Federal and State environmental regulation, focused 
on industrial and other point sources, we are now in a new generation 
of environmental management (from ``us vs. them'' to ``collaboration'') 
To continue success, we need additional tools, including fresh analysis 
of environmental conditions and stressors, coupled with public/private 
and federal/state partnerships, dynamic collaborations, effective 
incentives, creative funding programs, and targeted education, along 
with regulation and enforcement, to reduce current hazards and improve 
overall quality of life.
---------------------------------------------------------------------------
    (7) Stepping back, fits into evolution in New Hampshire, and U.S., 
in 20th into 21st century:
     1920-1930's Conservation 1960-1990 Federal and State 
Regulation 1990's Land Protection 215 century
     Personal, Corporate, Public Responsibility
Summary
    Comparative risk process worked at New Hampshire scale. After 30 
years of successful Federal and State environmental regulation, focused 
on industrial and other point sources, we are now in a new generation 
of environmental management. To continue success, we need additional 
tools, including fresh analysis of environmental conditions and 
stressors, coupled with public/private and Federal/state partnerships, 
dynamic collaborations, effective incentives, creative funding 
programs, and targeted education, along with regulation and 
enforcement, to reduce current hazards and improve overall quality of 
life.
    (1) Assumed points of agreement: Goal is to maximize environmental 
protection, with minimal costs. By separating fear from hazard, it is 
possible to more effectively prioritize actions Solutions that benefit 
multiple problems are preferable. Design approaches that productively 
engage multiple constituencies, and show results. Everyone has a role.
    (2) New Hampshire experience: Designed credible, non-advocacy 
process. Chose diverse participants that could: (a) leave 
preconceptions at the door; (b) listen to others, and work 
collaboratively; and (c ) bring a sense of humor to difficult 
discussions. Put environmental quality of life at the center, comprised 
of ``healthy people, healthy ecology, and healthy economy.'' Explicitly 
evaluated hazards using science, judgment, and values. Created 
continuum of hazards, used common vocabulary of criteria (severity, 
extent, reversibility, uncertainty). Recognized long-term (7-10+ years) 
nature of solutions.
     How different * * *  Unique features of New Hampshire's 
Project: The New Hampshire project had the advantage of following 
almost 20 other states through the comparative risk process. 
Innovations unique to New Hampshire include:
     Initial support and cooperation of state, private, and 
non-profit participants.
     Project housed at the neutral NH Charitable Foundation 
(NHCF), rather than environmental regulatory agency, public health 
agency, or State university.
     Defined ``quality of life'' considerations to include 
ecological, public health, and economic components, along with 
individual values.
     Focused on understanding and reducing hazard, with 
commitment to developing and implementing focused actions, using an 
integrated ranked list of risks to human health and ecological 
integrity as a guide.
     Used separate economic analysis to inform ranking and 
priorities for action.
     Public Advisory Group was very large (55 members), and 
took 8 day-long meetings over 5 months to rank the 55 risks into an 
integrated list that ``everyone could live with.''
     Benefited from volunteer efforts of over 100 technical 
experts in ecology, public health, and economics. Technical leaders 
writing ecology, health, and economic reports received a stipend up to 
$10,000 each, to ensure timely, accessible synthesis of information, 
for ease of use by 55 members of Public Advisory Group. Used geographic 
information system (GIS) for data analysis and presentation.
     Created innovative ``quality of life'' model that allowed 
individuals to explicitly identify their values influencing their 
ranking.
     Participated in concurrent ``collaborative assessment'' 
with independent technical experts experienced in supporting 30+ State 
projects.
     Identified action initiatives involving businesses, State 
and local governments, environmental and public health groups, 
educational institutions, and individuals.
     Wrote thinnest final report, containing all technical 
reports and ranking rationales.
     Work continues on reducing hazard, in context of 
Comparative Risk results.
     How successful?: good process, educated participants, 
contributed to decisionmaking such as:
    NOX--recently announced Northeast Regional Ozone 
Transport Assessment Group (OTAG) SIP call for ozone NH Clean Air 
Strategy NH Climate Change Action Plan Lead in natural environment (in 
sinkers, shot) Mercury (state strategy) Arsenic (program developing) 
NHDES adding ``Resource Protection'' to strategic plan Environmental 
organizations using study as technical reference and in organizational 
strategy.
    Also, Guide identifies 4 key actions to reduce hazard--specific 
projects, such as Minimum Impact Development Partnership, Economy/ 
Environment Collaborative, and NH transportation strategy, implement 
those actions.
    How failed?: Sludge--could use comp risk process to evaluate 
management options.
    MTBE--huge focus, while arsenic management only slowly getting 
underway.
    (3) What was learned? Change takes time (7-10+ year process to move 
to next generation of environmental management). Consistent, explicit 
process built credibility. Useful information, and helpful perspective 
for action by individual organizations. Knew from beginning that two 
phases needed: (a) Separate fear from hazard; (b) Reduce hazard. Need 
support for followup actions to reduce hazards.
    (4) So what? NH actions to (a) Separate fear from hazard; and (b) 
Reduce hazard:
     Studied and ranked 55 risks, using science consistent 
criteria, explicit judgment and values.
     Traced 55 risks back to 11 sources, then 4 key actions.
     New public/private partnership focusing on 2 key actions--
(a) sound land use and (b) efficient use of energy, resources, 
materials--by developing voluntary practices for good development 
(funded by USEPA Sustainable Dev. Challenge Grant). Also NHCF/McCabe 
funded Economy/Environment Collaborative, working on economic drivers 
to maintain NH Advantage of ``healthy people, healthy ecology, healthy 
economy'' with ``virtuous'' cycle.
     Using information, incentives, partnerships, 
collaboration, good publicity, along with modifying existing 
regulation, to implement.
    (5) Comments to Congress/USEPA: Not certain on advice.
    Do have some Q's: Is there a thought that there is a need to do 
things differently, or continue with current process? Is the purpose 
here to understand how to help Federal agencies be more effective?
    Some ideas: Current set of environmental hazards not amenable to 
legislation only--there's no single or suite of regulations alone that 
will work in this generation of environmental management.
     Why not take time to celebrate successes of first 
generation of environmental hazards reduced? (after 20-30 years of 
regulation, point sources clearly are much cleaner, and the economy 
very productive--Congress can show the effectiveness of its laws).
     Challenge today is even more difficult, because there are 
no clear ``villains,'' or easy solutions everyone is involved, at work, 
home, recreation; which is why information and clear understanding of 
the issues are essential.
     Acknowledge that managing next generation of hazards will 
need new strategies rather than primarily a regulatory approach. 
Possible actions:
    (1) Claim success in regulating point sources. (2) Now need to take 
the long view, and dedicate time to understand the problems. Let the 
public know what you are doing, and why. (3) Convene annual hearings 
for several years; ask for consistent information on regional and local 
conditions. (4) Develop an action plan to support work of locals--
encourage community-based solutions informed with accessible data and 
supported by sufficient funding.
    In short, Federal role can be to stimulate require consistent 
regional and local information about environmental conditions and 
trends to assemble a national picture, and then support Federal, state, 
local actions based on environmental data. Convene annual deliberations 
that encourage results-oriented environmental quality--using 
environmental indictors as measures of progress and linking agency 
budgets to reducing impacts. Local citizens become involved, get 
results, and see effects of Federal support on the ground, in their 
communities.
                                 ______
                                 
     Responses by Katherine Hartnett to Additional Questions from 
                             Senator Smith
    Question 1. New Hampshire has been a leader in the use of 
Comparative Risk assessment. How have you used that method to become 
more results-oriented?
    Response. In essence, we were able to begin to separate fear from 
hazard, and to focus on reducing hazard to our environmental quality of 
life, defined as ``healthy people, healthy ecology, healthy economy.'' 
In New Hampshire, most hazards were traced back to how we use land and 
energy/materials/resources.
    The first generation of environmental management used ``command and 
control'' to achieve results the main tools were ``end of the pipe'' 
regulation and enforcement to reduce releases of pollution to air, 
water, and land (the individual ``environmental media''), through Clean 
Air Act (CAA), Clean Water Act (CWA), Safe Drinking Water Act (SDWA), 
Resource Conservation and Recovery Act (RCRA), ``Superfund'' 
legislation (CERCLA and SARA), etc., and to mitigate environmental 
damage National Environmental Policy Act (NEPA). Examples of the 
effectiveness in New Hampshire are summarized in the right-hand column 
on page seven of For Our Future, and in left-hand column on page six.
    The comparative risk process led us to recognize a transition into 
the next generation of environmental management, where the sources are 
many, the tools are varied, and everyone has a part. Our new model is 
outlined below:

    Today: People, Ecology, Economy--From ``Illness'' to ``Wellness''
------------------------------------------------------------------------
               Illness Model                       Wellness Model
------------------------------------------------------------------------
1970-1980's,..............................  1990-2000+
``Us'' vs. ``Them''.......................  ``We''
Public health/economy vs. environment.....  Integrated public,
                                             ecological, economic health
Adversarial/Confrontation.................  Collaboration
``Point'' sources (smokestacks,             Many sources
 wastepipes).
``End of pipe''...........................  ``Upstream''
Remediation/mitigation....................  Prevention
Corporate Polluters.......................  Efficient Producers and
                                             Consumers
Regulation................................  Marketplace and Education,
                                             along with Regulation
Air pollution control devices.............  Energy efficiency/Demand
                                             reduction
Diseases from environmental exposure......  Health through lifestyle
                                             (diet, exercise, balance)
``What is the environment doing to us?''..  ``What are we doing to the
                                             environment?''
------------------------------------------------------------------------

    In New Hampshire, we used an inclusive, non-advocacy, science-based 
process that involved all players to build credibility and visibility 
needed to maintain an effort for the long-term (7-10+ years). Expanding 
on my October testimony, specific results to date include:
     NOx--recently announced Northeast Regional Ozone Transport 
Assessment Group (OTAG) SIP call for ozone
     NH Clean Air Strategy
     NH Climate Change Action Plan
     Lead in natural environment (in sinkers, shot)
     Mercury (state strategy)
     Arsenic (program developing)
     NHDES added ``Resource Protection'' to strategic plan and 
programming
     Environmental organizations continuing to use study as 
technical reference and in organizational strategy
     receiving requests for copies the 1997 Report of Ranked 
Environmental Risks in NH
     hearing frequent reference to the study in a wide range of 
meetings
     In 1997-98, collaboration with NH Public Health 
Association in their successful $1.1 million, 7 year ``Turning Point'' 
grant from WK Kellogg and RW Johnson Foundation (New Hampshire was one 
of only 14 states nationally to receive funding).
     In 1999, selection as one of 41 (of 650 applicants) to 
receive a major national competitive USEPA Sustainable Development 
Challenge Grant to work on reducing hazard through the Minimum Impact 
Development Partnership ($117,438 over 3 years).
     In the Spring 2000 session, key participation in the NH 
Legislature study commission (HB 1390) directed to build on the work of 
the NH Comparative Risk Project by improving public health and medical 
practice to reduce environmental exposure.
    In summary, the process allowed us to: (1) step back, 
systematically evaluate current hazards using a process that explicitly 
combined science, judgment, and values, and separated fear from hazard; 
(2) establish that we had moved to the next generation of environmental 
management, where we created a new model to describe our progress and 
current situation; and (3) create wide range of initiatives to reduce 
hazard (see page 26 of For Our Future).

    Question 2. Has the NH Comparative Risk Assessment project had a 
lasting impact on the public and on the other stakeholders?
    Response. We focused on two audiences: (1) key decisionmakers and 
(2) members of the public belonging to relevant constituency groups, 
such as Business and Industry Association of NH, NH Public Health 
Association, Audubon Society of NH, Society for the Protection of NH 
Forests, and the NH legislature. Please see answer to question S-1 
above for indication of effectiveness--we believe we have had lasting 
impact on the perspectives of many key decisionmakers, and are making 
progress on constituency groups. Because of the complexity of this 
generation of environmental management, we had expected lasting impact 
to take hold within 7-10 years (from 1994). As illustration, interest 
in and support for Minimum Impact Development (MID) practices have 
accelerated within the last year (see S-3 for more information on MID).

    Question 3. How are you currently using the results of your 
project?
    Response. Following the rationale illustrated on pages 10-11 in For 
Our Future, we are focused on encouraging sound land use practices, and 
efficient use of energy, materials, and resources. Since 1997, all but 
two of the projects listed in the right-hand column on page 26 of For 
Our Future to reduce environmental hazard have been completed or at 
least partially funded. Currently, as mentioned in my testimony 
(Section 4 ``So What?'', at the top of page 3 of 3), our main 
initiative is the Minimum Impact Development Partnership, a public/
private partnership to identify, define, and build ``good 
development,'' that is energy efficient, protects habitat, and 
minimizes pollution. Implementing minimum impact development should 
reduce most of the 55 risk identified, especially those higher ranked 
risks. Our strategy assumes maintenance of the current regulatory 
system to continue to encourage reduction in pollution releases.

    Question 4. Do you have any legislative suggestions to improve the 
use of Comparative Risk Assessment in setting environmental priorities?
    Response. As mentioned in the introductory paragraph, New Hampshire 
used a collaborative, non-governmental partnership comparative risk 
process model for our project, which we believe works best at a State 
(NH), regional (Elizabeth River, VA), or local (Columbus OH) scale. We 
defined our purpose as protecting environmental quality of life, 
comprised of the combination of healthy people, healthy ecology, and 
healthy economy. Another comparative risk approach is the inter- or 
intra-agency model, used to directly address agency priorities (such as 
described in USEPA's Unfinished Business or Science Advisory Board's 
Reducing Risk, mentioned in the introductory paragraph and Senator 
Baucus' Question #2 BACKGROUND).
    Both approaches found widespread public recognition of the problems 
perceived in the first generation of environmental risk. After thirty 
years of progress and many successes, we found that we have moved into 
a new set of challenges. For specifics on a process to identify and set 
this next generation of environmental priorities, please see my 
testimony, section (5) Comments to Congress/ USEPA on page 3 of 3.
    Also, as I mentioned in my verbal testimony, three other Federal 
initiatives are examples of next generation initiatives that help State 
and local communities reduce environmental hazard associated with how 
we use land and energy, materials, and resources: (1) Transportation 
Equity Act (TEA-21) process and funding to diversify transportation 
options into an integrated, connected, multi-modal convenient network 
to reduce congestion; (2) USEPA's Sustainable Development Challenge 
Grant program and (3) Conservation and Reinvestment Act (CARA).
                                 ______
                                 
     Responses by Katherine Hartnett to Additional Questions from 
                             Senator Baucus
    Question 1a. The committee has heard a lot about ``good science'' 
and scientific ``uncertainty,'' but I see that the Project ranked 
particulate matter, ground level ozone, and arsenic in drinking water 
as among the highest risks in New Hampshire. There are some in Congress 
who do not believe that the identification of these problems or the 
estimation of their risks is based on ``sound science.'' Can you tell 
me how your project dealt with scientific uncertainty in your project?
    Response. At the project level, we recognized and accepted that 
uncertainty is an inherent component of the scientific process, which 
is why explicit judgment and values are so important in policy and 
decisionmaking. Two examples illustrate the concept:
    Smoking.--The epidemiology of lung cancer associated with smoking 
has been known since the 1960's. The exact mechanism of the toxicology 
was established only very recently. So ``scientific uncertainty'' 
created a generation-long debate over the effects of smoking on 
smokers.
    Particulate Matter.--Based on clear trends that showed increased 
deaths and hospital admissions during periods with higher levels of 
PM2.5, in the mid-1990's, USEPA moved to extend its 
regulation to smaller particles, even though the causal mechanism was 
unclear. A non-partisan expert panel recently independently replicated 
EPA's results, with an analysis that confirmed the association between 
elevated PM2.5 and excess mortality (see attached article 
from SCIENCE, 4 Aug 2000, p. 711).
    At the risk specific level, ``uncertainty'' was one of the four key 
criteria evaluated and explicitly ranked, on a defined scale of 1-5, by 
the ecological and public health technical work groups. The three other 
criteria were ``severity,'' ``extent,'' and ``reversibility.''

    Question 1b. Did you use conservative estimates, or apply 
principles of precaution, in the face of uncertainty?
    Response. We did both. Technical experts identified the ranges of 
estimates; and stakeholders often injected principles of precaution on 
their own. We also wrestled with the inherent conflict between low 
severity high occurrence risks (such as chlorination by-products in 
water supply or food additives and preservatives) and high severity low 
occurrence risks (such as earthquakes or exposure to high level 
radioactivity).

    Question 1c. How were you able to reach the consensus with 
stakeholders on ranking issues such as particulate matter, ground level 
ozone, and arsenic in drinking water where there were scientific 
uncertainties?
    Response. Stakeholders were committed to ``getting something done'' 
and producing a ranked list of risks that would lead to risk reduction 
by separating fear from hazard. We created a non-advocacy, accessible 
science-based, iterative evaluation process, where everyone had their 
say and all listened to other points of view. We all worked hard to 
maintain a fair, unbiased, and credible process, to facilitate reaching 
consensus, by first building trust among stakeholders. Each participant 
increased their understanding of the nature of science, where 
uncertainty is expected, and learned more about many controversial 
issues. Everyone was dissatisfied, to at least some extent, with the 
final ranked list a hallmark of a consensus-based work product. And 
each always had the option of deciding ``I can't live with this'' 
result--which paradoxically, no one exercised. Additionally, 
discussions incorporated evaluation of the uncertainty, severity, 
extent, and reversibility associated with 55 risks to environmental 
quality of life. Finally, and perhaps most importantly from the 
perspective of participants, rationales for each risk ranking were 
recorded in Chapter 6 of the 1997 report.

    Question 2. I see that you used over 100 technical experts in a 
number of sciences to review the environmental issues facing your 
state. But in the end, you had a public advisory group--not the 
technical experts--decide how to rank the risks of these issues. In 
fact, based on your written testimony, which states that a risk ranking 
was based on what ``everyone could live with,'' it seems these rankings 
were negotiated. Can you explain why you used this approach rather than 
basing the ranking solely on the work of the technical experts?
    Response. Public perception shapes public policy. And as Congress 
knows well, public policy is a subjective process, at best balancing 
scientific evidence with individual belief, experience, values, and the 
collective political process. The findings of technical experts alone 
would have become just one more element competing for attention in the 
larger process.
    Our process started with a mix of public perception and expert 
opinion on environmental hazard, incorporated scientific information 
with consistent criteria, and then provided a forum for diverse 
stakeholders to find the common ground ``that they could live with.'' 
Everyone participating changed some ideas based on new perspectives. 
The ranking was rooted in science, and began an extended process of 
public education to update that perception with new information about 
the changing nature of environmental hazard.
    PROCESS NOTE: The objectivity of the ranking process was 
demonstrated in that participants stuck with a long and intricate 
process--8-day-long meetings over 5 months. Participants arrived with 
their initial rankings of a subset of risks, posted those rankings in 
small groups, discussed their rationales, and reranked. The results of 
the four small group rankings were aggregated, and mathematically 
averaged, then discussed again as a large group. It was very 
significant that rarely was even a slight adjustment to the aggregate 
ranking considered, because the aggregate spanned the perspectives of 
the group. Also, capturing the rationales for the ranking provided 
context and illuminated the thought process.
    BACKGROUND: The ranking was a product of late 1990's scientific 
knowledge, judgment about that science, and individual values about 
what matters most. In 1993 when the New Hampshire project began, public 
perception of environmental risk had been formed by the images from the 
1960' and 1970's--rivers on fire, polluting industrial smokestacks, 
toxic wastes leaking out of illegally buried 55 gallon drums, etc. In 
1987, in Unfinished Business, USEPA experts had ranked the most 
pressing environmental risks of the late 1980's. In the follow-up 1990 
report, Reducing Risk, USEPA's Science Advisory Board noted that the 
risk list identified by agency experts was almost inverse to that 
perceived by the public.

    Question 3a. I'm impressed by the inclusiveness of your projects. 
I'm sure that one of the big benefits was that the participants in 
these projects developed a much better understanding of the risks posed 
by various environmental issues. What about the benefits to the 
understanding of the public at large?
    Response. Thanks for your comment about inclusiveness; it was 
important to us. Pls. see answer to Senator Smith's Question 2.

    Question 3b. Have you actually studied whether the project has 
changed public attitudes or, more generally, whether and what the 
public-at-large learned from it?
    Response. We have not had the time nor resources to study public 
attitudes. Because of limited resources, we did not set out to 
influence the public-at-large, but rather focus on two specific 
audiences, as described in the answer to Senator Smith's Question 2.

    Question 4. Could you give me examples of how the results of your 
comparative risk project has influenced the budget, policies, and/or 
activities of your State government?
    Response. The New Hampshire project intentionally was designed to 
involve all players who shape environmental policy--business, 
environmental organizations, public health experts, citizen groups, 
along with State and local government--because initiatives to improve 
environmental quality of life will come from all sectors. Please see 
answer to Senator Smith's Question 1.

    Question 5. Has your comparative risk project changed the State's 
priorities when it comes to how it interacts with, and what it requires 
of, local governments in New Hampshire?
    Response. Not yet. Changing how State government interacts with 
local government is part of the work of the Minimum Impact Development 
Partnership. The nature of what the State government can require of 
local government is very limited in New Hampshire. Most importantly, we 
intentionally designed our process to empower all citizens to act (see 
pages 12-25 of For Our Future).

    Question 6. What were the most important results of your 
comparative risk project?
    Response. Process: Please see answer to Senator Baucus' Question 1c 
and Question 2 PROCESS. Outcome: Please see answer to Senator Smith's 
Question 1.

    Question 7. What were the keys to the success of your project?
    Response. The process, which created a non-advocacy, neutral forum, 
provided accessible science, with explicit technical criteria, 
evaluated by judgment informed by belief and experience, and individual 
values (more at Senator Baucus' Question 1c and Question 2 PROCESS).

    Question 8. In implementing the comparative risk assessment, what 
problems did you encounter that you could not, or could only partially, 
overcome?
    Response. Within the process, a number of participants felt 
frustrated by the consensus-based nature of the final list, and so, 
gave it less than full support. Also, one public health advocate 
continued to believe that ecological risks shouldn't have been ranked 
above those related to public health.
    Additionally, some advocacy groups outside the process didn't 
``buy-in'' on the results--for example, a small group opposed to land 
application of biosolids (``sludge'') have succeeded in polarizing and 
sensationalizing that issue, despite the relatively low risk ranking. 
So those interested in ``single issue'' politics did not agree with a 
process that built common ground, and placed risk in context.

    Question 9. Do you think a comparative risk project similar to the 
one done in New Hampshire could be performed on a national scale? Why 
or why not?
    Response. As described in the introductory paragraph and elsewhere, 
there are at least two basic approaches to ranking risks along a 
continuum of hazard (i.e., ``comparative risk''). In my written 
testimony (section (2), page 1 of 3), I noted the key characteristics 
of New Hampshire's public, non-governmental process--participants (1) 
left preconceptions and vested interests at the door; (2) brought an 
ability to listen to others and work collaboratively, and (3) had a 
sense of humor to ease difficult discussions. If Congress or others can 
create such a setting at the national scale, perhaps it might be 
possible--depending on the purpose of the effort. USEPA met with some 
success with the inter-agency process in 1987, and SAB in 1990 (as 
noted in Senator Baucus' Question 2 BACKGROUND).

    Question 10. In the panel on residual risk, many concerns were 
expressed about EPA's case study residual risk assessment for secondary 
lead smelters. This seems, in some ways, to be the nature of risk 
assessments. In fact, it often seems that every time a risk assessment 
is done these days--whether it is to regulate an environmental problem, 
update a standard, or better understand a problem such as climate 
change--it is greeted with an extremely high level of controversy.
    Given this, how realistically do you think it is for us to consider 
doing a comparative risk assessment that would set EPA's budget 
priorities--something that would require a separate risk assessment for 
each of the Nation's environmental problems--but still avoid 
controversies over each and every risk assessment the priorities are 
based on?
    Response. As defined in the first paragraph on page 1, comparative 
risk process is quite different from that of risk assessment.
    Rather than using separate risk assessment, as outlined in 
testimony on comments to Congress/EPA (page 3 of 3), we believe it is 
time to move into the next generation of environmental management, 
using new tools. National Science Foundation under Rita Colwell is 
doing so, with their focus on ``biocomplexity'' as the key to effective 
management in the 21st century.
    However, if Congress were to choose to further explore the role of 
national comparative risk process, much work has been done by the 
National Academy of Public Administration. Congressional staff are 
likely familiar with Setting Priorities, Getting Results (1995), a 
clear articulation of the role of risk-based decisionmaking at USEPA. A 
subsequent report, Resolving the Paradox of Environmental Protection 
(1997), comes with an appendix tracking implementation of the 1995 
recommendations at EPA. Their third report, Environment.Gov--
Transforming Environmental Protection for the 21st Century, is due out 
next month, in November, 2000, with recommendations building on the 
previous two. Resources for the Future also studied use of comparative 
risk, in Worst Things First? (1994), and Comparing Environmental 
Risks--Tools for Setting Government Priorities (1996).

    Question 11. What should the states and the Federal Government be 
doing to collect public health data that would help in performing 
better risk assessments?
    Response. Certainly, more data can help illuminate better 
solutions. Data are most useful when: (a) collected based on a 
strategic assessment of what we need to know to understand the 
relationship between inputs and outcomes; (b) analyzed objectively 
before decisions are made; and (c) reported consistently and regularly. 
Use of data is an iterative process with making policy. An example: 
USEPA initially regulated volatile organic compounds (VOC's) as a key 
component in formation of ground level ozone (``smog''). Over many 
years, additional data and analysis revealed that in New Hampshire, 
nitrogen oxides (NOx) were the limiting factor. Only 
recently have regulations been changed to incorporate the improved 
scientific understanding of air pollution chemistry. Another example is 
current focus on PM2.5 as a component in acid rain, ground 
level ozone, and regional haze associated with the public health 
outcome of excess urban mortality, ecological outcome of decreased soil 
and forest productivity, and economic outcome of reduced visibility.
    More generally, as outlined in our ``illness/wellness'' model, 
public health and ecological health are interrelated; good data on the 
both are needed, within a context that promotes health, rather than 
catalogues extent of illness. As discussed in the previous paragraph, 
``good data'' means relevant information, properly collected, 
effectively analyzed, and consistently reported, in an iterative 
process that modifies practices as understanding increases.
                                 ______
                                 
                  [From Science Magazine, Volume 289]
                             Air Pollution
                 panel backs epa and `six cities' study
                          (By Jocelyn Kaiser)

    The Environmental Protection Agency (EPA) has won a major victory 
in the fierce battle over its tough new standard for particulate air 
pollution. Dealing a sharp blow to critics from industry, a nonpartisan 
research group has reevaluated key data that EPA relied upon to set 
that standard and has come out firmly behind the agency. Although all 
scientific debate isn't over, the reanalysis ``puts to bed many of the 
concerns that were raised'' 3 years ago, asserts John Vandenberg, an 
EPA environmental scientist.
    At issue was EPA's 1997 decision to extend its regulation from 
particles 10 micrometers or less in size to those a mere 2.5 
micrometers or less across (PM2.5). EPA based its decision 
largely on two controversial studies that linked these tiny particles, 
released mainly by motor vehicles and power plants, to higher death 
rates.
    In the Six Cities study, Harvard researchers examined the relation 
between levels of PM and sulfates (a component of fine particles) and 
death rates among more than 8,000 people in six U.S. cities, following 
them for 14 to 16 years. The American Cancer Society (ACS) study 
followed over 500,000 people in 154 cities for 8 years. Both found a 
slight rise in death rates from health and lung disease in cities with 
higher levels of PM2.5, although the mechanism remained 
unclear. Based largely on the ACS death court, EPA calculated that the 
benefits of cutting PM2.5 to 65 g/m3 
over 24 hours would far outweigh the multibillion-dollar costs.
    After EPA proposed the standard in 1996, the American Petroleum 
Institute (API) and other industry groups blasted the two studies. Some 
scientists also argued in congressional hearings that the apparent link 
might result from other air pollutants, a less healthy lifestyle in 
dirtier cities, or other confounding factors. Industry groups sued to 
block the new regulations. A federal court decided that the science was 
sound but threw out the rules based on legal arguments, which will be 
heard by the Supreme Court this fall. At the same time, skeptical 
industry groups and some lawmakers demanded that the Harvard 
researchers turn over their raw data. The researchers refused, saying 
that subjects' confidentiality would be breached.
    To resolve the scientific and data-sharing issues, Harvard turned 
to the nonprofit Health Effects Institute (HEI) in Cambridge, 
Massachusetts. HEI assembled an expert panel to reanalyze both studies. 
In a report released last week, that panel concluded that the 
association between PM2.5 and excess mortality is real. The 
team, led by statistician Daniel Krewski of the University of Ottawa, 
replicated the studies from original data sets and got essentially the 
same results: slightly higher death rates in the dirtier cities (see 
table). The team probed the data for more than 30 possible confounders, 
from altitude to health services, and tested the link ``in nearly every 
possible manner'' with various analytical techniques. The results still 
held.

                             ACS Six Cities
------------------------------------------------------------------------
                                              Increased Death Rate
                                       ---------------------------------
    Increase in PM2.5 across cities          Original
                                           Investigators     Reanalysis
------------------------------------------------------------------------
18.6 g/m3....................               1.26          1.28
24.5 g/m3....................               1.17          1.18
------------------------------------------------------------------------
Confirmation. Reanalysis yielded results almost identical to the
  original studies: a rise in death rate of 28 percent (in the Six
  Cities study) and 18 percent (in the ACS study) from cleanest to most
  polluted city.

    Bill Frick, an attorney with the API, agrees that the reanalysis 
has ``eliminated some of the uncertainty.'' Another major epidemiology 
study released by HEI that looked at daily PM levels and deaths in 90 
cities has also cleared up earlier doubts (Science, 7 July, p. 22). But 
Frick argues that researchers still need to figure out which component 
of PM2.5 causes harm and hence what problem needs to be 
fixed--power plants or diesel trucks, for instance. A slew of new 
federally-funded research is addressing those questions and will feed 
into EPA's assessment of PM2.5 science this fall. Until EPA 
decides whether to adjust the standard next year, it won't ask states 
to comply with the regulations.
    Meanwhile, the legal scuffle over access to research data 
continues. In the wake of the controversy, Congress in 1998 passed a 
law, sponsored by Senator Richard Shelby (R-AL), mandating the 
federally-funded researchers release their raw data if requested under 
the Freedom of Information Act. To the relief of scientific groups, the 
White House interpreted the law narrowly, limiting it to grants awarded 
after fall 1999 and only to data used to support regulations. The U.S. 
Chamber of Commerce threatened to sue to broaden that interpretation 
and began the process by filing requests last December for the Harvard 
data. So far, EPA has refused to turn over the data because the study 
predates the law. Keith Holman, an attorney with the Chamber of 
Commerce, says the group hasn't yet decided whether to litigate the 
case.
    Statement of Michael J. Pompili, Assistant Health Commissioner,
                       Columbus Health Department
    Good Morning Chairman Smith and members of the Committee on 
Environment and Public Works. It is an honor to provide testimony to 
you this morning particularly on a process which I believe strongly in 
and which has been central to several programs which have been 
developed for the Columbus community over the past 10 years. Your 
willingness to discuss the use of comparative risk assessment in 
setting community priorities demonstrates your understanding that there 
are no simple answers to solving environmental issues that impact our 
communities and that it is critical to involve stakeholders in the 
process. During my next few minutes of testimony, it is my goal to 
share with you how we have successfully implemented several comparative 
risk processes in Columbus, Ohio, identify the central themes which 
have led to the success of these efforts and to make recommendations to 
you regarding the role of the Federal Government in such initiatives.
    The Community Environmental Management Plan was established through 
the Columbus Health Department, beginning in 1992. It is made up of 
five components:
    The Environmental Science Advisory Committee (ESAC) is a body of 18 
environmental scientists, educators and other professionals who assist 
city policymakers on a volunteer basis. ESAC is modeled after the US 
EPA's Science Advisory Board. Its goal is to help leaders make better 
decisions by offering advice, opinion and counsel on a wide range of 
environmental issues.
    Priorities 1995 is a classic example of a comparative risk 
assessment. This innovative effort used over 250 community volunteers 
to develop a comprehensive environmental blueprint for the city of 
Columbus. Project participants logged more than 5,000 person-hours in a 
2-year process that:
    (1) Identified the City's most pressing environmental problems; (2) 
Analyzed them to determine potential risk to citizens; (3) Ranked these 
problems in terms of severity; and, (4) Developed potential solutions 
to these problems.
    Columbus' Environmental Snapshot uses key indicators to provide the 
public with status and trend information on the State of the Columbus 
and Franklin County environment. In creating the Snapshot, the 
objective was to compile information already being collected by 
numerous governmental organizations into a single, easy-to-understand 
and user-friendly document. The information contained in the Snapshot 
represents both an educational resource and a means of gauging the 
success of past environmental efforts including a status report on the 
progress of Priorities 1995 initiatives.
    Columbus Community Risk Panel is a 35-member committee designed to 
help Greater Columbus residents make informed decisions about risk. The 
Panel, through various initiatives, serves as an ongoing resource to 
help develop a more informed citizenry and provide the community with 
accurate information on health and quality of life risks. Panel members 
include public officials and other community leaders from government, 
professional groups, public and private business, health care and 
education organizations, and the media. A key goal of the panel is to 
establish connections with citizens. This is accomplished through a 
variety of projects including: the establishment of community computer 
centers in inner-city churches, the Neighbor-to-Neighbor program, 
formation of Community Advisory Panels that bring industrial facilities 
and neighborhood groups together and establishing a web site for risk-
related information.
    Project CLEAR is a new citizen-driven initiative based on the same 
principles as our Priorities 1995 Risk Project. It is designed to 
address Central Ohio outdoor air quality, particularly issues related 
to ground-level ozone pollution. CLEAR's main objective is to involve 
citizens, businesses, local governments, and other organizations in 
evaluating and choosing strategies to improve air quality. What is 
particularly unique about Project Clear is that it moves beyond public 
opinion toward a public deliberation process.
    Three basic principles underly all of the components of the 
Community Environmental Management Plan: promoting the use of science 
and scientific information whenever possible; developing a more 
informed citizenry on issues of community health, environment and 
quality of life; and encouraging public participation in the 
decisionmaking process.
    These principles have not only lead to the success for our efforts 
but are appropriate at all levels of government: local, State and 
Federal. An excellent example of these principles operationalized at 
the State level was when Senator Voinovich, then Governor Voinovich 
embarked on a comparative risk project for the State of Ohio. Similar 
efforts have been conducted by 25 of the 50 states as well as at least 
12 local communities. The process represents a new way of doing things 
most importantly involving the public in meaningful ways on issues that 
impact their lives.
    So the question remains what role can the Federal Government play 
in this effort. The Federal Government's role is to establish national 
priorities. The use of a national comprehensive risk process could 
provide general direction in setting these national priorities, but it 
is very important to understand the limitations of a Federal 
comparative risk project. A Federal comparative risk project is doomed 
to fail if it means risks encountered in Florida are compared with 
those found in Oregon. Instead it may be most appropriate for the 
Federal Government to serve to support these efforts at the State and 
local level and actively promote the principles of sound science, 
informed citizenry and public participation in all environmental 
initiatives. Specifically the Federal Government can serve as a 
technical assistance center, both generating data and fulfilling the 
role of information resource. States and local communities will vary 
widely in their ability to successfully implement a comparative risk 
process. Federal support and technical guidance may allow for at least 
some degree of consistency and utility of effort. Because community 
participation and buy-in are critical in these types of initiatives and 
essential for any behavioral change to occur on the part of 
individuals, Federal emphasis and support for community participation 
at the local level may also be appropriate. Shifting from categorical 
thinking formulas to community thinking formulas will go a long way 
toward promoting involvement. Further, it may be helpful for states and 
local communities to look to the Federal Government for funding of 
comparative risk projects or at least linking to available funding for 
such efforts.
    Some of what I have described is not necessarily a new role. At one 
time, the Federal Government funded a U.S. EPA office to directly 
assist State and local folks interested in doing this type of work. 
This Regional and Statistical Planning Branch of the Office of Policy, 
Planning and Evaluation was extremely helpful to us in Columbus 
providing a $50k grant for our project and direct technical assistance 
in project formation and implementation. I have heard many other local 
project directors share these sentiments. Unfortunately, the office was 
disbanded a year or so ago and its personnel were re-assigned within 
the agency. To my knowledge, there is now no Federal entity that exists 
concerned with promoting and directly assisting State and local 
governments with projects dealing with risk-based decisionmaking.
    By recognizing the value of local communities in determining their 
priorities, a further role for the Federal Government is flexibility. 
While Federal standards and regulations are often warranted, it is 
important to allow for some tailoring of effort according to a local 
communities' need. US EPA's Project XL is a perfect example of this 
type of philosophy. In its current form, however, Project XL is 
somewhat cumbersome and a challenge to negotiate. We are quite pleased 
to have just signed the final agreement for an XL project in Columbus, 
an effort which took over 3 years to come to fruition.
    In asking for this flexibility, however, local communities need to 
hold themselves accountable and maintain the high, if not higher 
standards than those set forth at the Federal level. If by your 
flexibility at the Federal level you are demonstrating your trust of 
State and local government to make sound environmental decisions, we 
must safeguard this trust and work cooperatively with you toward common 
goals. Without a certain level of trust at all levels of government, 
even the most innovative programs are doomed to fail.
    In closing, let me once again reiterate the importance of public 
participation and connecting with our citizenry. More and more our 
citizenry is expressing dissatisfaction or disinterest in civic 
responsibility. While they are disengaging from the political process, 
we must fight to have them actively involved in directing resources and 
actions that will impact their own neighborhood and their quality of 
life. We must demonstrate government's trust in the ability of 
residents to make these programs work. I am a very strong believer that 
our citizenry will make the ``right'' choices if they are able to 
receive information in understandable ways, if they are presented with 
accurate portrayals of existing tradeoffs regarding risk and if the 
decisionmaking process reinforces the need to consider a full range of 
options available. If these themes may be woven through the Federal, 
State and local government, we may yet see a public which still seeks 
out their civic roles.
    Thank you for the opportunity to speak before you today.
                                 ______
                                 
     Report--The Columbus Community Environmental Management Plan: 
 Protecting and Improving the Environment by: Using Science, Informing 
           Citizens, and Emphasizing Community Decisionmaking
               the columbus environmental management plan
    The Columbus Community Environmental Plan (CEMP) is designed to 
protect and improve the area environment through three basic 
principles:
     Promoting the use of science and scientific information 
whenever possible;
     Developing a more-informed citizenry on issues of 
community health, environment, and quality of life; and other issues 
dealing with risk,
     Using members of the community to help make risk decisions 
where feasible.
    The Community Environmental Management Plan is administered through 
the Columbus Health Department, and has four basic components:
The Environmental Science Advisory Committee (ESAC)
    ESAC is a body of 18 environmental scientists, educators and other 
professionals who assist city policymakers on a volunteer basis. Its 
goal is to help leaders make better decisions by offering advice, 
opinion and counsel on a wide range of environmental issues. ESAC 
considers and evaluates questions submitted by the Mayor, City Council, 
Board of Health or City Department managers, focusing specifically on 
the science behind environmental issues. Services can include client 
meetings; document review, analysis and evaluation; property site 
inspection and preparation of summary documents.
Priorities `95
    This innovative effort used over 250 community volunteers to 
develop a comprehensive environmental blueprint for the city of 
Columbus. Project participants logged more than 5,000 man hours in a 2-
year process that:
    (1) Identified the city's most pressing environmental problems;
    (2) Analyzed them to determine potential risk to citizens;
    (3) Ranked these problems in terms of severity; and,
    (4) Developed potential solutions to these problems.
Columbus' Environmental Snapshot
    This community document uses key indicators to provide the public 
with status and trend information on the State of the Columbus and 
Franklin County environment. In creating the Snapshot, the objective 
was to compile information already being collected by numerous 
governmental organizations into a single, easy-to-understand and user-
friendly document. The information contained in the Snapshot represents 
both an educational resource and a means of gauging the success of past 
environmental efforts.
Columbus' Community Risk Panel
    This 35-member committee was formed in January 1998 to help ensure 
that Greater Columbus residents are making informed decisions about 
risk. The Panel, through various initiatives, serves as an ongoing 
resource to help develop a more informed citizenry and provide the 
community with accurate information on health and quality of life 
risks. Panel members include public officials and other community 
leaders from government, professional groups,. public and private 
business, health care and education organizations, and the media.
            environmental science advisory committee (esac)
    ESAC is a body of 18 environmental scientists, educators and other 
professionals who assist city policymakers on a volunteer basis. Its 
goal is to help leaders make better decisions by offering advice, 
opinion and counsel on a wide range of environmental issues.
    ESAC considers and evaluates questions submitted by the Mayor, City 
Council, Board of Health or City Department managers, focusing 
specifically on the science behind environmental issues. The committees 
resulting work products will differ according to the issue under 
consideration. Services can include client meetings; document review, 
analysis and evaluation; property site inspection and preparation of 
summary documents. Because ESAC is an independent, volunteer 
organization, it offers decisionmakers an objective (different) 
perspective that can either confirm judgments or suggest new avenues of 
thought.
    Issues considered by ESAC include:
     The possibility of health threats to police officers from 
lead exposure at the police firing range.
     An evaluation of City sewer line construction practices.
     Watershed impacts from land application of manure from 
area egg farm.
     Review of Columbus noise ordinance.
     Consideration of proposed uses for sewage sludge 
incinerator ash.
     Adequacy of a hazardous waste remediation plan for U.S. 
Air Force property adjacent to Port Columbus International Airport.
                             priorities `95
    This innovative effort used over 250 community volunteers to 
develop a comprehensive environmental blueprint for the city of 
Columbus. Project participants logged more than 5,000 man hours in a 2-
year process that:
    (1) identified the city's most pressing environmental problems;
    (2) analyzed them to determine potential risk to citizens;
    (3) ranked these problems in terms of severity; and,
    (4) developed potential solutions to these problems.
    One of Priorities `95 greatest strengths was that it incorporated 
both scientific information and public opinion in determining which 
environmental problems are most serious and how these problems should 
be addressed. Priorities `95 concluded with the development of almost 
200 recommendations for environmental improvement.
    Since the projects conclusion, the City has worked to address many 
of the Priorities `95 recommendations. Notable efforts include:
     Development of a parkland dedication ordinance in 
conjunction with new residential development.
     Development of a rabies public outreach/informational 
campaign to increase pet vaccinations.
     Acquisition of non-productive city properties for 
redevelopment as community gardens, beautification projects or 
neighborhood playgrounds.
     Establishment of a 6-county coalition to address the issue 
of atrazine runoff in the Scioto River watershed.
     Development of a Recreation and Parks Department 
containerized tree program that reduces growing time of planting stock 
by over 50 percent.
                       the environmental snapshot
    This community document uses key indicators to provide the public 
with status and trend information on the State of the Columbus and 
Franklin County environment. In creating the Snapshot, the objective 
was to compile information already being collected by numerous 
governmental organizations into a single, easy-to-understand and user-
friendly document.
    A comprehensive community process was developed to select the 35 
environmental indicators contained in the document. More than 40 
governmental personnel, environmental scientists and members of the 
general public served as advisors to select appropriate environmental 
indicators. Their participation ensured that the most technically 
relevant and easily understandable information would be used. Data is 
presented for five environmental areas, and includes indicators for:
     Urban Conditions.--Population; Platted Land; Building 
Activity; Land in Farms, and more.
     Air Quality.--Ambient Air Trends; County Vehicle 
Emissions; Registered Passenger Vehicles; and more.
     Drinking Water.--Finished Water Chemical Levels; County 
Well Water Chemical Levels.
     Surface Water.--Major Sources of Impairment; Fish Tissue 
Analysis; and more.
     Solid Waste.--Waste Generation, Reduction & Recycling; 
Destination of Generated Tonnage; and more.
    Over 250 copies of the report are distributed each year to 
community groups, civic associations, community leaders and 
individuals. The document is updated annually, an educational resource 
that can help provide users with greater insight into the direction of 
environmental trends and a means of gauging the success of past 
environmental efforts.
                     columbus community risk panel
    This 35-member committee was formed in January 1998 to help ensure 
that Greater Columbus residents are making informed decisions about 
risk. The Panel, through various initiatives, serves as an ongoing 
resource to help develop a more informed citizenry and provide the 
community with accurate information on health and quality of life 
risks. Panel members include public officials; community leaders from 
government agencies, professional groups, public and private business, 
health care and education organizations; and the media.
    Panel members meet quarterly, however activities of the panel are 
ongoing. Current Community Risk Panel Projects include:
     Development of Project CLEAR, a 2-year community 
initiative designed to produce air pollution reduction strategies for 
the Central Ohio area. The project will specifically examine issues and 
strategies related to outdoor air quality, focusing on precursors to 
ground level ozone formation.
     Creation of Community Computer Centers, providing 
computing sites with Internet hookup in inner-city areas. The programs 
purpose is to provide health and environmental information to 
populations that may not have computer access. The program is initially 
focusing on establishing centers in African American churches to build 
on the strong relationship that traditionally exists between these 
churches and their congregations.
     Neighbor to Neighbor, a community initiative bringing 
people together to learn about specific things they can do to improve 
their health, environment and quality of life. Neighborhood residents 
form teams, which meet regularly with a trained leader in each others' 
homes. With the help of a trained leader, the teams learn about simple 
things that all of us can do to improve the health and environment, and 
choose specific actions to help save energy, minimize waste or improve 
health.
     Creation of Community Advisory Panels (CAPs), an outreach 
mechanism to bring neighborhood concerns to the attention of local 
plant facility managers. The CAPs help citizens better understand how 
facilities are working with hazardous materials onsite. Participants 
meet regularly to discuss plant operations, facility environmental and 
safety programs, etc.
                                 ______
                                 
     Responses by Michael J. Pompili to Additional Questions from 
                             Senator Smith
    Question 1. You recommend that the Federal role be one of technical 
and funding support to State and local agencies. You also recommend 
that the Federal Government promote sound science and be more flexible. 
In return, local and State agencies will be more accountable for 
results. What specific recommendations do you have for the Congress?
    Response. It is important that Congress spend more time on process 
building instead of dealing with specific media issues. For example, I 
have been actively involved with the U.S. EPA dioxin reassessment. 
While having problems with specific parts of the assessment, the use of 
the U.S. EPA's Science Advisory Board needs to be a very important part 
of any review. Emphasis should be provided on supporting these 
organizational mechanisms instead of specific reviews.
    Shifting from the current categorical thinking model of addressing 
a problem to a community involvement model would be a substantial step 
forward. Because community participation and buy-in are critical, 
components in solving the complex environment problems we face today, 
it is important we change how we interact with our local citizenry. The 
current Federal models are extremely deficient in this area, and need 
to be examined in just about all phases of environmental legislation 
such as the Resource Conservation Recovery Act, Superfund, Clean Air 
Act Amendment, etc. We talk public hearings not public participation. 
Emphasis is on exact levels of chemical contamination, not public 
deliberation. Emphasis is on specific levels of testing not how the 
different levels of government interact with their citizenry.

    Question 2. Please describe the feedback you received from your 
stakeholders during and following the Comparative Risk Assessment 
Project?
    Response. The main benefit that was achieved through the 
implementation was the; building of trust and the strengthening of 
relationships between the various stakeholders that exist within our 
community.
    Project stakeholders, regardless of their backgrounds or 
qualifications, can generally be broken down into three general 
categories:
    (1) community volunteers who had no professional scientific or 
environmental background,
    (2) community volunteers who work in the research or environmental 
arena, and
    (3) city of Columbus department or division representatives.
    All of the participants found the project challenging. The 
necessity of group decisionmaking, the need to make decisions not only 
on the basis of available technical information but also with 
information on people's values, and the time required to carry out the 
project were mentioned by most all participants as significant issues. 
In addition, some participants were uncomfortable wrestling with 
technical information.
    However, by the end of the project, most of the participants 
directly charged with analyzing, ranking and making risk-reduction 
recommendations were grateful to have gone through the process. All 
stated they had a much deeper understanding of the environmental issues 
we studied, and more appreciation for the difficulties in setting 
appropriate public policies. Our project chair, a former national 
office-holder for the Sierra Club, stated he learned more about 
environmental protection in the 2-years with our project than he had in 
his adult lifetime as an environmental activist.
    Some city of Columbus department or division representatives who 
participated may have been most affected. Some of their comments 
following the project spoke to their new ability to take many of the 
concerns or ideas raised through the comparative risk process and work 
with them on a daily basis. This type of continuity resulted in 
implementation of a number project recommendations, and a general 
growth in environmental awareness by some of the very people that are 
in the best positions to improve the City's environmental protection 
efforts.
    One measure of satisfaction may be seen in that many participants 
agreed, following the project, to form a new volunteer environmental 
organization dedicated to helping city officials implement project 
recommendations. The group has continued to function since its 1996 
formation and presents annual awards to civic leaders for their 
environmental efforts.
    We have continued to buildupon this trust by following through on 
the recommendations and also by reporting back to the community and our 
participants on the status of their recommendations.
    Finally, we have continued to work with our participating local 
governmental bodies in working with them to implement the various 
Priorities 1995 recommendations.

    Question 3. What were some of the important lessons you and your 
stakeholder's learned from the process and what would you do 
differently if you had to do it all over again?
    Response. First, the process, if done properly, does result in a 
valuable environmental planning document and a group of participants 
that are much more educated about environmental issues. It provides a 
thorough and systematic way to simultaneously deal with a wide range of 
environmental issues. It offers a significant way for the public to 
help governmental decisionmakers craft environmental policy. It is 
critical that in processes of this type, those that have the ability to 
implement solutions play a significant role in the comparative risk 
process.
    At the same time, there are drawbacks to the comparative risk 
process. It's lengthy and can be time-consuming. This can create a 
problem for some people who may want to serve on a voluntary or short-
term basis. Also, getting the public actively engaged in an assessment 
and planning process can be difficult. Meaningful public participation 
is critical to the success of the process, but it's often difficult to 
obtain in the absence of any environmental crisis or hot-button issue. 
In addition, the lack of data or technical information on local 
environmental problems can be a significant hurdle. Projects need to 
gather as many technical resources as possible, both in terms of 
suitable personnel and information. It is also important to understand 
that the issue of using exact science was not really an issue. Our 
participants, who actually gathered the information, had the 
information reviewed by our Environmental Science Advisory Board. After 
this reexamination, they reviewed the data, incorporated their values 
and beliefs to achieve their final ranking.
    Finally, there's a tendency for projects to spend the majority of 
time assessing and ranking environmental problems. Project directors 
must spend an equal amount of time and effort determining strategies 
for implementing recommendations, creating new programs, etc.
    Our process could be improved by: (1) streamlining the process so 
that projects could be completed or repeated in less than the currently 
required 2-year timeframe; (2) devoting more time and resources to 
conducting a more-efficient public outreach campaign; (3) enlisting the 
support of more environmental scientists/``technical experts'' to 
gather the technical information and complete the technical analysis 
portion of the project; and (4) spending considerably more time 
planning; for the risk management portion of the project. We devoted 
only about 30 percent of the total time to this portion of the project 
our process.

    Question 4. What are the key obstacles you face in setting 
priorities and managing risk effectively at the local level?
    Response. Substantial challenges are occurring at the local level 
that are having significant impact on setting risk priorities and 
managing risk effectively at the local level. They are as follows:
     Information overload,
     Complex issues,
     Quick results desired, and
     Limited budgets
    Information Overload.--Every day our local citizenry is bombarded 
with. ``important risk information'' that is being provided to assist 
them in making informed choices. Currently this information is provided 
in a condensed format and is often slanted toward a particular view. 
Usually this information is provided in a manner that has dueling 
experts who have totally opposite views and use terms that are foreign 
to everyone but the experts.
    Additionally people now have access to the Internet which opens a 
whole new myriad of issues.
    With the Internet an abundance of information is now available with 
the vast majority being non peer reviewed and slanted to a particular 
agenda. This is an issue that will exist for the foreseeable future and 
I do not think this problem has an easy solution.
    Complex Issues.--The easy fixes have been achieved. The issues 
before us now are complex because they incorporate beliefs and values 
that require substantial tradeoffs and usually have volumes of 
conflicting information available to support all sides of an issue. 
This is why I consistently go back to working on a deliberative process 
of public involvement and deliberation before an issue is addressed.
    Quick Results.--Our public and therefore our elected officials want 
quick actions and are less patient to wait for the long term 
sustainability that is desired with most of. our current issues.
    Limited Budgets.--As with our local governmental actions, the 
limited amount of financial resources forces the priorization of 
resources. This is an area where the Federal Government can be very 
helpful. In a large amount of situations it would be very beneficial if 
the Federal Government could provide seed money to demonstrate the 
value of citizen involvement and participation in local priority 
settings.
    If these initiatives were successful then there is a far better 
chance that these initiatives will be carried on because of the low 
relative costs compared to the potential large benefits.
                                 ______
                                 
      Responses by Michael J. Pompili to Additional Questions from
                             Senator Baucus
    Question 1a. I note that one of the outgrowths of your project is a 
focus on ground level ozone--an environmental problem that some here in 
Congress believe does not require more stringent regulation because 
that would not be based on ``sound science.'' Can you tell me how your 
project dealt with scientific uncertainty in your project?
    Response. The goal of Project CLEAR is to recommend strategies to 
reduce emissions that contribute to formation of ground-level ozone in 
Central Ohio. The project will develop these recommendations through a 
combination of public involvement through civic forums and objective 
analyses by several technical working groups. Project CLEAR is a 
partnership of the Columbus Health Department, The Ohio State 
University, and the Mid-Ohio Regional Planning Commission. Stakeholders 
from business, government, non-profit organizations, and universities 
are represented and involved.
    Two factors led to the initiation of this project. The first is the 
possibility that Central Ohio will violate existing Federal EPA ozone 
standards or certainty that our region will violate the proposed 
Federal standard for ozone. The second is concern among some 
stakeholders about the health threats posed by ozone.
    CHD and other Project CLEAR partners are aware that ``scientific 
uncertainty'' exists around the nature and extent of health effects 
from exposure to ground level ozone.
    Having or facilitating a scientific and/or political debate about 
the ozone standard is beyond the scope of Project CLEAR. Nor is trying 
to rank the ``problem'' of ground level ozone among other health and 
environmental concerns facing our region. In local government, we must 
comply with Federal and State mandates and enforcement actions. It is 
important to understand that, fundamentally, the purpose of Project 
CLEAR is to take a proactive approach toward the standards and the 
possibility that central Ohio may find itself in violation of it. This 
fundamental purpose requires us to educate and involve our community 
and undertake analyses of emission reduction potential of various 
strategies. While the larger debate is interesting and important, it is 
not germane to the fundamental purpose of this project.
    The project partners selected Dr. Paul Berkman, an Earth Scientist 
at the Byrd Polar Research Center at The Ohio State University (OSU), 
as Chairman of Project CLEAR. In 1997, Dr. Berkman convened a national 
symposium. on ground-level ozone at OSU. The symposium brought together 
experts from industry, government and various perspectives within the 
scientific and health community for a balanced program on this issue. 
Dr. Berkman has worked diligently to ensure scientific objectivity in 
Project CLEAR.
    Project CLEAR has established a scientific working group that is to 
provide general scientific oversight to the project.
    (2) The Project CLEAR Steering Committee includes representatives 
from industry, government, non-profit groups, and many others.
    (3) Project CLEAR provides information from a wide variety of 
sources to stakeholder participants and interested members of the 
public. These sources are linked on the project web site and in other 
written materials.
    (4) Project CLEAR has developed an ``issue guide'' concerning 
ground-level ozone in Central Ohio. Several representatives from 
industry, government, environmental organizations and others worked 
together to develop the guide. (We have enclosed a copy.)

    Question 1b. Did you use conservative estimates, or apply 
principles of precaution, in the face of uncertainty?
    Response. This question is not applicable to the main objectives of 
Project CLEAR.

    Question 1c. How were you able to reach the consensus with 
stakeholders on ranking issues such as ground level ozone where there 
were scientific uncertainties?
    Response. (1) Project CLEAR is not designed to undertake a process 
to rank environmental issues. Please see the overview for a more 
complete explanation; (2) The Project CLEAR Steering Committee will 
recommend strategies to reduce ozone-forming emissions by the end of 
2001. These recommendations will be made by consensus and will be based 
on cost, ability to implement, emission reduction impact, according to 
analyses of technical working groups. They also will be based on public 
involvement featuring up to 20 deliberative issue forums from fall of 
2000 through early summer of 2001.

    Question 2. I see from your written testimony that two of your 
prime emphases were science and community-based decisionmaking. Some 
would see these two as inconsistent, since the general public brings 
their experiences, judgments, and values ``to the table'' whereas 
science is ostensibly objective. (a) Can you explain how science and 
community-based decisionmaking were melded in your comparative risk 
project? (b) Please explain why you chose to have the public make 
ranking and priority decisions rather than simply relying on the work 
of the technical experts.
    Response. My first point would be that it is a misconception to 
think that science is ``objective.'' In many areas, there are honest 
disagreements among scientists as to the extent and severity of an 
environmental problem, the ``correct'' meaning or interpretation of 
data, etc. In making their conclusions, scientists themselves use their 
own values and opinions as a filter through which they look at data and 
information.
    This is no different than what the non-scientific public does in 
making decisions. The information all of us consider is filtered 
through our own individual values and opinions. The advantage that the 
scientist may have is simply that he or she may have access to and 
knowledge of more information. The strength of the comparative risk 
process is that it strives to gather all of the relevant scientific 
information possible and then get it into the hands of project 
participants for consideration. Linking the concepts of science and 
community decisionmaking together is not inconsistent, it simply means 
that the public should have the benefit of knowing and considering all 
of the relevant information--that the public should have the 
opportunity to make the most informed choice possible.
    We attempted to meld these ideas in our project in a number of 
ways. First, our technical committee (i.e., our ``scientists'') wrote 
environmental analyses based on the scientific information available, 
their own knowledge and ''experiences, etc. These analyses were 
forwarded to the project's management team for their review. In 
addition, the analyses were summarized, distributed to members of the 
general public for comment end discussed at a community open-house.
    All comments from if he general public concerning the technical 
reports were documented and submitted to the project management team. 
The project management team considered both information contained in 
the technical analyses and the public feedback from those analyses to 
rank our 30 environmental issues in terms of severity.
    The public, in fact, did not do the project risk ranking . . . it 
considered the information produced by the project's technical 
committees, commented on their findings, and their comments were passed 
to the project management committee for its ranking. We specifically 
chose not to give ranking responsibilities solely to the technical 
experts because we felt that the project's success hinged on buy-in 
from the public. Leaving the ranking solely in the hands of ``technical 
experts'' would hurt our credibility and leave I,us open for public 
criticism, ultimately damaging; our ability to develop project 
recommendations that the public would support.
    Lawmakers make laws in much the same way . . . they rely on 
technical experts to provide scientific information, but they realize 
that the public will not accept policies crafted solely by these 
experts. They use community feedback, as well as their own values and 
opinions, to develop appropriate laws, policies and procedures.
    It must be stressed that even though our project ranking (i.e., 
``priority decisions'') was done by a project management committee and 
not the general public, the public's values and opinions played a 
significant role in the ranking outcome. The project management 
committee built an explicit mechanism into the ranking procedure to 
reflect public input on the scientific findings of the technical 
committees. Individual ranking decisions could be adjusted based on (1) 
the level of feeling that the public may have registered about a 
particular environmental issue, and/or (2) whether a particular group 
is disproportionately impacted by a specific environmental issue. In 
numerous instances, project management committee rankings were 
subsequently adjusted to reflect; information gathered from the public.

    Question 3a. I'm impressed by the inclusiveness of your project. 
I'm sure that one of the big benefits was that the participants in 
these projects developed a much better understanding of the risks posed 
by various environmental issues. What about, the benefits to the 
understanding of the public at large?
    Response. The Priorities `95 Comparative Risk Project was our 
attempt to involve the public in setting our communities environmental 
priorities. Community participation and buy-in are critical components 
in solving the complex environmental problems we face today. To that 
end we utilized many various outreach mechanisms to reach our public. 
These outreach mechanisms included:
     Public Opinion Surveys;
     Community Meetings;
     Distribution of educational materials;
     Community-wide Open House; and
     Media events
    As we continue down this path with our CLEAR program, we are 
further expanding our community outreach efforts to include public 
deliberation sessions in many parts of the central Ohio community.
    Benefits to understanding of public at large:
     As previously explained, even with our substantial 
community outreach, vast pockets of the public still are uninformed 
about the process. The areas where the most substantial impacts were 
achieved were with our State and local (city and county) elected 
officials and the environmental community.
    I do not want to imply that all environmental groups were pleased 
with the process, since specific environmental groups elected not to 
participate, but overall the response was positive and this success has 
now led to our CLEAR program.

    Question 3b. Have you actually studied whether the projects have 
changed public attitudes or, more generally, whether and what the 
public-at-large learned from it?
    Response. Studied whether changes in public attitude have occurred:
     Concerning the studying of public attitudes, we have not 
formally conducted a public attitudes survey. The main reason, as 
always, was the lack of funding to perform the surveys. We are trying 
to perform a more thorough review within the CLEAR program as we are 
working with the Ohio State University, but again that will be 
dependent on resources. Additional, we want to critically review the 
advantage of using a public deliberative process instead of the current 
public hearing process.

    Question 4. Could you give me some examples of how the results of 
your comparative risk project have influenced the budget, policies, 
and/or activities of your local and State government?
    Response. A number of City department or division representatives 
actively participated on our comparative risk project committees; 
working to analyze environmental issues, gauge the public's response to 
various technical reports, and evaluate implementation alternatives. 
Since the project's conclusion, these representatives have returned to 
their City positions and have been able to work with many of the 
project issues and concerns in the normal course of their employment. 
This has resulted in a number of initiatives being implemented in 
direct or indirect response to comparative risk recommendations. The 
City can point to a number of specific achievements since the project's 
conclusion. Among them:
     The creation of a Natural Resource Manager position within 
the Columbus Recreation and Parks Department to oversee and coordinate 
issues concerning department parkland and park habitat.
     Current City efforts in modifying the Mid-Ohio Regional 
Planning Commission's Watercourse Protection Ordinance, for eventual 
submission to Columbus City Council for approval. The ordinance 
addresses a number of recommendations concerning green space and 
habitat protection.
     Development of a Stormwater Master Planning Review to 
review stormwater design criteria and policies so that the natural 
conditions of ravines, creeks, rivers, meadows, woodlands and wetlands 
can be preserved or restored if possible.
     Creation of new city code requirements detailing 
additional requirements for provision of sidewalks when subdividing 
land, and increasing the Public Service Director's ability to require 
sidewalks in new developments or enlargements. The work is in 
addresssing a Priorities `95 recommendation to construct walkways to 
improve access or reduce walking distances for pedestrians.
     The launch of the Stay Tobacco-free Athlete Mentoring 
Program (S.T.A.M.P.) pilot. The program matches high school athlete 
mentors with sixth-grade; students in an effort to discuss issues 
relating to tobacco use and encourage participants to remain tobacco-
free. The effort addresses a recommendation to encourage school and 
community-based programs on the effect of smoking.
     Adoption of a Parkland Dedication Ordinance, which 
providers for the dedication of parkland as part of the re-zoning 
process for residential and non-residential projects of more than one 
acre. This ordinance, jointly developed by the departments of Trade and 
Department and Recreation and Parks, addressed a recommendation calling 
for green-space set-asides in connection with new development.
     The Department of Recreation and Parks receiving a 
community award for adopting a containerized tree growing process that 
reduces growing time of planting stock from 7 to 3 years. This has 
allowed the department to grow more of its own trees, and select 
particular species, rather than rely on what is available from 
commercial growers. The city is now growing 5,000 trees annually in 
efforts to fill 45,000-50,000 vacant right-of-way locations. Plantings 
will improve aesthetics, neighborhood cooling and reduce storm water 
runoff. This effort addresses a Priorities `95 recommendation to plant 
native shrubs and plants whenever feasible.
     The Department of Recreation and Parks assisting the Mid-
Ohio Regional Planning Commission in forming a number of citizen river 
stewardship groups. One of the project recommendations advocates the 
City encourage creation of Citizen Watch Groups to monitor activities 
that may adversely impact area waterway corridors.
     Efforts by the Division of Refuse Collection to initiate 
recycling programs at Columbus apartment complexes. Priorities `95 had 
recommended that the City encourage development of a pickup system for 
department recyclables.
     Development of the Neighborhood Quality Interaction Team 
program, a community-based initiative that consolidates and better 
coordinates city inspection services among the departments of Health, 
Refuse, Trade and Development and Police. The pilot office is located 
in the Franklinton area. Plans are to duplicate the initiative in other 
City neighborhoods. The effort is in response to an Priorities `95 
recommendation to develop neighborhood programs to improve zoning and 
health code enforcement.
     Establishment of an Urban Pet and Wildlife Management 
coalition to address a variety of pet and wildlife issues. The 
coalition; developed by the Columbus Health Department, published a 
comprehensive report outlining a number of recommended actions to 
address urban animal problems. The report, and anticipated ongoing 
efforts by the coalition, address a Priorities `95 recommendation to 
develop a community outreach program and a public information campaign 
on rabies.
     Establishment of a 6-county coalition to address the issue 
of atrazine in the Scioto watershed. The Division of Water helped form 
this coalition, consisting of representatives from the city of 
Columbus, Ohio Department of Natural Resources, Ohio EPA, private 
industry, area farmers, OSU Extension Service, Ohio Wesleyan University 
and Otterbein College. The partnership is identifying potential 
pollution sources, conduct field sampling, monitor the watershed and 
develop an action plan for reducing atrazine use and resulting 
pollution. The coalition's work addresses a Priorities 1995 
recommendation to convene the agricultural, scientific and regulated 
communities to develop a chemical management plan for Central Ohio 
watersheds.

    Question 5. What were the most important results of your 
comparative risk project?
    Response. The main benefit that was achieved through the 
implementation was the building of trust and the strengthening of 
relationships between the various stakeholders that exist within our 
community.
    Project stakeholders, regardless of their backgrounds or 
qualifications, can generally be broken down into three general 
categories:
     community volunteers who had no professional scientific or 
environmental background,
     community volunteers who work in the research or 
environmental arena, and
     city of Columbus department or division representatives.
    All of the participants found the project challenging. The 
necessity of group decisionmaking, the need to make decisions not only 
on the basis of available technical information but also with 
information on people's values, and the time required to carry out the 
project were mentioned by most all participants as significant issues. 
In addition, some participants were uncomfortable wrestling with 
technical information.
    However, by the end of the project, most of the participants 
directly charged with analyzing, ranking and making risk-reduction 
recommendations were grateful to have gone through the process. All 
stated they had a much deeper understanding of the environmental issues 
we studied, and more appreciation for the difficulties in setting 
appropriate public policies. Our project chair, a former national 
officeholder for the Sierra Club, stated he learned more about 
environmental protection in the 2-years with our project than he had in 
his adult lifetime as an environmental activist.
    Some city of Columbus department or division representatives who 
participated may have been most affected. Some of their comments 
following the project spoke to their new ability to take many of the 
concerns or ideas raised through the comparative risk process and work 
with them on a daily basis. This type of continuity resulted in 
implementation of a number project recommendations, and a general 
growth in environmental awareness by some of the very people that are 
in the best positions to improve the City's environmental protection 
efforts.
    One measure of satisfaction may be seen in that many participants 
agreed, following the project, to form a new volunteer environmental 
organization dedicated to helping city officials implement project 
recommendations. The group has continued to function since its 199Ei 
formation and presents annual awards to civic leaders for their 
environmental efforts.
    We have continued to buildupon this trust by following through on 
the recommendations and also by reporting back to the community and our 
participants on the status of their recommendations.

    Question 6. What were the keys to the success of your project?
    Response. Two factors were critical in the success of our project. 
The first was the appointment of our project chair. Because of the 
complexity and length of the comparative risk process, it is essential 
that these projects be manned by an individual who:
     has credibility with other project members concerning 
their environmental knowledge and experience.
     is perceived among project participants as ``fair,'' or 
neutral, concerning the airing/balancing of different environmental 
philosophies and goals that are part of these projects.
     is committed to public input and public participation 
regarding the process.
     will devote the significant amount of time required over 
the 2 years to assist with project management, task delegation and 
followup, etc.
     is personally committed to the success of the project.
    Unless the project chair can meet each of these criteria, a 
comparative risk projects faces considerable handicaps in successfully 
achieving its goals.
    The second critical factor was the inclusion of key city of 
Columbus personnel in the project . . . particularly in the 
implementation phase. Project organizers recognized that any City 
implementation efforts would only be realized if city of Columbus 
personnel were intimately aware of the project and supported its 
eventual recommendations. To ensure that this happened, they made a 
conscious effort to build this into to project by recruiting some City 
staff, mid- and upper-level management personnel to participate. As a 
result, these participants had knowledge and input concerning the 
potential project recommendations, their implementation feasibility and 
creation of initiatives or programming that would meet the 
recommendations' intent.

    Question 7. In implementing the comparative risk assessment, what 
problems did you encounter that you could not, or could only partially, 
overcome?
    Response. Generating significant public knowledge, awareness and 
excitement about the project was a challenge. Our public involvement 
committee was forced to be rather creative at times concerning our 
public outreach efforts. In a city the size of Columbus, with all of 
the various initiatives competing for the public's (and the media's) 
attention, this may have been the most difficult aspect of the project. 
We would have liked a greater level of public involvement from the 
community.

    Question 8. I appreciate your recommendation that Federal supports 
are provided so more communities like yours can do their own 
comparative risk projects and set their own priorities. But putting 
this aside, do you think a comparative risk project similar to the one 
done in Columbus could be performed on a national scale and be used to 
establish budget priorities for the Agency?
    Response. The main role of the Federal Government in environmental 
protection is to provide leadership and direction in meeting our 
national environmental priorities. Therefore, it is very important that 
a general direction be provided for insuring the overall protection of 
our Nations' air, water and lands. What is at issue is not that this is 
a noble goal, but how as a Nation we desire to reach these goals.
    One of the hardest things for us to learn with our Priorities `95 
project was to give up control; to trust our citizenry within their 
specific neighborhoods that they would make the ``correct'' decisions 
for the betterment of the greater Columbus community. Well they did! 
Yes, we had pet projects, specific contentious issues, etc.; but 
overall they looked at the bigger picture. This is the fundamental 
issue that has to be addressed by the Federal Government.
    Does the Federal Government trust states and local governments with 
providing meaningful input into setting our national goals? My answer 
is that this can be achieved through a process of inclusion and openess 
that needs to be directed within the various regions of the country. 
Will it be difficult--yes, will it be beneficial--definitely--if it is 
done correctly. Could it be a disaster--yes, if it is controlled too 
much by Washington, DC.
    I strongly encourage the examination of performing a national 
environmental priority comparative risk project, but only with 
significant involvement with governmental stake;holders on the 
national, State and local levels.

    Question 9. In the panel on residual risk, many concerns were 
expressed about EPA's case study of residual risk assessment for 
secondary lead smelters. This seems, in some ways, to be the nature of 
risk assessments. In fact, it often seems that every time a risk 
assessment is done these days--whether it is to regulate an 
environmental problem, update a standard, or better understand a 
problem such as climate change--it is greeted with an extremely high 
level of controversy.
    Given this, how realistic do you think it is for us to consider 
doing a comparative risk assessment that would set EPA's budget 
priorities--something that would require a separate risk assessment for 
each of the Nation's environmental problems--but still avoid 
controversies over each and every risk assessment that the priorities 
are based on?
    Response. Any risk assessment work will produce some level of 
controversy. One reason is the nature of the task--the impossibility, 
because of uncertainties, of absolutely defining the level and 
likelihood of hazard to people, or groups of people, from an 
environmental threat. Risk scenarios are all based to some degree on 
assumptions--assumptions that are open to honest debate or disagreement 
among individuals, whether they are scientists, members of the 
regulated community, or the general public. Risk assessment work, 
particularly in the area of comparative risk, implies to many that 
winners and losers will be created as the result of the process. Those 
associated with a ``high-risk'' issue will probably support the process 
and results. Others concerned with ``low-risk'' issues may question or 
dispute the process out of fear it would de-legitimize their concerns.
    But the fact that comparative risk cannot eliminate controversy 
should not be used as an argument against using the process. By 
comparing the severity of one problem against another, the process does 
forces participants to do something that each do daily in our everyday 
lives--make choices and evaluate various alternatives based on the 
information we have available. Decisions cannot be made in a vacuum. 
Actions and choices have impacts that must be considered before 
decisions are made. The comparative risk process recognizes this in its 
attempt to consider environmental problems in the context of other 
problems, and in its attempt to make these decisions using all 
available information.
    In a sense, every organization that puts together a budget uses a 
type of comparative risk process. The budget process is nothing more 
than a systematic assessment determining the level of funding that will 
be attached to each of an organization's various functions, programs or 
activities. In part, this assessment is made by considering the 
importance of activities, and the impact of carrying them out relative 
to other possible budget choices. Agency budgeting using the principles 
of comparative risk would be nothing more than a formal recognition of 
this fact. Such a process would simply be a systematic assessment of 
environmental problems using defined criteria to determine the levels 
of risk resulting these problems. Potential criteria could include the 
number of people affected, severity of effect, reversibility of effect, 
level of uncertainty, disproportionate populations affected, etc. There 
would certainly not be unanimous agreement about the budgeted funding 
levels resulting from this type of assessment. However, a systematic 
analysis using this type of criteria to determine the EPA priorities 
would certainly be a step in the right direction.

    Question 10. You indicated that the Federal Government could be 
doing a better job of providing funds and more accurate data to the 
states so they can do more comprehensive comparative risk assessments. 
What, if any, efforts are the states undertaking to improve the 
comparability and standardization of the data that they collect? What 
public health data do Ohio or other states provide as part of the 
Federal-State partnership?
    Response. Unfortunately, I have very little knowledge within this 
area. This question would be far more appropriate for Katherine 
Hartnell of the New Hampshire Comparative Risk Project.
                               __________
   Statement of J. Clarence (Terry) Davies, Senior Fellow, Resources 
                             for the Future
    I am pleased and honored to be able to share with the committee my 
views on the important subject of comparative risk assessment. My views 
are only that and do not represent the institutional position of 
Resources for the Future (RFF). RFF is a research institution that does 
not take positions on policy issues.
    Comparative risk assessment (CRA) is an important analytical tool 
that deserves the attention this committee is giving it. The 
fundamental goal of most of our environmental programs is to reduce or 
prevent risk. Thus, identifying and comparing risks is a logical 
starting point for evaluating progress and identifying future 
directions and priorities.
    There are, however, important limitations inherent in the use of 
CRA. Most importantly, we have no common metric to deal with the many 
diverse kinds of risk that government addresses. When I was at EPA we 
referred to this as the ``how many whales is your grandmother worth'' 
problem. How do we weigh the risk of pesticide poisoning of trout 
streams to the risk of causing cancer in humans? How do we compare the 
risk of cancer to the risk of long-term neurological damage? How do we 
compare one type of cancer to another?
    There are answers that can be given to these questions, but the 
answers are heavily dependent on values. Even if scientific 
understanding were perfect and data were complete and accurate, the 
value elements inherent in CRA would prevent CRA from ever being a 
purely scientific undertaking. The science and the data in most cases 
are woefully incomplete, and this adds further elements of uncertainty 
and value judgment to CRA.
                         different types of cra
    There are different kinds of CRA, and some distinctions are 
important. In particular, there is a basic difference between comparing 
individual pollutants or activities and comparing programs. Comparing 
mercury to lead is very different from comparing air pollution to water 
pollution. This hearing is focusing primarily on the latter, on 
programmatic CRA, and it's important to keep this in mind.
    More generally, the type of CRA undertaken, and the process used to 
make the comparisons, should depend on the purpose for which the CRA is 
being done. Doing a CRA to establish research priorities involves 
different considerations than CRA to establish enforcement priorities.
                              uses of cra
    CRA serves a variety of different purposes. Among the more 
important:
     CRA serves to focus people on the question of what are the 
benefits of a program or action, what are we getting for the resources 
expended. In this sense, CRA and the Government Performance and Results 
Act (GPRA) serve the same beneficial purpose.
     CRA can be a starting point for setting budgetary and 
other priorities. In a recent evaluation of pollution control efforts 
in the United States, I questioned whether EPA priorities were in line 
with risk considerations, given that most of the risks identified as 
highest in CRA analyses ranked lowest in EPA budget expenditures. 
However, such comparisons of risk rankings to budget expenditures are 
useful only in a broad sense. There are other important factors, aside 
from risk, that should and do enter into budgetary priorities.
     CRA can serve to identify neglected problems. Indoor radon 
is a good example of a problem where analyzing the risks highlighted an 
environmental problem that was receiving little attention. David 
Konisky at RFF has recently completed an analysis of all the CRA 
efforts undertaken to date in the United States, and his analysis shows 
how some neglected problems have surfaced. With your permission, I 
would like to submit this paper for the record.
     CRA, like all good analysis, can make the assumptions 
behind decisions more transparent. These may be assumptions as to why 
something was not done as well as to why something was. We all know the 
very high risk of cigarette smoking. Documenting the high risk 
encourages us to ask why more action is not taken and what alternative 
courses of action are available.
     CRA helps to identify needed data. Very often, in the 
process of asking about relative risks, we discover we do not have the 
data necessary to answer the question. For example, of the 80-100,000 
chemicals in commercial use, we have adequate toxicity information 
about only a few hundred.
     CRA can catalyze and mobilize opinion so that action can 
be taken. CRA, especially at the State or local level, can be a way of 
getting people to agree on an agenda for action and then to act. 
Arguably, most of the recent State CRAs have been as much about 
political mobilization as about risk analysis.
                           limitations of cra
    As I noted at the beginning of my testimony, the assumptions and 
values that unavoidably enter into both risk assessment and CRA are a 
major consideration. Risk assessment is an odd mixture of science and 
non-science, and CRA necessarily suffers from all of the limitation of 
risk assessment.
    CRA suffers from additional methodological problems. For example, 
how should the risk-reduction effect of current efforts be considered? 
If there were no public programs to protect drinking water in this 
country, drinking water would rank among the highest risks, as it does 
in many developing countries. However, because there are protection 
programs, the current risks from drinking water in the United States 
are not great. In the context of budgeting, for example, this poses 
difficulties for CRA. We cannot do zero-based budgeting if the analysis 
of risks assumes current levels of spending.
    Most importantly, CRA deals only with risk, and risk is only one of 
several factors that should enter into most government decisions. Cost 
is an obvious other factor. To the extent that decisions should be 
based on cost-benefit analysis, risk gives only the benefit side of the 
equation. Furthermore, you cannot do a cost-benefit analysis of a 
problem, only of a solution. Whereas CRA deals with problems, cost-
benefit deals with solutions. So getting from one type of analysis to 
the other is not simple because the two types of analysis are analyzing 
two different sets of things.
    Aside from risks and costs, public decisionmakers need to consider 
such things as due process, administrative feasibility, legality, and 
political support. No one has yet developed an analytical method for 
putting together all these factors.
    Two other limitations of CRA should be noted. First, how the CRA is 
done can have an important effect on its outcome. Konisky's paper shows 
that how broadly the categories are defined (e.g. particular pollutants 
vs. outdoor air pollution vs. all air pollution) can make a big 
difference in the resulting risk ranking. Second, how and when to 
involve the public in the process poses a variety of questions. The 
value aspects of CRA mean that the public should play a key role. 
However, this raises problems of how to incorporate technical and 
scientific information. Granger Morgan at Carnegie-Mellon University 
and others are conducting interesting experiments on this question.
                         the statutory context
    Congress has given EPA only limited flexibility. With approximately 
1,000 pages of legally binding guidance, there are only a few choices 
left to the Air Office, for example. No amount of analysis will change 
the basic agenda of EPA, which is set by the environmental statutes.
    Many, arguably most, provisions of EPA's laws are not based on 
risk. For example, most of the standards in the Clean Water Act are 
technology-based standards, so analysis of risk is, at least in theory, 
irrelevant to setting these standards. Even where Congress has employed 
risk-based standard setting, as with the National Ambient Air Quality 
Standards (NAAQS), the scientific basis is sometimes deficient or 
outdated. The statutory language on NAAQS assumes a risk threshold (a 
level below which there is no risk) whereas we have understood for more 
than a decade that there is no threshold for most of the criteria 
pollutants. It is difficult to use good science to make decisions if 
the relevant statutory provisions do not allow good science to be used.
    The fragmented, medium-based (air, water, soil) nature of the 
pollution control laws, programs, and budgets also hinders the use of 
CRA. Most risks cut across media lines, so the scientific data about 
risk does not follow the budgetary or program categories. The risks of 
arsenic are within the purview of the air office, the water office, and 
the office of solid waste. Nitrogen poses risks in air, water, and 
soil. Climate change is an air problem, a water problem, and a land 
problem. The United States is one of the last industrialized countries 
to cling to a non-integrated pollution control system, and difficulty 
in using risk information is one of the penalties we pay.
                              conclusions
    Despite its limitations, CRA is a valuable analytical tool. It may 
be most useful for the questions it raises and as a way of initiating a 
process leading to more transparent and defensible decisionmaking. How 
well it serves these functions will depend heavily on whether Congress 
itself asks for relevant risk information and uses the answers in its 
budgetary, oversight, and legislative actions.
                                 ______
                                 
 Responses by J. Clarence (Terry) Davies to Additional Questions from 
                             Senator Smith
    Question 1. You provided some of the benefits of conducting 
``comparative risk assessments''. You also stated how the science and 
the data in most cases are woefully incomplete. Please explain how Risk 
Managers at EPA or at the States or Municipalities could improve their 
performance of risk management if they had a better understanding of 
type and magnitude of risk they are dealing with.
    Response. A better understanding of the type and magnitude of risk 
would enable managers to focus on the most important problems in the 
most efficient way. Conversely, it would enable them to avoid wasting 
resources on minor or non-existent risks, including the critical 
resource of public attention and concern.

    Question 2. You stated that comparative risk assessment is a tool 
that helps us take the first step in managing risk effectively by 
defining the problem. You also testified that we need to go beyond 
defining and ranking the problem. You stated that we need to focus also 
on solutions. Please describe the tools available to risk managers for 
identifying alternative risk reduction strategies and the criteria for 
selecting the right programs.
    Response. Identifying alternative risk reduction strategies is not 
straightforward, and I am not aware of any good analytical tools to 
assist in the process. In reality, such strategies are usually based on 
legislative mandates, and the mandates are usually based on strategies 
that have been tried in other contexts. The most basic criterion for 
selection is, in my view, cost-benefit analysis broadly defined. By 
broadly defined, I mean that non-quantitative factors must be included 
in the selection process.

    Question 3. Please provide your recommendation on how to proceed 
from here to achieve more effective environmental programs.
    Response. As I indicated in my testimony, I think two of the most 
important steps would be legislative creation of a Bureau of 
Environmental Statistics and enactment of an integrated pollution 
control statute. My version of the latter includes the former.
                                 ______
                                 
 Responses by J. Clarence (Terry) Davies to Additional Questions from 
                             Senator Baucus
    Question 1. You stated in your testimony that comparative risk 
assessment can be a ``starting point'' for setting budgetary and other 
priorities. You go on to say that comparisons of risk rankings to 
budget priorities are useful only in a ``broad sense.'' Please explain 
further what you mean by these comments.
    Response. CRA is only a starting point because a number of other 
important factors must be considered in priority-setting. These other 
factors include cost, equity, legislative and judicial requirement, 
administrative and political feasibility.

    Question 2. Since it is basic to risk assessment, what is the 
appropriate way for the committee to decide when the science used in 
them is ``good science'' or not?
    Response. There is no foolproof way to evaluate the science used. 
Whether the science has been peer-reviewed and whether it has been 
published in a reputable journal are the usual criteria, and I do not 
know of better ones.

    Question 3. Clearly, science is needed to inform decisionmaking. 
But what, in your opinion, is the proper role of nonscientific 
considerations, such as societal values, in informing decisions on the 
risk rankings and priorities that are developed from comparative risk 
assessment?
    Response. Non-scientific considerations are important and 
unavoidable. See my response to Question No. 1. Also, consider that 
science, by definition, can never tell us what should be, only what is.

    Question 4. In the panel on residual risk, many concerns were 
expressed about EPA's case study residual risk assessment for secondary 
lead smelters. This seems, in some ways, to be the nature of risk 
assessments. In fact, it often seems that every time a risk assessment 
is done these days--whether it is to regulate an environmental problem, 
update a standard, or better understand a problem such as climate 
change--it is greeted with an extremely high level of controversy.
    Given this, how realistic do you think it is for us to consider 
doing a comparative risk assessment that would set EPA's budget 
priorities--something that would require a separate risk assessment for 
each of the Nation's environmental problems--but still avoid 
controversies over each and every risk assessment the priorities are 
based on?
    Response. I do not think that it would be realistic to do a CRA 
that would, by itself, set EPA's budget priorities, but for the reasons 
stated above and in my testimony, not because of controversy. There is 
always some controversy about science, and much of the conflict over 
EPA science is really a conflict over interests and values rather than 
over science.

    Question 5. I would be interested in your thoughts on what problems 
would likely be encountered, and how successful we would likely be, if 
we attempted to perform a national comparative risk assessment in order 
to set EPA's budget priorities.
    Response. In Chapter 2 of Comparing Environmental Risks, a 1996 
book which I edited, I try to describe some problems and choices that 
are faced by all CRA efforts. How to define the categories to be ranked 
and how to involve the public are probably the two most difficult 
problems that would be encountered. Overall, I would not be very 
optimistic about the success of such an effort.

    Question 6. You mentioned that the Nation should have a Bureau of 
Environmental Statistics. As you may recall, such a proposed 
independent Bureau was part of legislation in the 101st Congress (S. 
2006) but faced significant opposition. Now, the Pew Commission on 
Environmental Health has proposed a national system for collecting data 
on public health through the Department of Health and Human Services 
and States. The committee could benefit from any views you may have on 
this latest proposal, if you have the opportunity to review it.
    Response. I have not had a chance to review the Pew proposal. 
However, the proposal relates to data on human health, not to data on 
the natural environment.
                               __________
        Statement of Elizabeth L. Anderson, President and CEO, 
                      Sciences International, Inc.
    My name is Elizabeth L. Anderson. I am president and CEO of 
Sciences International, Inc., (Sciences) a consulting firm 
headquartered in Alexandria, VA, that specializes in providing support 
to the public and private sectors on health and environmental issues. 
Previously, I was director of the first Carcinogen Assessment Group 
(CAG) and the expanded Office of Health and Environmental Assessment 
(now the National Center for Environmental Assessment) at the U.S. 
Environmental Protection Agency (EPA). I established and directed the 
Agency's central risk assessment program for 10 years, and was 
executive director of the Committee that recommended adopting risk 
assessment and risk management as EPA's approach for regulating 
carcinogens and later other toxicants. The Committee also wrote the 
Agency's first risk assessment guidelines. I represented EPA on 
numerous interagency committees. I am also a founder and past president 
of the Society for Risk Analysis and am currently Editor-in-Chief of 
Risk Analysis: An International Journal, which is published bimonthly 
by the Society and serves as an international focal point for new 
developments in risk analysis for scientists of all relevant 
disciplines.
    I frequently serve as a peer reviewer for governmental 
organizations on issues dealing with risk assessment. For example, I 
recently served as a peer reviewer for the South Carolina Department of 
Health of the document Assessment and Recommendations for the South 
Carolina Air Toxics Standard; I am a member of the External Review 
Committee, Los Alamos National Laboratory; I chaired the External 
Review Committee, United States Department of Agriculture's Office of 
Risk Assessment and Cost-Benefit Analysis; and I served on the Board of 
Scientific Counselors, Committee to Review EPA's National Health and 
Environmental Effects Research Laboratory. I currently serve on a 
National Academy of Sciences/National Research Council Committee and am 
a peer reviewer for the Academy. A copy of my Resume is attached.
                       purpose of this testimony
    Although Sciences is involved in a wide range of risk assessment 
issues and investigations, a focus of the research and analysis work 
conducted by me and my colleagues at Sciences is improvement in the 
sciences that support human health and environmental exposure and risk 
assessments, such as those conducted today as part of EPA's comparative 
risk assessments and the hazardous air pollutant (HAP) residual risk 
program. A major need in comparative risk assessment is development and 
use of scientifically supported methods and data to identify and 
appropriately address areas of most important environmental risk. This 
need is evident most recently in EPA's mandated HAP residual risk 
program which involves an unprecedented use of risk assessment and is 
being required while the science of risk assessment is still very much 
in flux. In that program, over 175 industry categories subject to 
maximum achievable control technology (MACT) standards currently being 
developed must have residual risk assessments completed to serve as the 
basis for risk management decisions. These risk assessments are 
required 8 years after promulgation of each MACT standard and will in 
total involve emissions of the 188 HAPs from literally thousands of 
facilities. The risks must also be estimated for all types of climates 
and terrains, wide ranges of population distributions, direct and 
indirect (i.e., multipathway) exposures, human and ecological effects, 
and consideration of maximum individual as well as total population 
risk. This would be an extremely difficult and challenging task for any 
risk assessment program.
    My purpose today is to provide my thoughts on the direction and 
progress of the use of risk assessment by EPA and what actions might be 
taken that would make that use more effective and more soundly based in 
science and, thus, more responsive to our Nation's needs. My analysis 
is based largely on two important recent documents which describe how 
EPA is currently intending to apply risk assessment. The first is the 
Residual Risk Report to Congress (Report No. EPA-453/R-99-001), which 
was published in March 1999 and provided the Agency's broad scientific 
guidelines for managing that program. The second is EPA's first draft 
residual risk assessment document which was released for Science 
Advisory Board (SAB) review in January of this year. It provides the 
first detailed application of the guidance from the Report to Congress 
for performing residual risk assessments, and was applied in a case 
study to the secondary lead smelting industry.
    Let me briefly describe the comparative risk and residual risk 
assessment programs and their goals. Then I will identify a number of 
issues that make risk assessment complex and implementation of these 
programs exceedingly difficult. Finally, I will offer several 
recommendations for improving the risk assessment process.
                      comparative risk assessment
    Comparative risk assessment is broadly the process whereby human 
health and environmental risks are identified and evaluated and the 
risks compared to assist in setting priorities and in making informed 
regulatory decisions. At the core of the process must be sound risk 
assessment science and stakeholder participation to provide the 
necessary framework for sound and socially responsible decisionmaking. 
Comparative risk assessments typically look at all types of risks in 
all environmental media and seek to provide sufficient information to 
make appropriately informed decisions. These decisions must necessarily 
rely on the identification and use of accurate risk assessment methods 
and data.
                 epa's residual risk regulatory program
    Risk assessment is currently being used in EPA's residual risk 
regulatory program. The 1970 Clean Air Act Amendments first required 
the EPA to identify and then regulate HAPs to levels that provide an 
``ample margin of safety to protect the human health.'' The term 
``ample margin of safety'' was defined by EPA in 1989, after the U.S. 
Court of Appeals ruled that the first step in the regulation of a 
hazardous or toxic air pollutant was to determine a safe or acceptable 
level of risk based only on health factors without regard for technical 
feasibility or cost. However, the regulation of HAP exposures without 
consideration of social and economic costs or technical feasibility was 
difficult to implement and only seven HAPs were regulated under the 
1970 Amendments.
    Consequently, Congress established in section 112 of the 1990 Clean 
Air Act Amendments (1990 Amendments) a new regulatory process for HAPs. 
First, a list of HAPs was specifically mandated by Congress and EPA was 
required to publish, over an 8-year period, MACT standards for the 
sources of the listed HAPs. Next, 8 years\1\ after publication of each 
MACT standard, the EPA was required to promulgate additional standards 
if needed to ensure protection of public health and the environment. In 
other words, the risks remaining after imposition of the MACT 
standards, the so called residual risks, would be determined and 
additional controls imposed if those risks are judged not to meet the 
``ample margin of safety'' criterion. The EPA began publishing MACT 
standards in late 1993 and was supposed to be completed with the entire 
program this year, although that is unlikely to happen.
---------------------------------------------------------------------------
    \1\ The first group of MACT standards was given 9 years.
---------------------------------------------------------------------------
    While relatively straightforward in concept, implementation of the 
residual risk requirements under section 112(f) of the 1990 Amendments 
has been difficult and is far from complete. One hurdle was cleared 
with the definition of ample margin of safety in 1989. EPA's published 
risk decisionmaking policy set as a goal: ``(1) protecting the greatest 
number of persons possible to an individual lifetime cancer risk level 
no higher than approximately one in one million (1  
10-6), and (2) limiting to no higher than approximately one 
in ten thousand (1  10-4) the estimated risk that a 
person living near a source would have if exposed to the maximum 
concentrations for 70 years.'' EPA further stated that a maximum 
individual risk (MIR) of one in ten thousand should ordinarily be the 
upper end of the range of acceptability. As risks increase above this 
benchmark, EPA stated that they become presumptively less acceptable 
under section 112, and would be weighed with the other health risk 
measures and information in making an overall judgment on 
acceptability.
    This risk policy has largely been accepted and it was codified in 
the 1990 Amendments in section 112(f)(2)(B). However, it has 
limitations in that it only addresses cancer, inhalation risks, and 
risks to individuals. We now know that many HAPs are not carcinogens, 
that humans can be exposed through ingestion and skin contact, and that 
broader population risks must also be considered in addition to 
individual risks. EPA has not yet provided complete guidance for how to 
treat noncarcinogens and population risks in making decisions under the 
residual risk program.
    Recognizing that substantial work remained to be done in planning 
and implementing the residual risk requirements of the 1990 Amendments, 
Congress required in section 112(f)(1) that the EPA submit a report to 
Congress that describes Agency plans for complying with the 
requirements of the 1990 Amendments dealing with residual risks. As 
noted above, EPA submitted in March 1999 the final Residual Risk Report 
to Congress (Report No. EPA-453/R-99-001). The report describes a 
residual risk assessment strategy design that involves at least two 
tiers of risk assessment a screening assessment followed by more 
refined assessment for those HAPs and sources with a potential for 
excess human health or environmental risks. A specific concern of mine 
is that the necessary refined levels of assessment, the methods for 
estimating the refined risks, and the criteria for determining when and 
how they are to be used, have not been articulated. Some of the 
specific scientific and technical issues are described below.
                    scientific and technical issues
    There are several scientific and technical issues that will be 
important to many future residual risk and comparative risk 
assessments, issues that have not yet been fully addressed. For 
example, section 112(f)(2) in the 1990 Amendments requires 
consideration of the environmental effects (also called ecological 
effects) of HAPs in addition to human health effects. This requirement 
was new in the 1990 Amendments and encompasses risks to wildlife, 
aquatic life, or other natural resources. These risks largely result 
from HAPs, such as PCBs, dioxins, and mercury, that are persistent and 
can bioaccummulate. The EPA has published broad guidance for conducting 
ecological risk assessments (Guidelines for Ecological Risk Assessment, 
EPA/630/R-95/002F, April 1998), but substantial interpretation and 
judgment are necessary for their application.
    As noted above, HAPs in the past were defined and regulated 
primarily based on adverse effects resulting from inhalation of the 
pollutant by humans. More recently, the EPA has begun broadening this 
to consider all potential routes of exposure. For example, HAPs may 
deposit on, and be adsorbed into soil, plants, and surface waters with 
which humans can come in contact. Contaminated food crops, animal food 
products, and fish that are consumed by humans may result. These risks, 
too, are largely associated with HAPs that can bioaccummulate. Other 
EPA programs are requiring multipathway risk assessments in some 
instances but multipathway risk assessment is new to EPA's residual 
risk program; to date, the principal experience has been with hazardous 
waste combustion sources and some hazardous waste sites. One problem is 
that multipathway risk assessments have typically been designed and 
applied to individual facilities and they require extensive data and 
analysis. When these applications are focused on facilities, the use of 
site-specific data in lieu of generic assumptions is found to make an 
important difference in the risk outcome. Application to broad source 
categories is a very different matter. These assessments will tend by 
necessity to rely on conservative (meaning health protective), generic 
assumptions. However, intensive and focused efforts are needed to 
identify the generic parameters that are the risk-drivers through a 
sensitivity analysis to replace the generic assumptions with more 
accurate scientific data.
    EPA is also considering the estimation of broader population risks 
in addition to individual risks in the residual risk program. For 
example, EPA's ample margin of safety language requires the protection 
of the ``greatest number of persons'' to a risk no greater than one in 
one million. However, the manner in EPA will address population risks 
has not yet been defined. One risk characterization process was 
described in the 1994 National Research Council report (Science and 
Judgment in Risk Assessment) as including two population risk metrics: 
(1) distribution of individual risk across the exposed population 
(e.g., the number of individuals at risk in various risk intervals such 
as 10-3 to 10-4, 10-4 to 
10-5, and 10-5 to 10-6), and (2) 
estimated population risk, expressed as average annual incidence.
            current application of residual risk assessment
    To date, as noted above, EPA has completed just one draft residual 
risk assessment, a case study of the secondary lead smelting industry, 
which was reviewed by EPA's Science Advisory Board (SAB) on March 1 and 
2, 2000. I reviewed this draft assessment in detail and presented oral 
comments to the SAB. In my comments, I concluded that the SAB's 
comments on the earlier Residual Risk the Report to Congress had not 
been fully addressed in formulating the case study. Significant gaps in 
the science, the methods, and the data remain that can only be resolved 
through more detailed assessment, often including source and site-
specific assessments.
    EPA appropriately described a tiered process where an initial, 
conservative screening assessment is done to conserve resources. 
Depending upon the results, the tier one assessment is to be followed 
by a more refined assessment; where risk outcomes are low, this 
screening assessment can indicate no further study is needed. However, 
where risks are of possible concern, a clear commitment is needed to 
refine the screening level assessment and to articulate criteria for 
when and how to provide a more accurate assessment. Currently, EPA has 
not provided clear guidance on the necessary levels of refinement, the 
methods and data to be used, or even the criteria for deciding when and 
how to initiate the refined assessment. These are critical to making 
responsible and scientifically sound regulatory decisions. While I am 
sensitive to the Agency's resource limitations and the resultant 
inability to conduct full site-specific risk assessments for every HAP 
source in every source category, I believe that more refined source 
data can often be reasonably obtained and utilized to further refine 
the assessments. The Agency must be equally sensitive to the profound 
potential economic impacts of further residual risk regulation of 
sources that have already expended tremendous resources in meeting MACT 
standards. I strongly support the need to further regulate any source 
that is found to clearly and unambiguously exceed acceptable risk 
levels. However, I do not believe it is in the Nation's best economic 
interest to force needless expenditures when residual risks are not 
excessive. A refined risk assessment is needed in order to make these 
determinations. The use of upper bound generic approaches usually 
provides a poor basis for regulatory actions.
    Even implementation of the two-tiered strategy described in the 
Report to Congress is associated with a number of likely problems. 
First, given the growing complexity of the science of risk assessment 
and the wide variability in HAP sources, more than two tiers of risk 
assessment will usually be needed to ensure relative accuracy as well 
as cost- and resource-effectiveness. These considerations are necessary 
because screening risk assessments, with rare exception, estimate risks 
that are excessive, which can mislead the regulatory process, 
unnecessarily raise public concern, and possibly miss identification of 
the most important risks. Recent studies that I and my colleagues at 
Sciences have conducted concluded that these two tiers of risk 
assessment can be associated with risk differences of several orders of 
magnitude.
    The Report to Congress also implied that the EPA would conduct all 
of the necessary residual risk assessments for the more than 175 source 
categories. However, our knowledge of the EPA HAP regulatory program 
and staff, based on past working relationships and recent personal 
communication, indicate that the Agency almost certainly does not have 
the resources to accomplish this enormous assignment. The more likely 
outcome is that the EPA will rely on more simplified models and 
averaged, rather than site-specific, data. This approach will typically 
define residual risk estimates that are greater than actual risks. 
These simplified approaches cannot adequately inform regulatory 
decisions.
    With inadequate resources and substantial data gaps, I can see no 
way for EPA to carry out the residual risk program within the 
prescribed time without outside partnerships to aid in developing 
appropriate information, working together, where possible, to ensure 
that the best data and methods are used in the Agency's analyses, and 
filling the EPA's resource shortfall with analytical and data gathering 
support. In addition, with risks estimated using ``model plants,''\2\ 
and other approaches that rely on averaged data, industrial facilities 
will often need to ensure that more site-specific data and methods are 
employed to determine whether the model plant risks are realistic. In 
our work, we have found that these averaged approaches typically lead 
to risk overestimates.
---------------------------------------------------------------------------
    \2\ Model plants are generally composites serving as average 
examples of groups of typical industry facilities.
---------------------------------------------------------------------------
    For many industrial source categories, the initial conservative 
screening assessment could find that residual risks are unlikely to 
exceed levels of concern at any industrial facility and no further 
risk-related regulation would be forthcoming. However, for many other 
source categories, much more accurate and rigorous assessments may be 
needed in order to determine whether further regulation is required. In 
other words, if a screening approach indicates risks near or above 
presumptively acceptable risk levels, or ecological, population, or 
multipathway risks are potentially indicated, much more detailed and 
accurate assessments will be indicated. A sensitivity analysis should 
be performed early in the process to determine those site-specific 
parameters that are the most important to the risk outcome. These are 
called the risk drivers. Data collection can then be focused more cost-
effectively. In some cases, individual facility, site-specific risk 
assessments using probabilistic exposure and risk assessment techniques 
will be required to define the most realistic risks for the facility. 
The criteria and methods for conducting these more refined assessments 
must be established, including the following:
    1. Detailed characterization of the industry sources (point and 
area) including location and dimensions of all emission sources, 
emission quantities, building sizes and shapes, and other relevant 
factors.
    2. Detailed characterization of the surrounding terrain, including 
U.S. Geological Survey topographical and digital elevation maps.
    3. Detailed characterization of the population distribution, often 
within 50 kilometers around the facilities.
    4. Hourly, onsite meteorological data or, if not available, long-
term data from the nearest National Weather Service station.
    5. Specific emission characteristics, including release height, 
temperature, and velocity, and duration and upset conditions.
    6. Agreement on appropriate dispersion models to be used.
    7. Agreement on, and often reanalysis of, appropriate health 
criteria to be used for the emissions (see the discussion of the IRIS 
data base later in this testimony).
    8. Agreement on, and often reanalysis of, other health effects 
besides cancer risks to be considered.
    9. Identification and assessment of possible ecological concerns.
    10. Identification and assessment of multipathway effects, 
including defining realistic pathways and receptor considerations 
(e.g., it is rare that a farmer eats 100 percent of his daily diet from 
farm grown poultry, beef, pork, and produce).
     specific areas of concern with epa's residual risk case study
    The process used by EPA in its first residual risk assessment was 
an appropriately conservative first step that is useful for setting 
priorities for assessment while conserving Agency resources. However, 
as presently developed and described by EPA, the process remains a 
screening tool that can reasonably exclude sources from further 
assessment, but cannot with accuracy determine whether the residual 
risks associated with any specific source are above or below accepted 
levels of risk concern. If used more broadly, the process is almost 
certain to result in a significant number of false positives namely, 
sources for which additional regulation appears needed when, in fact, 
the actual risks are below acceptable levels of concern. This outcome 
is likely to occur because screening level risks are calculated without 
properly accounting for the many limitations and uncertainties in the 
data, models, and methods used by EPA in conducting the assessment, and 
because of the intentional bias to protect public health where data are 
uncertain. Inappropriate regulation can only be prevented by the use of 
much more refined assessment, often including site-specific or 
category-specific data, thus allowing the decisions needed to support 
further regulation of those sources that require further control. One 
illustrative example of the problem caused by reliance on screening 
tools was an initial screening level analysis that indicated that most 
of the Nation's coke ovens were above EPA's acceptable cancer risk 
level as provided in the 1989 benzene decision. Site-specific analysis 
of several facilities using improved data, a better model which we 
developed, and health criteria that we re-evaluated, actually found 
residual risks to be on average three orders of magnitude below the 
screening level risks and actually well below EPA's acceptable cancer 
risk level.
    In cases where substantial uncertainties and significant 
limitations in data exist, risk management decisions should not be made 
until these limitations are appropriately addressed. In its initial 
residual risk assessment of the secondary lead smelting industry, EPA 
concluded that the risk estimates likely fell ``between the estimates 
made with and without fugitive dust emissions.'' This risk range 
spanned more than two orders of magnitude and is so large that the 
results are impossible to interpret. In this case, at a minimum, better 
quality, site-specific data of such risk-drivers are needed to refine 
the risk assessment so that the results are useful.
    EPA's use of conservative methods, models, data, and assumptions 
early in a source category analysis is appropriate to conserve Agency 
resources and help prioritize actions for later analysis. However, the 
use of implausible and unrealistic methods, models, data, and 
assumptions, particularly when better methods and data are easily 
obtained, is clearly inappropriate and in this case led to a number of 
potentially erroneous conclusions. For example, EPA's first draft 
residual risk assessment resulted in risk estimates high enough that 
(if true) serious adverse human health and ecological effects would 
likely be easily observable in the nearby areas. However, the lack of 
apparent evidence of significant human or ecological impacts near the 
sources of concern gave every indication that EPA's estimates were 
unrealistic. Inaccurate and incomplete data, coupled with excessively 
conservative assumptions, lead to excessive risk estimates. Two 
specific examples are described below:
    1. The assumption in the residual risk assessment that a local 
farmer obtains drinking water from an untreated local surface water 
source that exceeds maximum contaminant levels (MCL) for antimony is 
unrealistic. More realistically, water would be obtained from wells or 
public water systems. This assumption was not conservative, it was 
implausible.
    2. The modeled surface water concentration near one facility 
resulted in estimates of huge fish tissue concentrations and large 
potential risks to the recreational fisherman. Moreover, the modeled 
concentrations were sufficient to cause serious effects for aquatic 
organisms, such that there would be a question of fish availability for 
consumption. However, the lack of collaborative evidence (e.g., fish 
kills in the vicinity of secondary lead smelters) indicated that the 
estimates substantially over predicted actual concentrations. High 
estimated risks need to be flagged and confirmatory information needs 
to be developed.
    EPA's first residual risk assessment process also was incomplete 
because it left unaddressed many potentially important issues that 
could have significant impacts on the ultimate residual risk estimates. 
For example:
    1. While EPA clearly put a lot of effort into many aspects of the 
risk assessment process, it did not focus its data collection efforts 
on the most sensitive risk-driving parameters. EPA further described 
the assessment as an ``iteration,'' stating that it would be replaced 
with a more refined, and possibly site-specific, assessment pending 
SAB's comments and any additional emissions information, as necessary. 
Although EPA did not provide further details on the next iterations, I 
believe that the SAB clearly should review the most refined assessment 
intended to provide the best basis for their scientific evaluation and 
comment.
    2. EPA identified major issues and uncertainties at the end of each 
section of the assessment but the issues and uncertainties were only 
dealt with qualitatively and no indication was provided as to how these 
issues and uncertainties would be addressed in the context of the 
downstream risk management decisions on this or other industry 
categories.
    3. While EPA acknowledged substantial gaps in data, methods, and 
procedures, it was not clear what the Agency will do about the missing 
information. EPA could choose to move ahead with residual risk 
regulation based on this level of assessment for this source category 
and plan to keep returning to the source category to further revise the 
regulations every time new guidance or methods are finalized; however, 
regulation based on inadequate assessment information will undoubtedly 
lead to inefficiency and waste.
    4. There was no discussion on how the risk assessment results will 
be applied in a risk management decision.
    EPA's first draft residual risk assessment also utilized emissions 
data gathered from limited, short-term stack tests at limited numbers 
of facilities, which was then assumed to represent long-term averages 
for all facilities. Fugitive emissions estimation procedures were also 
admittedly poorly characterized and uncertain. Use of limited emissions 
data can dramatically affect the risk results. The uncertainties are 
compounded by the fact that modeling of fugitive emissions is much more 
difficult than for stack emissions. For example:
    1. In its first residual risk assessment, EPA frequently stated 
that its estimation of fugitive emissions is uncertain, but continued 
to use the uncertain data, which can be a risk-driver, to develop risk 
estimates. The uncertainty in fugitive emission estimates, especially 
for particulate matter, is common, owing to the technical difficulty in 
capturing or measuring the emissions. This fact argues strongly that 
better data be gathered to minimize the uncertainties in the estimation 
of fugitive emission rates and composition, before these uncertainties 
are carried through the risk assessment.
    2. EPA also used after-MACT emissions which were estimated to 
support the proposed MACT published in 1995, rather than actual, 
measured current after-MACT emissions. Because industries are typically 
complying with the MACT standards by the time (i.e., 8 years after the 
MACT standard is published) the residual risk assessment is conducted, 
actual after-MACT emissions data should be used. The use of real world 
data, when available, even in the initial screening level assessment is 
appropriate.
    Recent multipathway risk assessments typically prepared or overseen 
by EPA are much more site-specific than the evaluation presented in the 
first draft residual risk assessment. This assessment utilized numerous 
assumptions and procedures that were not only implausible, but easily 
corrected. Furthermore, many of the input parameters were questionable. 
If realistic comparative risk and residual risk regulatory and economic 
decisions are to be made using risk assessment, it is essential that 
the models, methods, data, and assumptions be appropriate, validated, 
and properly used. A major uncertainty arises from the use of models 
that are both incomplete and not designed to rigorously address the 
issues involved with residual risk assessment and regulation. In the 
residual risk assessment, for example:
    1. The oral exposure-dose equations do not include a 
bioavailability factor, thereby assuming that 100 percent of a chemical 
is absorbed upon exposure. The assumption that the bioavailability of 
all chemicals is 100 percent is contrary to the scientific literature 
and has the potential of leading to considerable overestimates of 
exposure dose (e.g., absorption of a chemical that is adsorbed to 
particulates or soil may be significantly hindered).
    2. The assessment also assumed that particulate matter 
concentrations are available in the breathing space of a resident near 
the source. Air concentrations directly produced from the air 
dispersion modeling are simply multiplied by an inhalation rate to 
calculate the inhalation dose, and, hence, assume 100 percent retention 
and absorption of this air concentration. In fact, a smaller percentage 
of inhaled particles are retained in the lung, and depending on the 
size of the particulates, some of the inhaled particulates will be 
deposited in the respiratory tract, where a considerable fraction will 
ultimately be swallowed and should, therefore, be added to the 
ingestion pathway where oral bioavailability would govern the 
absorption of the chemical.
    3. In many instances, default parameter assumptions were relied 
upon without accounting for the characteristics of a site. The reliance 
on generic default values for key parameters in lieu of site-specific 
data significantly decreases the likelihood that the modeled exposures 
will provide a reliable indication of actual exposures. Examples of 
inappropriate generic assumptions are: the assumption that persons are 
exposed 24-hours per day to outdoor air at their residence; use of home 
grown produce and animal products representing 100 percent of an 
individual's intake of these products; use of default soil-to-plant 
uptake factors (these vary considerably depending on soil types and 
local geochemistry); and, selection of inappropriate exposure pathways.
    4. Uptake of metals into fruits and vegetables often drives the 
home gardener's indirect pathway risks and is one of the pathways for 
which great uncertainties exist. Plant uptake also has important 
implications for the meat and milk pathways. The generic guidance used 
in the first residual risk assessment greatly simplified the 
methodology for assessing concentrations in fruits and vegetables. This 
process has historically been subject to many different methodologies 
and data sources and this pathway has been one of the most difficult 
areas for risk assessors to model. The empirical values used to predict 
soil-to-plant transfer of metals are approximate over a wide range of 
soil conditions. Soil geochemistry (e.g., pH) is an important factor in 
the bioavailability of metals to plant roots and governs metals uptake 
into the edible portions. It is recognized that sufficient data often 
may not exist to characterize uptake using geochemical soil parameters 
and, therefore, default uptake factors are often used. Nevertheless, 
where pathways that rely on plant uptake drive the risks, a site-
specific assessment must account for the effect that local soil 
conditions have on plant uptake; the risk outcome most likely will be 
changed substantively.
    5. The draft residual risk assessment concludes that the drinking 
water pathway accounts for 73 percent of the total cancer risk and 70 
percent of the total non-cancer risk for a subsistence farmer at the 
site with the highest ingestion (indirect pathway) risks. Drinking 
water also accounts for 97 percent of the farmer's indirect exposure 
cancer risk and 79 percent of the indirect exposure non-cancer risk. 
Notwithstanding the fact that the surface water concentrations are 
likely to be overestimated due to the assumptions regarding fugitive 
and stack emissions and shortfalls in the dispersion modeling, the 
unrealistic assumption was made that nearby surface water is used 
untreated for drinking water purposes. It would be illegal for any 
public water supply system to supply drinking water with the estimated 
levels of contaminants.
    6. Several key inputs to the air dispersion model were not 
included. For example, all of the emission points at a facility were 
assumed to be co-located at the center of a facility; fugitive 
emissions were modeled using the same source area at each facility; and 
building downwash and local terrain features were not accounted for. 
Inclusion of these inputs is easily accomplished and could have a 
significant impact on the resulting concentration estimates and risks.
    The uncertainty/variability analysis in the first residual risk 
assessment was limited in its scope and usefulness. The purpose of an 
uncertainty/variability analysis is to focus on the facilities, 
pollutants, and exposure pathways with the highest risks identified in 
the multipathway analysis. The first residual risk assessment does not 
say how the quantitative uncertainty analysis will be used in the 
regulatory processes. In addition, the evaluation implied that most of 
the meaningful uncertainties had been accounted for and that the 
results supported and validated the point estimates. However, of four 
possible input parameter categories--emissions, transport and fate, 
exposure, and dose-response--only two, namely emissions and exposure, 
were addressed in the uncertainty analysis. Omission of two parameter 
categories sidesteps the issue of developing a complete framework for 
treating the risk quantification in a realistic manner. Furthermore, 
many exposure variables have not been studied to establish their 
chemical and physical distributions (e.g., variability in consumption 
of farm grown produce and animal products).
    Even given the limited scope of the uncertainty analysis, the input 
parameters used in the Monte Carlo analysis addressed only a narrow 
subset of the factors that influence the deterministic risk outcomes. 
Emission variables that could not be quantified for probabilistic 
analysis included: detection limits; test results from one facility 
used to quantify emissions at another facility; frequency of plant 
closing; and, fugitive emission estimates. The study ultimately relied 
on very limited emissions data. These are challenging issues that are 
resource intensive to address but, nevertheless, can have an enormous 
impact on the risk outcome.
    In the case study residual risk assessment for the secondary lead 
smelting industry, screening level ecological risk assessment was 
conducted to estimate potential risks to aquatic and terrestrial 
communities from HAPs emitted from the facilities that remained after 
the initial screening. This screening level ecological analysis was 
intended to identify which HAPs require more analysis and was designed 
to be conservative, with assumptions generally overestimating actual 
exposure concentrations, thus overestimating the actual potential for 
ecological risks. The ecological screen indicated a high potential for 
ecological impacts but the results are misleading for the following 
reasons:
    1. The screening level ecological assessment does not provide 
sufficient information to draw appropriate conclusions as to whether an 
adverse environmental effect, as defined in section 112(a) of the 1990 
Clean Air Act Amendments, has occurred. Section 112(a) states that 
``[T]he term `adverse environmental effect' means any significant and 
widespread adverse effect (emphasis added), which may reasonably be 
anticipated, to wildlife, aquatic life, or other natural resources, 
including adverse impacts on populations of endangered or threatened 
species or significant degradation of environmental quality over broad 
areas.'' This appears to provide a much broader definition of 
ecological effects than was used in the case study, requiring 
significant and new methodological and data needs.
    2. The ecological receptors are representative of sensitive species 
and communities at a generic site; no regard was given to site-specific 
information.
 the role of epa's integrated risk information system data base (iris)
    The accuracy of comparative risks and residual risks relies heavily 
on toxicity criteria from EPA's IRIS data base. Let me present here a 
brief history of the development of IRIS and why it is uniquely 
important to the risk assessment process. I will also discuss the 
limitations and problems of IRIS in meeting the Agency's current risk 
assessment goals.
    IRIS is an electronic data base containing information on human 
health effects that may result from exposure to various chemicals in 
the environment. I played a significant role in establishing the IRIS 
data base at EPA. The initial purpose of IRIS was to compile health 
information into one central data base, and to ensure internal 
consistency among the various EPA Regions' and Offices' health 
assessments. It was originally planned for internal use only, and was 
never intended for direct regulatory use without the careful scrutiny 
by the Agency. Indeed, the original disclaimer to the preface of each 
IRIS file clearly indicated that the IRIS summaries are subjected to 
constant revisions to incorporate new data and new methodology, are 
subject to review by EPA scientists, and are designed to be used to 
support risk assessments. There was no mention of any direct regulatory 
purpose for the IRIS data base.
    In recent years, there has been increasing reliance on IRIS for 
toxicological information and regulatory guidance, even though the 
latter is inconsistent with its original purpose. In recognition of the 
need for a more streamlined approach to preparing IRIS assessments and 
to establishing consensus, the Agency recently initiated a commendable 
IRIS pilot program. Briefly, the program entails the development of 
chemical-specific ``Toxicological Review'' health assessment documents 
prior to updating or developing an IRIS summary, input from the public, 
and external peer review process. On April 1996, EPA announced in the 
Federal Register that 13 substances will be reviewed under the pilot 
program. To date, 10 of the 13 substances have been updated. Obviously, 
the progress made by the pilot program in updating the IRIS files has 
been slow, which could have serious impacts on a program, such as the 
residual risk assessment program, which have a required completion 
schedule. The IRIS data base currently contains over 500 chemicals, 
including the 188 HAPs required to be regulated in the residual risk 
program. Many of the IRIS files are outdated and, while updating is 
laudable, 10 updates in 4 years is an entirely inadequate response. 
Reasons for the slow progress include resource limitations. In 
addition, new advanced methods to perform RfD's/RfC's and cancer 
assessments are being developed, including new methods for dosimetric 
adjustments, benchmark dose methodology, categorical regression 
analyses, biologically based models with consideration of mechanism of 
action, and physiologically based pharmacokinetic (PBPK) models. Thus, 
updating an IRIS file necessitates not only updating and evaluating the 
most recent literature but also reassessing the data using these new 
and complex methods.
    As mentioned earlier, EPA's first residual risk assessment relied 
on toxicity criteria obtained from IRIS. However, the IRIS files were 
not reviewed to determine whether they were outdated. If a particular 
chemical is a risk driver in the residual risk assessment, the validity 
of the toxicity factors used must be investigated. Acceptance of 
published IRIS criteria without review can lead to considerable 
uncertainty in the final residual risk results. For example, 
reevaluation of EPA's cancer unit risk value for coke oven emissions by 
my company found, using updated epidemiological data and techniques, 
that the actual cancer unit risk factor is about one-fourth of the IRIS 
``official number'' for coke oven emissions which was prepared in 1984 
under my direction. That evaluation was intended only as an initial 
value pending publication of epidemiology studies that were undertaken 
at the time. However, our reevaluation was provided to EPA about 2 
years ago, but IRIS still has not yet been updated. Clearly, a 1984 
evaluation based on limited and unpublished data is inadequate for use 
in regulatory decisionmaking in 2000.
    In summary, IRIS was not originally intended to be used for 
regulatory purposes or for that matter to provide complete 
toxicological data on a particular chemical. It is most useful as a 
screen that allows one to quickly access toxicity information that may 
be of help for risk assessment purposes. It is clear that there is a 
serious need to update IRIS. The use of outdated IRIS information has 
serious implications to the use of any risk assessment in 
decisionmaking.
    Risk assessment provides a thorough evaluation of scientific 
literature as a basis for regulatory decisionmaking and provides the 
impetus for improving the process in order to facilitate better 
decisionmaking. Risk assessments support many different kinds of 
decisions. In comparative risks assessments, the totality of the risks 
are viewed to improve priority setting, decisionmaking, and stakeholder 
involvement. Residual risk assessments support specific decisions 
mandated under the risk requirements of the Clean Air Act. These 
decisions demand well thought out, comprehensive, and scientifically 
supported risk assessment methodology. This need poses an unprecedented 
challenge for EPA to develop the processes and then conduct 
comprehensive risk assessments across a range of chemicals, sources, 
and regulatory programs. This places heavy resource demands on EPA, and 
the required resources may not be available. Nevertheless, it would not 
serve our Nation well to make regulatory decisions under any program by 
defaulting to generic risk assessment approaches or using out of date 
data files in IRIS because of resource constraints. The best science 
should form the basis for risk management decisions; otherwise our 
decisions are not well informed and can be flawed. It is also crucial 
for all stakeholders to have at least some understanding of how EPA 
intends to use the information developed in the residual risk 
assessment to make risk management decisions. Only then can the 
assessment's adequacy be judged.
    The first residual risk assessment conducted by EPA is not 
sufficient to meet the needs of decisionmakers under the residual risk 
program. At best, it presents a process that can only be described as a 
screening assessment, even when including multipathway and ecological 
analyses. A screening assessment is a necessary part of the initial 
risk assessment process for this program, but it falls far short of the 
refined risk assessment (based on more source-category specific data) 
that is required to make regulatory decisions.
    Earlier this year, the SAB reviewed the EPA draft residual risk 
assessment method and its first application to the secondary lead 
smelting industry. Because the method requires substantial improvement, 
it is essential for the SAB to review the next draft of this approach. 
More refined risk assessments should not simply be screening 
assessments with more data; rather, they should rely on new methods and 
approaches to address important risk factors such as when to refine 
conservative screening values, how to assess population risks, how to 
characterize after-MACT standard emissions, how to assess ``significant 
and widespread adverse'' ecological risk, when monitoring data are more 
suitable than modeled data, and what criteria will be used to determine 
when the risk assessment process will be triggered. These 
methodological issues need to be reviewed by the SAB because they are 
not settled matters in the realm of risk assessment and will be of 
generic importance across most, if not all, of EPA's risk assessment 
programs.
    Any more refined risk assessment methodology should be 
characterized by the use of category-specific, and selected site-
specific, data for the elements that are the risk-drivers as identified 
in screening assessments. The generic assumptions used in a screening 
assessments such as those conducted by EPA are designed to be 
conservative; consequently, they can generate many false positives. 
Regulatory decisions cannot be based on such assessments; more specific 
data are needed to determine whether or not actual residual risks of 
concern exist. While this task varies in degree of difficulty, EPA can 
focus its further data collection on those elements identified by the 
screening assessment as the risk-drivers. Much of those data should be 
readily obtainable.
    The residual risk assessment methodology should also explicitly 
incorporate realistic assumptions and data in both the screening and 
more refined phases of the assessment. As seen in EPA's case study 
assessment of the secondary lead smelting industry, implausible or 
unrealistic assumptions, methods, and data can fatally skew the results 
of an assessment. Such results have the potential to cause needless 
data gathering by EPA and industry in order to demonstrate that 
nonexistent risks are not real; unfounded public concerns may also be 
avoided if the results of a screening assessment are immediately 
scrutinized to determine if they are realistic.
    Finally, if the IRIS data base is to be used for regulatory 
purposes or for that matter to provide complete toxicological data on 
any particular chemical, it must be updated across the board and then 
maintained in an up-to-date manner. The use of outdated IRIS 
information has serious implications to the use of any risk assessment 
in decisionmaking.
                              conclusions
    Extraordinary complexity of the risk assessment is called for by 
the comparative risk and residual risk programs. In 1976 when the first 
risk assessment process began at EPA, risk assessment and risk 
management focused largely on single chemicals such as air pollutants 
and pesticides. The complexity of risk assessment has grown over the 
years with the most complex risk assessments being conducted at 
Superfund sites and for combustion sources. These risk assessments 
addressed multipathway risk assessment issues and ecological risks but 
have been focused on single facility or single sites. The comparative 
risk program and the residual risk program as prescribed under the 
Clean Air Act Amendments of 1990, require unprecedented use of risk 
assessment across the board for over 175 industry source categories and 
literally thousands of facilities. In addition, the residual risk 
program, for example, must address the toxicity of all 188 chemicals on 
the hazardous air pollutant; the comparative risk program needs to 
address considerably more chemicals. Adding considerably more to the 
complexity, the residual risk program calls for the use of multipathway 
risk assessment and regulation of environmental risks with significant 
and widespread effects to wildlife, aquatic life and other natural 
resources, including impacts on endangered or threatened species or 
significant degradation of environmental quality over broad areas.
    The current EPA guidelines for conducting the residual risk program 
(and there are no such guidelines for the comparative risk program but 
it probably will follow much the same process), primarily employ 
available data and generic and upperbound risk assessment approaches. 
The guidelines mention a tiered approach but do not make a clear 
commitment to proceeding to a clear approach where risks appear to be 
high nor are there any guidelines or criteria for when or how to do so.
                            recommendations
    1. The unprecedented complexity and cost of conducting the risk 
assessment program called for by both comparative risk and residual 
risk must be conducted by a carefully orchestrated tiered approach. The 
first tier should employ the very best available data and commit to an 
approach that provides the greatest accuracy possible in the risk 
assessment at this stage so as to avoid unfounded public health 
concerns over issues that may not be of substance. The risks that are 
so identified should also be subjected to an analysis to see if they 
appear to be unreasonably high. Several examples of such unreasonably 
high risk have been given in this testimony. For those sources that 
appear to have low risk after the Tier 1 assessment, no further work is 
needed. For other sources, if the risks appear high, a sensitivity 
analysis should guide further data collection to focus resources on 
refining those parameters, including toxicity values, to arrive at a 
more accurate risk assessment. Refined risk assessments that are 
focused on defining real risk are necessary to guide the risk 
management decisions. The resources necessary to conduct these risk 
assessments both within EPA and on the part of involved parties, need 
to be recognized. In addition, I see no way that these risk assessments 
can be refined without some kind of partnership to refine data with 
involved parties.
    EPA's current draft guidelines fall far short of addressing a 
process that will ensure that any of these steps are followed beyond 
providing the initial upperbound risk assessment. The shortcomings of 
effort are laid out in considerable detail in this testimony.
    2. Policy related issues need to be clarified. Historically, EPA 
has limited its risk guidance in the hazardous air pollutant regulatory 
program to carcinogens, inhalation risks, and risks to individuals, and 
has not addressed how broader population risk must be considered. 
Further, language in the 1990 Clean Air Act Amendments for residual 
risk states that environmental risks must also be considered. These 
policy issues together with how multipathway risk assessment will be 
considered under the residual risk program should be clearly 
articulated at this time. There should be an opportunity for public 
comment to arrive at final criteria to define how these issues are to 
be addressed and guidance must be developed to more accurately estimate 
the effects.
    3. Emissions data must be improved. Historically, EPA has used 
readily available emissions data, for example using estimated rather 
than measured post-MACT emissions, to estimate current risk. The risk 
assessment can be no more accurate than are the emissions that are used 
in the dispersion modeling.
    I recommend first that the most accurate available emissions data 
be used in the Tier 1, screening level risk assessment. Second, for 
those sources that appear to be associated with risks of concern, I 
recommend that subsequent refinements in the exposure data be sought 
before a final risk assessment is completed. Again, I see no way for 
EPA to arrive at the necessary accuracy in risk assessment without a 
partnership with the organizations and facilities involved.
    4. Use of the IRIS data base, as a repository of operational, 
regulatory toxicity values, must be revised. Historically, the IRIS 
data base was established to provide a repository for all of the 
information available in the agency with respect to toxicity for 
particular chemicals. Initially, it was primarily established to ensure 
consistency across agency programs and to serve as an internal data 
system to make available work that had been completed to date on 
individual chemicals. The Risk Assessment Forum, for which I was the 
first director, set up the IRIS data base and commenced the stewardship 
program to enter new chemicals and to put in information that was 
existing in the agency at the time the data system was established. In 
the beginning, it was clear that the data base was not necessarily 
intended for direct use in regulatory decisions without refinement; the 
preface reflected the fact that the data base was not intended for 
these purposes. Since that time, however, the IRIS data base has become 
not only the most important source of regulatory toxicity values for 
use across all of EPA's programs, but is widely used across State 
programs and internationally as well. The files for over 500 chemicals 
that are contained in this data base are in many, many cases vastly out 
of date both with respect to the current literature and the use of 
current methods for dose response extrapolation. To illustrate the 
difficulties, EPA began in 1996 a full-scale review of 13 chemicals in 
IRIS. At this time, only 10 of those updates have been completed.
    The current guidance that has been issued for the residual risk 
program, and practices for the comparative risk program, use these 
toxicity values as if they are intended for immediate regulatory use 
without refinement. This is inappropriate. All risk assessment programs 
in EPA, in particular in this instance, the comparative risk and 
residual risk programs, should explicitly recognize that these toxicity 
values are vastly out of date and must be refined where risk drivers 
are identified. This recognition should be part of the iterative 
process for the Tier 2 and subsequent stages of risk assessment 
refinement for these programs.
    I recommend, as everyone else does, that resources be committed to 
EPA to update all of the over 500 chemicals in IRIS and to keep the 
data base refined and up to date. In making this recommendation, I 
realize that this is an almost impossible task. Nevertheless, I think 
all efforts should be made to carry it out to the extent possible. To 
be totally practical, I further recommend that the preface to the IRIS 
data base be re-stated to recognize reality, that is that the IRIS data 
base can probably never be a current source of all the latest 
information in the literature with application of the latest risk 
assessment methodologies necessary to provide the accuracy essential in 
risk assessment to inform risk management decisions. I further 
recommend that a partnership be established between EPA and private 
institutions to refine toxicity values, particular in the Tier 2 part 
of a risk assessment process where risk drivers have been identified 
through a sensitivity analysis. By this method, we can focus precious 
resources on those most important factors that can improve the 
scientific basis for our decisions.
    5. Uncertainty and variability analyses must be applied more 
explicitly. Historically, EPA has come to recognize the importance of 
performing variability and uncertainty analysis but to date has been 
able to do so only for a limited number of factors. the purpose of 
uncertainty and variability analysis is to focus on the facilities, 
pollutants, and exposure pathways of greatest concern to the estimated 
risks identified in the multipathway analysis. Four important parameter 
categories are emissions, transport and fate, exposure, and dose-
response.
    Further, historically the uncertainty and variability analysis has 
been stated in some cases only qualitatively and not quantitatively or, 
in some limited cases, there have been quantitative statements of 
uncertainty. All too often, this section of the risk assessment is an 
afterthought that is never mentioned again in the risk management 
process.
    I recommend that there be clear guidelines developed for the use of 
uncertainty and variability analysis in making risk management 
decisions. I recognize that this may be a difficult task to undertake 
but I think it is an important one. For example, the first guideline 
could be that where uncertainty is so great, a next tier of risk 
assessment is necessary before any informed risk management decision 
can be made. Second, where a risk management decision is based on a 
risk assessment that is highly uncertain, the decision should be 
considered an interim decision until more refinements in the data and 
methods can be accomplished. There should be a clear commitment to 
revisit that decision as soon as the improved risk assessment 
information is made available. I feel certain that guidelines such as I 
have suggested here could be developed that would ensure that 
appropriate use of uncertainty and variability analysis is made during 
the entire risk assessment and risk management process.
    Thank you for the time to address this committee, I would be happy 
to entertain any questions you may have.
                                 ______
                                 
    Responses by Elizabeth L. Anderson to Additional Questions from 
                             Senator Smith
    Question 1. You stated that the science of risk assessment has 
grown in complexity. How and what changes do you believe need to occur 
for the EPA to be able to meet those challenges you identified in 
conducting risk assessments?
    Response. The science of risk assessment has grown considerably in 
complexity since we first Megan to apply it to environmental 
decisionmaking over 20 years ago, and it will continue to evolve. 
However, it has reached a State where it can provide highly useful 
information to risk managers, as long as appropriate assumptions, 
methodologies, and data are used and proper decisionmaking criteria are 
applied. In my testimony, I identified a number of issues associated 
with EPA's initial residual risk assessment. I offered a number of 
recommended improvements, summarized below, that could be undertaken by 
EPA in methodology, application, and resource distribution that could 
help the Agency meet its challenges.
    First, multiple tiers of assessment must be utilized in order to 
cost-effectively evaluate wind regulate residual risks. EPA has adopted 
the multi-tiered approach but the Agency's initial residual risk 
assessment only used two tiers. Studies by me and my colleagues have 
shown that several tiers of assessment are often needed to effectively 
refine the process to distinguish the significant residual risks from 
those of low importance. I recognize that this process often requires 
utilization of more resources, but it minimizes the very real 
possibility, arising from the use of limited tiers of assessment, of 
regulating sources that do not in fact result in risks of real concern 
in the exposed populations.
    Second, important issues have not yet been dealt with in guidance 
or practice by EPA. For example, section 112(f)(2) in the 1990 Clean 
Air Act Amendments requires the regulation of environmental risks in 
addition to human health risks; however, EPA has not yet published 
guidance on how this should be done under the Clean Air Act. Such 
guidance is critically needed to the risk decisionmaking process. As 
another example, EPA discussed in the 1999 Residual Risk Report to 
Congress the need to consider broader population risks in addition to 
the risks to the maximally exposed individual upon which risk 
assessment has focused in the past. Again, guidance for considering and 
dealing with broader population risks has not yet been published, and 
is critically needed.
    Third, EPA has historically used available emissions data in 
conducting risk assessments, even when the data were limited and out-
of-date. Risk assessments can be no more accurate than the emissions 
data used. I recommended in my testimony that EPA strive to improve its 
emissions data base and that essential to that outcome are partnerships 
with the organizations and facilities that have the best and most 
current data. The National Research Council, in its recent report 
Strengthening Science at EPA: Research Management and Peer Review 
Practices, also urged EPA to acquire and apply the results of research 
conducted or sponsored by other Federal and State agencies, 
universities and industry.
    Fourth, EPA's integrated risk information system (IRIS) data base 
must be revised and updated. As I discuss in the response to the next 
question, much of IRIS is out of date and if it is to be used in 
regulatory priority setting and decisionmaking, necessary resources and 
management direction must be applied to improve it and its application. 
I expand on specific recommendations in my written testimony.
    Finally, the use of uncertainty and variability analysis must be 
applied more explicitly. While EPA has historically recognized its 
importance, this process has been used only in a limited way. Guidance 
for its more explicit use must be developed and then applied 
systematically in the risk assessment and risk management process.

    Question 2a. How many values are there currently in the IRIS data 
base, and how many of them, to your knowledge, have been updated? What 
is involved in reviewing and updating an IRIS value and how important 
is this review to the residual risk program and other risk-driven 
regulatory programs at EPA? How much could an IRIS value change as a 
result of this review and what would it mean for the final risk 
assessment?
    What is the Size and Status of IRIS?
    Response. According to the EPA Summary Report: Characterization of 
Data variability and Uncertainty: Health Effects Assessments in the 
Integrated Risk Information System, (August 2000 review draft) stated 
that there were 537 chemical specific assessments in IRIS as of January 
31, 2000. One has been added since that time, for a current total of 
538.
    According to the September 26, 2000, SAB letter to the 
Administrator entitled Review of the Draft Report to the Congress 
``'Characterization of Data Uncertainty and Variability in IRIS 
Assessments, Pre-Pilot vs Pilot/Post-Pilot'', the average IRIS file was 
last changed 10 years ago. In many cases, the last activity was when 
the file was first added to the data base. In 1995, EPA established the 
IRIS Pilot Program. Since that time, four substances were added to IRIS 
and 16 files were revised. Clearly, this pace needs to be greatly 
accelerated both because so many files are currently out of date and 
because the State of the science is changing rapidly in response to 
such initiatives as the HPV program, the Children's Health Initiative, 
and the endocrine disruptor screening and testing program. 
Alternatively, the IRIS file should be appropriately labeled as a 
reference file, not as a source of toxicity values for direct use in 
risk assessment. I see no way to make informed public health decisions 
that have significant social and economic costs without making 
provisions to review and revise the toxicity information in IRIS as a 
particular agent becomes the risk driver in these decisions.

    Question 2b. What is involved in the Review and Update of IRIS?
    Response. Much is involved in the review and update of an IRIS 
file. These files contain scientifically reviewed information on the 
carcinogenic and noncarcinogenic effects associated with exposure to a 
substance. The review requires knowledge of inhalation and oral 
toxicology; methods by which dose-response relationships, risk, and 
uncertainty are characterized; statistical procedures used to evaluate 
data; and scientific data bases relative to the health or ecological 
effects of the substance under study. The sequence of events involved 
in revising an IRIS file includes the following steps.
    Analysis, Interpretation and Synthesis of Information and Data.--
The review initially involves obtaining the published information on 
the toxicity/carcinogenicity and supporting data on the health effects 
of the pollutant. Analyses of these data for validity, accuracy, 
generation and characterization of exposure concentrations, and 
statistical analysis of exposure and response measures determine the 
usefulness of the information in establishing non-cancer and cancer 
concentration dose-response relationships. Appropriate data analyses 
include relatively new qualitative and quantitative dose-response 
modeling techniques such as: (1) physiologically-based pharmacokinetic 
(PBPK) modeling, (2) benchmark concentration (dose) analysis, (3) 
categorical regression, and (4) linear dose-response or mechanistic 
models. Use of these advanced methods ensures that correct conclusions, 
correlations, extrapolations, and contradictory results are identified 
in the process of dose-response assessment. In instances where 
confidential business information (CBI) information must be used, 
standard U.S. EPA CBI procedures must be followed.
    Data Array Analysis, RfC/RfD/ARE and Cancer Unit Risk Derivation, 
and Calculation.--Data secured for developing risk reference 
concentrations (RfCs), risk reference doses (RfDs), acute reference 
exposures (AREs), and cancer unit risk values must be arrayed in a 
manner that can be quantitatively evaluated. The analyses involve the 
identification of the critical effect, principal study, supporting 
studies, and appropriate mathematical models for fitting the data 
according to EPA procedures. For inhalation studies, appropriate 
duration adjustments of the exposure concentration must be made 
depending on whether the pollutant exists in vapor or aerosol form and 
the data array modified accordingly. Derivation of the RfC, RfD, and 
ARE and preparation of confidence statements involve application of 
appropriate uncertainty factors, evaluation of study quality, and 
identification of data base deficiencies and discussion of any 
scientific controversies surrounding the chemical or effects noted. 
Derivation of cancer unit risk values involves application of 
appropriate models and explanation for their selection as well as 
qualitative narratives categorizing the chemical's carcinogenicity. For 
example, decisions must be made to employ the default approach, the 
linear non-threshold dose-response model or the more refined approach 
using the mode of action data, to define more accurately the dose-
response characteristics, where data are available. The difference in 
outcome at low doses can be as much as several orders of magnitude. 
These quantitative procedures are incorporated into a summary narrative 
for peer review by the EPA and into a report describing the rationale 
for developing or not developing an RfC, RfD, ARE, or cancer unit risk 
values for a given substance. A support document (toxicological review) 
is also prepared to go with the summary narrative. This support 
document discusses in greater detail aspects of the studies described 
in each of the summary narratives (e.g., the RfC, RfD, and cancer 
assessment). It also provides additional toxicological information, 
generally of a secondary nature, that relates to a given chemical's 
effects in both humans and laboratory animals, including any pertinent 
in vitro findings, such as genotoxicity results, and metabolic or 
mechanistic studies.

    Question 2c. How important is the IRIS review to the residual risk 
program and other risk-driven regulatory programs at EPA?
    Response. Accurate and current IRIS files are absolutely essential 
to the legal and scientifically supported implementation of EPA's risk-
based regulations, or an alternative approach is needed. Regulations 
that are based on inadequate, out-of-date, or unvalidated toxicological 
data will almost certainly be challenged and would likely be 
overturned. More importantly, the Agency has committed to producing 
regulations based upon sound science and peer review, and many of the 
current IRIS files do no meet these goals.

    Question 2d. How Can a IRIS Value Change Risk Results?
    Response. The IRIS value has a significant impact because it is 
directly proportional to the risk estimate. In one example of the 
impact of change, reevaluation by my company of EPA's published cancer 
unit risk value for coke oven emissions found, using updated 
epidemiological data and techniques, that the actual cancer unit risk 
factor is about one-fourth of EPA's published IRIS number for coke oven 
emissions. The published value was derived originally in 1984 under my 
direction, but was intended only as an initial value pending 
publication of epidemiology studies that were on-going at the time. 
However, the file was never updated by EPA, even though the anticipated 
epidemiology studies were completed. Our more recent reevaluation was 
also provided to EPA over 2 years ago, but the IRIS values still has 
not been revised. Clearly, a 1984 evaluation based on limited and 
unpublished data is inadequate for use in regulatory decisionmaking in 
2000. Use of the updated cancer unit risk value for coke oven emissions 
would lower risk estimates by a factor of four. When combined with 
reduced exposure resulting from an updated exposure model also 
developed by my group for the coke oven industry, the estimated maximum 
individual risks associated with exposure to the coke oven emissions at 
the Nation's two largest coke facilities were reduced from EPA's 
estimated values, which were well above the Agency's level of concern, 
to values well below the Agency's level of concern. Use of EPA's 
published value could lead to a conclusion that additional regulation 
to reduce residual risks is likely to be required for this industry. 
Our revised assessment would suggest that no additional regulation is 
likely to be required for this industry. If additional regulation were 
required, it could entail millions of dollars in new control 
expenditures and the possible loss of hundreds of jobs from plants that 
may not be able to afford the added costs and, as a result, would 
close. The most important contribution risk assessment can make to the 
regulatory process is to present refined information that can 
distinguish the more important, real risk from the unimportant, 
insignificant risk. This outcome can only evolve when screening level 
risk assessments are further refined.

    Question 3. What do you recommend that the EPA do to improve the 
quality of its regulatory decisions in terms of risk assessment and 
benefit-cost analysis?
    Response. As I noted in my testimony and discussed above, I made 
several recommendations in my written testimony for improvement in risk 
assessments, recommendations that could significantly improve the 
quality of the regulatory decisions that are needed. At the heart of 
these recommendations are three principal needs. First, better guidance 
and decision criteria must be developed by EPA and agreed upon that 
detail the necessary processes for reaching appropriate risk decisions. 
EPA has published only partial and incomplete guidance and criteria to 
date. Second, partnerships must be formed between EPA and the regulated 
industries to improve the quality of the data upon which risks are 
estimated. Such partnerships have been ineffective for the most part 
and have not been aggressively sought by EPA or the regulated 
industries. finally, important EPA data bases, such as IRIS, must be 
reviewed and updated to provide more confidence in the risks that are 
estimated, or alternative courses of action adopted. I made alternative 
recommendations in my written testimony. These improvements will take 
time and resources, but could be expedited through the same kinds of 
partnerships I recommend for improving the quality of industrial 
facility emissions data.

    Question 4. What can the Congress do to accelerate the adoption of 
a more effective decisionmaking process?
    Response. Section 112 of the 1990 Clean Air Act Amendments 
establishes the list of hazardous air pollutants (HAPs) and defines a 
general process for identifying source categories of the HAPs, 
publishing emission standards based on maximum achievable control 
technology (MACT), and evaluating and further regulating residual risks 
at a later date, where necessary. However, section 1121eaves to EPA the 
exact process for meeting this mandate. In the 10-years since passage 
of the 1990 Amendments, EPA has published some but not all of the 
necessary guidance and criteria for this program. The Agency has also 
allocated resources to the extent possible, given its many other 
important responsibilities, but there has clearly been a shortfall in 
resources needed to accomplish what is required in section 112.
    I believe that Congress can best influence effective decisionmaking 
by several means: (1) recognizing the complexity of the tasks that have 
been assigned to EPA, (2) ensuring that the rush to meet deadlines does 
not jeopardize the scientific basis for making informed decisions, (3) 
supporting development by EPA of the necessary criteria and guidance 
for an iterative risk assessment process that can ensure that sound 
decisions are made, (4) encouraging reallocation of EPA's resources in 
ways that facilitate improvement in the risk assessment process, and 
(5) encouraging partnerships between EPA and outside organizations that 
have resources and information that can assist EPA in providing refined 
and carefully conducted risk assessments to inform the regulatory 
process.
                                 ______
                                 
    Responses by Elizabeth L. Anderson to Additional Questions from 
                             Senator Baucus
    Question 1. Ms. Anderson, you raised many specific concerns about 
EPA's residual risk assessment case study. It often seems that every 
time a risk assessment is done these days--whether it is to regulate an 
environmental problem, update a standard, or better understand a 
problem such as climate change--it is controversial. Given this, how 
realistic do you think it is for us to consider doing a comparative 
risk assessment that would set EPA's budget or regulatory priorities--
something that would require a separate risk assessment for each of the 
Nation's environmental problems--but still avoid controversies over 
each and every risk assessment the priorities are based on.
    Response. I agree that historical risk assessments have often been 
controversial. However, it is important to recognize that risk 
assessments can be designed to achieve different purposes and for that 
reason can vary substantially in their level of sophistication and 
complexity. The risk assessment aimed at setting regulatory priorities 
typically would be a national assessment that evaluates broad 
categories using screening tools and aggregated data. The models, the 
data, and the methodologies are focused at providing general 
comparisons of environmental problems to assist in setting regulatory 
priorities. On the other hand, the risk assessment aimed at 
establishing source category regulations and necessarily affecting 
specific facility operations, control costs, and jobs, must not only be 
much more sophisticated and but also often facility-specific. This 
assessment process requires more precise models, facility-specific 
data, and methodologies that are detailed enough to ensure that real 
risks are being identified and subsequently regulated. I believe that 
the science of risk assessment is currently at a level that can 
effectively help us set regulatory priorities, but that to be 
successfully applied to regulatory decisionmaking there must be 
additional guidance, direction, resources, and a commitment made to an 
iterative process to provide accurate, refined assessments for 
significant regulatory decisions where the social and economic 
consequences are substantial. Otherwise, it may lead to regulating 
insignificant risks at great cost while real risks go unidentified and 
unregulated.

    Question 2a. Your testimony suggests that you oppose regulation or 
making risk management decisions where there are ``substantial 
uncertainties and significant limitations in data.''
    Are there some good ways that Congress, EPA, or others can identify 
``substantial uncertainties and significant limitations in data''?
    Response. First, when I discussed ``substantial uncertainties and 
significant limitations in data'' in my written testimony, I said that 
risk management decisions should not be made until these limitations 
are addressed. I also did not mean to imply that these uncertainties 
and limitations are unanswerable. For example, as I presented in my 
written testimony, a sensitivity analysis can be used to identify the 
most important risk drivers. These parameters can then be inspected to 
determine if better data or methods are available to refine the 
particular value (e.g., refining a toxicity value from IRIS that may be 
10 years out of date or replacing estimated, old emissions data with 
more current and accurate data). In my written testimony, I noted a 
number of areas where EPA is moving in the right direction but needs to 
develop more complete guidelines and criteria for assessment and 
decisionmaking. For example, to reduce the uncertainties and 
limitations EPA could make a greater effort to develop and utilize 
partnerships with the regulated industries to gain access to much more 
accurate and complete emissions and other facility-specific data. The 
science of risk assessment is at a stage where it can be accurately 
used as long as appropriate assumptions, models, and data are 
incorporated. EPA has been slow to gather and incorporate these 
techniques but with encouragement from Congress and additional 
resources I believe that risk management decisions could be made that 
are realistic and supportable by the science. I have stressed that EPA 
has been assigned a most complex task. I am not criticizing EPA for 
tackling this enormous task; rather, I am offering what I hope are 
constructive approaches to ensure that decisions are made on the basis 
of sound science, not highly uncertain and perhaps incorrect portrayals 
of risk.

    Question 2b. Given that data collection is very time and resource 
consuming, how much data is enough?
    Response. I do not necessarily agree that data collection has to be 
time and resource consuming. Historically, it has not been data 
collection that has been time and resource consuming; rather, the time 
and resource consumption has been spent in figuring out the correct 
process for using the collected data in conducting risk assessments. 
For example, it took EPA 8\1/2\ years to complete and publish the 
Residual Risk Report to Congress, required in section 112(f)(1) of the 
1990 Amendments, and almost another year after that to release the 
first draft residual risk assessment. I do not believe that the delay 
was data collection; rather, it was in developing a rational and 
scientifically supportable process. I believe that EPA has now 
developed an appropriate framework for the job that needs to be done. 
However, they must go further and develop more complete guidance and 
criteria to facilitate the ultimate decisionmaking. Finally, I believe 
that the science of risk assessment is now mature enough that we know 
when we have enough data and we have uncertainty and variability 
techniques available to allow us to evaluate the quality of the data we 
have and its influence on the ultimate risk estimates and on the 
subsequent cost-benefit analyses.

    Question 3a. You indicated that EPA's first draft residual risk 
assessment resulted in risk estimates high enough that serious adverse 
human health and ecological effects would likely be easily observable. 
You go on to State that ``the lack of apparent evidence of significant 
human or ecological impacts'' showed that EPA's risk estimates were 
unrealistic. The GAO stated at the same hearing that there are serious 
gaps and limitations related to environmental data. My own experience 
with the town of Libby, MT, has suggested that routine monitoring of 
the incidence of public disease is inadequate.
    Given this, are we really in a position to see the ``apparent 
evidence of significant human or ecological impacts'' to which you 
refer?
    Response. I agree that in many instances it is difficult to measure 
the incidence of public disease. This is most difficult when the 
incidence of disease resulting from a specific environmental exposure 
is not significantly different from normal. The tools of epidemiology 
often are not accurate enough to detect significant impacts because of 
limitations such as small population size and the presence of many 
confounding exposures. However, because of the assumptions and methods 
used, EPA's case study assessment predicted risks in some cases that 
were so high that serious impacts would almost have to have been 
observed; for example, the predicted levels of some toxicants were so 
high that fish would not have survived. Such toxicity impacts in 
surface waters should be observable. I recommended several actions to 
prevent a reoccurrence of this. First, EPA should perform a sensitivity 
analysis and identify the risk drivers. Then it should reassess its 
assumptions and methods related to these factors and select ones that 
are more scientifically supported. Second, EPA should evaluate the 
results of its calculations and determine whether the results are 
realistic and make sense. Finally, EPA should conduct more complete 
uncertainty and variability analyses to better understand in the 
estimated quantities the lack of precision due to imperfect science and 
the natural variability of the parameters in nature. In summary, I am 
not suggesting a process of verifying risk based on observations, but 
rather on applying good scientific principles in an iterative process. 
First, resources can be conserved by performing upper-bound screening 
level assessments. Second, for those circumstances where the risks 
appear to be significant, identify the most significant parameters and 
attempt to improve the scientific basis for these parameters and, 
consequently, the outcome of the risk assessment. One check to inspect 
whether or not risk assessment outcomes are realistic is to compare the 
predicted levels of exposures with toxicity thresholds. Where levels 
are predicted to be exceedingly high, relative to these thresholds 
(e.g., approaching or above fish toxicity values), one can question 
whether fish kills have been observed.

    Question 3b. Is there ``evidence'' or data that disprove EPA's 
estimates?
    Response. EPA typically does not identify specific facilities in 
their risk assessments, and industry is reluctant to have specific 
risks ascribed to specific facilities. Rather, EPA relies generally on 
model plants (i.e., composites serving as average examples of groups of 
typical industry facilities). Thus, it is generally not possible to 
seek specific evidence or data near specific facilities to disprove the 
estimates because those facilities have not been identified. Our 
conclusions on EPA's case study were based on the collective many years 
of risk assessment experience of myself and my colleagues, and the fact 
that some of EPA's estimates were so high as to be well beyond the 
normal distribution and, thus, likely to be observable. In cases where 
the hazard index is exceeded at the upper bound by 60 fold, if the 
risks are real, effects should be observable. Such predicted high 
exceedances are rare but in this case, EPA also noted that the risks 
are highly uncertain because of uncertainties about fugitive emissions. 
It is in these circumstances that the scientific basis for the risk 
assessment must be refined before informed decisions can be made.

    Question 4. I would be interested in your thoughts on what problems 
would likely be encountered, and how successfully we would likely be, 
if we attempted to perform a national comparative risk assessment in 
order to set EPA's budget or regulatory priorities.
    Response. I absolutely support establishing regulatory priorities 
on a more scientifically supported risk basis and I believe strongly 
that this can be realistically accomplished using today's risk 
assessment science. EPA began its first comparative risk assessment in 
the mid-1980's, but to the best of my knowledge that assessment was 
largely exploratory in nature and necessarily utilized available 
methods and data. Thus, it was almost certainly doomed to failure 
because the methods and data available at that time were inadequate to 
consider and compare the many complex issues, issues such as multiple 
pathway exposures, ecological risks, population risks, non-carcinogenic 
risks, and others. I also seem to recall that the study was conducted 
with no substantial added resources to attempt to gather better data or 
to develop better methods.
    However, the conduct of a comparative risk assessment is possible 
today, given appropriate direction and resources. A significant amount 
of data would need to be gathered and methods need to be refined to 
properly focus on the task but, as I noted earlier, I believe that the 
science of risk assessment is currently at a level that can effectively 
help us set regulatory priorities.

    Question 5a. I understand that you have been critical of the EPA 
and the data it chooses to use for its analyses.
    Do you agree with the SAB's suggestion that, in the interest of 
``sound science,'' when industry has data or analyses to inform these 
risk assessments, industry should provide that information to the 
Agency?
    Response. I want to make it very clear that my comments on EPA's 
case study were not intended as a criticism of the Agency and its 
regulatory process. Given the available resources and time pressures, I 
believe the Agency did the best that it could and I have been very 
careful to point out that EPA has been assigned a most complex task 
that has not been tackled before. My comments were more directed at the 
broader issue of ``how can we better evaluate risk and use that 
information to make the best decisions to protect the public health and 
the environment, taking into account social and economic costs?'' In 
other words, it is not possible to regulate everything indiscriminately 
and it may be unnecessary. It is important to identify real risks and 
assure that public health and environmental protection is appropriate 
and adequate. Sound risk assessments are necessary to properly inform 
the process. I provided the SAB with a number of recommendations, many 
of which I repeated in my testimony. Importantly, I fully support the 
SAB's suggestion that industry needs to be more involved to help 
facilitate the collection and use of the best data and to share 
facility-specific information that is helpful to this challenging task.

    Question 5b. Is this what you meant by ``outside partnerships'' in 
your testimony?
    Response. Yes. Industry has historically been involved in reviewing 
and commenting upon EPA's regulatory packages. EPA also regularly seeks 
emissions and source characterization information through information 
collection requests (ICRs). However, EPA is limited in the number of 
facilities to which it can send ICRs and industry has a natural 
reluctance to ``open its books'' for regulation development to an 
Agency that also has enforcement oversight. However, I believe that EPA 
and industry must both decide to work together in partnership if 
realistic and scientifically supported regulatory decisions are to be 
made. Without these partnerships, I believe there will be gaps in 
knowledge (e.g., in data exchange, facility operations, or other 
factors where information and data exists but may not find their way 
into the risk assessment process). Where EPA has not used the best 
information available as a basis for its decisions, it is highly likely 
that legal remedies will be sought. It is clearly more effective to 
have a cooperative and well-informed process rather than a distrustful 
one where the best available information is shared and dissected during 
legal proceedings.

    Question 6a. In your written testimony, you indicated that it is 
not in the Nation's best economic interest to force needless 
expenditures when residual risks are not excessive.
    What do you consider to be excessive?
    Response. Because I do not believe there is any ``bright line'' 
which defines an excessive risk, there is no one answer to this 
question. Risk must be looked at in its totality and include 
consideration of the type of adverse effect (e.g., cancer or non-
cancer, chronic or acute), the affected human populations (ranging from 
a few individuals to a large population), the existence of ecological 
effects, and other important factors. Each situation must be considered 
individually and appropriate risk management decisions made using all 
available information. Only in that context can a decision be made as 
to whether a risk is excessive or not.

    Question 6b. Are you referring to the cancer risks to the maximally 
exposed individual or some other test?
    Response. I noted in my testimony how EPA focused initially only on 
cancer risks to the maximally exposed individual. However, there are 
many other adverse health and ecological effects, and much more of the 
population is exposed than just that person maximally exposed. All of 
my testimony assumes that proper risk assessments must look at all 
potentially adverse effects and the total exposed population.
                               __________
      Statement of Dr. Morton Lippmann, Professor, Department of 
  Environmental Medicine, New York University School of Medicine and 
 Interim Chair, U.S. Environmental Protection Agency Science Advisory 
                                 Board
    Mr. Chairman and members of the committee, I appreciate the 
opportunity to testify on the scientific basis for, current limitations 
of, and opportunities for future improvements in quantitative risk 
assessment as a tool for environmental risk management. I'd like to 
share with you some what I've gleaned from my service on EPA's Science 
Advisory Board and as a member of the National Research Council's 
Committee on Research and Peer Review in EPA.
      defining and characterizing environmental risks and benefits
    In theory, it should be possible to engage in rational comparative 
risk analyses as a means of selecting cost-effective means for the 
protection of the public's health and our common natural environment. 
At present, however, the available knowledge base is generally too 
limited to adequately guide risk-based actions by legislators and/or by 
governmental agencies to protect and/or improve the environment. What 
we need is a strategic plan to extend the range and depth of knowledge 
for risk assessment, taking advantage of the scientific and technical 
capabilities that are advancing so remarkably in the current era. We 
also need an effective means of organizing that knowledge, effectively 
communicating it to appropriate stakeholders, and we need processes for 
the identification of socially acceptable means of risk-based 
intervention to prevent, ameliorate, and/or to reverse environmental 
degradation by more efficient and effective means.
    In other words, we must be careful to distinguish between what 
capabilities we can hope for and expect to be available in the not-too-
distant future, and what current tools can provide for us now. We must 
also recognize that advancement and refinement of our tools for 
quantitatively determining risks and benefits will not just improve on 
their own. New research resources will need to be invested to further 
develop and hone these tools. With appropriate investments in risk 
assessment research, we can look forward to ever increasing 
capabilities for more quantitative risk assessments, more definitive 
comparative risk assessments, more definitive benefit-cost analyses, 
and more efficient and effective risk management options.
    In recent years, as a result of my chairmanship of various EPA 
Science Advisory Board (SAB) Committees (Clean Air Scientific Advisory 
Committee, Human Exposure Committee, Secondary Data Use Committee, 
Environmental Tobacco Smoke (ETS) Risk Assessment Review Committee, 
Dioxin Risk Assessment Review Committee), and as my membership on the 
Steering Committees for the SAB Reports on Future Risk, Reducing Risk, 
and Beyond the Horizon, my continuing participation in the SAB Advisory 
Council on Clean Air Act Compliance Analysis (Council) reviews of the 
Benefits and Costs of the Clean Air Act, and my contributions to the 
recently completed National Research Council's Report on 
``Strengthening Science and Peer Review at the EPA'', I have become 
quite familiar with the capabilities and limitations of the predictive 
models and of environmental and epidemiological data bases available at 
EPA for risk and benefits assessments. In this regard, I have come to 
recognize that EPA is heavily dependent on its predictive models for 
exposure and risk estimation. Unfortunately, many of these models have 
not yet been fully validated. The adequacy of EPA's models for 
quantitative risk assessment is discussed in greater detail in the 
testimony of Dr. Philip Hopke in Panel 3.
    This hearing is focused on the capabilities and limitations of 
current knowledge and technical means of comparative risk assessment 
for guiding new legislative mandates, societal choices, and individual 
decisions based on risk avoidance. In my remarks, I will focus on 
health risks associated with exposures to airborne chemicals and 
mixtures thereof in our communities.
    In order to determine the extent of any health risk existing among 
the members of the population of concern resulting from the inhalation 
of airborne chemicals we need to know: (1) the distribution of the 
concentration of the agent in the air and, for airborne particulate 
matter (PM), the distribution of particle sizes; and (2) the unit risk 
factor, i.e., the number of cases and/or the extent of the adverse 
effects associated with a unit of exposure. For more sophisticated 
analyses, we may also need to know more about the population of 
concern, such as the distribution of ages, pre-existing diseases, pre-
disposing factors for illness, such as cigarette smoking, dietary 
deficiencies or excesses, etc.
    When basic information on ambient levels and unit risks is 
available, it is relatively straightforward to compute, tabulate, and 
compare the risks associated with the different chemicals in our 
community air. However, based on the experience gained in the Council 
Review of the Benefits and Costs of the Clean Air Act, such direct 
comparisons can, in practice, only be made with any quantitative 
reality for a handful of chemicals, i.e., the so-called criteria 
pollutants, whose ambient air levels are routinely monitored and for 
which directly measured human exposure-response relationships have been 
developed. For hundreds of other airborne chemicals, known collectively 
as hazardous air pollutants (HAPs), a.k.a. air toxics, there are 
neither extensive ambient air concentration data nor unit risk factors 
that do not intentionally err on the side of safety. This disparity has 
resulted from the different control philosophies built into the Clean 
Air Act (CAA) and maintained by the EPA as a part of its regulatory 
strategy. The rationale for the distinction is that criteria pollutants 
come from numerous and widespread sources, have relatively uniform 
concentrations across an airshed, require statewide and/or regional air 
inventories and control strategies for source categories (motor 
vehicles, space heating, power production, etc.) focused on the 
attainment of air quality standards (concentration limits) whose 
attainment provides protection to the public health with an adequate 
margin of safety. There is also a long history of routine, mostly daily 
measurements of criteria pollutant concentrations throughout the 
country.
    By contrast, HAPs sources are far fewer in number and are 
considered to be definable point sources at fixed locations. Downwind 
concentrations are highly variable, and generally drop rapidly with 
distance from the source due to dilution into cleaner, background air. 
The national emission standards for hazardous air pollutants (NESHAPs) 
are based on technologically based source controls and are intended to 
limit facility fenceline air concentrations to those that would not 
cause an adverse health effect to the (most exposed) individual living 
at the fenceline. Also, until quite recently, there has been no program 
for routine measurements of air toxics in our communities.
    Most of the unit risk factors for air toxics are based on cancer as 
the health effect of primary concern. In these studies, and in studies 
to assess noncancer effects the data are most often derived from 
controlled exposures in laboratory animals at maximally tolerated 
levels of exposure. The translation of the results of these studies to 
unit risk factors relevant to humans exposed at much, much lower levels 
in the environment is inherently uncertain, and is approached 
conservatively, following the model pioneered for food and drug safety 
beginning in the 1930's by the Food and Drug Administration (FDA). The 
resulting unit risk factors are generally based on an assumption of no 
threshold and a linear extrapolation to zero risk at zero dose. They 
are generally described in terms of being 95 percent upper bound 
confidence limits, but this descriptor is undoubtedly conservative in 
itself.
    When these conservative unit risk factors are used for the 
prediction of the consequences of human exposures, they are multiplied 
by estimates of predicted ambient air concentrations which are, 
themselves, in the almost universal absence of air concentration 
measurements, almost certainly upper bound estimates from pollutant 
dispersion models that apply to the most highly exposed individuals in 
the community.
    The resulting estimates of health risk are therefore highly 
conservative upper bound levels. Thus, they are inherently incompatible 
with population impacts estimated for the more widely dispersed 
criteria pollutants. The margins of safety for criteria pollutants are 
generally less than a factor of two, rather than the multiple orders of 
magnitude of safety factors built into the risk assessments for air 
toxics.
    The same considerations discussed above, i.e., the limitation of 
available knowledge for determining realistic unit risk levels has also 
made it virtually impossible for EPA to meet its Congressional mandate 
to determine residual risks after the imposition of technology-based 
controls of air toxics, as discussed in greater detail in the testimony 
provided to this Hearing by Dr. Philip Hopke in Panel No. 3.
    The highly conservative nature of unit risk factors for air toxics 
was well illustrated by a calculation made during work done for EPA 
during the preparation of the Congressionally mandated report on the 
Benefits and Costs of the Clean Air Act: 1970-1990. It was determined 
that the imposition of the vinyl chloride NESHAP had prevented 6,000 
cases of cancer. Vinyl chloride is a known human carcinogen that 
produced a very rare tumor (angiosarcoma of the liver) in highly 
exposed vinyl chloride production workers. The handful of cancers 
observed among these workers was not large in relation to overall 
cancer incidence, but this particular tumor was such a rare one that 
even the first few cases that were observed among a group of vinyl 
chloride production workers were sufficient to establish a causal 
relation. Since the calculated cancer incidence reduction was 
considerably larger than the historic incidence level for this cancer, 
it was obvious that the benefit claimed for the imposition of the 
NESHAP was grossly exaggerated.
    The lack of any alternative quantitative approach to the 
quantitative estimation of health effects due to exposure to air toxics 
has left EPA with no viable option for the realistic estimation of 
population impacts. With prodding from the SAB Council, the Agency has 
recognized the need to develop one. That effort is now underway, 
through EPA and SAB sponsorship of a first Workshop (June 22 and 23, 
2000) in a series designed to address the issue directly. Extension of 
this initiative would lead to the development of a capability to 
produce more unbiased predictions of the health consequences of HAPs 
exposures for benefits assessments.
    In the meantime, EPA needs to undertake a public education program 
about the essential nature of its widely distributed and commonly used 
unit risk factors. This is especially urgent in view of its recent 
initiative to support a nationwide network of routine air quality 
monitoring stations for a large number of representative air toxics. 
Pilot studies have already demonstrated the multiplication of measured 
levels times the current unit risk factors suggest that urban dwellers 
are at lifetime risks of excess cancer greater than one in a thousand. 
Exaggeration of risks pertaining to the general public could produce a 
considerable problem for EPA in its communication to the public, and 
could lead to a loss in its credibility.
    Comparative risk analysis, as currently practiced, has other 
inherent limitations as well. Even when we can reasonably and reliably 
estimate the exposure-related numbers of cases of premature mortality, 
hospital admissions, other uses of medical, clinical and pharmaceutical 
drug resources, lost time from work or school, reduced physiological 
and functional capacities, we face daunting societal equity and 
valuation challenges in inter-comparing numbers of incident cases of 
quite variable clinical severity and psychological impacts. For 
carcinogenic agents, it has become customary to expect regulations to 
be effective in limiting the risks of lifetime exposures to no more 
than one-in-ten thousand and often to less than one-in-a-million. For 
less dreaded diseases that also reduce lifespan, such as chronic 
obstructive pulmonary disease and heart attack, which also are 
exacerabated by air pollutant exposures, a much higher risk level has 
been considered acceptable by regulators and the public. By contrast, 
economists do not make such a drastic distinction. EPA's recent White 
Paper on the economic valuation of cancer mortality concluded that the 
economic literature did not provide a basis for a greater benefit for a 
prevented cancer death than for other causes of premature deaths.
    The National Research Council (NRC) committee that issued its 
report on ``Strengthening Science and Peer Review at EPA'' was well 
aware of the current limitations of comparative risk assessment when it 
concluded that:

          Scientific knowledge and technical information are essential 
        for determining which environmental problems pose important 
        risks to human health, ecosystems, the quality of life, and the 
        economy. We need scientific information to avoid wastefully 
        targeting inconsequential risks while ignoring greater risks. 
        We need such information to reduce uncertainties in 
        environmental decisionmaking and to help develop cost-effective 
        strategies to reduce risk. We need science to help identify 
        emerging and future environmental problems and to prepare for 
        the inevitable surprises.

    The quotation above provides a good part of the background that led 
to the key recommendations of the NRC Report regarding the management 
and use of science in regulatory programs, and the need for and Agency 
management of its own research program to fill key gaps in our current 
abilities to quantify risks. Focus on this need should be a priority 
for the recommended position of Deputy Administrator for Science in 
EPA. This individual should have the background and judgment essential 
to ensure that current risk-related knowledge is appropriately used to 
develop, describe, and guide scientific input into regulations, and to 
ensure communication of the knowledge gained by the regulatory programs 
in terms of further research needs for risk assessment and risk 
management. The Deputy Administrator for Science could also provide 
oversight for EPA's new Office of Information in regard to facilitating 
more data entry into and wider access to and usage of EPA's 
environmental monitoring data sets that are now seldom used for 
secondary data analysis and/or model validation.
    The NRC Report also concluded that research on risk assessment and 
risk management was not only needed, but needed to be conducted by EPA, 
since no other Federal agency had the mandate, need, or desire to 
conduct such research.
    Finally, it should be recognized that research on risk assessment 
and risk management needs to be a long-term core component of EPA's 
research program. Core research needs stability, a feature which has 
not been a hallmark of EPA's Office of Research and Development (ORD). 
Tenure for a Presidentially selected and Senate confirmed Assistant 
Administrator (AA) for ORD has been 3 years or less, and Acting AAs for 
ORD have occupied the position for about half of the whole history of 
EPA. Thus, the NRC Report recommended that the position be changed to a 
6-year term-appointment, with the AA selected for expertise in both 
science and research management. This change would help to ensure the 
primacy of a longer term view of research goals focused on EPA's unique 
role as a regulatory agency that relies strongly on sound science to 
guide the formulation of its standards, guidelines, and cost-effective 
risk management.
    The differences in EPA's current abilities to make estimates of 
health risks for air toxics on the one hand and estimates of benefits 
resulting from its successes in source controls on the other, while 
notable and unfortunate, are remediable, and the research needed to 
overcome the current deficiencies should be given a high priority. The 
ORD has come a long way in recent years in terms of its development and 
updates on its strategic plan, its inventory of science activities and 
capabilities through the Agency, its closer coordination with research 
programs in NIH, NSF, and CDC, and its shift of resources toward an 
extramural grant program in which EPA's research needs are met, in 
part, through individual investigator-initiated proposals that address 
critical information needs identified in Requests for Applications. It 
will also soon occupy new state-of-the-art research facilities in 
Research Triangle Park, NC that will enhance its capabilities.
    In summary, our current abilities to determine residual risks of 
air toxics and to compare risks quantitatively are quite limited by key 
gaps in knowledge, and by reliance on unvalidated predictive models for 
exposure and for dose-response. A major part of the problem is the 
existence of two very different cultures of risk assessment: (1) for 
carcinogens; and (2) for other toxicants. Carcinogen risk assessments 
seldom have been based on relevant data on either low-dose exposure on 
human exposure-response data at concentrations anywhere near ambient 
levels. They require high-dose to low-dose extrapolations and generally 
animal-to-human extrapolations as well, using unvalidated predictive 
models. In the face of such a high degree of uncertainty in the output 
of the models, conservative assumptions are used to ensure that potency 
and exposures are not underestimated. Thus, yields of risk estimates 
are almost always far higher than the real risks. Such risk estimates 
cannot be fairly compared to the risks associated with criteria air 
pollutants, which are determined largely from the product of measured 
air pollutant concentrations and measured responses among humans 
exposed to either ambient air or to controlled exposures in chambers. 
Fair comparisons can only be done within the separate categories of 
pollutants.
    Comparative risk assessment is an idea whose time is coming, and if 
EPA is provided with appropriate research resources to harness the new 
technical approaches and sophisticated research tools now emerging to 
fill in key knowledge gaps, it can make comparative risk assessment 
more useful and feasible in the not-too-distant future. If the 
recommendations in the NRC ``Strengthening Science at EPA'' report are 
adopted, the prospects for such advances would be greatly improved. In 
the meantime, the resources now dedicated to performing comparative 
risk assessments would be more productively employed if redirected to 
improving the technology for quantitative risk assessment and for 
filling key knowledge gaps that have been identified in the analyses 
already performed.
    Dr. Hopke, in his testimony in the next panel will address the 
major knowledge gaps limiting EPA's ability to perform the residual 
risk assessments mandated for HAPs in the 1990 Clean Air Act 
Amendments, even for an industrial sector like secondary lead smelters 
that is relatively data-rich. In my view, we should celebrate the 
success of the application of the best available technology approach in 
greatly reducing emissions and ambient concentrations of air toxics and 
limit the use of quantitative risk analyses of residual risks to the 
screening out of deminimus risks.
    Finally, I encourage the Congress to implement the legislative 
changes needed for the creation of the new position of Deputy 
Administrator for Science in EPA and for transforming the position of 
Assistant Administrator for Research and Development in EPA to a 6-year 
term appointment. These changes will help ensure institutional 
stability and a more long-term framework for core research. I also 
encourage Congress to consider explicitly giving EPA a mission 
statement that includes the performance of a long-term research program 
as a means of enhancing its capabilities for effective and efficient 
stewardship of its environmental responsibilities.
    In closing, I want to thank the committee for inviting me to 
testify on these important issues related to scientific aspects of 
environmental risks and on opportunities to improve the practice and 
utility of risk assessment and risk management.
                                 ______
                                 
Dr. Morton Lippmann, Acting Chair,
Science Advisory Board (1400A),
U.S. Environmental Protection Agency,
Washington, DC.
    Dear Dr. Lippmann: Thank you for your letter of May 19, 2000, 
transmitting the Science Advisory Board (SAB) Advisory on the Draft 
Agency Case Study Analysis of the Residual Risk of Secondary Lead 
Smelters (EPA-SAB-EC-ADV-00-005). During the review of the Residual 
Risk Report to Congress in August 1998, the Science Advisory Board 
requested that the Environmental Protection Agency (EPA) provide an 
example residual risk assessment for its evaluation. We submitted our 
draft assessment of the secondary lead smelter source category and 
would now like to respond to your letter transmitting the SAB advisory 
for this case study.
    The purpose of seeking an SAB advisory was to get feedback on the 
methodologies EPA will use to assess residual risks and the application 
of those methods to a specific source category. We asked the SAB to 
comment on: (1) the appropriateness of the methods used, given the 
currently available methods; and (2) the appropriateness of the 
application of those methods. We sought SAB feedback early in our 
residual risk assessment process in order to be able to apply the 
advice received to other risk assessments under the residual risk 
program which, due to statutory requirements, needed to be started 
soon.
    This draft case study does not include all risk assessment 
components needed to make a regulatory decision under the Residual Risk 
program (e.g., an assessment of population risks). Because of this, we 
agree with the SAB that peer review of the final complete assessment is 
needed. We intend to seek such a review in 2001.
    We are pleased that the reviewers recognize that methods used in 
this case study assessment are consistent with the methods described in 
the Residual Risk Report to Congress, that the assumptions used are 
consistent with current methods and practice, and that the models used 
for the air pathway are the most appropriate for the task. Our response 
to additional comments and recommendations highlighted in your review 
are enclosed.
    This SAB advisory will help us design the final iteration of the 
secondary lead smelter risk assessment. We are also applying your 
advice to the other risk assessments we are required to conduct under 
the residual risk program. Thank you for your assistance.
            Sincerely,
                                          Carol M. Browner.
                                 ______
                                 
                               Attachment
  Responses by Environmental Protection Agency to Additional Comments 
                    from the Science Advisory Board
    Comment. Population risk estimates are lacking from the case study.
    Response. EPA will include an assessment of population risks in the 
final iteration of the assessment, following the method we outlined in 
the draft case study.

    Comment. Ecological screen is adequate but refined ecological risk 
assessment is lacking, as are the methodologies.
    Response. EPA did not present a more refined ecological risk 
assessment in the draft case study, as we have not yet completed 
development of a refined ecological risk assessment methodology for the 
residual risk program. We are working to develop a refined methodology 
and will use our most current methodology in the final iteration of the 
secondary lead smelter risk assessment.

    Comment. Uncertainty and variability analysis should be fully 
integrated into all phases of the assessment, not just an auxiliary 
analysis after the deterministic assessment.
    Response. EPA agrees with the Science Advisory Board that 
integrating uncertainty and variability analysis into the overall 
assessment rather than conducting it as an add-on analysis of the 
deterministic results is important. EPA is incorporating that advice 
into our assessments. We are conducting uncertainty and variability 
analyses at each phase of the assessment to determine how assumptions 
are supported by the data, and what the implications are for each 
assumption. While there is no consensus among experts on a methodology 
to conduct uncertainty and variability analysis, we will continue to 
seek out experts and use methods which are appropriate to the task.

    Comment. The model used for multimedia fate, transport and multi-
pathway exposure assessment, the Indirect Exposure Methodology (IEM) 
has several limitations, and has not been sufficiently evaluated. 
Results should be viewed with informed caution and results ground-
truthed against available data. TRIM is seen as major improvement.
    Response. EPA recognizes the importance of evaluating models and 
ground-truthing the results of the models we use in support of 
regulation. EPA intends to evaluate model inputs and ground-truth 
results to the extent data are available. (Data were not readily 
available on the four facilities we evaluated but may be available for 
others; for other source categories, such information maybe more (or 
less) available.). EPA will ensure that the limitations and 
uncertainties of IEM outlined by the SAB are clearly articulated to the 
risk managers. We agree that TRIM will generally be an improvement 
relative to IEM. We look forward to further comments on our approach to 
multimedia modeling in the peer review of the completed assessment.

    Comment. There is insufficient explanation about the interface 
between risk assessment and risk management; without this context it is 
difficult to adequately review the assessment.
    Response. EPA will explain more about the Residual Risk program 
mandate and its approach to risk management in the final iteration of 
the assessment. We will specifically describe how the risk assessment 
feeds into the risk management process.

    Comment. There is incomplete toxicity data on some HAPs and the 
data in Integrated Risk Information System (IRIS) may be seriously out 
of date for others.
    Response. EPA is not limited to using data within IRIS. EPA has 
identified a number of additional peer reviewed data sources, from 
which relevant information can be obtained. These data sources include 
peer reviewed data bases developed by the Agency for Toxic Substances 
and Disease Registry and California EPA. The SAB concurred with our use 
of the data from these sources, which allow EPA to both assess HAPs for 
which assessments are not currently available on IRIS and to consider 
information from other sources that may be more current and relevant 
than that available on IRIS. HAPs with no assessments on IRIS or 
elsewhere receive priority in our yearly list of IRIS assessment 
starts. Additionally, we are carefully considering the SAB's 
recommendation to develop interim methods for assessing HAPs without 
available assessments.
                                 ______
                                 
 Responses by Morton Lippman to Additional Questions from Senator Smith
    Question 1. In your testimony, you stated that ``comparative risk 
assessment'' is an idea whose time is coming. For this to happen, 
according to your testimony, EPA has to harness the new technical 
approaches and research tools to fill in key knowledge gaps. Why is it, 
in your opinion, that EPA has not taken a more aggressive approach to 
fill those gaps?
    Response. The EPA's research program has developed and refined a 
research. strategy in recent years that includes an increased emphasis 
on long range generic needs such as quantitative risk assessment. Also, 
it is about to open its new state-of-the-art research facility in 
Research Triangle Park, NC, which will give it the capacity for 
applying new research tools. The basic problems that have limited EPA's 
progress in addressing the knowledge gaps in this area have been 
reviewed recently by the National Research Council in their report 
entitled ``Strengthening Science at the U.S. Environmental Protection 
Agency''. These problems include:
     Lack of a core focus on the art and science of risk 
assessment. The NRC report stated that ``The Assessment Center should 
focus on being a research organization dedicated to advancing the State 
of practice in risk assessment, not a performer of individual risk 
assessments that could be done by EPA's regulatory offices'' (NRC 
Report: p. 85).
     The NRC Report noted the absence of published strategic 
and management plans for the ORD Laboratories and Centers. Strategic 
planning has, so far, been a ``top-down'' effort that is only partially 
effective. The NRC panel expressed concern that ORD has not yet 
provided adequate delegation of opportunities for leadership and 
accountability throughout the organization (NRC Report: p. 68).
     Staff Resources. The NRC reported noted the aging of the 
ORD staff and the Agency's difficulties, in the face of periodic job 
freezes and personnel ceilings, in recruiting new talent with 
appropriate background and training for new challenges.
     Funding. ORD capacity to meet new scientific challenges is 
constrained by living within an overall budget that is essentially 
flat, at best, in terms of purchasing power, and strained, in terms of 
flexibility, by an increasing level of earmarks for projects that have 
not been appropriately peer-reviewed.
    The NRC Panel's recommendations, if implemented, could greatly help 
EPA to better address these problems. For example, a principal 
responsibility of the new Deputy Administrator for Science and 
Technology would be to ``Ensure that the most important scientific 
issues facing EPA are identified and defined, including those embedded 
in major policy or regulatory proposals'' (NRC Report: p. 130).
    The NRC Panel's recommendation that ORD make a concerted effort to 
give its research managers a high degree of flexibility and 
accountability (NRC Report: 
p. 133) could empower the director of the Assessment Center in ORD to 
mount a concerted and sustained effort to create and manage a core 
research program on the art and science of risk assessment as part of 
the Center's own strategic plan.

    Question 2. You testified that EPA overestimates health risk for 
air toxics. Exaggerating risk when managing environmental programs is 
counterproductive and a disservice to the public. Conservative 
assessments have a place, but consistent excessive conservatism is 
misleading. Resources that could be used to address neglected 
environmental problems would instead be used to address problems whose 
risks are exaggerated. When there are critical data gaps, and obsolete 
analytical tools, the effectiveness of programs and progress cannot be 
measured objectively. Please explain what the SAB is doing to ensure 
that EPA understands the significance of the problems you identified.
    Response. EPA has established Risk Assessment Guidelines that have 
been reviewed and endorsed by SAB. These Guidelines have been 
recognized as having a conservative bias by both EPA and SAB, i.e., in 
the face of uncertainties involved in having to rely on the limited 
data bases in the literature, they have incorporated reliance on 
substantial margins of safety. The objective has been to be protective 
of public health. Furthermore, the more limited the data base, the 
greater the overall margin of safety tends to be. In fact, the Food 
Quality Protection Act has mandated that when adequate data 
establishing that children are not more sensitive than adults, then an 
additional tenfold safety factor be used in assessing risks related to 
the food supply.
    The problem of excessive conservatism that you address in the above 
listed question arises when the EPA risk assessors believe that they 
have no other option than to use reference doses or reference 
concentrations and their established technique for modelling exposures 
(that are also inherently conservative) to: (1) develop quantitative 
estimates of risks; or (2) to compare the various risks to public 
health caused by exposures to environmental chemicals. They do not, and 
in reality cannot, know how conservative their calculated risks really 
are in each case. The problem is compounded when comparing risks using 
risk coefficients of varying ages prepared under various historic 
versions of the Risk Assessment Guidelines.
    SAB has recently taken several initiatives to call this problem to 
the attention of EPA. Our Advisory on the USEPA's Draft Case Study 
Analysis of the Residual Risk of Secondary Lead Smelters (EPA-SAB-EC-
ADV-00-005) was dated May 2000, and our followup letter to the 
Administrator (Executive Committee Commentary on Residual Risk 
Program--EPA-SAB-ECCOM-00-005, dated July 25, 2000), put the concerns 
we had about this issue in a broader context. (A copy of this brief 
letter Commentary is attached.) Another example is the initiative taken 
by the SAB's Advisory Council on Clean Air Act Compliance Analysis 
(Council), in cooperation with EPA, to conduct multidisciplinary 
Workshops focused on the development of techniques for establishing 
best estimates of human exposures and risk coefficients that can be 
used to obtain more realistic health benefits for benefit-cost analyses 
(EPA-SAB-COUNCIL-ADV-00001, dated Oct. 29, 1999). In its advisory role 
on the performance of both the 1970-1990 retrospective analysis and the 
1990-2010 prospective analysis of the benefits and costs of the Clean 
Air Act performed by EPA, the Council agreed that substantial health 
benefits accrue to controls on criteria pollutants, most notably for 
controls on particulate matter and lead, where credible risk factors 
and population exposures are well established. On the other hand, such 
benefits could not be established for the controls imposed on the 
emissions of air toxics. The first Workshop, focused on Benefits of 
Reductions in Exposure to Hazardous Air Pollutants: Developing Best 
Estimates of Dose-Response Functions, was held on June 22 and 23, 2000 
The second Workshop, focused on the Distribution of Human Exposures, is 
planned for early next year. Through these Workshops, the groundwork is 
being laid for what could become a new and more realistic paradigm for 
quantitative risk assessment. This is what I had in mind when I stated 
that ``comparative risk assessment is an idea whose time is coming.

    Question 3. You testified that a major part of the problem with the 
current EPA risk assessment stems from having 2 very different cultures 
of risk assessment: (1) for carcinogens and (2) for other toxicants. 
Please describe what SAB is doing to remedy this problem.
    Response. My response to this question can be found in my response 
to Question 2, in terms of the SAB advisories and commentaries cited 
therein.
                                 ______
                                 
                      U.S. Environmental Protection Agency,
                                     Washington, DC, July 25, 2000.
EPA-SAB-EC-COM-00-005

Hon. Carol M. Browner, Administrator,
U.S. Environmental Protection Agency,
Washington, DC.

Subject: Executive Committee Commentary on Residual Risk Program

    Dear Ms. Browner: The Executive Committee (EC) of the Science 
Advisory Board (SAB) is writing to alert you to potentially significant 
issues arising from with the Agency's efforts to implement the residual 
risk requirements of the Clean Air Act Amendments of 1990.
    In 1998, the SAB sent you a report (EPA-SAB-EC-98-013) on its 
review the Agency's Report to Congress on the methodology to be used in 
assessing the residual risks associated with the post-Maximum 
Achievable Control Technology (MACT) emissions of hazardous air 
pollutants (HAPs) from 174 source categories across the country. The 
Board endorsed the Agency's plan but identified the need to see the 
methodology applied to a specific case in order to determine whether 
the methodology was viable in practice, as well as in principle.
    This spring, the SAB reviewed an Agency interim work product that 
indicates how the Office of Air and Radiation (OAR) plans to implement 
this methodology in practice. The results of that review were sent to 
you in May in the ``Advisory on the USEPA's Draft Case Study of the 
Residual Risks of Secondary Lead Smelters'' (EPA-SAB-ECADV-00-005). In 
short, the Board found that the Agency has made a good faith start in 
using the methodology to assess the residual risks from this source 
category but went on to cite significant scientific problems that raise 
serious concerns about the potential for the Residual Risk Program, as 
currently conceived, to successfully achieve its goals. In particular, 
we understand that secondary lead smelters were selected as the first 
HAPs source category for the residual risk exercise, in part, because 
it contains a limited number (24) of facilities, and because it has a 
large monitoring data base, compared to most of the other 173 source 
categories. In light of the relatively favorable knowledge base for 
this case study and the quite limited success that it has achieved to 
date, the SAB believes that the large number of data-poor categories 
will prove to be even more intractable to this type of analysis than 
the secondary lead smelter category has been shown to be to date. In 
summary, it is not clear that scientific analysis will be able to 
generate the type of information envisioned in the CAAA. While 
decisions can be made in the absence of such scientific information, 
they will not be sufficiently precise for the intended purpose.
    While our concerns may turn out to be ill-founded, we recommend 
that the Agency and Congress seriously re-consider the current Clean 
Air Act Amendments mandates and their implementation strategy that 
depends on scientific analyses that will be resource-demanding, at a 
minimum, and, quite possibly, impossible to carry out in a credible 
manner.
    In summary, while we certainly endorse the concept of science-based 
decisionmaking at the Agency, we also recognize that no one is well 
served by asking science to take on an impossible task.
    We would look forward to meeting with Agency leaders and 
Congressional personnel to discuss these concerns and what might be 
done about them.
            Sincerely,
                               Dr. Morton Lippmann,
                                             Interim Chair,
                                            Science Advisory Board.
                                 ______
                                 

U.S. Environmental Protection Agency, Science Advisory Board, Executive 
                           Committee FY-2000

                             interim chair
    Dr. Morton Lippmann, Professor, Nelson Institute of Environmental 
Medicine, New York University School of Medicine, Tuxedo, NY
                                members
    Dr. Henry A. Anderson, Chief Medical Officer, Wisconsin Division of 
Public Health, Madison, WI
    Dr. Richard J. Bull, MoBull Consulting, Inc., Kennewick, WA
    Dr. Maureen L. Cropper, Principal Economist, DECRG, The World Bank, 
Washington, DC
    Dr. Kenneth W. Cummins, Senior Advisory Scientist, California 
Cooperative Fishery Research Unit and Adjunct Professor, Fisheries 
Department, Humboldt State University, Arcata, CA
    Dr. Linda Greer, Senior Scientist, Natural Resources Defense 
Council, Washington, DC
    Dr. Hilary I. Inyang, University Professor and director, Center for 
Environmental Engineering, Science and Technology (CEEST), University 
of Massachusetts Lowell, Lowell, MA
    Dr. Janet A. Johnson, Senior Radiation Scientist, Shepherd Miller, 
Inc., Fort Collins, CO
    Dr. Roger E. Kasperson, University professor and director, The 
George Perkins Marsh Institute, Clark University, Worcester, MA
    Dr. Joe L. Mauderly, director & senior scientist, Lovelace 
Respiratory Research Institute, Albuquerque, NM
    Dr. M. Granger Morgan, Head, Department of Engineering & Public 
Policy, Carnegie Mellon University, Pittsburgh, PA
    Dr. William Randall Seeker, Senior Vice President, General Electric 
Energy and Environmental Research Corp., Irvine, CA
    Dr. William H. Smith, Professor of Forest Biology, Yale University, 
New Haven, CT
    Dr. Robert N. Stavins, Albert Pratt Professor of Business and 
Government, Faculty Chair, Environment and Natural Resources Program, 
John F. Kennedy School of Government, Harvard University, Cambridge, MA
    Dr. Mark J. Utell, Professor of Medicine and Environmental 
Medicine, University of Rochester Medical Center, Rochester, NY
    Dr. Terry F. Young, Senior Consulting Scientist, Environmental 
Defense Fund, Oakland, CA
       liaison for childrens health protection advisory committee
    Mr. J. Thomas Carrato, Assistant General Counsel, Regulatory 
Affairs, Monsanto Company, St. Louis, MO
                   liaison for science advisory panel
    Dr. Ronald Kendall, director & professor, The Institute of 
Environmental & Human Health, Texas Tech University/Texas Tech 
University Health Sciences Center, Lubbock, TX
             liaison for ord board of scientific counselors
    Dr. Jerald L. Schnoor, Professor of Civil Environmental 
Engineering, Iowa University, Iowa City, IA
                      science advisory board staff
    Dr. Donald G. Barnes, Staff Director/Designated Federal Officer, 
Environmental Protection Agency, Science Advisory Board (1400A),1200 
Pennsylvania Avenue, NW, Washington, DC 20460
    Ms. Priscilla Y. Tillery-Gadson, Program Specialist, Environmental 
Protection Agency, Science Advisory Board (1400A),1200 Pennsylvania 
Avenue, NW, Washington, DC 20460
    Ms. Betty B. Fortune, Office Assistant, Environmental Protection 
Agency, Science Advisory Board (1400A),1200 Pennsylvania Avenue, NW, 
Washington, DC 20460
                                 notice
    This report has been written as part of the activities of the 
Science Advisory Board, a public advisory group providing extramural 
scientific information and advice to the Administrator and other 
officials of the Environmental Protection Agency. The Board is 
structured to provide balanced, expert assessment of scientific matters 
related to problems facing the Agency. This report has not been 
reviewed for approval by the Agency and, hence, the contents of this 
report do not necessarily represent the views and policies of the 
Environmental Protection Agency, nor of other agencies in the executive 
branch of the Federal Government, nor does mention of trade names or 
commercial products constitute a recommendation for use.
    Distribution and Availability.--This Science Advisory Board report 
is provided to the EPA Administrator, senior Agency management, 
appropriate program staff, interested members of the public, and is 
posted on the SAB website (www.epa.gov/sab). Information on its 
availability is also provided in the SAB's monthly newsletter 
(Happenings at the Science Advisory Board). Additional copies and 
further information are available from the SAB Staff.
                                 ______
                                 
       Responses by Morton Lippmann to Additional Questions from 
                             Senator Baucus
    Question 1. In your testimony, you say that, at present, ``the 
availability knowledge base is generally too limited to adequately 
guide risk-based actions by legislators and/or by government 
agencies.'' In the context of a national comparative risk assessment to 
define EPA's budget and regulatory priorities, do you mean that it is 
currently not possible to conduct a comparative risk assessment for 
such a purpose?
    Response. If your question refers to a comprehensive comparison, 
then the answer is yes. However, it is important to recognize that 
reasonably realistic assessments are possible. For example, it is 
generally possible to distinguish the truly large risks from those that 
are considerably smaller. Also, assessments have been made for the 
category of criteria air pollutants. For these pollutants, appropriate 
investments in exposure, risk, and benefits analyses have been made by 
EPA, and the results are evident in the reports on the Benefits and 
Costs of the Clean Air Act. However, such investments have not been 
made for the category of air toxics and, without the data bases that 
flow from such investments, credible comparative risk assessments are 
not possible.
    At the same time substantial impediments will remain that cannot be 
``solved'' by science. For example, social values--not science--must 
guide how one weighs health vs. ecologic risk and risks to children vs. 
risks to adults.

    Question 2. Since it is basic to risk assessment, what is the 
appropriate way for the committee to decide what is ``good science'' 
and what is not?
    Response. Science is a method of inquiry that generates data that 
are available in the intellectual market place for all interested 
parties to buy or not to buy. Its reliability and appropriate usage in 
scientific analyses is policed by the process of peer-review which, 
while not infallible, is generally regraded as a stamp of credibility. 
The usage of scientific information in the formulation of environmental 
risk assessments, standards, and benefits analyses is the issue here. 
The basic question is: Has the analysis of scientific data base in the 
peer-reviewed literature been comprehensive and objective, and has that 
data base been used in a credible and appropriate manner? Here also, 
appropriate peer review is the key to the usage of scientific 
information for ``good'' or ``bad'' ends. The Science Advisory Board 
(SAB) has long been a reliable arbiter of such usage, but it cannot 
review all such usage in an Agency as large and complex as EPA. 
Therefore, it is fortunate that EPA has, in recent years, made 
considerable progress in organizing and using other appropriate 
mechanisms for scientific peer review of its products. This encouraging 
progress was noted by the National Research Council (NRC) in its recent 
report ``Strengthening Science at the U.S. Environmental Protection 
Agency''. Adoption of the recommendation in the NRC report for the 
creation of the position of Deputy Administrator for Science and 
Technology at EPA would further advance the Agency's ability to defend 
its ``good'' usage of science.

    Question 3. Clearly, science is needed to inform decisionmaking. 
But, in your opinion, is there also a role for non-scientific 
considerations, such as societal values, in informing decisions on the 
risk rankings and priorities that are developed from a comparative risk 
assessment?
    Response. Clearly, the simple answer to your question is yes. All 
risks are not of equal consequences, and risk management options may 
involve other risks than the one being controlled. Consideration can 
and should be given to balancing benefits and costs. The SAB has 
recognized that policy decisions, which must recognize societal factors 
in addition to the physical and biological sciences, need to be made by 
properly constituted authorities. The SAB has been expanding its range 
of expertise by involving social scientists, in order to incorporate 
the data and technique of their fields to inform the decisionmaking 
process. At the same time, the SAB has been careful not to cross the 
science-policy interface in its recommendations to the Agency.

    Question 4. In your oral testimony, you talked about the 
conservative nature of EPA's risk assessments for HAPs. I would like to 
clarify my understanding of your comments on this point. You appeared 
to indicate that the reason that EPA uses conservative assumptions, 
such as safety factors, is because as we learn more about HAPs in the 
future it could be found that some of the chemicals are as toxic as 
predicted by the risk assessments made using the current models. 
Therefore, the convention is that, in order not to underestimate the 
potential risk associated with these HAPs, conservative assumptions are 
applied to risk estimates of all HAPs. Is this a correct interpretation 
of your testimony on this point?
    Response. Yes.

    Question 5. In the panel on residual risk, many concerns were 
expressed about EPA's draft case study on residual risk assessment for 
secondary lead smelters. This seems to be the fate of many, if not 
most, risk assessments. In fact, it often seems that every time a risk 
assessment is done these days--whether it is to regulate a 
environmental problem, update a standard, or better understand a 
problem such as climate change--it is greeted with an extremely high 
level of controversy. Given this, how realistic do you think it is for 
us to consider doing a comparative risk assessment that would set EPA's 
budget priorities--something that would require a separate risk 
assessment for each of the Nation's environmental problems--but still 
avoid controversies over each and every risk assessment the priorities 
are based on?
    Response. As long as the different stakeholders in our society 
focus on their individual concerns about the impact of regulatory 
decisions and processes they will engender controversy put pressure on 
the Agency and Congress to support their view and, at times, bring 
their concerns into the Courts. Quantitative risk assessments can only 
inform, not resolve such controversies. When such risk assessments are 
scientifically credible, as they mostly are for criteria air 
pollutants, they are especially valuable. When they are highly 
speculative, and heavily biased in a conservative direction, such as 
those for air toxics, they are probably only useful in establishing 
very low (de minimus) risk levels. Such usage is, however, often useful 
for the many cases where conservatively estimated risks are, indeed, 
very low. That is, if the admittedly over-estimated risks are low, 
there is nothing to worry about.

    Question 6. I would be interested in your thoughts on what problems 
would likely be encountered, and how successful we would likely be, if 
we attempted to perform a national comparative risk assessment in order 
to set EPA's new budget and regulatory priorities.
    Response. As noted above, I believe that comparative risk analyses, 
when based on appropriately generated data, can help significantly in 
the priority setting process. However, even with appropriate risk 
estimates, there will still be difficult, value-based decisions to be 
made.
    For the balance of my response, I would like to broaden the issue 
of EPA's budget.
    First and foremost, I believe that EPA's budget for research and 
development is far too low for the roles that ORD is expected to play 
in providing the reliable and relevant data that are needed for the 
protection of the environment and the public's health. Inadequate 
funding hamstrings the ability of science to inform regulatory 
decisions of enormous complexity and importance. The environmental 
quality issues that impact public health and the environmental future 
are more complex than they have ever been, but EPA and its ORD are 
still focused largely on generating scientific and technical 
information for the short-term regulatory agenda. As noted in the 
recent NRC Report, the ORD budget has remained a small percentage of 
EPA's overall budget and, furthermore, the options for its optimal 
usage have been greatly reduced by the increasing proportion for 
``earmarks''. In considering the structural changes for EPA recommended 
by the NRC Report, i.e., the creation of a Deputy Administrator for 
Science and Technology, and in making the Assistant Administrator for 
ORD a 6-year term appointment, Congress should also consider giving the 
EPA a more comprehensive and unified mission that includes a directive 
to conduct both basic and applied environmental research, as well as a 
program of environmental monitoring that can generate baseline and 
trends data of the highest quality. Such data will be essential for the 
more reliable health, ecological, and environmental quality risk 
assessments that can truly and effectively inform legislative and 
regulatory enforcement agendas.

    Question 7. In your testimony related to residual risk, were you 
stating that the residual risk program is addressing risks that are not 
a problem, or when you look at the array of air pollution problems, 
such as fine particulates, that these other problems should be a higher 
priority for the Agency?
    Response. Given current scientific capabilities for determining 
residual risks in a meaningful way for 174 source categories and/or for 
189 hazardous air pollutants, the current process will, in my opinion, 
be overly expensive in terms of cost and a wasteful use of personnel 
resources. Air toxics releases and exposures have been greatly reduced 
in recent decades. Some of this progress was directly attributable to 
the 1990 CAA mandate to apply best available control technology. Of 
equal or greater importance has been the control of primary particulate 
emissions and emissions of ozone and fine particle precursors for the 
purpose of meeting the NAAQS for PM and ozone. Further emission 
reductions can be anticipated as a result of the need to meet the 1997 
NAAQS revisions for PM and ozone in many parts of the country in order 
to comply with the new NAAQS, and to reduce the impact on the public's 
health. Real risks associated with PM and ozone exposures that are 
occurring at and even below the levels of the 1997 NAAQS are now well 
established. Congress should revise its mandated timetable for residual 
risk determinations if it desires the Agency to generate credible 
state-of-the-art best estimates of low-level risks. If, on the other 
hand, Congress is satisfied with rough screening risk assessments that 
would identify the most plausible post--MACT risks, then the current 
approach may suffice. However, more case studies would need to be 
reviewed to evaluate the utility of such screening.

    Question 8. I'm a little confused about where some opponents of 
regulation might take your comments. You have talked about unvalidated 
predictive models at EPA. I think you said that we have ``no viable 
option for realistic estimation of population impacts'' due to air 
toxics exposure. Could someone infer from what you are saying that you 
don't believe that we should reduce air toxics emissions as 
expeditiously as practicable?
    Response. Someone could, and probably will, make such an inference, 
which would be an unfortunate and unintended consequence of having such 
comments on the public record. As noted in my response to your previous 
question, there are serious health effects that can result from air 
toxics emissions, at least via the role of air toxics emissions on 
exposures to PM and ozone. These warrant continued and perhaps even 
tighter control over air toxics emissions. It is also prudent to 
acknowledge that some specific air toxics are likely to have their own 
specific adverse effects on public health, even if we can't quantify 
them reliably at this time with our current risk assessment methods.

    Question 9. I believe you stated in your written testimony that we 
should ``put off any great effort at quantitating [their] residual 
risks until we have the ability to perform more realistic and credible 
risk assessments.'' Senator Inhofe seemed to construe that to mean you 
were advocating that we discontinue any regulatory efforts to reduce 
residual risk for the foreseeable future, because the science of risk 
assessment will always have significant quantitative uncertainties. Is 
that interpretation of your position correct?
    Response. No. The reasons for my negative response to this question 
are provided in my response to your previous question.

    Questions 10a and b. You indicated that ``yields of risk estimates 
are almost always far higher than real risks.'' What is a ``real risk'' 
data point in that case? Are there any reliable studies confirming that 
``yields of risk estimates are almost always far higher than real 
risks?''
    Response. I had two reasons for my perhaps too dogmatic statement 
cited above. First, I participated in the Council review of the air 
toxics analyses performed for EPA during the preparation of EPA's 
retrospective analyses of the Costs and Benefits of the Clean Air Act. 
Fourteen air toxics were reviewed and for two of them, i.e., vinyl 
chloride and asbestos, the enforcement of their NESHAPS was credited 
with having prevented 6000 and 7000 cancer deaths respectively. Vinyl 
chloride produces a rare tumor in humans, angiosarcoma of the liver: 
Asbestos, at low exposure levels, causes about equal numbers of 
mesothelioma and excess lung cancer deaths. Angiosarcoma and 
mesothelioma, a cancer of the pleural and/or peritoneal linings, are 
very rarely seen tumors, and the number of cancers that the risk 
assessments had estimated were prevented were far greater than the 
historic background incidence of these tumors. Therefore these 
estimates are not credible as being realistic risk estimates.
    My second reason for believing that most risks are overstated was 
my knowledge about the multiple margins of safety incorporated in the 
risk assessment methodologies and the conservative nature of the 
exposure assessment methods. These methods are not generally designed 
to, and therefore cannot, generate accurate estimates of actual risks. 
Rather, they are designed to generate possible regulatory levels that 
are intended to have no significant risk.
                                 ______
                                 
           [From the Risk Policy Report, September 22, 2000]
                            In the News--Air
   scientists question sab's criticism of epa's residual risk program
    Several members of an ad hoc Science Advisory Board (SAB) panel are 
criticizing a commentary issued by the SAB's own executive committee 
that questioned whether EPA was equipped to implement a major residual 
risk analysis program that reburies EPA to assess 174 industrial source 
categories.
    The residual risk analysis program, mandated by section 112(f) of 
the Clean Air Act, requires the agency to conduct assessments of 174 
industrial source categories after their air toxics emissions sources 
have been controlled by maximum achievable control technologies (MACT) 
to determine if further controls are necessary. Under the CAA 
amendments of 1990, residual risk assessments must be completed 8 years 
after the MACT standards for each hazardous air pollutant (HAP) are 
set.
    Prompted by the ad hoc SAB panel's critical review of the agency's 
approach to the residual risks posed by secondary lead smelters, the 
executive committee July 25 urged EPA Administrator Carol Browner and 
Congress to ``seriously re-consider the current Clean Air Act 
Amendments mandates and their implementation strategy that depends on 
scientific analyses that will be resource-demanding, at a minimum, and, 
quite possibly, impossible to carry out in a credible manner.'' While 
the committee endorsed the concept of science-based decision making at 
the agency, it also recognized ``that no one is well served by asking 
science to take on an impossible task.''
    But several members of the ad hoc SAB lead smelters panel now say 
the commentary goes too far. According to one panelist, ``we were 
highly critical but took a constructive approach by emphasizing that 
the agency needs to have a probabilistic approach to the data early 
on.'' This source says it is ``quite possible for the agency to carry 
out such analyses in a credible manner.'' Several members reportedly 
have approached the ad hoc panel's chair, Phillip Hopke, with their 
concerns about the executive committee's commentary. Another smelter 
panel source emphasizes that the investment of more time and resources 
in the program would be worthwhile in the residual risk program ``given 
that you're dealing with a sophisticated industry with some past 
history of litigation.'' The issue captured the attention of Senate 
lawmakers who scheduled a hearing on the residual risk issue in late 
July, but cancelled it because of scheduling conflicts.
    EPA officials, meanwhile, have maintained that the agency has the 
resources and technical skill to conduct the analysis and will work 
with industry stakeholders to collect the data required to conduct 
residual risk analyses and move forward with decisions (Risk Policy 
Report, May 15, p.7; April 18, p33). One of the central reasons the 
executive committee opted to write a commentary was that EPA has 
substantial information on lead emissions unlike many of the other HAPs 
that must still be reviewed. Residual risk analyses call for the 
characterization of multiple HAPs, ecological risk analysis, population 
risk estimates and careful assessment of uncertainty and variability 
(Risk Policy Report, June 19, p. 15).
    Accordingly to one EPA official ``in my view the commentary went 
beyond what the SAB is charged to do which is to peer review science. 
Should the board tell the agency when there is an adequate basis for a 
decision that is the essence of making a policy call, and without 
seeing the details of the original analysis, in my view they went over 
the line.''
                               __________
  Statement of Lee P. Hughes, Vice President, Corporate Environmental 
                       Control, Bayer Corporation
                            i. introduction
    Good morning Chairman Smith, Chairman Inhofe, Senator Baucus, and 
members of the committee. My name is Lee Hughes and I am Vice President 
of Corporate Environmental Control for Bayer Corporation. I have 
responsibility for environmental matters for Bayer's United States 
(U.S.) operations, including compliance with the Clean Air Act (Act).
    I am here representing the American Chemistry Council (Council). 
The Council represents the leading companies engaged in the business of 
chemistry. Our members apply the science of chemistry to make 
innovative products and services that make people's lives better, 
healthier and safer. As we conduct our business, we are committed to:
     improved environmental, health and safety performance 
through Responsible Care,
     common sense advocacy on major public policy issues, and
     health and environmental research and product testing.
    The business of chemistry is a $435 billion-a-year enterprise and a 
key element of the Nation's economy. The chemistry industry is the 
Nation's largest exporter, accounting for ten cents out of every dollar 
in U.S. exports. This industry invests more in research and development 
than any other business sector.
    I commend Chairman Smith, Chairman Inhofe, and Senator Baucus for 
holding this hearing on the important subject of residual risk under 
the Act. The Council supported the 1990 Clean Air Act Amendments, and 
for more than a decade has actively and collaboratively worked with the 
Environmental Protection Agency (EPA) on its development of many air 
toxics programs. We are proud of the tremendous progress we have made 
reducing air toxics. For example, American Chemistry Council members 
led all other U.S. businesses in cutting emissions of 30 key hazardous 
air pollutants (HAPs) reported under the Toxics Release Inventory (TRI) 
since 1990. While all U.S. manufacturing facilities reduced emissions 
of these HAPs by 52 percent, Council members cut our emissions of these 
substances by 64 percent.
    Our industry supports the Clean Air Act's approach for regulating 
air toxics, which first requires technology-based controls and then 
looks at any remaining or ``residual'' risks. We believe the residual 
risk effort can build on air toxics reductions to date and evolve into 
a scientifically credible and effective regulatory program that 
characterizes, prioritizes, and manages identified risks.
    There are some early warning signs, however, that barriers exist to 
achieving this goal. Your attention to this program, contemplated by 
the Act, is an important step toward identifying, understanding, and 
addressing these challenges. I would like to talk today both about the 
progress we have made on air toxics as well as the issues we need to 
address to ensure that the residual risk program gets off on the right 
track.
 ii. the chemical industry has significantly reduced air toxics under 
                           the clean air act
    The Act establishes a phased process for reducing air toxics 
emissions from various industry sectors. Companies first implement 
technology-based air toxics regulations, which are designed to 
establish a common level of superior air pollution control across each 
industry. This soon to be complete Maximum Achievable Control 
Technology (MACT) program is expected to reduce annual HAP emissions 
from stationary sources by over 1.5 million tons from 1990 levels.
    The chemical industry was one of the first industries subject to 
MACT regulations. The result has been dramatic air toxics reductions 
from chemical sources according to EPA's own numbers. We are proud of 
this achievement, as well as the many voluntary efforts our industry 
has underway, such as Responsible Care(r), to continuously improve our 
environmental and community performance. Responsible Care(r) represents 
our commitment to respond to public concerns about the safe management 
of chemicals and has rapidly become the single most important 
performance improvement initiative within the chemical industry.
        iii. key elements of a successful residual risk program
    Eight or nine years after an industry's technology regulations are 
promulgated, the Clean Air Act requires EPA to evaluate whether air 
toxics risks from the regulated processes remain. If risks are 
identified, EPA must promulgate new standards to provide an ``ample 
margin of safety'' to protect public health and the environment from 
those risks. EPA is now evaluating the chemical and other industries 
subject to MACT standards to determine if their emissions pose 
unacceptable remaining risks. If regulations are needed for the 
chemical industry, they are due in 2003 under the Act's timeframe.
    This means that many important decisions are being made now about 
how the residual risk regulatory program will be designed and carried 
out. The American Chemistry Council and its members are working 
collaboratively with EPA on this effort. We believe that the residual 
risk program must build on the emission reductions and successes of the 
MACT program. In addition, our experience to date indicates that the 
following key principles must be a part of the residual risk program to 
ensure its success:
     Prioritize real and scientifically validated risks.--We 
support the use of prioritization techniques to rank remaining risks 
posed by pollutants and sources within each evaluated industry 
category. A prioritization approach to residual risk will screen out 
negligible risks and focus regulatory efforts where risk reduction will 
produce the greatest public health benefits. EPA already has taken this 
approach in some of its work on the lead smelter industry, and we 
support this effort.
     Use the flexibility provided in the Act to reduce risks in 
innovative and effective ways.--We support the risk management process 
endorsed in the Act, which sets out key issues that must be considered 
in designing this program. These include the scope of remaining risks, 
the public health significance of HAP emissions, the cost of further 
controls, and what risks are acceptable in the world in which we live. 
The Act endorses a risk management process that considers an acceptable 
level of risk based on health considerations, and then sets an ``ample 
margin of safety'' based on cost, feasibility, and other factors. EPA 
is not required to set a bright line that all sources must meet 
regardless of other factors. This means the residual risk program can 
be flexible, realistic, and encourage innovative approaches to risk 
reduction.
     Use high-quality data and peer-reviewed methods to 
realistically assess risk and make regulatory decisions.-- We believe 
EPA must use realistic exposure assumptions to accurately characterize 
residual risks. This approach will place risks in context and avoid 
overly conservative risk estimates. Also critical are validated risk 
estimation methods and health benchmarks that fully account for all 
currently available information. We believe a transparent and open 
peer-review process also is an essential part of risk assessment. Where 
there are gaps in our knowledge, we support Congress providing the 
mechanisms, time, and research to fill these gaps.
iv. key limitations in present information, data, and methodologies to 
          assess residual risks within the statutory deadlines
    To accomplish these important goals and design a successful and 
realistic residual risk program, we must heed some early warning signs. 
Our collaboration with EPA to date and other experiences, such as with 
State air toxics programs, reveal some key limitations and shortcomings 
in EPA's present information, data, and methodologies to assess 
residual risks. EPA itself alludes to many of these troublesome areas 
in its March 1999 Residual Risk Report to Congress. The Agency's 
Science Advisory Board goes into more detail on present limitations in 
its May 2000 Advisory on EPA's Draft Case Study Analysis of the 
Residual Risk of Secondary Lead Smelters. We are concerned that, 
without attention, these limitations will jeopardize the success of 
this evolving regulatory program. Our concerns include the following:
     Outdated health information.--The President's Commission 
on Risk Assessment and Risk Management, created under the Act, has said 
that ``data to assess the health risks of most hazardous air pollutants 
for regulatory purposes are lacking'' and ``the status of exposure data 
collection is no better.'' EPA's IRIS (Integrated Risk Information 
System) data base, broadly perceived as the primary source of health 
information on hundreds of chemicals, is critically out of date and 
contains information of varying quality. IRIS' widely acknowledged 
weaknesses are a true hindrance to the development of accurate risk 
assessments.
    The American Chemistry Council is dedicated to studying and 
improving our collective knowledge of the health effects of chemicals. 
Through our Long-Range Research Initiative, our members will spend more 
than $100 million on health and environmental research related to 
chemical use and exposure during the next 5 years. In addition, our 
High Production Volume Chemical Testing program for screening and 
testing thousands of chemicals, launched in 1998 as a partnership with 
EPA and Environmental Defense, will require investments of at least 
$500 million. These efforts and others, such as the current program at 
the Chemical Industry Institute of Toxicology to develop a risk 
assessment for formaldehyde using EPA's new cancer guidelines and the 
latest science, are aimed at filling the IRIS gaps. Many of our 
companies also have submitted or are preparing new IRIS assessments. We 
strongly endorse EPA's recent efforts to open up the IRIS program to 
such submissions, and encourage the Agency to further expand this 
initiative.
    However, these efforts alone are not enough. Staff and dollars for 
IRIS must be increased. The process for updating IRIS also must be 
expedited so new information on chemicals can be integrated or used in 
regulatory decisions without requiring that the entire IRIS evaluation 
process be repeated. IRIS is stuck in the last century, and we urge 
that it be modernized and expanded before its limitations lead to more 
erroneous risk assessments. Erroneous assessments may result in 
unfounded public concern about air quality as well as waste limited 
resources. Our experience shows that using the best science will 
significantly reduce the uncertainty in making residual risk decisions 
and assure that this evolving regulatory program addresses real risks 
in the most effective manner.
     Non-peer reviewed data, models and methods.--Good risk 
assessments depend on high-quality science. We commend EPA for 
presenting its preliminary secondary lead smelter case study to the 
Science Advisory Board. This exercise, however, highlighted EPA's data 
problems and showed that many of EPA's risk evaluation methods are not 
peer-reviewed. We believe it is absolutely critical that EPA commit 
that the data, models, and methods used for regulatory decisionmaking 
will be consistently and comprehensively subjected to a transparent 
scientific review process. This process must be balanced and engage 
academics, industry, states, scientists, and non-governmental 
organizations in an open process. Adequate time, funding and resources 
for followup to recommendations is also important so scientific input 
can be fully incorporated and addressed.
     Incomplete emissions data and site characterization 
information.--Good risk assessments depend on a highly credible source 
of post-MACT emissions data for the many sources to be evaluated. Good 
risk assessments also depend on accurate information about facility 
locations, distance to neighbors, stack heights, and other important 
details. EPA's most recent emissions data set is from 1996, which for 
our industry represents pre-MACT emissions levels. Since this data was 
not collected for risk assessment purposes it also contains other 
significant limitations. Our industry is voluntarily providing EPA with 
better information about the chemical sources now under review, but the 
task is immense. More effort is needed by all parties in this area to 
do a better job collecting, categorizing, and assessing such data.
     Flawed fugitive emissions estimation methods.--Good risk 
assessments also depend on accurate estimates of ``fugitive 
emissions''--low-level emissions from, for example, piping connections 
or valves. More simplistic methods currently in use were not intended 
for risk assessment purposes and tend to grossly overestimate fugitive 
emissions. Companies have developed new and more accurate ways to 
estimate these emissions. To reduce uncertainty in risk assessment, 
these improved methods need acceptance and use by EPA and other 
regulatory agencies.
     Statutory time constraints.--We are concerned that these 
significant limitations can not be addressed under the present 
statutory time clock. As noted by the Science Advisory Board, EPA must 
conduct over 170 residual risk assessments and these ``data gaps are 
likely to be even more of a problem'' in future assessments. To add to 
the challenges, the Act requires compliance with new residual risk 
standards within 90 days of promulgation-a near impossibility for most 
sources. Despite our best efforts, it will not be long before a 
residual risk standard deadline is missed. Unless action is taken now, 
this program may end up operating under court ordered deadlines and in 
settlement discussions, hindering our ability to make good decisions 
founded on science.
                             iv. conclusion
    We are convinced that there is a better way for this program to be 
carried out, provided we heed these warning signs and keep the key 
elements for a successful program outlined here in the forefront of our 
minds. Our industry is committed to working with you, EPA, and other 
stakeholders to ensure that this regulatory program gets off to a solid 
start.
    In closing, we must strive to prioritize risk reduction efforts and 
maximize the effectiveness and resources of all stakeholders to achieve 
cleaner air. To accomplish these goals and design an effective residual 
risk program, we need to base regulatory action on prioritized 
environmental challenges, use peer-reviewed and state-of-the-art 
scientific methods, and generate accurate health and emissions data. I 
reiterate our commitment to work with you and all stakeholders to 
achieve these goals.
    Chairman Smith and members of the committee, thank you for hearing 
my testimony today. I appreciate the opportunity to provide you with 
our views on this important topic. I would be happy to answer any 
questions you may have.
                                 ______
                                 
 Responses by Lee P. Hughes to Additional Questions from Senator Smith
    Question 1.--In the likely event that the IRIS values are not 
updated in time for residual risk standards, do you believe there 
should be a process for EPA to consider new toxicity information during 
the residual risk rulemaking process? Isn't this critical to ensuring 
that the standards are based on the best science possible?
    Response. We agree it is unlikely that IRIS values will be updated 
in time to be used in the residual risk assessments,\1\ and for that 
reason, it is critical that EPA develop an efficient, expeditious 
process to incorporate the latest and best science into residual risk 
assessments and the risk management decisions that follow. Due to the 
significant Maximum Achievable Control Technology (MACT) reductions, it 
will be important to correctly identify and characterize remaining 
risks. Application of an out-of-date IRIS value could create the 
appearance of risks when none exist or underestimate risks that need 
attention. We are committed to working with you and the Agency to 
develop an appropriate process that enables EPA to consider new 
toxicity information during the residual risk assessment and rulemaking 
process.
---------------------------------------------------------------------------
    \1\ Since 1995 EPA has added only four chemicals to the IRIS data 
base and revised the files for only 16 others. For more details on 
IRIS' limitations, see Science Advisory Board Environmental Health 
Committee, Review of the Draft Report to Congress Characterization of 
Data Uncertainty and Variability in IRIS Assessments, Pre-Pilot vs. 
Post-Pilot (Sept. 26, 2000) 7; EPA Screening Evaluation Report: 
Presentation and Discussion of Uncertainty and Variability in IRIS 
Assessments (July 2000), Table 3; ICF Consulting, Screening-Level 
Assessment of the Need to Update EPA's IRIS Data base (March 17, 2000), 
Exhibit 2.

    Question 2. In your testimony you stressed the importance of 
updating the IRIS data base at EPA that contains the health benchmarks 
or values EPA will use in the risk estimation process. Specifically, 
you stated that the process for updating IRIS must be ``opened up.'' 
What do you mean by this statement and do you have any specific 
recommendations?
    Response. EPA recently acknowledged that IRIS is a public resource 
and that its maintenance and upgrading are not merely matters of EPA 
internal management prerogative.\2\ When we referred to ``opening up'' 
the IRIS updating process, we were referring to recent positive steps 
EPA has taken to involve non-EPA parties in the management and 
operation of IRIS, including:
---------------------------------------------------------------------------
    \2\ See EPA FY2000 Annual Performance Plan and Congressional 
Justification, at VII-37 (``[IRIS] is widely used for risk assessments 
and other health evaluations at all levels of government, as well as in 
the private and public sectors. . . . Risk assessors everywhere look to 
EPA to provide it.'')
---------------------------------------------------------------------------
     More active solicitation of available information about 
chemicals that EPA is reviewing;
     Allowing outside groups on a limited basis to produce 
drafts of the toxicological review that will speed the process and can 
constitute the underlying data for the Agency's conclusions regarding 
benchmarks; and
     External peer review of the IRIS decisions, with the 
opportunity for the public to provide comments to EPA.
    We also recommend that EPA take the following additional steps to 
further ``open up'' the IRIS process:
     Conduct the IRIS needs assessment requested by the Senate 
Appropriations Committee's fiscal year 2001 report.--Congress needs to 
know the real scope of the IRIS backlog and what priority chemicals are 
not currently part of IRIS. The assessment should include 
recommendations from State environmental officials, industry, public 
interest groups, and the general public. The assessment should address 
the budget needed to bring the IRIS program up to a high level of 
quality in an acceptable number of years.
     Encourage outside scientists familiar with current 
literature on specific chemicals to provide draft toxicological reviews 
for EPA consideration.--This maintains EPA's independence and 
capitalizes on the private sector's and other government agencies' 
abilities to perform some of the basic literature reviews that 
contractors now do for EPA. This approach is being successfully 
employed in the European Union, where industry groups provide many of 
the draft science documents and risk assessments that are the starting 
point for government consideration. European regulatory and science 
review groups use these evaluations to develop potency factors and make 
health-based regulatory decisions.
     Allow other stakeholders to nominate chemicals for 
priority updating.--This will ensure that the most urgently needed 
updates are identified and carried out in time to affect future 
regulatory decisions.
     Develop interim procedures to account for IRIS 
limitations.--For example, EPA could conduct less resource-intensive 
``partial'' IRIS updates where there are important new studies on a 
chemical, rather than a comprehensive entire file review. Or, new 
studies could be listed in IRIS with a disclaimer informing users that 
the health information does not include a consideration of these latest 
studies.

    Question 3.--Comparative risk assessment is a tool used to 
characterize and rank environmental problems. Do you believe that EPA 
uses enough benefit-cost analyses (BCA) in characterizing the 
effectiveness of environmental solutions? Is EPA's use of BCA 
appropriate?
    Response. We believe that EPA should use BCA more often when 
characterizing and ranking environmental problems, particularly today 
when many of the easy solutions to reducing pollution have been found 
and accomplished. Under the decisionmaking process for residual risk 
required by the Clean Air Act, however, EPA is required to consider 
cost, feasibility, and other factors when setting the required ``ample 
margin of safety''. See Sec. 112(f)(2)(B) (reference to benzene 
rulemaking, 54 Fed. Reg. 38,044). Thus, for residual risk the use of 
BCA is not only appropriate, it is required.
                                 ______
                                 
 Responses by Lee P. Hughes to Additional Questions from Senator Baucus
    Question 1a. You've noted some gaps that you believe need to be 
filled to adequately characterize residual risk. I assume you mean that 
must happen before regulations can be issued. Is that correct?
    Response. We do not believe that all residual risk regulations 
should be delayed until all data gaps are filled. Our testimony touched 
on two key gaps--a lack of post-Maximum Achievable Control Technology 
(MACT) emissions information and outdated health effects information on 
hazardous air pollutants (HAPs). In many cases, there is adequate 
emissions information for the sources at issue, and health effects 
information on the relevant HAPs for EPA to make sound regulatory 
decisions.
    However, for some HAPs and some source categories, we will need 
more current and better information to produce sound, scientifically 
based decisions. We are committed to working with EPA to identify which 
HAPs need priority attention and to determine what steps need to be 
taken to allow EPA to make solid decisions. We also will continue our 
work to voluntarily provide EPA with current, post-MACT emissions 
information (see response to Question 2, below). EPA still may find 
that additional data gathering in this area is needed to complete 
regulatory decisions. These are the gaps that we believe may affect 
EPA's ability to issue some residual risk rules within the statutory 
deadlines.

    Question 1b. How long would it take to fill those gaps if more 
resources aren't given to EPA to do the work?
    Response. There is no doubt that the ``gap filling'' workload is 
heavy and that EPA needs adequate resources to fill key data gaps in 
emissions information and health effects information. While we cannot 
predict how long this effort might take, we do have the following 
suggestions for managing the workload:
     Determine whether EPA has adequate resources to fill these 
gaps and whether the Agency is properly allocating these resources. We 
are concerned that there has not been a meaningful increase in the 
funding EPA has allocated to ``air toxics research'' or ``air toxics 
standards'' in the fiscal year 2000 or fiscal year 2001 budgets;
     Identify and prioritize which HAPs are most critical to 
the residual risk rulemaking effort and need timely and complete 
evaluation;
     Determine where better post-MACT emissions information is 
needed and how we can collectively do a better job gathering this 
information in the future; and
     Assess how gaps may be filled through the non-EPA and 
private sector efforts underway to improve our collective knowledge of 
the health effects and emissions of pollutants.

    Question 1c. Do you think the regulated industries would be willing 
to pitch in and provide additional resources beyond those you mentioned 
in your testimony?
    Response. While we cannot speak for other industries, the chemical 
industry is already making a serious contribution to chemical research 
and testing. We are proud of our efforts and believe they will 
contribute to our overall knowledge. As our work progresses, we will 
assess how we can make additional contributions. Some of our present 
research activities are described below:
     Through the American Chemistry Council's Long-Range 
Research Initiative, our members will spend more than $100 million on 
health and environmental research related to chemical use and exposure 
during the next 5 years.
     Our High Production Volume Chemical Testing program for 
screening and testing thousands of chemicals, launched in 1998 as a 
partnership with EPA and Environmental Defense, will require 
investments of at least $500 million.
     Many of our companies have submitted or are preparing new 
IRIS assessments, which will help fill additional gaps.
     We are working with EPA on a major program to address 
children's health issues.
     See response to Question 2, below, regarding specific 
input on post-MACT emissions information for the residual risk program.

    Question 1d. Would a per pound tax on HAPs emissions be an 
efficient way to obtain such resources?
    Response. An emissions tax would be a highly inefficient means of 
promoting accurate risk assessments and risk management decisions for 
residual risk. Segregation of funds from a dedicated revenue source 
would create additional resource management problems for EPA. 
Additionally, in the past two budget proposals EPA sought to allocate 
significant funds to non-statutory areas (e.g., Clean Air Partnership 
Fund), rather than to congressionally-mandated programs like residual 
risk. In fact, there has been no meaningful budget increase for ``air 
toxics standards'' or ``air toxics research'' in 2 years. Congress 
should evaluate whether present resources are appropriately applied.
    A tax also is inconsistent with the Act's structure for managing 
HAPs from major stationary sources. Industries assessed for residual 
risk already have installed MACT at a significant cost to many 
companies. A tax on HAPs would punish these sources for good faith 
compliance with the law.

    Question 2. Has EPA enabled your industry to provide input on the 
residual risk program and on the specific risk assessment for your 
industry?
    Response. We have had a good working relationship with EPA 
concerning the overall conceptual framework for the residual risk 
program over the past several years. We have taken advantage of formal 
opportunities to provide input to the Agency, such as our commenting on 
the Report to Congress on Residual Risk and the Secondary Lead Smelter 
Case Study. In addition, EPA has been willing to meet with us and to 
share ideas at appropriate times.
    This year EPA moved into the risk assessment phase for the sector 
of our industry subject to one of the first residual risk evaluations 
(facilities subject to the 1994 Hazardous Organic NESHAP (HON)). We 
have provided EPA with information about HON facilities, their 
locations, and emissions. Just last week we contacted over 60 companies 
requesting their voluntary assistance to provide site-specific 
emissions information to EPA to improve the residual risk assessment.

    Question 3. What improvements could be made to the relationship to 
ensure an open and collaborative sharing of data?
    Response. We will need to work collaboratively with EPA and other 
stakeholders in the coming months on issues relating to regulatory 
structure, risk communication, and risk management. One improvement to 
the relationship could involve open recognition by all parties of the 
tight: statutory deadlines. Our experience shows that in the face of 
fast approaching deadlines EPA often reduces stakeholder dialog and 
input, as stakeholder meetings are viewed as an impediment to achieving 
deadlines rather than a means to improve the regulatory process. We 
expect that part of the necessary open and collaborative process will 
be an honest assessment of what can be accomplished under the Act's 
deadlines.
                               __________
Statement of Robert Brenner, Deputy Assistant Administrator, Office of 
        Air and Radiation, U.S. Environmental Protection Agency
    Mr. Chairman and members of the committee, I welcome the 
opportunity today to testify on EPA's plans for implementing the 
residual risk program, which is one component of a broader strategy 
mandated in the Clean Air Act Amendments of 1990 to protect public 
health and the environment against toxic air pollution.
    The 1990 Amendments called for a two-phased approach to reducing 
toxic air emissions from major industrial sources. First, EPA is to 
issue industry-by-industry standards to ensure that all sources are 
appropriately controlled. Second, in the residual risk phase, EPA is to 
assess the remaining risks from those industries and, if necessary, 
require reductions in toxic air emissions to protect health and the 
environment.
    Congress reached a bipartisan compromise on the residual risk 
provisions in 1990 after years of dialog and debate over the best way 
to achieve effective and reasonable air toxics control. A decade later, 
EPA continues to believe that it makes sense to evaluate whether 
Maximum Achievable Control Technology (MACT) standards provide the 
public with adequate health and environmental protection, and to take 
action if they do not. Although the job will not be easy, EPA with the 
aid of the scientific community (including the National Academy of 
Sciences) has developed risk assessment methodologies and risk 
management procedures that allow for making reasoned decisions on 
whether to require further emissions reductions, based on the available 
scientific information and consideration of uncertainties.
    Today, I will describe the general approach to risk assessment and 
risk management that EPA will use in deciding whether further 
reductions in toxic air emissions are needed from industrial facilities 
that have met technology-based emission limits. To set the stage, it is 
useful to put the program in context by providing some historical 
background and outlining EPA's overall air toxics strategy.
            air toxics and the 1990 clean air act amendments
    At the time Congress amended the Clean Air Act (CAA) provisions on 
hazardous air pollution in 1990, it was well established that the 
public is exposed to air toxics such as lead, benzene, dioxin, mercury, 
chromium, and other compounds. It was also known that toxics found in 
the air can cause cancer or other serious health effects such as 
neurological damage, miscarriages, birth defects, or lung damage.
    Industry reports required by the Emergency Planning and Community 
Right-to-Know Act of 1986 revealed that manufacturing industries alone 
had emitted more than 2.7 billion pounds of toxic chemicals into the 
air in 1987. Risk assessments indicated that individuals living near 
some industrial facilities faced potentially high cancer risks. Studies 
found that millions of people in American cities faced some elevated 
risks from a complex mixture of toxic chemicals emitted by multiple 
sources ranging in size from big petrochemical plants to dry cleaners 
to motor vehicles. And atmospheric deposition of hazardous air 
pollutants was identified as contributing to toxic pollution in the 
Great Lakes. Neighboring states and Canada had issued health advisories 
against eating certain varieties of fish caught in the Great Lakes 
because they contained elevated levels of PCBs, mercury and other 
toxics.
    All this was highlighted in congressional hearings. During the 1990 
revision of the Act, Congress concluded that the pre-1990 hazardous air 
pollutant provisions had provided fertile ground for 20 years of 
emotional and often endless debate and litigation. Those provisions 
called for EPA to list and regulate hazardous pollutants one at a time 
based on the risks they posed. The result was gridlock. In 20 years, 
EPA listed only eight pollutants and regulated only seven. The 
regulations covered only some of the sources emitting those pollutants.
    In response, Congress overhauled the Clean Air Act to ensure 
effective actions to protect public health from nearly 190 toxic air 
pollutants. The Act mandates a two-phased approach: cut toxic emissions 
substantially by requiring maximum achievable controls considering 
costs on major sources, and use targeted approaches to reduce 
particular types of risks.
    In the first phase, EPA is directed to issue technology-based 
emissions standards on an industry-by-industry basis to bring down the 
amount of toxics in the air and reduce exposure to air toxics among 
citizens living nearby. This approach--requiring dirtier facilities to 
achieve the level of performance already being achieved by cleaner 
facilities of the same type--has proven very successful. MACT standards 
issued to date will reduce annual emissions of air toxics by 1.5 
million tons--many times the reductions achieved by standards issued 
during the 1970-90 period. To provide industry with greater flexibility 
on ways to comply with MACT standards, we develop numerical emissions 
performance standards whenever feasible, and typically include other 
features such as alternative compliance options or emissions averaging.
    As we work to complete the MACT standards, we are implementing the 
second phase of the toxics program targeted to particular types of 
risks. Key components of this second phase include:
     assessing residual risks of toxic air emissions from MACT-
regulated sources to determine whether further controls are needed to 
protect public health and the environment.
     implementing the Integrated Urban Air Toxics Strategy, 
which is aimed at reducing risks in urban areas from 33 priority 
pollutants emitted by small ``area'' sources, motor vehicles and other 
sources.
     continuing assessments of atmospheric deposition of air 
toxics into the Great Lakes, and considering additional actions that 
may be needed to reduce emissions of those toxics.
     conducting National Air Toxics Assessment activities to 
provide citizens, localities, states and ourselves with better 
information on toxic emissions, exposure and risk.
                       the residual risk program
    In crafting the 1990 Amendments, Congress recognized that in the 
case of some industries, emissions reductions achieved by the MACT 
program might not be sufficient to protect public health and the 
environment. So the 1990 Amendments direct EPA to evaluate the 
remaining risks from each regulated source category. If necessary to 
protect public health or the environment, EPA is to issue residual risk 
standards requiring further emissions reductions. Any such standards 
are to be issued within 8 years of the date the MACT standard was 
issued (nine years for certain early standards).
    The details of these provisions represent a hard-won compromise 
achieved by the 102d Congress, which spent as much time developing the 
residual risk provisions as it did on any portion of the 1990 
Amendments. The provisions reflect attention to a variety of 
conflicting concerns--the concerns of people exposed regularly to air 
toxics in the air that they breathe, the economic concerns of 
industrial facilities, and concerns about the uncertainty, imprecision 
and complexity associated with risk assessments of toxic air 
pollutants.
    Those concerned about elevated risks from air toxics include 
minority and low-income residents who often are disproportionately 
represented in neighborhoods near industrial sites. In evaluating 
residual risks, EPA will look closely at potential exposures in nearby 
neighborhoods and be cognizant of subpopulations such as children and 
pregnant women who may be especially vulnerable to some toxic 
pollutants.
    For many source categories, this program will be challenging to 
implement because of data gaps and uncertainties involved with risk 
assessments for hazardous air pollutants, and differing views among 
stakeholders over how risk assessors and risk managers should account 
for uncertainties. These issues are not new. Under the old pollutant-
by-pollutant regulatory system in the 1970 Clean Air Act, these issues 
severely hindered implementation of the Federal air toxics program. 
While there have been great strides made in the field of risk 
assessment since the 1990 Amendments, risk assessment by definition 
will always entail uncertainties.
    Knowing this, Congress designed the residual risk provisions of 
the1990 Amendments to provide for decisionmaking in the face of 
uncertainties. To lay the groundwork for the residual risk program, 
Congress required three reports--two by independent panels of 
scientists, and one by EPA--to address issues concerning risk 
assessments and risk management. Congress also provided a detailed 
framework to guide EPA's residual risk decisions in a world in which we 
don't have all the information we would like.
    Today, all three statutorily required reports on risk assessment 
and risk management are complete. A 1994 report by the National 
Research Council (NRC) of the National Academy of Sciences, mandated by 
section 112(o) of the CAA, reviewed EPA's risk assessment methods. A 
1997 report by the congressionally mandated Commission on Risk 
Assessment and Risk Management (CRARM), mandated by section 303 of the 
1990 Amendments, examined risk assessment and risk management issues 
relevant to hazardous substances under various Federal laws. After 
evaluating these reports, EPA in 1999 provided a major Report to 
Congress describing how the Agency will implement the residual risk 
program, using the available scientific information and methods.
    EPA's implementation approach for the program reflects the 
suggestions of the scientific committees. For example, the NRC report 
noted that neither the resources nor the scientific data exist to 
perform a full-scale risk assessment on all the chemicals listed as 
hazardous air pollutants (HAPs) and their sources. Therefore, the NRC 
supported an iterative approach to risk assessment of source categories 
emitting HAPs. This approach would start with relatively inexpensive 
screening techniques used to determine whether the evaluated source 
category is below the statutory level of concern, or whether we need to 
conduct a more refined analysis before we can make a determination. (We 
will not regulate based on the results of a screen.) As a particular 
situation warranted, we would move to a more resource-intensive level 
of data-gathering, model construction and model application to produce 
a risk assessment providing greater certainty. The result would be a 
process that supports the risk management decisions required by the CAA 
and provides incentives for better data and further research, without 
the need for costly case-by-case evaluations of individual chemicals of 
every facility in every source category. The CRARM agreed that the EPA 
should use an iterative approach when conducting risk assessments and 
elaborated on the general approach presented by the NRC. The Agency is 
using an approach that is consistent with that presented by the CRARM 
to undertake its residual risk assessments.
    After a residual risk assessment is conducted, EPA must determine 
whether a residual risk standard should be established to achieve 
further emissions reductions. Specifically, EPA is to issue a residual 
risk standard for a source category if required ``to provide an ample 
margin of safety to protect the public health, or to prevent, taking 
into consideration costs, energy, safety and other relevant factors, an 
adverse environmental effect.'' Congress provided specific guidance on 
how this residual risk decision is to be made for hazardous air 
pollutants that lack a health effects threshold (e.g., many 
carcinogens) by endorsing the framework EPA developed for the 1989 
benzene national emissions standard. This framework--developed through 
notice and comment rulemaking in response to a 1987 decision by the 
Court of Appeals for the District of Columbia Circuit--calls for a two-
step decisionmaking process considering multiple factors.
    In the first step, EPA determines a ``safe'' or ``acceptable'' risk 
level that considers all health information--including the risk level 
of highly exposed individuals, the number of people exposed within each 
lifetime risk range, the overall incidence of health effects, the 
science policy assumptions associated with the risk measures, and the 
weight of evidence that a pollutant is harmful to health. EPA 
ordinarily will presume that a 1 in 10,000 lifetime risk of cancer to 
the individuals exposed to the maximum level of a pollutant represents 
the upper end of the range of acceptable risk. However, this is not a 
rigid line; rather it is a presumption to be weighed with the other 
factors.
    In the second step, EPA determines the level of the enforceable 
emissions standard needed to provide an ``ample margin of safety.'' In 
choosing this level, EPA considers again all health information--
including the number of persons at risk levels higher than 
approximately 1 in 1 million, the nature of the assumptions underlying 
the risk assessment, and weight of evidence that a pollutant is 
harmful. In determining the margin of safety, EPA also considers costs 
and economic impacts of controls, technological feasibility and other 
relevant factors.
    This congressionally-endorsed approach is consistent with risk 
management approaches of other EPA programs intended to broadly protect 
public health. For example, other EPA programs use a risk management 
range of 10-6 to 10-4 under their reasonable maximum exposure scenario 
to guide their decisionmaking for carcinogens.
    Also, the methods used to generate risk estimates for the residual 
risk program are consistent with those of other EPA programs. To 
address uncertainties, EPA makes scientifically sound judgments and 
assumptions about hazard and exposure to generate ``reasonably 
conservative'' risk estimates. By ``conservative'' we mean that true 
risks may be higher, but are likely to be lower. There are parameters 
that can substantially increase or decrease the estimated risk; EPA 
does not use conservative assumptions for all of these. For example, 
where we lack adequate information to support a quantitative assessment 
for a pollutant, we implicitly assume that the risks from that 
pollutant are zero. The result, in the end, is that our risk estimates 
are plausible and do not represent worst case estimates.
    This committee has expressed interest in the findings of an EPA 
Science Advisory Board (SAB) panel that recently reviewed a case study 
illustrating the approach EPA plans to use to conduct risk assessments 
for the residual risk program. The SAB subcommittee said that EPA 
methodology ``is consistent with the methodology described in the 
Report to Congress,'' (which the Science Advisory Board reviewed and 
supported in 1998), and that ``the assumptions used are consistent with 
current methods and practice.'' The subcommittee also made valuable 
substantive comments and suggestions for improvements, which EPA is 
incorporating. While the SAB did not find any ``showstoppers'' (their 
word) with the approach used, they did identify several issues that 
should be addressed such as a more fully evaluated model to predict 
exposure to toxics through multiple media, and improved data collection 
efforts. The SAB expressed particular concern about the availability of 
sufficiently precise scientific information that would support residual 
risk analysis. EPA is incorporating the Science Advisory Board's 
suggestions into our residual risk assessments. We are providing the 
committee with a copy of our formal response to the SAB. As we stated 
to the SAB, EPA will obtain peer review on the full case study risk 
assessment when it is completed.
    As mentioned earlier, we are working to improve our data on air 
toxics (through our NATA or National Air Toxics Assessment activities) 
and our risk assessment methods. For example, we are improving the 
National Toxics Inventory, which is a repository of source specific air 
toxics emissions data from states; working with states and cities to 
expand monitoring of ambient air toxics levels (a plan which received a 
positive review from the SAB); and developing a new, better, multi-
pathway methodology in TRIM (Total Risk Integrated Methodology), which 
has received two very favorable reviews from the SAB. We are also 
conducting national- and local-scale air quality, multimedia and 
exposure modeling to help characterize risks associated with air toxics 
exposures. Furthermore, we have been working with our colleagues in the 
Office of Research and Development for nearly 2 years to develop the 
Agency's Air Toxics Research Strategy. This strategy helps us to 
prioritize our research efforts on health and environmental effects and 
exposures to ambient and indoor sources of air toxics. Over time, these 
activities will help us set program priorities, provide the public with 
risk information, and track progress toward meeting national air toxics 
program goals.
    In light of current uncertainties, some may suggest that EPA wait 
for more complete information before attempting to assess and address 
any risks from air toxics remaining after MACT. The flaw in this 
approach is that, in some cases, individuals may continue to be exposed 
to unsafe levels of toxics around these facilities while we fail to act 
based on information that is available now. For other source 
categories, available information may reassure concerned citizens that 
the facilities near them are well controlled. In the field of 
environmental protection, as in much of life, there are few decisions 
for which we would not like to have more information. The reality is 
that to avoid paralysis, we must make reasoned choices based on the 
information we have.
    Looking ahead, EPA has no preconceived notions of what residual 
risk analyses will show. Our plan is to use the available information 
to assess residual risks from each source category. We will use the 
most up-to-date credible and relevant information on chemical hazards. 
Taking into account uncertainties and the assumptions in the risk 
analysis, we will make a reasoned judgment as to whether the weight of 
the evidence supports requiring further emissions reductions to protect 
public health and the environment. If there is not sufficient evidence 
of a threat, EPA will not issue a residual risk standard. If toxic 
emissions are unsafe based on the framework provided by Congress, EPA 
will take protective action.
    Mr. Chairman, thank you for the opportunity to testify. I would be 
pleased to answer any questions that you may have.
                               __________
   Statement of Dr. Philip Hopke, Chair, Residual Risk Subcommittee, 
      U.S. Environmental Protection Agency Science Advisory Board
    Mr. Chairman and members of the committee, my name is Dr. Philip 
Hopke. I am testifying today as an individual, and I am honored to be 
here to discuss with you my views of the Residual Risk Subcommittee's 
(RRS) report on the residual risk methodology as described in EPA's 
Report to Congress (USEPA, 1999), as applied to the secondary lead 
smelter source category (USEPA, 2000). I chaired the RRS which is a 
subcommittee of the U.S. Environmental Protection Agency's Science 
Advisory Board's (SAB) Executive Committee. SAB is an independent FACA 
committee established by Congress. My testimony will reflect the 
consensus views of myself and the other members of the RRS, with added 
input and endorsement of the report from the SAB's Executive Committee.
    On March 1-2, 2000, the Residual Risk Subcommittee conducted a peer 
review of an Agency draft case study of the residual risk assessment 
methodology for the secondary lead smelter source category (USEPA, 
2000). The SAB understands that the Agency plans another iteration, 
including additional data collection and analysis before the results 
are considered for use in a regulatory context. The review of the 
seven-volume set of material focused on eight specific questions that 
are addressed in detail in the accompanying SAB report.
    In short, the Subcommittee concludes that the Agency developed a 
useful, self-described ``work-in progress.'' The methodology used in 
this interim work product, as far as it currently goes, is consistent 
with the methodology described in the Report to Congress. Further, many 
of the assumptions used are consistent with current methods and 
practice. The case study provides an example of how the approach 
presented in the Report might be implemented. However, it also raises a 
number of concerns that we have provided in our report on this document 
(EPA-SAB-EC-ADV-00-005 ``An SAB Advisory on the USEPA's Draft Case 
Study Analysis of the Residual Risk of Secondary Lead Smelters''). The 
major concerns will be highlighted here.
    Because the Subcommittee has not yet seen a full residual risk 
analysis and, thus, is unable to comment on the complete process, a 
number of important concerns were identified that should be addressed. 
Specifically, this interim analysis does not include the following 
important elements:
    (1) an ecosystem risk assessment
    (2) a health risk assessment that includes population risks
    (3) a full analysis of uncertainty and variability
    (4) a computer model for assessing multimedia transport and fate 
that has been adequately evaluated
    (5) a clear description of the process and how the assessments will 
be linked to the eventual risk management decisions.
    With respect to the specific approaches taken in the interim 
analysis, a number of questions are discussed in detail in the 
Subcommittee's report.
                       ecosystem risk assessment
    One of the greatest shortcomings of the case study in its 
incomplete State is that only the first stage screening analysis has 
been done for the ecological risk assessment. Even in this screening 
the top carnivore species were not included. This is the group of 
organisms at greatest risk from persistent and accumulated toxic 
chemicals. While the Office of Air Quality Planning and Standards 
(OAQPS) acknowledges that a full ecological risk assessment is needed, 
the Subcommittee is disappointed at the pace at which the assessment is 
being developed and implemented for ecology and natural resources. It 
would appear that a more concerted and scientifically complete analysis 
will be needed in order to meet the mandate of the Clean Air Act 
Amendments (CAAA) with respect to ecological risk.
         health risk assessment that includes population risks
    Regarding the health risk assessment portion of the case study, the 
Subcommittee finds that, within the limitations of data and resources, 
the approaches employed by the Agency were able to qualitatively 
identify potentially high human health risk situations. However, the 
Subcommittee also concluded that the currently available science 
presented in the working document is insufficient to be comfortable 
with the quantitative values estimated by the models currently used. In 
particular, the analysis calls into question the ability of the model 
to reliably quantify the amount of the deposited contaminant 
transferred in the food chain. In addition, the current risk assessment 
will have to be further developed in order to include population risks 
if it is to meet the needs of the Agency.
  computer model for assessing multimedia transport and fate that has 
                       been adequately evaluated
    The case of multimedia computer models is one of the other major 
areas with which the Subcommittee has concerns. It seems that the 
models were applied without due consideration of the plausibility of 
the assumptions and the physical meaning of the results. In several 
cases, results presented in the draft report were implausible in that 
the predicted concentrations would have produced immediately observable 
results on the affected human and ecological populations. For example, 
ambient lead concentrations measured because of the National Ambient 
Air Quality Standard for Particulate Lead could be used to test the 
concentrations at site boundaries of these facilities. Thus, it 
suggests that overly conservative estimates were likely to have been 
used. Such results could be eliminated if an iterative process were 
used in which implausible results are flagged so that the Agency can 
make appropriate revisions in the model and/or its inputs, and the 
model run again. A number of plausibility checks were described by the 
Subcommittee, and in public comments, that would provide checkpoints in 
the analysis and, thereby, indicate the need for alternative 
assumptions and recalculation. Inclusion of these checkpoints would be 
helpful to both the Agency and the reader.
    In addition the models being used need to undergo rigorous peer 
review. In this test case, a model, IEM-2M, originally used for mercury 
movement in the environment was modified for lead. However, this model 
was never rigorously reviewed even for its utility in the mercury 
modeling. The Agency has been developing a new multimedia exposure 
model, Total Risk Integrated Methodology (TRIM), that has undergone an 
initial review by the SAB that was encouraging. However, it appears now 
that the completion of this model and its use in risk assessment has 
been slowed so that it may not be available in the near term. This 
delay produces serious doubts in any of the assessments that have to be 
based on a temporary model that has not been subjected to careful 
external scrutiny.
              full analysis of uncertainty and variability
    The lack of a more rigorous treatment of uncertainty and 
variability may lend an aura of precision to the risk estimates in the 
case study that is not warranted and could, thereby, be misleading for 
Agency decisionmakers. In particular, the uncertainty analysis omits 
some important aspects of uncertainty and does not clearly distinguish 
between uncertainty and variability.
clear description of the process and how the assessments will be linked 
               to the eventual risk management decisions
    Moving beyond the strictly technical aspects of the document on 
which the SAB has been asked to provide advice, I would like to share 
with you my comments on what the subcommittee understood to be the 
Agency's intention to make decisions based on these results. 
Specifically, the Agency is mandated under Section 112(f) of the Clean 
Air Act to conduct the residual risk assessment and to make a decision 
about whether or not further regulation is necessary in order to 
protect public health and the environment. In particular, as stated in 
the Agency's response to the previous SAB review of the Report To 
Congress (SAB-EC-98-013), ``the decision made with the results of the 
screening analysis is [either] no further action or refine the 
analysis, while the decision made with the results of the more refined 
analysis is [either] no further action or consider additional emissions 
control.''
    As discussed above, as currently presented, the results of the 
refined analysis will provide essentially the same answer as the 
initial screening analysis; that is, an even more refined analysis is 
needed. Therefore, the case study has not achieved its decision 
objective, and another level of analysis or iteration is needed. A 
better-informed decision will be possible if the results of the case 
study more fully reflect both the best estimate of the risk combined 
with an adequate uncertainty/variability analysis that will more 
clearly define the range of risks.
    An important policy question arises as to how good do such residual 
risk assessments need to be. The understanding the RRS came to during 
its discussion is that when the form of controls specified in Title III 
was being considered by Congress a decade ago, the expectation for the 
level of these residual risk analyses was quite low. The scientific 
basis of risk assessment has grown considerably over the past 10 years 
and thus, the level of expectation from the scientific community such 
as those who have served on the SAB Subcommittee has risen 
considerably. Thus, the Subcommittee has expressed its concerns 
regarding future assessments.
    The present source class, secondary lead smelters, is a relatively 
data-rich category. Because of the existence of the lead National 
Ambient Air Quality Standard (NAAQS) and the concern for blood lead 
levels in children, there are more data in the vicinity of these source 
types than are likely to be available for other HAPs from other source 
types. The basic Congressional approach of imposing controls and 
assessing residual risk is a sensible response to the problem of HAPs 
emissions. However, the number of HAPs and the number of source types, 
coupled with the limited data on speciated emissions and quantitative 
dose-response information, makes the residual risk task into a 
substantial one.
    At this time, it appears that there have not been sufficient 
resources provided to EPA to allow their Office of Air Quality Planning 
and Standards (OAQPS) to collect and assess all of the pertinent data 
from EPA, state/local air quality, and public health agencies that 
could be fruitfully brought to bear on this problem. For example, the 
Subcommittee was told that it had not been possible to get the lead 
NAAQS monitoring data from AIRS to provide checks on the fugitive 
emissions estimates because of resource limitations.
    There are certainly not sufficient resources to permit the testing 
of specific HAPs for their toxicity if those dose-response data are not 
already available. Such testing would be expensive and may not be the 
best use of limited resources. In the case of secondary lead smelters, 
only seven of the 50 identified HAPs were excluded from the residual 
risk assessment due to the lack of dose-response data. This lack of 
data will likely pose much greater problems when other source 
categories are addressed in the future. Such data gaps could lead to 
the omission of compounds from the assessment, resulting in a 
subsequent underprediction of the residual risk. It may be possible to 
utilize computational chemical methods to provide at least an 
estimation of the possible risk. However, that would require some 
limited additional effort.
    Accordingly, I wish to use this opportunity to express the RRS's 
concern regarding the level of analysis that can and should be done to 
assess the residual risk as part of the control of hazardous air 
pollutant emissions. The RRS believes it is possible to provide more 
quantitative and useful human health and ecological risk assessments 
than is currently envisioned for a reasonable investment of additional 
resources for data collection and some additional outside expertise as 
appropriate. The resulting assessments will be much more credible.
    As we all know well, science alone does not a decisionmake. Science 
can inform but policy decides when making regulatory judgments. I say 
this, because many non-scientific considerations are taken into account 
when making decisions (e.g. legal precedent, policies, values, 
economics, technical feasibility, etc.). Each must be considered 
carefully and applied wisely if the decisions are to be effective and 
widely accepted by the public. However, while the decision inputs based 
on values, politics and other social considerations are often 
debatable, we expect the science to be based on facts determined by 
measurable, repeatable observations of nature. More explicit 
recognition of this problem by members of Congress could help the 
Agency carry out its duties more effectively and could help provide the 
public with a clear understanding of how Congress interprets National 
priorities.
    I want to express my gratitude to the members of the Committee for 
inviting me and giving me the opportunity to discuss the SAB Residual 
Risk review message with you. I look forward to your questions.
                                 ______
                                 
 Responses by Philip Hopke to Additional Questions from Senator Baucus
    Question 1. Are you suggesting that we stop the residual risk 
program until the quality of risk assessments can be improved or are 
you saying that, with some additional effort, this program will work? 
If you agree with the former point, when will we know whether the 
appropriate level of quality has been reached to justify regulating?
    Response. I believe that adequate quality residual risk assessment 
can be performed, but that some additional effort will be needed to 
perform them at a reasonable level of sophistication. The purpose of 
the residual risk assessment is to be ascertain with a reasonable level 
of certainty that no undue risk remains after MACT is put in place. The 
keys are to be able to use what data and other information that are 
currently available to make it clear that a sensible approach is being 
taken to estimate the risks. The scientific community wants to make 
sure that all of the details are dealt with as best we know how so when 
we observe that there are insufficient resources to poll EPA's own data 
base to compare modeling results with measurements, we feel that there 
is something wrong with the process.
    There will never be perfect models, but we want to use the best 
model possible. When the choice is between an unreviewed model 
developed for another purpose and a general use model like the Total 
Risk Integrated Methodology (TRIM) that received favorable initial 
reviews because it tries to provide a more complete picture of reality, 
it makes sense to vigorously complete TRIM rather than continuing to 
use the more limited model. It bothered our committee that there was 
not a clear commitment to get TRIM into service as quickly as 
practical.
    It also did not appear there was a clear plan about how to deal 
with toxic species for which quantitative dose/response data are 
available. We are not advocating expensive toxicological testing, but 
we do believe that some focused structure/activity relationship 
calculations could set some credible upper bounds on the risks for 
these untested species.
    Thus, the major problems we saw with the process did not require 
major new efforts but rather the ability to utilize data EPA already 
had on hand, the Agency's ability to complete the model development and 
testing they already had underway, and their ability to provide a 
logical framework to deal with the toxic species for which quantitative 
data are not and will not be available. We envisioned that a reasonable 
increase in effort could ameliorate these problems.

    Question 2. Do you have any idea of the resources that might be 
necessary for it to work well?
    Response. I do not have a specific dollar figure as I am not sure 
of typical contractor (researcher?, model developer?) costs. However, 
there is also added value for these costs. For example, the EPA has a 
variety of uses awaiting the completion of TRIM and thus, the value in 
completing and testing this model provides a much greater benefit than 
for the residual risk program alone. I would anticipate that a modest 
calculational chemistry effort with an appropriate academic group could 
provide the unit risk estimates for the unmeasured dose/response 
values. Given the risk reduction that can be reasonably anticipated as 
coming from MACT, it is sensible to limit the costs associated with the 
residual risk estimation. However, given the costs to implement MACT, 
the regulated industries as well as the potentially exposed individuals 
should be able to have reasonable confidence in the results of the 
analysis.

    Question 3. During the hearing, I believe you indicated that 
``Congress should clarify how good is good enough,'' in terms of the 
quality of the risk assessments for further regulation. Does that mean 
that you advocate amendments to the Clean Air Act to provide such 
clarification?
    Response. Yes. It is hard for those involved in the risk assessment 
to determine the level of assessment needed as the basis of regulatory 
decisionmaking. Our natural inclination is always to do the most 
detailed and quantitative analysis possible. However, that is likely to 
be more detailed, more precise and far more costly than is needed for 
the purpose of determining if further controls are needed to protect 
the health of those living in the vicinity of such facilities. Clearly, 
EPA has a view of how much effort is needed based on their perception 
of the development of the 1990 Amendments. However, since there is no 
clear record of what was intended at that time, it is hard for people 
coming into the process to decide how much effort and rigor are 
required. Thus, a clearer view of the political context of the risk 
assessment process would be helpful to everyone involved in the 
accomplishment and review of this task.
                                 ______
                                 
  Responses by Philip Hopke to Additional Questions from Senator Smith
    Question 1. Are the SAB's recommendations for residual risk 
assessment, such as inclusion of ecosystem risk assessment, population 
risks, etc., . . . , also valid for conducting ``comparative risk 
assessment''?
    Response. Yes, we certainly want to understand the risks to the 
broader population as well as to the most highly exposed individuals. 
It is also important to judge the ecosystem risks. Clearly, the public 
values all of these factors. The relative ranking of these different 
risks, however, is a management decision that needs to take other 
factors into consideration in coming to decisions. There is no simple 
scale of comparability between risks to individuals, to populations, 
and to ecosystems that would permit an approach to ranking overall 
risks. They must all be included in the evaluation of the options in 
order to make the most well informed decision possible.

    Question 2. Dr. Lippmann testified that a major part of the problem 
with the current EPA risk assessment stems from having 2 very different 
cultures of risk assessment: (1) for carcinogens and (2) for other 
toxicants. Are your findings consistent with this being the source of 
the problem?
    Response. I think the problems are more complex than simply culture 
differences within the Agency and come back to some of the discussion 
we had at the hearing regarding the stovepipe approach that governs 
much of the Agency's organization and practice. For example, lead in 
airborne particles is a criteria pollutant for which a National Ambient 
Air Quality Standard is defined under Title I while according to the 
Clean Air Act, lead compounds are hazardous air pollutants under Title 
III. We need to take a more holistic view of the specific problem of 
air quality and the broader issues of environmental quality management. 
To a significant extent such a major change in conceptualization must 
come from Congress since the natural tendency of the Agency will always 
be to organize around major facets of the governing legislation.
    Some of the problems associated with the risk assessment process 
stem from differences in the level of information available to the risk 
assessor. There is a much richer data base for possible health impacts 
of ambient pollutants like the criteria pollutants. The data regarding 
cancer risks is much more limited. As we obtain a better understanding 
of the molecular basis for cancer, some of this data disparity will be 
eliminated, but that will take some time. The question then arises as 
to how conservative we feel we need to be in estimating the risks and 
how well these assumptions that are made in conservative risk 
assessments are explained and justified to the regulated industries and 
the public.
    With respect to our findings concerning the residual risk process, 
I do not think this dichotomy of information availability is the 
problem. The problem is more related to the lack of clarity in defining 
how confident in the quantitative results the Agency need to be in 
order to make regulatory decisions and what needs to be done in order 
to attain such quality of results. In the absence of this definition, 
reviewers typically will demand more detail and the highest level of 
analysis in order to minimize the uncertainties.
  Statement of Felice Stadler, National Policy Coordinator, National 
             Wildlife Federation's Clean the Rain Campaign
    Thank you, Mr. Chairman, for providing me the opportunity today to 
submit comments on the U.S. Environmental Protection Agency's residual 
risk program.
    My name is Felice Stadler, and I coordinate the National Wildlife 
Federation's national Clean the Rain Campaign. The campaign seeks to 
raise public awareness about how toxic air pollution contaminates our 
lakes and streams and advocate for national and local policies to 
phaseout the emissions of mercury and other persistent bioaccumulative 
toxics. In my testimony this morning I will explain why emissions of 
toxic air pollutants must be reduced by residual risk standards. While 
we recognize that EPA needs to refine its methodology for performing 
residual risk assessments, we firmly believe that the program must be 
preserved and adequate resources be provided to allow the agency to do 
the critical assessments needed to protect humans and wildlife from 
actual harm.
    This is a timely subject. As you know, mercury is a highly potent 
neurotoxin. Just 2 weeks ago, the National Wildlife Federation released 
a report showing that mercury levels in New England's rain are up to 
four times as high as EPA's standard for aquatic life in surface 
waters. One year ago, the National Wildlife Federation released a 
similar report showing even higher mercury concentrations in rain 
falling on Great Lakes states. When mercury-laden rain falls into 
lakes, it contaminates the water, the fish and other aquatic life 
living in the water, and the people and wildlife who eat the fish. This 
example illustrates the importance of reducing the emissions of toxic 
air pollutants that are daily contaminating our rain, our lakes, our 
fish and our children.
    As you are aware, Congress amended the Clean Air Act in 1990 to 
establish a more effective program to reduce toxic air pollution. 
Congress required major sources that emit any of 188 listed toxic air 
pollutants to meet performance standards based on the best industry 
practices to minimize toxic releases.
    Over the past decade, we have witnessed a significant reduction in 
toxic air pollution emitted by large and small industry throughout the 
United States. Over 20 technology-based rules have been finalized, 
affecting over 48 categories of major industrial sources. Each year 
these rules will remove approximately one million tons of over 100 
different air toxics--almost 10 times greater than the reductions 
achieved between 1970-1990. (U.S. EPA, 1998, Taking Toxics out of the 
Air: Progress in Setting Maximum Achievable Control Technology 
Standards Under the Clean Air Act, EPA/451/K-98-001)
    Have those reductions solved the air toxics problem in communities 
and ecosystems throughout the United States? Certainly not. People and 
wildlife continue to be exposed to toxic air pollution which harms 
their well-being.
    I have already alluded to the contamination of our waters by 
mercury. Mercury emitted into the air is the leading cause of mercury 
pollution in the Nation's lakes and streams. The National Academy of 
Sciences recently reported that over 60,000 children a year may be 
adversely affected by exposure to mercury in the womb. Forty one states 
and territories have issued formal advisories warning people to 
restrict or avoid eating the fish they catch because of mercury 
contamination. Scientists have documented harmful changes in 
reproductive patterns in loons exposed to mercury.
    Dioxin is another persistent bioaccumulative toxic air pollutant. 
It is the most potent carcinogen and reproductive toxin EPA has ever 
evaluated. Dioxin levels measured in food are above those that 
scientists believe are harmful to people and wildlife.
    Clearly, only part of the problem has been addressed, and it is 
vitally important that EPA move to the next phase of its national air 
toxics strategy, the residual risk program. If EPA is prevented from 
implementing the risk-based element of its air toxics strategy, 
significant air toxics problems will remain. There are three main 
reasons to move forward with the residual risk program.
    First, without a residual risk program, EPA will not be able to 
address the harm from the most toxic air pollutants, those that, like 
mercury and dioxins, persist and bioaccumulate in the environment. This 
special class of pollutants is harmful at extremely low levels, and 
uniquely harmful to people and wildlife because they become 
increasingly toxic as they move up the food chain. For example, mercury 
is one million times more toxic in fish than in surrounding water, so 
when we eat fish we are consuming concentrated mercury. Those most 
vulnerable to the effects of these toxic compounds include unborn 
children, women, low-income communities, and communities of color. EPA 
is not required to address the full extent of the harm posed by these 
most toxic compounds through technology standards. Therefore, the 
residual risk program is critical to ensure these unique risks are 
appropriately addressed.
    Second, EPA's technology standards do not take into account the 
cumulative risk that occurs when industrial sources are concentrated in 
an area. There are hundreds of communities throughout the country that 
face a disproportionate risk from exposure to toxic air pollution 
because of heavy concentrations of industrial sources. In Memphis, 
Tennessee, you can see sources of toxic air pollution in every 
direction--a petroleum fueling station, a six-lane highway, a refinery, 
a lead smelter, and a factory. Less than a block away from these 
sources, there is low-income housing and a playground. Unfortunately, 
this picture is not unique. Risk-based programs enable EPA to evaluate 
these real life scenarios that are all too common for countless 
citizens.
    Third, Congress and EPA never intended the technology-based program 
to address entirely all toxic emissions from all listed sources. 
Technology-based standards provide the best industry can offer at the 
time they are imposed, but this does not necessarily translate into 
being the most stringent or comprehensive approach. In fact, when EPA 
issued the proposed Portland cement kiln rule 2 years ago, EPA 
announced it would evaluate the need to make the standard more 
stringent to address mercury emissions as part of the residual risk 
phase.
    It is EPA's tentative conclusion, however, that concerns as to 
health risks from mercury emissions from these sources may be 
appropriately addressed pursuant to the timetable set out in the Act, 
namely through the residual risk determination process set out in 
section 112(f) of the Act. 63 Fed. Reg. 14202.
    The residual risk program allows the agency to revisit a regulatory 
decision once more information has been collected and the effect of the 
initial rule has been evaluated. Without the residual risk program, 
this category of sources, and others like it, would likely never be 
adequately regulated under the Clean Air Act.
    In conclusion, I want to raise the issue of uncertainties relating 
to the residual risk program. Every risk assessment must contend with 
uncertainties--who is exposed, how much they are exposed to, the health 
effects of pollutants. Requiring every uncertainty to be addressed 
before taking action would effectively mean no action will be taken. 
EPA is refining its tools to carry out the residual risk program, and 
should be given the opportunity to go forward and implement the 
program. But policy paralysis will be the result if EPA is required to 
address every uncertainty before acting; our children will be the most 
directly affected by delay.
    Finally, I would like to close with two recommendations to improve 
how we regulate sources of air toxics. First, the risks to people and 
wildlife from the most toxic pollutants--those like mercury and dioxins 
that bioaccumulate and persist--are well established: any release of 
these pollutants causes harm. For that reason, in international 
agreements the United States has committed to ``virtual elimination'' 
of these pollutants. To properly address the unique risks posed by 
these pollutants, EPA need not engage in complicated risk analysis; 
instead, it simply needs to set a schedule for phasing out the 
emissions of these chemicals from all sources, and then apply 
progressively lower emissions standards to meet that goal.
    Second, rather than merely relying on pollution controls to solve 
the Nation's air toxics problem, we urge Congress and the agency to 
look at solutions that encompass pollution prevention. This applies to 
both the technology-based program and the residual risk program. EPA 
has the tendency to assume that all pollution is unavoidable and that 
bolting on technology will solve the problem. Instead, it is time for 
EPA to begin to assess what pollution could be avoided altogether and 
develop policies that reflect a commitment to more sustainable and less 
toxic solutions.
    I thank the committee for inviting me to testify and welcome the 
opportunity to answer any questions.
                                 ______
                                 
 Responses by Felice Stadler to Additional Questions from Senator Smith
    Question 1. Do you agree with the SAB's recommendations to improve 
the EPA's risk assessment?
    Response. Yes. We agree that EPA could improve upon its risk 
assessment, especially its analysis of ecological impacts. However, we 
would reiterate the overarching comment made by the Chair of the SAB: 
with adequate resources, EPA could overcome several of the limitations 
noted, including data collection and refinement of analyses.

    Question 2. Does the public, in your opinion, benefit from 
participating in a CRA project?
    Response. Yes. It is essential for the public to have the 
opportunity to participate in comparative risk assessment projects, 
especially those conducted on the State or local level. Because the 
process itself is strongly value laden, all stakeholders should have an 
opportunity to provide input on how to prioritize issues of concern. 
Local communities are at the front lines of the pollution problem, and 
often do not have the resources to become engaged in policy discussions 
at the State or Federal level. Any dialog that takes place that 
determines which risks become a priority must involve communities most 
directly affected by those decisions.
    In general, NWF does not endorse using CRA's to drive policy 
decisions. While intellectually this technique has some appeal, it 
raises a lot of questions and concerns. For example, how easy is it to 
compare two different types of activities (air emissions vs. water 
discharges), one chemical to another (benzene vs. mercury), one health 
endpoint to another (neurodevelopmental effects vs. cancer). In 
addition, CRA's would result in key questions never getting raised, 
questions of responsibility: Who is responsible for the pollution? Can 
the pollution be prevented? What tools are available to reduce the 
pollution? These questions are critically important and must be central 
to any pollution policy decisions.

    Question 3. Some have criticized EPA's risk assessments, saying 
that they are too conservative. Do you believe that to be the case?
    Response. No. The SAB did not consider conservative modeling to be 
inherently improper, either. Rather, it was concerned that EPA failed 
to validate conservative modeling by checking predicted outcomes 
against known outcomes.
    We support the use of conservative modeling. Policy decisions 
should be made with the information at hand, rather than delaying 
action in the face of uncertainty. We will never have the luxury of 
knowing the answer to every scientific question before needing to act.
    In fact, EPA does not always use conservative assumptions. EPA has 
been criticized repeatedly for designing risk assessment models based 
on what is safe for healthy, adult, white men. For this reason, EPA 
needs to be conservative in order to avoid underestimating risks to the 
most vulnerable populations children, the unborn, women, elderly, and 
people in overburdened communities.
    Moreover, EPA does not appear to be using conservative assumptions 
with respect to non-carcinogenic HAPs, which may make the risks posed 
by carcinogenic HAPs seem greater. EPA should address the disparity in 
the treatment of carcinogenic and non-carcinogenic HAPs in two ways. 
First, EPA should assess the risks of the most harmful non-carcinogenic 
HAPs persistent, bioaccumulative toxic substances, such as mercury--
using assumptions that are no less conservative than those used in 
assessing the risks of carcinogenic HAPs. Second, as the SAB 
recommended, EPA should develop and make greater use of uncertainty and 
variability (``U&V'') analyses. U&V analyses can be used to compare and 
adjust the results of conservative and non-conservative risk 
assessments.
    In sum, using conservative assumptions and modeling is not 
inherently inappropriate because we are dealing with HAPs, which are 
causing real harm not merely creating a risk of harm to human health 
and environmental integrity.

    Question 4. Some of the witnesses have indicated that Congress 
needs to step in to provide EPA additional time prior to requiring 
regulations to reduce residual risk. Their main reasons for proposing a 
delay are the quality of risk assessments, the lack of sufficient 
resources to conduct these assessments, and the need for Congress to 
clarify what it considers to be a good risk assessment. What are your 
views on these reasons?
    Response. EPA is making a concerted effort to refine its risk 
assessments in order to meet the deadlines imposed by the Clean Air 
Act. Any delay of those deadlines will result in prolonged exposure to 
HAPs. Rather than extend the deadlines, then, Congress should focus on 
fully funding EPA's air toxics program. Congress is currently not doing 
this, which impairs and inhibits the quality and speed with which the 
agency can complete its initial screening assessments and its detailed 
risk assessments.
    Congress should not attempt to delve into the scientific 
complexities of residual risk by trying to clarify what constitutes 
``good risk assessment.'' The field of risk assessment is continually 
evolving in scientific circles, and EPA is working to track these 
developments and update its methodology to reflect the new approaches 
that are emerging. Congress does not have the expertise to determine 
whether EPA's risk assessment is sound. If Congress is interested in 
the evolving science of risk assessment, we respectfully suggest it 
should request annual briefings from EPA on this subject.

    Question 5. Would NWF support requiring HAP emitters to provide 
financial support for conducting residual risk assessments?
    Response. NWF would support such a requirement only if HAP emitters 
do not receive in exchange any influence over the design or performance 
of the assessments. Furthermore, should EPA choose to contract with an 
independent firm to conduct an assessment, EPA must first screen the 
firm to ensure the absence of any conflict of interest, and must 
closely oversee the guidelines and protocols the firm uses.
    Allowing a single source or a category of HAP emitters to conduct 
residual risk assessments for their own facilities would be 
problematic. As you heard at the Senate hearing, issues like 
uncertainty are often driven by values and priorities rather than 
scientific justification. Given this fact, a risk assessment conducted 
by a HAP emitter would be suspect.
    In addition, a risk assessment conducted by a single source likely 
would not take into account the impact of pollution from neighboring 
sources. It would look only at emissions at its own fence line. 
Cumulative exposures are critically important and must be addressed 
through the residual risk program.

    Question 6. You mentioned some of the flaws associated with the 
existing process by which EPA assesses risk--the lack of consideration 
of cumulative risk, transgenerational risk, etc. How could EPA improve 
its process?
    Response. EPA could begin to improve its process by setting clear 
priorities based on the type of pollutants being emitted. Toxic 
compounds that bioaccumulate and persist in the environment, that 
contaminate our food supply, that are easily passed from mother to 
child, and that damage critical organ systems, should be phased out. 
EPA could simplify its risk assessment approach and make policy 
decisions based on the inherent toxicity of this special class of HAPs, 
concluding that they should be handled differently.
    In terms of addressing cumulative risk, for compounds that are both 
air and water contaminants, and possibly food contaminants, EPA must 
consider all these different routes of exposure when calculating risk. 
Evaluating the risk of inhalation alone is inadequate. If EPA's air 
division does not address multi-pathway exposures in its risk 
assessment, and if there is evidence that other routes of exposure are 
likely, the inhalation risk level should serve as the floor rather than 
the ceiling. In this case, we would argue that the most conservative 
minimum risk level one in one million should be used for cancer and 
non-cancer effects to protect the most vulnerable populations.
                               __________
   Statement of George E. Parris, Ph.D., Director, Environmental and 
         Regulatory Affairs, American Wood Preservers Institute
                                preface
    We are honored to address the Senate Committee on Environment and 
Public Works. We are also honored to speak for the American Wood 
Preservers Institute, which represents an industry of many small 
businesses that has been instrumental in the economic growth of this 
country by making railroads, marine shipping, rural electric utilities, 
telecommunications and house construction economically feasible while 
conserving our forest resources.
    The American Wood Preservers Institute strongly supports the use of 
quantitative risk assessment and risk-cost-benefit analyses in 
regulatory decisionmaking. Without these inputs from the real world, 
regulatory decisions would be based on intuition and political 
considerations. However, the risk assessment methodology is evolving 
and must reflect our current understanding of science; and the cost and 
benefits analyses must consider both direct and indirect impacts 
(inside and outside the regulated community). When applied objectively, 
risk assessment and risk-cost-benefit analyses are the foundation of 
rational policy, regulations, and standards. Unfortunately, when 
obsolete risk assessment techniques are applied and cost and benefits 
are selectively chosen for consideration, politically motivated policy, 
regulations and standards can masquerade as being unbiased and 
rational.
      part i. the role and value of risk-cost-benefit analysis in 
                             decisionmaking
    The regulations and standards for protection of human health and 
the environment that are promulgated to implement environmental 
statutes (1) must use scientifically valid methodologies, (2) must be 
applied consistently so that decisionmakers apply finite resources in 
the most efficient way, and (3) must be reasonable in terms of 
balancing risks, costs and benefits (i.e., they must meet a reasonable 
threshold of utility).
    The Congress (not bureaucrats or political appointees of the 
Executive branch) must set broad policy guidelines for (1) acceptable 
risk, (2) equitable allocation of finite resources to reduce risks, and 
(3) minimum requirements for risk reduction per unit of money spent by 
government or the private sector to justify action.
    The wood preserving industry provides examples of the types of 
problems that we believe are currently common in environmental laws, 
regulations, standards, and enforcement policies. I will address some 
of these here:
  part ii. the methodology of risk assessment must be scientifically 
                                 valid
    The risk of contracting fatal cancer underpins of most of our 
environmental standards and the public perception of risk of many 
activities and products. Since most of the communicable diseases that 
killed millions of children and adults in previous generations have 
been tamed by better hygiene and antibiotics, cancer has become the 
leading unpredictable and uncontrolled risk in most peoples' lives. In 
turn, quantitative risk assessment methodology has been introduced to 
attempt to make the risk of cancer predictable and to provide a 
rational basis for control of that risk.
    However, the risk assessment methodology that is still used today 
was invented primarily between 1930 and 1970 at a time when our 
understanding of the nature and cause of cancer was very rudimentary. I 
want to briefly recount the history of our quantitative risk assessment 
methodology and show how it needs to be changed to reflect current 
scientific knowledge in biochemistry and genetics (see appendix).
    It should be noted that the regulatory agencies have clung 
tenaciously to the original concepts in spite of growing evidence that 
they are inapplicable in most cases. The exercise of prudence is 
certainly a desirable trait in a regulatory agency, but the credibility 
of the regulatory agencies (particularly the U.S. Environmental 
Protection Agency) is being eroded among knowledgeable observers 
because they are currently so far behind the state-of-the-art.
    My industry is currently affected by EPA risk assessments for 
dioxins and arsenic. We believe that the methodology used in these risk 
assessments is fundamentally flawed (as discussed below) resulting in 
risk projections that are so large that the EPA is being led to actions 
which will unnecessarily limit the use of our products and which will 
cause unnecessary alarm in the general public.
Clearly Many Carcinogens Should Not be Assessed by the Target Theory
            (1) The Fundamental Requirement of the Target Theory is Not 
                    Met
    The fundamental requirement of the target theory (linear no-
threshold [LNT] model) of mutagenicity/carcinogenicity is direct damage 
to the DNA independent of any biochemical system. Few chemicals have 
been shown to directly damage (e.g., form adducts with) DNA. Some 
chemicals have been shown to form adducts with DNA after being 
metabolized to active electrophiles or free radicals. Unless, such 
reactions are demonstrated in vitro, there is no scientific 
justification for applying the target theory (linear no-threshold 
model) of risk assessment.
            (2) The Target Theory Ignores Chemical and Physical 
                    Modulation of Dose 
                    Efficiency
    Most chemical and physical barriers that stand between a chemical 
as dosed and the DNA target of mutation are progressively less 
effective as the dose of the chemical increases. In many cases, there 
may be a threshold below which a chemical agent never reaches the DNA. 
Thus, we would expect most dose response curves to be non-linear, i.e., 
sub-linear.
            (3) The Target Theory Ignores DNA Repair
    The existence of DNA repair mechanisms means that even for direct 
acting genotoxic agents (e.g., x-rays), the dose-response curve should 
be sub-linear at low doses. Since DNA repair occurs after a damaging 
event, DNA repair would not require, an absolute threshold, but the 
quantitative difference between a true threshold (i.e., zero risk) and 
a sub-linear dose-response curve may be un-measurable.
            (4) The Target Theory Incorrectly Assumes that Mutant Cells 
                    Progress to 
                    Cancer
    Many cell clones in the body contain mutations, they normally do 
not progress to cancer because (i) they are not immortal and hence 
become extinct before clinically significant tumors develop or (ii) 
they are triggered to undergo apoptosis by proteins that scan the DNA.
Most Carcinogens are Threshold Carcinogens
    There are many mechanisms through which a chemical can indirectly 
cause genotoxicity that leads to cancer. Even in those cases where 
direct genotoxicity has been observed, indirect mechanisms may be the 
principal contributor to genotoxicity at high doses. The importance of 
recognizing that fact and developing our risk assessment policy around 
this concept is that for those cases, there is a threshold of exposure 
below which the risk is effectively zero. By managing exposures 
(through appropriate regulation) such that the total exposure is below 
the appropriate threshold, a very high level of health protection can 
be provided with great flexibility in compliance that lead to health, 
environmental and economic benefits.
    In practice the thresholds can be established two ways: (1) 
epidemiologically (bioassay and environmental) and (2) biochemically. 
The biochemical approach involves determining in vitro threshold of 
genotoxicity (it is not necessary to determine the mechanism of action) 
using appropriate tissue cultures and determining what the attenuation 
factor is between environmental medium and blood plasma (e.g., what 
concentration in drinking water is required to give the concentration 
in blood plasma equal to the genotoxic threshold determined in vitro).
   part iii. the cost and benefit analyses must consider direct and 
                            indirect impacts
(1) Comparative Risk Assessment
    The Environmental Protection Agency has excused itself from 
explicit compliance with the National Environmental Policy Act (NEPA) 
on the grounds that rulemakings by the USEPA are equivalent to the 
analysis required in an Environmental Impact Statement (EIS) under 
NEPA. Unfortunately, that policy has resulted in the programs 
implemented by the USEPA including the regulation of waste (RCRA), 
water (SDWA), air (CAA) and remediation of environmental contamination 
(CELERA) taking unexpected and undesirable directions. Basically, the 
USEPA has developed implementation approaches that focus on only one 
element of what is actually a multi-component situation. I will discuss 
the environmental remediation program under CERCLA (Superfund) as an 
example.
    Basically, the decisions concerning (1) whether or not to remediate 
and (2) what the target final concentration of contaminant should be 
are driven either by compliance with applicable or relevant and 
appropriate requirements (ARARs) or a toxicological risk assessment 
that addresses the potential risk to persons who may (or may not) 
actually live on the contaminated land and may (or may not) actually 
drink the groundwater, etc. Notice that all the focus is on hazards and 
risk caused by the chemical (usually toxicological) in the contaminated 
media. Once the chemical risk (usually carcinogenic risk) to the people 
who are exposed (or who may possible be exposed in the future) is 
deemed to be above a target set by policy (e.g., 40 CFR 300.430) the 
process is committed to a course of action that requires remediation.
    There is a major flaw in this approach. Fundamentally, the 
decisionmaking guided by the regulation disregards all other risks and 
impacts of the proposed action. If you look at environmental 
remediation projects, what you discover is that they are basically 
construction projects. They involve drilling wells, pumping water, 
excavating soil, hauling soil and debris from place to place (often on 
public roads), construction and operation of treatment systems, etc. 
Disregarding the chemical or radiological hazards to workers and the 
general public associated with these projects (including the potential 
hazards presented to people living near landfills where waste may be 
disposed offsite), the construction work and transportation alone 
represent risky operations (especially when protective clothing for 
protecting workers from chemical risks are factored in because they 
usually increase heat load, restrict vision and make the worker more 
awkward). Construction projects, of course, also involve environmental 
impacts (e.g., damage to habitat or taking of wildlife).
    It would be desirable to have a more balances weighting of risk in 
the CERCLA program so that the presumption that remediation is always 
preferred can be analyzed.
    Another example where narrow focus on one element of risk can 
produce undesirable conclusions is associated with the use of wood 
preservatives. For example, unnecessarily limiting the use of a wood 
preservative because of erroneous risk assessments might result in the 
harvesting of more trees (depletion of natural resources) and more 
accidents and deaths in the logging and sawmill industry.
(2) Balancing Risks, Costs and Benefits
    There should be some reasonable analysis of costs, risks and 
benefits associated with regulations and standards. The wood preserving 
industry has provided clear examples of poor risk-cost-benefit 
decisionmaking by the USEPA. In the 1992 budget process, it was pointed 
out that the hazardous waste regulations for wood preservatives cost 
5.7 Trillion dollars per avoided premature death! This set a record for 
inefficient use of our financial resources. Viewed differently, 
spending $2 million on highway safety saves at least one life in a few 
years, but spending the same amount on controlling waste from wood 
preserving does not save a life over a million years. Obviously, the 
benefits of such regulations are insignificant, while the costs are 
very real.
    In the cases of the current debate over the regulation of arsenic 
in drinking water, it should be embarrassing for USEPA regulators to go 
to international conferences where scientists from West Bengal and 
Bangladesh describe real, widespread, overt clinical signs of chronic 
arsenic intoxication from drinking water at levels of arsenic 
approaching 1,000 ppb and then argue that the United States should 
spend billions of dollars to reduce the concentrations of arsenic in 
drinking water from 50 ppb to 5 ppb, when benefit of such a move are at 
best hypothetical. The only cases that the USEPA claims show any damage 
at the current regulatory standard in the U.S. are actually among 
people that are not covered by the current standard and would not be 
covered by the standard because they are on private wells.
    Interestingly, USEPA cost estimates for implementation of the 
current proposed maximum contaminant limit (MCL) for arsenic only 
addresses some of the most obvious cost (e.g., treatment equipment) to 
the ``regulated community'' i.e., public water utilities. The cost of 
acquiring land to build a treatment plant on and the cost of waste 
disposal are severely underestimated or ignored by the USEPA. Moreover, 
entire classes of economic impacts are not even mentioned by the 
USEPA's proposal. For example, the MCLs are routinely adopted as 
applicable or relevant and appropriate requirements for CERCLA 
remediation and in this way, the new MCL for arsenic will affect the 
wood-treating industry.
    Even private real estate values may be affected by the new arsenic 
MCL. Suppose that you are a private land owner with a well with 40 ppb 
of arsenic from natural sources. Currently if you sell your house, 
there is no issue about the purity of the water. But, if the MCL for 
arsenic were reduced to 5 ppb, you would need to disclose that your 
well was ``contaminated'' to prospective buyers. Moreover, the cost to 
cure this ``defect'' by installing a point-of-use treatment device will 
cost (by the USEPA's estimates) several hundred dollars each month 
(forever). Considering that typical mortgages (principal and interest) 
are $1,000 to $2,000 per month, an additional burden of e.g., $300 per 
month will necessarily reduce the value of the real estate by 15-30 
percent. It implication for property values in large parts of the 
western United States, Michigan, Wisconsin, Minnesota and other states 
is staggering.
    Ignore the proposed MCL for arsenic for a moment and focus on the 
underlying risk assessment. Heretofore, the USEPA has used similar risk 
assessments to estimating the risk associated with soil contamination 
and pesticides residues (which have exposure scenarios that have 
nothing to do with water). But, because the USEPA retained a drinking 
water standard that was consistent with a much lower level of concern 
about arsenic, the risk assessment per se was not burdensome. Now that 
the USEPA is accepting the risk assessment as the driver for regulation 
of drinking water, the implications for other modes of exposure are 
enormous. The risk assessment will be used in the waste programs, the 
pesticide programs, in the air programs as well as the water programs.
    Finally, in the context of risk-cost-benefit analysis, I would like 
to report arsenic contamination of the Madison River in Wyoming. At the 
source, the concentration of arsenic is 360 micrograms per liter and 
the pollution can be traced at least 470 km downstream until the 
Madison River joins the Missouri River where the concentration of 
arsenic is still 19 micrograms per liter. I am sure that if this were 
caused by a wood preserving plant, our industry would be expected to 
pay whatever cost was necessary to stop this flow of arsenic. But, the 
source of the arsenic (and other toxic metals) is the Yellow Stone 
National Park.
                                 ______
                                 
                                Appendix
  history of the evolution of quantitative risk assessment for cancer
    1850: LRemember that the microscope was not invented until the 
early 1800's and that led to the discovery of cells and the 
identification of chromosomes (i.e., condensed forms of DNA visible 
under a microscope during the cycle of cell division).

    1870: LThe concept of inheritable traits was introduced in the 
period 1850-1870 by Gregor Mendel (1822-1884)

    1890: LThe role of microbes in causing some diseases was not 
understood until 1877-1887 through the work of Louis Pasture (1822-
1895)

    1890: LCancer was recognized as a disease in the 1800's, but it was 
not until the late 1800's that exposure to specific chemical substances 
was associated with the increased incidence of some cancers.

    1910: LIn the period 1890-1910 the work of Paul Ehrlich established 
the concept of dose-response relationships for pharmacology and 
toxicology. Much of this research also involved arsenic (III) which was 
one of the few effective drugs used to treat protozoal diseases 
(sleeping sickness and syphilis). Invariably, for a specified 
biological end point (e.g., acute toxicity) there were thresholds below 
which no effects were observed and the responses of individual members 
of the exposed population tended to fall into a bell-shaped curve 
(normal distribution). Integration of this bell-shaped curve produces 
an S-shaped curve known as the dose-response relationship (i.e., 
probability of effects at a specific dose).

    1920: LIt was not until the period 1908-1918 that chromosomes were 
linked to inheritable traits and mutations by Thomas Hunt Morgan (1866-
1945).

    1935: LDuring the early 1900's, radioactivity was intensely studies 
including the effects of x-rays on tissue. It was observed that (within 
the range of exposure considered) the frequency of mutations caused by 
x-rays was linearly related to the total dose (intensity x duration) 
not the intensity or the duration of exposure alone. This observation 
gave rise to the erroneous idea that (for x-rays) intensity did not 
matter and only the total dose needed to be considered.

    1940: L``Target theory'' became the acceptable way to predict 
damage to chromosomes (and hence mutations) through bombardment with 
agents (such as x-rays). This was consistent with the notion held at 
the time that (1) chromosomes normally were never damaged; (2) if 
chromosomes became damaged, they was never repaired; and (3) any damage 
to chromosomes would result in either immediate death of the cell of a 
mutant cell line.

    1953: LIt was not until 1953 that the structure of DNA making up 
chromosomes was explained by Watson and Crick.

    1961: LNormal cell clones were shown to be mortal (normally die 
after a set number of replications, i.e., generations) and cancer cell 
clones were shown to be immortal by Leonard Hayflick.

    1962: LSilent Spring published by Rachael Carson provoking 
systematic public fear of manmade chemicals.

    1970: LThe process of DNA repair was discovered and articulated by 
J.E. Cleaver and others while working on the cause of the inheritable 
disease xeroderma pigmentosum.

    1970: LThe U.S. Environmental Protection Agency was founded and 
began establishing policies concerning management of risk caused by 
manmade (industrial) chemicals. The target theory of mutations was 
accepted and extrapolated in two ways (i) it was applied across the 
board to chemicals (not just high energy radiation) and (ii) the theory 
was assumed to relate to cancer as well as mutations. Note that high-
energy radiation can go directly to chromosomes without passing through 
chemical or physical defenses present in the body. Chemical agents must 
pass through both chemical and physical barriers before reaching the 
nucleus and the DNA.

    1971: LRecombinant DNA discovered.

    1972: LApoptosis (programmed death and recycling) of stressed and 
damaged cells was articulated by Kerr, Wyllie and Currie.

    1992: LChromosome telomere shorting during DNA synthesis related to 
cell clone mortality.

    2000: LFormulation of a new model for cancer risk assessment in 
progress.
                               __________
                               U.S. Science Advisory Board,
                                                      May 19, 2000.
EPA-SAB-EC-ADV-00-005

Hon. Carol M. Browner, Administrator,
U.S. Environmental Protection Agency,
Washington, DC.

Re: Advisory on the USEPA's Draft Case Study Analysis of the Residual 
Risk of Secondary Lead Smelters

    Dear Ms. Browner: On March 1-2, 2000, the Science Advisory Board's 
(SAB's) Residual Risk Subcommittee of the SAB Executive Committee 
conducted a peer review of an Agency case study of the residual risk 
assessment methodology, described in its Report to Congress (USEPA, 
1999), as applied to the secondary lead smelter source category (USEPA, 
2000). The review of the seven-volume set of material focused on eight 
specific questions that are addressed in detail in the accompanying SAB 
report.
    In short, the Subcommittee concludes that the Agency has developed 
a useful, self-described ``work-in progress''. The methodology used in 
this interim workproduct, as far as it currently goes, is consistent 
with the methodology described in the Report to Congress. Further, the 
assumptions used are consistent with current methods and practice. The 
case study provides a valuable example of how the approach presented in 
the Report is going to be implemented.
    However, because the Subcommittee has not yet seen a full residual 
risk analysis and, thus, is unable to comment on the complete process, 
a number of important concerns were identified that should be 
addressed. Specifically, this interim analysis does not include the 
following important elements: an ecosystem risk assessment; a health 
risk assessment that includes population risks; a full analysis of 
uncertainty and variability; a computer model for assessing multimedia 
transport and fate that has been adequately evaluated; nor a clear 
description of the process and how the assessments link to the eventual 
risk management decisions. The attached consensus report contains a 
discussion of a number of additional issues related to the specific 
approaches taken in the interim analysis.
    Looking to the future and the 173 other source categories to be 
addressed in the residual risk program, the Subcommittee is concerned 
about the data gaps that are likely to be even more of a problem than 
they are in the case of secondary lead smelters. Both the Agency and 
the Congress need to recognize this problem in order to ensure that 
there is an adequate data base to support the residual risk analysis 
program.
    During the review by the Executive Committee, a number of important 
concerns were raised that will be the subject of a subsequent SAB 
Commentary. In addition, the Health and Environmental Effects 
Subcommittee (HEES) of the SAB's Council on Clean Air Act Compliance 
Analysis (COUNCIL) and the Agency will host a June 2000 workshop on 
dealing with hazardous air pollutants (HAPs). The workshop and its 
outcomes could prove useful insights that are applicable to the 
implementing of the Residual Risk Program.
    We appreciate the opportunity to provide advice on this effort. The 
Agency staff was open, collegial, cognizant of shortcomings in the 
document, and accepting of the Subcommittee's suggestions. Given the 
incomplete State of the document at this time and the precedent-setting 
nature of this--the first of 174--residual risk analyses, we conclude 
that a peer review of the final Agency Report on secondary lead 
smelters is in order. We look forward to your response.
            Sincerely,
                                       Dr. Morton Lippmann,
                             Interim Chair, Science Advisory Board.

                                   Dr. Philip Hopke, Chair,
                                        Residual Risk Subcommittee,
                                            Science Advisory Board.
                                 ______
                                 
                                 notice
    This report has been written as part of the activities of the 
Science Advisory Board, a public advisory group providing extramural 
scientific information and advice to the Administrator and other 
officials of the U.S. Environmental Protection Agency. The Board is 
structured to provide balanced, expert assessment of scientific matters 
related to problems facing the Agency. This report has not been 
reviewed for approval by the Agency and, hence, the contents of this 
report do not necessarily represent the views and policies of the U.S. 
Environmental Protection Agency, nor of other agencies in the executive 
branch of the Federal Government, nor does mention of trade names or 
commercial products constitute a recommendation for use.
    Distribution and Availability: This Science Advisory Board report 
is provided to the USEPA Administrator, senior Agency management, 
appropriate program staff, interested members of the public, and is 
posed on the SAB website (www.epa.gov/sab). Information on its 
availability is also provided in the SAB's monthly newsletter 
(Happenings at the Science Advisory Board). Additional copies and 
further information are available from the SAB Staff.

 SAB Advisory on the USEPA's Draft Case Study Analysis of the Residual 
    Risk of Secondary Lead Smelters, Prepared by the Residual Risk 
               Subcommittee of the Science Advisory Board

      residual risk subcommittee members: secondary lead smelters
SAB Members*
    Dr. Philip Hopke, Department of Chemistry, Clarkson University, 
Potsdam, NY (Chair), Member: SAB's Clean Air Science Advisory 
Committee; Dr. Stephen L. Brown, Risks of Radiation Chemical Compounds 
(R2C2), Oakland, CA, Member: SAB's Research Strategies Advisory 
Committee, SAB's Radiation Advisory Committee; Dr. Michael J. 
McFarland, Engineering Department, Utah State University, River 
Heights, UT, Member: SAB's Environmental Engineering Committee; Dr. 
Paulette Middleton, RAND Ctr for Env Sciences & Policy, Boulder, CO, 
Member: SAB's Advisory Council on Clean Air Act Compliance Analysis; 
Dr. Jerome Nriagu, School of Public Health, University of Michigan, Ann 
Arbor, MI, Member: SAB's Integrated Human Exposure Committee.
SAB Consultants*
    Dr. Gregory Biddinger, Exxon-Mobil Company, Fairfax, VA; Dr. 
Deborah Cory-Slechta, Department of Environmental Medicine, University 
of Rochester, Rochester, NY; Dr. Thomas J. Gentile, New York State Dept 
of Environmental Conservation, Albany, NY; Dr. Dale Hattis, Clark 
University, Worcester, MA; Dr. George E. Taylor, Biology Department, 
George Mason University, Fairfax, VA; Dr. Valerie Thomas, Center for 
Energy and Environmental Studies, Princeton University, Princeton, NJ; 
Dr. Rae Zimmerman, Robert Wagner Graduate School of Public Service, New 
York University, New York, NY
Science Advisory Board Staff*
---------------------------------------------------------------------------
    * Members of this SAB Subcommittee consist of: (a) SAB Members: 
Experts appointed by the Administrator to 2-year terms to serve on one 
of the 10 SAB Standing Committee; and (b) SAB Consultants: Experts 
appointed by the SAB Staff Director to a 1-year term to serve on ad hoc 
Panels formed to address a particular issue; in this case, the 
application of the Agency's Residual Risk Policy to the case of 
secondary lead smelters.
---------------------------------------------------------------------------
    Dr. Donald G. Barnes, Designated Federal Officer, U.S. 
Environmental Protection Agency Science Advisory Board (1400A), 1200 
Pennsylvania Avenue, Washington, DC 20460; Ms. Priscilla Tillery-
Gadson, Management Associate, U.S. Environmental Protection Agency 
Science Advisory Board (1400A), 1200 Pennsylvania Avenue, Washington, 
DC 20460; Ms. Betty Fortune, Management Assistant, U.S. Environmental 
Protection Agency Science Advisory Board (1400A), 1200 Pennsylvania 
Avenue, Washington, DC 20460
                                 ______
                                 
                          1. Executive Summary
    On March 1-2, 2000, the Science Advisory Board's (SAB's) Residual 
Risk Subcommittee of the SAB Executive Committee conducted a peer 
review of an Agency draft case study of the residual risk assessment 
methodology, as described in its Report to Congress (USEPA, 1999), as 
applied to the secondary lead smelter source category (USEPA, 2000). 
The SAB understands that the Agency plans another iteration, including 
additional data collection and analysis before the results are 
considered for use in a regulatory contexts. The review of the seven-
volume set of material focused on eight specific questions that are 
addressed in detail in the accompanying SAB report.
    In short, the Subcommittee concludes that the Agency has developed 
a useful, self-described ``work-in progress''. The methodology used in 
this interim workproduct, as far as it currently goes, is consistent 
with the methodology described in the Report to Congress. Further, the 
assumptions used are consistent with current methods and practice. The 
case study provides a valuable example of how the approach presented in 
the Report is going to be implemented.
    However, because the Subcommittee has not yet seen a full residual 
risk analysis and, thus, is unable to comment on the complete process, 
a number of important concerns were identified that should be 
addressed. Specifically, this interim analysis does not include the 
following important elements: an ecosystem risk assessment; a health 
risk assessment that includes population risks; a full analysis of 
uncertainty and variability; a computer model for assessing multimedia 
transport and fate that has been adequately evaluated; nor a clear 
description of the process and how the assessments link to the eventual 
risk management decisions. With respect to the specific approaches 
taken in the interim analysis, a number of questions are discussed in 
detail in the attached consensus report.
    One of the greatest shortcomings of the case study in its 
incomplete State is that only the first stage screening analysis has 
been done for the ecological risk assessment. While the Office of Air 
Quality Planning and Standards (OAQPS) recognizes that a full risk 
assessment is needed, the Subcommittee is disappointed at the pace at 
which the assessment is being developed and implemented for ecology and 
natural resources. It would appear that a more concerted and 
scientifically sound analysis is needed in order to meet the mandate of 
the Clean Air Act Amendments (CAAA).
    Regarding the health risk assessment portion of the case study, the 
Subcommittee finds that, within the limitations of data and resources, 
the approaches employed by the Agency were able to qualitatively 
identify potentially high human health risk situations. However, the 
Subcommittee also concluded that the currently available science is 
insufficient to be comfortable with the quantitative values estimated 
by these models. In particular, the analysis calls into question the 
ability of the model to reliably quantify the amount of the deposited 
contaminant that is transferred to the food chain. In addition, the 
current risk assessment will have to be further developed in order to 
include population risks if it is to meet the needs of the Agency.
    The lack of a more rigorous treatment of uncertainty and 
variability may lend an aura of precision to the risk estimates in the 
case study that may not be warranted and could, thereby, be misleading 
for Agency decisionmakers. In particular, the uncertainty analysis does 
not consider the propagation of uncertainties of the model parameters 
throughout the analysis.
    In the case of multimedia computer models, the Subcommittee is 
concerned about the extent to which such models were applied without 
due consideration of the plausibility of the assumptions and the 
physical meaning of the results. There should be an iterative process 
in which implausible results flag problem areas, so that the Agency can 
make appropriate revisions in the model and/or its inputs, and the 
model run again. A number of plausibility checks were described by the 
Subcommittee and in public comments that would provide checkpoints in 
the analysis and, thereby, indicate the need for alternative 
assumptions and recalculation. Inclusion of these checkpoints would be 
helpful to both the Agency and the reader.
    Finally, an overarching comment is that the case study should 
provide more details of what was done, how it was accomplished, and how 
the results link to the eventual risk management decisions. It is 
critical that the process be described as clearly as possible, 
especially articulating why particular choices were made at various 
decision points in the risk analysis. The current document is lacking 
in this regard.
    Moving beyond the strictly technical aspects of the document on 
which the SAB has been asked to provide advice, the Subcommittee would 
like to comment on what it understands is the Agency's intention to 
make decisions based on these results. Specifically, the Agency is 
mandated under Section 112(f) of the Clean Air Act to conduct the 
residual risk assessment and to make a decision about whether or not 
further regulation is necessary in order to protect public health and 
the environment. In particular, as stated in the Agency's response to 
the previous SAB review of the Report To Congress (SAB-EC-98-013), 
``the decision made with the results of the screening analysis is 
[either] no further action or refine the analysis, while the decision 
made with the results of the more refined analysis is [either] no 
further action or consider additional emissions control.'' As discussed 
above, the Subcommittee concludes that, as the currently presented, the 
results of the refined analysis provide the same answer as the initial 
screening analysis; that is, they will not suffice as a basis for risk-
based rulemaking, and, therefore, an even more refined analysis is 
needed. Therefore, the case study, at this stage, has not achieved its 
decision objective, and another level of analysis or iteration is 
needed. A better-informed decision will be possible if the results of 
the case study more fully reflect the inability to define the risks 
more precisely.
    Outside the bounds of this particular analysis, the Subcommittee 
expressed two broader concerns regarding future assessments. First, the 
present source category, secondary lead smelters, is relatively data-
rich. Because of the existence of the lead National Ambient Air Quality 
Standard (NAAQS) and the concern for blood lead levels in children, 
there are more data in the vicinity of facilities of this source 
category than are likely to be available for other HAPs from other 
types of sources. For many or most other source categories, the number 
of HAPs and the number of source types, coupled with the limited data 
on emissions and quantitative information on health and ecological 
effects, makes the residual risk task substantial.
    Second, while the basic Congressional approach of imposing controls 
and assessing residual risk of remaining HAPs emissions makes sense, in 
concept, it appears that there have not been sufficient resources 
provided to collect and assess all of the pertinent data from state/
local air quality and public health agencies that could be fruitfully 
brought to bear on this problem. There are certainly not sufficient 
resources to permit the testing of specific HAPs for their toxicity if 
those dose-response data are not already available. In the case of 
secondary lead smelters, only seven of the 50 identified HAPs were 
excluded from the residual risk assessment due to the lack of dose-
response data. However, lack of data will likely pose much greater 
problems when other source categories are addressed in the future. Such 
data gaps could lead to the omission of compounds from the assessment, 
resulting in a subsequent underestimation of the residual risk. 
Appropriate recognition of this problem is needed by both Congress and 
the Agency in order to develop an adequate data base to support the 
residual risk analysis program.
                            2. introduction
2.1 Background
    Section 112(f)(1) of the Clean Air Act (CAA), as amended, directs 
ERA to prepare a Residual Risk Report to Congress (RTC) that describes 
the methods to be used in assessing the risk remaining, (i.e., the 
residual risk) after maximum achievable control technology (MACT) 
standards, applicable to emissions sources of hazardous air pollutants 
(HAPs), have been promulgated under Section 112(d). The RTC was 
intended to present EPA's proposed strategy for dealing with the issue 
of residual risk and reflected consideration of technical 
recommendations in reports by the National Research Council [''Science 
and Judgment''] (NRC, 1994) and the Commission on Risk Assessment and 
Risk Management (CRARM, 1997). As a strategy document, the Agency's RTC 
described general directions, rather than prescribed procedures. The 
announced intent was to provide a clear indication of the Agency's 
plans, while retaining sufficient flexibility that the program can 
incorporate changes in risk assessment methodologies that will evolve 
during the 10-year lifetime of the residual risk program.
    In 1998, the SAB conducted a formal review (SAB, 1998b) of the 
draft RTC (USEPA, 1998) and its proposed methodology. In their review, 
the SAB noted that it was difficult to assess the Agency's methodology 
without first seeing it applied to a specific case.
    In the summer of 1999, the Agency asked the SAB to provide advice 
on the application of the residual risk methodology to the specific 
case of lead smelters. This source category was selected since it was 
relatively small (fewer than 30 facilities nationwide) and data rich.
2.2 Charge
    In the months leading up to the SAB meeting, the Agency and the 
Board negotiated a Charge consisting of the eight questions below.
    (a) Overall.--Is the methodology that the Agency applied in this 
risk assessment consistent with the risk assessment approach and 
methodology presented in the Report to Congress? (EPA-453/R-99-001)? 
Are the assumptions used in this risk assessment consistent with 
current methods and practices?
    (b) Model Inputs.--Are the methods used to estimate emission rates, 
and the method used to estimate species at the stack appropriate and 
clearly described?
    (c) Models.--Does the risk assessment use appropriate currently 
available dispersion models both at the screening level and at the more 
refined level of analysis? Are the models applied correctly? Given the 
State of the science, does the risk assessment use an appropriate 
multi-pathway model? The assessment uses the IEM-2M model, with some 
modifications. Is the IEM-2M model appropriate for use in this 
regulatory context? With regard to the modification and application of 
the model, did the EPA appropriately modify the model for use in this 
risk assessment, and did the Agency apply the model correctly? Is there 
another model or another approach that is available at this time that 
EPA should consider?
    (d) Choice of Receptors.--The Agency identifies the home gardener 
as the appropriate receptor to estimate risks to the residential 
population and the farmer to embody high end risks. Are these receptors 
appropriate for this task?
    (e) Ecological Risk Assessment.--Given currently available methods, 
are the models used for the ecological assessment appropriate? Are they 
applied correctly? Are the ecological benchmarks appropriate?
    (f) Health Risk Assessment.--Section 3.4.1 of the Report to 
Congress identifies several data sources that the Agency would draw 
upon for choosing dose-response assessments to be used in residual risk 
assessments. The Report also states that EPA will develop a hierarchy 
for using such sources. Given available dose-response information, is 
the hierarchy presented in this assessment appropriate (see especially 
footnote #6, section 2.2.1)? For each chemical included in the 
assessment, is the choice of dose-response assessment appropriate? Are 
the dose-response assessments appropriately incorporated into the 
assessment?
    (g) Uncertainty and Variability Assessment.--Did the assessment use 
appropriate currently available methods to identify the variables and 
pathways to address the uncertainty and variability assessment? Are the 
methods used to quantify variability and uncertainty acceptable? Are 
there other, more appropriate methods available for consideration?
    (h) Presentation of Results.--Does the Agency's document clearly 
present and interpret the risk results? Does it provide the appropriate 
level of information? Do the figures and tables adequately present the 
data? Do the formats provide for a clear understanding of the material?
    The Charge guides an SAB review, but it does not constrain the 
range of comments that the Subcommittee members can legitimately offer.
2.3 SAB Review Process
    The SAB Subcommittee was recruited following nominations received 
from SAB Members and Consultants, the Agency, and outside 
organizations. The group met in public session on March 1-2, 2000 at 
the main auditorium of the USEPA Environmental Research Center in 
Research Triangle Park, NC. Written comments prepared before and after 
the meeting by Subcommittee members, and made available at the meeting, 
form the basis for this report. Individual comments are included in 
Appendix A for the edification of the Agency as an illustration of the 
issues identified by the Subcommittee members and of the range of views 
expressed. Those comments are not a part of the consensus report. A 
more detailed description of the SAB process for this review can be 
found in Appendix B.
               3. responses to specific charge questions
3.1 Charge Question 1: Overall
    Is the methodology that the Agency applied in this risk assessment 
consistent with the risk assessment approach and methodology presented 
in the Report to Congress (EPA-453/R-99-001)? Are the assumptions used 
in this risk assessment consistent with current methods and practices?
    The methodology presented in this report is consistent with the 
Report to Congress, as far as it currently goes, and many of the 
assumptions are consistent with current methods and practice. However, 
the Subcommittee has not yet seen a full residual risk analysis and is 
unable to comment on the complete analysis process. More specifically, 
this was an interim analysis that did not include such important 
elements as an ecosystem risk assessment, a health risk assessment that 
includes population risks, a full uncertainty and variability (U&V) 
analysis, a computer model for assessing multimedia transport and fate 
that has been adequately evaluated, nor a clear description of the 
process and how the assessments link to the eventual risk management 
decisions. At this interim stage, it looks only at four of the 23 
sources from the secondary lead smelters category. Nonetheless, the 
report does provide a valuable indication of how the approach presented 
in the Report to Congress is going to be implemented in practice. With 
respect to the specific approaches used in the case study, there are a 
number of questions that are discussed in detail in response to the 
specific charge questions below.
    A general comment is that the case study should provide more 
details of what was done and how it was accomplished. It is critical 
that the process be as clear and fully articulated as possible. More 
details are needed on how each model has been modified from prior use. 
For example, it is not clear how the IEM-2M model was modified from its 
prior use in the mercury assessment in order to be used for the 
secondary lead smelter emissions. The interested and knowledgeable 
reader should be able to follow what changes were made and understand 
why such modifications were made.
    There is clearly a significant problem with how fugitive emissions 
are being treated. In this analysis, much of the residual risk results 
from fugitive dust emissions. However, there is little direct 
information in the Agency's document on how these emission rates were 
modeled. In the Agency presentations at the meeting, four approaches to 
modifying the fugitive emissions were provided.
    It should be possible to utilize existing data to help refine the 
emissions estimates. At many or most of these facilities, there are 
ambient monitors generating data to determine compliance with the lead 
(Pb) National Ambient Air Quality Standard (NAAQS). These data should 
provide an opportunity to estimate the routine emissions around the 
plant and potentially observe the differences in concentrations before 
and after whatever steps were implemented to comply with the fugitive 
part of the MACT standard. Information on the frequency and extent of 
upset conditions at these plants could be used to supplement monitoring 
data from routine operations. Anytime data are available to provide 
ground truth, the Agency should compare those data to the model 
results. This feedback approach would mitigate against the generation 
of results that appear unreasonable.
    A number of concerns were raised about the manner in which the 
models appear to have been applied without adequate consideration of 
the plausibility of the assumptions or the physical meaning of the 
results. An iterative process is needed in which, even in the absence 
of external comparison data, when implausible results are obtained, the 
model inputs can be appropriately revised and the model run again. For 
example, when excessively high blood lead levels are estimated (e.g., 
200 g/dL), the analyst should reexamine the model inputs and 
make appropriate modifications. Similarly, where excessively low breast 
milk contaminant levels were estimated, the analyst should also 
reexamine the models. A number of such plausibility checks were 
described by the Subcommittee or in public comments that can provide 
checkpoints in the analysis to indicate the need for alternative 
assumptions and recalculation. The resulting discussion of these 
implausible results and the changes made to the calculation would be a 
useful modification to the current approach.
    Only the first stage screening for potential hazard was available 
for consideration of the ecological risk. It is recognized by OAQPS 
that a full assessment of ecological risk is needed, but the rate of 
progress in this direction has been slow. The methods and supporting 
assumptions made are general, at best, and would need to be more 
definitively treated in a refined ecological risk assessment (See 
Charge Question 5 for more details). The Agency should devote 
sufficient effort and resources to insure a credible ecological risk 
assessment for this prototypic case study.
    One of the critical problems for future residual risk analyses will 
be the availability of data. Secondary lead smelters emit lead and 
other HAPs. Emissions and related ambient monitoring data for lead are 
generally available. Data on the other HAPs are less available, making 
future assessments of residual risk associated with these other HAPs 
more of a challenge. Even when data are available, the data will need 
to be evaluated to determine their appropriateness for ground-truthing 
risk estimates. In addition, there is a significant question about how 
available are the critical input data needed to credibly characterize 
the residual risks from the other 173 source categories. In the present 
analysis, missing information, such as the toxicity of a number of 
HAPs, led to those compounds being excluded from the analysis. There 
may be molecular modeling approaches (e.g., Quantitative Structure-
Activity Relationships (QSAR)) that would permit estimation of relative 
toxicity of the organic HAP compounds for which data are not available 
and a screening analysis of their likely effect on the overall risks 
could possibly be developed.
    The Subcommittee felt that, within the limitations of data and 
resources, the approaches adopted were able to identify potential high 
human health risk situations. However, they also felt that the science 
is insufficient to be fully confident in the quantitative values 
estimated by these models. There are significant concerns regarding the 
nature of the full ecological risk assessment because a complete 
analysis has not yet been presented. There is concern that the apparent 
precision of the resulting risk estimates may be overstated and that 
more effort is needed to present results that better reflect the 
uncertainties and variability in the analysis. The review material did 
not give a clear picture of how the results of the analysis would be 
used in the risk management process. Such information would have helped 
the Subcommittee to comment more precisely on the adequacy of the 
analytic results to support the decisionmaking process.
    In any event, it is recognized that at some point management 
decisions will have to be made based on results stemming from analyses 
of this type. The Agency is mandated under Section 112(f) to conduct 
the residual risk assessment and to make a decision to implement 
further regulation or to make a decision that no further regulation is 
needed. In response to the previous SAB review (SAB, 1998b) of the 
Report to Congress, the Agency responded that, ``the decision made with 
the results of the screening analysis is [either] no further action or 
refine the analysis, while the decision made with the results of the 
more refined analysis is [either] no further action or consider 
additional emissions control.'' As discussed above, the results of the 
more refined analysis provides the same answer as the initial 
inhalation screen; that is, an even more refined analysis is needed. 
Therefore, the case study, in its current state, has not achieved the 
decision objective, and another level of analysis or iteration would be 
needed. The case study needs better quality input data/estimates on 
fugitive emissions, a more in-depth and refined analysis, a clearer 
presentation of the steps taken in the analysis and the results 
produced, and a more serious effort to fully integrate uncertainty and 
variability into the analysis. In summary, a better-informed decision 
will be possible if the results of the case study more fully reflect 
the inability to define the risks precisely.
3.2 Charge Question 2: Model Inputs
    Are the methods used to estimate emission rates, and the method 
used to estimate species at the stack appropriate and clearly 
described?
            3.2.1 Inhalation Screening
    The fundamental equations used by the Agency to estimate the 
specific inorganic and organic hazardous air pollutant (HAP) emission 
rates for process and process fugitive emissions are described by 
Equations 1 and 2, respectively. These equations provide a technically 
sound methodology for estimating specific HAP emission rates based on 
the metal HAP and hydrocarbon emissions data provided in the Background 
Information Document (BID) (USEPA, 1994). Although the Subcommittee can 
support the Agency's initial decision to employ the AP-42 based 
fugitive HAP emissions estimates in the inhalation screening study, the 
combined effect of using these conservative data with a conservative 
air pollution concentration model has clearly resulted in an 
overestimation of ambient HAP air concentrations. On the other hand, 
``upset'' conditions were not assessed with any data in this 
assessment, and considerable lead may be emitted from these facilities 
under such circumstances. This could lead to an underestimation of 
ambient HAP air concentrations. To ensure that the use of SCREEN3 will 
result in realistic predictions of ambient air pollutant 
concentrations, the Agency should evaluate the underlying assumptions 
adopted in the area source emissions algorithm, as well as the quality 
of emissions data, to determine if they warrant further refinement.
    Although the Agency should be commended for its creative and 
resourceful use of existing data to estimate specific HAP emission 
rates, the Subcommittee identified several opportunities for the Agency 
to improve its general description and use of the reported data sets. 
First, the Agency should provide a better and more complete description 
of the data elements contained in Tables B.1.1 and B.1.2. A reviewer of 
these tables would find it difficult to discern what statistical 
measurement is actually being reported; i.e., mean, median, or upper 
confidence limit (UCL). Second, the Agency should explore using means 
as inputs to the HAPs emission rate estimate methodology, since the 
means of these likely skewed distributions would provide a quick 
screening tool that is more conservative than the median and less 
conservative than the 95th percentile upper confidence limit (UCL). The 
concern is that simply using of the 95th percentile UCL would screen 
out very few, if any, sources. Countering this concern, of course, is 
the unknown impact of upset conditions, as noted above, whose analysis 
also needs attention. Finally, to provide a reviewer of the methodology 
an opportunity to reproduce any or all of the emission rate estimates, 
the Subcommittee recommends that the Agency provide an example within 
the document that illustrates the proper use of Equations 1 and 2.
    As noted in the response to Charge Question 7 below, the 
Subcommittee found that the analysis of uncertainty and variability was 
incomplete in several respects, thereby depriving the risk manager of 
important information when making these important decisions.
            3.2.2 Multipathway Risk Assessment
    To estimate the specific HAP emission rates from both the process 
and process fugitive emission sources, the Agency employed site-
specific HAP emissions information from facility compliance reports, as 
well as information from the BID data base, where necessary, in the 
multipathway risk assessment. Although the Subcommittee commends the 
Agency for demonstrating resourcefulness in employing the best 
available site-specific data to generate HAP emission rates, there is 
concern over the general approach used by the Agency in employing 
secondary data to estimate site-specific HAP emission rates in the 
multipathway risk assessment.
    To improve the scientific defensibility of both the stack and 
fugitive HAP emission estimates for the multipathway risk assessment, 
the Subcommittee developed several recommendations for consideration by 
the Agency. First, prior to using secondary data for site-specific 
emission estimates, the Agency needs to evaluate the quality of the 
individual data sets using a clear, easy-to-follow, and well-documented 
methodology. Development and implementation of a technically sound data 
quality evaluation methodology will provide the Agency with a framework 
for establishing the minimum data quality criteria for use in residual 
risk estimates. Second, to leverage limited time and resources, the 
Agency should collaborate with its industrial partners to identify and 
collect additional site-specific monitoring data for use in estimating 
process and process fugitive HAP emission rates. Third, because of its 
relative importance in characterizing human health and ecological risk, 
existing air monitoring data, where available, should be employed by 
the Agency for the groundtruthing of site-specific fugitive HAP 
emission estimates. Information on the frequency and extent of non-
routine, or upset, conditions must be considered. Finally, to assist a 
reviewer in reproducing any or all of the final risk assessment 
numbers, the Agency should present a detailed example illustrating the 
basic process by which a data element contained in a NESHAP secondary 
lead smelter compliance report is used to generate final human health 
and ecological risk estimates.
3.3 Charge Question 3: Models
    Does the risk assessment use appropriate currently available 
dispersion models both at the screening level and at the more refined 
level of analysis? Are the models applied correctly? Given the State of 
the science, does the risk assessment use an appropriate multi-pathway 
model? The assessment uses the IEM-2M model, with some modifications. 
Is the IEM-2M model appropriate for use in this regulatory context? 
With regard to the modification and application of the model, did the 
EPA appropriately modify the model for use in this risk assessment, and 
did the Agency apply the model correctly? Is there another model or 
another approach that is available at this time that EPA should 
consider?
            3.3.1 Does the risk assessment use appropriate currently 
                    available dispersion models both at the screening 
                    level and at the more refined level of analysis?
    Both the SCREEN3 and Industrial Source Complex Short Term 3 
(ISCST3) models have become widely accepted tools-of-the-trade and 
probably are the most suited for this point source category. However, 
there are minor shortcomings in the models that need to be clearly 
articulated. The conservative screening nature of SCREEN3 is designed 
to ``capture'' all facilities that may need further investigation. As a 
result, the output should result in many false positives which may 
reduce the credibility of the model.
    In the current assessment, the Agency uses the IEM-2M model for its 
multipathway analysis. Although it is the only multipathway modeling 
tool that the Agency has readily available for use, there are a number 
of concerns regarding the model that are discussed elsewhere in this 
Advisory. In the meantime, it should be noted that OAQPS is in the 
process of developing the Total Risk Integrated Model (TRIM) as a 
flexible, state-of-the-art model for evaluating multimedia chemical 
fate, transport, and risk of HAPs. A recent review of this effort by 
SAB's Environmental Models Subcommittee found TRIM to be promising and 
innovative, while providing a number of recommendations for further 
improvement (SAB, 2000). When TRIM becomes available, it should provide 
an improvement over the modeling framework used in the current report.
    While understanding the need for the Agency to move ahead with the 
Residual Risk Program, the Subcommittee is concerned that the IEM-2M 
model, as currently employed, is not able to provide the level of 
technical information that is needed for making scientifically sound 
regulatory decisions. Conceptually, the TRIM model is a significant 
improvement over IEM-2M. However, TRIM faces development challenges of 
its own that will require resources to address. Therefore, the Agency 
faces the difficult near-term choice of trying to improve an inferior 
model or committing to complete a superior model. The Agency needs to 
develop a plan for how and when they will use these models and how they 
will effect a transition from one to the other.
            3.3.2 Are the models applied correctly?
    A number of assumptions in model execution can affect the outputs. 
For example, it was assumed that all emissions come from the center of 
the facility, when, in fact, the exact location of emission source--
currently unknown--should have a strong influence on predicted downwind 
exposure levels. Locations of stacks in relation to buildings and 
building sizes can also result in an incorrect estimation of exposure 
rate. Also, using meteorological data from the nearest reporting 
meteorological station is an approximation commonly employed. However, 
risk assessors and risk managers need to be aware of the suitability of 
this approximation in some locales, such as those with complex terrain 
and/or long distances between the facilities and the station.
    A major issue which must be addressed is how to consider historical 
lead and other persistent chemical contamination at the site which was 
deposited prior to the promulgation of the MACT standard but which may 
nonetheless substantially contribute to on-going exposures post-MACT. A 
residual risk analysis that does not add exposures to baseline 
contamination to the estimates of on-going contamination may vastly 
underestimate the hazard quotient at the site and incorrectly conclude 
that the on-going releases pose risks at less than threshold levels.
    The Agency chose four cases with relatively high projected risks as 
illustrative examples, including both urban and rural settings. The 
Subcommittee understands that the terrain in each of these four cases 
was unremarkable, and, consequently, it was reasonable to model them in 
that way. In the final residual risk assessment for this source 
category, all of the facilities in the category will be modeled 
individually, and complex terrain, downwash, and other model 
adjustments will need to be incorporated into that analysis, as 
appropriate.
    Other issues raise questions that should be addressed in subsequent 
reports. For instance, classification of metals as persistent, 
bioaccumulative toxicants (PBTs) is problematic, since their 
environmental fate and transport cannot be adequately described using 
models for organic contaminants. Also, hazard indices for the ingestion 
pathway were developed separately from those for inhalation, and the 
impact of this strategy on the non-cancer results is unknown.
            3.3.3 Given the state of the science, does the risk 
                    assessment use an appropriate multipathway model? 
                    The assessment uses the IEM-2M model with some 
                    modifications. Is the IEM-2M appropriate for use in 
                    this regulatory context?
    The IEM-2M modeling was performed as a set of linked Excel 
spreadsheets. Although pertinent equations were given in Appendices, 
the implementation of the modeling effort needs to be carefully 
examined. The spreadsheets were not provided to the Subcommittee in 
time for substantive review by the members, and implementation of 
complex spreadsheet models can often lead to unsuspected errors. 
Therefore, the Subcommittee was unable to verify the figures and can 
only encourage the Agency to carefully examine the quality control 
applied in the construction of the spreadsheets. Further, the 
spreadsheets should be available to the public.
    The Subcommittee understands that use of the IEM-2M model for the 
case of mercury (Hg) has benefited from some limited peer review. 
However, adaptation of the model to address HAPs other than Hg does not 
appear to have been rigorously evaluated (Rimer, 2000). In view of the 
unique environmental chemistry of mercury, extrapolation of the model 
to other metals must be made with extreme caution.
    Through application of the model to a number of source categories 
and a number of pollutants with different behaviors, the Agency will 
have the opportunity to evaluate the model, at least in part. While 
human exposure data are rare, data on environmental concentrations of 
pollutants in various media are more widely available. In many cases, 
simply knowing that the model estimates are within an order of 
magnitude of measured environmental concentrations would provide much 
greater confidence in the model as an analytic tool. In particular, it 
would be important for the Agency to show that the multipathway model 
produces approximately correct estimates results for the concentrations 
in food of dioxins/furans and mercury, two important and difficult to 
model pollutants. If the evaluation exercises indicate that the model 
is at variance with reality, the model will have to be revised and 
previous results may need to be recalculated.
    At the same time, the Subcommittee recognizes that the Agency is 
moving toward final development and implementation of the TRIM computer 
model, which would replace the IEM-2M model. Therefore, the Agency will 
have to balance the competing needs of making significant improvements 
to the old model vs. completing development and evaluation of the next 
generation model.
    In its present form, the model can be used to show that there may 
be a relationship between atmospherically deposited HAP and the total 
burden of the particular contaminant in a target ecosystem. It cannot 
reliably quantify the amount of deposited HAP expected to be 
transferred to the human food chain. While some of the problem could 
arguably be related to an overestimate of fugitive emissions, it is 
clear that missing process considerations in the model severely limit 
its ability to simulate the movement of materials in the environment. 
For example, the transfer coefficients have been estimated without 
considering the effects of biogeochemical processes on contaminant 
reaction rates, speciation, and bioavailability. By ignoring the 
physical and chemical drivers, the IEM-2M model may have yielded 
grossly unrealistic concentrations of some contaminants in 
environmental contaminants. Table 6.8 (p. 160, Vol. I) provides an 
excellent example of the model inadequacy. The calculated 
concentrations of lead in surface water near a secondary lead smelter 
is reported as 103 to 106 g/L, which is a high enough 
concentration of lead to sterilize the water. These unrealistic 
estimates should be identified as such, and appropriate adjustments 
made. In real life, most of the deposited lead would be adsorbed onto 
particulates and removed to the sediment. This scavenging removal could 
readily reduce the dissolved lead concentration to the measured value 
of 0.002-2.0 g/L. Exaggerated concentrations, as well as 
unrealistic risks that have been reported for other contaminants, might 
likewise be traced to model deficiencies. This is an example of how the 
results of the model can be compared with what can be reasonably 
assumed about the functioning of a water system. The consequence of 
this comparison should be a reevaluation of the results so that the 
estimated concentrations are brought into line with what would be 
reasonably observed in real ecosystems. A simple re-scaling of the 
fugitive emissions estimates, alone, is not likely to solve some of 
these obvious problems.
    The IEM-2M has a number of limitations of which the decisionmakers 
need to be aware. The model does not differentiate between natural and 
anthropogenic fractions of a contaminant in a given environmental 
medium. It estimates the incremental levels/effects without considering 
the levels/effects of the contaminant that have already been built up 
in the environmental medium. The Subcommittee suggests that the Agency 
discuss how inclusion of baseline concentrations (that is, 
contributions from natural plus anthropogenic sources other than the 
post-MACT facility) would affect estimated total and attributable 
risks. The model does not insure mass balance, nor does it account for 
feedback mechanisms between environmental media. While the IEM-2M can 
be used to estimate individual excess risk, it is not at all clear from 
the documentation that it can provide the spatial and temporal 
distributions of exposure that will be needed to provide the link to 
distributed populations. Therefore, additional refinement made be 
needed so that the model can be used to estimate the population risk.
    Uncertainty analysis, a critical adjunct to risk analysis, is not 
included in the IEM-2M model. In view of the uncertainties and 
assumptions in the model, ground-truthing should be an essential aspect 
of the model analysis.
            3.3.4 With regard to the modification and application of 
                    the model, did the EPA appropriately modify the 
                    model for use in this risk assessment, and did the 
                    Agency apply the model correctly?
    The IEM-2M model should be regarded, at best, as a work-in-
progress. The Subcommittee understands that the IEM-2M will be replaced 
by the TRIM model, referenced above, once the latter has been 
sufficiently well-developed. In the meantime, in light of the 
limitations noted about the IEM-2M, its results must be regarded with 
informed caution.
3.4 Charge Question 4: Choice of Receptors
    The Agency identifies the home gardener as the appropriate receptor 
to estimate risks to the residential population and the farmer to 
embody high end risks. Are these receptors appropriate for this task?
    The home gardener and the farmer are acceptable receptors for this 
task, but their assumed exposure scenarios need to be modified in order 
to provide a more realistic estimate of the risks to typical members of 
the local community. Specifically, the input assumptions for both 
scenarios may be unrealistically high compared to the real exposures of 
the local residential and farm communities, particularly regarding 
inhalation and food preparation activities. The inhalation exposures 
assume that the receptor is exposed to outdoor concentrations 24 hours 
per day. The food ingestion pathway assumes that home-grown produce is 
not washed. The risk model results are very sensitive to these 
assumptions. Moreover, these exposure assumptions make it especially 
difficult to check the model results through comparison with data. 
Existing and potential data on human exposure levels are likely to be 
from people in nearby communities who do not have these high-end 
exposure behaviors. For these reasons, the Subcommittee recommends that 
the Agency also model the exposure of home gardeners who are not 
outside all the time and who do wash their home-grown produce.
    Further, the case study assumes continuous exposure over a lifetime 
for inhaled HAPs but exposure over shorter periods for ingestion of 
soil, water, and produce containing HAPs; i.e., 12 years for a home 
gardener and 17 years for a farmer. The reason for this apparent 
inconsistency should be made clear.
    The overall characterization of the risks to the local community 
needs to be clarified when the population exposure assessment is 
completed.
3.5 Charge Question 5: Ecological Risk Assessment
    Given currently available methods, are the models used for the 
ecological assessment appropriate? Are they applied correctly? Are the 
ecological benchmarks appropriate?
            3.5.1 General Statement
    In the previous SAB review of the residual risk issue (SAB, 1998b), 
the Subcommittee strongly encouraged the Agency to elevate the 
prominence of ecological risk and to establish a commitment to 
ecological concern that was more nearly co-equal to that of human 
health. The recommendation was driven by the neglect of ecological and 
natural resources considerations in the draft Report to Congress 
(USEPA, 1999).
    At the March 1 briefing, the Agency stated that the risk to 
ecological and natural resources will not be addressed at this time in 
other than a screening level analysis; i.e., a hazard assessment, 
rather than a risk assessment. This position is unfortunate, even for a 
document that is admittedly a work-in-progress, since this shortcoming 
was strongly identified in the Board's earlier report (SAB, 1998). Such 
a position would be unacceptable in the final document in that it would 
ignore the legal mandate to avoid ``an adverse environmental impact'' 
that is ``significant'' and ``widespread'' and likely to result in the 
``degradation of environmental quality over broad areas'' (CAAA Section 
112(a)(7)). By pursuing a hazard assessment for secondary lead smelters 
rather than a risk assessment, the Agency will likely generate a large 
number of ``false positives'' that will make the task of the risk 
manager more difficult. It could also have the unwarranted effect of 
setting a precedent for using hazard assessment for ecological and 
natural resources analysis in lieu of a risk assessment for future 
residual risk analyses.
            3.5.2 Given currently available methods, are they for the 
                    ecological assessment appropriate?
    As a matter of first importance, the document should indicate 
whether the ecological risk assessment presented here is being 
developed in accordance with the Agency's Ecological Risk Assessment 
Guidelines (EPA, 1998). These guidelines have been developed over 
several years, have involved many experts from the ecological science 
community, and have been endorsed by the SAB (SAB, 1997).
    The ecological risk screen is underpinned by five concatenated 
models, with the term ``model'' used loosely to include both formally 
constructed code, as well as more simple spreadsheets. The source, 
dispersion, deposition, and multipathway models are the same as those 
used to conduct the human health characterization. The fifth and last 
model--and the one unique to ecology and natural resources--is the 
spreadsheet to screen for ecological effects using the Hazard Quotient 
(HQ) and Hazard Index (HI) methodologies. The only two models that are 
specifically relevant to ecology and natural resources are the 
multipathway and ecological effects models.
    (a) Multipathway Models.--The multipathway model is appropriate for 
the task of characterization of exposure and supporting a risk 
assessment. The model has the necessary features to handle the 
transport, transformation, and fate of organic and inorganic compounds 
in multiple media; i.e., soil, water, air and biota. In light of the 
results from both human health and ecology analyses, the ``screened 
risks'' appear to result from a few critical parts of the code, most 
notably soil-to-plant uptake, atmosphere-to-plant deposition and 
accumulation, bioaccumulation in the food chain, and transport in 
aquatic environments. Because these processes are so instrumental in 
the overall risk analysis and because the model's validity was 
repeatedly questioned, it is recommended that these critical subcodes 
be peer-reviewed to assure that the mathematical formulation is 
reasonable, current, and scientifically defensible. However, as noted 
above in Section 3.3.3, the Agency needs to balance efforts to improve 
the IEM-2M model against the need to develop and implement the next 
generation models, such as TRIM.
    Although multipathway methods are more than adequate for the task 
of screening and are certainly the appropriate method for a risk 
assessment, it is not necessary to use multipathway models in the 
initial screening assessment. Traditionally, multipathway models are 
reserved for those compounds that are persistent and bioaccumulative 
toxicants (PBTs). Unless the entire list of HAPs is made up of PBT 
chemicals, it would be more efficient to screen using simple fate and 
direct exposure models. If a PBT compound were to pass the toxicity 
screen (HQ<1.0), the hazard of direct contact would likely be 
insignificant, and the Agency could decide if the compound warrants a 
review of higher trophic considerations based on size and spatial 
distribution of the industry source category, plus the dispersion 
potential of the HAP. If the sources were many, large, and widely 
distributed, it might pass the test of being ``widespread'' and likely 
to result in ``degradation in environmental quality over broad areas''. 
Otherwise, only compounds with HQ>1.0 would be the subject of the 
multipathway analysis.
    (b) Ecological Risk Screening (i.e., Hazard Model.--The Agency 
provides a rudimentary hazard ranking or screening process for culling 
through the HAPs associated with secondary lead smelters source 
category. The method is based on the 
generation of Hazard Quotients (HQs) which are simple ratios of 
environmental concentrations to effects-based environmental benchmarks. 
The benchmark is a concentration level in a medium at which little or 
no potential exists for an hazard. As a screening tool, this approach 
is valid, although it necessarily results in a high number of ``false 
positives''. Screening ecological hazards with this approach is well-
established for use in ranking and prioritizing hazards associated with 
chemicals; e.g., new product design and approval, risk-based corrective 
actions at contaminated sites, and prioritization of resources in 
regulatory programs.
    As is well-stated in the case study, this conservative methodology 
is only used either to remove chemicals from further risk management 
consideration (i.e., the risk is acceptable) or to indicate that there 
is a need for further analysis. The HQ approach with such conservative 
effects benchmarks is really aimed at protecting all individuals in the 
ecosystem and, by inference, to protecting the structure and function 
of the ecosystem in which that individual lives.
            3.5.3 Are they (the models) applied correctly
    Given that this analysis is a screening exercise (i.e., hazard 
assessment) and not a risk assessment, the models are applied 
correctly, with the exception of the summation of HQs, as discussed 
below. There are several key aspects of the application for a screening 
exercise that warrant the Agency's attention:
    (a) Top Carnivores.--This functional group is omitted from the 
model in terrestrial ecosystems; yet it is likely to be the most 
responsive functional group for PBTs. The rationale for not including 
this functional group (i.e., ``Data are not available'') is contrary to 
what can be done in a screening exercise.
    (b) Background Concentration.--For ecological systems, the 
inclusion of geochemical background concentrations is more important 
than for human health, particularly for those chemicals that have a 
natural source; e.g., manganese, mercury, and nickel. The natural 
background issue should be re-evaluated in order to address the risk to 
ecological and natural resources.
    (c) Summation of HQs.--Generating an HI by summation of HQs for 
chemicals in different classes (e.g., metals and organics) or for 
obviously different organics (e.g. phthalates and PAHs) goes beyond 
current good practice in screening ecological risks. The resulting HI 
is possibly misleading. Summation of HQs should be limited to chemicals 
that operate via the same mode of action on the same target organ or 
system.
            3.5.4. Are the ecological benchmarks appropriate?
    It is not possible to completely answer this question from the 
information given. The selected benchmarks represent the current State 
of the practice for screening assessments, many of which have been 
developed for use at contaminated sites as a means of focusing 
management action on only the chemicals of greatest concern. For some 
of these situations, especially those involving water and sediment, 
there may be different benchmarks for freshwater and marine systems, 
and it is not clear which was used in this case.
    What is clear is that these numbers should not be used in a 
sophisticated risk assessment. The data behind these criteria may 
support a risk assessment, but the final ``criteria value'' can only be 
used to eliminate chemicals of concern. As HQs are refined, the 
exposure estimate should be refined to reflect site-specific 
conditions, and the characterization of effects should also advance 
from a general benchmark to an estimate of a toxic threshold, based on 
dose-response data for a representative or surrogate species.
3.6 Charge Question 6: Health Risk Assessment
    Section 3.4.1 of the Report to Congress identifies several data 
sources that the Agency would draw upon for choosing dose-response 
assessments to be used in residual risk assessments. The Report also 
states that EPA will develop a hierarchy for using such sources. Given 
available dose-response information, is the hierarchy presented in this 
assessment appropriate (see especially footnote #6, section 2.2.1)? For 
each chemical included in the assessment, is the choice of dose-
response assessment appropriate? Are the dose-response assessments 
appropriately incorporated into the assessment?
    The Agency has used a reasonable approach to summarize the toxic 
effects and the dose-response values for the HAPs included in the 
multipathway analysis. The document succinctly summarizes a tremendous 
body of information and accurately describes the endpoints upon which 
reference doses are derived. The important information related to each 
is adequately summarized.
    The toxic effects and dose-response analysis information are 
derived from multiple sources according to the following hierarchical 
structure: Integrated Risk Information System (IRIS), Agency for Toxic 
Substances and Disease Registry (ATSDR) toxicology profiles, Health 
Effects Assessment Summary Tables (HEAST) and State of California 
Environmental Protection Agency (CalEPA) values. However, the document 
does not provide the rationale for the specific ranking. The 
clarification provided at the March 1 meeting should be a part of the 
document, including the intent to make chemical-by-chemical decisions 
about which data base to use and the often higher quality of 
information in the CalEPA data base (CalEPA, 19 . . .) than is found in 
the older HEAST compendium (USEPA, 1994).
    The residual risk exercise emphasizes, once again, the importance 
of having accurate, current information in the Agency's IRIS data base. 
As it has been stated in the past (NRC, 1994; USEPA, 1999), the SAB 
continues to encourage the Agency to create and maintain a credible set 
of data in IRIS. Another SAB panel will review a Congressional-directed 
study of IRIS later this year.
    While the case study has employed methods that are routinely used 
at the Agency, the Subcommittee has some concerns. The approach appears 
to utilize the default assumption that all health effects described are 
of comparable severity and concern. For example, risk estimates derived 
for some of the HAPs compounds are based on rather vague endpoints, 
such as body weight loss, which are not explicitly associated with any 
disease process; whereas, in other cases, the assessment may center on 
effects, such as pulmonary or neurotoxicological effects, that are of a 
more grave character. This approach is another example of the 
conservative stance taken through much of the analysis. However, the 
risk assessor and the risk manager need to recognize and appreciate 
these differences in potential severity of health effects when 
comparing and combining the results of the analysis.
    Another supposition which may ultimately prove problematic is the 
assumption that effects of mixed exposures are additive. In reality, 
mixtures may produce effects that are additive, synergistic 
(potentiated), or even attenuated. The current default assumption is 
necessitated by the absence of any information with which to more 
precisely model such effects and, therefore, represents a conservative 
approach.
    A related point is the difference in confidence with respect to 
cancer potencies calculated from human vs. experimental animal data. 
Unit risk estimates based on human data are generally maximum 
likelihood estimates calculated from studies that, if anything, have 
biases toward underestimating human incidence of carcinogenicity 
because they are usually based on worker populations, not children, who 
are arguably more susceptible. Exposure estimates in this case usually 
have substantial uncertainties that tend to bias comparisons of more 
vs. less exposed workers toward the null and, therefore, toward lower 
estimates. On the other hand, animal-based unit risk estimates include 
a number of procedural assumptions that are thought to usually lead to 
overestimates of risk, such as the use of 95 percent confidence limits, 
choice of the most sensitive species for projection to humans, etc.
    The Subcommittee is concerned about the potential problems 
associated with a residual risk assessment that must omit HAPs in 
assessments of the risk of noncancer endpoints due to the fact that 
there are no dose-response data on these compounds currently available 
and that Agency policy dictates against using probabilistic values. For 
example, in the case of secondary lead smelters dioxins/furans are 
omitted from consideration as a non-cancer risk due to the lack of 
data. While the Agency indicated at the March 1 meeting that dioxins/
furans would be included in the next iteration of the process, other 
compounds are, and presumably would continue to be, omitted due to the 
lack of data. The document needs to address this limitation directly 
and indicate how the decisionmaking process will take these 
vulnerabilities into account. As one possible way to address the 
problem, the Subcommittee recommends that the Agency explore the use of 
quantitative structure-activity relationships (QSAR) to assess whether 
any of the organic HAPs with insufficient dose-response information 
might, in fact, be a significant concern that is currently being 
overlooked. While QSAR would not play a definitive role in the 
analysis, it could identify potential problem compounds that are 
otherwise ignored entirely in the current case study.
    The Subcommittee understands that the Residual Risk Program is 
following current Agency guidance by calculating hazard quotients (HQs) 
for non-carcinogens, with the implicit assumption of a threshold in the 
dose-response curve. However, the HQ approach is not a true risk 
assessment (i.e., a probabilistic estimate of the likelihood of harm), 
is not based on a biologically compelling foundation, and does not 
explicitly address the possibility of low-dose effects above or below 
the reference dose (RfD), even for highly non-linear dose-response 
relationships. As a part of its overall effort, the Agency should 
continue work on developing and implementing a more scientifically 
based risk assessment procedure for non-carcinogens that would lead to 
improved risk assessments. For example, some reports now suggest that 
the slope defining Pb effects is actually steeper at blood lead levels 
below 10 g/dL than above it.
    As noted above, the Subcommittee is concerned about how some of the 
results of this analysis will be treated. In particular, while the 
generation of hazard index (HI) values can be useful, despite its 
implicit limiting assumptions (e.g., additivity of all effects), there 
is no indication in the document of how these values will be used in 
the final decisionmaking process. Without some indication of how they 
will be used and for what purpose, the Subcommittee is unable to 
comment effectively on the appropriateness of HIs in this case.
    Also, as discussed above, it is clear that the residual risk 
analysis results in an estimate of incremental exposure and, in the 
case of cancer, incremental risk of disease. However, it is not clear 
how the Agency plans to use the incremental exposure estimates in the 
case of non-cancer effects, when these additional exposures (that is, 
in addition to already existing exposures from other sources) might 
subject some elements of the population to a ``level-of-concern''; 
e.g., HI>1.
    Two examples are included in the document that relate the derived 
HQs to anticipated consequences of human exposures: the cases of lead 
and dioxins/furans. The lead case allows some type of human health risk 
assessment, since blood lead levels associated with specific human 
health effects have been well documented. However, in both cases, the 
outcome suggests problems with the models. Specifically, the derived 
blood lead values are so high that they would be associated with gross 
toxicity; e.g., acute encephalopathy and even mortality. If such 
effects are real, it is quite likely that the problem would have 
already been discovered by the local medical community. Therefore, 
these derived blood lead values are a clear indication that the 
multipathway model has problems and needs to be revised.
    As noted above, the Agency indicates that some of these problems 
may not be problems of the model per se, but rather problems associated 
with overestimates of fugitive emissions. While the Subcommittee agrees 
that overestimates of fugitive emissions may play a role here, there is 
no indication of the extent of that role. On the other hand, it is 
quite clear that the model fails to consider biophysical chemical 
processes that definitely play an important role and that the model has 
not benefited from a rigorous peer review. (The model was not a major 
focus of the SAB review of mercury (SAB, 1998a).) In fact, some 
consideration should be given to using the TRIM model in its incomplete 
version rather than continuing to use IEM-2M. A more integrated and 
complete uncertainty and variability analysis would help to clarify 
these matters.
    Additionally, Table 6.9 compares modeled concentrations of dioxins/
furans in human milk with measured concentrations in human breast milk. 
It shows that modeled concentrations are notably lower than those 
measured in human milk. These findings are interpreted as indicating 
that emissions of dioxins/furans from secondary lead smelters are a 
minor contributor to overall dioxins/furans nationwide. An alternative 
interpretation (namely, that dioxin is not adequately modeled in the 
residual risk assessment paradigm) is not even considered, which 
clearly seems to be an oversight.
    Finally, at this stage in the development of the assessment, the 
Agency has not generated any population risk estimates. The 
Subcommittee would like to emphasize the fundamental importance of 
generating such estimates in the final document. Currently, there is 
little discussion of how this critical step will be taken.
3.7 Charge Question 7: Uncertainty and Variability Assessment
    Did the assessment use appropriate currently available methods to 
identify the variables and pathways to address the uncertainty and 
variability assessment? Are the methods used to quantify variability 
and uncertainty acceptable? Are there other, more appropriate methods 
available for consideration?
    In short, the uncertainty and variability (U&V) assessment is one 
of the weakest parts in the draft case study and appears to be a rather 
peripheral afterthought to a main analysis, rather than an example in 
which U&V considerations are fully integrated into a project. As noted 
above, this concern was mentioned prominently in connection with the 
multipathway exposure model results.
    The fact is that U&V analysis has advanced significantly over the 
past 10 years. The combining of traditional point-estimates of 
parameters, together with and their separate ranges of uncertainty, 
hardly qualifies as even a ``quick-and-dirty'' analysis these days. 
Instead, readily available computing power and increased experience 
with distributions for various quantities (e.g., EPA Exposure Factors 
Handbook (USEPA, 1997) have combined to made distributional analysis of 
U&V, even simple Monte-Carlo analysis, much more the standard 
expectation for the field. These techniques have by no means reached 
the level of being ``cookbook manipulations''. Rather, they do require 
skilled, knowledgeable judgments on a case-specific bases. However, 
they are being applied with much greater frequency, providing the basis 
for much more informed decisions, particularly in significant 
decisionmaking contexts, such as the residual risk program under 
discussion here (Cullen and Frey, 1999; Thompson, 1999; Hattis and 
Froines, 1992; Hattis and Burmaster, 1994; Hattis et al, 1999).
    In the first instance, the terms ``uncertainty'' and 
``variability'' need to be clearly defined and consistently used. 
Variability refers to real differences in things or people that would 
be seen even with perfect measurement or estimation techniques; e.g., 
the differences in the body weights of the individuals in an exposed 
population around a lead smelter. Uncertainty, by contrast, refers to 
the imperfection in our knowledge of the values of a specific 
parameter; e.g., characteristics of the throughput of material at a 
particular lead smelter. Generally, uncertainty can be reduced by 
gathering better information, but real variability will be unchanged, 
although it can be better characterized by better information.
    The failure to distinguish variability from uncertainty in the 
present analysis almost guarantees confusion. Variability and 
uncertainty are different things and require different techniques for 
estimation. For example, soil type may vary from facility to facility, 
but it may be relatively uniform at any one facility. If the soil type 
is not known at a particular facility, the distribution that describes 
variability among facilities where soil type is known can be used to 
construct an uncertainty distribution for the particular facility.
    Without understanding the distinction between uncertainty and 
variability, a risk manager cannot make a fully informed decision based 
on the results of the U&V analysis. A properly prepared analysis of 
uncertainty and variability analysis should help a risk manager to 
answer the question, ``What actions must I take in order to assure that 
no more than Y percent of the population exposed incurs a risk greater 
than X, with confidence Z?'' In other words, the risk manager should be 
able to understand not only how risk might vary from person to person, 
as described by X and Y, but also how sure we are about our estimates, 
as described by Z (cf., Hattis and Anderson (1999), and Hattis and 
Minkowitz (1996)). That kind of goal for the U&V analysis is not made 
explicit in the Agency's case study.
    Although it is challenging to carry out an analysis that fully 
separates considerations of uncertainty and variability, and although 
it is sometimes a matter of perspective whether a given distribution 
describes uncertainty or variability, the Subcommittee did not find the 
Agency's justification for combining the two in its analysis 
convincing. For example, consumption rates of water and food really do 
vary from person to person, and the corresponding calculated risks due 
to any specific smelter's emissions would also vary accordingly. On the 
other hand, the distribution used for the annual average emissions of 
the smelter is dominated by uncertainty, since so few data are 
available from post-MACT facilities. However, there is little 
expectation that annual average emissions (in g/sec) would vary 
substantially from year to year.
    The Agency chose to use distributions for emissions and for some 
elements of the exposure analysis, but not for the parameters of the 
fate and transport models or of the toxicity analysis. While the 
Subcommittee understands that it is currently Agency policy not to 
undertake distributional analyses of toxicity information, the Agency 
should reconsider this policy. Some members of the Subcommittee believe 
that omitting the uncertainties in the toxicity data from the 
assessment vitiate much of the benefit of performing the U&V analysis, 
and that the literature does contain early illustrative efforts to 
estimate uncertainty and variability for risks of both cancer and non-
cancer endpoints (Hattis et al. (1999); Hattis and Barlow (1996); 
Crouch (1996)). Moreover, omitting any distributional treatment of the 
transport and fate module makes any conclusions from the U&V analysis 
suspect. Although the Subcommittee agrees that iterative calculations 
using the full ISCST-3 and IEM-2M models would be computationally 
intractable, it does not seem unreasonable to introduce some overall 
uncertainty distribution to represent the uncertainties in risk 
introduced by all of the assumptions and parameter choices embedded in 
those models. The governing notion is that the while distributions 
based on data are certainly preferred, the use of subjective 
distributions--fairly (unbiased) developed, technically rationalized, 
and clearly presented--can provide useful and valuable insights that 
can credibly inform the decisionmaking process.
    In this case, the Subcommittee also found that the description of 
how some of the distributions were derived to be incomplete, even for 
the parameters that were included in the analysis. Although in many 
cases the Agency simply took distributions that had already been 
described for other Agency purposes (e.g., the Exposure Factors 
Handbook (USEPA, 1997)), in others it seemed to arrive at a 
distribution with very little evident rationale. For example, the 
document states, ``we assumed that annual lead emissions follow a log-
normal distribution, with the emission rate falling within two orders 
of magnitude of the value given in the compliance report 95 percent of 
the time'' (later corrected to 99 percent of the time). Although the 
document is far from clear on this point, in oral presentations EPA 
representatives indicated that this assumption was based on some 
analysis of emissions observations by a knowledgeable contractor, Dr. 
Christopher Frey--which was useful, reassuring information. In the next 
iteration of the document, this analysis should be presented in detail 
and, to the degree possible, the analysts should consider the need for 
adjustments in observed emissions data across plants to account for 
differences in throughput characteristics, among other relevant 
factors. To the degree that day-to-day and/or plant-to-plant variations 
in emissions can be explained on the basis of factors such as 
throughput, the estimate of uncertainty in annual average emissions may 
be reduced.
    Another major problem is that the current analysis does not follow 
existing EPA guidance on the documentation and presentation of 
distributional analysis (USEPA, 1997). Specifically, that guidance 
emphasizes that the model itself and derivations of distributions used 
in the analysis must be transparently presented in sufficient detail 
that a reviewer can reproduce them. Therefore, the case study itself 
should have included, as an appendix, both the extensive display of 
results for each stack, as well as the spreadsheet model equations and 
the mathematical form of the distributional assumptions that were used. 
The Subcommittee believes that any report of the results of a U&V model 
must include documentation of the model spreadsheet itself, the 
dependencies among parameters that are or (in the case of independence 
assumptions) are not built into the model, and the precise mathematical 
form of the distributional assumptions. For example, from the current 
presentation it is not clear if correlations have been built into the 
emissions of lead and other HAPs from different stacks that might 
reflect different processing rates on different days, or whether these 
are considered as independent.
    Finally, the Agency's treatment of ``upset conditions'' is not 
clear. While there is a description of the assumptions made to account 
for such occurrences, the explanation/justification of the assumptions 
is lacking. Since emissions associated with upset conditions can, in 
some cases, outweigh the impact of emissions during normal operation, 
it is especially important that this situation be directly addressed 
and clearly explained.
    In summary, the Subcommittee was unconvinced by the rationale for 
the selection of variables and pathways to address in the U&V 
assessment and found the methods for quantifying the U&V suspect in at 
least some respects. The Subcommittee recommends that the Agency redo 
the analysis starting with a clearly stated management objective, 
incorporating a better degree of separation of variability from 
uncertainty, and generating a more comprehensive treatment of the most 
important sources of uncertainty and variability.
3.8 Charge Question 8: Presentation of Results
    Does the Agency's document clearly present and interpret the risk 
results? Does it provide the appropriate level of information? Do the 
figures and tables adequately present the data? Do the formats provide 
for a clear understanding of the material?
    This Charge Question addresses the important issues of (a) risk 
characterization, which goes beyond numerical presentations of results 
to qualifications and discussions of uncertainty and data limitations 
(USEPA, 1999, p. 70), and (b) risk communication, which conveys those 
results in easily accessible terms to interested and affected parties. 
The focus of the discussion here is on the presentation of the results. 
The majority of Subcommittee views on the various aspects of the 
results themselves are found in response to the earlier Charge 
Questions.
            3.8.1 Initial Screening Analysis
    According to EPA, the screening analysis is designed to obtain 
preliminary inhalation risk estimates for the 23 facilities and 50 
HAPs. In the course of the analysis, many other simplifications and 
conservative assumptions are made, such as generic assumptions about 
releases of HAPs from smelter facilities. The default release 
characteristics used in the SCREEN3 modeling are clearly presented in 
Table 2.2. The Agency has indicated that all of the assumptions used in 
the initial screening analysis are not conservative and that best 
estimates (simplifying defaults) are used. A sensitivity analysis or 
other qualitative discussion of the effect of these selections on the 
results should be included in order to give the reader a better 
appreciation of the robustness and the conservativeness of the initial 
screening analysis.
    In some cases, the report identifies areas in which information was 
not available, e.g., housekeeping procedures for fugitive emissions. 
During the Agency presentation at the meeting, four possible approaches 
to estimating fugitive emissions were presented: back calculating from 
lead monitoring data, theoretical modeling, extrapolating from another 
source that has conducted fugitive emission testing, and direct 
measurement. These approaches should be identified in the report, along 
with general methods for dealing with missing data, to help the reader 
understand what would be required to gather this information.
    The discussion of the screening (Section 2.2.4) portrays easily 
readable risk results for each HAP for cancer/non-cancer risk. It 
presents maximum and minimum risk values for each individual organic 
and metal HAP. The table should include an explanation of the maximum 
and minimum values; i.e., they are simply the range of estimates 
determined for all of the facilities.The text discussion clearly 
indicates the bottom line (risks above one-in-a-million) and the fact 
that some of the HAPs are associated with higher values. Procedures for 
arriving at the risk estimates and identifying where overestimates 
occurred are clearly presented.
    Uncertainty estimates are not presented in the tables, nor are they 
discussed in this section. This should be explained in the results 
section. The text should expand on the potential impact of the 
discussion in footnote 8 concerning the lack of dose-response values 
for the ten HAPs that have not been considered in the case study due to 
a lack of available dose-response information.
    The form in which numbers are presented in Tables 2.3 and 2.4 
(i.e., as exponents) is not easily communicated to the public, and 
perhaps an alternative means should be considered. The Agency should 
keep this form for the Tables, but should consider using consistent 
cancer risk expressions in the narrative of the case study, avoiding 
the use of different expressions for cancer risk. For example, the use 
of the expression 8-in-10,000 should be changed to 800-in-a-million. 
This will allow the lay reader to place the results into the common 
context of the less than one-in-a-million expression which appears in 
the CAAA and throughout the case study.
    Section 2.2.4.2 identifies a large set of defaults and assumptions, 
without providing an explanation or rationale. More discussion of these 
defaults and assumptions is warranted, including statements about how 
they affect the final result. If the effects of the assumptions are 
unknown (as identified in this section), some discussion of why this is 
the case should be included.
    The conclusion section for the initial inhalation screening 
analysis (parts of Section 2.2.4.3), are troublesome because of their 
lack of specificity with respect to the chemicals being discussed and 
the sources. For example, in the statement ``Metal HAP risk results 
exceed these levels'', the identity of the metal HAP is unclear. 
Furthermore, any conclusions for this section are questionable since, 
as is pointed out in the report, the largest source is fugitive dust 
emissions which are very uncertain due to uncertainties in emission 
rates and the failure of the estimates to agree with NAAQS measurements 
made in the vicinity of these facilities.
    Section 2.4 (Overall Summary of the Initial Screening Analysis) is 
very brief and would benefit from a description of the organization of 
the initial screening analysis and how it leads to the multipathway 
screening analysis. The selection of facilities for the refined 
analysis needs to be placed into some type of risk management 
framework. These facilities were obviously selected since they 
represented the highest risk (e.g. cancer risk > 9000-in-a-million and 
HQ>70). However, a defined process is needed for selecting which 
facilities will be included in the refined analysis. For example, if 
the 100-in-a-million cancer risk value were used only two of the 23 
facilities would pass the screening criteria. The use of this cancer 
risk range would be consistent with the benzene decision and the 
Commission of Risk Assessment and Risk Management (CRARM) 
recommendations by having the total cancer risk from the facility being 
in the range of less than one to one hundred in a million for the 
screening assessment. In addition, if a hazard quotient of 10 is used 
as an action level for the screening assessment, as recommended by 
CRARM, then a decision to eliminate facilities 6, 9, 12, 20, 25 and 29 
for further analysis of noncancer health effects can be made. A section 
entitled 2.X Initial Screening Analysis: Selection of Facilities for 
Refined Multipathway Analysis should be added in the Chapter 2 results 
section in order to present this rationale more clearly.
    Section 2 needs to provide a better description of the 23 
facilities that have undergone the initial screening analysis. This 
information would include a general physical description of the 
facility size, location (urban, suburban, rural or industrial) and 
terrain, the annual amount of material throughput, the degree of 
facility enclosures (total or partial enclosure of fugitive sources), 
and, perhaps most importantly, the current HAP emission inventories for 
these facilities. The inventory information could be obtained from the 
1996 or more current National Air Toxics Assessment (NATA) project that 
the Agency is working on or HAP emission statements filed with State 
environmental agencies. Some of this information is readily available 
from the ``Locating and Estimating Air Emissions from Sources of Lead 
and Lead Compounds'' (USEPA, 1998). This information would be very 
useful for the risk manager when evaluating the initial screen inputs 
and results and would serve as a check on those facilities which would 
be selected for further refined analysis. The brief discussion 
contained in the case study is inadequate.
            3.8.2 Multipathway Analysis
    Section 3.3 (Results and Key Issues of the Multipathway Analysis), 
is much too long for a results and issues section. The heart of this 
material is on pp. 94-96, so a reorganization of this portion of the 
report would be in order.
    The Subcommittee found a need for a discussion about a few key 
issues, in addition to those already listed in Section 3.3.2. 
Specifically, these are the lack of consideration of background 
concentrations in the risk analysis and the effects of the adjustment 
of the nickel inhalation unit risk estimate which reduces the 
conservatism of the cancer risk estimates.
    The Report to Congress (USEPA, 1999) discusses the need to include 
background risk and the difficulty associated with this specific issue. 
The case study does not address background risk issues around any of 
the 23 facilities in the human health and ecological risk assessment. 
This is serious omission from the case-study, and the Agency should 
address this issue at a minimum from a qualitative/quantitative point 
of view, well beyond the comparisons made in Chapter 6. The absence of 
an assessment of background risk seriously impacts statements about the 
conservative nature of the refined screening assessment.
    The use of only 25 percent of the inhalation unit risk estimate for 
nickel subsulfide needs to be explained in greater detail, since it 
will have a large impact on the total cancer risk estimates in the case 
study.
    Some Subcommittee members thought the tables and figures were clear 
and comprehendible; others felt they could be clarified. For example, 
the plots and bar charts presented as a part of the Agency's briefing 
on March 1 were very helpful and could be added to the document.
    HAPs that were not included in non-cancer endpoints should be 
clearly identified, together with an explanation of why they were 
omitted.
            3.8.3 Uncertainty and Variability Analysis
    As indicated in Section 3.7 above, the Subcommittee had serious 
concerns about the handling of the U&V assessment. The comments below 
pertain primarily to the format and presentation, rather than the 
adequacy or completeness, of the underlying analysis. In short, the 
Subcommittee finds that the presentations (e.g., graphical and tabular 
displays) are conceptually sound and effective. However, many of the 
procedures used in the assessment are not as well-laid out as they need 
to be.
    The tables and figures used throughout Section 4 provide a concise 
and well-thought out approach for the presentation of variability for 
each scenario evaluated. They allow the reader to evaluate the broad 
spectrum of risk and the impacts of the various exposure parameters 
used in the refined multipathway risk assessment. These tables and 
figures significantly enhance the comprehensibility of the variability 
assessment results. For example, the use of a 13.3 m3 inhalation rate 
in the multipathway analysis (Table 4.3), when cross-referenced with 
Table 4.4, indicates that the inhalation value used is between the 25th 
and 50th percentile and is really not that much of an extreme 
conservative assumption. When the inhalation rate is coupled with the 
70-year duration of exposure and the fraction of the day at home, the 
final risk estimate falls into the 95 percentile for inhalation risk. 
This is consistent with the recommendations contained in the NRC (NRC, 
1994) and the CRARM (CRARM, 1997) reports and the language in the 1990 
CAAA to estimate risk for ``. . . the individual most exposed to 
emissions from a source . . . '' This presentation format allowed the 
reader to understand in a rather simplistic manner the amount of 
conservatism that was used in the refined multipathway risk analysis 
for each exposure parameter. So, if the risk manager wanted to observe 
the impact of setting each parameter (maximum inhalation rate, maximum 
exposure duration, maximum ingestion rate , maximum time spent 
outdoors, etc.) and the impact it has on the risk estimates, it can be 
done rather quickly.
    The inclusion of the point estimates in Tables 4.5 and 4.6 is an 
excellent way to concisely present information to the risk manager. The 
use of a large circle to identify the final cancer risk estimates on 
the probability figures (Figures 4.2a--4.7b) that would be used by the 
Agency to characterize the risk for the final risk management decision 
would significantly enhance the presentation of the results and make 
them easier to interpret. The tables and figures provide the risk 
manager with the ability to view the broad spectrum of risk 
predictions, which includes risks to the average exposed individual 
(AEI), the maximum individual risk (MIR) and the maximum exposed 
individual (MEI).
    The use of distributional analysis is unclear. The technique was 
used for some steps in the risk assessment, but not all. For example, 
the distributional analysis was clearly used for exposure estimates, 
because data from the Agency's Exposure Factors Handbook (USEPA, 1997) 
were used. However, it is not clear whether the same data source was 
used for the emission estimates.
    As noted in 4.8.7 above, the selection of variables and methods of 
quantifying variability and the distinction between uncertainty and 
variability is not clear. Such a discussion should be firmly grounded 
in the Agency's risk management goals and a clear understanding of how 
these results will be used to help achieve those goals.
            3.8.4 Risk Characterization
    In Section 5.7 the focus is whether the HQ values are above or 
below 1. The Agency should consider the robustness of such ``bright 
line'' decisions in light of the uncertainties involved. Section 5.8 
was clear and acceptable to the group.
            3.8.5 Summary and Discussion
    Keeping in mind the limitations and problems identified with the 
methodology above, this section presents a good summary of results. 
Tables 6.1 and 6.2 provide a good overview summary of the final results 
for the refined multipathway risk assessments. The presentation of 
results could be greatly enhanced with the addition of more site-
specific information to the case study. The collection of additional 
data should not be an overwhelming task. The Agency should consider the 
importance of such a refinement before the case study becomes a public 
document.
    The discussion in Section 6.2.1.1 should be expanded. The pre-
NESHAP monitoring data from New York indicates that the NAAQS for lead 
can be exceeded and that the stringent control of fugitives can result 
in a dramatic lowering of ambient concentrations of lead and probably 
other metal HAPs in the vicinity of secondary lead smelters.
    Section 6.2.1.5 needs to be expanded since it provides information 
on an excellent biomarker for potential exposure; i.e., blood lead 
levels. The inclusion of this type of information would greatly enhance 
the case study. The Center for Disease Control and Prevention (CDC) and 
State Health Departments should be consulted to find out if there is 
any other information on blood lead levels in children who reside in 
communities that are in close proximity to secondary lead smelters.
    Table 6.7 should be modified by including the distance to the 
monitors, as well as a brief discussion of siting issues (e.g., 
predominant downwind or upwind monitoring locations) before any 
comparisons are made. The same point can be made for the comparisons of 
the surface water concentrations. However, the Agency does 
appropriately acknowledge that the comparisons in Table 6.8 are not 
meaningful.
    In summary, the information in the report is generally well-
presented in some instances and could be significantly improved in 
others, as noted above. However, it is important to gather and evaluate 
more site-specific information, using the risk assessment tools 
presented in the case study, before any final risk management decisions 
are made for this source category.
                             4. references
    Commission on Risk Assessment Risk Management (CRARM), 1997, 
``Framework for Environmental Health Risk Management'', Final Report, 
Volume 1; ``Risk Assessment and Risk Management in Regulatory Decision-
making'', Final report, Volume 2.
    Crouch, E.A.C., 1966, ``Uncertainty distributions for cancer 
potency factors: Laboratory animal carcinogenicity bioassays and 
interspecies extrapolation.'' Human and Ecological Risk Assessment 2: 
103-129.
    Cullen, A.C. and Frey, H.C., 1999, ``Probabilistic Techniques in 
Exposure Assessment Handbook for Dealing with Variability and 
Uncertainty in Models and Inputs'', Plenum Press, New York.
    Goble, R. and Hattis, D., 1995, ``When the Ceteris Aren't Paribus--
Contrasts between Prediction and Experience in the Implementation of 
the OSHA Lead Standard in the Secondary Lead Industry,'' Report to the 
Office of Technology Assessment, U.S. Congress, by the Center for 
Technology, Environment, and Development, Clark University, July.
    Goble, R., Hattis, D., Ballew, M., and Thurston, D., 1983, 
``Implementation of the Occupational Lead Exposure Standard,'' Report 
to the Office of Technology Assessment, Contract #233-7040.0, MIT 
Center for Policy Alternatives, CPA 83-20, October.
    Goble, R. and Hattis, D., 1995, ``When the Ceteris Aren't Paribus--
Contrasts between Prediction and Experience in the Implementation of 
the OSHA Lead Standard in the Secondary Lead Industry,'' Report to the 
Office of Technology Assessment, U.S. Congress, by the Center for 
Technology, Environment, and Development, Clark University, July.
    Hattis, D., and Anderson, E., 1999, ``What Should Be The 
Implications Of Uncertainty, Variability, And Inherent `Biases'/
`Conservatism' For Risk Management Decision Making?'' Risk Analysis, 
Vol. 19, pp. 95-107.
    Hattis, D., Banati, P., and Goble, R., 1999, ``Distributions of 
Individual Susceptibility Among Humans for Toxic Effects--For What 
Fraction of Which Kinds of Chemicals and Effects Does the Traditional 
10-Fold Factor Provide How Much Protection?'' Annals of the New York 
Academy of Sciences, Volume 895, pp. 286-316, December.
    Hattis, D. and Barlow, K., 1996, ``Human Interindividual 
Variability In Cancer Risks--Technical And Management Challenges'' 
Human and Ecological Risk Assessment, Vol. 2, pp. 194-220.
    Hattis, D. and Burmaster, D.E., 1994, ``Assessment of Variability 
and Uncertainty Distributions for Practical Risk Analyses'' Risk 
Analysis, Vol. 14, pp. 713-730, October.
    Hattis, D. and Froines, J., 1992, ``Uncertainties in Risk 
Assessment,'' In Conference on Chemical Risk Assessment in the DoD: 
Science, Policy, and Practice, Harvey J. Clewell, III, ed., American 
Conference of Governmental Industrial Hygienists, Inc., Cincinnati, 
Ohio, pp. 69-78.
    Hattis, D., and Minkowitz, W.S., 1996, ``Risk Evaluation: Criteria 
Arising from Legal Traditions and Experience with Quantitative Risk 
Assessment in the United States:'' Environmental Toxicology and 
Pharmacology, Vol. 2, pp. 103-109.
    Hattis, D., Banati, P., and Goble, R. ``Distributions of Individual 
Susceptibility Among Humans for Toxic Effects--For What Fraction of 
Which Kinds of Chemicals and Effects Does the Traditional 10-Fold 
Factor Provide How Much Protection?'' Annals of the New York Academy of 
Sciences. Volume 895, pp. 286-316, December, 1999.
    Hattis, D. Banati, P., Goble, R., and Burmaster, D., 1999, ``Human 
Interindividual Variability in Parameters Related to Health Risks, Risk 
Analysis, Vol. 19, pp. 705-720.
    National Research Council (NRC), 1994, Science and Judgment in Risk 
Assessment, National Academy Press, Washington, DC.
    Rimer, Kelly, 2000, USEPA personal communication to Dr. Barnes, 
March 24.
    Science Advisory Board (SAB), 1997, ``Review of the Agency's Draft 
Ecological Risk Assessment Guidelines'', EPA-SAB-EPEC-97-002.
    Science Advisory Board (SAB), 1998a, ``Review of the EPA's Draft 
Mercury Report to Congress'', EPA-SAB-EHC-98-001.
    Science Advisory Board (SAB), 1998b, ``Review of the USEPA's Report 
to Congress on Residual Risk'', EPA-SAB-EC-98-013, USEPA, Washington, 
DC.
    Science Advisory Board (SAB), 1999, ``TRIM.FaTE Module of the Total 
Risk Integrated Methodology (TRIM)'', EPA-SAB-EC-ADV-99-003, USEPA, 
Washington, DC.
    Science Advisory Board (SAB), 2000, ``An Advisory on the Agency's 
Total Risk Integrated Methodology (TRIM)'', EPA-SAB-EC-ADV-00-004, 
USEPA, Washington, DC, May.
    Thompson, K.M., 1999, ``Developing Univariate Distributions from 
Data for Risk Analysis,'' Human and Ecological Risk Assessment 5, 755-
783
    USEPA, 1994, Secondary Lead Smelting Background Information 
Document for Proposed Standards, Volume I. Final Report. EPA 453/R-94-
024b, Office of Air Quality Planning and Standards, Research Triangle 
Park, NC, June.
    USEPA, 1994, ``Health Effects Assessment Summary Tables (HEAST)'' 
Supplements 1 and 2, Order numbers: EPA540R94059 and EPA540R94114, 
Department of Commerce National Technical Information Service, 
Springfield, VA.
    USEPA, 1997a, Risk Assessment Forum, Office of Research and 
Development, ``Guiding Principles for Monte Carlo Analysis,'' EPA/630/
R-97/001, March.
    USEPA, 1997b, Office of Research and Development, ``Exposure 
Factors Handbook'', Vol. I, II, and III, EPA/600/P-95/002Fa, August.
    USEPA, 1998, Risk Assessment Forum, ``Guidelines for Ecological 
Risk Assessment'', Federal Register (93)26846-26924, 14 May.
    USEPA, 1999, ``USEPA's Report to Congress on Residual Risk'', EPA-
453/RR-99-001.
    USEPA, 2000, ``A Case Study Residual Risk Assessment for EPA's 
Science Advisory Board Review: Secondary Lead Smelter Source 
Category'', EPA Contract No. 68-D6-0065, Work Assignment no. 3-02, EC/R 
Project no. HRA-3002, prepared by EC/R Incorporated, January.
                                 ______
                                 
                               APPENDIX A
                Written Comments of Subcommittee Members
    Each member of the SAB's Residual Risk Subcommittee prepared 
written comments, centered on the Charge Questions. These materials 
were available at the meeting March 1-2, 2000. As a result of the 
public meeting, some of the Members altered their original drafts and 
asked that the revised versions be included in an Appendix to the 
Subcommittee's consensus Advisory. Other Members chose not to submit 
their comments for inclusion in the document.
    Therefore, this Appendix contains the final written comments from 
those Subcommittee Members who chose to submit them for this purpose. 
These materials are included in this SAB document so that the Agency 
and the public can (a) benefit from the specific comments and (b) 
appreciate the range of views represented on the Subcommittee.
    While all of these statements are commended to the Agency for 
careful consideration, unless a comment is addressed explicitly in the 
body of this SAB Advisory, it should be viewed as a statement from an 
informed individual, not as the collective view of the Subcommittee.
                               __________
  Statement of Dr. Gregory Biddinger, Exxon-Mobil Company, Fairfax, VA
                            general comments
    1. A Risk Assessment strategy should be designed in alignment with 
a risk management process.
    Although this may seem like an obvious and generic point, I feel it 
is very relevant to make at the onset of these comments. It became 
clear during the review of this case study that the linkage between the 
ecological risk assessment (ERA) and risk management process is weak 
and this weakness is likely due to a lack of clear definition on how 
the risk management process will proceed. I believe this lack of 
clarity as to how the ERA will be used to support any risk management 
decisionmakes it difficult to either design an ERA process that goes 
beyond a screening step or to define what are the Next Steps for ERA in 
this specific case study.
    Recommendation: The footnote on Page 34 of Volume 1 indicates that 
OAQPS is working on developing a risk management decision framework for 
the residual risk program. That framework should be presented to the 
SAB review group to evaluate alignment between the risk assessments and 
the risk management process. If the strategy is not final, revisions to 
the case study should be deferred until the framework is available.
    2. With regards to Ecological Risk assessment, the Agency needs to 
define what is meant by the management goal of ensuring that HAP 
emissions do not result in ``an adverse environmental effect''.
    In order to evaluate the Questions associated with Charge 5, which 
is fundamentally, were the appropriate models used correctly, it is 
essential to understand what environmental attributes are being 
protected and at what spatial scale. In section 5.2.1 the agency sites 
Section 112(a)(7) of the Clean Air Act Amendments (CAAA) to say it is 
``any significant and widespread adverse effect, which may reasonable 
be anticipated to . . . or significant degradation of environmental 
quality over broad areas ``. The key and operative terms in these 
statements, which require clarification, include (1) significant, (2) 
widespread (3) adverse (4) environmental quality and (5) broad areas. 
Without a clear definition of what the agency believes is the intent of 
these words in the CAAA, it is not possible to assess the correctness 
of the agencies actions. Based on an assessment strategy that uses 
hazard Quotients (HQ's) and conservative ecotoxicological screening 
benchmarks, I would have to assume the Agency's goal is to protect 
individuals in all populations and in all places.
    Recommendation: The Agency needs to provide the appropriate 
clarifying discussion in Section 5 of Volume 1 or through the 
development of a technical policy statement which can be cited in this 
section.
    This exercise should not be viewed as a philosophical exercise. In 
developing this clarifying analysis the Agency should identify some 
practical rules or decision logic which can reasonably be used to 
eliminate source categories from ecological risk. Some (but not the 
only) possible rules for not doing an ERA include:
    (a) Source categories with a few small facilities in different 
regions.
    (b) Source categories with a few large facilities but no persistent 
or bioaccumulative HAP's.
    (c) Facilities in source categories where the primary releases 
(e.g. downwash, etc.) are contained to the site.
    3. The Ecological Risk Assessment provided is a screening risk 
assessment and clearly is not intended to be used for risk management 
decisions other than ``No Action'' or ``Further Analysis''. But the 
recommendation(s) of the assessors for any followup options are 
missing.
    The Agency is to be commended for so clearly stating in a number of 
places in the case study that the environmental hazard assessment 
undertaking is not adequate for making a final risk management decision 
that would require controls or other actions to mitigate ecological 
risks. This reviewer is left with the question ``What will the Risk 
manager be able to do with this analysis?'' If the assessors felt that 
more sophisticated or detailed analysis was necessary than they should 
have at least said so, even if they believed performing that analysis 
was not in the scope at this point in the analysis. The case study is 
incomplete with the ERA as provided because the next steps are not 
clear. It would not at all be a breach of the risk assessor and risk 
manager roles for the assessors to provide some further definition of 
what they could do to explore the significance of some of the High HQ's 
for various aspects of exposure to key metals (e.g. Antimony) from the 
Fugitive emissions at facilities 3, 4 and 13.
    Recommendations: The case study needs to include a section on Next 
step options with recommendations for the risk manager to consider.
    4. The sources of uncertainty in the ERA are understated.
    In section 5.7.3 the report reviews the sources of uncertainty 
associated with the screening level risk assessment. This review on 
uncertainty doesn't completely account for the uncertainty associated 
with the exposure estimates. Although it does identify inclusion of 
assumption of bioavailability and the exclusion of some pathway it does 
not account or refer back to any analysis of the uncertainty associated 
with the dispersion and fate. The uncertainty reviewed in section 4 
associated with emission rates, dispersion, environmental fate and 
pathway analysis could easily overwhelm the uncertainty described in 
section 5.7.3.
    Recommendation: Section 5.7.3 should recognize the uncertainty 
passed through from the dispersion, fate and pathway models.
Charge Question 5: Ecological Risk Assessment
    1. Given currently available methods, are the models used for the 
ecological assessment appropriate?
    In addressing this question it is important to consider my general 
comments listed above. The method of using Hazard Quotients (HQ's) and 
their summation, Hazard Indices (HI's) to screen ecological hazards is 
well established for use in ranking and prioritizing hazards associated 
with chemicals. The method has had significant use in new product 
design and approval, Risk-Based Corrective Actions at contaminated 
sites and prioritization of resources in regulatory programs. As is 
well stated in the document such a conservative technique is only used 
to remove chemicals from further risk management consideration (i.e., 
the risk is acceptable) or to indicate that there is a need for further 
analysis. What this case study does not do is take or even identify the 
next steps to refine the analysis of those chemicals that fall above an 
HQ or HI of 1.0. One would have expected that some refinement of the 
exposure and effects characterization for metals with the highest HQ's 
would have been explored. If only to see if less conservative or site-
specific modifications to the exposure characterization or full use of 
dose-response data for relevant surrogate species might have brought 
the HI exceedances into acceptable ranges. As it stands now we are left 
with some significantly high HQ's implying to an unsophisticated 
audience that a serious problem exists but without any framing of an 
approach to validate or refute such an implication. As a risk assessor, 
I recognize that this is only the first step and that these HQ's can 
drop orders of magnitude when they are refined, but any lay audience 
reading this review and seeing HQ's of 400 with no action recommended 
is likely to be alarmed.
    Recommendation: The Agency needs to have a process that goes beyond 
the initial step of ecological risk assessment that is taken in this 
draft case study and either (a) refines the hazard screening process by 
improving the estimates of exposure and selecting more appropriate 
Toxicity Reference Values (TRVs) or (b) moves into a risk assessment 
process that is based on more complete and relevant profiles of 
exposure and effects.
    2. Are the (available methods) applied correctly?
    For the most part yes but one particular aspects of the application 
of the HQ approach goes beyond current good practice, that is the 
summing of HQ across all chemicals. Suinination of hazards for 
chemicals which are operating with the same mode of action on the same 
target organ or system may be acceptable. But summarizing across an 
array of benchmarks which are based on a variety of endpoints, some of 
which are NOAELs and some are LOAEL's is not conservative it is 
misleading. I can't see any way that metals and organics could be 
considered additive to either the individual or at the population.
    The only classes of chemicals in this case study which might allow 
such a summing technique would be the summation of HQ's for Dioxin/
furan congeners and the summation of PAH's. But for PAH's it would 
still be necessary to break the summations into high and low molecular 
weight categories. If this were being done for assessment of acute 
hazards I would be more accepting but with chronic toxicity 
criteria the endpoints could vary across growth, development, 
reproduction and survivorship.
    3. Are the ecological benchmarks appropriate?
    It is not really possible to completely answer this question from 
the information given. The benchmarks that were selected represent the 
current State of the practice for screening benchmarks. Many of these 
benchmarks were developed for use at contaminated sites to focus 
management action on only the serious chemicals of concern. For some of 
these lists especially the water and sediment benchmark series there 
may be different benchmarks for freshwater and marine systems. Which 
were used? The lower of the two? Which ever was available? For 
screening purposes this is not likely going to be a problem or 
certainly any error of application could be caught in the next round of 
refinements.
    What is clear is that these numbers should not be used for any 
sophisticated risk assessment. The data behind these criteria may well 
support a risk assessment but the final ``criteria value'' can only be 
used for what has been done here which is to eliminate chemicals of 
concern. As HQ's are refined not only should the exposure estimate be 
refined to reflect site specific conditions, but also the 
characterization of effects should advance from a general benchmark to 
an estimate of a toxic threshold based on dose-response data for a 
representative or surrogate species.
    Recommendation: If the Agency is going to do 174 source categories, 
it is worth the effort to develop a matrix of Toxicity Reference Values 
(TRV's) for various receptors and endpoints for each of the HAPs that 
could be used as screening values. If the complete dose-response 
relationships are available, then the same data could be used for (a) 
screening (NOAELs), and (b) first risk approximations (EC10 or EC20) 
and (c) complete risk distributions (Slope of the dose-response curve). 
Although this is not a small task, such a front-loaded effort could 
stream-line much of the subsequent source category analyses. If the 
Agency were to embark on such a task, I recommend leveraging this 
effort with interested industry coalitions.
                       section specific comments
Section 5.1
    The language in paragraph 1 of page 130 is confusing. Suggest 
discussing hazard potential rather than potential risks.
    Are all of the cited EPA documents available to the public? Is EPA 
1999d available? If not should it be cited?
Section 5.2.1
    As previously stated in general recommendation No. 2, this section 
should be expanded to give the agencies interpretation of the 
management goal from the CAAA. This would require defining such terms 
as: (1) Significant, (2) Widespread, (3) Adverse, (4) Environmental 
Quality and (5) Broad Areas.
Section 5.3
    This section is weak because of the lack of interpretation of the 
management goal in section 5.2.1. It should be more clearly stated that 
the assessment endpoint is No or limited adverse effects to individual 
members of sensitive populations. There is no real consideration of 
impacts to structure or function. It is only a simple extrapolation to 
suggest that if no individual is adversely affected than neither will 
the service of its population or the structure and function of 
communities and ecosystem it lives in be affected. This assessment is 
being done in a fashion to protect individuals; there is nothing wrong 
with this if that is the agency's interpretation of adverse 
environmental effects. I would suggest it is a bit stringent but for a 
screening assessment not atypical. But ultimately the assessment of 
residual risk should be at a level of population or higher.
Table 5.1
    Citations for Suter et.al. and Will, M.E. et.al. are in conflict 
with the reference list.
Section 5.7.2
    The discussion incorrectly states that all facilities had HQ's >1 
for metals. Facility 2 was not reported in section 5.7.1.1 or in 
appendix E to have HQ's >1 with or without fugitives emissions. This 
inconsistency needs to be corrected.
Section 5.8
    As stated previously, this section should address recommendations 
to the manager about the need for followup actions.
            Sec. 2.3 The use of lists to identify Persistent and 
                    Bioaccumulative compounds is inappropriate.
    Recommendation: The Agency needs to specifically design or adapt a 
process to support a Residual Risk process.
                                 ______
                                 
    Statement of Dr. Stephen L. Brown, Risks of Radiation Chemical 
                     Compounds (R2C2), Oakland, CA
    These comments are submitted to alert the Subcommittee members to 
some issues I will want to discuss in our meeting on points OTHER than 
on my main assignment--the uncertainty and variability analysis. Along 
with my co-discussant, Dale Hattis, I will be submitting a formal, 
although preliminary, writeup on that subject.
                             overall effort
    Overall, I have mixed feelings about the case study. On the one 
hand, its overall structure and components are similar to those in many 
of the risk assessments conducted in the past few years by or for USEPA 
and other environmental agencies such as the California EPA. It 
features some standard and generally well accepted models such as 
ISCST-3 as well as a detailed multipathway model, IEM-2M. It uses 
values for many of the needed parameters that can be found in standard 
sources such as the IRIS data base of toxicity information and the 
Exposure Factors Handbook. It features a screening level analysis prior 
to the main analysis that is designed to help the latter focus on the 
most important HAPs and facilities. It includes a variability/
uncertainty analysis and a risk characterization section that are both 
recommended in recent EPA guidance on the conduct and presentation of 
risk assessments. Many of its assumptions are similar to those in other 
EPA risk assessments and therefore consistent with them.
    On the other hand, it shares most of the deficiencies of those same 
comparison risk assessments and seems to introduce a few of its own. 
The conservative assumptions inherent in most Agency risk assessments 
are repeated here, and are not adequately balanced by the supposedly 
less biased uncertainty analysis. Many of the case-specific assumptions 
are inadequately described, let alone well justified, in the text 
supplied to the Subcommittee. Some of the predictions of the assessment 
are truly astounding (e.g., the blood lead levels calculated when 
fugitive dust emissions are included in the assessment), yet there 
seems to have been little attempt to identify and correct the problems 
that might have led to such conclusions. Even though the case study is 
not supposed to be a final assessment for the secondary lead smelter 
category, it should have included more thorough quality control to 
demonstrate how such an activity would be included in a final 
assessment.
    In reviewing the assessment, I was struck by how similar the 
structure was to assessments conducted under AB2588, the California 
statute titled the Air Toxics Hot Spots Act. That act is specifically 
designed to evaluate the risks from emissions to air by stationary 
sources in California. In that case, the risk assessments are conducted 
by the facility itself using guidance provided by the State, and the 
assessments are reviewed by the local air district for conformity with 
that guidance and accuracy of inputs and outputs. The facility may 
submit an alternative assessment with more site-specific information 
and less conservative assumptions, including a distributional analysis 
in some cases, but the local authority is not obligated to review those 
assessments. The standard assessment is usually conducted with the aid 
of a computer model such as ACE2588 or HRA96 that was designed to 
follow the guidance precisely. Users are allowed to use some site-
specific information, such as stack characteristics and the location of 
actual water bodies used as drinking water sources. The models include 
not only direct inhalation exposures via concentrations calculated by 
ISCST-3 but also via multimedia pathways similar to those in IEM-2M 
(although IEM-2M features a more detailed water partitioning model 
because it was designed specifically for mercury). Another similar 
multimedia risk assessment model designed for emissions to air is TRUE, 
developed by the Electric Power Research Institute for assessing fossil 
fuel power plants. TRUE includes a mercury model similar in design to 
IEM-2M. TRUE is generally less conservative than the AB2588 models, but 
is still described as conservative by its authors.
    I will now provide comments by Section of the Case Study, more or 
less in page order.
                              introduction
    I was disappointed not to see a clearly articulated description of 
the decision that this type of risk assessment is to serve. Although 
the obvious application is to the residual risk requirements of the 
CAAA, it is not clear that EPA knows how it will interpret those 
requirements in evaluating the outputs of the risk assessments. For 
example, how will risks to highly exposed individuals be weighted in 
comparison to the population risks for the whole exposed population? 
How will a highly exposed individual be defined? Some fixed percentile 
of a distribution? A qualitative representation of such a percentile, 
such as the RME? A hypothetical maximally exposed individual or MEI? 
What are the quantitative criteria that will trigger further risk 
reduction actions? Will those actions be applied to only those 
facilities whose calculated risks are above the criteria, or will the 
whole category be affected? What level of assurance will be demanded 
that the criterion is met in order to State that the residual risk 
requirement is met? Without knowing rather well what questions will be 
asked, the Agency may not provide useful answers.
    In the Introduction, the concepts of the unit risk estimate (URE) 
and the reference concentration (RfC) are introduced for inhalation 
risks. Although it is clear that both of these numbers are applicable 
to continuous lifetime exposure to a constant concentration in air, it 
is not clear that calculated concentrations may need to be adjusted for 
exposure duration before being used to determine risk using the URE or 
RfC. This lack of clarity is not entirely dispelled in the later 
section on Dose Response. One stakeholder commenter believes that the 
duration adjustment was appropriately made for ingestion exposures but 
not for inhalation exposures. More generally, the document could use 
considerable improvement in the exposition of what was actually done in 
the risk assessment.
             initial screening level residual risk analysis
    The idea of screening level analyses to focus further risk analysis 
on the facilities and HAPs most likely to violate the residual risk 
limits is sensible. In fact, multi-level screens may be appropriate, 
not just one initial screen. However, the screening analysis as 
designed could be improved. First, screening on only inhalation 
exposures may give a false sense of security about some facilities or 
chemicals if other pathways are in fact substantial contributors to 
risk. For some HAPs emitted to air, pathways other than inhalation may 
be orders of magnitude more important to risk, particularly if the fate 
parameters are such that concentrations in soil will buildup over a 
long time before plateauing as removal processes become effective. It 
may be necessary to build in some HAP-specific screening-level 
multipliers for multimedia effects into the inhalation risk 
calculations. On the other hand, it appears that the screen for 
secondary lead smelters may have been too conservative in that all 
facilities and many of the individual HAPs exceeded the screening 
criteria when fugitive dust emissions are included. If a screen does 
not screen out anything, it is not very effective.
    I am also not particularly impressed with the rationale for 
selecting the HAPs to take forward into the multipathway analysis. The 
occurrence on a list of ``PBT'' (persistent, bioaccumulative, toxic) 
substances is, in my view, a weak substitute for a more quantitative 
classification. The actual risk posed by a substance depends on all 
three attributes, and others, in a complex way dependent on the actual 
conditions of fate, transport, and exposure. It is possible to examine 
complex multimedia models and create simplified models that reproduce 
their results in a crude fashion, preserving how the effects of half-
life, BAFBCF, and toxicity interact. I again recommend an effort to 
create HAP-specific multipliers for screening purposes to help identify 
the HAPs that should enter the multimedia assessment.
                  multipathway residual risk analysis
    As stated in my overall impressions, in many ways the multipathway 
analysis is equivalent to or better than other regulatory-responsive 
risk assessment models, featuring a widely accepted air dispersion 
model along with a highly detailed multimedia transport and fate model. 
My reservations have more to do with implementation than with overall 
concept.
    Perhaps my foremost reservation is about the emissions estimates. 
As I understand it, no facility has more than one set of tests (e.g., a 
1- to 3-day measurement protocol) subsequent to achieving MACT. 
Furthermore, there is no evident attempt to correlate the emissions 
testing results with any explanatory input such lead throughput during 
that period, type of operation, or type of emission control equipment. 
(The latter two factors do seem to be used as a guide to extrapolations 
from one set of measured results to a different facility, however.) The 
document does not discuss any inherent temporal variability, such as 
variation in throughput, that might make a snapshot of emissions 
inappropriate for calculating an annual average. Perhaps these points 
are all discussed in the underlying data sources, but they do not 
appear in the current document. As stated in my preliminary comments on 
uncertainty, the variability seen in the lead emissions estimates may 
be more representative of day-to-day variations than to annual average 
variability. There is no evident test of correlations between lead 
emission rates and HAP-to-lead emission ratios, that might occur, for 
example, if lead emissions followed lead throughput but some other 
source (e.g., refractory brick) were the source of a different metal. 
The Agency clearly has little confidence in the fugitive dust emissions 
estimates--all derived from pre-MACT data, as I understand it--but 
still presents risk results as some sort of upper bound on risk. I 
contend that such an upper bound is probably not reasonable, given the 
failure of monitoring data to confirm the concentrations of lead or 
other HAPs offsite.\1\ Unless the Agency is prepared to undertake 
empirical studies of fugitive dust emissions from secondary lead 
smelters, it might be better advised not to do any quantitative 
analysis, simply stating that risks might be higher had fugitive dust 
been included. I suspect the same may be true for other source 
categories.
---------------------------------------------------------------------------
    \1\ I am not as sanguine about the virtues of ``model validation'' 
for the multimedia model as some of the other reviewers of the Case 
Study. The model is designed to estimate media concentrations averaged 
over some vaguely specified future time period after continuous 
operations at MACT conditions with no prior operation. Measurements of 
media concentrations that can be conducted in the present, however, 
will not capture the effect of future emissions, so there might be 
underestimates, and will capture the effect of higher pre-MACT 
emissions, so might be overestimates, of the desired validation 
quantity. Moreover, the proper temporal and spatial averaging 
techniques to make model predictions and measured concentrations 
strictly comparable are not easy to specify. Perhaps the best we can 
hope for is the identification of gross inconsistencies.
---------------------------------------------------------------------------
    Another major concern is the seeming inconsistency between the very 
detailed multimedia modeling, which includes such abstruse topics as 
sediment-water partitioning with BCF and BAF adjustments to fish 
concentrations side-by-side with an inability to locate stacks in 
relation to facility boundaries or the assumption of home garden 
consumption at a nearby residence. It would seem to entail little work 
to telephone the facility for information or make a site visit in 
comparison to developing all the inputs for the IEM-2M model, yet such 
inexpensive efforts could improve confidence in the risk estimates 
greatly.
    I generally agree with the hierarchy of choice for selecting 
toxicity values to be used in the model. Some commenters have 
questioned the use of CaIEPA values as one of the possibilities, but as 
a member of the Risk Assessment Advisory Committee, I have examined 
that Agency's methods and believe them, on balance, to be as good or 
superior to USEPA's. I therefore cannot fault OAR for using the IRIS 
values when available and ATSDR, CaIEPA, and HEAST values when IRIS is 
silent. Nevertheless, some of the toxicity numbers appear to affect the 
results markedly and should be viewed with caution. I am especially 
concerned about the values for antimony and for manganese. The antimony 
RfC is based on irritation, for which application of standard 
uncertainty factors may not be appropriate. The antimony RfD is based 
on toxicity endpoints that include blood glucose and cholesterol, not 
clinical illness. The manganese RfC is based on ``impairment of 
neurobehavioral function,'' an endpoint that is probably to some extent 
subjective and less severe than endpoints used to define other toxicity 
values. I recommend that EPA's Risk Assessment Forum explore ways to 
make the IRIS data base more consistent (perhaps by explicitly 
considering severity of endpoint) and to verify any values that seem to 
drive risk assessments.
    I note the importance of particle size distributions in defining 
deposition velocities and other parameters for dry and wet deposition, 
which can greatly influence the overall deposition rates and risks for 
the same estimated air concentration. I understand that the 
distribution for stack and controlled fugitive emissions was assumed to 
be similar to those observed in emissions from baghouses, and generally 
ranges downward from 10 microns. However, I did not find this 
assumption to be stated in the document, nor did I find information on 
the assumed distribution for fugitive dust emissions or how the 
particle size distributions were translated to deposition velocities. 
Generally speaking, reductions in particle size tend to spread 
deposition over a greater area but reduce peak deposition at the RME 
location. However, if the particle size distribution is dominated by 
particles so large that they deposit onsite, reducing the particle size 
may actually increase the RME deposition.
    Although the actual model inputs include a provision for chemical 
degradation after deposition, this mechanism of HAP removal from soil 
and water is not mentioned in the text. It should be. I also understand 
that the locations of actual water bodies were used for the drinking 
water and fish concentration calculations, not some hypothetical water 
body co-located with the RME, but again this procedure was not 
described in the text. I also am not sure whether these water bodies 
are actual, or only potential, sources of drinking water for the local 
community. The text is also unclear about the fraction of all produce 
consumed that is assumed to be contaminated by the smelter. In some 
cases, it appears that a 100 percent assumption was used, whereas 
elsewhere, it appears that some standard EPA assumptions less than 100 
percent were used. I am particularly concerned that any significant 
part of ``grain'' consumption is assumed to be locally produced, at 
least for home gardeners.
    Non-cancer risks are represented by the hazard quotient/ hazard 
index structure that, with all its limitations, is the standard Agency 
method for the so-called ``threshold'' toxicants.\2\ The averaging 
period for exposures to be used in non-cancer risk assessments is 
generally taken to be 1 year in Agency assessments, and that practice 
seems to have been followed here. On the other hand, the averaging 
period for exposure to carcinogens is taken to be a lifetime, at least 
for all carcinogens treated as having linear dose-response 
relationships with no threshold. That assumption implies that cancer 
risk varies linearly with duration of exposure if daily exposure is 
held constant. Although it is reasonably clear that the Agency has 
taken duration into account in exposure averaging for the ingestion 
routes of exposure, one of the stakeholder commenters has alleged that 
the Agency did not do so for the inhalation route, thereby 
overestimating risk by the ratio of a lifetime to the assumed duration 
of exposure. If true, this error should be corrected. If not, 
explanatory text should be added.
---------------------------------------------------------------------------
    \2\ The Agency views lead as a non-cancer risk that nevertheless 
has no identifiable threshold, and treats it with the IEUBK model. In 
reality, toxicity data rarely if ever identify a true threshold and the 
RfD or RfC is set as the practical equivalent of no risk. Probably more 
at issue is the assumption that risk of cancer is more likely to vary 
linearly with exposure at low exposure than is the risk of non-cancer 
effects.
---------------------------------------------------------------------------
    I would have expected that lead would be the most important risk 
from a secondary lead smelter. Cursory inspection of Tables 3.13-3.16 
might suggest to the unwary that it is not, because no hazard quotients 
are presented for the ingestion routes, and the hazard quotients for 
inhalation are not as high as for some other HAPs. However, this 
impression is due to two facts that are not as emphasized as they might 
be. First, the inhalation hazard quotient is calculated from the 
primary NAAQS for lead, which is not purely a health-based number. 
Second, the ingestion hazard quotient is not calculated at all, because 
the Agency refuses to promulgate an RfD because of the asserted non-
threshold nature of lead. Therefore, the significant analysis for lead 
is accomplished through the IEUBK modeling procedure described in 
Section 3.3.1.4. From Table 3.23, it can be seen that predicted blood 
lead levels can be quite high, especially for the fugitive dust 
scenario. Although some discussion of the lack of conformance of these 
predictions with observed blood lead values is presented, I think that 
the magnitude of these values casts grave doubts about the validity of 
the modeling. See, however, Footnote 1 on the difficulties of making 
comparisons of model predictions with measurements.
                 initial ecological screening analysis
    Although my expertise is not on the ecological side, this section 
struck me as more straightforward, polished and easier to understand 
than most of the health risk assessment sections. I note that it is 
screening-level in terms of the evaluation of the significance of media 
concentrations, but is more-than-screening-level in terms of the 
calculation of media concentrations, as it uses the same ISCST-3/IEM-2M 
outputs as does the multimedia health assessment. The text suggests 
that some organics and acid gases might be included in a more detailed 
assessment, but was not clear what reasons would induce the Agency to 
include them.
    The text states that single point estimates are used to evaluate 
media concentrations, but does not State at what geographic location. I 
infer that they are probably the RME locations used for the health 
assessment, but the location should be made explicit. Averages over 
some reasonable range for the organisms assessed might be more 
reasonable.
                   summary and discussion of results
    In general, the summary is a reasonable representation of the 
procedures and findings from the preceding sections. It also attempts 
to discuss a number of issues that might be troubling to a reader, 
including the comparison of modeled concentrations with measured ones. 
However, my overall impression is that the risk characterization is 
more optimistic about the quality of the analysis than is justified. 
For example, in Section 6.4, the Agency states: ``For any particular 
pollutant, pathway and exposure scenario the resulting distributions 
can be used to identify the confidence or probability that risks will 
be below or above specific risk levels (e.g., acceptable risk).'' Given 
the deficiencies in the uncertainty analysis, let alone those in the 
deterministic assessment, I think that is a gross overstatement. Nor do 
I think that the uncertainty analysis in any way validated the 
determuustic assessment, although that is also suggested here.
    I also found the section on children's health gratuitous, 
unconnected to the main analysis, and full of overstatement. For 
example, the description of newborns having a ``weaker immune system'' 
omits the temporary carryover immunity from the mother. Although 
children eat more food per unit body weight than adults for some foods, 
they eat less for others (e.g., fish). And those differences are 
already captured in the exposure analysis by age. The fact that cancer 
risks, even if due to early life exposures, are expressed later in life 
is not mentioned, and the reader is left with the impression of a 
potential epidemic of children's cancer due to lead smelters.
    Finally, I want to share one procedure that I always followed when 
preparing AB2588 assessments. Because I was usually contracted to a 
facility owner, I wanted to be sure that the results were not 
overstated through error, even if overstated through mandated 
assumptions. I therefore always traced back the dominant risk drivers 
by pollutant, exposure pathway, and source. I often found simple errors 
to be responsible, such as entering a number that was expressed in 
different units than needed, or even copying errors. Sometimes the 
problem was more subtle, such as including a route of exposure that was 
actually not possible for the specific facility. I am not convinced 
from reading the Case Study that the Agency took similar efforts to 
assure quality, and I recommend it do so. My experience can be extended 
for those who are worried about risks being understated by looking at 
pollutants that were expected to show higher risks but did not.
                               __________
  Statement of Dr. Deborah Cory-Slechta, Department of Environmental 
            Medicine, University of Rochester, Rochester, NY
    There are two major but related aspects of the residual risk 
analysis which are disconcerting. The first is the extensive degree of 
uncertainly in the models that have been developed and the total or 
cumulative uncertainty of the overall risk analysis. To the credit of 
its authors, the models are well thought out progressions that go from 
an initial identification of what may be the major contaminants from 
the smelters to a multiple pathway analysis that includes multiple 
sources of exposures as well as multiple types of receptors. Models for 
each component of these pathways feed into the overall derivation of 
the resulting HI values. The logic and inclusiveness of this 
progression is a major strength of the approach. In addition, the 
multiple pathway analysis approach includes consideration of different 
age groups, at least early age groups. However, the actual derivation 
of the HQ and HI values is almost totally dependent upon substituted 
values rather than upon actual data and these are propagated through 
the process. Thus, there is really no validation of the model that has 
been attempted to date. Certainly no systematic attempt to validate the 
model was undertaken; but even the assessment against some known 
entities is not considered. The outcome is really presented in the 
abstract. While there is repeated discussion of the uncertainties of 
the analyses, there is no discussion following either Chapters 3 or 4 
of Volume I as to the realities and or the limitations of the findings. 
This represents a major weakness of the approach, recognizing what may 
be difficulties in obtaining data for the most relevant parameters of 
the models.
     Also with respect to issues of validating and understanding the 
model, there is little indication of how the actual default assumptions 
used alter the outcomes and any tests to look at how modifying these 
assumptions changes the outcomes, or drives the outcomes. Its not clear 
how the validity of the model can be established without understanding 
how its components work and influence outcomes.
    The uncertainty analysis does little to provide additional 
reassurance with respect to the validity of the model. The description 
of the outcome of this analysis is presented but with little attention 
to its conclusions and to how these conclusions relate to the validity 
of the residual risk model, particularly the multipathway analysis. For 
example, the plots presented with respect to outcome are somewhat 
difficult to comprehend and do not provide a straightforward assessment 
of uncertainty. The analyses presented in Chapter 5 of Volume I are 
plotted in a manner that is not intuitively obvious and must be 
extracted. It is indicated, almost as an aside, that the range 
predicted for each cancer or non-cancer effect spans at least two 
orders of magnitude. How acceptable is this range? What would typically 
be an acceptable range of values from such an analysis?
    Some of the predicted values from the residual risk assessment 
suggest problems with the default assumptions. For example, the 
residual risk assessment predicts blood lead values from Facilities 3, 
4 and 13 for infant blood lead levels of over 200 g/dL. These 
are extraordinarily high, likely much higher than even encountered in 
an occupational context these days. Surely, if such blood lead values 
were being generated, they would result in obvious toxic effects and 
even lethality in infants and would be evident.
    Similarly, the residual risk assessment derives exposure values for 
dioxins and furans were found to be considerably lower than those 
reported in breast milk in all of the facilities. The residual risk 
assessment concludes that this means that emissions of dioxinslfurans 
from secondary lead smelters are a minor contributor to overall dioxin/
furan emissions nationwide. Not considered here is the alternative 
explanation that dioxinslfurans may be inadequately modeled. The 
comments suininarized in No.s 3 and 4 above suggest that by the simple 
potential mechanisms of validating the model, it does not work well.
    Two major assumptions upon which the residual risk assessment is 
based are not adequately justified nor explained. The assumption that 
cancer as an endpoint has no threshold, whereas non-cancer endpoints do 
exhibit thresholds has no obvious biological basis. It also is not well 
supported by more recent reanalyses of data suggesting that Pb 
exposures below 10 g/dL (a value used as a type of risk 
threshold) may actually produce larger effects than those above 10 
g/dl. It is also notably inconsistent with the rest of the 
document, since this is certainly not the most conservative approach. 
If this assumption is to remain in the residual risk assessment, then 
some type of rationale for it should be provided.
    Another assumption that is problematic is that the effects of HAPs 
are considered to be additive. This may need to be a default assumption 
given the relative absence of a data base from which to conclude 
otherwise. Assumptions of synergistic or potentiated effects may be 
overly conservative and thus not appropriate in this case. Again, 
however, some rationale for the reliance on this assumption should be 
provided.
    The focus on dioxin as a cancer risk really fails to embrace the 
fact that these compounds have marked effects on the immune system, the 
reproductive system, and perhaps the nervous system as well. This 
component of dioxin/furan effects should be included in the non-cancer 
effects.
    Some of the distinctions between the subsistence farmer and the 
home gardener seem somewhat arbitrary. For example, why wouldn't the 
home gardener also be ingesting animal products, in fact those grown on 
the subsistence farm; local processing and distribution of these 
products certainly occurs.
    One major component of the document that seems to be missing is any 
real discussion of the outcomes of the multipathway analysis with 
respect to known values as determined from other sources for emissions 
of the various metals and organics chosen as well as any exposure data 
for these compounds in smelter workers and or groups living around 
smelters. How do values computed relate to any known emission or 
exposure data?
    A related point is that the document does not really put the risks 
generated into an adequate public health context. What do these derived 
risk estimates mean with respect to public health? The values generated 
are presented without really providing any discussion of their 
relationship to known toxicity levels for these compounds.
    A minor point, but wouldn't chicken be a better choice than pork 
with respect to total human consumption in the category of animal 
product ingestion?
                                 ______
                                 
   Statement of Dr. Thomas J. Gentile, New York State Department of 
                   Environmental Conservation, Albany
    1. Overall: Is the methodology that the Agency applied in this risk 
assessment consistent with the risk assessment approach and methodology 
presented in the Report to Congress? Are the assumptions used in this 
risk assessment consistent with current methods and practices?
    The risk assessment methodology presented in the case study is 
consistent with the framework described in the Report to Congress (RTC) 
with some significant exceptions. Overall, the case-study approaches 
incorporates the iterative approach (e.g. refine the risk assessment by 
reducing the conservatism by including site-specific detail). It 
carefully identifies the assumptions and impacts of the assumptions on 
the risk estimates presented. In addition, the public health risk 
assessment is consistent with current methods and practices. Although I 
have some concerns about the adequacy of the ecological assessment, 
these concerns may be due to my unfamiliarity with the current State of 
the science about ecological risk assessment practices.
    However, the case study does not go far enough in providing site-
specific information to make the important risk management decisions 
concerning the adequacy of the NESHAP to protect public health and the 
environment. There was an attempt to incorporate some site-specific 
information (e.g. facility compliance stack test, State stack test, 
receptor locations, ambient measurements and local blood lead levels), 
but more site specific information (e.g. the degree of partial or total 
fugitive emissions enclosures, specific terrain information for 
receptor modeling, soil sampling results for metals in the local areas) 
needs to be obtained by working with State and Local Public Health and 
Environmental Agencies and industry. This point is evident when a 
comparison is made between the screen and refined risk estimates for 
inhalation only exposure (Table 1).

    Table 1.--A Comparison Between The Refined And Screen Inhalation Cancer Risk Estimates For The Facilities
                                          Selected For Refined Analysis
                                   [All Risk Estimates Are Cases Per Million]
----------------------------------------------------------------------------------------------------------------
                                                                                 Risk
                                        Initial      Refined      Refined     Reduction     Risk Reduction  w/
              Facility                   Screen     Screen w/o   Screen  w/      w/o             fugitives
                                                    fugitives    fugitives    fugitives
----------------------------------------------------------------------------------------------------------------
2...................................         6000           10           52          600  115
3...................................         9000            5         2240         1800  4
4...................................         6000          268         6950           22  risk increases
13..................................        10000           16          130          625  7
----------------------------------------------------------------------------------------------------------------

    The increase in risk for facility 4 as a result of the refined 
modeling raises concerns, which may go beyond the lack of refinement of 
the fugitive dust emission estimates in the refined analysis. This 
needs to be explored in greater detail in the case-study. The obvious 
differences which impact the risk assessment between facility 4 and the 
others is the size of the facility as determined by the number of 
emission points (n=13), the furnace type and the closer receptor 
impacts (Table 3.7 in case-study). However, the most troubling aspect 
is that Facility 4 had stack test data reported for all of the HAPs 
which were assessed in the refined screening exercise. It also had the 
smallest incremental reduction in risk (22 times) when just the process 
and process fugitive emissions impacts from inhalation exposure are 
considered. The other issue is that Facility 3 also had stack test data 
reported for all of the HAPs which were assessed in the refined 
screening analysis and had the largest incremental reduction in risk 
(1800 times). An in depth analysis of these large differences in risk 
reductions (1800 versus 22) needs to be examined more closely in the 
case study. In addition, they have probably been subject to stringent 
State air toxics requirements under the California Air Toxics Hot Spots 
Program. Is there a State Air Toxics Hot Spot Risk Assessment for these 
facilities? If it is available has OAQPS conducted an independent 
evaluation of the results and actions which were taken to reduce risk?
    This is extremely important since the refined analysis for 
facilities 3 and 4 was based more site specific emissions information. 
The increased risk observed for facility 4 in the refined analysis 
indicates that the initial screening assumptions may not be overly 
conservative in all cases. The only way to check this would be to 
obtain some basic site-specific information to insure that the 
parameters used in the initial screen are always going to be 
conservative for all facilities.
    In summary, a detailed site specific description of the four 
facilities selected for the refined analysis should be suininarized and 
included in volume 1. The brief discussion in section 3.1.1 is 
inadequate and should be expanded. This qualitative expansion should 
include cross references to other sections where site specific data is 
used in the refined analysis. For example, the use of actual stack 
characteristics for the refined analysis which is found in Table 3.3, 
the use of local met data which is found in Table 3.4 and the use of 
actual receptor locations which is found in Table 3.7. This would place 
all site specific or cross references to site-specific information into 
one important place and would help the reader conceptualize the 
differences between the facilities under evaluation.
    In context of the framework presented in the RTC, it appears that 
the refined analysis can not answer the question: Is human health risk 
acceptable? The fugitive emissions issue (e.g. lack of refinement) and 
the lack of site-specific information clearly result in negative answer 
to the question: Are information and analysis sufficient to evaluate 
management options? This answer indicates that a further refinement of 
the case-study or another iterative step is needed before an evaluation 
of the risk management options can be considered.
    The Agency is mandated under Section 112(f) to conduct the residual 
risk assessment and make a decision to implement further regulation or 
to make a decision that no further regulation is needed. In response to 
the previous SAB review of the RTC, the Agency responded that, ``the 
decision made with the results of the screening analysis is no further 
action or refine the analysis, while the decision made with the results 
of the more refined analysis is no further action or consider 
additional emissions control.'' As discussed above, the results of the 
refined analysis provides the same answer as the initial inhalation 
screen, that a more refined analysis is needed. Therefore, the case 
study has not achieved the ultimate decision objective and another 
level of analysis or iteration is required. The case study should do a 
more in-depth refined analysis or an additional step-wise iteration to 
improve the case study for risk management decisionmaking.
    An examination of the initial screen results indicates that it has 
provided important information about which hazardous air pollutants 
(HAPs) need to be considered in the multipathway and refined analysis. 
However, the results from the above Table are disconcerting. How can 
the refinement and the removal of conservative assumptions and HAPs 
from consideration result in an increased inhalation risk for receptors 
around facility 4? It is important to narrow the scope and refine the 
residual risk analysis in the first step, however, extreme caution must 
be exercised when eliminating HAPs and facilities from consideration as 
a result of the initial screening. It is clear that the use of post 
NESHAP emission rates in the initial screen would provide a better 
starting point for the case study.
    The impact of consolidating emission points into a centroid 
emission point needs to be carefully considered and analyzed. The 
Office of Air Quality Planning and Standards (OAQPS) should evaluate 
the work that has been conducted with the Office of Pollution 
Prevention and Toxics (OPPT) on the Risk Screening Indicators Model 
concerning the use of centroid emissions locations versus the use of 
facility specific stack and location parameters. An analysis conducted 
by OPPT found that the impacts in the area close to the facility fence 
lines was underestimated by a factor of three to seven when the 
centroid was used to estimate emission impacts. As distance from the 
facility increased the centroid modeling provided more consistent 
predictions when compared with the model using actual stack emission 
parameters and location characteristics. Therefore, some of the 
conservatism of the initial screening and the refined screening 
exercises may be questionable if receptors are in close proximity to 
the facility fencelines.
    The selection of facilities for the refined analysis needs to be 
placed into some type of risk management framework. These facilities 
were obviously selected since they represented the highest risk (e.g. 
cancer risk > 9000 in a million and HQ > 70). However, a defined 
process is needed for selecting which facilities will be included in 
the refined analysis. For example, if the 100 in a million cancer risk 
value was used only 2 of the 29 facilities would pass the screening 
criteria. The use of this cancer risk range would be consistent with 
the benzene decision and the Commission of Risk Assessment and Risk 
Management (CRARM) recommendations by having the total cancer risk from 
the facility being in the range of less than one to one hundred in a 
million for the screening assessment. In addition, if a hazard quotient 
of 10 is used as an action level for the screening assessment as 
recommended by CRARM, then a decision to eliminate facilities 6, 9, 12, 
20, 25 and 29 for further analysis of noncanccr health effects can be 
made. One can construe from the selection of only four facilities that 
a decision of no further action may be made for the other 19 facilities 
based on the initial screening assessment.
    In summary, there is a need to gather more site specific 
information for the initial and refined analyses than what was gathered 
and presented in the case-study.
    The RTC discusses the need for including background risk and 
discusses the difficulty associated with this specific issue. The case 
study does not address background risk issues around any of the 23 
facilities in the human health risk assessment. This is serious 
omission from the case-study and there is a need to attempt to address 
this issue at a minimum from a qualitative and quantitative point of 
view, well beyond the comparisons made in Chapter 6. No assessment of 
background risk seriously impacts statements about the conservative 
nature of the refined screening assessment.
    I disagree with the statement on page 134 of the case-study that 
any attempt to include background concentrations in the ecological 
assessment ``. . . were beyond the scope of this assessment.'' This is 
a critical part of the ecological risk assessment since these 
facilities have been probably impacting the local ecosystems for a long 
time prior to the addition of NESHAP controls. An assessment of 
background risk in addition to the screening level assessment is 
absolutely necessary before any decisions can be made about the 
significance or conservativeness of the ecological risk assessment.
    The RTC also discusses the assessment of acute effects from short-
term HAP exposure. The case study contains no discussion or assessment 
of acute effects from HAP emissions for this source category.
    2. Model Inputs: Are the methods used to estimate emission rates, 
and the method used to estimate species at the stack appropriate and 
clearly described?
    The methods used to estimate emission rates for the initial screen 
and refined analysis are clearly described. However, there is a concern 
that the emission rates used for the lead to metal HAP ratios in the 
initial screen are biased low based on the actual stack test results 
from facilities 3 and 4. A comparison of the lead/HAP metal ratios used 
in the initial screen and refined analysis are presented in Table 2.

    Table 2.--A Comparison Of The Lead To HAP Metal Ratios Used In The Initial And Refined Screening Analysis
----------------------------------------------------------------------------------------------------------------
                                                                                      Initial
                                                            Initial      Refined       Screen        Refined
                        Metal HAP                            Screen     (Process)     Process        Process
                                                           (Process)                  Fugitive       Fugitive
----------------------------------------------------------------------------------------------------------------
Arsenic.................................................         0.09         0.31         0.03      0.035-0.098
Chromium................................................      0.05(1)      0.00048         0.01    .00013-0.0014
Cadmium.................................................         0.02        0.031         0.01       0.02-0.045
Nickel..................................................         0.08        0.179         0.06        0.13-1.99
----------------------------------------------------------------------------------------------------------------

    (1) The ratio for the initial screen is total chromium and for the 
refined analysis it is hexavalent chromium. An adjustment of the 
initial screen total chromium values using the 1 percent assumption as 
hexavalent provides almost the same value used for the refined process 
and process fugitive emissions.
    The differences between the arsenic and nickel ratio values used in 
the initial screening analysis and the refined screen analysis clearly 
undermines the conservativeness of the initial screen risk results 
presented in Tables 2.4a and 2.4b. If the stack test results from 
facilities 3 and 4 are post NESHAP , then a decision should have been 
made to use those results in the initial screen versus the median 
values estimated from Background Information Document (Table B1.3--
Appendix B).
    The Agency should consider requesting stack emissions test for 
process and process fugitive at some of the facilities in order to 
obtain better emission estimates for use in the screening assessment 
case-study.
    The Agency carefully needs to reevaluate the fugitive emissions 
rates since the modeled annual concentrations of lead with fugitives in 
Appendix C are unrealistically high for facilities 3 and 4. There is a 
need for site specific information on the effectiveness of fugitive 
emissions control after the implementation of the NESHAP housekeeping 
standards. Fugitive emissions from this source category are an issue 
and need to be carefully evaluated. In 1987, there were two exceedances 
of the National Ambient Air Quality Standard (NAAQS) for lead (1.5 
g/m3) in the vicinity of a secondary lead smelter. The 
elevated lead concentrations (2.46 and 1.61 g/m3) at the 
monitor were the result of malfunctioning emissions control equipment 
and fugitive emissions from the plant. Monitoring of lead around the 
plant was increased by the addition of two downwind monitors. The plant 
upgraded the process emission controls, but the concentrations of lead 
were still elevated, but below the NAAQS when compared to other 
monitoring sites in the State. Further investigations concluded that 
fugitive emissions from the plant were a problem that needed to be 
addressed. The entire facility was enclosed and placed under negative 
pressure. HEPA filters were installed on all air exchange units and 
other housekeeping practices were required. This facility currently has 
16 emission points. The annual geometric mean of lead at one monitoring 
site dropped from a high of 0.71 g/m3 (1987) to 0.06 
g/m3 (1993) after all of the facility upgrades were in place. 
The highest quarterly average measured at the two remaining monitoring 
site in 1996 were 0.06 g/m3. These two monitors are located 
275 meters from the facility fence line. The third site was shutdown at 
the end of 1995.
    The incorporation of this type of information into the case study 
and the refined screening analysis will result in a more informed risk 
management decision for this source category.
    3. Models: Does the risk assessment use appropriate currently 
available dispersion models at the screening level and at the more 
refined level of analysis? Are the models applied correctly? Given the 
State of the science, does the risk assessment use an appropriate 
multipathway model? The assessment uses the IEM-2M model, with some 
modifications. Is the IEM-2M model appropriate for use in this 
regulatory context? With regard to the modification and application of 
the model, did EPA appropriately modify the model for use in this risk 
assessment, and did the Agency apply the model correctly? Is there 
another model or another approach, that is available at this time that 
EPA should consider?
    The decision to use facilities 2,3,4, 13 because these represented 
facilities with the highest excess cancer rate and highest hazard index 
based on the initial screening produced a situation where only simple 
terrain would be used in the refined analysis. This process could have 
biased the modeling results to underestimate impacts at other 
facilities, with complex terrain, which were not designated for refined 
analysis. The Agency should reevaluate if any of the 29 facilities are 
in areas of complex terrain.
    The exposure inputs into the IEM-2M and IEUBK model are 
conservative which is clearly acknowledged by the Agency throughout the 
case study. The Agency should continue refine the risk assessment using 
site specific information as discussed in many of my other comments. 
There is a strong need for another iteration to refine the case study 
which is acknowledged by the Agency in section 6.7. The case study 
should remain a Pre-Decisional Document until the next iterative 
refinement is conducted. OAQPS should work diligently with State and 
Local Health and Environmental Departments, the Agency for Toxics 
Substances and Disease Registry, Industry and the EPA Regions to 
further refine the case study. This step is absolutely necessary before 
any decision about unacceptable risk is made for the majority of the 
facilities identified in the case-study. The uncertainties associated 
with the fugitive emission parameters are the driver for a more 
detailed risk assessment within the source category. This need is 
discussed by CRARM on page 23 of the RTC.
    4. Choice of Receptors: The Agency identifies the home gardener as 
the appropriate receptor to estimate risk to the residential population 
and the farmer to embody high end risk estimates. Are these receptors 
appropriate for this task?
    The receptors identified by the Agency are appropriate and 
adequately represent the maximum individual risk (MIR) concept which is 
discussed in the RTC.
    5. Ecological Risk Assessment: given the currently available 
methods, are the models used for the ecological assessment appropriate? 
Are they applied correctly? Are the ecological benchmarks appropriate?
    The case study does not include a discussion of other ecological 
stressors (e.g. criteria pollutants) which may have an impact on the 
surrounding ecosystem. The effect of this omission on reducing the 
conservativeness of the ecological risk screen is mentioned on page 
147. However, any refined analysis of ecological risk is going to have 
to account for these additional ecosystem stressors, especially the 
effects on terrestrial plants exposed via direct contact with criteria 
pollutants (in this case sulfur oxides) in the ambient air.
    6. Health Risk Assessment: Given available dose-response 
information, is the hierarchy presented in the assessment appropriate 
(see especially footnote #6, section 2.21)?
    The hierarchy presented in the assessment is appropriate. I agree 
with the use California Environmental Protection Agency values over 
HEAST values for all of the reasons outlined in footnote No. 6.
    For each chemical included in the assessment is the choice of dose 
response assessment appropriate?
    Overall, the choice of the available dose-response data used in the 
case study is appropriate. I have concerns about the elimination of 
HAPs from consideration in the case study if they have no available 
cancer or noncancer public health values. Seven organic HAPs are 
eliminated from consideration in the case study. It is difficult to 
assess the impact of the elimination of these organic HAPs from the 
case study. However, the effect may be negligible since emission rates 
in Appendix B for the organic HAP emissions omitted from consideration 
are low. The Agency should consider the development of default or 
surrogate values based on the available toxicity information or 
structure activity relationships with other HAPs which have dose 
response data.
    Why is propanol identified as a HAP in the case study? I can not 
locate it on the list of 188 HAPs identified by the Clean Air Act.
    The application of the use of risk ranges for benzene and 1,3-
butadiene in the initial screen needs to be discussed. Do the cancer 
risk results presented in Table 2.3 use the high or low end of the 
range?
    The use of only 25 percent of the inhalation unit risk estimate for 
nickel subsulfide needs to be explained in greater detail, since it 
will have a large impact on the total cancer risk estimates in the 
case-study.
    Are the dose response assessments appropriately incorporated into 
the assessment?
    Yes, the available dose response assessments are appropriately 
incorporated into the assessment, with a few exceptions as noted above.
    7. Uncertainty and Variability Assessment: Did the assessment use 
the appropriate currently available methods to identify the variables 
and pathways to address the uncertainty and variability assessment? Are 
the methods used to quantify variability and uncertainty acceptable? 
Are there other, more appropriate methods available for consideration?
    8. Results Presentation: Does the document clearly present and 
interpret the risk results? Does it provide the appropriate level of 
information? Do the figures and tables adequately present the data? Do 
the formats provide for a clear understanding of the material?
    It is very difficult to present such a large amount of information 
in a clear and concise manner. The case study does a good job of 
presenting and interpreting the risk results. The discussion of the 
initial inhalation screening results should include a discussion of how 
the maximum and minimum risk values presented in Table 2.3 were 
defined. The Agency should indicate that they are simply the range of 
estimates determined for all 29 facilities.
    The Agency should consider using a consistent cancer risk 
expressions in the narrative of the case study. The lay reader will be 
confused by the constant interchangeable expressions of cancer risk. 
For example, the use of the expression eight in a ten thousand should 
be changed to 800 in a million. This will allow the lay reader to place 
the results into the context of the less than one in one million 
expression which appears in the Act and throughout the case study.
    The identification of the key issues and assumptions are clearly 
identified in the result sections of the the initial inhalation screen, 
the refined multipathway screen , the variability and uncertainty 
analysis, and the ecological screening assessment. The addition of a 
discussion about a few key issues concerning the lack of a background 
risk analysis and the effects of the adjustment of the nickel 
inhalation unit risk estimate could be added to the key issues 
identified in Section 3.3.2.
    The tables and figures used throughout Section 4 provide a concise 
and well thought out approach for the presentation of variability and 
uncertainty for each scenario evaluated. They allow the reader to 
evaluate the broad spectrum of risk and the impacts of the various 
exposure parameters used in the refined multipathway risk assessment. 
These tables and figures significantly enhance the comprehendability of 
the variability and uncertainty assessment results. The inclusion of 
the point estimates in Tables 4.5 and 4.6 is an excellent way to 
concisely present information to the risk manager. The tables and 
figures provide the risk manager with the ability to view the broad 
spectrum of risk predictions, which includes the average exposed 
individual (AEI), the adjusted maximum individual risk and the maximum 
exposed individual (MEI).
    Tables 6.1 and 6.2 provide a good overview summary of the final 
results for the refined multipathway risk assessment. I have some 
concerns about Section 6.2.1 Comparison of Modeled Concentrations with 
Measured Environmental Concentrations. As discussed through out my 
comments this section can be greatly enhanced and another iterative 
refined multipathway risk assessment step which relies on more site 
specific information should be added to the case study.
    The effort which will be needed to gather the relevant information 
for this next step should not be considered overwhelming or beyond the 
scope of the case study. It should be considered as a necessary 
refinement which needs to be conducted before the case study becomes a 
public document. The discussion in section 6.2.1.1 needs to be 
expanded. The pre-NESHAP monitoring data from New York indicates that 
the NAAQS for lead can be exceeded and that the stringent control of 
fugitives can result in a dramatic lowering of ambient concentrations 
of lead and probably other metal HAPs in the vicinity of secondary lead 
smelters. Table 6.7 should be modified by locating the distance to the 
monitors and include a brief discussion of siting issues (e.g. 
predominate downwind or upwind monitoring location) before any 
comparisons are made. The same point can be made for the comparisons of 
the surface waters concentrations. However, the Agency does 
appropriately acknowledges that the comparisons in Table 6.8 are not 
meaningful.
    Section 6.2.1.5 needs to be expanded since it provides information 
on an excellent biomarker for potential exposure (e.g., blood lead 
levels). The inclusion of this type of information would greatly 
enhance the case study. The CDC and State Health Departments should be 
consulted to find out if there is any other information on blood lead 
levels in children who reside in communities that are in close 
proximity to secondary lead smelters.
    In summary, there is a strong need to gather and evaluate more site 
specific information using the risk assessment tools presented in the 
case study before any final risk management decisions can be made for 
this source category. The case study should undergo another iteration 
before being released to the public.
                            editorial notes
    The overview presented in section one, the case study, is very 
good.
    Section 2.2 needs to include the chemical abstract service registry 
numbers and the identity of the chemicals as they are primarily 
identified in Section 112 (b) of the Clean Air Act (e.g., 2-methyl 
phenol is identified by 112 (b) as o-creosol, iodomethane should be 
identified as methyl iodide, etc.)
    Table 6.8--the units (g/l) are missing.
                               __________
     Statement of Dr. Dale Hattis, Clark University, Worcester, MA
    Below are my updated responses (following discussion at the 
meeting) to the questions posed to the Secondary Lead residual risk 
review Subcommittee:
    Charge Question 1. Overall--Is the methodology that the Agency 
applied in this risk assessment consistent with the risk assessment 
approach and methodology presented in the Report to Congress? (EPA-453/
R-99-001)? Are the assumptions used in this risk assessment consistent 
with current methods and practices?
    Response. I have very considerable difficulty making an appropriate 
response to the first part of this question. I was not provided with a 
copy of the Report to Congress that is specifically referred to. Fairly 
recently, I was sent a copy of a substantial earlier SAB review of that 
document from which I can make some inferences about the risk 
assessment approach and methodology that was presented in the Report to 
Congress. However there does seem to be very significant commentary in 
the SAB review of the need to ``validate'' models, and to conduct 
appropriate analyses of the population variability of regulated risks 
and give a fair estimation of the uncertainty in the variable risk 
distributions. The current document, though very extensive in many 
ways, does not seem to reflect a serious effort to assemble and analyze 
a substantial body of post-MACT emissions and exposure (e.g., community 
blood lead) information that could be juxtaposed with the emissions 
estimates made in the early 1990's when the MACT standards were set. 
The documents do not appear to describe a systematic search for such 
information, do not present the specific emissions information that was 
collected, and do not document in nearly adequate detail the specific 
analyses that were done with the emissions information. There is no 
visible attempt to juxtapose model projections of either emissions or 
exposures (e.g., for blood lead) with such data and to form the bases 
for an updated set of distributional exposure and risk projections.
    There is a great deal of discussion in the SAB review, and in the 
EPA residual risk assessment, of the need to conserve scarce EPA 
resources by limiting the analysis in various ways (by structuring the 
analysis in a series of tiers beginning with generic conservative 
assumptions, restricting the HAPs covered, the facilities examined in 
detail, etc.). Sadly the implementation of this approach does not seem 
to have lead to an economical analysis that can be said to have 
succeeded in producing meaningful insights into the likely level of 
risk posed to real people in the immediate vicinity of these 
facilities. There is no more expensive analysis than an analysis that 
does not produce results that can meaningfully inform public policy 
choices. The screening level analysis as it stands probably is adequate 
to focuses EPA's attention on lead and a few metallic HAP's, and away 
from the great majority of organic HAP's, but that result probably 
could have been foreseen with considerably less work than appears to 
have been devoted to this project. Certainly something is seriously 
amiss when the document can show projections of essentially lethal 
blood lead levels (200 g/dL and above) for the case where 
fugitive emissions are included--and very significant blood lead levels 
(68 g/dL) even without fugitives for one of four modeled 
facilities--without that leading to some attempt to pursue the issue 
with blood lead observations or some deeper conclusion than that the 
fugitive emissions estimates are probably ``conservative''. Maybe they 
are ``conservative'', but then to blithely exclude both the fugitive 
emissions and all exposures to lead entirely from the ``variability/
uncertainty analysis'' without further reappraisal of the source of the 
apparent estimation problem seems to turn the screening results on 
their head. Any ``tiered'' analysis procedure that leads the 
investigators to exclude such a major source of concern as lead from 
important parts of the secondary lead smelter analysis has a serious 
fundamental problem, at least as implemented here. This is particularly 
true in the light of the fact that emissions of the other HAP's that 
are included in the variability/uncertainty analysis are estimated as 
ratios to lead.
    The context of this residual risk analysis is a long term possible 
consideration of the need for emissions control measures that go beyond 
the available control technology-based standards that were mandated in 
the first round of controls following the passage of the 1990 iteration 
of the Clean Air Act. Almost by definition, when you are building the 
informational basis for considering the need for technology-forcing 
measures, you need to have data that would be sufficient to support 
decisions that might involve very substantial technical and economic 
restructuring of an industry. At the same time, the context also 
involves considering the possibility that appreciable residual risks 
remain for people in communities surrounding these facilities that mean 
that the promise of the 1990 Act to provide an ample margin of safety 
for health protection is still not being fulfilled 10 years after the 
promise was made. This context demands that EPA take the time and 
devote the resources needed to fairly assess the current public health 
problem posed by these facilities. Otherwise no actions based on such 
an analysis are likely to survive Congressional and Judicial oversight.

    Charge Question 2. Model Inputs--Are the methods used to estimate 
emission rates, and the method used to estimate species at the stack 
appropriate and clearly described?
    Response. Briefly, no. The primary data should be provided in the 
document and the detailed analysis steps should be given in sufficient 
detail to allow an informed reader to reproduce the analysis. My 
understanding from the extra documents that have been provided to me in 
the context of the variability/uncertainty analysis is that the 
existing data base is not extensive--onsisting apparently of three 
``runs'' (of undetermined duration) measuring Lead, Arsenic, Cadmium, 
and Nickel emissions from various stacks at two different facilities--
constituting in all about 168 separate measurements if I have counted 
correctly. For a large number of other HAP's and other facilities my 
understanding is that there is some additional information available 
from recent (post 1990) measurements for four facilities, but that the 
primary sources of estimates of emissions is the 1994 Background 
Information Document for setting the MACT standards. The bases of these 
estimates and their applicability to current conditions is not 
discussed.
    In addition, the authors should take a more creative approach to 
assembling other types of data relevant to emissions than they have 
apparently considered. For example, to estimate fugitive emissions, one 
clue might be air exposure levels measured for workers in this industry 
by OSHA industrial hygienists. [Some helpful background on the history 
of air and blood lead levels in the industry can be found in a couple 
of past reports I helped do for the Office of Technology Assessment--
Goble et al., (1995, 1983)]. Such air levels, when combined with 
general ventilation assumptions and baghouse capture efficiencies, 
should provide some basis for new estimates of at least some process 
fugitive emissions, as should air measurements from environmental 
monitoring conducted near the facilities, and children's blood lead 
measurements that are routinely collected by agencies in several 
states, and which may therefore be available for communities near the 
facilities under study. In addition, it should allow some estimation of 
fugitive emissions from other parts of the process than the battery 
breaking and materials handling steps that are presently included as 
contributing fugitives in the current process flow diagram. What 
happens to the air around the workers working at other steps than the 
first two? Is it captured and treated to remove some dust? With what 
efficiency? Additionally, it would seem sensible to make systematic 
comparisons of observed community air levels with those predicted from 
the dispersion models.

    Charge Question 3. Models--Does the risk assessment use appropriate 
currently available dispersion models both at the screening level and 
at the more refined level of analysis? Are the models applied 
correctly? Given the State of the science, does the risk assessment use 
an appropriate multipathway model? The assessment uses the IEM-2M 
model, with some modifccations. Is the IEM-2M model appropriate for use 
in this regulatory context? With regard to the modification and 
application of the model, did the EPA appropriately modify the model 
for use in this risk assessment, and did the Agency apply the model 
correctly? Is there another model or another approach, that is 
available at this time that EPA should consider?
    Response. These questions cannot be fairly answered from the 
information provided. There was just not a sufficient presentation of 
the assumptions inherent in the IEM-2M model for me to evaluate it. I 
was provided with very large spreadsheets of the model, but without a 
great deal more time and appropriate documentation of the structure and 
assumptions built in to the model it is just impossible for me to make 
a sensible evaluation. I don't know and cannot easily infer, for 
example, how it differs from other multimedia models that are 
available, such as CALTOX.

    Charge Question 4. Choice of Receptors--The Agency identifies the 
home gardener as the appropriate receptor to estimate risks to the 
residential population and the farmer to embody high end risks. Are 
these receptors appropriate for this task?
    Response. I'm not at all convinced of this. My impression is that 
the chief pathway responsible for transferring gasoline air lead to 
children when gasoline lead was still allowed was a dust-hand-mouth 
pathway. It seems to me that this pathway, together with more recent 
information on the efficacy of community soil cleanups in reducing 
blood lead levels, needs to be evaluated as part of any fuller analysis 
of the issue. I understand EPA's desire to exercise its IEM-2M models, 
and this should certainly be one part of the analysis, but key issues 
need to be addressed, such as the persistence of dust contaminated with 
lead and other metallic HAP's in neighboring communities, rates of 
exchange between outdoor dust and indoor dust, and the magnitude and 
duration of exposures that result from emissions and deposition of 
indestructible metallic compounds in urban and other communities.

    Charge Question 5. Ecological Risk Assessment Given currently 
available methods, are the models used for the ecological assessment 
appropriate? Are they applied correctly? Are the ecological benchmarks 
appropriate?
    Response. This is not my area of expertise, and I have not 
evaluated this portion of the document.

    Charge Question 6. Health Risk Assessment--Section 3.4.1 of the 
Report to Congress identifies several data sources that the Agency 
would draw upon for choosing dose response assessments to be used in 
residual risk assessments. The Report also states that EPA will develop 
a hierarchy for using such sources. Given available dose response 
information, is the hierarchy presented in this assessment appropriate 
(see especially footnote No. 6, section 2.2.1)? For each chemical 
included in the assessment, is the choice of dose response assessment 
appropriate? Are the dose response assessments appropriately 
incorporated into the assessment?
    Response. I do not have the cited Report to Congress, and I have 
not thoroughly evaluated this aspect of the document. However, I would 
suggest that at least for lead, where there are quantitative estimates 
of relationships between children's blood lead levels and IQ, that the 
results be taken to estimate likely individual and population aggregate 
impacts in quantitative terms--how much relative deficit for how many 
kids. Additionally, I believe that cancer impacts can and should be 
evaluated in population aggregate terms as well as in terms of risks to 
particular percentiles of the estimated exposure distributions. This 
would allow decisionmakers in Congress and EPA to assess the public 
health productivity of investments made under the residual risk 
provisions of the Clean Air Act.

    Charge Question 7. Uncertainty and variability assessment--Did the 
assessment use appropriate currently available methods to identify the 
variables and pathways to address in the uncertainty and variability 
assessment? Are the methods used to quantify variability and 
uncertainty acceptable? Are there other, more appropriate methods 
available for consideration?
    Response. Although there are some glimmers of creative analysis of 
data in the uncertainty/variability portion of the effort (e.g. the 
attempt to calculate metal HAP/lead ratios over a longer time period 
than covered by the directly observations), the current analysis is 
very disappointing in numerous ways. First, the scope and objectives of 
the analysis fall far short of what any sensible decisionmaker will 
wish to have in order to make informed choices under the residual risk 
mandate of the 1990 Clean Air Act. To fulfill the mandate of the Clean 
Air Act, EPA needs to not only be confident that it has addressed the 
most significant hazards posed by the industry under study, but to 
define what it means by an ``ample'' or ``adequate margin of safety'' 
in distributional terms, (e.g., X level of probability of harm of a 
particular type or severity for the Yth percentile of the exposed 
population with Z degree of confidence-See for example Hattis and 
Anderson, 1999; Hattis and Minkowitz, 1996). EPA then needs to develop 
an analysis that addresses the likely real variability and fairly 
appraised uncertainty for at least the HAP's and exposure pathways that 
are thought to pose the greatest potential for public health harm for 
the industries studied. In the present context, omission of the 
variability and uncertainty of lead exposures and risks, and omission 
of some analysis of the uncertainty in fugitive dust emissions and 
exposures means that the analysis is substantially irrelevant to some 
of the most important concerns that arise from the earlier screening 
and multipathway efforts.
    The failure to distinguish variability from uncertainty in the 
present analysis almost guarantees confusion. Variability and 
uncertainty are different things and 
require different techniques for estimation. It is a shame that the 
individual variability in estimated exposures is essentially completely 
neglected even though existing dispersion modeling techniques, combined 
with data on the population distributions around the studied 
facilities, could readily produce such information. This 
information would seem central to the required analysis. The fact that 
it is not undertaken, at least at this stage in the development of the 
project, suggests that the current variability/uncertainty analysis is 
largely a placeholder for some later effort that, it is hoped, will be 
planned as a more central part of some future analysis.
    A second major problem is that the current analysis does not follow 
existing EPA guidelines on the documentation and presentation of 
distributional analysis. Those guidelines, drawn up in part at 
workshops that I attended, emphasize that the model itself and 
derivations of distributions used in the analysis must be transparently 
presented in sufficient detail that a reviewer can reproduce them. I 
have recently received several spreadsheets that contain portions of 
the model, but in the very limited time available I have not been able 
to get them running sufficiently to even examine the model structure, 
distributional assumptions, and correlation/dependency assumptions 
made. The document itself should have included as an appendix not the 
endless display of results for each stack, but the spreadsheet model 
equations, and the mathematical form of the distributional assumptions 
that were used.
    In summary, in the present effort, the uncertainty/variability 
analysis appears to have been an afterthought, perhaps undertaken at a 
late stage in the development of the principal results. Unless analyses 
of variability and uncertainty are undertaken integrated into the warp 
and woof of the primary study, they will likely continue to be 
unsuccessful and unsatisfactory in illuminating the major issues 
involved in the evaluation of the real choices facing EPA 
decisionmakers, Congress, and the public.
    Some more technical suggestions can be made for pursuing the 
probabilistic analysis in future work:
    (a) In assessing the distribution of metal HAP to lead ratios, the 
analysts should explore the possibility that some air exhaust streams 
might be systematically different than others. In particular arsenic, 
which is more volatile than the lead and most other inorganic HAP's may 
appear in larger concentrations relative to lead in some air streams 
than others depending on the temperature of the process and exiting 
gas. The data should be examined to see if such mechanism-based 
expectations are borne out in the available observations. If so, then 
some metal HAP to lead ratios could be varied across process streams 
(and perhaps across facilities) to reflect the mechanism-based 
associations.
    (b) In representing the interindividual variability of exposure 
factors such as consumption of different kinds of produce and fish, the 
analysts should seek data to quantify variability observed on different 
time scales than the 1-3 days that are typical for direct dietary 
studies. Some downward adjustment clearly needs to be made to calculate 
variability over longer time scales from shorter term data. However, 
because some dietary preferences are likely to be relatively consistent 
characteristics for individual people, it is not reasonable to estimate 
long term dietary exposure variability either by simply assuming that 
each separate 1- or 3-day period is a random draw from an observed 
population distribution of consumption. Some data bearing on the 
difference in effective variability in fish consumption inferred for 
longer vs. shorter timeframes is reviewed in Hattis et al. (1999).
    (c) In Section 4.4 the document should clearly explain the 
implications of the assumptions that are being made. For example, the 
statement is made on p. 127 that because of data insufficiency, no 
analysis of correlation among emission parameters and exposure factors 
was undertaken. The statement should be clarified to say that the 
correlation could not be undertaken because the data wasn't available 
for it.

    Charge Question 8. Results Presentation--Does the Agency's document 
clearly present and interpret the risk results? Does it provide the 
appropriate level of information? Do the figures and tables adequately 
present the data? Do the formats provide for a clear understanding of 
the material?
    Response. As discussed above, the presentation of the basic inputs 
and methodology is very far from being adequate to provide a document 
that is even transparent enough for a thorough review, let alone a 
document that appropriately assess the uncertainty and variability for 
decisionmaker and the dependence of the results on key sets of 
assumptions. Without documentation of the derivation of the results and 
their uncertainties, the results cannot be appropriately conveyed to 
decisionmakers and the public. Moreover the neglect of real population 
variability in both exposures and risks deprives the reader of 
important information that is needed to arrive at risk management 
judgments.
                               reference
    Goble, R. and Hattis, D. ``When the Ceteris Aren't Paribus---
Contrasts between Prediction and Experience in the Implementation of 
the OSHA Lead Standard in the Secondary Lead Industry,'' Report to the 
Office of Technology Assessment, U.S. Congress, by the Center for 
Technology, Environment, and Development, Clark University, July, 1995.
    R. Goble, D. Hattis, M. Ballew and D. Thurston, ``Implementation of 
the Occupational Lead Exposure Standard,'' Report to the Office of 
Technology Assessment, Contract No. 233-7040.0, MIT Center for Policy 
Alternatives, CPA 83-20, October 1983.
    Goble, R. and Hattis, D. ``When the Ceteris Aren't Paribus---
Contrasts between Prediction and Experience in the Implementation of 
the OSHA Lead Standard in the Secondary Lead Industry,'' Report to the 
Office of Technology Assessment, U.S. Congress, by the Center for 
Technology, Environment, and Development, Clark University, July, 1995.
    Hattis, D., and Anderson, E. ``What Should Be The Implications Of 
Uncertainty, Variability, And Inherent `Biases'/'Conservatism' For Risk 
Management Decision Making?'' Risk Analysis, Vol. 19, pp. 95-107 
(1999).
    Hattis, D., and Minkowitz, W.S. ``Risk Evaluation: Criteria Arising 
from Legal Traditions and Experience with Quantitative Risk Assessment 
in the United States.'' Environmental Toxicology and Pharmacology, Vol. 
2, pp. 103-109, 1996.
    Hattis, D. Banati, P., Goble, R., and Burmaster, D. ``Human 
Interindividual Variability in Parameters Related to Health Risks, Risk 
Analysis, Vol. 19, pp. 705-720, 1999.
                               __________
  Statement of Dr. Michael J. McFarland, Engineering Department, Utah 
                  State University, River Heights, UT
    residual risk assessment secondary lead smelter source category
    SAB Charge Question No. 1. Are the methods used to estimate 
emission rates and the method used to estimate species at the stack 
appropriate and clearly described?
                   initial inhalation risk screening
Findings
    The method used to estimate the HAP emission rates involve the use 
of several data sets from the Background Information Document from 
which the MACT standards were initially derived. The first data set 
(Table B.1.1) includes estimate emission rates (in metric tons/year) 
for each of the three emission sources including: (1) process stack 
emissions (both organic and metal HAPs), (2) process fugitive stack 
emissions and (3) fugitive emissions. The second data set (Table B.1.2) 
includes ratios of specific organic HAP emissions to total hydrocarbon 
emissions from the stacks of three (3) types of secondary lead smelter 
furnace types. The final data set includes the median metal specific 
HAP to lead ratios (Table B.1.3) as well as the total metal HAP to lead 
ratio for each of the three emission sources that include: (1) process 
stack emissions, (2) process fugitive stack emissions and (3) fugitive 
emissions.
    Although Table B.1.3 indicated that the reported data were the 
median metal (total and specific) HAP to lead ratios, it is unclear 
whether Tables B.1.1 or B.1.2 were also reporting median values or 
another statistical measure (e.g., mean or average) of the sampling 
data. Moreover, since the purpose of the initial inhalation screening 
analysis was to employ a lower tier conservative approach to screen 
those HAPs that did not pose a significant human health risk, it would 
seem more appropriate to use the upper limit of a confidence interval 
(e.g., 95 percent) of the HAP ratios for estimating emission rates 
rather than mean (or median) values to estimate inhalation risk. Given 
the wide range in HAP ratios found in the data tables, use of an upper 
confidence limit would provide greater protection from deletion of 
species that may, in fact, represent a significant human health and/or 
ecological risk. The same argument can be applied to the use of a mean 
or median total HAP emission rate (Table B.1.1) for estimating specific 
HAP emission rates. The large range in reported data suggests that a 
more defensible risk screening evaluation would be achieved by 
selecting an upper limit of a prescribed confidence interval of 
emission rates for input into the general inhalation risk model rather 
than the use of an average emission rate.
    Another concern regarding the inhalation risk model inputs was the 
specific management of the acid gas data. Both chlorine 
(Cl2) and hydrogen chloride (HCl) emissions were included in 
Table B.1.2 and treated as organic HAPs in the emission rate 
calculations. The concern with regard to the acid gas data stems not 
only from the placing of the inorganic acid gas emissions in the table 
for organic HAPs (i.e., Table B.1.2) but, it is also unclear as to 
whether the total organic HAP process emission rate data (Table B.1.1) 
includes the contribution from the acid gases.
    Although there are some concerns regarding the input data quality 
for the initial inhalation risk screening, the mathematical equations 
used to estimate the specific HAP emission rates are fundamentally 
sound. The specific metal HAP emission rates (EHAP) from 
each of the three emission sources (i.e., process stack emissions, 
process fugitive stack emissions and fugitive emissions) were estimated 
by substituting the estimated total metal HAP emission rates (metric 
tons/yr) for each emission sources (ETMH-Table B.1.1), the 
median metal HAP to lead ratio (RHAP--Table B.1.3) and the 
total metal HAP to lead ratio (RTMH-Table B.1.3) into 
Equation 1.
    EHAP = (ETMH)/
RTMH)(RHAP)

where

    EHAP = Individual metal HAP emissions (i.e., antimony);
    ETMH = Total metal HEP emissions;
    RTMH = Ratio of total metal HAP emissions to lead 
emissions;
    RHAP = Ratio of individual metal HAP emissions from lead 
emissions.

    The specific organic HAP emission rate (EVOC) from the 
process stack emission source was estimated by substituting the 
estimated total hydrocarbon emission rate (metric tons/yr) from Table 
B.1.1 (ETHC) and the ratio of specific organic HAP to 
hydrocarbon emissions (RVOC-Table B.1.2) into Equation 2.

    EVOC = (ETHC)(RVOC)

where

    EVOC = Individual organ HAP emissions;
    ETHC = Total hydrocarbon emissions;
    EVOC = Ratio of individual organic HAP emissions to 
total hydrocarbon emissions.
Recommendations
    Although the data input descriptions were, in general, well 
written, there are several areas where significant improvement could be 
made. The specific recommendations for this section of the review 
include the following:
    The data in Tables, B.1.1 and B.1.2 can be improved by explicitly 
stating the statistical measurement parameter being reported.
    Consideration should be given to the use of upper confidence limits 
(of the HAP ratios) as inputs to the inhalation risk model.
    The text should provide greater clarity as to how the acid gas data 
are being managed.
    To provide clarity in the use of the mathematical relationships, 
quantitative examples should be inserted into the text that illustrate 
the use of Equations 1 and 2.
    An example should be provided (perhaps in an appendix) illustrating 
how raw emission data from each emission source (i.e., process stack 
emissions, process fugitive stack emissions and fugitive emissions) is 
managed to generate final risk numbers.
                         multipathway analysis
Findings
    The method used to estimate emission rates for the multipathway 
analysis included the use of compliance reports from stack tests for 
specific facilities (i.e., Facilities 2, 3, 4 and 13--Table C.1.1) as 
well as the EPA data base developed in the Background Information 
Document (BID). The MACT standards require that facilities report, at a 
minimum, both the total lead and total hydrocarbon emission rates. For 
Facilities 3 and 4, additional compliance testing was conducted that 
allowed specific organic and metal HAP emissions to be estimated. These 
facility-specific emission estimates were then used to generate 
specific emission ratios including: (1) organic HAP to total 
hydrocarbon ratio and (2) metal HAP to total lead ratio.
    To estimate specific organic HAP emissions for Facility 2, the 
organic HAP to total hydrocarbon ratio generated from Facility 3 data 
was multiplied by the total hydrocarbon emission rate from Facility 2. 
Similarly, to estimate specific organic HAP emissions for Facility 13, 
the organic HAP to total hydrocarbon ratio generated from Facility 3 
data was multiplied by the total hydrocarbon emission rate from 
Facility 13. Since diethylhexyl phthalate and naphthalene were not 
measured in Facility 3-stack test, EPA data base information was used 
to generate the organic HAP to total hydrocarbon ratio for these 
species for Facility 2 and 13.
    To estimate specific organic HAP emissions for Facility 3 and 4, 
averages from three (3) stack test measurements for each facility were 
reported (adjusted for nondetects). Since diethylhexyl phthalate and 
naphthalene were not measured in Facility 3-stack test, EPA data base 
information was used to generate the organic HAP to total hydrocarbon 
ratio for these species. It was not possible to estimate diethylhexyl 
phthalate and naphthalene emissions in Facility 4 since the MACT 
standards do not require total hydrocarbon measurements for reverbatory 
furnaces.
    To estimate specific metal HAPs for process emissions for Facility 
2, the metal HAP to total lead ratio developed for Facility 3 was 
multiplied by the lead emission rate found in the Facility 2 compliance 
report. Similarly, for Facility 13, the metal HAP to total lead ratio 
developed for Facility 3 was multiplied by the lead emission rate found 
in the Facility 13 compliance report. Facilities 3 and 4 reported 
specific metal HAP emission rates for process emissions. It should be 
noted that Facility 3 did not test for antimony and Facility 4 did not 
test for manganese or mercury. The emissions of these metal species 
were estimated using EPA data base information to develop the metal to 
lead ratio, which was then multiplied by the lead emissionrate from the 
facility compliance report.
    To estimate specific metal HAPs for process fugitive emissions for 
Facility 2, the average of the fugitive metal HAP emissions to total 
lead ratio developed for Facility 3 and 4 was multiplied by the lead 
emission rate found in the Facility 2 compliance report. Similarly, for 
Facility 13, the average of the fugitive metal HAP emissions to total 
lead ratio developed for Facility 3 and 4 was multiplied by the lead 
emission rate found in the Facility 13 compliance report. Facilities 3 
and 4 reported specific metal HAP emission rates for fugitive process 
emissions. Finally, the Background Information Document (BID) estimates 
for fugitive emissions used in the initial inhalation screening were 
employed in the multipathway analysis.
    With regard to metal speciation, 99 percent of the chromium 
emissions is assumed to be Chrome (III). This assumption was based on 
one furnace measurement and the fact that the secondary lead smelters 
operate under a reducing environment. For mercury speciation, it was 
assumed that all of the evaluated mercury was in the form of divalent 
particulate mercury (HgO).
    Although the multipathway analysis employs site-specific data, it 
is unclear whether the comparability of the data been evaluated. In 
other words, in many cases, EPA data base information is used in 
conjunction with site specific data to generate specific HAP emission 
rates with no verification that the data sets contain elements of 
equivalent or similar quality. The absence of data quality evaluation 
leads to several fundamental questions that are summarized as follows:
    What criteria were used to determine when Facility 3 data should be 
used for estimating organic HAP emissions from Facility 2 and 13 versus 
EPA data base information?
    Are emission estimates provided in Table C.1.1 averages, median or 
upper limits of a confidence interval?
    How many samples comprise the emission values reported in Table 
C.1.1? Can ranges or standard deviations be given?
    Do the State compliance stack permits specify the number of samples 
to be taken? In other words, are all data of a known quality?
    Descriptions of Facility 3 and 4 stack tests indicate that three 
stack test were conducted to estimate organic HAP emissions. Does this 
mean three samples?
    It is unclear as to why the average of Facility 3 and 4 process 
fugitive metal HAP emissions were used to derive a specific metal HAP 
to total lead ratio for Facility 2 and 13.
Recommendations
    Since HAP emission rates were generated using various facility data 
sets as well as the EPA data base, the most important general 
recommendation is that the Agency verifies the comparability of the 
data.In other words, use of data of varying quality in the risk 
assessment models would generate final risk numbers of questionable 
value. Therefore, the quality of each data set should be compared and 
documented prior to having its elements used in the risk assessment. 
Second, since there is no specific protocol employed for estimating the 
HAP emissions from each of the four facilities, it is strongly 
recommended that quantitative examples be inserted into the text that 
illustrate each unique approach. Finally, additional recommendations 
regarding data inputs to the multipathway model include the following:
    a. Specify the type of statistical measurement being reported in 
Table C.1.1 (i.e., means, median, upper confidence limits, etc.).
    b. Specify the number of samples that comprise the emission values 
reported in Table C.1.1 and provide both ranges and standard 
deviations.
    c. Provide an explanation as to why the average of Facility 3 and 4 
process fugitive metal HAP emissions were used to derive a specific 
metal HAP to total lead ratio for Facility 2 and 13 rather than some 
other statistical measurement.
                                 ______
                                 
  Statement of Dr. Paulette Middleton, RAND Center for Environmental 
                     Sciences & Policy, Boulder, CO
         1. links to other key epa activities dealing with haps
    Other EPA activities that have direct bearing on the residual risk 
assessments should be noted in the document. These activities 
demonstrate that EPA is actively improving on the current framework. 
While the current approaches used in the document under review here are 
acceptable in the current timeframe, many of their shortcomings may be 
addressed as a result of these other ongoing efforts. Acknowledgment of 
this could be done upfront in the introduction where discussion of 
model appropriateness and future assessments are mentioned. They also 
could be placed at the end of the report where next steps are sited and 
where it is noted that SAB comments will be considered in next steps.
                                2. trim
    In particular, it should be noted that EPA/OAQPS is developing TRIM 
as a flexible, state-of-the-art system for evaluating multimedia 
chemical fate, transport, exposure and risk of HAPs. The recent SAB/
Environmental Models Subcommittee review of this effort found it to be 
effective and innovative and outlined a number of recommendations for 
improvement. When TRIM becomes available, it should provide an 
improvement over the modeling framework used in the current report.
   3. sab/epa workshops on the benefits of reductions in exposure to 
                        hazardous air pollutants
    As stated in the description of these up and coming workshops, 
``HAPs have been the focus of a number of EPA regulatory actions, which 
have resulted in significant reductions in emissions of HAPs. EPA has 
been unable to adequately assess the economic benefits associated with 
health improvements from these HAP reductions due to a lack of best 
estimate dose-response functions for health endpoints associated with 
exposure to HAPs and also due to a lack of adequate air quality and 
exposure models for HAPs. EPA is conducting two workshops to develop a 
proposed methodology to generate estimates of the quantified and 
monetized benefits of reductions in exposure to HAPs. The first 
workshop will focus on developing best estimates of dose-response 
functions that relate changes in HAP exposure to changes in health 
outcomes. The second workshop will focus on (1) integrating these dose-
response functions with appropriate models of HAP concentrations and 
human exposure and (2) translating these into economic benefits that 
would estimate changes in health risks resulting from regulations that 
reduce HAP emissions.'' The results of these workshop discussions, in 
particular the reviews of models and methods, could well provide 
additional valuable input to this ongoing evaluation of the residual 
risk review and development of next steps.
             4. questions and comments on the current study
a. Missing HAPs
    Have all of the potential important HAPs been included in the 
screening analysis? Can understanding of the processes be used to 
better substantiate the list of HAPs considered for screening?
    Why are the acid gases not included in the analysis?
    Organics are not considered beyond the screening. Can this 
screening result be better substantiated?
b. Emission rates
    The development of emission rates for individual HAPs needs to be 
more clearly described. Here are some outstanding questions that need 
to be answered before providing a reasonable evaluation of 
appropriateness of the emissions estimates used in the modeling (both 
screening and multi-pathway).
    What exactly was measured at the representative sites and how were 
the measurements done? How valid are the extrapolations of 
representative measurements to annual averages? How valid are the 
extrapolations to other facilities?
    Are the processes leading to the emissions fairly constant 
throughout the year? How variable are the fugitive emissions at a given 
site?
                              5. modeling
    The model choices have been defended reasonably well. However, as 
noted above, improvements are needed and may be forthcoming with TRIM. 
Models seem to have been applied appropriately. However, several 
concerns are noted below regarding the assumptions in the modeling that 
could have an impact on the overall analyses.
                              6. screening
    There needs to be more convincing discussion of the 
representativeness of the building and meteorology general parameters 
chosen.
    Are the facilities being considered reasonably represented by the 
general building and stack configurations assumed? Stack height and 
building heights are particularly important variables.
    Is the meteorology of the sites being screened adequately 
represented by the standard worst case meteorology? Wind speeds and 
directions relative to the selected receptor sites are particularly 
important variables.
                            7. multi-pathway
    Again, are the assumptions about standard building parameters 
reasonable? The assumptions about building parameters are retained in 
the multi-pathway analysis. This is probably reasonable provided the 
actual facilities are similar in construction.
    What particle parameters and sizes are assumed in the modeling? 
This is very important to clarify since the ISCST3 does show different 
results for assumptions about larger particle sizes. If all of the 
particles considered are assumed to be less than 10 microns, then I 
doubt there is any difference in deposition and concentration patterns 
from those for the gases. This needs to be clarified since the 
exposures are sensitive to assumptions about particle size and particle 
versus gas.
                              8. receptors
    A suggestion. The ISCST3 can produce patterns of concentrations and 
deposition at regular distances from the source. It might be helpful to 
provide these patterns as well as analysis at specific receptors. 
Patterns help provide an assessment of where risks might be important 
in the future. Is this type of analysis thought to be beneficial to the 
overall residual risk assessment?
                    9. model/measurement comparisons
    The results presented seem to be reasonable for the air models. 
However, the other comparisons are difficult to understand and are 
being discounted. The way that these comparison are being presented 
detracts from the work and tends to make one more skeptical of the 
findings.
                            10. uncertainty
    It would be helpful to even more explicitly tie uncertainties to 
well-defined next steps.
  Statement of Dr. George E. Taylor, Biology Department, George Mason 
                        University, Fairfax, VA
     a case study residual risk assessment secondary lead smelter 
                            source category
    The SAB review of the draft Residual Risk Report to Congress was a 
challenge in light of the report being framed in very general way. In 
my participation of that review, I was uneasy about the review solely 
because I was unable to see the trajectory for the analysis in a 
quantitative sense.
    The Secondary Lead Smelter Source Category analysis is a giant step 
forward and helps me be more confident that the analyses will be 
quantitatively based and linked to the literature on human health and 
ecology. The Agency is commended for pursuing that tack.
    There are a number of general issues that are of concern however in 
the draft document and the presentations at the meeting. These general 
issues are outlined. Collectively, these suggest to me that the current 
draft is well short of being scientifically defensible with respect to 
natural resources and ecology.
1. Attention to Ecology and Natural Resources
    The attention to ecology and natural resources was a major concern 
in the Residual Risk Report to Congress, and I strongly encouraged the 
Agency to place ecology at parity with human health in this effort. 
Some assurances were made in that review exercise that ecology would be 
given more attention.
    In the case of the Secondary Smelters, the case for ecology and 
natural resources is again diminished by the Agency. The effort is 
clearly well behind the analysis being conducted for human health and 
is not at a stage where this reviewer can be comfortable with a 
positive review. In short, while we have made some progress, there is 
insufficient analysis conducted to meet the legal mandate of the CAA.
    This issue is a major one and warrants high visibility. My 
recommendation is for the committee to exhort the Agency to be more 
forthcoming with resources in order to get the task done in a 
scientifically sound manner.
2. Not a Risk Assessment But a Risk/Hazard Characterization
    The title of the Agency's report is A Case Study Residual Risk 
Assessment: Secondary Lead Smelter Source Category. Risk 
Characterization. Following the original review of the draft Residual 
Risk Report to Congress, this reviewer was expecting an analysis that 
was more nearly a risk assessment. What was presented was a hazard 
characterization for ecology and natural resources, and the analysis 
was preliminary at best. Moreover, the Agency stated that no further 
work toward a risk assessment would be conducted for ecology and 
natural resources.
    As a consequence, the current analysis does not meet the legal 
mandate of the CAA.
3. If this is the final product for this source category. . .
    Because this report establishes a methodology for analyzing 179 
source categories, it is very important that this report be done right. 
In light of the Agency's commitment to a preliminary hazard 
characterization in lieu of what is the legal mandate, I am concerned 
that this document will establish a precedent for all subsequent 
analyses so that ecology and natural resources are poorly addressed. As 
it now stands, the methodology produces a high number of false 
positives and fails to incorporate some pathways and receptors that are 
the most sensitive ones in an ecosystem with respect to persistent and 
bioacceumulated chemicals.
    The proposed methodology is not likely to be of value in assessing 
the residual risk to ecology and natural resources and is likely to 
leave the risk manger with a formidable problem in handling the 
purported risks.
4. Linkage to Risk Manager
    The shortcomings of the current report are presented above and are 
worthy of attention. Above and beyond these shortcomings is the linkage 
of the risk assessment to the task of the risk manager. There is no 
discussion of how the risk manager is likely to use this assessment.
    It is recommended that a framework for the risk management be made 
a part of this report. The same recommendation was made for the 
previous report (Residual Risk Report to Congress) by the SAB.
5. Conclusion That the Analysis is Conservative
    This assertion is stated throughout the report, and I am not in 
full agreement with that distinction with respect to ecology and 
natural resources. My rationale is twofold. Most importantly, the 
omission of fish eating birds (top carnivores) removes one of the top 
predators in terrestrial/aquatic systems and one of the receptors that 
is highly valued (charismatic megafauna). In my analysis of the report, 
mercury would easily have been identified as a risk had this trophic 
level been included; it probably would have been the dominant risk. The 
argument that predatory fish are included does not suffice since 
predatory birds consume predatory fish, so there is an additional 
trophic level for bioaccumulation. The argument that data do not exist 
to evaluate this receptor is not accurate.
    The second point is more tangential. The analysis for ecology 
identified a number of HAPs with concern in the screening exercise. 
Most, if not all, of these are likely to be ``false positives''. For 
example, antimony is screened as a risk, but I have never read a paper 
dealing with ecotoxicology to plants of antimony. The citation for the 
benchmark is an old paper published in an agricultural setting. The 
point is the false positives are almost to the point of being ``silly'' 
and can be easily discounted by the risk manager. This ``silliness'' 
might establish a precedent for ecology and natural resources that 
would permeate all 179 analyses.
    I would much prefer to see a screening exercise that covers the 
potential serious risks (e.g., Bioaccumulated HAPs in top carnivores) 
than marginal risks, and I think that is the objective of the legal 
mandate.
6. HAPs That are Persistent and Bioaccumulated
    The tenet is stated that any HAPs that is persistent and 
Bioaccumulated is automatically carried to the next level (multipathway 
not refined analysis?). I think those terms are confusing (e.g., if it 
is Bioaccumulated, by definition it is persistent; some persistent HAPs 
may not be Bioaccumulated). I am not certain what this statement means.
    Most HAPs by definition are persistent. Lead, Ni, Hg, etc. . . . 
are elements and by definition are persistent. Most of the HAPs are 
also accumulated to some extent simply because many are lipophilic 
either as elements or in the complexes they form. So, there must be a 
threshold for bioaccumulation. Does that have to be a trophic 
enhancement factor of 2?
7. Background Concentrations
    This issue was raised in the previous review and I encourage the 
Agency to re-think its position. While there may be some rationale for 
assuming a zero background concentration in the screening exercise, 
there are some major liabilities even at this level for pursuing this 
line of reasoning.
    Even more difficult is the next level of analysis in which 
exposure-response functions might be generated. Given that many of the 
HAPs are elements and are common geochemical constituents in the crust, 
not addressing this issue is likely to undercut the conclusions 
significantly from a scientific basis.
                           specific comments
    This review supplements the forgoing analysis, which is more 
general. The comments herein are more specific and either supportive of 
the above or individualistic.
    1. More refined analysis. The argument is presented often about the 
next iteration, which is a refined analysis. The structure and 
refinements to be done in that analysis are not presented. Is this to 
be a full risk assessment?
    2. Screening for chronic effects protects for acute effects. While 
I can appreciate why shortcuts are used, I am not certain that this 
position is true. I can think of several cases where chronic exposures 
would not protect against acute exposures. For example, if you had a 
fugitive emission of a toxic chemical with a high 1 hour exposure, over 
the course of the season that exposure would not be significant but may 
very well compromise some receptors (e.g., radiochemicals, ozone). Can 
you provide a citation that supports the position?
    3. Background concentration. This issue was raised in the previous 
review, and I am not in favor of the position being taken in the 
report. While the screening exercise may opt to assume that the 
background concentration is zero, this is NOT a conservative decision. 
In fact, it may significantly negate many HAPs (particularly those that 
are elements common in the earth's crust) from ever accumulating enough 
to exceed a threshold. I recommend that the Agency re-consider its 
position on background exposures, particularly as one moves on to more 
refined analyses. From my perspective, this omission negates the 
Agency's position that the analysis is conservative. Moreover, I do not 
think you can conduct a more refined analysis without including a 
background exposure for either human health or ecology. But, in the 
case of the latter, it is clearly critical.
    4. Modifications to the multipathway model. It is noted that the 
analysis used the multipathway model in the Mercury Report to Congress 
for this modeling effort but that the model was modified on a HAPs-
specific basis. Those modifications are important to State since they 
could underpin the analysis.
    5. Dispersion modeling. The report uses a dispersion model 
(Gaussian) to handle the offsite transport of HAPs. The guts of the 
model are not presented and key aspects are missing that might help 
skeptics relate to the code. Is deposition velocity (Vg) the operative 
parameters for driving deposition? If so, what nonlinear relationship 
is being used? Is particle size a part of the emission data? If not, 
then Vg cannot be used.
    6. Figure 3.1 is missing but discussed in the text.
    7. Plant Characteristics. Plants appear to be one of the critical 
parts of the model as the exposure to humans is preceded by deposition 
to leafy vegetable. This part of the code needs to be reviewed for such 
features as leaf area index, Vg, seasonality of phenology, yield, 
foliar leaching, etc. My suspicion is that none of these factors are 
part of the model, so it is unclear that the model handles the 
atmosphere-leaf transfer very well.
    8. Figure 3.3. It is customary in compartment model diagrams to 
show compartments/state variables as boxes and transfers as ovals or 
some other geometric shape. They mean very different things. Also, is 
the half-life (T\1/2\) part of the model for HAPs? If so, a table of 
T\1/2\'s should be published. This is an important parameter.
    9. The argument is presented that the mercury concentration in fish 
is a function of the mercury concentration in water. Is that true? I do 
not see how this could be coded into an aquatic model with multiple 
trophic levels? The mercury concentration in water must be processed 
through several intervening trophic levels before it gets to fish and 
thereafter it is bioaccumulated as a function of the trophic level.
    10. The summary for all sections is not a summary. The summaries 
relate the methodology but not the summary of using the mythology for 
this exercise on lead smelters.
    11. What are the endpoints in ecology and natural resources? In 
human health it is the farmer and his family. Clearly State the 
endpoints for this hazard characterization.
    12. It is stated that the structure and function of the ecosystems 
is an endpoint. I have difficulty with that position.
    13. It is stated that rare and endangered species are an endpoint. 
Again, I have trouble with that position.
    14. Are receptors the same as assessment endpoints?
    15. Why are carnivorous terrestrial wildlife omitted? These are 
likely to be the ``charismatic megafauna'' of most interest and the 
ones at greatest risk form HAPs that are bioaccumulated.
    16. EC50 derivation. The argument is presented to derive some 
benchmarks from EC50's by dividing by a factor of 10. I am not certain 
that is justified. I would prefer to simply leave the benchmarks as 
stated in the literature rather than deriving some. This will eliminate 
a number of false positives and will help add credibility.
    17. Summing HQ's. As noted above, this approach needs to be done 
with extreme caution.
    18. Bioaccumulation. It is stated that bioaccumulation is assumed 
to be 100 percent. I am not sure what that means. Does that mean 100 
percent of the HAP in the system is bioaccumulated to the next trophic 
level? If so, what BAF is used?
    19. All chemicals without data are analyzed further. This is 
difficult to imagine. But, if there are insufficient data to conduct a 
screening analysis, how could there possibly be enough data to do a 
more refined analysis?
    20. Fugitive Emissions. While I understand that fugitive emissions 
can be important, I am skeptical of the methodology that shows the 
entire assessment being driven by fugitive emissions. From my knowledge 
of ecology and human health, that simply does not compute.
    21. False positives for ecology. This is where I think the 
methodology suffers, and I recommend that some remediation is in order. 
The ecology risk section concludes that several HAPs--antimony, 
chromium, and nickel--are a significant enough risk to warrant further 
study. I am not aware of any report for antimony in plants that would 
warrant that conclusion and probably the same for chromium and lead and 
nickel. The creation of many false positions that are unrealistic will 
be self defeating in the long run.
    22. False negatives for ecology. In contrast to the above concern, 
there are some HAPs that are missing for methodological reasons. The 
most notable is mercury, which can be traced to the absence of top 
carnivores in terrestrial ecosystems.
    23. Appendix F, Table F.2. The equation for calculating dry 
deposition simply does not work as portrayed. The units do not cancel 
out to arrive at the correct units.
    24. Appendix E. The hazards with fugitive emissions are an order of 
magnitude higher than those without fugitive emissions. This seems 
inordinately high.
    25. Distance for dispersion. The distance used for dispersion and 
assessment needs to be defined. Clearly it is not the distance traveled 
by the HAPs after emission, which for some of these (e.g., mercury) is 
global.
    26. Air stagnation events. How are air stagnation events handled in 
the model?
    27. Criteria pollutants. While I understand some of the legal 
mandate for this analysis, I suspect that some of the most significant 
residual risk from these categories will be the impact of the criteria 
pollutants, notably ozone and PM2.5. This liability is best 
presented up front so the caveats are well articulated.
                               __________
Statement of Dr. Rae Zimmerman, Robert Wagner Graduate School of Public 
               Service, New York University, New York, NY
                     basis for case study selection
    The rationale for the choice of secondary lead smelters as a case 
that will become a prototype is only briefly described and should be 
expanded. Why is it significant and prototypical? Is it like other 
industrial emission sources?
    The change in capacity or use of these smelters might be one reason 
for their being a significant case. The discussion on p. 5 alludes to a 
reduction in the number of lead smelters nationwide in 1999 over 1993-
1994 levels. Capacity is really key, however. Has the capacity of the 
remaining smelters increased? Is the need for them changing, i.e., what 
is the quantity of lead-acid batteries needing recycling?
    One very strong reason for its selection is that it is central to 
the debate over electric cars (see debate in Science, 1995). The 
contribution of lead smelters to air pollution in the course of 
recycling lead-acid batteries is part of the overall assessment of the 
relative environmental impact of electric cars over the conventional 
automobile. Thus, the relative risk associated with secondary lead 
smelters addresses a much broader health debate.
                         methodological issues
    A number of methodological issues need greater explanation or some 
references to justify methodological approaches and choices.
    a. p. 6--the expediency of using a surrogate standard for all 
metals is clear, but why was lead selected?
    b. p. 9--what is the justification for using inhalation analysis 
for all HAPs rather than the ingestion route also, e.g., via soil 
deposition and subsequent entrainment in exposure areas? p. 14 also 
notes that inhalation pathway is the most important route of exposure, 
which needs a short explanation.
    c. Decisions are made throughout the analysis, and should be 
explained. For example:
    d. p. 9 How is the subset of facilities selected--just high 
emission rate rather than mix of HAPs? In other words a facility with a 
high emission rate may have low concentrations of HAPs.
    e. p. 10 Receptor locations chosen as the point of maximum air 
concentration--was this regardless of the number and type of HAPs?
    f. p. 10 How were the three HAPs and three pathways selected for 
the variability and uncertainty analyses?
    g. Is there any way of identifying which of the HAPs present in the 
emission stream are likely to react with one another to increase or 
reduce residual risk?
    h. The rationale behind the use of very numerous assumptions/
defaults at any given point in the assessment is difficult to evaluate, 
e.g., p. 24, 32. On p. 24, for example, there are numerous simplifying 
assumptions for the inhalation screening analysis.
    How do these assumptions interact with one another and affect the 
results?
    i. In areas where information is not known, can't the Agency 
undertake some scenario building to at least identify some of the 
boundaries? For example:
    (1) Geographic differences in the location of the smelters and the 
effects of this variation on exposure are not included, but need to be 
factored in somehow into the analyses. For example, p. 24-25 the 
building downwash or terrain options for SCREEN3 were not used because 
site specific information was not available. This is important, 
however, since the report specifically identifies that the use of such 
options can result in higher values for air pollutants. What about 
using locational scenarios?
    (2) Where information on d/r for HAPs was not available the HAPs 
were excluded from the analysis (p. 33)--Does the uncertainty analysis 
at least include the fact that ``HAPs for which quantitative d/r 
assessments are not available'' were excluded from the quantitative 
analysis?
    j. p. 30 The technique for aggregating cancer risks is additivity. 
The drawbacks of this yet the need should be clearly stated, as well as 
how additivity is likely to affect the results.
                                 ______
                                 
                               APPENDIX B
             a more detailed description of the sab process
    The SAB Staff recruited Dr. Philip Hopke, Chair of the Chemistry 
Department at Clarkson University, to serve as Chair of the 
Subcommittee. Working with the Chair, other SAB Members and 
Consultants, Agency Staff, and submissions from the American Industrial 
Health Council (AIHC) and the Natural Resources Defense Council (NRDC), 
the SAB Staff compiled a list of over 30 scientists and engineers who 
were subsequently surveyed for their interest in and availability for 
participating in the review. The Chair and SAB Staff made the final 
selections for membership on the Subcommittee and assigned different 
members lead and associate responsibilities for each of the Charge 
Elements.
    The Agency transmitted review materials to the Subcommittee members 
in late January. In mid-February SAB Staff convened a conference call 
with Agency staff to identify gaps in the information sent to the 
Subcommittee and to identify areas that the Agency should be prepared 
to clarify at the face-to-face meeting.
    In addition, public comments were received from the following 
parties and distributed to the Subcommittee Members before the meeting:
    a. Association of Battery Recyclers and the Lead Industries 
Association: Robert Steinsurtzel and Michael Wigmore--Swidler Berlin 
Shereff Friedman (Counsel for Association of Battery Recyclers), Jane 
Luxton and Cynthia A.M. Stroman--King and Spalding (Counsel for Lead 
Industries Association, Inc.), Dr. Teresa S. Bowers--Gradient 
Corporation, Russell S. Kemp--Lake Engineering.
    b. Cambridge Environmental Inc: Dr. Edmund Crouch and Dr. Stephen 
Zemba.
    c. Indiana Department of Environmental Management: Mr. Michael 
Brooks
    d. Residual Risk Coalition: Dr. Elizabeth Anderson--Sciences 
International, Inc.
    e. Sanders Lead Company, Inc.: Mr. Billy Nichols, Dames & Moore.
    On March 1-2, 2000, the Subcommittee convened in the Main 
Auditorium of Environmental Research Center at the USEPA laboratory in 
Research Triangle Park, NC. Minutes of the meeting are available. Each 
member of the Subcommittee submitted written comments on the Charge 
questions for which he/she had lead responsibility. Two members of the 
public (Dr. Elizabeth Anderson and Dr. Teresa Bowers, see a and d 
above) provided comments on the technical issues under discussion. 
Following a full day of discussion, Subcommittee members drafted and 
reviewed responses to the Charge questions.
    The Subcommittee members were given the opportunity to refine their 
pre-meeting comments for their inclusion in the Appendix A to the 
Advisory. These written materials formed the basis of this Subcommittee 
Advisory that was drafted by the Chair and the SAB Staff and 
subsequently modified/approved by the Subcommittee. [An SAB 
``Advisory'' is a term-of-art used to denote review of an Agency 
document that is still undergoing development, in contrast to an SAB 
``Review'' of a final Agency product.] The Subcommittee-approved draft 
was sent to the SAB Executive Committee (EC) for action during a 
publicly accessible conference call on May 1, 2000. At that meeting the 
EC approved the Advisory, subject to final approval by designated 
vettors, Dr. Kenneth Cummins and Dr. Linda Greer.
                                 ______
                                 
                               APPENDIX C

                                Glossary
------------------------------------------------------------------------
 
------------------------------------------------------------------------
AEI.......................................  Average exposed individual
ATSDR.....................................  Agency for Toxic Substances
                                             and Disease Registry
BID.......................................  Background Information
                                             Document
CaIEPA....................................  California Environmental
                                             Protection Agency
CAAA......................................  Clean Air Acts Amendments of
                                             1990
CDC.......................................  Centers for Disease Control
                                             and Prevention
CRARM.....................................  Commission on Risk
                                             Assessment and Risk
                                             Management
HAPs......................................  Hazardous air pollutants
HEAST.....................................  Health Effects Assessment
                                             Summary Tables
HI........................................  Hazard index
HQ........................................  Hazard quotient
IEM-2M....................................  Indirect Exposure
                                             Methodology
IRIS......................................  Integrated Risk Information
                                             System
ISCST3....................................  Industrial Source Complex
                                             Short Term model
MACT......................................  Maximum achievable control
                                             technology
MEI.......................................  Maximum exposed individual
MIR.......................................  Maximum individual risk
NAAQS.....................................  National Ambient Air Quality
                                             Standard
NATA......................................  National Air Toxics
                                             Assessment
NESHAP....................................  National Emission Standards
                                             for Hazardous Air
                                             Pollutants
NRC.......................................  National Research Council
OAQPS.....................................  Office Air Quality Planning
                                             and Standards
PAHs......................................  Polyaromatic hydrocarbons
QSAR......................................  Quantitative Structure-
                                             Activity Relationships
PBTs......................................  Persistent bioaccumulative
                                             toxicants
RfD.......................................  Reference Dose
RTC.......................................  Agency's 1998 Report to
                                             Congress
SAB.......................................  Science Advisory Board
TRIM......................................  Total Risk Integration Model
TRVs......................................  Toxicity Reference Values
U&V.......................................  Uncertainty and variability
USEPA.....................................  United States Environmental
                                             Protection Agency
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