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U.S. Eir'IRONMINTAL PROTECTION AGENCY
HEARING
Proposed National Emission Standards
for Identifying, Assessing and Regulatin
Airborne Substances Posing a Risk of
Cancer, and Advance Notice of
Prcoosed Oeneral Standards
Crystal Room
Shamrock Hilton Hotel
6900 Main
Houston, Texas
Thursdav, March 13, 19SO
9:00 a.m.
BEFORE: Joe Padgett, Chairman
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450R80101
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3 U.S. ENVIRONMENTAL PROTECTION AGENCY
4 PUBLIC HEARING
5 ON
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8 Proposed National Emission Standards
for Identifying, Assessing and R.egulating
9 Airborne Substances Posing a Risk of
Cancer, and Advance Notice of
10 Proposed General Standards
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Crystal Room
Shamrock Hilton Hotel
16 6900 Main
Houston, Texas
Thursdav, March 13, 1930
18 9 : 00 a .m.
19
BEFORE: Joe Padgett, Chairman
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EPA PANELISTS
Dr. Elizabeth L. Anderson, Director
Office of Health and Environmental Assessment
RD-689
401 M. Street, S.U.
Washington, D.C. 20460
Robert D. Bauman
Strategies and Air Standards Division
MD-12
Research Triangle Park, N.C. 27711
Allyn M. Davis, Director
Air & Hazardous Materials Division
EPA Revion VI
First International Building
1201 Elm Street
Dallas, Texas 75270
(Mr. Davis not present during
evening session.)
Todd M. Joseph
Office of General Counsel
A-133
401 M. Street, S.W.
Washington, D.C. 20460
Robert G. Kellam
Strategies and Air Standards Division
MD-12
Research Triangle Park, N.C. 27711
David R. Patrick
Emission Standards and Engineering Division
MD-13
Research Triangle Park, N.C. 27711
Josenh Padgett, Director
Strategies and Air Standards Division
MD-12
Research Triangle Park, N.C. 27711
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CONTENTS
SPEAKERS
Richard Krablin
David Marrack
A. A. Gunkler
J. Bruce Bate
Keith Ozmore
Stephen C. Davis
Dennis S. Lachtman
R. G. Dillard
L. L. Krohn
Ivan G. Smith
W. L. Senn
Meg Titus
Jim Mullins
Frances B. Smith
Harry M. Walker
Judy Martin
Brandt Mannchen
Janet Maier
John Fafoutakis
Lou Ann Anthony
PAGE
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ATTENDEES
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NAME
Richard Olafson
Clyde Roberts
Richard H. Coe
Frances V. Smith
J. B. Bates
J. E. Lihenberg
W. P. Anderson
Gene Speller
Martin E. Brittain
Carlos I. Diaz
Gary H. Baise
A. Linkier
D. E. Fitzgerald
Roy McClure
R.ebecca S. Tolton
Dan R. Harlow
Ted M. Nairn, Jr.
Lisa R. Soldani
V. P. Piana
D. Morrack
R. Helms
David Burroughs
REPRESENTING
The Lubrizol Corp.
Shell Oil
Shell Oil
League of Women Voters
of Houston
Northern Petrochemical
City of Houston BAQC
Tenneco Inc.
TACB
EPA, Region 6, Dallas
Uvalde Rock Asphalt
Beverage Fairbanks
Dow Chemical
Atlantic Richfield
Dupont
Gulf States Utilities
Diamond Shamrock Corp.
Cosden Oil & Chemical Co
Texas Eastern Transcorp
Phillips Chemical Co.
Individual
Kimberly- Clark
Texas Eastern Corp.
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REPRESENTING
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Roger Tower
Dick Flannery
Harriet Mofore
Candy Peer
Elsie Randall
J. M. Annenheuser
B. F. Gallowav
D. D. Malzahn
Bruce Williams
L. L. Krohn
B. A. Buenehe
P. L. Shipley
J. W. Kaufman
S. W. Fretwell
R. Krablin
W. D. Broddle
D. R. Trew
T, W, Sims
D. Vli
Phillip Morris
Lucas W. Brandt
Robert E. Abbott
W. P. Toland
W. L. Senn
Celanese Chemical Co.
Texas Air Control Board
Individual
Individual
Individual
Goodyear T & R Co.
Goodyear T & R Co.
American Natural Resources
American Hoechst
Union Oil Co.
1CI American
Phillips Petroleum Co.
Phillips Petroleum Co.
Oxirane Corp.
Anaconda Copper Co.
Conoco Inc.
Cities Service Co.
Texas Stell Co.
Houston Health Dept.
American Hoechst
Oxirane Corp.
Conoco Inc.
Badische Corp.
Exxon Chemical Co., U.S.A.
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NAME
REPRESENTING
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Hoyt C. Ambrosius
F. P. Miller
J. R, Venable
H. M. Walhen
H. H.Nelson
C. W. Umlkut
J. A. Mullins
B. R. Vehnekamp
B. F. Ainelins
Glenda Greene
M. L. Sagenhal
J. C. Ledvina
T. J. May
Keith Ozmore
Glenda Barrett
J. C. Molina
M. Lawsen
Michael Tenoso
James L.Loyles
E. G. Stock
Norman D. Radford,
Texaco Inc.
Continental Carbon
Rohmand Haas Texas
Individual
Monsanto
Exxon Chemical Co. U.S.A
Shell Oil Co.
Shell Oil Co.
Shell Oil Co.
Shell Oil Co.
Shell Oil Co.
Conoco Chemical
Illinois Power
(illegible)
League of Women Voters
of Houston
ARCO Chemical Co.
Deer Park Progress
Harris County Pollution
Control
Harris County Pollution
Control
Westinghouse Electric Corp
Jr. Vinson & Elkins
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NAME
Don Cox
Paul Vavra
Wm. D. Utidjihn.M.C.
J. G. Collins
J. F. Erdmann
W. F. Muller
Bob Skorpul
R. E. Savory
A. Gomez
Joseph M. Baretincic
John Harris
Gregory David
C. L. Green
Ron Lanz
R. G. Dillard
I. G. Smith
J. Tappen
Dennis Lachtman
Al Auenoso
C. H. Rivers
Elizabeth Lankford
Edelia Lee
Dr. Eugene Brams
Dr. Pat Brams
REPRESENTING
Temple-Eastex
GBCPA
Union Carbide Corp.
Goodyear
Union Carbide Corp.
Goodyear
Rice University
Pennzoil Co.
Texas Air Control Brd.
IMC Sterlington
Shell Oil Co.
Dow Chemical
Alcoa
AIHE
Texas Chemical Council
Sierra Club
Phillips Uranium Corp.
Envirotech Corp.
U. of H., Downtown
Shell Chemical Co.
Citizen, Environmental Coal
EPA, Dallas
Prairie View A&M Univ.
Pollution Assessors
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NAME
Kurt T. Guenther
Virginia Chaffee
D. A. Kuhn
R. D. Towe
Joan Jones
Michael D. Henke
Charles R. Shaw
Susan Duffrey
Noll Shenor
John J. Zimmerman
Stephen C. Davis
Dennis L. Lachtman
John R. Summer1in
Jess A. McAngus
Dave Stang
Brenda Gehaw
Greg Retter
B. Scott
Jim Scott, Jr.
Jeff Lambert
Kurt Jackson
J. T. Adams, Jr.
Maureen Lennon
REPRESENTING
Rice University
Pennzoil Company
Conoco Inc.
Petro-Tex Chemical
Galveston Bay
Conversation P.A.
Gulf Oil Chemicals
M. D. Anderson Hospital
Rice University
Rice University
American Mining Congress
American Mining Congress
American Mining Congress
Rice University
Pace Consultants
Rollins Environment
Individual
Rice University
Rice University
Individual
Individual
H-GAC Realty Systems Agency
ARCO Petro. Products
API
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NAME
REPRESENTING
Thomas R. Scovel
Texaco Inc.
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John Fafoutakis
Judy Martin
L. E. Anthony
James L. Moore
Jerold C. Lambert
Charles H. Medlock
J.M. Baretincic
Brandt Mannehon
Janet Maier
EVENING SESSION
Individual
Individual
Individual
Texaco Inc.
Airtrol Corp.
Airtrol Corp.
IMC Sterlington
Houston Sierra Club
Individual
(There were 4 illegible signatures which could not
be deciphered.)
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3 CHAIRMAN PADGETT:
4 Good morning.
5 My name is Joe Padgett, and
6 I'm the Chairman of this public hearing, informal
7 public hearing, on EPA's proposed airborne
8 carcinogen policy and the advanced proposal that
9 we are making on draft generic for practice and
10 operation standards.
11 This proposal was published
12 in the Federal Register, October 10th, and a
13 series of public hearings was scheduled for this
14 week, the first two days of the week being in
15 Washington, B.C.; March the 10th and llth."
16 The third day, March the 12th,
17 was in Boston; and today, here in Houston.
18 We will be meeting today during
19 the day, and we also will have an evening session
20 for several speakers who have elected to talk in
2} the evening.
22 There is a list of speakers who
23 have registered their intent to speak, and should
24 be back in the back of the room on a table. I
25 assume that you have that information.
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The way we are conducting the
hearings, they are intended to provide opportunity
for interested persons to present their views and
to submit information for consideration by EPA
in the development of a final policy to identify,
to assess and to regulate airborne carcinogens.
These hearings are informally
structured. Those who are providing oral testimony
will not be sworn in nor will formal rules of
evidence apply.
Questions after each individual
speaks -- questions will be posed by the EPA
panel members, whom I will introduce shortly, for
the purpose of understanding better what they
have said and perhaps emphasizing or clarifying
different points that may have come up in their
testimony.
There will be no questions by
the participants or others in the hearing room;
but if individuals have questions that they would
like to see asked, they can write those
questions down and hand them to one of the EPA
staff members who will be at the back of the room
to bring up to the Chair for submittal; this, of
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1 course depends on the time available.
I
2 We have asked each participant
3 to try to limit his oral presentation to no more
4 than ten minutes and then we will allow another
5 period of time for questions by the panel.
6 Participants are asked to state
7 their name and organization, if any, prior to
8 ! beginning their oral presentation. We would also
9 appreciate it if those participants who have
10 prepared statements bring those up and make them
11 available to the panel members and to the
12 Hearing Stenographer.
13 This proceeding is being
14 reported, and copies of the verbatim transcript
15 will be available for inspection and copying at
16 the EPA Regional Office Libraries and the EPA
17 Central Docket Section in Washington.
18 Copies of the documents --
19 some of the copies of some of the documents are
20 available at the hearing. The proposed policy
21 and the AMPR for generic standards and several
22 other pieces of material. If there is other
23 information that you would like, I would suggest
24 that you write down your request and give it to
25 the staff person so that that information, if
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available, could be sent to you.
The record, the hearing
record, will remain open 30 days from this date --
that would be April 14th -- for submittal of
additional information which is pertinent to
information generated here or in prior hearings
this week.
We plan, as best we can, to
call witnesses in the order listed on the list
that I think you have, the list of witnesses;
however, if certain witnesses have special
problems, planes, trains to catch, schedules --
whatever -- we will see if we can accommodate
your desires.
With that, let me just run
through the panel members, the EPA panel members,
starting with my left. Over on the far side,
we start with Bob Bauman, who is with the EPA Air
Programs office.
Next is Bob Kellam, also with
the EPA Programs office.
Next is Al Davis, who is the
Director of the Air & Hazardous Materials Division,
Region VI.
On my right is Todd Joseph -- my
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immediate right -- Todd Joseph, Office of General
2 Counsel and Doctor Elizabeth Anderson, Office of
3 Health and Environmental Assessment.
4 And then, David Patrick, who
5 is with the Emission Standards and Engineering
6 Division in the Air Programs office.
So, I believe, unless there
are some questions that someone may have relative
9 to the organization of the meeting, we will just
10 start with the first witness.
I would like --
There are a few seats up front
.- for those who have just come in.
(There was a brief pause in
14
the proceedings.)
16 CHAIRMAN PADGETT:
17 The first witness will then
lg be Richard Krablin.
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TESTIMONY OF RICHARD KRABLIN
MR. KRABLIN:
My name is Richard Krablin and
I am from Denver, Colorado.
I am testifying on behalf of
the Anaconda Copper Company as their Manager of
Health, Safety and Environment. I appreciate
the opportunity to address EPA today and will
keep my statement brief.
Of the many issues attendant
to the proposed regulations, Anaconda has chosen
four that are of special significance tc our
company, our principal business is the discovery
and production of mineral resources.
Four areas of major concern to
our company are illustrated by the following
questions and statements:
Considering the often repeated
concern by EPA of the scarcity of its resources,
has the contribution of airborne carcinogens to
the total cancer burden justified requiring these
complicated and far-reaching policies and
procedures?
Neither the cost nor benefits
of this policy has been provided.
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. 16
Does EPA, while living in a
political climate and dealing with an emotional
issue such as cancer, recognize the adverse
impact on businesses that will result from
listing a substance as having a high, moderate or
low probability of carcinogenicity?
Serious adverse impacts are
likely to affect such business operations even
though only an incomplete scientific evaluation
has been performed.
Is early listing under
Section 112 of the Clean Air Act really necessary
to increase the priority of consideration of
a particular substance and thereby accelerate
the development of regulations, or does the
listing itself help justify the conclusion of
carcinogenicity?
EPA has available other
mechanisms such as Advance Notice of Proposed
Rulemaking, ANPR, and the Toxic Substances
Strategy Committee, to establish priorities and
notify the public of impending rulemaking.
Is an industry such as ours,
which is limited by the nature and location of
the mineral resources, aided or hindered in
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long-range planning by these proposed procedures?
Although, for example, EPA
has listed factors that will be considered for
new sources, no insight is provided for planning
purposes as to how these factors will be
implemented.
With regard to my first
question on the need for an airborne carcinogen
policy, Anaconda believes the EPA efforts are
misplaced.
The advantages and disadvantages
of these regulations are not sufficiently
documented to support the additional bureaucracy,
and the expenditure of taxpayers' time .and money
that will result upon their implementation.
The Agency should document in
better fashion the contribution of ambient
airborne carcinogens to the nation's total cancers
when compared to other environmental sources,
including diet, stress, cigarette smoking, and
other factors in addition to air and water.
Can EPA expect the public to
confirm the validity of the proposed regulations
when, in fact, resultant costs and benefits are
not provided and the health problem addressed may
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be minimal when compared to other existing health
issues?
It is our belief that the
problem of airborne carcinogens has not been
shown to be of such magnitude that this proposed
complex policy is justified.
The second question is one of
special concern to Anaconda, as a representative
of an industrial category specifically mentioned
in the policy as emitting carcinogens, which we
might add, has been concluded only on the basis
of a preliminary analysis.
Even without the listing of any
particular substance as a carcinogen, our industry
is already placed on the defensive. What has
been gained?
The process of listing a
substance, as proposed in the procedures, despite
which category or list it is placed on, will
automatically label the substance a carcinogen
in the public mind. We do not agree that such an
association -- and that's all it will be -- will
be beneficial.
Guilty until proven innocent
may be necessary in some cases of toxic exposure
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where the evidence is strong and potential risk
substantial, but not for suspected and unproven
airborne carcinogens. At a minimum, full
scientific analysis should be performed prior to
a Section 112 listing decision, so that all parties
can understand whether a risk is equal to, for
example, an extra day of exposure to the sun, or
in fact, is of serious concern.
Regulatory alternatives and
consequences also need to be considered since the
Clean Air Act requires promulgation of emission
regulations 180 days after listing. This raises
another very important omission by EPA.
No procedure for removing a
substance from the listing has been proposed.
Substances that are listed as a result of
preliminary analysis may indeed prove not to
warrant a Section 112 regulation and a mechanism
to unlist them should be available.
The third issue which concerns
Anaconda is that of the purpose of early listing,
we believe, is not clear, nor does it serve any
particular need. We do not believe that an early
listing, a regulatory decision, is a valid way
to focus EPA priorities.
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In a mining situation a
selected substance will in all likelihood be
subject to controls from other Federal, State
or local agencies since often the substance is
emitted in combination with other substances, for
example, with suspended particulates.
The result of the preliminary
listing will not be to focus EPA's priority, but
rather will result in an indictment of the mine.
Other agencies may not wait for EPA to finish its
information-gathering activities and regulatory
analysis, and may act on incomplete information.
The selected substance will
always be suspect in the public's mind. EPA
has many internal mechanisms for establishing
priorities. If this is the purpose, a regulatory
decision such as Section 112 listing, should not
be used except for proven, significant health
risks.
The last issue that I would like
to discuss is that the air carcinogen policy does
not permit long-range planning for industries,
such as mining. The obvious limitation on mining
operations is that location is required at the
site of resource.
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The cancer policy has three sets
of requirements for new sources: Presumptive
emissions standards, risk-avoidance criteria and
alternative standards, and describes factors that
will be used to establish such levels.
However, no indication is given
on the weighing of these factors and how EPA
will arrive at the standard. This level of
vagueness hinders industrial planning processes
and prevents meaningful public input into the
rulemaking process.
The purpose of the publication
of these regulations and the hearings are to
improve the process, to alert the public of
regulatory proceedings and to allow for public
input. Anaconda does not believe that the
regulations accomplish these goals. Instead, they
seem to be aimed primarily at avoiding challenges
later in the process.
To us, airborne carcinogens are
indeed unique air pollutants and may need special
treatment. However, the effort is most
effectively accomplished on a case-by-case
examination, unfettered by an attempt to generalize
with procedural regulations such as these proposed.
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EPA should use its limited
resources to make a thorough evaluation of the
need for regulating hazardous airborne substances,
which may or may not include carcinogens.
There is a enidemiological
evidence which shows that industrial air
contaminants account for less than one percent of
the total lung cancer in the U.S. At this time,
it is not apparent that these regulations would
reduce that factor.
Anaconda and other industries
will not be aided by these regulations, and let
us not pretend that they shouldn't be. As part
of the public, industries must be able to plan for
the future within the existing regulatory
framework. Procedures that allow for such planning
are indeed aids to industry and the public at
large.
We sincerely hope EPA will
consider these comments and focus its attention
on regulatory procedures that will improve public
health in a cost-effective manner.
Thank you.
CHAIRMAN PADGETT:
Any questions?
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MR. KELLAM:
Dr. Krablin, you mention in
your testimony that you felt that EPA should not
list a substance unless we had found or been able
to prove that there was a significant health
risk.
Could you tell me what kind of
evidence you would consider sufficient in that
regard?
In other words, do you feel
that we need to be able to establish,
epidemiologically, that people were dying as
result of emissions of that substance from a
source category?
Or would you consider that
certain types of animal studies might be
sufficient in that regard?
MR. KRABLIN:
Both of those points you
mentioned refer to medical evidence of these
carcinogenicity of a substance. I am not a
medical doctor.
I might ask, instead, as an
alternate question, just what it is that EPA
may chose to decide as criteria for listing a
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1 carcinogen, which I think is the real issue.
2 It is just not clear to us, or
3 to me
4 MR. KELLAM:
5 Do you feel that the criteria
6 that are developed in the proposed policies are
7 to stringent or not stringent enough?
8 MR. KRABLIN:
9 Our position is that the
T0 i procedures are wrong. I cannot evaluate the
JT criteria, as I note it, for assessing
!2 carcinogenicity.
U What I am evaluating and what
14 we are commenting here, is that the approach of
.. EPA is to label carcinogens and then establish
]6 evidence after the fact. And that is what we
17 are judging.
18 MR. KELLAM:
19 I understand. But you do say
20 that you would, I assume, favor listing if there
21 were proven significant health risks? And I'm
22 just trying to get a better understanding of what
23 you mean when you say that.
24 MR. KRABLIN:
25 I think that the use of
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Section 112 for a substance, such as asbestos,
was a case-by-case approach -- and an appropriate
one -- to the concern over carcinogens.
MR. KELLAM:
Would you agree that the action
that the Agency took in the case of vinyl chloride
was also appropriate use of Section 112?
MR. KRABLIN:
I'm not familiar with your
vinyl chloride details, so I can't comment.
MR. KELLAM:
Thank you.
CHAIRMAN PADGETT:
Ms . Anderson?
MS. ANDERSON:
Yes. In the Federal Register
notice, the Agency specifically requested
informational comments on the evidence for the
airborne-carcinogen problem.
I notice you make a reference
in your statement:
"There is epidemiological evidence
which shows that industrial air
contaminants account for less than
one percent of the total lung
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1 cancer in the "
2 United States.
3 I think we would be interested
4 in getting your reference to that, or the study
5 that you are referring to; and I think ths*- x/e
6 would like to have that submitted.
7 MR. KRABLIN:
8 We would be glad to submit that
9 CHAIRMAN PADGETT:
Are there any other questions?
(There was no response.)
12 CHAIRMAN PADGETT:
13 Thank you.
14 Dr. David Marrack?
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Z7
STATEMENT OF DAVID MARRACK
MR. MARRACK:
Mr. Padgett, I am here as a
private, concerned citizen -- whatever may appear
elsewhere.
I particularly wish to address
the problem and the policies needed to control
airborne carcinogens. The -- To come to the
right place, as you are well aware, this area
has some quarter of or thereabouts of petrochemical
industry in this country, one of the highest
concentrations of such in the world.
We welcome you here today; it's
very nice to see you down here.
The epidemiology of cancer in
Texas has been particularly studied in detail --
and detail that's not available anywhere else --
by University of Texas M.D. Anderson Hospital,
Epidemiology Department.
The cancer-mortality data were
collected by looking at the clinical records and
the histology of autopsy and surgical specimens,
probably the most accurate epidemiological data
available anywhere, and certainly for this county.
The Macdonald's -- Eleanor
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Mcdonald study of the incidence of lung cancer
in this area is published -- and I have copies
of that for you, sir -- and is done by census
tracks around Houston and covers the period 1940
to 1969 and an update is being done at the
present time.
An earlier study demonstrated
three important facts, that lung cancer in White
males increased some twofold in the fifteen-year
period.
The tracks which increased lung
cancer correspond to those under the prevailing
winds from the ship-channel industries.
And there is other evidence --
both wealthy and poor-- on either side of that
area didn't have this problem.
(Handing out materials)
And I thought you might like to
pass that down to the Chairman.
(Due to the speaker's foreign
accent, his diction was partially unintelligible.)
The (unintelligible) and the
wind wheel which you have illustrates this
clearly. This has your major water supplies;
they don't correspond with this distribution. It
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also has the food-distribution system, which
doesn't correspond either.
The obvious, common medium is
air. I point out, naturally, that about one
quarter of the current population tend to get
cancer and about one-fifth of it is going to die
from it, which is extremely sensitive.
As much as eighty percent of
this cancer is considered to be induced from
industrial products -- and, of course, I include
in that tobacco.
Including mass productivity,
including injury compensation, and emotional
trauma, the direct costs of this infliction is
around eighteen billion per annum, recurrently.
I point out to you that about
three times the cost of an Alaskan pipeline
occurring every year.
The reason is not apparent.
You are not addressing birth defects, and I would
submit to you for consideration, that there are
factors that cause abnormal cell growth leading
to cancer are the same that cause birth defects.
About three percent of fetuses
needing treatment before their fourth week have
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birth defects.
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The cost of these to the nation
has been estimated to be about three times that
of cancer; in other words, some sixty billion per
annum. That's ten to the ninth power.
These costs are a non-productive,
economic burden and represent, to a great degree,
a public subsidy of the industries making use of
chemicals.
To put it another way, the hugh
recurring annual costs are part of the production
costs which are externalized by industries'
accountants. This makes a mockery of the product
selection by the market place costs. It is urgent
that the real cost of cancer and birth defects
and some other diseases, too, which are induced
by similar cancers , be placed where it belongs,
on the products precipitating these conditions.
Testing for mutagenic properties
of chemicals singly or in combination by the
hierarchy of the Aimes test is not accurate.
Dr. T. C. Shoe (phonetic) has shown that non-
mutagenic -- i.e., non-DNA events -- could lead
to cell-multiplication disruption, as in cancer.
The (unintelligible) cells must
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also be used as (unintelligible). Further, that
many inherited variances in humans and their
susceptibility to cancer. And (unintelligible) of
any testing program for chemical carcinogens.
And this, incidentally, was
discussed in this building last week, at the
Indiana (unintelligible) Symposium.
EPA, making of standards for
only four agents, I think it is, in the last ten
years is far too slow, again. You need to reach
a rate of about twenty per annum to catch UT> .
The sources of carcinogens
reaching the public are tobacco products, other
chemicals and radiation and the manufacture,
transport and use and waste disposal.
EPA must require that each of
these steps be effectively managed to contain our
human exposure. Regular monitoring and quality
control are steps which are also required.
Let's have a quick look at some
of the carcinogenic problems that are going on
around.
The bar graph taken from the
data of Dr. Saccomanno, and the American Cancer
Society and prepared by Dr. Saccomanno, it shows
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1 the effects of uranium mining and of smoking,
2 taken singly and, in combination, together.
3 Both factors together cause
4 seven hundred per hundred thousand lung cancers
5 compared with 12.6 for a non-smoker, non-miner.
6 Now, that's unacceptable.
7 Vastly more important, it
8 attempts to reduce uranium miners' exposure since
9 the seventies is causing that seventy per one
10 hundred thousand rate to fall; i.e., controls
^ actually work.
j2 I pointed out to you the data
13 appears to not reflect the induction of other
14 cancers that may occur from uranium mining and
15 smoking.
16 The impact of a (unintelligible)
,» smoker is equally ghastly in terms of human
lg health and just as costly to the public. Smoking
with active uranium exposure, uranium miners'
exposure, greatly aggrevates the problem. This
2i was discussed by Dr. Cellokaus (phonetic) in the
22 Journal of American Medical Association for
23 August 3, 1979, page volume 2 -- volume 242,
24 page 458.
25 The inter-action with other
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carcinogenic chemicals and smoking have been less
carefully studied to date.
The available data suggests
that they are equally viscious combinations.
(Unintelligible) are carcinogeni<
You would expect this from the nature of thier
chemistry, and this is discussed by Reynolds in
"Toxic (unintelligible) Energy --"
Sorry. "Toxic Injury of the
Liver," Part B, Chapter 14. The editor is
Dekker; Farber & Fisher, published in 1980. I'm
not sure it's yet on the bookstands.
And also in "Free Radicals in
Biology," Volume IV, edited by Pryor; 1980 at
Academic Press.
Prior to (unintelligible)
i
hydrocarbons seem to be regulated at the top.
Well, let's just look at the
ethene dichloride (phonetic) and vinyl chloride
as these regulations in Texas (unintelligible) .
Ensuring the adequacy of the current regulations.
The standards are set in the
upper limit of air concentration. Yet, what's
needed is a limit for total air -- air mass in
the region. You must cover all releases: fugitive
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excursions, start-ups and shut-downs. It's
absurd to have a limit of parts per million for
fugitive vinyl chloride and then ignore the
excursion releasing 20,000 pounds of vinyl chloride
monomer on an unsuspecting and non-consenting
public -- and I might point out it happened in
June of 1976 within five months, again, in two
different parts of the ship channel.
In fact, a review of the Texas
Air Control Board records shows for the year '76
and '77 there was average of six excursions per
month along the local area. The initial releases
recorded stem downward from 20,000 pounds per
incident.
There's no data on the public
and fetal-health effects of these releases; none's
been sought.
The present regulations do not
cover all plants processing or handling vinyl
chloride monomer. It's an intermediary or bi-
product waste; it's outside the Federal
regulations. And that's obviously not
(unintelligible).
Smokers and airborne
carcinogenic agents are permitted together, both
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in the workplace and amongst the public, who are
not advised of and not consenting to carcinogenic
exposure. The informed consent, as understood by
members of the medical profession, is not practicec
by Industry. I consider this discriminatory. It
obviously needs correction.
Transportation of carcinogens
should be minimal and on-site use should be made
an attractive, economic sort of advantage. EPA,
at least in this area, has been tardy in analyzing
the composition and acting on the known, hazardous
toxic wastes in the area, like the one on Highway
1A6 and 1-45, which is outside Texas City. We
have a lovely miasma of vinyl-chloride vapor
over it. It's been known for 18 months and yet
nothing of significance has happened yet.
i
The responsibility of control
of these carcinogenic and birth-defect-causing
agents and the proof and justification of all
actions by Management and the introduction and use
in commerce for export are done to protect human
health and the environment must rest squarely and
clearly with those who produce, otherwise have or
use these agents (sic).
It's two hundred years, sir,
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1 since the birth of (unintelligible), the first
2 recognized carcinogen. And a mass of accummulated
3 evidence since then.
4 It's clear that smokers and
5 carcinogenic smokers are incompatible with
6 (unintelligible).
7 Statements of parties who deny
the effects of airborne chemicals and cancer
carcinogenesis is obviously suspect and their
motives for denying the obvious should be
reviewed.
Western Europe and USSR are
vigorously proceeding to clear up their
14 carcinogens in the environment. We tolerate a
15 (totally unintelligible). We brag about our high
16 j chemical living but quality of our health-care
17 systems (unintelligible) the high quality.
18 Get our house cleaned up.
19 Thank you.
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1 I CHAIRMAN PADGETT:
j
2 i Questions?
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3 | MS. ANDERSON:
i
4 Pursuing the same question I
I
5 asked the last witness, in these hearings we have
6 heard a range of testimony along the nature of
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7 | the airborne carcinogen problem.
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8 From your testimony, it is clear
|
9 that you have looked at a lot of the evidence.
10 Just to review the range of testimony that we
11 have heard, we have heard one witness say that the:
12 j is no evidence whatsoever that air pollution
13 ! causes cancer.
14 Another witness says that it
15 is de minimus. Another one says it is less than
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16 one percent. Another says between one thousand
17 I and two thousand cases of cancer caused by air
18 pollution.
19 And we have heard a fifth one
20 say it is highly significant.
|
21 But other than citing specific
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22 ; studies, to place no number on this. And I'm
23 wondering if, in your work, you could add to this
24 range of testimony that we have heard.
!
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1 MR. MARRACK:
2 I thought I already had. You
3 have in front of you a bargraph which shows one
jj
4 | for uranium. And if you read that paer, it is
5 appalling considering the number. I happen to have
6 here samples -- not the whole paper; just the
7 | front pages. I have a number of pages.
8 j There are two copies. You might
9 I have them included in the record.
I
10 ; Yes, of course, there are a
11 tremendous accumulation of data going from the
12 more obvious chemicals, the chlorhydrocarbons --
13 whether they are our old friend, chloroform, the
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14 ethylene dichloride and vinyl chloride, which
15 represent some of the largest mass of chloride
16 hydrocarbons in the public domaine down to nickel
17 I compounds, chromium, arsenic, you name it, almost j
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18 ; every one of certain metals. Group IV and V, and i
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19 mainly, chlorinated compounds seem to be the I
20 obvious problem. Others I have not looked at
21 | so carefully.
22 I MS. ANDERSON:
23 I But in terms of the total j
j
24 j contribution, would you say it is significant --
25
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MR. MARRACK:
Obviously, if it goes -- I
don't have it with me.
Looking at that bargraph for the
uranium miners, if you don't smoke, never mine
uranium, the figures are 12.6 per hundred thousand
of population.
If you smoke more than two packs
of cigarettes a day, it is 265 per hundred thousam
break. And those are figures of the American
Cancer Society.
The Saccomanno data for
non-smoking uranium miners -- this is before 1970
in 1965, in fact -- it is 20, or double. And for
the non-smokers, if you do both cigarette-smoke am
mine uranium, the figure is 700. And that is almo
60 times.
You can't treat single chemicals
on their own. You've got to take a holistic view,
and maybe that's one of the major problems of
EPA's approach at this present time.
MS. ANDERSON:
This is an impressive study in
terms of occupational exposure. Of course, the
emphasis today is on the ambient exposures. And
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1 I suppose --
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2 i MR. MARRACK:
| ' ,
3 i Some of the papers on the vinyl
4 j chloride are in that bunch that you have there. j
|! I
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5 j. And others clearly show the problem. |
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6 j And unfortunately, we are really
7 i not going at -- as I can see it -- really getting
8 out to get the data.
9 Obviously, the first place to
10 start -- The lead time for cancer is anywhere
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11 i from 20 to 30 years; that's an awful long time to
12 wait to find out what's happening.
13 . On the other hand, pregnancies
14 don't last forever and represent the same kind of
15 biological defect as when birth defects occur.
16 They occur with very high incidence today; about
17 three percent for reasons we don't entirely under- i
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18 stand. And, obviously, part of that at least is
19 environmental.
20 And the fact that the component
21 is environmental is rather easily determined. The
22 only problem is you have to regard miscarriages
23 as a form of birth defect.
24 Something like 80 percent of
25 miscarriages are associated with deformed fetuses.
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1 And most of them don't know when they are aborting
2 Records of these are hard to come by. So these
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3 [ are the kinds of data that would be well worth
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4 | getting hold of.
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5 | And these are the sort of
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6 | data that I submit should have been an urgent
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7 matter after that release of 20,000 pounds of
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8 i vinyl chloride in the ship channel area. But
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9 ! no one knows a thing about it. Unfortunately,
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10 j it is a totally improper experiment on a non-
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11 I consenting public.
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12 And I just think we didn't
13 know anything about it.
14 MS. ANDERSON:
15 We have a question submitted
16 i to the panel from the floor. It is really a
17 ; request for information.
18 "The witness said 80
19 percent of cancer is caused
20 by industrial products.
21 Can he supply data to show
22 I that?"
23 MR. MARRACK:
24 The World Health Organization
25 has a publication on that. The New York Academy
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of Sciences, I think it is Volume 272, has a_
2 massive data on that and a more recent one I
;
3 | don't remember the volume --No. I don't know it.
4 It was within the last year or so. It was a
5 symposium last year.
6 The American Cancer Society
7 comes up with the same sort of figures.
8 USSR has the same kind of figures
9 Now, admittedly, in the area of industrial products
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10 cigarettes don't grow on trees. We process them.
11 We throw all sorts of fungicides |
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12 I and pesticides all over them and all the manufacturj-
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13 ing processes. j
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14 It is obviously an important
15 factor in the development of carcinogens as a whole!.
16 The data on the birth defects in
17 J operating-room women is extremely interesting.
18 i I'm sorry I didn't bring the papers or reference
19 with me, but I can find it, about the increases
20 of weighted birth defects and miscarriages in
21 i operating-room females by about three percent --
22 | three times, I mean, and more interesting is the
23 i partners male -- who work in operating rooms,
24 their spouses or those who get pregnant by them
25 have about half that incidence. In other words,
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1 the male is carrying a defect to the female and
2 appears to be directly acquired by exposure to
3 something in the operating rooms of which the
4 volatile anesthetics are an obvious factor which
5 | is not present in exposure to other hospital
5 I personnel which are controlled.
7 I CHAIRMAN PADGETT:
8 | Any other questions?
9 ! MR. KELL.AM:
10 | You mentioned the use of
11 | formalian (phonetic) cell transformation tests
12 and bacterial mutagencity tests. It wasn't quite
13 clear to me. How do you feel that EPA should view
14 such tests in trying to evaluate the potential
15 for human carcinogenicity of a substance?
16 | HR. MARRACK:
17 ! I don't think it's EPA's job.
18 ! I don't see why I should tax-fund that. I think
19 j it's the job of the industry who wants to use
20 I this chemistry and put it in the realm. It's
21 their responsibility. It is clearly their job.
22 I If you want to change these
23 j things, you got to show it's safe. You've got
24 obviously a built-in backlog of things that EPA
25 investigates.
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MR. KELLAM:
2 Thank you.
3 CHAIRMAN PADGETT:
4 Any other questions?
5 | (There was no response.)
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6 I CHAIRMAN PADGETT:
7 j Thank you.
8 | Mr. Gunkler, from Dow Chemical?
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STATEMENT OF DR. A. A. GUNKLER
MR. GUNKLER:
My name is Al Gunkler, and I am
an employee of Dow Chemical Company. My degree
is in Chemical Engineering at the Ph.D. level.
I have had 29 years of experience in plant
operations and have managed research, production
and process engineering design functions.
I am very much aware of the many
requirements for the design of safe,
environmentally responsible, operable production
units. My philosophy is not unlike yours, in
that I feel we should continue to reduce emissions
and exposure to chemicals in a practical manner,
just as we have done in a remarkable way over the
past 30 years.
I have also had many years of
hands-on experience in handling a multitude of
chemicals, some of which are carcinogenic by
your proposed definition. I have a healthy respec
for the properties of chemicals -- respect, but
not fear.
Incidentally, many of these
chemicals are the ones that our former speaker
talked about; and if they were like they say,
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I -- and my 8,000 fellow employees -- would be
gone by now.
The importance of the proposed
EPA air carcinogen policy is shown in the following
statement, which armears in the supplement of the
EPA proposal.
I quote:
"A requirement that the risk from
atmospheric carcinogen emissions
be reduced to zero would produce
massive dislocations, given the
pervasiveness of at least minimal
levels of carcinogenic emissions
in key American industries. Since
few such industries could soon
operate in compliance with zero
emission standards, closure would
be the only legal alternative."
Unquote.
The preamble points out that
the administrator is not required to consider
negative toxicology data nor risk benefit
assessment and that he will use his judgment as
to how much regulation is needed. For the EPA
to place upon industry another barrier to
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productivity with such an open-ended proposal,
it would seem that all data would be considered
a clear indication of the need for regulation
would have to be apparent. But that is not the
case with the EPA proposal : In our written
comments, Dow expressed the following major
concerns.
There is evidence that chemicals
in the ambient air have contributed to the
incidence of cancer.
The consequences of listing a
product as a human carcinogen are significant,
contrary to the document statement in the light
of the limited direct consequences of listing.
In view of these two facts, a
proposal that listing will be done without
reference to contrary data or public participation
is irresponsible.
The proposal fails to recognize
pertinent scientific data essential to an accurate
and reasonable estimate of carcinogenic risk.
The proposal is legally
questionable if it does not meet the statutory
requirements of Section 112.
Our written comments deal
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extensively with the above statements. These
comments emphasized that there was obviously no
intent by Congress to regulate, under 112, a class
of chemicals generically. It was reserved for
chemicals of extra ordinary concern, to be
considered on a case-by-case basis.
It was not intended to operate
to preclude public debate and input into the
scientific bases and assumptions that go into
the EPA judgment of what is a human carcinogen.
We feel that the EPA has used
a section of the law -- Clean Air Act, Section
112 -- to accomplish a purpose for which that
section was not intended.
I would like to address those
concerns which are supported by my personal
experience in manufacturing, process engineering
and business.
The first are the problems
generated by easy listing of a chemical based
upon a preliminary evaluation of partial data.
Engineers pride themselves on being able to design
plants to meet specifications. But the reality
of the manufacturing world is that easy listing
with the resultant uncertainty whether the
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control requirements will consist of work practice
standards, an unspecified best available
technology, or something more stringent will
hamstring significant process development and
construction decisions.
Let me clarify that if there
were evidence that the most probable estimates
of risk indicated a significant potential health
impact beyond that of competing relative risks
or generally accepted levels of risk, I recognize
that Section 112 would have to be applied as
described in the statute.
The chemical industry understand
its responsibility to deal with realistic
uncertainties. But experts have shown there is
no evidence of correlation of low-level air
pollution with community cancer, let alone with
identified carcinogens, and reduction of exposure
to high-level concentrations in the workplace is
being accomplished through other means. Thus,
there is no need for this proposal.
The EPA proposal would provide
listing of many substances. We anticipate that
the loose criteria for listing would precipitate
petitions for listing of many additional materials
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1 For instance, it can be predicted
2 that the Carter Administration's major initiative
3 for a synthetic fuels program will be affected.
4 The comment in the document,
5 quote, "In light of the limited direct consequences
6 of listing," unquote, is false. Similar listings
7 have already caused harm.
8 Realistically, we urge you to
9 | reconsider the fast listing part of the proposal.
TO We must have realistic, most probable estimate
jl of risk before listing.
12 We don't have to look far for
13 an example of the ease with which this air policy
14 can be needlessly overextended, beyond the
15 problems of listing.-
16 The EPA has drafted proposed
17 | rules for Benzene under Section 112. Since it has
18 been singled out, you would expect it to be, at
19 least, as much of a problem as any of the many
20 chemicals the EPA may choose to regulate.
21 Therefore, it is a good example.
22 The EPA has concluded that under
23 worst-case assumptions, Benzene could conceivably
24 account for as many as three chronic deaths per
25 year among 7.3 million people exposed within 20
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kilometers of chemical manufacturing plants. This
involves multiplying one-chance in 2.5 million
hazard by 7.3 million people to get three.
The point I want to make is that
we are dealing with hypothetical numbers in an
area close to statistical insignificance.
Recognizing the ultra conservative assumptions that
go into such an analysis, particularly the no-
threshold linear response assumption, the most
reasonable conclusion is that no one will die
of cancer from Benzene in the ambient air from
this source.
The mandating of technical
solutions to non-problems -- and there is no
evidence that chemicals in the ambient air
contribute to community cancer -- will create
real hazards that are, at least, equally
significant.
Construction and operation of
process equipment involves real hazards, as a
process engineer, I would be very unlikely to
suggest the same best-available-technology
solution to all production units built at different
times with different technology.
For instance, to return to the
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Benzene-containment proposal, the EPA has suggested
that all vents in 17 different production units
be routed to furnaces, which they presume are
on-site. No reference is made to the fact that
flammable mixtures may have to be transported
thousands of feet, in some cases, to obey this
mandate.
A second technical approach
with less inherent physical hazard was rejected
because it is only 95 percent as efficient. The
five percent difference in a given plant will
presumably cause one theoretical cancer in 1350
years, during which time a half-million people
will die of cancer from natural and life-style
causes in that particular exposed area.
The probability of on-site
accidents in over the same time frame caused by
this additional equipment will be statistically,
at least, as high.
Another example of over-reaction
is EPA's suggestion that Benzene be banned as a
future raw material in Maleic Anhydride production.
This prohibition is based on the impossibility of
containing all Benzene molecules. Therefore, some
theoretical cancer hazard will exist.
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The solution is to
mandate Lne use of butane as a raw material. We
know butane can be handled safely, but is must be
admitted that handling a liquified flammable gas
under pressure has its own hazards, versus the
handling of Benzene which is a liquid at room
temperature.
Additionally, the availability
and costs of raw materials vary markedly over the
years. Locking ourselves out of raw materials
based solely upon upper-limit risk estimates is a
luxury an energy-and-raw-material-deficient nation
cannot afford.
We reject the idea that
Government control is the preferred solution to
perceived problems. There are economic and
marketing reasons for industry to build safe,
operable plants and to put safe products on the
market.
There are, by EPA's own count,
47,000 commercial chemicals. An EPA estimate in
ILRG document is that a maximum of 26 chemicals
is presumed to have caused some chronic problems
and these only in the workplace, not ambient air.
Of these, only two or three account for over 90
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percent of the perceived harm.
2 Personal freedom in the
3 marketplace leads to the innovation Congress
4 expressly wishes to preserve. It is a fragile
5 j benefit easily taken away by a Government
.. i pressured to do something.
7 Difficult as it may be, it is
important that the EPA focus on real problems
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9 i and not expend its efforts on generic solutions,
Q for administrative convenience.
i The principles of identification
of carcinogens and risk estimation in this
regulatory proposal are those of the IRLG
document, published in Feruary '79. The IRLG
14
is only now beginning to review the many
substantive comments on their draft publication.
16
We urge EPA to recognize that
many of the comments persuasively recommend the
18
need for utilizing quality scientific determination^
and risk estimations as the first step in the
20 I
regulatory process. We understand that Douglas
21
Costle has referred to the IRLG document as a
22
23 negotiated document among five regulatory agencies .
24 Rightfully, public comment was
25 solicited. Thoughtful and wise deliberation on
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the public comment is now expected. EPA has the
opportunity to utilize the public commentary on
the IRLG document for its own decision-making
under 112.
A lack of evidence suggesting
that airborne carcinogens contribute to the
incidence of community cancer allows a much more
reasoned approach to the identification and
solution of problems then is evidenced by this
proposed policy.
The kind of analysis EPA made
on Benzene is very useful and suffers only from
a lack of realism as to its significance. A
similar case-by-case approach will satisfy not
only health concerns but the intent of Congress
under Clean Air Act, Section 112.
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1 CHAIRMAN PADGETT:
2 Thank you, Dr. Gunkler.
3 Any questions from the panel?
4 MR. PATRICK:
5 Yes, Dr. Gunkler, I would like j
6 j to ask one question. In your discussion of some
7 specific EPA suggestions on control of process
!|
8 i units, I presume you were mentioning the Benzene-
9 | containment -- the 17 production units --
j
10 I You mentioned that we had
11 j rejected an approach that was 95 percent efficient.
12 Could you give me some more details on that. I
13 wasn't aware that we had done that.
14 MR. GUNKLER:
15 Well, you proposed letting
16 all of the gasses to a furnace. Another approach
17 ! was to absorb as irmch as you could in the refrigera)t
18 ed condenser and run the gas to the vat, from that
19 I to a flare, and then you can't tell how efficient
20 i a flare is, but it would reject that after you
21 i absorbed most of the organics in the refrigerated
22 i condenser, the likelihood of the gas going to the j
23 flare would be inflare"would be inflammable is
24 much less than if you sent the whole thing to
25 a furnace.
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I think it is rather a
peculiar rejection, incidentally. I don't know
why.
MR. PATRICK:
As you said, the problem is
that there are no data to support that, and that
really was the point of the draft, to try to
generate some information and see if we could
get some more information. I think we would like
to go that route.
MR. GUNKLER:
We're going to get 90 or 95
percent to the flare, if you want to send that
stuff to the furnace. That isn't a solution.
MR. PATRICK:
Of course, most -- or a good
many plants already do routing to their furnace
and that was another major reason for -- for
going that route.
MR. GUNKLER:
If the furnance is nearby,
I have no dispute with that.
Now, there are some plants
where it is three miles away; and so, obviously,
that would be a problem.
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1 MR. PATRICK:
2 That's all, sir.
31 MR. BAUMAN:
||
4 j I would like to ask a
5 i question, sir.
6 In your testimony you state
7 | that a proposal -- that listing will be done
8 | without reference to contrary data or public
9 | participation is irresponsible.
10 ! And then furtheron you say that
11 if Contress did not intend to operate to preculude
12 public debate and input into the scientific bases
13 and assumptions that go into the EPA judgement of
14 ' what is a human carcinogen --
15 I And I was not aware that we
16 | had implied that we would do that without any
17 j public participation.
18 But, irrespective of that
19 comment, what procedures or precesses do you
20 advocate or do you propose so that there be public
21 j participation and that there be evidence to
22 ! the contrary --
23 MR. GUNKLER:
24 In the proposal, you have
25 suggested that you will look at data from whatever
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2 j The administrator doesn't have to agree with the
3 i risk assessment.
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4 You will take the position
5 that you choose to use, and there's nothing in
6 there that says that there will be a public hear-
7 ing or that you will come to the industry who
8 is being controlled and ask -if or their data. Nothi:
9 in that document that says that.
10 MR. BAUMAN:
11 So I gather, then, that your
12 proposal -- or the position that you advocate -- i
I
13 that there be some sort of a public meeting prior
14 to the listing decision? Is that correct?
15 j MR. GUNKLER:
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16 j My proposal is that there
17 | should not be a generic standard, but a case-by-ca
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18 I basis.
19 But, in any case, there should
20 be a meeting in which industry is allowed to
21 ! present their facts.
i
22 Again, until the IRLG document
23 is resolved, your answer is always going to be
24 that there is no-threshold and we will draw a line
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25 straight to zero, which I find difficult to accept
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1 We got tangled up in what is the
2 definition of a polychlorinated biphenol. When
3 we found out that "mono" was being called a
"poly" by the EPA, within a month of two we were
5 able to get that "mono" down below 50 parts per
6 million.
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7 But our customers said we
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8 |j don't want anything to do with anything that's
9 j got "poly" in it. And we quit buying and we i
10 i have shut down one $6-million plant.
11 I MR.."BAUMAN:
12 Thank you, Dr. Gunkler.
13 . You are saying that that was
14 as a result -- that action was as a result of
15 the listing and not the regulation? Is that
16 correct?
17 j MR. GUNKLER:
18 I Yes. This is no longer a
19 polychlorinated biphenol. It is well below the
20 50 parts per million. It's a legal product. There
21 is no longer any reason for the customer not to
22 buy it and use it. But he has chosen to say he
23 doesn't want it.
24 MR . BAUMAN :
25 I see. Thank you.
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First, I had a comment and
then a question.
This is with respect to
the IRLG document and your statement that you
think this policy rests heavily on that document,
that it shoudl be held up until the document
is reissued and the comments considered.
first of all, with regards
to the non-threshold concept, the EPA guidelines
for assessing carcinogenicity in the IRLG documen-
are consistent in saying that where there is
evidence to the contrary, it would certainly
be considered. If we don't have any evidence
that can give us information about the shape of
the base result, then one model that is recommendei
is the linear no-threshold model.
But with regards to the
comments on the IRLG document, since it is regarde
as a consistent scientific backgrounc document
consistent with EPA's guidelines for assessing
carcinogenicity, I wondered what in particular in
that document you feel has such a heavy bearing
on this policy that it might be changed and so
substantially affect this policy that is should
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1 be held up, the document is a rather general i
2 j scientific background, scientific basis for !
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3 I carcinogen risk assessment. I
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4 MR. GUNKLER: I
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5 I think you expressed it. You j
6 said until they can prove that there isn't a |
7 straight line to zero. Therefore, we assume
8 : human carcinogens. The only reason we can't
9 prove it is a straight line to zero is because
we take a million rats to prove it. That is a
11 very difficult thing to do.
The IRLG document leads up to
13 the idea that one test, one positive test, will
14 on an animal that we will now call it a
i
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15 human carcinogen.
16 j It also says, that no contrary
17 data -- You-cah.-ruh'this" test once and it's
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18 | positive for human carcinogen. And we can run
19 it five times negative, and that will not be
20 considered. That's in the document.
21 | MS. ANDERSON:
| !
22 | That is not -- I think you |
23 are not understanding":--"! didn't" think ' that' s
24 i what it said, because we have been very careful to
25 be sure that we wrote into the document the full
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consideration of all studies, including negative
evidence. It does not state that this kind of
evidence will not be considered.
MR. GUNKLER:
It will be considered --
you say the same thing about epidemiology, that it
will be considered but that it will not be used --
that it will offset the idea of one animal
test being a positive test for human carcinogens
I shouldn't be arguing with
you. You're the experts. I'm not. I just feel -
MS. ANDERSON:
I'm not intending to set up
an argument. I 'was just interested. I think it's
very important to see what specifically in this
document, you think, has a substantial bearing on
this.
So it's the one-animal test.
MR. GUNKLER:
The one animal test; the
rejection of epidemiological data, which you say
can never be done --
You see, I'm quite concerned.
We had a good study in our Michigan plant in 1954.
We had 1,000 employees on the payroll. And we
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1 followed them for 20 years and we found among
2 those 8,000 employees who were exposed to much
3 higher levels of chemicals than the public will
4 ever be exposed to, that there were less cancers
5 and less tests among the population that would
6 have been predicted.
7 I just You know, I have
8 I a little trouble believing that parts per billion
9 ! in the amibient air are the problem that we are
]0 i addressing.
11 j And I think when you carry
12 it so far as to those 17 plants, what you are
13 proposing -- we will save one cancer among
14 two and a half million people exposed every
15 four years.
16 That is the statistical
17 significance of your controls. And I find that
18 ' a mighty small number.
19 MS. ANDERSON:
20 ! That is not what I was asking.
21 I was asking about the bases
22 I MR. GUNKLER:
23 I think the IRLG document says
24 one animal test, regardless of the animal. And
25 your judgement -- Incidentally, we are not saying
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you only use good judgement. But it will be EPA's
judgement that it was a valid test, that negative
tests will not be accepted as proving there isn't
a problem and the epidemiological tests will --
most will be considered but probably not be valuab
because it will be so difficult.
MS. ANDERSON:
I think pertinent to the
acceptance of data based on evidence from on
animal tests, if there are submissions that you
might give to EPA, we would be interested to see
them and that is information that would indicate
strong evidence from one-animal test should be
rejected, for example, in the case of aflotoxin.
Aflotoxin would have been
just entirely a human carcinogen if the evidence
based on the positive results in the rat had been
ignored and it was negative in the mouse and
positive in the rat and it was only confirmed
through positive epidemiological studies. But
there is evidence only from one animal test to
rely on.
I think evidence to the contrar
is important.
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1 MR. GUNKLER:
2 If there is one animal
3 test where'-there is high evidence of carcinogenicity,
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4 ji it's different than if there is a very low statistical
t
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5 insignificance. It kind of repels the assessment. (
6 If you have one test that is !
7 at very low levels, if you are running a tenth
8 of a part per million or something like that, and
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9 you find a high carcinogenicity, I would find that i
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10 would be good evidence. But I would think it j
11 | would have to be pretty firm.
12 I guess we are saying it's
13 very important that we not label our products human
14 carcinogens unless we have sound proof.
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15 MR. JOSEPH:
16 I Dr. Gunkler, you have indicated
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17 that you think airborne carcinogens which are
18 present at very low ambient levels in communities
19 i around facilities emitting those substances are
20 not responsible for any amount of increased
21 cancer.
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22 | Is that right?
i
23 f MR. GUNKLER:
24 Yes.
25 i
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MR. JOSEPH:
2 I take it, then, that you
3 believe that these substances have thresholds for
4 action carcinogens.
!
5 MR. GUNKLER:
6 ! I do.
7 I am not I am not a
!
8 toxicologist. I just feel from my experience
j
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9 of exposure and everything that there must be.
10 MR. JOSEPH:
11 You also stated that it was
I
12 j next to impossible to establish the level of those
13 thresholds because of the number of experimental
14 animals that would need to be used to do that.
15 ! How, then, is EPA to establish
16 i what might be a safe level or where those threshol
17 j might be.
18 I MR. GUNKLER:
19 I think the evidence is that
20 there is no problem in the ambient air and that
21 \ we syould be looking for those one or two or three
22 | or four that we might be able to establish are
23 ; particularly potent carcinogens and work on those
24 j by a case-by-case basis.
25 i I don't think that the evidenc
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1 of problem in the ambient air is such that we
2 ! need to go on a generic standard to suddenly
3 control a whole lot of chemicals without
4 considering all of the data.
5 MR. JOSEPH:
6 Let me just clarify that this
7 proposal is not intended to do that.
8 j This proposal is intended to
9 ! be a decision framework and set of statisticals
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10 j on which to proceed case by case/ after considera-
|
11 i tion of all data available on a given substance
12 and after the opportunity --
13 Well, if you read it closely,
14 you will see that that in fact is what it does.
15 MR. GUNKLER:
16 Certainlyr "efforts to go'.out
17 | and monitor your area regularly -- which I have j
18 no objection to, incidentally although I
19 wouldn't consider sending a man out there to leaks
20 all the time. I would go to an area and monitor
21 it which is not one of the possibilities.
22 You put that out immediately.
23 MR. JOSEPH:
24 You're talking about the
25 leak-detection program?
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MR. GUNKLER:
Leak-detection program and
best available technology would imply that you
do it on a case-by-case basis.
MR. JOSEPH:
No. That is not what the
proposal says.
MR. GUNKLER:
You're saying the only thing
would be done is leak detection.
MR. JOSEPH:
The only thing that is done
in any way generically or automatically in any
sense is the leak-dectection program. But even
that does not come into play at all until the
specific chemical has been listed and the specific
chemical is not listed until EPA has considered
all of the available evidence and part of the
consideration of the available evidence is the
review by EPA's Science Advisory Board after
publication in the Federal Register of the notice
that the meeting will take place and an opportunit]
for any interested member of the public to submit
comments on any of the information being considere'
or to submit additional information.
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1 MR. GUNKLER:
2 Is that in this document?
, |i MR. JOSEPH:
l!
4 Jl For the most part, yes.
MR. GUNKLER:
. , I don't think it's in there.
o
7 MR. JOSEPH:
g | You might be correct, that
the document does not refer to the fact that
these determinations of carcinogenicty may be
,. reviewed by EPA's Science Advisory Board.
12 MR. GUNKLER:
13 I think EPA
,, MR. JOSEPH:
14
15 To that extent, we should
clarify your question.
1? MR. GUNKLER:
18 I think EPA will be fair
,_ and all that.
20 But what you have done is laid
out a program here, saying that you can shut down
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22 all of industry if you so choose and there is '
nothing in there that says that you have to listen
to anything we say. But because you are reasonabl
25 people you will only do this to a certain extent
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!! 7:
!
1 and that is exactly what that says and we have
i
2 a problem there.
3 MR. JOSEPH:
!
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4 We thought it was documented
5 to control problems only where problems exist and
6 [ to avoid shutting any large segment of an industry
7 MR. KELLAM^:
8 | Just a point of review,
9 I under Section 112 in the Clean Air Act, there is
10 ! a statement that says that prior to listing any
11 j substance under 112, the Agency will consult to
12 the maximum extent practicable with its advisory
13 committee.
14 I think that's what Mr. Joseph
15 was referring to.
16 j1 MR. GUNKLER:
17 ! That's what I was saying, I
18 ! think.
19 Nothing in there says that
20 we get involved.
21 | CHAIRMAN PADGETT:
22 j Any other questions?
23 i (There was no response.)
24 UNIDENTIFIED SPEAKER:' I am Gary
25 Base (phonetic), Counsel for Dow. And with
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1 respect to the listing provisions in Mr. Bauman's
I
2 question earlier, what we really want is spelled
3 out in the AIC program, and that is a set of
4 procedures to guarantee that you obtain all of
5 the scientific data.
Right now, you have purely
7 a discretionary approach. And I refer you to
8 the AIC proposal, which sets out the requirements
9 I we think you should undertake for the listing.
10 I CHAIRMAN PADGETT:
11 The next speaker is J. Bruce
12 | Bate.
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STATEMENT OF J. BRUCE BATE
MR. BATE:
I am J. B. Bate with Northern
Petrochemical Company. I will offer oral
testimony to enlarge on written testimony
previously submitted by Mr. B. J. Anderson of
our Company.
There is little understanding
of the mechanism that allows uncontrolled cell
growth commonly referred to as cancer. A great
deal of time and money has been expended over the
years in exploring the subject.
Many causes and factors have
been postulated including germs, virus,
submicroscopic organisms, chemicals, complex
trigger mechanisms, heredity, physical
susceptability and others.
Learned researchers under
government, private and business auspices have
struggled with the problem. Mountains of data
have been compiled, indexed, interpreted,
misinterpreted, logically and illogically combined
publicized, sensationalized, taken out of context
and otherwise misused. Nevertheless, progress has
and is being made in understanding cancer and
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other toxicological effects.
Cancer, as our second leading
cause of death in the United States today, is
feared because of its frequency and because no
obviously successful cure is known. It is hoped
by all that the causes and mechanisms of cancer
can be discovered and controlled.
The regulations in the form
proposed can only delav the progress that must be
made. The use of regulations not based on
ordered scientific criteria but on rigid
determinations will effectively freeze science.
The so-called cancer epidemic
that has made sensational reading is in fact not
with us. Most forms of cancer have not increased
if the data from U. S. government and the
National Cancer Institute is considered. Indeed
in some forms cancer has decreased.
The incidence of lung cancer
has risen alarmingly. The EPA and many
researchers acknowledge that cigarette smoking may
be the cause of this. The increase in lung
cancer today can be shown to have a 20-year-lag
relationship to the annual per-capita consumption
of cigarettes.
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EPA has chosen to dismiss this
and instead have proposed regulations under the
Clean Air Act, Section 112, to regulate classes
of chemicals. The regulations proposed will not
measurably increase public protection.
The E^*, seeks to demonstrate a
need for this standard based on three premises:
Cancer is a terrible disease, and this is right.
That a cancer epidemic exists, and this is not
so; and, that the so-called epidemic is largely
due to industrial stationary sources. The last
two are not supported by facts.
The EPA policy will not
measurably increase public protection but will
place serious limitations on the U. S. economy and
result in substantially increased costs for
consumers.
EPA wrongly guesses that the
cost of compliance will be small. An Arthur D.
Little economic study of the policy projects costs
of compliance to run into the millions of
dollars. This impact in these davs of runaway
inflation should require an economic analysis
before any regulations are implemented.
In addition to showing no
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1 apparent need for the proposed regulations, no
2 scientific validity can be seen. Terms are
3 ill-defined; for example what is meant by
i
4 ! potential human carcinogen and significant risk is
5 unclear. Also, there is no mechanism for
6 consideration of comprehensive risk assessment
7 early in the regulatory process.
8 EPA has been a participant in
9 ! the Interagency Regulatory Liaison Group and
10 S other efforts to develop a comprehensive and
meaningful national cancer policy. Yet it now
12 I proposed rigid regulations inconsistent with
13 such efforts.
14 That concludes my testimony
15 CHAIRMAN PADGETT:
16 I Thank you, Mr. Bates.
17 Questions?
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MS. ANDERSON:
I wanted to ask two things.
The first is on the second page of your testimony.
I think what you have said is
a bit misleading. At least, I don't believe
anywhere in the policy is there a mention of a
cancer epidemic or that such an epidemic is
largely due to industrial stationary sources.
Could you point out where the
Policy says that or implies that?
MR. BATES:
The implication is the need
for control and the fact of the cancer epidemic
is broadly talked of through the press and others.
What is the objective of
having a cancer policy?
MS. ANDERSON:
I think the legal mandate is
clear. We don't have to have an epidemic to
protect the public. I don't think EPA in any of
its programs has ever taken the position that
.there is a cancer epidemic or that we need to
have a cancer epidemic before regulatory action
is considered.
And the second thing I wanted
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1 to ask is: You say that this Policy is inconsistent
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2 | with the efforts of the IRLG work. j
3 I wondered in what respect you i
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4 find statements in this Policy inconsistent with [
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5 j that effort? I
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6 | MR. BATES:
7 The evidence of this is offered
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8 i by the American Industrial Health Council, in both j
9 their written and oral testimony, which you have
10 j already heard.
11 MS. ANDERSON:
12 We are unaware of any
13 inconsistencies. We will look at those documents.
14 Thank you.
15 CHAIRMAN PADGETT:
16 We have some other questions.
17 | I just -- On your first page
18 I you had a statement:
19 "The use of
20 regulations not based on
2i ordered scientific criteria
22 but on rigid determinations
23 will effectively freeze science."
24 ! Will you elaborate on that.
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1 MR. BATES:
I
2 i Yes.
3 If you are going to classes
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4 i of compounds and without first investigating them
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5 i thoroughly and proving them to be carcinogens and
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6 | be effective carcinogens in the concentrations
7 that are encountered in the atmosphere, restrict
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8 those, put them on lists under the Section 112,
9 this will to a considerable extent stop the progre
10 that is being presently developed in determining
11 | what is the cause of cancer.
12 CHAIRMAN PADGETT:
13 In what way will it do that?
14 MR. BATES:
15 It will stop the research
16 being carried on. It will make it non-meaningful.
17 ! CHAIRMAN PADGETT:
18 | On page 2 you had a statement:
19 | "EPA has chosen
20 to dismiss this and instead
21 have proposed regulations under
22 ! the Clean Air Act, Section 112,
23 | to regulate classes of chemicals."
24 Are you referring there to the
I
25 generic regulations?
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MR. BATES:
2 That is correct.
3 CHAIRMAN PADGETT:
4 j Are you talking about what
5 j we tend to call "housekeeping" regulations, not
the basic best-available-technology regulations
but other regulations that might later be set for
specific sources, of specific sources of specific
9 { chemicals?
10 MR. BATES:
11 I Yes
12 CHAIRMAN PADGETT:
All right.
Any other questions?
(There was no response.)
16 CHAIRMAN PADGETT:
i
Thank you very much. J
]8 I understand that Keith Ozmore :
is substituting for Reginald Hirsch. Is that
2Q correct?
21 j MR. OZMORE:
22 Yes, sir.
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STATEMENT BY KEITH OZMORE
MR. OZMORE:
Thank you, Dr. Padgett, for the
opportunity to be here this morning.
As you will note on your
schedule, this presentation was supposed to have
been made by Mr. Reginald Hirsch, who is Chairman
of the Air Conservation Committee of the American
Lung Association.
Mr. Hirsch, and conveniently, he
found himself to have to be in court this morning.
So I have been elected to fill in for him.
At the outset I want to say this
This statement has been drafted through e.
consensus of about 12 people who serve on my Air
Conservation Committee. And when question time
comes, I want to emphasize that I am a lay person
and I have never been bashful about saying that I
don't know the answer to a question.
If I can answer your questions,
I shall; if not, I would like to have the
opportunity to take those questions back to my
Committee and can come UP with a consensus to the
response and include it in the expanded version
of this paper for inclusion in the record.
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I wear several hats. I am also
Environmental Assistant to Congressman Bob
Eckhart, who represents the Eighth District in
Harris County, which includes, possibly, the
world's greatest chemical complex.
Most of the ship-channel
industries are in the District he represents.
While I do not represent the other two
organizations, I am a member of the Citizen's
Environmental Coalition in Harris County, and I am
a member of the Air Quality Task Force of the
Health Systems Agency which is in the process of
developing a regional health plan. In all of
those capacities, I am concerned about the
question you are discussing today.
The Air Conservation Committee
and the Lung Association, as you know, have long
been involved in supporting programs to trv to
reduce respiratory diseases both in the
anti-smoking field and through the control of
chemicals that cause disease.
Thank you for the opportunity
to apt>ear here today to testify on the
Environmental Protection Agency's proposed rules
concerning the control of airborne carcinogens.
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I am Keith Ozmore and I
represent the Air Conservation Committee of the
American Lung Association. The Committee and the
Association, as you know, have long been involved
in programs to reduce respiratory diseases, in
both clean air programs and programs to educate
citizens to the dangers of cigarette smoking.
We are confident that an
unknown, but significant, number of future cancer
cases can be prevented by an improved control of
airborne carcinogens now. Current cancer rates
probably do not reflect the growth in the use
of chemicals since the early 1960's. This growth
and use is likely to result in an increase in
cancer rates in the future.
There is a lack of data caused
by the long latency period reauired for such
cancers to show up; for instance, consider the
increase in number of asbestiosis and lung cancer
caused by exposure to asbestos as long ago as the
1940's, when thousands of wartime workers were
exposed to asbestos in the war plants. We feel
like this question must be addressed by the EPA.
We would disagree with an
earlier speaker on the concept that a person is
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innocent until guilty applies here. We are not
2 talking about people; we are talking about agents.
3 We're talking about dangerous substances, and if
4 they're not controlled before they are released
5 into the environment, innocent people may very well
6 be sentenced to death, because they were not
7 controlled. So I am talking about innocent people
g who may die because of these emissions.
9 While the incidence of lung
10 cancer among smokers who have been exposed to
n asbestos is extremely high, at the present time
lung cancer incidence among non-smokers is
increasing. Can this increase be linked to the
I »3
increased production of carcinogenic chemicals in
14
recent years?
16 There is evidence that lung
17 cancer rates in highly industrialized counties
18 such as Harris County are higher than the rate in
19 non-industrialized counties. Would this perhaps
-g indicate that the high production of organic
2] chemicals in the world's greatest petrochemical
22 complex may well have an impact upon the number
23 of cancer victims? While all the facts are not in,
24 we feel like this question must be addressed by
the EPA. Let me discuss for a few moments what we
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-"- 8
feel the EPA might do to implement an airborne
carcinogen regulation program.
First, it should establish a
candidate list of carcinogens which may be emitted
from stationary sources as air pollution. As a
minimum, the two dozen or so substances which are
now known to cause cancer in humans should be
regulated. Furthermore, the Agency should list
other substances as hazardous air pollutants for
further study and regulation where appropriate.
On this point the Association is disappointed that
the Agency has moved so slowly in implementing
Section 112 of Public Law 95-95.
To date, only four substances
have been so regulated, out of the several
hundred potential hazardous t>lllutants . Because
of the time necessary to carry out research and
bioassays, the Association wants to call unon the
EPA to expedite its implementation of the program
at the earliest possible time.
Secondly, the EPA should resolve
in the proceeding certain essential scientific
issues which arise in the same manner and must be
resolved on the same evidence for each
individual carcinogen. These scientific issues
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1 would be foreclosed from futher consideration in
2 proceedings to regulate individual substances.
i
3 When significant new information
4 is presented which calls for a different
5 resolution of the scientific issues regarding
6 generic classification, such issues will be
7 reconsidered and then only in the contest of a
8 general proceeding to amend the general rules.
9 | This resolving and foreclosing
10 of the generic scientific issues is essential if
^ | a national and efficient consistent airborne
12 carcinogens policy is to be imt>lemented and a
13 significant number of substances brought under
14 control.
The third point which we wish
10
)6 to emphasize is that the EPA should establish in
17 this hearing that when a carcinogen is listed as
1g a hazardous air pollutant, any reasonably
available measure should be required to reduce
emissions to the lowest point practicable, even
if this were to require reductions below whatever
emissions limits are justified by consideration
23 of toxicity.
The reason for this recommendatioi}i
24
is that no threshold value can be established for
25
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carcinogenic agents, and the only practical
recourse is to limit exposure to the public to
carcinogenic agents whenever possible.
It is our belief that the burden
of proof must be placed upon the manufacturers of
chemicals to show that emissions into the air are
not damaging to human health or the environment.
Our position is based on the
old saw, the proof of the pudding is in the
eating, or in this case, the proof of the air is
in the breathing. If we have two or more
industries emitting different substances, with
those substances intermingling, the results of
breathing such ambient air may be far more
dangerous than breathing just the one pollutant.
A program should be devised which would tend to
decrease such a problem.
On this point, we would also add
that dispersal of sources of carcinogenic air
pollutants is not an acceptable alternative to
controlling their emissions. Solution to
pollution by dilution is not a viable alternative.
The Association generally
approves the concept of risk assessment which
includes both carcinogenicity and exposure to the
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public. However, we feel that the EPA should
2 abandon its arbitrary reliance on ouantitative
3 risk assessment methods. They are simply too
4 unreliable and imprecise to play an important role
5 in determining the level of controls applied to a
hazardous substance.
While such estimates may have
g a role in the grossest form of priority setting,
9 j that would be valid only if the Agency more
explicitly recognizes the uncertainties of the
estimates and commits itself to not using them in
any vrav in subseauent standards setting.
The Association agrees that the
I 0
generic standards, discussed in the Register are
14
appropriate for the current effort to quickly
reduce fugitive emissions, storage and transfer of
16
carcinogens
18 However, we feel that the
19 should expand the scope of the proposed first-step
20 generic controls that will be applied quickly to
include those controls on process emission points
which are not expensive, or likely to be
23
22
inconsistent or duplicative of more effective
technological controls to be considered thereafter
25 Furthermore, the Agencv should
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1 consider restructuring these interim rules in
2 ways which may enhance voluntary compliance and
3 permit more effective enforcement.
4 Very careful consideration shoulc
5 be given to the siting of plants which emit
. i hazardous pollutants. At this date, data is
7 insufficient on the synergistic efforts of two
8 I or more pollutants as compared with the effect of
9 j a single r>ollutant. For instance, we know that
1Q : cigarette smoking and exposure to asbestos
| exacerbates the lung cancer problem.
12 Finallv, the Agency must take
13 into consideration all the costs of implementing
14 such controls. We agree that the cost to the
15 industries must be considered, since that cost is
16 passed on to the consumer. However, at the same
17 ! time, the Agency must consider not onlv the costs
18 of health care but the human suffering and trauma
19 which is caused to millions of Americans who will
20 contract some form of cancer during their lifetime.
2i How can you place a benefit-cost
22 concept on human lives and suffering?
23 Thank you.
24 CHAIRMAN ^ADHETT:
25 Thank you, Mr. Ozraore
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2 I would like to add one more
3 : thing. Congressman Eckhart sur>r>orts this in its
j
4 entirety.
5 j MR. KELLAM:
6 Mr. Ozmore, I have two related
7 ouestions and you mav want to submit them later
3 in writing during the rebuttal period.
9 On the second nage of your
10 | testimony, vou recommend that EPA establish a
n candidate list of carcinogens.
12 I would like to ask vou if vou
,3 have anv suggestions as to the criteria that the
14 Agency should use to select or nominate
15 substances to that list; and, secondly, given that
16 such a list would be Dut together, how should the
17 Agencv use this under Section 112?
lg MR. OZMORE:
How should the Agency use the
candidate list?
MR. KELLAM:
! Yes. It is not clear to me.
22 j
Bv "candidate" list, do you mean
a list of substances from which some should be
24
selected for regulation under 112? Or whether the
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entire list should be regulated as resources
became available? Or exactly what do you mean?
MR. OZMORE:
I would not answer that on mv
own since I am representing the Committee here;
and I think I would need to refer that to the Air
Conservation Committee for response.
MR. KELL.VI:
Thank vou.
MR. PATRICK:
Mr. Ozmore, I won't nut vou
on the spot and ask vou for details right now.
On the front page of vour
testimony vou made the statement that your
Committee recommended application of controls on
process points which were not extensive or
inconsistent or duplicative or more effective
controls that might be considered later.
Any Particular examples that you
might have along that line, we would appreciate
hearing about them.
MR. OZMORE:
Very well.
MS . A1IDERSON :
I had just one comment that I
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think that I would like to make for vou to take
back to vour Committee and mavbe have them think
a little further on this noint, and that is I
would -- reallv largelv discarding the notion
of Quantitative assessment since we know that the
potency of carcinogens can vary as much as a
millionfold or more; for example, if cigarette
smoke and saccharin were potent carcinogens, we
would probably have an epidemic on our hands.
It would certainly make some
sense, as far as EPA's thinking is concerned, to
take this into account in some fashion, that it's
a potent factor, that the state of the art, while
verv under-developed, is sufficiently developed
to take this into account and you emphasize the
idea of looking at cost to try to get the most
improved men in public health for the least
cost.
I think the proposal has
proposed limited use of ouantitative risk
assessment and I think it would be desirable to
have your group rethir.k this and look at the
proposal and think if vou think what is being
proposed is reasonable.
MR. nZMORE:
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Surelv.
MR . BAUMAN :
I would like to follow up just
with one more comment on Dr. Anderson's remarks.
On page four of vour testimony,
you suggest that the Agency must consider not only
the costs of health care but the human suffering
and trauma which is caused.
And I would like to ask vou if
you could consider how that might be done. I
realize that vou are saying that auantitative --
testimony is that quantitative risk-assessmen
may not be a wav to do that .
Yet I know of no other way to
consider that other than just arbitrarily. And
I would like to have some idea of how that might
be accomplished .
MR. OZMORE:
Well, I could go back to mv
earlier statement, that we think the burden of
proof has to be rilaced on the manufacturers of
the chemicals.
This concent already is embraced
in the Toxic Substances Control Act, which
Congressman Eckhart was very active in having
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1 enacted. We see no reason whv this same concept
2 should not applv to dangerous substances which
3 are already in the marketplace and in the
4 environment.
5 "The proof of the pudding is in
j the eating." If you test those chemicals and find
61
out that they are dangerous, they should not be
! admitted into the environment.
0
; We will look at that and see if
1 we can expand on it further.
11 ! MR. BAUMAN:
12 I guess what I'm saying is that
13 if you ask Industry to tell you how much human
14 suffering and trauma is involved, it probablv
15 will be very little.
16 MR. OZMORE:
17 That's the point I'm getting at
18 this morning. I don't agree with that.
19 CHAIRMAN PADGETT:
20 Thank you.
21 Excuse me. Are vou finished?
22 MR. BAUMAN:
23 Yes , sir .
24 CHAIRMAN PADGETT:
25 I have a question from the Floor,
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and I'll .lust read it as proposed:
"How does the witness
conclude that the number of
cancer tests presented by
the Policy will be significant
if the number is unknown?"
I don't know --
MR. OZMORE:
I think any increase is
significant, whether it is known or unknown.
CHAIRMAN PADGETT:
Let me ask you a Question
relative to siting.
*
You mentioned very careful
consideration should be given to the siting. Do
vou have any particular thought on siting?
MR. OZMORE:
I think you have to look at
the possible synergistic effects of whatever is
being emitted by the industries and look at those
synergistic effects to determine whether there
is going to be increased danger from the breathing
of the intermingling of two or more substances. I
is just not that simple.
Plants which cause synergistic
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effects should be dispersed.
CHAIRMAN PADGETT:
Thank you.
Any other auestions?
(There was no response.)
MR. OZMORE:
Thank you very much.
CHAIRMAN PADGETT:
Thank you very much.
We have a request from Steve
Davis and Dennis Lachtman to testifv now, based
on personal scheduling problems.
So, if there is no objection,
I will call on Steve Davis.
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STATEMENT OF STEPHEN C. DAVIS
MR. DAVIS:
Good morning, Mr. Chairman,
and members of the hearing panel.
My name is Stephen C. Davis.
I am Corporate Manager of Industrial Hygiene for
Utah International, Incorporated. I also serve
as Chairman of the Carcinogens Subcommittee of
the American Mining Congress.
With me today to testify is
Mr. Dennis S. Lachtman. Today we will expand
upon several of the t>oints made in the written
comments prepared by this subcommittee and
submitted last month by AMC on the proposed EPA
Airborne Carcinogens Policy and Procedures.
First it should be noted that
the American Mining Congress is an industry trade
association with membership of over 500 companies
actively engaged in the exploration, development
and production of essential minerals and fuel
resources vital to our country's continued
prosperity and national resources.
We are here to discuss a
regulatory proposal that may greatly affect the
ability of this industry to continue to provide a
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1 stable and secure flow of basic minerals resources
2 essential to our national productivity and
3 security
4 The points I will address todav
5 concern: One, the lack of a sufficient
6 demonstration of need for the proposed program;
7 two, the allocation of limited societal resources;
8 three, the premature nature of the EPA proposal;
9 and four, inconsistency of the proposal with other
10 | Federal carcinogens control programs. My
11 colleague, Mr. Lachtman, will focus his
12 presentation on what AMC feels is one of the
13 weaker points of the Agency's proposal, the-
14 listing process for carcinogenic substances.
15 In the preamble to the proposed
16 regulation, EPA suggests three basitr premises xfor
17 its proposal. These are: one, that cancer is a
18 serious life-threatening disease; two, that the
19 United States is suffering from an epidemic of
20 cancer, and that air pollution plays a significant
21 role in this cancer epidemic.
While we agree that cancer is
23 certainly a serious life-threatening disease,
- EPA's remaining premises are not supported by its
_ analysis in the preamble nor by the existing
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facts. Conseouently, EPA has not demonstrated
the requisite need for its proposed national
procedures.
EPA's implication that the
United States is suffering from a cancer epidemic
is based on the broad definition of an epidemic
as the excessive occurance of disease. In
medicine, epidemiology, however, the term epidemic
is normally applied to contagious disease and is
restricted to diseases that spread rapidly and
are temporary in nature.
Although the absolute number of
cancers has increased since 1930, the cancer
death rates, when adjusted for age, have remained
relatively constant and in some cases have
decreased. The overall cancer incidence rate, the
number of new cases adjusted for age distribution
of the population, has decreased slightly since
1950. The one major exception to this trend is
lung cancer.
As reported by the Surgeon
General in his 1979 "Report on Health Promotion
and Disease Prevention", overall cancer death
rates have increased only slightly for men since
1937 and have actually decreased slightly for
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women over this same period. However, if lung
cancer attributable to cigarette smoking, which
has been shoxro to be responsible for as much as
80 percent of the cancer observed, is eliminated,
the cancer death rate for both men and women is
actually decreased.
To turn to environmental factors
and air pollution, we see that EPA also
attributes a large proportion of cancers to
environmental factors. EPA indicates that the
"World Health Organiz
experts have suggeste
all human cancers may
We believe byusing a \
of "environmental fac
things as smoking, di
has by implication va
proportion of cancer
to air pollution and
chemical sources.
Dr.
Director of the World
International Agency
developed the concept
cultural as well as cJ
Century I
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tion, and other individual
that 60 to 90 percent of
be due to these factors."
ery expansive definition
ors" which includes such
t, and occupation, EPA
tly overstated that
ish which is attributable
n particular to industrial
John Higginson, founding
Health Organizations'
or Research on Cancer,
that the total environment,
emical, was responsible
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for environmental cancers. When questioned recent
Science about misinterpretation of his
conclusions relating to environmental cancers ,
he stated:
"They have been
misinterpreted, funnily enough,
not among the majority of the
scientists with whom I have
contact, but by the chemical-
carcinogen people and especially
by the occupational people,"
He further stated:
"I mean, people would
love to be able to prove that
cancer is due to pollution or
the general environment. It
would be easy to say 'let us
regulate everything to zero
exposure and we have no more
cancer.' The concept is so
beautiful that it will overwhelm
a mass of facts to the contrary."
He concluded:
"In other x^ords , I
believe that overemphasis on
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chemical carcinogens has
distorted our approach to the
environmental theory for
many cancers."
A little further on that
subject, Dr. Philip Handler, President of the
National Academy of Sciences, recently stated:
"Several hundred
specific chemical comnounds have
been thus examined in the last
few years and a considerable
fraction found to be both
mutagenic and carcinogenic.
Nevertheless, we should lay to
rest the idea that it is these
man-made compounds, abroad in
the land, that are responsible
for the fact that 24 percent
of Americans die of cancer.
They are not. The possible effects
of all known man-made chemicals,
when totalled, could contribute
only a miniscule fraction of the
total of all carcinogenesis in
our population. As I noted
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earlier, current age-corrected
incidence rates are much what
they were before most of these
chemicals were introduced into
our surroundings. They certainlv
cannot account for the even
higher age-corrected cancer rates
in some, more primitive,
countries which do not yet
enjoy the benefits of a diverse
chemical economy."
To turn now to the allocation
of limited resources, EPA acknowledges the limits
of our national resources in principle by
suggesting in the Dreamble that generic standards
will be "low cost and readilv implemented control
procedures." Yet the American Industrial Health
Council, AIHC, ooints out, based on a studv
conducted by Arthur D. Little, that the total
costs to industry to control a single organic
chemical, Benzene, would be 1.1 billion dollars
for generic and best available technology, BAT,
controls. AIHC also notes that costs to control
perchloroethvlene would exceed 100 million dollars
Fiftv-five million would be reauired for generic
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controls and 50 million dollars for BAT controls.
2 Thus, according to AIEC, the
3 cost to control only two synthetic organic
chemicals, Benzene and perchioroethylene, exceeds
1.2 billion dollars. Those figures do not include
, the other 38 chemicals or the countless others
o
_ that may be identified in the other five source
0 groups established bv EPA.
0
9 EPA's proposal is not low-cost
and it seems to misdirect our national resources
away from other more vital and more clearly
12 substantiated causes of cancer.
13 EPA proposed regulatory
14 procedures are premature, in our thinking, and
there are several reasons in our judgment that
16 EPA's proposed rulemaking is premature at this
17 time. Obviously, the first reason, as we just
1g discussed, is the absence of a demonstrated need
19 for these regulations.
20 EPA, as the hearing panel is
21 well aware, is participating in the effort of the
22 Regulatory Council to adopt a government-wide
23 policy for all federal carcinogen programs.
24 The statement published for
25 public comment in October 197^ bv the Pv.egulatory
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Council was auite detailed and raised a number
of significant, complex issues. Numerous comments
were received and if the final statement is to have
any real imt>act on federal agency nrograms, the
development of those programs should await
completion of the Regulatory Council statement.
Further, the EPA is part the
Interagencv Regulatory Liaison Group effort to
develon a common scientific basis for identificatio
of potential carcinogens and estimation of risks .
The ability of the IRLO to
achieve this goal will be severely hampered by
EPA promulgating precise regulatory procedures
at this time. Similarly, EPA *s flexibility to
implement IE.LG conclusions will be restricted.
The EPA's proposal is also
premature because the Agency has not completed
the regulatory analysis required by Executive
Order 12044 and by its own regulations. We
certainly agree with EPA that this is a major
regulatory proposal.
The potential effects of this
nrot^osal are extremely far-reaching. AIHC has
already demonstrated to this hearing panel that
the costs of applying BAT controls to only a few
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1 of the candidate substances far exceeds the 100
2 million dollar threshold for a full regulatory
3 analysis.
4 To sidestep the requirements of
5 Executive Order 12044, as EPA has suggested in
6 the preamble, is to make a complete mockery of this
7 Presidential directive. Until a regulatory
8 analysis is done, this proposal is premature.
9 Finally, I would like to talk
JQ i about guidelines instead of regulations..
jj | Finally on this point, we believe
12 if EPA adopts any procedures at this time, they
13 should be adopted as guidelines rather than rigid
14 regulations.
As Mr. Lachtman will discuss,
I the proposal contains many new concepts and
16 ;
important regulatory Phrases with x^hich there is
,0 | essentiallv no operating experience under the
I o *"
Section 112 program. Many critical terms are
either undefined or only briefly and vaguely
explained.
21
22 However, EPA indicates clearly
23 in the preamble that it considers that any final
24 rule will only be subject to judicial review in
25 the D. C. circuit. Further, EPA states that
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"litigation of the issues posed by this rule
will not be available in connection with
subsequent rulemakings in which it is applied."
While we seriously question this legal
interpretation, to the extent that EPA is correct,
a very clear understanding of the terminology
and the process described is critical to public
understanding and acceptance of the program.
Under these circumstances it would be far better
to publish procedures for this program as
guidelines rather than rigid regulations.
The present proposal gives us
the ver uncomfortable feeling that EPA wishes to
suppress discussion and preclude adjustment of its
procedures as the need arises. We definitely
appreciate certainty in any regulatory process bu'c
not at the expense of burdening all of us -- the
public, the Agency, environmental groups, and
Industry alike -- with a process that experience
may demonstrate is unworkable. Experience will
be our best teacher; maximum flexibility is
essential while we gain this experience.
Certainty, consistency and
predictability in regulatory programs are, of
course, extremely important goals to those
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1 regulated. One wav for E^A to achieve these goals
2 i is to assure consistency with other federal
3 carcinogen control efforts. Whether E^A accepts
4 or rejects our suggestion to publish its
c procedures as guidelines, there are several ways in
. j which it should change it s proposal to increase
6
interagency consistency.
I First, as discussed earlier in
0
my remarks, EPA should withhold further action
10 i on its policy and procedures proposal until the
11 \ Regulatory Council and the IRLG work is completed.
12 Second, as the Agency is well
13 aware, the Occupational Safety and Health
14 Administration, OSHA, just recently published its
15 final policy on "Identification, Classification
16 and Regulation of Potential Occupational
17 Carcinogens." OSHA and EPA act under different
lg authorizing statutes but, as in the past, both
19 agencies will potentially be involved in regulation
of the same substances and source categories.
2i Obviously, there will be a
22 significant need to have harmonious regulatory
23 procedures in these areas where the agencies'
24 interest will overlap. Divergent controls should
2s not result from essentially identical records.
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Turning to the provisions of
the OSHA t»olicy, we note that OSHA's Category I
Potential Carcinogens, equivalent to EPA's High
Probability of Human Carcinogenicity category, is
based on evidence of Carcinogenicity in humans or
in a single mammalian species in a long-term
bioassy where the results are in concordance with
some other scientifically evaluated evidence of
a potential carcinogenic hazard.
EPA's equivalent category only
requires that "best or substantial evidence exist
from epidemiological and/or at least one mammalian
study."
The EPA does not require
concordant evidence of Carcinogenicity to label
a substance as a high-probability carcinogen.
We believe the OSHA approach is more scientifically
sound and at least should be used by EPA as well.
EPA makes no provision for the
evaluation of non-positive results. OSHA, however,
stipulates that "where non-positive and positive
results exist in studies in the same species , the
non-positive results will be evaluated." This
allows the Agency to weigh evidence that refutes
the categorization of a substance as a carcinogen.
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1 EPA's unwillingness to acknowledge this type of
2 | evidence runs counter to good science and to the
3 best interest of the public.
i
4 ! That's the end of my
I
5 statement.
6 CHAIRMAN PADGETT:
7 Okay. Thank you.
8 We'll discuss this first ,'
j
9 before we move into the next one, I suppose. :
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10 MR. DAVIS: j
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11 Yeah. I think so. We were |
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"2 planning to just have the two testimonies together |
But if you prefer, we'll go ahead and I'll be open
14 for questions now.
15 CHAIRMAN PADGETT:
16 i Okay.
l
!7 j MS. ANDERSON:
18 | Yes.
19 j You started your statement
20 by saying that, in the preamble, EPA states
21 three basic premises --
22 j MR. DAVIS:
23 ( I actually said "suggests."
24 j MS. ANDERSON:
25 Your statement says "states" -
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1 MR. DAVIS:
2 j I know.
1
3 MS. ANDERSON:
4 Okay.
5 Because I find two out of
6 the three are rotten.
7 j MR. DAVIS:
8 Yes.
I
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9 j MS. ANDERSON:
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10 J But what I would like to do
11 | in a more constructive way, there is a paragraph
12 that I think does raise the issue and I would
13 like to know which parts of this statement you are
14 disagreeing with.
15 The paragraph taken from the
16 preamble says that:
17 I "...although airborne
18 carcinogens may induce cancer
19 j in a number of body sites,
20 lung cancer is thought to be
21 i a principal form of cancer
22 related to air pollution.
23 j "While cigarette
24 smoking is probably the most
25 important cause of lung cancer
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in the United States, many
2 scientists believe that various
3 j air pollutants increase the
4 risk of cancer from smoking
i
5 and other carcinogenic
6 insults.
7 "Available estimates
8 also indicate that occupational
9 exposures are responsible for
10 ; a significant portion of lung
11 ' cancer incidence in the United
12 | States."
13 Are you disagreeing with --
14 that -- I think that kind of summarizes what we
15 were saying.
16 Are you disagreeing with all
17 i that paragraph
18 i MR. DAVIS:
19 Let
20 MS. ANDERSON:
21 j -- part of it and if so which
!
22 j part?
23 MR. DAVIS:
|
24 Let me state that you'll notice
25 that we do say an implication that there is an
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1 epidemic. There are several areas in the preamble j
2 j in that same general area of the proposal that
3 ! tend to suggest that there -- the Agency considers
4 | this an epidemic, not in the classical sense but
5 i also that the epidemic -- a significant proportion
6 of that epidemic can be tied directly to air
7 j pollution.
8 i Quote:
9 ' "Cancer is
10 | currently the second leading
11 i cause of death in the
12 United States...."
13 A little further on down,
14 quote:
15 "The most recent
16 statistical " "recent
17 ! statistics show a continued
18 increase in total cancer
19 j incidence, due principally to
20 increased lung cancer."
21 | Further on down, under
22 | causes of cancer, importance of environmental
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23 ; factors,
24 j "Studies of human
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25 cancer rates and world-wide
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1 geographic variations and \
2 I observation of incident rates
3 in migrant populations revealed
4 the factors in the human
5 , environment are probably ;
responsible for a large
portion of cancers."
Moving over to the third
9 column, we discuss, finally -- part of the
10 ! sentence, it says:
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11 ' "The dimension of
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12 the problem posed by airborne
13 carcinogens remains significant."
14 And with those kinds of
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15 j statements, and particularly the link that is made
16 between the incidence of cancer and the problems
17 j of cancer and environmental factors and then
18 i focusing on the aspect of air pollution one comes
19 | to the conclusion that -- that the Agency is
20 suggesting this kind of relationship.
21 i MS. ANDERSON:
22 i Well, we certainly didn't
23 intend suggesting -- I think the language as it
24 was read to you -- that air pollution is causing
25 a major epidemic of cancer. I think what I read
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j
you quite accurately reflects what we're tring j
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2 to say. j
3 ! But more specifically in askin
4 j which of those statements in this paragraph you
5 ; would disagree with just to dissect it a bit do
6 you think that there are problems in occupational
7 exposures?
8 j MR. DAVIS:
9 i Where precisely are you? I
10 have the proposal in front of me.
11 j MS. ANDERSON:
12 I'm just asking you -- I'm
13 dissecting this paragraph a bit.
14 Do you think that -- are you
15 saying -- do you think that there are or are not
16 problems perhaps in the occupational environment?
17 | MR. DAVIS:
18 ! I think that if you --
19 MS. ANDERSON:
20 from air pollution.
21 1 MR. DAVIS:
22 ! In toe occupational environment)1
I
23 MS. ANDERSON: !
24 Right.
25
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1 MR. DAVIS:
2 Okay.
3 There are instances and
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4 certainly OSHA has regulated a number of
5 i carcinogens which have -- they had evidence of
6 ! causing excess cancers in ::the working population.
7 MS. ANDERSON:
8 Do you think the problem
9 j stops at the fence line of that industry or
10 * can it expand into the immediate surrounding
11 populations living near that industry?
12 MR. DAVIS:
13 I think that would be
14 something that certainly a reasonable person might
15 expect.
16 But in most cases it is
17 I yet unproven.
18 | MS. ANDERSON:
19 Do you think that the mandate |
20 that Congress has given EPA to regulate
21 carcinogens means that no regulatory action should
22 ! be taken until we can actually see if that's in
23 j the surrounding population by positive
24 epidemiology studies.
25
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1 MR. DAVIS:
2 That is a hazardous position
3 | to take.
4 : {Laughter]
5 j MS. ANDERSON:
|
Then -- how do we -- how do
we look at this particular problem outside the fence
i
What do we use -- in other words, what are you
9 i suggesting
10 MR. DAVIS:
11 j Again, I would hate to --
12 i retreat into a disclaimer, if you will, of not
13 being a toxicologist or an epidemiologist. But
14 some of the areas that Mr. Lachtman will address
15 and hopefully we will have further developed by j
i i
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16 I toxicologists and" biostatisticians relates to the
17 way in which the carcinogen becomes defined and |
j
18 i the way 'in which" it goes through the IRLG screen, j
19 i And I think it's a matter of
20 the mechanism by which you establish carcinogenicit^
2i ! a high probability, moderate and low, which is
22 very important --
23 I MS. ANDERSON:
24 I have just another topic,
25 one other question, and that is, you suggest that
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1 EPA should hold up its policy pending the IRLG 1
I
2 final considerations of permits.
3 First of all, just to commen
a bit, the document .that .was released By the IRLG
did have the agreement of the four major
regulatory agencies active in this area plus
participation from the National Cancer Institute.
8 i Comments have been submitted
i
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9 ! but OSHA did not withhold its policy pending final
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10 I consideration of these comments.
11 j The IRLG report does appear
12 to be consistent with other reports that have been
13 issued by other scientific bodies. You seem to be
14 dodging the OSHA approach. I wonder why you think
15 that EPA should hold up its -- its policy --
16 j MR. DAVIS:
17 { Okay. Two -- two responses
18 | to that.
19 I As I understand it, first of
20 all, the IRLG document is not finalized and it
21 . has not received full scientific review by the
22 ! scientific community.
23 i All the comments are not in
24 : and have not been digested.
25 I Secondly, with regard to the
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1 OSHA policy that's currently presented, we were
2 || simply pointed out some advanteages not necessarily
I
3 , concurring with the -- with the total policy.
4 j| MS. ANDERSON:
i
5 Now, the --
I
6 MR. DAVIS:
I
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7 And certainly the inconsisten-
8 cies that exist between the two -- the OSHA rule
9 and the current proposal.
10 | MS. ANDERSON:
11 ! Yes-
12 We have heard some other
13 comments, primarily from environmental groups,
14 suggesting that it is more automatic to have
15 I a specific category.
16 ' EPA has -- took its approach
17 i three and a half years ago before OSHA's policy
18 ' was -- was even proposed and that was to take
19 it -- take the approach of considering all of the
20 data in the aggregate on a case-by-case basis
21 by certainly considering all negative data, all
22 ! positive data, so as not to have automatic triggers
23 that would throw a chemical into a particular
24 i category since in looking at the evidence we have
i
25 seen that the quality and kinds of studies that
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1 have been conducted^have varied enormously.
2 j I think in taking this
!
3 approach they certainly didn't plan -- EPA 'to
4 i ignore anything but rather quite the contrary.
5 | I wondered if you had happily
6 been over or reviewed the EPA's guidelines for
7 taking this weight-of-evidence approach?
S
8 | MR. DAVIS:
]
9 | One of the things that we
10 i find in the current proposal is the lack of
i
11 explicit statements with regard to the use of
i
12 non-positive data and I think there was an early
13 statement and I'm not going to attribute it to
14 which speaker but there is a concern that the
15 terms are vague and that we just do not see any
16 opportunity for full scientific input into the
17 | process.
18 | Now, perhaps the Agency has
19 | implied these. But they are not -- they are certainly
20 not explicit as we see it in the proposal.
21 ! MS. ANDERSON:
22 | Do you find that the OSHA
23 | the OSHA approach to categorizing carcinogens more
24 acceptable than this weight-of-evidence approach?
25
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MR. DAVIS:
Not necessarily more
acceptable. What we had spoken to was the aspect
of concordant evidence, the need for having
substantial additional evidence to back that up.
And, again, I would suggest,
not to defer, but I would suggest that Mr. Lachtman
will be dealing with some of those issues.
MS. ANDERSON:
along this line.
And just one final question
Since you did mention the
OSHA approach, do you think that in their policy
they have permitted more public participation
in a scientific presentation of data than EPA
is considering in its policy is that one of your --
MS. DAVIS:
It would appear that there
is more public participation available in the
OSHA approach and also that the record, if you
will, will be reopened and reexamined by any
interested person.
MS. ANDERSON:
My colleague just pointed out
one thing that I think you did admit from your
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1 testimony and that is in pointing to inconsistencies
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3 evidence on how probability carcinogenicity |
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4 you mentioned that it's inconsistent with OSHA '
!
5 with regards to OSHA considering epidemiology !
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6 i plus a single mammalian species, OSHA's third
7 category is a single mammalian species in an
8 adquately-conducted long-term bioassay study in
|i
9 appropriate circumstances where the Secretary
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10 ! determines the requirement for concordance is
i
11 i not necessary (sic).
12 So I think this does put --
13 put the --
14 MR. DAVIS:
15 Where the Secretary determines
16 that concordance is not --
17 | MS. ANDERSON:
18 In other words, OSHA is
19 saying that in appropriate circumstances, one
20 species might be okay with them, too.
21 MR. DAVIS:
22 In certain circumstances.
23 But that is not apparently an assumption at the
24 outset,that would be by exception rather than the
25 rule. That's the way I would interpret that.
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MR. JOHN ZIMMERMAN, S3.:
If I might clarify just one
point about our view of -- the Mining Congress
view of this thing.
I'm John Zimmerman, Sr.,
Counsel for the Mining Congress.
In relationship to OSHA
versus EPA, what we hear you saying I think I like
the sound of.
But our problem is the
words in the proposal don't seem to carry out
all the contexts we hear coming from the hearing
panel.
And, of course, what we're
premising our testimony and our written comment
on is the precise words that we see in the
proposal.
In terms of the weight-of-
the-evidence test, we certainly applaud your use
of a weight-of-the-evidence test. But what we
felt when we read your proposal, your October 10th
proposal, was some pulling back from that weight-of4
the-evidence test, a very selective use of
phraseology from the interim guidelines.
And particularly in terms of
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a seemingly reduction in this peer review that
]
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2 precedes the listing action, I think that the i
!
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3 point we're trying to make on the OSHA policy here j
j j
4 is the weight of concordant evidence and the
i
5 consideration of concordant evidence seems to
6 be partly OSHA proposals.
7 We don't like necessarily
8 i in OSHA the automatic-listing aspect of the
9 i proposal. But certainly the consideration of
!
10 | concordant evidence seems to be more possible in
i
11 the OSHA proposal than in the EPA October 10th
12 proposal.
13 And certainly when they do I
14 have that third category for one animal test without
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15 I concordant evidence, they raise that to a very
16 high level to Agency determination before they're
17 willing to accept a one-mammalian test. It has
18 j to be a Secretarial decision.
19 We don't get that sort of
20 feeling out of the October 10th EPA proposal.
21 MS. ANDERSON:
22 Just a comment on that.
23 If that's the way it comes
24 across, I think that is just a problem with the
25 i verbiage in the proposal because I know the
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proposal -- I can't tell you exactly now where it
2 refers to both the IRLG document and the EPA interi
3 guidelines.
4 And it says that policy will
5 follow both and both policies certainly emphasize
the importance of taking all data in the aggregate
when considering evidence of carcinogenicity and
8 1 the guidelines are quoted in part.
j
9 j] Perhaps if it doesn't come
10 i across clearly, that's a problem that we can take
11 I into account in rewriting, just to be a little
1
12 clearer.
13 CHAIRMAN PADGETT:
14 Any other questions?
i
15 | MR. PATRICK:
16 Just one real brief point of
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j
17 ! clarification.
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13 i In your discussions of
19 { resources, you reference this recently completed
20 R- D. Little assessment for the American Industrial
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2i Health Council.
22 | I don't think we need to get
!
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23 j into that because they made their presentation
24 in Washington. We will be getting back with them
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25 at a later date to discuss those their
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assumptions and their numbers and their conclusions
I I did want to just clarify
one point and make sure that you understood. You
discussed -- you began a particular paragraph by
saying the generic -- talking about generic
standards as being in EPA's words "...low-cost
and readily-implemented control procedures."
And then you immediately
started talking dollars in terms of both generic
and best-available-control technologies --
MR. DAVIS:
It seems like a reasonable
thing to group those, because that is a sequential
thing -- not an automatic, but a sequential
ocurrence.
And we did split figures and
show the figures for generic versus BAT -- and I
think the Little study does that kind of thing.
MR. PATRICK:
They split the costs and we
will be discussing their assumptions with them
later.
MR. DAVIS:
Right.
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MR. PATRICK:
I just wanted to make sure
that you didn't think that our statement that
generic standards were low-cost implied in any
way that we were saying that the best available
technology was low cost.
MR. DAVIS:
No.
MR. PATRICK:
Okay.
CHAIRMAN PADGETT:
I have a couple of questions
from the audience. One I should have asked
Dr. Gunkler, I guess, first.
"If there is no
proof that industry _
emissions cause lung
cancer, how do you explain
the Anderson data which
shows dramatic increase
in lung cancer down along
the Houston Ship Channel
industry?"
MR. DAVIS:
Certainly, I'm at a loss to
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I
to explain the Anderson data since I'm not j
I
2 j familiar with it.
i
3 }| CHAIRMAN PADGETT: i
i i
4 Another question which refers i
to the guidelines. Perhaps this will be addressed |
by the next speaker, but:
"If you are trying
to eliminate inconsistencies,
why do you want guidelines
an uncertain enforcement
rather than rigid regulation?"
12 MR. DAVIS:
Perhaps we -- I don't know
whether I can answer that, except that I guess in
15 a sense by backing off the question a little bit
16 and look at the procedures as they are currently
written.
What we see is throughout
the process, both in the process, if we look at
20 the beginning stages of the candidate substance
2] i and the listing as a high-probability carcinogen
22 ! with automatic implementation of generic controls
23 and then the possibility of going on to BAT and
24 then even higher control mechanisms, we see an
25 i automatic thightening process..
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We see -- and again, maybe I should \
I
I
stop on this, because I believe Mr. Lachtman i
I
does refer to it. j
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We also see that the procedure,
I
as they are written at this point call for a review;
in five years, again with the view towards
tightening the controls.
And if that gets locked in,
that kind of thinking, then we have some problems
with it. There are other areas, again, I think
Mr. Lachtman will address, that we have concerns
about in terms of vague terms which have not
been defined. We don't they've been defined
adequately in order to be able to define them.
MR. JOSEPH:
Have you identified them
more specifically in your written comments?
MR. DAVIS:
Yes.
CHAIRMAN PADGETT:
Okay. Thank you very much.
MR. KELLAM:
Mr. Davis, on page 4 of your
testimony, as part of your discussion of the
implied cancer epidemic and the role of air pollutio
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1 j in cancer incidence, you consider the lung cancer
2 as attributable to cigarette smoking, and I quotes
3 | "...which has been
i
4 shown to be responsible for
5 i as much as 80 percent of the
6 cancer observed."
7 And eliminating that, conclude
8 j that the cancer death rate for both men and women
9 | is actually decreasing.
10
1
|
11 | One of the earlier witnesses
12 today presented testimony citing the .potentiation
13 of cancer risks by combination of cigarette-smoking
14 and other agents, such as ionizing radiation and
15 asbestos.
16 ; Do you generally agree with
17 , those studies that have shown potentiation? !
i i
18 MR. DAVIS: j
i
19 I I think there is evidence
20 that would indicate that there is potentiation
21 between cigarette-smoking and tobacco-smoking.
22 i I would also further state
23 that in the general thought of that thinking that
24 we try to present with that argument is that
25 and I think -- I can't find the statement and
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precisely quote it but we feel that perhaps
2 these efforts controls (sic) are misdirected when
3 I in fact it is acknowledged that cigarette-smoking
is such a major contributor to lung cancer and
that we do have limited national resources and
6 ! that cancer is a severe problem and that perhaps
7 these resources should be directed or allocated
elsewhere in cancer prevention and controls.
9 CHAIRMAN PADGETT:
10 All right. I think we need
11 to move on.
12 MR. DAVIS:
13 Thank you very much
14 CHAIRMAN PADGETT:
15 I Thank you.
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STATEMENT OF DENNIS S. LACHTMAN
MR. LACHTMAN:
Good morning, Mr. Chairman and
members of the hearing panel. My name is Dennis
S. Lachtman. I'm Director of Health Sciences for
Envirotech and I serve on the American Mining
Congress Carcinogens Subcommittee.
We share with EPA the goal of
assuring protection of public health from hazards
associated with carcinogenic substances. I think
xtfe all recognize our national resources are finite
so we should channel our efforts to maximize the
health benefits derived from commitment of
resources to pollution abatement.
There are several aspects of the
EPA proposal which need improvement to optimize
health benefits. I will concentrate my remarks
on the changes we feel are necessary in the listing
procedure segment of the proposal. Our written
comments address other stages of the procedure
as well.
Throughout the nroposal there
are numerous terms critical to an understanding
of the listing procedure that are not adeauately
defined.
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The very broad spectrum of
interpretation is possible for many of these
terms. Such terms, as "significant risk to
public health," "ample margin of safety," and
"unreasonable risk" need more definition. While
such terms are discussed conceptually, the
specific application of these conceptual phrases
i s left to interpretation.
A ^olicy so critical to the
interests of the public health should not be
left to subjective interpretation.
The term "unreasonable residual
risk" can only be interpreted on a subjective
basis in the present proposal. Describing an
unreasonable residual risk as a function of
protection with an ample margin of safety compounds
the ambiguity. To understand what constitutes a
reasonable versus an unreasonable risk requires
more guidance than is provided in the proposal.
The term "sufficient quality" is
used by EPA to justify reliance on only one
positive anir.-.al study without a second "positive"
study in a different species. EPA states that
when the original study is of "sufficient quality"
an assessment of carcinogenesis can rely on that
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one study. The undefined use of this term makes
this EPA policy statement extremely ambiguous.
No criteria are advanced to define what constitutes
a study of sufficient quality.
Where critical terminology is so
vaguely defined, there is a real danger that the
best interests of the public health may not be
adequately protected from potentially ill-advised
subjective interpretations in the future.
Section 112 listing requirements
basically hinge on two criteria. These criteria
are: one, whether a substance appears to
demonstrate that it is a high-probability human
carcinogen and, two, whether there is evidence of
significant public exposure via the ambient air
from emissions.
We find these criteria for
listing are unclear and incomplete. The
probability-determination -- high, moderate or
low probability -- fails to reouire adequate
analytic interpretation of animal and human data.
The proposal also refuses to
consider negative finds, i.e., data rejecting
carcinogenic activity. It is strongly implied
that any one positive result must prevail over a
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spectrum of negative findings. As a matter of
scientific inquiry, this viewpoint is unacceptable.
It is not appropriate to use a
single positive response from an animal bioassay
to always override the negative results from
numerous other studies having an equal or superior
degree of reliability.
Limitations and conclusions must
apply to any study, be it negative or positive.
Just as any negative conclusion must be defensible
and reliable, so should any positive conclusion
be properly interpreted and have adequate
documentation.
A reasonable and prudent
scientist has no difficulty in recognizing that
in general, a "yes" statement has the same value
as a "no" statement. Certainly a mechanism must
exist to evaluate the quality and adequacy of
study design.
The value of animal experiments
and human studies can vary tremendously according
to the quality of the experimental protocol and
the adequacy and reliability of the data --
CHAIRMAN PADGETT:
Excuse me a second.
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If there's a way that you can
summarize some of your statement, if you would
do that, it would give us more time --
MR. LACHTMAN:
Surely.
The other variable for the
listing procedure is evidence of significant
public exposure. The problem here is one of
terms.
Exactly what determines whether
a significant or nearly significant or barely
significant exposure occurs? The criteria for
what constitutes the number of people exposed and
at what levels needs elucidation.
It is unreasonable for EPA to
expect people of divergent views to readily agree
upon this vague term. This lack of definition
has a propensity to deter efforts to protect the
public health.
It appears that EPA in the
listing requirements is reiving in part on the
draft IRLG criteria. The IRLG draft document
does not take a well-balanced approach to
evaluating animal data in determining
carcinogenicity. The IRLG screening method would
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be more effective if replication of animal data
played a more important role in determining
carcinogenieity.
While the IRLG report states,
"The methods used for regulatory purposes in making
a qualitative determination that a substance poses
a carcinogenic hazard to humans are based on a
substantial scientific concensus that has emerged
from experience, research, debate and review,"
there is no indication of the false-negative and
false-positive rates implied by the proposed
screen.
They do introduce a note of
caution on false-positives. However, the National
Cancer Institute researchers go much further in
their statement, and I think it is important to
read this:
"There is danger in relying
solely upon statistical significance
without incorporating biological
knowledge and corroborative evidence
such as the presence of a dose-
response relationship or experimentally
consistent results in different
species or sexes."
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The problem with the IRLG
screen is that the quality of data and statistical
methodologies consistent with biological
principles are not adequately considered. As
reported in a criticue by the Engine Manufacturers
Association, EMA, to the IRLG work group -- by
using a study design similar to that recommended
by the IRLG -- the probability of labeling a
harmless substance as a carcinogen can be
staggeringly large.
Further, for example, in using
ten animal studies, like the one used in the IRLG
screen, it was determined that of every thousand
harmless substances tested only two will escape
the carcinogenetic label. What this'means is
that 998 substances of 1,000 tested that do not
cause cancer would be falsely labeled. These
substances would be banned or saddled with a false
label and subsequent unnecessary regulation.
While it is beyond the scope of
this present testimony to go through EMA's
mathematical derivations, we would be happy to
supply them in the future and we are attempting
to amend them in a more standardized form. But
it is -- we will get back to that later.
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But statistical errors and
probabilities of this magnitude clearly
overestimate the risk of cancer and appear to
be disproportionately exaggerated.
False-positive and false-negative
rates for any hypothetical screen can and should
be examined in detail for a variety of hypothetical
spontaneous tumor rates and carcinogenic effects.
The optimal strategy should have both the false-
positive and false-negative rates at reasonable
low levels.
The bioassay procedures and
screens relied upon in the EPA airborne
carcinogen listing proposal do neither of these.
Generally speaking, the cancer assessment listing
methodology oversimplifies what is a very complex
situation.
Ergo, the state of the art in
cancer-identification is far more complex and far
more unknown than I think is stated.
Another problem with the general
criteria for listing of carcinogens is the
failure to adequately consider potency. The two
criteria -- carcinogen Probability and significant
human exposure -- contemplate prioritizing by the
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Agencv so that the most important substance
from a public health standpoint are regulated first
Potency should be an equally
important consideration in setting priorities for
listing. Accordingly, it is inappropriate to place
substances which may vary as much as a millionfold
in potency in the same category.
No consideration has been given
to either the relative or absolute potency of
carcinogens. This is surprising. It is widely
recognized that chemical carcinogens exhibit a
wide range of potency in laboratory animals. For
example, using rodents, it has been estimated
there is a millionfold difference in potency
between aflatoxim B1-, one of the most potent
carcinogens known, and sacchrine, one of the
weakest.
A rational balance should be
attained between the risk and benefits in the
regulation of carcinogens. It is vital to develop
some scheme to estimate potency.
In terms of the mechanism for
correcting listing procedures, by erroneously
identifying substances as carcinogens, there is a
potential danger to public health. Many important
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and useful substances could be replaced by more
harmful materials. Valuable drugs or chemicals
could be discontinued on the basis of flimsy or
unsound data. In cases where substances are of
vital importance and substitutes are not likely
to be as efficacious, it is necessary that a
mechanism exist for correcting improper listing
actions.
The results of one poorly
designed animal study should not determine that
a non-carcinogenic substance will be listed and
regulated as a carcinogen.
There is no means identified in
the EPA airborne carcinogen listing procedure for
removal of an improperly listed substance. This
is a major problem. A means must be devised to
rectify this inadequacy. One suggestion is for the
scientific review panel that you've heard so much
about -- independent. I think another course
would be to open up the criteria for listing.
In addition to the scientific
flaws in the proposed listing process, there are
significant procedural problems we perceive.
Essentially, there is a complete absence of public
participation in the listing of a substance as a
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hazardous air pollutant under Section 112 of the
Clear Air Act.
I'm happy to see that this
apparently is not the intent. As we've stated
before, it is the language. But it is not the
intent that we wanted.
The only public involvement
prior to listing is the totally passive one of
being "notified" of EPA's preliminary screening
process and determinations of carcinogenicity.
Such a lack of direct public participation prior
to listing is contrary to Executive Order 12044
which requires that opportunities be provided for
early public participation and comment. Further,
EPA's- proposed process violates the requirement of
Section 117 (c) of the Clean Air Act that EPA
actively consult with appropriate advisory
committees, independent experts and federal
departments and agencies prior to such a listing.
Limited participation to the
post-listing establishment of generic standards
or final emission standards is too little, too
late.
Public participation prior to
listing is especially critical because the proposed
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EPA scheme does not appear to allow a substance
to be unlisted.
Nowhere in the discussion of
subsequent proceedings, such as setting generic
standards or final emission standards, is there
recognition that regulation of the listed pollutant
may not be appropriate.
This is particularly clear in
EPA's statement that quantitative risk assessment
will only be used for setting priorities or
setting the degree of control necessary for a
particular source category.
Every phase of EPA's process
after listing involves decisions that can only
lead to tighter controls. Even the five-year
review of standards is limited to tightening
controls. We sincerely hope that the lack of any
procedure to remove a pollutant from the Section
112 list is an oversight. The absence of such a
procedure in the present proposal is contrary to
the authority provided in Section 112.
The procedures should allow
relaxation of standards based on new or different--
or information which is preceived to change.
And I think that's the basic
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tenet in science. This is basically not true if
it does change.
And, also, as I said before,
we don't share EPA's view that there are
"...limited direct consequences of listing..."
procedure.
And in terms of the use of
quantitative-risk assessment under 112, we feel
that, rather than being used in the prioritization
sense, that that is really only being used or
that that's akin to being used to tightening a
noose rather than an open scientific process.
So we feel that there's a
maximum -- there's a very limited -- finite amount
of resources. And in order to prioritize things,
it'd be heluful to have auantitative process
available in the listing procedures, you know,
rather than listing thousands of things initially.
I think the first things
listed should perhaps be the most important.
And I think that's all.
CHAIRMAN PADGETT:
Thank you.
Mr. Kellam?
Perhaps I can just ask the
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second part of my question which is, in view of
the fact that there may be significant potentiation
of cancer incidence for people who both smoke
and are exposed to environmental agents, do you
feel that it is appropriate to exclude the lung
cancer incidence that you would normally attribute
to smoking in reaching a conclusion that
perhaps the overall rates of cancer are decreasing
and, therefore, such things as air pollution may
not play a signifcant role?
MR. LACKTHAN:
I think if one is looking
at a significant role and stepping back away from
EPA for a moment, if one were in a position of
omnipotence, if you look at the problem, you
certainly would eliminate cigarette-smoking,
because that is the proven cause and there may
be synergism.
I think that air pollution
still remains a problem. If you see that
syngerisra, I think that is clear that there is
still a problem there.
But I think that we have a
situation of priorities here, and I hate to see
something so simple as reduction in tobacco is
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1 overlooked at the expense of something that is
2 far more difficult to control. I think they both
3 should be controlled.
4 MR. KELLAM:
5 Would you make any distinction
6 between what some people would consider the
7 voluntary risk of smoking versus the involuntary
8 risk of exposure to environmental or ambient
9 environmental substances?
10 MR. LACHTMAN:
11 Yes. Well
12 MR. KELLAM:
13 Exclude the passive -- I
14 am well aware it's not really a voluntary risk.
15 MR. LACHTMAN:
16 Yes. I would make a distinc-
17 tion.
18 MR. BAUMAN:
19 Mr. Lachtman, I would like
20 to ask a qustion or go to a little bit -- might
21 comment on your testimony, I guess, having to do
22 with the comment that you made regarding public
23 participation while I realize that you have
24 summarize your comments, there are more intensive
25 remarks in your prepared testimony, however you did
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say that on page 8:
"Essentially, there
is a complete absence
of any public partici-
pation in the listing
of a substance as a
hazardous air pollutant
under Section 112 of the
Clean Air Act. The
only public involvement
prior to listing is the
totally passive one of
being, quote, "notified,"
unquote, of EPA's
preliminary screening
process and
determinations of
carcinogenicity."
My comment would be that
I think you quit reading a little too soon. The
statement in the Federal Register notice goes
on to say:
"This notification will
serve to advise the public
[unintelligible & inarticulate]
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. the local agencies and
2 industry of potential
3 hazards associated with
the substances examined
c will indicate which
, substances are receiving
7 further attention "
and I'd like to emphasize the next clause --
" and will request the
involvement of interested
10
11
parties --"
12 MR. LACHTMAN:
12 Is that notification prior
14 to listing?
15 MR. BAUMAN:
16 Of course.
17 MR. LACHTMAN:
I'm pleased to hear that,
19 and perhaps I did over look it.
20 Iljri not sure of the context
that completely. But I think, you know, if
22 that's mandated, I think there is a problem if
23 you propose something be listed, you know, there
24 are some psychological and other problems associated
25 with that if that's done in a cavalier fashion.
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I don't, suggest that would
occur, but it certainly is a possiblity. And
I guess then that was the point I was trying to
raake.
MR. BAUMAN:
Thank you.
MR. JOSEPH:
I would just like to ask you
two or three questions.
Two clarifications. I'd
like to confirm for you that this proposal is not
intended to override your Section 117 of the
Clean Air Act under which we consult with EPA's
Science Advisory Board before listing a substance.
I think we've mentioned
earlier this morning. And it's not intended to
override the provision of Section 112 itself
under which a substance is removed from the list
of hazardous air pollutants after a public hearing
after post-regulations and certain showings are
made.
My question is: You
suggested that rather than listing some very
large number of chemicals and then trying to
sort out what we should do, we ought to proceed
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1 to list just the most important substances first
2 and work on them.
3 I take it that you agree that
4 there are some substances, at least, then, which
5 we may find pose soiae risk of increased cancer
5 incidence?
7 MR. LACHTMAN:
8 Yeah. I'd be surprised
9 if there weren't.
10 MR. JOSEPH:
11 If
12 MR. LACHTMAN:
13 I mean, presumably, if you
14 found nothing, then I don't know what we're all
15 doing here.
16 I think that's an important
17 problem.
18 MR. JOSEPH:
19 Thank you.
20 MR. LACHTMAN:
21 But in terms of your comment,
22 I do respect the EPA Science Advisory Board. But
23 I don't think that they alone have a responsibility
24 of representing the entire scientific community.
25 I think there are pockets of
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1 intelligence in the scientific community that are
2 I outside the Scientific Advisory Board t hat perhaps
3 ought to be sollicited more often. They are on
4 all sides of the spectrum, and people that don't
5 have an opportunity.
6 And we're making our comments
7 to get the processes broadly as open as possible
8 and I feel that the people I have talked to on
9 occasion from the Scientific Advisory Board would
10 concur with that to have as much opportunity as
11 possible, because the area of carcinogen
12 estimation, treating cancer, is in such a state
13 of the Dark Ages that I think to limit, you know,
14 this course in conversation and exchange of ideas
15 is a mistake.
16 MR. JOSEPH:
17 I'.think as Mr. Bauman indicate
18 to you, the intent is not to limit it, but to
19 sollicit it.
20 MR. LACHTMAN:
21 I'm glad to hear that.
22 MR. BAUMAN:
23 Are you aware of the fact
24 that the Scientific Advisory Board meetings are
25 open meetings, open public meetings?
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MR. LACTHMAN:
2 Yes, I am.
3 MS. ANDERSON:
I am concerned about the rathe
5 extreme view taken regarding the language in the
6 proposal about the significance of one-animal
7 test and perhaps it is out fault but that seems
8 to be one of the thrusts in your testimony.
9 The Agency does have a track
10 record here for a little over three and a half
11 years now the Agency has been conducting scientific
12 risk assessments. There are quite a few documents
13 that have been made public.
I don't think in reviewing
15 this history you will find any evidence of a
16 single decision where a snap decision has turned
17 on one study without regards to all the evidence
in considering the significance of the study,
19 particularly where the response is borderline.
20 This one example comes to
21 mind and it was a pesticide where a decision was
22 made by the program office not to regard it as
23 a carcinogen based on the scientific risk assessmen
where there were two slight blips in two studies
25 in an array of about a dozen and these two slight
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blips were based on one pathologist's review of
the slides and in that case the data taken in the
aggregate was regarded as not evidence (sic) of
carcinogenicity.
So I turn your attention to
the track record of the Agency.
Nonetheless, I wonder how
you would feel -- are you saying that you think
we should rule out the importance-ofviewing one
positive result from a bioassay when you look
at cases such as aflotoxin where the rat was
positive, the mouse negative, the response to
the well-known carcinogen bischloromethylether
and now we're looking at results similar to this
where in fact the site of action is the same as
with bischloromethylether and that is the current
studies underway on formalydehyde, are you saying
that in no case -- understand your extremes on
the one hand, but now getting to the other hand,
are you indicating that you think there's -- there
might not be cases where the significance of one
positive aniiual-bioassay study would not be com-
pelling evidence for the Administrator's considera-
tion under this policy? (sic)
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] MR. LACHTMAN:
2 Oh, I think it certainly
3 could be and I wasn't saying -- wouldn't rule
4 out that case.
5 I'm saying that as I read it
6 and I think maybe my testimony wasn't clear, but
7 as I read the EPA policy, it appears that it has
8 to be.
9 And what I'm saying is that
10 I think in certain situations a positive study
11 that's well-executed and, you know, would be
12 considered by, you know, the state-of-the-art
13 scientists, you know, whatever, you know, to
14 be reasonably well conducted, you know, is an
15 appropriate, you know, area of concern.
16 I think it should try -- they
17 should try to replicate -- I know with the
18 ANNO-2 (phonetic) data, you know, in Germany,
19 there's a lot of problems trying to replicate
20 some of those data. We've been over there and,
21 you know, we've found some very interesting
22 reasons for why you can't replicate it. And we
23 don't suspect you ever will.
24 But getting back to the point,
25 you know, I think that you have to consider those
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1 things, because, you know, in the rhetoric, the
2 way it reads, if you limit yourself to the language
3 I think that it is very important to change that
4 language and also to give some sort of guidance
5 on whether it a high- or a low-quality study.
6 I think there have been some attempts to do that.
7 But if you define it a little
8 bit further, I think we will all benefit.
9 MS. ANDERSON:
10 The IRLG document certainly
11 attempted to do that.
12 MR. LACHTMAN:
13 I reviewed that document
14 rather extensively, and I think the data were
15 actually -- we are more guilty of not doing that
16 than your proposal.
17 The point I'm trying to make
18 is that you often hear this statement, that there
19 is "no free lunch." Protecting the public from
20 carcinogens, from a public-health point of view,
21 the best thing to do is to eliminate the exposure;
22 absolutely. To just shut everything down. Just
23 keep that narrow focus in regards to your objective
24 But perhaps there may be side-
25 effects of that, like, you know, perhaps
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1 substitutes --
2 [Extremely loud laughter
3 from the audience drowned out
4 several of Mr. Lachtman's words.]
5 MR. LACKTHAN:
6 -- perhaps people couldn't
7 eat. You know, unfortunately, we don't have the
8 luxury of being able to do that.
9 And so when you have a policy
10 that I have referred to as being overly pessimis-
11 tic and you make the Class-I-type error or you're
12 overestimating the occurrence of something, you
13 have no assurance in terms of a substitue that
14 the agent you're replacing is going to be
15 more efficacious -- or in fact it could be
16 a real danger to public health because it may
17 be more harmful.
18 And I think, you know, we have
19 seen this -- don't quote me on this -- but --
20 [Again, a burst of extremely
21 loud laughter from the audience
22 obliterated several words.]
23 MR. LACK THAN:
24 -- something such as DDT, you
25 know, that was not a -- that was an environmental
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problem in terms of human exposure in the
organophosphates.
Certainly, there was some
problems to humans that occurred with OP ' s that
were never seen with DDT.
And I would suggest that
there's a misapplication, there's an overreaction
here. And I don't want to get some people in
the petroleum industry upset with that. But I
think that's a concrete example of where., you know,
there's an abuse on one side, you jump the gun
to the other extreme, you have more problems.
CHAIRMAN PADGETT:
Okay. Thank you very much.
The next one -- speaker
scheduled is Ivan Smith. And then there's one
other person who asked to speak before lunch.
Now, the question I have is
Is Mr. Smith in the audience?
MR. SMITH:
Yes.
CHAIRMAN PADGETT:
Raise your hand.
Do you have any problem with
speaking after lunch or do you have --
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1 MR. SMITH:
2 Whatever you prefer. It will
3 be less than ten minutes.
4 CHAIRMAN PADGETT:
5 Okay.
6 I suggest, then, that we
7 take Mr. Smith and then Mr. Dillard, who is
8 substituting for Mr. Button, who also has a
9 short statement. So I suggest that we take those
10 two statements before lunch; and then we will break
11 MR. L. L. KROHN:
12 I was scheduled to -- In order
13 to make travel arrangements, I request to speak
14 before lunch also.
15 I was advised that you were
16 going to go through lunch.
17 CHAIRMAN PADGETT:
18 This is much more interesting
19 than eating.
20 Do you have any problem with
21 speaking right after lunch? It will be one
22 hour right after we break.
23 I think Mr. Dillard will
24 be first and then we will take Mr. Krohn.
25 Is R. G. Dillard in the
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audience?
(There was no response.)
Mr. Krohn? Sir?
iSome collateral, unrelated
conversation ensued off the record.J
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-b
STATEMENT OF R. G. DILLARD
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MR. DILLARD:
Mr. Examiner, ladies and
gentlemen, my name is R. G. Dillard and I am
appearing on behalf of the Texas Chemical Council.
The Council is an association
of S3 chemical companies and indirectly affects
420,000 Texans employed in the chemical industry.
Over half of the nation's
petrochemicals are produced by member companies
operating in Texas. The Council has a long history
of cooperation with the State and Federal agencies
in the furtherance of responsible environmental
legislation and regulations. We appreciate this
opportunity to comment on EPA's Airborne
Carcinogen Regulations and Proposed Generic
Standards.
First, the basic premise of
the EPA's Airborne Cancer Policy needs to be
examined. An often-quoted estimate used by the
EPA is that 60 to 90 percent of all human cancers
may be due to "environmental factors." It
should be emphasized that the term "environmental"
is being applied in a very broad sense. This
broad definition includes:
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"Chemical exposures from
smoking, diet, occupation, drinking
water, and air pollution; various
forms of radiation, including
sunlight; and some forms of
physical irritation."
The use of these "environmental
factors" in pointing to a cause of cancer, does
not suggest any direct relationship between cancer
and air pollution, and in fact, is not far from
the erroenous view that everything causes cancer.
According to the American
Industrial Hygiene Council, the evidence the EPA
cites to link cancer to industrial air pollution
consists of "recent findings suggesting that a
large number of airborne chemicals and
radionuclides to which people are exposed may be
implicated in cancer and other diseases related
to genetic damage."
From this quotation, the EPA
infers that the ambient air is filled with
chemicals causing serious harm to human health.
A more accurate conclusion would be that some
substances x\rhich may be carcinogens at high-dose
levels are found onlv in trace concentrations
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in the atmosphere.
The primary argument presented
by the EPA in justification of the Airborne
Carcinogen Policy rests on the Agency statement
that cancer rates are increasing due primarily
to increases in lung cancer, and that lung cancer
is thought to be the principle form of cancer
related to air pollution.
It is on this basis that the EPA
feels that the standard is necessary to protect
the public health. The fact is, as shown by an
article in the Scientific American by Cairns and
cited by the EPA, the lung cancer rate is
increasing only in women. Further, the 1979
Surgeon General's Report on Smoking and Health,
also cited by the EPA, states:
"Increases in lung cancer
mortality among females cannot
be explained by exposure to
Occupational Carcinogens.
Increases in cigarette consumption
are responsible for these trends."
Thus, by citing this report,
the EPA itself has indicated that cigarette
smoking, not air pollutants, is responsible for
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163
the increase in lung cancer mortality rates in
The TCC is supportive of
meaningful regulations which have a clear
demonstrative need. The study cited by the EPA
shows only that :
1. Cancer is a serious health
problem in our society.
2. Various substances inducing
carcinogenic effects at high dose
levels can be found in trace
concentrations in the ambient air.
The evidence does not establish
that exposure to the levels of substances which
are found in the ambient air either cause or
contribute to cancer. In addition, the EPA fails
to show that industrial emissions are the source
of these trace substances. On the basis of
these observations, the TCC feels that the EPA
has not justified a crash program -- and I
emphasize that -- has not justified a crash prograrr
to solve a problem for which there is a
questionable need and an undemonstrated urgency.
In fact, hasty adoption of the EPA ' s Proposed
Airborne Carcinogen Policy could dilute ongoing
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164
efforts for controlling the carcinogens through
established regulations.
Once again, the TCC is supportive
of meaningful regulations which have a clear
demonstrated need. The generic standards proposed
on October 10 failed to show a demonstrated need,
and they are redundant with existing regulations.
Fugitive emissions, such as those
the EPA proposes to control under the generic
standards, include ground-level emissions already
regulated by the Occupational Safety and Health
Administration, OSHA, requirements. OSHA has
adopted workplace performance standards for many
of the chemicals that the EPA may ultimately
regulate.
The EPA would be duplicating
OSHA's existing regulatory efforts in adopting
the proposed generic standards, and would impose
detailed work practice standards in addition to
those required by OSHA's existing performance
standards.
If OSHA's performance standards
are inadequate, or not being enforced, the answer
is not for the EPA to establish its own regulatory
scheme, but for OSHA to either more vigorously
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enforce its standards, or to change them. The
addition of the EPA Fugitive Emission Controls,
as proposed on October 10, would appear to give
little or no added benefit, in terms of reducing
harm to the public.
Pursuant to Section 110 and 172
of the Clean Air Act, the EPA expressly requires
all State Implementation Plans to adopt Control
Technique Guidelines within one year of
promulgation. The Proposed Control Techniaue
Guidelines will allow more control of fugitive
sources than the Generic Standards .
The Texas Air Control Board
regulations, which are a part of the State
Implementation Plan specifically control source
emissions of volatile organic carbon compounds.
Regulations V and VI of the Texas Air Control
Board set minimum standards for existing sources
and require any new construction or modifications
to control emissions well beyond the proposed
controls of the Generic Standards.
The Toxic Substances Control
Act evaluates and prioritizes the effects of
chemicals produced. These regulations zero in on
the most harmful chamical substances and direct
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j efforts towards their control.
2 The National Emission Standards
2 for Hazardous Air Pollutants already regulate
4 and control carcinogens, such as vinyl chloride
5 monomer.
Consequently, the means of
_ controlling airborne carcinogens through OSHA,
0 ! State Implementation Plans, the Toxic Substances
i
Control Act, and the National Standards for
1 Hazardous Air Pollutants are already in existence.
11 | These efforts should not be
12 diluted by additional general standards, such
13 as those proposed by the EPA on October 10. If
14 allowed to stand, these Proposed Regulations
15 would result in a needless duplication of efforts,
16 one of the very practices that Administrator
17 Costle and President Carter have most often spoken
18 out against.
19 The Texas Chemical Council feels
20 that the EPA's efforts would be much more effective
21 by taking steps towards enforcement of the
22 existing standards, rather than seeking a general
I
23 and diluted approach to a problem to which no
~ '
24 demonstrated need has been shown.
25 Finally, we feel that the legal
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I 167
basis for adoption of a generic standard under
Section 112 has a questionable origin. It seems
to be clear that the EPA views the Generic
Standards as interim measures to be adopted as
part of the phased program of emissions controls.
The Texas Chemical Council feels that this phased
approach is at odds with the approach of Section
112.
The language of Section 112
clearly shows that Congress authorized the
promulgation of only a single emission standard
or, in exceptional cases, a design standard.
There is no indication in Section 112 or its
legislative history that Congress intended the
Administrator to adopt a multi-step approach as
proposed in the October 10 Federal Register.
Furthermore, Section 112 speaks
in terms of setting an emission standard for
such "pollutant," for a "hazardous air pollutant"
and for such "hazardous air pollutants." It is not
apparent that a Section 112 emission standard can
or should cover a class of pollutants.
To avoid this legal problem, the
Agency plans to propose the Generic Standards for
a particular substance, when it is listed under
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Section 112, possibly with some customizing of the
standards. Such customizing, however, apparently
will be limited significantly in that only unique
and unusual situations will be a basis for
modifying the Generic Standards.
Consequently, we believe that the
Agency's scheme will apply the Generic Standards
to a number of substances and, thus, it effectively
becomes a generic standard which is not authorized
by Section 112.
In addition, the TCC believes
that the EPA misuses Section 112(e)(l) as a basis
for the Generic Standards. This section provides
that where the Administrator determines that it
is not feasible to prescribe or enforce a numerical
emission standard, a design standard may be
promulgated.
Section 112 (e) (2) provides
that, for the purposes of Section 112(e)(l), "the
phrase 'not feasible to prescribe or enforce an
emission standard' means any situation in which
the Administrator determines that (A) a hazardous
air pollutant or pollutants cannot be emitted
through a conveyance designed and constructed to
emit or capture such pollutant, or that any
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requirement for, or use of, such a conveyance
would be inconsistent with any Federal, State or
local law; or, (b) the application of a
measurement methodology to a particular class of
sources is not practicable due to technological
or economic limitations."
The use of design standards is
strictly limited to those situations which are
enumerated in Section 112 (e) (2). The Texas Chetnica
Council submits that there is no showing or
suggestion in the Federal Register documents that
carcinogenic substances, as a class, fall within
the exceptions enumerated in Section 112 (e), or
that the Administrator willmake the necessary
findings before applying the Generic Standards to
a particular substance. Absent the required
judgment of "infeasibility", the proposed
standards would not be authorized under Section 112
The proposed rule's framework
for listing also does not conform to the
substantive and procedural requirements of Section
112. Based on its inaccurate estimation of the
consequences of Section 112 listings, the Agency
proposes to list substances without thoroughly
evaluating all relevant scientific evidence to
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170
determine if a significant public-health risk
e xists.
B.ather than conducting the
quantitative risk assessments and exposure
analyses needed to make this determination, the
Agency intends to sidestep them. Instead of
addressing head-on the complex economic and
energy issues posed bv the threshold decision to
regulate, EPA defers tl.eir consideration.
Under the Proposed Rule, the
Agency runs the risk of promulgating costly
regulations only to find out later, after
conduting appropriate studies, that regulatory
action was not appropriate in the first place.
This approach is inconsistent with the language
of Section 112, the legislative history of the
Clean Air Act, recent case law, and fundamental
policy considerations.
Finally, the Agency fails to show
that the Generic Standards satisfy the ample
margin of safety requirement of Section 112(e)(l).
The Generic Standard scheme suggests that in most
instances the Agency intends to impose additional
standards to provide an ample margin of safety.
If the imposition of additional controls is
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required to provide an ample margin of safety,
then the initial controls, the proposed Generic
Standards, would not provide such a margin.
In summary, the Texas Chemical
Council feels that the Proposed Generic Standards
have shown little basis of need and no basis
for urgency, that the Proposed Standards would be
redundant with the existing regulations controlling
hazardous air pollutants, and have a questionable
basis of law under Section 112 of the Clear Air
Act.
Additional regulations would
divert time and economic resources away from the
existing programs resulting in dilution of
enforcement of meaningful regulations, which would
in turn, be to the detriment of the public interest
in developing an effective cancer regulation
program.
We appreciate y'all giving us
the opportunity to come forward.
CHAIRMAN PADGETT:
Any questions?
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1 MR. PATRICK:
2 One clafification, in your
discussion of Section 112 (e), where it discusses,
4 of course, the requirements for being able to
5 apply work practice standards, your statement that
6 v/e could not use work-practice standards under this
7 part of the Act, and I'm am just uncertain whether
8 your reason is that you don't believe or that
you believe that these emissions could be controlle
and/or measured, which seems to be the major reason
11 in Section 112 (e), that allow you to go to work
12 practices or --
13 I'm not sure which one of
'those two are you really banking your conclusion
15 on?
16 MR. DILLARD:
I would like for you to restate
18 that because the first part of your question is a
19 little vague to me.
20 MR. PATRICK:
21 Your discussion on page 5
22 of Section 112 (e)
23 MR. DILLARD:
24 Yes?
25
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-- that section says basically
that where it is not feasible to prescribe or
enforce numerical standards, that design standards
may be promulgated.
And then you give a couple
of criteria for determining whether we can go
that way or not.
I guess my question is: Ar.e
you saying that the emissions are not significant
and that is why we can't use the work practices?
Or are you saying that those criteria aren't met,
that you can, in fact, control those emissions
and measure those emissions -- which, really, are
the two criteria?
MR. DILLARD:
I think your question about
being able to measure -- I think the key question
here is that, having done so, is it still something
that should be controlled if it is not a data
basis, if it is something that needs to be
controlled?
MR. PATRICK:
So it is really significant?
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MR. DILLARD:
Yes.
MR. PATRICK:
That was just really for
ray clarification.
Thank you.
CHAIRMAN PADGETT:
Thank you.
Mr. Krohn?
MR. KROHN:
My name's Les Krohn. I'm
Manager of Environmental Control for the Marketing,
Refining and Transportation segment of the Union
Oil Company.
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STATEMENT OF L. L. KROHN
MR. KROHN:
Union directs its remarks to
the draft generic technical standards relative
to hydrocarbon exposure and leaks from refinery,
pipeline and terminal facilities. We would
refer you to the comments of the American
Petroleum Institute on EPA's proposed policy and
procedures for identifying, assessing and
regulating airborne substances nosing a risk of
cancer. We support those comments.
With respect to the draft,
generic technical standards, the proposed
standards parallelthe Control Techniques
Guidelines, the CTG's, concerning leaks.
Union has particpated extensively
with the API in developing these CTG's and worked
wLth the Radian Corporation in developing a data
base relative to refinery valve and flange leakage.
The EPA is currently proposing
generic standards which are more stringent than
those described in the CTG's and our experience
indicates this additional control is not warranted.
Union would point out that many
of our facilities are located in remote areas
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176
where exposure is at a minimum, far below any
risk assessment currently under consideration.
Also many of our crudes and
products contain minimal quantities of material
thought to have carcinogenic potential. Sweeping
regulations as proposed would include light oil
terminals and pipeline facilities as well as
refineries.
EPA is proposing a policy for
the identification, assessment and regulation
of airborne carcinogens. In that assessment, EPA
must consider, possibly on a case-by-case basis,
the impact of its regulations where actual
exposure is well below any carcinogenic potential.
Union provides the following
comments where we feel EPA is going beyond the
established CTG in considering a more stringent
standard.
With regard to the minimum
concentration of Benzene in a hydrocarbon stream,
we feel that 10 Percent should be the concentration
level to implement control procedures. This
, conforms to the 10 percent standards for vinyl
chloride.
A gaseous leak should be defined
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as 10,000 parts per million volume. This is
consistent with the CTG encompassing a vast
majority of emissions. Union has gone through
extensive testing and has successfully demonstrated
that the 10,000 parts per million level is the
minimum concentration that demonstrates
reproducibility.
The inspection schedule as
described in the CTG should apply for the generic
standards as well. Experience with equipment at
our facilities has demonstrated that the duration
of repairs and the frequency of leakage does not
warrant a monthly vapor-detector inspection along
witha complete and detailed record of emissions
and leaks. The cost benefit of a program of this
type is very unfavorable.
Although a 15-day repair
interval is at times adequate, there are other
cases where specialized labor and materials are
necessary to complete repairs. We would suggest
that a 45-day period be considered or that some
allowance be made for extenuating circumstances.
With respect to safety-valve
discharges, most refineries, including Union Oil
facilities, vent their discharges to flares. Such
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". 178
discharges cannot be accurately or visibly
monitored; however, the majority of carcinogenic
substances that mey be present would be destroyed
in the flame of the flare. Adequate technology
for reporting discharges from flares currently
does not exist. This requirement should be
deleted from the standards.
The reauirement to notify the
EPA Regional Office at least one week in advance
of certain inspections, observation and monitoring
is unrealistic and overly restrictive. Currently,
operational shutdowns and start-ups at our
refineries are conducted with the knowledge of
the local APCD and this should suffice for
environmental control of the operation.
The monitoring of seals on
compressors and pumps is routinely and adequately
done by our Operating personnel. In order to
inspect the shaft-seal interface by instrument
in many cases required that the guards be removed,
making the operation unsafe. Some leakage for
lubrication purposes is required, and we feel that
a visual inspection is much more reasonable and
practical.
The requirements to paint tanks
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white is completely unnecessary. Many tanks are
painted aluminum, a color that is comparable to
white. Much of Union's tankage has been painted
a soft pastel for aesthetic reasons and has been
readily accepted by the neighboring communities.
The tank-painting stipulation should be deleted
from the proposed rule.
The test method outlined calls
for reporting results as "ppm volume as hexane."
Test equipment can be calibrated with hexane and
results should be given as "ppmv calibrated to
hexane" as the test results cannot be accurately
reported as equivalent hexane.
Union intends the above comments
to be constructive and helpful in the development
of the generic standards.
Union has had over 85 years of
refining and pipeline experience that have
developed techniques for minimizing the loss of
fugitive emissions.
We are Proud of our maintenance
procedures and proud of our housekeeping and take
pride in our facility operations. If you should
have any Questions requiring further comment,
we'd be happy to reply.
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1 CHAIRMAN PADGETT:
2 I'm sure we have a few.
3 Just a minor comment on the tank painting. What
4 is the -- What do you estimate that the white
5 versus some other color or aluminum amounts to
6 in terms of reductions of emissions?
7 Is it your opinion that --
8 MR. KROHN:
9 There's a slight difference.
10 There are some engineering standards for that.
11 There would be a slight variation.
12 CHAIRMAN PADGETT:
13 You're suggesting that it's
14 ' just not worth it?
15 MR. KROHN:
16 Yes. It's not worth it, really
17 Of course, it depends in the area of products and
18 crude just what level, whether it is once percent
19 or ten percent and what level we come to and some
20 tanks have a very minimal or some products --
21 crudes -- have very minimal amounts of suspected
22 carcinogens and they may not need to be painted if
23 the level is not high enough.
24 MR. PATRICK:
25 I just had a couple of
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clarifications and a couple of requests, I think.
I just wanted to make one thing, I think;, clear
really on something that you said; and also,
Mr. Dillard, previously, you make reference to
proposed generic standards.
I just want to make sure that
you understand that this is not a proposal of
generic standards.
The generic, technical
standards are strictly an advance notice, not
intended in any way to be a proposal.
MR. KROHN:
Okay. I understand that,
and I want to "get my licks in now."
MR. PATRICK:
Another clarification: You
speak about the CTG's and I do want to make sure
that you understand that the distinction we see
between the emissions that are being controlled
with the CTG's, these .are guideline documents
aimed at controlling the law of organics strictly
for the purpose of reducing organic'emissions to
the -- or contribution to the photochemical-spawn
problem. We don't think it's necessarily to
consider that and hazardous-chemical emissions to
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1 be equivalent and that's really some of the reasons
2 why we have looked at these a little differently.
3 You made two or three
4 statements concerning extensive testing and
5 successful demonstration of cost-benefit analysis
6 as being applied for some of the things that
7 Union has done.
8 We would certainly appreciate
9 seeing that information -- it may be in the
10 record already; I haven't looked through the complejte
11 record.
12 MR. KROHN:
13 I'd be happy to submit some
14 of the work that we did at our San Francisco
15 refinery.
16 And I think we demonstrated
17 the mutagenicitability is below 10,000 and we just
18 couldn't plan -- we could never reproduce the
19 same results after --
20 MR. PATRICK:
21 You understand some of
22 the problems. We would appreciate seeing that
23 data.
24 MR. KROHN:
25 I'd be happy to send it to you
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CHAIRMAN PADGETT:
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any questions?
Does anybody else have
(There was no response.)
CHAIRMAN PADGETT:
Thank you.
MR. KROHN:
Thank you.
CHAIRMAN PADGETT:
Now I think it is time we
can eat.
I would like for us to report
back at 1:30. We will reconvene; and if Mr. Smith
is in the audience, we will start with him. And
if not, we will move on to the next speaker.
(Whereupon, at the hour of
12:29 p.m., the hearing in the
above-entitled matter was adjourned,
to reconvene at 1:40 p.m., this
same day, Thursday, March 13, 1980.)
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AFTERNOON SESSION
STATEMENT OF IVAN G. SMITH
184
(1 :40 p.m.)
MR. SMITH:
I'm George G. Smith. I'm
Vice-President of the Lone Star Chapter of the
Sierra Club.
We welcome this regulation of
airborne carcinogens as long overdue control of
industrial toxic effluents into the air we all
breathe. The regulation of airborne carcinogens
is especially important in Texas where we have
both large concentrations of petrochemical
industries as well as a large population at risk.
He have at least eight vinyl
chloride and polyvinyl plants in the Houston area
for instance. There is real reason to view the
emissions of the Gulf Coast petrochemical complex
with alarm in the light of the elevated lung
cancer mortality reported by Mason and McKay in
their 1974 study for the National Institute of
Health.
The approach of the EPA in this
issue seems sound, but r-srhaps over-cautions in
concern for business economic health and less
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185
aggressive than it could be toward protecting
the public health.
We agree with the concept of the
zero threshold for carcinogens, recognizing that
while zero risk and zero emissions are difficult
to attain, they are important goals for the
protection of public health. So we urge you to
keep this goal for all carcinogens.
The models chosen for estimating
disease resulting from exposure should indeed be
ones that avoid understating the risk so that you
make sure to err on the side of safety. We urge
that you take care in making quantitative risk
assessments since synergism of other environmental
factors make these imprecise.
The initial generic clean-up
requirements for listed carcinogens represent a
low-cost, low-technology housekeeping approach that
makes good sense. These controls are needed
especially in this area where the enormous
hydrocarbon emissions contribute to the small
particulate haze so that the respirable particulate
here are likely heavily laced with carcinogens.
These controls should be at
least as stringent as the ones required for ozone
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186
control, including things like floating roofs
with double seals, better pump seals , and more
strict monitoring of leaks.
Careful scrutiny of sitings
suggested is important to avoid a concentration
of industries which would increase carcinogenesis
by synergism or endanger large numbers of people.
In the case of existing
industries concentrated in one area as found in
Houston, stricter standards need to be set because
of the additive effect of the multiple plants.
The consideration of alternative sites has been
all but ingnored in Texas up until now, and it is
time that surrounding residents be given some
real consideration.
In the question of offsets, we
urge you to take special care not to allow air
quality to deteriorate through a number game. We
urge you to look at the actual versus the permitted
emissions -- where the acutal are often less than
permitted, so that in the computation of the
offset the air would become more toxic, which has
happened in the past.
We agree with the principal of
using single animal studies to list carcinogens
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187
for regulation. Since the first phase of
regulation is simply better housekeeping, these
reouirements will be relatively inexpensive, and
further studies for verification can be made as
more effective controls are designed.
While some people have made light
of animal studies, we should be reminded that
people may be 60 times as sensitive as animals
to a toxic substance as in the case of Thalidomide.
So here again the EPA must lean toward the side
of safety in its decisions.
We agree that little is to be
gained by setting UP an outside screening panel
for evaluating carcinogens, since industry-
experienced researchers and environmentally-
concerned researchers would quickly come to
loggerheads over interpretation of data. EPA
must make these decisions, not Industry or
environmental activists.
There are some parts of the
proposal which give us concern. Much is made of
balancing costs of controls with the benefit of
the substance regulated and consideration of
plant closures. Indeed, plants may need to be
closed when the hazard to human health is too
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188
great.
It appears that the EPA may be
overly generous in its concern for old plants
with granting waivers for compliance. It is too
difficult to assess the value of health and life,
and the EPA must truly protect health in these
decisions.
A re-evaluation of your priority
approach to carcinogenic agents that are
supposedly present in small Quantities would be
in order at this time. These should be evaluated
carefully since they may pose a larger than
expected hazard because of nearby residences or
synergism with other pollutants.
In your measurements of exposure,
it would be well to consider people working
ourside or exercising outside as well as the
susceptability of young children. We may be
setting 10- or 20-year time bombs in our children
who live near petrochemical plants.
We feel the EPA should reconsider
the possibility of using unannounced spot checks
of facilities to check compliance.
We urge you to move as rapidly
as possible to control airborne carcinogens and
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establish a list of high-priority substances to
be regulated without delay and to establish a
further list of substances to be studied on an
accelerated basis.
Thank you for this opportunity
to comment on these proposals. We hope for your
careful consideration and rapid control of
carcinogens in our air.
CHAIRMAN PADGETT:
Thank you.
MR. SMITH:
Thank you.
CHAIRMAN PADGETT:
Any comments?
(There was no response.)
CHAIRMAN PADGETT:
Thank you.
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CHAIRMAN PADGETT:
G. W. Fuller? Is G. W. Fuller
in the audience?
4 (There was no response.)
5 A representative from the
6 Texas Air Control Board?
7 (There was no response.)
8 ! Okay. We'll come back to him.
9 I W. L. Senn?
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STATEMENT OF U. L. SENN
MR. SENN:
Mr. Padgett, members of the
hearing panel.
I appreciate the opportunity
to express my views on EPA's proposed policy on
airborne carcinogens.
My name is Bill Senn and I
appear before you on behalf of Exxon Chemical
Company, U.S.A. in my capacity as Manager of our
chemicals manufacturing operations in Baytown.
Two additional facts that may
help you in evaluating my comments are, first,
I am Chairman of the Environmental Health
Committee of the Texas Chemical Council; and,
secondly, I reside in Baytown, less than a mile
from the Exxon Chemical Plant. And my family
and I are directly affected by the air quality
of the community in which we live.
Exxon Chemical recognizes the
benefit of identification, assessment and
regulation of carcinogenic risks, including any
associated with industrial activities, when a
valid need has been demonstrated.
In my opinion, EPA is premature
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132
in proposing this policy in the absence of a
substantiated need. To this end, I am supporting
and we are supporting totally the r>osition and
provisions adopted by the American Industrial
Health Council.
Furthermore, we feel that
adequate protection of air duality is already in
place under other provisions of the Clean Air
Act and is assured by in-plant controls, based on
current industrial hygiene science. Nevertheless,
this issue that we're addressing here today should
be approached with caution and priorities should
be established to address specific problems.
We believe that EPA's proposed
policy shows an unrealistic perspective of the
incidence and causes of cancer and it overstates
considerablv the potential role of airborne
industrial chemicals in causing cancer. The facts
confirmed by Government data are that the incidence
rate of cancer has declined somewhat since 1947
and without the increase in lung cancer, which is
attributable by most -scientists to cigarette
smoking, the cancer mortality rate would be
declining. Thus, I feel the EPA is in the
unsupportable position of acting on the basis of
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speculat ion.
Not only does this a-DT>roach cause
inflationary pressure and financial disservice to
taxpayers, but it clouds the negative role that
factors such as smoking, diet and alcohol
consumption play in cancer causation.
Lest there be any doubt about
Exxon's commitment to clean air, clean water,
and the control of toxic substances, you should
know that Exxon has spent 2.8 .billion dollars on
environmental conservation in the U.S. since 1965.
At the Bavtown Chemical Plant
alone, we expect to spend over 50 million dollars
on environmental conservation over the next
three years.
In conclusion, Exxon Chemical
U.S.A. recognizes its responsibility for the
environmental impact of its operations and
products. We do not rely on regulations in pursuit
of that policy, nor do we oppose expenditures
when we are justified.
I assure you, that further, of
my concern for environmental conservation as
a private citizen residing with my family in
our Baytown Chemical Plant community.
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Thank you, Mr. Padgett.
CHAIRMAN PADGETT:
Thank you.
Any comments?
MS. ANDERSON:
Dr. Senn, with regard to your
statements on the fact that the incident rate
of cancer has declined somewhat since 1847 and the
mortality rate is also declining, we have heard
testimony and in fact have it in writing from
Dr. Marvin Seiderman (phonetic), of the National
Cancer Institute, a different opinion on this,
that the incident rate is increasing and has
steadily been increasing where we have data to
show this and also the mortality rate, when
adjusted, has also been increasing.
Are you aware of these
differences in opinion about these data?
MR. SENN:
Yes. My comments were based
primarily on the findings or testimony of Dr.
Robert Morgan, whom I think testified earlier in
Washington this week.
But I am aware that there are
divergent views on the interpretation of the
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statistics.
CHAIRMAN
Anvthing else?
MR. JOSEPH:
Just one nuestion, Dr. Senn.
Given the divergence of the
testimonv in these hearings, as illustrated on
whether enidemiologv is a sensitive-enough tool
to tell us whether some -- some number less than
enidemic proportions of cancers are being caused,
or are being contributed to, bv air pollution,
emissions of carcinogenic substances, given the
divergence on the interpretation of what data do
exist, if EPA x^ere to come to the conclusion that
it is impossible at this t>oint to draw reliable
conclusions from the et>idemiological data, what
would vou have the Agencv do?
MR. SENN:
My first ster* would be to have
the Agencv embark on a very thorough studv to
sort out and determine, on a sound scientific
basis what true enidemiological information
exists and why that is a sound scientific basis;
and then take vour action off of that basis.
MR. JOSEPH:
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T-?hat if, after evaluating all the
nossible epidemiologv on a basis that vou would
consider sound and scientific, the conclusion
were that it didn't tell us the answer?
MR. SENN:
Then I think you have to step
back and ask them to tell you their problem.
MR. JOSEPH:
Thank vou.
CHAIRMAN PADGETT.-
Dr. Anderson?
MS. ANDERSON:
As a follow-up to that last
ques-tion, does this mean that you think the Agencv
should then not take action under the Clean Air
Act until we do have positive evidence, that is,
I guess what is generally regarded as Positive
evidence that people are getting cancer from
air pollution?
MR. SENN:
I think that is right. I think
that we need to determine not that thev are getting
cancer, but that an exposure at certain levels
might produce cancer in those individuals.
I think the exposure of those
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individuals to airborne carcinogens is separate
from whether those materials cause cancer in the
people.
MS. ANDERSON:
We've certainly heard testimonv
on this problem. Several epidemiologists who
have -- all have indicated that when vou start
to see this kind of positive evidence, that really
would indicate a large problem. Do you have
a comment on that?
MR. SENN:
No really. I have been exposed
to some et>ideraiological studies; I am not an
epidemiologist, per se.
If vou're talking about the
long-term latent effects before vou begin to
notice it, I think there is a big bodv of
knowledge out there right now that you could
devote vour activitv to acquiring and coming dox-m
on what the specifics are and then working with
specific problems as they occur.
CHAIRMAN PADGETT:
Mr. Kellam?
MR. KELLAM:
Dr. Senn, on the first nage
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198
of v-rur testimonv, vou state, and I ouote.-
"We feel that adeauate
protection of air aualitv is
alreadv in place under other
provisions of the Clean Air
Act."
Just as a point of clarification,
it is not clear to me whether vou mean that we
currentlv have sufficient authority under the
Clean Air Act or whether you feel that, indeed,
no further regulation of air pollution is
necessary?
MR. SENN:
No, that's not what I said.'
What I said was, x^re believe there is adeauate
protection of air quality already in Place, either
under the Clean Air Act or by in-plant controls;
so there is really more than just the Clean Air
Act.
By the in-plant controls, we
monitor inside the limits of our plant the levels.
He monitor exposures. We follow the health of
our people.
I guess I have a little hard
tine if we are controlling things within the
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"lant, why outside the nlant that it is critical
to move this ranidlv without going and getting
the scientific data and making a rather exhaustive
studv.
MR. KELLAM:
I understand your point.
But isn't it true that a lot of
the technioues that you would use in your r^lant
to control or limit the exnosure of your workers
indeed may vent through the roof and into the
ambient air?
MR. SENN:
Not necessarilv.
MR. KELLAM:
I'm not saving exclusively,
but --
SENN:
You are talking about venting?
Vents? Flares?
MR. KELLAM:
vou say, using current industris
hvgiene science; and I assume that those are
ster»s that you take to protect the workers?
MR.
That is right.
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MR. KELLAM:
I think vou have answered mv
ouestion. Thank vou.
CHAIRMAN PADHETT:
Any other Questions?
(There was no response.)
CHAIRMAN PADGETT:
Thank you.
MR. SENN:
Thank you.
UNIDENTIFIED SPEAKER:
Mr. Chairman, with respect to
the information that Dr. Anderson raised regarding
Dr. Sneiderman (phonetic) , is that information
received in the last 48 or 72 hours? Or when
was that information made available? 5
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CHAIRMAN PADGETT:
All right.
Meg Titus?
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STATEMENT
MEG TITUS
MS. TITUS:
Mv name is Meg Titus , and I 'm
sneaking on behalf of the League of Women Voters
of Tlxas, because our organization believes that
our goal of promoting an environment beneficial
to life is well served if anv toxic substances
can be controlled at the outset rather than going
down the sewer, into the dump or ut> the
smokestakc, we su^tsort adoption and implementation
of nolicies which will nrovide effective controls
of carcinogenic air pollutants.
It is generally agreed that one
in four Americans will contract cancer, that the
maloritv of these cancers are preventable and
that stationary sources contribute a substantial
fraction of the cancer causes, and I will site
some World Health Organization factors .
The World Health Organization
and assorted scientific groups have estimated
that 60 to 90 r>ercent of human cancers are
associated with environmental factors.
It is also generally recognized
that Section 112 of the Clean Air Act Amendments
of 1977 which contains the Congressional mandate
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relating to controlling airborne Pollutants as
well as airborne carcinogens has not been
effectively implemented to date as only four of tl
hundreds of hazardous air pollutants have
standards.
Policies and procedures for
controlling potential carcinogens must somehow
greatly accelerate the pace of implementation of
Section 112 to adequately protect the public
health.
Ue find the counties x-;ith the
highest cancer rates in the country in our own
Oulf Coast area. Many studies indicate that
cancer of the liver, lung, brain,'nasal cavity,
larynx and eye as well as melanomas can be
largely attributed to the environmental hazards
surrounding the petrochemical industry.
It is estimated that 70 to 90
percent of these cancers are environmentally
related -- R. Doll, ""Prevention of Cancer", 1967;
Higginson, "Environment and Cancer", 1972, Pages
69-89.
The Petrochemical industry
itself can no longer cope with the risks of its
own operations, due to the industry's skvrocketin,
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insurance premiums with renewals sometimes 50
times higher than their older rates.
In addition, we are just
beginning to realise the profound effects these
substances may be having on future generations.
Many substances which are carcinogenic can also
r>roduce mutations and/or abnormalities in the
development of the fetus if the pregnant mother
is exposed.
The gravitv of this situation
is profound -- the effects irreversible and mav
effect the lives of innocent people for
generations to come.
As an example of this sort of
toxic airborne emission, let's look at Benzene --
one for x^hich a standard has not yet been set.
Production of Benzene has increased about five
percent per year for the Past decade, with total
1977 production at about 11 billion pounds,
some 90 percent of which was produced in petroleum
refining and petrochemical industries. Some of
its end-product uses are as an octane booster
in gasoline, nvlons, pesticides, adhesives,
coating, inks, paints, varnishes and moldings.
Nearlv 55,000 full-time workers are exposed to
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Benzene, of whom 55 r>ercent work at facilities
that have no engineering controls or protective
eauipment.
NIOSH estimates that about two
million workers are now exposed to Benzene.
The Sanford Pvesearch Institute
estimates that the general population is exposed
to lower but unregulated exposure amounts. This
study further documents that these estimates have
been confirmed by limited industrv monitoring
including that bv the American Petroleum
Institute. The studv also documents that over
half the Benzene supply in the United States
comes from a small -number of petroleum refineries
in Texas, California, Louisiana and Illinois.
It is further estimated that
more than six million people who live within the
vicinity of these refineries are being
constantly exposed to Benzene emissions in the
.1 parts per billion range. A wide range of
chemical manufacturing plants through the U.S.,
but particularly concentrated along the Oulf
Coast, leak substantial quantities of Benzene
into the atmosphere. Another source of Benzene
exposure are gasoline stations of which there are
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S06
about 200,000 in the United States.
With the chasing out of lead
additive, Benzene use as an octane booster has
doubled over the last four years to current levels
of from 1 percent to 2.5 percent in most brands.
This is mostly liberated during fill-ur» from the
displacement of gasoline XvTithin the gas tank
producing recent Benzene levels averaging 250
oarts per billion immediately adjacent to the
gasoline pumps.
Estimates of average Benzene
levels from these sources range from 1 to 4 Darts
per billion in downtown Dallas and other cities
across the country -- Ibid., page 87.
documentation of Benzene
as a cancer-causing agent and as the cause of
other occupational diseases, such as aplastic
anaemia and chromosomal effects, I refer vou to
The Workplace, Case Studies in The ^olitics of
Cancer by Mr. Epstein, 1979, pages 132 to 137.
An emergencv standard was
granted May 29, 1979 after a petition bv the
AFL-CIO but was strongly protested by the API
and the "Federal Court of the New Orleans Fifth
Circuit granted a stay of the emergency standard
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of 1 part per million. The League of Women Voters
of Texas urges the EPA to do evervthing possible
to move more rapidlv toward regulation of Benzene
and the hundreds of other potential carcinogens
than it has since the passage of the Clean Air
Act of 1970.
Protection of public health is
the issue and the present standard of 10 parts
per million is not adeouate protection of the
public health.
We agree with the follox^ing
conclusions found in the proposed policv - ;, '
procedures for Regulation of Airborne Substances
Posing a Risk of Cancer as set out in the Federal
Register, Volume 44, October 10, 1979. We agree
that the public has frequent exposures to
potential carcinogens from stationary sources.
We agree that no safe level of a carcinogen has
been identified. We agree that an increasing
number of persons can be expected to develop
cancer from even low levels of exposure. We
agree that positive results from either
human-et>idemiological or animal-toxicological
studies are adequate to establish the
carcinogenicitv of a substance. We agree that
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any proposed national emissions standards for each
source category should be based solely on
potential health effects.
The Texas League commends the
E'PA's strong; acknowledgement that airborne
carcinogens do pose a major public health problem
which will reauire tough emissions controls to
prevent serious illness and deaths. We also
commend the EPA for planning to list and regulate
manv more potential carcinogens, for urging
industry to search for substitute processes that
may eliminate carcinogenic emissions altogether
from the workplace and the ambient air, and for
insisting that new plants develop strong
emissions controls.
We believe, however, that
current epidemiological methods are insufficiently
reliable to provide an adeauate and complete
assessment of the impact on public health of
multiple carcinogens and their potential
synergistic effects.
Airborne carcinogens are still
another incremental hazard to add to the manv
other exposures we all receive daily. We also
believe that 10 years has been an inexcusably
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long time for the EPA to have st>ent in addressing
Section 112 which states that within 360 days
of placing a substance on the Hazardous Air
pollution List, EPA must set standards to protect
the -public health with "an ample margin of
safety." Section 112 (a) (1) , (b)(1)(A)(b)(1) (B) .
You have scarcely begun the
task as you have listed only six hazardous air
pollutants up to this time and standards, some of
which v;e feel are inadequate, have been set for
only four. The League urges vou to begin
immediately to list and regulate a specific number
of potential carcinogens and we support the twenty
per year proposed by the Environmental Defends
Fund, and this this be done on a scheduled
nrlority basis with adeauate publicity about the
listing so that Industry will be certain to know
that regulation is imminent and will be based on
health not economic factors, and also so that
the public can be certain of protection.
If further financial resources
are reauired for the EPA to make this commitment
the League in Texas can be counted on to support
your efforts to obtain them.
believe the EPA should make
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everv effort to facilitate the listing and
regulating rirocess bv avoiding the rehash of
such matters as the validitv of animal studies
or the concept of "no safe dosage." Much time
could be saved in this process if the EPA would
accent and make it known that it would adhere to
the following statements contained in the HEW
document entitled, "Estimates of the Fraction
of Cancer in the U.S. P^elated to Occupational
Factors," September 15, 1978. Thev are:
The estimate that onlv one
to five percent of total cancers in the U.S.
are attributable to occupational factors have
not been scientifically documented and have little
meaning for estimating even short-term future
risks.
Most cancers have multiple
causes: It is a reductionist error and not in
keeping with current theories of cancer causation
to attempt to assign each cancer to an exclusive
single cause.
Because cancer incidence is
stronglv dependent on age and duration of exposure,
and because most cancers occur late in life, any
industrial epidemiological studies detect onlv a
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small fraction of cancers, that is, those
developing earlv.
fast exposure to asbestos is
expected to result in UP to two million excess
cancer deaths in the next three decades; this woul
correspond to roughly 13 to 15 percent of the tota
cancer mortality exnected in that period.
Reasonable projections of the
future consequences of t>ast exposure to establishe
carcinogens suggest that at least five of them --
Benzene, arsenic, chromium, nickel oxides and
r>etroleum fractions -- may be comparable in their
total effect to asbestos,
These projections suggest that
occupationallv-related cancers mav comprise as
much as 20 percent or more of total cancer
mortality in forthcoming "decades. Asbestos alone
will probably contribute UP to 13 to 18 percent
and the data on the other five carcinogens suggest
at least 10 to 20 percent. These data do not
include effects of radiation or effects of a
number of other known chemical carcinogens.
Although exposure to some of the
more important occupational carcinogens has been
reduced in recent vears, there are still manv
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312
unregulated carcinogens in the U.S. workplaces.
A number of occupations are characterized bv
excess cancer risks that have not vet been
attributed to specific agents.
There is no sould reason to
assume that the future conseauences of present-day
exposure to carcinogens in the workplace will be
less than those of exposure in the recent past.
patterns and trends in total
cancer hypothesize that occupationallv-related
cancers comprise a substantial and increasing
fraction of the total cancer incidence.
The conclusion that a substantial
fraction of cancers in the U.S. are occupationallv-
related is not inconsistent with conclusions that
a substantial fraction of cancers are also
associated with other factors such as cigarette
smoking and diet (sic).
Occupationallv-related cancers
offer important opportunities for prevention.
The League of Women Voters of
Texas believes that EPA, OSHA, NIOSH, the
National Cancer Institute and the International
Agency for Research on Cancer all should use the
above as the basis for future action to eliminate
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si;
future debate on these widely-accented principles.
Our organization also believes
that the EPA proposal to use a Quantitative risk
assessment for each chemical to decide if risk
exists even after the use of BAT flies in the
face of Section 112. That section requires
standards which provide an ample margin of safety
for airborne pollutants. We find no statutory
license for accepting any amount of residual risk
as you propose to define "unreasonable risk."
We agree with Senator Muskie's
statement, and I auote:
"The bill provides the
Secretary with the authority to
prohibit the emission of
hazardous substances. The
Committee was presented with
strong evidence that anv level
of emission of certain pollutants
may produce adverse health effects
that cannot be tolerated.
It seems to us that the EPA is
proposing to accept a certain number of deaths
as a result of not being able to identify a
threshold for carcinogens. We believe the Senate
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Committee did not accent that concept, nor do we.
We believe that in order to
provide the greatest possible incentive for
Industry to move quickly to reduce risks to the
public from carcinogens, EPA should reauire that
one vear after a standard is set either the
emissions goal should be zero for known
carcinogens, or a substitute should have been
found, or documentation should be presented by
Industry that no available technology could attain
zero carcinogenic emissions.
We read Section 112 as an
important technology-forcing portion of the
Clean Air Act Amendment with the burden of proof
on Industry, not on the EPA, for not meeting the
mandate of the law. Further, an offset policy
should be developed to assure continued emission
reductions.
We believe that dispersion
approaches such as the risk avoidance criteria
and the proposal for providing waivers will
encourage an increase in carcinogenic emissions in
areas of low population and we did not think that
was the intent of the law.
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Texas is also concerned that ouantitative risk
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assessments when dealing with carcinogens are
unrealiable and, therefore, unwarranted. All
current knowledge in this area is related to
oualitative analysis and, given the factors of
long latency periods and unknown or unmeasured
exposure levels, we believe quantitative risk
assessment to be not only imprecise but
unacceptable, as no portion of Section 112
suggests its use or suggests that balancing risks
and benefits can be considered under this portion
of the law.
Under a separate rulemaking
notice entitled, "National Emission Standards for
Hazardous Air Pollutants : Advance Notice of
Proposed Generic Standards", EPA sets out a group
of housekeeping standards and requirements for
sources to use in controlling carcinogenic
emissions. We support the concept of such
requirements as a auick method for reducing fugit:
emissions. However, some of these proposals seem
to be less stringent than RACT , reasonably
available control technology, for hydrocarbons.
TJe urge that these be strengthened not onlv to
reduce health risk but, judging from previous
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industry actions, they may reduce industry costs.
A single rulemaking to at>r>ly
to all pollutants in this category could save a
great deal of time as opposed to separate
proposals for aach chemical as it is added to the
list to be regulated.
We also support housekeeping
recmirements for storage, pumping and processing
hes£ potential carcinogens, as well as for their
production. For example, as the Court was
drafting its final decision, a study was released
for the Manufacturing Chemists Association
showing that control of process vents and Benzene
storage tanks could achieve 95 percent reduction
of all emissions for considerably less cost than
previous estimated.
Both Government and Industry
resources should quickly focus on these generic
housekeeping measures to reduce carcinogenic
emissions as soon as possible.
Out state air duality position
as well as our national position reouires us to
urge the above outlined measures relating to rules,
policies and procedures for identifying, assessing
and regulating airborne substances posing a risk
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of cancer be implemented rapidly. We also urge
that the final rules be drafted in such a manner
as to encourage voluntary compliance.
Thank you for the opportunity
to present our views.
MR. PATRICK:
One of the important things at
these public hearings is to find out -- where
things are being misinterpreted.
A perfect example of that
is our housekeeping reauirenents are being
interpreted by you as being less stringent; and
Mr. Krohn determines them as being more stringent
And it seems like we've got
to do a little bit of rewriting on that.
CHAIRMAN PADGETT:
Dr. Anderson?
MS. ANDERSON:
On the use of quantitative
risk assessment, to look at residual risk, the
thrust of vour comments presumed the use of this
tool essentially would -- from the Agency's point
of view -- permit a certain amount of cancers to
stay out there after the application of the best
available technology.
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218
Looking at it another way,
suppose we had applied best available technology
and we didn't take into account notency -- which
seems to vary widely amongst the carcinogens --
and that there are two determinations; whether or
not something can cause cancer and then how potent
it is .
Suppose that the residual risk
there from a chemical as potent, say, as dioxin,
if we didn't take any account of this, x
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same ability to affect tmblic health -- which we
know isn't true.
MS . TITUS:
Yes; I know.
CHAIRMAN PADGETT:
Sort of into the same area: On
nage 6, you state:
"...EPA should require
that one year after a standard
is set either the emissions
goal should be zero for
known carcinogens, or a
substitute should have been
found, or documentation
presented by industry that
no available technology could
attain zero carcinogenic
emissions."
Assuming that Number three is
the course of action, then, is it your statement
that that would be a sufficient standard or --
I am not sure exactly what vou
have said here.
MS . TITUS:
Yes. I can see why there might
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be some confusion on that.
I think that our position would
be that if there were no method available for
reducing those carcinogens, then further search
should be made for a substitute. Thev should
simple not be allowed to be emitted into the air.
CHAIRMAN PADGETT:
But in the meantime, thev would
simply live with the best available technology.
MS . TITUS:
Until a substitute -- I suppose
that would be rather inevitable.
CHAIRMAN PADGETT:
So you are saying there is no
potential alternative for more stringent action
in the case of particularly strong --
MS . TITUS:
We would like to see the EPA
take the strongest possible option for controlling
them under any circumstance.
We feel the option should be
chosen which would be most likely to reduce
carcinogenic emissions and come closest to
attaining a zero emission.
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CHAIRMAN PADGETT:
Any other Questions?
(There was no response.)
CHAIRMAN PADGETT:
Is D. W. Fuller in the
audience now?
(There was no response.)
CHAIRMAN PADGETT:
How about someone from the
Texas Air Control Board?
(There was no response.)
CHAIRMAN PADGETT:
Our next speaker, then, is
Jim Mullins.
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1 STATEMENT OF JIM MULLINS
2 MR. MULLINS:
3 Good afternoon, Mr. Padgett and
members of the panel.
5 I am a Senior Staff Engineer
. with the Shell Oil Company Environmental Affairs
o
7 Department.
8 My purpose today is to provide
9 a summary of Shell's written comments on both
10 | the proposed rulemaking regarding the policy for
identifying, assessing and regulating airborne
substances posing a risk of cancer, and the
13 proposed rulemaking regarding generic standards
14 under the NESHAPS program.
15 With me is Mr. Brynn Aurelius
of Shell's legal organization who, with myself,
17 will be glad to respond to questions the panel
18 may have following my presentation.
19 The proposed policy appears to
be based on the premise that industrial airborne
substances are known to be responsible for a
significant proportion of the cancer that exists
23 today. In this respect, the proposal reiterates
., a statistic that has been repeatedly misunderstood
24
. Namely, "60 to 90 percent of all human cancers
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may be due to environmental factors." Although
it is further stated in the proposal that the
term "environmental factors" must be understood
to include chemical exposures from smoking, diet,
occupation, drinking water, air pollution, various
forms of radiation, including sunlight, and some
forms of physical irritation, the conclusion
which has been reached by EPA creates the
impression that industrial airborne substances
present a great risk of cancer.
EPA has not presented data, and
we are not aware of any data, whoch would support
this conclusion. In fact, there has been previous
testimony at an earlier procedure (sic) which
actually supports a conclusion of no known effect
Without adequate data to supper1
this Agencv position, there is no justification
for the broad-based generic regulation that has
been proposed. Furthermore, this new policy is
not needed because the Agency already has the
authority to regulate hazardous airborne pollutan
Even more inexplicable is the
Agency's proposal to abandon its previous policy
of separation of scientific issues from regulator;
issues. The "Interim Guideline" under which the
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Agency now operates, and indeed parts of the
proposed rulemaking, take cognizance of this
principle.
The preamble to the proposed
rulemaking states that judgments concerning the
probability of human carcinogenicity, a scientific
issue, are made based on the quality and weight
of evidence. This implies that the Agency wishes
to address scientific issues separately from
regulatory issues. Unfortunately, this logical
process is contradicted by the proposed rule.
The net effect of the proposal
is that we are faced with a procedure that
prescribes listing and an arbitrary degree of
control, best available technology, prior to any
significant assessment of the risk. It is not
reasonable to regulate a substance if there are
no data to indicate that the substance poses a
significant risk.
It is even possible that there
will never be a Quantitative risk assessment of
the type proposed by the Agency since the policy
states that one will be made after the imposition
of BAT only if possible.
This situation has been created
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because the Agency has not adhered to its stated
principle of separation of scientific and
regulatory issues. EPA has instead chosen to use
rigid, fixed criteria and automatic classification
This action results in an
approach to zero-risk because it is a de facto
attempt to eliminate all risks from airborne
carcinogens. Under the proposal, substances coulc
be listed under Section 112 of the Clean Air Act
if there were a single mammalian study demonstrati
the induction of certain benign tumors under
severe conditions of high-dose exposure.
Under the proposed criteria, it
is evident that the proposed policy is an
indiscriminate mixture of scientific and
regulatory issues. Generic regulations, while ,
ostensibly offering regulatory agencies a means
to sneed up the promulgation of regulations, in
the long run will do the country harm because the?
compromise complex scientific issues and lead to
poor utilization of the resources of this country
Because of the minimal
requirements that must be met to classify a
substance as a "high-probability" carcinogen, and
the undefined "significant-exposure" level,
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substances will be regulated without benefit of
a quantitative risk assessment of the type
detailed by EPA.
If we are to gain the maximum
benefit from our country's resources, it is
essential that the quantitative risk assessment
be conducted prior to, and used as a basis for,
listing a substance as a hazardous air pollutant.
Turning to another concern, we
believe the proposed policy thwarts the
reauirement of Section 112 of the Clean Air Act
to provide for public review and comment on a
decision to list a substance as a hazardous air
pollutant.
Under Section 112, the Agency
is required to conduct a public hearing regarding
the decision to list a substance within 210 days
of that listing. The proposed policy fails to
provide this required step in the rulemaking
procedure.
We believe that the Agency must
provide for public review of the decision to list
as well as all the evidence used to make that
decision. An opportunity must also be provided
at such a hearing for the presentation of
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information which is relevant to the listing
decision. It is only after such a hearing that
the Agency may proceed to regulate under
Section 112.
Fe also believe that the propose
requirement to regulate a substance to the level
of best available technology, or BAT, as a minimur
in addition to its wastefulness of resources,
goes beyond the requirements of Section 112. Wit!
this approach, the Agency has pre-determined that
nothing less than BAT will provide an ample margii
of safety to protect the public health. Without
benefit of a quantitative risk assessment, it is
impossible to judge such a margin of safety. To
regulate at the BAT level, without such a
demonstration, is simply not authorized by
Section 112.
Another issue of concern is the
Agency's conclusion that the proposed policy does
not meet the criteria contained in Executive
Order 12044 for requiring a regulatory analysis
because, and I quote, "The policy does not impose
regulatory requirements on any emission source."
This conclusion is inconsistent with both the
title and thrust of the proposed rulemaking.
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Simply because the Agency chooses to call the
regulation a "policy" does not relieve the Agency
from the requirement for a regulatory analysis.
The Policy describes very
specific regulatory actions for substances that
meet very rigid criteria. Only the names of the
substances are missing. And even here, the Agency
has already identified, but not accounced, 40
substances for which carcinogenicity determinations
and preliminary-exposure estimates are underway.
The Policy will have sharply defined results
which can be measured and Quantified. Under the
policy the Agency will be able to list a
suspected carcinogen -and trigger all that must
follow under Section 112, before the required
regulatory analysis is conducted.
At this time, I would like to
comment on the Advance Notice of Proposed
Rulemaking for Generic Standards under the NESHAP
program. Our initial concern here is that the
proposed generic rules appear to put the cart
before the horse. The concept of regulating very
minor sources prior to preparation of a
quantitative risk assessment or consideration of
other routes to reduce exposure is wasteful of
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limited resources and clearly not an effective
way to deal with the problem of control of
hazardous air pollutants.
It a regulation for control of
fugitive emissions is ever justified, we believe
the rules proposed here are too rigid and
potentially ineffective. The Agency states it has
considered three alternate approaches for these
controls .
It has rejected the approach
of requiring specific performance levels since it
claims that there are insufficient data available
to set performance levels for the type of emissior
being considered. We agree that this approach
would be very difficult.
We do not agree, however, with '
rejection of the second approach -- that of
individual plant systems developed from
EPA-issued guidelines. This type of system has
been adopted by EPA in its current NESHAP standarc
for vinyl chloride and in our opinion meets or
exceeds the level of control contemplated by
EPA's actual proposal.
In our written testimony we
have presented data which indicate that a system
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utilizing fixed-point monitors is extremely
effective in controlling fugitive emissions.
Leak frequencies of less "than
one percent for equipment such as flanges and
valves have been demonstrated. We do not advocate
fixed-point systems as the mandatory regulatory
scheme, however, since circumstances differ at
each facility. We believe that each source should
be allowed to adopt a leak-detection and repair
r>rogram that is compatible with its design and
operating characteristics while meeting certain
guidelines provided by the Agency.
In the area of recordkeeping
and reporting, the proposal is inconsistent with
the recordkeeping and reporting requirements
already in place under NESHAP for vinyl chloride
controls. This will be confusing to Industry
and serve no useful purpose.
In closing, we recommend the
following:
The Agency should revise its
current conclusion that industrial
airborne substances present a
significant risk of cancer to the
public. The available data simply
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do not support such a position.
A generic type regulatory policy,
such as proposed, is not needed.
If a new regulatory policy is
to be promulgated, the Agency should
maintain its philosophy of separating
scientific policy from regulatory
policy, as described in its "Interim
Guideline."
The Agency should recognize that
a rigid generic classification system
without quantitative risk assessment
will expend this Nation's limited
resources without obtaining maximum
benefit.
Quantitative risk assessment of
the type detailed by EPA should be
used prior to, and as a basis for,
listing a substance under Section 112.
The adoption of this, or any
similar policy, cannot substitute
for the requirement to provide for
public hearing and comment on the
decision to list a specific substance.
The requirement that Best Available
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Technology will be the minimum
with Section 112 requirements. The
provides the "ample margin of safety"
and no more.
6
A regulatory analysis of the
proposed policy, as required by
Executive Order 12044, can be and
should be made.
The use of the generic-type
fugitive emission control for the
initial regulation stet> is not cost
effective. All types of control
should be considered, and only those
that meet the economic and "ample
margin of safety criteria" should
be promulgated.
Any fugitive emission control
scheme that is adopted should be in
the form of guidelines which will
allow each source to utilize control
procedures that best fit its
particular circumstances.
Our written testimony discusses
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the points I have made today more fully and also
presents other concerns which we have. I
appreciate the opportunity to appear here today
and will be glad to respond to auestions the panel
may have.
MR. PATRICK:
Jim, just a couple of quick
things.
You're advocating, really, a
guideline-type approach that is something we
talked about in Washington.
You also stated on page 7
that the standards for vinyl chloride met or
exceeded the level of control contemplated by
EPA's actual proposal.
Do you regard those requirements
to be a good basis or sufficient from the
standpoint of emission control --
MR. MULLINS:
Well, in the case of fugitive-
emissions control data for vinyl chloride through
leak detection, I was talking about a program
established and approved by EPA; that's the
guideline I arn talking about.
MS. ANDERSON:
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I think perhaps something else
isn't coming through clearly in the Policy. I
wonder why you read the Policy and determined
that EPA is going to depart from its stated
policy in the interim guidelines separate from
the regulatory decision?
In other words, I'm wondering
why it's coming through to you regulatory policy
and thus is not following the Agency's guidelines
in assessing carcinogen risk.
MR. MULLINS:
I believe that is a regulatory
decision that has mixed science and the
regulations.
I think that science should
determine what is a carcinogen and what is the
level of risk and the confidence levels that
scientists have in that level and then regulatory
decisions are made after that determination to
decide what levels of control we will go to.
MS. ANDERSON:
I think it's unfair to say that
neither of these two points deviate from the
interim guidelines that were published in May
of 1976.
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Were you here earlier when
they talked about the significance of the single
study?
MR. MULLINS:
Yes, I was.
MS. ANDERSON:
But I just wonder -- I don't
think that it should be read and I think this is
an area where we probably will need to do some
work, because I don't think that the Policy is
intending to say that a single study that is very
flimsy and border-line and poorly conducted and
so forth all by itself is being used to list
something as a cancer risk under any one of EPA's
seven laws.
But rather than in some cases <
it certainly does make sense to regard informatioi
from a single aminal test as such examples that I
gave this morning were, for example, the
aflotoxin situation and I wondered if you have
any feelings on using single-animal tests and
certainly looking at everything else we have all
the other related information.
But do you regard this as a
reasonable use of a single-animal test?
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The aflotoxin data being that
aflotoxin was tested and the mouse was negative
and the rate positive and there are a number of
chemicals tested this way and then we'll have an
onportunity to get human epidemiological data.
We often can confirm that indeed what is expected
is demonstrated in human population.
Do you think the Agency should
ignore results of this tyt>e in single-animal
species?
MR. HULLINS:
I don't think it should be
ignored. I think efforts should be made to
confirm them. I think other types of studies
should also be looked at, both positive and
negative rather than using just the one.
I think as I stated, there are
in the preamble to the proposed policy much of
the statements which you have just made and it
would appear that use of the interim guidelines
might be the type of thing that's being proposed.
But when you get to the acutal Appendix C that is
being proposed, a lot of that does not come
through.
MS. ANDERSON:
I think that's the idea of the
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interim guidelines. You mean --
Notice taken that these
guidelines would apnlv to seven or six, at the
time I think, toxic substances.
MR. PATRICK:
I thought of one other thing.
You made a statement that the
requirements for BAT as a minimum was not
consistent with 112 and its language about ample
margin of safety.
I think the thought there was
when you can't define a threshold, how do you
define ample margin of safety?
And it has been, I think,
a...BAT concept really fit that better and then
assigned BAT as a minimum and then look for
residual risk going above that. And we see that
as consistent with the BAT concept in 112.
Do you -- You apparently have
a different interpretation of that when you have
under the assumption of no-threshold. Do you
still see smoe more individualized level of
determination of what's the adeauate controls?
MR. MULLINS:
It is indeed true that best
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available control technology must be -- will be
the minimum. There may be cases where that is
indicated.
MR. BAUMAN:
On page 5 of your testimony,
the second paragraph, you make some remarks about
7 the public participation in both the decision
8 ! and the evidence.
9 j And I gave my views earlier
this morning. . .
To your testimony I do feel the
policy does speak to that issue.
,~ I do have a question, though,
with regard to your statement on page 4. You
say that:
.. "...substances will be
16
reulated without benefit of
. a quantitative risk assessment
of the type detailed by EPA.
And my question to you is, what
do you mean by regulation or what do you mean --
How do you define the term "regulation"?
22 "
23 Are ou referrin now to the
24 emission regulations for the BAT or what?
25 MR. MULL INS:
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I am referring both to BAT and
the generic standards. The Policy seems to state
to us that the generic standards and best
available technology will be mandated as the
minimum level of control and the risk assessment
will be used onlv to determine if we should
go any further.
It seems to me that if that
risk assessment is made after those controls
have been imposed, it is too late. We have
already spent the money and put it in.
Indeed, the risk assessment for
any given substance may show that BAT went
further than we need it to.
MR. KALLAM:
Mr. Mullins, on page 3 of your ,
testimony, you indicated, as other witnesses
have, that you feel that the policy suffers from
its use of rigid fixed criteria and automatic
classifications.
My first question is: Do you
feel that -- Do you mean by these criteria, the
listing criteria that we use?
MR. MULLINS:
Yes.
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MR. KALLAM:
On the following page, you
refer to the " ...undefined 'significant-exposure'
level."
That is also one of our criteria
for listing. Am I to understand that as far as
exposure is concerned, you are more worried about-'
MR. MULLIUS:
Yes. I am concerned that the
EPA will list the substance if it determines that
there is a significant exposure. But there is
no guideline given as to what is a significant
exposure.
MR. KALLAM:
Would you then prefer us to
have fixed, rigid criteria for exposure?
MR. MULLINS:
I think it ought to be a
guideline. I think each substance has to be
evaluated or the exposure of each substance has
to be evaluated; what you need a guideline on is
what is significant in relationship to other
substances that we are looking at.
If you look at one given
substance this year and find an exposure level
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that is considerably lower, you may consider that
that is significant. There doesn't seem to be any
guideline for saying -- relating the significance
of the exposure between chemicals.
MR. KELLAM:
I think that's the conclusion
that we reached. Thank you.
MR. PATRICK:
I had one question from the
audience concerning that statement about fixed-
point monitoring systems .
(Addressing the audience:) If
you will see me after the meeting, I will give
you the names of the people you can talk to to
get more information on that.
CHAIRMAN PADGETT:
Dr. Walker was listed to speak
this evening. He asked to be moved UP.
There are several times where
I have called out the names of a couple of people
who have been listed to talk and they have not
been here.
Let me just ask a general
question: Is there anyone in the audience who
thinks that they were listed to speak this
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34
STATEMENT OF FRANCES B. SMITH
MS. SMITH:
Thank you, Mr. Chairman, for
this opportunity to comment on the EPA proposed
rulemaking on emissions of cancer-causing
substances into the air.
I am Frances Smith, representing
the League of Women Voters of Houston, which
has a deep concern for public health, and has had
an active interest in air quality in general and
airborne carcinogens in particular, for several
years .
In 1977 , the League of Women
Voters of Houston, and the Texas League, sponsoret
in conjunction with the University of Texas Healt'
Science Center at Houston, and Tenneco Chemicals,,
Incorporated, a Conference on Environmental
Cancer.
This conference focused on
several aspects of the problem, including airborn<
carcinogens. The concern, which prompted this
conference, grew out of the awareness that proper
control of carcinogens in the present may reduce
cancer rates in the future, and that current
cancer rates reflect exposures which pre-date the
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1 increased production and use of chemicals which
2 has occurred since the early 1960's, because of
3 varying latency periods.
4 We are aware of the work of
5 Hoover, Mason and McKay, and also Blot and
6 Fraumeni which show that lung cancer rates are
7 higher in highly-industrialized counties than
0 I non-industrialized counties in the United States.
o
9 And Enstrom, as noted in a letter in Science,
.. ! reported last year that there has been a
significant increase, since 1935, in the lung
cancer rate among non-smokers. Therefore, as
13 residents of an industrial area, we urge you to
14 control the hazards from airborne carcinogens
15 as rapidly as is feasible.
16 We note that three carcinogens
17 are now listed under Section 112 of the Clean Air
18 I Act Amendments. We support your efforts to
19 control now some of the airborne carcinogens
20 through the use of generic standards for source
2i categories. We would expect that more of these
22 will eventually be listed under Section 112. We
23 urge your continued evaluation of the twenty-six
24 chemicals termed known human carcinogens by the
25 International Agency for Research on Cancer.
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We realize that it is difficult
to determine a threshold for carcinogens , if
indeed there is one. We realize also that neither
zero-risk nor zero-emissions are probably
attainable in all cases. However, these facets
of the control problem do not diminish at all the
arguinentthat carcinogenic emissions should be
reduced to the lowest feasible level to reduce
the hazards to the general public.
We recognize the need for risk
assessment, but only as a means of setting
priorities. Qualitative, not Quantitative,
inferences can be drawn from evaluation of the
extent of general public exposure and evaluation
of carcinogenicity. Given the complex organic
emissions from highly industrialized areas, such
as ours, adeouate risk assessment is difficult.
Will the increments of each carcinogen be
considered additive or synergistic? Surely they
should not be considered entirely separately.
Some flexibility may well be
desirable in the screening and classification
systems. We agree that some generic classificati'
system would enable a more rapid control of
airborne carcinogens. But we urge you to careful
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consider new approaches, should a more reliable
and workable classification system emerge from
current research on chemical reactivity.
Thus, we support your approach
in reducing airborne carcinogens quickly through
generic standards, and urge you to proceed as
rapidly as possible to list additional substances
under Section 112. We believe that an ample
margin of safety should be preserved for the
protection of the general public.
The League of Women Voters of
Houston is aware that there is much debate in the
matter of airborne carcinogens , but believes
sufficient knowledge exists to permit us to
proceed. Debate is healthy, but the public health
demands that such debate not be permitted to
delay protection of that public.
Thank you.
CHAIRMAN PADGETT:
Thank you.
What comments do you have
relative to siting of new sources?
MS. SMITH:
We do not choose to comment on
that.
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CHAIRMAN PADGETT:
Thank you.
Any questions?
(There was no response.)
CHAIRMAN PADGETT:
Thank you very much.
Dr. Walker?
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1 STATEMENT OF HARRY M. WALKER
2 MR. WALKER:
3 Thank you, Mr. Padgett.
Today I am speaking not in my
c i official capacity but strictlv as a concerned
0 I
citizen of Dickenson, Texas.
6
7 I am Dr. H. M. Walker of
Dickenson, Texas. I am an atmospheric chemist
and am a professional in the field of air
pollution. The remarks that I am about to make
regarding the subject of this hearing represent
my personal and professional views as a concerned
13 i citizen and as a professional in the field of
air pollution and regulatory affairs.
15 My great concern regarding
16 | today's subject is that it represents a major
17 escalation of the regulatory process in the
18 United States. Today, when the newspapers, the
19 politicians, the scientific community, and the
20 business community have virtually reached a
21 ! consensus that over-regulation is seriously
22 | damaging our nation, our economy, our level of
23 innovation and our ability to mount any national
24 program of consequence, we have before us a
25 sx-zeeping new regulatory proposal of almost
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unlimited potential for interference with the
activities of citizens in all walks of life.
Consider this -- the air
pollution program which has, over the oast ten
years, had vast negative impact on the economy,
which has contributed significantly to the nation'
inability to resol\re its energy crisis and which
has in many respects yielded only very
Questionable benefits, deals only with the
regulation of a mere six criteria pollutants plus
four additional materials under the NESHAPS
program.
The program proposed today
seeks to control 40 or 140 or 600 of thousands
of materials depending upon which sentence in
the proposal document one chooses.
Let us clearly recognize that
the program under discussion does not seek to
control materials which are known to cause human
cancer by virtue of their being present in the
ambient atmosphere. It seeks to control anv
material which, by laboratory animal testing, can
be shown to merely nreturbe the natural rate of
formation of tumors, both malignant and non-
malignant in groups of animals specifically
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selected because their natural tumor rate is very
high -- or which proves rautagenic in a synthetic
test tube procedure such as the Aimes test. Or
which becomes epidemiologically associated with
cancer in any situation, almost certainly one
not involving ambient air exposure.
I inject the latter observation
because I am totally unaware of any epidemiological
association of any specific material with cancer
among any population where the only exposure was
ambient as this is as contrasted to workplace air.
In other words, the policy
proposed permits the regulation of materials in
the ambient air, not based only upon firm
showing that their presence has caused human
cancer but merely on subjective judgment about
the weight of evidence where the evidence will be
almost entirely on such indirect sorts .
Also of great concern to me is
the total absence of any weighting to be assigned
to the potency of any carcinogen, which has been
mentioned previously, several times today. Thus
it would appear that perhaps benz_idine_ and
saccharin may merit equal priority in the pending
regulatory campaign.
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With the background that dozens
and perhaps hundreds of the essential materials
of civilization are likely to be involved in the
program, the correlatory postulate advanced --
namely that the only acceptable level for such
materials will be zero is indeed frightening.
In these days when the triumphs
of analytical chemistry have rendered commonplace
the measurement of materials at levels of just
a few parts per billion or even just a few parts
per trillion, zero is seldom an attainable number.
With such premises it seems
obvious to me that in most cases the regulatory
approach will become simply an absolute ban. A
policy of loose criteria plus a zero objective in
the hands of an over-zealous regulator has the
potential, for starters, to remove from the benef:
of mankind, the diesel engine, coal, heavy-fuel-
oil combustion, most pesticides, most chlorinated
solvents, most dyes, most plastics, many
minerals, chemicals, drugs -- in short, a
significant portion of those materials which
provide the basis for our standards for human
confort and living in the United States today.
It has the potential for the
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disruption, if not in some cases the elimination,
of industries and activities which, and I quote
from your document, "fall into six broad groups;
one, mining, smelting, refining, manufacture and
end use of minerals and other inorganic chemicals;
two, combustion; three, petroleum refining;
four, synthetic organic chemical industries and
end use application and waste disposal;..." and
some others I won't mention. In short, most
of the major essential industries of America are
to be further seriously regulated.
Now, of course, this is not
really going to happen. Neither the EPA nor
any other governmental body can ban many materials
of such major benefit. Just as the FDA found
that it could not ban saccharin in the face of
an obvious public willingness to accept the
material on the basis that its benefits outweighed
its risks and this latter consideration, I note,
seems to be entirely missing from the proposal
under discussion today.
What would take place would be
a very selective enforcement effort under such a
sweeping policy. In effect, whatever is regulated,
whatever is banned or whatever is ignored will be
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determined by arbitrary decision of the regulators
working under a policy so sweeping that it
constrains them not at all.
The Policy, in practice, will be
a vehicle for government by men, not by laws --
totally incompatible with our American system.
I strongly recommend that you wh
are judging this issue recognize the enormous
potential for over-regulation inherent in this
policy, as written, and also take cognizance of
the fact that the pendulum has turned, that the
nation is in no mood for any new escalation in
the level of arbitrary interference in the
economic system or in the lives of citizens, for
alledged benefits which are hypothetical and
tenuous at best.
i
I, therefore, recommend that
the policy be revised to require:
1 - Unequivocal levels of proof as
to real human carcinogenicity
before the qualification of
any material.
2 - That carcinogenic potency be
given serious weight in such
aualification.
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3 - That risks versus benefits
be similarly given major
consideration.
4 - That target abatement levels
shall not be zero but shall
be reasonably related to
levels and exposures of
demonstrated carcinogenesis.
Such a policy should provide
clear guidance and leave little leeway for
arbitrary regulation. Certainly it should
prove far more desirable from the standpoint
of the economy, of the nation and even of EPA
and should avoid the regulatory chaos which
would be inevitable if the proposal is adopted
without significant improvement.
And I thank you for your
attention.
CHAIRMAN PADGETT
Before we start, I have one
question from the floor, which you can either
answer or not answer.
"Please declare vour
employer for financial interest
in regulation of cancer."
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MR. WALKER:
I have no financial interest in
the regulation. My employer is MOnsanto Company,
and I do not speak for Monsanto Company. And I
speak because I have a serious concern, myself as
a citizen, with some knowledge into the matter,
CHAIRMAN PADGETT:
Thank you.
Relative to your first
recommendation on the last page of your x
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CHAIRMAN PADGETT:
2 I Without getting into a real long
3 discussion on this, because that is really not our
4 purpose here, in my understanding of epidemiology,
5 from several days of testimony, from the various
questions, first of all it is a fairly imprecise
, tool.
8 j We have heard estimates, such
9 as the best it can do is indicate when there is
10 | a 50 percent increase in a particular type of
cancer; it will tell you that. But that's really
12 about the best it can do.
13 The second thing is that it
requires a good ten, to twenty, to forty years to
15 work, depending on who you ask; some say ten to
16 thirty and some say twenty to forty.
17 So we're talking about that much
18 of a lag time.
19 Now, are you saying that there
should be that lag and reliance on that imprecise
-. tool before any consideration should be given to
._ control of a particular chemical?
23 MR. WALKER:
. I agree that a lifetime in many
/4
cases is very long. Certainly many chemicals who
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will become candidates for consideration under
this regulation have also been here ecually long
and if problems have not surfaced in that time
then that would be evidence that there is not
a problem.
CHAIRMAN PADGETT:
But you're suggesting a fixed
approach, inflexible approach, if you will, that
would require this or -- I'm not sure --
Because, you see --
There are chemicals that are
relatively new and many chemicals have not been
around in sufficient quantities.
MR. WALKER:
That is true; that is true; I
feel like people can always come UP with a
perhaps-this-is-a-problem sort of analysis.
Perhaps, because it's something like something
else that was going to be a problem, could be,£
problem.
But I think the issue is far
too important to proceed that arbitrarily. And
I feel that these tests -- the Aimes Test, the
animals studies and so forth should be done. But
each one should represent simply a screening step
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1 to move to the next higher level.
2 But there is certainlv no
, one-to-one correspondence between a few positive
3
. animal tests and human cancer. Invariably, the
5 animal tests are done in such high concentrations
that that alone is one of the reasons you don't
6
have a true applicability.
8 CHAIRMAN PADGETT:
9 Again, your feeling is that
10 | you should wait until you get that uneouivocal,
11 true epidemiology?
12 MR. WALKER:
13 I would say in the majority of
14 cases -- Now that's where possibly you could
15 introduce the thought of potency.
16 CHAIRMAN PADGETT:
17 Okay. Thank you.
18 MS. ANDERSON:
19 In mentioning the saccharin
20 case, I gather that you read this policy as being
21 virtually the same as the Delaney Clause -- which
22 of course, I'm sure you know, is unique in all
23 the Federal regulations in that it establishes
24 an absolute ban on the chemical which has been
25 shown to be associated with the induction of
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cancer in humans or animals.
And of course, when the FDA tool
its action on saccharin, it was taking action
that Congress said it had to take and it was
because Congress essentially changed the law of
saccharin that's still on the market.
MR. WALKER:
Yes.
MS. ANDERSON:
So I'm not sure I see that as
relevant to this topic, and I'm wondering how
you read this Policy to imply the sane thing that
the Delaney Clause dictates to the FDA --
MR. WALKER:
Actually, with the factors you
list there, you have a more sweeping ability
under this nolicy to condemn material that isn't
under the Delaney Clause. So I think if I recall
correctly, the Delaney Clause was confined to
animal testing --
MS. ANDERSON:
The Delaney Clause is animal
or human --
MR. WALKER
Oh --
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MS. ANDERSON:
It says as soon as you find
an association, that the substance can no longer
be intentionally be added to food which is an
absolute ban.
MR. WALKER:
Yes.
MS. ANDERSON:
I don't think there's any
intent of this policy and I'm wondering how you
read in this policy that as soon as there is any
association the EPA would absolutely ban certain
substances. I don't see the --
MR. WALKER:
You list a lot of criteria, some
of which are less demanding, like the Airaes Test,
and so forth as possible causes for listing and
let me -- zero allowable concept would lead you,
I think, rather rapidly --
Now, this may not be your
intention now -- but I think inevitably with that
line of logic it's going to -- the retreat will
be in that direction. "When in doubt, ban."
MS. ANDERSON:
I think -- " brought that up
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simply because I think we see this policy being
interpreted in the extremes in both directions and
I think this certainly is a very extreme
interpretation of the policy and I don't believe
it's written --
MR. WALKER:
No. I would agree it isn't
v ritten exactly that way but just the discussion c
zero implies that I think leaves the door open
for that.
CHAIRMAN PADGETT:
Mr. Joseph?
MR. JOSEPH:
Dr. Walker, I was just
wondering if you had the opportunity to read the
extended discussion and the supplemental statement
basis and purpose at the end of this Federal
Register publication, which discusses at
considerable length why the Agency does not belie-'
that zero emissions are required by Section 112?
MR. WALKER:
I did not dwell on that tailend
of it in particular detail .
MR. JOSEPH:
You might find some comfort in
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1 that.
2 | CHAIRMAN PADGETT:
3 Thank you very much.
4 Once again, now, let me ask:
5 Is there anyone -- Let's make sure I don't miss
. anvone.
6
7 Is there anyone here who was
0 scheduled to speak or who wants to speak in this
. j afternoon's session? Anyone that I missed?
! (There was no response.)
11 CHAIRMAN PADGETT:
12 He have the evening session
13 scheduled to begin at 7:00 p.m. At this point, we
14 have five individuals, I believe, who will speak
J5 at that session.
15 So if there are no further
17 speakers, then we will adjourn.
18 I would remind you that the
19 record will be held open for 30 days from today
20 for the submission of additional, supplementary
2! information and comments into the record relative
22 to this hearing.
23 The hearing is adjourned, then,
24 until 7:00 p.m.
25 (Whereupon, at the hour of
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3:10 r>.n., the hearing in the
above-entitled matter was
adjourned, to reconvene this
same date, Thursday, March 13,
1980, at 7:00 p.m., at the
same location.)
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E V E N I N 0
SESSION
S64
(7:06 p.m.)
CHAIRMAN PADGETT:
I want to welcome you to the
continuation of the informal public hearing on
EPA's proposed airborne carcinogen policy and the
advanced notice of proposed rulemaking on draft
generic practice and operation standards.
My name is Joe Padgett. I'm
the Chairman of the session. And very shortly, I
will introduce or call out the names of the
other panel members.
This proposed policy was
published in the Federal Register October 10th.
There are copies of the Policy back on the back;
and I think most of you have copies of it.
The public hearings have been
held in three places -- two days, Monday and
Tuesday in Washington; Wednesday in Boston; and
today, here in Houston.
We had a session today. We
adjourned about 3:00 o'clock and we are reconvening
now at approximately 7:00 o'clock.
The hearing is being reported
and so your comments will be put in the record.
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And we are holding the public record open for 30
days until April 14th for submission of any other
comments, written comments, thatn you would like
to make in response, to supplement or rebut
anything, that you would like to submit as a resul
of information received here at the public
hearing.
Basically, each person will be
asked to speak; and the nominal time is
approximately ten minutes or so for your remarks.
Following that, we will have
questions -- if the panel has any questions of
you -- for the purpose of understanding better
what you have said and clarifying your comments --
not for the purpose of particularly arguing or
defending.
The transcript for both this
hearing and the other hearings that we have had
will be available for inspection and copying at
the various EPA Regional Office libraries -- the
nearest one is in Dallas -- and also at the EPA
Central Docket Section in Washington, D.C.
We have, I believe, four
witnesses whom we will be calling in the order in
which they are listed, unless there is some reasor
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why a witness would like to change the order.
The panel members: On my far
left is Bob Bauman. And next to him, Bob Kellam,
both of the Air Programs office.
I am also in the Air Programs
Office.
Todd Joseph is on my immediate
right. He's with the Office of General Counsel.
And next to him is Dr. Anderson,
who is with the EPA office of Health and
Environmental Assessment.
And on my far right is Dave
Patrick, who is also in the Air Programs Office.
Unless you have any questions,
we will proceed with the calling of the first
witness.
The hearing record will remain
open for 30 days, until At>ril 14th.
First on my list is Judy Martin.
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STATEMENT OF JUDY MART III
MS.MARTIN:
I appreciate EPA offering
citizens an evening hearing that we have have the
opportunity to present comments on the proposed
policies for controlling the emissions of
cancer-causing substances in the air.
As a member of several groups
concerned about air quality in the Houston area,
I have become aware of the difficulties EPA faces
in proposing pollution control strategies vrhich
satisfy the public's concern for environmental
protection, x^hich adequately implement Congress1
legislative intent and which are acceptable to
Industry and feasible to implement.
The proposed rules regulating
the emissions of airborne carcinogens seem to
strike a balance among the contending interests
EPA must respond to. The rules incorporate a
concern for the public health impact of carcinoge'
by establishing testing and identification
procedures and an ample margin of safety in the
consideration of emission standards.
They also recognize Industry's
need for rapid responses to fugitive emissions
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268
1 without costly equipment purchases, but rather
2 through generic, broadly applicable standards
which emphasize improved work procedures to detect
. and repair leaks.
4
Since the number of substances
EPA might investigate is large, it seems
6
necessary to focus on indentifying the most
dangerous ones which have a high probability of
8
human carcinogenicity and thus are a significant
cancer risk. Listing under Section 112 as a
hazardous air pollutant immediatelv is a good
II i -
first step. And the subsecment imposition of
12
generic standards on all industries possibly
emitting or producing such substances in a logical
14
second step. And the further step of a
15
quantitative risk assessment on all high rrob?M.lit;
16
carcinogens is necessary to establish the need for
17
further regulations based on level of
18
carcinogenicity and exposure of the public.
19
The risk assessment procedure
should probably be carried out on some of the
lower probability carcinogens as well so they are
not overlooked as substances needing regulation.
I would hope that the process of quantitative
- -
assessment would not ignore the real-life impact
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of low-level exposure of humans over a long
period of time.
I agree that there is no safe
threshold for exposure to carcinogens and that
human exposure should be as low as feasible.
The screening and ranking procedure is thus
necessary to give us a better understanding of
which substances must be most rigidly controlled.
I am very much in favor of
dealing directly with the sources of excess
emissions in a timely manner by requiring leak
detection and repair. Relying only on ambient
monitoring to expose fugitive emissions is
inadequate because of dilution of carcinogens in
the general atmosphere and the time delay in
recovering data on monitored excesses. preventin,
fugitive emissions is a much more satisfactory
program.
The generic standards which rel
on tightened procedures by plant personnel on
a regular basis that specifies proper maintenance
rather than high capital expenses is a. low cost
control strategy which should be agreeable to
Industry.
Emission standards and further
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control strategies must be based on the protection
of public health. Dealing with new sources on
a case-by-case basis may be effective as long as
emission standards and BAT are followed and
the question of new plant siting is thoroughly
explored. There are too many variables to be
considered by EPA in waivers or granting alternate
emission standards.
Thank you.
CHAIRMAN PADGETT:
Thank you.
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STATEMENT OF BRANDT MANNCHEN
HP.. HANNCHEN:
My name is Brandt Mannchen. I'i
representing the Houston Sierra Club.
Concerning page 58642 of the
summary of this document, it is stated that
"Listing under Section 112 would be accomplished,
where applicable, by the proposalof generic
standards for source categories producing or
handling significant quantities of the substance.1
The "where applicable" should be removed. If the
source is listed under Section 112 then there
must be generic standards for its control.
The whole purpose of such
standards is to reduce immediately at least some
of the tonnages of carcinogenic materials being
emitted into the air until such time as further
studv determines what the ultimate emission
reduction mechanism is to be.
At the very minimum the generic
standards should be used even on dispersed,
hard-to-control, or small sources to reduce the
overall ambient concentrations of carcinogens.
We fully support the concept
of a no-threshold level for carcinogenic
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272
substances. That is whv it is so very important
to reduce to the maximum possible all carcinogenic
emissions whether bv particular control eouipment
or substitution. In fact, we favor substitition
wherever possible as the best way to completely
eliminate carcinogenic risks.
We are very distrubed that these
regulations do not include mutagenic or
teratogenic substances. These are at least as
harmful as carcinogens and need to be regulated
as well. Their effects, like carcinogens, are
hard to detect and have a long residence time
before they make themselves known.
When referring to the known
threshold level, I would like to make a comment
concerning Industry's claim that there is indeed
a threshold level for carcinogens. If these
claims are valid, then the onlv way they can
gain credence of acceptance is by publishing them
and their supporting data in accepted, reputable
scientific journals, like Mature or Science,
where they can undergo rigorous Peer review.
When putting possible carcinogens
in one of three groups; high-substantial evidence,
moderate-suggestive evidence, or low-ancillary
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evidence, cage 58647, E^A must be careful not to
simply leave the chemicals in these grour>s with
no further data being gathered, analysed, or
tested. Anv chemical nut in the low or moderate
groun simnlv because enough data has not been
produced must be nut on a testing schedule which
will produce results quickly so further
verification of the proper classification of the
chemical can be made.
On page 53647 (b) Preliminary
Evaluation of Ambient Exposure, if sampling data
is not available then EPA must have a mechanism
whereby it will be gathered as quickly as nossible
to clarify what the ambient levels are.
Also, some substances may be
emitted in significant amounts but only or mostly
in conjunction with other pollutants. Therefore,
not onlv should specific sources of the pollutant
be sampled but also those which include the
chemical as a by-nroduct, a major conmonent, or
a less-than-major constituent of the emissions.
One aspect to take into account
is if or how quickly the carcinogens degrade or
break down in the environment.
It is alarming the synergistic
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274
effects are ignored. In conjunction with a
sampling program an ongoing program of synergistic
testing needs to be done to find out about these
mechanisms and at x^hat, if there is a concentration
minimum, do these reactions not occur. Indeed,
known substances with synergistic effects or
susnected effects must be regulated much more
stringently than those without them.
On page 58655, even if the new
source meets the requirements of the Risk
Avoidance Criteria for the applicable source
categorv, it should not automatically be permitted
to meet the BAT standard instead of the National
Emission Standard. One reason for this is because
there is at present no mechanism which prevents
residential building around the industrialized
areas and thus, increasing the densitv in the
area and the number of people exposed.
In addition, the possibility that
even small levels of carcinogens may be cumulative
in their effect and the fact that many of them
may be carried far away from their place of
emission could cause an unnecessary risk for
people living bevond the E^A stipulated distance
criteria.
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Concerning the proposed Generic
Standards, EPA must be reouired to make periodic
inspections of plants for fugitive emissions leak;
so that the companies' maintenance programs will
be adeauately monitored to ensure compliance.
The concentration value which
constitutes a leak should be 1000 parts per millic
and the number of days to fix the leak should be
seven working days and the standards should effect
eauipment which comes into contact with a liauid
mixture containing one percent more by weight
or volume of organic chemicals listed by EPA as
carcinogenic air pollutants.
For storage equipment of greate:
than 40 cubic meter capacity the chemical storagi
regulations should apply. We support the use of
8-hour limit for linuid spill clean-ups but, if
the spill is larger than a certain size, it may
take longer to clean-up, so perhaps there should
be a size limit included here for the 8-hour
clean-up.
We have listed a variety of
carcinogens which we are concerned about, and
there are about 20 or 21 of them; and I won't go
through all of them. But these are the ones
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that we are particularly concerned about. This
is by no means an exhaustive list but these are
at least some of the specific compounds and/or
sources which emit these compounds which need to
be regulated. Some of these are already regulated
but there is a need to keep emissions as low as
possible because of the no-threshold level, so we
want as stringent controls as possible.
As far as mutagens and teratogens
we have a few of those listed also, to be looked
into, as far as testing.
We appreciate the opportunity
to comment and anticipate your final decision.
CHAIRMAN PADGETT:
Thank you.
I'd appreciate it if you'd
read the list.
MR. MANNCHEM:
1) Arsenic
2) Beryllium
3) Asbestos
A) Benzene
5) Nitrosamines
6) Various pesticides
(2,4,5T, et cetera,)
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7) Cadmium
8) Nickel Carbonyl
9) Radiation
10) Coke oven emissions
11) Chromium
12) Diesel Exhausts
13) Vinyl Chloride
14) Selenium
15) Carbon Tetrachloride
16) Polycyclic Organic Hatter,
which includes polycyclic aromatic hydrocarbons
like:
- Benzopyrene
- Idenot>yrene
- Benzacephenanthrylene
- Benzofluoranthene
- Dibenzopyrene
- Polynuclear imino-Heyerocvclii
compounds, and Polynuclear aza-heterocyclic
compounds like Dibenzacridine
-7,12 Dimethylbenzanthracene
- Benzophenanthrene
- 3 Methylchlolanthrene
17) Toluene
18) Chloroform
19) Methyl ethyl ketone
20) Catalytic cracking of crude
oil.
(There was a pause in the
proceedings.)
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1 CHAIRMAN PADGETT: .
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2 i Do you have all that (addressing i
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5 More or less, I believe.
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7 Do you have the data? Could
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12 them happened to be Politics of Cancer, Malignant
13 Neglect.
14 Another one had to do with
15 Health Effects of Air Pollutants (sic) by George
16 ! Walbott. These are mainly. -.-
17 I MS. ANDERSON:
18 Most of w- most of them -- now,
19 I know about ....
20 MR. MANNCHEN:
21 Okay.
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Really, my only question would
be, you made a statement that the generic fugitive
or the generic standards that we are -- to be
listed as advance notice should not be on a where-
applicable basis, but really, I gathered, in ever}
case whenever we had a listing for a hazardous
pollutant or for chemical carconogen, there shoulc
be generic standards; you don't leave any sort of
flexibility.
Now, I presume by that you mean
that there just should be some tpes of generic
standards that are -- that deal with the kinds
of housekeeping problems that we listed here.
These particular ones happen
to deal more with very volatile kinds of chemicals
MR. MANNCHEN:
Right.
MR. PATRICK:
You weren't -- I'm assuming tha-
you weren't indicating that these should be appli«
across the board to even unvolatile or less-volat:
materials?
MR. MANNCHEN:
Just whatever-you list in 112
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1 I think there should be generic
2 standards for them. Yeah.
3 CHAIRMAN PADGETT:
4 Do you have any ^comments?
5 MS. ANDERSON:
6 Just one other comment.
7 I think I understand what
8 you're saying about the no-threshold limit. And
9 perhaps that is certainly a valid way to base
10 that policy.
You're saying in specific cases
12 where something other than a no-threshold shape-
13 to-the-dose-response curve is to be applied that
14 it should be based on data that has been published
and subjected to peer review, on a case-by-case
basis?
17 MR. MANNCHEN:
18 When I'm referring -- Are you
19 referring to the statement I made about industry's
20 comments? Is that what you're talking about?
MS. ANDERSON:
22 Well, earlier in your statement,
23 you said --
24 MR. MANNCHEN:
25 Okay. I was referring to that,
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simply because we seem to have this -- these two
sides.
One says there's a threshold
one says there's not a threshold. As far as I've
been able to determine, all the things I've seen
said there's no threshold. No one's been able
to determine threshold on any carcinogen.
So if industry says there
ins't a I mean, there is a threshold, then it1
up to them to bring forth the data and bring it
out in respectable scienctific journals and let
it stand peer pressure and review and everything.
And if it's good data and everything, it'll stand
up. Tha's all I'm saying.
MS. ANDERSON:
Thank you. I think that's
what we say in EPA guidelines for assessing
carcinogencity risk and also in our Federal docum
which establishes a scientific .basis and that is
if you find a situation where you can identify
a threshold, then present new information
MR. MANNCHEN:
All right.
MS. ANDERSON:
Thank you,
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1 CHAIPJ-IAN PADGETT:
2 How do you see the goal of
3 risk assessment in -- in control of carcinogens?
4 MR. MANNCHEN:
5 I'm not real keen on risk
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8 feelings are just that, you know, carcinogens
9 i are real tough, mutagens, teratogens.
10 It would just be smart policy
11 ! to keep the emissions as low as possible, control
12 as many sources as you can; and that's why I
13 mentioned substitution, because that way, you
14 get rid of the carcinogen completely. If there's
15 any way, I think that would probably be the best
16 i route to go. \
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17 I would also like to mention, '
18 ! you asked Judy Martin before about siting. Especially
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19 j in Houston, we have no zoning in this area, and I
20 ! think it is extremely bad when you can see -- I
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22 an oil refinery here and right nextdoor is a residerj-
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being affect by possible carcinogenic emissions
or others.
And it's kind of a really
deplorable situation when something like that
occurs. And it may get to the point where some
sort of land-use controls are needed because
I just don't think you should be siting either
way, either industrial plants in residential area
or residential areas near industrial plants.
Maybe, you know buffer zones
or -- oh -- what do they call them -- just areas -
just strictly for plants, industrial parks, et
cetera, et cetera, should be the types of things
that we should more toward .
But I just can't see mixing
the two, because to me they are incompatible when
you've got hazardous substances in the air.
CHAIRMAN PADGETT:
Thank you.
Can you give us a copy of
your speech --
MR. MANNCHEN:
Yes. I was going to, anyway
CHAIRMAN PADGETT:
That would help with the
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spelling of some of those chemical terms.
2 MR. MANNCHEN:
2 I'm not sure they're exactly
4 spelled correctly.
5 MR. KELLAM:
6 Mr. Mannchen, .1 j.ust wanted
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7 to pursue one of the comments that you made that
8 I had to do with your preference for the substitution
9 i of -- of other types of substances for airborne
10 j carcinogens.
11 MR. MANNCHEN:
12 All right.
13 MR. KELLAM:
14 One of the things that we've
15 come across in looking at substitution as an j
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16 i alternative is that in many cases we know less i
17 about the substitutes than we know about the
18 ! chemicals we're trying to regulate. !
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19 i MR. MANNCHEN: i
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20 < Right. !
21 j MR. KELLAM: j
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22 Would you have any suggestions;
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23 for houw we would "clear" or in Siome say render |
24 innocent a substance before we use it as a
25 I substitute?
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Well, it's obvious you shoul(
go ahead and take a substitute for carcinogen
without it having been tested. I think that's --
That's not the way to go, because like you said
it could be worse if you find out later that this
might be even a worse carcinogen than the other
thing.
I think if you're going to
substitute something, you've got to know what it
is and how it affects people and that means
carcinogenicity , it means mutagenicity , that mean
teratogenicity , that means chronic or acute
poisoning -- whatever, I mean, you got to know
about, because you don't want to go ahead and
put something worse in than what you've got.
MR. KELLAM:
Secondly, you mentioned that
as far as pollutants which have demonstrated
synergism --
MR. MANNCHEN:
Yes?
MR. KELLAM:
-- or potentiation of
carcinogenic effects should be regulated more
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1 stringently, in some cases I think such things as
2 \ co-carcinogens may not directly induce cancer
3 i but only in combination with another agent.
4 Would you have any comments
5 | on how the Agency should view such things as
co-carcinogens or potentiating agents that
7 are not themselves direct cancer inducers?
8 i MR. MANNCHEN:
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9 i I see. Okay.
10 Well, again, since these
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11 I potentiators seems to be such integral with the
12 carcinogen itself, I would say you might have to
13 go ahead and regulate those, too, as much as
14 i possible.
15 j I would personally be in
16 | favor of it.
17 I MR. KELLAM:
18 | One final question, just a
19 ! follow-up on Dave Patrick's question.
20 j I -- the generics that we
21 ! currently have that are published separately, but
22 ; really incorporated in this Policy, really apply
23 to the synthetic-organic chemical manufacturing
24 i industry and the reason we call then "generic"
25 i is that they're a great deal there are many
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similar processes in that industry that lend
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MR. MANNCHEN:
Right.
MR. KELLAM:
Is your suggestion that
these generics should be expanded, or modified,
in some way so that they would apply across not
only this industry but also smelting and refinery
or other industries that are very dissimilar, I
think, in many ways.
MR. MANNCHEN:
Okay.
Those particular generic
standards you've got there may not apply to other
industries; but that doesn't mean you can't make
generic standards for each industry, like smelting,
for instance.
You can make maybe some simple
generic standards -- if there are any; I don't knov
but to go ahead and cut down the amount now until
you can get your long-range policy into effect
to where you can deal with it more directly.
But I think that it's real
crucial that we go ahead and cut down on the amouni
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1 of carcinogens in the air right now as much as
2 possible and it seems a good idea that generic
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3 I standards are a good way of doing that.
4 MR. KELLAM:
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5 ', Thank you.
6 MR. MANNCHEN
7 j Thank you.
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8 CHAIRMAN PADGETT:
9 Janet Maier?
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STATEMENT OF JANET MAIER
MS. MAIER:
I'm Janet Maier and I'm
speaking as an individual.
I feel that the policies
proposed by EPA and its information here offer
a reasonable approach towards reducing the risks
associated with airborne carcinogens.
The plan, I think, should
be implemented as soon as possible. But there are
some suggestions that I have regarding areas that
I don't think were adequately addressed.
I think we cannot ignore syng.n:
synergistic effects, as Mr. Mannchen was discussing
with you.
Also, I think that the effects
of mutagenic and teratogenic substances cannot
be overlooked if you look at the cost in both
dollars and psychological anguish that these bring.
It is something that is too significant to ignore
I support the Sierra Club's
position of Houston, Texas on this issue and I
also would like to emphasize the emphasis of the
no-threshold level for carcinogens and encourage
implementation immediately of the generic standards
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1 ! for maximum, short-term protection until we have
|
2 the long-term into effect.
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3 I was one of the people that
4 j wrote in and specifically asked for an evening
5 hearing and I'm really glad that this has happened.
]
6 ! I guess what concerns me is
7 when is the average working person expected to
8 ! have the chance to speak. !
9 i This is my first time speaking!
10 i at a hearing. I'm kind of new at this business. j
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11 ! But I guess I have a fair education and a fair j
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12 awareness of what is going on. j
13 But I think that the average j
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15 j such as this. Industry can sink millions of dollar^
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17 i a well-organized front,-- of course, individual i
18 ! industries, I'm sure, and perhaps some professional
19 groups together.
20 But I think the average person
21 has a poor chance of being represented here. They
22 I do have a huge investment in their health. I
23 I was wondering "like how many people are here tonight
24 are not with an industry of some kind.
25 Probably not very many. How
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1 many people are here?
2 [Laughter]
3 How many people know of the
4 Federal Register on the street? I never knew of
5 one until I became interested and worried about
6 the air pollution here in Houston.
7 Let's see.
8 I'd like to see more of the
9 efforts on your part to publicize these things
10 and I realize a lot of it's technical and the
11 average person would not understand some of the
12 things -- the technical details going on. But I
13 think it can be brought down to a lay-person's
14 level with some effort and some investment in
15 the cost that that would take.
16 But I think it's terribly
17 important. I'd love to know how many people, you
18 know, bodies, are represented in the people you
19 have heard in the last few days in comparison
20 to the average person on the street.
21 Is that clear?
22 The number of people -- I
23 don't know the statistics, but I'd like to know how
24 may people are involved, either by job or by
25 stockholding, in the companies that will be .involve
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in controls on carcinogens as compared to the numbei
of people in the country at large.
Virtually every person in
this country will be breathing the air which
5 carries the carcinogens, teratogens and mutagens.
6 And that's something that I think would be of
7 importance to everyone if it was explained on their
8 level so they could understand that.
I think we've seen some of
10 our mistakes in the past in emissions which turned
11 out to be carcinogenic, not only airborne but
12 other kinds. And I think it is time now to act
very strongly to stop that until we can catch
up with our awareness of the effects of all this
15 so we can control that.
16 And I think it is interesting
17 that this hearing deals with cancer, in particular,
18 because it's my understanding that cancer is
uncontrolled growth on the cellular level and I
20 think maybe in this country we have a bit too much
uncontrolled growth economically or industrially
22 and it can be very devastating to us in the form
23 of a cancer also if we don't control it. And that
24 is how you control growth and that's part of the
backbone of this country. But just as growth in the
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human being starts out as necessary and it has to
get to a certain point to be an adult, and then
there's a level of growth that's necessary to
maintain that.
But if it gets out of hand,
it's fatal. And I think EPA can use the power to
control that.
CHAIRMAN PADGETT:
Thank you.
(The speaker prepared to leave.)
CHAIRMAN PADGETT:
Wait a minute . Before you
leave --
MS. ANDERSON:
I think we all find it
very refreshing that you all come out tonight and
on behalf of the panel, we thank you for coming.
You were wondering how many
private citizens have spoken to us. And just to
give you some feel, I've looked back through the
speakers who came to the panel, here at Boston
yesterday -- and roughly -- there are quite a
few; in the neighborhood of about 15 or so out of
25 represented individual neighborhood groups.
I think we found it very
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refreshing to hear these statements from people
2 who, I think, someone said earlier -- the statement
3 have not been necessarily grilled by their attorney
4 [Laughter from the audience obliterate^
5 several words]
6 MS. MAIER:
7 I work in a very poor area
8 and the City, probably the lowest-income school
9 in Houston, according to statistics.
10 And as I mentioned before,
]l there are no joining, quote-unquote, areas here
12 and there's industry all around.
13 And I think it's just vital
14 that these peoples' interests be kept in mind
15 even though they're not here to speak and probably
16 aren't very aware of what's going on.
17 CHAIRMAN PADGETT:
18 Thank you.
19 The next speaker I have
20 listed is Sylvia Grickle (phonetic).
21 Is Sylvia here?
22 (There was no response.)
23 Anybody from the Union?
24 (There was no response.)
25 Was there someone else who
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wanted to speak?
MR. JOHN FAFOUTAKIS:
Yes, sir.
I'm a private citizen.
CHAIRMAN PADGETT:
May we have your name.
MR. FAFOUTAKIS:
I'm John Fafoutakis. I signed
the sheet out front.
last.
CHAIRMAN PADGETT:
How do you spell it?
MR. FAFOUTAKIS:
Okay.
Make a lot of room for the
[Laughter]
MR. FAFOUTAKIS:
F-a-f-o-u-t-a-k-i-s; first
name is "John."
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TESTIMONY OF JOHN FAFOUTAKIS
2 MR. FAFOUTAKIS:
3 First of all, I want to
4 thank the EPA for coining to Houston and taking
5 public comment.
Secondly, I wish to publicly
chastize the news media in Houston for giving your
c arrival such very poor advance notice. Virtually
9 no advance notice was given of your arrival to
allow the general public, as well as industry,
to come up here to give good general input, both
the pros and cons, about these emission regulations
The television media did
14 virtually nothing to announce your arrival. In
15 the Houston Chronicle, a very, very small article
was listed in yesterday's paper announcing your
17 arrival.
18 And I think this is very
poor because the people do not know what is
20 in effect just around the corner with the EPA.
They don't know what you are proposing because
22 they're not being informed by the media. The
23 media has done a very poor job and it's quite
24 understandable with their past performance.
25 One of the things that concern
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me is the threshold level for pollutants and
carcinogenic materials that have been discussed
thus far this evening, when we really look at
virtually every substance -- both carcinogenic
and even so-called harmless substances have at
one point or another some sort of a tolerance
level.
Even water, for instance,
just clean, pure water; one person's body can
absorb just so much of that water before their
cells literally drown in it.
So in order for industry or
the Environmental Protection Agency or anyone to
try to discern any specific tolerance level is
a virtual impossibility I believe because what may
be a threshold for one particular individual --
someone, let's say --
I, for instance, can tolerate
only a certain amount of percentage, a certain
percentage of carcinogenic material; perhaps anothe:
individual can tolerate a lower threshold level and
yet another individual can tolerate a much higher
level.
So to try to set any arbitrary
standard, any arbitrary threshold level would be
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1 very, very arbitary indeed, because you cannot do
2 it, you cannot set a general standard and accept
3 everyone "expect" everyone to be able to
4 somehow hopefully comply with that standard.
5 One of the things that I'm
6 concerned about, too, having lived in the Denver,
7 Colorado area, the EPA has done quite a bit of
8 well, you might say, work in the Denver area in
9 trying to clean up their very obvious pollution
10 problem that they're having up there.
11 And one of the solutions
12 that they're coming up with is actually something
13 that I vehemently disagree with and that's the
14 forcing you might say through mandates, forcing
15 the reduction of vehicular miles travelled by
16 drivers, by automobile drivers.
17 And this was also one of
18 the EPA's proposals that we had given to us in
19 the Houston area back in around 1973-74, if you
20 recall.
21 I was wondering if such
22 proposal, since I haven't had the time coming in
23 here this evening to fully read your proposal,
24 are these proposals under consideration for the
25 Houston area, for reduction of let's say vehicular
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1 miles travelled or anything like that?
2 MR. JOSEPH:
3 This proposal deals only
4 with the emission of --
5 MR. FAFOUTAKIS:
6 -- stationary sources?
7 MR. JOSEPH:
8 Right.
9 Carcinogenic compounds from
10 stationary sources.
11 MR. FAFOUTAKIS:
12 Okay.
13 But if, let's say, the
14 stationary sources are reduced to a certain level,
15 whether it's an EPA level or just the quote "the
16 lowest possible level," and yet pollution continues
17 to be a problem, would then the automobile somehow
18 take the blame?
19 Because one of the things I
20 was distressed to see when I was living in the
21 Denver area is although automobiles up there were
22 being increasinglu subject to more stringent
23 pollution inspections and things like that and
24 they were, as a matter of fact, being targeted by
25 EPA and in particular by the Colorado Air Resources
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Board, in being the main cause of pollution.
2 It was in fact industry which
3 was causing the bulk of Colorado's pollution. If --
I don't wish to start deviating and go over to
Colorado, but I just want to give you this as an
example.
One short drive down a little
8 stretch of Interstate 225 in northeastern sections
9 of Denver, Colorado will show you very readily the
10 copious amounts of air pollution being emitted
from several industrial stationary sources whereas
those individual sources were polluting the air
let's say thousands of times more than any particul4^
bus, or truck, or automobile could. They were
not the ones being penalized; the ones being
penalized were the everyday people who were just
17 trying to drive theircar to and from work, being
18 told that possibly some sort of a reduction in
vehicular miles travelled was going to be mandated
2Q upon those people and I'm concerned that these
controls will be placed upon the American public
22 unfairly.
23 And as an example to show what
24 industry has done, let's say the automotive industry
25 has done, to reduce vehicular emissions, I have with
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1 me a copy of an EPA report on the Texas Motor
2 Vehicle Emission Control Pilot Testing Program I
3 went by there earlier this afternoon and had my
4 personal car checked on the EPA monitoring devices.
5 Now, it's an 1980 model,
6 and according to 1980 standards, 1980 standards
7 call for at least -- well, 200 parts per million
8 of hydrocarbons or less.
9 My particular vehicle on
10 the second idle registered well under the 200
11 hydrocarbons -- as a matter of fact it was registe:
12 only 23 hydrocarbons -- 23 parts per million in
13 hydrocarbons.
14 EPA's standards also called
15 for two percent carbon monoxide for the 1980
16 model year or less. And my vehicle was emitting
17 two one-hundreths of a percent of carbon monoxide.
18 And on the propane gain, wher
19 they give it a propane test, the value should be
20 ten or more; and my vehicle read "100," which
21 is roughly ten times cleaner than the standard
22 calls for.
23 So it seems that at least
24 Detroit has made a very legitimate effort to reduc
25 vehicular emissions.
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1 And I'm sure that there are
2 those in other industries who are making similar
3 legitimate efforts in order to try to reduce
emissions from their stationary standards.
5 One of the things that we must
6 not overlook that Nature causes a large number of
7 pollutants to be emitted into the atmosphere.
8 For instance, the three
greatest volcanic eruptions that have taken place
10 world-wide, in this century, have done more to
11 pollute the atmosphere than all this is
12 according to Stanford -- than all of the manmade
13 pollutants.
14 So what we have here is
15 Nature by Her own acts has contributed more to
pollution even the Indians who were living in
the state of California back in the 1600's referred
18 to California as the "land of the smoke," simply
because of the hydrocarbons which were emitted
by the natural sources: trees and vegetation
were great enough back then for the Indians to
22 notice visible smoke.
23 Now, obviously they didn't
have Dow Chemical or any of the other chemical
25 plants or rubber plants or petrochemical plants
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operating in California in the 1600's.
2 But we have to realize that
3 there are certain sources which we have no controls
4 whatsoever, no matter how well-intentioned the
5 EPA, or the Texas Air Control Board may be, or
private citizens or environmental groups may be.
There are certain sources,
mainly Nature, that we cannot control under any
circumstances.
So we must remember that when
we do formulate and when we do promulgate rules
12 for emission controls that we do not take a
12 meat-axe approach and try to acheive limits that
14 are somehow unattainable, limits which were set
15 forth a few years ago when EPA was in Houston
around, I believe, '73 or '74, with their proposals
17 to try to reduce vehicular miles travelled in the
18 Houston area by sorae magical 75-percent figure
without an adequate mastering of the system or
2Q anything else.
Some of the standards that
22 were being discussed at that time were -- had
23 required cleaner than is available in the middle
24 of the Gulf of Mexico, where no stationary pollutic
25 sources exist, where no vehicular pollution sources
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1 exist.
2 So we have to use a more
3 reasonable approach, a more balanced approach and
4 we have to realize that industry, with its money
5 limitations can emit only a certain amount of
, funds,can expend only a certain amount of funds
7 for pollution control efforts simply because if
you just tell industry haphazardly, "You will
reduce your pollution levels to a certain standard
no matter what the cost," then what can we expect
to pay for this added benefit?
12 Now, true, everyone wants
13 cleaner air, whether it's industry -- I'm a '
14 private citizen. I'm not here representing any
15 of the industrial sources in the Houston area
16 or anywhere else. I'm not representing any sort
17 of a lobby group whether it's environmentalist
18 of industrial.
19 I'm a private citizen concerne
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They have to pass this bill
on to the consuming public.
If you fine an industry
for instance for pollution violation, do we
seriously think the industry is going to absorb
that fine?
No. They will have to pass
it on to the consuming public. No one is going
to allow their plant to absorb the cost. This wil
merely mean higher prices to the consuming public,
just like it really -- it really angers me whenever
Government officials say, "We're going to tax
this industry or that industry. We're going to
levy a tax," like the so-called wind-fall profits
tax, when in fact industry merely passes the
tax along to the consuming public and it is the
consumer not the industry who has to pay for it
in the end.
So I think a balanced approach
cooperation with industry and the :EPA is necessary
not a meat-axe approach trying to achieve an
infinitesimal amount of pollution, a quote, "no-
pollution aspect," because we can't do it. And
I think industry is doing a fine job. And in
cooperation with the EPA and a balanced program, I
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1 think we can lick the pollution problem. But
2 the things that we have to realize, again, in
3 summation, is that there are sources of pollution
* of which we have no control over, particularly
5 pollutants, as Stanford University pointed out in
6 a study around 1973, that some 93 percent of all
7 hydrocarbons are emitted by Nature, not by man.
8 So we have to realize this
9 and we have to realize that industry has to be
10 given cost-effective guidelines because they
11 can't just expend all of their funds fighting
12 pollution.
13 It has to be done in a
I4 balanced approach.
15 Any questions?
16 CHAIRMAN PADGETT:
17 No, I think we agree with
18 you on that.
19 Do you have any comment?
20 MR. FAFOUTAKIS:
21 Mr. Padgett, if I may make
22 one suggestion, since you gentlemen and ladies are
23 here with EPA, has anyone as far as reducing
24 vehicular emissions to a greater level, doing
25 whatever part you can to reduce emissions, has
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anyone thought of asking the refineries to
concentrate more on gasohol, because having lived
up in the Colorado, Wyoming area, I do know that
gasohol does work, I have used it in vehicles befor
that gasohol as a matter of fact can reduce
emissions far greater than any catylitic converter
or anything like that simple rather than trying
to clean up the emissions after it's gone through
the engine this is a cleaner burning fuel which
allows lower emissions levels, greater fuel
economy and more power for the vehicular engine
(sic).
And gasohol, I think, would
also be beneficial in helping the farmers to
get over their plight of not being able to sell
all that grain that were going to sell to the
Soviet Union and other countries which is of
course being boycotted by the President.
So I think this would be
a very good point here to expand the use of
gasohol to further reduce vehicular emissions
even for non-controlled vehicles such as pre-
catylitic-converter vehicles and heavy-duty
trucks which of course do not have emission
controls on them.
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Thank you very much.
2 ii CHAIRMAN PADGETT:
3 Thank you.
4 Do we have anyone else who
wants to speak tonight?
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TESTIMONY OF LOU ANN ANTHONY
MS. ANTHONY:
My name is Lou Ann Anthony
and I'm talking as a private citizen.
I did read this EPA proposed
legislation and I would like to compliment the
authors for their very even-handed and intelligent
review of what I preceive to be the current state
of the art.
I would like to make three
brief statements in support of what I perceive
to the EPA's position on three things.
First of all, in the article
it was viewed as what would be the optimal kinds
of data we would like to base our decisions on?
And I think rightfully it's
pointed out that good epidemiological evidence
in humans would be our first choice.
But I K>uld like to suggest
that we do not ignore or denegrate animal testing.
To the best of my knowledge, there are only two
substances benzene and arsenic -- which are
factors which are known to produce can.cer in human
and don't produce it in animals.
So I think the correlation
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1 between animal data and human data is quite strong
2 and I hope you don't neglect it and simply go to
3 saying, "We have to have epidemiological evidence
4 in humans for our criteria for defining whether
5 something is a human carcinogen." So I would
5 urge retention of animal testing.
7 I would also like to suggest
8 that one of the criticisms of using animal testing
9 is that it is 1) expensive and 2) it takes a
10 long time. Typically, carcinogen tests take
11 soEiething like three years and maybe cost something
12 like $500,000.
13 Many scientists are suggest-
14 ing the use at least in a preliminary sense of
15 the in-vitro Aimes Test, which is basically
16 a mutagen test, and there is a strong correlation
17 of a number of substances. I think the correlation
18 is something like 70 percent that substances
19 which are mutagenic are later found to be
20 carcinogenic.
21 So this is a relatively
22 inexpensive screening test which may be used as
23 preliminary data to at least suggest the substance
24 is a carcinogen.
-, Secondly, I would urge that
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the EPA change the philosophy which seems to be
expressed in the proposed standards. Again, the
philosophy -- and that in the absence of
identifiable expressed thresholds that carcinog<
do pose some risk of cancer at any exposure level 1
And I think a number of
speakers have spoken to this and have urged retentJ
of this process. And I would like to express my
support of this philosophy as well.
And finally I would like to
urge the continued interpretation of the language
of Section 112 that states that the EPA, or as it
is expressed in the language of the proposal,
the "administration," provide an ample margin of
safety to protect the public health.
And what I'm trying to get
at here that I urge you not go to a risk-benefit
ratio kind of philosophy which oftentimes industry
has proposed as an alternative to this type of
language.
I think using risk-benefit
ratio or risk-benefit analysis is a cop-out,
because we have to at some point appoint someone
to be that all-knowing, all-seeing person who can
put a dollar value on cancer. And I don't think
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1 that can be done.
2 So I would hope that this
3 type of analysis would not be used for determining
j
4 whether something is a carcinogen or what level
5 of carcinogen it is supposed to be.
6 Thank you very much.
7 CHAIRMAN PADGETT:
8 Any questions?
9 MR. KELLAM:
10 Just one question. Ms. Anthon
11 you mentioned that you feel the bacterial
12 immunogenicity tests that Bruce Aimes pioneered
13 would be useful in and low-cost -- in determining
14 whether substances have a high -- or whether
15 substances might be genuine carcinogens.
16 But do you feel that it
17 should be given or that EPA should consider
18 regulating a substance if the only evidence that's
19 available is a positive mutagenicity assay?
20 MS. ANTHONY:
21 No. But I'm saying that this
22 could be used -- You know, one of the speakers
23 earlier on said, you know, there's many potential
24 carcinogens and one of the things that EPA's
25 trying to determine, "Well, which ones are we going
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1 to focus on?" Or "Which are the ones that we
2 should be concerned about as co-carcinogens or
3 promoters?" or so forth
4 And I'm just suggesting that
5 this is a technique where we might get at some of
6 these additional substances.
7 MR. KELLAM:
8 So you feel that might be
9 a useful screening test to
TO MS. ANTHONY:
11 Right. I'm not saying that
12 this should be the only piece of data which says,
13 "Aha! We're going to ban this."
14 But I'm saying that this coulc
15 be used as a useful screen.
16 MR. KELLAM:
17 All right.
18 Thank you.
19 CHAIRMAN PADGETT:
20 Is there anyone else who'd
2i like to speak tonight?
22 (There was no response.)
23 CHAIRMAN PADGETT:
24 If not, dthen, we will adjourn
25 the meeting. Thank you for coming.
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1 (Whereupon, at the hour of
2 8:02 p.m., the hearing in the
3 above-entitled matter was closed.)
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CERTIFICATE
This is to certify that the attached proceedings
before the Environmental Protection Agency, in
the matter of the
U.S. Environmental Protection Agency
Public Hearing
Houston, Texas
Thursday, March 13, 1980
on
Proposed National Emission Standards
x>?ere held as herein appears and that this is the
official transcript thereof for the files of the
Environmental Protection Agency.
Christonhe Preval ,
Crtified Shorthand Reuorte
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