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
-------
This page intentionally blank
-------
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
-------
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.
-------
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
-------
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
-------
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.
-------
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-
-------
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.
-------
-- 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
-------
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:
-------
"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-
-------
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.
-------
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
-------
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
10
-------
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.
11
-------
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
-------
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
-------
. 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
-------
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
-------
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
-------
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
-------
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
-------
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. •
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
'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
-------
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
-------
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
-------
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
-------
"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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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.
51
-------
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-
53
-------
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
54
-------
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
55
-------
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
-------
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
57
-------
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
58
-------
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.
59
-------
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
61
-------
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
62
-------
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.
63
-------
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.
64
-------
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.
65
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
79
-------
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
80
-------
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.
81
-------
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.
82
-------
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.
83
-------
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.
84
-------
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.
85
-------
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
86
-------
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
87
-------
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,
88
-------
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
89
-------
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.
90
-------
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
91
-------
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
92
-------
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.
93
-------
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.
94
-------
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.
95
-------
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
96
-------
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
97
-------
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
98
-------
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.
99
-------
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.
100
-------
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?
101
-------
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
102
-------
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
-------
in the utilization of models being developed as well as for com
parisons with "known" compounds.
Thank you for your attention.
104
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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-;
118
-------
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
119
-------
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.
120
-------
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
121
-------
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
-------
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
-------
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. ,
124
-------
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.
125
-------
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,
126
-------
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.
127
-------
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
128
-------
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.
129
-------
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-
131
-------
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.
132
-------
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
-------
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
142
-------
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
143
-------
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
-------
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
-------
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. • .
146
-------
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.
147
-------
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
------- |