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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
                           Century Reporters, Inc.
                               (713) 496-1761

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                                           450R80101
 i

 2

 3             U.S. ENVIRONMENTAL  PROTECTION AGENCY

 4                        PUBLIC HEARING

 5                              ON

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 7

 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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                         Century Reporters, Inc.
                             (713) 49* 1791

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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
                         Century Reporters, Inc.
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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
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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.
                         Century Reporters, Inc.
                             (713) 496-1701

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    NAME
                      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.
                         Century Reporters, Inc.
                             (713) 496-1701

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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
                         Century Reporters, Inc.
                             (713) 496-1791

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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
                         Century Reporters, Inc.
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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
                         Century Reporters, Inc.
                             (713) 496-1791

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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.)
                          Century Reporters, Inc.
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 2                                              (9:10  a.m.)

 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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                                                         12
 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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                                                13

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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                                                          14
         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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                                                           26

 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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                                                 31

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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                                                 34
 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.

20

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 1  I                 CHAIRMAN PADGETT:
   j
 2  i                        Questions?
   i
 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
   i
 7  |      the airborne carcinogen problem.
   i
 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
   i
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
   i
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.
   !
25
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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
   I
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
   j                                                          i
18  ;      every one  of certain metals.  Group IV and V, and   i
                                                             i
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 --
  I!                        '                                  i
 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
                                                            i
 5 j.      And others clearly show the problem.               |
                                                            i
                                                            i
 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
  i
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
                                                             I
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
   i
 3  [      are the kinds of  data that would be well worth
   |
 4  |      getting hold of.
   i
 5  |                         And these are the sort of
   i
 6  |      data that I submit should have been an urgent
   i
 7        matter after that release of 20,000 pounds of
   I
 8  i      vinyl chloride  in the ship channel area.  But
   I
 9  !      no one knows a  thing  about it.  Unfortunately,
   I
   I
10  j      it is a totally improper experiment on a non-
   I
11  I      consenting public.
   j
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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                                                         42

         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
   I
10       cigarettes don't grow on trees.  We  process them.

11                          We  throw all sorts of fungicides |
                                                             i
12 I      and pesticides all over  them and all the manufacturj-
                                                             I
13        ing processes.                                      j
   I                    '                                      i
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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   I
 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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                                                              44




                      MR. KELLAM:




 2                            Thank you.




 3                    CHAIRMAN PADGETT:




 4                            Any other  questions?




 5 |                           (There was  no response.)
   I



 6 I                   CHAIRMAN PADGETT:




 7 j                           Thank you.




 8 |                           Mr. Gunkler,  from Dow Chemical?




 9




10




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                                                45

       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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                                                46


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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                                                 47
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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                                                 48

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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                                                49

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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                                                          50

 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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                                                51

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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                                                         54


         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

   i
   i
 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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                                                          56


 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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                                                          58



 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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 1  I      source and you will make  an  assessment,  maybe.
   i

 2  j      The administrator doesn't have  to  agree  with the


 3  i      risk assessment.
   i

 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:

   i
16  j                          My proposal is that there


17  |      should not be a generic standard,  but a case-by-ca
   I

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
   i
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.
   i

 7                            But our customers said we
   i

 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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                     MS. ANDERSON:
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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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                                                             i
                                                             i
                                                             i
 1        be held up,  the  document  is  a rather general       i

 2  j      scientific background,  scientific basis for        !
                                                             i
 3  I      carcinogen risk  assessment.                         I
                                                             i
 4                     MR.  GUNKLER:                            I
                                                             i
 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
   i
15        human carcinogen.

16  j                           It  also  says, that no contrary

17        data -- You-cah.-ruh'this"  test once  and it's
   i
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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                                                          64

 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,
                                                             I
 4  ji      it's different than  if  there  is  a very low statistical
                                                             t
                                                             i
 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
   i
 9        you find a high carcinogenicity,  I would find that i
                                                             i
                                                             i
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.
   i
15                    MR. JOSEPH:

16  I                           Dr. Gunkler,  you have indicated
   i
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.
   I
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
   i
 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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                                                           68

  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
   I
 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
                                                             l

                                                             i

 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:
   !
   i
 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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                                                           72


  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.


 13


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25
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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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                                                           76

 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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                                                         78
                                                            |
 1        to  ask  is:   You say that this Policy is inconsistent
                                                            I
 2 |       with  the  efforts of the IRLG work.                 j


 3                            I wondered in what respect you i
  i!
                                                            i
 4        find  statements in this Policy inconsistent with   [
                                                            I

 5 j       that  effort?                                       I
                                                            i
                                                            i
 6 |                   MR. BATES:


 7                            The evidence of this is offered
                                                            j
 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.


25




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                                                    .. 7-  79
 1                    MR. BATES:
   I
 2  i                          Yes.

 3                            If you  are  going  to  classes
   i
 4  i      of compounds and without  first  investigating  them
   i
 5  i      thoroughly and proving them to  be  carcinogens and
   i
 6  |      be effective carcinogens  in the concentrations

 7        that are encountered  in the atmosphere,  restrict

   1
 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.


23


24


25
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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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                                                      ~.  84
         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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                                                     rr 86



 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
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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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                                                          88
         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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 1                   MR. OZMORE:



 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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                                                 92

 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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                                                      :   94



 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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                                                         98

 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
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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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                                                         104




         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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                                               105

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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                                                        106
 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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                                               107
"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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                                                        108



  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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                                               109

                  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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                                                        110


 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.       :

                                                             i
10                       MR.  DAVIS:                           j
                                                             i
                                                             i
11                              Yeah.   I think so.  We were   |
   I                                                          i
                                                             i
"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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                                                        Ill

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
  !
9 j                    MS. ANDERSON:
  i
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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                                                         U3

                                                             i
 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

   i
23  ;      factors,


24  j                              "Studies of human
   i
   i
   i
25                      cancer rates  and  world-wide
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                                                         114
                                                             i
 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:
   i

11  '                              "The dimension of
   i
   i
12                       the  problem posed by  airborne


13                       carcinogens remains significant."


14                             And  with those kinds of
   i
   I
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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                                                         us
                                                             I
                                                             j
         you quite accurately reflects what we're  tring     j
                                                             I
 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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                                                         U6
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  1                      MR.  DAVIS:

  2                             Okay.

  3                             There are instances —  and
   l
  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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                                                        117


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
                                                             i
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
  11
9 !      but  OSHA  did  not withhold  its policy pending final
  L

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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                                                        119

 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
   i
 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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                                                       120


 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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                                                         1S2

                                                             i
                                                             t
  1       testimony  and  that  is  in pointing to inconsistencies
                                                             i

  2       between  the  EPA  approach of what is substantial    j

                                                             i
  3       evidence on  how  probability carcinogenicity        |
                                                             i
                                                             i
  4       you mentioned  that  it's  inconsistent with OSHA     '
                                                             !

  5       with regards to  OSHA considering epidemiology      !

                                                             i
  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
   I

 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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                                               123

              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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                                                              i

          a seemingly reduction in this peer review that
                                                              ]
                                                              I
  2        precedes the listing action, I think that the       i
                                                              !
                                                              |
  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
                                                             i
                                                             i
 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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                                                        125


         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
   i
   j
17 !      clarification.
   I
   i
13 i                           In your  discussions of


19 {      resources, you reference  this recently completed


20       R- D. Little  assessment for the American Industrial

   i
2i       Health Council.


22 |                           I  don't  think we need to get
   !
   I
23 j      into that because they  made their presentation


24       in Washington.  We will be getting back with them
   i
   I
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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                                                        128 j
                                                            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
                                                   |
                                                   i
                     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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                                                     • I  130


  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
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 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.

16

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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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                                               133

                  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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                                                134

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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                                                137

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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                                               138
                  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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                                               139

                  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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                                                140


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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                                               141

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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                                                142


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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                                               143

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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                                                144

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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                                                145


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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                                                153

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-of•viewing  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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                                                        166
 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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                                               168


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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                                                169
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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                                               177

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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                                                         180


 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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                                                         182

  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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                                                           190

                        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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                                               300

           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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                                                                  20.

                   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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                                                20

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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                                                210

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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                                                21

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.

                  The League of Women  Voters  of
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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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                                                        222
 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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                                                22
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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                                               22
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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                                               228

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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                                                zz

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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                                                230
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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                                                        232
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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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                                               23:

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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                                                234
                   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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                                                S3

                  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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                                               236

                  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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                                                24

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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                                               24

                  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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                                                250

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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                                             7  253

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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                                                        256

                    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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                                                         262



 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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                                               26

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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                                               26:
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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                                                         278
 1                   CHAIRMAN PADGETT:                        .
   I                                                           i
 2 i                         Do you have all  that  (addressing i
                                                              i
 3        the  Reporter)?                                      ;
                                                              i
                                                              I
 4                   THE REPORTER:                            |
   |
 5                          More or less,  I  believe.
   I
 6                   MS. ANDERSON:

 7                          Do you have the  data?   Could

 8        you  give us some references, say,  for Toluene?

 9                   MR. MANNCHEN:
   i
 10 !                         I -- I could go  back and  look.
   j
 11  j       I  took this out of several source  books.  One of

 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.
   i
 22  1                         But those are  essentially the
   i
 23  !       source books which I got most of these out  of.

 24  |                  CHAIRMAN PADGETT:
   i
25                           Dave,  do  you have any comments?
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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

  ji
 6 j       assessment  myself.
  I

 7                             I personally — just my own


 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.                                         \
  i                                                           I

17                             I would also like to mention,  '


18 !       you asked Judy Martin before about siting.  Especially
                                                             I
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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
                                                             !

21        won't name  any particular plant -- but you can see  !


22        an oil refinery here and right nextdoor is a residerj-
                                                             i

23        tial  area and you know that those emissions are

                                                             I
24        going into  the air and you don't know what's        i
                                                             i
                                                             i
25        happening to  those people; you don't know if they' rje
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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
   i
 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
                                                             i
                                                             >
 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.                !
                                                             i
 19  i                    MR. MANNCHEN:                         i
                                                             i
 20  <                            Right.                        !

 21  j                    MR. KELLAM:                           j
                                                             i
 22                              Would you have any suggestions;
   I                                                          I
 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:

    t
    j

  9  i                           I see.  Okay.




 10                             Well, again, since these
    i
    i
    i

 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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                                               287



similar processes in that industry  that  lend
                                                    i
                                                    i

themselves to a generic approach.                   !



             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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                                                            288
 1        of  carcinogens in  the air right  now as much  as

 2        possible and it seems a good idea  that generic
   i
 3  I      standards are a good  way of doing  that.

 4                      MR. KELLAM:
   i
   i
 5  ',                             Thank you.

 6                      MR. MANNCHEN

 7  j                             Thank you.
   I

 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.
   I
  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
   i                                                          i

 11 !      But I guess I have a fair education and a  fair      j
   ;                                                          i

 12       awareness of what is going on.                      j


 13                            But I think that  the  average  j
                                                             i

 14       citizens do not have adequate awareness of a hearing

                                                             i
 15 j      such as this.  Industry can sink millions  of dollar^
                                                             I
 16 J      into research, hire health experts  and present      j
                                                             i

 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
                                 Century Reporters, Inc.
                                    (713) 496-1791

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