Transcript of Proceedings
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
PUBLIC HEARING
The Development of a Short-Term
National Ambient Air Quality Standard
For Nitrogen Dioxide
United States Environmental
Protection Agency
401 M Street, S.W.
Waterside Mall Room 2814
Washington, D.C.
April 19, 1978
Pages: 1 thru 162
ACME Reporting Company
Official Reporters
1411 K Street. N.W.
Washington, D. C. 20O05
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PUBLIC MEETING
THE DEVELOPMENT OF A SHORT-TERM NATIONAL AMBIENT AIR
QUALITY STANDARD FOR NITROGEN DIOXIDE (NOj)
April 19, 1978
"'•:;: - ATTENDEES
Ann Gasui - Library Congress
William.C. Triplett - Honda
Kathleen Commerford - Mission Hill Health Management Boston
S. Gill - General Electric Company
W. E. Jackson - U. S. Steel Corporation
Irene Zuk - Interdevelopment, Incorporated
M. Rowe - Brookhaven National Laboratory
John C. Elliott - Tennessee Valley
Marvin Fast - Environmental Protection Agency
Bernard Reilly - DuPont, Wilmington
Niel Helmers - DuPont, DuPont de Nemours
Rieu Altman - Prat & Whinsey Aircraft
Robert Reid - Energy and Environmental Analysis
John Chernisky - Department of Transportation
Kevin Kilroy - BFG Chemical Company
George P. Likpa - WETC, Boston, Massachusetts
Charles K. Brown - Potomac Electric Company
H. Reiquam - El Paso National Gas
R. M. Evans - Acurex
H. B. Mason - Acurex
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ATTENDEES (con't.)
Libby Scopino - Environmental Protection Agency
Charles T. Drevna - National Coal Association
Leslie G. Polgar - American Petroleum Association
Edward J. Burgess, Jr. - Georgetown University
Kathleen Wiston - George Washington University
Lesley Ewiuy - Energy Envionmental Analysis
G. Gleason '-. Environmental Protection Agency
H. Sawanurd - Japanese Embassy
G. E. Pashel - Bethlehem Steel
Kelshermar -Automotive News
Linda Durkel - Bureau of National Affairs, Inc.
Alan Eschenroeder - ERT, Santa Barbara, California
San Bonawitz - Toyota
Malcolm D. Hawk - American Petroleum Institute
Bruce S. Bailey - American Petroleum Institute
John S. Hahn - American Petroleum Institute
Robert F. VanVoohees - American Petroleum Institute
John W. Shiller - Ford Motor
R. S. Spindt - Gulf Research Development
Ernest Linde - Environmental Protection Agency Sciences Advisory
Board
A. S. Everett - Everett and Association
J. C. Preston - Tenneco Incorporated
W. M. Ollison American Petroleum Institute
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ATTENDEES (contld>) 4
T. L. Montgomery - Tennessee Valley Authority
R. S. Wiener - Envirotech/Chemico
G. J. Love - Systems Sciences Incorporated
C. M. Losinger - United Engineers and Constructors
C. Loyd - Fairfax County Health Department
J. D. Rosen - General Motors
Bob.'Kaper - Coal Daily
John Krzerainsk- Silver Spring, Maryland
Rip G. Rice - Tacota Engineering
Ivy Baer - Center for Auto Safety
Joyce Kinnard =» Center for Auto Safety
Stephen Miller - Environmental Protection Agency
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MR. HAWK: Good morning. I am Malcolm Hawk, Counsel
for Exxon Company, U.S.A., and Chairman of the Photochemical
Oxidants/Nitrogen Dioxide, Steering Committee of the American
Petroleum Inaitute, fore whom I appear this morning. Accom-
panying me are experts in various fields, to assist me in
answering any questions you may ha*re> Drs Burce Bailey, Dr.
Gordon Everett, Dr. Edward Burger, and Dr. Kathleen Weston.
API welcomes this opportunity to present its comments on v >.*•-•
*
whether or not there is a need for a standard for the
control of short-term exposure to nitrogen dioxide.
Determination of the need for a short-term nitrogen
dioxide standard is to be based on air quality criteria
developed under Section 108(c) of the Clean Air Act. However,
this determination is made difficult by the critical lack-of
data in certain key areas including expecially community
health and exposure. Thus, EPA must determine first the leve]
at which significant adverse human health effects result from
short-term exposures to nitrogen dixoide and, second, whether
these levels can be expected to occur in ambient air. The
paucity of evidence to make these assessments is attributable
in part to the unjustifiably restricted scope of the draft
criteria and in part to the limitations of the few available
epidemiological studies on the health effects of nitrogen
dioxide.
Nevertheless the. limited evidence that is available
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UNITES STATES ENVIRONMENTAL PROTECTION AGENCY
PUBLIC HEARING
The Development of a Short-Term
National Ambient Air Quality Standard
for Nitrogen Dioxide
Waterside Mall
Room 2814
401 M Street, S.W.
Washington, D.C. 20460
Wednesday
April 19, 1978
REPORTER'S TRANSCRIPT
Reported by: Ms. Kathy Boyd
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PUBLIC MEETING
THE DEVELOPMENT OF A SHORT-TERM NATIONAL AMBIENT AIR
QUALITY STANDARD FOR NITROGEN DIOXIDE (N02)
April 19, 1978
ATTENDEES
Ann Gasui - Library Congress
William C. Triplett - Honda
Kathleen Commerford - Mission Hill Health Management Boston
S. Gill - General Electric Company
W. E. Jackson - U. S. Steel Corporation
Irene Zuk - Interdevelopment, Incorporated
M. Rowe - Brookhaven National Laboratory
John C. Elliott - Tennessee Valley
Marvin Fast - Environmental Protection Agency
Bernard Reilly - DuPont, Wilmington
Niel Helmers - DuPont, DuPont de Nemours
Rieu Altman - Prat & Whinsey Aircraft
Robert Reid - Energy and Environmental Analysis
John Chernisky - Department of Transportation
Kevin Kilroy - BFG Chemical Company
George P. Likpa - WETC, Boston, Massachusetts
Charles K. Brown - Potomac Electric Company
H. Reiquam - El Paso National Gas
R. M. Evans - Acurex
II. B. Mason - Acurex
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Libby Scopino - Environmental Protection Agency
Charles T. Urevna - National Coal Association
Leslie G. Polgar - American Petroleum Association
Edward J. Burgess, Jr. - Georgetown University
Kathleen Wiston - George Washington University
Lesley Ewiug - Energy Envionmental Analysis
G. Gleason - Environmental Protection Agency
II. Sawamurd - Japanese Embassy
G. E. Pashel - Bethlehem Steel
Kelshermar -Automotive News
Linda Durkel - Bureau of National Affairs, Inc.
Alan Eschenroeder - ERT, Santa Barbara, California
San Bonawitz - Toyota
Malcolm D. Hawk - American Petroleum Institute
Bruce S. Bailey - American Petroleum Institute
John S. Hahn - American Petroleum Institute
Robert F. VanVoohees - American Petroleum Institute
John W. Shiller - Ford Motor
R. S. Spindt - Gulf Research Development
Ernest Linde - Environmental Protection Agency Sciences Advis
Board
A. S. Everett - Everett and Association
J. C. Preston - Tenneco Incorporated
W. M. Ollison American Petroleum Institute
Acme Reporting Company
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ATTENDEES (cont'd.) 4
T. L. Montgomery - Tennessee Valley Authority
R. S. Wiener - Envirotech/Chemico
G. J. Love - Systems Sciences Incorporated
C. M. Losinger - United Engineers and Constructors
C. Loyd - Fairfax County Health Department
J. D. Rosen - General Motors
Bob Kaper - Coal Daily
John Krzeminsk- Silver Spring, Maryland
Rip G. Rice - Tacota Engineering
Ivy Baer - Center for Auto Safety
Joyce Kinnard = Center for Auto Safety
Stephen Miller - Environmental Protection Agency
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2 9:00 a.m.
3 CHAIRMAN PADGETT: I think it is time to convene
4 the meeting. My name is Joe Padgett. I am with the
5 Environmental Protection Agency, Strategies and Air Standards
6 Division. I will serve as Chairman of the meeting. The
7 purpose of the meeting is to receive comments relative to
8 determining a short-term national ambient Air quality
9 standard for nitrogen dioxide.
10 This is a public meeting, and it was announced in
11 the Federal Register on March the 27thf As you came in, I
12 assume each of you have registered with Kathy Moore, who is
13 at the desk back at the door, and I assume that you have
14 picked up a package which contains a copy of that Federal
15 Register notice and also a list of the speakers we antici-
16 pate hearing this morning.
17 If you haven't registered or if you don't have a
18 hand-out, please see Kathy Moore.
19 I will read just a few excerpts from the Federal
20 Register notice, but I will not read the entire notice, and
21 I suggest that those of you who have not read it, would
22 perhaps be advised to try to scan it during the early part
23 of the meeting.
24 In 1971, EPA promulgated a national ambient air
25 quality standard for nitrogen dioxide, at a level of 0.05
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PPM annual average. Since the promulgation of this long-
term standard, scientific studies have suggested that some
adverse health effects of NO2 are associated with short-term
peak exposures rather than chronic exposure to lower levels.
Inthe 1977 amendments to the Clean Air Act, Congress
directed EPA to review the scientific basis for the short-
term standards, and to promulgate such a standard unless
it could be shown that a standard was not requisite to
protect public health from short-term exposure to NO2.
EPA's Office of Research and Development subse-
quently has prepared a draft summary of the scientific
basis for a short-term standard in the criteria documents
entitled, "Health Effects for Short-Term Exposure to Nitro-
gen Dioxide."
This is a draft document. It was issued as an
external review draft in December, 1977, and is available
from EPA.
On the basis of the scientific data and the
interpretation now available as summarized in the criteria
document, EPA's staff is considering recommending the
proposal of the standard in the range of .25 to .5 PPM on
our average. We invite your co-ments, and information
relative to the interpretation of the scientific data pre-
sented in the criteria documents, and any other information
which you consider relevant for the purpose of establishing
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the final standard which we will propose.
We anticipate that a standard would be proposed
by the end of June of this year. Following proposal, there
will be a comment period during which we plan to hold another
public meeting on the proposed regulations. Promulgation
of the final standard we would expect to be sometime in
December of this year.
The meeting today will be informally structured,
individuals who provide oral statements will not be sworn
in, nor will any formal rules of evidence apply. Questions
may be posed by the panel members, which are up in the front
here, and l.will ask them to introduce themselves shortly.
Those questions are for the purpose only of clarifying the
comments of the speakers. We don't plan any cross examina-
tion by other participants. If time allows, however, those
in the audience who have questions, if they will write them
down and hand them to me, I will see if we can ask those of
the speakers.
We ask each speaker, and I think this has been
discussed with the speakers as they called in to make known
their intents to speak, to limit his or her remarks to ten
minutes maximum. I am allowing another ten minutes approxi-
mately for questions which will be asked by the panel
members, or which may be asked based on written questions
that I would receive from the audience.
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In addition to the oral statements, the oral
remarks which will be provided, given today, if the speakers
or if anyone else for that matter, desire to submit any
summary written material, we will be able to consider
comments that reach us by May first. A verbatim transcript
of the oral comments that will take place today will be
prepared, but we don't have any plans to review or to edit
or to correct those statements. The transcript, combined
with the written comments, will constitute the public
record of the meeting. The record will be transmitted
within about ten days to the EPA Public Information and
Reference Unit; Waterside Mall, here. And copies of that
record will be available for inspection and for copying
during the working hours.
We have a document number on a request PS 78-1,
-9, excuse me, which you should refer to if you want to
examine the record. Copies of the transcript can be purchase
from the Acme Reporting Company, which is doing the trans-
cription for us here today. If you want to purchase a copy,
you should see Ms. Boyd, who is our public stenographer.
With regard to copies of the statements, I think
the speakers have been asked to supply three copies of the
statements,' one would go to the public stenographer, two
would be fore the Docket.
Now, in addition, although perhaps it hasn't been
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made clear, if you have additional copies of your statements
we would very much appreciate it if you could supply a copy
for each of the panel members, since we would hope to
follow your statement as it is given, and I think it would
be helpful to us to ask questions relative to your statement,
Now I would like to introduce, or have the panel
members introduce themselves, and as we call on them, they
will state their name and that part of EPA with which they
are affiliated.
Stan, would you start, please?
MR. COERR: My name is Stan Coerr. I am with
the Office of Air Quality Planning Standards.
MS. BARUCH: My name is Roberta Baruch, with the
General Counsel's office.
DR. GARDNER: My name is Donald Gardner. I am
with the Health Effects Research Laboratory.
MR. BERRY: I am Mike Berry, with Environmental
Criteria and Assessment Office.
MR. STOLPMAN: My name is Paul Stolpman, with the
Office of Air and Waste Management.
MS. TAYLOR: My name is Debra Taylor, with the
Office of Planning and Evaluation.
CHAIRMAN PADGETT: Finally, I would like to
introduce Bob Kellam, who is sitting over here, who is with
our staff, and has played the major role in setting up the
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meeting.
If you have looked at your hand-out, you will see
some very precise times for each speaker — 9:20, 9:40,
10:00, and so on. It is my objective to stay generally on
a schedule of a maximum of twenty minutes per speaker with
the statement and the questions, but we can conceivably
shift around. We probably will take a break sometime in
the middle of the morning, so please don't pay too much
attention to those times, and those of you who are scheduled
to speak probably ought to stay pretty much within earshot
certainly a good twenty to thirty minutes ahead of when you
think you might speak so that you will be available to
speak.
As you come up, those speakers generally speaking,
I assume that you will give your name, your affiliation and
so on as you start out for purposes of identification.
We will try as best we can to call on speakers in
the order in which they are given in the agenda, so with that
I would like to call on Mr. Starke from Shell Oil as our
first speaker.
MR. STARKE: Thank you, Mr. Padgett. My name is
Edward Starke. I am a senior staff engineer in the Environ-
mental Affairs Department of Shell Oil Company, Houston,
Texas.
My comments today are presented on behalf of both
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i Shell Oil Company, and its divisions.
2 We commend the Environmental Protection Agency for
3 holding this meeting to receive public comments on a
4 possible short-term nitrogen dioxide standard before the
5 Agency takes any action to propose such a standard formally.
6 We say this because promulgation of any national ambient
7 air standard at any level, triggers massive activity by
8 agencies of Federal, state and local governments, involving
9 enormous cost.
10 More importantly, if an over-lenient standard is
11 set, thepublic health and welfare may suffer. On the other
12 hand, if an overly stringent standard is set, the nation's
13 society and economy may suffer needlessly, and our limited
14 resources may be diverted from desirable programs and
is wasted on unnecessary ones.
16 Therefore, we submit the EPA should consider
17 promulgation of a national standard only in those cases
18 where a demonstrated need exists and where good and substan-
19 tial factual evidence is available and has been objectively
20 appraised.
21 After having reviewed the first and second drafts
22 of the EPA proposed criteria documents, and after having
23 read the Federal Register notice announcing this meeting,
24 we in Shell conclude that inadequate information has been
25 presented upon which EPA can itself either propose or
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promulgate a scientifically valid short-term primary standard
for nitrogen dioxide.
We recommend that EPA defer any further action on
proposing such a standard until such time when a need can be
demonstrated and where more adequate and more reliable
data becomes available. We further recommend that until
such time, EPA report back to Congress that the Agency has
in fact discharged its statutory obligations under
Section 108 and 109 of the amended Clean Air Act with
respect to a short-term primary nitrogen dioxide standard.
And that: at, this time, the Agency can find no sufficient
and no significant evidence that the primary standard
contemplated by Congress is in fact needed to protect the
public health.
Our reasons for these conclusions and recommenda-
tions follow: E1*A itself acknowledges that the data
presented in the 1971 criteria document provided a tenuous
basis for the present long-term nitrogen dioxide standard.
And that at that time, it contained insufficient information
upon which to base short-term standards. We agree, thus
only new information not appearing in the 1971 criteria
documents might be useful in a justification of a short-
term standard at this time.
The draft of the proposed criteria document
presents very little new evidence that its either
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intermittent or short-term exposures to low levels of nitro-
gen dioxide produce any adverse biological effects. A few
biological responses to low level short-term exposures have
been identified, but their significance remains to be
established.
In view of the paucity of the short-term
exposures data, the drafts of the proposed criteria documents
included many studies involving long-term exposures to
nitrogen dioxide. We note with interest that the second
draft document itself states that the concentration of
nitrogen dioxide rather than time or duration of exposure
is of greater significance in determining if a biological
effect will be induced. Because the whole basis for conduct-
ing chronic toxicity studies rests on the fact that certain
kinds of biological responses will not be demonstrable
following short-term exposures, it follows both logically
and intuitively that backwards extrapolation of long-term
exposures effects to short-term exposures effects is unwar-
ranged and unacceptable.
Inadequacy of the data base for the short-term
nitrogen dioxide standard is eloquently demonstrated in the
text of March 27th, 1978, Federal Register notice. In it,
four bases are cited by EPA's staff in considering recommend-
ing the proposal of a standard somewhere in the range of
0.25 to 0.50 PPM on an average. The first of these
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suggestions is on the basis of certain clinical studies,
that pulmonary effects are associated with exposures above
a threshhold of 1.5 PPM. This statement seems to be somewhat
in conflict with the draft criteria document which suggests
that 1.5 PPM is in fact a no effects level. The text of the
Federal Register notice goes on to state that the pulmonary
effects involved acute bronchitis, but not other individuals,
who by virtue of other respiratory conditions, might be
more sensitive to nitrogen dioxide. Unquote.
That statement we view to be speculative, and we
view it to be unsupported by any medical findings. If such
a speculation is to be voiced at all, it should be made
part of EPA's consideration of what constitutes an adequate
margin of safety, which topic, incidentally, in our
judgment, remains unarticulated by EPA despite the evident1
legal requirement to do so.
The second indicates that studies with laboratory
animals shows or show a threshhold for reduced resistance
to infections at 0.5 PPM. What the Federal Register notice
seems to have neglected to state, however, is that the
doseages involved in one case were 0.5 PPM for four hours
per day for eight to ten days, and in other cases, 0.5 PPM
for periods ranging from seven days to one year.
For reasons already mentioned, we believe that
EPA should differentiate clearly between short-term and
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long-term exposures. More fundamentally, and acknowledged
.by EPA in the Federal Register notice, animal data are not
easily translated into a human threshhold.
Any use of animal data in supporting a national
primary standard should be justified by a comparison' of
air flow and circulatory dynamics and anatomical
structures present in the test animal, and in man. Concern-
ing the activities model, for example, it is known that the
respiratory exchange rate in a mouse is considerably higher
than that in man, and may have a substantial effect, there-
fore on the total dosage administered to the animal. Also,
the lung function of the mouse is subject to a different
kind of pathology than that of man. Such differences must
be taken into account in any attempt to extrapolate effects
from one species to another.
The third suggests on the basis of certain epidemi-
ological studies that nitrogen dioxide concentrations above
0.5 PPM are implicated with an increased incidence of
respiratory disease. From the very limited epidemiological
evidence contained in the draft criteria documents, the
basis for this claim is inexplicable. Almost all of the
data pertain to long-term exposures. Interpretation of the
data are further confounded by the knowledge that any
observed effects are produced by all pollutants present and
cannot be attributed solely to nitrogen dioxide. In fact.
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in many of the epidemiological studies cited in the draft
criteria documents, other air pollutants reportedly were
present in significant amounts, but were not measured.
Lastly, as indicated in the Federal Register
notice, many of the air monitoring data obtained during
the cited epidemiological studies must be regarded as being
variably inaccurate and, hence, unreliable.
We believe the fourth requires no comment from
Shell, since we agree with EPA assessments that neither
the study nor its findings are appropriate as the basis
for a national standard.
Although EPA has made an attempt to identify the
nitrogen dioxide measurements methods used in the key
health effect studies, considerable uncertainty remains
about the accuracy and validity of the nitrogen dioxide
concentrations which are cited as being responsible for the
biological responses noted by the various investigators.
Large measurement errors often can occur in the absence of
rigorously controlled sampling, analytical calibration,
quality assurance and data validation techniques. It seems
to us curiously inconsistent for EPA on one hand to require
an ambient air monitoring facilities to use very rigorous
controls to produce data of sufficient accuracy to be
acceptable for inclusion in the SAROAD system, while EPA,
on the other hand, accepts, at face value and without
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any further verification, whatever data may be reported in
health effect studies.
The Clean Air Act requires primary standards to
be based upon air quality criteria, and to be set at the
level determined by EPA to be necessary to protect the
public health, allowing for an adequate margin of safety.
The legislative history of the Act makes it^equally clear
that primary standards should be set at the highest level
consistent with the aforementioned goals. This, of course,
is intended to prevent unnecessary social and economic
dislocations. To simultaneously satisfy both requirements
of a primary standard, EPA needs an abundances ~crf accurate
data. We submit that such data are not presented in the
draft criteria documents. We further submit that the draft
criteria documents present no convincing evidence that a
short-term nitrogen dioxide standard is needed.
Assuming that EPA can establish a meaningful
threshold for short-term exposures to nitrogen dioxide, it
still remains necessary for EPA to articulate its method-
ology for incorporating the large margin of safety that
seems to have been included in the 0.25 to 0.5 PPM range
recommended by the EPA staff for a proposed short-term
primary nitrogen dioxide standard.
In 1971, EPA promulgated a long-term national
primary and secondary ambient air quality standard for
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nitrogen dioxide. Justification at that time was tenuous.
There was a paucity of health effects data. The key health
effects data used then by EPA now are considered to be of
dubious validity partly because of inaccurate air quality
data and partly because the effects observed could be
attributable in whole or in part to other air pollutants.
Nevertheless, by reason of having promulgated such
a standard in 1971, forty-seven air quality control regions
were classified as Priority I, and the affected states were
required by law to prepare state implementation and to
adopt an emission control regulation for nitrogen dioxide.
This involved great effort and expense.
In 1973, it became clear that forty-three of
these air quality control regions had been improperly
classified on the basis of air quality data obtained by the
same type of test method used in the key health study
which subsequently was found to be inaccurate.
Consequently, they were reelassified to Priority
III. While EPA could require states to develop implementa-
tion plans and adopt emission control regulations, EPA
was and remains powerless to require states to invoke state
regulations more stringent than those required by EPA.
We are of the opinion that the stage that existed
in 1971 is analogous to the stage now set by EPA in 1977,
and we trust that EPA has benefitted from its earlier
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experience and will not now attempt to promulgate a short-
term nitrogen dioxide standard that will be similarly
infirm and unjustified.
Thank you.
CHAIRMAN PADGETT: Thanks, Mr. Starke. Are there
any questions from the panel?
MR. COERR: Mr. Starke, would your company
suggest that EPA disregard the WBO guidelines for the
short-term standard for nitrogen dioxide?
MR. STARKE: My recollection is that the WHO
short-term guideline is in the order of 0.1 to 0.7 PPM,
and I have forgotten the details. I am not suggesting that
you disregard it. But I do believe that that guideline,
just like your proposed standard, is based upon very ques-
tionable data, both from the standpoint of the adequacy
and the accuracy.
MR. COERR: You would agree that nitrogen dioxide
at some level of concentration on a short-term basis could
be considered a toxic gas?
MR. STARKE: By toxic, you mean producing adverse
health effect at some level — yes, it would be true, it
would produce adverse health effects on some people.
MR. COERR: Does your company have a position as
to what is the threshold for t£fcose effects flMsfefe-Mlgh
MR. STARKE: The only basis for our having an
be?
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opinion on that matter would be the content of the most
recent document on this subject, which is your final draft
which suggests to us that nitrogen dioxide present in air
has a no effect level of 1.5 PPM, when an individual is
exposed to that concentration and we do not believe that
any of the monitoring data that presently are available
using a reliable test method, suggests that ambient air
in any part of the United States approaches that level.
MR. COERR: The 1.5 no effects threshold you are
referring to came I believe from Chambers' studies dealing
with adult bronchitis.
MR. STARKE: Is that my understanding?
MR. COERR: Does your company have a position
that there are no more sensitive groups within the general
population that we should try to protect with our standard?
MR. STARKE: I think that that question is best
answered by what it is we said in the text, that if there
is reason to believe that there is some group that may be
particularly sensitive to nitrogen dioxide that it should
be incorporated into the margin for safety, but !• don't
see how one can get from 1.5 PPM no effects threshold
to 0.25, to 0.50 range using any reasonable margin for
safety, particularly since there is no documentation for
it at the present.
MR. COERR: I understood your earlier points. I
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guess I am asking does your company have a position that
there are or are not more sensitive populations?
MR. STARKE: We have no reason to know that there
are, and we have no reason to believe that there are not.
MR. COERR: Just to save some time, what piece
of legislative history suggests that the standard should be
at the maximum consistent with the margin of safety in
protecting the public health?
MR. STARKE: You are referring to my statement
about the highest level consistent?
MR. COERR: Right.
MR. STARKE: That is contained in the legislative
history of the Clean Air Act that is published, I believe,
by the Department of — Superintendent of Documents of
the Government Printing Office, and a readon of legislative
history of the 1970 amendments which I believe has not
been changed in any way by the '77 amendments, indicates
that yes, Congress did intend that the air quality standards
be achieved and be attainable and also for that reason,
they asked that the standard be set at the highest level
>.
consistent with protection of the public health for a
primary standard allowing for this adequate margin for
safety.
In other words, it 3«afc wasn't.downward ratcheted
toward zero. They intended they be attainable and also be
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set at the highest level consistent with the other goals.
MR. COERR: Thank you very much.
DR. GARDNER: I would like to ask you a couple of
questions.
In your statement, you say you note with interest
that concentration of N02 rather than time of duration is
of great significance,'and then you say that the backward
extrapolation from long-term exposure to short-term exposure
is unwarranted.
If you believe that the concentrations is more
important than length of exposure, or could be, then it
would follow that we certainly should have a short-term
standard.
MR. STARKE: Well, this has to be qualified to
some degree. Clearly, if you have an extremely high concen-
tration for just a fraction of a second, conceivably the
person wouldn't even breath it.
On the other hand, I think it is reasonable to
believe that if you had an exposure of 0.01 PPM constantly
during 365 days, it would be equally uninjurious. Therefore,
that comment has to be taken not exactly as I stated, but
if over a period of one hour, or two hours, or three hours,
as your criteria document suggests there is a threshold
effect that is more important than chronic exposures, then
that would be, provide a basis for an air quality standard,
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once again, from the data that are contained in the criteria
documents, I don't see that the level that has been estab-
lished of 1.5 PPM for a three hour exposure, constitutes a
basis for proposing or promulgating a national short-term
NO2 standard because these sorts of levels just are not
experienced in the ambient air in the United States.
DR. GARDNER: Would you like to make any comment on
the Orehek study?
MR. STARKE: I think my only comment was that we
agree with you, it does not constitute a valid basis for
scientifically supportable short-term standards.
DR. GARDNER: Then one last question about the
model system, and that is the statement that the pathology
in the mouse is different than in man.
We know that. As far as infectious
the host defense mechanism that is involved when an animal,
man or mouse is healthy or well, is the same in both, don't
you agree?
MR. STARKE: I am not prepared to make a statement
on that. I am not a medical man.
DR. GARDNER: Thank you.
MR. BERRY: Mr. Starke, you mentioned that the
measurement methodology is uncertain in the key health
studies. What has Shell Oil done or your representatives
done to look into this problem, and can you identify more
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specifically what studies use an uncertain measurement
methodology?
MR. STARKE: Well, I think so far as the Chatta-
nooga Sutdy, which receives prominent display in Chapter
Five, hare is a method requiring no further clarification.
It is just held in disrepute.
So far as other things that have been done, we
in Shell did commission a report to be prepared for us by
Radiant Corporation, that investigated the various types
of analytical calibration techniques that were available
in the days, I don't know, up to about 1974, I believe,
in connection with the various health studies which were
then known to us, and a copy of that has been provided to
you people in EPA, I believe to the Health Effects Research
Laboratory, and it -points out that some of the test methods
such as the Saltzman, are quite capable of giving good data
if they are dynamically calibrated, but if they are staticall
calibrated the data are equally suspect as the Ja'cobe
Then EPA itself has performed a number of studies
that suggest even the nawerc-aa methods such as the luninescen
methods are accurate to only -HO percent or -10 per
cent at best, now that presents a real dilemma to both the
regulatory agencies and to those people who asked..to
comply with an ambient air quality!standard. If, for
(
example, you set an ambient air qublity standard at 1.6 PPM,
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for a one hour average, let's say, and the analytical
monitors record 0.9, there is a five percent chance that
you have already exceeded the standard.
If the monitor reads 1.0, there is only a 50/50
chance that the violation has been reported or recorded.
If it hits 1.0, there is still a five percent chance that
the standard has not been exceeded.
Now, these are the kind of problems that we forsee
in the analytical methods that represent a real problem to
the monitor, the monitoring network, and to the regulatory
agencies, but this is done under the best conditions, plus
or minus ten percent under the best of conditions and
under very carefully controlled and precisely defined
sampling methods, analytical methods, calibration methods,
quality assurance methods, and data validation methods.
Now, the medical investigators presumeably are
well experienced. They are honest people, but for the most
part in my opinion, they are not experienced and not
expert users of monitoring equipment.
MR. BERRY: Excuse me. Have you — has Shell
Oil talked with any of these investigators to see if they
have used proper methods?
MR. STARKE: We in Shell have not done it
ourselves, for example, in connection with the ozone inves-
tigation of Nieding, a group did visit him and found all
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sorts of problems with the test methodologies used, and
these are pretty well documented. These are a source of
real concern as to the accuracy and validity of the concen-
trations of the pollutants that were recorded by the investi-
gator at the time the adverse health effects were noted.
CHAIRMAN PADGETT: Thank you, Mr. Starke.
MR. STOLPMAN: I have a couple of questions;
just a couple, Joe.
CHAIRMAN PADGETT: Make it brief.
MR. STOLPMAN: I will, Joe.
With regard to the sending of individuals to the
laboratory implying, or I guess stating, that the CRC
did send some scientists to von Nieding to review his
laboratory.
MR. STARKE: I was not among them, but I have
heard pretty authoritative reports.
MR. STOLPMAN: That is being made available to
the EPA.
MR. STARKE: I believe it was given to the
Science Advisories Board's subcommittee for photochemica
oxidants from the von Nieding ozone work.
MR. STOLPMAN: Can you tell me whether^the^members
who went under Contract to CRC were members of SAB?
•f t- --
MR. STARKE: No, I do not know. I believe that
one of them was a panelist, whether or not he is a member
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of the subcommittee or whether he was an invited guest I
can't say.
MR. STOLPMAN: Okay. You indicated earlier on
that the recommendation of the World Health Organization is
based on inadequate data or inadequate studies. Can you
cite for us at those times what those inadequate studies
are?
MR. STARKE: Basically, as I understand the
World Health Organization guideline, it was revealed by a
panel of experts about three years ago, and they were using
essentially the same type of studies and data that are
available here, and probably not as extensive as are reported
in the final draft.
MR, STOLPMAN: You are saying the World Health
Organization with the same studies we have available to
us, essentially arrived at a recommended standard in the
.1 to .17 PPM range?
MR. STARKEY: That evidentally seems to be the
case.
MR. STOLPMAN: You are saying that they somehow
either misread or decided to use inadequate data to support
that standard?
MR. STARKE: I don't know how they arrived at
that number, but they did arrive at that number.
MR. STOLPMAN: You are implying they decided to
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use inadequate data and EPA should have more insight and
not use that same data?
MR. STARKE: I think that so much is at stake in
this nation, if it is supportable, a valid national ambient
air quality standard must be better documented than a
guideline.
MR. STOLPMAN: I assume it is more than at stake
in this nation, there are other nations that it is probably
at stake also.
Just briefly on the margin of safety, you are
implying, I believe that what EPA should do is take a
threshold that is implied for a less than sensitive popula-
tion, and somehow devise a margin of safety from that
population rather than going to a, to the most sensitive
population and providing a margin of safety from that
population, for that population.
Is that what you are implying by essentially
saying that we should crank in the more sensitive popula-
tion within our margin of safety concept?
MR. STARKE: I think I am saying that a standard
should be set on accurate, reliable data. Now, if the
data indicates as in our judgment the short-term NO2 data
indicate, that the no effects level for nitrogen dioxide
short-term exposures is 1.5, to a particular type of
particularly sensitive individual, in this case bronchitis,
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then that constitutes the threshold from which you establish
the margin of safety as required by law to take into account
unknown effects, and then you establish your standard.
MR. STOLPMAN: So essentially you are saying that
the EPA should not take into account the suggestion that
asthmatics might be sensitive to levels in the .1 to .15
range?
MR. STARKE: Unless you can document that, I
don't think it is a proper basis for establishing a
threshold.
MR. STOLPMAN: It is not a question of document-
ing. I guess it is a question of whether EPA should use
the studies that show that as a basis for standard setting.
MR. STARKE: That is part of this constant
racheting downward as I pointed out as we view the legisla-
tive history of the Clean Air Act. The standards must be
set at the maximum level consistent with protecting the
public health.
CHAIRMAN PADGETT: I think we better move on.
Thank you very much, Mr. Starke.
Dr. Brewster?
DR. BREWSTER: Having just arrived on a late
earlybird from Wilmington, I regret I didn't hear all the
comments by the previous speaker.
My name is Dr. Van Brewster. I am the Assistant
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Medical Director of the Du Pont Company, and I am presently
on assignment at Haskell Laboratory for Toxology and
Industrial Medicine. My eighteen years in medicine include
six years as a full-time plant physician, and eleven years
as a private practitioner.
Du Pont appreciates the opportunity to express its
views on the possible health effects from short-term
exposures to nitrogen dioxide. The Du Pont Company has
supported adoption of national ambient air quality standards
to protect human health. We feel that during the standard
setting process, if sound medical evidence is available,
then economic costs and availablity of demonstarted control
technology should be relatively unimportant considerations.
On the other hand, we urge that when the scientific
evidence is ambivalent and thoroughly inadequate, then
consideration should be given to gathering more data rather
than guessing at a safe level. If, as in this situation, a
statute seems to mandate that EPA set a standard, then the
lack of data should not be obscured by an unrealistically
high safety factor that contributes nothing to human health.
Rather, we suggest the standards be set to protect people
from hazards reasonably known, then adjusted as valid and
appropriate data become available.
I find no convincing scientific evidence that
adverse human health effects are caused by short-term
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exposures of nitrogen dioxide at 1.5 PPM as stated in EPA's
draft on "Health Effects for Short-Term Exposures to
Nitrogen Dioxide.°
In reviewing the draft, I noted that most of the
350 references dealt with long-term exposures, not short-
terra exposures. These studies will be pertinent when EPA
reviews the criteria for long-term exposures, and we trust
that if these documents show the annual standard for N02
as not proper that it will be adjusted. I feel, however,
that most of the results of these studies are not pertinent
or even useful in determining the effects of short-term
exposures.
Mentioned in the draft are some studies which
measured the effect of other chemicals in combination with
nitrogen dioxide. I do not deny the possibility of an
additive effect, but this could be covered by a safety
factor and should not influence our evaluation of nitrogen
dioxide alone. So when one separates the "wheat from the
chaff", EPA's conclusions are based largely on those few
human studies in which there was a change in airway
resistance.
The animal studies which attempted to measure the
effects of infectious agents and nitrogen dioxide will be
addressed in a moment.
In placing so much emphasis on airway resistance,
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EPA has unfortunately equated adverse health effects with
reversible physiological changes and has thus ignored the
natural defense mechanisms of the human body. Many factors,
including emotional distress, can cause temporary physiolo-
gical changes. However, we do not necessarily call them
disease or adverse health effects.
Every physician has been taught that a disease or
adverse health effect should be determined only after
considering the entire lab data, the symptoms and the
physical findings. This has been confirmed by me personally
many times in the practice of medicine. Yet the conclusions
expressed in the draft and in the EPA notice of March 27th
have ignored this very basic lesson.
As an example, let us consider the studies of
von Nieding and also Beil and Ulmer. Even if one accepts
the validity of their techniques, which have been challenged
by many investigators, we should consider their negative
data which far outweigh the positive data. Not highlighted
in the draft is the following quotation from von Nieding's
experiment in which human subjects were exposed to five PPM
for two hours, and I quote:
"In the actual exposure experiments, the
following parameter did not show changes when
compared with the value in the control series:
Alveolar 02 and CO2 partial pressure/ the
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arterial CO2 partial pressure, pHa, the
expiration curves of helium, the closing
volume, and the flow/volume curve (P 0.1).
The application of one, two and three
percent solutions of acetylcholine provoked
only a slight bronchial obstruction or none
at all."
Von Nieding also reported that the thoracic gas
volume shoved no change with exposure.
In the study by Beil & Ulmer, human subjects were
exposed up to 5.0 PPM for fourteen hours and 7.5 PPM for
two hours. There were no significant changes in the pulmon-
ary artery's oxygen pressure or CO pressure, nor were
there any significant changes in the endexspiratory thoracic
gas volume, except in the later stage of the fourteen-hour
exposure at 5.0 PPM.
The airway resistance after acetylcholine did
not show a significant increase until the subjects were
exposed to 7> 5 PPM for two hours, and 5 = PPM for fourteen
hours. And lastly, Beil and Ulmer stated that the airway
resistance showed no dose-response dependence at concentra-
tions of 2.5 PPM and above.
Another negative finding in the studies is the
absence of any symptoms such as shortness of breath, which
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is the most common symptom of subjects with pulmonary
insufficiency. In spite of the many negative findings
listed above, these are the very studies upon which EPA
has based its conclusions.
Some analysts associate reversible increases of
airway resistance with future lung disease. This assumption
deserves critical scientific scrutiny and cannot be proved
by simply showing that airway resistance is increased in
lung disease. Unless new evidence is determined which
suggests that reversible changes usually lead to irrevers-
ible changes, there will be no basis for this assumption.
My last comments relate to the possible effect of
short-term exposures on susceptibility to infection. The
main concern here is whether the particular tests done can
be applied to humans. It seems the studies with mice are
the primary basis for EPA's concern with susceptibility at
low levels. Even test animals varied considerably when
exposed to nitrogen dioxide and infectious agents. The
squirrel monkeys have shown more resistance than hamsters,
and the hamsters much more than mice. Also, the large amoun^
of infectious agents used was unrealistic, being much more
than one would expect in the real world. As stated in the
draft, even the control mortality was ten to fifteen per-
cent,.
In conclusion, I regret that we are unable to
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present to you new data upon which a short-term standard
can be determined with confidence. The truth, unfortunately
is that reliable data on short-term exposures are very
limited. Even so, it would be a grave mistake, out of
frustration, to rely on a reversible and possibly inaccurate
measurement such as airway resistance when other parts of
the test showed no change, and it would be a mistake in
this case to determine human susceptibility to infection
on the basis of studies with mice, when the dose of infecti-
ous agents is unrealistic and when there is good evidence
that mice are more susceptible to infection than other
animals. And, lastly, we caution EPA in the interpretation
of epidemiological studies. The effect of short-term expos-
ures should not be confused with the effects of other factors
such as the annual mean exposure.
It is unfortunate that the Clean Air Act Amendments
of 1977 seem to compel EPA to set a short-term standard for
N02 by August 1978, despite the clear absence of adequate
data. We urge against an arbitrarily low standard to
compensate for this vacuum of information. We also urge EPA
to ensure an adequate program of research so that an
appropriate standard can be set as soon as possible.
Du Pont again expresses its appreciation for the
opportunity to participate in your discussion.
CHAIRMAN PADGETT: Thank you, Dr. Brewster.
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Paul, do you want to lead off this time?
MR. STOLPMAN: Sure. I won't be last this time.
I have two short questions.
One is, you have indicated that you caution EPA
on its interpretation of epidemological studies. ..Which
ones do you have in mind — there are seven. Is that in
general?
DR. BREWSTER: It is a general comment. In
reading through all of them, and I guess the time element
here involved, I did not get into the epidemological
aspects as much as I hope the others do later, but I do
see in all of these studies this tendency to ignore the
long-term effects. I think it is Chattanooga that showed
very high increases, and you may correct me if I am wrong,
I think it is Chattanooga that showed the high increases
year round.
MR. STOLPMAN: That is just a general caution to
EPA?
DR. BRBWSTER: Yes. I appreciate the problem
that epideraologists have.
MR. STOLPMAN: In regard to the Beil and Ulmer
and the von Nieding studies, were those subjects sensitive
subjects, or were those healthy subjects?
DR. BREWSTER: These were healthy subjects.
MR. STOLPMAN: Should we draw a firm conclusion
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from exposures of NO2 to healthy subjects in this agency?
DR. BREWSTER: I think you should, and possibly
consider the safety factor after that.
MR. STOLPMAN: Dr. Brewster, there again you would
recommend that we crank into the safety factor, we not pro-
tect with the margin of safety the most sensitive, but that
we somehow simulate those people into our margin of safety
concept?
DR. BREWSTER: Ideally, I would like to do both.
That is the ideal situation, and possibly if we had some
experiments that we could do, of course it is difficult
to find a healthy and unhealthy rat and draw a good conclu-
sion from that, but in humans, it would be ideal if you
could do both.
MR. STOLPMAN: What EPA should look to, I guess
in your opinion, is then studies on healthy people, and
perhaps studies which have been carried out on the sensitive
populations at matrix.
DR. BREWSTER: If good information is available.
MR. STOLPMAN: So the question then is whether
it is good or not, not that we should, do it.
DR. BREWSTER: Right.
DR. GARDNER: I would like to expand on that a
little bit. Von Nieding did some studies on chronic bron-
chitis and effects at 1.6 to 2 PPM.
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Would you like to comment on that? You didn't bring it up
in your comments.
DR. BREWSTER: The main thing that frustrates
me being a practitioner and having been a practitioner,
for so many years is that we would let this one particular
part of the test influence our overall conclusion. Having
been a private practitioner, this is contrary to what I
have experienced and what I have been taught all my life,
and so I really think his tests, both on those that were
more susceptible, if they were, and the normal, just
don't convince me from private experience.
DR. GARDNER: As a physician, you know that
disease is not usually a one-to-one cause and effect
relationship, there is a lot of pre-disposition factors,
and if an animal or a man gets such and such a concentra-
tion of bacteria, it doesn't mean he is going to get sick.
DR. BREWSTER: That is correct.
DR. GARDNER: Pre-existing disease, stress and
things like that can cause the individual to become sick;
if he is absent this stress he is liable to be well.
DR. BREWSTER: Yes.
DR. GARDNER: In the infectious model, evidence
of the amount of bacteria the animal got the NO2 must have
done something to the host defense mechanisms to make these
individuals more susceptible.
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DR. BREWSTER: I think your question is a good
question. I will not make light of it, except that I guess
any time I deal with the extremely unrealistic situation
I am not comfortable with the results. We don't know what
would have happened if we exposed the mice to levels that
were what you and I both would consider realistic, so to
jump from that point to the other, to me is an assumption
that at least I can't make in my mind.
DR. GARDNER: But at some level of NO2, whatever-
it may be, there must be some alteration in the host defense
mechanisms that makes these animals die.
DR. BREWSTER: Well, I go back to the idea that
a.good percentage of the control died.
DR. GARDNER: This is intentionally built into
the design of the experiment. They examine included any
study where there was zero death in the controls because
they wanted to make sure that the micro organism could pro-
duce a death, even in the control animal and within the
population of animals or people. There are those individuals
that will succumb to infectious agents.
DR. BREWSTER: I fully appreciate the purpose
for it. You have to have something to measure and mortal
is easy to measure.
I appreciate the reason that they did it, but
once we get through, I am uncomfortable with the data.
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DR. GARDNER: The last question about your
reversible and adverse effects, would you consider as a
physician that any health effects that were reversible would
not be an adverse effect?
DR. BREWSTER: Let me think of that.
Dr. Gardner, would you ask that question again?
DR. GARDNER: Your statement is that it is
unfortunate to equate adverse health effects with reversible
physiological changes. Now, would you say that any
reversible health effects would not be, would they all be
hon*-adverse health effects? If it is reversible, is it
still a health effect?
DR. BREWSTER: If it is reversible, I do not
consider it a health effect in most cases.
DR. GARDNER: Like asthma?
DR. BREWSTER: I realize your question now. I am
with you. I think in his cases, the effect is of very
short duration, and so when you get through, when you have
a reversible health effect, as a physician, you look at
it and say, gee, this may be significant, or it may not
be significant, and with all the facts you make a judgment
on that particular case, but I think it is a mistake experi-
mentally to just assume that you have a reversible health
effect, and that means gee, that proves future lung
disease, even though I can accept your example on the
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asthmatics, but we have got to think of all of it* just
not that one particular case.
Does that answer your question?
DR. GARDNER: Finft. Thank you very much.
MS. TAYLOR: You and the previous speaker have
cautioned EPA against the use of epidemological studies
presuraeably because the extrapolation from long-term
exposures to short-term exposures is a very difficult one.
However, most of the, or some of the mostinteresting and
suggestive epidemiological studies that have been used
for this standard have been the cook stove studies.
As a physician, would you consider the exposure
to high levels of NO2, one or two hours per day, as might
be happening in the case of cook stoves which are used pri-
marily in the evening and might not be used at other times
during the day, but day after day after day a short-term
exposure phenomenon or a long-term exposure phenomenon?
DR. BREWSTER: I would have to balance it. I
would have to balance it with the overall, consider that
as a factor as I made my determination this is, the only
thing.
Of course, as an epidemologist, I appreciate the
frustrations you have in getting good data. We just don't
have the data, where you have someone exposed for one or two
hours and then for the rest of the day, there is no
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exposure, if that is significant like that, I don't know
whether it is.
MS. TAYLOR: And the ambient air bad hours of
N(>2 exposures come in lumps and even though we chose to
set a standard that only looks:-at an hour at a time. In
the real world you would expect similar phenomenon as to what
might be happening.
DR. BREWSTER: You get the peaks in the morning,
I appreciate that. But still you have got to go back and
consider the annual mean, and ask your question, at least
be honest with yourself, and say, gee, which one of the
two is this caused by, is it the overall exposure, or is
it just that peak exposure?
I think it is a difficult question, and I am not
being critical of any epidemologist. I sympathize with them,
but I am just saying, gee, consider all the facts.
CHAIRMAN PADGETT: Time for one more question.
MR. COERR: As I hear you, you are saying~tftftt
EPA, if we were to either say short-terra standard, and you
advocate that we don't, should not necessarily set the
standard at a level which would prevent certain segments -
of the population of having increased airway resistance,
that that is not an adverse effect for the purposes of
the environmental agency setting standards for the nation,
that we should set m standard somewhere tolerant of
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1 of increased airway resistance in segments of the population
2 if that is what is happening.
.1 DR. BREWSTER: Well, I hate the word tolerate, any
4 health effect, I guess I first want to establish if there
5 is a health effect. If we established one, I would be just
6 as uncomfortable with it as you are. We don't want to do
7 that. Du Pont certainly doesn't want to do that, but I
8 think we have just got to have something to work on first.
9 And I regret that I don't have a magic number of offer you,
10 and I don't envy you in your judgment, but I just simply
n think you are placed in a situation without any good data on
12 short-term exposures, and did I dodge your question?
13 MR. COERR: Not quite. If we believe that there
14 is a possibility of increased airway resistance from segments
15 of the population in certain concentrations on a short-term
16 basis of NO2, should we use that information in setting the
17 standards or do you believe, I know you believe that a
18 one-time excursion up and down isn't going to be too signifi-
19 cant, but the question is, should we use the possibility of
20 repeated instances of airway resistance increase?
21 DR. BREWSTER: Plug that into the computer of your
22 division, yes, if it is repeated but I would think if you
23 have repeated excursions, every day, it is going to be a
24 reflected — probably in the annual mean.
25 MR. COERR: Thank you.
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DR. BREWSTER: I hope I answered that question.
Do you have any other questions?
CHAIRMAN PADGETT: I think that is fine,
Dr. Brewster. Thank you very much.
DR. BREWSTER: Du. Pont appreciates the chance to
be here.
CHAIRMAN PADGETT: Thank you, sir.
Mr. Malcolm Hawk?
(continued on the following page.)
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44/A
MR. HAWK: Good morning. I am Malcolm Hawk, Counsel
for Exxon Company, U.S.A., and Chairman of the Photochemical
Oxidants/Nitrogen Dioxide, Steering Committee of the American
Petroleum Insitute, for whom I appear this morning. Accom-
panying me are experts in various fields, to assist me in
answering any questions you may have. Dr.; Burce Bailey, Dr.
Gordon Everett, Dr. Edward Burger, and Dr. Kathleen Weston.
API welcomes this opportunity to present its comments on
whether or not there is a need for a standard for the
control of short-term exposure to nitrogen dioxide.
Determination of the need for a short-term nitrogen
dioxide standard is to be based on air quality criteria
developed under Section 108(c) of the Clean Air Act. However,
this determination is made difficult by the critical lack of
data in certain key areas including expecially community
health and exposure. Thus, EPA must determine first the level
at which significant adverse human health effects result from
short-term exposures to nitrogen dixoide and, second, whether
these levels can be expected to occur in ambient air. The
paucity of evidence to make these assessments is attributable
in part to the unjustifiably restricted scope of the draft
criteria and in part to the limitations of the few available
epidemiological studies on the health effects of nitrogen
dioxide.
Nevertheless the limited evidence that is available
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from well-conducted human clinical studeis does not demonstra
a need for a short-term standard.
The Clean Air Act Amendments of 1977 require the
Administrator to "revise and reissue criteria" relating to
concentrations of NC>2 over periods of not more than 3 hours.
The 1977 Amendments further provide that the Administrator
shall promulgate a short-term standard for NC>2 "based on
the criteria issued under Section 7408(c) of this title, he
finds that there is no significant evidence that such a
standard for such a period is requisite to protect human
health."
API believes that the Agency has failed to fulfill
its responsibility under this section to revise and reissue
criteria on which to decide whether or not a short-term NC>2
standard is necessary. The truncated draft criteria document
which EPA released on December 12, and which has been revised
only modestly since then, does not meet the requirements
of the Clean Air Act.
Moreover, the second draft is more restricted than
its predecessor. At the Science Advisory Board Subcommittee
meeting on February 22, the Succommittee asked EPA to make
various changes in the document, including substantial
revisions to Chapters 1 and 6, and to submit these revisions
to the Subcommittee. Instead, EPA chose to drop Chapter 6,
which addressed the risk posed to health by NO2, and revised
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! and resubmitted only Chapter 1. Thus, the revised draft
2 cannot be considered to provide a comprehensive assessment
3 of the adverse human health effects, if any, which might
4 results from exposure to prevailing short-term levels of
5 N02-
6 Also at the Subcommittee meeting, EPA conceded that
7 the document is incomplete for failing to address adequately
8 such important subjects as measurement and monitoring techniq
9 models to relate emissions to ambient concentrations, the
10 effects of atmospheric transport, and sources and sinks of
11 NO/NO2 emissions. Furthermore, EPA stated that it intends
12 for this truncated document to be superceded by a complete
13 revised criteria document for nitrogen oxides which is to
14 be released early next year.
is Rather than providing a basis for comfort, EPA's
16 statement simply underscores the incompleteness of the short-
17 term criteria document. The subjects which EPA admits are
18 important for inclusion in a complete criteria document are
19 critically important to determining the need for a short-term
20 standard. For a one to three-hour standard, the consequences
21 of error in measurement and monitoring are magnified and it
22 is even more difficult to relate accurately emissions to
23 ambient concentrations. A thorough treatment of the extent
24 and frequency of human exposure to NO2 is necessary for the
25 Administrator and the public to determine the risk posed by
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i NO2. It would be unwise for EPA to withhold consideration
2 of these important issues until after a decision is made on
3 whether or not to promulgate a short-term standard.
4 Notwithstanding these various inadequacies of the
5 draft criteria, no significant evidence demonstrates the need
6 for a short-term standard to protect human health. In
7 announcing this meeting, EPA indicated that some evidence migtyt
8 support a short-term NC»2 standard of between 0.25 ppm and
9 0.5 ppm. However, we find that the evidence simply does not
10 support this suggestion. Available human clinical, epidemio-
n logical and animal studies have been analyzed and found to
12 provide no significant evidence that there is any risk to
13 human health from short-term N(>2 concentrations in the 0.25
14 to 0.5 ppm range being considered by the Environmental
15 Protection Agency.
16 Clinical studies using human subjects are the most
17 reliable means of assessing the short-term effects of specific
13 concentrations of a pollutant on human health. The i
19 can minimize the confounding effects of other pollutants, and
20 can determine more reliably the concentrations of the pollutant
21 under study. Furthermore the investigator, by observing humans
22 directly, eliminates any need for uncertain extrapolations
23 from other species .
24 Significantly, EPA's draft criteria as reviewed by
25 the Science Advisory Board on February 22, revealed that no
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reliable human clinical study has demonstrated significant
adverse human health effects at or below NO2 concentrations
of 1.5 ppm for 3 hours or less.
Moreover, human clinical observations are not contro
verted by data collected in epidemiological studies or animal
studies. The criteria document acknowledges that the results
of the Ghattannoga Community study cannot be ascribed to
short-term NO2 concentrations, in view of the confounding
influence of significant concentrations of other pollutants.
In the gas stove study conducted in England and Scotland,
investigators did not measure NO2 concentrations in the homes
and did not control for tobacco smoking. American studies
have not replicated the results of the United Kingdom study.
Consequently, the United Kingdom study fails to provide
significant evidence on which a standard could be based.
In summarizing the results of animal studies, the
criteria document reports no study which has demonstrated
that adverse health effects occur at NC>2 or less. The
criteria document does address 139 pages to a detailed report
of animal studies, some of which found health effects by usin
NO2 concentrations greater than 1.5 ppm and/or exposure times
generally much longer than 3 hours. The mouse infectivity
model is subject to substantial criticism for the extremely
high bacterial dosages used, a problem that might be compli-
cated further by the recently raised concern about widespread
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lactate dehydrogenase-elevated virus in laboratory mice.
These problems cast substantial doubt on the applicability
of mouse infectivity data to man.
Had EPA followed the advice of the Science Advisory
Board by including in the criteria document a discussion of
the risk posed by N02, we might be better able to judge the
significance of these effects at high dosages. We do know
that because of fundamental differences in anatomical structute
and functioning between human lungs and those of many animal
species, it is unlikely that man receives as high a dose of
a pollutant in a one to three-hour time period as do many
animal species. Therefore, all other factors being equal,
NO2 should not cause adverse effects in man at ambient con-
centrations lower than those required to cause such effects
in animals.
Given the fact that 1.5 ppm of NO2 for 3" hours or
less apparently is a no-effect level for adverse effects on
human health, it is important to determine whether or not
that level is found in the ambient air. The limited evidence
presented in the criteria documents fails to demonstrate that
ambient N02 concentrations in the United States even approach
1.5 ppm for 3 hours or less.
EPA reports only a handful of instances for which
hourly values of .53 ppm have been recorded, and values above
0.3 ppm are admitted to be relatively rare. However, these
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are hourly values; 3-hour concentrations will generally average
considerably lower. The only conclusion to be drawn is that
current ambient short-term NO2 concentrations, even the rare
high peaks, do not appear to pose an adverse effect on public
health.
In sum-, for N02, as for EPA's recent experience with
atmospheric sulfates, there is insufficient evidence on which
to base a standard. The course of action for EPA is clear.
EPA should acknowledge that evidence presently available does
not demonstrate that a short-term standard for NO2 is requisi
to protect the public health. Furthermore, EPA should revise
and reissue a full-scale criteria document, rather than rely
on the admittedly incomplete document which now presumes to
be a final draft.
API plans to submit futehr written commentary and
reports on these issues in the future. My colleagues and I
wouldbe happy to try to respond to any questions you might
have. Thank you very much.
CHAIRMAN PADGETT: Thank you.
MR. BERRY: Have you read the transcripts of the
SAB Meeting, Mr. Hawk?
MR. HAWK: I have not read the transcript, but Dr.
Gordon Everett was at that hearing and is familiar with it.
MR. BERRY7t Chapter 6 was discussed at length there
and if you would like to see this transcript, it is from the
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Acme Reporting Company; on Page 1-134 we discussed Chapter 6
and Chapter 1, which was done in the recent draft of criteria
document, and that is all I will say about that.
CHAIRMAN PADGETT: Done?
MR. GARDNER: : Yes. A couple of small questions.
You talk about the extremely high bacterial doses, used. Do
you know what those doses were?
MR. HAWK: Dr. Everett or Burger —
MR. GARDNER: You talked about the extremely high
bacterial doses used. Can you tell me how high, high is?
What was it in the concentration of the lungs Iof the
animals.
DR. BURGER: Infactivity studies?
MR. GARDNER: Yes, approximately 400 microorganism
is all it takes to get the effects. I was just wondering
whether that is high or not. Another question here, your
statement on Page 6, there is a fundamental difference in
anatomical structure and functioning between human lungs and
animals, and it is unlikely that man receives as a high dose
of pollutants in the 1 to 3-hour exposure.
Are you familiar with the work of Miller, et al.,
who has mathematically modeled another oxidant ozone and has
shown in the guinea pig and rabbit, the two animals he used
that the dose of the pollutants would be the same in a man as
in those two species of animals?
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MR. HAWK: May I ask my medical specialists?
DR. BURGER: I am familiar with the model, and I am
not clear as to how to interpret it. Furthermore, it applies
to one species, the rabbit, and I am not quite sure how to
extrapolate to the animal you are most familiar with, which
is the mouse on which the discussion of this subject is heavily
based.
MR. GARDNER: • I was really getting at this para-
graph here where it says that man would be unlikely to receive
the same dose as an animal, regardless. That is the point
that I was asking
DR. BURGER: I guess I am not sure of what the answer
to that is.
DR. EVERETT: We think one of the things we have
commented on — that Miller model, by the way, was at some
length in the submissions to the agency on photochemical
oxidants, and one of the things that we think that we may be
seeing is that there is indeed a somewhat higher concentration
to the animal, given the body weight of the animal in
comparison with the exposure. This is one of the things that
we have concerns about, the other question that is raised with
regard to the bacterial doses has to do with a comparison on
what may be considered to be an environmentally reasonable
sort of a dosage over a given period of time, in comparison
with the lengths of the insult.
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I think that we have perhaps a difference of opinion
here with regard to concentration, but feel that there may
be a considerable amount of utility in terms of mechanism
in infectivity model. The mechanism might be biological,
revealing of things that should be looked at in another
context or a different concentration, but the problems that
we have come up with and are looking at it at the present
time, as Dr. Burger says. We are not quite sure how to deal
with some of these things because the connecting studies seem
to not be present so that one can draw any rfirm conclusions
from it.
Some of the material has been presented by the
agency in the animal infectivity models.
MR. HAWK: If I could respond to the first question,
which was asked, it was pointed out to me on Pages 1-136 of
the hearings of Science Advisory Board on february 22, in a
discussion of the revisions of Chapters 1 and 6, the Chairman
of the Science Advisory Board, Dr. Whittenberger, indicates
that his group would each prefer to have the two kept
separately, there would be advantages in having it kept
separately; it seems to me that we are in agreement on that.
The EPA apparently has chosen another course, and we just
wanted to point that out.
CHAIRMAN PUDGETT: Stan.
MR. COERRSr: Mr. Hawk, you talk about the confouridi:ig
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effects of other pollutants in clinical studies. Does API
believe that there may be a possibility of enhanced sensitivi
to nitrogen dioxide because of the presence of other
pollutants, mainly their synergistic effects? - -.
MR. HAWK: Dr. Burger?
DR. BURGER: I am familiar with the suggestion, but
I guess I am not satisfied with the results that have been
found from experimental studies as to making an interpretatio
MR. COERR:>; You think that the possibility is
indeterminant?
DR. BURGER: Undeterminant.
MR. COBRR,:::- if there was a synergism, does API
believe that EPA should use that synergism somewhere in its
decision making about the level of the standards?
MR. HAWK: I would say if one has been demonstrated
and been proved, it is something that EPA might well want to
take into consideration, but the lack .of that proof, I think,
suggests that the time is not yet ready for that to be done.
MR. COERR- ••:.- Thank you.
CHAIRMAN PADGETT: Any other comments? Okay.
Thank you.
MR. HAWK: Thank you very much.
Mr. John Shiller;
MR. SHILLER: Good morning. My name is John Shiller
I am with the Environmental Research Department of Ford Motor
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Company. We wish to use the opportunity provided by this
public meeting to comment briefly on EPA's proposal of a shor
term nitrogen dioxide standard in the range of 0.25 to 0.5
ppm, one hour average. We plan on providing additional
comments in written form after we have had some needed time
to further study the final short-term criteria draft document
that was just recently released by the agency.
Today our comments will focus on the relationship
between concentration and the dimensions of averaging time
and exposure frequency.
The agency has announced Air Quality Standard Pro-
posal for nitroden dioxide specified a concentration range
and averaging time, but not the frequency which determines
allowable public exposure. Since the public is exposed to a
distribution of NC>2 levels which is composed of low concen-
trations upon which are super imposed higher intermittent
levels, we were disappointed to learn that EPA plans to
promulgate a short-term nitrogen dioxide standard before
complete revision of the nitrogen dioxide criteria document
now postponed to 1979.
We feel that it is critical for the agency to
evaluate both long-term and short-term health data together
and their relationship to environmental concentration
frequency, distribution and impact on public health. Although
the draft short-term criteria document contains long-term data,
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i this information tends to get promoted as being short-term
2 which would be less likely to happen if health data are
3 evaluated in terms of a concentration frequency distribution
4 covering both the short-term and long-term spectrum.
5 For example, considering the intended us of the
6 short-term criteria document, the relevance of almost all of
7 the animal studies need further qualification because they
8 usually involve continuous or repeated long-term exposures
9 to nitrogen dioxide. Not only is there a question of how
10 to extrapolate animal data to man, but also the question of
11 how to extrapolate long-term data to an intended short-term
s
12 standard. Yet, long-term animal studies are listed in Table
13 1-2, of that revised short-term criteria document, with a
14 short-term caption which is misleading.
15 Animal studies suggest a threshold for reduced
16 resli.>aice to infection at about 0.5 ppm for mice while
17 priraates or squirrel monkeys require much higher concentra-
18 tions to product similar effects. Using the data in Figure
19 4-1 of the revised short-term criteria document, a continuous
20 exposure to 0.5 ppm N©2 for more than 170 hours would be
21 required before health effects start to occur in mice which
22 are known to be very sensitive to NC>2 and other pollutants.
23 The extrapolation of this data to a short-term standard is no
24 straightforward but it seems reasonable to conclude, however,
25 that if a short-term standard is established at the upper
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i limit of EPA's suggested range that is, 0.5 ppm N02 assumed
2 not to be exceeded more than a few times per year, then a
3 safety factor would result not only in terms of a significantly
4 lower exposure duration but also perhaps to the possibility
5 that man is more likely to be less sensitive than rodents.
6 In contract to animal data, human clinical health
7 studies include some pertinent information on short-term
8 exposure to nitrogen dioxide. As outlined in the revised
9 criteria document, the short-term threshold associated with
10 respiratory function in either healthy or bronchitic indivi-
11 duals is 1.5 ppm. Since some of the changes observed in
12 respiratory flow resistance at concentrations near this level
13 would not be perceptible by most people, it is difficult
14 to correctly evaluate the significance of such changes to
15 public health. Current scientific thought supports the
16 principle that change is not necessarily equated with adverse
17 health effects. Since this concept to some extent is discuss)
18 in the criteria document we won't belabor the point here only
19 to point out that EPA's proposed range of standards appears
20 to be significantly below the threshold needed to protect
21 public health based on clinical and animal data.
22 Community exposure studies addressing nitrogen
23 dioxide are difficult to evaluate due to the many possible
24 uncertainties in real world situations. The Chattanooga
25 studies are probably of questionable validity. The only
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community study listed in the summary Table 1-2 of the revisei
short-term criteria document is the Melia gas stove study
which appears to be related more to long-term than short-term
exposure.
Air pollution research has focused almost exclusivel
on the atmospheric environment and has virtually neglected
pollution indoors. The relationship of smoking, cooking with
gas, and space heating to N02, CO, SO2, and respirable
particulate pollution is not adequately understood and
requires further study. While the study by Melia suggests
some correlation of greater respiratory disease in British
homes with gas stoves, other gas stove studies indicate no
correlation. Since the concentration of NO2 and other
pollutants occurring in the homes surveyed by Melia were not
monitored and that the data were not adjusted for tobacco
smoking, it is technically incorrect to assume in the short-
term criteria document that the children in those homes were
exposed to 0.25 to 0.5 ppm N02 with a frequency unspecified
based on another sutdy conducted at a different time in a
different country by Wade and others.
Furthermore, it is not clear how the range of 0.25
to 0.5 ppm NO2 can be supported considering that N02 and
other pollutants levels are greatly influenced by house
volume, air changes per hour, and fuel usage rate and since
higher levels have been observed by a number of investigators
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Hollowell, and others at the Lawrence Berkeley Laboratory
found nitrogen dioxide levels in kitchens of homes with gas
stoves to be as high as 0.53 ppm with one top burner operatin
for less than 30 minutes and as high as 0.9 ppm with the oven
operating for 20 minutes. Concentrations of NO2 were observe*
to be as high as 0.64 ppm for 8 hours in the bedroom of a hou
with a forced-air gas-fired hearing system operating under
normal conditions. In a controlled experimental room main-
tained at 0.25 air changes per hour and with the oven <6f a
new gas stove on for one hours, 2.5 ppm N02 was observed.
Macriss at the Institute of Gas Technology found that
kitchen NO_ concentration rises rapidly to a maximum of
about 0.6 ppm in a home located in a suburb of Chicago using
very light cooking loads. Others have observed peaks 1 parts
permillion. Clearly, the effect of indoor pollution requires
further evaluation of this intermittent but frequently used
source of exposure before an extrapolation is made of such
long-term intermittent data to either a short-term or long-
term ambient air quality standard.
Although it would not be appropriate for EPA to
consider the feasibility of NOx control requirements in
establishing a health threshold, it is entirely correct for
the Agency to consider feasibility when it establishes a
safety factor as long as public health is protected. The
feasibility of achieving standards in the range of 0.25 to
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0.5 ppm appears to vary greatly. This is where an under-
standing of atmospheric chemistry and ambient monitoring dat;
is of great assistance even though information is incomplete.
We are currently studying the feasibility issues
and plan to provide additional comments in a written submission
upon completion of this work. Past EPA data and projections
seem to suggest that costly control programs may result from
standards below about 0.5 ppm; however, this evidence is not
clear-cut and needs further study.
Since costly control programs might results from
standards at least in the lower levels of EPA's suggested
range, it is essential that the need for such a requirement
be carefully established before promulgation. Based upon
evaluation of health data, a standard between 0.5 and 0.75
ppm nitrogen dioxide which includes a safety factor not to
be exceeded more than once per month was recommended in our
previous comments to EPA. Taking feasibility into account,
perhaps 0.5 ppm NO2 would provide the greatest safety factor
without incurring the risk of costly and disruptive control
programs: At this level, indoor pollution appears more
significant in terms of public exposure, yet the need to
control indoor NO2 pollution has not been established.
In summary: It is critical for EPA to evaluate both
long-term and short-term health data together in terms of a
concentration frequency distribution covering both the
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long-term and short-term spectrum.
The limited health data on nitrogen dioxide suggests
the range of 0.5 to 0.75 ppm NO2 not to be exceeded .more than
once per month would be adequate to protect public health
with margin of safety.
Taking feasibility into account, perhaps O.'5;ppra
N02 would provide the greatest safety factor without incurrin
the risk of costly and disruptive control programs.
Not enough is know about indoor pollution and requir
further study. Although indoor NO2 can be more significant
to a certain segment of public exposure than current outdoor
pollution levels, a health risk ahs not be proven. An
opportunity exists for further health studies based on indoor
pollution levels.
CHAIRMAN PUDGETT: Questions?
MR. COERR: First of all, I appreciate your courtesy
in providing the references nicely in the statement. That
mekes our job easier, and we also look forward to getting you
information on feasibility. I also admire your courage in
taking a position that is not in the standards, both in the
previous submission and this one, something we can empathize
with some of the problems in that.
I am curious to know a bit about how you arrived
at this recommendation. For example, what was the sensitivi
population that you had in mind, and what was the numerical
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safety value that you may have considered?
MR. SHILLER: That was outlined in our comments to
EPA dated February 7, and references are listed there. We
went through a number of health studies, which we list in
that document, and use those as the basis for our recommenda-
tion.
MR. COERR: Could you review those quickly for me
just right now?
MR. SHILLER: We discussed there was studies on
respiratory flow resistance. I am trying to think of the
authors.
MR. COERR: Let me be more specific. Maybe it would
be faster if you take respiratory disfunction to be an
adverse effect considering that proposal?
MR. SHILLER: We feel that changes are not necessari
an adverse effect, but we considered that it was an indicatio i
of something that is happening and made our recommendation
below that level including a safety factor, but it is not
necessarily a health effect.
MR. COERR: The threshold for that you took to be
what?
MR. SHILLER: One and a half ppm. We listed some
of the studies that were in that range that showed no effect
MR. COERR: Using about a 50 percent safety factor,
maybe a little bit more?
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MR. SHILLER: From 0.5 to 0.75, yes, right. We
compared to 1.5 ppm.
MR. COERR: This didn't necessarily address the
problems with asthmatic or elderly or children?
MR. JHILLER: There were studies of bronchitis in
there, but there is no data available on these other sensitiv<
populations.
MR. COERR: Thank you.
CHAIRMAN PADGETT: Any comments?
MR. STOLPMAN: I have a question, just a couple of
questions about the gas stove studies. Do you have any reason
to believe the the households with gas stoves contain fewer
smokers than the households without gas stoves?
MR. SHILLER: No. There is none, I have no informa-
tion on the statistics either way.
MR. STOLPMAN: You don't have any reason to believe
that there is a bias one way or the other on that?
MR. SHILLER: I have no reason to believe, no.
MR. STOLPMAN: You suggested that the gas stove stu
was a long-term exposure study; why do you draw that conclusion
and what do you use for a basis for stating that?
MR. SHILLER: Just that the exposure could happen on
a daily basis.
MR. STOLPMAN: So it could be short-term peaks that
happen everyday is what you are implying?
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MR. SHILLER: Right.
MR. STOLPMAN: So you feel that although the child
may be in the kitchen only one hour, or whatever peridd -of
time he is in the kitchen getting that exposure, the fact
that that is happening day in and day out, you consider that
to be a long-term exposure?
MR. SHILLER: I consider it long-term; it is not
just the kitchen that has the level. It permeates throughout
the house as a number of investigators have shown, although
not the other rooms i:in the homes are lower levels.
MR. STOLPMAN: You compared the Melia study to other
studies and indicated that the other studies did not confirm
the findings of the British gas stove study. Were those the
same populations, were the children in the populations
compared, the ones you compared to the Melia study where it
was children that were examined?
MR. STOLPMAN: So it was essentially children in
the British and adults in the other sutdies that you sighted?
MR. SHILLER: Yes.
MR. STOLTMAN: Okay. Do you understand the incident!
of bronchitis and asthma in England versus the United States?
Is it higher?
MR. SHILLER: No, I don't. I think the gas stove
study by Melia was something in the order of 4, 5 percent
indicent rate.
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MR. STOLPMAN: Do you know what it was in the other
studies that you compared to the Melia study?
MR. SHILLER: No, I don't.
CHAIRMAN PADGETT: Any other questions? Okay.
Thank you, Mr. Shiller. I think we will take about a ten
minute break. I have 10:35; we will reconvene at 10:45.
(A short recess was taken)
(Continued on next page)
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DR. FREUDENTIIATL : I am Dr. Peter C. Freudenthal.
I am a director of Air and Noise Environmental Programs of
the consolidated Edison Company with offices at Four Irving
Place, in New York City. I am also co-chairman of the
Health Effects Committee of the Utility Air Regulatory Group,
UARG. My statement is offered on behalf of UARG, an adhoc
organization of 58 electric utility systems and the Edison
Electric Institute, the utility industry's principal
association. The UARG's individual utility company members
constitute more than 70 percent of the electrical generation
in the United States.
i must apologize for not being able to provide you
with a written copy of the statement at this time. We will,
however, be sending you written comments prior to the May
3rd deadline . .
UARG has provided extensive comments on the December
12, 1977 drafts short term no critera. EPA should refer to
our previous comments for expansion of our comments today,
which are directed towards the March 31st draft.
Based on our review of the available data, we believe
the credible health effects data on short-term exposure to
NO2 are limited and do not justify an ambient air quality
standard of 0.25 to 0.50 ppm over a one-hour period as being
considered by EPA.
EPA cites several studies which purport to show the
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1 of adverse health effects after short-term exposure to low
2 level of NO . Critical review of those studies, however,
3 indicates that they do not provide an adequate scientific
4 basis for the establishment of a primary ambient air
5 quality standard for short-term exposure to NO2- The change
6 that EPA made in the summary conclusion sections of the March
7 criteria document have only partially implemented the
8 SAB recommendations. For example, the inclusion of table
9 1-2, in the March criteria document, and the citation of
10 SHY, in the abstract, inclusion of table 1-2 of certain of
11 the studies, and the citation of SHY in the abstract are
12 contrary to the recommendation of the SAB. Specifically,
13 SAB recommended deletion of references to SHY in summary
14 packages and to have all summaries accompanied by the
15 appropriate caveates. Table 1-2, without the warnings
16 expressed in the text, possess an even graver potential
17 for misuse of EPA's data base NOT sections that SAB wanted
18 EPA to revise.
19 There are several areas of contention regarding the
20 physiologic and biochemical relevance of certain studies, and
21 therr treatment in the final criteria document. I shall
22 address these in turn.
23 Animal studies — Ehrlich used an ineffectivity model
24 to find significant increased mortality in mice, exposed
25 to 0.45 ppm N02' f°r s^x to 18 hours per day, for up to
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six months, and challenged by streptococcus pyogenes. Dr.
Jacob's report on this model, attached to earlier coirunents,
describes the model as a qualitative indicator of effects,
given the difficulty in translating animal studies to
humans. As such, it cannot serve as a qualitative basis
for a primary ambient standard. Second, Sherwin T. Layfield'i
study possess some experimental difficulties and inconsisten-
cies, the densitometric exchange variable and lack of
specificity of the Schwartz stain raises specifics about the
albumin values, animal to animal variability is large,
Lowry total protein measurements also susceptible to many
interfering species. Since renal histopathologic alterations
were observed and most of the positive reaction to Lowry
reagent, a percent to have been due to diabyzable smaller
size substances, it is unlikely that measurable renal
damage actually occurred.
Clinical studies-- Orehek, using 20 asthmatic subjects,
pre-exposed them .to low level of N02' then directed them
with a brong constrictor, carbachol measured airway
resistance. Some of the subjects showed enhanced effects af-
ter NO2 pre-treatment. For the most part, these effects
were independent of N02 concentrations. Furthermore, clean
air used in the experiment was not properly scrubbed for
pollutants, potentially introducing serius error not studied.
This study has been labeled as controversial, leading EPA
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to question .the appropriateness of using it as the basis
of an air quality standard. In a decision EPA acknowledges
the above noted problem of data analysis in the abstract,
nevertheless, this work by its inclusion in the abstract
chapter one, table 1-2 is given undue weight in terms of its
significance to conclusions regarding M02 effects.
The research of von Nieding showed adult broken critics
experienced increased airway resistance when subject tc
a single NO exposure of 1.62 ppm for the 15 minutes but
showed no effect at concentrations o!r 1.5 ppm. This study
should be put into perspective. However, firsc, increased
airway resistance is a reversible physiological response
and absolute increases should not necessarily be treated
as adverse health effects. Because of certain difficulties
in the study, von Neidings's conclusion provides too weak
a basis for establishing a standard. Third, the data for
the exposure at lower concentrations for two to four hours,
indicate a no effects even when NO is co-administered with
other pollutants.
Finally, von Nieding's research has been
closely scrutinized by others who have visited his laboratory
during these visits serious problems were uncovered with
the facsimile and experimental protocols, including the
inability to categorize the nature of the pollution anci the
functional assessments. EPA has already been alerted to
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these problems. At this point, the most can be said of
von Nieding's results is that they are not definitive.
We note that section 1.4.2 of the March criteria
document, I am referring to epidemological studies, qualifies
the discussion of the Meliar study of pediatric illness in
British homes with and without gas cook stoves, by acknow-
ledging the failure of the authorities to account for smoking
and to monitor indoor pollution levels. However, the discus-
sion continues to rely on Wade's American NO- data, as
applied to the Melia study to support quantitative associa-
tions of NO- with childhood illness.
We do not believe there is any basis upon which EPA may
assume that the concentrations of NO or other confounding
2
pollutants in British homes is similar to NO concentrations
in American homes.
Should EPA choose to retain discussion of the
Melia study in chapter one, we recommend that pollution
levels indicated by Wade not be included. We believe that
the speculative estimates of the indoor pollution levels
in England are especially inappropriate in chapter one,
and table 1-2 of the final criteria document and should be
deleted.
Accordingly, conclusion "G" in section 1.5 should
be revised to indicate that in the one indoor air pollution
study which indicated higher rates of respiratory disease
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in homes with gas stoves, now pollution, by that I mean NO2
or other pollutants data, is available.
The value of the Melia report is further reduced
by the contrary findings of Mitchel, and of Lutz, Cote,
Keller, relating findings on a similar study in American
homes, and by a third study reported in 1976 by the U.S.
E.P.A. Taking into account other pollutants, and using on-
sight monitoring, showing NO concentrations up to one ppm,
the American investigators found no variations in health
between the experimental subjects and the control group.
Because the American studies contradicted the
conclusions of Melia, we believe it is misleading to
reference Melia in conclusions E.and G, at table 1-2. without
also referencing the American studies.
The SHY epidemiblogical study in Chattanooga suffers
deffects, principally SHY failed to consider any pollutants
other than NO . Such a failure prevents attributions of
health effect to any substance. Moreover, SHY'a NO measure-
ments were invalid since they were based on an inaccurate
and now abandoned monitoring technique. Futhermore, the
accuracies and the representativeness of the Saltzman NO2
data has not been established.
In a discussion, the follow up stud^ by Hassel
bled filed to confirm NO associated health effects.
In summary, EPA has little inequivacable data
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upon which to rely, the reliable data that do exist are
often for intermittent exposure to NC>2 repeated for many days,
weeks or months or are for continuous exposures. Most of
the human studies show no health effect at low levels of
HO , those that do, von Nieding or Oreheck, have serious
£•
deficiencies and have not be replicated. The animal
studies are not quantitatively transferrable to humans,
accordingly, the use of the numerical results of these
studies, is of questionable validity. EPA should carefully
evaluate the onset of responses to exposure to NO concen-
tration, averaging time, frequency, so that it can identify
a threshold for these effects and quantify the safety
factor inherent in an alternative standard.
We believe that the results of the safety margin
analysis will show that the combined effects of 0.25 to 0.5
ppm standard over one hour with an insufficient number of
allowable exceedances would represent an unjustifiably
large safety factor, imposing large compliance costs for lit-
tle if any, identified benefit to public health. Of course,
an important part of this analysis would be the policy trade-
offs that are made between the extents of the margin and
the costs of complying with the standard. This analysis
should be made available for public comment.
In conclusion, the above noted problems in the
March criteria document should be resolved prior to the
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establishment of an ambient air standard for short term
exposures to NO . In a decision to the numerical value
of that standard, EPA should perform a careful analysis: of
the averaging time and frequency of allowable exceedance
that are a necessary part of this standard. EPA cannot,
however, focus entirely on the ambient standard. In the
same time frame that it is considering the standard, EPA
must formulate control strategies, and publish information
to the States on those strategies. Under Section 108
of the Clean Air Act, this information must be issued at
the same time that the final criteria document is issued and
the standard proposed.
There is very little science upon which to base
the strategy, for example, atmospheric chemistry of N02
emissions is poorly under. Diffusion modeling is not pre-
sent and a little air quality monitoring data exists to
simplify the task of assessing the contributors to ambient
ran concentrations. The data available to us indicates that
INU2
low level emissions from mobile and industrial sources
appear to be the principal contributors to ambients con-
centrations of NO_. Accordingly, they should be the tar-
&
gets of any control strategies, but historically we have
accepted that electric utilities are especially vulnerable
to pollution control requirements. In this case, however,
control of NO2 from existing power plants is difficult,
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and possess potentially high costs in enginerrimj , equip-
ment, maintenance, and safety, for a minimal reduction in
ground level NO concentrations.
Thank you.
CHAIRMAN PADGETT: Thank you. Questions?
MR. STOLTMAN: I have some question. You indi-
cate that there is evidence that the air in the von Nioding
laboratory was not properly scrubbed. Could you state chat
evidence to us here.
DR. FREUDENTHAL: A team sent to visit tho von
Nieding laboratory, I believe, it was sent by CRf.
MR. STOLTMAN: They were under CRC Contract';"
DR. FREUDENTHAL: I believe that is correct.
There is some mention of this in the transcript of the
Science Advisory Board meeting. I believe the bnst
reference would be the report of that team and the infor-
mation provided by SAB.
MR. STOLTMAN: Has that report been made available
to EPA or the SAB?
DR. FREUDENTIIAL: I wouldn't know about that.
MR. STOLTMAN: Can you get us a copy of that report.
because it hasn't been to date?
DR. FREUDENTIIAL: I will endeavor to obtain a
copy for you.
MR. STOLTMAN: Have you ready that report?
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DR. FREUDENTHAL: I have discussed some of the
conclusions with people who were on that trip.
MR. STOLTMAN: Was there actually scientific moni-
toring or was this a visual inspection?
DR. FREUDENTHAL: I think that should be — a
reference to the report would provide a better answer to
that.
MR. STOLTMAN: You will supply for the record that
report to EPA?
DR. FREUDENTHAL: I will endeavor to obtain that
for you.
MR. STOLTMAN: You indicated investigators who
went to see von Nieding had serious problems, that EPA was
alerted to these problems. Other than the very general
comments made in the SAB meeting, how was EPA and the SAB
made aware of those problems?
DR. FREUDENTHAL: Very specifically, my comment,
I was referring to the comments that were made at the SAB
meeting, and additionally, to comments which UARG has
provided.
MR. STOLTMAN: Comments you provided, so you would
say that it is just comments that you have made, not any
particular studies that have been made available to EPA
which indicate the problems that have been experienced?
DR. FREUDENTHAL: I don't know. The specifics of
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all comments and all studies which EPA has in the records.
I believe EPA has better knowledge of that.
MR. STOLTMAN: You raised some questions about
the difficulty in perhaps NO levels in American homes
versis British homes. I am wondering what evidence you
have got to suggest that there should be any difference in
NO levels in British homes versis American homes.
2
DR. FREUDENTHAL: Right now, I have no basis at
all to make any conclusion especially quantitative conclu-
sions with respect to the similarity or the difference of
NO levels in British homes or American homes. I have
2
never seen any studies comparing NO levels in British homes
versis American homes.
MR. STOLTMAN: You have no indication. There is
a difference then?
DR. FREUDENTHAL: I have no indication; there is
a similarity.
MR. STOLTMAN: On the other hand, you have no
indication there is a difference and if we show in future
months there is a similarity —
DR. FREUDENTHAL: I would have no basis to contest.
that. However, I think that is a very important factor to
evaluate. The Melia study is certainly a very interesting
study. It is just very difficult to interpret the data
without any pollution data from the homes in which the
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studies were conducted.
MR. STOLTMAN: Would you suggest that EPA should
collect some data in British homes and compare them to
American homes?
DR. FREUDENTHAL: That is correct, for various
pollutants, NO is among those that should be collected.
2
MR. STOLTMAN: It would be nice to collect the
four various pollutants, but are you saying essentially that
there might be higher levels of other pollutants in homes
with gas stoves, versis non gas stoves, I mean is there
SO or something in the air?
DR. FREUDENTHAL: That would depend upon the heatin
systems. I think part of the evaluation should consider,
for example, the availability of electric space heating
in the homes which use electric cook stoves, as compared
to,let;'s say, open hearth heating which may in fact cause
other pollutant variables or, for example, the use of un-
vented gas room heaters.
MR. STOLTMAN: Thank you.
MR. GARNDER: I would like to ask two questions.
With this group that went over to visit von Nieding, and
they have a document about the critisism of their work that
you seem to know quite a bit about, do you know whether
CRC or the committee, any of them, have talked with von
Nieding or written to him communicating or trying in any
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way to get his input on what they criticized?
DR. FREUDENTHAL: It is my understanding they did
meet with von Nieding.
MR. GARDNER: After the critisism, they met with
him? Did they talk with him about these critisisms? Did
he have an opportunity to respond on a scientific basis?
DR. FREUDENTHAL: I really don't have information
on that.
MR. STOLTMAN: Who should we ask to get that
kind of information, is it Dr. Frank?
DR, FREUDENTHAL: I believe Dr. Frank is part
of the team that visited the von Nieding laboratory and I
think firsthand information of Dr. Frank might be very
useful.
MR. STOLTMAN: Dr. Frank, if we wanted to follow
up, would be the man you would suggest that we talk to?
DR. FREUDENTHAL: I think that would be a wise
choice.
MR. BERRY: Dr. Frank at University of Washington?
DR. FREUDENTHAL: That is correct.
MR. GARDNER: The second question I would like to
ask, that I asked before, I might get your opinion and
that is on the reversible changes or reversible effects.
If a individual has reversible change effects, like an asth-
matic, do you call this an adverse health effect?
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DR. FREUDENTHAL: It depends on what you are
referring to. If you are talking about a very ininor
change in air way resistance, which is a minor change
which is, for example, changes which are of the order
of magnitude which the person might get from walking from
a warm room into the cold outdoors, that such a change is
reversible, but not triggering labored breathing or wheezing,
then that is a sort of affect which I think I would consider
as being a normal physiological respond.
MR. GARDNER: With a sound scientific study, and
if you had statistically significant effects, you
would say that it would not be an adverse health effect?
DR. FREUDENTHAL: I think that statistically
significant physiological effect are of interest, but they
are not necessarily of health poor.
CHAIRMAN PADGETT: Anything else? Okay. Thank
you ver much. Dr. Stanley Dawson is next.
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DR. DAWSON: (Showing slides)
Panel, Members of the Public, I am Stanley
Dawson, Assistant Professor of Environmental Health
Engineering, Department of Physiology, Harvard School of
Public Health.
I am speaking on behalf of the Brookline Selectme
Ad hoc Committee on the Harvard Energy Plant, and my trip
was sponsored by the Brookline Citizens to protect the
Environment; who are here today in a group to appear later,
with a Brookline Boston Coalition Group.
I will concentrate in these brief remarks on
interpreting the significance of the health effects data
on nitrogen dioxide with particular reference to the lower
level data.
First of all, I will talk about the threshold
of cell sensitivity. Cells clearly respond to nitrogen
dioxide at concentrations of 200 micrograms per cubic
meter, as pointed out in the criteria document. Odor
perception in humans is immediate at that level, indicating
responsiveness of olefactory cells of the nasal epithelium
Impaired dark adaptation in humans is rapid minutes,
indicating ready access of the pollutant gas to the blood
plasma. Thus, not only is the airway epithelium activated
but the circulatory system is effectively infiltrated.
Furthermore, there is evidence of impairment of
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the respiratory defenses themselves in in vitro tests.
In tissue culture, results of the tests shown in the first
slides, by Samuelsen, Rasmussen and Crocker have shown
enhanced epithelium damage and set death, after a four
hour exposure, instead of the usual growth of the cells
that you would expect in a normal situation. In an
exposure to .15 parts per million N02 is you see on the
slide you get a distinct line of cell survival..
Now, Frason, et al, a French group have shown
increased inpairment of bacterial activity after one hour,
and this slide here shows at the top the various concen-
trations of pollutants, but let's look at 200 micrograms
per cubic meter that we are talking about. The top dashed
line is a normal sort of growth. The bottom line is
exposure, sorry, is into dusting the bacterialcidal agent
and then the little blip at the right-hand end of that,
going up, is where the effect of the nitrogen dioxide are,
so after 12 hours you are getting an effect of a nitrogen
dioxide.
Now, the key issue, however, is when the in vitro
defense-system is impaired or whether unrepaired internal
damage occurrs. So I will just briefly talk about small
mammal exposures, which is a part of the documents. That
varies extensively. For exposures of about 1,000 micrograms
per cubic meter, over many days, there is abundant evidence
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of damage in small mammals. Cats have impaired oxygen
uptake. Mice developed edema. Guinea pigs at 750 microgram:
per cubic meter had increased serum proteins in lung
lavage. Their red blood cells were affected at 700 and
a 1,000 micrograms per cubic meter and there was evidence
of organ damage.
Mice exhibited increase mortality from pathogen
challenge and non-invasive proliferation of peripheral
bronchial epithelial cells occurred 560 and 940 micrograms
per cubic meter? Mice alveolar macrophages were altered
morphologically and their antibody titers were reduced.
Growth was reduced. Guinea pigs at 740 microgram per cubic
meter3 had increased destructive enzymes and lung protein
content. Mice evidenced excess tracheal mucosa and ciliary
damage, also bronchial hyperplasia, alveola edema, alveolar
size increase and fibrosis.
What do these have to do with human exposures,
at shorter times, say one to three hours? The standard
we are talking about today, and at lower levels, going down
to the 200 micrograms per cubic meter of cell sensitivity?
First they show they potency of NO- generally
in attacking the healthy mammalian lung. Evidence is of
unrepaired damage of defense mechanisms, both epithelium
and macrophages and of ready penetration to the circulation
A clear application of the animal data so as to
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assess effect on man will have to await extension and
validation of models such as that proposed by F. Miller at
EPA by James Butler, my close colleague at Harvard, and
by Morgan and Frank,invSeattle. In the meantime, we can
apply some of those ideas approximately to show that
average bronchial and alveolar concentration,and
therefore dose, of NO- are not likely to be so very differe
between man and mouse, in spite of vast differences
in scale and some differences of ventilatory frequency
at rest.
Of course, I might just interject here, humans
don't always rest. Sometimes they like to exercise, and on
observation made in L.A., a smog area, is that people going
back there now aren't immediately confronted with the
irritation but as soon as they try to run, they feel
distinctly different than they do when they try in other
parts of the country.
There is already one peice of evidence of unrepai
damage in a larger mammal at a lower concentration of
nitrogen dioxide, namely 470 micrograms per cubic meter, fo
a short exposure a four hour/day, five days a week for 24
or 36 days. This was Buells observation of swollen
collagen fibers in the rabbit.
And there is a slide of normal collagen fibers.
The arrow here is one break in the collagen there, in the
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normal fiber, the loose ends is another abnormality.
Wherever there are arrows there are abnormalities, and
there is another in a classic work. 1970, Finally, I
would talk about the human implications of the human
bronchial challenge results.
The answer is not known directly to this
question, what damage occurs in humans, at the cells
sensitivity level of 200 micrograms per cubic meter, but
it is strongly suggested by an interpretation of the recent
bronchial challenge studies of slight-to-mild asthmatics
by Orehek and of apparently normal subjects by von Nieding.
The key study of Orehek shows that in 13 our of the 20
asthmatics, the amount of challenge drug required to produce
a given broncho-constriction was distinctly less in an NO-
atmostphere of 200 micrograms per cubic meter for one hour
than in the control atmosphere.
I do not think that the health significance of
this result is sufficiently appreciated in the drafts
of Health Effect for Short-term Exposures to Nitrogen
Dioxide.
Evidence from lung mechanics measurements and
cell structure studies is accumulating to support a
hypothesis, as articulated recently for example by S. Pennul
of Johns Hopkins, Director of Respiratory Services in the
hospital there, that any agent -inducing ^or enhancing bronchc
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KB:jg:4-6 i constriction is, in the process, harmful to lungs.
2 It is not simply that there is increased difficulty in
3 breathing, there is evidence of actual damaged tissue in
4 the lungs. Epidemiological evidence is furnished, for
5 example, by Barter and Campbell, who sorry — there is a
6 picture of the Orehek results which it is a bit late to
7 do that now.
8 Let's go back to that if you like. Epidemiologic
9 evidence is furnished, for example, by Barter and Campbell,
10 who found in a five year period, a greater decrement in
11 lung function in workers in a dusty environment who had
12 initial indications of metacholine, asthma obstruction, tha
13 metacholine response indicating asthma and/or obstruction,
14 than in workers who did not, and here is the picture '
15 plotted — the decline of the amount of air that you can fo
16 out of your lungs in one second, which is one of the :
17 standard measures of how good your lung is and we see a
18 decline correlating very nicely with the fall in FEV, one
19 after metacholine. In other words, over a five year period
20 that is the vertical plot, it shows the decline of the FEV
21 one, and the horizontal scale is the sensitivity to meta-
22 choline, so the more sensitive you are to metacholine the
23 more your lungs will decline.
24 Now, this of course, has only relevance to the
25 lung in that nitrogen dioxide, is something that causes
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your lungs to constrict, and so you are getting more of the
response, but this is now all general evidence, on the fact
that the bronchial constrictive agents, whatever they are,
produce damage in your lungs, and bring to this irreversible
damage.
Cell structure evidence was recently furnished
by J. C. Hoggs, at the University of British Columbia
in Vancouver, and could workers, who recently have shown
that during histamine broncho-constriction, tight junctions
between the bronchial epithelial cells are opened
sufficiently for particles to penetrate to the basement
membrane. Such damage to the epithelial barrier certainly
presents a repair problem, and it also means that any
harmful particles present, whether radioactive or other
toxic dust, can reach the basement membrane, where they may
lodge, causing damage for extended periods.
Thus the Orehek study indicates real risk to
asthmatics at 200 micrograms per cubic meter. Normal
subjects have been found by Beil and Ulmer to require much
greater concentrations of pure nitrogen dioxide for two
hours to increase the constriction response. But von
Nieding found the constriction response is increased at
low two-hour;levels of mixed pollutant, which is 100 NO ;
50 ozone, and 300 SO,, as can readily occur in American
cities.
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And here is,this is actually in the criteria
document, this reference, but just very briefly, you can
see the chbline code responses on the left, and then on the
upper-left, and then the lower left column thing are the
control situation, and the middle column MIK concentrations
are the ones we are talking about here, the MAK are in
higher concentrations which we are trying to deal with
today.
Nadal has confirmed the increased construction in
pure ozone at 1,000 micrograms per cubic meter in dogs and
humans, so it is a real important test.
The prudence of keeping hourly exposures below
200 micrograms per cubic meter, even for normal humans, is
apparent in the above interpretations. I would urge the
Administrator to set a short-term standard so as to reach
that goal at the earliest feasible time.
CHAIRMAN PADGETT: Questions?
DR. GARDNER: First, I would like to talk about
the in vitro studies, and of course, any time you utilize
in vitro studies you are bypassing all the normal host
defense mechanisms, the effect it might be to remoye the
gas, before it gets to the target organ, in these cases,
alveolar macrophage, things like that, so what -you: are"
doing when you have around 0.1 part per million, if
half of that is removed you are getting down to a .
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concentration that is getting to the lung at near background
level. Are you aware that in the Rasmussen and Crocker
Study that the senior author said, in a news report, our
findings are not directly transferable to humans or
animals?
OR. DAWSON: I am not aware that he said that.
I didn't see the report. It makes sense to me. It is not
directly comparable, and all I am trying to point out is
that these cells are sensitive at 200 micrograms per cubic
meter.
Certainly you would want to correct for absorption
lun bronchial trait if you are talking about what is;
delivered to alveolar.
DR. GARDNER: Would you have any idea how much
that would be at the level, at the nose level to get an
effect at deep lung?
DR. DAWSON: I would not like to say until I have
modeled that for California.
DR GARDNER: In the Orehek Study, are you aware
that none of the individuals had any symptoms of the
exposure to the N02 or to the barbocol plus NO ? They
did not exhibit any symptoms?
DR. DAWSON: Yes, that has been said. I can't
recall.
DR. GARDNER: He didn't mention it in the paper,
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and there was no wheezing or any asthma type symptoms during
the exposure.
DR. DAWSON: It was not mentioned. Parts of my
remarks is that isn't the relevant things. The relevant thinj
is the damage that can be done to the bronchial epithelial.
MR. STOLPMAN: Was it made clear that these were
symptom free periods for these asthmatics?
DR. DAWSON: It wasn't stated as such, but Orehek
*
is a very, very competent investigator. The article was
reviewed by the highest caliber people in this country,
with a term of apprenticeship, and I assume —
MR. SHOLPMAN: My reading was that it was symptom
free periods.< Thank you.
DR. GARDNER: In the Orehek Study, did he use
any non-asthmatic controls, do you recall?
DR. DAWSON: No, he didn't use any. I mean in the
painer.
DR. GARDNER: That was reported in the study. The
other thing Tmight say, your comment about evidence of an
unrepaired damage of defense mechanisms, here again, you
are talking about alveolar macrophage and things, do you have
have idea about the turn over rate of these type of cells?
DR. DAWSON: I don't know the numbers.
DR. GARDNER: It is quite rapid.
DR. DAWSON: For example, Buell, in fairness,
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points out that after waiting instead of looking at it
immediately, if you wait seven days to sacrifice, he does
see it, but my point is the lungs are open to invasion while
that is happening.
And so even if it does get repaired within seven
days, that sounds pretty dangerous to me.
DR. GARNDER: Okay.
MS. TAYLOR: Do you have any evidence or would
you know of any evidence to support Dr. Permutt's hypothesis
that would be with gaseous pollutants as opposed to particles
DR. DAWSON: Well, no, his hypothesis is a
generalized hypothesis. That whatever causes bronchial
constriction is damaging or potentially damaging, and he
didn't distinguish between particles or gas or whatever,
and I can actually furnish you a formal statement that they
used in the Massachusetts hearings, where he qualifies
everything.
MS. TAYLOR: That would be useful.
MR. STOLPMAN: EPA in the statements —
public statement called this meeting, indicated we were
at .25ppm, and you are recommending a considerably lower
standard for EPA to adopt. Can you tell me what EPA
is doing wrong in their rationalization or their approach to
setting the standard, I mean that we would be so much higher
than the number you would be recommending?
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DR. DAWSON: The Deputy Administrator, however,
whose recommendation was based on this criteria document and
I am saying that the Orehek Study and that sort of thing
about bronchial constriction was not given anywhere near
sufficient weight, that there is a whole area of medicine
that was essentially neglected as far as I can tell and in
fact, Dr. Schenker, who comes next, will speak more about
some of those matters, so that they just didn't weight it,
and I think that they gave not a very good analysis of it,
and certainly a very poor interpretation from my point of
view, and also, I think that there were statements in the
document that were really an improper impuning -of von
Nieding's laboratory, for example, that Where it wasn't
specific and some in the abstract that weren't reflected in
the text and things like that.
MS. STOLPMAN: In your opinion, those studies were
given relatively under substantiated criticism?
DR. DAWSON: Yes, and being ignored. It was
reported, it was criticized unduly and unfairly and then it
was mainly from the point of view of what I think is a
pivotly important study about what happens in humans.
Also I just would add one thing and that is:about the
statistics on the Orehek Study. There was even some
criticism of statistics about before and after nitrogen
dioxide, and that conceivably could be a valid criticism,
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but that is independent of this business here of the
collagen response, carbachol response, and this is just
something that stands absolutely by itself, absolutely
here.
MR. COERR: First of all, have you sent the
material prepared for the SAB by Dr.-McFadden criticizing the
Orehek Study.
DR. DAWSON: No. I noticed that he had prepared
something by we were unable to get it in time for this, so
I haven't sent it.
MR. COERR: My principal question is how EPA
should use this information, as I understand what you are
suggesting, is that with the carbachol, kind of experiment,
there is a bronchial constriction attributed to NO2 at
very low levels and that constriction rather than being
the irritation or minor thing, constitutes a possibility of
irreversible damage to the lung.
To what extent can we regard that situation as
in any way analogous to that of the population, in other
words, is this such a contrived experimental situation, a
very sensitive experimental technique, that it is irrelevant
to what a population, a sensitive population in this country
would see or do you believe that it is relevant? Obviously
people are not breathing carbachol.
DR. DAWSON: Well, again, Dr. Schenker will cover
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some of this himself, but first of all, I think that there
are a lot of estimates, and this was directly asthmatic, The
is a direct application there, that in other to protect
asthmatics at least according to the Barter and Campbell
Approach, even if you don't want to protect them from the
difficulty in breathing, you do want to protect them from the
cell damage.
Well, I think there is that thing, straight away
on the asthmatics, but also I think that especially as the
von Nieding holds up there are serious implications for
normals, and it is beginning to make a hypothesis that never
minds whether or not you have asthma-; that stretching of your
lung airways is in itself causing,gradually over the years,
damage.
MR. COERR: So that you would expect that this kind
of research would indicate psychological impairment over a
long period of time.
DR. DAWSON: Absolutely. That is the hypothesis
as I say, there is some evidence now, for that. I should
also say about, — I don't know whether Dr. Schenker is
going to get to this, he has quite a long statement anyway,
but one should distinguish between certainly the generalized
irritants, and the specific allergic irritants such as tree
pollen or something like that, but Jim Hawk at least claims
that in his laboratory he finds that they act very similarly,
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so the carbachol is a good mimic, of the sort of allergic
response that you would have in nature.
MR. COERR: Would you expect epidemiological
studies to be able to detect what you are suggesting as a
physiological impairment?
DR. DAWSON: Well, that same group in Bringham;
(phonetic) has suggested tests of factory workers which would
begin to get to that, that nicely controlled population,
as to more general populations, I myself don't have anything
specific to suggest. It seems to me such an important
thing that perhaps a massive test should be done.
MR. COERR: Thank you very much.
MR. STOLPMAN: Can 1C.ask one quick short question?
Were you made aware publicly of the SAB meeting on NO2?
Was there any notification that you received of such a
meeting?
DR. DAWSON: Well, the first thing that I heard
publicly was in this register.
MR. STOLPMAN: Announcement for this hearing —
thank you very much.
CHAIRMAN PADGETT: Thank you very much.
Dr. Schenker.
DR. SCHENKER: My name is Dr. Marc Schenker. I am
a board certified internist with training in pulmonary
medicine. I am here representing the Brookline Citizens to
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protect the Environment, a citizens group concerned with
maintaining a healthy environment to live in and breath.
I wish to comment on the criteria document on Healthy Effects
for Short-term Exposures to Nitrogen Dioxide, concentrating
my testimony on the effect of NO2 on bronchial reactivity
and its relation to respiratory tract infections and
obstructive airways disease.
I believe the subject of airway reactivity has
major public health significance because of the potentially
large segment of the population affected at low levels of
NO2 and the two serious late consequences of increased
obstructive airways disease and chronic lung infections
resulting from repeated short-term exposures.
What are the populations known to have increased
airway reactivity? The standard test for hyperreactive
airways is a histamine or cholinergic challenge by inhalation
with resultant increased airway obstruction, so called
bronchial provocative tests. The foremost group with a
positive response is asthmatics, whose incidence is usually
estimated to be between three and four percent of the population.
Asthma is part by definition is a disease in which
there is hyperreactive airways to various stimuli, and the
absence of a positive bronchial challenge is distinctly
unusual. The incidence of hay: fever may be twice that of
asthma, and approximately 50% of persons with hay fever will
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KB:jg4-17i have positive bronchial provocative tests. Relatives of
persons with asthma also have positive tests more frequently
than normal. Chronic bronchitis and emphysema occur in .
about 10 to 15% of the adult population and these people
may have increased reactivity in the absence of a
history of attacks of bronchospasm. Of greater significance
is that 11 children as well as anyone with an acute
respiratory tract infection appear to have increased airway
reactivity.
What is the mechanism of hyperreactive airways and
how long does the effect last?
While heredity is clearly important, population
studies have demonstrated that environmental influences
are significant in the development of airway reactivity and
asthma. Studies of identical twins have shown that one twin
can have asthma and the other be assymptomatic with negative
bronchial challenge test. Japanese studies of school
children have correlated incidence and morbidity from asthma
with air pollution levels.
Increased airway obstruction after bronchial
challenge has been demonstrated in asthmatics after influenza
vaccine, and in normal, non-asthmatics after upper respiratory
tract infection. This effect has been postulated to
occur becuase of epithelial damage caused by the infection
sensitizing the airway receptors to inhaled irritants and
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leading to Increased bronchoconstriction. Bronchial
hyperirritability has been shown to last up to three weeks
in healthy non-smoking individuals after exposure to a low
concentration of ozone for two hours.
What is the effect of NO on the airways and are
there potential unmeasured effects?
Morphologic and physiologic alternations of
pulmonary cells have been shown at concentrations of N02
as low as 190 microgram per cubic meter, which was just
discussed by Dr. Dawson. In one of these studies, alveolar
macrophages obtained by bronchopulmonary lavage exposed in
vitro to a concentration of 190 microgram per cubic meter
NO for 30 minutes shows morphologic changes, a decrease in
bactericidal activity and a reduction of ATP content. It
is therefore not surprising that Orehek has shown a
statistically significant increase in specific airway
resistance in 13 of 20 asthmatics after exposures to 190
micrograms per cubic meter for one hour.
These asthmatics all had slight to mild asthma
and none were on long term corticosteroids. Persumably
the mechanism is similar to that mentioned previously,
namely that epithelial damage in the airways sensitizes
them causing increased bronchoconstriction to challenge
testing.
Von Nieding has also shown increase sensitivity
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of the bronchial tree to acetylcholihe, which is similar to
carbachol, after two hour exposure to the even lower N02
concentration of 100 micrograms per cubic meter when combined
with 50 micrograms per bubic meter and 300 micrograms per
cubic meter.
While this study did not isolate the effect of
N02, it is noteworthy that the O3 and SO2 concentrations
were below the existing U. S. standards. This study also
raises the very important question of synergism of pollutants
an effect that has been shown in some animal models.
But even these sensitive studies may fail to
measure the effect of NO2 on the small airways. This region
of the lung, because of its overall low resistance, does
not affect most measures of airway obstruction and yet in
cigarette smokers it is one of the first regions of the
lung to show physiologic and pathologic changes. Small air-
way abnormalities may also cause an increase in chest
infections without a change in routine measures of airway
obstruction or on chest X-ray.
An area of major important is the increased
sensitivity of children to air pollutants. Most studies
of adverse effects of air pollutants and current air quality
standards are based in part or in whole on healthy adults,
rather than children who appear to be significantly more
sensitive. There are several reasons for this increased
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sensitivity in children. One reason is that the lungs are
not mature at birth but only slowly develop into adult lungs,
and there is evidence that some cell types more prevalent
in developing lungs and more sensitive to NO . The
volume of air inspired by children in relation to body
weight is larger than that of adults. Up to age four the
average child inhales more than twice the volume of air
per body weight than is exchanged by adults and children
greatly increase their ventilatory rate during exercise and
play. Both of these factors increase the delivery and
opportunity to absorb specific pollutants.
Many studies have demonstrated the increased
adverse effect on children of W^- A recent paper by
Melia showed more bronchitis, cough and wheezing in children
from homes using gas stoves compared to children in homes
using electric stoves for cooking. The N02 levels as were
measured by Ward.and by others in homes with gas stoves
as between 470 and 940 micrograms per cubic meter.
In the Chattanooga school children study of Dr.
Shy, when the data was reassessed using NO- levels determined
by the Saltzman technique hourly NO- levels above 376
micrograms per cubic meter consistently and clearly resulted
in an excess of acute respiratory illnesses.
Are there long term effects from increased airway
reactivity?
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There are many pieces of evidence that indicate
that increase airway reactivity or acute airway responses and
respiratory tract infections early in life lead to more rapid
deterioration of pulmonary function as adults. In a
five year prospective study of 34 mild bronchitics, Barter
and Campbell showed that the greater the bronchial reactivity
at the onset of the study, the more significant was the
deterioration in pulmonary function. In a study of more
than 3,000 subjects, Burrows showed that skin test reactivity
or atopic predisposition was associated with many respiratory
symptoms in adults including cough and recurrent chest
infections.
A subsequent paper by Burrows demonstrated that
the subjects in the groups with a history of pediatric
respiratory illness had an excess decline in pulmonary
function with increased age. Douglass and Waller in Britain
have shown that air pollution has a major effect on the
incidence of lower respiratory tract infections in children
under two years old and a follow-up of this prospective
study showed that prevalence of cough at 20 years of age
correlated with the history of lower respiratory tract
infections under two years old.
Reid has demonstrated an urban/rural gradient of
deaths from chronic bronchitis, controlling for multiple
variables and Including cigarette; smoking has shown that
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cohorts of children with high mortality from chronic
bronchitis continue to have a higher mortality from
bronchitis as adults. This finding is consistent with the
California Air Resources Board's conclusion that, "It seems
probably that the exposure of children to pollutants in early
life will have some impact on respiratory function and
general health throughout life."
What is the significance of these stddies on the
proposed short-term standard for NO2?
The criteria document has summarized much of the
experimental work on NO2, but I feel it has not give enough
weight to the adverse short and long term consequences of
increased bronchial reactivity, particularly in regards to
the effects on children. Clearly on N02 concentration of
190 micrograms per cubic meter can cause alveolar cell
alterations. Increased airway obstruction following
bronchial challenge in asthmatics has been shown at this
same concentration of N(>2.
Finally, evidence has been reviewed showing
that airway reactivity is associated with childhood
respiratory infections and that these may lead to more
chronic lung disease in adults. By the time a decrease in
ventilatory function can be noted, a great deal of damage
has already occurred.
Consideration of a short-term standard must
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i also take into account the necessary safety factor to include
2 such potentially significant variables as the synergistic
3 effect of multiple air pollutants, the effect on quiet
4 areas of the lung such as the small airways, the increased
5 delivery of pollutants and adverse effects with exercise
6 and the effects on children, a more sensitive element of
7 the population.
8 Again, quoting the California Air Resources Board,
9 "since studies indicate that children exhcange from two to
10 eight times as much air as adults, based on body weight,
11 and thus can absorb more pollutants in the lung, it may be
12 appropriate to apply an additional safety margin of one
13 half to one-eighth of the air quality standard: based on
u adult effects in order to protect the health of children."
15 The World Health Organization has noted that "in view of
16 the uncertainty concerning the lowest adverse effect level
17 and the high biologica activity of N02, the Task Group
18 concluded that a considerable safety factor was required.
19 And they suggested a factor of three to five times
20 in their report.
21 i urge the committee to carry out their mandate
22 as set forth in the Clean Air Act to protect the public
23 health by recommending .a short-term standard for NO2 at
24 least equal to the WHO standard of 190 to 320 micrograms per
25 cubic meter for a maximum of one hour exposure not to be
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exceeded more than once a month.
Thank you.
CHAIRMAN PADGETT: Thank you. Tom, would you
like to start.
DR. GARDNER: In the Orehek Study the changes they
observed were small, totally reversible, and undetectable
by the subject. As an internist, how do you look at this
as being an adverse effect especially with studies with von
Nieding, Orehek, Holland, these individuals, did not see
any effect at higher levels?
DR. SCHENKER: Well, I guess, it has been implied
the effects were not sensed by the subjects, although that
isn't indicated in the report, but as a pulmonary physician,
I should point out some other aspects of the airway obstructi >n
namely that, and this has been reported in articles when
there is an absence 6f finding 6n-lungs examined, even
absence of symptoms. There is significant airway-obstruction
so that has generally been shown by McFadden in one paper
he wrote. But furthermore, symptoms or findings on examinati
at rest may not be the total story, because with exercise,
findings that are insignificant at reat become significant
that is, we find reduced exercise ability, and a number of
more^ recent pulmonary function tests utilizing exercise
testing are showing these findings to be true in obstructive
airway disease.
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We can find significant abnormalities at reast
that weren't apparent on any testing at exercise, I am
sorry, that weren't apparent on any testings at rest.
DR. GARDNER: In your statement you talk about the
in vitro studies, that we know about, and was presented befor
and then you say it is therefore not surprising that Orehek
has shown the significant increase in airway resistance.
Now, isn't that a pretty big step to go from in
vitro test to Orehek study?
DR. SCHENKER: I think there are a couple of
reasons to suggest that, one as I indicated, asthmatics
have hyperreactive airways for a number of reasons, and
what I was trying to show by the in vitro studies is
that the cells can sense that level, but I think that
the effect, the fact that the effect was apparent in the
Orehek Study indicates that the cells in the airways
are sensing the NO and we know from the sensory studies
that 200 jnicrograms per cubic meter is sensed by subjects
as well as the dark adaptation, so I think that we are
showing that that level is getting into the body, and also
that it is having an effect on airway resistance in
asthmatics, but I would point out that in some of the
other studies with ozone or in normal subjects and also in
the von Nieding Study.
DR. GARDNER: Lastly, are you aware in the WHO
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documents the Task Force recommended that the Orehek Study
should be duplicated and they did not take that into con-
sideration when they set their standard.
DR. SCHENKER: Yes, I am aware of that, although
they relied on the unknown factors strongly in their
recommendations of a safety factory, and I believe their
threshold limit value was felt to be 980, but possibly 470.
MR. STOLPMAN: You are implying that the World
Health Organization recommended a standard of .1 to .17 without
Oreheki
DR. GARDNER: They realized that the Orehek Study
was there, but did not take it into consideration in setting
the standard.
DR. SCHENKER: Orehek is a recent study and people
have not to much disputed the fact,is the significance at
this time and it is the significance I have been trying to
emphasize.
MR. STOLPMAN: At this time perhaps it is relevant
that they didn't even consider a study which shows very
little level, perhaps symptoms, in setting what they consider
to be a safety standard. Can I ask you, I get the impressio
in reviewing your interim statement, that you consider the
Orehek Study to be something of a conservative study, and
first it was done on mild to slight asthmatics, it was done
on adult instead of children, done at rest instead of at
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exercise, and it was done during symptom free periods, if
indeed one were trying to set a standard to protect public
health of a sensitive population. Wouldn't one have*-to
essentially test that kind of a population, perhaps children
at exercise, during symptomatic periods.
DR. SCHENKER: Absolutely.
MR. BERRY: I have one brief question, would you,
as a physician, care to comment on the need to replicate
the Orehek work or would you consider that you are satisfied
based on this one study.
DR. SCHENKER: As a physcian, and scientist, I
think it should be replicated we will have to take the study
for what it is, and we can't ignore it at this time. It is
a competent investigator who has done a study that has been
reviewed a number of times and felt to be a valid finding.
MR. BERRY: Do you believe that that study is
strong enough to support the type of national decision that
this standard setting exercise will end up with?
DR. SCHENKER: Well, I think I have tried to put
Orehek in the context of long term adverse effects. The
questions of increased bronchial reactivity, in childhood
causing increased respiratory symptoms and infections, and
a number of studies showing that it is those children who
will then go on to have v:-Oblems in later life, the British
studies, Burrows work, —
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MR. STOLPMAN: So we shouldn't get the impression
that the Orehek Study is essentially the silver bullet behind
your recommendation for a >15 standard?
DR. SCHENKER: No.
MR. --STOLEMAN: It is just one study in the overall
scheme of things?
DR. SCHENKER: Yes.
MR. COERR: Just a general question, are there
ethical barriers to the use of chamber studies with children
in this country that would attempt to replicate the Orehek
Study?
DR. SCHENKER: Yes. There are strong barriers
against any human^experimentation studies and there are also
difficulties with studies in children, at younger ages,
particularly before school age. Voluntary pulmonary function
maneuvers are often not possible, so we can't measure those
parameters directly, but there are also ethical barriers,
clearly.
MR. COERR: So that it wouldn't be feasible for the
agency to consider undertaking such studies to corroborate
the Orehekvwcrk on other than the healthy adults or something
DR. SCHENKER: Yes, I would agree.
CHAIRMAN PADGETT: Okay. Thank you very much,
Dr. Schenker.
Dr. Hermos,
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DR. HERHOS: Lad lot and Gentlemen of the
and Legislation, my n«m« U Dr. John' Hema*. I eft • <
resident of Brook line, Massachusetts, a physician at the
Boston Veterans Administration Hospital and an Assistant
Professor of Medicine at Boston University School of
Medicine. Today, I am representing the N.O. MATEP
Coalition, which is Neighborhood Organizations Mobilized
Against the Total Energy Plant (of Harvard University).
In comparison to my colleagues, talks you might
find this presentation somewhat short on facts, and a littl
long on emotion, but it will hopefully contain an emphasis
on some areas that have not been covered today .
It is our position that the EPA set a short-
term standard for NO2 that is consistent with the recom-
mendation of the WHO Task Group on Oxides of Nitrogen,
that it includes a margin of safety which is consistent
with recent research data and with the uncertainties
regarding the potential injurious effects of this bio-
logically active pollutant, and which recognizes variability
in the sensitivity to NO effects by exposed populations.
Moreover, we wish to restate that it is the mission of the
EPA, as determined by Congress in the Clean Air Act, to
set a short-term NO standard which is influenced only by
the goal to protect the public health, and which, if
necessary, forces technological changes to meet that goal.
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I will deal briefly with three areas in this
presentation,1the intent of the Clean Air Act for National
Ambient standards,2the puzzling question of protecting a
highly sensitive population, and the need for a more than
adequate safety margin.
It is probably unnecessary for me to relate to
the panel what I believe to be your mission, but I am very
much aware of the fact that some industries and some elected
representatives have vested interests in maintaining our
present state of air quality, or lack of air quality. As
I previously stated, and as is clear from the preface of
your criteria, document, standards for NOj are to be set on
the basis of health data in order to protect public
health. There is an excellent review of this implication
of the Clean Air Act, titled "The-.Evolution of 'Technology-
Forcing* in the Clean Air Act? and I am sure familiar to
many of you by John Bonine (phonetic), in Environment
Reporter, Monograph No. 21, July 25, 1975, which focuses
on the important concept in this legislation.
I will quote some of the statements in that article
that will perhaps be of more interest to some in the
audience and those who have previously testified.
"A recent survey of the Act and its inter-
pretation in Court said: 'Although the Act was not
the first federal statutory attempt to control air
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quality, its perspective was unique? rather than
regulate from the standpoint of what was technically
feasible,,it started from a point of determining
what air standards were necessary to protect
the public health, and it required technology to
meet those standards.'"
Senator Muskie quoted, "Predictions of
technological impossibility or infeasibility are
not sufficient as reasons to avoid tough standards
and deadlines, and thus to compromise the public
health . . . Only a clear cut and tough public
policy can generate the needed effort."
And there are other comments by Democrats,
Republicans, House Members, Senate Members, as well and
who have reviewed the Act so we have heard today comments
on what it would do to industry.
Those are not relevant factors. We are strictly
talking about health data. There was a letter in regard
to the Harvard Energy Plant Conference which further
illustrates the importance of attempting to force techno-'
logical change to-improve air quality and protect health,
the writer of the letter was neither an opponent nor
proponent for the plant, he was a Clinical Professor of
Medicine, and a Pulmonary Specialist at Harvard Medical
School. And just reading some of the underlined portions of
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that letter again, relevant to the mission having read all
2 available arguments pro and con on the Harvard Energy
3 Plant remaining unconvinced, the toxic levels of nitrogen
4 dioxide are really under. r
5 In the problem with which we are dealing, any
6 level of nitrogen dioxide is too far as far as I am con-
7 cerned whether from the diesel engines or from the other
8 smoke stacks, more importantly, from automobile exhaust,
9 rather it seems to be side stepping the real issue, complete
10 removal of the nitrogen dixoide from the engines exhaust
n before it gets to the top of tall chimneys, while arguing
12 over safer toxic concentrations of nitrogen dioxide about
13 which there seems to be a considerable lack of accord.
14 Then the last paragraph ever sent that can be
15 raised here across the country to get at the root of the
16 problem, elimination of nitrogen dioxide, from whatever
n sourve, is of benefit not only to Brooklyn residents but
is to people the world-over.
19 Let's acquire a broader perspective on the problem
20 and that is clearly the Intent of the Clean Air Act and
21 that is clearly, again, I don't have to repeat for you, I
22 am sure, the mission of the EPA and this Panel.
23 NOW, the second area or issue that has been of
24 gome concern to us in Boston, is how the EPA interprets
25 i$s directive to protect the health portions of the populati
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that may be particularly susceptible to injurious effects
of NO2?
Specifically, will the standard that you set take
into account asthmatics, where there is direct experimental
evidence of increased sensitivity, and will it take into
account elderly or hospitalized persons, where increased
susceptibility might be inferred or suspected, but where
there is no direct evidence at present?
Now, there is a very confusing, apparently,
clarifying statement on page VII in your December criteria
documents, which I believe I have time to read.
According to — well, I will read it quickly, the
standard f rfr :po*ltf*a*t?s needs to be set at the requisite
to protect public health determine on the base of the
published ^air quality criteria allowing an adequate margin
of safety.
According to the Senate Public Works Committee
which originated this concept a health based standards,
primary standard should be set at maximum permissible
air level of air pollution related to a time which will
protect the health of any group of the population. It
says, "Furtherrclarifying comments regarding such health
based standards, the Senate's Committee indicated that
A, and this is the confusing part and I hope that you will
enlighten us as to what you will do with this, ambient; air
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quality is sufficient to protect the health of such persons
whenever there is an absence of a statistically related
sample of persons in sensitive groups from exposure to
ambient air, and be, for these; purposes, a statistically
related sample, is the number of persons necessary to
test in order to detect a deviation in the health of
any person within such sensitive groups which is attributablje
to the condition of the ambient air.
What we would like to know, based on that state-
ment, if that is the criteria you have to go on, does that
mean we have to show statistical evidence that one sus-
ceptible group^is more sensitive than another, or do we
have to show that there are enough of a highly susceptible
population in a given spread of total population, in order
to set that standard?
I am not sure we are certain about where we should
go with that. We would be glad to help you with that
problem.
Thirdly, I would like to consider several factors
which support the view that the short term in 20 standards
included a large safety factor. A comment off the record,
the WHO Task Group was developed primarily by experts
from industrialized countries, Germany, United States,
Japan, Swedan, -people who have the same concerns that we
have for continued industrial growth, energy needs and also
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concern for public health, however, the use of these
criteria will be used by developing countries as well,
countries that don't have agencies such as ours, where
energy and development is a very important criteria.
So these by na means were an illicit group who set this
standard. They set a tough standard, but it is a standard
that was based on health data.
I don't think they had an action to grind
regarding the needs of industry because they indeed are
concerned with industrial development in all those ,r
countries.
Number 1, why there should be a large safety
factor, first:, is the uncertainty factor, NO2 biologically
active, and many of of its long term effects are< unknown.
The WHO Task Group noted very clearly that the
lowest level of NO2 which may adversely effect health are
not known, and that the proposed short-term levels of 190
to 320vmicrograms per cubic meter may be inadequate to pro-
tect public health. The data presented by Dr. Dawson
indicate that with more sensitive experimental methods,
toxic effects are being identified which may directly relate
to human health.
Additionally, NO2 is an important precursor of
ozone, a known toxic pollutant, but there is no curremt way
of pinpointing ozone to specific polluting sources.
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And thus, it is much more difficult to control,
but we can control N02.
Number 2, with Some exceptions,most human and
animal data are derived from healthy subjects. As sensitive
populations may be those most adversely effected, and as
threshold levels may well be lower in these subjects, a wide
safety margin would be prudent until more evidence is
gathered and critically reviewed.
And I refer you back to page VII, where it
specifically states the Senate's Public Works Commissioner
further indicated that a margin of safety should be allowed
to provide a reasonable degree of protection against hazard
which research has not et identified. Here we have cities
that more and more studies will find more and mote
relevant data.
Number 3, increased broncheoreactivity to
specific test substances may be an important marker or
precursor to chronic obstructive lung disease. I refer you
to the testimony of Dr. Schenker.
Number 4, combination of pollutants with N02
most likely have additive and perhaps synergistic adverse
effects. These data are reported in your criteria document
draft. In this regard, there is particular concern for
the characteristic'-pollutant emitted from diesel engines,
which may be an important future source of ambient
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Much more information is need to determine if small hydro-
carbon particulates and N02 from diesel exhaust enhance
each others toxic pulmonary effects.
And I refer you tonarreport that youvjnay be
familiar with by Citizens for Cleaner Air, Incorporated,
their report to the National Highway Traffic Safety Admin-
istration, which concerns itself specifically with dieael.
emissions and small hydrocarbons.
Number 5, these are reasons for a wide safety
factor, monitoring -data has in general, not always been
accurate in measuring levels of NO2- Monitors cannot be
expected to be placed at sights->6f highest concentrations.
We had considerable difficulty in Massachusetts at State
Departments of Environmental Quality Engineering inter-
preting the varying results from various monitors from
various sights, and although EPA tried their best to
straighten out what was again very confusing data, the
difficulty is clear% Monitoring data cannot be fully
relied upon.
Additionally it has been mentioned there may be
significant exposure to NO2 within households, and these
are NO, levels that can neither be monitored nor
presently subjected to controls.
These factors clearly support the need for .a
margin of safety that has a reasonable chance to protect
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the public health, and to provide protection against hazards
which research has not yet1 identified.
In conclusion: il) EPA has a mandate from the
people of the United States through Congress to set a short-
term NO2 standard soleiy based on health data and solely
for the protection of the public health. If the appropriate
technological changes are needed and made to meet that
standard, EPA would have done its job well.
2) Although its directive may be unclear, it wouli
be unrealistic for the EPA to ignore unusually susceptible
or sensitive portions of the population in their standard.
The alternative, which may not be particularly attractive
to you, would be to set an inadequate standard with a
warning that it may not be sufficient to protect significant
portions of the population.
This'rmay be analogous to our problem with cigarette
smokers, one half of the Government saying, promoting
smoking, the other half trying to protect against health
effects. I don't think the standards should be ambiguous
in that respect.
3) Based on the health data available to you,
and that presented today, a standard in the suggested range
of .25 to .5 parts per million is grossly inadequate to
tect public health, and includes not reasonable margin of
safety.
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We urge a standard no higher than that recommended
by the WHO Task Group, a standard which you have the data
to support, and whicnis within your mission to make.
Thank you. =
CHAIRMAN PADGETT: Questions?
OR. GARDNER: I have one.
In the rOx&hek Study these investors have
demonstrated that other non-specific stresses advanced
such an inspiration, expiration, can also shift the
dose response* to carbachol, and therefore perhaps things
like temperature, and exercise, these would do it, so
in that context of these non-specific events that could
change it, what's your opinion as to the significance of
the study?
DR. HERMOS: I am not a pulmonary physician,
and I repeat some of the things Dr. Schenker said. I
think one of the most important things is the quality of the
study. I think we have heard from our friends in industry.
Trying to relate an experimental design to solving a clinica
problem that we have, or a standard problem,people don't
do studies to answer the questions that you and I may be
trying to answer today, they set up laboratory studies that
can product reproduceable results, and try and get their
answers, and this way the Orehek Study is relevant because
it is subject to critical *••— per review and clearly
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published in the most prestigous journal of Scientific
Investigation, Clinical Investigation.
In regard to the relevance, I am not sure other
than my concept would be that the bronchial constrictor
agent used in this study to get a dose response could
have been maybe no different than all the other things
that turn on asthmatics wheeze, emotion, pollens,
going out in the cold ot exercise, so I think its relevance
is that under these conditions in the present of
points one parts per million NO2 there was an enhanced
response.
The allergic fact may be the final pathway in
bronchial constriction , whatever other allergic or
factor turns on. bronchial constriction, N02 appears to
enhance it, so I think that is clinically relevant, and
then the data that Dr. Schenker presented on its possible
relevance to development of long-term chronic obstructive
diseases is very relevant.
DR. GARDNER: Your comments and your colleagues
about the quality of the study and the professionalism of
Dr. orrfeheJc-: is well taken, but I have a problem with some
of the people, before us,talk about Dr. Von Niedihg';s
study who is also very well known throughout the world, for
his NO, studies and has published in some of the best
journals in the country, and then some visitors went over
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and visited his laboratory and now we have some questions
concerning his work.
Do you know of anyone that has communicated with
Dr. Ofce'heK; and tried to make similar judgments on his work?
DR. HERMOS: No, I don't. I probably won't be
the person to ask, but I don't.
CHAIRMAN: PADGETT: Any other questions?
Thank you very much. Ms. Commerford,
where is she? Would you mind speaking right after lunch?
MS. COMMERFORD: It is very short.
CHAIRMAN PADGETT: If that is okay, it is 12:15,
and I think we willbreak for lunch and we will come back
at 1:00. I believe in three quarters of an hour, that
should be, I guess, sufficient time. If you are sure that
is okay. So we will return at 1:00 o'clock.
(Whereupon,at 12:15 the hearing was recessed
to reconvene at 1:00 p.m. the same day.)
(Continued on the next page.)
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AFTERNOON SESSION
1:07 p.m.
MS. COMMERFORD: My name is Elizabeth Commerford.
I live and work in a neighborhood of Roxbury, Massachusetts.
I have no special scientific technical or medical expertise
to bring to you for the question before you. I think in that
sense, I represent the vast majority of people who will be
effected by your work here today and who neither know of nor
have access to your intention.
My sister and I came to Washington to convey to you
the concerns of the people in your neighborhood. If this
hadn^t been school vacation week in Boston, we wouldn't have
been able to come. We are here to point to one case example
of the effect of N02 regulations on our lives.
It has been impossible for us to accept or under-
stand the cavalier attitude that leaves the people from
industry to say that in the absence of hard data to
convince them otherwise, they expect EPA to pass on establish
criteria for the protection of public health. For the pass
four years, we have appealed helplessly at Harvard University
the biggest industry in our own neighborhood, bought and
demolished an acre and a half of residential housing, to make
way for an enormous oil fueld diesel power plant, which,
when completed, will be receiving oil deliveries every 56
minutes, and releasing emissions from a 315 foot, 35-story
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122
tall smokestack. This is two blocks away from my house.
On January 31 of this year, our State Department
of Environmental Quality engineering, ruled that the N02
emissions from this plant would be injurious to the public
health; a decision which Harvard promptly appealed. Harvard
meanwhile, continues construction of this plant, secure in
the presumption that the combination of their expensive legal
talents and a decision by EPA which will be either soft or
no action at all, will end up overruling our state's decision
At no time has Harvard been forced to publicly
address the question of the need for this facility. Its
$110 million cost has gone unquestioned, and it has by virtue
of its nonprofit tax exempt status, received noise and
zoning variances. Only the State Department of Air Quality
has had the regulatory mandate to scrutinize the project-
effects on ordinary people living in the impact area.
Those ordinary people include very low and moderate
income neighborhoods like my own, where people are residing
in either city residential neighborhoods, within one mile of
the site; there are 15 public shcools, 7 hospitals, 5 nursing
homes, and a density of population, which is the highest in
our state.
We,in Roxbury and in the adjoining area of Brooklyn
have the second highest percentage of elderly in the entire
country. Our age adjusted mortality figures for pneumonia
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and other respiratory diseases are 50 percent above the state
average. We live in a city whose remaining clean air space
is in itself a major resource, which must be aggressively
developed.
People make up the neighborhoods; the neighborhoods
make up the strength of our city. The consequences of inacticn
or error will be born by us, not by the engineers or the
decision makers. We are not willing to have our elderly and
our children be the subject of long-term retrospective
epidemiological studies of the effects of nitrogen ."dioxide
on a highly susceptible population.
Our state has taken steps to protect us from this.
We and our state's position must not be dismissed by EPA.
Thank you.
CHAIRMAN PADGETT: Thank you. Any questions from the
panel?
MR. STOLPMAN: Is it your feeling then that EPA's
actionrin setting the American Air Quality Standard will
come to fall on the state's ambient standard, if indeed our
standard is more relaxed that the state would either loose in
Court or would have to roll back its standard?
MS. COMMERPORDt Our state applied a safety factor
in judging emissions from this plant, which would protect out
population which is highly susceptible. I have no doubt, but
that the proponents will use any less stringent standard set
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by EPA to pull every trick in the book to discredit our
state judgment on the public health need.
MR. COERR: Ms. Commerford, I can appreciate your
concern. Do you have any personal knowledge about the level
of NO2 and its effects on people?
MS. COMMERFORD: About a year ago, I didn't even
know what the hell N02 was. I have read, ^probably compared
to the average citizen, about 100 percent more. I have a
friend who has a child who has asthma, and it was because of
Sam, the little boy with asthma, and the readings that we did
around the effects of the NO2 on asthmatic children, that we
really began first to go to the state air pollution people.
Frankly, our concern was having a factory across the
street, and it wasn't until about a hear and a half ago, a
year ago, that we realized that contrary to what we had been
told, that this plant would meet all applicable standards and
would be a very .clean plant, that we learned that there was
even a NO2 question existent, if you will. We have learned
a lot since then.
MR. COERR: Thank you.
CHAIRMAN PADGETT: Any other questions? Thank you
very much.
Thernext speaker will be Dr. Tony Cortese.
DR. CORTESE: Thank you, Mr. Padgett, members of
the panel, members of the public, my name is Anthony Cortese.
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DR. CORTESE: I am Director of the Division of
Air and Hazardous Material of the Massachusetts Department
of Environmental Qualities Engineering. I would like to
apologize for the fact that Mr. Kinlock from our department
is not here. He will submit a written statement in a couple
of days.
I do not have a written statement, but I will
submit to you a fairly detailed statement in the next couple
of days. I come to you, before you this morning, because we
are concerned about the issue of nitrogen dioxide and its
impacts on health. As I think you can probably ascertain,
there is a large contingent from Massachusetts that is very
concerned about the air quality standard that EPA proposes
for nitrogen dioxide.
I am not here to make recommendations on the
actual number that you should set because the decision that
our department issued in December of approval of the Harvard
Power plants diesels is an adjudicatory appeal, and I do not
feel that I can make any recommendations.
However, I would like to indicate just some of
the aspects of the decision. On January 31st, of this year,
we did disapprove the construction of a total energy plant
in Boston because of the one-hour ambient N02 levels that
would result from the facility when added to backgrounds.
We have determined that this would be potentially
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injurious to health. In referencing our decision, on a safe
exposure level, we consulted with ten medical experts around
the world, we held two public hearings, we had testimony from
nine other medical experts in the context of our public hear-
ings, and we reviewed all the scientific information that was
available to us at that time, including the World Health
Organization criteria documents, and your first draft of the
nitrogen dioxide criteria documents.
From this information our department determined
that a one-hour exposure level for the impacted population
from the power plants would be 200 micrograms per cubic
meter for one hour which is equivalent to 0.1 parts per
million.
I would emphasize in making that decision we
looked at the susceptibility of the population that would be
impacted by the plant. Some of the information was presented
to you earlier. We have a higher proportion of elderly people
impacted by the plants, over twice the urban population of
the United States.
The demographic and the health statistics were
rather compelling in our opinion. We have 50 percent higher
respiratory incidence, disease incidence, in the area. The
age adjusted mortality rates were greater than double the
expected rate.
Within a mile of the plants we had seven hospitals
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five nursing homes and 15 public schools.
I will submit for the record, if you wish, a
copy of all of the testimony that we did receive from all
of the medical experts, and a copy of our 85-page decision
which documents the reasons in detail for our disapproval
of the power plants and more importantly, for the determina-
tion of a safe exposure level for this population.
I would like to make some comments as a scientist
on the criteria document as it is written in three areas.
First of all, I believe that with all of the testimony you
have heard today and the conversations over the Orehek study,
the criteria document does not adequately address the problems
or the significance of the Orehek study.
I believe that some of the information related
to the Campbell study should be treated very carefully. If
EPA decides not to dismiss the Orehek study, I think it shoulc
be done with a rather thorough discussion of the implications
of that dismissal.
Secondly, there is concern that in the beginning
of Chapter 5 the criteria document cites a recommended
exposure level from the National Academy of Sciences of one
part per million. When it goes to the World Health Organiza-
tion, it only talks about the lowest adverse effects level
that WHO determined.
I think it is appropriate for the public reading
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this document to indicate that WHO rrecommended a standard of
109 to 320 micrograms per cubic meter. My point is that the
treatment of the different standard setting organizations
should be consistent. If you are going to indicate that one
group recommends a certain standard, I think you should
indicate what the other groups do as well.
Otherwise, I would recommend taking it out of
the document completely.
Thirdly, I was concerned as some of the previous
experts were early this morning about the treatment of the
Melia study and the conclusion to be drawn from the studies
that have indicated potential problems in homes with gas
stoves. I think that, as you have heard, some studies have
shown higher than half a part per million for N02 concentra-
tions and also the way the study indicates concentrations
lower than .25 done at .15 parts per million for two hours.
In the conclusion of the document you should
cite the complete range from all the way up to, as we heard
this morning, .6 parts per million and not just intermediate
range of .25 to .5 parts per million. That is the conclusion
of my testimony. As I indicated to you, I will prepare a
short statement summarizing what I have this morning, and
submit for the record as many copies as you may feel you
need of the testimony that we have.'in our decision on the
Harvard Power Plant.
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CHAIRMAN PAnCF-TT: Quest ions?
MR. STOLTIIAM: T have at leas I ono.
You indicated that you contacted or polled or
somehow talked to 10 medical experts around the world. Ho
you have, could you indicate to this panel who those experts
were? Are they American experts only? Did you poll
Dr. Orehek and Dr. von Nieding?
DR. CORTESE: I did not poll Mr. Orehek or
von Nieding. The only international representation was
Dr. Bauch of the World Health Center. I do have a List of
people that we did poll and I will provide that to you. 1
would indicate that of the total 19 respondents, that we
had through oral testimony or from written communications
from my department of the 19, tAvo gave us no recommendation
on the appropriate air quality standard in our particular
situation.
I remind you that this was oriented towards the
population that we had described and the situation of the
power plant. Four had recommended a standard as high as
450 to 480 micrograms per one hour; five had recommended the
World Health Organization of 190 to 320; and eight recommended
190 micrograms for one hour.
MR. STOLTMAM: Were these people essentially --
did you send out a questionnaire asking the question, "What
would you recommend for a standard given these situations?"
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1 DR. CORTESE: That is correct, I have that. I
2 sent two sets of letters out, one was in specific response
3 to the Orehek study which I asked for some responses.
4 MS. TAYLOR: Were any of the same people on both
5 your health expert panel and on, either on any of the EPA
6 panels?
7 DR. CORTESE: I think there may have been one or
8 two. I just didn't look very carefully in the criteria
9 document this morning.
10 MS. TAYLOR: You haven't examined — have you
11 examined the testimony of people in the two proceedings to
12 see if they are consistent?
13 DR. CORTESE: No, I have not done that.
14 MS. TAYLOR: When were your proceedings held?
15 DR. CORTESE:. We have held public hearings in
16 early December and late December, the communications to many
17 of these experts there was one batch during August of '77,
18 and another batch in November of '77, so it was really the
19 latter part of last year, and it was considerably before
20 the Science Advisory Board meetings.
2i MS. TAYLOR: It was during the period of prepara-
22 tion of the criteria document?
23 DR. CORTESE: That is right.
24 CHAIRMAN PADGETT: What was the standard, the state
25 standards that you ended up with?
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DR. CORTESE: Recommended a maximum for this
particular population in this area of 200 micrograms per
cubic meter for one hour.
CHAIRMAN PADGETT: Not to be exceeded once per
year.
DR. CORTESE: Once per year.
CHAIRMAN PADGETT: Is that just for that local
area, i3 this a state-wide standard?
DR. CORTESE: That is correct. We are waiting
to see many terms of state standards, what EPA proposes
before we go ahead and enact the state standard.
MR. STOLTMAN: Is that actually higher than what
the World Health Organization recommended, or is it
comprable?
DR. CORTESE: It is very comparable. I don't think
you can tell ten micrograms difference.
MR. STOLTMAN: The World Health Organization indi-
cates once a month rather than once a year.
DR. CORTESE: That is correct, I think when you
look at it; we looked very carefully at the air quality
data. When you look at it statistically, the chances if
you have one hour once per month versis one hour once
per year, it-doesn't turn out to be very much difference
because it turns out that your second maximum hour, or
day, they generally come together in clusters, so I really
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1 don't think there is much difference between the once per
2 month versis once per year, although there isn't very much
3 data on which to base that decision.
4 MR. COERR: Have you received comments subsequent
5 to your act — substantive comments that would pertain to
6 the level of the standard?
7 DR. CORTESE: No, I have not.
8 MR. COERR: Out of curiosity, what sort of a
9 modeling technique did you use to estimate the relation-
10 ship between emissions from the power plant and the 200
11 microgram standard?
12 DR. CORTESE: We used current EPA air quality
13 modeling guidelines. The company itself, the consultants,
14 used some other modeling technique, which were even more
15 conservative than the EPA modeling guidelines. We did
16 make some assumptions, went through a careful analysis and
you will see that in the decision document; looking at the
is conversion of NO2, making some assumptions about that, and
19 looking at a range of concentrations as opposed to just
20 using a technique, and determining that that is what the
21 maximum levels were.
22 MR. COERR: From your record, in this, which
23 population did you consider to be, the sub-population,
24 to be the most sensitive from the point of view of adverse
25 effects of nitrogen dioxide?
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l DR. CORTESE: Well, you could have taken your
2 pick because we had so many relatively unhealthy popu-
3 lations in the area. We concentrated quite a bit on asth-
4 matics, and on children because of the large population
5 density in the area.
6 MR. STOLTMAN: With regard to asthmatic, do you
7 have evidence that that particular population has a more
8 higher concentration of asthmatics than the national average?
9 Is it because of the hospitals there?
10 DR. CORTESK: We didn't have specific information
11 on asthmatics. We did have specific information on the num-
12 ber of children in the area, we did have specific information
13 on the number of people with excess respiratory disease. We
14 didn't have specific information on asthmatics.
15 MR. STOLTMAN: In terms of children, is it a
16 higher than average population of children in that parti-
17 cular area?
18 DR. CORTESE: I don't know if it is higher than
19 the average population much as it is just a very high popu-
20 lation density. I don't have a specific answer to that.
21 MR. STOLTMAN: There is no reason, if it turns
22 out to be asthmatic children that are the most sensitive,
23 perhaps that we have to try to protect in EPA with our
24 ambient standard, there is not necessarily any indication
25 that you have got that that area around the power plant or
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at the area you were trying to protect has an abnormal
population in terms of asthmatic children?
DR. CORTESE: I don't have any information about
that. I don't have any reason to believe that it would be
substantially different. I think the figures that have been
cited about 3 percent of the population being asthmatic, I
thing it is probably a problem for this area as well.
MR. BERRY: I think an important question as
a follow-up to Paul's question, some of the experts that
you had take a look at the scientific basis for your
state standard, we have what we believe to be some of the
most expert people in the field in the country representing
our document. Did you by any chance contact Dr. Shy?
DR. CORTESE: Yes, he was one of the respondents.
MR. BERRY: Dr. Crocker, Dr. Horvek, Dr. Hackman?
DR. CORTESE: No. I did talk to some of these
individuals over the phone, but I did not solicit their
advise directly. I will give you a list of the people that
I did contact./
MR. BERRY: Very fine.
MR. STOLTMAN: You did contact Dr. Nelson and
Dr. Findley and Dr. Shy and others?
DR. CORTESE: That is correct. I might add that
there were several pulmonary physicians that commented on
the appropriateness of the Orehek study, and Dr. Shenker
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was one of them as you have heard this morning, and the
pulmonary physicians did believe that the Orehek Study
was relevant to a real situation. That was why my comment
about if -you are going to set a standard which does not
take into account the potential adverse effects of the
Orehek study, I think that it is appropriate for EPA to
thoroughly treat that. I further think that in any
standard that you do set or propose, that you indicate
whether or not there is any scientific evidence that indi-
cates that there maybe a health effect below the level at
which you are proposing the standard. I think it is
important especially in light of the World Health Organi-
zation recommends. that the public be fully aware that
any standard that you do set does contain some potential
risk, if you so believe that that is the case.
MR. COERR: Ydur do conclude that airway resistance
is an adverse effect in health?
DR. CORTESE: We had no basis to conclude that
it was not. There was no information that was submitted
to us as a department nor have I been able to find any in
the literature that indicates that changes in airway
resistance are not related to long term chronic airway
disease. I think if the jury is out on that, you have
to then talk about philosphy. Do you try to establish a
standard on the basis of protecting against unknown, or do
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you decide that until you know what it actually is, you
do not set such a stringent standard. It is a very
important public health philosphy that has to be dealt
with. L*. It is not a simple one especially when the costs
are great.
DR. .CORTESE: It is very obvious we adopted the
philosphy that in the absense of nothing what the effects
might be, and in the absense of having definitive informa-
tion, that we thought it was appropriate to disapprove
the power plant on the basis of a very tight safe exposure
level.
MR..COERR: Probing that a minute, do you have
precedents for that?
DR. CORTESE: Precedents?
MR. COERR: For that philosphy; as; a publi-c
health approach.
DR. CORTESE: I can't specifically cite that.
I think you can just go back and look at a lot of public
health related decisions that have been made over the
years both in the environmental area and in other nonenviron
mental areas, in the areas of public health. I think there
is substantial evidence for that belief.
I think that is what Congress intended in the
Clean'iAir.. Act-of:1970and in the amendment of '77. I
would add one thing, I would like to, as a scientist, to
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add my recommendation to your recommendation, which is that
the Orehek study will have to be repeated and it ought to
be done fairly soon. I don't know if you have any plans,
but I would strongly recommend that, and if you do decide
not to set an air quality standard that is tight enough to
protect against potential effects that might be shown by the
Orehek study, I think that should only be done if there are
plans to replicate that study very quickly so that the pub-
lic can feel safe in the potential effects that occur.
MS. TAYLOR: When you set a standard in Massachusetts
and I don't know who the representative of Massacuseetts woul 1
be, do you have funds available to do your own health research
and to what extent do you have to rely on people like EPA
to conduct research in this area?
DR. CORTESE: We have to rely totally. ;i have no
funds for research in the state budget. In fact, in
order to do the kind of job that we did on this particular
project we had to set aside major other things for a period
of about three months. We just don't have any funds for
that and we have to rely totally on EPA for its research.
MR. BERRY: Is Massachusetts's complants with
the criteria document one of study interpretation, or one
of the facts we might have overlooked, studies you feel
should be included here?
DR. CORTESE: I think it is somewhat interpretation
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I am concerned that there are ways to interpret scientific
studies. I just think in the case of the Orehek study,
there needs to be a fuller treaties of that particular issue.
I think it has to deal with the question of whether or not
we have any evidence that changes in airway resistance, do
relate to chronic airway disease. Campbell should have
been cited. I think there is interesting evidence in that
case. I on the question of the citings of the numbers,
the World Health Organization, as far as the public is
concerned is a very important independent standard setting
body, and I think you have to try, I know that EPA is
making an independent decision, but I think the public
views EPA as an important component of the whole world's
health and environmental issue and I think that there should
be a fuller treaties of what the World Health Organization
did recommend because otherwise if you were to read the
World Health Organization document and the EPA document,
they seem to have divergent views and I know that is not
an easy thing for EPA to deal with. I think to the extent
you can. You ought to address some of the major issues that
WHO addressed Mr. Berry; the original study you found
that we might have overlooked, you feel is Barter and Camp-
bell.
. DR. CORTESE: As far as overlooking -- I think
there was some information provided to you earlier today
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about the Rasmussen study, and if I understand the problems
of in vitro studies, it opens a whole can of worms
in adding that to the criteria document, but there is
some interesting evidence there.
CHAIRMAN PADGETT: Thanks very much, Tony.
DR. CORTESE: You are welcome. I am told that
in lieu of Mr. Elder's making an oral presentation, his
paper, which we have, will be submitted for the record, and
I believe there are copies of his paper back on the back
table, and I guess you have a copy of the paper also.
MR. COERR': Yes, sir.
CHAIRMAN PADGETT: So the next speaker then will
Be Fran Dubrowski.
MS. DUBROSKI: I am speaking on behalf of the
National Resources Defense Council. Before beginning, I
should point out that Dr. Karen Ahmed, our staff scientist,
who assisted in preparing these comments, and who has a
public health background, unfortunately could not be here
today. However, I am sure that Dr. Ahmed would be happy
to answer any questions you might have with respect to the
substantive part of our comments.
Our main concern with the criteria document is
that it does not accurately reflect the lowest observed
effects threshold for short-term N02 exposure. The criteria
document concludes that pulmonary effects from short-term
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exposure to NO are associated with thresholds above 1.5
ppm, or 2,820 micrograms per cubic feet. In reaching this
conclusion, the document undervalues the significance of
a 1976 study of asthmatics performed by Orehek.
In this study, 13 of 20 test subjects demonstrated
increases in specific airway resistance and increased sensi-
tivity to the effects of a broncho-constricting agent after
a one hour exposure to 0.1 ppm. The Orehek study is signi-
ficant because it is the only report available to EPA on
the effects of NO2 on a susceptible segment of the population
in this case asthmatics.
Despite the obvious implications of this study,
EPA has concluded that until the studies are replicated by
other competent investigators, utilization of the study
results for assessment of maximum safe exposure levels is
believed to be inappropriate. EPA's Federal Register notice
of this meeting concludes that the study is of controversial
significance and is not appropriate as the basis for an
air quality standard.
The reservations which EPA has articulated in its
criteria document with respect to the utility of the Orehek
data may be subsumed under four main categories. These
categories may be described as follows:
First, a concern that the dramatic responses
observed in three of the test subjects account for the
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statistical significance of the adverse symptoms noted in
the remaining 10 asthmatics who were negatively affected
by N02 exposure;
Second, a concern that the adverse effects observed
in the 13 responses were not asthmatic in nature nor signi-
ficantly adverse.
Third, a concern that variable results were pro-
duced at higher concentrations of NO-; and last, a concern
that the results of the study have not yet been reproduced
by other investigators.
NRDC believes that none of these concerns warrants
the conclusion that the data should not be used in deter-
mining the maximum safe exposure level for short-term NO2 ^
First, with respect to the number of test subjects
affected by exposure to NO , the Orehek study demonstrated
statistically significant increases in both specific
airway resistance and sensitivity to broncho-constricting
agents in the group of individuals responding to N02 exposure
In fact, the probability that increased sensitivity to the
effects of bronchoconstricting agents occurred as a result
of random error in these individuals is less than in a
thousand. It should be noted that the Orehek study was
conducted in a laboratory setting on individuals between the
ages of 15 and 44. Had the study been more representative of
the general population of asthmatics that is to say, had
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. 142
the study included younger or elderly asthmatics or asthmatic
in an exercise situation one would have expected the
results to be even more dramatic.
The response of even this select group of asthmatic
however, demonstrate the existence of a segment of the
population which is sensitive to N02 exposure at extremely
low levels. The legislative history of the Clean Air Act
makes it clear that data of this nature cannot be ignored
in setting ambient air quality standards. The Report of the
Senate Committee on Public Works states as follows: "In
requiring that national ambient air quality standards be
established at a level necessary to protect the health of
persons, will not necessarily provide for the quality of air
otherwise dependent on a controlled internal environment
such as patients in intensive care units or newborn infants
in nurseries. However, the Committee emphasizes that inclu-
ded among those persons whose health should be protected
are particularly sensitive citizens such as bronchial
asthmatics and emphysematics who in the normal course of
daily activity are exposed to the ambient environment
Ambient air quality is sufficient to protect
the health of such persons whenever there is an absence of
adverse effect on the health of a statistically related
sample of persons in sensitive groups from exposure to the
ambient air...For purposes of this description, a statisti-
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cally related sample is the number of persons necessary to
test in order to detect a deviation in the health of any
person within such sensitive group which is attributable
to the condition of the ambient air." Judged by this
standard the Orehek data is appropriate as the basis for
an air quality standard.
Second, the responses to N02 exposure detected by
Orehek and his colleagues should not be dismissed merely
because none of the subjects experienced an asthma attack.
As EPA acknowledges, the responses to a single short-term
exposure to NO2 in a controlled laboratory situation may
not reflect the full magnitude of the response to be anti-
cipated in ambient situations since the effect of the pollu-
tant in the latter context may be exacerbated by exercise,
repeated intermittent or continuous exposure to that concen-
tration of pollutant, or simultaneous exposure to that con-
centration of pollutant, or simultaneous exposure to other
ambient pollutants.
Even if EPA were to adopt the unrealistic assump-
tion that the responses detected by Orehek would not be
aggravated in ambient situations, it still does not follow
that increases in airway resistance should be dismissed.
It has been suggested that any agent which increases airway
resistance should...be considered likely to increase the
risk factor of an individual's contracting serious chronic
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1 lung diseases. EPA's conclusion that pulmonary effects
2 are associated with a threshold of 1.5 ppm is itself based
3 upon a study of airway resistance in individuals exposed
4 to NO . The health effects data, therefore, warrants more
5 serious consideration of the Orehek study than appears
6 in EPA's current draft of the criteria document.
7 Third, the fact that variable results were produced
8 at higher concentrations of NG>2 does not negate the findings
9 of the Orehek study. Orehek and his colleagues hypothesized
10 an all or none effect; that is increasing the dose does not
11 yield a further effect until a specific threshold is
12 reached. An objective presentation of the study results
13 would require discussion of this hypothesis.
14 Finally, the fact that the Orehek study has not yet
15 been reproduced does not support EPA's decision to ignore the
16 study results. In this context, it is important to note
17 the: • Orehek study was published in 1976. In view of
18 the potential significance of the results, EPA's failure to
19 initiate additional studies to determine the health effects
20 of exposing asthmatics to low concentrations of NO2 is
21 inexcusable.
22 Although there are not reported studies which
23 directly duplicate the Orehek findings, confirmation of the
24 effects of low concentrations of N02 can be found in the
25 animal studies and epidemiological studies identified by EPA
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1 and in two recent invitro studies. One, published by
2 Voisin in 1977, and a second, conducted by Rasmussen in
3 1977, show morphological changes in macrophages at levels
4 of 0.1 ppm and cell destruction at levels of 0.15 ppm
5 respectively. Both of these studies have been previously
6 cited to EPA, but are not discussed or acknowledged in
7 the criteria document.
8 Other scientific experts asked to evaluate the
9 significance of existing health effects data on short-term
10 NO exposure have given greater weight to the Orehek findings
11 In a recent attempt to correlate expert opinion on N02 health
12 effects, the Massachusetts Department of Environmental
13 Quality Engineering asked 19 experts to recommend a safe,
14 short-term exposure level for NO . The results of this
15 survey, submitted to EPA by Massachusetts DEQE, indicated
16 that no recommendations were received for a standard above
17 0125 ppm and 13 of the 19 respondents either recommended
18 or were interpreted to suggest a standard of 0.10 to 0.17
19 ppm. Several experts cited the Orehek study as a basis for
20 their recommendations .
21 Similarly, a WHO Task Group on short-term N02
22 exposure selected a nitrogen dioxide level of 0.5 ppm as an
23 estimate of the lowest observed adverse effect level for sho
24 term exposures in animals and humans. The Task Group con-
25 eluded that, in light of the Orehek findings, the actual
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health effects threshold is not known and may be signifi-
cantly lower than the observed level of 0.5 ppm. The Task
Group therefore recommended a minimum safety factor of 3-5
and a maximum exposure limit of 0.10 to 0.17 ppm.
Since EPA's Criteria Document contains no dis-
cussion of a recommended standard, it is unclear what factors
or safety margins were employed to arrive at the 0.25 to 0.50
ppm one hour average proposed in the Federal Register. It
is clear, however, that the proposed standard may well be
two and a half to five times the maximum safe exposure
level for susceptible asthmatics. The proposed standard
also provides little or no margin of safety above the adverse
effects levels detected in animal infectivity experiments
and epidemiological studies, several of which have been
performed on children.
In adopting an ambient standard for short-term
exposure to N02/ EPA has a responsibility to protect all
segments of the population, including asthmatics, the elder-
ly, children, and individuals with chronic heart and lung
disease. When EPA cannot state with confidence the no
effects level for all segments of the population, EPA must
employ a considerable margin of safety in using data obtained
on healthy subjects and cannot afford to ignore data on
susceptible individuals. These considerations would support
a standard well below that currently under consideration by
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EPA's staff.
CHAIRMAN: Comments?
DR. GARDNER: Do you feel that if Orehek had
reproduced his experimental subjects, exposed them again,
this would have strengthen his data. He only used the one
time if he would have exposed them again, at a later date
and showed the same response, do you think this would have
added validity?
MS. DUBROWSKI: I think that if Orehek had
exposed his subjects to repeated doses of nitrogen dioxide
at that particular level, or continuus over a prolonged
period of time, I think that that would point out and
support the conclusion that a .1 ppm standard is needed
for an ambient situation because individuals in an ambient
situation are exposed to whatever the maximum safe exposure
level is more than once. I don't think that the fact that
he didn't do that invalidates the study. I think all that
we are saying is that there could be more data to indicate
what actually happens in an ambient situation.
DR. GARDNER: In his study, he had both responders
and non-responders, and I belive there was one individual
there, I think he is number 6, I think, who was extremely,
highly sensitive and was a real strong responder. I am
wondering if you would like to comment on if that individual
would have been left out of the test as an outlooker or
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1 something, would you still think you would have had statis-
2 tically significant results.
3 MS. DUBROWSKI: I believe there were three indi-
4 viduals who exhibited dramatic responses, and 13 individuals
5 who did respond and it was the combination of the 13
6 including the three who exhibited a dramatic response that
7 lead to the statistical significance. I.haven't performed
8 a statistical analysis of subject number 6, so I really
9 couldn't say if number 6 were there, what the results would
10 be.
11 MR. STOLTMAN: Just a couple of points of clari-
12 fication. You seem to imply that EPA has proposed stan-
13 dards in the range of that point 25.5. I want to make it
14 clear for the record that EPA has not prosecuted that
15 standard.
16 MS. DUBROWSKI: I understand there is no out-
17 standing proposed standard, however, you suggested that
18 would be the range that you would operate within.
19 MR. STOLTMAN: Number two, I think you drew a
20 conclusion from the Federal Register now that EPA has
21 concluded that it cannot and that the Orehek study is not
22 appropriate for standard setting and I will just read you
23 the quote, it is simply, that the suggestions that it
24 is not appropriate at this time, is what we stated so again
25 I don't think we are on the record in this Federal Register
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1 as saying we can not use that study as a basis for stan-
2 dard setting. Let me ask you a question, I reviewed the
3 transcript of the SAB meeting on NO2/ there seemed to be
4 a"large absence of representation from environmental groups.
5 Can you tell me if you were informed with adequate time of
6 that particular meeting?
7 MS. DUBROWSKI: I was not personally and I don't
8 believe, although I am not positive about that, that any-
9 one at NRDC was involved.
10 MR. STOLTMAN: IS there anyway you could check as
11 to when NRDC was in anyway informed?
12 MS. DUBROWSKI: I would be happy to check and
13 submit that.
14 MR. STOLTMAN: For the record — thank you very
15 much.
16 MR. COERR: You do read the Federal Register?
17 NRDC does scan the Federal Register.
18 MS. DUBROWSKI: Yes, we do.
19 MR. COERR: The public meeting: was announced in
20 the Federal Register.
21 MS. DUBROWSKI: I am not sure if it was.
22 CHAIRMAN PADGETT: Yes, it was .
23 MR. COERR: I had a question. Does NRDC take a
24 position as to what the short-term one hour standard should
25 be?
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1 MS. DUBRCWSKI: I think we would say that it..
2 should definitely be below the range that has been suggested.
3 I think we would probably concur on the basis of the availa-
4 ble evidence with what Massachusetts and World Health Organi-
5 zation have recommended as a short-tenn standard, that is,
6 of 1.0 to 1.7 ppm standard.
7 MR. COERR: Thank you.
8 DR. GARDNER: I have another question I would like
9 to ask regarding the in vitro studies. You know the amount
10 of problems people have been extrapolating: from in vitro,
11 were you aware that Dr. Crocker, who is the second authority
12 on the Rasmussen paper, was also a contributing authority
13 to the criter document?
14 MS DUBROWSKI: I was not aware of that.
15 DR. GARDNER: And I think it just has to be recog-
16 nized that any time you are dealing with in vitro models,
17 you have to be very careful about extrapolating concentration
18 and time of exposures to what you might find,--, .expect to fin
19 in the host.
20 MS. DUBROWSKI: I understand, there-are problems in
21 extrapolation, I think we were citing those studies because
22 they are not included in the health effects document and
23 probably should be and because they do provide additional
24 evidence that low contentrations of NC>2 are signigicant.
25 MR. STOLTMNA: One second, I think, Joe, that
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is from the audience. Perhaps you could read the question.
CHAIRMAN PADGETT: Are there any other questions?
This is a question from the audience, at the last meeting,
numerous experts mentioned EPA should be influenced in set-
ting a short-term NO standard by the WHO guidelines of
.10 to .17 ppm one hour average not to be exceeded more
than once a month.
"WHO determined no base existed for a long term
NO standard. Do these same experts deliver advocate EPA —
revoke its present long-term standard and refrain from
proposing one in the future?"
MS. DUBROWSKI: I don't believe NRDC is advocating
that, we do drop the long-term standard. I don't recall
if that is an accurate quote from the World Health
Organization Task Group Report or what the rationale for
that was, so I am at a loss to respond to that critisism,
but no, we are not suggesting that the standard be dropped.
CHAIRMAN PADGETT: Okay. Thanks very much, Fran.
OUr next speaker is William Haring.
MR. HARING: Good afternoon. My name is William
Haring of Denver, Colorado. I am a staff attorney with
the Sierra Club Legal Defense Funds representing Sierra.
As you are aware, Sierra Club is greatly concerned
with the short-term NO2 issues contemplated in the EPA
announcement of this meeting in the March 27, 1978 Federal
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Register. Studies both within and outside EPA are grim in
projecting vast increases in NO2 in the ambient air in the
very near future. Those massive intrusions are just years,
not decades, away. The NO2 hazard is compounded by the
characteristic proximity of heaviest concentrations to areas
of heavy urbanization. Since short-term exposures have now
been recognized as no less dangerous than long term, the
decision by the agency on this issue may be one of its
most critical in implementing the Clean Air Act.
EPA's efforts to comply with Section 109 of the
Clean Air Act Amendments of 1977 may fall far short of
providing true protection to the public, based upon the
substance of the March 27 Federal Register announcement,
particularly the indication of a staff recommendation of
a standard in the range of 0.25 to 0.55 ppm, one hour
average. While the -wording of the announcement invites
comments and information confined to the interpretation of
the scientific data presented in the criteria document
it must be acknowledged by the agency and emphasized that
there are substantial protective policies upon which the
data are to be weighed and interpreted.
With regard to the conclusions on available data
set forth in the announcement, itself, it can be generally
agreed that intermittent or continuous exposures to 0.5
ppm of NO2 or greater in laboratory animals results in a
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number of adverse effects on health, including increased
susceptibility to bacterial infection, evidence of bron-
chitic and emphysemateous-like changes in lung tissue, change
in lung function and immunological system changes. However,
there are some studies showing exposures to concentrations
below 0.5 ppm which, while being less conclusive, do indi-
cate effects in the structure of certian lung fibers and
in conditioned reflexes of the central nervous system. It
it significant that most animal studies have used normal
animals under highly controled conditions with exposures
to single air pollutants. The animal studies cannot be
claimed as typically accounting for synergistic effects,
or as responsive to susceptible human population segments.
We agree that most controlled human exposure
studies of healthy individuals show changes in pulmonary
function at one to two hour concentrations greater than 1.5
ppm. However, some important caveats must be added to this
very very broad generalization. The intake of NO2 and other
gases appears to be associated with an increased retention
of inhaled particulate matter in the respiratory tract. Thi
effect on particulate disposition in humans could represent
additional risks if the materials included toxic substances,
or pathogens. In addition, there is the likelihood that a
synergistic effect or the combination of NC>2, 0 and SO
exposures at concentrations often present in urban areas
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can result in an increase in airway resistance in healthy
subjects when they are exposed to a broncho-constrictor.
The broncho-constrictor may be an appropriate model for
natural allergens. I think it was discussed this morning
and certainly it isn't anything identical but it certainly
is a-reliable mimic.
As to sensitive subjects, controlled human
exposure studies on the effects of NO2 exposure on two
types of chronic respiratory disease: chronic bronchitis
and asthma. Clearly, exposure of chronic bronchitis patients
to N02 concentrations above 1.5 ppm results in changes in
pulmonary function, including increased airway resistance
and a decrease in the alveolar-arterial oxygen pressure
difference. In addition, exposure to 0.1 ppm N02 for one
hour significantly increases the effects of a broncho-
constricting agent on asthmatics, as reflected in the so-
called Orehek, et al., study of 1976.
We agree that epidmiological studies associate
increased incidence of respiratory disease with higher level
of NO in the air, but question whether o.§ PPm can be
characterized as a threshold in light of the studies by
Kagawa and Toyama of 1975 and 1976, Linn, et al. of 1976,
and by Melia, et al, 1977 where children in homes in which
gas stoves were used had significatnly higher incidences of
respiratory illnesses than those children in homes where
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electric stoves were used. In short, we believe the epi-
demiological studies indicate short-term exposures between
0.25 to 0.50 ppm are more properly the levels where results
and adverse effects of human health can be expected.
I will stop and appreciate Mr. Stoltman's statement
of the NRDC's expert.
As to the sensitive subject studies, the results
obtained by von Niedling and the recent study by Orehek of
1976, suggest a mere exposure to 0.1 ppm of N02 for one hour
significantly enhances the effects of a broncho-constricting
agent on asthmatics. It was apparently the Orehek study
which was referred to in the Federal Register announcement
as "controversial" and "not appropriate as the basis for
an air quality standard."
Unfortunately, whether it is controversial or other-
wise , we submit that the epidemiological work by Shy, et. al.
in 1970, Melia, et al. in 1977 and Linn, et al, in 1976
should be considered extremely significant; in addition,
the controlled human exposure studies by Orehek, et al. of
1976 and Von Niedling, et al. of 1977 must be given
considerable weight, whether they be labeled "controversial*
or otherwise. Finally, the in vitro studies by Voisin, et
al. 1977 and Rasmussen, et al. 1977 must be acknowledged
and also given weight. In short, there is a substantial
body of data suggesting a potential for adverse health
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effects at NO2 exposures as low as 0.1 ppm (190 w/m )
one hour.
EPA appears to totally discount the Orehek study
even though it was apparently performed and document well,
was completed without any apparent confounding factors, the
exposure to NO was significantly low, and that the indivi-
duals on whom the study was performed were believed to be
susceptible to air pollution effects and constitute a signi-
ficant segment of this country's population.
In providing an adequate margin of safety within
the context of legislation aimed at human health protection,
it is again noteworthy that a large segment of our citizenry
could be labeled as susceptible to adverse effects of NO,,,
that the urbanized population centers are in close proximity
to the major man-made NO pollution sources. There is no
known level of biologically active pollutants, such
which is not potentially harmful to some degree to the
human population. The concept of a threshold effect level
will always remain controversial to some degree. Under
these circumstances, the safety margin of 2 to 3 from the
lowest exposure level consistently observed as adverse, the
previously chosen general pattern for national ambient air
quality standards, is very likely inadequate.
The suggestion that prudence requires a very
conservative safety factor with NO2 was emphasized by the
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World Health Organization in its report, Environmental
Health Criteria for Oxides of Nitrogen (published in 1977) .
In determining a safe exposure level the Task Group con-
eluded; and I have a quote which I won't read but which I
think is familiar to everyone in the room. We have been
doing this. They came down with the .1 to .17 ppm one
hour exposure.
At this point the EPA response to Section 108 (c)
of the 1977 Amendments to the Clean Air Act appears pre-
liminary and tentative. What purports to be the criteria
document will not be meaningfully finalized. At present
the materials fail to consider certain recent studies which
are relevant, including Barter and Campbell, 1976, Voisin,
1977, and Rasmussen, 1977. Even given the problem with
extrapolating, which we have discussed in many cases this
morning, and this afternoon.
in conclusion, we submit that the 1977 WHO study
should be afforded considerable weight, and that the standard
promulgated by EPA should approximate that of the VnilO
recommendation. In addition, EPA should acknowledge and
emphasize the significance of the Orehek study and those
studies which indicate similar findings. Some gaps are
evident in the present body of knowledge on this subject,
no one can deny that. Predictably, some groups participatin
in this rule-making process will find it expedient to
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l dwell on uncertainty. Without question, more work is needed,
2 in particular on highly susceptible ij coups of people, but
3 the problems of doing testing on such people arc obvious.
4 While some critics of the Orehek study have suggested that
5 the increase in airway resistance is not significant
6 because the effect is reversible, and clinical symptoms
7 were not manifested at the time of experimentation, at
8 least that is what is indicated and suggested today. There
9 is substantial opinion that the health significance of the
10 broncho-constriction in the Orehek study goes far beyond the
11 increases in airway resistance. Other data exists indicating
12 that increased airway reactivity to non-specific airway
!3 challenges might be an important factor linked to the
14 predisposition of the population to serious chronic lung
15 disease. It is a reasonable conclusion that any agent which
16 increases airway reactivity should be considered to increase
17 the risk of contracting serious lung disease.
18 Thank you very much for your consideration. I will
19 be glad to answer your questions.
20 CHAIRMAN PADGETT: Questions?
21 DR. GARDNER: You presented several of the effects
22 that was found at point five parts per milliter. In most
23 of those studies, animal exposures were for more than just
24 a few hours . ..Does it bother in extrapolating from these
25 long-term effects to short-term effects?
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MR. HARING: Certainly it bothers me.
DR. GARDNER: Do you think it is all right to
relate long-term effect to what somebody might.find in ...
short-term?
MR. HARING: Surely. It didn.11 .bother me to do
that. .It iidnlt 'bother me under these circumstances, no.
DR. GARDNER: You n»ad§ a statement that the
intake of NO and other gases appear to associate with
increased retention in the inhaled particles. What data
is that?
MR. HARING: I can't quote the specific data.
DR. GARDNER: I don't recall the information or
i
studies like that.
MR. HARING: I can try and submit that to you,
supplement my statement.
DR. GARDNER: You also made a comment about
the work of a combination of NO ozone and SO^, the
£• £
von Nielding study, are you aware that Hackney at a later
time, 1975, rather in '11, studied ozoning and NO? at higher
levels in what von Niedling did attribute the effects
to ozone and not to NO .
MR. HARING: I heard the Hackney study discussed.
Yes, I am aware of the Hackney study. I don't believe in
anyway neutralizes the von Nieding study.
DR. GARDNER: Lastly, in the Shy study, the
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cpidemioloqical work, in the document, COMU.ICMI V.L; .u\- :r.
that there inav he sulphates and nitroyon rau-s air,.-
with the measurement n\ethod. Do you think Liii-^ sho
taken into consideration.
MR. RARING: I think they shoulu be noteo :»:v.:
I think they do tend to detract somewhat from the Chctttaaooya
study. They do not suggest the Chattanooga study can be
passed over on that basis alone. I think that in far, far
too great a diminution of the situation.
MR. COERR: Bill, I was confused as to what data
you were referring to in your last paragraph, ''Other data
exists indicating the increased airway reactivity to non-
specific airway challenges might be an important factor..."
MR. HARING: I have to again refer -- I haven't
done it here. I can't remember it. I can't quote it from
memory.
MR. COERR: If you would let us know.
MR. HARING: Yes.
DR. GARDNER: Was anyone from the Sierra Club at
the Science Advisory Board Meeting?
MR. HARING: No, no one was there to my knowledge
Thank you. . . .
CHAIRMAN PADGETT: To follow up on a question
we asked the previus speaker, did you know about the
SAB meeting?
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MR. HARING: We weren't made specifically aware of
it. We do get the Federal Register. I presume it was in
there from the comments that Stan Coerr made.
CHAIRMAN PADGETT: You generally were aware of it
but ho one -- you just didn't get a chance to focus on it
so to speak.
MR. HARING: I don't think we can afford to fly
in for it. We have very limited resources. I have to check
when we come to Washington. This is a very good time to
come.
CHAIRMAN PADGETT: Thank you. Clarence Ditlow.
(Discussion held off the record.)
CHAIRMAN PADGETT: Are there any other speakers
that we failed to have on our list? Okay. Hold on a
second. I think as far as the main meeting is concerned, we
will technically adjourn, but as you heard from our dis-
cussion with Clarence Ditlow's representative, we will
keep the door open until Mr. Ditlow gets here, assuming he
gets here around three or so, so that his statement can be
taken and so those who are interested in waiting around and
hearing that statement are perfectly free to do so. But
other than that, the meeting is technically adjourned. Thank
you very much for coming.
(A brief recess was taken.)
CHAIRMAN PADGETT: Word was received from Joyce
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Kinnard, Mr. Ditlow's representative, to the effect that
he would not be able to come in time to give an oral
statement. Therefore, the meeting has been adjourned with-
out his statement. However, he will provide a written
statement for the record.
(Whereupon, the hearing was adjourned at 2:15 p.m.)
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