SELECTED ASPECTS
   OF THE CONTROL
OF TOXIC SUBSTANCES
       (A Compilation of Speeches)
         MAY 1976
     U.S. ENVIRONMENTAL PROTECTION AGENCY

       OFFICE OF TOXIC SUBSTANCES
        WASHINGTON, D.C. 20460

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EPA 560/4-76-002
              SELECTED ASPECTS OF THE CONTROL
                    OF TOXIC SUBSTANCES

                   (A Compilation of Speeches)
                            by the

                MEMBERS OF THE STAFF OF THE
                OFFICE OF TOXIC SUBSTANCES
          U.S.  ENVIRONMENTAL PROTECTION AGENCY
                  WASHINGTON, B.C.  20460
                           MAY 1976

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                        PREFACE
  This collection  of speeches by members of the staff of the
Office of Toxic  Substances, together with a previously pub-
lished compilation of speeches by the Director (A Framework
for the Control of Toxic Substances. Office of Toxic" Substances,
April 1975),  in  large measure reflects the evolution of  the
interests,  policies, and  programs of the  Office  during  the
last several years. Hopefully this collection, and particularly
the more recent items, will be helpful to specialists and per-
sons concerned  with  governmental  policies and objectives in
this area.

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                  TABLE OF CONTENTS
Preface                                               i
  ,
CHEMICAL AND ENVIRONMENTAL CONCERNS           1
   Glenn E. Schweitzer                   '

INTERNATIONAL DIMENSIONS OF REGULATORY         9
 DECISIONS
   Glenn E. Schweitzer

PESTICIDES AND THE TOXIC SUBSTANCES CONTROL   19
 ACT
   Cynthia C.  Kelly

FLAME RETARDANT CHEMICALS AND THE TOXIC      23
 SUBSTANCES CONTROL ACT
   Michael J.  Prival

ADDRESS TO THE CONFERENCE ON THE ENVIRON-    31
 MENTAL IMPACT OF WATER CHLORINATION
   Edward M.  Brooks

PERSPECTIVES ON TOXIC SUBSTANCES CONTROL      41
   Cynthia C.  Kelly

AN APPROACH TO THE CONTROL OF TOXIC SUB-      47
 STANCES
   Glenn E. Schweitzer

NEEDS OF THE ENVIRONMENTAL PROTECTION        53
 AGENCY FOR MUTAGENIC ASSAY DEVELOPMENT
   Michael J.  Prival

ENVIRONMENTAL ASPECTS OF CHEMICAL USE IN      61
 PRINTING OPERATIONS
   Farley Fisher

ENVIRONMENTAL LEVELS OF PCS'S                   67
   Vincent J. DeCarlo

MONITORING:  THE TRIGGER FOR ACTION             79
   I. Eugene Wallen

CHEMICALS AND THE ENVIRONMENT                  85
   Glenn E. Schweitzer

HEARINGS ON PCBs                                  91
   Glenn E. Schweitzer
                            iii

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              TABLE OF CONTENTS (cont.)
PROGRAM OF THE OFFICE OF TOXIC SUBSTANCES   101
 IN RELATION TO MICROCOSM METHODOLOGY
 DEVELOPMENT AND THE OTS ECOLOGICAL
 EFFECTS PROGRAM
   Carter Schuth

COST/BENEFIT CONSIDERATIONS AND THE TOXIC    109
 SUBSTANCES CONTROL ACT
   Edward M. Brooks

ENVIRONMENTAL ASPECTS OF CHEMICAL USE IN    115
 V/ELL-DRILLING OPERATIONS
   Farley Fisher

RISK ANALYSIS AND SETTING STANDARDS FOR       121
 CHEMICAL CARCINOGENS
   Michael J. Prival

ENVIRONMENTAL ASPECTS OF CHEMICAL USE IN    125
 RUBBER PROCESSING OPERATIONS
   Farley Fisher

TOXIC CHEMICALS REGISTRIES IN THE UNITED      131
 STATES
   I. Eugene Wallen

ROLE OF THE ENVIRONMENTAL PROTECTION       143
 AGENCY IN ESTABLISHING STANDARDS ON TRACE
 CONTAMINANTS
   Farley Fisher
                            IV

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       CHEMICALS AND ENVIRONMENTAL CONCERNS

                        Delivered by
                    Glenn E.  Schweitzer
              Director,  Office of Toxic Substances

                          to the
      43rd Annual Meeting of the Adhesives Manufacturers
                          Association
            Lake of the  Ozarks, MO - May 13, 1976

A National Perspective in an Election Year

     Every four years a Presidential election fills the air with prom-
ises, hopes, and frustrations.   While called  rhetoric,  the  debates
surrounding  the election process nevertheless force us to consider
at least in a very  cursory way many of the issues of the  day and
to reflect on some of our underlying values.  For at least  a moment
we step back from the trees and take a  broader look at the forest.

     This year is no different.   The ever present issues of  defense
spending, tax inequities,  medical care, and educational deficiencies
blanket the front pages of  our newspapers.  Permeating every dis-
cussion is concern over the size of the Governmental bureaucracy
and the constant  rise  in the federal budget.   Political responses
range from vague promises to reduce  Governmental  control over
bur spending habits and our life  style to very specific legislative
proposals that require termination and reauthorization of all Govern-
mental programs every four years -- an approach so artfully labelled
"sunset .

     One thread that seems to run through all the political statements
over the last few months is the need for reasonable accommodation
of a  variety of conflicting interests in every Governmental endeavor.
All must benefit from new approaches while no one gives up any cur-
rent advantages.   Social equality must  not be jeopardized  by eco-
nomic progress.   Economic opportunities for all must not stifle the
economic incentives that inspire a few.

     In no area are the inherent conflicts of interest and the competi-
tion  among value systems more obvious than in our efforts to balance
environmental concerns with economic growth and  with  energy
conservation.  We long  ago abandoned the idea that environmental
control is free.   The appropriate  size of the price tag is now the
issue.  Unfortunately, it is  too easy simply to attribute the loss of
jobs and the rising cost of living to environmental controls and to
generalize from  local impacts to a comparable national  problem.
Indeed, politicians at all  levels of Government are using the environ-
mental control is sue to serve their particular interests.  Meanwhile,
the very serious and very complex environmental trade-offs are sel-
dom debated in a sound and unemotional manner.

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Recent Environmental Trends

    During the past five years there  has been some progress in
slowing the rate of pollution --in beginning to clean up  some of
our rivers and to prevent the continued growth of air pollution in
some of our  cities.  At  the. same time, as our population and  our
economy   continue  to  expand and as  the  potential for pollution
increases,  progress clearly is not as  rapid as envisioned several
years ago. Whether we underestimated the magnitude and complexity
of the tasks,  whether the parties directly impacted by requirements
to slow pollution are rebelling,  or whether  the momentum  of the
environmental  movement has been blunted through the long and tor-
tiious routes  of legal machinations accompanying  regulation, it is
clear that  we have a long way to go in preserving our environment
for the generations of the future.

    At the national level, our timetables for controlling  automobile
exhausts  and for  controlling point source discharges are slipping,
but we have not abandoned our environmental goals in any area.
Unfortunately,  I cannot think of any area where we have advanced
our timetables, but hopefully with the recovery of the economy,  some
of the difficulties of the last several years may be behind us.

    Meanwhile, the movement for regulatory reform has picked up
a great deal of momentum in the Congress, in the Executive Branch,
and, of course, in business circles.  It has been long accepted that
Governmental  regulation is essential to compensate for inequities
attendant  to a  free marketplace.   However, the  ever  increasing
number of regulatory activities at the Federal, state, and local lev-
els have raised genuine  concerns as  to the appropriate role of
Government in controlling almost  every thread  of the fabric of our
economic and social system. Regulatory reform initially was spurred
by concerns over economic imbalances resulting from regulation and
over allegations of economic favoritism among the regulated parties.
More recently  the concerns underlying the move for regulatory re-
form are  encompassing the social as well  as economic inequities
that may accompany individual regulatory actions.

    While the debate begins with the philosophical questions as to the
most appropriate  Governmental role in society, regulatory reform
advocates very quickly focus on specific regulatory decisions which
do not coincide with their views.   Relatively  little time is  spent
addressing the general policies which form the framework for  speci-
fic regulatory decisions.   Let me cite  two examples where  I think
we are making progress, at least in the environmental area.  First,
there is now a  tendency to limit and sharpen the number of regula-
tions to prevent or correct  specific types of problems rather than
broad scale approaches which simply extend the net of Governmental
control without concomitant impact which benefits society.  Secondly,
meaningful public participation in the  regulatory decision-making
process is becoming more and more of a reality.   However,  some
elements  of our society are at a considerable disadvantage in know-

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ing how or having the wherewithal to participate.

     There seems to be little doubt that chemical pollution in  the
broadest  sense is and will continue to be for many years a major
environmental concern.  The inherent characteristics of chemical
products,  the contaminants associated .with these products,  and the
chemical  discharges associated with the manufacturing, processing,
use, and disposal of the products have become major items of con-
cern in Washington, in State  capitals, and  in the press.  Our early
efforts to  control the gross pollution parameters  (e.g., COD, BOD,
TSS),  to regulate food,  drugs, and pesticides,  and to  protect  the
worker in the plant are recognized as important steps in addressing
chemical  pollution.   However, these steps have  not been entirely
effective and indeed neglect the vast majority of the industrial chemi-
cals which eventually find their way into the environment.

     In reviewing developments during the past year in Washington,
perhaps the most volatile environmental issue has been the prob-
lem of environmental carcinogens.  While the frustrations of  several
EPA lawyers  and scientists  at the National  Cancer  Institute have
provided the grist for Congressional hearings, the questions involved
are far rhore profound than might be suggested by such superficial
actions.   It seems virtually impossible to disentangle  scientific fact
from scientific judgments  and from value judgments in generalized
statements about environmental carcinogens. In my view, while cer-
tain guidelines can be developed for raising the flag  of  concern
over suspected carcinogens, regulatory actions to limit uses of such
chemicals must  be based  on  a chemical-by-chemical assessment.

Pending Legislation to Control Toxic Substances

     As you are aware,  for more  than five  years the  Toxic Sub-
stances Control Act has been pending in the Congress.

     The fundamental  public  policy issues which this legislation
addresses are: Does the public have a right to know what chemicals
are being manufactured, what chemicals are likely to reach the public
and its ecological resources, and what are  the likely effects of
these chemicals on man and the ecology?  Does  the public have  the
right to participate indecisions -- which up  until now have been made
almost exclusively by  industry --as to whether man or the  ecology
should be  exposed to these chemicals?  The Toxic Substances Con-
trol Act would establish mechanisms for the public  to exercise these
rights, both directly and acting through Governmental agencies.

     This legislation has four purposes:

 --  To develop authoritative information about the production,
    use, and  effects of commercial chemicals -- information
    that will improve  regulatory decisions made  by  several
    agencies under a variety of existing laws as well as under
    the new legislation.

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 -- To anticipate and prevent environmental problems and the
    economic dislocations attendant to corrective actions by
    evaluating the risks associated with commercial chemicals
    prior to major commercial investments.

 -- To help insure that in the regulatory decision-making pro-
    cess the total impact of regulations on society are taken
    into account,  including consideration not only of environ-
    mental risks but also of impacts on the economy,  business,
    and employment.

 - - To provide institutional mechanisms for coordinating regu-
    latory approaches  to toxic  chemicals  being taken by a
    number of Governmental agencies under a variety of laws.

    With regard to the status of the  legislation, about  six weeks
ago the Senate passed one version of the legislation and  the House
Commerce Committee is currently considering a version  which dif-
fers in some  respects.   I cannot predict the  Congressional time-
table.

    Should the legislation be enacted and signed  into  law,  as a
first step  EPA  will undertake an intensive period of consultation
with all  interested  parties prior to developing  an  implementation
strategy or preparing any particular  regulations.  While  in many
areas the intent of Congress will be quite clearly spelled  out  in the
legislation and in the Committee reports,  the EPA Administrator
will undoubtedly  have a considerable degree of  discretion in many
instances.   Despite a very tight implementation timetable for initial
actions which will probably be specified in the law, we nevertheless
feel that all interested parties  should have  the opportunity  from
the outset to make their suggestions on the most sensible imple-
mentation strategy. We estimate that the initial round of  structured
consultations will take about two months, although obviously consul-
tations will continue throughout the lifetime of the legislation.

    While I do not plan to trace the many twists and turns of the
various bills, let me make a few  comments about several provisions
which we know  have been of particular concern to the  Adhesives
Manufacturers Association.  We commend your efforts  in making
your views known to both the executive and legislative branches, for
it is important that as this proposed law makes its way through the
legislative process the implications be as well understood as pos-
sible.

    With regard to mixtures, the  Congressional intent  clearly is
not to  equate mixtures with chemical substances.  At the  same time
there is recognition of the need to retain the option of considering
that certain mixtures on a selective basis might indeed be of envir-
onmental concern due to the effects of individual ingredients or the
combined effects of  several  ingredients acting in concert.  Thus,
mixtures presumably would not  be subjected to any comprehensive

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requirement concerning prertiarket notification or annual  reporting
although on a case-by-case basis the Administrator could address
specific  mixtures which might be of  particular environmental con-
cern.  There is, of course,  the problem of defining what is meant
by a mixture, or by a non-reactive mixture.  The Japanese consider
for the purposes of their premarket notification that dry mixtures
are not  accompanies by chemical reactions.   On the other hand,
they recognize that liquid mixtures often involve chemical  reactions
and therefore pose quite complicated legal and procedural problems.

     Turning more specifically  to your concerns,  let me cite lan-
guage  in the  recent Senate report on the pending legislation:

    "There are mixtures such as,  adhesives,  paints and inks,
     which can produce chemical  substances upon  end use.
     Chemical  substances produced upon end use of such mix-
     tures should not be considered new chemical substances
     automatically subject  to  the  premarket notification pro-
     visions  of this  section.   Manufacture  is  defined under
     section  3(a)(7) to mean to 'import, produce, or manufac-
     ture for commercial purposes.' These types of substances
     would not be covered under the premarket notification pro-
     visions because they are not manufactured for commercial
     purpose, per se.  Similarly, minor reactions occurring
     incidental to the mixing process or upon storage of a mix-
     ture, such as the cross-linking of polymers, would  not
     constitute a basis for subjecting such mixtures to the pre-
     market notification provisions intended for new chemical
     substances because the resulting substances are not manu-
     factured for commercial  purpose. "

    "Such chemical substances arising during the formulation,
     storage  or use of such mixture should be considered as
     byproductsof the precursor substance or substances.   The
     responsibility for reporting and testing  such byproducts
     under the provisions of this legislation would then fall upon
     the manufacturer of the precursor substance. Of course,
     the Administrator may specifically subject any mixture to
     the premarket notification provisions.
                                           i

    "Subsection (k) specifically  exempts from the premarket
     notification provisions chemical  substances  which  are
     manufactured or  intended to be manufactured in  small
     quantities solely for scientific  experimentation or analysis
     or for chemical research.  The  Administrator is author-
     ized to include  those kinds of chemical substances when
     they may result in an unreasonable risk to injury to human
     health or the environment. "

     And with regard to the currently pending version of the legis-
lation in the House:

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   "The  term 'mixture' means any  combination of two  or
    more chemical  substances  if the combination does  not
    occur innatureandis not,, in whole or in part, the result
    of a chemical reaction; except that such term  does in-
    clude a combination  which  occurs, in whole or in part,
    as a result of a chemical reaction if each of the chemi-
    cal substances comprising the combination is not a new
    chemical  substance  and if the combination could have
    been manufactured for commercial purposes without a
    chemical reaction in the mixing process."

    In all of these areas, we anticipate  that there will be relatively
good guidance  from  the Congress.   However,  in preparing imple-
menting  regulations, many minor problems will undoubtedly be un-
covered.   It is the purpose of  the two-month consultation period
to identify- the problems more precisely prior to proposing specific
regulations.

The Longer Term Perspective

    The adverse effects  of  chemicals in  the  environment are now
front page news in the press and command prime time on  television.
While the public media may not be a good barometer of the severity
of the problems facing our society, nevertheless itis a potent factor
in determining future  directions of governmental policy. The fre-
quency of chemical  incidents will undoubtedly continue to rise, and
more and more linkages between chemicals and health and ecological
problems will be identified.  Furthermore, as our sampling and an-
alytical  techniques  continue to become more  sophisticated,  more
and more man-made chemicals will be found'in our drinking water,
in our food  resources, in the air, in the water,  in the soil, and
in the flora and fauna.   It is against this background of concern,
a concern which is understandable to every citizen, that  the chemi-
cal industry must face the challenges of the decades ahead.

    All signs are that chemicals will  continue  to undergird our
economy in many ways.   They  will provide us with the industrial
and consumer  products needed  to  maintain our standard of living.
They will contribute heavily to a favorable balance of  payments.
They will reduce our reliance on using non-renewable resources  to
solve many urgent human needs.

    The chemical industry is expected  to  increase its  efforts  to
assess the environmental acceptability of its products. Simply com-
plying with current regulations is not enough.  Industry has a better
appreciation of many  of  the potential problems associated with its
products than  does  Government.  Industry is expected to increase
its investigations of the properties of its products,  the  byproducts
of its manufacturing processes,  and the impact of these products
and byproducts on the  worker,  on  neighborhood residents, and  on
the surrounding ecological  resources.  The major share of the re-
sponsibility for needed epidemiologicaliinvestigations, for toxicolo-

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gical studies, and for fenceline monitoring rests with industry.  The
Government   has  an  obligation to  provide guidance  concerning
acceptable standards and to insure  the adequacy and  validity of
industrial  investigations.  However,  the initiation and  conduct of
the investigations are the responsibility of that segment of society
that derives  direct economic gain from producing those chemicals
which are of concern.

     I am hopeful that in the years ahead,  industry will more actively
seize this responsibility and reduce the necessity for large numbers
of Governmental regulations.   Seldom are regulations promulgated
when industry itself has recognized the problem and taken corrective
actions.   Indeed, industry initiative is  the keystone  to minimizing
unnecessary Governmental interventions that can have a disruptive
effect on normal business patterns.

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    INTERNATIONAL DIMENSIONS OF REGULATORY DECISIONS

                        Delivered by
                    Glenn E. Schweitzer
             Director,  Office of Toxic Substances

                           to the
          National Conference of American Society for
                   Public Administration
             Washington, DC -- April 20, 1976

The Growing Array of Regulatory Activities

    The realities of the need for the meshing of international and
domestic  considerations in  Governmental  decision-making are not
difficult to uncover in the regulatory area.  At the same time,  appro-
priate methodologies and practical  approaches  for  clarifying and
integrating such  considerations are far more elusive.   Seldom are
the issues as sharply defined as was the  case with the Concorde,
and even  then many of the  technical  and economic factors were far
from  clear.

    In response to the growing array of regulatory activities, parti-
cularly at the Federal level, regulatory reform has become a popu-
lar theme within  the Congress,  the Executive Branch, and the busi-
ness community.  While regulatory intervention by Government has
in principle long been condoned as necessary to help correct inequi-
ties resulting from a free  marketplace, the spread  of regulations
continually raises concerns over the  appropriate role of Govern-
ment  --  a role  that impacts,  and  often decisively, on the inner
fabric of our economic  and social systems.

    The calls  for regulatory reform have often related to  domestic
economic dislocations  and  charges of economic favoritism which
result from regulatory activities, and more recently to social im-
balances  that accompany regulation.   Regulatory reform is having
an impact.  For example,  we are becoming increasingly sensitive
to the need for more sharply focused regulatory actions to prevent
and redress  significant distortions  in national priorities  resulting
from  a free marketplace, rather than fuzzy, broad-scale approaches
that simply  compound  our  concerns.    Also, we welcome recent
recognition of the rightful role of the public  to participate in a more
meaningful way in the  decision-making process.  However,  we are
only beginning to appreciate how global interdependence is bringing
an increasingly important aspect to  regulatory decisions.

    The international dimension certainly adds a  layer of complica-
tion to an already complex web of interrelated regulatory, economic,
and social objectives attendant to policies and decisions of regula-
tory agencies; for this dimension  is fraught  with legal, financial,
political,  and even scientific diversities.  Nevertheless,  responsible
Governmental regulatory actions on  the domestic front should re-
                                  9

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fleet international considerations if the broadest  aspects of our
national  interest are to be served, and indeed,  in some instances,
if domestic regulations are to achieve their intended purposes.

    There are many types of regulations.  This discussion will be
limited to Federal regulatory actions  intended   to protect human
health  or ecological resources from harmful chemical products or
contaminants.   Such actions are largely within the purview  of the
Environmental Protection  Agency,  Food and Drug  Administration,
Department of Labor,  Department of  Transportation,  Department
of Interior,  and Consumer Product Safety Commission.   Of course,
a number of  research organizations of many Federal agencies sup-
port these activities.

The Role of International Cooperation

    Serious  cooperation in  the  development  of international  ap-
proaches to health and sanitation standards for international travel-
ers and for shipments of perishable goods across borders goes back
many decdes.  Many United Nations bodies and other international
organizations are involved.

    Similarly, international  collaboration in research has long been
a way of life in the scientific community.   International references
are frequently cited in the scientific documentation supporting reg-
ulatory actions,  and this  distribution  of the research load among
nations seems to be having some payoff for the United  States.   Also,
in the field of toxic  chemicals, harmful incidents  in one country have
on occasion alerted other nations to the need for prompt preventive
or corrective actions, such  as in the cases of mercury, cadmium,
hexachlorobenzene, and thalidomide.

    In addition to  the benefits 6f relevant research results and  prob-
lem anticipation  resulting from  international cooperation,  several
other considerations are  often  cited  in justifying  collaboration.
These  include the moral responsibility of the world's largest pol-
luter to  share advanced scientific and technological expertise,  the
likelihood that U. S. economic exports will follow in the wake of ex-
ports of  U.S. science  and technology,  and the support of political
objectives through technological collaboration on a bilateral or multi-
lateral basis. In any event,  the United States is  and will undoubted-
ly continue to be committed to a wide range of formal and informal
cooperative efforts through Governmental  and non-Governmental
channels.

    Sometimes,  an  international approach is essential if regulations
are to  be meaningful.  For  example,  should limitations on certain
types of  fluorocarbon discharges to protect the ozone layer be war-
ranted,  concerted  international  actions would seem critical,  given
the widespread manufacture and environmental  discharges of these
chemicals.    Similarly,  the need for multinational  action to help
prevent contamination of the oceans and Great Lakes by widely used
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and persistent  chemicals is reflected in  a variety of international
arrangements.   An interesting example of the international aspects
of regulations has been the need to insure the availability of unleaded
gasoline in Mexico and other countries for US tourists driving cars
equipped  with  catalytic converters.   And of  course Europe,  and
to a lesser extent  some  US border communities, have long been
seized with the international aspects of air pollution.

   Concern  has  been voiced over competitive  imbalances, and re-
lated  effects  for  trading patterns,  resulting from .inconsistent envi-
ronmental standards among nations. However, authoritative evidence
is in short supply  as to the real world  effects of the differences
of stringency in environmental controls in different countries.  The
developing countries contend, at least  within the UN Conference on
Trade and Development, that environmental decisions of the devel-
oped countries could adversely affect imports  from the developing
countries, imports which  might become  environmentally unaccep-
table  due to  their  inherent properties  or possible  contaminants.
Also, while the imported product itself may not be of environmental
concern, in the process of further manufacture or processing, envi-
ronmental measures might  be applied which could jeopardize the
competitive position of the product.

International Trends in the Chemical Industry

   During the past decade both the sellers and buyers of chemicals
have rapidly  expanded international operations.   International trade
in chemicals now exceeds $50 billion annually.   Chemical exports
contribute more than $4 billion to our balance of payments annually.
U. S.  companies are investing  heavily abroad,  financing the invest-
ments through transfer of capital from the United States, reinvest-
ment  of foreign earnings,  reinvestment of depreciation  reserves,
and sale of securities abroad.   Total foreign  investments of U. S.
chemical firms are now on the order of $10 billion.  Foreign plants
of U. S. based multinationals  have  had a  mixed impact on U. S.
exports, replacing some items but stimulating  the flow of others.
At the same  time several  foreign subsidiaries in the  United  States
have chemical  sales in this country exceeding  $1 billion annually.
Among the areas of particular importance to these subsidiaries are
fibers, drugs, and dyes. Joint ventures and licensing arrangements
further extend the international reach of many of the larger com-
panies.

   Foreign investments are stimulated by many factors,  and inhib-
ited by others.  Tariff and non-tariff barriers, proximity to markets
and supplies, production and labor considerations, and local politi-
cal and economic trends are  all central to investment decisions.
Patent protection, strength of the scientific community, and availa-
ble technology  and engineering services are particularly important
in highly innovative fields.
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    The impact of pollution havens on major decisions involving pro-
duction facilities in the chemical industry is not clear.  However,
available evidence suggests that local environmental regulations are
seldom a decisive factor in major investment decisions.

    Once investments are in place, an international ripple effect can
result from product-oriented regulatory decisions.  In responding to
constraints imposed  on the manufacture or use of a product in one
country, the concerned multinational firm would normally review
its world-wide operation involving the product.   One type of con-
clusion might be that a ban on some or all of the uses of a chemical
in one country (e.g.,  the United States) so limits  the market that
production for world-wide sale is no longer profitable. Another type
of conclusion might be that limitations on manufacturing can readily
be overcome by importation of the chemical product.

Examples of Regulatory Impacts

    The experiences of the drug industry in responding to  the 1962
amendments to  the Food, Drug, and Cosmetics Act are frequently
cited to illustrate the  impacts domestically and internationally of
product regulations.   One report states that  since  1961,  the per-
centage of new  drugs initially  introduced in the United States has
slipped from over 30 to less than 10 percent of the worldwide intro-
ductions.  The requirements imposed by the Food and Drug Admini-
stration (FDA) concerning approval prior to human testing and prior
to clinical  trials have undoubtedly  had an influence on industrial
decisions as to the locations for drug  development activities.   A
second factor which may influence the location of animal experiments
and clinical trials in some cases is the attention research findings of
local investigators will receive in local medical journals  which in
turn can encourage doctors to  prescribe  the  new drugs.   A third
consideration is the reticence of one  Government (and particularly
FDA) to accept with minimal questions research results from abroad
and drug approvals by another Government.  Finally, costs of R and
D activities abroad may be lower.

    Turning to the pesticide area, our domestic concerns  over the
adverse impact  of DDT on ecological resources and the concurrent
concerns of developing couuntries over its value to combat malaria
are well known.   As we accelerate our  effects to re-examine other
common pesticides, we are likely  to be confronted with similar
dilemmas.   Also,  as tolerances for pesticide residues which are
present as food contaminants are expanded and perhaps tightened,
certain imported  products may be affected.   Another example of
immediate concern relates to ethylene dibromide, an important fumi-
gant used by the Department of  Agriculture to treat imported grain,
which has  been  shown  to be  a  very  fast acting carcinogen at high
dose levels in laboratory animals.

    Recent regulatory actions by the Occupational Safety and Health
Administration  and by EPA directed to industrial  chemicals have
                              12

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probably had international repercussions, both by affecting produc<-
tion costs and by stimulating regulatory agencies in other countries
to take  similar regulatory actions.   Should toxic substances legis-
lation directed to  the  testing and regulation of a broader range of
industrial chemicals be enacted in the United States, and in other
countries as well, international concerns will probably loom large
in a variety of future regulatory actions.  Let me cite two examples
of the types of concerns which have arisen  with regard to industrial
chemicals.

    In attempting to assess the economic impact  of an air emission
standard for vinyl chloride in early 1974,  limited  attention was
given to the international aspects of possible  price  rises of  PVC
due to the costs of installing and operating the control technology
required to  reduce sharply the emission levels.  Among the factors
that were identified as potentially important were the following:

 -- About one-third of  PVC was produced and consumed in
    the United Sates, with  exports less than 5 percent of total
    production and imports almost negligible.

 -- A steadily increasing wo rid-wide demand for PVC was at-
    tracting new production  facilities in many countries, with
    the required technology well known on a broad international
    scale.

 -- Import duties  on PVC were 11/4 cents per pound plus
    6 percent ad valorem  from MFN countries and 4 cents
    per  pound plus 30 percent ad valorem from others.  Given
    the US market  price of  18 to 24  cents per pound,  there
    had  been little incentive to import PVC  resin.

 -- Because of short supplies of PVC in the United States and
    unattractive foreign  prices,  there had been  little export
    incentive.

 - - Deaths attributable to exposure  to vinyl chloride had been
    reported in at least five countries with regulatory action in
    each of these countries likely.

    Against this very general type of analysis, it seemed reasonable
to conclude that pollution control costs that would add several percent
at most to the cost  of PVC  would have a very minor impact on the
export/import situation. Concurrently, analyses suggested that sub-
stitute products would not significantly invade  the PVC market  as
the result of such  costs.   At the same time, virtually no attention
was given to what  might be called  the micro effects,  such as the
likely steps the several foreign  subsidiaries planning  to  invest in
PVC plants in the United States would take in the  face of increased
investment costs and the likely steps by US firms planning invest-
ments overseas.
                              13

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   . Another recent  example, with  a different set of international
considerations,  is the current  effort to phase out the manufacture
and import of polychlorinated biphenyls (PCBs).   Let me be speci-
fic.

 — In 1972, a  Decision of the  Organization  for  Economic
    Cooperation and Development (OECD) called on member
    countries to limit the use of PCBs to closed  electrical
    systems as  a  key  step in reducing the possibilities of
    environmental discharge.   To  date, only one country,
    Japan, has taken the necessary steps to comply.

 -- Although PCBs manufactured in  the United  States  are
    used only in closed electrical  systems, imports from
    Europe of about 500,000 pounds annually are  being used
    largely in open  systems.   There is no practical  way of
    inventorying the imports of PCB-containing equipment.

 -- Substitutes for PCBs, and particularly silicone oils,  are
    being introduced in Japan while  other  substitutes  with
    more questionable environmental acceptability are being
    offered for sale  by both US  and foreign chemical  manu-
    facturers.

    Legislation is  pending which would ban all manufacture  and im-
portation of PCB  --a step which  will require major adjustments in
the electrical industry.  Should this  approach be adopted by all  or
at least  most nations  manufacturing PCBs, there is an excellent
opportunity to  reverse the contamination  levels from  this highly
persistent chemical.   Our principal concerns are that the replace-
ment fluids not  significantly increase energy consumption (with the
well known international implications), and that  regulatory actions
be sufficiently stringent and well enforced to insure that the environ-
mental gains outweigh the costs involved.

The Challenge for Public Administration

    None of us are sufficiently broad in our outlook, our knowledge,
or our experience to appreciate fully the dimensions of regulatory
Impacts  at home and abroad.   Thus, an institutional approach that
will enrich without  stifling decision-making seems  in order.  But
what does this mean in practice?

    In my view,  we  do not need to reorganize  the Federal agencies
nor create new standing committees  or other organizational mechan-
isms to integrate international concerns into the regulatory process.
Rather we should  use the existing processes,  and particularly the
comment and hearing  procedures which accompany almost every
major regulatory  decision, more effectively.   There are offices in
several Federal Departments concerned with the  flow of technology
across borders  which  do not participate in or even have an up-to-
date awareness of the regulatory processes affecting the technology.
Even within the regulatory  agencies themselves  there are organ-
                              14

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izational entities  dedicated to international  activities which  are
sensitive to global considerations but which are not fully integrated
into the decision-making chain.

   Industrial groups,  and particularly several of the trade asso-
ciations,  do not hesitate  to submit for the formal record and to
articulate informally their international as well as domestic con-
cerns on specific  regulatory actions.   This type  of input is very
valuable.   At the same time,  however, groups representing other
segments of the interested  public  with differing perspectives are
not as well  equipped nor as well  informed to make meaningful con-
tributions  to  the  record.    Thus,  the inputs  of Federal  agencies
are particularly important to establish as sound a basis as possible
for the eventual decisions.

   With regard to the  analytical tools for  assessing  in  advance
international impacts,   the complexities  of the chemical industry
seem to  defy  rational analysis.  Given the diversity of chemicals
and their uses, the interdependences among sectors of the industry,
and the  seemingly constant  changes in availability of  substitutes,
macro economic models have serious  limitations.   A  product-by-
product examination that does not lend itself to easy programming
is probably the rule rather  than the  exception.   One very useful
approach in this regard is case  studies of past impacts resulting
from specific regulatory actions.  These retrospective analyses can
be helpful in developing  very crude check lists for considering future
actions.

   Perhaps the most vexing problem  is the inconsistency in regu-
latory approaches among the highly industrialized countries,  whether
the area be drug testing or the banning of specific chemicals.  In
my view, we have not fully utilized bilateral opportunities to achieve
parallel  actions by  the most important Governments, and too often
our multilateral efforts impress only a handful of international civil
servants and  consulting professors.  Improved approaches seem
imperative  to  insure that US  actions taken on a  unilateral basis
achieve their objectives without unnecessarily jeopardizing our inter-
national competitive position.

   Clearly, any Governmental decision is only as good  as the capa-
bilities of the people involved in the process leading to the decision.
I doubt that any of  our training grounds  for  Governmnental offi-
cials -- our universities, our Civil Service schools, or our Agency
development programs -- have given  serious consideration to the
necessity for bringing  together regulatory and international  skills
in a structured manner despite the publicity attendant to the Stock-
holm Conference several years ago.  As  our training institutions
move more heavily  into the interfaces of the technology and policy
aspects of the regulatory  sciences, the realities of modern inter-
national  economics  must envelop the more traditional disciplines.
Perhaps this is an area where public administration canhave a major
impact in bringing the international dimensions into our technologi-
cal decisions of the  future.
                                 15

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                   SELECTED REFERENCES

 Backman, Jules, The Economics of the Chemical Industry,  Manu-
    facturing Chemists Association, February 1970.

 Behrman, Jack N. and Carter, William G. , Preliminary Analysis
    of Problems of  International Business  Cooperation in Environ-
    mental Protection, July 1975, Unpublished Manuscript.

 "Chemical Trade:   There's Room for All", Chemical Week,  March
    31, 1976.                                     '•      ~

 Conroy,  Dennis,   Will  Dirty Industries  Seek Pollution Havens
    Abroad?, May 6,  1974, Unpublished Manuscript.

 Decision Making for Regulating Chemicals in the  Environment,
    National Academy of Sciences, 1975.

 Effects of Environmental Policies  on  Trade in Manufactures and
    Semi-Manufactures  of  Developing Countries,  Report by the
    UNCTAD Secretariat.  TD/B/C. 2/150,. April 1, 1975.

 Environmental  Quality, Council  on  Environmental Quality,  First
•~~' through Sixth Annual Reports.

 Grabowski, Henry G.  "The Effects of Regulation on Pharmaceutical
    Innovation:   Empirical Evidence  and Policy Options. "   Report
    for National Science Foundation in preparation.

 Herter, Christian A. , "Protecting the Environment",  Vital Issues,
    Center for Information on  America, Washington,  Connecticut,
    Volume XXIII, No. 5,  January 1974.

 "international Environmental Control",  Stanford Journal of Interna-
    tional Studies, Volume VII, Spring
 The Kline Gui-de_ *° _fr^ Chemical Industry,  Charles H. Kline  and
    Co.,  Fairfield. N.J., 1974.

 Mulloy, Patrick M. , "International Aspects of Environmental Prob-
    lems: Can the World Community Cope with Them?"  Land and
    Natural Resources Division Journal, U.S. Department of Justice,
    Vol.  11, No.  8, August 1973.

 Pearson,  Charles, Discussion of Studies on the Effects of Environ-
    mental Policies in Trade in Manufactures and Semi-Manufactures
    of Developing Countries,  UNCTAD,   TRD/B/C. 2/150/ Add. 1,
    May 5, 19757

 Preliminary Assessment of the Environmental Problems Associated
    with Vinyl Chloride and Polyyinyl Chloride (with  Appendices),
                              16

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    Report of the  Activities and Findings of the Vinyl Chloride Task
    Force, Environmental Protection Agency.  September 1974.

Sarrett,   Lewis  H.,  "impact  of FDA  on Industrial  R and D",
  .  CHEMTECH,  January 1975.

World Chemical Outlook,  '76",  Chemical and Engineering News,
    December 22, 1975^

Welles,  John G., Multinationals Need  Environmental Strategies,
    Columbia Journal of World Business, Summer 1973.
                               17

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     PESTICIDES AND THE TOXIC SUBSTANCES CONTROL ACT

                         Delivered by
                       Cynthia C.  Kelly.
              Environmental Protection Specialist

                             to the
     State Federal FIFRA Implementation Advisory Committee
                Washington. DC -- March 10, 1976

    Federal regulation of certain toxic substances dates back to the
beginning of the century.  Pesticides have been Federally regulated
for over  sixty years, beginning with the Insecticide Act of 1910,
while food and drugs have been regulated since 1906. Those chemi-
cals which fall  under current laws - - pesticides,  drugs,  and food
additives  -- represent, however, only 4 percent or less of existing
chemicals,  as measured in  terms of annual sales value.  While
there are some  1, 800 registered active pesticidal ingredients, there
are over  two million known chemicals of which  at least 30,000 are
currently in commercial production. To these are added some 1,000
.new chemicals introduced in commerce each year.   Of  the more
than two million known chemicals, only a few  hundred have been
adequately tested.

    .As stated  in the introductory section of the pending Toxic Sub-
stances Control Act,  Congress finds that humans and the environ^
ment are  being  exposed to  a  large number of chemical substances
and mixtures each year, some of which may present an unreasonable
risk to  health or  the environment.  Accordingly,  it is  the  stated
intent of Congress to provide in the Toxic Substances Control Act
adequate authority  to regulate these potentially hazardous chemical
substances and mixtures.

    One of the main thrusts of the legislation is  to provide some
mechanism for ensuring that hazardous chemicals are identified and
properly  tested before they are exposed to humans and the environ-
ment in significant quantities.  All versions of the legislation would
provide EPA with authority to control certain problems before they
are introduced into commerce.  This important feature  has  often
been termed a "front-end" approach.  Manufacturers of new chemi-
cals would be required to submit information  concerning the quanti-
ties to be  produced, uses, by-products, and any test data developed,
to the Administrator prior to commercial production.   EPA would
have 90 days in  which to review this information and initiate action,
if warranted, to restrict the production or use of that new chemical.
Under certain versions of the legislation, EPA might require further
testing  to clarify  the health and environmental effects of the sub-
stances.

    Some  have made an analogy between this  permarket notification
provision and the pesticide registration process.  However, such an
analogy is misleading.   First,  Congress has not resolved the issue
                               19

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 of whether all new chemicals  or only ones which belong to certain
 chemical  classes  listed in advance by EPA will have to be subject
 to premarket notification requirements.   Moreover,  no version of
 the legislation incorporates  a  "registration" or "certification" re-
 quirement.   In most versions of the legislation, unless EPA prom-
 ulgates  a rule  based on a finding of  unreasonable risk or a belief
 that there may be unreasonable risk  presented by a chemical,  the
 chemical  may be marketed at the end of the 90-day period without
 an affirmative action by EPA. In other  words, there are no extensive
 testing  requirements mandated by  the  legislation to "prove"  the
 safety or efficacy of new industrial chemicals.

    Aside from the  authority to  review  certain  chemicals (and in
 some versions of the legislation all chemicals) prior to their intro-
 .duction  into commerce,  the Toxic  Substances  Control Act could
 greatly  enhance our knowledge about  the  2 million existing chemi-
 cals.  Under the reporting authority  of  the  legislation,  EPA can
 .request information on the health and  ecological effects, the distri-
 bution,  the uses,  the  kinds and levels of  exposure, and byproducts
 qf all chemicals. Further, if the effects of a chemical are uncertain
 or unknown  and there is  reason  to believe that  the chemical may
 cause or contribute  to an unreasonable risk, then EPA may require
 that the manufacturer of  that chemical test for certain effects ac-
 ,cprding to,EPA standards for test protocols.  EPA has broad dis-
 cretionary authority over testing requirements.  For  example, the
 kinds of tests which EPA may require range  from acute toxicity
 studies  to environmental fate,  carcinogenicity,  and teratogehicity
 tests.   •

   
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ticular phase of the  existenc e  or use of a  toxic substance,  such
as in the workplace or during  transport,  or in products such  as
pesticides or drugs. With the alternative being a collection of special
purpose bills introduced to remedy each new crisis  that can not be
adequately addressed by existing laws,  the pending legislation pro-
vides a clearly needed rational approach to deal with problems which
fall outside the narrow scope of the existing regulatory framework.

    The legislation provides authority which is not contained in any
existing authorities,  and  which is critical to effective control of
certain chemical  hazards.  The authority  includes prohibiting or
limiting the manufacture of a chemical substance or mixture. While
EPA estimates  that banning of a chemical altogether will be rare,
perhaps once every three  or more years,  such an action may be
the only way to cope with  certain problems.  Poly chlorinated bi-
phenyls (PCBs) are examples of chemicals which are so persistent
in the environment and toxic to  humans and wildlife,   that when
acceptable alternatives are developed, banning the manufacture and
importation of PCBs seems tobethe only effective way of controlling
continued  contamination and threat from these chemicals.   In addi-
tion, the pending legislation provides authority to prescribe certain
quality control  procedures to  eliminate  hazardous contaminants,
as well as to issue disposal and labelling requirements.

    Pesticides  are explicitly  exempt,   insofar as they are manu-
factured or distributed in  commerce for use as a pesticide, from
any regulatory action, including  reporting and testing requirements.
If a chemical which has both pesticidal and non-pesticidal uses could
be regulated  under either  FIFRA or TSCA, under most versions of
the legislation,  the Administrator would have discretion to use  what
he determines  is  the most appropriate authority to protect against
the risk.   The  legislation  clearly states,  however,  that decisions
to use TSCA  to  address a chemical problem will not affect the ex-
tent to which  human health or  the environment is to be protected
under such other Federal law.

    In contrast to  other major  environmental authorities,  imple-
mentation of the Toxic  Substances Control Act will be a highly  cen-
tralized Federal activity.  However, there is provision for State
regulation of toxic substances similar to that in Section 24 of FIFRA.
In general, States  may establish or continue such regulations if they
are consistent with or more stringent than Federal regulations and
do not create  difficulties  in marketing, distribution, or  otherwise
unduly burden inter state commerce. Unlike FIFRA, present versions
of TSCA do not  authorize the Administrator to delegate to any State
the authority  to cooperate in the  enforcement of the Act nor are
there provisions similar to those under FIFRA for training.

  Obviously, this legislation will be a very complicated one to imple-
ment and to  coordinate, not only with the States and regions,  but
with other Federal agencies. There are a number of provisions in the
current versions of the legislation which require the Administrator
                                21

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of EPA to consult with other agencies before taking certain regula-
tory actions.   Further, the following excerpt from a recent speech
delivered by  Administrator Russell Train to the National Press
Club underlines the intention of EPA to implement the legislation in
full consultation  not only with  other agencies  but  with representa-
tives of all major interests.

   "We have done a great deal over the past several years to improve
the regulatory process at EPA --in particular, to make it far more
open and equitable. Our decisions are subjected to more searching
Scrutiny,  more critical  review, frohi  sources inside and outside
the Agency and the government, than those of any other agency.  We
have made a  strenuous and increasingly successful effort  ... to
get all the major interested and affected parties actively and effect-
ively involved throughout the process of developing a regulation. We
also have the most open and rigorous process of economic impact
analysis performed by any agency of the Federal government.

    It is along these lines,  according to these processes,  that we
would  exercise our authority under  toxic substances legislation. If
the legislation does not require  it,  I would - - on my own - - appoint
an Advisory Committee which is broadlly representative of all major
interests to help  advise us on implementation of the Act. "

    I predict that when the legislation  is  enacted,  EPA will  fully
appreciate and welcome advice  from those,   such as yourselves,
experienced in regulating toxic substances.
                               22

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       FLAME RETARDANT CHEMICALS AND THE TOXIC
                SUBSTANCES  CONTROL ACT

                       Delivered by
                 Michael J. Prival,  Ph. D.
           Acting Chief, Chemical Testing Branch

                          to the                 ,
      National Academy of Sciences Committee on the Fire
             Safety Aspects of Polymeric Materials
              Washington, DC -- January 27,  1976

    I would like to  thank  Dr. Shane  and Dr. Reinhardt for inviting
me to serve on this panel.   I would like to begin by  talking about
the Toxic Substances Control Act, and then discuss one experimental
technique which we hope will assist  us greatly in implementing the
Act.  I  will then mention some results which have been obtained
on one flame retardant chemical,  tris(2,3-dibromopropyl)  phos-
phate.

THE TOXIC SUBSTANCES CONTROL ACT ,              .

    The Office of Toxic Substances is the Office within the Environ-
mental Protection Agency responsible  for coordinating efforts  to
implement the provisions of the pending legislation which will hope-
fully soon be known as the Toxic  Substances  Control Act of 1976.
This Act will give  EPA the responsibility for determining which of
the thousands of chemicals in commerce,  excluding drugs,  pesti-
cides, foods  and food additives,  are  likely to pose unreasonable
risks to health or the environment.  As I will mention later, flame
retardant chemicals  appear  as a  class to  be among the types of
chemicals which warrant attention by  EPA.  I would like to outline
the major provisions of the pending Toxic Substances  Control Act.
I will base my discussion on the current version  of bill H. R.  10318
(Committee Print,  Jan. 9,  1976)  which was recently reported out
of the House  Subcommittee,  though  most of  the provisions I will
mention are similar in other versions of the bill.

    Basically,  the  Act will  give EPA both  the authority to  obtain
information necessary to assess the health or environmental impact
of the manufacture  or use of a chemical and  the authority to take
regulatory action when this is needed to reduce some health or envi-
ronmental threat, taking into account the economic and social bene-
fits derived from the  chemical.  This regulatory action would  be
taken only if the problem cannot be adequately addressed under other
authorities.  If EPA finds manufacture, processing, distribution in
commerce,  use or  disposal of a chemical is likely to cause  or
contribute to an unreasonable risk to health or the environment  --
a risk that outweighs the benefits -- then the Agency will be empow-
ered to take  necessary action along a number of lines.   These in-
clude banning or limiting quantities of chemicals or labelling  to
require certain use or disposal procedures.   The regulatory au-
                              23

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thority granted by  the Act  is quite  broad,  though it is to be applied
selectively in a manner designed to prevent overlapping jurisdiction
with other agencies,  such as the Consumer Products Safety Commis-
sion and the  Department of Labor.

    The law also gives  EPA broad authorities to obtain information
necessary in making the judgment whether chemicals pose a risk
to health  or  environment.  These can be divided into (1) the author-
ity to require reporting of information relating to  chemicals, and (2)
the authority to  require testing of  chemicals when  there is reason
to think that there may be  an unreasonable risk and adequate  test
data are not  available.

    One major problem we  face is to try to determine what chemi-
cals are made and used in the United  States, what are they  used
for, and in what quantities.  The Toxic Substances Control Act would
enable  EPA to require, when necessary, manufacturers and proces-
sors of chemicals to report what chemicals they are making, the
uses of these chemicals, the amount produced for each use, the by-
products of manufacturing,   processing,  use, and disposal of the
chemical, all existing data concerning  adverse  environmental and
health  effects, and an estimate of  the  number of people occupa-
tionally exposed to  the chemical.  This information,  if we  learn
to code, store, manipulate, and retrieve  it effectively, will obviously
help us enormously in setting priorities for further risk assessment.

    According the  House bill, H. R. 10318, once EPA has compiled
an initial list of chemicals in commerce, anyone  who wants to make
.or use  a chemical  not on the list must notify  EPA a"t least 90 days
in advance of their intention to make  or use a new chemical.  How-
ever, the  Administration considers that this premarket notification
should  be  limited to selected classes of/chemicals set forth  on a
premarket notification  list. In any  event, similar notification is
required for significant  uses of old chemicals.  EPA will then have
the opportunity to review the relevant information  prior to marketing
and may decide that certain tests are required.

    I have mentioned both the authority to regulate chemicals and the
.authority to obtain data relating to the production and uses of chemi-
cals.   My principal  interest is  with the  third  type  of authority
granted by the  law: the  authority  to require manufacturers and
processors of chemicals to test these chemicals in order to help
us determine whether they  pose  an unreasonable risk to health or
the environment.  The types of tests which can  be required under
the law span a wide range.

    We usually categorize tests into four groups.

    First, there are  tests relating  to the chemical composition and
physical properties of the chemical product.  This could include not
only such  paramters as melting and boiling  points and molecular
structure  of  the principal  component,  but also  in  some cases an
                                24

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identification and quantification of significant impurities.  Secondly,
there are  tests  which give insight into the environmental fate of
chemicals,   including  tests  for  persistence,  movement through
various environmental compartments, bioaccumulation potential, and
monitoring around points of possible release into the  environment.

    The third type of tests includes test for effects of chemicals on
the environment, here  defined  as including everything but humans.
Determinations  of toxicity  to fish and  birds are examples of such
tests.   The fourth category of tests  includes  those  which are de-
signed to tell us something about the effects of a chemical on human
health.   This would  include both toxicological and epidemiological
investigations.

    Depending upon the circumstances,  the  bill provides  that either
the manufacturers of a chemical,  the processors, or both would be
responsible for ensuring that  any required tests are performed.
There is a cost  sharing provision in the bill to enable all interested
parties to divide the  responsibility  for obtaining the   data, thus
avoiding needless duplication of effort.  In addition, there is a pro-
vision for partial  reimbursement of costs by parties who decide to
enter a market  after others have had  required testing performed.
Equitable administration of this cost reimbursement  provision may
become quite a problem for EPA.

    Reports in the last  week  concerning  the results of the FDA
investigation of the testing  facilities of a major drug house, Searle
& Co.,  have  brought to light another potentially difficult problem
relevant to the  Toxic Substances Control Act, namely,  the main-
tenance of the accuracy and completeness of test data submitted by
industry and  of the public's confidence in the integrity of  such data.
Obviously procedures will  have to be worked  out to deal with this
potential problem.

    Another difficult  problem we have  to face in implementing the
testing provisions of  the Toxic Substances Control Act is the selec-
tion of those chemicals or chemical  classes which  should be sub-
jected to test requirements and the designing of the standards for
the test to be performed. The Stanford  Research Institute has com-
piled a  list of approximately 27,000 commercially available chemi-
cals other than  those used  only as laboratory  reagents.   Even this
list is certainly incomplete.  Obviously we cannot rely on full scale
environmental and toxicological  evaluations of all these chemicals
to'decide  which ones require further testing.   We need some way
of establishing priorities.

    Ideally, we would like simple, rapid, inexpensive, and reprodu-
cible test methods which can be applied to hundreds or thousands
of chemicals and which are predictive of effects of  interest to us.
Such tests should have a near zero rate  of so-called false  negatives,
that is, results which falsely indicate the safety of a chemical which
                                  25

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is really a hazard.   In addition, the rate of false positives should
be reasonably low.

    One area in which such a "p re screen"  test seems to hold great
promise for the purpose of prioritizing chemicals for more elaborate
testing  is in the correlation between mutagenicity of chemicals  to
bacteria and  carcinogenicity to mammals.  I  would like to discuss
the Ames test for mutagenicity in bacteria,  both how it is performed
and what it may mean.

THE AMES TEST:

    Attempts in the 1950's to determine whether there was a cor-
relation between carcinogenicity and mutagenicity of chemicals led
to the conclusion that no such correlation exists.   Even at that time,
however,  it  was recognized that the lack  of correlation could have
been due, at  leastin part, to differences in the metabolic fates of the
chemicals in the different organisms used to assay carcinogenicity
and mutagenicity. As our understanding of the  action of  carcinogens
increased, it became evident that  many  chemicals  cause  cancer
when administered to experimental animals only after they have been
altered biochemically to other  chemicals. Aromatic amines, for
example,  appear  to require N-hydroxylation before they can exert
their carcinogenic action; polycyclic hydrocarbons appear to require
epoxidation.   Recognizing the significance of these findings for the
correlation between bacterial mutagenicity and carcinogenicity, sev-
eral investigators including Dr. Bruce Ames set out to determine
if carcinogens  would induce mutations in bacteria  in the presence
of enzymes capable of converting the parent compound to active me-
tabolites which might be formed in mammals. Since the liver appears
to have the  broadest  spectrum of metabolizing capability of any
mammalian organ, Dr.  Ames used extracts of rat liver to "activate '
his test compounds.

    The Ames  test  is performed  as follows  .  .  .  [Discussion  of
the methodology to be  given here.   For  a complete description of
the protocol,  see Ames,  B.  N. et  al.,  Mutation  Research, 31,
347-364, 1975].            -

    Ames1 group has compiled  information on the bacterial muta-
genicity and  carcinogenicity of  about 300  chemicals and found that,
using his bacterial strains and the rat liver activating system, about
90% (157/175) of the carcinogens show up as mutagens, and about
13% (14/108) of the chemicals classified as non-carcinogens showed
up as mutagens.   In a paper soon  to appear in the  Proceedings of
the National  Academy of Sciences, McCannand Ames discuss possible
explanations  for the false negatives and false positives in  the test.
I will give  Dr. Shane a copy of this  paper  to distribute to interested
committee members.

    It is possible that unknown chemicals  found not to be mutagenic
in the Amestestmay be carcinogens nonetheless. Hopefully further
                                 26

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refinements in the bacterial strains and in the techniques will reduce
the number of these false negatives.   There also may be some non^-
carcinogens which will give a .mutagenic response in the Ames test.
Regulatory agencies and most  others concerned with safety evalua-
tion are not at this point  prepared to decide  that  a chemical is a
carcinogen based upon a positive result in a bacterial mutagenesis
test.  At the same time,  however, we cannot ignore the weight of
the evidence  which has been compiled showing a strong correlation
between carcinogenicity and  mutagenicity.   A positive result in the
Ames test  would seem to cast a high level of suspicion on a chemi-
cal. Thus, while the significance of a negative result in the Ames
test may be  questioned,  it  may be  reasonable to  conclude that a
chemical which is positive and to. which humans are exposed should
be subjected to a more  thorough toxicological investigation, includ-
ing an evaluation of carcinogenic potential.    While EPA has  not
reached any  final conclusions in this regard,  this type of approach
appears to  have many attractive features.

FLAME RETARDANT CHEMICALS:

    In considering chemicals which are appropriate for evaluation
under the provisions of the Toxic Substances  Control  Act, chemicals
such as flame retardants,  especially  those used for textiles, would
seem to be among the  candidates.   First,  they are relatively new
products.    They have  achieved a very high level of widespread
human exposure  in a short period of time and this exposure is  ex-
pected to increase in the  future.  Some of them are brominated,
and alkyl bromides may be expected  as a class to include a number
of good alkylating agents.  There is evidence that alkylating ability
may be correlated with mutagenicity and carcinogenicity. Some of
them are phosphate esters,  which may raise questions about both
cholinesterase inhibition and delayed neurotoxicity.

    Many people first had their attention drawn to the possible prob-
lems associated  with flame  retardants by  an  advertisement which
appeared in 1974.   This ad  pictured a little girl holding a doll  and
wearing pajamas which were flame  retardant due  to the presence
of vinyl bromide.   While I don't know if there is any available vinyl
bromide monomer in such pajamas, the structural similarity of this
compound to vinyl chloride  and the  use  to  which it was being put
impressed  many people.  Vinyl bromide has,  like vinyl chloride,
been reported to be mutagenic in the Ames test.

    Since the Ames test and certain other mutagenicity tests using
microbes appear to have such great promise as indicators of car-
cinogenicity, we have  let  a contract to Dr.  Herbert  Rosenkranz
of the Columbia University College of Physicians and Surgeons to
test about 80 chemicals representing a wide range of industrially
significant  products.    He  has found that  one of the compounds,
tris(2,3-dibromopropyl) phosphate,  was  mutagenic  to  one of  the
Ames strains of Salmonella,  TA-1535. Dr.  Ames has told me that
his laboratory has also found tris to be mutagenic,  thus confirming
                             27

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Dr. Rosenkranz1 result.

    It is still possible that the mutagenicity of commercial samples
of tris could be due to an impurity.  Since the results from 9 different
commercial  samples were roughly similar quantitatively,  if they
were,due  to an impurity it  must  have been an impurity that was
relatively constant  in all .samples,  including  HV (high volatiles)
and LV (low volatiles) samples.

    Dr. David  Brown of the  Stauffer Chemical Company obtained  a
sample of highly purified tris for Dr.  Rosenkranz.  The mutagenicity
of this material  was compared  to that of the commercial grade.
The results showed that the purified chemical has  roughly the same
mutagenic potency as the commercial tris(2, 3-dibromopropyl) phos-
phate.

    A published paper by Dr.  Fred Kerst of the Michigan  Chemi-
cal Company   lists  several known impurities in commercial tris.
Dr. Rosenkranz obtained samples of these and tested them for muta-
genicity. The impurities are 2, 3-dibromopropanol, 1, 2, 3-tribromo-
propane, and  1, 2-dibromo-3-chloropropane.   While each of these
chemicals did show mutagenic activity, the activity  was not sufficient
to account for the mutagenicity of the commercial tris(2, 3-dibromo-
propyl) phosphate.

    It would thus appear likely that the mutagenicity of commercial
tris canbe attributed to the compound tris( 2, 3-dibromopropyl) phos-
phate itself rather than to an impurity.

    As I stated before, a positive result in the  Ames test does not,
in itself, constitute a sufficient basis for concluding  that a chemi-
cal is a carcinogen.  It does, however, raise suspicions.  The work
of Dr. Lisk' s group at Cornell and the work on contact sensitization
at DuPont raise the possibility that  significant exposure to, and per-
haps absorption of,  tris can occur from normal use of this chemi-
cal in children's sleepwear. The work of these groups also indicates
that release  of this chemical to  the environment  may occur during
laundering of treated fabric.   When  these experiments are consid-
ered in light of the mutagenicity results,  it would appear that cer-
tain steps should be promptly taken concerning this chemical.

    Given the  industrial  investment  in tris, there would probably
be a reluctance to abandon this chemical on the basis of the available
test results.   However,  it would be appropriate  to conduct further
experiments to determine whether or not there  is in fact any hazard.
The mutagenicity  data point out the need for further work on the
bioavailability of tris  from fabrics, the carcinogenicity of tris and,
possibly, its mutagenicity in other test systems. The basic premise
behind the  Toxic  Substances  Control  Act is  that industry should
finance the  testing of  chemicals  it  makes and   uses.   We  hope
the manufacturers and users of tris will support the necessary re-
search on this chemical.
                                 28

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    The lesson I have learned so far from my reading about flame
retardant chemicals is that the following of standard safety testing
procedures by  industry or  by government,  while better than no
testing at all,  is no substitute for the work of interested and innova-
tive researchers, such as  those  at  Cornell, at DuPont, and at the
University of Utah.  Flame  retardant  safety is obviously an area
requiring more  than the rote performance of routine tests.  Routine
testing of  tris,  for example, failed to  indicate any potential prob-
lems.  Only if those involved show a willingness and ability to seek
out and analyze potential problems  in  innovative ways  will we be
able to find and deal with any problems which may exist in a respon-
sible and timely fashion and thus reduce the  possibility of flame
retardants  from  becoming next month1 s  toxic  substance  of the
month.
                               29

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 ADDRESS TO THE CONFERENCE ON THE ENVIRONMENTAL
             IMPACT OF WATER CHLORINATION

                       Delivered by
                     Edward M. Brooks
              Chief,  Special Projects Branch.

                          to the
  Conference on the Environmental  Impact on Water Chlorination
     Oak Ridge National Laboratory, Oak Ridge, Tennessee
                      October 22,  1975
    I'm delighted to have the opportunity to talk to you this evening.
I must confess that, being neither scientist nor engineer,  I approach
the opportunity with no  little trepidation.  I am somewhat consoled
by the fact that  my topic has to do with decision-making in the
regulation of  chemicals, since most decision-makers in this area
are also not  scientists  --a  fact which must no doubt frustrate
many of  you  from time to  time.   Of  course there is that  body
of opinion which holds  that the regulation of toxic substances is too
important to  leave  to  toxicologists.   In any event,  the information
exchanged --or lack thereof  -- between scientists and the decision-
maker is what I want to discuss tonight.

    When he approached me to give  this talk,  Dr. Jolley was kind
enough to suggest a number of questions I might address,  among
which I found four particularly provocative:

     1.  What  type of toxicity  data are considered  in making regu-
        lations ?

     2.  Can cost-benefit analyses be applied in  developing regula-
        tions?

    3.  What  is  the mechanistic procedure or protocol for devel-
        oping regulations? and

     4.  What can data generators do to make decision making easier ?

     All four questions touch upon a more general proposition I now
put to you, namely  that  regulations to control serious chronic toxi-
cants are not developed within a consistent logical framework"!  I
will first  demonstrate the truth" of  this general proposition,  and
then explore a few reasons why it is the case and what, if anything,
ought be  done.   Before embarking let me define, for purposes
of discussion, two key phrases in Brooks' proposition. By "serious
chronic toxicants"  I mean those that are of concern because they
may cause death or illness to humans --  either after many years
of continuous exposure,  or after a latency period  of many years, --
at levels markedly below the  dosage at  which  the tolerable levels
of risk can  be  detected in laboratory  test animal experiments.
Such toxicants include, but are  not, in my opinion, limited to, human
chemical carcinogens.
                               31

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    The term  "consistent logical  framework", refers to a system
that imposes  a stipulated set of values, principles and rules upon
the manner in which data art evaluated and exploited to reach deci-
sions -- such  that different players,  operating independently with
the same information,  or lack  of information,  reach  essentially
the same conclusions.    A major function of  such a system is  to
compel consideration of costs, risks and benefits across  the range
of available regulatory options.

    The value of such a rational  approach to  regulatory  decision-
making is generally appreciated. The National  Academy of Sciences
recently completed  a study entitled Decision Making for Regulating
Chemicals in  the Environment, ^  the fruit of  which is a  series
of 34  recommendations -- from four of which I quote in part.

    "17.   The quality of chemical  regulatory decisions  is
           dependent largely upon  the adequacy of the avail-
           able information.   To  develop an adequate data
           base, research efforts  in basic clinical  and envi-
           ronmental toxicology and epidemiology and in eco-
           nomic analysis must be strengthened ..."

    "30.   Highly formalized methods of benefit-cost analy-
           sis can  seldom be used for making  decisions
           about regulating chemicals in  the environment.
           However, benefit-cost  and decision frameworks
           can be useful in organizing and  summarizing rel-
           evant data on regulatory alternatives which the
           decision  maker must review. "

    "31.   Value judgments  about noncommensurate factors .
           in  a  decision such as  life,  health, aesthetics,
           and equity should be explicitly dealt with  by  the
           politically responsible  decision makers and not
           hidden in purportedly objective data and  analy-
           sis. "

    "32.   The decision process should require the agency's
           technical staff to present  a full set of  options
           with a corresponding range of  cost-benefit-hazard
     ' ':     data  and explicit statements on the  confidence
           limits of each analysis. "

    The Academy thus expects staff scientists to identify  several
regulatory alternatives and objectively estimate and present to the
politically accountable decision-maker the costs, risks and benefits
associated with each -- together with explicit probability statements
regarding  the  reliability of those estimates.  From  these analyses
the decision-maker  selects a regulatory option and,  in proposing and
promulgating  the decision, explicitly sets  forth the value judgments
he applied.
                                32

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    'Tis a consummation devoutly to be wished.

    It will be instructive to  look at  a few proposed or promulgated
regulations to see how closely they approach this ideal.  I emphasize
two points.    First, nothing that follows is intended  as criticism
of any given  regulatory  agency or decision.   Further, where dis-
crepancies are found between different regulations controlling the
same substance I offer,  in these remarks, no opinion regarding their
relative  merits.    My  purpose here is to examine  what has been
done  to assess possible weaknesses in the process rather than in
any particular regulation.   Secondly, I trust it goes without saying
that  any weaknesses found hardly constitute grounds  for not con-
tinuing to aggressively  implement our diverse authorities  as best
we can.  I will now discuss four proposed or promulgated stand-
ards  -- two  for asbestos and one for vinyl chloride and  aflatoxins.

Clean Air Act -- Sec. 112 -- Asbestos;

    In April  of 1973, EPA promulgated  a  regulation ^2^ to control
asbestos emissions at a level designed to protect human  health with
an "ample margin of safety".    In  the preamble to this standard
the Agency stated that no numerical concentration or mass emission
limit  was practicable  because  it is "impossible to estimate even
roughly the quantitative relationship between asbestos-caused  ill-
ness and the  doses that cause  those illnesses".  Although we con-
cluded that there are no levels known at which asbestos does not
involve risk, and that  the effects of inhaling asbestos are cumula-
tive,  we did  not  ban the substance outright because  to do so would
prohibit  many extremely  important activities.  Accordingly the
standard, in  major part, simply banned "visible emissions   of  as-
bestos.

OSHA -- Sec. 6 -- Asbestos;

    One week ago Thursday last, the Occupational Safety and Health
Administration of the  Department of Labor proposed  a  new stand-
ard^3) to regulate work place exposure to asbestos.    The initial
QSHA asbestos standard,W   promulgated in May of  1971,  was 12
fibers, not longer ,yjan  12  micrometers,  per cubic centimeter.   In
December of 1971 '5'   this was reduced to five  fibers, no longer
than five micrometers.   The current standard/6'  promulgated in
1972,  established the level at  five fibers,  but added the provision
that this would automatically go down to  two fibers on  July 1,  1976.
Now the October 9 proposal would  reduce the level, still further,
to 0. 5 fibers.  The proffered rationale is that (1) sufficient evidence
has accumulated  to warrant designating asbestos  a human carcino-
gen, (2)  a "no effect" level has not been demonstrated, and  (3) in
the absence of evidence to establish a safe level, employee exposure
must  be reduced  "as low as feasible".
                               33

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     Thus both EPA in its promulgation under  Sec.  112 of the Clean
Air Act  and OSHA in its promulgation under the Occupational Safety
and Health  Act concluded that there is no known exposure level for
asbestos at which adverse human health effects do not occur.  Within
that frame work EPA concluded that no numerical concentration limit
is  possible because  the  dose-response  relationship is unknown,
while OSHA not only established  a numerical limitation,  but  has
systematically reduced it over the years.

     The significant point is  that no  data  have been provided to
the decision-maker in either  Agency regarding the dose-response
relationship.   Relative hazard assessment is therefore out of the
question.   In this regard it is worth noting  that,  although the ra-
tionale for  the OSHA standard is to  reduce exposure levels to as
"low as feasible", no evidence is provided to suggest that 0.5 fibers
is either feasible or safe.  In point of fact the rationale and evidence
used to justify  the 1972 five fiber standard  could just as well have
been used to  justify the 1975  0.5 fiber proposal,  and vice versa.
The evidence to establish a "no effect" or "safe" level was just as
absent when OSHA promulgated the five  fiber standard to protect
against asbestosis as it was a week  ago  Thursday last when it pro-
posed  the 0.5 fiber  standard to'protect  against mesothelioma --
and this lack of evidence has nbtningeapparent to do with any special
attributes of carcinogens. Ifi neither 'instance were "no effect" levels
or dose-response relationships established.

     I now want to  contrast the OSHA  vinyl chloride standard  with
the tolerance for aflatoxins proposed by the Food and Drug Adminis-
tration.

OSHA  -- Sec. 6 -- Vinyl Chloride;

     In October of  1974 OSHA promulgated a standard' ' for vinyl
chloride  based  on (1) the fact that  31 vinyl chloride workers  had
died of angiosarcoma of the  liver,  (2)  Maltoni1 s experiments in-
ducing angiosarcoma in rats at 250 parts per million,  and (3) In-
dustrial Bio-Test  Laboratories'  studies inducing  angiosarcoma in
rats and mice at 50 ppm.  OSHA concluded, in accordance with the
1970 Report of the^ Surgeon-General's Ad  Hoc Committee on  the
Evaluation  ofLow^Levels of EnvironmenTal Chemical Carcinogens,
that, on the~~basis of the "demonstration of cancer  in two animal
species,  vinyl  chloride posed a carcinogenic hazard to man.   In
further accordance with that  Report,  OSHA took  the position  that
"safe exposure levels for carcinogenic substances  can  not be sci-
entifically determined" -- a position supported at the Hearings by
both NIOSH and NCI.   On the grounds that vinyl chloride is a  car-
cinogen  and "safe" levels for carcinogens cannot be established,
OSHA  promulgated a  "no detectable  level" standard as measured
by methods sensitive to one ppm.
                                 34

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 FD&CA -- Sec. 406 -- Aflatoxins:

     The Food and Drug Administration1 s proposed December,  1974,
 tolerance for aflatoxins^8'  in shelled peanuts and peanut products,
 provides an interesting contrast..  The Federal Register NPRM notes
 that 25 rats,  fed aflatoxins at 15 parts  per billion, all developed
 liver cancer,  as  did monkeys fed aflatoxins.  In addition,  epide-
 miological studies in Southeast Asia and Africa indicated a correla-
 tion between the incidence  of liver cancer in humans and  exposure
 to aflatoxins.   FDA  concluded  from   this  that aflatoxins were
 "poisonous or  deleterious  substances" and that  human  exposure
 should be held to the "lowest level possible".

     An FDA survey indicated that four percent  of the U. S.  peanut
 butter exceeded the 20 ppb level, seven percent exceeded 15 ppb,
 11 percent exceeded 10 ppb,  and  25  percent approximated one ppb.
 Thus, about  four percent of the  U. S. production  fell between  10
 and  15 ppb, and three percent between 15 and 20 ppb. FDA proposed
 a  15,  rather than 10, ppb tolerance  to "avoid causing significantly
 increased losses of  food  .

     Thus, in  quite  comparable situations -- with substances dem-
 strated to be carcinogenic in two animal species and  with  strong
 epidemiological evidence  implicating  them as human  carcinogens  --
 OSHA promulgated a "no detectable level" standard  (for vinyl chlo-
 ride) well below the lowest levels at  which any adverse effects have
 been found in  any species, while FDA  proposed a tolerance (for
 aflatoxins) at the same level at which 25 of  25 mice  developed liver
 cancer.   The  two  Federal Register Notices reflect the different
 philosophies.   First the OSHA text regarding vinyl chloride.

   "There is. little dispute  that vinyl chloride is carcinogenic
     to man and we so conclude.   However,  the precise level
     of exposure which poses a hazard and the question of wheth-
     er a ' safe'  exposure level exists  cannot be definitively
     answered  on the record.  Nor is it  clear  to what extent
     exposures can be feasibly reduced.  We cannot wait until
     indisputable answers to these  questions are available, be-
     cause lives of employees are at stake.  Therefore,  we
     have had  to exercise our best judgment on the basis of
     the best available  evidence.   These judgments  have re-
     quired  a  balancing process  in which the overriding con-
     sideration  has  been the  protection of  employees,  even
     those who  may  have regular exposures to vinyl chloride
     throughout their working lives".

And the counterpart  passage from the FDA proposal regarding afla-
 toxins.

   "in addition, because there is  no direct evidence that afla-
     toxins cause  cancer  in man or of what  may be  the  level
                                 35

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    of no effect, the Commissioner cannot conclude that there
    is any tangible gain from lowering the permissible level
    to either ten or  five ppb.    Such uncertain  benefit to
    the public health must be weighted against the clear loss
    of food that would result. "

    Again the point is not who, if anyone, is right or wrong,  but
rather that no data were provided to either decision-maker to permit
a reasoned analysis of the risks incurred at various possible expo-
sure levels.   Without  such  information  the levels can and will be
set almost anywhere from zero up  to the levels that obtain without
any regulation at all. Any consonance between such permitted expo-
sure levels,  and a balanced tradeoff between health and economic
impact considerations, will be purely fortuitous.

    The inadequacies  of these  regulations warrant a moment's re-
flection.   Most remarkable is  the fact that none makes any attempt
to specify an "acceptable" level of  risk.  Instead they offer analyt-
ically meaningless platitudes about  the need to  reduce exposures "as
much as possible" or "feasible". There are no estimates of the ex-
tent of the adverse human health effects presumed to be caused by
these substances,  much  less of the extent to which this incidence
is expected to be reduced by the regulation.   Not only is it impos-
sible to  evaluate how  well these regulations  achieve their objec-
tives '--. we can't even  define the objective.  In the most fundamental
sense;, then,  it is impossible to assess their worth.

   , Even if "acceptable" levels of risk had been established, how-
ever, there are still  no  health effects data available  to  indicate
the exposure levels at which those risk levels would be exceeded.
In this situation it is fatuous to  speak  of cost-risk-benefit analyses,
judicious tradeoffs, balancing competing factors, or any other phrase
that connotes a reasoned application of useful information.

    One must  ask how this came  to pass?   How is it we write
regulations in such an important area with  so little comprehension
of what we are about?   From whence comes the pressure to prom-
ulgate such regulations?  Why is  the scientific documentation such
a paltry product?  What impels decision-makers to act upon such
tenuous  evidence?   Aside from our  ignorance, what accounts for
the striking inconsistencies found  in  these regulations  - -  not only
in their stringency but, more basically, in their underlying philos-
ophy ?

    While there are obviously many reasons,  I would like to briefly
mention two contributing factors. First I believe that we may some-
times be moved to precipitate  and unwarranted action in response
to public pressure.  In  this regard,  incidentally,  I have just read
a perceptive  article in the Fall issue of The Public Interest^Xvhich
reflects my concern precisely.   I  commend it to your attention and
will attempt to whet your appetite with the following quote.
                                  36

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   "Of all the  heresies afloat in modern democracy, none.is
    greater, more steeped in intellectual confusion, and po-
    tentially more destructive of proper governmental func-
    tion than that which declares the legitimacy of government
    to be directly proportional to its roots in public opinion --
    or, more accurately,  in what the daily polls and surveys .
    assure us is public opinion.  It is this heresy that accounts
    for the constantly augmenting propaganda that issues forth
    from all government agencies today --the inevitable ef-
    fort to shape the very opinion that is being so assiduously
    courted  -- and for the  frequent craven abdication of the
    responsibilities of office in the face of some real or imag-
    ined expression of opinion by the electorate. "

    This tendency  to precipitate action in  the  face of uninformed
but a roused popular opinion is reinforced by the wide and increasing
discrepancy between our ability and  disposition to  detect the pres-
ence of potential toxic substances and our ability to assess the degree
of risk they pose.  EPA's recent and  continuing concern with  organ-
ics in drinking water illustrates  this  phenomenon.  Surveillance  and
analytical technology now yields  impressively precise quantification
of very low levels of organics in water,  while the state of the health
effects assessment  art apparently permits only crude qualitative
estimates of the human health hazards posed at these levels.   In
1969  the Federal  Water  Pollution  Control Administration found
chloroform, benzidine and bis -chloromethyl ether in the New Orleans
drinking water/10) In 1974 EPA found 66 organic chemicals in  the
New Orleans drinking water. '11^  This past year  we completed a
survey of the water in 80 cities and found at least one of  the six
organics  for which we sampled --  and most particularly chloro-
form -  in every location.'1^)  At  various  stages  in the course of
these events  substantial pressure  was brought to bear on EPA to
"do something".   But what do we really know?  When asked to  re-
view the findings of the 80 city National Organics  Reconnaissance
Survey, EPA's Science Advisory Board concluded that
         there maybe some cancer risk associated with con-
    sumption of chloroform in drinking water.   The level
    of risk,  estimated from consideration of the worst case
    and for  the expected  cancer site for chloroform  (the
    liver) might be extrapolated to account for up  to  40%
    of the observed liver cancer incidence rate.   A more
    reasonable as sumption, based upon current water quality
    data which  show much lower levels than the worst case
    in the majority of U.S. drinking  water supplies, would
    place the risk of hepatic cancer much lower and possibly
    nil.  Further, it is emphasized that both the experimen-
    tal carcinogenicity data and the mathematical and bio-
    logical extrapolation principles used to arrive  at the up-
    per estimate of risk are extremely tenuous. Epidemio-
    logic studies do not,  thus far,  support the conclusion of
    an increased risk of liver  cancer; although hypothesis
                                37

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    formulating studies in southern Louisiana suggest the pos-
    sibility  of  an association with, coi
    overall high cancer incidence. " '  '
    There is  no obvious solution  to this  problem.   It is clearly
important  for a public agency to be responsive to the public; this
notwithstanding  it is at least equally important to allocate resources
and conduct the public's business in an orderly and reasoned man-
ner.

    There is  also apparently no immediate solution to our inability
to quantify  the  human health  risks associated  with  low levels of
chronic  toxicants.  As I understand it, neither epidemiology nor
test animal experiments provide a really acceptable solution.  The
uncertainty regarding exposure level,  the  long latency or exposure
periods, and  the confusion created  by multiple exposures, all di-
minish the utility of epidemiology.   On the one  hand,  the problem
of translating from test  animal to  human response  and,  perhaps
more importantly,  the high dose/low  dose extrapolation problem,
seriously limit  the utility of test animal experiments.  This prob-
lem is so serious that Messrs. Hoel, Gaylor, Kirschstein,  Saffiotti
and Schneiderman,  in a recent article in the  first edition of the
Journal  of Toxicology and Environmental Health,(1^)  flatly  state
that     ~                                :

   "There  is no adequate method for determining the best es-
    timate of risk for a given dose and the  best estimate  of
    dose for a given risk. Because of model dependency there
    does not appear to be a reliable method for obtaining such
    direct estimates and  their required confidence limits."

    I have been  given  to  understand that  the  National Center for
Toxicological Research was established, at least in part, precisely
in order to illuminate this problem by using  very large  numbers
of test animals to generate experimentally derived points much low-
er on the dose-response curve.  I certainly hope my understanding
is correct  -- and that NCTR is soon successful in this endeavor --
for until we can quantify the  human  health risks associated with
very low levels of serious chronic toxicants I  see no hope of mate-
rially improving the standard-setting process.
                                 38

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                          FOOTNOTES

 1.  National Academy of Sciences.  .Decision Making for Regulating
    . Chemicals in the Environment, Washington, DC, 1975.

 2.  Environmental Protection Agency.   National Emissions Stand-
     ards for Hazardous. ,Air  Pollutants --  Asbestos, Beryllium,
     and Mercury.   Federal Register, Vol. 38, No.  66 - April 6,
     1973, p. 8820.

 3.  Occupational Safety and  Health Administration.   Occupational
     Exposure to Asbestos,  Notice of Proposed Rulemaking.  Fed-
     eral Register.  Vol. 40,  No.  197 - October 9,  1975,  p. 475~!T2~.

 4.  Occupational Safety and  Health Administration.   Occupational
     Safety and Health Standards,  National  Concensus Standards and
     Established Federal Standards.   Federal Register,  Vol.  36,
     No.  105  - May 29,  1971, p. 10466.

 5.  Occupational Safety and  Health Administration.  Emergency
     Standard for Exposure to  Asbestos Dust.  Federal  Register,
     Vol. 36, No. 234 - December 7,  1971,  p.  23207.

 6.  Occupational Safety and  Health Administration.   Standard for
     Exposure to Asbestos Dust.   Federal Register, Vol. 37, No.
     110 - June 7, 1972, p. 11318.

 7.  Occupational Safety and  Health Administration.   Standard for
     Exposure to Vinyl Chloride.   Federal Register, Vol. 39, No.
     194 - October  4,  1974, p. 3589TT;

 8.  Food and Drug Administration.  Aflatoxins in Shelled Peanuts
     and Peanut Products Used  as Human Foods,  Proposed Toler-
     ance. Federal Register,  Vol.  39,  No.  236  - December  6,
     1974, p. 42748.

 9.  Nisbet,   Robert.    "Public Opinion Versus Popular  Opinion",
     The Public Interest, Number 41, Fall 1975, p. 166.

10.  "industrial  Pollution of the Lower  Mississippi River in  Loui-
     siana."  U.S.   Environmental  Protection Agency, Region VI,
     Dallas,  Texas, April, 1972.

11.  "New Orleans  Area Water Supply Study."  Lower Mississippi
     River Facility, Slidell, Louisiana and U. S. Environmental Pro-
     tection Agency, Region VI,  Dallas, Texas, November,  1974.

12.  "National Organics Reconnaissance Survey."   U.S.  Environ-
     mental Protection Agency, Office of Research and Development,
     Cincinnati, Ohio, April,  1975.
                                   39

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13.  "Assessment of Health Risk from Organics in Drinking Water. "
     Environmental Protection  Agency,  Science Advisory  Board,
     April,  1975, p. ix.

14.  Hoel,  David  G.,  David  W.  Gaylor,  Ruth L.  Kirschstein,
     Umberto Saffiotti, arid Marvin A. Sehneiderman.  "Estimation
     of Risks of Irreversible Delayed Toxlcity, " Journal of Toxicol-
     ogy and Environmental Health, 1:133-151,  1975.
                                40

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        PERSPECTIVES ON TOXIC SUBSTANCES CONTROL

                         Delivered by
                       Cynthia C.  Kelly
              Environmental Protection Specialist

                     •       to the
       Industrial Health Foundation,  Inc. -- Annual Meeting
                      October 22,  1975

    While most American television  viewers were avidly watching the
Red Soxs1  five  to  four triumph in  the fourth game of the  World
Series last week, perhaps one of the most cogent presentations docu-
menting  the "American Way of Cancer" was shown.  Although those
involved in industrial  health are well  aware  of the problems of
chemical substances in the workplace,  the  CBS  special attempted
to educate the  American public about the pervasive presence of car-
cinogenic substances.   Scenes of a backyard barbeque with hot dogs
that might  cause the formation of  nitrosamines and  chocolate cake
that might be colored with Red Dye 2 were interspersed with scenes
of Asarco's Tacoma smelter and DuPont's Chambersworks factory
where exposure to potential cancer-causing substances was more
obvious.

    As part of  the  hour-long documentary^   EPA Administrator
Russell Train commented on the p'ending toxic substances control
legislation.   Train emphasized the need for this legislation to pro-
vide an overall approach to the problem of toxic substances.   Pre-
sently,  too often the Nation1 s population and environment provide
the testing grounds for  determining the effects that a chemical may
have on human health or the environment.  While billions of pounds
of new chemicals have been introduced in the past decades, we have
enjoyed their copious benefits without fully understanding their con-
current risks.  Dozens of chemicals  have been cited at Congressional
hearings on the toxic substances control legislation as examples of
substances which were once considered safe  for widespread use and
which were discovered  to have serious  adverse effects for man or
his environment. The tragic  consequences associated with workers'
exposure  to vinyl  chloride  and  asbestos are  familiar  to us  all.
The problems presented by others, such as polychlorinated biphenyls
in the nation's waterways, arsenic  in the environs of smelters, and
suspected carcinogens in drinking water,  have also received national
attention.  However, the effects associated with the abundant array
of remaining chemicals  to which  we are commonly exposed are un-
certain.

    The growing evidence of a correlation between exposure  to in-
dustrial  chemicals and  cancer has prompted Dr.  Umberto Saffiotti
of the National Cancer  Institute  to comment, "Cancer in the  last
quarter of the  20th century can be considered a social disease  whose
causation and  control are rooted in the  technology and economy of
our society. "   Other health problems such as birth defects, heavy-
                               41

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metal poisoning, and  respiratory  and other  disorders are  also
traceable to chemical substances intentionally or unintentionally pre-
sent in air, water, and food.  The adaptability of man and the envi-
ronment to the myriad of chemicals introduced is clearly being
challenged, with signs indicating a serious  deficiency in Nature1 s
ability to cope.

    The outcome of this competition clearly rests upon  the precau-
tionary measures that are developed to limit exposure to chemicals
when necessary without unduly curtailing  the  economic and other
benefits associated with them.   The pending toxic substances con-
trol act  would  provide a  critical tool for developing  a coherent
approach to prioritizing toxic chemicals for attention,  for assess-
ing risks,  and for balancing  costs, risks,  and benefits in making
regulatory decisions.

    During the course of the long debate over the pending legislation,
spokesmen from the chemical industry have often argued that pre-
sent authorities are sufficient to address the problems of toxic sub-
stances.  While these authorities may appear to be numerous, their
effects  are limited to  three broad areas.   First are consumer
protection statutes which  have  as their primary mission  the pre-
vention of acute risks to human health.   For the most part they
do-not extend  to products  which are hot strictly  "consumer" prod-
ucts such as those in industrial or commercial use.  Consequently,
although fluorocarbons such  as Freon can be  banned from  house-
hold aerosol   spray cans,  a  large percent  of  these fluorocarbons
cannot be regulated as they are used in industrial operations.  Fur-
ther, these statutes do not address problems of environmental pro-
tection  nor human exposure  to toxic   substances through environ-
mental  routes.

    A second  major category of current regulatory  authorities are
the media-oriented statues whose focus is typically on environmen-
tal,contaminants after they are manifested at the end of an outfall
pipe or smokestack.   These authorities are designed to control the
 'accessible"  aspects of a toxic  chemical problem which,  unfor-
tunately,  may not  always be the "critical" aspect of the problem.
This approach may hamper efforts to cope with the core of the envi-
ronmental and health risks posed by the manufacture, use,  and dis-
posal of toxic substances.          .

    Finally, there  are  statutes which deal with  a particular phase
of the existence or use of a toxic substance such as in the workplace
or during transport,  or as used  as a pesticide or drug.   With the
alternative being a collection of special purpose  bills introduced to
remedy each  new crisis, -the pending  legislation  provides a clearly
needed  rational approach to deal with problems  which fall outside
the narrow scope of the existing regulatory framework.

    One critical aspect of the legislation is the authority to control
certain problems before they appear in the environment.  This im-
                                42

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portant feature has often been termed a "front-end" approach.  As
you probably know,  the legislation would require premarket noti-
fication of all  new chemicals in  commercial quantities and signi-
ficant new uses of existing chemicals.   Information concerning the
quantities to be produced, uses, and by-products would be submitted
to the Administrator prior to commercial production.   If there was
reason to believe that  the intended production or uses of the sub-
stance posed an unreasonable risk, appropriate action could betaken
to limit the production or use or to require further testing to clarify
the health and environmental effects of the substance.

    While no one  pretends  that all potential hazards associated with
the chemicals  submitted for premarket review could be anticipated
during the 90-day review period,  nonetheless  those who may poten-
tially benefit from such an approach are not only  the worker, con-
sumer, and environmentalist, but also the producer.  By examining
the potential dangers associated  with  the production and use of  a
product before investing considerable capital,  the chemical industry
can later avoid the serious disruption and losses attendant to reme-
dial action after the fact. This approach should be far more attrac-
tive to industry than the present unpredictable  and sometimes costly
system of ad hoc controls.

    Another major criticism  raised by opponents of the legislation
is the estimated  costs  and economic  impact that  it would have on
the chemical industry.   The reports of the Manufacturing Chemists
Association and  Dow Chemical Company are cited by  industry as
the basis for their claims that the legislation would adversely affect
the chemical industry.   While the industry studies project costs to
industry of  up to  $1.3 and  $2 billion annually,  a study done by
EPA estimates the costs will range up to a little over $100 million.

    The major  discrepancies  between the cost estimates prepared
by industry  and EPA are largely based on differing assumptions
concerning EPA  implementation strategies  and concerning adjust-
ments by  industry with regard to the overall  approach to develop-
ment of new products as a result of the existence of the legislation.
In general,  EPA's cost estimates are based  on assumptions con-
cerning the selective implementation of the Act, whereas the other
studies assume across-the-board requirements  for testing and ex-
tensive regulatory actions.

    For example, the Dow study assumes that  about $1 billion would
be lost to industry each year  due to regulatory actions which result
in the abandoning of the equivalent of 48  industrial facilities valued
at $20 million each.   The clear implication is that uncontrolled in-
dustrial chemicals are currently causing widespread environmental
damage--damage so extensive that after consideration of both the
environmental  risks and  economic  benefits  associated  with such
chemicals,  an annual  cost of $1  billion for corrective action by
industry would be warranted.   Both MCA  and EPA  assume that
major regulatory actions such as a ban on the production or major
                               43

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use of a substance would be infrequent, perhaps one ban every three
to five years  with  one or tvo major use actions  taken each  year.

    On the other  hand,  the MCA  study assumes that industry would
test all new chemicals and new applications as if EPA required them
to be  tested.  This reasoning results in  costs that are equivalent
to mandatory testing requirements.  However, such testing require-
ments are contrary to  the intent of  the legislation, which  is that
testing requirements should be discretionary and selectively applied.

    In considering testing requirements, currently regulated chemi-
cals such as pesticides do not provide a good  analogy with chemi-
cals subject to the proposed legislation. Pesticides are deliberately
toxic  and  are deliberately dispersed widely into  the environment.
By using the analogy of pesticide testing requirements, the industry
studies present a  somewhat  distorted picture  of  what is  likely to
happen with testing of currently unregulated  chemicals,   both in
terms of the quantity of chemicals  likely to be tested and  the costs
of individual test requirements.

    In recognition of the differences between  industrial chemicals
and pesticides,  food additives, and drugs which are currently sub-
ject to stringent testing requirements, the Administration  and Con-
gress have repeatedly rejected the  concepts of registration and certi-
fication for industrial chemicals.  Nonetheless, an analogy is fre-
quently made between  the impact of the  Drug  Amendments of 1962
and the potential impact of the pending toxic substances legislation
in terms of product innovation.   While requirements for  extensive
testing and certification are mandated for new drugs, similar re-
quirements are not mandated for industrial  chemicals under the
pending legislation. Aside from this, the hypothesis that the indus-
trial chemical industry may suffer economically if the present level
of product innovation is not  maintained  seems to be contradicted
by the drug industry1 s  growth in  profits  during the ten years after
the implementation of the Drug Amendments  even though the number
of new drugs declined during those years.

    Finally, industry's  projections  of the effect  of the legislation
on unemployment are difficult to  accept.  Using an economic input-
output model, the MCA study estimates unemployment rates  of 20,000
to 80, 000 annually.   However,  these projections are outside the
range of sensitivity of the model that was used.   In  this regard,
spokesmen  for the AFL-CIO have  indicated that the unemployment
impact of 1,000 annually was a reasonable estimate.

    In conclusion,  any  of  the costs of the impact  of the legislation
must  be measured against $105 billion spend on national health costs
and approximately  two million work-years lost due to cancer alone
each year.   Compared with these  costs, a limited investment in
preventive testing and other measures seems reasonable.

    Perhaps the  issue  of  most interest to  you is how the pending
                                 44

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legislation would enhance present  authorities directed to industrial
health concerns.  As Sheldon Samuels of the AFL-CIO testified be-
fore the Senate last July,  the millions of Americans in the industrial
workforce "havethe most to gain or to  lose by,the control or failure
to control the proliferation of toxic substances in the environment
of the workplace and the community. " While the Occupational Safety
and Health Act of 1970 provided important authority to remedy pre-
sent conditions, it did not  provide for the screening and  control
of chemicals prior to their entry into the workplace.  As discussed
earlier, the premarket review requirements of the pending legisla-
tion provide such a preventive,  "front-end" approach to identifying
and preventing exposure to  chemical hazards.

    A further shortcoming   of the present  authorities available to
address occupational health  problems is the lack of authority to
require the generation of safety  data.  Although OSHA allows for
some measure of regulatory control for known toxicants,  in the case
of chemicals whose effects are unknown or only partially  known,
the Government currently must sponsor its own  testing program to
determine the safety of the substance.   Under the toxic substances
control legislation,  EPA may require that industry perform  tests
according  to EPA standards for  test  protocols  if there is  reason
to believe that the chemical presents or may present an unreasonable
risk to  human  health or  the environment.   Such testing may range
from acute tests to carcinogenicity or teratogenicity tests.

    In determining which chemicals to test, EPA  will consult and
coordinate with the Department of Labor and other relevant agencies.
Occupational exposure considerations will certainly be a significant
factor in selecting testing candidates. However, it should be empha-
sized that  the pending legislation is clearly intended to complement
and supplement existing laws and regulations  such as the occupation-
al health safety requirements.  In implementing any part of the toxic
substances  control legislation,  EPA will be careful not to overlap
with any existing authority such as OSHA.

    In addition  recent versions of the legislation provided EPA au-
thority  to  require industry to send lists of and, if desired, health
and safety studies concerning the  effects of  a chemical  substance,
including occupational exposure and clinical studies.  These aspects
of the legislation have the  potential to enhance greatly the present
information concerning chemical hazards in the workplace.

    While workers in the chemical and related industries are most
directly exposed to   toxic substances,   as  documented on the CBS
special the average  American is coming in contact with chemicals
with increasing  frequency  and magnitude.    The responsibility to
improve control of  chemical hazards  belongs both to Government
and industry. While  the chemical industry has taken steps to expand
its capabilities  to assess the toxicity of its products through the
Chemical Industry Institute for Toxicology and other forums, there
is a critical need for  a systematic approach to addressing toxic sub-
                                 45

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stances.   Such  an approach  would be a fundamental contribution
of the toxic substances control legislation.   Without a strong legis-
lative mandate calling for concerted action  by the Federal Govern-
ment and industry in  this field, the information needed to  under-
stand and to  take  responsible and  effective action  directed to the
problem of hazardous chemicals will not be adequately developed.
At the same  time, we can no longer afford to continue  to gamble
with the unknown and to react to chemical crises only after the tragic
effects  are manifest.
                                  46

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   AN APPROACH TO THE'CONTROL OF TOXIC SUBSTANCES

                       Delivered by
                    Glenn E. Schweitzer
             Director,  Office of Toxic Substances

                          to the
            National Association of Manufacturers
            Annapolis, MD -- September 30, 1975

Recent Developments Concerning Toxic Substances

    Hardly a week goes by  that another chemical is  not implica-
ted as posing a hazard to health or the environment.  While we are
now accustomed to television and newspaper accounts of the problem
related  to  industrial chemicals,  last month even the lead article
of Sports Illustrated  was devoted to the resurgence of the problems
associated with polychlorinated biphenyls.

    I do not advocate using the press as a barometer for measuring
the frequency or severity of chemical problems.  However,  there
is little doubt that the list  of more than 100 problem chemicals
cited  during the past four years of testimony on the Toxic  Substances
Control Act  will  continue  to grow.  The latency periods  for the
manifestation of effects of relatively new chemicals are  drawing to
an end.   Monitoring programs are continuing to uncover previously
unsuspected levels of environmental contamination.  And  the results
of expanded toxicological investigations   --  particularly chronic
studies --are showing an increasing range of effects for many chemi-
cals.

    Meanwhile,  the efforts  of Federal  and State  agencies,  public
interest groups,  and industry to cope with these developments can
only be  described as chaotic.  The Federal agencies,  often relying
on hastily collected and inadequately analyzed data,  are straining to
use existing authorities to address types  of problems which were
not envisioned as  targets for control when the statutes were devel-
oped. As vividly demonstrated by the polychlorinated biphenyl prob-
lem,  the use of  existing authorities to shut off individual  spigots
of amultispigotted problem is often neither an environmentally effec-
tive nor a cost effective approach.   Also, there are many important
routes of environmental exposure associated with the manufacture,
use, distribution,  and disposal of toxic chemicals  beyond the reach
of existing authorities.

    Another shortcoming of  present Federal programs,  despite the
data collected by  the Bureau of the Census and International Trade
Commission,  is  the lack of information collected about uses and
about by-products necessary to estimate likely chemical exposure
patterns as envisaged under the proposed legislation.  No authori-
ties exist to obtain premarket information on new chemicals or new
uses.  And the tiarrowly  focused testing authorities of the Depart-
                                47

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ment of Transportation,  Consumer  Products Safety Commission,
and fuel additives section of the Clean Air Act cannot be relied upon
to generate data useful in assessing many of the health and environ-
mental effects of industrial chemicals that may be of concern.

     Impatient Congressmen are introducing special purpose bills
to cope with chemicals such  as  fluorocarbons  on a case-by-case
basis.   Oregon,   Illinois,  Wisconsin,  and other states are taking
steps to curb toxic chemical problems of special concern to them.
Public interest groups are accelerating their efforts  to require EPA
and other agencies to respond to the never ending series of chemi-
cal incidents, and it seems inevitable that  very shortly the courts
will become more deeply involved in setting standards  for toxic
substances.   At  the same time,  industry  is expanding its assess-
ment activities  directed to industrial  chemicals through  CUT  and
other forums,  hopeful but uncertain that the results  of these  efforts
will be acceptable to the regulatory agencies. Also, industrial uncer-
tainty remains high --to say the least  -- as to Governmental cri-
teria for. prioritizing toxic chemicals  for attention, for  assessing
risks,  and for balancing costs, risks, and benefits in reaching regu-
latory  decisions.

     The void  in   Governmental leadership in the toxic  substances
area --.an area  wherein those who are exposed to the risks do not
necessarily derive comparable benefits --is glaringly  apparent.
However, in the  absence of a strong legislative mandate calling for
concerted  action by the Federal Government and industry  in this
field, the necessary high quality  resources will not be  mobilized
and applied. Without  such a mandate  the  field will become even
more chaotic  and fraught with confusion in the  years ahead. The
scientific uncertainties and the economic stakes involved argue per-
suasively for the development and use  of the best  possible infor-
mation  -- information that is both authoritative and credible --
in decision-making in  this area.  Development of such information
is the heart of the Toxic Substances Control Act.

     The Toxic Substances Control Act  should go a long way toward
introducing an element of predictability, stability,  and rationality
into the overall approach to addressing toxic chemicals. Its  emphasis
on improved data for decision making would seem indisputable.   Its
requirement to explicitly balance risks and benefits  in regulatory
decisions  is a welcome step  to improved understanding  by all as
to the decision-making ground rules.  And, of course, the call for
the review  of the health and environmental aspects of new chemi-
cals before heavy investments are  in place is   designed  not only
to prevent avoidable incidents but also  to minimize economic dis-
locations  attendant to such preventive actions.
                                 48

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Economic Impact of the Legislation

     Recent reports by industrial groups  on the  likely  costs  and
economic impact associated  with  the legislation,  and particularly
the reports of Dow Chemical USA and of the Manufacturing Chemists
Association, have  frequently been cited as a basis for opposing the
legislation at a time when the status of our economy is particularly
worrisome.   However,  let me cite several examples from these
reports which  illustrate some of the  serious  questions  that have
been raised as to the usefulness of the reports and the  reliability
of their projections.

     First, it has been estimated in one of these reports  that about
$1 billion would be  lost to industry each year  due to regulatory-
actions which result in the abandoning of the equivalent of 48 indus-
trial facilities  valued at $20 million each.   The clear implication
is that uncontrolled industrial chemicals are currently causing wide-
spread environmental damage --damage so extensive that after con-
sideration of both the environmental risks  and economic benefits as-
sociated with such chemicals,  an annual  cost of $1 billion for cor-
rective action  by industry would  be warranted.   It apparently is
further assumed that in taking corrective  action under the proposed
legislation, industry could not  recover any of the facilities for any
other purpose nor  recoup  any  of the losses through amortization,
tax, or other financial arrangements.   In addition, no allowance is
made for substitute products which might be introduced by the  affec-
ted companies or by other companies to fill the voids resulting from
regulatory actions.  These assumptions are difficult to accept.

     As a second  example, it has been assumed that EPA would re-
quire comprehensive testing, such as is currently required  for regis-
tration of pesticides,  for each  significant new chemical innovation.
The cost to industry of  such  comprehensive testing is  estimated
at over $700  million annually,  after allowing for the testing that
would be conducted  by industry in  the absence of the legislation.
I consider  this assumption to be unrealistic and  inconsistent with
the intent of the legislation.  In considering  testing requirements,
pesticides  do not provide  a good  analogy.  They are  deliberately
toxic and  are deliberately dispersed widely into the environment,
including  dispersal  on food  sources.   Thus,  the need for extensive
testing is clear.   Industrial chemicals are  not usually  developed
because of their toxicity properties nor  are they usually intended
to be placed in the food chain.  In recognition of these  differences,
the concepts of registration and certification for industrial chemi-
cals have been repeatedly  rejected by the Administration  and the
Congress.

     Next, it has been estimated that one company would be required
to hire an additional 75 to 100 regulatory  experts,  lawyers, know-
ledgeable professionals, and support personnel to prepare informa-
tion for EPA, to answer EPA questions, and to interpret regulatory
requirements.   In  addition $1  million annually would  be required
                                49

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to keep  abreast  of  EPA's intereactions  with other  regulatory
agencies. These estimates appear to be high.

    Also, it has been estimated that in order to maintain the cur-
rent rate of innovation within the chemical industry after the Toxic
Substances  Control  Act  is in effect,  up  to $600 million annually
must be  added to  the industry's current R&D budget to offset new
R&D costs associated with the  more  complex  commercialization
cycle and with testing and other compliance costs. In addition, it
is estimated that  up to  $530  million annually would be required to
cover costs associated with premarket screening, premarket delays,
testing,  and  other related costs.  The report provides little basis
for the $600 million estimate, and there appears to be considerable
overlap  between the two types of costs.  In the absence of access
to the data base,  we are very uncertain as to  the validity of these
estimates  and  the  extent  of the  double  counting that  might be
involved.

    With regard to estimates concerning regulatory actions, the in-
cremental costs of using more expensive substitute sin place of chemi-
cals that are banned has been identified as a major cost element.
As a case in point, the impact of a ban  on the use of PCBs in closed
electrical systems has been estimated. However, this is precisely
the use which has  usually been excluded from recommended limita-
tions on PCBs because no adequate substitutes were available.  Thus,
in effect a "worst case" and  probably unrealistic example has been
chosen as a  basis for estimating the costs of  regulatory actions.

    Finally,  the  estimate  that  implementation of the Toxic Sub-
stances  Control Act would  result in unemployment rates of 20,000
to 80, 000 annually is  difficult to understand.   Not only  are  these
predictions  far beyond the sensitivity  of the model that was used
but are inconsistent with the programmed rate of the model.  In this
regard spokesmen for the AFL-CIO have indicated that  an impact
of 1, 000 was a reasonable estimate.

    Meanwhile, the claims  of environmental groups  that the  cost
of a testing  requirement could be  as low as a  few hundred dollars
seem to  neglect the realities of today.

    Given these extreme positions, we have felt obligated  to make
our best estimate of likely impact.   Therefore, despite our reser-
vations concerning the highly speculative nature  of such projections,
five months  ago we set forth our  estimate that the annual cost to
industry associated with implementation of the legislation.  Accord-
ing to our estimates,  the cost impact  would be on the order of $80
to $140 million annually --  or between one and two percent of the
net profits after taxes of the affected sector of industry.  Of course,
the impact would not be spread evenly, with some companies affec-
ted to a  greater degree and  others  to  a lesser  degree.   After re-
viewing  information that has been developed in recent months, we
continue to believe that our estimate is reasonable.
                                 50

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The Character of the Legislation

    Now turning  to the specifics of the legislation, let me comment
on several provisions of particular interest to you.

 - - The legislation  should explicitly require that in taking
    regulatory actions under Section 6, consideration will
    be given to  the  impact of the actions on business,  em-
    ployment, and the economy.

 -- The legislation  should clearly separate premarket noti-
    fication   requirements,  which  should  encompass all
    chemicals produced in commercial quantities, from more
    circumscribed authorities concerning premarket  screen-
    ing, which   might  be more accurately  described as
    Governmental intervention during the premarket  period.

 -- A proposed  rule during the premarket period limiting
    the production or use of a new chemical under Section 6
    should not become immediately effective.    The likely
    environmental benefits which would ensue do not appear
    to warrant this abridgement of due process prior to com-
    pletion of the rulemaking process.

 -- The concept  of lists, in the context of either premarket
    or testing requirements, would only add confusion and
    delay to  responsible implementation of the law.   If a
    chemical warrants  regulatory attention,  a two-step pro-
    cess is unnecessary.   In addition the list concept would
    inevitably  result  in  unnecessarily implicating listed
    chemicals which do not subsequently become the subject
    of regulatory actions.

 -- Comprehensive   annual reporting  on  all commercial
    chemicals is  not of sufficiently high priority to warrant
    the cost to industry and Government  which would be re-
    quired to conduct an effective program.  Therefore, the
    legislation should not make this a mandatory require-
    ment but rather provide EPA with discretionary  author-
    ity to require annual reporting as needed.

 -- Similarly, the requirement for mandatory comprehen-
    sive reporting of all health and safety studies conducted
    by industry  during the past 40 years should be replaced
    with discretionary  authority for EPA in  this regard.

    In conclusion,  I would simply stress that recent  events have
confirmed  the need  for this legislation.  The existing legislative
framework does  not provide an adequate basis for sound environ-
mental decisions.  Nor does it provide the focal point for national
leadership so urgently needed in this field.
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      NEEDS OF THE ENVIRONMENTAL PROTECTION AGENCY
            FOR MUTAGENIC ASSAY DEVELOPMENT

                       Delivered by
                  Michael J. Prival, Ph. D.
              Acting Chief, Chemical Testing Branch

                           to the
     National  Center for Toxicological Research Science Advisory
         Board Subcommittee on Mutagenesis at N. C. T. R.
              Jefferson,  AR -- September 29, 1975
    The Environmental  Protection  Agency functions under a series of
laws which  gives us the broad responsibility  for protecting human
health, non-human species, and the physical environment from chemi-
cals which are released into the environment  due to  human activity.
In general the  Agency itself is responsible  for obtaining the  data re-
quired to justify it's regulatory activities. Thus, for most air or water
pollutants which may come into contact with humans, the EPA would have
to perform  the research required to assess toxicity.  This is done
through a  research  program conducted both in EPA laboratories and
through grants  and contracts.

    There are  two specific areas  in which  EPA has the authority  to
place the  burden of testing for human health effects upon the manufac-
turers of  chemicals.  These areas are  pesticides and fuels  and fuel
additives.

    Every formulation of a pesticide shipped in interstate commerce
must be registered  with the Environmental Protection Agency.   The
granting of a registration for a pesticide formulation is dependent upon
the submission of adequate safety data by the manufacturer of the pesti-
cide or formulation.  There are over 30, 000 such pesticides formula-
tions currently registered containing over 1000 pesticidally active in-
gredients.  Three to four hundred  of these active ingredients are used
in such a  way as  to make contamination of food or animal feed likely,
and for these pesticides the EPA must establish tolerances or allowable
concentrations  in  the food or feed.  This past June the EPA proposed
regulations stating that mutagenicity  testing will  be required for the
registration of all pesticides requiring food or feed tolerances or other-
wise significantly contaminating the human  environment.  For pesti-
cides which  are  already registered,  this proposed mutagenicity re-
quirement would be  implemented in a phased manner over a five year
period from  1977 through 1982.   For pesticides  which are not cur-
rently registered, initial registration would require mutagenicity test-
ing. The  exact nature  of such testing is at this point unclear and  is
a matter of serious concern within  the Agency.

    The Clean  Air Act  of 1970 gives the  Environmental Protection
Agency the right to  require  manufacturers  of fuels and fuel additives
for motor vehicles to register these products and to test them to deter-
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mine potential public health effects.  The EPA has not yet implemented
the .testing requirement  authority granted by the  law due in part to the
great complexity of the fuel additives problem.   When a manufacturer
wants? to add a particular additive  to gasoline, it is not only the toxi-
city  of the additive which  is of concern but also the toxicity of the
combustion products of the additive and the toxicity of any new combus-
tion  products  from other components of the  fuel which may be formed
due to the presence of the new additive.  Of course, combustion prod-
ucts vary not only with fuel  composition but also with the properties
of the engine and the development of protocols for toxicological evalua-
tion  of fuel additives is correspondingly complex.

    In addition to  its authority over pesticides and fuels and fuel addi-
tives,  the EPA may be granted a much broader authority to require
industrial testing of chemicals if the Toxic Substances Control  Act
is enacted into  law. This act would extend  EPA1 s authority to require
such testing to virtually all industrially produced chemicals except for
food additives and drugs. There are probably mo re than 10,000 chemi-
cal compounds currently in commerce which may come under the author-
ity of the proposed legislation with several hundred new ones added each
year.

    It is  interesting that many  of the laws under whose authority  EPA
acts, including the proposed Toxic Substances Control Act, specifically
mention  mutagenicity as an area of Congressional concern and EPA1 s
regulatory authority.

EPA' S CURRENT WORK IN MUTAGENESIS

    I would now like to  briefly review EPA's current activities in the
area of mutagenesis.   Since EPA is organized  more along the lines
of legislative  authorities  than  by scientific disciplines,  there is no
central office or laboratory responsible for mutagenesis work and my
list of EPA1 s  activities may be somewhat incomplete.

    Four contracts  for mutagenicity studies have been let as part of
the %EPA' s Substitute Chemicals Program, which is an activity of EPA's
pesticides and  research offices.   In the first contract,  the group at
Washington University in  St. Louis led by  Barry Commoner has been
studying the correlation between  carcinogenicity and mutagenicity in
Salmonella typhimurium. This is being done  by testing the mutagenicity
of 50 known mammalian carcinogens and 50 chemicals generally believed
to be non-carcinogenic.

    A series of  so-called  "substitute pesticides" is being evaluated by
several  mutagenicity  tests at  the Stanford  Research  Institute and the
WARF Institute in  Madison.  The Stanford Research Institute has been
using the Ames Salmonella test,  mitotic recombination in yeast, un-
scheduled   DNA  synthesis in human fibroblasts  and dominant lethal
testing in mice.   The WARF Institute has  been looking for sex-linked
recessive  lethal   mutations and  chromosome   breakage and loss in
Drosophila treated with  the pesticides.   It should be noted that there
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are particular difficulties  associated  with trying to test insecticides
in Drosophila since these  chemicals have been specifically designed
to be highly toxic to insects.

    A rather ambitious program of test methods  development is under
way at the Mason Research Institute as part of EPA's Pesticides Pro-
gram's effort in mutagenesis.  Part of this program is  to involve the
development of an in vivo mutagenesis assay based upon genetic alter-
ations of behavior or metabolism  inthedescendents of treated animals.
The rationale for developing such a method is that these characteristics
are controlled by a large number of genes and the assay may be cor-
respondingly more sensitive than the currently available  mouse  speci-
fic locus tests.

    In the area of air pollution, toxicological studies of platinum com-
pounds which may  contaminate the air due to the use of catalysts in
automobiles  are being conducted by the Stanford Research Institute.
These studies include  analysis of chromosome aberrations in periph-
eral lymphocytes in rabbits.

    It is anticipated that a contract  will soon be let by EPA to screen
pollutants which may result from fuel combustion and fuel conversion
processes such as coal  liquefaction and gasification.   This contract
willprobably utilize  microbial indicator systems and test  crude ex-
tracts resulting from  these  industrial processes.   It is anticipated
that parallel chemical analyses will be part of this program.

    In the area of Toxic  Substances,  a contract has  recently been let
to Columbia  University to  assess the mutageniclty of about 85  indus-
trial chemicals  using Salmonella, E.  coli,  and Saccharomyces cere-
visiae strain  D4.   The purpose of this contract is  to help us assess
the utility of current protocols for screening industrial chemicals from
widely different chemical classes.

    The problem of organic chemicals  contaminating  drinking water is
a major issue in EPA with over  200 organics now having been identi-
fied  in tap water in  the United States.   Extracts from drinking waters
and several identified water contaminants of high concern,   including
bis(2-chloroisopropyl)  ether,  are being tested  for  EPA in the Ames
system at the University of Cincinnati.

    EPA is quite   concerned   about assessing  the safety  of utilizing
treated sewage as a source of drinking water.  The Stanford Research
Institute is studying  organic extracts  from advanced waste treatment
plant effluents in the Ames system  and in  Saccharomyces cerevisiae
strain D3.  They will also be looking at about 20 chemicals which have
been or are  likely  to be  found in drinking water utilizing these same
indicator systems.

    The possibility  that some  of the potentially  harmful  organic com-
pounds found in tap water may be produced during  the chlorination of
water for disinfection raises the issue of the mutagenicity of compounds
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resulting from drinking water treatment. A contract with the Stanford
Research Institute in progress to study the mutagenicity of 32 organic
chemicals which have been or may be  found in drinking water.  These
compounds will be tested both before and after treatment with ozone,
since ozone   is  the  most liikely  alternative disinfection  method if
chlorination  turns out to be  causing serious problems.  The indicator
organisms used will be the Ames tester set of  Salmonella and Sac-
charomyces cerevisiae strain D3. In addition, samples of actual sewage
effluent  resulting from  several types of disinfection processes will be
studied.  The samples will include effluents disinfected by chlorination,
chlorination  followed by dechlorination with sulfur dioxide, ozonation,
bromochlorination, and an untreated control.

    A group at Louisiana  State University led by Dr.  William Pelon
has been studying the mutagenicity of Mississippi River water using
the Ames system.

    The only ongoing in-house mutagenesis  program in  EPA involves
the assessment of a  series of inorganic chemicals found in drinking
water utilizing the BUDR-visible light isolation technique with Chinese
hamster ovary cells.   Thus far compounds of  arsenic, beryllium,
cadmium, cobalt, nickel, and selenium have been tested with cadmium
and beryllium tentatively giving positive results and all others being
negative.

    In general the problems  faced by  the   EPA  in  the area of toxi-
cological testing are the same as those of others concerned about human
exposure to  chemicals.  Problems which  are particularly  severe at
EPA, however, include:  too many chemical to test; too little informa-
tion about human exposure to each chemical; and the fact that many
chemicals in the human environment remain unidentified.

    I have tried to break down the types of  chemicals which  should be
subjected to toxicological,  including mutagenic,  evaluation into three
categories.

    The first category would be single chemicals with known structures
to which human exposure is high.  In this category we might place the
3-400 pesticides  which are permitted to leave measurable residues in
food.  We might be able to put some high-priority widespread drinking
water contaminants in this group as  well   as some of the major  air
pollutants such as sulfur dioxide and  oxides  of nitrogen.   A few  so-
called trace contaminants such as poly chlorinated biphenyls would also
fit into this category.  These chemicals obviously should be subjected
to a reasonably thorough mutagenic evaluation in a variety of test sys-
tems.

    The second group of chemicals includes those with known structures
to which human exposure is thought to  be relatively low.  These would
include registered pesticides for which food tolerances are not  re-
quired, most organic chemicals which have been identified in drinking
water, and those air  pollutants which tend to be localized or infrequent.
                                56

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such as those emitted by small or unusual  industrial processes.  For
this class of  chemicals it  is  clear  that  some sort of prescreen  is
necessary  since the resources  for  a thorough mutagenic evaluation
will clearly not be available.   Such a prescreen would serve two pur-
poses.  First, it would help us  set priorities for which chemicals  should
be subjected to a more complete test  regimen.  Secondly, it might help
us make initial judgments which can lead  to a  stronger  or weaker
regulatory  response  to other  possible problems asociated with the
chemical.

   The third  class of chemicals which EPA has to deal with are those
environmental mixtures whose chemical identity is not firmly established
and which can vary greatly with time.  This  includes over 90 percent
of the organic matter found in drinking water, much of the particulate
matter in air, and effluents from most industries and all sewage treat-
ment plants. We also face the  problem that the environmental metabo-
lites of pesticides and industrial waste products may be unknown and
it is these metabolites to which humans are likely to be exposed  rather
that the parent  compound.   There are obviously serious difficulties
associated with testing uncharacterized mixtures and drawing meaning-
ful conclusions from test results.

   Each of  the  three categories  of  chemicals I  have mentioned may
require a different approach to mutagenesis  testing. Thus each cate-
ory raises somewhat different  problems as  to current research needs.

   For the  first category,  the known high-exposure chemicals which
should be subjected  to thorough mutagenic evaluation, the basic need
is for sensitive reliable indicators of mammalian mutagenicity capable
of detecting a broad spectrum of genetic  events.  The most urgent
problem in  this area would  seem to  be  the development of a sensitive
assay for heritable point mutations in whole mammals in which  muta-
tions in a large fraction of the genome can be detected.  While develop-
ment of such  systems is in  progress, their general availability is  at
best several years off.  In the meantime it may be necessary to depend
on test  systems which do not  directly measure heritable mutations  in
whole mammals.  If results from such systems are properly evaluated
in the light  of pharmacokinetic  data derived from whole mammals,
convincing arguments for regulating a chemical as a mammalian gene
mutagen might be made.  This points up  the  need for the perfection  of
more  routine procedures to demonstrate the  presence of the active form
of a mutagen in  the germinal cells of whole mammals and the reaction
of these  compounds  with germ cell  DNA.  While there are practical
reasons  for developing such methods in male animals, the  demonstra-
tion that a possible mutagen does not reach the testes cannot be consid-
ered convincing evidence of  non-mutagenicity in the absence of cor-
responding  data in female animals.  Thus the development of pharma-
cological techniques for mutagens in male animals alone will still leave
us unable to  make  knowledgeable  health  judgments  and regulatory
decisions.

   The second category of environmental chemicals which  I mentioned
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includes those thousands for which human exposure is thought to be at
low levels or infrequent. The obvious need here is for the development
and validation ofprescreens.  If rapid,  relatively inexpensive, and re-
producible tests for mutagenicity could be validated against those tests
thought to  be more relevant indicators  of mammalian mutagenicity,
we would then know the usefulness of these tests for prioritizing chemi-
cals for further testing.   If we had a good idea of the rate of the so-
called "false positive" and "false negative" results which the prescreen
gave for various chemical  classes, then we would also be able to esti-
mate the degree of concern which might be warranted by positive re-
sults in the prescreen before more comprehensive testing is completed.
The most serious  problem in the development  of prescreens at  this
time appears  to be the lack of suitable methods for detected chemicals
which cause only chromosomal mutations. The limited  range of generic
events currently detectable at the prescreen and at the whole mammal
level makes an increased understanding of the correlation between chemi-
cal induction of  gene mutations and of chromosomal aberrations quite
important.  Similarly, it would be important for us to understand whe-
ther any chemical  mutagens can act uniquely at meiosis and,  if so,
to develop prescreens capable of detecting such mutagens.  A greater
understanding of the relationship between chemical structure and muta-
genic activity would help enormously in selecting those chemicals to
be subjected to the prescreen or at least those which should be screened
first.

   In general the third  category  of  chemicals, those mixtures which
have not been characterized, will  require a prescreen type of evalua-
tion as well.  The use of mutagenic prescreen techniques may in fact,
help us to isolate those components of uncharacterized mixtures which
pose the greatest mutagenic or carcinogenic hazard.

   There has been great  deal  of concern  expressed about the need
to develop  methods for quantitating the mutagenic potency of chemi-
cals. We must be carefulnot to divert too many  resources to quantita-
tion when methods  for identifying qualitative mammalian mutagens re-
main to be developed and validated.   We may find  ourselves  in  the
position of making quantitative risk estimates for mutagens based upon
one type of  genetic event when the agent in question is capable of pro-
ducing other types of  mutations which we  are  incapable of detecting.
This could lead us to seriously underestimate risks.

   Let me mention two problems in mutagenicity testing which may be
unique to the needs of the Environmental  Protection Agency.

   The first, which  I have already alluded to,  is the fact that people
may be exposed not to the chemicals released  into  the  environment,
but to a metabolite which is created in the environment.  The  questions
that have  been  raised  recently concerning  the mutagenicity of corn
metabolities of  atrazine and the possible presence  in drinking water
of N-nitroso compounds, possibly including  derivatives of pesticides,
cannot be ignored.   Perhaps we will have to  develop environmental
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activating systems to supplement our mammalian activating systems.
These might include terrestial plants, aquaria, or systems inoculated
with sewage sludge.

    The second problem unique to EPA stems from our responsibiity
for protecting both environmental health and human health.   I am not
aware of any  evaluation of the possible impact of chemical  mutagens
on natural  populations of  plants and animals.   The type of analysis
necessary for natural populations is fundamentally  different than that
required for humans, in that  we are concerned about each individual
case of human disease or disability, while  for natural populations we
are concerned only about the continued  survival and functioning of the
species. I would like to know, for example, whether there are species
which would  not  have  the capacity to survive and  function normally
if the mutation rate were  to increase by a factor  or two or five or
ten.

    One of the most difficult  problems which regulatory agencies have
to face in dealing  with toxic chemicals is  the continuing question of
whether or  not those chemicals which  are  toxic  to animals are also
toxic to humans?   If  anything, this problem will be more serious  for
mutagenesis than for carcinogenesis because the long time lag between
exposure and effect  apparently causes many  people to have serious
difficulty in understanding the significance of mutagenesis to humans.
Particular effort should be  devoted  towards the understanding of the
correlation between heritable mutagenic effects  and chromosomal aber-
rations in peripheral lymphocytes since this is the one area in which
observations can be made directly in humans.

    In view of the primitive state  of the art in most  areas  of muta-
genicity testing, the uncertain  relevance of many  assay systems to
heritable effects likely to occur in man,  the  lack of  experience with
a wide spectrum  of chemical classes for many of the assay  systems,
and the tremendous potential  for  harm' which  chemical mutagens in
the environment may  have,  it is impossible to be very specific  as to
what areas of research are  the most important. Research on a broad
front is obviously needed and we must  be careful not to  stifle  basic
research which will  ultimately help us  to deal with some of  the prob-
lems we now face.   Among the high priority  items for the next few
years, however,  would be:   (1) a broadening of the chemical  data base
for existing test systems supplemented with suitable metabolic activa-
tion techniques so  that we can make more rational judgments  as to
the utility of these systems for testing a wide range of  chemicals,
(2) the development of systems which can detect mutagens capable of
causing point mutations in whole animals with far greater sensitivity
than methods currently available, and (3) the development of chemical
methods for studying the interaction of  mutagens with germ cell DNA
in both male and female animals.
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       ENVIRONMENTAL ASPECTS OF CHEMICAL USE IN
                 - PRINTING OPERATIONS

                        Delivered by
                    Farley Fisher, Ph.D.
               Branch Chief for Early Warning

                          to the
Conference  on Environmental  Aspects of Chemical Use in Printing
                        Operations
     King of Prussia, Pennsylvania -- September 22-24, 1975

Opening Comments

    I would like to welcome you all to the opening of the conference
on Environmental Aspects of  Chemical Use in Printing Operations
aponsored by  the Office of Toxic  Substances of the Environmental
Protection Agency.

    I am Farley Fisher,  Chief of the Early Warning Branch of the
Office of Toxic Substances of EPA.  I am going to be your general
chairman here, which  means I am pretty much of a figurehead.

    However,  since  I  am largely  responsible for setting up this
snowball, which has  developed into this conference, let me say just
a few words about  why we decided to hold this conference  and what
we hope to accomplish.

    The mission of the  Early Warning Branch  in EPA  basically
is to identify potential environmental problems and to try to achieve
some sort  of  study  and, if  possible,  some sort of  resolution of
those problems before the matter becomes one of general concern
and has to be settled in an arena where speed  is of the  essence,
where frequently,  rational  thought and careful  consideration  get
sacrificed in order for things to be done rapidly.

    As part of our attempt to accomplish this, we thought, about
2 years ago, that it  might be nice to look at a few industries where
people seemed to have  the feeling there were a lot of things going
on,  but nobody really knew what.   The idea was to find out exactly
what the problems are or if business is justalotof rumormongering
and in fact,  the problems are  not nearly  as severe as many unin-
formed people  seem to think  they are.   Accordingly,  we set up a
series of conferences,  which we  hope will be a continuing series.
We  invited people who are knowledgeable,  who have things to say,
to come to  a public forum which would be organized in such a way
that all persons,  including those  not on the program, would have
an opportunity  to contribute what they could so that we could get a
reasonably good picture of exactly what the situation in question is.

    Somewhere along the line we abandoned the notion of holding
conferences by industries and felt that it would make more sense to
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do it in terms of a series of processes without necessarily identifying
them with industries, even though in many cases the correspondence
would be rather close.  Consequently,  this conference is on printing
processes.   We  hope to discuss any printing operation, regardless
of the type of industry to which it is nominally attached.

    This is the third conference in the series.  I think the series
has been successful at what we hoped it to do.  These conferences
have shown that they can, in fact, stimulate a lot of good discussion
and stimulate people to do some thinking about things they might not
otherwise have considered.

    It is inevitable when you hold a meeting for a general audience
that many of the people find some  of the  matter presented rather
elementary while others consider it  quite new and interesting.   I
anticipate that most of you, at one time or another, will feel bored
by the presentation  on  the grounds  that  you have  heard it  before.
Bvit I also think very strongly that every one of you will find a great
number of papers that will  in fact tell you things that you  did not
know before. I certainly hope every one of you goes away from here
knowing something you did not know when you came.

    I want to make it clear that this is not a witch hunt. This is not
an attempt to put the printing industry behind the eight ball.   There
are no regulatory actions  which are expected to stem, in a direct
sense, from this conference.

    I want to encourage everybody to be open and candid in what they
have to say  because I think that is the only  way we are going to
accomplish what we are here to do.

    The emphasis in this conference is on the environmental aspects:
the external  environment, including air and water pollution,  waste -
disposal problems,  and  matters of this nature.   We  realize that
it is very difficult if not impossible,  to  separate the  environmental
concerns  from what you might call microenvironmental concerns,
the occupational  setting,  and some of the papers today will  in fact
deal with occupational studies.  We consider this quite appropriate.
However, it is my  hope  that we  do  not allow this to turn into  a
conference on industrial hygiene.  The idea of the conference is to
discuss the environmental aspects of chemical uses.

    Mr. Frank  Ayer,  who is standing by  the  door there, is the
conference coordinator from Research Triangle Institute.   He and
his staff are available  to help you with your problems. If you have
any questions,  please  seek  him out.    You will notice he  already
has grey hair, so you are not going  to hurt  that too much more.

    We are trying something a little bit  different in this conference
from what we  have done  in the past.   Because this is  a  general
audience and we  realize that the industry itself is broken into some
rather specialized components, we are  going to start with a brief
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review of practice in printing operations.   This review is based on
a technical  study,  which was performed by RTI  as a planning step
in designing this conference.   In the past, we have not  presented
the results of this study at the conference itself, but we  have found
that this frequently meant that  speakers who really wanted to talk
at a technical level had to go back and give a primer to much of the
audience about what they had to say.  This study, I realize is going
to be old  news  to  those of  you who  are  experts in the  field,  but
we hope,  by presenting it, to bring some of the nonexpert audience
up to a  level that  will  permit  the  other  speakers to launch right
into technical material.

SESSION IV:  IMPACT OF NEW DEVELOPMENTS AND CHEMICAL
  FORMULATIONS

Opening Comments

    Our final session is on the Impact of New Developments  and
Chemical Formulations.   It  was with considerable pessimism that
I originally  accepted the idea that we should try to hold a session
on new developments.  My first  reaction was, "Who is going to want
to talk about something that they are trying to keep under their hats
until they are ready to sell?"

    I must say that I have been very gratified by the response from
the industry.  We  do  have a number of people here who are going
to talk about some relatively new techniques and methods,  which
may offer real advantages from the point of view of environmental
control.
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                CONFERENCE SUMMATION

    This concludes our conference.   I hope you have  all learned
something:  maybe not as much as I have,  but I hope you have all
found it profitable.

    Before we close,   I would like to express my appreciation to
our four  session  chairmen:    Dr.  Burachinsky,  Dr.  Schaeffer,
Mr. King,  and Mr. Downie;  and to  our roster  of  speakers who  I
think have done a very nice job of presenting us with  an awful lot
of material.   I would  also like to thank all of  you who  attended,
who participated from the floor,  asked questions,  and  made com-
ments.  I would like to thank the staff of the Holiday  Inn, Valley
Forge,  for their cooperation and the facilities they provided us, and
the Montgomery County Convention and Visitors Bureau for their
assistance in manning the registration desk and helping some of us
out with some arrangements.   I owe  thanks to a few organizations
who gave us  considerable assistance  in putting this program toge-
ther:  the Graphic Arts Technical Foundation, the Gravure Research
Institute,  the  Association  of   Photographic Manufacturers,  the
National Association of Printing Ink Manufacturers,  and  the Printing
Industries of America.

    At this point,  I am supposed to give some general summation
and impressions from the conference. This is always very embar-
rassing because I am  told that  I  am to summarize  a conference,
but I am not to say anything that might be interpreted as  a govern-
ment policy.    So, I have  to make that caveat  and say  that I am
speaking for myself.    I am not the kind of person who can sit here
for 2-1/2 days and immediately have everything figured out and know
exactly what it all means.  I have to go home and  sit down with
the record and think about a lot of the things I have heard.

    I do have just a couple of general impressions  that  I will share
with you.   One is that  I really  have the impression, Dr. Muggli1 s
comment notwithstanding,  of an industry which, at least on the sur-
face,  is really quite innovative. It is not an industry that is opposed
to new techniques  and new ways of doing things.  This impresses me
because I know of a lot of industries of which that  simply  is not true.
I think that this innovation holds out  a very great promise,  but we
have to remember it  also carries with it an attendant risk.  This is
true  environmentally as well as economically.   Every new advance
is somewhat  untried.   No matter how much we worry  about it, no
matter how much  thought  and commiseration and debate we have,
whenever something  new really comes into  use we find  out things
about it we just did not  know before.

    And so we do have to keep our guard.  We  do have  to  take
all the care we can.   And we  really have to trust  a  little bit to
luck if we are going to improve,  to  make  a better future and not
a poorer future for ourselves and the people who follow  us.
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    I also have the feeling that the industry is at least aware of some
of its problems,  and those it is aware of,  it is making  a serious
attempt to deal with.

    It is also very instructive that we have learned that people who
made environmental improvements as  recently   as   5  years ago,
despite the  advice  of their bankers  that it  was a waste of money,
have found themselves  coming out  smelling very nice in the money
market.  This tells us something that I  think any  third grader knows
but which we  tend to forget when we grow up; namely, that waste
is waste.

    All this  stuff that EPA,  the various States, and other people
are  complaining about dumping in  the environment because they
don't like it there is in many cases useful stuff.   Throwing it away
is just not a commonsense thing to do.  We have to make an effort.
After all,  the best way  to deal with  waste is to  realize that it
need not be a waste,  that  maybe it is a useful commodity in its own
right.   I think we have  seen some very good examples of that here,
and I hope that we can keep on moving in this direction.

    I've probably said enough for the time being. Before I adjourn
the meeting,  however, I would like  to open it up for comments from
the floor for one last time, in case anybody does  have something
they have not had a chance to say up to now.

Mr .Frederick Wootton (Prince George's County Health Department,
    Cheverly, Maryland):  I have sat here  for 2-1/2 days and have
    enjoyed  it.   I  don't know  if I really have enough information
    to put out.    Sixty-five percent  of  all your  taxes are going to
    the military.   I should point out that,  being a health person,
    I believe  that possibly we could  divert some of these funds to
    some  of  the research that you  all have said has cost you so
    much.

Mr. David Friedman (Food and Drug Administration, Washington,
    D. C.):   We  have heard several comments  by  some  speakers
    that there is an adversary atmosphere between industry and the
    various  government agencies,  and  that there should  be  more
    cooperation.  I want to suggest  to everyone that the relationship
    need not be antagonistic; we are not out  to "get" anyone.    If
    industry and  trade  organizations-would  cooperate,  would give
    us the information  we need - - before new developments  are in
    progress, when new techniques are being developed  --if they
    would work with  the various environmentally active agencies,
    industry might  be able to  find out what not to do.    It is a
    lot easier to reformulate before environmental damage,  or be-
    fore commitment in the marketplace, than it  is afterwards.  We
    are out to try to prevent problems, and  not simply deal with
    them once they are known to exist.
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Mr. TheophilusR. Carson (Food and Drug Administration, Washington,
   D. C.):  I would  like to commend Dr. Fisher  and Mr.  Ayer for
   the wonderful job they did in getting this together as fast as they
   did.  I had to  take  someone  else's place;  that is why I am here.

Mr. Al Jasser (Anchor Chemical Company,  Hicksville, New York):
   I want to commend  you,  Dr.  FisHer,  for  the conference.   I have
   one plea  from industry.   The prdblem you have stated at another
   time was that  there is not communication.   This young man from
   FDA again repeated that there should be cooperation.  Industry is
   always willing to cooperate with government if  it can understand
   what government  wants.   If the language in the Federal Register,
   for example,  were  such that my staff could understand it  without
   lengthy conferences, we would be well along in the way of coopera-
   tion.  We are  very happy to cooperate.   Is there something that
   you can do in seeing to it that the directives, orders and prospective
   regulations are in  clear, simple language so that we in business
   don't have to take a special course?

General Chairman Fisher;  I would  point out to you, first off,  that
   I  am a chemist myself;  most of the government people here,  I
   imagine are technical people of one type or another.   Most of the
  ? industrial people here, I imagine, are technical people of one type
   or another--engineers,  chemists, and so  on.   But the fact of the
   matter is that the government is run by lawyers.  They write the
   Federal  Register.   Business is not really run by scientists and
   engineers either.   Business is run by businessmen.  I think all
   we can really strive to do is maintain communication at the techni-
   cal level so that we at least know what we are supposed to  be doing.
   I know it's just a plain fact of life that when you get into the higher
   levels of management in either government or industry,  a lot of
   information can be obscured.

       I would like  to  make one more comment which I have heard
   made privately on a number of occasions.   Dr.  Shaeffer and I have
   discussed it at some length.   That is, many of these engineering
   advances  that we have heard discussed here,  many of  the fancy
   pollution control devices, are really practical only inlarge installa-
   tions.  But, in fact, we are  dealing with an industry which has an
   awful lot of small installations.   In a sense, we have been a little
   unfair, because I really do not think we have addressed  the prob-
   lems of these  small operators.   Many of  the things which we did
   discuss are not practical from their  point of view.  I think that
   is an area which  requires more thought and a  little more effort.

       If there are no  further comments, I will call the meeting ad-
   journed.  I want to thank you all for your cooperation and attendance.
                               66

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             ENVIRONMENTAL LEVELS OF PCB' S

                         Delivered by
                  Vincent J. DeCarlo, Ph.D.
     Branch Chief for Monitoring and Information Systems

                            to the
International Conference on  Environmental Sensing and Assessment
           Las Vegas, Nevada  -- September 15, 1975

ABSTRACT

    Since the 1966 discovery in  Sweden that chlorinated biphenyls
were widely dispersed in the  environment, their environmental levels
have been  the  subject of many studies with the  results indicating
that PCB's can have adverse ecological  and toxicological effects.
However, a well  planned national  approach to environmental  sam-
pling has not been attempted, thus hindering making a national as-
sessment of the PCB problem.  This paper reviews the levels that
are currently being found in  the environment.

INTRODUCTION

    Since the 1966 discovery in  Sweden that chlorinated biphenyls
were widely dispersed  in the environment,  their levels have been
the subject of many studies  both abroad and in the United States.
Extensive laboratory and environmental measurements indicate that
PCB1 s can have  adverse ecological  and  toxicological effects, are
very resistant  to environmental degradation, and  are  being dis-
charged by many  different sources.

    This paper  will focus on  the current PCB data base in an effort
to assess the PCB levels in the environment on a national basis*
ENVIRONMENTAL PCB SOURCES

    Before the  PCB data base is examined, it would be of interest
to review how these chemicals get into the environment.  The major
sources contributing to the environmental levels of PCB's  are indus-
trial effluents,  manufacturing processes, consumer and industrial
waste materials, sewage treatment facilities, and accidental spills.
Lacking  extensive air and  soil data  from these sources, available
water data are  shown in Table 1. The 5 major PCB spills in 1973-75
all involved transformers.  In 4  of those  incidents,  the PCB's were
spilled on  soil while in the fifth the transformer was dropped on
a pier and  the  contents were spilled into the water.   In the latter
incident,  283 gallons  were spilled, and  it was estimated that  only
70-90 gallons were recovered.  In all cases  the material that could
be recovered was drummed up and entombed at a cost approaching
$2. 3 million.
                               67

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REVIEW OF THE PCB DATA BASE

    To assess the scope  and extent of PCB's in the environment,
all national surveys and national data bases maintained by the U. S.
Environmental Protection Agency  (EPA) were examined, including
STORET,  the national  water quality storage and  retrieval system,
the National Soils Monitoring Program for Pesticide Residues,  and
the Human Monitoring Program.  In addition, data from special data
bases maintained by  the United States Geological  Survey  and the
open literature were also examined along with available unpublished
reports.   Using these data,  maps were  constructed  showing the
concentrations of PCB's in urban soils and the aquatic environment.

    The data from the national surveys  show that a great deal of
effort has  been expended and continues to be expended, but that the
data are very limited.  On examination,  all States  are believed to
show some level of PCB contamination.   In Table  2,  States which
had significant levels  in  at  least one medium are listed  with their
reported PCB levels  for surface  and  ground water, bottom sedi-
ments,  and fish.  In Table 3,  a number of localized studies are listed
along with  the reported environmental data.   In all these studies
the most extensive measurements have been in fish.

WATER

    On the  basis of the national aquatic environmental data collected
in 1971-1972  and in  1974,  a continuing widespread  accumulation
of PCB's in water, sediment, and fish appears to be occurring. How-
ever,  no  trend  analysis is possible with the available  measure-
ments.   For example,  whole water measurements have been taken
throughout most  of the country, but those states reporting non-zero
readings are few in  relation to the number of states showing zero
concentrations.    This is diie both to the low solubility of PCB's
and to the  usual  analytical  procedure that limits detectability to
the 0.1 ppb level.  More meaningful water concentrations were ob-
tained in the Lake Ontario1  and Orange County, California  studies
where concentrations in water at the ppt (ng/1) level were measured.
At these levels,  changes in  PCB concentrations could be  found with
distance and time and could be related  to other measurable para-
meters, such as  PCB concentrations in sediment, flora, and fauna.

SEDIMENTS

    Since PCB's  are  relatively insoluble,  it is not  surprising  that
bottom  deposits  have shown significant  concentrations.   Although
30 states collected samples in the 1974 study,  15 had less than 4
stations reporting and showed zero  readings.    Of the  remaining
15, with at least 4  reporting stations, 13 showed  detectable  con-
centrations. Since the 13 states involved were not  necessarily the
same in both studies,  only a very broad conparison may be made,
i. e, five states had lower concentrations,  four states were higher,
and  four did not  sample again3.     We may conclude,  then,  that
                                  68

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in those states with any monitoring effort in the 1974 study,  PCB's
are present  in bottom deposits and the levels are not any lower
than in the  1971-72 study.   Considering the persistence of PCB's,
a significant proportion of the nation's waters are now affected  and
will continue to be.

SOILS

    The National  Soils  Monitoring Program is a small  sampling
effort  studying only 5 urban areas each year.  However, PCB's were
detected in three of the  five  cities  sampled in  each  of the years
for which data are available, 1971-73.  Of the 22 positive readings,
17 of them were below 1 ppm.  Of the cities sampled in 1973,  Pitts-
field,  Mass.,  was of particular interest  because it has a large
transformer and condenser  plant using large  quantities of PCB's.
Six different sampling sites within one mile of the plant  show no
detectable PCB residues.  In contrast, the soil surrounding another
facility in Illinois  using  PCB's in the manufacture of investment
casting waxes  was recently measured for PCB content.   Samples
taken in an area one-quarter  mile  radius around the plant ranged
in value from 0. 77-5. 2 ppm.   The PCB's identified were mixtures
of Aroclor  1260  and decachlorobiphenyl.   Levels  up to  1.8 ppm
Aroclor 1260 were found at 1-1/4 miles from the plant.  Samples
were collected from this  facility as part of a study being conducted
for the Office of Toxic Substances at sites suspected to have PCB
concentrations.   Other sites sampled in March of 1975 were in the
vicinity of an investment  casting company in Michigan and the PCB
manufacturer in  Illinois.  Surface  soil samples were collected at
each site up  to a distance of approximately one mile from the plant
boundary, at 1/4 mile intervals in all directions.  PCB's were  de-
tected  in soils at both  sampling locations.    Concentrations ranged
from the detection limit of 0.001 ppm to over  20 ppm.  The distribu-
tion of all PCB's analyzed  appears higher near the plant site  and
generally decreases with distance from the site.^   Details of the
sampling sites and the concentration levels measured are  shown
in Figure 1.

AIR,

    PCB measurements   in  air along with  the related  transport
studies are practically nonexistent.  Harvey and Steinhauer^ have
reported levels ranging from 3.9 - 5.3 ng/m3.   Air measurements
by Bidleman and Olney for Rhode Island ranged from 2.1 -9.4 ng/m3
and from 0.21-0.65  ng/m3  at Bermuda.**    Snow melt water data
from Wisconsin ranged from zero to 0. 24 ppb.  The suggestion  has
been made that atmospheric  fallout  may be the most significant
source of PCB discharge to the waters of the  state of Wisconsin.7

FISH

    Fish have been studied on  a nationwide basis by the Department
of the Interior  since  1967.    In the  1969  study,  PCB levels were
                               69

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identified in fish from 35 states.8 Data from the nationwide sampling
programs, 1970-1973, are  currently being prepared but were not
available for  this report.   Consequently,  nationwide fish data are
not available  any more currently than 1969, with the exception of
the isolated  studies listed  in  Table 3.  The 1969  national study
showed PCB  levels  generally within the FDA  5 ppm guideline. In
the Great Lakes area,  PCB  levels in fish from Lake Michigan were
so high, 7.6-10.9 ppm,  that FDA seized shipments of coho salmon
in May 1975. 9

   Although  transport mechanisms are  not well known and would
vary through different ecosystems, it is interesting to consider the
Lake Ontario  Ecosystem Study summarized in Table 4.  From this
study an estimate of biomagnification is possible giving a sediment
to fish  ratio  of 1:120.   The FDA guideline of 5 ppm in the edible
portion of fish corresponds  to  a sediment concentration of 41 ppb-
a figure exceeded in all 13  states reporting through USGS in 1974.

HUMANS

   With PCB's as widespread  across various media as they  are,
it is  expected that levels would  be identified in humans as well.   The
Human Monitoring Program, in 1972, found that 3,035 out of 4, 102
samples from 31  States showed levels  ranging from less  than 1
ppm  to more  than 3 ppm.   In 1973, 964 out of 1, 277 samples from
28 States again showed levels  in  the same range.   In both years
approximately 75 percent of the adipose tissue analyzed contained
some polychlorinated biphenyls. Unfortunately we  do not know  age,
occupational,  or residential  histories of the cases involved, so it is
difficult to trace the levels back to the potential sources.

CONCLUSIONS

   Although  there are many national  and  state groups collecting
environmental PCB data, limitations in  the current data base  pre-
vent  one from making a uniform national assessment of PCB envi-
ronmental levels. It appears that if a well planned national approach
to sampling were attempted,   the data base could be improved in
a very short period  of time.
                                70

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REFERENCES

    1.  Haile,  C. L., Veith, G.  D., Lee,  G. F., Boyle, W. C.,
       Chlorinated  Hydrocarbons in  the  Lake Ontario Ecosystem
       (IFYGL), June 1975.

    2.  McDermott,  D.  J.,  and Hansen,  T. C.,  "inputs of DDT,
       PCB and Trace Metals from Harbors, "  Coastal Water Re-
       search Project Annual Report, 1975.

    3.  U.S.  Geological Survey,  Private Communication,  Quality
       of Water Branch, Reston, VA, August 1975.

    4.  Environmental Polychlorinated Biphenyl Contamination near
       Sites of Manufacture and Use"jEnvironmental Science and
       .Engineering, Inc., 1975.

    5.  Harvey, G. R.  and Steinhauer, W. G., "Atmospheric Trans-
       port of Polychlorinated Biphenylsto the North Atlantic, " At-
       mospheric Environment,  Vol.  8, 1974.

    6.  Bidleman, T.  F., and Olney, C.  F., "Chlorinated Hydro-
       carbons in the Sargasso Sea Atmosphere and Surface Water,"
       Science,  Vol.  183, February 1974.

    7.  Kleinert, S. J.,  Environmental Status of PCB's in Wiscon-
       sin, Department  of Natural Resources.

    8.  Henderson,  C.,  Inglis,  A.,  Johnson,  W.  L.,  "Organo-
       chlorine  Insecticide  Residues in Fish -  Fall  1969 National
       Pesticide Monitoring  Program,"  Pesticides  Monitoring
       Journal,  Vol. 5,  No. 1,  June 1971.

    9.  Bremer,  Karl E., Draft copy of "Statement of Concerns of
       the Lake  Michigan Toxic Substances Committee  related to
       PCB's,"  June  1975.
                               71

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                         TABLE 1
           ENVIRONMENTAL SOURCES OF PCB's
       Source                 Effluent Water Concentrations (ppb)

PAPER MILLS
   Wisconsin1                          0.1  -   18.5
WASTE PAPER MILLS
   Wisconsin1                                   18.5
INDUSTRIAL EFFLUENTS
   California2                          0        76
   Wisconsin2                           .04  -    0.25
   Ohio2                             0          17
   Michigan3                             .1   - 7000
MUNICIPAL WASTE WATER
 TREATMENT PLANTS
   Michigan3                            0.5
   Wisconsin1                            .05 -   17
   Ohio 2                               10    -   17
   California2                           0.16 -   76
CAPACITOR AND TRANSFORMER
 FACILITIES
   New York4                                 2800
   Massachusetts                                42.5
PCB MANUFACTUJUNG FACILITY
   East St. Louis                                   . 87
SPILLS                                         Variable
    li  Kleinert,  S. J.,  Environmental Status of PCB in Wis-
       consin, May 8, 1975, Wisconsin Department of Natural
       Resources.

    2.  PCB's and the Environment, Report  of the Interde-
       partmental Task Force on PCB's,  National Technical
       Information Service, 1972.
    3.  Statement of Concerns of the Lake Michigan Toxic Sub-
       stances   Committee Related to Poly chlorinated Bi-
       jhenyls^  June 1975.  Prepared by Karl F*.  Bremer,
            'A", Chicago, m.
phenyl
USEP,
   4.  Unpublished Data  -  Royal J. Nadeau and Robert P.
       Davis,  Investigation of Polychlorinated Biphenyls in
       the Hudson River, Hudson Falls -  Ft.  Edward Area,
       August 1974.

   5.  Field Sampling and Analysis of Toxic Pollutants Interim
       Report',  Battelle,  Pacific  Northwest  Laboratories,
       August 1974.
                               72

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                         TABLE 2
        SELECTED STATE DATA ON ENVIRONMENTAL
                    LEVELS OF PCB'S

              Surface and          Bottom
              Ground Water1      Sediment1        Fish-
State              yg/1              yg/kg            ppm

 AL                                             1.53-5.48
 AR                             20-2,400        1.69-3.88
 CA             0.1             20-190
 CO             0.3
 CT             0.1-0.2           5-3502        2.16-5.34
 FL             0.1-2.1           5-3,200       0.10-1.25
 GA                             10-1,300        0.52-1.18
 IL                                              1.21-11.3
 IA                                              0.35-1.41
 MD             0.1             10-1.200        0.56-1.31
 MA             0.2
 MI                                              4.00-11.7
 MN             0.1-0.3                         0.44-1.09
 MS                             50-170
 NB                                             0.47-4.58
 NJ              0.1               3-8002        0.10-4.00
 NY             0.1-4.0           3-13,OOO2      2.68-9.50
 OH                                             1.73-8.07
 OR                               1-5-140        0.71-3.62
 PA             0.2               6-7002        1.94-2.48
 PR             0.1
 SC                              30-200          0.10-7.3
 TX             0.1-3.0         7.9-290         0.10-0.22
 UT                                             0.15-2.14
 VA             0.1               5-80
 WV                              10             0.31-1.20
 WI               ,                               1.24-14.8
  1.  All data in  this column taken from Hans J. Crump-
     Wiesner,  Herman R. Feltz and Marvin L. Yates, ' A
     Study of the Distribution of Polychlorinated Biphenyls
     in the Aquatic  Environment, " Jour.   Research U.S.
     Geol. Survey 1, 603 (1972, unless otherwise noted).

  2.  USGS Sediment data, 1974.             ?

  3.  All data in this  column taken fromCroswell Henderson,
     Anthony Inglis  and Wendell  L. Johnson, "Organo-
     chlorine  Insecticide  Residues  in  Fish-Fall  1969
     National Pesticide Monitoring  Program, "  Pesticide
     Monitoring Journal 5, 1(1971).
                             73

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                                  TABLE 3

                          SELECTED PCB STUDIES

                         Fish           Water       Sediment      Plankton
  Lakes                (ppm)           (yig/D        (yg/kg)        (ppm)

 Lake Ontario1'2     0.14  -    9.17   0.035 -   0.097 43   -  245    3.4  -11.8
 Lake Erie3'4       0.2   -    7.8
 Lake Superior5      0.3   -    5.6
 Lake Huron6       0.16  -   11.0
 Lake Michigan 6,9   0.1   -  165.3                     3.72-  636
 Cayuga Lake10      3.4   -    9.7
 Lake St. Clair16     tr   -    3.8    0.1   -   0.2

  Rivers

 Iowa
  Mississippi River110.9   -    5.5
 Texas
  Brazos River12                    0.1   -   0.5
 Utah
  Green River12                     0.1
 New York
  Hudson River1^    7     -  350      1.0   -2,800     6.6 -  6.700,000
Michigan
  Saginaw River6'14 6.9   -  165.3    0.1   -   0.21
  Kalamazoo River7,15              0.1   -   0.45  100    -  560
  Portage Creek7    0.01  -  164.56   0.1   -   0.48   10    -  475,400
 Wisconsin
  Milwaukee River8                  .02  -   2. 17

  Marine Environment

 Atlantic Ocean17'18 0.038-    0.190  0.0009-   0.0036
 Bay of Fundyl-9      0.07 -    1.54
 Gulf of Mexico/     0.032-    0.059
 Caribbean  Sea20,21                                               0.157- 1.055
 Southern
 California22       0.04 -   6.6    0.0015-   0.019
     1.  Clarence  L.  Haile, Gilman Veith, G. Fred Lee and William C.
        Boyle, Chlorinated Hydrocarbons in the Lake Ontario Ecosystem,
        EPA-660/3-75-002,   June  1975,   UTSIE. P. A.,  Corvallis,
        Oregon.

     2.  Klaus  L.  Kaiser,  Mirex,  "An Unrecognized Contaminant of
        Fishes from Lake Ontario," Science  18, 523 (1974).

     3.  Richard  L. Carr,  Charles  E. Finsterwalder and Michael J.
                                       74

-------
    Schibi,  "Chemical Residues in Lake Erie  Fish -- 1970-71,"
    Pesticides Monitoring Journal 6;23 (1972).

 4.  John   R.  M.  Kelso and Richard Frank,  "Organochlorine Resi-
    dues, Mercury, Copper and Cadmium in Yellow Perch, White
    Bass and Smallmouth Bass, Long Point Bay, Lake Erie, " Trans.
    Amer. Fish. Soc., 103:577(1974).

 5.  Unpublished data.  Gilman D.  Veith and G.  E. Glass, PCB's
    and DDT in Fish from Western Lake Superior,  U. S. E. P. A.,
    Duluth, Minnesota.

 6.  Unpublished Data  -  John L. Hesse,  Bureau of Water Manage-
    ment, Michigan Department of  Natural Resources,  June 1973.

 7.  Unpublished data - State of Michigan Water Resources Commis-
    sion, Polychlorinated  Biphenyl  Survey of the Kalamazoo River
    and Portage  Creek  in the  Vicinity of the City of Kalamazoo,
    1972.

 8.  Gilman D.  Veith and Fred G. Lee,  "Chlorobiphenyls in  the Mil-
    waukee River, " Waj£r_Research, 1971.

 9.  Unpublished data - Schacht 1974, EPA 600/3-74-002.

10.  Carl  A.  Bache,  James W.  Serum,  William  D.  Youngs and
    Donald J.  Lisk, "Polychlorinated Biphenyl Residues: Accumula-
    tion in Cayuga Lake Trout  with Age," Science 177:1191 (1972).

11. Lauren G. Johnson and Robert L. Morris, "Chlorinated Insecti-
    cide  Residues in the  Eggs of Some Freshwater Fish, " Bulletin
    of Environmental  Contamination and  Toxicology 11:503  (1974).

12. Jean  A. Schulze,   Douglas   B.   Manigold and Freeman L.
    Andrews, "Pesticides in Selected Western Streams 1968-1971,"
    Pesticides  Monitoring Journal 7:73 (1973).

13. Unpublished data   -  Royal J. Nadeau  and Robert  P.  Davis,
    Investigation  of Polychlorinated Biphenyls in the Hudson River
    (Hudson Falls - Ft. Edward Area, August 1974).

14. Unpublished data - John L.  Hesse, Monitoring for Polychlor-
    inated Biphenyls in the Aquatic Environment, May 1973.

15. Unpublished data  -  Michigan  Water Resources  Commission,
    Evaluation  of the Aquatic Environment, of the Kalamazoo River
    Watershed, May 1972.

16. Michigan Department of Agriculture, Bureau of Consumer Pro-
    tection, 1973  Great Lakes  Environmental Contaminants Study.

17. T.  F. Bidleman and C. E. Olney, "Chlorinated Hydrocarbons
                                  75

-------
    in the Sargasso  Sea Atmosphere and  Surface Water, " Science
    183:516, (1973).

18. George R. Harvey, Helen P.  Miklas, Vaughan T. Bowen and
    William G. Steinhauer, "Observations on the Distribution of Chlo-
    rinated Hydrocarbons in Atlantic Ocean Organisms," Journal
    of Marine Research 32:103 (1973).

19. V.  Zitko,  O. Hitzinger and Pf. M. K. Choi, Contamination of the
    Bay of Fundy - Gulf of Maine Area with Polychlorinated  Bi-
    phenyls,   Polychlorinated  Terphenyls,  Chlorinated Dibenzo-
    dioxins and Dibenzofurans, Environmental Health Perspectives,
    1:47 (1972).

20. C.  S.   Giam,   A.  R.  Hanks,   R.  L. Richardson,  W. M.
    Sackett and M. K.  Wong, "DDT, DDE, and Polychlorinated Bi-
    phenyls in Biota from the Gulf of Mexico and Caribbean Sea  -
    1971,"  Pesticides Monitoring Journal 6:139 (1972).

21. C.  S.   Giam,  M.  K.  Wong,  A.  R.  Hanks,  W.  M. Sackett
    and R. L.  Richardson, "Chlorinated Hydrocarbons in Plankton
    from the  Gulf of Mexico  and Northern California, " Bulletin of
    Environmental Contamination and Toxicology 9:376 (1973).

22. The Ecology of the Southern California  Bight;  Implications for
    Water  Quality Management,  Southern  California Coastal Water
    Research Project,   1500  East Imperial Highway,  El Segundo,
    1973.
                                  76

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                    TABLE 4
          LAKE ONTARIO ECOSYSTEM X

 FISH, yg/g
  Alewife                          .14   -    4.36
  Smelt                           1.40   -    3.49
  Slimy Sculp in                    1.58   -    9.17

 WATER ng/1                     38      -   97

 SEDIMENT, ng/g                 43      -  245

 NET PLANKTON, yg/g            3.4    -   11.8

Haile,  C.  L., Veith,  G.  D.,  Lee,  G. F. Boyle,
W. C.,  Chlorinated Hydrocarbons in the Lake Ontario
Ecosystem (IFYGL), June,  1975.
                        77

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                                       Figure 1
                 CONCENTRATION OF PCB'S IN SOIL WITH DISTANCE
                                         (PPm)
0.02
                          11/4 mi
            AROCLOR 1260
    INVESTMENT CASTING COMPANY
     1.8
                          11/4 ml
            AROCLOR 1260
INVESTMENT CASTING WAX MANUFACTURER
   .40.001
                        11/4 ml
           decachloroblphenyl
 INVESTMENT CASTING WAX MANUFACTURER
  AROCLOR 1242
PCB MANUFACTURER
   AROCLOR 1260
PCB MANUFACTURER
                                                                              11/4 mi
 decachlorobiphenyl
PCB MANUFACTURER
                                               78

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          MONITORING: THE TRIGGER FOR ACTION

                      Delivered by
                I. Eugene Wallen, Ph. D.
       Deputy Director, Office of Toxic  Substances

                         to the
       National Symposium on Environmental Monitoring
         Las  Vegas, Nevada  -- September 15, 1975

    Vinyl.chloride air emissions . . . organics in drinking water . . .
asbestos fibers in waste water effluents . . . polybrominated bi-
phenyls in  fish  .  . . these and many other toxic chemical concerns
are being clarified  by current  monitoring efforts of the  Office of
Toxic  Substances.   In each of these instances, the speed and direc-
tion of the responses of Governmental regulatory machinery are crit-
ically  dependent on monitoring data -- particularly  recent data which
can provide a reasonably sound basis for generalizations.

    Two of the key informational concerns in addressing  chemical
problems are toxicity and  exposure,  and  monitoring data provide
the backbone of  exposure estimates.   While toxicity data may often
be inadequate, acceptable monitoring  data are rarely available at
standard-setting time.

    What are  the problems inhibiting  the ready availability of  solid
monitoring  data?   Why are the available data generally not well
suited for standards setting?  Why are we continually surprised by
unanticipated  chemical problems?  Who has the resources? These
questions go to  the  heart of this conference.  Their answers inevi-
tably involve  a blurry mix of scientific, technical, organizational,
and budgetary issues.   Perhaps a brief review of  a few recent case
histories,  together  with examples  of  current efforts, will help to
provide a perspective for  the applications of monitoring data in
the regulatory decision process.

EXAMPLES  OF  RECENT  TOXIC   SUBSTANCES  MONITORING
 EFFORTS

Vinyl Chloride

     Initial  EPA  monitoring activities were  directed primarily to
air emissions at PVC polymerization facilities.   Upon  discovery
of the  relationship of vinyl chloride to Angiosarcoma, monitoring
patterns, sampling and analysis approaches and equipment, and data
interpretation techniques were  hastily developed by  several EPA
laboratories in  early 1974.   A preliminary sampling effort at one
facility provided much needed experience in refining the approaches
to be used  in  more  refined efforts at  seven other industrial com-
plexes.  The  entire  sampling and analysis program was carried out
in less than three months, and there is no doubt that the results had
a major impact  on the EPA decision to set an air standard for vinyl
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chloride.   Details of the  approach and the results are set forth in
the report Preliminary Assessment of the Environmental Problems
Associated with Vinyl Chloride and Polyvinyl Chloride, Environ-
mental Protection  Agency,  September 1974.   In retrospect, this
ad hoc monitoring  effort was probably about as good as could have
Eeen expected given the time and resource constraints and the lack
of previous experience with vinyl chloride.   One major shortcoming
was the failure to convene a meeting of all the sampling and analysis
teams early in  the program to identify problem areas and promote
greater uniformity in the approaches that were used.

    The recent discovery of vinyl chloride in drinking water and near
waste disposal sites  has caused a reexamination of the initial con-
clusions that these were not areas of serious concern.  Initial moni-
toring data,  coupled  with tests of the  behavior of  vinyl chloride
in water,  suggested that there was little likelihood that vinyl chloride
would reach drinking water supplies as the result of vinyl chloride
effluent discharges.   With regard to landfills, it was assumed that
wastes from PVC plants and discarded PVC products would probably
not be problems.     Monitoring of  selected  sites hopefully  would
clarify  the need for  regulatory actions other than current steps
directed to air emissions.

   ,A third type of concern is  related to the possible migration of
vinyl chloride out of finished  PVC products into the environment;
thus possibly establishing a background level of the vinyl chloride
monomer in air. While skeptics have doubted this possibility, there
are several  unconfirmed  and unexplained  reports  of detection of
vinyl chloride distant from  either vinyl chloride or  PVC  plants.
Sampling  for vinyl chloride is planned at a number of potential
sites where monomer migration might have taken place.

Organic s  in Drinking Water

    The report Preliminary Assessment of Suspected Carcinogens
in Drinking Water, Environmental Protection Agency,  June 1975,
detailed the initial results of an EPA monitoring  survey of organic s
in drinking water.   Eighty water supplies were chosen and six spe-
cific organics of potential concern .  . .  the four trihalomethanes
(chloroform,  bromodichloromethane,  dibromochloromethane,  and
bromoform),   carbon tetrachloride,  and 1,2 dichloroethane .  . .
were found.   These  80  supplies provided a reasonably representa-
tive sample of  community drinking  water supplies  that  chlorinate
their water, and represented a wide variety of raw water sources,
treatment techniques,  and geographical locations.   Based on the
survey findings, it appeared that chlorination may have contributed
to the formation of the four trihalom ethanes.

   For a more comprehensive  survey  of the organic content of fin-
ished water,  a  second portion of the  Survey investigated 10  of the
80 cities  with sites representing 5 major categories of  raw water
sources.   Preliminary  analyses of  the  drinking water of the first
five cities have identified  over 85 organics.  The water supplies of
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the five remaining cities were surveyed more recently, and the re-
sults are expected to he reported by the end of the year.

    The results of this monitoring effort are having a major impact
on the  regulatory and research efforts of EPA.  Indeed, it has  prob-
ably been the most important single activity in shaping future Agency
actions concerning organics in drinking water.

Environmental Levels of Asbestos

    A nation-wide asbestos sampling program is underway to deter-
mine the environmental levels of asbestos  resulting from discharges
from various  sources.   Thirty-two  sampling locations  have been
chosen to include four major  categories  of asbestos dischargers.
A natural site category was selected because of asbestos^ock for-
mations which may contribute  significant amounts of asbestos in run-
off or  emissions as a result of natural weathering processes.  Other
site categories are asbestos mining; mining of other ores (such as
talc and vermiculite  which may also be  sources  of asbestos); and
asbestos manufacturing.    For all categories, both air  and  water
samples are being taken.  Over 60 sampling sites have been chosen,
including water supplies of several major  cities,  such as San  Fran-
cisco,  Denver,  Chicago,   Atlanta,  and Dallas.   The sampling has
begun  and  a report detailing  the analyses should be available  by
mid-1976.

Previously Unidentified Pollutants in Water

    As  a part of the early warning efforts of the Office of Toxic Sub-
stances, 200 water samples from sites in industrial areas through-
out the country  are being collected and analyzed.  It is anticipated
that collections will be made  at about 100 sites in 30 to 40 industrial
areas.   Each sample will be  subjected to  three subsample analyses
to screen for (1) inorganics, (2) volatile organics, and (3) non-volatile
organics.   The purpose of this monitoring program  is  to identify
specific chemicals in surface waters having an industrial effluent
origin, and then to clarify which  should  be of concern  in view of
their potential to reach man through drinking water, fish products,
or recreational exposure. The monitoring information, together with
data on the toxicity of the identified chemicals,  should provide a
basis for initial judgments on the possible need for regulatory actions.

Multimedia Exposure to Halogenated Organics

    A fifth  program involves monitoring  studies  to determine the
levels  of selected halogenated organics in air, water,  soil, and food
in four limited  geographic areas,   and  parallel investigations to
determine the levels of the same  chemicals in the blood, tissue, and
urine of human populations in these areas.  A review will be under-
taken of the causes of death in these areas in comparison with death
rates in other areas, as well as with national averages. The sources
of environmental discharges of the chemicals also will be identified.
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    This project  is intended to utilize monitoring, epidemiological,
statistical,  and other analytical techniques in clarifying the degree
to which different types of pollutant sources may contribute to human
health problems.

THE USE OF MONITORING DATA IN SETTING STANDARDS

    An estimate of likely exposure  should,  of course,  be central
in deciding  the need for,  character  of, and impact resulting from a
proposed regulatory  action  to curtail  the discharge of a chemical
into the environment.   Current environmental levels, fluctuations,
and trends are of interest in assessing the benefits to the environ-
ment  of  curtailing exposure, as well  as in  detailing the costs in-
volved in achieving reduced  exposure levels.  In grappling with the
costs of regulation, --for example, in setting maximum contaminant
levels in drinking water, allowable chemical concentrations in water
effluents, or pesticides tolerances  -- the severity and urgency of
the problem and the  numbers of  activities which would be affected
by different types of compliance are all critically dependent on moni-
toring data.  More often than not,  the available data are so incon-
clusive that these questions are  only  answered in  a very cursory
way. However, as economic concerns over regulatory actions height-
en, the insistences by the  Congress and the courts as well  as  by
the Executive  branch  of the Government that hard evidence back up
those actions increase.

REVIEW AND EVALUATION OF EXISTING MONITORING DATA

    Sources of monitoring information generally were prepared for
purposes other than regulation of specific chemicals.  When these
data are compiled  as a part of the consideration of proposed  regu-
lation, they  must be reassembled and reformattedso as to contribute
to calculations of the exposure of man and the environment to a par-
ticular substance.  Some of the considerations used in such calcula-
tions  must  include the relative importance of the alternative path-
ways  from  the environment to man or  other affected organism; the
geographic  sites of exposure; the internal variability of the affected
populations; the  effects of acute  or chronic  rates of exposure; the
persistence of the chemical; the toxicity of its breakdown products;
and other similar  characteristics.   Although monitoring data may
be used  to  gain significant  insight into several of these considera-
tions,  they  generally must be selected  according to application.

    Monitoring information to be gathered will include concentrations
and recent  trends in air, surface and drinking water, groundwater,
soil,  food,  sediment,  aquatic and terrestrial organisms, and human
tissues and  body fluids.  Details will also be needed on the methods
of collecting the samples,  interferences, meteorological data, and
analytical methods employed.

    Already existing monitoring data will come from computerized
searches, specialized data  centers,  university programs,  federal
programs,  state  programs,   and science information exchanges.


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These data  must be keyed to  the specific  types of limitations nec-
essary to reduce discharges into the environment,  thus reducing the
risks of environmental exposure. Data will be collected on a highly
selective basis, with no necessity of obtaining  comprehensive moni-
toring data for all sources and all media.

DATA GAPS

    It will be necessary to identify data gaps and develop an appro-
priate environmental sampling plan designed  to yield the data re-
quired.  Major air,  water, soil, sediment,  and biota  monitoring
programs may have to be undertaken.  In identifying suitable sam-
pling sites,  pertinent  meteorological,  hydrogeological,  and demo-
graphic considerations, along with identification  and evaluation of
the various  sources of discharge, must be considered.   Acceptable
criteria must be developed with a defensible rationale for selecting
the sites  and the types of sampling  to be undertaken.  It often
may be desirable to establish  seasonal trends of toxic  substances
levels at various locations and the concentration levels  in different
media.  In  some cases cross-media  transport mechanisms must
be considered.

SAMPLING  EQUIPMENT

    A wide spectrum of sampling equipment must be available and
used to collect and preserve the integrity of the samples.  Concen-
trations of the sample may be required in the field for  some toxic
chemicals.   The analytic laboratory  must be sufficiently equipped
to perform  quantitative trace  chemical analyses in various media.
Readily available instrumentation should include atomic absorption
spectrophotometer, spark source mass spectrograph,  high and low
resolution mass spectrometers, gas chromatograph/mass spectro-
meter, UV-visible spectrometer, gas chromatograph, and associated
items.

DATA PACKAGE

    The data must be  fitted into integrated packages that will  pro-
file human and  environmental exposure  to these  chemicals  in the
media of concern,  and assess the  degree of  harmful exposure of
animals, plants, and microorganisms from the production, use,  and
disposal of these chemicals.    The profile must be keyed to the
available approaches  for reducing environmental levels by control-
ling sources.

    Relevant data are required  on the  levels of the chemical which
are identified in air, drinking and surface water,  groundwater, dust,
sediment, soil, and other media. Reported sources of contamination
should be indicated and, for those substances that occur naturally,
background  levels  should  be identified.   Maps  should be provided
showing the distribution of sampling areas and levels identified wher-
ever possible.
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    Data also  are needed concerning  (1) behavior of the chemicals
in the environment; (2) occurrence of the chemical in food and other
products that come in contact with man;  (3) exposure and biological
accumulation; and (4) environmental trends.

    In conclusion, although monitoring data may be collected for re-
search,  demonstration, management, or other purposes,  properly
massaged  data are useful to the regulator in a variety of contexts
and they may trigger or obviate several types  of regulatory  con-
siderations.
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             CHEMICALS AND THE ENVIRONMENT

                       Delivered by
                    Glenn  E.  Schweitzer
              Director, Office of Toxic Substances

                           to the
           American Dye Manufacturers Institute,  inc.
          Absecon,  New Jersey -- September 11,  1975

    Two weeks ago,  the lead article in Sports Illustrated highlighted
a series  of unfortunate incidents  affecting fishing activities which
have resulted from environmental contamination by polychlorinated
biphenyls.  For many of you, this magazine may simply be a vehicle
for passing time in an airplane.  For others, and for myself,  Sports
Illustrated reflects many of those activities that make life truly en-
joyable.  While we are accustomed to encountering problems result-
ing from industrial chemicals in our newspapers,  in popular maga-
zines,  and in the trade press, now even the last recluse for sports
lovers has been invaded.

    It may  seem  that polychlorinated biphenyls are a long way from
dyes.  However, the types  of  concerns surrounding this chemical
and many other  commercial chemicals as well will continue to trig-
ger actions by regulatory agencies and public interest groups, and
indeed by industry itself, which can have significant  implications
for your  industry.

    Today, I would like  to  report to you on recent developments in
several areas which have stimulated a considerable amount of dis-
cussion within and outside  Government during recent months.  A
number of  issues are being brought to a head in large measure by
specific actions on the part of Congress and the regulatory agencies.
Indeed, specific actions are often required to bring into sharp focus
important policy issues which had previously been considered large-
ly in the  context of academic discussions.
                                    i)
    More specifically,  I would like to  make a few observations on
the environmental decision-making process, approaches to the con-
trol of carcinogens, and the likely impact  of the Toxic Substances
Control Act on  industry.   These areas are obviously interrelated.
Also, while I will try to confine my remarks to industrial chemi-
cals, clearly there are many overlaps in the approaches to the con-
trol of industrial  chemicals and chemicals used for other purposes
such as consumer products, food  additives, drugs, and pesticides.
At the  outset, let me emphasize that my comments will be oriented
toward raising issues and questions rather than prescribing solu-
tions.  This seems appropriate since in most cases general prescrip-
tions either must be so broad as to be almost meaningless or, if
specific,  they frequently ignore the complexities of the real world
of chemicals.
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The Environmental Decision-Making Process

    Obviously,  a key concern in  any decision-making  process  is,
"Who decides?"   In  the  environmental area,  the answer to this
question varies with the particular type of decision. Within Govern-
raent, the decision maker can  range  all the way from an appellate
court to a relatively junior Government official.   Outside  Govern-
ment, a Board  of Directors may decide or, at the other extreme,
an individual customer may determine the fate of a chemical.

    A key related  concern is how and  when issues are escalated up
the decision-making ladder.    Within  Government,  the escalation
process depends both on internal procedures and on  the  extent to
which an adversely affected party decides to press the issue.  The
squeaky wheel does command attention.

    Related to  the participants  in the decision-making process is
the structure of the process itself.   While the larger companies
and the better  financed public interest  groups can keep abreast of
the procedural steps leading up to  a decision, we are increasingly
concerned over the difficulties  facing smaller organizations which
all too  often learn about an important decision only after the fact.
Many trade associations are providing a useful service to the smaller
companies in this regard, although it seems  only realistic to recog-
nize that smaller companies will continue to have greater difficulties
in staying abreast of and influencing the decision-making process.

    Certainly in the case of EPA, many individuals and groups within
and outside the Agency are involved in influencing any major decision
that eventually emerges.   The internal and external review mecha-
nisms,  the  comment and hearing procedures, and the opportunities
for informal inputs may not seem adequate to an outsider. However,
from the point of view of a regulatory official,  there would  seem
to be many opportunities for all interested parties to provide inputs
into the  decision-making process.  This, of course, does not mean
thatthe decision would necessarily reflect any particular input,  since
there is bound to be controversy in any decision which has major
environmental impact  and attendant  economic effects.

    At the same time,  I am not implying that the decision-making
process cannot be improved.   For example, the National Academy
of Sciences has raised the question  as to whether a Commission for
making regulatory decisions affecting the environment would be pre-
ferable  to a single EPA  Administrator.   The Academy  has also
urged more extensive  external reviews of pending EPA decisions,
although in almost the same breath  has urged that the time involved
in the decision-making process be shortened.

    Another important  aspect of environmental decision making re-
lates to  the burden of proof.   This aspect has been underscored
in recently introduced legislation which would seem to shift a greater
burden  to those parties that  derive commercial benefits from the
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chemicals in  question.   However,  these legislative  proposals are
limited to the burden of proof in a judicial proceeding  and thus
are only indirectly related to requirements for considering regula-
tory actions during the development and promulgation of regulations
and during adjudicatory hearings.  With regard to industrial chemi-
cals in general, and the Toxic Substances Control Act in particular,
the initial burden of establishing the  need for  regulatory actions
would  remain with the regulatory agencies.

    Industry is understandably concerned that  an extreme interpre-
tation  of burden of  proof requirements might call for industry  to
prove  a negative -- that is,  that there is no hazard  or risk  asso-
ciated with the use of  chemical --a task which some argue is im-
possible.   At the same time,  it seems  clear that the proponents
of the use of chemicals which are  deliberately  given to people  or
deliberately introduced into the environment should demonstrate the
efficacy and  safety of these chemicals.   This principle is  set forth
in our laws governing the development and  use of food additivies,
drugs, and pesticides.  With regard to industrial chemicals, includ-
ing those  chemicals which are not intended for widespread distribu-
tion in the environment, industry also has a responsibility to insure
the safety of their employees,  the residents surrounding manufac-
turing facilities, and other people and environmental resources that
may come into contact  with the chemicals.  Of course, the criteria
to be used in assessing the hazards associated with  chemicals clear-
ly must take into  account the intended uses,  the  likelihood  of un-
intended uses, and the attendant possibilities of environmental re-
lease.

    Another aspect of decision making relates to the weight to  be
given to the costs,  the risks,  and the benefits associated with the
concerned chemical or chemicals.   For some time EPA has been
committed to a careful consideration of all of these factors in addres-
sing industrial chemicals. However,  translating a very  general,
albeit very sincere, commitment into practical decision making  is
not always easy.   Formulas do not exist for trading off health and
ecological considerations against  economic and societal benefits.
Nevertheless,  I believe that  all will  agree that in every  case all
relevant considerations should be  clearly arrayed for the  decision
maker, considerations which incorporate the best  available data
and which identify the unknown factors as  well as the known factors.
The basis for  the decision should then  be  fully explained to the
public.

The Control of Carcinogens

    The evidence linking  some industrial chemicals with increased
cancer incidence continues to mount.  The recent setof "cancer maps"
prepared  by  the National  Cancer Institute shows  very conspicuous
high levels of incidence of certain types of cancer  in many areas
characterized by heavy concentrations of the chemical industry. The
bioassay  program of that same institution is uncovering more and
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more important  chemicals which produce tumors  in experimental
animals.    Other toxicological  investigations and epidemiological
studies are also highlighting previously unsuspected cancer risks as-
sociated with exposure to certain chemical.

    At the same time that additional chemicals are being implicated
as possibly being the causative agents for induction of  cancer,  our
monitoring programs are detecting levels of many of these chemicals
in different environmental media.  Perhaps the discoveries of great-
est concern  are  resulting from  our monitoring programs directed
to drinking  water supplies.   In any event, new data on  toxicity and
likely exposure levels are constantly adding concerns over the risks
associated  with  the manufacture,  use,  distribution, and disposal
of chemicals in general, and of carcinogens in particular.

    But how can the risks associated with  carcinogens be assessed?
Three approaches have usually been  tried.   The  first  approach is
simply to decree that any risk is unacceptable --a concept repeat-
edly rejected by  EPA.  Another approach is to attempt to extrapo-
late from the rate of tumor incidence in one or more animal experi-
ments and  using various statistical techniques to derive a risk fac-
tor (e.g.  less that 1 to  1,000,000; less than 1 to 1/100,000) at
the level of  exposure likely to be encountered in the environment.
This risk factor is  then multiplied  by the number of  people  who
are likely to be exposed to the chemical to  provide an estimate of the
risk to the  overall population.  This approach, while  appealing to
many, and particularly those interested  in quantifying  risk/benefit
tradeoffs,  is inevitably plagued by uncertainties in  both the animal
test data and the exposed  population estimates.   A third,  and in
my view a preferred approach, involves less precision, but hopefully
more realism  in deriving estimates.   All available data on health
effects are  arrayed,  including the carrying out of statistical extra-
polations when possible  to provide  very general estimates of the
levels of risks to an individual.   Consideration is also given to the
monitoring  and related data concerning exposure levels.  No attempt
is made to  derive a single risk number,  but  all data are examined
in reaching a  conclusion as  to a "ballpark"  level  of  risk.   If a
single number is required, the best  estimate is then bracketed with
estimates of the uncertainties and a qualitative description of the
uncertainties.

    There is no  reason not to balance the costs, risks,  and bene-
fits associated with carcinogens in much the same way  that these
factors are  balanced  in decisions involving  other  chemicals.  In
my view, the only methodological differences in assessing the need
for controlling carcinogens as contrasted to non-carcinogens --
assuming such a distinction can be made  -- relate to the techniques
for assessing  risks.   Of  course, as a practical matter,  we cannot
neglect the  fact that a major element  in addressing carcinogens will
inevitably be the emotional aspect of dealing with the risk of cancer
which has affected the lives of so many people.   At the same time,
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it is far  from clear that  cancer should be our principal health con-
cern in assessing chemical hazard.

Toxic Substances Legislation

    As you know, currently both. Houses of the Congress are active-
ly working on the Toxic  Substances Control Act -- a much needed
piece of legislation that has been pending for more than four years.
While there are significant differences between the several versions
of the legislation, all versions provide for annual reporting of chemi-
cal production activities,  testing by industry of selected chemicals,
industrial notification of the Government of the identity of new chemi-
cals prior to their introduction into commerce,  and authority to
limit production or use when there  is an unreasonable risk that can-
not be adequately addressed under  other existing authorities.

    A major thrust of this legislation is to examine the health  and
ecological effects of new commercial chemicals before  major in-
vestments have been made  for  their  production.  This "front-end"
approach -- designed to  cut off problems at the  pass -- will  not.
only address potential  problems before the  damage is  done,  but
will also minimize the economic dislocations attendant to corrective
actions.

    With regard  to  the impact of the legislation  on industry,  the
reports prepared by industry -- and particularly Dow and Snell --
have in our view  distorted some of the impacts that are likely to
result.   Therefore, I would urge caution in citing these reports  as
an authoritative estimate  of what is likely to happen when the legis-
lation is  enacted.

    Clearly,  the final shape of the  legislation and the  character
of the implementing regulations will affect the impact.   Perhaps it
would be useful to underscore several aspects of the legislation which
we consider particularly important in this regard.

 --  Any  requirements  to publish  a  list  of chemicals  as a
    preliminary  step  to  establishing requirements for  pre-
    market screening or for testing are unadvisable.  If there
    is sufficient  evidence to suspect  a chemical or chemical
    class, the appropriate requirement  should be established
    forthwith.   There  is  no need for a list which will simply
    delay and confuse  the process and raise premature con-
    cerns  about the eventual regulatory  fate of a number of
    chemicals.

 --  There should be a provision to exclude research chemi-
    cals product in very  small amounts from pre-market re-
    porting requirements when appropriate.

 --  Comprehensive annual reporting of all commercial chemi-
    cals is not  of sufficiently high  priority to warrant the
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    expense that would be incurred by industry and Govern-
    ment to  carry  out such a requirement in a responsible
    fashion.  Rather,  selected  reporting of those chemicals
    of possible concern makes far more sense.

 •- Similarly, we  do not consider mandatory submission of
    all health and safety studies conducted by industry during
    the past 40 years desirable.  Rather, authority to request
    such studies as needed would be far preferable.

 -- EPA has no intention to require  extensive premarket test-
    ing on all new  chemicals.   On the one hand, we cannot
    predict what chemicals will  be  developed, and as a prac-
    tical matter it  is  not  possible to develop test  require-
    ments that make sense for all possible chemicals and all
    possible uses.   Of equal importance is our conviction that
    concentrating the  limited available resources on a  few
    classes of chemicals which  are known to be troublesome
    will pay far higher environmental dividends than a broad
    shotgun approach.

Common Goals

    The objectives  of the programs of my Office are quite straight
forward,  namely, to  reduce  the probability  of  chemical incidents
harmful to man or the environment through

 -- safer products,
 -- cleaner and safer manufacturing processes, and
 -- better product handling and disposal

without necessarily

 -- increasing product costs,
 -- blunting R&D activities,
 -- distorting configuration of the industry, or
 -- jeopardizing the U. S.  competitive position.

    Obviously,  these  goals are not  unique to us or to the Govern-
ment in general, nor  are  they particularly controversial.   Never-
theless,  I feel  that it is important to make such goals explicit.

    From my vantage point, there are two routes for reaching these
goals.   Industrial actions can be forced by  regulations,  or indus-
trial actions can be undertaken on a  voluntary basis.  Clearly, there
will be  a mix of these approaches.    I  would hope  that we could
rely increasingly on voluntary steps by industry,  which are usually
less painful for all  concerned, but  actions in this regard rest  with
you.
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                   HEARINGS ON PCBs

                      Delivered by
                   Glenn E.  Schweitzer
            Director, Office of Toxic Substances

                          to the
         Wisconsin Department of Natural Resources
            Madison,  WI -- August 29, 1975

    I greatly appreciate the opportunity to present the views of the
Environmental Protection Agency concerning the environmental prob-
lems associated with the manufacture,  use, distribution, and dispo-
sal of poly chlorinated  biphenyls (PCBs).   Since its  initial days the
Agency has been concerned with practical steps that could be taken
to clarify and reduce the environmental risks attendant to commer-
cial applications of PCBs. More recently the Agency has intensified
its efforts to  help insure that unnecessary hazards are effectively
curtailed.  Thus, we fully share your concerns,  and we will continue
to work with the State Governments and other interested organiza-
tions in seeking feasible solutions to this problem.

    In view of the background papers that are available and the de-
tailed statements being  presented  by   specialists participating  in
these hearings,  I will limit my comments to a brief  summary of the
history of the PCB problem,  recent developments that  have height-
ened interest  in PCBs,  and the current spread of  EPA activities
directed to  PCBs.   I  will then comment on several  aspects of par-
ticular interest to the State of Wisconsin.

1972 Findings of Interdepartmental Task Force and Ensuing Actions

    In May 1972,  the  Interdepartmental Task Force concluded that
PCBs were highly persistent,  could be found in all  parts of the
environment,  could bioaccumulate in fish by a factor  of up to 75,000,
and could have serious adverse effects  on human health.  The Task
Force urged discontinuance of all uses of PCBs except uses in closed
electrical systems and called for enactment of the Toxic Substances
Control Act to provide a needed regulatory mechanism  to deal with
PCBs and other problems of this type.

    Largely as a result  of the activities of the Task Force, the
Monsanto  Company,  the sole US producer of  PCBs at that  time,
voluntarily  limited its  sales  to manufacturers of  closed  electrical
systems.   Also, EPA  promptly announced that it would begin re-
stricting  the  discharges of industrial effluents  so  that the levels
of PCBs in rivers or  lakes do not  exceed 10 ppt.   FDA took steps
to establish PCB tolerances for several types of food (from . 2 ppm
in baby food to  5  ppm  in fish) and to  limit PCB contamination in
food packaging and food plants.

    As a further follow-up to  the Task  Force recommendations, the
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General  Services Administration amended its procurement speci-
fications to ban  PCBs in off-shore oil  operations.   The American
National Standards  Institute issued guidelines  for industry on the
use, disposal,  and labelling of PCBs.

    Internationally,  a  Decision of the  Organization  for Economic
Cooperation and Development (OECD) 1973provides that PCBs shall
not be used for industrial or commercial purposes except in certain
closed systems.   However, even with respect to the excepted uses,
the OECD  Council (a)  decided that PCBs should only be used  when
adequate environmental  co'ntrols are exercised and when benefits
outweigh the risks, and (b) recommended that countries  work toward
the elimination of PCBs in small capacitors.   The Decision leaves
it to Member countries to go beyond the  Council agreements and,
in effect, invites governments to phase out PCB uses  wherever pos-
sible.   Japan,  in the  wake  of  PCB  contamination of  rice oil that
adversely affected 1000 people, banned future production or import
of PCBs.  More  recently the  government  of Canada has begun to
collect necessary data for restricting  PCBs pursuant  to a new En-
vironmental Contaminants Act which should be enacted  this year.

Developments Since  the Task Force Report

    Health  and Ecological Effects

    Recent research results have heightened concern over the toxi-
city of PCBs previously  documented in the Report of the  Interde-
partmental Task Force.   Concentrations as low as 2.  5 and 5 ppm
have produced  serious adverse health effects in monkeys,  including
loss of hair,  acneform lesions, loss  of weight,  increased secretion
of total  urinary  ketosteroids,  irregularities in menstrual cycles,
impaired ability to  maintain pregnancy, and undersized offspring.
A still unpublished report indicates malignant liver  tumors in rats
exposed to one  grade of PCB at levels of 100 ppm.  Several super-
ficial .reports  of chloracne among workers exposed  to PCBs have
been received.    Also,  concentrations  of  5 ppm  in fish eggs have
resulted in fry  mortality.

    In considering these  effects it is important to  remember that
there are eight commercial  grades  of PCBs,    and their toxicity
characteristics  may vary to some degree.  However, there is no
basis for assuming  that  any one of  the grades is not a potential
hazard.

    Monitoring  and Exposure Data

    As a result of the FDA actions described above, the PCB levels
in foods  have  been steadily declining.  At the same time,  however,
the levels  detected in fish and wildlife appear to have increased.
Available monitoring data for PCBs in  the ambient  air, water,
sediment,  soil,  or  human tissues do not  provide a  good basis for
estimating national  environmental trends.   For example, analyses
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of water samples  have seldom  extended into the parts per trillion
range, and thus only rarely have  PCBs  been detected..  Limited
adipose tissue samples for FY 1972 and 1973 indicate a slight down-
ward trend  with levels in excess of 3 ppm being observed.   Un-
usually high levels of PCBs have been detected in  recent months
in the fish  in Lake Michigan (up to 165 ppm),  Lake Pepin (up to
40 ppm), the Hudson River (up to 350 ppm), and Southern California
(up to 6.6 ppm), although the average levels are significantly lower
than these upper limits.  PCBs have been detected  in sludge from
sewage treatment plants as well  as in the effluents from these plants.
PCBs have been identified in only two drinking water supplies during
the past year.  There have been five water spills  involving  PCB
leakage from transformers during the past year, and currently there
are tens of thousands of capacitors,  each containing several gallons
of PCBs, awaiting disposal.

    Production, Imports,  and Uses

    While Monsanto is believed to be limiting its sales to manufac-
turers of closed electrical systems, information has been received
by EPA indicating  that PCB  reprocessors may be selling PCBs for
other uses.    It is believed  that most of the  PCB imports (which
exceeded 375,000  pounds in  1974) are not used in closed electrical
systems.  Among the PCB uses which  are known to persist in the
US at present are applications in investment casting processes, heat
exchange fluids, and hydraulic fluids. There are a variety of other
potential uses of PCBs although firm evidence of  such current uses
is not in hand.

    With regard to substitutes, Dow Chemical has developed a prod-
uct for use in large power capacitors, and Dow Corning has a prod-
which can substitute for PCBs in certain transformer applications.
At least  one  of these substitutes is reportedly being introduced at
the present time in Japan.

    Recent Regulatory Actions

    In 1973,  Water Quality Criteria  were proposed  to limit PCBs
to 2 ppt in ambient waters.  Also, a national effluent standard for
PCBs was proposed under Section 307(a)  of FWPCA.  PCBs were
included in  the advanced proposal of a hazardous substances  list
under Section 311  of the FWPCA in  1974.  Finally, NPDES permits
that limit the discharge of PCBs have been issued for at least six
facilities; preliminary  reports  indicate  that approximately 10-15
other discharge permits may contain effluent limitations for PCBs.
In addition,  the effluent guidelines promulgated for the steam elec-
tric -power generating category contain limitations requiring no dis-
charge of PCBs.  A significant percentage of the permits issued for
this category to date contain these limitations.

    As  you know,  several states are  currently considering imposing
limitations on PCBs.
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Ongoing Activities of EPA

    The following  EPA  activities  to  assess and control the PCB
problem have been underway for some time.

    1.  A water quality criteria  level of 1 ppt will soon under-
    go interagency review prior to final promulgation.   The
    originally proposed level of  2 ppt has been reduced in view
    of the recent ecological effects data.

    2.  Detailed documentation necessary to support a national
    standard for water effluent discharges under Section 307(a)
    is being assembled  with  issuance of a  revised  proposed
    standard scheduled in the near future.

    3.  Proposed levels of harmful quantities of PCBs acci-
    dentally released into navigable waters and rates of  pen-
    alties for  such spills are currently being developed  pur-
    suant to Section 311 of the FWPCA.

    4.  A laboratory  demonstration program is underway to
    develop and test  control technology for treatment of PCB
    manufacturing wastes, including the aqueous effluent  from
    PCB users   and   the   discharge   from  leaks   from
    transformers and capacitors.

    5.  The scientific  literature concerning the  health and
    ecological effects of PCBs is  being reviewed.   Further,
    a continuing research program is investigating the meta-
    bolism and  effects of PCBs.  As part  of this program,
    several studies have examined the effects of PCBs in rats
    after long-term  feeding regimes,   especially effects on
    reproduction,  liver  function, carcinogenesis,  and hemo-
    globin metabolism.

    6.  Collection and analysis of adipose tissues are continu-
    ing.

    7.  Several laboratories have been conducting research on
    the ecological effects and environmental fate of PCBs.

    8.  Studies of the behavior of PCBs in soil, with particu-
    lar attention to possible ground water contamination fol-
    lowing  a spill, are underway.

    9.  Analyses of the' technological and cost aspects of using
    substitutes for  PCBs  in  closed  electrical  systems are
    underway.

   10.  Technical  assistance  is  routinely provided  on the
    storage and disposal of PCB-containing wastes.   In addi-
    tion test burns of capacitors containing such wastes in a
    high temperature incinerator are planned for early 1976.
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Newly Initiated Activities of EPA

    In view of the new evidence concerning the toxicity of PCBs and
the recent  reports of high environmental levels in several areas
of the country,  EPA has accelerated its efforts  directed to PCBs.
These activities,  being carried out in cooperations with other Fed-
eral and State agencies, include:

    1.  The  National Academy of Sciences is being requested
    to give special attention to whether a drinking water stand-
    ard  for  PCBs is needed. Meanwhile, monitoring for PCBs
    in drinking water supplies is being expanded.

    2.  Information concerning the best sampling and analysis
    techniques for PCBs in different media is being assembled
    and  reviewed  to provide guidance to the  Regions, states,
    contractors, and other organizations involved in monitor-
    ing.

    3.  A limited  number of ambient air, water,  sediment,
    soil, and fish  samples are being collected and analyzed
    from throughout the country.   These data, together with
    existing  data,  will provide  an  up-to-date overview of the
    current  level  of  environmental contamination by  PCBs.

    4.  In response to local concerns, several  Regions will
    be measuring PCB levels in effluent streams  from indus-
    trial and municipal sources,  receiving waters,  and asso-
    ciated fish populations to  assist  in relating specific  dis-
    charges  to environmental levels of particular concern.

    5.  Information concerning the  use  and  distribution  of
    PCBs and the  levels of PCBs in effluent discharges has
    been requested from 84 companies which are believed to
    handle PCB compounds or mixtures in their  operations.
    These requests for information have  been made pursuant
    to EPA's authority under Section  308  of FWPCA and Sec-
    tion 114  of the Clean Air Act.

    6.  A special  review of past and recent data to assess the
    carcinogenic potential of PCBs is underway.

    7.  Test data on the chemical properties and potential bio-
    activity of substitutes for PCBs have been requested from
    Dow Chemical and Dow Corning.

    8.  Imported PCBs and polychlorinated terphenyls (PCTs),
    are being analyzed to identify possible contaminants.   In
    additon,   the techniques for detecting  PCBs,  PCTs, and
    polybrominated biphenyls  (PBBs) are being examined to
    determine whether interference among the substances pre-
    vents reliable analysis for any one of them.
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    9.   General guidance for proper disposal of wastes con-
    taining PCBs will be developed.

    10.    The Department of Defense,  the General Services
    Administration,  and other agencies will  be requested to
    review and to amend as  appropriate  their  procurement
    specifications and those of their  contractors  concerning
    the purchase of PCBs and materials containing PCBs.

    11.   Consultations with the Japanese Government are be-
    ing initiated  concerning their experience in implementing
    a ban on the production and import of PCBs.

    12.   Consultations with OECD Governments are continuing
    in an effort to determine the effectiveness of the 1973 De-
    cision in reducing  the  PCB problem on a worldwide basis
    and to encourage expeditious carrying out of the provisions
    of the 1973 agreement.

    13.   Consultations are being conducted with the  Canadian
    Government to inform  them of our information and activi-
    ties concerning  PCB users  in Canada and to coordinate
    future actions.

Reducing Contamination Levels in the Aquatic Environment

    EPA considers  that a PCB  concentration of 1 ppt in the  am-
bient water environment represents an appropriate goal for the na-
tion.  This conclusion  is reflected  in the Water Quality Criteria
which are currently undergoing final  review prior to promulgation.
We would  suggest that this  goal serve as very broad guidance  in
developing strategies  on a nationwide basis  and locally to control
discharges of PCBs into our waterways.

    However,  we are  not  prepared  at this  time to provide more
specific  guidance on the control strategies that  should be adopted
nationally or locally concerning the regulation of individual dischar-
gers.  We  are developing a nationwide strategy  with a significant
component of our approach to be reflected in a toxic effluent stand-
ard for PCBs scheduled for proposal early next year.  At the same
time, we recognize that a nationwide standard might not be adequate
in addressing local problems in some areas, and the control strate-
gies adopted locally may of necessity require an elaboration of the
national approach.

    In any event, we believe  that better information is needed  con-
cerning the specific facilities discharging into the aquatic environ-
ment before reaching a final judgement on a national standard. Also,
it is important to clarify the portion of the PCB contamination prob-
lem which can be attributed to specific dischargers and the practical
feasibility  of reducing the discharges.  As  a key step in this regard,
on August 16, we requested from 84  companies detailed information
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concerning their activities involving PCBs including details on their
uses of PCBs and monitoring data in  the  effluent  stream and in the
receiving waters. With this information in hand, we believe we will
be  in  a  much  better  position  to  develop meaningful regulatory
approaches which take into account the realities of current indus-
trial activities.

The Role of the  Toxic Substances Control  Act

    As I have indicated,  EPA is currently utilizing or preparing to
utilize authorities under the Federal Water Pollution Control  Act
which address the problems of effluent's and spills containing PCBs
in an effort to reduce the environmental levels of PCBs.  Additional
authorities may also be  used if  warranted by  further information
concerning  levels of PCBs in drinking water or  even possibly in
air. However,  each of these available  authorities  has  a limited
focus and none  provides  the most critically needed authority --to
limit selected uses and distribution of PCBs.  Indeed, even with the
cooperation of Monsanto to limit production  as well as  the use of
existing authorities,  it  seems clear that the PCB problem will con-
tinue to persist  in some form.

    Under the pending Toxic Substances Control Act, however, EPA
would have  the  needed authority and could deal  with  the problem
in a far more effective  manner.   In addition to authority to restrict
the production and use of PCBs, the legislation would, if necessary,
enable EPA to require  testing concerning  the  health and  ecological
effects of the proposed  substitutes for PCBs.

    With regard to the  limitations that might be  considered  under
this legislation,   the  1972  Task Force Report  concluded  that there
were appropriate substitutes, presumably  at reasonable cost, for all
non-electrical uses  of  PCB.  We have no information which  would
contradict this  conclusion.   However, we currently are  carefully
analyzing each  PCB  use and the  technological,  environmental,  and
cost aspects  of  possible  substitutes to insure the soundness of the
conclusion.    Also, we are carefully reviewing  the recent develop-
ments concerning substitutes for PCBs in  closed electrical systems
before reaching our final conclusions concerning the extent and char-
acter of limitations that would be appropriate under this  authority.
We are optimistic that  we  will  have  this authority within a  few
months,  but  as  you  know,  further movement  in  this regard rests
with Congress.

    Finally,  one key aspect of the Toxic Substances  Control  Act
should be emphasized:   the authority to review new chemicals be-
fore they are marketed and if  appropriate  require testing or take
steps to  limit the production or  use  if there is reason  to believe
a hazard to human health or the environment might ensue.  This
preventive or "front-end" approach to the control  of chemical haz-
ards would provide a more reasonable and  cost-effective approach
than current  efforts  to correct problems after the damage has been
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done.   Not only would  the public benefit from  the environmental
point of view but also the economic costs to industry would be mini-
mized by  taking actions prior to the  time'major investments would
be made.   It is clear that the past policies of allowing uncontrolled
proliferation of chemicals such as PCBs in the environment, chemi-
cals which have proven to  be  both persistent as well as hazardous,
can no longer be tolerated.

Experience in Japan

    The most  relevant foreign experience in regulating PCBs  has
probably been the recent  efforts  in  Japan where PCBs have been
under governmental  regulation since  1972.  The Japanese Govern-
ment has recently provided us with some  preliminary insights as to
their experience.  The following comments are based on the initial
reports we have received, and  we  plan to obtain more definitive
information in the near future.

    According to information provided by the Japanese Government,
there has been practically no production, import, or export of PCBs
in Japan since  1972.   The only two companies which had been pro-
ducing PCBs in Japan  stopped  production and suspended sales in
early 1972.   One exception has been the production of PCBs for
railroad transformers which was  discontinued in September 1973.
Use of existing stocks of railroad transformers and condensers, but
no new equipment, using PCBs is permitted.  Even this limited use
is subject to the restriction that no discharge of PCBs to the envi^
ronment may  occur. Beginning in 1976,   paper plants will be pro-
hibited  from accepting PCB contaminated paper for recycling and
such plants will  be  required  to build treatment plants which  will
meet general discharge standards.

    Further, we understand that the import of equipment using PCBs
has also been virtually  eliminated as of September  1972, and for
those few products which are  permitted into the country, importers
must cooperate with  the ultimate users to ensure that the compo-
nents containing PCBs are recovered and properly disposed.  Dis-
posal is regulated by the Waste Disposal  and Public Cleaning Con-
trol Law which  was  amended in February 1975 to include  PCBs.
Currently  there are no regulations for  labelling or handling PCBs.

    The present limitations on the use, import, and export  of PCB
are based  on  Article 3  of the Chemical Substances Control  Law
which went into effect  on June 10,  1974.  Any manufacturer  who
wishes to produce PCBs in the future  must apply to the Ministry
of International Trade and  Industry,  although approval of  such a
request is regarded  as  highly unlikely.   The Japanese Government
projects that a total ban on PCBs will take effect in approximately
six to ten years, when  the current  stock of equipment  containing
PCBs is exhausted.

    The Japanese Government has established  PCB  contamination
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limits for fish and shellfish of 3 ppm for near-shore varieties and
0. 5 ppm for ocean varieties.    These limits are derived from, a
basic limitation for hum an intake of 5 mg/kg of body weight per day.
Guidelines first  set in 1973 for water quality and bottom sediment
were revised  in  February 1975  to "not detectable" (less than 0. 5
ppb) for ambient water  and 10 ppm for bottom  sediment.  These
standards are not necessarily permanent standards, since they were
set with current  monitoring capabilities in mind.  Under the Water
Quality Control Law,  the authority used in setting these standards,
penalties are imposed for exceeding authorized limits.   Monitoring
of the water quality  and bottom sediment by each prefecture is re-
quired by this Law.

    We have only very sketchy  information concerning effluent limi-
tations.   According to the reports we have received, the Japanese
Prime Minister's Office Ordinance based on Article  3 of the Water
Control  Law sets the maximum permissible  PCB concentration in
effluents at the point  of discharge into rivers or lakes at 3  ppm.
Coupled with this limitation is a provision  authorizing a penalty for
exceeding the  effluent limit.

    The environmental levels of PCBs in Japan have subsided in the
last two years and are expected to continue  to  diminish.   In a 1974
survey of bottom  sediment including  1789 samples, 14 samples had
PCB concentrations of over  50 ppm,  37 had concentrations of 10 to
50 ppm, and 21 had concentrations of 5 to  10 ppm. In the previous
year,  some PCB levels had exceeded 10,000  ppm; no  such peaks
were found in  1974.  Concentrations of PCBs in the milk of mothers
were down over the previous two years, although 25 percent of the
samples were contaminated in  excess of the prescribed level.

    The Japanese Association  for Disposal  of  PCBs is responsible
along with local Governments for the collection and temporary stor-
age of household electric applicances and other electrical equipment
containing PCBs.  The Association will develop PCB treatment tech-
nology and  treatment plants for disposal, although the latter effort
has been delayed by public opposition to the selection of  proposed
treatment plant sites.

    Substitutes for PCBs that  are currently in use in Japan include
(1) for carbonless carbon  paper, alkyl naphthalene,  alkyl phenyl-
ethane,  (2) for heat transfer, diphenyl,  diphenylether,  alkyl di-
phenyl, alkyl  naphthalene,  alkyl benzene, and mineral oil, and (3)
for transformers and capacitors, mineral oil and silicone oil.

Conclusion

    In conclusion, I would like to stress that  EPA intends to continue
to give high priority  to the problems associated with PCBs.   The
recent data on toxicity and levels of environmental  contamination
have heightened our concerns and have stimulated considerable new
activity.
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    Much is known about PCBs, and much more will be known in
a few months  as our current data collection efforts are brought to
fruition. In recognition of the national interest in the PCB problem,
and particularly the interest  in the Great Lakes area, I am pleased
to Announce that in late fall EPA, in cooperation with other Federal
agencies, will sponsor a national symposium in Chicago  to further
clarify   selected  aspects of the  PCB  problem.   The  State of Wis-
consin herewith receives our first  invitation to participate.
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     PROGRAM OF THE OFFICE OF TOXIC SUBSTANCES IN
   RELATION TO MICROCOSM METHODOLOGY DEVELOPMENT
        AND THE OTS  ECOLOGICAL EFFECTS PROGRAM

                        .Delivered by
                        Carter Schuth
             Chemist,  Chemical Testing Branch

                            to the
            Meeting on Substitute Chemical Program
          Fredericksburg, VA -- July 30-August 1, 1975
    Good morning.   I'd like to  thank  the Office of Research and
Development and the Office of Pesticide Programs  for this oppor-
tunity to advertise the environmental fate and effects  testing pro-
gram of the Office of  Toxic Substances.   As you  may know, the
several  versions of the  Toxic  Substances Control Act  currently
pending in  the  Congress  all have  provisions  for EPA to require
certain types of test data  from industry on chemicals and chemi-
cal classes in order to determine if a chemical substance presents
an unreasonable  risk to health or the environment.  The  task for
us  is thus not the  testing  of chemicals,  but  the  description and
interpretation of adequate test methodologies -- the results of which
will serve as bases for decision-making as to the need for regula-
tory action by  EPA.  I would like to discuss with you this morning
the part of our program  which  is directed toward environmental
fate and effects  testing.   This  is spelled out on the first  slide.
"The Office of Toxic Substances: Objective:  Evaluation and Demon-
stration of Methods for Environmental Testing of Chemicals. "

    As an aside,  let me elaborate a bit on the  significance of envi-
-ronmental fate and/or effects.   For reasons which are  probably
best described as bureaucratic or for the sake of  simplicity and
organization,  we  tend  to deal with fate separately  from effects --
especially in  the  discussion which is  to follow.  More  emphasis
seems to be placed on fate in  our  program at this  time.   This is
due to our feeling that an understanding of environmental fate is
essential in arriving at some estimate of the probability of observ-
ing (and causing)  environmental and human health effects,  (i.e.
exposure).   A  need  crying to be filled is the development and
demonstration of reliable and simple screening techniques for these
effects. Bear in mind that Bob Metcalf's original idea was to devel-
op in his model  ecosystem  an (if you will) 'Svrhite rat" for the envi-
ronmental toxicologist as an appropriate laboratory model.   It is
not sufficient to estimate  fate  without  some attention to  possible
effects.    I would strongly encourage  the behavioral  work  of the
Gulf Breeze lab and others as a promising enterprise.  In addition,
I'd  like to pass on a  comment  brought to my attention   by John
Buckley.   We can all collect reams of data from any given model--
but as regulators and the regulated  what is the information we need
and, very importantly,  what is the information  we don't need?
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    Now, to return  to  my  topic  -  I  wish to  discuss with  you the
environmental testing activities of OTS.

    In support of this objective is a contract effort involving three
separate but  related activities--as seen on the next  slide:  Meth-
odology assessment; demonstration projects; and chemical-  orprob-
lem-specific information services.   Whereas I want  to concentrate
my comments on the second topic, I will briefly make  mention of the
other two.   A number of methodology assessments have been com-
pleted or are in the final stages of completion.   These are state-
of-the-art  reviews involving a comprehensive literature search and
review, interviews with specialists in the various fields, and evalua-
tions by the  contractor as to the usefulness and convenience of the
test methodologies.   The six  topics on the next slide comprise  a
listing of the reports that have been undertaken by  this program.
Most have  been completed and are available through the National
Technical Information Service in Springfield, Virginia.  I have pre-
pared a handout with the  exact title,  an abstract,  and information
on ordering the reports.   If there are insufficient copies of this for
those who are interested,  I will be glad to mail this information
to anyone who gives me  his or her name and mailing address at
the end  of this  session.   In addition to information on the meth-
odologies for determining the environmental fate of chemicals, we
are sometimes  interested in knowing what information is available
on the fate or effects of specific chemicals.  We are also interested
in keeping  abreast of  current developments  in the various meth-
odologies.    For these services, we turn to  task  order contracts
which can produce information and reports on a very short schedule.
The next slide lists several reports under  the category of chemical-
specific information services.  This information is  gathered from
the published literature,  scientists working  the  field, and  educated
guesses on the part of the contractors.  To date we have investigated
the environmental fate of six carcinogens  (as  defined by OSHA) and
benzene.   Ongoing are studies of the environmental fate of poly-
nuclear aromatic hydrogens, including some nitrogen heterocycles.

    I'd like  to turn now  to the part of our program that involves
model systems  directly.   The studies listed  under parts  A and  B
have been started under  FY 75 funding. The third category is pro-
posed for this year.  Among the many criticisms of laboratory models
for determing environmental fate and/or  effects is  the recurring
charge that we  know very little or nothing about the reproducibility
and variability of the various systems. In  response to this,  we have
undertaken the  two studies shown in part A.   Dr. Thomas  Johnson
of the Fish Pesticide Laboratory in Columbia,  Missouri has  been
working for  several years on what he has called a "modular food
chain.'  This model system appeals to us as being relatively uncom-
plicated, inexpensive, and indicative of actual environmental condi-
tions.   I  needn't mention that  concentration of toxicants in food
chains is of primary concern to EPA. In orderto assess the modular
food chain's  utility in a regulatory mode,  we  have signed an inter-
agency agreement with the Department of the Interior for the Fish
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Pesticide Laboratory to  investigate the reproducibility and varia-
bility of the modular food chain using  four chemicals and various
concentrations of these chemicals.   By analogy,  the model terres-
trial-aquatic ecosystem first described by Metcalf et al.  has been
met with less than universal acceptance. We have signed" a contract
with the Illinois  Natural History Survey to undertake a study of the
reproducibility of that model  using the same four compounds.  In
this way, we hope to get good comparisons of each  system.  The
intent in this project is to better understand the two systems rather
than generate new information about potentially  hazardous chemi-
cals.   In  fact, it can be viewed  as the  study  of two  simple and
inexpensive systems  using "Benchmark" chemicals.  In addition to
studying the reproducibility of  each  system with respect to  the same
chemicals,  we are interested in assessing the utility of each system
with respect to certain  types  of  chemicals.   So, we  have set  up
criteria for the selection of chemicals in order to achieve this com-
parison.  We wish to look  at compounds  which display a range of
C-14 isotopes as well as being well-characterized  as  to possible
metabolities. We have selected decachlorobiphenyl, hexachloroben-
zene, di-2-ethylhexyl phthalate, and atrazine.

    In addition to wanting information on the  reliability of the simpler
models, we ask  ourselves  what  can  they tell us about the "real
world. "  Dr. Howard Johnson of the Michigan State  University has
signed a contract to study the fate and effects of two of the previously
mentioned chemicals in model stream communities.   These model
streams have been set up  in  a converted fish hatchery in  Paris,
Michigan.   They are supplied with communities of  organisms and
pristine water from a stream which has been diverted  to flow through
the concrete channels in the hatchery.  Dr.  Johnson and his staff
will determine the fate of the chemicals in the various trophic levels
of the model streams as well  as  observe  effects of the chemicals
on the  organisms.   Our  rationale in selecting the model streams
involved the belief that field  studies are both  very difficult and
expensive.   Analogies of the model stream results and monitoring
data will be possible and will  be useful in validation of  our models
and the environment we strive  to protect.

    It is our intention as regulators to require of industry only the
necessary information on its products that is needed for responsible
decision-making. It has been  suggested to us that these model sys-
tems are too complicated and that the measurement of simple physi-
cal and chemicals parameters gives the same information. This is
an area that we are now investigating and feel sure will fit into the
program that I've described  to you this morning.

    The last category encompasses the utility of physical and chemi-
cal parameters  to indicate the environmental fate and transport of
chemicals.   As we discussed  yesterday, these numbers are useful
                              103

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in the utilization  of  models being  developed as well  as  for com
parisons with "known" compounds.

    Thank you for your attention.
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               OFFICE OF TOXIC SUBSTANCES

OBJECTIVE:  Evaluation and demonstration of methods for environ-
              mental testing of chemicals

Contract Efforts in Support of Objective;

    1.  Methodology Assessments
    2.  Demonstration  Projects
    3.  Chemical- or Problem-Specific Information Services

    Methodology Assessments

       a.  Survey of Industrial Test Practices
       b.  Persistence  and Routes of Degradation of Chemicals in
           the Environment
       c.  Transport  of Chemicals in the  Environment
       d.  Methods to Assess the Effects of Chemicals on Terres-
           trial Animal Species
       e.  Methods to Assess the Effects of Chemicals on Plants

    Demonstration Projects

       a.  Reproducibility and Variability
              Modular Food Chain
              Model Ecosystem

       b.  Validation  Studies
              Model Stream

       c.  Physical-Chemical Measurements
              Octanol/Water Partitioning Coefficients
              Water Solubility
              Vapor Pressure

    Chemical- and Problem-Specific Information Services

       a.  Environmental Fate of Selected Carcinogens
       b.  Benzene:    Environmental Sources of Contamination,
                        Ambient Levels, and Fate
       c.  Environmental Fate of Selected PNAH's
       d.  Environmental Fate of Selected Aza-arenes
                              105

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            Environmental Fate and Effects Testing
              of the Office of Toxic Substances

Contracting Efforts;

I.   Methodology assessments

    A, Industry Survey  of Test Methods of Potential Health Hazard

    Nine companies selected as representing a cross section of pro-
minent producers of chemicals were surveyed with respect to meth-
ods used to assess  toxicological and environmental  properties  of
new and  existing chemicals.   Four progressive  levels of investi-
gational  effort depending upon extent,   frequency,  and  nature  of
chemical use are identified:   1)  Single or  infrequent exposure  --
Acute and irritation tests, 2) Occasional low-level  exposure -- Short-
term  repeated dose,  sensitization,  fish and bird studies,  3) Fre-
quent low-level, occasional high-level exposures --Teratology, muta-
genicity, metabolism, biodegradation, environmental transport stu-
dies,  4)  Frequent high-level,  general consumer,  unavoidable expo-
sures -- Reproduction, lifetime, carcinogenic,  environmental fate,
food chain studies.   Factors influencing the  decisions regarding the
level(s)  of investigation needed or  the  initiation of the next higher
level  series  of  studies  are explored.    A   chemical-by-chemical
assessment by competent pharmocologists,    toxicologists,   and
chemists is still needed.  Lack of a mechanism to trigger expanded
levels of testing is a serious problem.

    Available through National Technical Information Service (NTIS),
Springfield, Virginia  22151; Accession No.  PB 239-840

    B. Review and Evaluation of Available  Techniques for  Deter-
       mining Persistence  and Routes of Degradation of Chemical
       Substances in the Environment

    This report reviews and evaluates the present state of techniques
which have been used to determine the environmental persistence
(biological,  chemical and photochemical degradation)  and  routes
of degradation of chemicals released in the environment  by human
activities.   The techniques that were identified were reviewed and
then evaluated for  their ability to  simulate  natural environmental
conditions,  convenience of procedure,  time requirements,  neces-
sary  equipment  and reproducibility.  The ultimate evaluation was
based on how well the methods have worked with well-known environ-
mental contaminants.  A cost analysis of the test methods was under-
taken to  determine  the feasibility  of comprehensive  screening  of
chemicals  for environmental  persistence.   A  relationship between
chemical structure and  environmental persistence  is presented and
some theoretical grounds  for such  correlations are discussed.  An
attempt has been made to categorize chemicals for their  suitability
to various  test methods based on consideration  of physiochemical
properties,  toxicity, environmental release factors, and commercial
                              106

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economic factors.

    To be available through NTIS soon.

    C. State-of-the-Art and  Recommended  Testing for  Environ-
       mental Transport of Toxic Substances

    In progress.

    D. Laboratory Test Methods to Assess  the  Effects of Chemi-
       cals on Terrestrial Animal Species

    This report presents a review of test species and methodologies
utilized in toxicological research on terrestrial animals.  It involved
an extensive survey of available literature, interviews with  toxicolo-
gists, physiologists,  and ecologists,  and visits to research  facilities
around the country.   The report  contains reviews of each major
animal group  and individual species (where specific information was
available) that have  been used as test subjects  in past or present
toxicological  research programs.    Suitability for use in such test-
ing, both actual and  potential,  and general  information relative to
laboratory maintenance and possible alternative species is presented
for each group.  Brief synopses of general characteristics for each
group and/or  species are also included.   Existing methodologies
used in toxicological  research are discussed and evaluated for their
particular applicability to testing programs and general recommen-
dations for approaches to toxicity testing,  test animals, and methods
are made.

    Available  through NTIS,  Accession No.  PB-241505/AS  $12.00

    E. Test Methods  for  Assessing the Effects of Chemicals  on
       Plants

    The purpose of this  report is  to indicate suitable test species
and methods for the determination of toxicity on plants.  Plant expo-
sure to air,  soil, and water contaminants have been considered.
The loss of a volatile compound into  the atmosphere in the form
of a gas or aerosol during manufacture may indicate a potential  haz-
ard to plants via the vapor phase, thereby necessitating air  pollution
testing.   Material was obtained both from published literature and
unpublished sources.  Many knowledgeable members of the scienti-
fic community were interviewed.

    To be made available through NTIS.

II.  Chemical- and Problem-Specific  Information Services

    A. Review of the  Environmental Fate of Selected Chemicals

    A search of the scientific literature and evaluation of such liter-
ature on the environmental fate of the following compounds  has  been
reported:  benzidine  and  its salts; 3, 3'-dichlorobenzidine; 1-naph-
                             107

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thylamine;    B-propiolactone; 4, 41 ^methylenebis(2-chloroaniline);
ethyleneimine;   and   bis(chloromethyl)ether.    Some intelligent
guessing based on structural  analogies for the chemicals is made
where little information was available.  These chemicals are known
carcinogens but little is known of their environmental fate.  Empha^
sis is placed on reporting or estimating kinetic values for potentially
important pathways of degradation.   In cases where no data were
available, independent calculations for free radical reactivity were
made.

    Available  through NTIS;  Accession  No.  PB-238908/AS  $3.75

    B. Benzene: Environmental Sources of Contamination,  Ambient
                 Levels,  and Fate

    This report reviews and  evaluates available information perti-
nent to an assessment of benzene contamination of the environment.
Benzene losses from commercial (production  and use) and non^
commercial (automotive emissions and oil spills) sources are con-
sidered.  It is estimated that of the total  quantity  that is released
to the environment, more than half results from motor vehicle emis^-
sions.  Monitoring data somewhat support this contention.   Avail-
able information on the environmental persistence of benzene
gest$ that it degrades slowly.

    To be made available through NTIS soon.
                              108

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             COST/BENEFIT CONSIDERATIONS AND THE
                TOXIC SUBSTANCES CONTROL ACT

                         Delivered by
                        Edward M. Brooks
                Chief, Special Projects Branch

                            to the
Critical Items Workshop on  Cost/Benefit Techniques of Hazardous
       Materials,  Toxic Substances,  and Solid Waste  Control
              Holiday Inn, Tysons Corner,  Virginia
                        June 23, 1975

    Good Morning.  The agenda calls for me to discuss a number of
issues which  presuppose an  ongoing  Toxic  Substances  .Program.
Since my office, unhappily,  continues to function without enabling
legislation I'll depart somewhat from the  prescribed format and,
instead, highlight those provisions of the proposed Toxic Substances
Control  Act most pertinent to  Cost/Benefit analysis and briefly
discuss one of the more challenging aspects.   If time permits,  I'll
also share with you my reasons for  doubting -- regretfully -- that
cost/benefit  analyses  will   ever  significantly inform  or  direct
Federal health-related rulemaking,  and point  out that while these
reasons seem  to  preclude the  application  of cost/benefit analysis
in this area they also illustrate the urgent need for such application.

    There are four bills presently under consideration. The. Senate
Commerce  Committee has  held hearings  on  S.  776 -- the most
recent version of which is a Staff Draft Working Paper dated June 6.
There are three bills in the  House.  The Eckhardt bill is the major
one and is reasonably close,  I understand, to the  Senate version.
William Brodhead has introduced a bill favored by Labor and Envi-
ronmentalists, and  John  McCollister  has  introduced one  favored
by Industry.   I will treat with the June 6  version of S.  776 --in
part because it is the most senior of the four,  but mainly because
it is the only one I've read.

    Some of you may expect comment upon two highly publicized,
widely discrepant, projected annual costs of implementing this Act --
one prepared by EPA (estimating $110 million) and one by the Dow
Chemical Company  (projecting a  $2 billion  tab).    I will  discuss
neither of these efforts because  I consider both too speculative to be
relevant to our concerns here.

    Turning to  S.  776,  let me  first point out the bill's concern,
stressed throughout,  with cost/benefit considerations. The opening
"Policy" statement,  after declaring  that adequate authority should
reside with EPA to regulate chemical substances,  then goes on to
state:

   "Such authority should be exercised in such a manner as
    to  assure  technological  innovation and commerce  in
    chemical  substances  and products  containing chemical
    substances are not unduly impeded ..."
                              109

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 This is not empty language.   Both major authorities vested in EPA
by this Act --to require risk assessment data from manufacturers
 of specific chemicals, and to prohibit or restrict such manufacture --
 are substantively linked to the concept of "unreasonable risk" which,
 in turn,  is ejqplicitly defined to mean:

   ". .. any risk associated with the manufacture, processing,
    importation, or  distribution in commerce for a specific
    'purpose if such risk outweighs the benefits. "

        There are four significant authorities vested in EPA by this
 bill to which cost/benefit considerations are clearly relevant:

     1.  to require  risk  assessment  data  from the producers
        of chemical substances;

     2.  to screen new chemical substances prior to permitting
        their production;

    3.  to regulate hazardous chemical substances; and

    4.  to require reports from producers regarding the nature,
        volume of production,  and use of the chemicals pro-
        duced.
        >•

    The authority to require risk assessment data from producers is
 perhaps  the most  important.   Section 4 directs the Administrator
 to prescribe "criteria for data development"  to assist in determining
 whether1 the production 67specific chemical substances  poses an
 "unreasonable risk".   EPA is to promulgate such criteria, within
 two years of enactment, for each of the 300 substances it considers
 potentially most   hazardous.   Thereafter producers must develop
 and submit whatever data  are necessary to satisfy these criteria.
 EPA's authority  here is broad.  It  may specify both  the adverse
 effects of concern -- selecting any that may cause an unreasonable
 risk -- and the particular methods and tests to be used in generating
 these data.

    In addition to specific  criteria for particular substances,  EPA
 must prescribe comparable but generic "criteria", to be applied to
 all new chemical  substances,  and to substances for which  a signifi-
 cant new use is proposed.  It is in connection with this authority
 that EPAis empowered to screen chemical substances prior to their
 manufacture or introduction in commerce. These generic "criteria"
 are to be promulgated within one year of enactment, and anyone pro-
 posing to produce a new chemical  substance thereafter must submit
 the required  risk assessment data, within the prescribed format
 and satisfying  the criteria, at least 90  days prior to commencing
 production.   The  Administrator then has three options within that
 90 day period:

     1.  he may  take no action,   in  which case the proposed
        production may commence at  the  end of  the 90  day
        period;
                                  110

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    2.  he may promulgate a rule prohibiting or restricting the
       proposed production; or

    3.  he may,  if  he deems more or  different information
       desirable,  issue an order  temporarily continuing the
       prohibition on the proposed production until such time
       as EPA promulgates a new rule revising the relevant
       "criteria".   The proposed  activity then remains pro-
       hibited until the new  rule  is promulgated, new data
       satisfying the new criteria are submitted, and  either
       the 90 day  review period has lapsed or a restrictive
       order has been issued.

    Section 6 of the bill authorizes EPA to regulate hazardous chemi-
cal substances.    Whenever  the Administrator concludes that any
chemical substance (new or existing)  other than a pesticide, drug,
food or tobacco product presents an "unreasonable risk" which can-
not be adequately handled under other Federal laws, he must pro-
mulgate  a  rule  regulating that substance.  Again, the options are
broad.   The rule may flatly proscribe production or use of the sub-
stance;  limit the  amount  or concentration that  may be; produced;
prohibit  or limit particular distributions or uses; or prescribe con-
ditions --  including labeling  and providing instructions for use or
disposal  -- .under  which  the substance may be manufactured, pro-
cessed,  imported or distributed.

    Finally,  Section 8 would  enable EPA to require  any producer
to maintain  whatever  records and  submit  whatever  reports the
Administrator deems necessary, including:

    1.  the trade name, chemical identity, molecular structure
       and location of manufacture of any chemical substance
       produced;

    2.  the uses  to which such substances are put;

    3.  the amounts produced;

    4.  the number of workers exposed, and levels of  expo-
       sure;  and

    5.  any health  or safety data regarding the  chemical sub-
       stance that is being, or has been, produced by or for,
       or is known to, the producer.

    That  summarizes the relevant provisions of the Act. The cost/
benefit implications of both the reporting and  regulatory require-
ments  regarding existing chemicals seem relatively straightforward.
In both cases the costs and benefits are known or, at least theoreti-
cally,  ascertainable.   These authorities are, in this respect, com-
parable to rulemaking under most  provisions of the Federal Wster
Pollution Control Act,  the Clean  Air  Act, the Marine  Protection,
Research and Sanctuaries Act, the Occupational Safety and Health
Act, or the Consumer Product Safety Act.
                              Ill

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    The wicket is a bit stickier regarding the screening and regula-
tion of  new substances.   First, in assessing the implications of
regulating substances that have yet to be manufactured we are nec-
essarily reduced to estimating what might be  (with respect to both
costs and benefits) rather than measuring wfiatis.  This immediately
introduces  levels of uncertainty into the analysis which  can soon
lend an Alice-in-Wonderland quality to the exercise.

    A second problem is the relatively unspecified and open-ended
nature of the  proposed  premarket  screening process.    As noted
above, the procedure calls for the Administrator to (1)  establish
the groundrules for developing and submitting risk assessment data,
(2)  receive and  evaluate the submitted  data,  (3)  if deemed nec-
essary,  continue indefinitely the prohibition on production in order
to change the groundrules to obtain more or better data,  (4) carry
out a formal rulemaking procedure to modify the groundrules,  (5)
evaluate the new data  generated and submitted in response to  the
new groundrules, and (6) conceivably prohibit, and probably restrict,
the proposed activity on the basis of that evaluation.  The inherent
uncertainties  in  this process will certainly affect -- to a largely
unknowable extent -- industrial  research and development commit-
ments.

    In this situation,  moreover,  the benefits of rulemaking may be
overestimated while the costs go unrecognized.

    Benefits will tend to be exaggerated because of the invariable
tendency to make  "worst case" assumptions in the process of assess-
ing risks in a health-related rulemaking situation --in order to err,
if at all, on the side of  "safety". While  reasonable men may differ
as to the  propriety of this tendency it is,  I believe,  an ineluctable
aspect of health-related rulemaking.   Popular opinion to the con-
trary notwithstanding,  bureaucratic careers seldom founder on the
shoals of too much solicitude for human  health. Once these "worst
case" assumptions have been  formalized in a "Criteria Document"
justifying and providing the rationale for a rule, the hyper-conserva-
tive nature of the premises tends to be forgotten or ignored, and the
"benefits" --thosehighly theoretical lives saves -- become reified.

    In contrast,  the significant  costs may not even be recognized --
much less weighed in the balance -- simply because history doesn't
reveal her alternatives.   Cost/benefit analysis can  be  reasonably
expected  to crank in the costs of  not producing those goods that
are explicitly prohibited or restricted by rule.    A more serious
problem,  and  one largely ignored,  is the cost associated with not
producing goods  as a consequence,  not of  explicit prohibition,  but
of the dampening effect upon industrial  research and development
due to the increased costs and  risks created by  the uncertainties
in the rulemaking process described  above.  Research efforts not
undertaken, and  goods not produced,  are not missed and are there-
fore not treated as costs.

    A dramatic example of this problem is presented by Sam Peltzman
in his study, Regulation of Pharm ac eutic al Innovation; 1962 Am end -
                              112

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ments,  in a discussion of hidden costs in  the Food, Drug and
metic Act.

  "The unequal emphasis placed on  the  benefits and costs
    of risk taking may be explained,  if not excused, by the
    contrast between the anonymity of the beneficiaries and the
    visibility of the victims.   A recent example,  taken from
    Wardell,  illustrates  this point.   He  cites the case of a
    benzodiazepine hypnotic  (nitrazepam)  which was approved
    for marketing in the United States in!971, but was available
    abroad five years earlier.  One advantage of this drug over
    other hypnotics is its safety in overdosage.   From data
    on foreign market penetration of nitrazepam,  and U.S.
    deaths from overdosage from hypnotics, Wardell concludes
    that the 5-year delay in U.S. marketing cost  over 1,200
    lives.  Since  three times that  many die  from  hypnotic
    overdosage, the specific identity of the victims of this de-
    lay will never be known.

    If Wardell1 s data are anywhere close to the mark, this one
    obscure incident has cost more lives than the widely publi-
    cized chloramphenicol tragedy.    Wardell  concludes  that
    "introduction of a new drug that  produced fatalities any-
    where approaching this magnitude would be regarded as a
    major disaster,  but the undoubted  occurrence of deaths
    through failure to introduce a drug has so far gone un-
    remarkecFI   It  is this fact, rather than the  particulars
    of the case, that should temper optimistic appraisals of
    current regulatory policy. "

    In this  respect, the proposed provisions for screening and regu-
lating new  chemicals under  the Toxic Substances Control Act are
similar to  the Food, Drug and Cosmetic Act and to some provisions
of the Federal Insecticide, Fungicide and Rodenticide Act -- first in
that the assessment of costs and benefits, because they necessarily
depend upon an estimation of the consequences  of prohibiting or not
prohibiting an  activity that ,has not yet occurred, is an uncertain
exercise at best; and secondly in that the relative ease of appreciat-
ing the benefits of regulation  contrasts sharply with  the difficulty
of even discovering the costs.   This is particularly so when those
costs involve a gradual, cumulative disinclination to develop,  manu-
facture and/or  market new products in the United States.

    While this is an extremely difficult problem it is one that should
concern anyone interested in the cost/benefit equity aspects  of health-
related rulemaking  --  because it  is  in this area that over zealous
regulation  can do the most damage.
                             113

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     ENVIRONMENTAL ASPECTS OF CHEMICAL USE IN
             WELL-DRILLING OPERATIONS

                         Delivered by
                     Farley Fisher,  Ph.D.
                Branch Chief for Early Warning

                            to the
Conference on the Environmental Aspects of Chemical Use in Well-
                    Drilling Operations
              Houston, Texas -- May 21-23,  1975
Opening Comments

     Good morning to you  all.   I would like to welcome you to  the
conference on the Environmental Aspects of Chemical Use in Well-
Drilling Operations sponsored by the  Office of Toxic Substances
of the Environmental Protection Agency, and  arranged by the Re-
search  Triangle Institute for us.

     I am  Farley Fisher; I am the chief of the Early Warning Branch
of the Office of Toxic Substances of the  EPA.   I would  also like to
introduce Mr.  Frank  Ayer from RTI,  the conference coordinator;
he is largely responsible for the arrangements we have  here today.
Mr. Ayer and Mrs. McGuffey,  his assistant, are available to assist
you with any problems you may have.

     In addition, before we start, I would like to introduce at least
three of your session chairmen so that you will know them.  James L.
Lummus, Amoco  Production Company, is going to  be  our session
chairman today.   Dr.  C.  S. Giam of Texas A & M  University will
serve as chairman Thursday.   And Dr. Albert J. Fritsch, Center
for Science  in  the Public Interest,  will be our session chairman
on Friday.

     The purpose of this conference is to explore what is known about
the environmental effects  of the techniques and chemicals used in
various types of well-drilling operations.  I think that  as  the pro-
gram develops it  will be  clear  that the heaviest emphasis  is on
drilling of  oil wells,   but it is not  our intention to neglect  other
types of wells.  And it certainly is not inappropriate  for persons
to raise points dealing with wells other than  those  --  brine wells
or sulfur  wells, for example.

     We do want to talk somewhat about the  commonality of technol-
ogy, and  also about the distinctions in  technology between various
types of well-drilling operations.

     I hope that we have a  diversity of viewpoints represented, and
I hope that everybody will  feel by the time  we are through that they
have had an opportunity to  air their views.
                               115

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    It is not our intention at a meeting of this type to try to resolve
any of the issues which may come up, but rather merely io get them
out in the open,  so  that  they  can  be discussed further in private
or in other  fora, with the hope that within a relatively short period
of time  we  may  decide which are  real issues  and which are not,
and for  those  that  are  real  issues,  decide exactly what can  be
done to  help alleviate the problem.

    The topics to be  covered in the conference cover a very wide
range.   We are  going to talk about well-drilling techniques that
are used, and in some cases techniques which are proposed for use.
We are  going to  talk about disposal problems with  spent muds.
We are  going to  talk about ground water contamination, which is a
real bugaboo.  And we are going to talk about regulatory attitudes,
what kind of regulations exist now,  and exactly what effect they are
having,  good or bad, and several other items as well.

    Now, one can  say>  "Why in the world  are you looking at this
problem?"  or "Why are you looking at this area?   We  do not think
it is a problem,  and  after all,  the environment  is in  pretty good
shape.  The States  of Texas and Oklahoma  have not fallen into the
sea yet, despite the fact that people said they would. "

   , The answer  to that  is  that we are not sure things are quite as
good as we  would like.  You  do hear stories,,  from time to  time,
about aquifers being contaminated, about vegetation being destroyed,
and various other  things which  could or could not be a result of
well-drilling practices.

    There are some very serious problems of which we are only
starting to  become  aware in a national  sense, although they have
been the focus of individuals' concerns for many years.

    There is the question of ground water contamination, which is
a very serious thing, especially from the point of view that once
it has occurred there is really very little we can do to reverse it,
and that there is  frequently a very  long lag  time  between the event
causing the  contamination and the actual appearance of the contami-
nation.

    There is the question of the disruption of marine ecosystems,
which has received  up to now considerably more attention than the
ground water, and which is, once again, something we do not  really
understand very much about.

    So we feel that there are very real questions.   We do not know
that the answers to those are and we are not pretending we  know
what the answers are.  We hope that what transpires here  in the
next 3 days  will bring us a little closer to those answers.

    People  will also say, "We are in an energy crunch.  The gov-
ernment  is  supposed to  be encouraging people to drill more  oil
                             116

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wells, drill geothermal  wells, and so on. You people want a brake
on this whole operation."  And the response to that, which I really
consider to be a rather  childish objection, is that we are not trying
to put a brake on anything.  Our concern is to see that what is done
is done in as environmentally  sound a manner as possible.

    No matter how serious we think our current neeeds for oil are,
they pale when compared with ourr ultimate need for water.   And
we would be making a very drastic mistake if we decided to trade
off oil in the short term for water in  the long term.    This is the
kind of mistake we simply cannot afford to make.

    It might be appropriate for  me to spend just a few  words on
what we are not intending to discuss here.   We have designed this
conference around the operation of drilling and installing a well.
It is not  our intention here  to  get into  problems associated with
accidents or improper operation of a well.  In other words, we are
not going to get into the subject  of oil spills  or gas ruptures, sub-
jects  which have  been  treated in considerable depth at other meet-
ings,  and of which many people are well aware. .  In order to con-
centrate on what  we came here for, I would ask that we try to avoid
getting sidetracked on matters of this type.

    I am very  happy to  see you all here.  I am looking forward to
a very profitable and educational 3 days, and I hope you are doing
the same.   Success of  that  will depend very much  on  all of you
feeling free to contribute what  you have to contribute to the dis-
cussion as  it progresses.
                              117

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                   CONFERENCE SUMMATION
    I would like to make a few acknowledgments. First, to  Mr. Frank
Ayerand his staff at the Research Triangle Institute for their work;
to our  session chairmen, Jim Lummus, Dr. Giam^ Pat Wennekens,
and Al Fritsch for  their help and cooperation; to the army of you
who spoke  at this symposium.  I certainly learned  a lot from you
and hope everybody else here did the same.   To a few people who
were not quite apparent who  were a great help  to us and, in some
respects, instrumental in bringing this program together, the Texas
Mid"-contment Oil  and Gas Association,  especially George Holliday
and Frank  Wheeler,  and also the National Water Well Association
and Jay Lehr; these people were extremely helpful to us in locating
and corralling people to present  papers  here at this conference.,
And, also,  to the Shamrock Hilton for their facilities and the help
of their staff.  And,  finally,  but perhaps  most importantly, thanks
to all of you who participated from the floor, raised a lot of questions
and good points,  and kept a lot of people honest.   What we were
trying  to do is get  a  lot of things out and  I think we have done that.

    There are a few things which might be worth saying.   I am in
a job of trying to  find where the,  bones are  buried in the pollution
business. I know that makes me very unpopular with ,a .lot of people;
they'tend  to look at me as kind of a prosecutor or witch hunter.pr
something.  But let me say that we have real, environmental problems
and we really do not have to go around inventing new ones.

    I think  we have had a  lot of very good discussions here.  I am
inclined to  agree  that we  did not really  see  any data that caused
anyone immediate alarm. There were some if's and but's and may-
be's.   Maybe some of these need to be looked at further.   I am not
going to discuss them because  I have to  ruminate on them before
I decide things like that,   ljut  on the whole,  I think we are finding
an industry which,  at least,  knows what  good practice is.  And I
hope it is working hard to attain it.  There seems to be a case to
EPA for not butting in on this matter. The States and the Geological
Survey, seem to be  pretty much on top  of  this  field,  doing their
best to regulate it.   One has to wonder  why we need another  bull
in the arena.

    I was also struck by a couple of other things.  One is that we
avoid accepting simple answers to what are complex questions.  And
I must say, I am not  sure what an LCso  on  trout means in terms
of environmental damage. lam not sure I would want to say anything
regarding safety or danger on the basis of a test like that.  Environ-
mental harm is much more complex than  killing a few trout.   And
I think that we cannot hope in the near  future to invent a few very
simple things that we can do and get  a  magic answer that says:
"Yes,  this is safe;  no,  this is not safe."  We are going to have to
take chances for a long time to come.    And we are always going
to have to watch what we do, especially when we start doing some-;
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thing new.

     This, of course,  is not an excuse for not being careful about the
new  things that we do, and  not trying to reason ahead about what
their implications might be.  Which leads to another point; namely,
that  we must also remember that theory is no substitute for experi-
ment and  experience.  The fruit  of the pudding is in the eating.
If the ground water is drinkable even after years arid years of drill-
ing in an area,  there is a very good argument for the fact that the
practices used in drilling were not upsetting the water.

     However, we are drilling in new places all the time.   And it is
certainly true, as many of you  have pointed out, that we are using
new  techniques all of the  time.   So the fact that we did things right
50 years ago  does not mean that  we are doing them right today.
So we do have to be on the lookout and be on our guard.

     I hope all  of  you have  found  this meeting as stimulating,  as
interesting, and as informative as I have.   I  want to thank you for
your patience.

     At this  point I will throw the floor open for some general dis-
cussion if anybody wishes to  make some closing comments.
Mr. Robert B. Allred (Sun Oil Company,  Richardson, Texas):
    ronmental Canada, I just want to point out one thing.  I would
    not drink concentrated  sodium hydroxide.   I  would not  drink
    concentrated hydrochloric acid.  However, if they were mixed
    together at the proper end -points, I would gladly  drink them.

Mr.  Dennis G.  Wright (Environment Canada,  Winnepeg, Manitoba,
    Canada):  Point taken.  Granted,  there are a lot of common
    everyday chemicals and  things that occur naturally in the earth
    that are  used in drilling fluids.   But  there are also an awful
    lot of synthetic materials that are used as well.

Mr.  Allred;   But  give  them mixed together, do not give them indi-
    vidually.   I do not use an individual mud.  I use a mixture of
    things for the mud, not the individual products.

Mr.  Wright;   Right.  But when you are looking at that,  how can you
    separate the effects  of  a thinner  or disperser,  for example,
    from potassium chloride or caustic or something like that ? You
    cannot do that in the hole mud.  You have to do it individually.

Mr.  Allred:   But the environment does not come in contact with
    lignosulfonate, for instance.   The lignosulfonate goes into the
    clays and to the other chemicals.   It is not sodium chromium
    lignosulfonate anymore.  It has changed.

          And as the good doctor pointed out, you put the pressure
    and heat in that oil well and you  have got a good kettle for a
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    lot of things that come out.   And  some of them, I might point
    out,  may be worse than the  individual materials themselves.

          So look at it like it is. I just do not dump caustic in water;
    it is mixed in the mud.

General  Chairman Fisher;   I thank you.  And this conference is
    now  adjourned.
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        RISK ANALYSIS AND SETTING STANDARDS FOR
                   CHEMICAL CARCINOGENS

                        Delivered by
                   Michael J. Prival, Ph.D.
             Acting Chief,  Chemical Testing Branch

                           to the
             Washington Statistical Society Meeting
               Bethesda, MD -- April 23,  1975
    A brief  review of some recent Federal actions relating to the
control of chemical  carcinogens may  help to put into perspective
the usefulness of  statistical extrapolation of risk.   I will  restrict
my discussion to carcinogens,  although the methods for risk extrap-
olation which have been discussed today may be applicable  to other
toxic effects as well.  A discussion of the diverse methods by which
Federal  agencies  have regulated chemical carcinogens should make
it clear that the usual regulatory response to a newly  discovered
carcinogen is confusion. Statistical approaches to risk analysis may
help us to find  our way out of this confusion,  but so far they have,
if anything,  only been a part of it. This is not because the methods
are not valuable,  but rather  because we have not yet learned what
their value  is and,  more  importantly,  what their  limitations are.

    Any discussion of Federal regulatory policy on carcinogens must
begin with the Delaney clause of the Federal Food Drug and Cosmet-
ics Act. This clause states that chemicals which meet certain criter-
ia of carcinogenicity cannot be used as food additives.  In spite of
all of the  furor concerning this clause, it is interesting to note that
since its introduction in 1958, it has been invoked only twice to ban
food additives and both  of these were  trivial  components of food
packaging.

    It has been argued, however, that the Delaney clause represents
a bad regulatory principle.' For example, this clause might require
the FDA to immediately prohibit the use of food packaging containing
vinyl chloride if it became convinced  that vinyl  chloride is a car-
cinogen by  ingestion.   Since much of the plastic  food,packaging
used today contains vinyl chloride, this  might be a serious economic
problem.  Statistical approaches to estimating "virtually safe" doses
might help FDA out of this bind,  but this would be in conflict with
the Delaney clause.

    Mantel and his  colleagues have pointed out that a blanket require-
ment to ban all carcinogens as  food  additives provides a strong
incentive for manufacturers to fail to perform adequate experiments
which might demonstrate carcinogenicity.   The Mantel-Bryan pro-
cedure is a method for estimating "virtually safe" or "acceptable"
levels of chemicals independent of whether or not the chemical is
found to be  a carcinogen.   Acceptance of the Mantel-Bryan method
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thus would remove the strong regulatory response which now must
follow any significant positive finding of carcinogenicity.  This, it
is claimed,  will create an incentive  to industry  to increase doses
and numbers of animals  in the hope  of obtaining higher permitted
use levels of  additives in food.  .The principal problem with this
reasoning is the fact that regulatory agencies will hot,  in my judg-
ment,  set standards for non-carcinogenic chemicals as if they were
carcinogens.   I believe that  chemicals will continue to be  placed
in two classes, carcinogens and presumed noncarcinogens, with dif^
ferent regulatory principles applied to each. If this is correct,  then
one of the important assumptions behind the use of the Mantel-Bryan
method is invalid.

    The first regulatory attempt to use the Mantel-Bryan method was
in July 1973, when the Food and Drug Administration proposed using
it for  determining  the   concentrations of carcinogenic chemicals
which the analytical chemists must be able to detect before use of
these chemicals in food-producing animals  would be permitted. The
calculated risk level proposed for determining this  concentration
was one per hundred million.

    Five months after the FDA proposal,  the Environmental Pro-
tection Agency also  proposed using the Mantel-Bryan method, this
time to assist in setting a standard for the  known human carcinogen
benzidine, which is  used in making dyes.   This proposed standard,
which would limit the  discharge  of benzidine into the  water,  was
based on a calculated risk limit of one in a million rather than one
in a hundred million.

    One major criticism which has been leveled at the  EPA proposal
is that we have not clearly established that benzidine provides sub-
stantial benefits to society and therefore we should not permit any
exposure  at all.  While  there  is merit to this criticism,  it is not
clear to me how a zero discharge standard would be enforced since
the limit of chemical detection is relatively high.  Another problem
with a zero  discharge standard is that it would,  in effect, prohibit
the use of benzidine  in making dyes and there is evidence that some
of the chemicals likely to replace benzidine  are themselves carcino-
genic.

    An  alternative to setting standards for carcinogens either at
"zero" or at some arbitrary calculated limiting risk level is to make
the standard as stringent as is technically and economically feasible.
A number   of  regulatory actions involving carcinogens have been
based almost solely on such technical considerations. In April 1973,
the Environmental Protection Agency, armed with neither a suitable
analytical method nor any appropriate dose-response data, set limi-
tations on the  release  of asbestos by stating  simply  that:   "There
shall beno visible emissions to the outside air". In addition, certain
work practices  designed to  reduce the dispersal of asbestos into
the air.were required, such as wetting  and removing asbestos insula-
tion before demolition'of a building.  No numerical standard or risk


                               122

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 estimates were possible.

    The Food and Drug Administration, in addition to its reponsi-
 bilities  for regulating  food  additivies,  must also attempt to protect
 us from carcinogens which appear  naturally in our  food.   These
- substances-are-not-cover-ed-by—the- Delaney-clause.—Aflatoxins.-for-
 example, are caused by a mold which grows on peanuts.   Initially,
 the FDA set standards for aflatoxins at the limit of chemical detec-
 tion, but now the chemists have improved the analytical methods to
 the point that  perhaps 25% of our peanut butter would have to be
 confiscated if the detectability rule were still applied. Therefore,
 the FDA has proposed a maximum permissible level of aflatoxins in
 peanuts of 15  parts per billion, recognizing that when 25 rats  of one
 strain were fed diets containing aflatoxin B-l at this same concen-
 tration, which is now permitted in peanuts, every one of them con-
 tracted  carcinoma of the liver.   Clearly, the present standard is
 b£sed at least  as much  on practicality as it is on assessment of
 risk.

    In January of 1974, the  Department of Labor issued regulations
 on 14 carcinogens in the workplace.  These regulations are  based
 solely upon the technical feasibility of  limiting worker exposure
 while permitting continued use of the chemicals.    The standards
 simply specify work practices, such as adequate ventilation and the
 use of protective clothing, which must be followed when these car-
 cinogens are present.  Again no numerical limits on exposure were
 set.

    The Department of Labor   has  also promulgated a  regulation
 limiting the concentration of vinyl chloride in the workplace to  1 part
 per million.  The fact that vinyl  chloride has been shown to cause
 cancer in  laboratory animals exposed  to 50 ppm clearly indicated
 that the 1 ppm  standard is not based upon any concept of "virtual
 safety" or even a calculation of "acceptable risk. "  The Department
 of Labor standard also has the provision that vinyl chloride must
 be reduced to the lowest feasible levels if the 1 ppm standard cannot
 be met. This is because  the Government could not really determine
 in advance what levels would be feasible  for industry to achieve.

    I could give further examples, but the point I am trying to make
 is that  technological and economic feasibility  very often will limit
 the utility of risk analysis in writing regulations.

    Although there are  good arguments in favor of setting standards
 for carcinogens at the lowest "feasible"  level,  feasibility can be
 a slippery concept.   When we ask the engineers how low they can
 bring emissions or  effluents,  they  often  turn around and ask us
 what level we want and how much we are willing to spend. Feasi^
 bility often boils down to acceptable cost, and the judgment of what
 costs are acceptable depends solely on who is making the decision.

    In principle, of course,  we would want to take into account both
                               123

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the risks  and the costs of control and  somehow balance these to
achieve the best solution for society as a whole.  This requires that
the methods  for risk analysis be used not only to estimate a "virtually
safe" dose, but also to provide us with risk estimates at doses above
those which are  "virtually safe. "   This, of course, is a much more
difficult task  and  we are  faced with  the  serious  problem that when
we present  intermediate risk estimates  to administrators they  tend
to take  them seriously.   One of the dangers of statistical approaches
to estimating  risk  is that they provide us with enticing numerical  an-
swers which appear to be far more accurate than they are.

    It has been said that attempts  to set standards by an explicit bal-
ancing of  risks against costs may simply be  a tactic  for preventing
enactment of  stringent  regulations.   It  has been argued that the  bal-
ancing of  tenuous risk estimates against even less solid cost estimates
only provides sophisticated  excuses for regulatory inaction.  We do
not yet have enough experience with risk-cost-benefit analysis to know
whether these fears are legitimate.

    Do we need better methods for extrapolating risk?  Yes--Particu-
larly for  distinguishing  "conservative" from  "most likely" estimates
of risk.

    More  significantly, however, we lack the wisdom of knowing how to
use these methods in designing regulations.   We will only gain  this
wisdom through experience,   and  the  learning process we are  going
through is painful.   As more chemicals are found to be carcinogenic,
we will make many more mistakes.   This will  inevitably result in the
unwarranted overregulation of some  carcinogens and the unconscion-
able under regulation of others.                     ,
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        ENVIRONMENTAL ASPECTS OF CHEMICAL USE IN
              RUBBER PROCESSING OPERATIONS

                         Delivered by
                     Farley Fisher, Ph. D.
                Branch Chief-for-Early Warning    	
                           to the
Conference  on Environmental Aspects  of Chemical Use in Rubber
                    Processing Operations
                Akron,  Ohio  -- March 12-14, 1975

Welcoming and Introductory Remarks

    Welcome to this conference  on environmental aspects of chemi-
cal use in rubber processing.    This is the  first conference of this
type  sponsored by  the  Office of  Toxic Substances, and we hope it is
is the prototype for conferences  on a number of other industrial op-
erations as well.   Our object  here is to discuss the use of chemi-
cals  in rubber processing --to  analyze where these materials may
have an effect on the environment, either because of the substances
used in the  process or because of the types of products produced
therein.  We are definitely doing this with an attitude of exploration
and debate,  and we wish for  the conference to be lively.   In no
sense are we trying to  restrain people from expressing their views.
We have allowed for a  large number of question and answer periods
and I hope that you will  avail yourselves of the opportunity to ask
questions and make comments.

    Our keynote speaker for this meeting is Mr. Glenn Schweitzer,
who has been  Director of the Office of Toxic Substances for about
2 years now.   During  that period of time, Mr. Schweitzer has been
actively involved in the Toxic Substance Program at EPA.
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                 CONFERENCE SUMMATION

General  Chairman Fisher;  Our  plan  at this point  is to give each
    of the session  chairmen  5 to 10 minutes  to comment  on  his
    session or on the rest of the conference.   Unfortunately,  two
    of our session chairmen are not with  us today because of other
    commitments.  Mr.  Robert C.  Niles of Uniroyal,  Inc.,  Chair-
    man of Session I,  had  planned to be  here but unfortunately
    could not.   Mr. David Garrett of the Office of Toxic  Substances
    at EPA in  Washington was  to substitute for Mr. Niles,  but he
    too was unable to attend today.   However,  Session  I was very
    informative, especially concerning the  techniques for control-
    ling odor problems and effluent problems.

          Mr.  William E. McCormick of the American Industrial
    Hygiene  Association was  also  unable to be here  today, and I
    have asked Dr. George  Levinskas  to substitute for  him at this
    time.  Dr. Levinskas is eminently qualified  to serve in place of
    Mr. McCormick.  He is an industrial hygienist with  experience
    in occupational health, and currently holds the position of Man-
    ager of Environmental Assessment and Toxicology for the Mon-
    santo Corporation.

Dr. George J.  Levinskas (Monsanto Corporation,  St. Louis, MO):
    The sessions have  ranged quite widely from  experimental toxic-
    ity tests on animals, to clinical observations of human health,
    to chemical and physical studies measuring various parameters
    dealing with some phase of making or using  rubber.

          One  of the  speakers made a  passing  reference implying
    that animal toxicity data had no relationship  to and limited value
    for the assessment of the effects of chemicals on man.  I must
    take strong exception to that remark.   Test data obtained by
    exposing animals  to  chemicals are useful  in  predicting their
    probable effects on man.  There may be many difficulties in
    evaluating the low incidence of a given finding in animals. This
    is a situation comparable to  the difficulties an analyst has in
    detecting a peak in  a tracing  when it is not  much above  the
    background noise generated by  his instrument.   There may be
    uncertainties as  to the relative  susceptibility of man versus the
    animals for a given material.  There are many other problems
    in evaluating potential risk to  man from exposure  to  a given
    substance  as judged by animal  studies. However, despite  the
    real  and sometimes  imagined drawbacks to  animal tests, these
    tests have been,  are now, and  will  continue  to be useful in
    evaluating the health effects of chemical substances on man.

          Several  of the papers point up the need for the measure-
    ment of materials, qualitatively and quantitatively, in the envi-
    ronment.   We need  to know what, and how much, is out there
    before we  can begin  to  assess the potential hazards   to man
    or to the  environment of these  various  materials.   However,
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     because of today's technology,  chemists have exceedingly pow-
     erful analytical tools at their disposal.   We should remember
     that, while  discovery of a new contaminant raises a question
     as to its  significance, it does not necessarily portend doom or
     gloom.  In  fact, under different conditions, a  similar situation
     may be either bad or good.- A used tire dumped in a  lake or
     settled on the bottom of a swimming hole represents undesirable
     litter.  The same tire sunk in an estuary becomes a beneficial,
     artificial reef.  The reason we judge one situation to  be bad,
     and the other to be good, is based either on our personal expe-
     rience or on our prior conditioning to accept a belief.

          It has been remarked  at this conference  that researchers
     do not like to publish negative data, i.e., data supporting safety.
     Researchers prefer  to publish  findings.  I have no quarrel with
     that view.  However, we should be attempting to define  those
     areas in which there could be a high probability of risk.  This
     requires objective reporting of data.  The use of overtones and
     innuendos to imply that imminent disaster is coupled with every
     finding of a new environmental-contaminant, no matter how small
     its concentration may be,  is misleading.   It  can only confuse
   -  the litter tire and the reef tire.

Mr.  J. R. Laman (The Firestone Tire and Rubber Company,  Akron,
~    Ohio):  Our group in environmental engineering and I are sure
     that other environmental engineering groups in major corpora-
     tions are consistently seeking  to strengthen the interface with
     toxicology,  industrial medicine,  and industrial hygiene.   I feel
     that a major item for consideration was  left out of this confer-
     ence;  namely,  no one talked about the double line.   Unfortu-
     nately,  no attempts were made  to equate cost/benefit/risk with
     quality  of life, or lifestyle,.   When we talk  about this lunch
     counter  business, it involves  everybody.   Somebody has got
     to pay the costs.

          My field is  strictly the engineering approach; for exam-
     ple,  in  a water problem, we  get down to specified levels and
     then make an ecological judgment  of the system.   We  fine-
     tune as required.  We strike a good cost/benefit/safety balance.
     We must  never forget that our pollution control approach must
     be tuned to  the  highly developed  nations, which are competing
     for our markets and  services.   The highly developed  nations
     must embrace pollution control as a. cost of doing business,  as
     we are doing,  to  compete  fairly.   By  juggling the equation,
     some component of the equation will be affected.

          Let me  repeat  it again:   cost/benefit/risk equals quality
     of life,  or lifestyle.

          Since  we have the highest standard of living that humanity
     has known,  we must prudently chart our course; because if we do
     not,  it will be unfairly taken off the top.
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          The environmental engineers in this very worthwhile con-
    ference offered to us many pollution-free ways of disposing of
    tires.  Tires can be properly disposed of in incinerator boilers,
    fish reefs, and conventional reclaim.

          At this time, we should look at the economical feasibility
    of all the disposal technologies just discussed as well as other
    technologies just  emerging, which are described in the litera-
    ture.  By balancing the cost/benefit/risk ratio with economics,
    I am sure that we can find a suitable solution for the disposal
    of these  tires  without adversely affecting  the  ecosystem.   In
    conclusion,  we must  determine who is going to pay the price.

General Chairman  Fisher; Mr. Beliczky, do you have some more
    remarks?    ""

Mr. Louis S. Beliczky (United Rubber Workers International Union,
  !  Akron, Ohio): All of us know our moral and social responsibility
    in the  area of air pollution. Organized labor's role in air polr
    lution  problems has been minimal to date.   We  have probably
    been more concerned about  the workers' in-plant environmental
    health problems than about  out-plant emissions.

          We must have an awareness of the serious  hazards from
    air and water  effluents  to the  population  in general.  A few
    months ago  a news release implicated increased birth malfor-
    mations to areas along Lake Erie where polyvinyl chloride resin
    manufacturing  plants  were located:  Avon Lake,  Painesville,
    and Ashtabula.

          EPA reports conducted in 1974 indicated that vinyl chlo-
    ride was found by air and stream emission studies in the areas
    implicated.    No  real scientific studies to date have directly
    implicated  vinyl  chloride  to the increased incidence of birth
    malformations.   Before positive judgments are made, more
    objective studies  must be  conducted, 'keeping  in mind that at
    each site mentioned,  power-generating plants  have  been also
    operating for many years.

          We must be concerned that four carcinogens have been
    identified as being present in the carbon black actually used in
    the rubber industry.   The  fact that we are beginning to identify
    some of  the chemicals being produced  in rubber curing proc-
    esses  must be  emphasized.  Dr. Rappaport's presentation and
    studies being conducted by Harvard may lead  us to an identic
    fication of specific causative factors producing the many forms
    of cancer which  were mentioned by  Dr. Harris and Profes^
    sor Burgess.

          Greater emphasis must be placed on morbidity studies so
    necessary to follow up on the mortality '(epidemiological) data.
    Only through joint and concerted investigations can we hope to


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    succesfully control  the hazards to  which our workers are ex-
    posed.  The workers themselves negotiated the $10. 20 per year
    that is set aside for the university studies.

          Each segment of specialized  studies will eventually lead
    to • that-safe and-healthful-work environment  to-which each-work-
    ing man and woman is entitled.   Perhaps  the data will assist
    in controlling the whole  system--his environmental health  at
    work  and away from the job.

          I must respond to the statement of relating animal toxi-
    city data  to human beings.  I can only state that if a material
    has been proven to be carcinogenic to animals, but no data are
    available to document it as a causative agent in producing human
    cancer, it cannot be dismissed as being safe for human beings.

          This philosophy has been capriously applied to vinyl chlo-
    ride and to 2, 4, methylene-bis-2-chloroaniline (MOCA) by those
    who hold the dollars and cents of profit over lives.

          Indiscriminate judgments regarding workers' health are
    sometimes made by the uninformed and callous decisionmakers.
    Who really pays?   It is mainly the workers who pay from their
    pockets and/or with their health or lives.

Dr. Fisher:  The questions are:  What are the problems,  and where
    can we take these problems to make progress? We are limited;
    we are merely mortals and we cannot do everything at the same
    time.

          What are the areas we have to move into first to identify
    and then control those things that are the greatest threat to our
    health and our environment?  These are  the kind of  things I
    think  we are trying to get  at here, as they concern all of us.
    At the same time,  it is important not to get so hung up with
    talking about what we were going to do that  we do not actually
    make progress.

          I hope that having this meeting and these discussions have
    stimulated people to think in the areas where they had perhaps
    not thought before, because of ignorance, not because of intent.
    I hope you all learned something; I know I have certainly learned
    a lot here from all of you and I appreciate it very much.
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   TOXIC CHEMICALS REGISTRIES IN THE UNITED STATES

                      Delivered by
                I. Eugene Wallen,  Ph.D.
          Deputy Director, Office of Toxic Substances
                         to .the
                    Bilthoven Meetings
            Geneva, Switzerland - January 6,  1975

    The United States does not have a consolidated registry of infor-
mation on hazardous substances.   More thari twenty-two Agencies
of the Federal Government  as well as State and local governmental
units have  data files for one purpose or another.   Additional data
may be stored by industry,  by group of industries,  or by other pri-
vate organizations.  A directory of Environmental Information Sys-
tems in the Environmental Protection Agency lists 146 data systems
(21,air,  22 pesticides,   19  radiation,  4  solid wastes, 59 water, 21
general) that may contain data on toxic chemicals.

    The development of information  about the hazard  of chemical
substances has been responsive to the operational problems of occu-
pational exposure; containment and packaging; contamination of foods,
water, or air; control of spills, etc.,  rather than to the basic nature
of the substances.   The United States approach has been to provide
data oriented  to the specific potential problem, rather than to store
information by substances.    The existing lists have been prepared
to meet localized  issues rather than to  resolve national or inter-
national problems.

    The most comprehensive listing  of toxic substances in the U. S.
is that of the  National Institute for Occupational Safety and Health,
which Dr.  Herbert E.  Christensen will  report on.   A  report  will
be published within  the  next  few  months by the  National Academy
of Sciences called Water Quality  Criteria.    A 2 volume  report,
volume 1 will consist of criteria arranged alphabetically by water
use with the  limits for each pollutant followed by the supporting
scientific justification.    Volume  2 will  provide information on the
sources of polluting constituents, their mean  levels in major river
basins,  techniques  for biological   and physical  measurements,
methodology  for  bioassays,  the overall classification of water
quality, and the types of pollutants suitable for maximum daily load
measurements.

    Currently there are no plans for the development of an overall
registry in the United  States.  There would  be great difficulty in
developing a proper U.S. contribution to a common registry.  Among
the negative aspects of this  proposal  are (1) problems and expense
to the U.S. in acquiring, updating,  and formatting  the data,  (2)
evaluating the accuracy  and completeness of the data,  (3) considera-
tions of extent of use of such a registry, if established, (4) problems
of data management in  the  US system, and (5) reluctance of indus-
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try to provide significant data that might compromise international
trade,

    A modest UN referral service has been suggested as a rea-
sonable  alternative to the registry.  Such a referral service might
be a forerunner of a registry or an eridin itself.  For the immediate
period it may be the only  feasible way for the UN to obtain appro^
priate input into the U. S. multiple files of data.

High Volume Chemicals

    As an example of the  complexity of the  problem  I would like
to review recent work by my office in following up the Vinyl Chloride
carcinogenicity problem.  It was determined to make a preliminary
examination  of the fifty highest volume chemicals with respect to
the way agencies reflect an interest in them.   The May (3,  1974,
issue of Chemical and Engineering News had listed these chemicals
(Table 1) by rank in production volume and  in comparison of 1973
with 1972 production.
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                 Table 1  —  The  Top 50  Chemicals  in  Production Volume in  the
                                United  States
                                                               ^KULJUU I IUN
                                                                                             AVERAGE ANNUAL CHANGE
  Rank
1973 1572-

  1—1 - -Sulfuric acid               -       - ^—
  2   3    Oxygen, high arid low purity
  3   2    Ammonia, synthetic anhydrous
  4   4    Ethylene
  5   5    Sodium hydroxide, 100% liquid

  6   6    Chlorine, e.as
  7    9    Nitrogen, high and low purity
  8    8    Sodium carbonate, synthetic and natural
  9    7    Nitric acid
 10   10    Ammonium nitrate, original solution

 11   11    Phosphoric acid, total
 12   12    Benzene, all grades
 13   14    Propylene
 14   13    Ethylene dichloride
 15   15    Urea, primary solution

 15   18    Methanol, synthetic
 17   16    Toluene, all grades
 18   17    Ethylbenzene
 19   20    Formaldehyde, 37% by weight
 20   19    Styrene

 21   21    Xylene, all grades
 22   22    Vinyl chloride
 23   23    Hydrochloric acid, total
 24   25    Ammonium sulfate
 25   24    Ethylene oxide

 26   26    Butadiene (1,3-), rubber grade
 27   28    Carbon black
 28   27    Ethylene glycol
 29   30    Sodium sulfate, high  and low purity
 30  29    Carbon dioxide, all forms

 31   33    Dimethyl terephthalate
 32   32    Cumene
 33   39    Terephthalic acid
 34   36    Acetic acid
 35  -33    Calcium chloride, solid and liquid

 36  34    Cyclohexane
 37  35    p-Xylene
 38   31    Aluminum sulfate, commercial
 39   40    Phenol, total
 40   43    Acetone

 41   41    tthanol, synthetic
 42   37    Sodium tripolyphosphate
 43   42    Isopropanol
 44   45    Propylene oxide
 45   44    Acetic anhydride

 46  46    Titanium dioxide
 47  50    Vinyl acetate
 48   48    Sodium silicate (water glass)
 49   49    Acetaldehydc
 50        Acrylonitrile
              PRODUCTION
(Billions of pounds)    (Common units'*)
1973
— 63.-13-
31.87
30.94
22.41
21.36
20.60
16.38
14.99
14.86
13.89
13.00
10.65
8.76
7.90
7.12
7.12
6.78
6.50=
6.17
6.01
5.90
5.35
' 4.78
3.97
3.83
3.66
3.50
3.29
2.85
2.77
2.69=
2.67
2.49°
2.42
2.40°
2.35
2.32
2.27
2.25
1.99
1.97«
1.83
1.76
1.75
1.55
1.54
1.48
1.46
1.40°
1.35
1972-
62
.60
31
29.22
30
20
20
19
14
14
15
13
13
9
8
.39
.85
.43
.75
.06
.88
.96
.76
.06
.18
.47
8-. 60
6
5
6
6
5
5
5
5
4
.95
.96
.63
.43=
.65
.95
.33
.18
.60
3.72
3
3
3
3
2
2
2
.95
.53
.21
.30°
.65
.96
.06°
2.38°
2
2
2
2
2
2
2
1
1
2
1
1
1
1
1
1
1
1
.02°
.15°
.34
.29°
.20
.51
.00
.76
.87°
.07
.85
.51
.56
.44
.20
.32
.30=
.12
15
22
10
10

7
7
6
6
1
8
7
7
7

6
6
6

5
2
1
3
3
3
3
1
1
2
2
2
2
1
2
2
1
2
1
1

1
1
1

1

1
1
1973
,588 ft
385 bcf
,468 tt
.405 mp
,678 tt
,302tt
226 bcf
,496tt
,430tt
,943 tt
,498tt
,453 mg
,764 mp
,903mp
,120 mp
,118 mp
936 mg
,500 mp°
,173mp
,014 mp
818 mg
,348 mp
,3S9tt
,985 tt
,875 mp
,663 mp
,500 mp
,290mp
,424tt
,387 tt
,690 mp=
.665 mp
,490 mp=
,419 mp
,200tt°
,354 mp
,315mp
,136tt
,249 mp
,987 mp
,965 mp°
914 tt
,755 mp
,753 mp
,550 mp
772 tt
,483 mp
730 tt
,400 mp°
,353mp

1S72-
31.300-tt---

15
20
10
9

7
7
6
6
1
8
8
6
5

6
5
5

5
353 bcf
,193tt
,852 mp
,217 tt .
,873 tt
194 bcf
,439tt
,981 tt
,881tt
,531 tt
,252 mg
,472 mp
,600 mp
,950 mp
,956 mp
916 mg
,425 mp°
,650 mp
,950 mp
739 mg
.175 mp
2.302 tt
1
3
3
3
3
1
1
2
2
2
2
1
2
2
1
1
1
1
1
1
1
1

1

1
1
,858 tt
,950 mp
,527 mp
,210 mp
,300 mp°
,327 tt
.481 tt
,055 mp=
,380 mp°
,015 mpc
,150 mp°
,169tt
,285 mp«
,200 mp
,256tt
,995 mp
,759 mp
,870 mpc
,033 tt
,850 mp
,513 mp
,560 mp
718 tt
,204 mp
661 tt
,300mp«
.115 mp
U72-73
	 0.9%
9.1
1.8
7.4
4.5
4.3
16.5
0.8
-6.9
1.3
-0.5
16.1
3.4
-8.1
2.4
19.5
2.2
1.2
9.3
l.i
10.7
3.3
3.8
6.8
-1.9
3.9
9.0
-0.3
7.3
-6.3
30.9
-12.0
23.6
12.5
2.7
3.0
5.2
-9.6
12.7
13.0
5.1
-11.5
-5.1
15.9
-0.6
7.5
23.2
10.4
7.7
21.3
1971-72
7 oof
•070
10.7
4.5
13.0
5.7 •
5.6
15.5
4.0
4.5
3.7
9.4
16.4
22.9
13.8
9.2
20.3
4.6
28.9
24.9
27.1
20.8
19.3
9.7
2.0
9.8
5.6
6.1
7.5
-2.2
10.2
18.2
11.0
27.4
9.9
-3.7
30.7
32.4
5.5
11.8
14.4
14.7
-0.7
7.5
26.7
3.2
5.9
29.3
3.9
-12.8
13.9
19SS-73
2=0%
9.2
5
11
3
4
13
2
1
3
.0
.3
.8
.1
.7
.5
.2
.9
4.3
7
4
10
7
13
6
10
7
10
.8
.5
.5
.9
.3
.1
.0
.5
.2
8.8
12
6
-0
8
4
4
10
-0
5
15
14
21
6
0
2
12
-0
8
7
-1
-5
-3
12
-1
4
15
2
-2
5
.5
.5
.2
.1
.5
.5
.0
.8
.6
.5
.6
.2
.8
.7
.9
.0
.6
.2
.8
.7
.0
.3
.8
.5
.3
.6
.9
.5
.8
1963-73
4.2%
11.6
8.7
11.5
6.3
6.6
16.1
2.6
5.8
5.7
8.4
8.4
12.4
16.0
12.4
11.8
8.7
10.2
9.3
10.8
9.3
14,1
8.5
5.1
7.5
4.7
5.4
7.1
1.5
3.6
23.7
19.9
na
8.9
2.7
8.1
24.3
1.8
9.2
7.7
0.1
1.2
1.8
13.4
2.0
4.0
13.9
2.8
2.0
11.5
a Revised, b tt = thousand tons, bcf = billion cubic feet, mp — million pounds,
Bureau of the Census. Bureau of Mines, and Tariff Commission
                                                         133
                mg = million gallons, c C&EN estimate, na = not available. Sources:
                                                                                  May 6,  1974  C&EN

-------
    On a draft basis, matrices  have been developed that  reveal a
portion of the interest of U.S. Agencies in control of these 50 chemi-
cals.  These  matrices will have been modified during the interim
between preparation of this paper and the meeting itself; however,
they appear  to  be-of value even in their  current  status. Table 2
lists the  50 highest volume chemicals  in relation to the various
Offices of the EPA.  The  X marks in  the  table mean that some
type of activity  is  taking  place,  be it  regulation or a firm plan
to obtain information.
                               134

-------
Table 2 — Activity Checked by EPA Office with Reference to 50 High Volume Chemicals




                           Oil and Hazardous Materials
Effluent
Guidelines
Chemical Name FWPCA
Sulfuric Acid
Oxygen
Ammonia
Ethylene
Sodium Hydroxide
Chlorine
Nitrogen
Sodium Carbonate
Nitric Acid
Ammonium Nitrate
Phosphoric Acid
Benzene
Propylene
Ethylene Dichloride
Urea
Methanol
Toluene
Ethylbenzene
Formaldehyde
Styrene
Xylene
Vinyl Chloride
Hydrochloric Acid
Ammonium Sulfate
Ethylene Oxide
Butadiene
Carbon Black
Ethylene Glycol
Sodium Sulfate
Carbon Dioxide
Dimethyl Terephthalate
Cumene
Terephthalic Acid
Acetic Acid
Calcium Chloride
Cyclohexane
p-Xylene
Aluminum Sulfate
Phenol
Acetone
Ethanol
Sodium Tripolyphosphate
Isopropanol
Propylene Oxide
Acetic Anhydride
Titanium Dioxide
Vinyl Acetate
Sodium Silicate
Acetaldehyde
Acrylonitrile
X

X
X
•X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Proposed
Rules .
X



X
X


X
X
X
X




X
X
X
X
X

X
X









X

X

X
X





X

X
X
X
'X
Technical
Data
Available

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
•x
X
X
X
X
X
X

X
X
X
X



X
X
X
X
X
X
X




X
X
X
X
X
X
Pesti-
cides
X


X
X
X

X


X
X

X

X


X

X

X
X
X


X










X

X
X
X
X





X
Clean
Air
.X


X







X
X
X


X
X
X
X
X
X

X
X
X
X

X

X



X
X
X
X

X

X
X

X
X

X


Research and
Development
X
X
X
X

X
X





X
X
X

X
X
X
X
X



X
X

X


X




X
X


X









X
                                       135

-------
    The effluent guidelines column in the matrix refers to regula-
tions issued under authority of the Federal Water Pollution Control
Act, as amended.  The regulation of a given substance is based on
the water quality of its effluent considering  total suspended solids,
biochemical oxygen demand and/or other selected characteristics
(pH, temperature,  chemical oxygen demand,  reductions of certain
chemicals, etc.), depending upon the industry.

    The Oil and Hazardous Materials column refers to substances
designated  as   "hazardous substances" as  authorized under  the
Federal Water  Pollution Control Act.   The first column involves
direct  control  while  the second  column refers to  an information
base which was developed to assist in cleaning up after a hazardous
substance spill.

    The pesticides column lists the chemicals which are registered
under the Federal Insecticide, Fungicide and Rodenticide  Act.  Any
chemical so registered must have been studied in evaluation of haz-
ards to humans and to other components of the environment.  Only
that portion of the production of a chemical that enters into the pesti-
cide market could be controlled under this Act.

    The Clean  Air Act   provides broad  authority to control  air
quality.  Source performance standards,  primary and secondary am-
bient air quality standards, and regulations of new stationary source
emissions  are promulgated for control of  releases  of  particulates
and hydrocarbons.

    The EPA Office of Research and Development carries out inves-
tigations concerning  toxicological  effects  of  pollutants on aquatic
and terrestrial  plants and animals, on human health consequences
of releases of chemicals,  towards the development  of methods  for
high quality measurements of the occurrence of toxic substances in
the environment, and in gathering  data on  environmental levels of
chemicals and their persistence.

Non-EPA Activities

    Outside  the Environmental  Protection  Agency  several  U. S.
agencies are involved in studies of the high volume chemicals.  Some
of these agencies have programs included  in Table 3 (below)  and
described in the following paragraphs.

    The National Cancer Institute publishes a survey of compounds
which  have been tested  for  carcinogenic  activity.    Although  the
latest  data in the current survey are  1971, a cursory attempt  has
been made to determine whether  additional  chemicals from the top
50 list have been tested since then.  In addition to  the human data
a national registry of animal tumors is maintained. An international
group of experts in chemical  carcinogenesis meets  periodically to
evaluate the carcinogenicity of individual chemicals.
                              136

-------
Table 3 — Activities in Agencies other  than EPA wi'tji Reference to 50 High Volume
           Chemicals                                  ,^_
National fc *
Cancer iDept. of
HEW
Chemical Name Institute Transportation FDA
Sulfuric Acid
Oxygen
Ammonia
Ethylene
Sodium Hydroxide
Chlorine
Nitrogen
Sodium Carbonate
Nitric Acid
Ammonium Nitrate
Phosphoric Acid
Benzene
Propylene
Ethylene Dichlorlde
Urea
Methanol
Toluene
Ethylbenzene
Formaldehyde
Styrene
Xylene
Vinyl Chloride
Hydrochloric Acid
Ammonium Sulfate
Ethylene Oxide
Butadiene
Carbon Black
Ethylene Glycol
Sodium Sulfate
Carbon Dioxide
Dimethyl Terephthalate
Cumene
Terephthalic Acid
Acetic Acid
Calcium Chloride
Cyclohexane
p-Xylene
Aluminum Sulfate
Phenol
Acetone
Ethanol
Sodium Tripolyphosphate
Isopropanol
Propylene Oxide
Acetic Anhydride
Titanium Dioxide
Vinyl Acetate
Sodium Silicate
Acetaldehyde
Acrylonitrile
X

X

X



X


X

X
X

X
X
X
X
X
X
X
X
X

X






X
X
X


X
X
X

X





X

X
X
X

X
X
X
X

X
X
X
X
X
X
X
. X
X
X
X
X
X
X

X
X

X

X

X

X

X
X

X
X
X

X
X
X

X

X
X



X

X







X
X



X
X

X
X

X

X ,

X









X







X


X
NIOSH
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
'x
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Dept. of
Labor
OSHA
X

X

X
X


X


X

X


X
X
X
X
X



X
X
X
X

X

X

X

X


X
X



X
X
X


X
X
                                       137

-------
    The Department of Transportation issues regulations regarding
the transportation, packaging for shipment, loading, unloading,  and
labeling of  substances classified as "hazardous materials."  The
list of materials is under constant  review for revision.  Ordering
of priority attention is paid in considering the possibility of multiple
hazards (i. e., flammable plus explosive) and through an assumption
that the  least  expensive chemicals will  receive the least  care in
handling.

    The Food and Drug Administration listing is incomplete since it
only indicates those substances involved  in food additive petitions
pending  as  of June 30,  1974^  A thorough index of FDA activities
in reference to all chemicals was  not feasible to produce at this
time.

    The National  Institute  for Occupational  Safety  and Health  has
produced the excellent  publication. Toxic  Substances  List"T974,
which is being discussed by  Dr.  ChnstenserH   The listing in the
matrix is taken from that volume.  The Occupation Safety and Health
Administration promulgates regulations setting  standards  for  the
workplace based on criteria documents prepared by NIOSH. Those
high volume chemicals  for which there are existing standards were
indicated in Table 3.

    Additional data are being sought in amplification and completion
of the matrices.   An  attempt can be made to  update the tables at
the meetings, if this is desirable.

Monitoring Data

    Registers of  U. S.  toxic  substances  monitoring data are kept
by various Offices within and  outside EPA.  The data systems cur-
rently are being  surveyed for content of data on toxic substances.
A list of the data systems known or  believed to contain toxic chemi-
cals monitoring data is included as  Table  4 (below).

    The most important of these systems in terms of water data
volume is STORET.   This system  contains raw water quality data
stored under a variety  of parameter  names (dissolved, inorganic
suspended,  total,  etc.)   This computerized file may  be accessed
through  teletype  link  and  for less  than 3,000  lines of printout the
turnover time is approximately 5-24 hours.

    The principal  air monitoring data file is  S A ROAD.  This sys-
tem contains a diverse range of parameters including, as examples,
heavy metals, halogens,  organometallic compounds, and organic sub-
stances. The turnaround time for data,  including mailing from North
Carolina, is two to four days.  The System allows for storage of data
concerning air quality standards and emissions throughout the United
States.
                               138

-------
  Table 4 -- A Brief List of Known Monitoring Agencies in the
             United States

USDA
    Meat and Poultry  Inspection.  A National Monitoring Program.

U. S. Army

    Hydraulic Engineering Center.  A monitoring program.

USDI

    Fish and  Wildlife Service.   Duck wing analyses.  Mercury in
fish. Pesticide appraisal in  Starling, National Water Data System.

USEPA               •

    Estuarine and Coastal monitoring for halogenated hydrocarbons,
National Eutrophication Study.

USDHEW

    Diet Studies program, shellfish sanitation program.

USDC

    Monitoring by NOAA Air Research Labs,  Coastal Environment
and Marine Ecology, commercial fish pollutants

USTVA

    Water Quality, air quality monitoring.

Universities in 13 States

    Monitor for various pollutants (Amherst College, University of
Arkansas,  University of Southern California, University of Hawaii,
University of  Iowa, Iowa State University,  University of Maryland,
Massachusetts Institute  of Technology,  University of New Mexico,
New Mexico Institute of Technology,  Ohio State University, Oregon
State University, University of Rhode Island, University of Califor-
nia, University of  Georgia,  Texas A&M University, University of
Washington, and Woods Hole Oceanographic Institute).
                               139

-------
    The National Soils Monitoring Program is  concerned with the
levels of pesticides residue in soils and in croplands.  Samples are
taken from throughout the U.S. on the basis of one site per 400, 000
acres of soil.   All samples are  processed at a laboratory in St.
Louis, Missouri, and most analytical work is done at the same site.

    The Technical Assistance Data System is  a compilation of records
on more than 850 hazardous materials  (being expanded) from a variety
of sources.  A computer provides printouts via remote terminals to
furnish the major  informational  elements required in the control
of chemical releases as well as for enforcement and research acti-
vities in developing anti-spill programs.   Emphasis is  on  spill
characteristics, potential environmental problems with spills,  and
containment procedures.

    The National Pesticides Monitoring Program measures the pesti-
cides levels in water, soils, wildlife, fishes, food, feed and humans.
This monitoring takes place throughout the U.S. on an annual basis.
/ill  data are  sent  to the  EPA Ecological Monitoring Branch where
they are stored in a computer system.

    The Interstate  Carrier Water  Supply  Certification  Program
monitors bacteria and chemicals in water used on interstate carrier
systems.  Drinking water certification is required annually.  Samples
are taken by  EPA once  each year for chemical analysis.  About
25 parameters are measured.

    No principal data system exists for tissues or animal data, how-
ever, several data files are concerned with toxicological information
in one form or another, 7

Priorities Perceived by Congress

    Another approach to  U. S. interest in toxic substances  has  been
an examination of the substances mentioned  in Congressional hear-
ings concerning the Toxic Substances Control Act.  Table 5 (below)
lists these substances.

Prioritization Procedures                  '

    The selection of chemicals for  priority attention is a function
of any nation seeking to protect its citizens from the adverse effects
of toxic substances.    Activities  within  EPA in attempting to set
priorities include studies  in correlations of properties and/or struc-
ture with effects; studies  of identification systems for the establish-
ment of priorities; groupings of chemicals within chemical classes;
projects in current awareness of problems  with  chemicals;  and
various types of consultations and conferences. The ranking of chemi-
cals on a  scale of  environmental hazard is an important but difficult
process.
                              140

-------
Table 5  --
List of Chemicals Considered at U. S.  Congressional
Hearings on the Toxic Substances Control Act
    Aluminum
    Antibiotics
   -Arsenic	       	      	
    Asbestos
    Beryllium
    Boiler Cleaning Products
    Cadmium
    Cadmium Oxide
    Cadmium Sulfide
    Carbadox
    Carbamate
    Carbonates
    Carcinogenic Animal Drugs
    Chemical Reagents, Catalysts,
     and Intermediates
    Chromium
    Chlorinated Hydrocarbons
    Chlorinated Paraffins
    Chlorine
    Chlorodoxins
    Chloromadinone Acetate
    Copper
    Corrosion Inhibitors
    Corticosteroids
    Cyclamates
    DEHP (Diethylhexyl Phthalate)
    DDT, 2,4, 5-T
    Detergents
    Dialkyl Esters
    Dichlorvas
    Diethylstibestrol (DES)
    Dimetridazole
    Dinestrol Diacetate
    Endotoxins
    Estradiol Benzoate
    Estradiol Monopalmitate
    Food  Additives
    Fungicides
    Furaltadone
    Furazolidone
    Gasoline Additives
    Hexobarbitol
    Hydrogen Cyanide
    Inert  Polystyrene
    Inks
    Ipronidazole
    Iron Complexes
    Lead
    Lead  Acetate
                           Manganese
                           Medroxyprogesterene Acetate
                           Melegesterol-Acetate	
                           MER-29
                           Mercury
                           Methylate
                           Methyl Mercury
                           Mutagenic Drugs
                           Nickel
                           Nickel Carbonyl
                           Nihvorazone
                           Nihydrazone
                           Nitrofurazone
                           NT A (Nitrilotriacetic Acid)
                           Ochratoxin
                           Organophosphate Esters
                           PAE's (Phthalic Acid Esters)
                           Patulin
                           PCB's
                           Penicillic Acid
                           Pesticides
                           Phosgene
                           Phosphates
                           Phthalate Esters
                           Plating Additives
                           Polychlorinated Paraffins
                           Polychlorinated Terpenes
                           Polymerization Modifiers
                           Potassium Cyanide
                           Progesterone
                           PVC (polymerized vinyl chloride)
                           Reserpine
                           Silica
                           Silicates
                           Selenium
                           Sterigmatocystin
                           Sodium
                           Teratogenic Drugs
                           Testosterone
                           Testosterone Propionate
                           Thalidomide
                           Types of Talcs
                           Vanadium
                           Zeranol
                           Zinc
                           Zinc Sulfide
                              141

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    Aerosols  -
    Alkyl Benzene
    Antimony
    Arsenic Trioxide
    Barium
    Caustic Soda
    Cyanide
    Dyestuffs
    Ethyl Fluoracetate       "
    Flame Retardent Chemicals
      octabromodiphenyl oxide
      decabromodiphenyl oxide
    Freon Propellants
    Herbisan
Hydrocyanic acid
Mercuric salts
Molybdenum
Nickel Carbonyl
ONCB (orthonitrochlorobenzene)
Silver
Sodium Cyanide
Sodium Fluoracetate
Sodium Tripolyphosphates
Tetraethyl Lead
Urethane Foam
    Although   there  is  much interest in the  establishment of
priorities in considerations of decisions involving  regulation, re-
search and  monitoring for special  chemicals,  full  participation in
an international  registry  would be difficult for the United States.
Regulatory agencies are active at different levels of government and
with differing goals. The format of the existing information is varied
and its quality mixed.   There does not exist a management control
mechanism  where the interest in a registry  would have force and
continuity.  In  the  absence of a completed system it is easier to
obtain the needed data from existing sources.
    The idea of an International registry is an interesting one.
implementation will not be easy.
                       Its
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   ROLE. OF THE ENVIRONMENTAL PROTECTION AGENCY IN
    ESTABLISHING STANDARDS ON TRACE CONTAMINANTS

                        Delivered  by
                     Farley Fisher, Ph. D.

                           to the
 65th Annual Meeting of the American Institute of Chemical Engineers
            New York City, NY  -- November 30,  1972

    I do not plan to talk much about the problem of setting standards
in the sense that standards use numerical limits, but I do want to
discuss the activities in the EPA which are aimed toward the control
of contaminants.   The  EPA clearly is very concerned about trace
contaminants, and  in fact,  the  public concern over these materials
was the primary impetus for the very creation of the Agency.

    Up to the present time,  the major thrust within the Agency has
been t° control certain environmental  contaminants, which we will-
refer to as "media pollutants".   For example, we have talked about
air pollution, we have  identified five or so serious air pollutants,
and we are quibbling about whether  half a dozen others ought to be
considered  serious air pollutants.   For. those we have identified,
we've set standards, rather tough  standards in  some cases,  and
we've implemented programs to try and meet these  standards.  We
have also been active in the area  of water pollutants, where a similar
type of  problem exists,  and with the new water legislation, which
gives the  Agency  considerably  more authority  to control  effluent
outfalls, I think one can anticipate  that there will  be much more
activity in  the area of controlling trace environmental contaminants
in the water as they come out of the industrial process.

    I am only peripherally acquainted with the details of the activi-
ties going on in the Water and Air Programs.  I belong to the Office
of Toxic Substances which is a unit created io handle environmental
contamination problems which  cannot be effectively controlled by
these media authorities.

    An example of the  type.of problem which led to the creation of
such an Office is the PCB problem, where everybody sat around and
said,  "Oh,  boy,  this  stuff  is  all over the  place now.  We think
maybe it's dangerous."  But the Air people said, "it very seldom
occurs in the air", the Water people said, "Well sometimes it is in
water, but in fact  there is a very  small amount of the population
exposed to PCB's."  The  FDA people said,  "Well,  it is not a food
and is not used as  a  drug but it does occasionally occur in food
packaging,  but would  be dangerous  only in  case of a rather dire
accident,  so it is  not a serious concern to us although we will do
a little  bit about it, too." Now when we got all done,  we found that
the PCB's were still reaching  the environment in large quantities
and nobody  was really taking on the responsibility for it.  At this
point an interagency task force was formed which  finally  decided
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that something must be done,  but the Government had no authority
to do anything.   We were saved in this impasse by the Monsanto
Company which happened to be the only domestic producer of PCB's
and which voluntarily instituted controls on ,the chemical.   But the
whole problem simply pointed out  the fact that this existing piece-
meal approach to environment pollution, considering air  and water,
and really  leaving out  all  other  considerations, is not adequate.

    In other words, we are leaving ourselves wide open for a lot
of problems.   In  light  of this fact,  the Agency created the Office
of Toxic Substances.   To  create  an office makes it look like we
are doing something, but if the office has no authority to do anything,
what in  the  world is  it  all  about?   There  has been proposed in
the last congress a  Toxic  Substances Control Act.  Let me give
you an idea of the philosophy behind the so-called "Toxic  Substances
Control Act. "  The  Toxic Substances Control Act would require
testing of any industrial  material  for which there  was a reason to
suspect a serious hazard existed with regard  either to human health
or  to  general environmental balance.   In  the event this testing
confirms  the suspicion,  then the government, mainly  EPA, will
be authorized  to restrict  its use  in  a  number of  ways.  In some
cases, we  could banish these  products altogether,  but for the most
part we are  talking in terms of restricting them in  any of a number
of ways: use in certain geographic  areas, in terms  of limited quan-
tities which may be used,  or in terms of the specific applications
to which the material  may be applied.    Both the Senate and the
House in the last session of Congress passed different versions
of this  Act;  they  were not able to agree on a version  suitable to
both houses  before adjourning,  Consequently,  there is no legis-
lation at this point. However,  we do anticipate that it will be debated
again in the upcoming session of Congress.

    There  are, it is fair to point out, a couple of legislative author-
ities in the government not  administered by  EPA which do bite
at the edges of this problem of general environmental contamination.
These are,  first, the  Federal Hazardous Substances Act, designed
to protect consumers  from direct hazards from products they  buy
for personal use. This is the authority under which the sale of carbon
tetrachloride as  a home  cleaning  fluid was  banned.  This  is also
the authority under which various detergent tests are  being conducted
and some labeling restrictions are  being placed  on detergents to
warn consumers  that they may be toxic or corrosive.  However,
many detergents  are  not  required to carry  these  warning labels.

    The Hazardous Substances Act is really, however, rather lim-
ited in its scope  to products which are  sold for  direct use by con-
sumers and  which pose a  hazard  in their direct  use  or in their
storage in  the home.  It does not  cover indirect  hazards,  and I
think an excellent sample of this type of problem is  the NTA con-
troversy.  The problem with  nitrilotriacetic acid  is pretty clearly
not one of causing death immediately upon exposure,  for example,
if children should open a  box of detergent. The risks involved with
                              144

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 NTA are related to  what happens to the material  after the clothes
 are washed and  the  wash water is flushed down the drain and into
 the sewer.    At what point does the compound enter the  environ-
 ment generally?   There are a lot of  unanswered questions  as  to
 what its fate  is  in the environment, as to how much it will occur
-in-the-water-supply-i—and-as -to what -the- ultimate-effects.~will_b.e_.f rom_
 repeated low  level exposure to this material.

     Another  authority which has a surprising ability to impact this
 area is the Occupational  Safety and Health  Act.  This is a law which
 is designed, of course,  to protect workers in an industrial atmos-
 phere.  This Act does enable the officials of HEW and Labor acting
 in concert to  propose certain restrictions on these chemicals which
 are designed  for the protection of industrial workers,  but which,
 in many cases, will inevitably have the side effects of also improving
 the general environment in the neighborhood of industrial plants.
 And so we can anticipate that this Act,  which really was not passed
 for environmental  purposes,  may  have  environmental   fallout.
 Nevertheless, we feel the very  strong need for a more direct au-
 thority  to handle materials on a much more direct  scale than  is
 provided by these rather peripheral and tangential types of authori-
 ty.                                   ;

     These are a couple  of basic  philosophies that I would like  to
 impart to you regarding EPA thoughts in this area.  One is. that
 there is a growing feeling within the Agency that the intelligent and
 most effective and most economical way to handle problems of envi-
 ronmental contamination  is not by add-on devices on the smokestack
 or  the outfall pipe,  but rather by looking more closely at what  is
 really going on inside the plant and seeing what we can do to prevent
 the production of a pollutant in the first place.

     We also  feel that there are many  toxic products which can be
 safely used, including'many industrial and intermediate type prod-
 ucts.  I'm speaking now of products which can be safely used in an
 environmental sense,  not in terms of occupational problems.   In
 looking back at problems that have been of  concern up to the present
 time, it seems that by being a little more careful about how we can
 do  things, we can probably avoid a  lot of problems which we are
 now getting into. A  good example is mercury contamination of our
 waterways; it is largely just  a result of poor housekeeping on the
 part of certain industries.                          • .         • •

     Undoubtedly there will be some materials that we are going  to
 find are impossible  toxic substances and that we are going to have
 to abandon eventually. This may mean in some cases giving up cer-
 tain conveniences we now have,  although  probably not to any great
 extent.

     We are quite concerned with evaluating potential substitutes for
 toxic materials.  We are also very concerned .with the problem of
 trying to create an economic situation where a manufacturer will
                              145

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find it to  his benefit to use a safe alternative to a dangerous raw
material  even though it may cost him a penny or two a pound more.

    And finally there is a need forbetter industrial processes so that
we can produce  some  of the products that we use and enjoy in this
country and eliminate  some  of the contaminants  which are present
in these products and are causing us all kinds of problems.  One
thing  that  comes to mind in this regard  is the prevalence of dioxin
in 2,4, 5-T. It is generally felt that the dioxin is a general environ-
mental threat  much more severe than the herbicide itself.   If we
could make 2,4, 5-T which is free of dioxin, the Agency would feel
much better about  continuing its use as a herbicide.   Do not read
into that  any implication that the  Agency has made  a decision on
2,4, 5-T,  because it has not.

    Another example is the problem  of cadmium which may be con-
tained in zinc. Many people feel that  cadmium is a serious environ-
mental pollutant.   There are considerable data to substantiate  the
fact that cadmium  has severe adverse health  effects even at rela-
tively low concentration.  It's ores  occur with those of zinc, and
one of the principal routes of  entry of cadmium into the environment
comes from the fact that cadmium is entrained with zinc in existing
metallurgical processes.

    Both  the legislation and  the operating philosophy of the Office
realize that there are other considerations besides direct health and
ecological considerations.  Nevertheless we consider the health and
ecological considerations to be of primary importance  ifjfor no other
reason that if there is no health or ecological threat from the mate-
rial,  there is no reason for us to worry about  it and look at  the
other aspects that need to be  considered.

    But there are economic  factors which come into play in various
ways. We do have to worry about creating large-scale unemploy-
ment. We do  have to  worry about large-scale  disruption of  the
lifestyle or the economy, which of course, would occur if we started
to ban large numbers  of chemical products on a wholesale basis.

    We are worried very much about an abstract being which we
refer to as "social utility"  which is very  close to  the  quality of
life factor which is often mentioned.   I know you appreciate that
there are  many things which have a convenience or an aesthetic or
a general  humanitarian value which  our society recognizes as  far
in excess  of any economic value we put on the product.  An example
often  cited to  the Agency  is 'the use of  DDT for malaria control.
The economic impact of its use is probably minimal, yet most people
recognize the  social impact could be  great.

    We have to worry very much  about the state of technology.   It
is very nice for us  to say  that  you shall make  2,4,5-T without
dioxin.   But if  that can't be  done, this is tantamount to saying that
you shall  not make 2,4, 5-T.                 •    .
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    We have to worry about what alternatives are available.  If you
go out and  say that 2,4, 5-T is  dangerous,  everybody says, "Fine,
I won't  use  2,4, 5-T,  I'll  use  	, " and we  do not yet know
whether 	 is dangerous.  We may be jumping from the frying
pan into the fire.
    These are all very  important considerations of which  we are
aware.

    There is one more point I want to make.   I want to address the
question.   "Exactly what is the government going to do in order to
solve all these problems for industry?"  I have a very unpleasant
answer for you.   The government is not going to do very much.
Basically,  it  is the philosophy in the EPA that the costs  of testing
products and costs of ameliorating the risks imposed on society by
products should be  borne  by  the persons who  derive the  benefit
and not by the public at large.  The way to accomplish  this is to
require that the costs of testing, of control, of design modifications,
or whatever else is necessary to ameliorate the difficulty  should be
borne by the industry  producing the  product,  with the general as-
sumption that this industry  will, in the normal course of business,
pass these costs on to its customers.  The government should not
get into the business of spending tax dollars  to develop industrial
process or control technology except  in very exceptional cases.
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                                   TECHNICAL REPORT DATA
                            (Please read Instructions on the reverse before completing)
1. REPORT NO.
      EPA 560/4-76-002
                                                            3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
                                                            5. REPORT DATE
                                                                     May 1976
      Selected Aspects of the Control  of Toxic Substances
                                                            6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
                                                            8. PERFORMING ORGANIZATION REPORT NO.
      Office of Toxic Substances
9. PERFORMING ORGANIZATION NAME AND ADDRESS
      U.S. Environmental  Protection  Agency
      Office of Toxic Substances
      401 "M" Street, SW
      Washington,  DC  20460
                                                            10. PROGRAM ELEMENT NO.
              11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
      U.S. Environmental Protection  Agency
      Office of Toxic Substances
      401 "M" Street, SW
      Washington,  DC  20460
              13. TYPE OF REPORT AND PERIOD COVERED
                        Final
              14. SPONSORING AGENCY CODE
15. SUPPLEMENTARY NOTES
16. ABSTRACT
           This collection of speeches  by members of  the staff of the Office of
      Toxic Substances in large measure reflects the  evolution of the interests,
      policies, and  programs of the  Office during the last several years.   Hopefully
      this collection, and particularly the more recent items, will be  helpful  to
      specialists  and persons concerned with governmental  policies and  objectives
      in this area.
17.

a.
                                KEY WORDS AND DOCUMENT ANALYSIS
                  DESCRIPTORS
 Domestic and  International Economics
 Flame Retardant  Chemicals
 Impact of Water  Chlorination
 Control of Toxic Substances
 Mutagenic Assay  Development
 Chemicals in  Printing Operations
 Polychlorinated  Biphenyls
b.lDENTIFIERS/OPEN ENDED TERMS  C.  COSATI l;icld/Group
13. DISTRIBUTION STATEMENT
      Release Unlimited
                                              19. SECURITY CLASS (This Report)

                                                 Unclassified
                                                                          21. NO. OF PAGES
20. SECURITY CLASS (Tills page)
   Unclassified
                               JL56L
                                                                          22. PRICE
EPA Form 2220-1 (9-73)
                                           IH'I

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