PB-243 459
A FRAMEWORK FOR THE CONTROL OF TOXIC SUBSTANCES
(A COMPILATION OF SPEECHES)
Glenn E. Schweitzer
Environmental Protection Agency
Washington, D. C.
April 1975
DISTRIBUTED BY:
National Technical Information Service
U. S. DEPARTMENT OF COMMERCE
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BIBLIOGRAPHIC DATA
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4. Title and Subtitle
1. Report No.
EPA 560/4-75-004
A Framework for the Control of Toxic Substances (A Compilation
of Speeches)
Report Date
April 1975
6.
Of. of Toxic Subs., EPA
7.
Office of Toxic Substances, EPA
8. Performing Organization Rept.
No.
9. Performing Organization Nome and Address
Office of Toxic Substances
Environmental Protection Agency
401 "M" Street, SW
Washington, DC 20460
10. Project/Task/Work Unit No.
None Assigned
11. Contract/Grant No.
NA.
12, Sponsoring Organization Name and Address
Same as No. 9.
13. Type of Report & Period
Covered
ompilation of Speeches
14.
IS. Supplementary Notes
Collection of speeches of the Director of the Office of Toxic Substances from April
1973 to March 1975.
16. Abstracts
This collection of speeches 1n large measure reflects the evolution of the interests,
policies, and programs of the Office of Toxic Substances from April 1973 to March 1975
The speeches deal with questions that are of broad national concern: the identifica-
tion of chemical hazards, the need for development of toxicological and other data
on chemicals, the pending Toxic Substances Control Act, and need for regulation
to control toxic chemicals.
17. Key Words and Document Analysis. 17a. Descriptors
a. Toxic Substances Control, Regulation of Chemicals, Economic Aspect of Control,
Vinyl Chloride, Testing of Chemicals
I7b. Identifiers/Open-Ended Terms
b. Toxic Substances Control Act, Chemical Industry, Testing of Chemicals, Regulation
of Chemicals
i7c.cosATi Fieid/c,rouP c> TOX1C Substances Control Act, Office of Toxic Substances
18. Availability Statement
19. Security Class (This
Report)
UNCLASSIFIED
20. Security Class (This
Page
UNCLASSIFIED
121 No. of Pages
FORM NTIS-SB IBEV. 10-73) ENDORSED BY ANSI AND UNESCO.
THIS FORM MAY BE REPRODUCED
U3COMM.DC 828S-P74
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EPA 560/4-75-004
A FRAMEWORK FOR THE CONTROL OF
TOXIC SUBSTANCES
A Compilation of Speeches by
Glenn E. Schweitzer
Director
Office of Toxic Substances
Environmental Protection Agency
Washington, DC 20460
April 1975
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PREFACE
This collection of speeches by the Director of
the Office of Toxic Substances in large measure re-
flects the evolution of the interests, policies, and
programs of the Office from April 1973 to March
1975. In most cases, the activities of the Office have
reflected broad national concerns of interest to many
Federal agencies and to many non-Governmental or-
ganizations. Hopefully, this collection, and particu-
larly the more recent statements, will be helpful to
specialists and other persons concerned with Govern-
mental policies and objectives in this field.
Many of the ideas set forth in the speeches origi-
nated with different members of the Office staff, and
these contributions are gratefully acknowledged. Also
deserving special recognition is the unfailing secre-
tarial assistance of Mrs. Willie Wheeler and Ms.
Carol Kilgore in preparing texts that are invariably
put into final form under very tight deadlines just
prior to the presentations.
1H
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TABLE OF CONTENTS
The Risks, the Benefits, and
the Costs
18
Preface
1
TOXIC SUBSTANCES: LEGISLATION, GOALS
AND CASE STUDIES I
Toxic Substances Control Act '
Program Goals 2
Case Histories 3
ECONOMIC ASPECTS OF TOXIC
SUBSTANCE CON ROL S
Milestones During 1973 5
What Is Unique in Addressing Toxic S
Substances?
Some Considerations in Risk/Benefit 6
Analysis
Internalization of Social Costs 6
The Energy Crisis and Toxic Substances 7
Toxic Substances in the Mid-1980's 7
1974—A YEAR OF TRANSITION . 9
The Issues for 1974 9
The Chemical Industry and
Policy Issues 11
Looking Ahead 12
EPA PROGRAM INTERESTS AND TESTING 13
Testing Required of Industry 13
Policy Concerns in Developing Requirements 13
for Industrial Testing
Governmental Support of Testing 14
The Use of lexicological Data 14
ENVIRONMENTAL CONCERNS BEYOND 15
THE WORKPLACE
EPA Regulatory Authorities 15
The Materials Balance 16
The Need for Epidemiological and 16
Toxicological Studies
Monitoring, Persistence, and Migration 17
Studies
Concerns Over Disposal of PVC 18
CHEMICALS, THE ENVIRONMENT. AND 19
REGULATION
Toxic Substances Control Act
Chemicals and Corporate
Responsibility
The Vinyl Chloride Case Study
Toxic Substances in the Mid-1980's
20
21
22
23
REGULATORY ASPECTS AND RESEARCH 25
NEEDS
CHEMICALS AND THE ENVIRONMENT: THE 27
FUTURE IS NOW
Chemicals, the Worker, and the Environment 27
20,000 Chemicals 27
Vinyl Chloride—Better Late than Never? 28
The Need for a Legislative Mandate 30
Looking Ahead 30
VINYL CHLORIDE. THE TIP OF THE 31
ICEBERG?
Chemicals, Industry, and the Environment 31
The Case of Vinyl Chloride: Better Late 31
than Never?
Industry's Responsibility 33
Lessons Learned from the Vinyl 34
Chloride Experience
Looking Ahead 35
THE TECHNICAL IMPLICATIONS OF TOXIC 37
SUBSTANCES LEGISLATION
Limited Progress in 1974 37
Chemical Problems Continue to Emerge 37
Concepts Embodied in the Proposed Toxic 38
Substances Control Act
Prospects for 1975 40
CHEMICALS, REGULATIONS, AND THE EN- 41
VIRONMENT
Toxic Chemicals and the Soap and 41
Detergent Industry
A General Perspective 41
The Need for Toxic Substances 43
Legislation
Recent Enactment of Drinking Water 44
Legislation
IV
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Testing as a Key to Better
Understanding
44
TOXIC CHEMICALS AND REGULATORY 47
DECISION MAKING: PHILOSOPHY AND
PRACTICALITY
The General Framework 47
Trends in Regulatory Decision Making 47
Needs of Regulatory Decision Making 43
in the Near Future
The Scope of this Meeting 48
Examples of Practical Regulatory 49
Problems
The Output from this Conference SO
The Control of Toxic Substances in the 50
Years Ahead
CURRENT TRENDS IN THE CONTROL OF 51
CHEMICALS
The Rapid Growth of Chemical Problems 51
The Development of the Legislative Basis 51
for Controlling Toxic Chemicals
Intercepting the Problem at the Outset 52
Cost/Risk/Benefit Considerations 52
The Special Responsibilities of 53
Industry
A New Departure towards Common 54
Understanding
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TOXIC SUBSTANCES: LEGISLATION, GOALS,
AND CASE STUDIES
The Fourth Annual Conference on
Environmental Toxicology
University of California, Irvine
Fairborn, Ohio
October 16. 1973
I had hoped to be able to report to you today on
the passage of the Toxic Substances Control Act of
! ^73 and the initial steps being undertaken in the
implementation of this new law. However, there are
a number of complicated aspects of the legislation,
and it will still be some time until the conferees for
the Senate and the House are able to reconcile the
differences that exist in the two versions of the bill
passed in July by these bodies. We arc optimistic that
agreement soon will be achieved on nil provisions
and that this much needed regulatory authority to
control toxic substances will become luw.
In view of I he uncertainty as to the details of the
proposed legislation, I have decided to refer t<> its
specific provisions only briefly today and then
concentrate on some of the broader aspects o( our
overall program. Specifically. I plan to set forth
si-mc of the general goals of our approach to the
control ol toxic substances and then discuss severa I
case histories of very recent concern to us, the
problems toxic substances are causing in these
instances, and those aspects of the problems of
particular interest in toxicologists.
TOXIC SUBSTANCES CONTROL ACT
The proposed Toxic Substances Control Act
Mould give EPA new authority for (a) information
acquisition, and (b) restrictive actions. EPA could
require testing of chemical substances (both existing
and new) which are suspected to pose unreasonable
risks and also require other information from
manufacturers including the name of the substance,
chemical formula, amounts produced, actual or
intended uses, and known by-products. EPA could
then restrict the use and distribution of chemical
substances found to pose unreasonable risks. The
Agency could prescribe the amounts of a chemical
which may be sold to processors, limit the type of
processor to whom it may be sold, restrict the
amount a given type of processor may use, or limit
the sale or manner in which a substance may be used,
handled, labelled, or disposed by any person.
This new authority is important from two
standpoints. First, the Federal Government is given
direct authority to restrict substances presently in
commercial use (hat arc known to cause health or
environmental hazards, and when effects
information is lacking, to require testing of the
substance by the manufacturer to assess human or
environmental impact. Second, for substances not
yet in commercial production, the Agency could
require premarket testing and review of chemicals
suspected to be hazardous. The Agency would have
the opportunity to assess the risks before the new
substances arc commercially produced and to take
appropriate regulatory action to prevent toxic
incidents.
Given the extensive scope of the legislation, the
number of areas of initial emphasis will depend to a
significant degree on the staff and resources
available for implementation activities. In selecting
areas for priority attention consideration should be
given to Congressional mandates, severity and
urgency of existing problems which can be alleviated
by the new authority, opportunities to reduce future
problems of major dimensions, and necessity for
establishing long-term viability of implementation
procedures.
While the final version of the legislation may
influence the choice of initial activities, it seems
clear that the following activities should be high on
'.he agenda for early attention:
Elaboration and articulation of the criteria or
sets of criteria to be used, in weighing risks
versus benefits, and in determining when
regulatory action is needed. Clear
understanding by both industry and
Government of the ground rules for
restrictions is essential to the viability of
industrial R & D activities.
Determination of the character and scope of
initial testing requirements, including the
possibility of umbrella testing requirements .
for a broad range of chemical classes, and
identification of specific chemicals or classes
or chemicals of particular immediate concern.
While the selection of substances covered by
the standards for test protocols that are
initially promulgated will in large measure
reflect intuitive judgments concerning likely
ha/ardsand inadequacy of current data,
concurrent work is needed to provide a basis
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over the longer term for selecting areas of
concern.
— Development of regulations setting forth
timing, coverage, content, and format of the
reporting requirements for chemical
manufacturers and processors, including both
annual reporting and premarket notification,
as appropriate.
— Establishment of a data system for handling
the industrial reports and test results that are
submitted. Experience in the pesticide area
underscores the importance of early attention
' to establishing efficient and decision oriented
procedures to be effective when the first
reports arrive.
PROGRAM GOALS
Considering our program in its broadest sense,
our goals arc quite straight forward and are directed
to:
— clarification of the risks to health and the
environment associated with the.manufacture,
distribution, use, and disposal of new and
existing chemical substances, with particular
regard to chemical properties, production
levels and trends, and exposure of the
chemicals to man and the environment;
— more effective utilization of regulatory
authorities and related tools available to the
Agency to mitigate such risks, taking into
account the economic and social impact of
restrictions on toxic substances; and
— increasing the concern of and appropriate
actions by the chemical and related industries
to reduce risks to health and the environment
associated with their activities.
Of particular interest is the emphasis placed on
the responsibility of industry, for it is the course
taken by industry—with and without direct
Governmental encouragement—which will largely
determine the environmental risks posed by
chemical substances in the years ahead. The
importance of this industrial stewardship is apparent
when it is re-.'.i^ed that the annual value of chemical
substances manufactured in the United States which
are not subject to existing regulatory authorities
exceeds $150 billion.
Now let us turn to several specific activities of
interest, starting with the concept of early warning. In
this area our general goal is to identify and prioritize
previously unsuspected chemicals entering the
environment which are most likely to pose a
significant hazard to man or the environment in the
near future. Subgoals include:
— Criteria: To develop criteria and techniques
for determining on the basis of minimal
information which chemical substances should
be of greatest concern.
— Expert Opinion: To mobilize and use expert
opinion to assist in rapidly screening large
numbers of chemicals and predicting potential
problem substances.
— Data Analysis: To collect, collate, and
synthesize data from sources such as
monitoring, trend assessment, and industrial
reporting on those chemicals which appear to
deserve the highest priority in a manner that
will facilitate judgments as to whether the
chemicals should be candidates for further
investigations, testing, and/or control.
A second activity which is of particular interest to
this group is testing. In general, we are attempting to
improve the approaches by Government, industry,
and the scientific community to testing of chemical
substances enter ing commerce. Again, I would like
to underscore the role of our industrial firms as we
delineate our subgoals:
— Industrial Stewardship: To encourage
increased industrial concern and appropriate
action in testing both new and existing
chemicals.
— Regulatory: To require or encourage, as
appropriate, industrial testing of specific
chemicals for which inadequate data
concerning the risks associated with the
chemicals is available but which are suspected
to pose a hazard to manor the environment.
— Experimental: To provide experimental data
needed to determine appropriate standards or
restrictions for specific chemicals of near-term
concern.
— Public Awareness: To bring test data
concerning the safety of chemicals into public
view, in a way that will not compromise trade
secrets, thus facilitating a broader base of
understanding and inputs for evaluating the
necessity for restrictions for such chemicals.
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A third area of interest is research, recognizing the
overlaps between activities that arc classified as
research and programmatic activities. While the
research interests of EPA encompass many areas, the
three types of activities of priority interest to my
Office are:
— Test Methods: To stimulate development of
faster, cheaper, and/or more reliable test
methods, with particular emphasis on
approaches that provide data needed for
specific types of regulatory actions.
:— Trend Assessment: To improve assessments
and forecasts of technological developments,
economic and market trends, and material
production and use patterns which can assist in
anticipating environmental problems resulting
from chemical substances entering the
environment.
— Estimation of Exposure: To develop and apply
methods and background data needed for
assessing the extent of environmental and
human exposure to selected chemical
substances, including consideration of
environmental transport, persistence, routes of
entry into the environment, bioconcentration
and bioaccumulation, environmental
degradation, and retrospective, and
retrospective monitoring through sample
banking.
CASE HI STORIES
Recent discovery of hcxachlorobenzene (HCB) in
the fat of animals brought to slaughter has focused
attention on the hazards of this material. The most
serious case involved cattle in central Louisiana.
Other incidents of HCB contamination in the past
year have involved sheep in western Texas and in
eastern California. Sources of HCB in Louisiana
appear to be airborne emissions of manufacturing
plants which produce chlorinated hydrocarbons and
waste disposal practices of these plants. The Texas
and California situations have, been associated with
pesticides which were contaminated with HCB.
An immediate problem confronting EPA earlier
this year was the determination of a permissible
level of residues of HCB in food. In response to a
request from the Department of Agriculture, EPA
reviewed available data on the toxicology of HCB,
and concluded that it was not adequate to permit
establishment of a tolerance level for HCB in food.
This was confirmed in consultations with scientists
in the Departments of Agriculture and Health,
Education, and Welfare, and with other members of
the scientific community.
Nevertheless, HCB occurs in food frequently
enough that some guidance is necessary to protect
public health. An experience in Turkey in the mid-
fifties vividly demonstrated the health effects of
HCB when ingested over a long period. There is,
however, no experience which indicates the effects of
low doses on humans. Attempts in the United States
and abroad to determine the safe level of HCB in
experimental animals have been extremely limited
and sporadic, and at present there is a lack of
authoritative data. Experiments on a variety of
animals have been limited in design, scope, and
duration. Meaningful inferences are difficult to
draw although there are indications that repeated
dosages of HCB at low levels may be harmful.
Related to these uncertainties is the unknown
extent which meat products with low levels of HCB
residues are likely to reach individual consumers on
a repetitive basis. The sources of HCB of immediate
concern are confined to very small geographic
pockets which traditionally disperse a significant
portion of their products to markets around the
country. Similarly, little information is available for
assessing the economic impact of alternative
tolerance levels. In the original Louisiana
quarantine area, for example, there were up to
20,000 food animals with HCB in their fat at levels
ranging from O.I u>6.0ppm. However, the extent
that these levels could be reduced through fattening
with clean feed and through natural processes prior
to slaughter is uncertain. Similarly, the cost and
success of biochemical methods to reduce the levels
are difficult to assess. There are many other
economic costs related to establishing a tolerance
including the impact on the value of contaminated
land, the costs of alternative feed supplies and the
long-term impact on animal herds. Data are not
available to assess these types of impact.
Furthermore, the extent and levels of HCB residues
which will appear in the months and years ahead in
many areas of the country cannot be predicted.
On June t, EPA recommended an interim action
guideline of 0.5 ppm HCB in the fat of cattle, swine,
sheep, horses, and goats at the time of slaughter.
This was based on analysis of the best data available,
including toxicological studies and economic
considerations. At the same time several
toxicological. epidemiological, ecological, and
economic studies are being launched to provide an
improved basis for determining the permissible level
as the guideline is periodically reviewed.
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A second set of interesting case histories relates to
the emission standards for hazardous pollutants
established in April of this year under the Clean Air
Act. Limitations were set on mercury, asbestos, and
beryllium. While toxicologists have been concerned
with these standards, toxicology data which is
useable in quantifying an acceptable level of risk for
these substances has been conspicuous by its absence.
In the case of asbestos, the association between
occupational exposure to asbestos and higher-than-
expccted incidence of bronchial cancer was
recogni/ed. Also, asbestos has been identified as a
causal factor in development of cancers of the
membrane lining the chest and abdomen. However,
the lack of adequate quantitative data correlating
asbestos exposure to these and other malfunctions,
together with the difficulty in measuring asbestos
emissions, made establishment of allowable
numerical concentrations impractical. Therefore,
the standard relies largely on limitations on visible
emissions and on the specification of related air
cleaning technologies.
With regard to beryllium, the AEC limit of 0.01
micrograms/cubic meter, which was set in 1949. has
been adopted as the basis for the emission standard.
In the period since the implementation of the AEC
guideline, no reported cases of chronic beryllium
disease have occurred as a result of community
exposure, and (he Committee on Toxicology of the
National Academy of Sciences has concluded that
the AEC guideline represents a safe level of
exposure.
Now turning to mercury, it seems clear that the
airborne burden must be considered together with
the water- and food -borne HJ: dens. An expert group
concluded, based on its analysis of several episodes
of mercury poisoning in Japan, t^at 4 micrograms of
mcthylmercury per kilogram of bodyweight per day
would result in the intoxication of a sensitive adult;
application of a safety factor of 10 yielded an
acceptable exposure of about 30 micrograms per day
tor a 70-kilogram man, and this level is also
believed to provide satisfactory protection against
genetic lesions and poisoning of the fetus and of
children. It has been estimated that from average
diets, over a considerable period, mercury intakes of
10 micrograms per day may be expected, so that, in
order to restrict total intake of 30 micrograms per
day, the average mercury intake from air would
have to be limited to 20 micrograms per day.
Assuming inhalation of 20 cubic meters of air per
day, the air could contain an average daily
concentration of no more than I microgramof
mercury per cubic meter. Thus, this level serves as
the basis for the standard.
A third type of case history concerns current
efforts to set toxic pollutant effluent standards under
the Federal Water Pollution Control Act. On
September 7, EPA gave notice that standards would
be set on nine toxic pollutants. This standard setting
activity is currently underway with a publication
date of early December for the proposed standards.
Included on the list of pollutants are cyanide whose
acute toxicity properties are of major concern,
cadmium and mercury which are associated with
major chronic toxicity problems, and benzidine, a
known carcinogen. The adequacy of toxicological
data for supporting these standards varies from
substance to substance, but I can assure you that in
some instances it is sorely lacking. Nevertheless, in
all nine cases we are faced with the necessity to make
judgments as to an acceptable level or risk. When
the proposed standards are promulgated, the
toxicology community hopefully will take the time
to offer suggestions for improving the proposed
approaches, for refining the interpretations of test
data, and for generally pointing the way for future
standard setting activities as they relate to the use of
toxicological data.
In short, there are two types of problems related
to toxicological data in setting standards in the near-
term. First; how can the minimal test data which is
available be most effectively used;and, secondly,
how can future testing activity be best oriented to
provide useable data for refining at a later date the
standards that are being set? As an outsider with
only brief exposure to the standard setting process
and to the use of toxicological data, I have the
general impression that there is not a good
impedance match, at least in some areas, between
standard setting needs and the orientation of testing
activities. Furthermore, it appears that this difficulty
is largely attributable to the failure of those of us
responsible for programs to articulate our needs
sufficiently far in advance to enable the scientific
community to respond.
As we prepare to set standards for test protocols
and to consider restrictive actions under the Toxic
Substances Control Act, the importance of clear
articulation of program needs takes on even greater
significance. I am confident that in the years ahead,
we will erode the communication difficulties
between the program operators and the research
community with society being the beneficiary.
Scientific data is interesting, but only if it is
useable. Or in the words of Frank Lloyd Wright,
"Science can only give us the tools in a box... .but of
what use to us arc miraculous tools until we have
mastered the human, cultural use of them?"
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ECONOMIC ASPECTS OF TOXIC
SUBSTANCE CONTROL
Symposium on Economics of a Clean Environment
The Mitre Corporation
McLean. VA.
January 16, 1974
MILESTONES DURING 1973
Several toxic substance milestones during 1973
vividly illustrated the complexities of risk and
benefit assessments. '
f-
' The chemical industry is still reverberating
from the Department of Labor's stringent
interim standards for handling 14 carcinogens,
including several of considerable commercial
importance.
' FDA banned the use of DBS as a feed additive
over the strong objections of the cattle ranchers.
* EPA's promulgation of final air emission
• standards and proposed water effluent
standards for toxic pollutants are causing major
adjustments in manufacturing practices at many
facilities.
* Promulgation of final leaded gasoline
regulations culminated several years of effort to
address the severity of the problem of lead.
fnhalation and human health.
* Discovery of high levels of asbestos fibers in the
Duluth water supply has catalyzed a large array
of technical talent to address what could turn
out to be either a sleeping giant or a false alarm
of major dimensions.
* The tussock moth outbreak on the West Coast
highlighted the environmental and economic
"disbenefits" resulting from the ban on DDT.
* The contamination of cattle in Louisiana and
sheep in California with hexachlorobenzene—a
by-product of chemical plants and also a
contaminant in pesticides—clearly showed that
the balancing of very uncertain lexicological,
epidemiological, and economic data is often a
near-term necessity.
WHAT IS UNIQUE IN ADDRESSING TOXIC
SUBSTANCES?
There are essentially two aspects of the toxic
substance problem, namely:
* Steps to clarify and mitigate, as appropriate, the
risks associated with chemicals which are
believed to pose a problem; and
* Selection from the remaining universe of
commercial chemicals—numbering more than
20,000—those chemicals which deserve
attention to determine if they pose an actual or
potential problem.
With regard to the first aspect—namely, reducing
the risks from suspected chemicals—the approach to
risk/benefit analysis is probably not much different
than assessment of the risks and benefits associated
with other products and pollutants. Determination
of the risk/benefit relationship is based largely on
value judgments, and not quantifiable approaches.
As with almost all environmental control measures,
assessment of the environmental gain to society from
proposed control measures is usually difficult.
Assessment of the economic and social impact of
specific limitations must take into account secondary
and delayed effects, as well as the more obvious
immediate effects.
Toxicological and epidemiological data are
usually the starting point for a numerical standard.
These data are frequently spotty, more often than
not generated for scientific rather than regulatory
purposes, and plagued with interpretation
difficulties. Frequently, for toxic substances, the law
constrains the balancing of this data on risks with
available data on benefits in arriving at an
appropriate standard (e.g., certain sections of the
Clean Air Act and the Federal Water Pollution
Control Act). However, this disregard of benefits is
not the recommended approach. There should be a
balancing of risks and benefits, and indeed in most
regulatory actions there has been some balancing
which is often subsumed in adjusting safety factors
and other parameters affecting the standard. Even if
the substance of concern has a clear "no-effects"
threshold, this threshold is not necessarily the
appropriate level for setting the standard. For all
s. Instances—including toxic substances which cause
similar effects—the risk component derived from
scientific data should be appropriately adjusted to
take into account exposure levels and to balance the
risks with the benefits.
While the approach to suspected chemicals seems
reasonably straightforward, the risk/benefit aspects
in the search for the other bad actors in the universe
of chemicals cannot be easily described. How much
is society ready to pay to search out these problem
substances before they emerge on the immediate
horizon? This question is the heart of the
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"uniqueness" of the economics of toxic substances.
' Another difference between toxic substances and
gross pollution concerns relates to the
environmental impact of control measures. While it
is relatively easy to begin to quantify the economic
value of clean rather than dirty water, the effects of
toxic chemicals cannot be aggregated and the
chemicals must be considered one by one.
Toxic substance activities are particularly
sensitive to our lack of analytical and monitoring
capability to detect the trace amounts of some
chemicals that should be of concern. A sensitive
capability is particularly important in dealing with
very small amounts since very slight deviations can
represent very large proportional changes.
Frequently, the concentration of interest is below the
level of detection; in some cases in the past we have
been sufficiently clever to devise ways to monitor
indirectly and to enforce limitations below this
level. In addition standard reference materials have
too long been neglected as is currently being
demonstrated in our efforts to acquire comparable
data at d ifferent laboratories on asbestos.
SOME CONSIDERATIONS IN RISK/BENEFIT
ANALYSIS
Toxic substance problems arise in several forms:
* Effluents, emissions, solid wastes, and other by-
products of manufacturing activities.
* Spills and other accidental releases.
* Worker or consumer exposure in a closed
environment to a toxic substance associated
with a product.
* Other direct exposure of man and/or the
environment to a troublesome product, either
in its intended or unintended use.
* General build-up of the chemical in the
environment from natural, multiple,or
unknown sources.
* Potential exposure of a product that has not yet
reached the market place.
A variety of control strategies, in addition to
simply installing well-known pollution control
technologies, are obviously available in addressing
these classes of problems. Such strategies include
banning the product, restricting the use of the
product, or requiring certain types of labels. Also of
increasing interest are financial incentives attached
to product lines (e.g., disposal charge, product tax)
which will encourage recycling and/or appropriate
disposal techniques.
' Limitations on new products require particular
care. At first appearance, it would seem easier for
society to rationalize limitations on a product which
does not have behind it a significant manufacturing
investment than restrictions on a product already in
commerce. However, this approach grossly
oversimplifies sensible benefit analyses. Also, in
determining future benefits to society of substances,
the economic potential of the market should not be
the only indicator. Rather, there should be an
assessment of the total social benefit of the product,
recognizing that this is easier said than done.
Finally, in some cases there may be near-term
economic disadvantages in spending R&D resources
for duplicative products; but given the shifting
nature of our industrial fabric and consumer
patterns, in the long run there may be economic
advantages in such an approach.
Related to the limitations on new products a£ the
effects of I imitations on incentives for industrial <
R> D, including both the direct effects on specific
products and the cumulative and indirect effects on
the R&D climate. In recent months, for example,
several large firms have abandoned R&D on
pesticides in view of regulatory disincentives for this
type of activity.
Finally, in the long run, public confidence in the
national approach to the control of toxic substances
will be a decisive factor. Thus, individual decisions
should take into account public concerns, and
should be cast In terms understandable and
persuasive to the layman.
INTERNAL1ZATION OF SOCIAL COSTS
Recent interest in the "internalization" of social
costs of environmental pollution has focused in large
measure on effluent fees or taxes. Where the
industrial discharge is an unwanted (but at least, for
the moment, unavoidable) by-product from the
production ot desired goods or services, and where
the benefits and social costs inherent in the
externalized subsidy of this production arc not
equitably shared, such an effluent tax provides a
potential mechanism for amelioration of the
inequalities.
The control of adverse effects from toxic
chemicals involves somewhat different concepts.
and internalization of social costs presents
inherently more complex problems. Three sources
iif adverse effects may be cited:1
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— The unavoidable side effects from the intended
use of (he product (e.g. environmental
contamination with lead from the use of TEC
in motor fuels).
— The use of a product in ways not intended by
the manufacturer (e.g. use of PCB'sasheut
exchange fluids in food processing plants).
— The disposal of the product after completion
of the intended use (e.g. mercury contamina-
tion from disposal of batteries or flourescent
tubes).
Approaches to internalize social costs by fees or
taxes should satisfy three criteria. They should be
— effective in motivating changes in behavior
(hat tend to reduce the social costs.
— equitable in allocating benefits and burdens
upon the various affected segments of society.
— efficient in transferring the dollar costs
imposed upon the user of the "toxic material"
to those responsible for ameliorating damage
or the loss in environmental quality.
The costs to society associated with toxic
substances incTude:
— Costs of the regulatory agencies.
— Economic losses from condemnations or
destruction of products already in commerce.
— Added costs of products as a result of higher
development costs and lessened productivity •
of industrial R&D.
— Loss of benefits from products not reaching the
marketplace.
Benefits accruing to society include both
abatement of environmental hazards from existing
chemicals and avoidance of environmental hazards
by anticipatory actions. In all probability, even in
the immediate future, the hidden costs and benefits
will fa> outweigh the direct measurable costs and
benefits, thus further complicating any type of
comprehensive approach to internalizing costs.
THE ENERGY CRISIS AND TOXIC
SUBSTANCES
There are a variety of concerns related to toxic
substances as the energy crisis begins to impact on
the economy. Cutbacks in petroleum feed stocks
could drive industry to new processes and product
mixes involving toxic substances. However, at this
time there is no reason to expect a relaxation of
safety standards by industry or Government to case
the accommodation of such new processes ami
products.
A more troublesome problem relates to the by-
products of new energy sources, e.g., vanadium
associated with oil shale, toxic metals found in coal,
acid run-off from strip mines. Specific regulatory
steps may be necessary in these cases to insure that
environmental concerns are not lost in the race for
new energy sources.
A final consideration concerns environmental
control strategics which could lead to greater energy
requirements. Environmental restrictions that
reduce manufacturing efficiency arc in this category.
Also, specific product restrictions could aggravate
energy problems. For example, the DES ban has
forced the use of less efficient feed additives. As a
second example, a limitation on the use of mercury
in flourescent lights would force a return to
incandescent bulbs which require two and one-half
times as much ene'rgy per unit of light.
TOXIC SUBSTANCES IN THE MID-198()'S
By 1985, more chemicals will be in commerce, the
properties of many chemicals will he better
understood, and consequently the list of chemicals
considered to be hazardous to man and the
environment will undoubtedly be much longer.
Also, improved research and analytical capabilities
will show that the effects of these chemicals—acting
individually and syncrgistically—are much farther
reaching than currently suspected effects.
From the toxic substance point of view the quality
ol life in the chemical age of the Eighties, relative to
the current quality ol life, depends, in large measure,
on the outcome of the competition between
population and economic growth on the one hand
and the sophistication in approaches to responsible
regulation—by both industry and government.
Clearly, more people will he exposed to more
chemicals in more situations. Hopefully, we can
develop the necessary precualionary measures that
will limit exposure to chemicals when necessary, but
not unnecessarily curtail commercial activities.
There is. of course, a danger that society will not
act responsibly toward toxic substances through its
Governmental and other institutions, with the
inevitable outcome of endless legal confrontations.
The entire approach to toxic substances could
become bogged down in the courts. To avoid such a
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situation, the highest quality of government
leadership in this area is essential—leadership
characterized by technical credibility and openness
in dealing with controversial data.
If the regulatory pattern of the Sixties and
Seventies continues, during the Eighties the number
of toxic substances other than chemicals associated
with foods, drugs, cosmetics, and pesticides
regulated by Government will be relatively few—in
the dozens rather than hundreds pr thousands.
However, each of these regulatory decisions will be
significant in that they will set the framework and
the standards for the efforts of industry in self-
regulation of the bulk of the industrial chemicals.
Industry will probably be using testing and related
approaches to product safety which are not
significantly different from current approaches. The
Governmental thicket of regulations will
undoubtedly drive some of the smaller companies
out of new product development. Concurrently.
closer Governmental scrutiny of industry activities
will be necessary in the face of potential antitrust
problems as the larger companies consolidate their
positions.
By 1985, most of the emission stacks and effluent
pipes will be plugged. Our toxic substance concerns
will center largely on contaminants, non-point
sources, direct product exposure, and generally
unattributable build-up of toxic chemicals in the
environment. And, as the gross pollution effects
subside, previously undetected effects of individual
and combinat ions of chem icals in the water and in
the air will probably be unmasked.
Risk/benefit approaches should be well accepted
within a decade, although concerns will penetrate
much more deeply into social as well as economic
values. There should be far less concern over public
acceptance of the concept of accepting different
levels of risk for different chemicals, depending on
their social utility. Indeed, the economics of a clean
environment should be much closer to a reality.
Note: This text is based on contributions by a
number of panel members. .
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1974—A YEAR OF TRANSITION
Seminar on Early Warning Systems for
Toxic Substances
Battelle Memorial Institute
Seattle, Washington
January 31. 1974
During the past several weeks, talk in Washington
has centered in large measure on the achievements
during 1973—or perhaps we should say the events
during 1973. All agree that it was a tumuttous year
with our domestic and environmental concerns
largely overshadowed by unprecedented political
events at home and abroad.
i 1973 was to be the year when the momentum of
the environmental movement began to take us
around the corner in cleaning up the air and the
water. Our arsenal of regulatory tools for insuring
product safety and sound disposal practices was to
be expanded. And a degree of harmonization was to
be achieved between economic progress and
environmental controls.
But this was not the case. Energy concerns
threatened to reverse past environmental gains.
Congressional attention was diverted from the
-derails of environmental legislation. And perhaps
most unfortunately the influx of top young talent
into the environmental picture seemed to slacken.
However, environmental milestones were far from
lacking during 1973. For example, in the area of
toxic substances:
— The chemical industry is still reverberating
from the Department of Labor's stringent
interim standards for handling 14 carcinogens,
including several of considerable commercial
importance.
— FDA banned the use of DF.S as a feed additive
over the strong objections of the cattle
ranchers.
— EPA's promulgation of final air emission
standards and proposed water effluent
standards l.n toxic pollutants are causing
smajor adjustments in manufacturing practices
at many facilities.
— Promulgation of final leaded gasoline
regulations culminated several years of effort
to address the severity of the problem of lead
inhalation and human health.
— Discovery of high levels of asbestos fibers in
the Duluth water supply has catalyzed a large
array of technical talent to address what could
turn out to be either a sleeping giant or a false
alarm of major dimensions.
— The tussock moth outbreak on the West Coasi
highlighted (he environmental and economic
"disbcncfits" resulting from the ban on DDT.
— Finally, the National Center for Toxicologicul
Research in Pine Bluff. Arkansas, became a
viable operation that is making its mark in the
regulatory world.
THE ISSUES FOR 1974
While the number and diversity of issues in the
environmental field continue to grow, many of the
most important questions to be addressed in the
immediate future in my specific area of concern are
the well-known "old chestnuts". Traditionally, we
tend either to take these issues for granted or skirt
them because of their difficulty. In either case we
then focus on other questions which are also
important but which could be irrelevant if our
tin. lamental approach is not sound. Let me cite four
• if1 "ild chestnuts" which are currently near the
•i »ur list.
TfSiiiif; and Standard Scttini;: Can We
D U -;ter?
Emblazoned in laws and in the Federal Register
are standardized approaches to a very complicated
science — standardized approaches that date back
many years and, having gained a type of legal status,
seem almost immune from scrutiny and revision. As
an engineer I should feel comfortable in surrounding
the biological sciences with accepted quantifiable
approaches and easily defined safety factors, but I
am not. In my view, a thorough review — initially by
the scientific community itself — of the currently
accepted approaches to generation and
interpretation of test data is needed.
hi this regard. KPA recently proposed a
numerical standard for the carcinogen hcn/idine
based on the concept that in determining the
standards, the level of risk which is acceptable must
be considered in the light of the benefits derived
from the chemical. Derivation of this level of risk
requires types of test data not ordinarily generated
by toxicologists. thus suggesting a significantly
different approach to testing carcinogens, and
perhaps other chemicals as well.
In large measure the issue revolves around how
the scientist packages the toxicological data for the
decision-maker. It the scientist structures the
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experiment and packages the data to derive simply a
"safe" level for chemical exposure, then the
decision-maker has only one option, and all other
factors become irrelevant. The scientist has in fact
assumed responsibility for consideration of the total
impact of a regulation on society. On the other hand,
if the scientist presents several options, with
explanations of the health and environmental impli-
ations of each, then the decision-maker can indeed
take into account a wide range of social and
economic implications at different levels of
chemical exposure.
Risk/ Benefit Aspects of Toxic Substances: The
Theorist or the Pragmatist?
Even though toxic substances are by definition
dangerous to health or the environment, there seems
to he general agreement that in developing control
strategies some balancing of risks and benefits is in
order, as reflected in the EPA action on benzidine.
In the past, elaborate cost/benefit models have
frequently had little operational relevance. At the
same time we must do better than those past efforts
th:i; tend to focus only on the short-term, direct costs
olVi \ irohmental controls which are susceptible to
i|u. nation.
I ps the most formidable task is estimating (he
i ual gains to society—or the reduction of
rix . :- cicty—by decreasing (he level of a toxic
subs; ic« entering the environment. Human
poisoning, fish kills, and flora destruction can of
course frequently be related to specific discharges.
Rut those near-term, easily isolated incidents which
can he used to correlate discharge levels with
economic and social impact arc (he exception rather
than the rule. A second problem is to estimate how
much the level of exposure will be reduced by a
specific control measure. Even it good monitoring
data exist concerning current exposure levels, to
project ahead the impact of a proposed measure is
difficult indeed. And finally, ot course, is the cost of
the control measure, which usually involves much
more than simply purchasing control devices. For
example, in response to the Department of Labor
restrictions on carcinogens, one company was forced
to replace the carcinogen with another intermediate
chemical which turned out to be far more
cost /effective for the particular process. Had it not
been for the regulation, and subsequent R and D
effort by the company, this cost-saving innovation
would still be lying dormant.
What should be the approach to risk/benefit
analyses? With regard to the known problem
substances. I suspect that in the short run we will do
little better than weighted checklists to be used as
general gu 'dines for at least surfacing some of the
concerns b 'ore decision-making time. Case studies
of specific past decisions should he particularly
helpful in this regard. In the longer term, I don't
know if a more objective approach can be developed
that is broa«'ly applicable to balancing risks and
benefits.
Howevei i far more difficult problem faces us in
answering ic question: "How much is society ready
to pay to st irch out other problem substances before
they emerge as problems on the immediate
horizon?" Or "What should be the cost of early
warning?"
A (ienerulized Approach to Control Strategies for
Multimedia Pollutants: Reality or Fantasy?
A number of the most troublesome toxic
pollutants enter the environment from many
sources, follow multiple routes through the
environment, and come to rest in a variety ot places.
Studies have illustrated many of the complexities of
movement and fate of pollutants. Such studies were
particularly helpful in addressing the lead issue, as
one example.
Can there be a generalized approach to control
strategies for a large number of toxic pollutants with
multimedia characteristics? Perhaps the behavioral
ami use idiosyncrasies of different chemicals require
completely different approaches to the formulation
of control strategics. Twoof ourm'.ost relevant
experiences to date in developing control strategies
have been the attempts to control selected toxic
pollutants under different sections of their air and
water legislation. These single media approaches to
control strategies clearly underscore the difficulty or
generalized approaches.
Obviously, there should be some correlation
between the controls that arc selected to mitigate the
problem associated with a specific chemical and the
porhun of the problem that these controls actually
address. Similarly, in considering the total
allowable body burden for a chemical, there should
be some consistency in allocating the total among
individual control measures. But can we be much
more specific in generalizing approaches, say, to
three of the most widely discussed toxic chemicals,
namely, cadmium, mercury, and PCBs? It is difficult
to identify the common aspects of cadmium-coated
screws, mercury-containing dental amalgam, and
polychlorinatcd biphenyls used in transformers.
which would fit into general control strategies. Once
10
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again, at least as an interim step, I would argue tor
case studies as providing a background of experience
in addressing future approaches to multimedia
pollutants.
'An OpfKiiiontil F.arly Wurninx System: Is It
Practical?
The need to identity and remedy problems before
they take their environmental or health toll seems
axiomatic, liut cun this be done on more than a
token basis' Clearly, this question goes lo the heart
of this Conference.
Several upproachc . to problem identification
seem reasonably clear:
— Gatherings of experts, such as this meeting,
and also organized on an industry-by-industry
basis.
— Review of past incidents to identify early
warning indicators.
— Current awareness systems to identify reported
and unreported incidents involving toxic
substances.
— Forecasts of market and economic trends and
their impact on the future mix of products and
activities of the chemical industry.
Many of you have promoted activities in these
areas for some time, and we will be joining you in all
of these areas in the months ahead.
What is most needed now? Better use of existing
early warning systems? Bigger a'nd better systems'?
More systematic orchestration of the multiple
systems? I hope you will clarify these questions.
However, there undoubtedly will remain a major
gap between problem identification and preventive
action Bridging this gap is particularly difficult for
a bureaucracy that is basically reactive to immediate
problems—and reactive in a very short-term mode.
Thus, persuasive argumentation supporting the
action recommended by the early warning network
is essential.
% Even assuming that false alarms have been
separated from potentially serious problems, it will
be difficult indeed to impose restrictive measures
before the fact largely on the basis of
unsubstantiated data. In my view, unless there is
extensive cooperation on the part of industry in
vheeding the early warning signals—cooperation
rctlccted in a great deal of restraint on a voluntary
basis—the products of the best conceived early
warning systems arc not likely to make a major
impact on more than a small handful of a much
larger array of potential problem substances.
THE CHEMICAL INDUSTRY AND POLICY
ISSUES
The industrial representation at this Conference is
encouraging. Indeed, in recent months a number of
companies have shown considerable leadership in
enhancing product safety, in improving the
environmental compatibility of manufacturing
processes, and in expanding R and D efforts to
further clarify the risks of chemical activities.
For our present purposes we are interested
principally in those manufacturers and processors
who introduce chemical changes into their products.
The following characteristics of this sector of
industry—excluding the food, drug, cosmetics, and
pesticides segments—seem particularly relevant:
— The annual value added to products is in the
range of $ 110 billion, about double the level
ten years ago.
— About 20.000 chemical products arc in
commerce with an additional 500 chemicals
being added annually.
— More than 80 percent of sales is concentrated
in several do/en companies but there are
hundreds of additional small manufacturers.
— A large percentage of net income—ranging
from 20 to 50 percent—is usually reinvested in
R and D.
A number of policy considerations of particular
concern to industry permeate a regulatory approach
to this sector of industry, from early warning to
restrictions. Some of these concerns arc:
— The disincentives to R and D inherent in some
types of regulatory actions could blunt the
technological thrust of the industry.
— The configuration of the industry (e.g. large
and small manufacturers, specialized and
diversified firms) could be affected by
regulatory actions which are more painful to
certain types of companies.
— Regulatory actions undertaken unilaterally by
the United States could affect the
competitiveness of our products at home and
abroad.
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This docs not mean that environmental actions
should not affect economic interests, for
environmental control is not Free. However, we
should recognize that individual actions—arid also
aggregated actions—can have many secondary and
tertiary effects which may be far more significant
than the more obvious primary effects. The key
question of course is whether the environmental
gains from regulatory actions are commensurate
with any adverse economic and social impact—a
question that is easy to ask but difficult to answer, in
any event, we must treat early warning signals in a
responsible fashion lest the potentially affected
parties seek to bury the signals out of concern that
they will not be handled responsibly.
BOOKING AHEAD
Clearly Washington's preoccupation with non-
environmental issues will continue to detract from
the high level attention devoted to toxic substances
in the months ahead, particularly on Capitol Hill.
For some of the newer programs this may be a
fortuitous development which will allow us to do a
better job in planning long range activities, even
though all of us would like to move ahead with
operational activities.
During 1974 we should continue to press forward
vigorously on all fronts, recognizing that regulatory
actions will be more difficult amidst the general
skepticism as to the importance of environmental
control being expounded in some quarters. There is
no reason, however, why we should not make great
strides in many of the essential supporting activities.
There is general agreement on the importance of
increased efforts to clarify the need for, character of.
and impact resulting from steps to prevent and
mitigate environmental problems! Thus. I would
characterrze 1974 as a year of transition—a year
between a period of talk and rhetoric about the need
for new regulatory approaches to reduce risks
associated with toxic substances and a period of
accelerated action to address these risks. 1974
should be a year of coalescing ideas and energies, a
year of engaging all the affected parties, and a year
of setting the stage for a sensible long-term effort in
dealing with multimedia pollutants.
In future years, more chemicals will be in
commerce, the properties of many chemicals will be
better understood, and consequently the list of
chemicals considered to be hazardous to man and
the environment will undoubtedly be much longer.
Also, improved research and analytical capabilities
will show that the effects of these chemicals—acting
individually and synergistically—are much farther
reaching than currently suspected effects.
Even though in a few years the emission stacks and
effluent pipes will be largely plugged, and hopefully
sensible land disposal of hazardous wastes will be
required, more people will be exposed to more
chemicals in more situations—exposure from
contaminants, non-point sources, direct product
contact, aVid generally unaliributable buildup of
chemicals in the environment. I am confident thai
society can develop the necessary precautionary
measures that will limit exposure to chemicals when
necessary, but not unnecessarily curtail commercial
activities.
There is. of course, a danger that society will not
act responsibly in anticipating and remedying toxic
substance problems through its governmental and
other institutions, with the inevitable outcome of
endless legal confrontations. The entire approach to
toxic substances could become bogged down in the
courts—which would be a tragedy for us all.
Thus, the challenge to early warning is clear. It is
a challenge that will
— prioritize and focus the concerns of
Government and of society on those
chemical/biological inn., actions that require
particular scrutiny in the months and years
ahead;
— provide the time needed for sluggish
governmental, industrial, and commercial
mechanisms to take almost unprecedented
anticipatory actions; and
— instill a sense of public confidence that the
products of chemistry—both new types of
goods and substitute materials for rapidly
dwindling natural materials—can be made
compatible with an increasingly fragile
biosphere.
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EPA PROGRAM INTERESTS AND TEST5NO
Meeting on Environmental Cooperation
U.S.—European Communities
Washington, DC
February 7. 1974
Interest in lexicological and environmental
testing is shared by all EPA programs. Test results
often signal those substances that should be prime
candidates for regulatory control. Also, test results
frequently are the starting point for setting
numerical standards and tolerances.
TESTING REQUIRED OF INDUSTRY
Three EPA offices are currently involved in
developing and articulating requirements for
industrial testing for health and environmental
effects. Test data are required to determine the need
for product controls and, when appropriate, to set
specific numerical standards. It seems clear thui
there should be a degree of consistency in our
overall approach to industrial testing as rctlected in
the ground rules established by ihese programs.
Also, to the extent possible, consistency is desirable
among the approach of EPA and the approaches of
other agencies, such as the Food and Drug
Administration and the Consumer Product Safety
Commission.
For many years, registration of pesticides has
required the submission of industrial test data. Over
the years the data requirements have been
articulated in a variety of formal and informal
documents, but only recently,has there been an
attempt to consolidate past fragmented
requirements—including undocuniL'nted
requirements—into a coherent Agency approach.
These requirements relate to both product safety and
product efficacy. Within the next year, we hope to
publish guidelines which will set forth in some detail
testing requirements in support of applications for
pesticide registration.
Under ihe Clean Air Act the Agency can require
the testing of fuel additives for health and
environmental effects. This is a new program—in a
somewhat virgin area—and we are only now
attempting to develop such test requirements.
Perhaps, the most difficult problem is specifying the
composition of the substance to be tested. We are
primarily interested in the inhalation of exhaust
products which are the resul.of a variety of
complicated chemical reactions.
A third program, which is still being borne, will
provide the Agency with authority to require testing
of industrial chemicals suspected to pose a risk to
man or the environment. This proposed new
authority, which is currently pending in the
Congress, covers a much broader variety of
activities than existing authorities. The two principal
emphases will probably be on testing for chronic
health efforts and on testing for environmental
effects. These of course are the most uncertain areas
at present.
POLICY CONCERNS IN DEVELOPING
REQUIREMENTS FOR INDUSTRIAL
TESTING
There urea number of policy issues common to
these programs that we are currently addressing.
Among the more important concerns arc the
following:
Costa »j Testing: How much testing
isenough? At what point will testing costs
discourage R & D on new products that may
prove to be safer than currently available
products? Will testing requirements add
intolerable delays before marketing a product'.'
Flrxihilityin Test 'Rrquiremenis: How specific
should be the test requirements set by
Government? Should industry be afforded a
degree of flexibility in determining the details
of testing and in suggesting alternative
approaches to those specified by Government?
How can lest requirements allow for advances
in the state-of-the-art without being subjected
to constant revision? Will over-
standardization of test requirements dampen
innovative R & D on the part of industry?
Stains ofPnitix-uls: What status should he
accorded u> protocols developed by the
Government or with Governmental support.
by professional societies, and by industry
itsclT.' Should such protocols be mandatory, be
illustrative, or simply provide guidance?
Trade Secrets: Under what, if any, circum -
stances should safety dala developed by
industry be considered trade secrets? Should
there be a difference in (he confidentiality
aspects of safety data submitted by industry for
chemicals already in commerce and for
chemicals still in the R & D stage?
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— Sharing of Costs: Under what circumstances
should test costs be shared among several
manufacturers of the same chemical? How
should the costs be shared? Can cost sharing be
reconciled with anti-trust laws? What role «
snould the Government play in arbitrating the
details of cost spring?
(GOVERNMENTAL SUPPORT OF TESTING
In our view, the principal responsibility for testing
chemicals that are in commerce or will enter
commerce in the near future resides with industry.
The Government's primary role is.to insure that this
testing is adequate and that the test results are
considered in an effective way in assessing the safety
aspects of the chemicals. Given this role of
Government, several specific types of concerns
require Governmental support of testing activities:
— It may be necessary to verify in advance the
feasibility, adequacy, and reliability of
proposed tests to be required by industry.
— It may be necessary to confirm or supplement
test data provided by industry.
— The urgency or complexity of potential
environmental problems resulting from a
chemical may require a Governmental
response based on tests that are initiated
without delay.
— It may not be possible to identify the com-
mercial organization which has the logical re-
sponsibility for testing a specific chemical,
such as in the case of chemical contaminants of
unknown origin.
There are at least two other reasons why a
Governmental regulatory agency supports testing
activities. Laboratory scientists actively engaged in
testing activities are essential members of the
Governmental teams that develop specific testing
requirements for industry. Their input is essential to
broaden the perspective of the desk bureaucrats.
Secondly, the Government has traditionally
assumed responsibility for stimulating advances in
the state-of-the-art. These efforts include support for
new approaches to testing, refinement of existing
approaches, and demonstration projects that can be
adopted by industry. At the same time, as specific
problem chemicals emerge, it is important that
ovcrzcalous Government scientists—eager to clarify
the uncertainties—not launch testing efforts under
the guise of research that pre-empt the respon-
sibilities of industry.
Of particular interest are the rapidly developing
programs of the recently established National
Center for Toxicological Research in Jefferson,
Arkansas, which is jointly supported by EPA and the
Food and Drug Administration. This facility is
devoted to improving testing methodologies related
to chronic effects, with particular attention to the
shape of the lower end of the dose/response curve.
Funded atu level of about $15 million annually,and
emphasizing experiments involving very large
numbers of animals, this facility should have a major
impact on testing approaches throughout the world
in the years to come.
THE USE OF TOXICOLOGICAL DATA
Recently, EPA proposed a numerical effluent
standard for the carcinogen bcnzidine. The
derivation of this standard brought into sharp focus
the inadequacy of current approaches to testing for
the purposes of standard setting, both for
carcinogens and for other chemicals. In my view the
traditional approach of determining a no-effects
level in animals and then extrapolating to human
effects via safety factors is not adequate in many
cases, particularly when there are questions as to
whether there are thresholds and whether
irreversible effects are involved. On the other hand,
describing the risks in terms of probabilities of
incidents through existing statistical extrapolation
techniques—such as was done in the case of
benzidinc—and then balancing these alternative risk
probabilities against the costs of the environmental
control may not otter the optimal approach. In any
event, we are looking forward to an initial
confrontation of our biostatiticiansand our
tox'icologists on this very issue during the next
several weeks.
In large measure the issue revolves around how
the scientist packages the toxtcological data for the
decision-maker. If the scientist structures the
experiment and packages the data to derive simply a
"safe" level for chemical exposure, then the
decision-maker has only one option, and all other
factors become irrelevant. The scientist has in fact
assumed responsibility for consideration of the total
impact of a regulation on society. On the other hand,
if the scientist presents several options, with
explanations of the health and environmental
implications of each, then the decision-maker can
indeed take into account a wide range of social and
economic implications at different levels of
chemical exposure.
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ENVIRONMENTAL CONCERNS BEYOND
THE WORK PL. ACE
Working Group on Toxicily of
Vinyl Chloride-Polyvinyl Chloride
The New York Academy ol Sciences
New York, New York
May II. 1974
During the past several months vinyl chloride has
awakened all elements of the environmental
community to the presence of the plastics industry.-
In some respects it is fortunate that we have been
alerted in a rather dramatic fashion to the need for
greater attention to this important segment of our
industrial base which will surely continue to expand
in the years ahead. While this symposium is directed
to the existing and potential risks involved in the
.manufacture, distribution, and use of vinyl chloride
monomer (VCM) and polyvinyl chloride (PVC),
many of the types of considerations and
uncertainties that punctuate these deliberations
undoubtedly characterize a far broader swathe of
concerns over chemicals in general. Hopefully, we
can extrapolate from our current experiences with
VCM and PVC in identifying problems with other
potentially important commercial chemicals early in
their embryonic stage and thus minimize the •
economic dislocations attendant to corrective
actions.
Unfortunately, the proposed Toxic Substances
Control Act has been lodged in a Joint Committee of
the Congress for ten months. Thus, a very powerful
tool for addressing the vinyl Chloride problem, and
similar problems with other chemicals, in an
adequate manner is not available to the Federal
Government. We must rely on other statutory
authorities and on the power of persuasion in our
efforts to insure that our population is not being
unnecessarily exposed to concentrations of VCM
and other chemicals used in connection with VCM.
It is particularly distressing that until this statutory
authority is on the books, the Federal Government
will not be equipped—in terms of experienced
personnel and supporting resources—to grapple
with the intricacies of this type of toxic substance
problem in a manner which will insure full attention
to the balancing of risks and benefits.
Today I will report to you on the preliminary
investigations undertaken by the Environmental
Protection Agency during the past three months. We
are still several weeks away from reaching even
tentative conclusions as to what additional steps, if
any, should be taken by the Agency concerning
VCM/PVC activities. Our monitoring data are not
yet in hand. Similarly, our analytical studies are not
yet completed. Nevertheless, we are pleased to share
with you some of out initial thoughts. We will
welcome your comments on the efforts to date and
on further steps which arc necessary. In this regard.
the prioriti/ation of our efforts is particularly
important in view of the speed with which this
problem is evolving and the limitations on our
resources.
At the outset it is important to underscore that the
progress made to date would not have been possible
withcjut the extensive cooperation of other federal
agencies, industry, and environmental groups. We
have profiucd greatly from our discussions with
these organizations, through our on-site industrial
visits, and through constructive suggestions that we
have received.
EPA REGULATORY AUTHORITIES
To date EPA has exercised its authority in the
pesticides area to suspend the use of vinyl chloride
as a propellant in all pesticide products registered
for indoor use in homes, food handling
establishments, and other enclosed areas, with a
mandatory recall of stocks in the channels ol'trade.
In addition, in response to the Agency's request, all
registrants of pesticides which are used outdoors
have agreed either to withdraw their registrations or
to ain'end them to provide for the substitution of
another propellant in their products.
We are currently investigating what regulatory
actions, if any, arc needed with regard to air
emissions, water effluents, and solid waste disposal
at facilities involved in VCM and PVC activities. In
addition the Agency has responsibility in the areas of
drinking water standards, ocean disposal, and
municipal waste disposal—all areas of some
relevance to the VCM/PVC concerns.
As previously mentioned a principal authority
which is currently missing is the Toxic Substances
Control Act. The requirements for reporting of
industrial production data envisaged in the Act
would enhance our knowledge of the types and
extent of different uses of VCM. The testing
provision would enable us to obtain much needed
data—and particularly data on toxicity and
persistence—for assessing the risks associated with
low concentration levels of VCM, including those
levels that are likely to persist beyond the
workplace. The proposed regulatory provisions
would provide a mechanism for addressing those
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products using VCM not now subject to regulation
under other laws. Also, if considered appropriate,
steps might be taken to limit the amount of
unreacted VCM in certain PVC products which may
eventually migrate out of these products to pose an
unnecessary risk.
THE MATERIALS BALANCE
EPA's initial concern in this area centered on
reports in February of a materials loss of six percent
in the PVC production process. Our detailed
investigations indicate that these initial reports were
in the correct range. Clearly, the percentage of losses
will vary with the type of process, the age of the
plant, the level of technology that is employed, and
manufacturing practices. However, there is no doubt
that in the United States substantial amounts of
VCM—probably exceeding 200 million pounds
annually—and large quantities of PVC—probably
exceeding 50 million pounds—are being discharged
into the environment during the PVC production
process. Most of the VCM escapes directly into the
atmosphere as air emissions, with lesser amounts
dissolved in water effluent streams and entrapped in
sludge and solid wastes. PVC losses occur as
paniculate in air emissions, suspended solids in
water effluents, and components of solid wastes.
Clearly, a principal area of VCM leakage is
associated with the operation of the polymerization
kettles, including losses when they are opened for
recharging, cleaning, or sampling. Other losses
occur during the transfer of VCM from tank cars to
storage, during the drying process, and from leaks at
a variety of valves, flanges, and pump seals
throughout the process. Polymer losses are similarly
distributed among a variety ol activities including
dust collector losses, disposal of oversize particles,
and sampling losses. Our estimates indicate that
losses for a typical suspension process vary from
four to eight percent. In this regard two aspects are
particularly significant: there arc a variety of PVC
processes with differing problems and control
possibilities and in every case the number of
potential leakage points is very large.
For economic reasons and in view of the fire
hazard from VCM industry has always been
concerned with reducing its losses down to a point.
Now some plants are taking steps to reduce these
losses further in view of worker and environmental
concerns. We understand that the tightening up on
maintenance and housekeeping activities can indeed
have a significant impact, and several PVC plants
: reportedly are now operating close to the four
! percent level for total losses.
The data needed for conducting material balance
analyses during VCM production and PVC
compounding and fabrication processes are less
eadily available. However, we do not believe (hat
:hesc activities pose as serious an environmental
concern beyond the fence line of the plant, at least at
the present time, as the polymerization process. At
the same time in (he absence of constant vigilance
VCM losses to the atmosphere during the latter
phases of the VCM production process and during
transfer to and from storage can be significant. Also,
throughout the process there are many seals and
valves which inevitably lead to leaks. With regard to
compounding and fabrication, unreacted monomer
is inevitably associated with the polymer following
the polymerization process. In some cases this
monomer concentration reaches 7000 ppm although
a more representative level probably is in the range
of 500to 1000 ppm. During the mixing and heating
processes in the compounding and fabrication
plants, some of this VCM undoubtedly escapes into
the environment. Now, in efforts to reduce further
the level of unreacted VCM in the final product
many companies are introducing new techniques
which increase the migration rates during this phase
of production.
THE NEED FOR EPIDEMIOLOGICAL AND
TOXICOLOGICAL STUDIES
Since some elements of our population in addition
to the plant worker arc being exposed to some level
ol VCM. we must address the question: What is the
risk of such exposure?
In considering non-worker populations, we are
confronted with a host of new unanswered questions.
How relevant to this concern are the data generated
for estimating worker exposure risks'? Can
meaningful extrapolations be made from
toxicological tests at relatively high dose levels to
the lower levels of the dose-response relationship?
Can realistic extrapolations be made from
intermittent exposure, which characterizes the past
und present toxicological and epidemiological
investigations (e.g. eight hours per day, five days per
week) to sustained exposure at the same dose levels
or at lower levels? Are synergistic effects that result
from exposure to other chemicals as well as VCM
influencing the worker's response to VCM, and are
there similar opportunities for such synergism within
a non-worker population?
There are not sharp answers to these questions.
and indeed they go to the heart of many of the
fundamental uncertainties of the biological sciences.
To date the epidemiological and toxicological data
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that have been generated have been directed almost
exclusively to concerns over workers. This is the
data base that we in EPA presently have available. 1
doubt that anyone is more aware of its inadequacy
than are those of us responsible for regulatory
actions based on this data. Unfortunately, we often
have no choice but to make judgmental decisions
using whatever scientific information is available.
Other reports presented at this symposium review
past, current, and future studies directed to VCM.
While they will undoubtedly be helpful to our
assessment of the environmental problem, from our
point of view that are clearly not adequate in
improving the basis for estimating non-worker risks.
Let me cite three examples of the types of studies
which appear to be needed:
— Epidemiological investigations of populations
near chemical plants that are likely to have
been exposed to low ambient levels of VCM
over a prolonged period of time. It is the
responsibility of industry to support such
efforts which will help clarify whether
manufacturing activities pose a risk to
neighborhood residents. At the same time we
recognize the complexities involved in
designing and carrying out such studies, the
advantages of drawing on governmental
experience in this area, and the prutotypic
nature of such an undertaking. Therefore, it
seems likely thai EPA will be prepared to
participate in such efforts along with industry
and other interested parties.
— Toxicological tests at appropriate dose levels,
with a sufficiently large number of animals.
and with appropriate exposures to provide the
basis for meaningful conclusions concerning
the likely health effects of VCM in ambient air
near chemical plants. Such tests arc clearly the
responsibility of industry. Indeed, industrial
responsibility for the testing of the safety of its
products is a basic tenet of the Toxic
Substances Control Act. At the same time, we
are aware that some industrial firms are
concerned about the possible inadequacy of
commercial test facilities to accommodate the
needed tests. Therefore, if necessary, the
National Center for Toxicological Research,
which is supported by FDA and EPA, is
prepared to work with industry toward
suitable arrangements for utilizing available
buildings in Jefferson, Arkansas.
— Research on animals and in vitro experiments
to help clarify the toxicological significance of
o impurities in VCM, synergislic effects due to
exposure to other chemicals in addition to
VCM such as vinylidine chloride, and
metabolic reactions induced by VCM.
Government, industry, and academia all have
responsibilities in this area, and EPA is
currently considering specific steps that might
be taken to contribute to advancing the
frontiers, of our knowledge.
MONITORING. PERSISTENCE. AND
MIGRATION STUDIES
We are obviously concerned about current and
future background levels of VCM in the air and in
the water throughout the country. Our more
immediate efforts, however, arc being directed to
determining ambient and peak levels near chemical
plants.
Recently, we initiated a nationwide sampling and
analysis program to determine, at least in a
preliminary fashion, the VCM levels in ambient air
and in water and semi-solid effluents at about ten
PVC plants. These activities are currently
underway, and we hope to have the results within
several weeks.
Asa precursor to this nationwide effort, several
weeks ago we conducted a preliminary monitoring
program at the B. F. Goodrich plant in Louisville
using inadequately tested sampling and analysis
methods. At that time VCM levels were detected of
I lo 2 ppm in the ambient air outside the plant, 2 to 3
ppm in the primary water effluent, and 100 to 200
ppm in the sludge at the plant site. However, these
numbers could be in error by as much as an order of
magnitude due to the pioneering nature of the effort.
and no conclusions should be drawn at this time.
During the past several weeks we have made a
major effort to develop credible and standardized
sampling and analysis procedures, building on this
initial experience. Our current monitoring efforts
are based on this recently improved methodology.
The limit of detection for our current technique is
approximately .06 mg/liter in water and .06 ppm
(volume/volume) in air. However, when vacuum
cans arc used, the detection limit is .2 ppm because
the gas sample must be diluted. The technique we
are using is now publicly available with the hope that
our efforts toward standardization will lessen the
chaos characterizing current monitoring efforts of
several federal agencies and industry.
While the near-term objective of these monitoring
efforts is to gain a limited perspective of (he levels of
VCM near PVC plants, we should also learn more
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about the persistence of VCM in air and water from
our measurements. Samples are to be taken during
daytime and at night, and there undoubtedly will be
a range of temperature and humidity conditions.
However, we have not structured the measurements
with research as a principal objective, and we will
not be able to quantify persistence characteristics
with any degree of precision.
Limited laboratory experiments are also being
attempted to clarify persistence characteristics of
VCM. Related to our decision to suspend pesticide
sprays containing VCM, one laboratory test showed
that in an unventilated and unlighted chamber, less
than one percent of the VCM initially persent was
' dissipated after four days. Current efforts are
directed to clarifying the rate of retention of VCM
entrapped in water effluent streams, as well as
further work to understand the effect of light, heat,
and moisture on VCM in air.
There has been considerable discussion of the
amount of unreacted VCM monomer remaining in
PVC and the rates of migration out of the PVC.
Many companies are now seized with this problem,
and I suspect the number of samples being taken to
determine VCM concentrations and migration rates
has increased considerably in recent weeks. We do
not know whether such migration from finished
products contributes significantly to background
levels of VCM, but as you are aware PDA is seized
with several aspects of this problem directly related
to food. Should there be high levels of VCM
background in the environment, then our concern
over all sources of VCM—including migration from
many products—should intensify.
In all of these areas industry has a major
responsibility for determining and alerting the
public about the behaviour of its products. I would
hope that in the months and years ahead industrial
monitoring efforts at the fence line will increase
dramatically; persistence will become a key concern;
and the ultimate fate of chemicals will be less
uncertain. Already some chemical establishments
have rather broad sampling and analysis programs,
and as a direct result of VCM concerns, others are .
also making new efforts in this regard.
At the same time EPA has a responsibility to help
insure the adequacy of the national effort in keeping
abreast of the chemical cross-section of our
environment.
CONCERNS OVER DISPOSAL OF PVC
While we tend to lump all types of PVC into one
category, I am sure you are aware of the variances in
the chemical and physical properties of different
grades of PVC. Also, end products made from PVC
include a variety of other chemicals which are added
throughout the production cycle.
To date EPA's principal concerns relating to PVC
have been directed to possible problems attendant to
its disposal—either in incinerators or landfills. We
have not investigated in depth any of the special
problems associated with inhalation or ingestion of
low concentrations of PVC paniculate.
With regard to incineration, HCI is a primary
product of concern. Also, toxic metals may be
present as additives and thus cause inhalation
problems, either as metal or oxide vapors.
Landfill disposal operations have traditionally
assumed that PVC is stable with little likelihood of
biological degradation or undesirable leachates.
Taking a long-term perspective these assumptions
seem clearly overly simplistic, and we should
address in greater depth problems attendant to the
disposal of plastics. Experiences in the tropics, for
example, have demonstrated the effect of bacteria on
PVC which has not been specially treated for use in
humid areas.
THE RISKS. THE BENEFITS, AND THE COSTS
The current problems with VCM have brought
into sharp focus the practical aspects of balancing
the risks and benefits associated with commercial
chemicals. The costs involved to reduce these tasks
substantially may be formidable—or indeed may be
prohibitive. The aspect which is perhaps the most
troublesome goes to the heart of this meeting—What
is the risk now and under alternative regulatory
approaches?
In the years ahead more chemicals will be in
commerce, the properties of many chemicals will be
better understood, and consequently the list of
chemicals considered to be hazardous to man and
the environment will undoubtedly be much longer.
Also, improved research and analytical capabilities
will show that the effects of these chemicals—acting
individually and synergistically—are much farther
reaching than currently suspected effects.
As these realities of the chemical age unfold, there
must be a far greater sophistication in approaches to
responsible regulation. Hopefully, we will develop
the necessary precautionary measures that will limit
exposure to chemicals when necessary, but not
unnecessarily curtail commercial activities.
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CHEMICALS,THE ENVIRONMENT,
AND REGULATION
Quality Assurance Seminar
Burden,Inc.
Columbus, Ohio
June 5,1974
About 20,000 chem ical substances are
commercially produced and used in the United
States, with 500-700 new substances entering
commerce annually. They find a wide variety of uses
as industrial chemicals, in consumer products, and
in specialized uses such as drugs, food additives, and
pesticides. We estimate that about ten percent of
. U.S. industry is directly involved in introducing
chemical changes into its products. This is the sector
of industry of interest.
The problems presented by the presence in the
environment of some chemical substances are all too
well known (e.g. mercury, lead, asbestos). Others are
believed to pose a latent health or environmental
threat, while the effects associated with many of the
remaining chemicals, acting individually or
synergistically, are almost completely unknown.
However, it seems clear that the problems associated
with the presence of many chemical substances in the
environment—such as food and drinking water
contamination, destruction of biota, and water and
soil degradation—will undoubtedly continue to
grow in number, severity, and complexity in the
years ahead.
Some of the hazards associated with chemical
substances have been recognized and are controlled
by the Government, e.g. pesticides and drugs. Other
aspects of the toxic substances problem have only
recently been identified, and appropriate regulatory
measures do not yet exist. Still other pieces of the
problem have yet to be identified. Many gaps remain
in understanding why, how, and when a substance
can have a negative impact on health or the
environment, and how best to control or prevent
such hazards.
Thus, the concern of EPA with toxic substances is
two-fold: Identification and assessment of the risks
associated with the manufacture, distribution, use,
and disposal of chemical which could adversely
affect health and environmental quality; and
practical steps, including regulatory actions as
appropriate, to prevent or mitigate the problems
posed by such chemicals.
The risks associated with toxic substances are
related to many factors including the size of the
dose, duration of exposure, form of the substance
when released, and presence of other substances that
also contribute to environmental stresses. Problem
assessment is further complicated by the niany
unknowns that surround the characteristics a nil
behaviour in the environment of most toxic
substances, including such aspects as persistence,
degradation, accumulation, and movement among
environmental media. Good information is not
readily available concerning levels, distribution,
and trends in the environment of many substances of
concern. With regard to the adverse effect of toxic
substances, testing approaches for measuring
chemical properties and acute toxicity are
reasonably well developed. However, similarly well
developed test methods for determining chronic
toxicity and for estimating environmental impact are
not in hand.
The success of past efforts to reduce these
deficiencies and uncertainties has been spotty.
Monitoring systems generally lack the capability to
relate effects to specific substances, and research
.efforts are only now beginning to address many core
issues. Lack of effective integration of the many
Federal monitoring and data systems further
impedes rapid progress.
In seeking to control specific toxic substance
problems, the Government can draw on three types
of regulatory authorities;
— Consumer protection statutes which have as
their primary mission the prevention of acute
risks to human health: They, however, do not
address problems of environmental protection
nor human exposure to toxic substances
through environmental routes. '
— Media-oriented statutes which focus primarily
on problems at the point where they become
environmental contaminants, typically, after
they are manifested at the end of an outfall
pipe or smokestack.
— Statutes dealing with a particular phase of the
existence or use of a toxic substance such as
risk to workers, transportation-related
accidents, and use of pesticides which are toxic
by design.
Pending legislation is directed to enabling EPA to
deal with problems which do not currently fall
within the existing regulatory framework, and
.particularly with regard to drinking water
standards, disposal of toxic wastes, and problems
associated with use and distribution of chemical
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substances. In addition, EPA would have authority
to control certain types of problems before they
appear in the environment. In the absence of such
legislation, efforts to cooperate with industry on a
voluntary basis in addressing specific problems
beyond the reach of current authorities must
continue although the results of past efforts have
been somewhat uneven.
There are many interfaces among existing
regulatory authorities, and the passage of new
legislation will further extend the options for
addressing specific problems. Implementation of the
air and water acts, for example, has involved
selection of the most appropriate legislative
provisions within these acts for addressing problems
of toxic substances in addition to development of
criteria to determine if regulation is needed or
appropriate under specific provisions. Another >
example is the control of the use of certain pesticides
under the pesticide act while point source discharges
of these same chemical are being considered for
control under the water act. Further complicating
effective choice of regulatory options is the tendency
to search for problems to be controlled under
specific authorities rather than searching for the
authorities that will most effectively control
problems. This approach of controlling the
"accessible" aspects of the problem, which may or
may not be the "critical" aspects, can hamper efforts
to cope with the core of the environmental and
health risks posed by manufacture, use, and disposal
of toxic substances.
Central to consideration of regulatory options is
the balancing of the risks with the benefits related to
the action. The diversity of the tradeoffs make this a
formidable task. For example, the benefits from
employment of workers in chemical plants must be
balanced against occupational risks; U.S.
competitive ability in world markets weighs against
environmental testing costs or requirements of
expensive effluent or emission controls; and quality
of life benefits from chemical substances bear on the
degree of risks which can be tolerated. Restrictions
placed on existing activities will affect past
investments and established patterns of commerce
and employment. With respect to those chemicals
which have yet to be offered for commercial use,
barriers to market entry could be created through
pre-testing and screening requirements. If research
and development of new chemicals becomes so
difficult that it is no longer profitable, the
advantages to society, in terms both of new products
and development of less toxic alternatives to
existing products, are lost. In short, environmental
protection is not free. Care must be exercised in
assessing the impact of corrective actions on the
direction, configuration, and diversity of the
chemical industry as well as on the benefits to
society of chemical products.
TOXIC SUBSTANCES CONTROL ACT
The proposed Toxic Substances Control Act would
give EPA new author •/ for (a) information
acquisition, and (b) restrictive actions. EPA could
require testing of chemical substances (both existing
and new) which are suspected to pose unreasonable
risks and also require other information from
manufacturers including the name of the substance,
chemical formula, amounts produced, actual or
intended uses, and known by-products. EPA could
then restrict the use and distribution of chemical
substances found to pose unreasonable risks. The
Agency could prescribe the amounts of a chem ical
which may be sold to processors, limit the type of
processor to whom it may be sold, restrict the
amount a given type of processor may use, or limit
the sale or manner in which a substance may be used,
handled, labelled, or disposed by any person.
This new authority is important from two
standpoints. First, the Federal Government is given
direct authority to restrict substances presently in
commercial use that are known to cause health or
environmental hazards, and when effects
information is lacking, to require testing of the
substance by the manufacturer to assess human or
environmental impact. Second, for substances not
yet in commercial production, the Agency could
require premarket testing and review of chemicals
suspected to be hazardous. The Agency would have
the opportunity to assess the risks before the new
substances are commercially produced and to take
appropriate regulatory action to prevent toxic
incidents.
Given the extensive scope of the legislation, the
number of areas of initial emphasis will depend toa^5
significant degree on thestatfand resources
available for implementation activities. In selecting
areas for priority attention consideration should be
given to Congressional mandates, severity and
urgency of existing problems which can be alleviated
by the new authority, opportunities to reduce future
problems of major dimensions, and necessity for
establishing long-term viability of implementation
procedures.
While the final version of the legislation may
influence the choice of initial activities, it seems
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clear that the following activities should be high on
the agenda for early attention1:
— Elaboration and articulation of the criteria or
sets of criteria to be used in weighing risks
versus benefits, and in determining, when
regulatory action is needed. Clear
understanding by both industry and
Government of the ground rules for
restrictions is essential to the viability of
industrial R & D activities.
— Determination of the character and scope of
initial testing requirements, including the
possibility of umbrella testing requirements
for a broad range of chemical classes, and
identification of specific chemicals or classes
of chemicals of particular immediate concern.
While the selection of substances covered by
the standards for test protocols that are
initially promulgated will in large measure
reflect intuitive judgments concerning likely
hazards and inadequacy of current data.
concurrent work is needed to provide a basis
over the longer term for selecting areas of
concern.
— Development or regulations selling forth
timing, coverage, content, and formal of the
reporting requirements for chemical
manufacturers and processors, including both
annual reporting and premurket notification.
— Establishment of a data system for handling
the industrial reports and test results that arc
submitted. Experience in the pesticide area
underscores the importance of early attention
to establishing efficient and decision oriented
procedures to be effective when the first
reports arrive.
CHEMICALS AND CORPORATE
RESPONSIBILITY
A fundamental tenet ot the Toxic Substances
Control Act.iind indeed of the entire federal
approach to environmental control, is that industry
has a primary responsibility to insure that (a) its
products do not pose health or environmental
risks—direct or indirect, immediate or delayed, and
(b) the associated manufacturing activities do not
contribute to environmental degradation. Shorthand
characterizations of these areas of responsibility are
product safety and pollution control..
As you well know, ninny of our major chemical
companies have long experience in dealing with
FDA in the area of product safety. In some cases
FDA is quite precise as to safety requirements; other
determinations are made on a case-by-casc basis in
consultation with the concerned company. In
general, considerable care is taken by all parties to
insure that potentially harmful chemicals are not
added inadvertently to our food supply. However.
this pattern of Governmental regulation and
concomitant industrial concern does not extend far
beyond the perview of FDA, with growing
except ions in the areas of pesticides and consumer
products.
With regard to the possible health and en-
vironmental risks associated with the thousands of
other commercial chemicals not subject to
regulations, neither government nor industry has
exhibited adequate concern beyond the safety of
plant workers from acute health effects. At the same
time, during the past several years, industrial
attention to new chemicals—reflected in substantial
financial support of research and testing—seems to
be increasing. Unfortunately, a similar level of
concern over the non-acute affects of chemicals
already in commerce is not apparent. For example. I
suspect that current industrial support for chronic
toxicity investigations of the fifity leading industrial
chemicals is minimal—or perhaps imperceptible.
Two reasons apparently underlie this benign neglect:
(I) There are many producers of each chemical with
no party clearly responsible for taking the lead in
supporting safety investigations, and (2) An
overconfidence exists that there are no problems due
to the extensive experience with these chemicals
without obvious adverse effects.
Turning to pollution control, much of the
industrial effort to date has been reactive to federal.
state, and local requirements which have usually
been designed to reduce gross pollution effects.
Clearly, progress is being made in controlling gross
pollution, but at the same time far lessuitcntion is
being devoted to the discharge of individual
chemicals which could have delayed effects. In the
near-term, only industry has the wherewithal to
identify and abate the discharge.ofmany of the
particularly troublesome chemicals at individual
plants. In the longer term. Government most likely
will have to develop a similar capacity.
It is extremely important for a plant manager to
know the chemical mix of the air emissions drifting
over the plant fence into nearby neighborhoods.
Sim Marly, he should be fully aware of the chemical
cross section of his liquid and solid waste streams.
This approach obviously means a serious physical
monitoring effort on the part of industry—
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monitoring not only for gross pollution but for
individual chemicals as well. With rare exceptions
such industrial monitoring programs do not
currently exist.
Knowing what leaves the plant premises is of .
course only (he i'trst step. Determining the signif-
icance of such discharges—irrespective of the
lack of Governmental requirements—is clearly the
next step. Fortunately, many of the chemical
pollutants that are frequently encountered have been
studied rather extensively and assessing the effect of
these chemicals on nearby neighborhoods should not
be difficult. For the other chemicals which are not as
well known accelerated industrial efforts to clarify
their effects are mandatory.
I would hope that industry will take stronger
initiatives in these areas rather than just waiting for
Governmental regulations to descend. Strong,
positive actions now by industry could very well
temper eventual regulations that might otherwise be
developed from a point of overreaction arid cause
unnecessary economic disruptions.
THE VINYL CHLORIDE CASE STUDY
During the past several months vinyl chloride has
awakened all elements of the environmental
community to the presence of the plastics industry.
In some respects it is fortunate that we have been
alerted in a rather dramatic fashion to the need for
greater attention to this important segment of our
industrial base which will surely continue to expand
in the years ahead. Hopefully, we can extrapolate
from our current experiences with VC and PVC in
identifying problems with other potentially
important commercial chemicals earlier in their
embryonic stage and thus minimize the economic
dislocations attendant to corrective actions.
To date EPA has exercised its authority in the
pesticides area to suspend the use of vinyl chloride
as a propellent in all pesticide products registered
for indoor use in homes, food handling
establishments, hospitals, and other enclosed areas,
with a recall of stocks in the channels of trade. In
addition, in response to the Agency's request, all
registrants of pesticides which are used outdoors
have agreed either to withdraw their registrations or
to amend them to provide for the substitution of
another propellant in their products.
We are currently investigating what regulatory
actions, if any, are needed with regard to air
emissions, water effluents, and solid waste disposal
at facilities involved in VC and PVC activities. In
addition the Agency has responsibility in the areas of
drinking water standards, ocean disposal, and
municipal waste disposal—all arees of some
relevance to VC/PVC^bhcerns.
EPA's initial concern in this area centered on
reports in February of a materials loss of six percent
in the PVC production process. Our detailed
investigations indicate thai these initial reports were
in the correct range. Clearly, the percentage of losses
will vary with the type of process, the age of the
plant, the level of technology that is employed. and
manufacturing practices. However, there is no doubt
that in the United States substantial amounts of
VC—probably exceeding 200 million pounds
annually—and large quantities of PVC—probably
exceeding SO million pounds—are being discharged
into the environment during the PVC production
process. Most of the VC escapes directly into the
atmosphere as air emissions, with lesser amounts
dissolved in water effluent streams and entrapped in
sludge and solid wastes. PVC losses occur as
paniculate in air emissions, suspended solids in
water effluents, and components of solid wastes.
In considering non-worker populations, we are
confronted with a host of new unanswered questions.
How relevant to this concern are the data generated
for estimating worker exposure risks? Can
meaningful extrapolations be made from
, (oncological tests at relatively high dose levels to
the lower levels ot the dose-response relationship?
Can realistic extrapolations be made from
intermittent exposure, which characterizes the past
and present toxicological and epidemtological
investigations (e.g. eight hours per day, five days per
week) to sustained exposure at the same dose levels
or at lower levels? Arc synergistic effects that result
from exposure to other chemicals as well as VC
influencing the worker's response to VC, and are
there similar opportunities for such synergism within
a non-worker population?
There are no sharp answers to these questions, and
indeed they go to the heart of many of the
fundamental uncertainties of the biological sciences.
To date the epidcmiological and toxicological data
that have been generated have been directed almost
exclusively to concerns over workers. This is the
data base that we in EPA presently have available. I
doubt that anyone is more aware of its inadequacy
than are those of us responsible for regulatory
actions based on this data. Unfortunately, we often
have no choice but to make judgmental decisions
using whatever scientific information is available.
We are obviously concerned about current and
future background levels of VC in the air and in the
water throughout the country. Our more immediate
22
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efforts, however, are being directed to determining
ambient and peak levels near chemical plants.
Recently, we initiated a nationwide sampling and
analysis program to determine, at least in a
preliminary fashion, the VC levels in ambient air
and in water and semi-solid effluents at thirteen
PVC plants. These activities are currently
underway, and we hope to have the results very
soon.
There has been considerable discussion of the
amount of unreactcd VC monomer remaining in
PVC and the rates of migration out of the PVC.
Many companies are now seized with this problem,
and I suspect the number of samples being taken to
determine VC concentrations and migration rates
has increased considerably in recent weeks. We do
not know whether such migration from finished
products contributes significantly to background
levels of VC, but as you are aware FDA is seized
with several aspects of this problem directly related
to food. Should there be high levels of VC
background in the environment, then our concern
over all sources of VC—including migration from
many products—should intensify.
TOXIC SUBSTANCES IN THE MID-1980's
By 1985, more chemicals will be in commerce, the
properties of many chemicals will be better
understood, and consequently the list of chemicals
considered to be hazardous to man and the
environment will undoubtedly be much longer.
Also, improved research and analytical capabilities
will show that the effects of these chemicals—acting
individually and syncrgistically—arc much farther
reaching than currently suspected effects.
From the toxic substance point of view the quality
oflife in the chemical age of the Eighties, relative to
the current quality of life, depends, in large measure,
on the outcome of the competition between
population and economic growth on the one hand
and the sophistication in approaches to responsible
regulation—by both industry and government.
Clearly, more .people will be exposed to more
chemicals in more situations. Hopefully, we can
develop the necessary precautionary measures that
will limit exposure to chemicals when necessary, bui
not unnecessarily curtail commercial activities.
There is, of course, a danger that society will not
act responsibly toward toxic substances through its
Governmental and other institutions, with the
inevitable outcome of endless legal confrontations.
The entire approach to toxic substances could
become bogged down in the courts. To avoid such a
situation, the highest quality of government
leadership in this area is essential—leadership
characterized by technical credibility and openness
in dealing with controversial data.
If the regulatory pattern of the Sixties and
Seventies continues, during the Eighties the number
ot toxic substances other than chemicals associated
with foods, drugs, cosmetics, and pesticides
regulated by Government will be relatively few—in
the dozens rather than hundreds or thousands.
However, each of these regulatory decisions will be
significant in thai they will set the framework and
the standards for the efforts of industry in self-
regulation of the bulk of the industrial chemicals.
Industry will probably be using testing and related
approaches to product safety which are not
significantly different from current approaches. The
Governmental thicket of regulations may
inadvertently drive some of the smaller companies
out of new product development. Concurrently,
closer Governmental scrutiny of industry activities
may be necessary in the lace of potential legal
problems as the larger companies consolidate their
positions.
By 1985, most of the emission stacks and effluent
pipes will be plugged. Our toxic substance concerns
will center largely on contaminants, non-point
sources, direct product exposure, and generally
unattributablc build-up of toxic chemicals in the
environment. And, as the gross pollution effects
subside, previously undetected effects of individual
and combinations of chemicals in the water and in
the air will probably be unmasked.
Risk/benefit approaches should be well accepted
within a decade, although concerns will penetrate
much more deeply into social as well as economic
values. There should be far less concern over the
concept of accepting different levels of risk for
different chemicals, depending on their social
utility. And at the same time the role of corporate
responsibility should be better accepted by all
concerned.
23
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REGULATORY ASPECTS AND
RESEARCH NEEDS
Conference on Public Health Implications
of Components of Plastics Manufacture
National Institute of Environmental
Health Sciences
Pinehurst, North Carolina
August 29, 1974
This Conference has underscored the many gaps
in our understanding of the behavior of vinyl
chloride and the inadequacies of current research
efforts to improve the data base which supports the
regulatory decisions that must be made now. In
addition to the need for much better information on
the human health effects of exposures to low levels
of vinyl chloride, we know relatively little about
— the persistence of vinyl chloride in air and
water and the degradation products associated
with this chemical
— the ecological effects of vinyl chloride,
particularly as it interacts with aquatic
organisms
— the rates of migration of unreacted vinyl
chloride monomer from products containing
PVC during their use and disposal.
Perhaps, even more importantly the Conference
has highlighted what many environmentalists are
calling the "tip of the iceberg"—an iceberg of
chemical problems that will continue to float to the
surface during the decades ahead. For example, the
array of hundreds of chemicals added to plastics that
was shown here clearly illustrated the complexity of
the task of the researcher in attempting to provide an
early warning of future problems.
It certainly appears that except for continuing
concern over spills and accidents, Government and
industry have been rather complacent with regard to
the potential environmental threat from the high
volume industrial chemicals. This complacency is in
large measure attributable to the relative absence of
visible and uncontrolled dangers from exposure to
the chemicals during their long histories. In
addition, since many of these chemicals arc
manufactured by a number of companies, firms may
lack incentive to invest individual company
resources to clarify the safety aspects of their usage.
Clearly, the experience with vinyl chloride—the
twenty-second leading chemicals in terms of
production—underscores the problems that can
result from such complacency. Despite the
continuing commercial importance of these high
volume chemicals, it cannot be assumed that
adequate research, testing, and related safety
measures will be taken by industry, and vigorous
governmental leadership in this area seems essential.
The most immediate task confronting us all is how
to organize the limited resources—and I refer
principally to dedicated scientific talent—of
Government and industry to sort out the areas
requiring the most urgent attention. Should the
Toxic Substances Control Act be enacted, the
Federal Government will have a new responsibility
of particular importance to the prioritization of
these efforts. Hopefully, such a legislative mandate
can provide the impetus for more concerted efforts
toward'early recognition and correction of
potentially serious chemical problems.
This Conference has been a useful first step
toward imparting a sense of direction for addressing
the many unknown aspects of the plastics industry, li
certainly has helped clarify the dimensions of the
problem. Clearly industry must play a key role—in
monitoring, testing, and, where appropriate,
restraint—for in many cases only the manufacturer
of the chemical is in a position to suspect the
likelihood of hidden hazards associated with his
products.
25
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CHEMICALS AND THE ENVIRONMENT.
THE FUTURE IS NOW
25th Constitutional Convention of the
International Chemical Workers Union
Las Vegas, Nevadfi
September 23, 1974
CHEMICALS.THE WORKER. AND THE
ENVIRONMENT
It is indeed u privilege to he able to participate in
this meeting at a time when chemicals arc in the
forefront of your concerns and of mine. These past
twelve months have been punctuated with repeated
warnings that Government, industry, and labor must
direct greater attention and additional resources to
clarifying the risks associated with chemicals. We
cannot afford to learn about these risks after the
damage is done, but at the same time we cannot act
precipitously and unnecessarily curtail the influx of
chemical products so essential to the viability of our
economy.
Let me recount a few of the events of recent
months as viewed from the perspective of the
Environmental Protection Agency—events which
clearly dispel! any notion that our concerns are only
hypothetical, and unfortunately document the
reality of the problem.
— Last year the discovery of unusually high
levels of asbestos in the drinking water of
Duluth, Minnesota, gave impetus to a series ot
court actions and at the same time stimulated
extensive Governmental efforts to clarify the
hazards related to.the inhalation or ingcstion
of asbestos.
, — More than a dozen carcinogens that pose a
potential hazard in the work place have been
identified and strict precautionary measures
prescribed. Of particular environmental
concern is benzidine in view of its widespread
distribution in dyes and fabrics.
— The imprint on the worker and ihe en-
vironment of vinyl chloride may be with us
for many years to come. The problems we have
uncovered in recent months in addressing
vinyl chloride have raised a host of questions
with regard to all of the high volume industrial
chemicals.
— Last Friday, hearings were held in Washington
on arsenic. An unusually high incidence of
cancer among workers exposed to arsenic has
been reported, and there have also been
reports of high levels in the crops and in the
population adjacent to at least one smelter.
You may ask why a representative of the
Environmental Protection Agency—which has no
authority within the plants—was asked to speak to
this gathering which is concerned with the worker.
As you know, the Department of Labor and not EPA
has the primary Governmental responsibility for
safety in the work place. Our responsibility begins at
the fenceline. However, there are at least four
reasons why EPA is concerned with the worker, and
why I spend many hours in meetings with our
col leagues from the Department of Labor.
— We are vitally concerned with the health and
welfare of neighborhoods adjacent to
industrial complexes. More often than not a
large proportion of the residents are workers
and their families.
— Secondly, pollution control is not free, and the
costs of compliance with EPA regulations can
result in economic dislocations for the affected
industries with the livelihood of the workers
often at stake.
— In addition, many of the costs of pollution
control are passed on to the consumer and I
need not tell you who is the first to feel the
impact of higher prices for consumer products.
— Finally, the Department of Labor and EPA
regulate many of the same chemicals. Neither
of us has enough resources to do an adequate
job. Hopefully, by sharing our experiences we
both will be able to dp a better job.
20.000 CHEMICALS
About 20,000 chemical substances arc
commercially produced and used in the United
States, with 500-700 new substances entering
commerce annually. They find a wide variety of uses
as industrial chemicals, in consumer products, and
in specialized uses such us drugs, food additives, and
pesticides. We estimate that about ten percent of
U.S. industry is directly involved in introducing
chemical changes into its products.
The problems presented by the presence in the
environment of some chemical substances are all to
well known. Others arc believed to pose a latent
health or environmental threat, while the effects
associated with many of the remaining chemicals.
acting individually or syncrgistically, arc almost
completely unknown. However, it seems clear that
27
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the problems associated with the presence of many
chemical substances in the environment will
undoubtedly continue to grow in number, severity,
and complexity in the years ahead.
Some of the hazards associated with chemical
substances have been recognized and are controlled
by the Government, e.g. pesticides and drugs. Other
aspects of the problem have only recently been
identified, and appropriate regulatory measures do
not yet exist. Still other pieces of the problem have
yet to be identified. Many gaps remain in
understanding why, how, and when a substance can
have a negative impact on health or the
environment, and how best to control or prevent
such hazards.
Thus, our concern is two-fold: identification and
assessment of the risks associated with the
manufacture, distribution, use and disposal of
chemicals which could adversely affect health and
environmental quality; and practical steps,
including regulatory actions as appropriate, to
prevent or mitigate the problems posed by such
chemicals. Paramount in these concerns must be the
safety of the worker, who invariably has the greatest
degree of exposure to the broadest range of
chemicals.
VINYL CHLORIDE—BETTER LATE THAN
NEVER?
In January 1974, the B.F. Goodrich Company, the
largest U.S. producer of PVC resin, notified the
National Institute of Occupation;! I Safety and
Health that four workers from its PVC, poly-
merization plant in Louisville, Kentucky,
apparently had died from a rare cancer, angio-
sarcoma of the liver. All four workers had
been closely associated for many years with the
production of PVC resins. The rarity of the tumor
and the clustering of deaths at a single plant raised
suspicions that an occupational disease related to
vinyl chloride exposure had been found. Since that
time, ten additional cases of this tumor, which
developed in U.S. PVC polymerizations workers
since 1961 .have been confirmed. This tumor has
also been reported in seven workers at European
polymerization plants, one worker at a U.S. PVC
fabrication plant, two workers at European
fabrication plants, one worker at a European vinyl
chloride plant, and two residents in the general
population near U.S. fabrication plants.
Concurrently, toxicological data from animal
studies became available which further strengthened
the suspicion of vinyl chloride as the etiological
agent in the formation of the liver cancer. A broad
spectrum of cancers was reported by Professor
Cesare Maltoni of Italy in different animal species at
various exposure levels. His inhalation studies of
rats exposed to SOppm at repeated intervals
approximating occupational exposures have
produced angiosarcomasof the liver and abdomen
us well as tumors of the kidney and skin. In mice
exposed to vinyl chloride the same tumors have been
observed, with the addition of lung tumors. Animal
studies sponsored by U.S. industry have confirmed
Maltoni's observations at SOppm. Recent
epidemiological studies also suggest the possibility
of multiple cancers attributable to exposure to vinyl
chloride.
Meanwhile, statements by industry and Govern-
ment officials indicated that the material loss to the
environment during the PVC polymerization
process may he about six percent, with more than 75
percent of the losses being vinyl chloride air
emissions. Also, it soon came to light that vinyl
chloride was being used as a propellant in aerosol
sprays, and we were becoming more aware of
railroad accidents involving vinyl chloride tank
cars.
This series of events has finally stimulated a broad
range of corrective actions by Government and
industry—actions that should have been taken many
years ago. The Governmental actions include:
— The banning of the use of vinyl chloride as a
propellant in aerosol sprays by EPA, FDA,
and the Consumer Product Safety
Commission.
— Revision downward by the Department of
Labor of the standard for allowable levels of
vinyl chloride in the work place.
— Development by EPA of an air emission
standard for vinyl chloride.
— Development by FDA of regulations limiting
the amount of unreacted vinyl chloride
monomer in food packaging containing PVC.
— Broad monitoring programs by EPA and other
agencies to determine actual levels of vinyl
chloride within plants.Jiear^hemical
complexes, and Jn other areas.'
* v
— Expanded research to clarify further the
health aspects of exposure^) vinyl chloride
and the behavior and fate of this chemical in
the environment.
28
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Many of you muy be particularly concerned with
the possibility of a vinyl chloride hazard associated
with PVC fabrication activities. Initially, the
Government's primary concern and investigative
activities centered on the polymerization process.
Only now, with the recent reports of angiosarcoma
among former fabricators, has attention been
directed to the more than 8,000 fabrication plants.
The first step obviously is reliable monitoring—and
I emphasize reliable—to determine existing levels. I
regret to report that at present there is not available
information which would enable us to provide any
guidance on the likely hazard, if any, in or around
fabrication plants.
Industry, of course, has a special responsibility
concerning vinyl chloride. Let me outline some of
these areas of responsibility as viewed from the EPA
perspective.
Reducing Discharges of VCund Other Toxic
Chemicals
There is no doubt that industry has taken and can
continue to take a variety of immediate steps at
relatively little cost to reduce vinyl chloride
discharges. During the past few months many plants
have already started to tighten maintenace and
operating procedures; other plants are installing
improved pumps, seals, and disconnect devices;
while still other plants are introducing more
significant process changes. One company is
reportedly spending $3 million to tighten the
processes at a single PVC facility; another company
reports that it has I 00 engineers working to
introduce modifications that will dramatically cut
vinyl chloride losses at several plants.
Medical Surveillance
Clearly, recent concerns have triggered extensive
medical surveillance programs of workers
throughout the industry. These programs should
become routine to cover a far broader swath of
chemicals and other chemical complexes. Published
analyses of the results of such programs would be
very valuable to Government agencies. In addition,
industry should support medical surveillance
programs for residents in neighborhoods adjacent to
PVC complexes and other types of plants releasing
chemicals into these neighborhoods. The character
of such surveillance will obviously depend on the
type of chemicals involved and the arrangements
that can be worked out by industry with local health
authorities.
Ftncclinc Monitoring far Chemical Discharges
Traditionally, (he chemical industry has
conducted very little fcnceline monitoring not
required by federal, state, or local agencies to
determine the chemical discharges leaving plant
property: Clearly, a plant manager should know the
chemical injx of the air emissions drifting over the
plant fence into nearby neighborhoods. Similarly, he
should be fully aware of the chemical cross sect ion
of his liquid and solid waste streams. Thus, a far
more intensive physical monitoring effort on the
part of industry is needed.
Toxicological Testing
Until recently, the efforts of U.S. industry to
clarify the chronic toxicity of vinyl chloride were
nearly negligible, despite the commercial
importance of this chemical. The studies to date
have not been adequate, in terms of direct ion. scope.
or quality. Even the additional toxieological studies
which have been proposed calling for animal
exposures down to I ppm may not be sufficient.
Testing for Persistence and Environmental Effects
A related area is industry's responsibility to
clarify the environmental fate and effects of the
chemicals it manufactures, and in this case the
behavior of vinyl chloride in water and air
(including degradation products) and the fate and
effects of products containing PVC in soil and water.
This is a new area winch has not attracted sufficient
attention from industry but which is of crucial
importance in assessing environmental impacts of
chemical activities. Governmental leadership will
probably be essential in helping to point the way as
to the types of tests and analyses that are the most
appropriate.
Testing for Levels of Unreuctetl Monomer
In view of the likelihood that FDA will limit the
levels of unreactcd monomer allowed in PVC food
packaging, industry has recently accelerated efforts
to analyze the levels of vinyl chloride that arc
present in PVC resin used for food packaging and in
the packaging itself. This relatively inexpensive
procedure should be extended to other types of
products as well. It is particularly important that the
manufacturers of resin, who in general are well
equipped to carry out the necessary sampling and
analysis, advise their customers (i.e., the fabricators).
29
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of the quality of the resin in terms of unreacted
monomer in addition to the usual quality criteria.
The fabricators in turn have a responsibility to be
aware of the levels of unrcacted monomer that
persist in the products that eventually reach the
marketplace.
THE NEED FOR A LEGISLATIVE MANDATE
The fate of the much needed Toxic Substances
Control Act will be decided in Washington during
the next few days—a decision that can have a direct
and profound impact on our society in general, and
the worker in particular. For three years this
legislation has been delayed in the Congress. Despite
the broad consensus that the legislation is clearly
needed, procedural delays and delays over details
have prevented prompt action by'the Congress.
I know of no group with a more vital stake in this
legislation than this audience. What more dramatic
evidence than the vinyl chloride case is needed to
underscore the urgency of greater Governmental
and industrial responsibility in this area?
The Toxic Substances Control Act would provide
new authority for (a) information acquisition, and
(b) restrictive actions. The Government could
require industrial testing of chemical substances
(both existing and new) which are suspected to pose
unreasonable risks and also require other
information from manufacturers produced, actual
or intended uses, and known by-products. Then, if
warranted, the use and distribution of chemical
substances found to pose unreasonable risks could
be restricted.
This new authority is important from two
standpoints. First, the Federal Government is given
direct authority to restrict substances presently in
commercial use that are known to cause health or
environmental hazards, and when effects
information is lacking, to require testing of the
substance by the manufacturer to assess human or
environmental impact. Second, for substances not
yet in commercial production, prcmarket testing and
review of chemicals suspected to be hazardous could
be required. Thus, there would be the opportunity to
assess the risks before the new substances are
commercially produced and to take appropriate
regulatory action to prevent toxic incidents.
The authority to require industrial testing of
chemicals is designed to support the needs of both
EPA and the Department of Labor. However, the
new authority to regulate chemicals is limited to
chemicals outside the work place since there is no
intention to undercut the existing authority of the
Department of Labor in any way.
LOOKING AHEAD
In decades ahead, more chemicals will be in
commerce, the properties of many chemicals will be
better understood, and consequently the list of
chemicals considered to be hazardous to man and
the environment will undoubtedly be much longer.
Also, improved research and analytical capabilities
will show that the effects of these chemicals—acting
individually and synergistically are much farther
reaching than currently suspected effects.
In a few years the emission stacks and effluent
pipes will be largely plugged, and hopefully sensible
land disposal of hazardous wastes will be required.
At the same time, however, more people will be
exposed to more chemicals in more situations—
exposure from contaminants, non-point sources,
direct product contact, and generally unattributable
buildup of chemicals in the environment. The
chemical worker will continue to be on the front line
of much of the exposure, I am confident that society
can develop the necessary precautionary measures
that will limit exposure to chemicals when
necessary, but not unnecessarily curtail commercial
activities.
There is, of course, a danger that society will not
act responsibly in anticipating and remedying toxic
chemical problems through its Governmental and
other institutions, with the inevitable outcome of
endless legal confrontations. The entire approach to
toxic substances could become bogged down in the
courts—which would be tragedy for us all.
'With increasing frequency we are being awakened
to the latent health hazard from chemicals that have
not been adequately tested or analyzed. We are
becoming more and more concerned not only with
the problems that emerge today but with those that
will only be recognized tomorrow. Preventive
actions are the key; corrective actions can only be
inadequate and disruptive.
We have met the future, and it is now.
30
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VINYL CHLORIDE: IMF. TIP OF THE
ICEBERG?
Conference on VCM - The Processor's Perspective
Society of Plastics Engineers, Inc.
Palisades Sect ion * Vinyl Plastics Division
New York, New York
October 31. 1974
CHEMICALS. INDUSTRY. AND THE
ENVIRONMENT
About 2(),()(K) chemical substances arc
commercially produced and used in the United
States, with 500-700 new substances entering
commerce annually. They find a wide variety of uses
as industrial chemicals, in consumer products, and
in specialized uses such as drugs, food additives, and
pesticides. We estimate thai about ten percent of
U.S. industry is directly involved in introducing
chemical changes into its products.
The problems resulting from the presence in the
environment of some chemical substances are all too
""w'eTTknown. Others are believed to pose a latent
health or environmental threat, while the effects
associated with many of the remaining chemicals,
acting individually or synergistically. are almost
completely unknown. However, it seems clear that
the problems associated with the presence of many
chemical substances in the environment will
undoubtedly continue to grown) number, severity,
and complexity in the years ahead.
Some of the hazards associated with chemical
substances have been recognized and are controlled
by the Government, e.g. pesticides and drugs. Other
aspects of the problem have only recently been
identified, and appropriate regulatory measures do
not yet exist. Still other pieces of the problem have
yet to be identified. Many gaps remain in
understanding why. how, and when a substance can
have a negative impact on health or the
environment, and how best to control or prevent
such hazards.
Thus, our concern is two-fold: Identification and
assessment of the risks associated with the
manufacture, distribution, use. and disposal of
chemicals which could adversely affect health and
environmental quality; and practical steps,
including regulatory actions as appropriate, to
prevent or mitigate the problems posed by such
chemicals. In addressing these concerns we must, of
course, maintain an appreciation of the role of these
chemicals in our economy and of the societal
benefits that chemicals have brought to all of us.
TH E CASE OF VIN Y L CH LOR 1DE:
BETTER LATE THAN NEVER?
The Kmrrgtncr of the Problem
In January 1974, the B. F. Goodrich Company,
the largest U.S. producer of PVC resin, notified the
National institute of Occupational Safety and
Health that four workers from its PVC
polymerization plant in Louisville, Kentucky,
apparently had died from u rare cancer,
angiosarcoma of the liver. All four workers had
been closely associated for many years with the
production of PVC resins. The rarity ofthc tumor
and the clustering ol deaths at a single plant raised
suspicions that an occupational disease related to
vinyl chloride exposure had been found. Since that
time, at least 10 additional cases of this tumor,
which developed in U.S.-PVC polymeri/.ation
workers since 1961. have been confirmed. This
tumor has also been reported in u number of workers
at European polymerization and monomer plants,
one worker at a U.S. PVC fabrication plant, two
workers at European fabrication plants, and two
residents in the general population near U.S.
fabrication plants.
Concurrently, toxicological data from animal
studies became available which further strengthened
the suspicion of vinyl chloride as the etiological
agent in the formation of the liver cancer. A broad
spectrum of cancers was reported by Professor
C'esare Maltoni of Italy in different animal species at
various exposure levels. His inhalation studies of
rats exposed to 50ppm at repeated intervals
approximating occupational exposures have
produced angiosarcomasof the liver and abdomen
as well us tumors of the kidney and skin. In mice
' exposed to vinyl chloride the same tumors have been
observed, with the addition of lung tumors. Animal
studies sponsored by U.S. industry have confirmed
Maltoni's observations at SOppm. Recent
epidemiological studies also suggest the possibility
of multiple cancers attributable to exposure to vinyl
chloride.
Meanwhile, statements by industry and
Government officials indicated that the material
loss to the environment during the PVC
polymerization process may be about six percent,
with more than 75 percent of the losses being vinyl
chloride air emissions. Also, it soon came to light
that vinyl chloride was being used as a propellant in
aerosol sprays, and we were becoming more aware of
railroad accidents involving vinyl chloride tank
cars.
31
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This series of events finally stimulated a broad
range of corrective actions by Government and
industry—actions that should have been taken many
years ago. Given the long history of PVC production
which in the past resulted in much higher levels of
exposure to workers and to the general population
than are encountered today—together with the long
latency period between exposure and the
development of angiosarcoma—we obviously are
very concerned that many of the consequences of the
somewhat reckless handling of vinyl chloride in the
past will continue to be uncovered for some years to
come.
The Fabrication Process
Many of you may be particularly concerned with
the possibility of a vinyl chloride hazard associated
with PVC fabrication activities. Initially, the
Government's primary concern and investigative
activities centered on the polymerization process.
Only very recently, with the reports of angiosarcoma
among former fabricators, has attention been
directed to the more than 8,000 fabrication plants. A
first step obviously is reliable monitoring—and I
emphasize reliable—to determine existing levels. I
regret to report that at present we do not have good
information which would enable us to provide
guidance on the likely hazard, if any. in or around
fabrication plants. Since the only source of vinyl
chloride at most of these plants is the unreacted
monomer that may be present in the PVC resin, we
would not expect the air emissions to be high. At the
same time, however, these facilities arc often in
metropolitan areas which could result in exposure to
very large numbers of people.
At the outset the major concerns of the
Environmental Protection Agency with regard to
fabrication activities related to other chemicals. For
example, information is not readily available
indicating whether any substantial risk might be
involved from the ingestion or inhalation of PVC
paniculate. Also, a large number of chemicals are
used in PVC products as antioxidants, antistatics,
colorants, fillers, plasticizers, and stabilizers, and
many of them can reach man through a variety of
routes. The health effects of some of these chemicals
are reasonably well known; the effects of others have
yet to be explored. Several of them are particularly
good candidates for more detailed investigations,
e.g. cadmium, barium.
Disposal of Products Containing PVC
Hydrogen chloride is the major toxic material
released when PVC is burned. On the order of
32.000 tons of PVC are burned annually, releasing
approximately 18,500 tons per year of HCI as air
emissions. At the same time much more HCI is
probably now emitted to the atmosphere from coal-
burning power plants than from municipal
incinerators. However, there still could be a hazard
in the immediate vicinity of an incinerator as a direct
result of its HCI emissions.
HCI can also be major factor related to corrosion
during incineration at certain temperatures.
Specifically, incinerators with heat exchangers will
have corrosion problems on the fire side of the
exchange equipment when the combustion gases
contact the outer metal surface. Also, about 95
percent of our incinerators have some type of air
pollution control equipment that is exposed to the
high chloride environment resulting from refuse
combustion. The cooling and precipitating water
from the scrubbers that contacts the tlue gas contains
large quantities of chloride and is extremely
corrosive to the structure.
It is highly unlikely that large quantities of vinyl
chloride will be emitted during incineration of PVC.
There is no evidence that PVC will chemically
revert to vinyl chloride. Some small amounts of
entrapped monomer might conceivably survive
incineration, but these quantities would be very low.
Other air, water, or soil contaminants could result
during disposal of PVC products. The types of
additives of particular concern are: antioxidants—
phenols, amines, phosphates, and sulfur compounds;
antistatics—amine derivatives, quaternary
ammonium salts, phosphate esters, polyethylene
glycolesters; colorants—salts or oxides of metals,
aluminum,copper, and inorganic pigments;fillers—
silica,glass,calcium carbonate, metallic oxides,
carbon, cellulose fillers, asbestos; plasticizers—
phthalates, organic phosphates; stabilizers—lead
salts of acids, barium, cadmium, calcium, zinc, alkyl
tin compounds.
Recommendations of the EPA Task Force
Last month the EPA Vinyl Chloride Task Force,
which had been established in February, submitted
its Report to the Administrator. This Report
included the results of our initial monitoring
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program at ten PVC resin and two monomer plants.
preliminary analyses of the health effects of vinyl
chloride, studies on the fate and environmental
effects of vinyl chloride, and investigations of
industrial practices. Upon receipt of the Report. Mr.
Train announced that he hud accepted the
recommendation for the Agency to establish an air
pollution emission standard for monomer and PVC
resin plants and concurrently to investigate further
the need for a standard applicable to fabrication
plants. The eighteen other recommendations for
Agency action are currently in various stages of
implementation.
The process of setting an air emission standard
under the Clean Air Act will involve several months
of additional monitoring and other investigations.
data collection, public hearings, and other
regulatory steps as required by the Act. An
environmental impact statement will be prepared.
and public hearings held, to insure full public
participation in the development of this standard.
The current timetable is to promulgate the standard
within about one year.
Initial estimates indicate that using available
control technology emissions could be reduced by
about 75 percent from PVC resin plants and 90
percent from monomer plants, with a concomitant
cumulative increase in the cost of PVC resin of
about four percent. Also, it is estimated that the
available control technology, which includes a
variety ot control measures applicable to the
multiple emission points within the plants, could be
in place from .within several months to two years
after promulgation of appropriate regulations.
With regard to fabrication plants, monitoring of
the vinyl chloride levels in the ambient air near five
plants is planned as an early step to determining the .
need for an air emission standard.
I do not plan to list the other recommendations set
forth in the Task Force Report. However, recent
activities directed to carrying out several of the
recommendations may be ot interest.
Studies arc currently in progress to determine the
amount of vinyl chloride migrating out of PVC
products used in water distribution systems, such as
PVC pipe or storage tank liners. In laboratory
experiments, 3/4 inch PVC pipe simulating
household installations is being used. Also, water
samples from a reservoir that had recently installed
a new PVC liner are being analyzed.
Another area of immediate concern relates to
additional research on the environmental fate and
effects of vinyl chloride. We believe that industry
has a major responsibility to carry out such research;
however, in view of the newness of this area EPA is
conducting limited investigations that will help
point the way as to the most appropriate types of
studies. Our research laboratory in Duluth,
Minnesota, has begun acute bioassay studies and will
soon initiate limited chronic bioassay tests on
selected aquatic species. Meanwhile, our laboratory
in Athens, Georgia, will expand its previous work on
the aquatic fate of vinyl chloride with experiments
on the uptake and degradation by microorganisms,
chemical and photochemical transformation, and
air-water exchange. Finally, research at our
laboratory at Research Triangle Park, North
Carolina, centers on photochemical degradation
products of vinyl chloride.
Another recommendation called for studies near
disposal sites of waste products from PVC plants
and or municipal waste to determine if toxic
substances are leaching into thc.soil or ground
waters. The first study will soon begin.
INDUSTRY1 S RESPONSIBILITY
Reducing DischarxeS of Vinyl Chloride
and Other Toxic Chemicals
There is no doubt that industry has taken and can
continue to take a variety of immediate steps at
relatively little cost to reduce vinyl chloride
discharges. During the past few months many plants
have already started to tighten maintenance and
operating procedures; other plants are installing
improved pumps, seals, and disconnect devices;
while still other plants are introducing more
significant process changes. One company is
reportedly spending $3 million to tighten the
processes at a single PVC facility; another company
reports that it has 100 engineers working to
introduce modifications that will dramatical ly cut
vinyl chloride losses at several plants.
Medical Surveillance
Clearly, recent concerns have triggered extensive
medical surveillance programs of workers
throughout the industry; these programs should
become routine to cover a far broader swath of
chemicals and other chemical complexes. Published
analyses of the results of such programs would be
very valuable to Government agencies.
Fenreline Monitoring for Chemical
Traditionally, the chemical industry has
conducted very little fcnccline monitoring not
required by federal , state, or local agencies to
-------
determine the chemical discharges leaving plant
property. Clearly, a plant manager should know the
chemical mix of the air emissions drifting over the
plant fence into nearby neighborhoods. Similarly, he
should be fully aware of the chemical cross section
of his liquid and solid waste streams. Thus, a far
more intensive physical monitoring effort on the
part of industry is needed.
Toxicological Testing
Until recently, the efforts of U.S. industry to
clarify the chronic toxicity of vinyl chloride were
nearly negligible, despite the commercial
importance of this chemical. The studies to date
have not been adequate, in terms of direction, scope,
or quality. Even the additional toxicological studies
which have been proposed calling for animal
exposures down to I ppm may not be sufficient.
Tenting for Persistence and
Environmental Effects .
A related area is industry's responsibility to
clarify the environmental fate and effects of the
chemicals it manufactures, and in this case the
behavior of vinyl chloride in water and air
(including degradation products) and the fate and
effects of products containing PVC in soil and water.
The research by EPA should help structure such
tests, but the primary responsibility rests with
industry.
Testing for Levels of Unreacted Monomer
In view of the likelihood that FDA will limit the
levels of unreacted monomer allowed in PVC food
packaging, industry has recently accelerated efforts
to analyze the levels of vinyl chloride that are
present in PVC resin used for food packaging and in
the packaging itself. This procedure should be
extended toother types of products as well. It is
particularly important that the manufacturers of
resin, who in general are well equipped to carry out
the necessary sampling and analysis; advise their
customers (i.e., the fabricators) of the quality of the
resin in terms of unreacted monomer in addition to
the usual quality criteria. The fabricators in turn
have a responsibility to be aware of the levels of
unreacted monomer that persist in the products that
eventually reach the marketplace.
LESSONS LEARNED FROM THE
VINYL CHLORIDE EXPERIENCE
Many environmentalists are convinced that the •
problems of vinyl chloride are but the tip of a
chemical iceberg—an iceberg of problems that will
continue to float to the surface during the decades
ahead.
It certainly appears that except for continuing
concern over spills and accidents, Government and
industry have been rather complacent with regard to
the potential environmental threat from the high
volume industrial chemicals. This complacency is in
large measure attributable to the relative absence of
visible and uncontrolled dangers from exposure to
the chemicals during their long histories. In
addition, since each of these chemicals is
manufactured by a number of companies, firms may
lack incentive to invest individual company
resources to clarify the safety aspects of their usage.
Clearly, the experience with vinyl chloride—the
twenty-second leading chemical in terms of
production—underscores the problems that can
result from such complacency. Despite the
continuing commercial importance of these high
volume chemicals, it cannot be assumed that
adequate research, testing, and related safety
measures will be taken by industry, and vigorous
governmental leadership in this area seems essential.
The experience with vinyl chloride has triggered a
series of actions within the Federal Government
directed to a broader range of chemicals of
considerable interest to the plastics industry. Let me
touch on just three of these activities:
— Interagency efforts in Washington to identify
problem chemicals used in the plastics
. industry have expanded considerably in recent
months. Beginning with a meeting at
Pinehurst, North Carolina, in August, there
have been a number of interagency
consultations and discussions concerning
various aspects of the plastics industry. I do
not know what actions, if any, will result from
this upsurge of interest.
— In accordance with one of the Task Force
recommendations, EPA is currently reviewing
governmental regulatory and research
activities directed to high volume industrial
chemicals in general. A number of these
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chemicals are clearly of interest to the plastics
industry. Again no specific actions are being
contemplated at this time.
— The World Health Organization has recently
entered the plastics arena. During a meeting
earlier this month considerable attention was
given to the health and environmental aspects
of plasticizers and flame retardants used in
plastics and in textiles.
Also, as most of you know, the fate of the much
needed Toxic Substances Control Act, which has
been delayed in the Congress for three years, will be
decided during the next few weeks,. This legislation
can provide the basis for more concerted efforts by
Government and industry to assess the problems of
toxic chemicals and to take corrective steps, when
needed. The aim is to take these steps early in the life
of a chemical, thus minimizing health and
environmental risks, and also reducing the attendant
economic dislocations.
LOOKING AHEAD
In the decades ahead, more chemicals will be in
commerce, the properties of many chemicals will be
better understood, and consequently the list of
chemicals considered to be hazardous to man and
the environment will undoubtedly be much longer.
Also, improved research and analytical capabilities
will show that the effects of these chemicals—acting
individually and syncrgistically—are much farther
reaching than currently suspected effects.
In a few years the emission stacks and effluent
pipes will be largely plugged, and hopefully sensible
land disposal of hazardous wastes will be required.
At the same time, however, more people will be
exposed to more chemicals in more situations—
exposure from contaminants, non-point sources,
direct product contact, and generally unattributable
buildup of chemicals in the environment. I am
confident that society can develop the necessary
precautionary measures that will limit exposure to
chemicals when necessary, but not unnecessarily
curtail commercial activities.
There is, of course, a danger that society will not
act responsibly in anticipating and remedying toxic
chemical problems through its governmental and
other institutions, with the inevitable outcome of
endless legal confrontations. The entire approach.to
toxic substances could become bogged down in the
courts—which would be a tragedy for us all.
The iceberg is emerging.
With increasing frequency we are being awakened
to the latent health hazard from chemicals that have
not been adequately tested or analyzed. We are
becoming more and more concerned not only with
the problems of today but with those that will only
be recognized tomorrow. Preventive actions are the
key; corrective actions can only be inadequate and
disruptive.
We have met the future, and it is now.
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THE TECHNICAL IMPLICATIONS OF
TOXIC SUBSTANCES LEGISLATION
Symposium on Toxic Substances Control
and OSHA/NIOSH Regulations
Synthetic Organic Chemical
Manufacturers Association
Washington, DC
January 29,1975
LIMITED PROGRESS IN 1974
To many persons interested in more effective
approaches to the control of toxic substances, 1974
may have seemed like a very eventful year. OSHA,
FDA, and EPA were all very active on the
regulatory front; and the judiciary became more
involved than ever before—addressing asbestos,
mercury, dieldrin, vinyl chloride, and a number of
other chemicals. :
However, in many ways 1974 was a disappointing
year even while the tip of the iceberg of toxic
substances problems continued to break through the
surface of environmental damage on a broad front.
From my perspective relatively little progress was
made toward developing a more systematic
approach for addressing the sources of toxic
substances problems that are appearing with
increasing frequency in the general environment.
Significant additional resources were not
forthcoming from either Government or industry for
more concerted efforts directed to identifying
chemical problems early and to taking preventive
actions before major commercial investments are in
place. And the legislative basis for corrective action
remains fragmented and uncertain.
Perhaps the most significant development during
1974 was the enactment of legislation designed to
insure the safety of our drinking water supplies. This
wide array of new authorities will undoubtedly have
a major impact on many facets of our society in the
months and years ahead. As the implementation of
this new legislation unfolds, we will become
increasingly aware of the multi-media character of
many of the chemical problems we have tended to
view in a narrow perspective.
CHEMICAL PROBLEMS CONTINUE TO
EMERGE
During 1974 an array of old and new chemical
contaminants emerged as recognizable near-term
health hazards. Indeed, many of us have now
become so pre-occupied with health hazards that we
frequently tend to neglect the adverse ecological
effects from toxic chemicals. Summarized below are
a few of the recent chemical concerns that prompt
meetings such as this one.
— Vinyl chloride certainly has focused the
attention of the entire environmental and
industrial communities on the need for more
careful attention to the high volume industrial
chemicals in general, and plastics in
particular. The emergence of poly vinyl
chloride as an environmental concern has
underscored the presence of previously
unsuspected problems associated with air
emissions at manufacturing facilities. Also,
new concerns have been raised over unrcacted
monomer contamination of polymers and the
leaching into the environment of toxic
additives in plastics during use of disposal of
plastic products.
— Trace amounts of a wide variety of
halogenated organic compounds have been
discovered in the New Orleans drinking water
supply, including compounds strongly
suspected of inducing serious chronic effects.
These discoveries have raised questions about
the possible problems resulting from the
chlorination of waters containing chemical
wastes which react with chlorine.
— Arsenic, which is present in many important
natural ores and is also widely used in
pesticides, has now been more strongly
implicated as a possible etiological agent in
cancer deaths among workers.
— Release of freon into the atmosphere has been
cited by some experts as causing
decomposition of the ozone layer. These
experts fear that such depletion could lead to
an increase in human exposure to ultraviolet
light and thereby cause an increase in skin
cancer.
— Health effects data on sulturic acid mist, which
has been identified as an indirect by-product
from catalytic converters, point to the need for
more caution in this area. More recently, with
the advent of the energy crisis, concerns have
also heightened that conversion of power
plants from oil and gas to coal could further
aggrevate the problem of sulfates in the air.
— Discovery of lead in the blood of children
living near at least one copper smelter raises
still another set of problems with regard to this
well known toxic material.
Preceding page blank
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— Careful scrutiny of previously registered
pesticides has identified a number of chemical
compounds that in view of available
substitutes aeem to pose unnecessary health
and environmental risks.
CONCEPTS EMBODIED IN THE PROPOSED
TOXIC SUBSTANCES CONTROL ACT
A primary objective of this Conference is to
discuss the shape and impact of toxic substances
control legislation. Unfortunately, we are still some
distance from knowing the intent of Congress in this
area, and to comment on the details of an uncertain
legislative framework seems a little presumptuous.
Nevertheless, we have given considerable thought to
the "implementability" of different types of
legislative provisions and a few general comments
may be helpful. My comments will be directed
primarily to several of the concepts articulated in
the Conference Committee Working Print that was
prepared late last year, recognizing that the
legislation that eventually emerges may be
significantly different. Another caveat is that I do
not intend to be thorough in this presentation but
rather I will simply mention some of the highlights
of our concerns.
Reportinx Provisions
Three intertwined ideas are incorporated into the
Working Print provisions calling for industrial
reporting on the manufacture, use, and by-products
of commercial chemicals, namely:
(I) An initial inventory report by industry on all
commercial chemicals to provide a current
production baseline. This inventory could
then be used in determining future trends and
in identifying new chemicals and new uses, as
well as providing information on current
activities as specific problems arise.
Presumably this report inventory would be
updated periodically—perhaps every five
years. The intent apparently is to include all
chemicals, including those produced even in
the smallest quantities, in the inventory.
Obviously, we are concerned as to how
complete this inventory must be to serve its
purpose, without unnecessarily taxing the
resources of Government and industry in
preparing and processing reports. In this
regard. EPA would have authority to exempt
manufacturers on a selective basis from
reporting if the Agency finds that such reports
are not needed. The House version of the
Working Prim would also exempt small
business from this requirement.
(2) Annual reports to provide continuing
information on selected chemicals of
particular concern. These reports would assist
in determining the need for, character of, and
impact resulting from specific regulatory
steps. Such judgments presumably would call
for aggregated data, and particularly trend
data, extracted from individual reports.
(3) Reports on new chemicals. All chemicals
except those included in the original
inventory list or explicitly exempted by the
Administrator from the inventory would be
considered to be new. EPA would presumably
have the responsibility of publishing the
names of trie chemicals in the baseline
inventory. A principal purpose of the
reporting on new chemicals would be to
insure the currency of the inventory.
The extent to which the foregoing reports would
be used depends on (a) the Governmental resources
made available to review and analyze the reports,
and (b) the availability of the reports to
organizations in addition to EPA, which in turn is
heavily dependent on the amount of confidential
information included in the reports and the
procedures developed for handling confidential
information. • •<•..
I assume that the mechanics of the reporting
system would derive from an appropriate regulation
or set of regulations clarifying some of the,, i
uncertainties in terms such as "mixture" and
"manufacturer", setting up a reporting schedule, and
prescribing a report format. Presumably a,. ,
standardized Governmental reporting forfp, would
further clarify how various uses and by-products are
to be listed along with the appropriate identification
of the chemical. The information would h/e^
presented in such a way as to facilitate ttsggjtry into
an EPA data system, designed specifically ,tphandle
the reported information, with particular.concern
for the handling of confidential information
Test Protocols
The general intent of the test protocol section of
the Working Print seems reasonably straight forward,
at least with regard to existing chemicals. A number
of aspects will probably remain to be elaborated in
regulations, such as the specificity of testing
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requirements, perhaps more refined criteria for
determining the need for testing, and identification
of the responsible organizations to carry out testing
tor specific chemicals. If legislation is enacted, some
additional guidance may be provided in all of these
,areas although many of the important decisions will
undoubtedly have to be made on a case-by-case
basis. It seems clear that test results must be
standardized to the point that they provide an
acceptable basis for Governmental decisions but not
so standardized that sound and innovative industrial
approaches to testing are inhibited.
In my view two of our concerns related to test
requirements are particularly important. Testing
should be required only in those cases when existing
test data which are publicly available are not
sufficient for making judgments concerning
environmental or health risks. Secondly, to the
extent possible test requirements under toxic
substances legislation should be consistent with test
requirements under other regulatory authorities
directed to the same chemical classes, in this regard.
we consider as very important the Pesticides
Registration Guidelines currently under
development by EPA. V
During the past several years some companies
have taken major steps to upgrade their testing
activities—both in scope of coverage and in quality
of personnel. I hope that with or without new
legislation this trend will continue and extend to still
broader segments of industry.
Prcmiirket Screening
The concept of a list of selected chemicals and
chemical classes would delimit the number of
chemicals or chemical classes which could be subject
to premarket screening requirements, either for (a)
reviewing prior to introduction of new chemicals
into commerce certain types of test data for the
chemicals, or (b) reviewing in advance proposed
new uses of existing chemicals. Thus, it seems that
the list concept is directed principally to (a) newly
developed chemicals which fall into particulary
worrisome chemical classes that should be subjected
to premarket test requirements, and (b) those
existing chemicals which are of such concern that
any significant new use should be carefully
scrutinized in advance.
The area of premarket screening will undoubtedly
receive additional attention as the legislation is
further developed, if the list concept is adopted,
there will certainly be additional debate concerning
criteria for placing chemicals on the list. However, I
suspect that the version that finally emerges will
continue to be somewhat complicated both in
concept and in detail.
Two additional aspects of importance related to
premarket screening should also be noted. First,
there may be a requirement for notices in the
Federal Register of Governmental receipt of
industrial reports submitted pursuant to premarket
screening requirements. The concept is to provide an
opportunity for public interest and other groups to
evaluate data before a chemical enters the market or
is subjected to a new use. Given industrial concerns
over the confidentiality aspects of R&D activities,
procedures must be worked out to insure that this
industrial concern is given proper weight while at
the same time the legislative requirement for
publication of premarket information is met. A
second area of interest relates to defining "uses". At
present perhaps the best available means for
defining uses would be a modified version of the
Standard Industrial Code. Hopefully, in the longer
run a better environmentally oriented scheme can be
devised; however, development of an alternative
workable system seems to be a very complicated
task.
Regulating Hazardous Chemicals
The Working Print provides EPA with authority to
regulate selected chemicals of particular concern,
but presents only general guidelines concerning the
criteria to be used in determining when limitations
on chemical activities are appropriate. I am sure that
you share our concern about the more detailed
ground rules beyond broad legislative criteria that
are used in assessing the need for limitations on toxic
substances under this authority and other authorities
as well. It seems important that to the extent
possible, these ground rules be understood in
advance by all interested parties, and indeed that all
parties have a voice in shaping the ground rules.
As a step in this direction we have asked the
National Academy of Sciences to extend its past
studies of the approaches in assessing risks
associated with toxic chemicals in order to help (a)
clarify the best approaches to assessing benefits
gained from society's use of chemicals and (b)
develop techniques for balancing risks and benefits
in the decision-making process. The Academy is now
developing case studies of selected substances whose
uses have been curtailed in the past by Government
or industry, including DDT, polychlorinated
biphenyls, and polybrominated biphenyls, as one
input in determining how we can improve our
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decision-making process. In several weeks a one-
week working session involving representatives of
Government, industry, labor, and public interest
groups will be held by the Academy to develop
specific recommendations concerning decision*
making directed to toxic chemicals.
PROSPECTS FOR 1975
There seems to be little question that the number
of problem chemicals of immediate concern will
continue to grow during this year. More careful
scrutiny by the plastics industry of its products will
continue to identify particularly worrisome
compounds, with polybrominated biphenyls,
vinylidene chloride, acrylonitrile, and styrene
already under investigation. The testing programs at
the National Cancer Institute and other Government
facilities will continue to identify important
industrial chemicals, such as ethylenc dibromide,
which cause tumprs in animals. As pur monitoring
efforts continue to expand, and particularly with the
new thrust directed to drinking water, additional
chemicals of concern will surely be identified
throughout the country. In additional new problems
will develop in unlikely places.
OSH A, FDA, and EPA will continue to take a
variety of actions under existing regulatory
authorities. All of these agencies are becoming
increasingly sensitive to the important linkages
among many of the regulatory standards in food and
in the workplace and standards for the same
chemicals in the general environment. We need to
increase our efforts to improve the multi-agency
approach to toxic substances problems.
With regard to EPA activities I am hopeful that
Taster progress can be made in the development of
sound toxic effluent standards and refinement of
Effluent Guidelines under the Federal Water
Pollution Control Act. Our review of pesticides will
continue to identify active and inert ingredients that
require more stringent control. Meanwhile, the
preparation and promulgation of pesticides
regulations and guidelines will have a direct impact
on the approaches of industry to toxicological
testing. And, of course, further development of new
source performance standards under the Clean Air
Act will continue. These are but a few examples of
EPA efforts which will continue to impact on the
synthetic organics industry.
I am far less certain of legislative action during
this new session of Congress. For four years there has
been debate on the character of a Toxic Substances
Control Act. I believe that there has been adequate
debate, and now is the time for decisive action.
Surely, the Congress will also be reviewing other
regulatory authorities, as well, with a particular eye
to the interaction of economic, energy, and
environmental considerations.
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CHEMICALS. REGULATIONS. AND THE
ENVIRONMENT
Annual Meeting of the Soap and Detergent
Association
Boca Raton, Floridq
January 30. 197S
TOXIC CHEMICALS AND THE SOAP AND
DETERGENT INDUSTRY
Extrapolation of effects from animals to man.
Carcinogens, teratogens. and hiutagens. Persistence,
hioaccumulation.and degradation products. Rule
making, hearings, and judiciatory processes. Action
levels, tolerances, and interim standards. This
jargon, characterizing the toxic substances trade, is
rapidly becoming almost second nature to many of
our industries through long and continuing
involvement in the regulatory processes of
Government. I suspect that there are few twists or
turns in the regulatory obstacle course in
Washington that a number of your companies have
not encountered many times over.
To many of you the appearance of an EPA speaker
on your program probably signals another revival of
Governmental interest in phosphates or NTA.
However, now that I have covered those lopics, my
further comments will be directed to somewhat
broader aspects of our toxic substances concerns.
There is no doubt that in the years ahead your
industry will he deeply immersed in coping with the
ever expanding regulatory activities shaped by
Congress and State legislatures, and carried out by
Federal. State, and local agencies. Given the uses
and eventual disposal of your products—in the
household, by commercial service organizations.
and by many sectors of industry—there will continue
to be many opportunities for widespread exposure of
man and the environment to the chemicals which
you produce. The general concern over both the
known and the unknown effects of these chemicals
and over the interaction of these chemicals with
other materials in the environment points to
continuing scrutiny of your activities by
Government, environmentalists, and the general
public. Indeed, the public expects a greater degree of
safety and environmental consciousness from your
industry lhan from many other manufacturers of
industrial and commercial chemicals.
I am hopeful that the soap and detergent industry
will, in many respects, stay ahead of the often
cumbersome Governmental machinery designed to
protect our environment. By developing its own
programs of responsible limitations on the use of
toxic chemicals, industry frequently can reduce the
need for overly extensive Governmental
intervention into commercial activities which too
often is painful for all concerned.
A GENERAL PERSPECTIVE
Direction of our Environmental Concerns
In his Environmental Message of December 1974,
the President underscored the "maturity" of our
environmental commitment—a maturity that is
critical to responsible integration of our economic.
energy, and environmental objectives. This maturity
must be reflected in the restraint shown by industry
when considering the desirability of developing and
using products which may have questionable health
or environmental impacts. Similarly.
environmentalists must exhibit moderation in the
long overdue efforts to enhance the quality of the
environment, efforts which frequently curtail
commercial activities that are important
contributors to economic growth.
With specific regard to the development and
manufacture of chemicals, it is essential to adopt the
President's call to reject the extremes and to accept
the need for balancing environmental, economic.
and energy concerns. Almost 15 percent of our
industrial base is involved in introducing chemical
changes into its products; a significant share of our
energy resources is used as feed stock and as a
source of power for this segment ot industry; while at
the same time many of the products and by-products
of the chemical industry are discharged into the
environment.
»
For many years, the primary emphasis of our
environmental efforts has been to control what
might be called gross pollution effects, including
chemical oxygen demand, biological oxygen
demand, and suspended solids in water effluents and
SOX, N(>x, and paniculate in air emissions. While
these efforts are of course continuing, there is now
rapidly increasing attention being given to a number
of toxic chemicals. This is not surprising in view of
the growing list of recent environmental problems
that have arisen throughout the country as the result
of the presence of toxic chemicals, such as mercury,
polychlorinatcd biphenyls, asbestos, arsenic, vinyl
chloride, and more recently, organo-halogens in
drinking water supplies.
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Industrial Efforts to Reduce Environmental
Problems
In recent years, many segments of industry have
made very significant investments to control the
discharge of effluents and emissions into the
environment. These steps have heen taken in large
measure in response to Governmental requirements
at the Federal. State, and local levels. There seems
to be little doubt that such actions have had «
dramatic effect in slowing the rate of degradation of
our environment. However, all will agree that we
still have a long way to go in cleaning up our air and
water and in preserving our landscape.
Similarly, industry has over the years expanded its
efforts to insure the safety of its chemical products—
safety as viewed from the perspective of the worker,
of the housewife, and of the general population.
Such efforts have been spurred to a great extent by
Governmental regulations, in some cases by the
latent threat of lawsuits, and at times simply by good
business practices. For many years, direct acute
effects of chemicals have, of course, been of major •
concern; and more recently, complementary efforts
have been directed to the longer term and more
subtle health and ecological effects.
In vinie cases, industry has gone far beyond the
requirements laid down by Government for
pollution control levels to be achieved and for safety
requirements. For example, one major chemical
company has adopted the near term goal that all new
plants be designed to achieve zero discharge with
regard to process liquid waste effluents. Some
companies have significantly expanded their staffs of
toxicologists to address health problems beyond
those of immediate interest in Government
regulations. Other companies are conducting
ecological effects tests on chemicals which by
regulation arc only required to be tested for their
health effects. However, our general impression is
that most companies arc not moving much faster on
the environmental front than the rate at which they
are required by legally enforceable regulations.
Regulatory Framework
There are several regulatory authorities designed
to limit the entry into the environment of toxic
chemicals. For example, in the Clean Air Act and
the Federal Water Pollution Control Act there are
specific provisions directed to toxic and hazardous
contaminants, and the pesticides laws are designed
to prevent unnecessary environmental
contamination from pesticides. While the laws
administered by FDA, CFSC, an.d OSH A are not
intended to protect the general environment, they
do, of course, have some impact in this regard.
These and other regulatory authorities have
required an ever increasing RAD commitment by
industry. This trend will surely continue. I need not
ilcxcribi* for you the impact of such requirements on
(he competitive positions of large and smal I
companies, on the willingness of companies to risk
investment in new products and facilities, and on the
eventual appearance of new products in the
marketplace.
As the Governmental structures for regulating the
activities of the chemical industry continue to grow,
I would hope that there will be a greater
sophistication in our approach to regulation. This
sophistication should enable both industry and
Government to know in advance the ground rules
for judging the acceptability of products—ground
rules which will not be constantly changing. Of
particular importance in this regard is a more
consistent approach among Governmental agencies
and particularly agencies promulgating regulations
directed to the same chemical classes. The
relationships between workplace standards, levels of
food contaminants, and effluent and emission
standards, for example—all directed at the same
chemicals—need to be more clearly recognized than
ever before.
Trends in the Development of Chemicals
During (he next decade, many more chemicals
will be in commerce. At the same time the properties
ol chemicals—both old and new—will be better
understood. Consequently, the list of chemicals
considered hazardous to man and the environment
will undoubtedly be much longer. Also, improved
research and analytical capabilities will show that
the effects of these chemicals—acting individually
and syncrgistically—are much farther reaching than
currently recognized effects.
In many branches of the chemical industry,
'including your activities, research will continue to
illuminate opportunities for use of substitute
products. I am sure that increasing agricultural
pressures for phosphates, for example, make you
keenly aware of the importance of such efforts. In
this regard a continuing search for less hazardous
substitute products should become a hallmark of
your research, recognizing that in the short run such
substitutes may be more expensive and less
profitable. However, in the longer term the
introduction of such substitutes may well be less
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expensive to all concerned than the introduction and
subsequent withdrawal of cheaper products with
questionable health or environmental risks.
From the toxic substance point of view the quality
of life in the Chemical Age of the Eighties, depends,
in large measure, on the outcome of the competition
between economic growth on the one hand and the
sophistication in approaches to responsible
regulation—by both industry and Government.
Clearly, more people will be exposed to more
chemicals in more situations. Hopefully, we can
develop the necessary precautionary measures that
will limit exposure to chemicals when necessary, but
not unnecessarily curtail commercial activities.
THE NEED FOR TOXIC SUBSTANCES
LEGISLATION
Beginning in 1971, the Administration and
Congress have attempted to gain enactment of the
Toxic Substances Control Act. and it seems almost
certain that these efforts will be revived within this
Congress. This legislation has often been described
as "front-end" legislation designed to prevent
problems rather than simply providing a reaction
after chemical contaminants have caused severe
environmental or health damage. Also, preventive
action early in the life of a chemical could minimize
the economic disruptions attendant to corrective
actions. Another welcome aspect of this legislation is
its explicit call for a more deliberate balancing of
risks and benefits prior to Governmental regulatory
intervention in commercial activities. Finally, the
legislation provides the basis for assessment of the
entire life cycle of problem chemicals in determining
how best to ameliorate the problems. Too often
under existing legislative authority, we focus on the
manifestation of the problem which is rcgulatablc
under existing authorities rather than on those
aspects that are at the root of the problem.
The proposed legislation would give EPA new
authority for (a) information acquisition on
commercial chemicals, and (b) regulatory actions on
chemicals not now subject to regulation under other
authorities. EPA could require testing of chemicals
which are suspected to pose unreasonable risks and
also require other information from manufacturers
including the name of the substance, chemical
formula, amounts produced, uses, and known by-
products. Confidential information would, of
course, be respected. When shown to be necessary,
and only then, EPA could restrict the use and
distribution of chemicals that pose unreasonable
risks.
While the final version of the legislation may
influence the choice of the initial EPA activities in
carrying out the provisions of the law, it seems clear
that the following areas should be high on the
agenda for early attention:
— Elaboration and articulation of the criteria or
sett of criteria to be used in weighing risks
versus benefits, and in determining when
regulatory action is needed. Clear
understanding by both industry and
Government of the ground rules for
restrictions seems essential.
— Determination of the character and scope of
initial testing requirements and identification
of specific chemicals or classes of chemicals of
particular immediate concern. While the
selection of substances to be covered by the
standards for test protocols that are initially
promulgated will in large measure reflect
near-term judgments of experts concerning
likely hazards and inadequacy of current data,
concurrent work is needed to provide a better
basis over the longer term for selecting areas of
concern.
— Development of regulations setting forth
timing, coverage, content, and format of the
reporting requirements for chemical
manufacturers and processors, including both
annual reporting and premarket notification.
— Establishment of a data system for handling
the industrial reports and test results that are
submitted. Experience in the pesticide area.
for example, underscores the importance of
early attention to establishing efficient and
decision oriented procedures if large numbers
of reports are to be useful in assessing
problems in a systematic fashion.
While we are uncertain as to the precise course of
Congressional action concerning this legislation, we
anticipate that toxic substances bills will be
reintroduced in both the House and the Senate
within the next few weeks. I suspect that they will he
generally along the linesof the Conference
Committee Working Print which was prepared in
December in an effort to bring closer together
differing Senate and House positions in several key
areas. However, additional modifications will
undoubtedly be incorporated by each chamber.
Presumably another round of hearings will be held
during the spring, and it will not be surprising if the
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legislation is ugain referred to ;i Conference
Committee by summer.
Our understanding is that both enviromticntiil and
labor groups will he pressing vigorously for early
enactment of legislation. These groups have definite
views as to some of the provisions of such legislation.
With regard 10 industry you are in a better position
than urn I to predict the position that will be taken by
different segments of industry.
While the Administration has been clearly on
record as strongly supporting this type of legislation
in the past, the current position on the legislation is
still being formulated.
RECENT ENACTMENTOF DRINKING
WATER LEGISLATION
Towards the end of the. last Congress, the Safe
Drinking Water Act was passed providing EPA with
authority to conduct a wide swathe of activities
ranging from standard setting, to monitoring and
research, to assessing availability of water treatment
chemicals, to training and technical assistance.
Drinking water is one possible resting place for some
of the chemicals which are of interest to your
industry. Also, each of us consumes about two liters
of water each day. Therefore, continents on the toxic
substances aspects of this new authority may be of
interest. I will touch only on a few aspects of the new
law. and specifically on those aspects for which my
Office has some responsibility.
You will recall the reports of last fall concerning
suspected carcinogens in drinking water supplies in
several cities, and particularly organics in the New
Orleans water supply. These reports were the
principal force in triggering the somewhat
unexpected Congressional action. Indeed a specific
provision was incorporated into the law calling on
EPA to take steps to clarify and reduce the risks
associated with carcinogens in drinking water. This
requirement has led to a series of actions designed to
respond to this public health concern. An extensive
program of monitoring a number of water supplies
throughout the country is underway. Analyses of the
health effects of known contaminants in drinking
water are being expanded. Investigations of the
feasibility and costs of removing contaminants from
water supplies are being accelerated. Obviously.
these types of activities have been.carried out in the
past. However, the current efforts are broader and
more ambitious than ever before.
New efforts arc underway to clarify the source of
the drinking water contaminants. In many cases, the
sources are industrial discharge; sometimes the
contaminants may be traceable to pesticides or
fertilizer runoff; and in other cases natural
background levels may be responsible. Correlating
specific sources of chemical discharges into the
environment with contaminants found in specific
water supplies is not easy, however. This task is
further complicated when.the quantities of (he
chemicals are very small.
Perhaps the key element of the new legislation is
the determination of the levels of contamination in
drinking water which arc acceptable for specific
chemical pollutants. This determination is to be
made on the basis of both public health
considerations and technical and economic
feasibility. Within the next two months EPA is
scheduled to propose interim standards for about 30
contaminants with revised standards scheduled for
promulgation in about two years. It seems likely that
the revisions will include more chemicals, including
at least some of the organics which arc of particular
immediate concern.
In very simplistic terms, there would seem to be
two alternatives in reducing contaminant levels
which exceed prescribed standards: applying control
technologies at the water supply (e.g. filtration.
coagulation)or reducing the source of the
contaminant (e.g. at the effluent pipe, during field
applications). In either case there will be costs
involved, and hard decisions must be made as to the
most appropriate distributions of these costs.
TESTING AS A KLY TO BETTER
UNDERSTANDING
In all of these areas—in all of our regulatory
decisions—we are faced with uncertainties. The
health data are usually soft; the data on persistence
sparse; and the data on ecological effects almost nil.
Yet actions must be taken. We cannot afford to
allow our environment to become a testing
laboratory, nor our general population the test
species. At the same time no one advocates that the
absence of data indicates that a chemical is
environmentally acceptable.
Thus, in my view, a key to responsible decision-
making is better information on chemicals under test
conditions simulating, to the extent possible, the
types of exposure encountered in the general
environment. And it is industry that has the
responsibility to insure that such testing is conducted
on the products it sells. And it.is the responsibility of
Government to insure that industry is fully aware of
the type and extent of testing that will he considered
adequate in the regulatory process.
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Indeed, improved information—and particularly
lest information—as an essential ingredient for
responsible decision-making is the heart of the Toxic
Substances Control Act. With such legislation on the
books many of the currently disruptive uncertainties
over Governmental and industrial responsibilities
will be clarified. There will be a real opportunity for
productive efforts to jointly insure the enhancement
of our environment while promoting the continued
viability of the chemical industry.
Whether we be concerned with detergent builders
or optical brighteners, with borax or higher
bcnzenepolycarboxylates, we must consider both the
commercial benetits from our.activities and the
necessity for environmental safeguards. We all know
that (he balancing of costs, risks, and benefits is not
unique to the chemical industry; indeed it is the
essence of many of our daily activities as we drive
our car to the corner drugstore for a carton of
cigarettes. However, when the beneficiary of an
activity is different from the person exposed to the
risk, we can no longer be casual in balancing costs,
risks, and benefits. Thus, a more deliberate
approach to societal decisions is the challenge of the
years ahead.
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TOXIC CHEMICALS AND REGULATORY
DECISION MAKING
PHILOSOPHY AND PRACTICALITY
Conference on Principles of
Decision Making tor Regulating
Chemicals in the Environment
National Academy of Sciences
New Orleans, Louisiana
February 18, 1975
THE GENERAL FRAMEWORK
f
Integration of economic, energy, and
' environmental concerns. The need to avoid the
extremes and to exhibit moderation in applying
environmental controls. Balancing costs, risks, and
benefits. Maintaining environmental objectives
while adjusting the short-term timetables to
accommodate economic problems. The inevitability
of some level of risk in everything we do.
This rhetoric, characterizing the current climate
surrounding the environmental movement, appears
appealing and easy to grasp. But what does it really
mean as we address specific regulatory actions
directed to toxic chemicals?
On a macro scale, we sometimes feel we are able
to express the dollar costsof environmental control
measures, with some confidence in our estimates.
Recently, drawing on the practices of the
statisticians, we have begun to manipulate health
effects data in order to quantify the level of risk and
the size of the population at risk. At the micro level,
it often seems still easier to estimate the impact of
regulatory actions, answering such questions as:
What will a specific pollution control device cost in
a specific plant? What will the resultant contaminant
levels be in the stream or in the drinking water? Is
this level below a "no effects" level?
However, in my view the aggregation of micro
impacts is far more complicated than summing up
the parts. For example, a risk factor of I/! ,000,000
appears different when viewed from the perspective
of the I than from the perspective of the other
999,999. Also the cumulative effect of regulatory
actions, together with the uncertainty of future
actions, has a dramatic effect on the whole climate of
doing business. Many aspects of this effect are
difficult to identify, let alone quantify. Second
guessing the current and future attitudes of
regulatory agencies is becoming a way of life within
many chemical companies as they reach decisions on
the amount of resources to devote to R&D, the level
of investments in introducing new products or
continuing old products in the face ol evidence
suggesting possible environmental problems, and the
pollution abatement conservatism to be built into
the design of new plants.
TRENDS IN REGULATORY DECISION
MAKING
The legislative history of toxic substances
regulation is punctuated with inconsistencies as to
the weight to be given costs, risks, and benefits in
decision making. The most recent addition to the
annals of environmental law, the Safe Drinking
Water Act, addresses directly the perennial question
of the weight to be given to public health
considerations in determining enforceable
contaminant levels. This law calls for both (a) health
based contaminant levels—or health goals—and
(b) enforceable contaminant levels which explicitly
take into account technological feasibility und
reasonableness. Similarly, the many versions of the
proposed Toxic Substances Control Act have
consistently highlighted the need to weigh all
relevant factors including economic and
technological considerations in reaching regulatory
decisions. As you know, this philosophy is not
expressed with similar clarity in certain sections of
the Clean Air Act and the Federal Water Pollution
Control Act.
Meanwhile, we are increasingly requiring more
broadly based assessments of the impact of
regulatory decisions—environmental assessments,
economic assessments, and recently inflationary
assessments. Usually the procedure is to postulate a
numerical standard for a toxic chemical or a specific
type of limitation on the use of the chemical, with the
restriction designed to reduce environmental levels
to the point that concerns over health or
environmental damage disappear. Then an
assessment is carried out to see if the favorable
environmental impact from the restriction warrants
the concommitant economic costs. If the costs are
too high, the level of control is adjusted until an
appropriate balance is reached. Unfortunately, to
date this balancing act has been ad hoc at best, while
at the same time our new authorities are calling for
more systematic approaches to such balancing. As
the judiciary becomes more deeply involved in toxic
substances, it seems essential that these approaches
must improve both in form and in substance if
regulations are to be sustained by the courts.
In our zeal to balance risks and benefits in some
quantitative way, we frequently try to place numbers
on the risks associated with very uncertain health
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data. More often than not, in the quantification
process we drop the margins of error from our
deliberations. This has been particularly true in the
carcinogen area. Largely as a result of the work of
statisticians beginning ten or more years ago, there
arc now techniques for estimating risk factors.
However, too often the lawyers and economists seize
upon these numerical risk factors, frequently
forgetting that these experimentally derived
estimates may in fact have a very shaky relevance to
the real world.
NEEDS OF REGULATORY DECISION
MAKING IN THE NEAR FUTURE t
Clearly, our goal is to improve the decision-
making process, a process that is usually plagued
with insufficient time and with unbelievably soft
data. Nevertheless, decisions must be made,
decisionsthat hopefully will be both sensible and
defensible. We need to better use existing data—to
better assemble what we have, to see more clearly
what we don't have, to make reasonable
extrapolations across the data gaps, and then to
make judgments which best reflect the interests of
society. If legal constraints inhibit judgments which
best serve society, we should seek changes in the law.
We need to belter orient our data collection and
manipulation activities so that the information is
arrayed in a way in which it is more relevant to
decision making. I need not describe for you the
difficulties in trying to derive the roots for
numerical standards on the basis of a toxicological
experiment which was designed to expand the state-
of-the-art of toxicology. And, finally we need to be
able to better integrate data concerning a variety of
considerations—health, persistence, control
technology, economic dislocations. Is it possible to
move away from the past efforts of comparing apples
with oranges—away from the fruit salad approach
towards a truly blended regulatory punch?
THE SCOPE OF THIS MEETING
Jhis meeting is directed principally to advancing
the state-of-the-art in reaching regulatory decisions
on toxic chemicals which for one reason or another
have already been identified as highly suspect in
causing serious environmental or health problems.
The suspicion may have arisen from recent
epidemiological findings, toxicological experiments,
or monitoring data, or it may reflect an '
accumulation of scientific or public concerns not
necessarily tied to recent revelations. It may have
resulted from deliberate efforts to search out <
problem chemicals. In any event, given a problem
chemical, how can we more effectively decide
whether regulatory action is in order, and if it is,
how tight or how loose the regulation should be? We
are particularly concerned with decision making
which must be carried out in the near term in the
absence of what purists—or perhaps even reasonable
men—would call adequate time or data. There is
really no option to delay the decision until better
data are available. This does not mean that the
interim decision is necessarily the final decision; and
indeed, I have not been involved in a single
regulatory decision of any significance that has not
included as part of the package the requirement to
collect better data so that the decision can be
reviewed and perhaps improved at a later date.
There are several concerns closely related to the
regulatory decision which are not a principal focus
of this meeting although it is recognized that you
cannot totally neglect these aspects. One area of
considerable importance which is being explored in
a variety of other forums concerns methods for
selecting from the world of chemicals those
chemicals or chemical activities which require
priority regulatory attention. A second area
receiving considerable attention within EPA is the
selection of the most appropriate legal authority for
reducing identified problems. For example, what are
the respective roles of Effluent Guidelines and
Toxic Effluent Standards under FWPCA; when are
New Source Performance Standards more
appropriate than Hazardous Pollutant Standards
under the Clean Air Act; and which sections of the
Pesticide laws can most appropriately be invoked to
curtail certain problems? A third important aspect
relates to the generation of test data, a topic which
has already been explored in some detail by the
Academy.
At this session we would like to emphasize the
problems of decision making with less than optimal
data. A secondary interest, of course, relates to the
shaping of data collection activities, particularly in
those instances when there is sufficient time to
improve the data base before a regulatory decision is
necessary.
In general, we are concerned with two types of
regulations: firstly, product limitations where the
manufacturing, use, distribution, or disposal of a
chemical is regulated such as in the case of pesticides
or chemicals under the Toxic Substances Control
Act; and secondly, the determination of the
acceptable levels for pollutants—expressed as
numerical standards or as a control technology
requirement—such as in the case of hazardous air
emissions, toxic water effluents, drinking water
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contaminant levels, pesticides tolerances, and the
like. Further complicating the task is our special
interest in multimedia contaminants.
EXAMPLES OF PRACTICAL REGULATORY
PROBLEMS
Let me cite three regulatory areas which
exemplify the types of concerns that this Conference
might address. During the next several years, EPA
will be involved in a variety of decisions in all of
these areas. There are, of course, other areas as well,
and particularly pesticides and air emissions
problems, which my colleagues can address.
Regulatory Actions under the Toxic Substances
Control Act
The proposed Toxic Substances Control Act
would give EPA the authority to prevent or limit
production, distribution, or use of selected
chemicals or require that they be labeled with
instructions concerning use or disposal. The most
recent versions of the law require that in reaching
regulatory decisions the Administrator consider:
— The effects of the substance on health and the
magnitude of human exposure,
— The effects of the substances on the
environment and the magnitude of
environmental exposure, and
— The benefits of the substance for various uses
and availability of less hazardous substances.
•After considering these factors he could impose
regulatory action if he determines that there is an
"unreasonable risk" to health or the environment.
The purpose of this session is not to try to
determine what is an unreasonable risk since that
judgment must be made on a case-by-case basis.
However, we are hopeful that you can assist in
further clarifying the factors that should be weighed
in reaching such a judgment and in setting the
ground rules for arraying data in a way that the
judgment will be as fully informed as possible.
Again, it is important to keep in mind that the data
which will be arrayed will inevitably be far from
complete.
As one point of departure in our internal efforts to
assemble data in an orderly fashion for determining
the need for regulations under this proposed law, we
have identified the following five steps:
Assessment of the effect of various levels of
exposure of a chemical or its derivatives on
man or the environment;
Assessment of the likely levels of exposure
through material balance analyses;
Confirmation by monitoring ot actual
exposure levels;
Determination of the likely reduction in
exposure levels and attendant effects through
alternative regulatory actions; and
Assessment of the economic and social costs of
the alternative actions.
Under each of these categories we are attempting to
develop checklists of items to be considered. I am
sure that these data categories can be improved, but
perhaps of equal importance is how the data from
these categories arc to be meshed.
National Primary Drinking Water
In about two years EPA will propose revised
National Primary Drinking Water Regulations for
contaminants in drinking water, including probably
several dozen chemicals. These regulations must
take irito account both public health considerations
and feasibility of attainment. Thus, it seems
necessary to consider (a) health effects at various
contaminant levels, (b) monitoring data showing the
current and projected range of contamination in
water supplies, (c) costs involved in reducing high
levels to lower levels at the water supply,
(d) feasibility and costs of monitoring low levels,
(e) sources of the contaminants, and (f) costs of
reducing these sources as an alternative approach to
cleaning up the water after it is contaminated. The
problem i)f data collection and analysis is
particularly complicated since a single standard will
apply to 40,000 water supplies of all si/.esand
character. Short term variances will help with some
of the extreme cases. However, the need for reliable
statistical sampling will nevertheless be u
complicating factor. The problem as I see it is at
least twofold: collecting and displaying the data in
these categories in a meaningful way, and integrating
the data in a way which will enhance the soundness
in reaching judgments as to required levels. Again I
would add that much of the data may be soft and not
susceptible to easy quantification.
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Toxic Effluents that Cause Health Problems
We are currently involved in a major effort to
determine which chemicals currently being
discharged into our waterways constitute a health
hazard. One starting point is an examination of
monitoring information from drinking water
supplies, fish products, and recreational areas
concerning the presence of chemicals, and isolating
those chemicals that are (a) suspected to have
adverse health effects at relatively low levels.
(b) discharged by industrial facilities, and
(c) sufficiently persistent to reach man via the
recreational, drinking water, or food routes.
It is not too difficult to identify a few such
chemicals; however, it is far more difficult to
determine whether effluent controls on these
chemicals are warranted and if so, the degree of
control that is appropriate. The chemicals will
probably usually be present in trace amounts, and
the health hazards from these trace amounts, even
for carcinogens, are far from clear. The incremental
decrease in the trace amounts, and the attendant
health implications, which will be achieved by
turning off or reducing selected sources is similarly
not clear, particularly if industrial dischargers are
not the only source of contaminants. Finally,
whether the control costs are warranted by the
incremental health gain is also far from straight
tor ward. We anticipate that we will be grappling
with this problem for several years, and advice and
suggestions on appropriate methodologies would be
very welcome.
THE OUT PUT FROM THIS CONFERENCE
What can be realistically accomplished during the
next several days and during the report writing that
will continue for several months?
Perhaps most importantly, a greater sensitivity to
the multiplicity of societal interests bearing on
regulatory decision making will emerge—certainly
among the participants and hopefully among the
recipients of the report. This sensitivity should in
turn lead to a higher level of sophistication in our
decision making.
General principles which can serve as guideposts
in the field of chemical regulation would be
welcomed by all participants in the regulatory
process—the regulator, the regulatee, and the
adjudicator. Such principles are particularly timely .
as the influx of new people into this field continues
to grow. The scope, general appreciability, and
specificity of these guideposts are of course the crux
of the deliberations during the next several days.
With the benefit of hindsight, we should be able to
identify common shortcomings in past decisions
which an improved methodology can overcome.
And surely as we consider the types of decisions
ahead, specific ideas and suggestions will
undoubtedly emerge.
Finally, we are searching for practical suggestions
as to how we can significantly improve our data base
for decision making without "breaking the bank."
THE CONTROL OF TOXIC SUBSTANCES IN
THE YEARSAHEAD
From (he toxic substance point of view the quality
of life in the chemical age of the Eighties depends, in
large measure, on the outcome of the competition
between economic growth on the one hand and the
sophistication in approaches to responsible
regulation—by both industry and Government.
Clearly, more people will be exposed to more
chemicals in more situations. Hopefully, we can
develop the necessary precautionary measures that
will limit exposure to chemicals when necessary, but
not unnecessarily curtail commercial activities.
There is, of course, a danger that society will not
act responsibly toward toxic substances through its
Government and other institutions, with the
inevitable outcome of endless legal confrontations.
The entire approach to toxic substances could
become bogged down in the courts. To avoid such a
situation, the highest quality of Governmental
leadership in this area seems essential—leadership
characterized by technical credibility and openness
in dealing with controversial data. You have a
genuine opportunity to help stimulate such
leadership.
We all know that the balancing of costs, risks, and
benefits is not unique to the control of chemicals;
indeed, it is the essence of many of our daily
activities as we drive our car to the corner drugstore
for a carton of cigarettes. However, when the
beneficiary of an activity is different from the person
exposed to the risk, we can no longer be casual in
balancing costs, risks, and benefits. Thus, a more
deliberate approach' to societal decisions is the
challenge of the years ahead.
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CURRENTTRENDS IN THE
CONTROL OF7 CHEMICALS
Conference on Environmental Aspects
of Chemical Use in
Rubber Processing Operations
Akron, Ohio
March 12, 1975
THE RAPID GROWTH OF CHEMICAL
PROBLEMS
During the last several years the number and
frequency of harmful incidents involving toxic
chemicals have increased dramatically. Hardly a
week goes by without a new chemical emerging as an
immediate health or environmental problem, and
the public outcry over carcinogenesis and other
chronic effects of exposure to chemicals seems to
have literally exploded.
All levels of Government are taking steps in
response to the demands for action to clarify and
reduce the risks attendant to chemical exposure. No
longer arc pollution problems viewed simply in
terms of asthetics, inconveniences, or ecological
degradation; but they are now tied more closely than
ever before to very personal human health concerns.
No longer are the long drawn-out timetables
acceptable for corrective steps with regard to toxic
chemicals. No longer will the public accept the
philosophy that chemicals must be assumed safe
until proven hazardous. No longer are latent
problems, such as the mutagenic effects of chemicals
that may appear only in future generations, to be
ignored. No longer arc chemicals the unique concern
of only the manufacturers, the distributors, and their
employees, for the Chemical Age of the Seventies
has engulfed our entire society.
I need not review for this audience the unsettling
chain of events triggered by the linkages established
last year between cancer of the liver and exposure to
vinyl chloride. Many of the companies represented
here have been deeply involved from the outset of
this very tragic development, a development rooted
in the environmental complacency of the industry
during the forties, the fifties, and the sixties. We
have all become painfully aware of the difficulties in
assessing the risks associated with very low levels of
exposure to this chemical and in taking corrective
actions to reduce these risks. I am sure that all agree
that we can and must do better in the future in
preventing these types of tragedies—and
particularly in identifying and assessing problems
before the fact rather than after the damage is done.
Already tens of thousands of chemicals arc in
commerce, and the number is increasing every year.
Little attention has been given to the environmental
properties of many of these chemicals. Constantly
evolving research and analytical techniques arc
revealing that the potential effects of many others
are much farther reaching than previously
suspected. In short, during the years ahead all of us
will be exposed to many more chemicals in many
more situations, and the list of chemicals known or
believed to pose a threat to man or the environment
will be greatly expanded.
Our market forces are not designed to insure
environmental equity, and the risks and benefits
associated with chemicals are not evenly distributed
throughout our society. The archaic concept of
voluntary exposure to chemicals'—that we have a
choice as to whether we want to come into contact
with chemicals—has been replaced with the hard
reality that in fact the individual citizen has little
control over the chemicals to which he is exposed.
Thus, Governmental involvement in the chemical
arena will undoubtedly increase to keep pace with
the growing chemical burden in the environment.
THE DEVELOPMENT OFTHE LEGISLATIVE
BASIS FOR CONTROLLING TOXIC
CHEMICALS
For many years the Federal Government has hecn
deeply involved in chemical regulation through the
activities of the Food & Drug Administration, and
more recently in controlling pesticide use. The
Clean Air Act and the Federal Water Pollution
Control Act have special provisions directed la toxic
and hazardous chemicals in addition to their
broader provisions which also encompass chemical
pollutants. Indeed, these activities have to a large
extent established the framework for the current
spread of programs throughout the industry directed
to product safety and environmental control.
During the past several years the Department of
Transportation, the Occupational Safety and Health
Administration (OSHA)of the Department of
Labor, and the Consumer Product Safety
. Commission have significantly expanded their
efforts directed to toxic chemicals. Of particular
interest to EPA and OSH A is the close
interrelationship between concerns over chemicals
in the workplace and the possible discharges of these
same chemicals directly Or indirectly into .
neighborhoods near industrial facilities as the result
of air emissions or liquid effluents. In many cases a
large share of these nearby residents are the workers
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who may be exposed to the same chemicals on and
off the work premises. Also, we are concerned that
in dealing with persistent chemicals the long
'standing approach of better ventilation does not
appear to be an acceptable solution to meeting
workplace standards.
In December the Safe Drinking Water Act was
somewhat unexpectably enacted. The rapid
Congressional action on this legislation was
prompted by reports of trace amounts of organic
chemicals—including several possible
carcinogens—found in several drinking water
supplies, ajid particularly New Orleans. This
legislation, which calls for establishment and
enforcement of maximum contaminant levels in
nation-wide drinking water supplies, has far
reaching implications for industry. It seems unlikely
that municipalities will invest large sums of money
in removing chemical contaminants from their water
supplies without first attempting to identify and
control the sources of these contaminants. In many
cases the sources of concern will undoubtedly be
industrial dischargers.
The proposed Toxic Substances Control Act
offers an unusual opportunity to improve the
soundness and the fairness of regulatory decisions
concerning toxic chemicals. The heart of this
proposed legislation is the acquisition of more
authoritative information concerning both the risks
and the benefits associated with chemical activities.
Special emphasis is placed on better test information
which is predictive of the behavior of chemicals in
the environment. A second aspect of this proposed
legislation is provision for controlling serious toxic
chemical problems which cannot be adequately
addressed under other existing authorities.
An improved information base is critical to better
decisions concerning Governmental intervention in
chemical activities under a variety of regulatory
authorities. At the present time decisions are being
made on the basis of very sparse data. Even in the
absence of such information, decisions will continue
to be made, for action in this field cannot be
delayed. In this regard, the lack of hard data
concerning chemical behavior should hot be
considered a license for continued production and
use of the chemicals any more than we can assume
that activities should cease until they are proven to
be absolutely safe.
INTERCEPTING THE PROBLEMS AT THE
OUTSET
A main feature of the Toxic Substances Control
Act is the emphasis on identifying problems early in
the commercial lifetime of chemicals—before there
has been irreversible environmental damage and
before major economic investments are in place. At
present we find ourselves constantly reacting to
problem chemicals which are already widely
dispersed throughout our economy—chemicals
which have already caused environmental problems
and which represent substantial investments for
suppliers, manufacturers, and distributors.
Corrective measures invariably mean substantial
economic dislocations.
With 300 to 700 new chemicals being introduced
into commerce every year, it is only sensible to make
the extra effort to insure that these new products are
not going to cause problems later in their lifetime.
The extent of the research and testing needed to
reach a judgment as to potential environmental
problems will vary among chemicals and among
uses of the chemicals. However, the ground rules for
early assessment of chemicals need sharper
clarification and greater acceptance by all
concerned. In my view, the recent report of the
National Academy of Sciences Principles for
Evaluating Chemicals in the Environment has been a
major step forward in this regard. Further
development of the concepts set forth in this report,
and particularly relating these concepts to practical
problems, needs priority attention.
Of course, any Governmental intervention during
the pre-market phase must be sensitive to the
financial realities of R&D activities. Particularly
important is the need to avoid additional delays due
to uncertainty as to Governmental actions. Also, the
cumulative effect of actions directed to individual
chemicals can dampen the overall climate for
research. Finally, protection of the confidentiality of
activities directed to new chemicals is of critical
importance.
Unfortunately, this approach of early
identification and prevention of environmental
problems and economic dislocations will not help in
addressing chemicals currently in large scale
production. It is indeed unfortunate that this "pay
now and save later" philosophy was not adopted
many years ago. As problems continue to arise with
high volume chemicals, the short-term economic
adjustments will undoubtedly be severe.
COST/RISK/BENEFIT CONSIDERATIONS
Recently the Government has significantly
increased its efforts to not only assess but also to try
to balance the costs, the risks, and the benefits
involved in regulating toxic chemicals in the
environment. To the extent possible regulatory
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activities should be judged on the basis of their total
impact on society—impact on the standard of living,
effective resource utilization, and preservation of
social ns well as environmental values.
This change in direction in approaching
regulatory decisions has in large measure resulted
from a reorientation in the nature of some of the
legislative authorities under which EPA operates.
For example, the new Safe Drinking Water Act and
the proposed Toxic Substances Control Act are very
explicit in their requirements to take into account
economic as well as health and environmental
considerations. On the other hand certain provisions
of the Clean Air Act and the Federal Water
Pollution Control Act are far from clear as to the
weight, if any, to be given to economic
considerations. In a related development, recent
court action concerning the feasibility of the
workplace standard for asbestos has had a
considerable impact on the approach of OSH A.
Despite growing sophistication in the approach to
controlling toxic substances, rigorous
cost/risk/benefit analyses will seldom be possible;
for adequate time, data, or resources will usually not
be available to satisfy a purist. However, we can
certainly do better than we have in the past.
Many of us have had direct experience in
attempting to draw conclusions from biological data
which are invariably "soft." At the same time
pragmatic economists tell us that their data on
benefits may be even softer—and probably
characterized by uncertainty, incompleteness, and
perishability. They are particularly reluctant to
provide estimates of the societal benefits to be
derived from the use of chemicals which contribute
to improved health and living conditions, to greater
personal conveniences, to new recreational and
asthetic opportunities, and to maintenance of
national defense. Often, they are even less willing to
speculate as to how the marketplace will react if a
specific chemical is removed or if its price is
increased as the result of environmental controls. In
short, the economists can provide a shopping list of
some of the factors to be considered in regulatory
decision making, but they provide relatively little
guidance as to how these economic factors are to be
weighted or integrated or how they are to be meshed
with other considerations.
Several points related to costs seem to be clear,
however. If there are increased costs attendant to
environmental control, these costs will be eventually
passed on to the consumer. Secondly, there will
probably be local impacts attendant to specific types
of regulatory activities, and particularly limitations
on the manufacture or use of chemicals. These local
impacts can include business set-backs, employment
dislocations, and even depressed real estate values.
And finally, in general the market is sufficiently
flexible and our innovative capacity sufficiently high
to fill promptly the vacuum caused by the loss of«
single product with alternative products or
approaches to providing a similar service-
In view of the critical importance of
cost/risk/benefit assessments to responsible decision
making, we have recently launched several major
efforts to refine the methodologies which can
illuminate in advance the implications of regulatory
decisions. It is particularly important that value
judgments not be disguised in manipulating the data
base and that the bases for decisions be structured in
such a way that the public can understand the
rationale that is used.
THE SPECIAL RESPONSIBILITIES OF
INDUSTRY
In recent years, many segments of industry have
made very significant investments to control the
discharge of effluents and emissions into the
environment. These steps have been taken in large
measure in response to Governmental requirements
at the Federal. State, and local levels. There seems
to be little doubt that such actions have had a
dramatic effect in slowing the rate of degradation of
our environment. However, all will agree that we
still have a long way to go in cleaning up our air and
water and in preserving our landscape.
Similarly, industry has over the years expanded its
efforts to insure the safety of its chemical products—
safety as viewed from the perspective of the worker.
of the housewife, and of the general population.
Such efforts have been spurred to a great exient by
Governmental regulations, in some cases by the
latent threat of lawsuits, and at times simply by good
business practices. For many years, direct acute
effects of chemicals have, of course, been of major
concern; and more recently, complementary efforts
have been directed to the longer term and more
subtle health and ecological effects.
In some cases, industry has gone far beyond the
requirements laid down by Government for
pollution control levels to be achieved and for safety
requirements. For example, one major chemical
company has adopted the near term goal that all new
plants be designed to achieve zero discharge with
regard to process liquid waste effluents. Some
companies have significantly expanded their staffs of
toxicologists to address health problems beyond
those of immediate interest in Governmental
regulations. Other companies are conducting
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ecological effects tests on chem icals which by
regulation are only required to be tested for their
: health effects. However, our general impression is
that most companies are not moving much faster on
the environmental front than the rate at which they
are required by legally enforceable regulations.
Industry has a special responsibility to know what
chemicals are released during its manufacturing
activities and during the use of its products. Further.
industry has a responsibility to know the levels of
human and environmental exposure to chemicals
resulting from such releases. Industry has a
responsibility to know the likely hazards, if any,
associated with such exposures and to insure that the
public is aware of these hazards. Finally, industry
has the responsibility to take all possible steps to
minimize these hazards.
These are societal responsibilities which transcend
legal obligations imposed by Federal, State, or local
regulations. In the years ahead these responsibilities
must be given equal weight with product ;,
performance in judging a company's contribution to
society.
To accept these types of responsibilities implies
new dimensions in corporate activities, particularly
with regard to physical monitoring and to studies of
health and environmental effects of chemicals.
However, I am optimistic that the industrial
leadership of this country wil I respond to the
challenge—that this leadership will show restraint in
foregoing attractive commercial activities when
necessary in the face of environmental uncertainties,
thai it will expand its search fur less hazardous
products, and that it will reward its management tor
contributions to the health of the nation and to the
conservation of ecological resources with as much
enthusiasm as it rewards employees for increasing
sales.
A NEW DEPARTURE TOWARDS COMMON
UNDERSTANDING
This Conference signals a new departure in our
efforts to better understand the character, scope, and
implications of problems associated with chemical
activities. As additional activities in this field are
contemplated by Government, industry, labor, and
other interested groups, it seems imperative that we
have an authoritative examination of where we arc
today—the effect and implications of environmental
actions already instituted by Government and
industry and their future plans and programs.
Hopefully with a common base of understanding,
deliberations within Government, industry, and
labor will be more rationale, better, balanced, and
more objective. In the absence of this common point
of departure, there will only be a spiralling of
confusion, suspicion, and acrimony on the part of all
concerned.
This session, which draws on the expertise and
insights of representative! of many of the concerned
organizations, is designed to help establish the
baseline as to the current situation. Hopefully, the
forma! program represents but a small portion of the
exchanges that will take place during the next two
and one-half days. We are very encouraged by the
large industrial participation in this meeting. Of
particular interest to us are the steps being taken by
industry. For example, we know that massive R&D
efforts are underway to correct the problems
associated with PVC activities. To what extent are
similar efforts being extended to the rubber
processing activities of these same firms who have
been so involved with PVC during the past year?
The industry's concern over chloroprene, styrene,
and acrylonitrile, for example, have been well
publicized. Similarly, Government's concerns over
gross pollution effects (e.g. BOD, COD, TSS,
criteria air pollutants) are being reflected in water
effluent permits and in air emission controls. While
we should understand these actions, which are
important not only in themselves but also as either
successful or unsuccessful case histories, probably of
even more importance at this Conference is to look
ahead into future areas of possible concern—for we
all share an overriding interest in substituting
preventive for corrective actions.
I am pleased to note that the formal program calls
for an examination of progress in pollution control,
a review of the characteristics of specific chemicals,
a discussion of innovative uses of waste products,
and an assessment of the role of epidemiological
studies. All of these topics are central to current
efforts in controlling toxic chemicals. It seems clear
that in the future:
— pollution control requirements will give much
greater emphasis to limiting discharges of
selected chemicals;
— the environmental behavior of many more
chemicals will be examined in detail;
— productive uses of waste products will become
more and more of a reality; and
— epidemiological studies to correlate exposure
to chemicals with human health effects will
expand considerably.
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We give high importance to this Confererv - Environmental Quality. We are hopeful that it will
which is the first of several such meetings directed to make a major contribution to wiser decisions by
various aspects of chemical usage. This effort is Government and by industry—decisions (hut can
enthusiastically supported by the Administrator of have a significant impact on the price we pay for (he
EPA and by the Chairman of the Council on fruits of this Chemical Age.
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