AN APPROACH TO THE CONTROL
OF
TOXIC SUBSTANCES
November 12, 1973
HMC/OTS
-------
PREFACE
This Report is an initial step toward development of a long-term
strategy for controlling toxic substances. While a number of policy
directions are suggested, further refinement of these approaches is
clearly in order. Therefore, the Report will be revised periodically,
and initially on a semi-annual basis.
The Report is directed primarily to chemical substances exhibit-
ing adverse effects on man or the environment at relatively low con-
centration levels. At the same time it is recognized that almost any
substance can be toxic if exposure levels are sufficiently high, and
therefore it is .not practical .to specify which .chemicals or chemical
classes are or are not included. Additionally, the concern here is
only for toxic effects resulting from sustained chemical or biological
activity, and other hazardous effects, such as fire, explosions, and
radioactivity, are not considered.
The EPA approach to controlling toxic substances must be carefully
integrated with the myriad of related activities of other Federal and
State agencies -- including regulatory, monitoring, and research
activities. While better integration of all national efforts is a
central concern, this Report does not present the activities of other
interested organizations.
A principal purpose of this Report is to provide a broad perspective
for the activities of the Office of Toxic Substances. Also, it should
provide useful guidance in shaping the activities of a number of other
EPA offices. However, the activities of these other offices are
described in other Agency reports, and they are not set forth in this
Report.
-------
APPROACH TO CONTROL OF
TOXIC SUBSTANCES
-------
TABLE OF CONTENTS
Page
I. GENERAL APPROACH 1
Problem 1
General Program Goals 1
Strategy 2
Table 1 - Food Contamination 4
Table 2 - Environmental Damage . 4
Table 3 - Diseases 5
Table 4 - Industrial Trends 6
FI. RESTRICTIONS 7
Problem 7
General Program Element Goal 8
Industrial Stewardship 8
Regulatory ,t • 9
Criteria . .' 11
Problem Assessment , 11
III. TESTING 14
Problem 14
General Program Element Goal 15
Industrial Stewardship 15
Regulatory 16
Experimental 17
Public Awareness 17
IV. INDUSTRIAL REPORTING AND DATA PROCESSING 19
Problem 19
General Program Element Goal 19
General 20
Premarket 21
Existing Suspected Chemicals 22
Early Warning 22
Public Access 23
V. EARLY WARNING 25
Problem 25
General Program Element Goal 26
Criteria 26
Expert Opinion 27
Data Analysis 27
-------
TABLE OF CONTENTS (con't)
Page
VI. MONITORING 29
Problem 29
General Program Element Goal 30
Regulatory Actions 30
Early Warning 31
VII. CRISIS RESPONSE 34
Problem 34
General Program Element Goal 35
Problem Assessment 35
Regulatory 36
VIII. STRATEGY AND COORDINATION 38
Problem 38
General Program Element Goal 39
Program Coherence ..'....: 39
Problem Assessment 40
Regulatory Actions 41
IX. RESEARCH NEEDS 43
Problem 43
Estimation of Exposure 45
General Program Element Goal 46
Test Methods 46
Trend Assessment 48
Appendix 1 - EPA Regulatory Authorities of Particular
Relevance to Toxic Substances 50
Appendix 2 - Regulatory Authorities of Other Agencies
of Particular Relevance to Toxic Substances ... 53
Appendix 3 - Examples of Monitoring Networks Supported by
Other Agencies 54
11
-------
I. GENERAL APPROACH
PROBLEM
More than 20,000 chemical substances are commercially produced
and used in the United States, with 500 to 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. In 1972, the value
of the products of chemical manufacturers and processors exceeded
$200 billion, which represents a sizeable portion of U.S. manufac-
turing .activities.
The problems presented by the presence in the environment of
some of these substances are all too well knov;n (e.o. mercury,
lead, asbestos). Other substances are believed to pose a latent
health or environmental threat, while the risks associated with the
vast majority of chemicals, acting individually or synerqistically,
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 un-
doubtedly 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 neaative impact on health or the environment,
and how best to control or prevent such hazards.
Thus, the concern of EPA with toxic substances is twofold:
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.
GENERAL PROGRAM GOALS
-- Clarification of the risks to health end the environment
associated with the manufacture, distribution, use, and
disposal of new and existina chemical substances, with
particular regard to chemical properties, production levels
and trends, and exposure of the chemical to man and the
environment;
-------
-- More effective utilization of regulatory authorities and
related tools available to the Agency to mitiqate 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.
STRATEGY
Almost every EPA office with program, research, or legal
responsibilities is involved in some way with efforts to control
toxic substances. Since the toxic substances activities of most
offices are integrated into the overall program strategies of the
respective offices, the strategy reflected in this Report is
limited to the approaches of the Office of Toxic Substances. In a
sense the strategy of this Office can be considered as a core
strategy of the overall Aaency's efforts to control toxic substances.
The Office of Toxic Substances emphasizes the health and
environmental effects of individual and combinations of toxic sub-
stances. This approach contrasts with earlier emphases of the
Agency and its predecessor organizations on the broader gross
pollution effects. The Office's sustained overview of the many
dimensions of toxic pollutants involvino a critical mass of special-
ists includes the following types of activities:
-- Staff function; coordination and support of Aaency-wide
efforts in toxic substances, with particular attention to
multi-source and multi-media pollutants, consistency and
interrelationships of standards set under different
authorities, and coordinated anproaches with other agencies
(e.a. FDA, Consumer Products Safety Commission).
— Line function: lead responsibility for gap areas includ-
ing assessment of risks of and controls for new oroducts,
monitoring strategy, and research need assessment.
-- Crisis function: mobilization of Agency resources to
clarify the dimensions of the problem, development and
implementation of control strategies, and coordination
with other agencies.
These activities are carried out through the following program
elements which are described in some detail in subsequent sections
of the Report:
-------
-- Restrictions
— Testina
— Reportinq
— Early Warning
-- Konitoring
-- Crisis Response
-- Strategy and Coordination
-- Research Needs
Each program element is designed to make substantial contributions
to realization of one or more of the long-ranae goals. The dis-
tribution of effort among these activities will vary, according to
legislatively mandated deadlines, unexpected crises, and shifting
Agency priorities. No precise formula can be used in determining
resource distribution amona proaram elements beyond assurance that
a nucleus of staff resources will be directed to each area at all
times. As experience is gained in this program, and if the Toxic
Substances Control Act is enacted, it may be appropriate to dis-
tribute the emphasis among program elements in a more rigid fashion,
-------
TABLE 1
EXAMPLES OF FOOD CONTAMINATION FROM TOXIC SUBSTANCES
TDUD
Fish
Cattle
Grains and Cereals
Poultry
Fruits
Leafy Vegetables
SUBSTANCE
Mercury
Phthalates
Copper, Zinc
HCB
Lead, Zinc
Arsenic
Cadmium
-PC-Bs
Phenols
Nitrates
Lead, Cadmium
SOURCE
Chemical Industry Effluent
Dump
Mine Runoff
Chemical Industry By-product
Mine Runoff
Dump
Fertilizer Contaminant
Heat Exchange Fluid
Petrochemical By-product
Fertilizers
Sewage Sludge
EFFECT
TABLE 2
EXAMPLES OF ENVIRONMENTAL DAMAGE FROM TOXIC
SUBSTANCE
AQUATIC DAMAGE
Fish -Kills
Change Lake Ecology
Destroy Fish Population
WILDLIFE DAMAGE
Bird Reproduction
Duck & Geese Populations
Botanical Species
LAND DEGRADATION
Forest Destruction
Groundwater Contamination
Soil Fertility
DESTRUCTION OF ANIMALS
Cattle
rses
Hypochlorites, Fly Ash
Copper, Zinc
Phenols, Ethanol
PCBs
Lead
Sulfuric Acid
Lead, Zinc
Arsenic, Cyanide
Chlorides
Fluorides
Tetraethyl Lead
SUBSTANCES
SOURCE
Lagoon Ruptures
Mine Runoff
Refinery Products &
By-products
Plasticizers
Shot
Chemical Industry Wastes
Smelters
Disposal Sites
Landfills
Phosphate Lagoon Wastes
Landfills
-------
TABLE 3
EXAMPLES OF TOXIC SUBSTANCES IMPLICATED IN SELECTED DISEASES IN THE UNITED STATES
CAUSE OF DEATH
IN
HUMANS
PERCENT
OF
DEATHS
DEATH RATE PER
100,000
POPULATION
SUBSTANCE WHICH CONTRIBUTES
TO
SOME DEATHS
Heart Diseases
Cancer
38.5
16.8
366.1
160.0
Cadmium
Benzidene, nitrosamines, beta
naphthalamine, benzopyrene,
asbestos, chromates
Infant Mortality
Lung Diseases
2.2
1.6
21.4
15.4
Heavy metals, nitrates, nitrites
Asbestos, beryllium, toluene
diisocyanate, cadmium
Liver Diseases
1.6
14.8
Carbon tetrachloride, chlorinated
phenols
Congenital Anomalies
Kidney Diseases
0.9
0.5
8.4
4.7
Mercury
Lead, ethylene glycol, cadmium
sulfate
-------
TABLE 4
ANNUAL VALUE ADDED TO SELECTED CLASSES OF
CHEMICAL AND RELATED PRODUCTS
$64 Billion
$112 Billion
Stone,Clay,Glass*
Paper &. Allied*
Metals*
Textiles*
Plastics
&
Elastomers
Paints, Dyes,
Inks
Inorganics
Synthetic
Organics
Other Chemicals
1962 1972
*0nly that portion of industry involved in chemical processes included.
-------
II. RESTRICTIONS
PROBLEM
During the past several years the necessity of Federally imposed
restrictions to reverse environmental degradation and to protect
human health has been repeatedly demonstrated. The main problem in
the area of toxic substances is to select the substances of greatest
concern and then to determine how the hazards associated with these
substances can be most effectively controlled or reduced, given the
dearth of information about the behaviour of toxic substances and
their distribution in the environment. The Toxic Substances Control
Act would give the Agency far reaching authority to intervene in the
chemical industry in a variety of v/ays. Care must be taken to insure
that such intervention does not disrupt the industry unnecessarily.
Of particular concern .is the continued viability of the technological
base undergirding the industry's momentum.
Intertwined with the reaulatory authorities and actions of the
Government are the attitudes, activities, and voluntary actions of
industry in assessing the safety of products and exercising restraint
in the development and marketing of products which miaht pose risks.
Given the size of the sector of industry involved in commercial
chemicals not currently subject to reaulatory authorities -- with an
annual value of products exceeding $150 billion -- it seems totally
unrealistic to expect direct Governmental intervention to regulate
a large fraction of these products. In a sense, each of the more
than 20,000 commercial chemicals is a unique case -- both with re-
gard to chemical behaviour and in marketing and economic consider-
ations.
Central to consideration of regulatory options is the balancing
of the risks with the benefits related to specific actions. 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 weiahs against environmental testing costs or require-
ments 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 premarket testing and screening requirements. If
research and development of new chemicals becomes so difficult that
it is no lonaer 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.
-------
Attention must be given to 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.
GENERAL PROGRAM ELEMENT GOAL
To miticiate, through direct reoulatory actions and through
encouragement of voluntary actions, the most serious environmental
problems posed by currently uncontrolled entry into the environment
of chemical substances.
INDUSTRIAL STEWARDSHIP
Subgoal
To heighten industrial concern over the necessity to
clarify the risks to man and the environment associated with
chemical substances' and to take appropriate action to reduce
these risks.
Strategy
A principal thrust of the Aaency's efforts to reduce the
probability of adverse incidents affectina health or the environ-
ment as the result of chemical substances enterina the environ-
ment is to encourage voluntary steps by the chemical and allied
'industries to identify and limit those activities that pose a
risk. Ideally, such voluntary steps should become a fundamental
consideration in the decision-makina process of industry concern-
ing the desirability of developing and manufacturing chemical
substances.
The Agency's approach involves both the carrot and the
stick — i.e., public recognition of positive steps taken by
industry to reduce environmental risks (e.ci. Monsanto restrictions
on PCS production) and regulatory actions to force a reorientation
of industrial decision-makinq processes (e.q. limitations on
mercury discharges into navigable v/aterways). When necessary,
EPA will take direct restrictive actions. More often, efforts
will be directed to encouraging industrial actions on a much
broader front than is usually feasible through specific
regulatory measures. The approach to industrial stewardship
relies heavily on the following types of activities:
-- Repeated articulation in speeches, news conferences,
and published articles by senior agency officials of-
(a) the responsibility of industry in insuring the
8
-------
safety of its products, and (b) the successes and
failures of industry in this regard.
— Encouraaement of trade associations and professional
societies such as the Manufacturina Chemists Association
and the American Chemical Society to provide leadership
in stimulatina a qreater degree of industrial
responsibility, both in a general sense and with regard
to specific toxic substance problems that are partic-
ularly significant.
— Consultations with individual companies, and particularly
'the medium-sized and •smal I companies, 'to sharpen their
awareness of the need for a greater degree of steward-
ship at both the v/orkinq and decision-making levels.
The measurement of the current decree of industrial concern,
changes in this concern as the result of Agency efforts, and
the reflection of this concern in activities in the market
place as well as in the plant will of course be difficult.
However, assessments will be a valuable adjunct to efforts to
stimulate industrial stewardship.
Three-Year Mjlestones
Assess to the extent possible the scope and effectiveness
of voluntary industrial restrictions on the manufacture, use,
distribution, and disposal of chemical substances.
Assess the trends within selected companies to incorporate
environmental considerations into the decision-making process
concerning the introduction of new products into commerce.
REGULATORY
Subgoal
To restrict a selected number of activities associated
with the manufacture, use, distribution, and disposal of
chemical substances in a way that will not only reduce serious
environmental problems but will also demonstrate the favorable
benefit/cost ratio of such restrictive actions, trigger both
industrial and public concern over other related activities,
and generally focus broader attention on the toxic substance
problem.
-------
Strategy
Restrictive actions under the Toxic Substances Control Act
durinq the initial years can serve several purposes. They
should be designed to (a) mitiqate severe environmental problems
not currently being addressed by other regulatory authorities,
(b) prevent future environmental problems of larae magnitude,
(c) demonstrate a number of types of restrictions that are
appropriately promulgated under the law, and/or (d) address
activities involving a wide spectrum of industrial firms. In
short, in addition to addressing environmental problems,
deliberate efforts should be made in selectina restrictive
actions to test the parameters of the law, thus clarifyinq
whether there is need for further legislative refinements, and
to awaken industry to the EPA's commitment to toxic substances,
thus stimulating voluntary steps on the part of the industry.
Among the hioh priority candidate substances to be con-
sidered for possible regulatory action are:
-- Organic Chemicals: PCBs, NTA, HCB, HCBD, bis(chloroethyl)
ether, polytetrafluoroethylene, tributyltin
-- Toxic Metals: cadmium, mercury, arsenic, vanadium
— Chemical Classes: haloqenated aromatic hydrocarbons,
phosphate esters, benzenepolycarboxylates, fluoro-
carbons, azo compounds, aromatic hydrocarbons
— Use Classesj detergent builders, plasticizers, print-
inq ink pigments, hydraulic fluids, heat transfer
media, highway de-icers, dry cleaning solvents
-- Other: asbestos
As discussed below, criteria for selecting substances for
regulation and for determining the shape of the regulation will
be developed. Initially, these criteria will probably be crude.
They will be continually refined as experience is gained.
Three-Year Milestones
Promulgate 15 sets of restrictions on existing chemicals.
Promulgate five sets of restrictions on new chemicals.
10
-------
CRITERIA
Subaoal
To develop and refine the procedures, techniques, and
criteria for determining the need for, the character of, and
the impact resulting from restrictions on the production, use,
distribution, and disposal -- as well as associated activities --
of toxic substances.
Strategy
The ground rules for determining the need for, the
character of, and impact resulting from restrictions required
or recommended by EPA should be clearly understood in advance
by Government, industry, and other interested parties. In
the absence of such understanding, in many instances industry
probably v/ould be basinq R and D and other investment decisions
on wrong assumptions concerning those factors affectinq sub-
sequent Governmental decisions, l-'hether or not industry agrees
with Governmental decision-making criteria, it should be aware
of the criteria in order to make intelligent investment decisions,
On the other hand, industry, as well as other interested groups,
should have an input into the development of the criteria.
The new legislation sets forth in general terms the
criteria to be used (e.g. health effects, environmental effects,
economic considerations, alternative materials). The initial
approach in elaborating these criteria will be development of
weighted checklists, these checklists will be distributed for
comment and periodically refined as experience is accumulated.
In the future, development of a more elaborate approach to
criteria may be possible, but in any event1the useability of the
criteria must be a paramount concern.
Three-Year Milestones
Publish an initial criteria document, and a subsequently
revised version, articulating the considerations involved in
determining the need for, character of, and impact resulting
from restrictions on chemicals.
PROBLEM ASSESSMENT
Subqoal
To assess the environmental risks and societal benefits
associated with selected chemical substances as a basis for
determining the appropriateness of restrictions.
11
-------
Strategy
As chemicals, chemical classes, and use classes that
should be of particular regulatory concern are identified,
in-depth analyses of the appropriateness of restrictions will
be conducted, usinq the criteria described above. In some
cases, such as PCBs and mercury, most of the analytical work
may have been completed by other organizational units and the
principal task will be the packagina of the information into
a form which will facilitate reaulatory decisions. At the
other extreme it may be necessary to carry out laboratory work,
field surveys, -and literature searches to Generate the data
needed for sensible decision-makinc.
These analyses will include considerations of factors
such as:
— risks posed by the substance, in terms of toxicity,
exposed populations, and geographic distribution
-- current and projected market trends
-- available and projected technologies for controlling
the substance
-- extent and effectiveness of current regulations on
the substance imposed at the Federal, state, and
local levels
— available regulatory options and the practicality,
effectiveness, and irppact of each
-- current level of voluntary restrictions and
feasibility of encouraging additional voluntary actions.
The central purpose of these assessments is determination
of the appropriateness of regulatory action. They are not in-
tended to be scientific publications to advance aeneral under-
standing, but rather will be decision oriented studies. At the
same time they must have technical credibility so they can
serve as supporting documentation if regulatory action is taken.
Related to these in-house and EPA-funded contract activities
will be a parallel effort to stimulate industry to increase its
efforts to assess the need for restrictions. This approach
will include sharing with industry the methodoloaies used in
problem assessment, publication of EPA supported assessments,
and encouragement of publication by industry of its methodologies
and assessments.
12
-------
Three-Year Milestones
Analyze the need for, character of, and impact resulting
from possible restrictions on thirty chemicals.
13
-------
III. TESTING
PROBLEM
The inadequacies of current testing activities are reflected
in (a) the lack of data for settinq standards and tolerances on a
number of substances of near-term concern (e.g. benzidine, HCB,
asbestos), (b) environmental incidents revealing previously un-
suspected harmful properties of chemicals (e.g.-'PCB, dioxin, methyl
mercury), and (c) the conspicuous absence of inforniation for
identifying potentially harmful substances that can cause future
incidents. The .prob.lem .is two-fold: lack of .test data and
deficiencies in capabilities to interpret the test data.
At the same time, the testing programs of some of the larger
companies are impressive, recognizing that their basis for assessing
test results and incorporating such assessments into corporate
decision-making is profit-oriented. The testing programs of the
medium-sized and smaller firms are not well developed due to the
lack of R&D resources. Much industrial test data is riot released
by industry, thus limiting the capability of the Government and
public to participate in assessments of risks of commercial
chemicals. For some chemicals in wide usage no single company is
willing to finance the cost of testing.
Testing by Government laboratories and by the university
community is more often than not science oriented, with results
that are difficult to adapt to regulatory decisions. When Governmental
testing of specific substances for reaulatory ourposes is needed,
there are freguently delays in acguirina funding and the needed
priorities to displace on-going testing.
Testing covers a broad gamut of activities — the standard
toxicological test methods are relatively well understood but tests
for stability, degradation and breakdown products, biosccumulation,
environmental transport, and ecological effects are uncertain areas
at best. In addition, determining which types of tests to be
applied to which substances is usually far from obvious.
In the past, problems with toxic substances have usually been
identified after the fact. With hundreds of new chemicals being
introduced into commerce each year, and with production levels of
many others orowina rapidly, the need for greater reliance on pre-
dictive testing seems clear. Hhile the burden of testing of specific
products falls squarely on industry, EPA has a responsibility to
insure that the extent, quality, and timeliness of such testing is
commensurate with potential environmental problems.
14
-------
GENERAL PROGRAM ELEMENT GOAL
To improve the approaches by Government, industry, and the
scientific community to testing of chemical substances entering
commerce.
INDUSTRIAL STEWARDSHIP
Subgoal
To encourage increased industrial concern and appropriate
action in testing both new and existina chemicals
_S_tr_at_e_oy
Continuing consultations v/ith representatives of industry
will provide a basis for assessing the extent and effectiveness
of industrial testino procedures, for sensitizing industry to
EPA testing concerns, and for determinino the types of mandatory
test reguirements which can have the most significant impact
on industrial testing practices. During these consultations
efforts will be made to identify nodel industrial test patterns
and practices which should be publicized and otherwise dissemi-
nated. Also, industry will be encouraged to increase its
efforts to publish and otherwise make available test data.
There will be continuino discussions with industry con-
cerning proposed EPA approaches to test reguirements. These
discussions should enable EPA to draw on industrial experience
in developing EPA regulations, stimulate industrial concern
over testing with or without EPA regulatory actions, and
broaden industry's perspective as to the range of environmental
concerns. More specifically, EPA will establish a few broadly
based model testing recommendations which should affect at
least one product of most of the laroe and intermediate-size
chemical manufacturers. Industry will then be reguested to
provide comments as to how it would assess the results of such
model tests, thus assisting EPA in determining the adequacy of
the prepared approaches.
Three-Year Milestones
Complete assessment of the effectiveness and adequacy of
testing activities of large and medium-size manufacturers.
Complete assessment of the trends in industrial concern
for adequate testing as indicated by factors such as the types
and number of tests, the types and number of chemicals subjected
to tests, and the role of test results in decision-making.
15
-------
REGULATORY
Subgoal
To require or encourage, as appropriate, industrial
testing of specific chemicals for v.'hich inadequate data con-
cerning the risks associated with the chemicals are available
but which are suspected to pose a hazard to man or the environ-
ment.
Strategy
--The -two key tasks are 'the determination of -the cherricals
which are to be subjected to testina, and the actual test
requirements. A related testing issue concerns division of
industrial responsibility for testing of substances of interest
to more than one firm.
Selection of the initial chemicals and chemical classes
requiring testino will be based largely on subjective judge-
ments within very cieneral criteria such as known problem sub-
stances of current concern, production levels and trends,
inadequacy of available test data, widespread presence of the
chemical in the environment, and environmental incidents
involving the chemical. Meanwhile, methods for prioritizing
chemicals that should be subjected to testing will be developed
to provide a better basis for subsequent selections.
In general, the Agency will not prescribe test reguire-
-ments in great detail but rather will provide Guidelines con-
cerning the types of test data needed for decision-making.
Thus, several different specific tost protocols could satisfy
the test requirements for a specific chemical although each
protocol would have to consider the types of effects of concern
to the Agency.
Supporting these activities will be continuing reviews of
test methodologies. These reviews should be helpful both in
developing test requirements and assisting concerned parties
in being aware of the most effective test approaches to
determining different effects.
Three-Year Milestones
Promulgate 10 to 15 standards for test protocols for
selected chemicals, chemical classes, and use classes.
16
-------
Assess results and reach decisions concerning the need
for restrictions for three of the chemicals, chemical classes,
or use classes for which standards were promulciated.
EXPERIMENTAL
Subqoal
To provide experimental data needed to determine appropriate
standards or restrictions for specific chemicals of near-term
concern.
Strategy
Through participation on interaqency committees, and through
redirecting EPA supported testinq activities, efforts will be
made to orient Governmentally suoported testinq irore sharply
to regulatory needs. Both the types of experiments and the
structuring of experiments are of concern. The activities of
NCTR will be particularly important in this regard.
In addition an on-call testina capability at one or more
industrial laboratories will be developed to provide the response
capability needed for addressing specific chemicals which become
of near-term concern. This capability will be used to demonstrate
structuring of experiments th.it are more responsive to standard
settinci needs. In addition, this capability will provide
opportunities for experimenting with proposed requlatory
approaches to assess their feasibility. Finally, it will be
available to qenerate supplemental data if questions arise
concerning the test results submitted by industry under
regulatory authorities.
Three-Year Milestones
Provide test data needed to set standards or to take other
restrictive actions on three chemicals of near-term regulatory
interest.
Demonstrate how two or three types of routine testing can
be more sharply oriented to providing data of maximum value in
arriving at requlatory decisions.
PUBLIC AWARENESS
Subgoal
To bring test data concerninq the safety of chemicals into
public view, in a way that will not compromise trade secrets,
17
-------
to facilitate a broader base of understanding and inputs for
evaluating the necessity for restrictions for such chemicals.
Strategy
Low-key but conscious efforts will be made to better
acquaint the public with the strengths and weaknesses of testing
and with the relationship of testing to visible environmental
problems. As specific problems arise, the public will be made
aware of available test results and of the significance of these
results (e.g. as was the case with hexachlorobenzene).
Three-Year -Miles-tone
Establish a smoothly operatina system for responding to
public requests for test and related data that does not contain
trade secrets, for identifying trade secrets, and for resolving
uncertainties as to what constitutes trade secrets.
18
-------
IV. INDUSTRIAL REPORTING AND DATA PROCESSING
PROBLEM
An essential input to identifying and evaluating those
potentially troublesome chemicals or classes of chemicals which
should be given high priority attention is authoritative and timely
information on their levels of production, use, and by-products and
on the geographical distribution and the trends of these activities.
Such information, together with information on the physical and
biological properties of the chemicals, serves as the basis for
•assessing risks and weighing the appropriateness of alternative
control strategies.
Limited information is currently routinely available from the
reports of the Bureau of Census, Bureau of Mines, FTC, Tariff
Commission, and Stanford Research Institute, as well as from the
EPA permit program. Also, individual company reports include a
vast amount of unaggregated data. However, the information is not
packaged in a manner oriented to regulatory decision-making, with
the exception of the waste stream information in the permit program.
It is diffuse, often out of date, and spotty. It seldom, if ever,
relates to new chemicals. Finally, while EPA access to much of the
data is difficult, public access is further complicated by lack of
awareness of available sources and by bureaucratic reluctance to
release unpublished information prior to actual publication.
At present, regulatory decisions are being made on specific
chemical substances using only a small fraction of the data on
industrial activities and trends that should undergird such decisions.
Data are not readily available to support analyses of known problem
substances which are candidates for regulatory actions. Similarly,
industrial data are not available in a useable form for rapid
identification of previously unsuspected chemicals that should be
of regulatory concern.
In short, available data bases on industrial activities are
seriously deficient. On a case-by-case basis more detailed industrial
data can be obtained at considerable time and expense, but even then
such data are more often than not inadequate. At the same time, if
the Agency decides to exercise its full authority for industrial
reporting under the Toxic Substances Control Act, the volume of
data could be so overwhelming as to make the data almost useless.
GENERAL PROGRAM ELEMENT GOAL
To improve the ready availability in a useable form of
authoritative information concerning the manufacture, use, distribution,
19
-------
and disposal of chemical substances which together with data on
the physical and biological properties of chemicals is needed to
assess the necessity for, character of, and impact resulting from
possible steps to restrict or to encourage voluntary restrictions
on chemical substances which pose a risk to man or the environment.
GENERAL
Subgoal
Promulgate the regulations required to implement the annual
reporting, premarket notification, and related sections of the
Toxic Substances Control -Act.
Strategy
Within six to twelve months following passage of the
Toxic Substances Control Act proposed regulations will be pro-
mulgated setting forth the ground rules for industrial reporting
to EPA of information concerning the manufacture, distribution,
use, and disposal of chemical substances. A number of terms
will be defined with more precision (e.g., manufacturer,
commercial quantity, new use, intermediate, chemical substance,
by-product), confidentiality aspects will be elaborated, and
reporting requirements for exports and imports will be set
forth. Both annual and premarket reporting requirements will
be covered. In short, the regulations will cover who reports,
what is included in the reports, when reports are made, and
what format is to be used for reports.
Initially, the general approach will be to delimit the
reporting requirements to data that will be directly useable
for premarket screening, regulatory, or early warning purposes
as described below. The emphasis will be on obtaining data
that will be used rather than obtaining data to cover every
substance that has been in commerce for some time. The cost/
effectiveness benefits from this emphasis should more than out-
weigh the information gaps that are not filled.
The reporting requirements will be reviewed and updated
annually. During these reviews the desirability of broadening
or narrowing the reporting requirements based on past usage of
data will be considered.
20
-------
PREMARKET
Subgoal
To provide information needed to identify those new
chemical substances entering commerce which deserve in-depth
analyses to determine whether they pose a threat to man or
the environment.
Strategy
Given the uncertainty of ,the risks associated -with new
chemical products which may have toxic properties and the lack
of available information about these products, the premarket
notification authority in the legislation will be invoked to
the fullest practical extent. This information must be clearly
identifiable when it arrives at the Agency, be expeditiously
handled, and be quickly but carefully analyzed. In addition,
industry will be encouraged to provide the Agency with as much
notice as possible concerning new chemical substances and uses
and any available information in addition to the mandatory
information.
EPA should have a unique repository of current information
on new chemicals entering commerce and on new uses of old
shemicals. Given the Congressional and environmental concerns
over new commercial chemicals and the uniqueness of this EPA
data capability, the data processing complications associated
with obtaining all available information on these new products
are warranted . However, the data system must be able to
provide the information to the analysts in a useable form, and
in particular be able to flag chemicals (a) belonging to chemical
classes that have caused past problems, (b) being used in a
way that there is large exposure to man or the environment, or
(c) being produced in large quantities.
Three-Year Milestones
Develop methodologies for identifying in advance to the
extent practicable the types of new chemicals or new use
categories of particular concern, for presenting data in a form
that will allow rapid premarket screening to determine the
need for more intensive analyses, and for obtaining additional
information needed for carrying out such detailed analyses.
Provide the data needed to analyze 10 to 20 new chemicals
of particular concern.
21
-------
EXISTING SUSPECTED CHEMICALS
Subgoal
To provide information on selected chemicals currently in
commerce which due to their properties, production levels, and/
or uses might pose a threat to man or the environment.
Strategy
For chemicals strongly suspected of posing environmental
risks, and hence prime candidates for regulatory actions, ex-
tensive data from a variety of sources will be necessary. The
identification and prioritization of these substances will
initially be based largely on the use of best judgement within
rather general criteria, with parallel efforts initiated to
develop more refined criteria. The reporting requirements
levied on industry will reflect a reporting emphasis on pre-
determined classes of particularly troublesome chemicals.
The types of industrial data of particular interest in-
clude aggregated data on production levels including trends,
uses and the environmental exposure associated with each use,
and manufacturing processes which produce the substances of
concern as by-products. In addition, to assess the impact of
restrictive actions, information on individual manufacturers
will be necessary. Initially, aggregated data will come largely
from other Government organizations while the detailed breakdown
of this data will come from the required annual industrial
'reports and also voluntary information submitted to EPA by
industry.
Three-Year Milestones
Establish and have operating a system that presents both
aggregated data and data broken down as appropriate which can
provide the industrial information base needed for making
regulatory decisions.
Provide the industrial information needed to reach re-
gulatory decisions on 10 to 20 suspected chemicals.
EARLY WARNING
Subgoal
To provide information concerning other chemical substances
in commerce which, due to their levels of production, uses, and/
22
-------
or chemical and biological properties, may warrant in-depth
analyses to determine whether they pose a threat to man or the
environment.
Strategy
At one extreme the amount of data submitted by industry
on unsuspected chemicals which are in commerce could be over-
whelming, and hence almost useless. On the other hand, some
type of broad data net is needed to identify the potential
problem substances. Therefore, a close match must exist between
data analyst's procedures and capabil-iti.es and reporting re-
quirements. The basic approach is to provide enough information
to alert a trip-wire, rapid screening process which signals
the substances that warrant in-depth analysis. Specifically,
the industrial information should help pinpoint chemicals with
production and use -patterns which should be of concern. Thus,
the mandatory industrial reporting requirements will cover all
substances exceeding a certain production level or destined
for particular uses.
The format of early warning data is critical if it is to
be useful for rapid screening. Reporting requirements will
specify such a format.
Three-Year Milestone
Establish and have operating a system that provides the
industrial information needed to identify previously unsuspected
chemicals that should be of environmental concern.
PUBLIC ACCESS
Subgoal
To provide easy and rapid access by other agencies and
by the public to data submitted to the Agency without com-
promising trade secrets.
Strategy
Adequate resources will be provided to process rapidly
public requests for data submitted by industry although it is
highly unlikely that regular Agency reports containing collected
data will .be possible. -The procedures used by the EPA fuel
additive program for responding to requests for information
claimed to be trade secrets by industry will be adopted. In
short, the data identified by industry as confidential will be
23
-------
considered confidential. If public requests are received
for such data, determinations will be made by EPA on a case-
by-case basis as to whether the requested information is indeed
in the category of trade secrets or can be freely disseminated.
The affected company will be provided an opportunity to submit
supporting documentation for his claim of confidentiality prior
to the determination.
Three-Year Milestones
Establish and have in operation procedures for providing
rapid public access to industrial information that does not
involve trade secrets, for sorting out trade secrets, and for
resolving uncertainties as to what constitutes trade secrets.
24
-------
V. EARLY WARNING
PROBLEM
More than 20,000 chemical substances are presently in
commercial production. Many of these are entering the environment
in substantial amounts, and there is some environmental exposure to
most of them. In most cases, the potential toxicity of these
materials is unknown. Even when pertinent data are available,
they are frequently buried in the scientific literature or in in-
dustrial or government reports and have never been collected and
analyzed wi.th a view to implications they,may have reaardina
threats to health or the environment.
Review of all data on all chemicals, or even limited data on
most chemicals, is not practical. The time and resources required
would be astronomical.- It is necessary to concentrate resources
on a few chemicals, hopefully those with the greatest potential for
causing mischief in the environment.
The purpose of the early warnina activity is to survey the
universe of chemicals and to select those which warrant special
attention. Substances selected would be those showina potential
for causing adverse effects. Determination of the need for
regulatory action is not the immediate purpose in this activity;
it is limited to the preliminary step of identifyina substances
for more careful investigation and evaluation. If the selections
are well made, a rather large fraction of the substances recommended
for further investigation should prove to be good, candidates for
regulatory action.
The system should serve to alert the Agency to incipient crises
which may soon reach levels of public concern. In some cases, there
may be enough lead time to permit the Government to take steps to
avert the crisis; in others, at least the Agency would not be
caught totally unaware when the crisis breaks. However, it is not
suggested that the system could eliminate unanticipated crisis
situations.
The need for such an activity and the lack of ongoing efforts
in this area have been cited by a number of groups. For example,
the Panel on Hazardous Trace Substances of the CEO-OST Committee
on Environmental Health Research (the "Rail Committee") has recommended
the establishment of an ''Assessment Program for Hazardous Environ-
mental Chemicals" to help fill this void. Suoport for such a
program has been voiced by MAS, NSF, CEO, USDA, and MIH. While
recognizing the difficulty of the task, all of these groups agree
that a major effort to identify unsuspected hazardous environmental
chemicals is needed.
25
-------
GENERAL PROGRAM ELEMENT GOAL
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.
CRITERIA
Subgoal
To develop criteria and techniques for determining on the
basis of minimal information which chemical substances should
be of greatest concern.
Strategy
Two types of chemical properties are of concern: those
properties which are likely to cause trouble in the environment,
and those properties that can serve as early warm'no indicators.
These two sets of properties will not be the same, although
sound correlations between them may exist. The search for
these correlations and for correlation methodologies is the
essence of the early warning activity. For instance, per-
sistence may be a property of environmental concern, hut infor-
mation on persistence is not sufficiently available to make it
directly useful for early warm"no searches. However, if
correlations can be established between persistence and certain
structural or physical properties which are readily ascertain-
able, these properties could serve as the keys for early warning
"on persistent chemicals.
Past toxic substances incidents (e.g. dioxin, DDT, PCB, HCB,
mercury) will be reviewed to identify the salient features
that might be useful in anticipating future crises. When
possible, convenient measures or indicators of these features
will be developed and verified, and then applied against other
materials or situations to determine where similar situations
may exist or be created.
Supporting efforts to develop selection systems which are
relatively objective, using formal ranking schemes, mathematical
modelling, or other approaches will be undertaken.
Three-Year Milestones
Assess the utility of several quantitative and pseudo-
quantitative techniques for predicting future problems with
toxic substances.
26
-------
Identify and beqin to prioritize those properties of
chemicals which are suggestive of health or environmental
threats based on correlations that can be derived from past
experience and from theoretical considerations.
EXPERT OPINION
Subgoal
To mobilize and use expert opinion to assist in rapidly
,screening large numbers ,of chemicals and in .predicting potential
problem substances.
Strategy
A panel of experts conversant with environmental problems,
industrial technolony, and chemically-induced health effects
will meet on a reoular basis to assess possible problem areas,
to flaq chemical problems on the horizon, and to advise on areas
which may warrant early investigation.
A series of seminars on various industries which are
potential sources of toxic substances (e.g. detergents, plastics)
will also be supported in cooperation with other interested
agencies. These will consider innovations in the industry,
those activities or products that may be troublesome, and
measures that could be taken to reduce environmental exposure
to these products. These seminars could include retrospective
case histories. The seminar reports should be useful guide-
books for future analyses of the selected industries.
Three-Year Milestone
Establish and convene on a reaular basis a panel of experts
to provide advice on unsuspected chemicals which deserve
investigations and on the significance of the results of such
investigations.
DATA ANALYSIS
Subgoal
To collect, collate, and analyze data from sources such as
monitoring, trend assessment, and industrial reporting, as well
as the open literature, on those chemicals which appear to
deserve the highest priority in a manner that will facilitate
27
-------
judgements as to v/hether the chemicals should be candidates
for further investigations, testing, and/or control.
Strategy
Data analysis includes (a) awareness of current happenings
on a limited scale, and (b) trend analysis of likely future
developments. Both of these depend on indicators and para-
meters developed in the criteria activity.
Current problem awareness includes (a) surveys of engineering.
trade, and business journals and government reports, (b) data
collected from other federal agencies which have specific
relevant responsibilities such as reports of occupational
incidents to the Department of Labor, reports of animal or crop
damage incidents to the Department of Aariculture, and reports
of human disease incidents to the Center for Disease Control of
HEW, and (c) reports of local incidents obtained by extension
services of universities, newsletters of local environmental
organizations, and EPA offices. The third type of information
is the most difficult to acquire because it is so disperse, and
the feasibility of developing either a network manned by trained
regional personnel or a centralized clearing house will be ex-
plored.
Trend analysis requires data pertaining to less specific
economics, growth, and new-product indicators. Economic data
are obtained from standard published sources as well as directly
from the Department of Commerce. Growth data are obtained from
market journals and federal effluent permits. New product data
are available through the General Services Administration and
the Department of Defense (Defense Services Administration)
primarily through their new product applications and specifications
program.
When this network signals an alert, an analysis of infor-
mation pertinent to the problem will be undertaken. The depth
of these analyses will depend on the nature of the data and the
(apparent urgency of the problem. If this analysis confirms the
.'presence of a significant problem, it will be referred to the
{restrictions or crisis response activity as appropriate.
:Three-Year Milestones
Establish a current awareness network covering scientific,
trade, and business journals and Government reports to identify
potential problems and to analyze trends in technology and
commerce that could result in new types of problems.
Complete preliminary analyses on twenty substances.
28
-------
VI. MONITORING
PROBLEM
Adequate, timely, and reliable monitorinq data is critical to
the assessment of the risks posed by existino substances already
in the environment and by new substances enterino the environment.
Such data are required to determine the need for and effectiveness
of standards and tolerances for specific chemical substances, to
shape responses to actual or alleqed crises, and to target enforce-
ment activities. In short, monitorinn data provide the most reliable
barometer of the potential impact of substances in the real world on
•man and the environment whether viewed on a national or a limited
geographic basis. Also, such data can indicate the incremental
change in the status of the environment as the result of Agency
actions.
Despite extensive Federal and State monitoring programs, at
present there is little useable information on backoround levels,
geographic description, and trends for most toxic substances. At
standard settina time the monitoring data needed to assess the in-
cremental impact that the standards will have on ambient levels are
not generally available. This void is particularly noticeable when
information on organic chemicals and many heavy metals is sought.
Buildups of toxic substances in the environment are almost always
signaled after the fact by environmental incidents; only then is
monitoring activity focused on the problem substances. Virtually
no effort has been directed to the systematic use of monitoring
data for early warning purposes.
A principal deficiency within EPA is the lack of a sustained
effort to (a) articulate prioritized proaram needs for monitorinci
data on toxic substances in relation to standard settina activities,
and particularly the types of information needed, the specific sub-
stances of concern, and the timetable, (b) incorporate into existing
networks these and other toxic substances requirements, and (c)
extract, analyze, and present in a useable form information from
the monitoring data banks that can respond to program needs.
To a large extent the Agency's principal monitorina concerns
have centered on criteria pollutants and on gross pollution effects.
Only recently has attention been given to specific toxic substances --
and this attention is largely single media oriented.
V'hile many Federal and State agencies have active monitorina
programs, the feasibility of influencina these programs is difficult
at best. Also, as the Agency shifts the central responsibility for
monitorinq to the States and to permit recipients, the practicality
29
-------
of effectively orchestratina a unified multimedia national monitoring
approach targeted on selected toxic substances will become even more
difficult. However, a better job of ferretinq out data available
from existing proqrams and usinq this information to meet Agency
needs is clearly in order. A selective approach to specific sub-
stances and specific Geographical areas within the confines of
acceptable sampling and analytical methodology is essential lest
the Agency's toxic substances program drown in a sea of uninter-
pretable data.
GENERAL PROGRAM ELEMENT GOAL
To identify and quantify to the extent practicable the levels,
distribution, and buildup of toxic substances in man and the environ-
ment.
REGULATORY ACTIONS
Subgoal
To provide in a useable form data needed to assess the
necessity for and character of steps to control toxic substances
of particular concern.
Strategy
Clearly, comprehensive mom'tori no for all toxic substances
in all media, or even a significant fraction of these substances
in most media, is impractical. Thus, a close correlation between
the targetting of the monitoring effort and the perceived risk
posed by various substances as well as opportunities for re-
gulatory actions to linit these substances is imperative. In
short, the end user of the data should have a significant input
in determining what data are collected.
Monitoring activities should be designed to determine the
appropriateness of regulatory actions. Such activities may be
characterized as follows:
— reasonably comprehensive monitoring efforts targetted
on substances that are prime candidates for regulatory
actions under the Toxic Substances Control Act, the
Hazardous Waste Management Act, or the toxic and
hazardous pollutant provisions of the Clean Air Act
and Fl-JPCA during the next several years; such efforts
would cover a broad geographic area, using to the
fullest extent possible data from existing networks.
30
-------
-- more limited monitorinq, using selected networks in
selected geoaraphical areas, for other toxic substances
which are also of particular concern and which could be
regulated under other Federal and State statutory
activities.
The first step is to identify those chemical substances
of concern. Criteria for selection of toxic pollutants which
should be regulated are set forth in a variety of Agency
documents, and include such factors as toxicity, persistence,
production levels, and a history of past problems. To these
criteria should be added practical monitoring cons.iderations
that determine cost/effectiveness ratios, such as state of
monitoring technology, geographical distribution of sources, and
opportunities to piggyback on existing programs.
Once the initi-al list of target substances has been
developed -- a list that will be continuously refined and up-
dated -- a specific monitorina strategy for each substance
will be developed. These strateqies will be integrated to the
extent possible. In addition to using existina monitoring net-
works, careful consideration will be given to use.of the permit
program and the attendant opportunities for reguirinq monitorinq
of toxic substances.
Three-Year Milestones
Identify, characterize, and quantify to the extent possible
background levels and current releases into the environment on
both a national and localized basis of 10 to 15 toxic substances
of near-term regulatory concern.
Develop and have in operation a systematic approach to in-
corporating toxic substances nonitoring requirements into exist-
ing monitoring networks and to exploitina data collected from
these networks for toxic substances regulatory purposes.
EARLY WARNING
Subooal
To alert the Agency and other interested parties to the
presence or buildup in the environment of previously unsuspected
chemicals which might pose a significant threat to man or the
environment.
31
-------
Strategy
The search for unsuspected problem substances, which in-
dividually or in combination may create environmental problems,
will require a great deal of ingenuity and perception. Monitoring
and analytical technology is often substance-specific, and the
indicators of problems may vary from substance to substance.
The basic approach is for the EPA regional offices to serve
as the initial trip wire, following up leads from a variety of
monitoring sources. Buttressina this trip-wire mechanism will
be 'the "following cfctivittes:
-- development, initially on a pilot basis, of a system
of biota indicators which can serve as the basis for
keepinn abreast of environmental trends on a national
basis of selected classes of chemicals
-- development, initially on a pilot basis, of an approach
to selecting aeooraphical areas that are likely candidates
for environmental problems and to searching out the
latent chemical substances that should be of concern
in these areas
-- provision of teams of monitorino and assessment
specialists who can respond to trip-wire alarms and
assist in determining if an environmental problem is
indeed developino.
This combination of field sense, tuned to the idiosyncrasies
of specific geographic areas, together with adequate back-
stopping from headquarters, hopefully will uncover physical
evidence that can lead to better anticipation of environmental
incidents. Of particular interest in this reaard are a variety
of localized monitoring efforts, often classified as research,
funded by EPA, other Federal agencies, the States, and universities
which can be of considerable help in pinpointing problem areas.
Clearly, physical monitoring data are only one input -- but an
essential input -- to an early warning system.
Three-Year Milestones
Develop and have in operation on a pilot basis a system of
biota indicators which can serve as the basis for identifying
environmental trends indicating adverse environmental effects
resulting from specific chemical substances entering the environ-
ment.
32
-------
Develop and implement in one geographic area a physical
monitoring approach to locating and assessing potential "hot
spots" due to the unsuspected buildup of chemical substances.
33
-------
VII. CRISIS RESPONSE
PROBLEM
The increasing frequency during the past several years of
incidents of environmental contamination from toxic substances
strongly suggests that in the months and years ahead a quick response
to such incidents must become a way of life in EPA. The sources of
such problems may be traced to natural occurrences of the substances;
to the use, misuse, or disposal of commercial products; or to industrial
or transportation activities involving chemical substances. The sub-
stances may contaminate air, water, soil, or living organisms; may
•cause problems tn'food or drinking "water;-and may be-tiomagrrified.
The EPA regional offices are the Agency's principal response
capability. These offices have developed considerable experience
in dealing with air pollution alerts, spills of oil and hazardous
materials in waterways,' and misuse of pesticides. However, they are
not equipped to handle effectively many other contaminants, and
particularly the less familiar contaminants that build up over time
and contaminants which tend to fall between program areas.
Usually, responding to a toxic substance crisis involves three
related types of activities: assessing the immediate risks posed
by the substance and taking steps to reduce the risks, identifying
the source and extent of the problem substance and taking steps to
turn-off the source, and developing and stimulating appropriate
actions to help insure that the problem does not reoccur in other
areas of the country. More often than not the problem substance
will be ubiquitous, persistent, and toxic; will come from poorly
defined multiple sources; and will be affecting animals, fish,
plants, and other biological components of the environment. Also,
the scientific data needed for specific regulatory actions will
probably be sparse.
Further complicating responses are the regulatory, programmatic,
and other bureaucratic, ambiguities and overlaps within EPA and
among Government agencies. Also, the responsibilities and response
capabilities of the States will vary. In each case these must be
sorted out -- usually a relatively easy task in the field but a more
difficult task in Washington.
The experiences with PCBs, HCB, and asbestos involved all of the
foregoing considerations. In each case the immediate crisis response
has been followed with longer range action plans involving reallocation
of Agency resources. In this regard, the absence of Agency continoency
funds (notwithstanding the revolving fund for water spills) can cause
considerable delay in responding and program disruption through shift-
ing 'priorities.
34
-------
GENERAL PROGRAM ELEMENT GOAL
To provide an effective on-call capability for (a) assisting
EPA regional offices to respond to unanticipated buildups in the
environment of chemical substances that pose a substantial hazard
to man or the environment, and (b) developing and carrying out long-
term action programs to mitigate recurrent problems involving the
same substances on a nation-wide basis.
PROBLEM ASSESSMENT
Subgoal
To mobilize and deploy appropriate specialists for
clarifying the character and extent of specific crisis
problems and evaluating the short- and long-term impact
of the problem substances on man and the environment.
Strategy
In developing a quick response capability for
assisting the regional offices, the States, and other
interested parties to assess the extent and severity of
newly erupted problems, the following requirements will
be emphasized:
-- Versatile monitoring and data analysis capability
for determining the distribution and levels of the
problem substance.
— Rapid access to relevant reports and scientific
data concerning the properties of the substance,
its sources, and past incidents.
— Standing arrangements with other interested
Federal agencies that will facilitate rapid
coordination, division of labor, and sharing
of information.
-- Availability of a range of specialists who can
analyze highly technical aspects of the problem.
Except in unusual cases the regional offices will take the
lead in orchestrating EPA's involvement in a localized problem.
The headquarters on-call capability will be available to assist
with a limited number of problems, with the number dictated
by budgetary and manpower constraints.
35
-------
On the other hand, coordination of the longer range effort
to reduce the probability of similar incidents in other parts
of the country will be centered in headquarters. In addition
to insuring consistency among the efforts of EPA offices and
of Federal Agencies, the following types of considerations may
be important:
— Necessity for guidelines for identifying and
sampling potential hot spots around the country.
--' Availability of adequate laboratory capability to
analyze mon.itoring samples.
-- Needed research to clarify the properties of
the substance.
-- Opportunities for using the contaminated area
as a research test bed.
— Mobilization of the best expertise to assess
the problem on a national basis.
-- Priority that the problem deserves relative to
other toxic substances problems.
All regional offices will be invited to participate in
development of the nation-wide plans, and special efforts will
be made to keep them advised of developments in one region
-that may be relevant to another region.
Three-Year Milestones
Develop the necessary analytical and monitoring resources
needed to assess a wide variety of unanticipated incidents
involving the buildup of chemicals in the environment.
Develop and carry out action programs to clarify the risks
posed on a nation-wide basis by six crisis chemicals.
REGULATORY
Subgoal
To identify the regulatory and related steps needed for
reducing or eliminating the source of crisis problems, develop
the necessary information for carrying out the most appropriate
steps, and encourage the appropriate remedial actions.
36
-------
Strategy
The choice of the appropriate regulatory tools for
alleviating localized toxic substance problems must be tailored
to the specific situations. Frequently, State authorities or
voluntary actions on the part of the polluter will be more
effective and rapid than cumbersome Federal approaches. However,
in addressing the nation-wide problems, a Federal approach may
have many advantages.
As in the case of the problem of assessment, the regional
office should usually take the lead in sorting out the most
appropriate near-term response for .a.-localized problem, with
headquarters providing the necessary support and also a per-
spective of national implications of the various options. With
regard to the national problem, headquarters should take the
lead in collaboration with other interested agencies and with
opportunities for regional office inputs.
Three-Year Milestone
Foster development and implementation of restrictive
actions (either under Federal or State laws or on a voluntary
basis) to reduce the source of the problems associated with
six crisis chemicals.
37
-------
VIII. STRATEGY AND COORDINATION
PROBLEM
Responsibility for toxic substances activities is fragmented
within the Agency, and the policies governing these activities are
largely determined by the broader responsibilities and interests of
the concerned Assistant or Regional AdministraLor. More often than
not toxic substance activities are considered as just one subset of
more general pollution concerns, and relatively little effort has
been made to link the common toxic substance interests of different
offi'ces. 'Program offices tend to concentrate on that portion 'of
the problem which directly relates to their statutory authorities.
This focus of attention is usually dictated by deadlines, with
resources deployed to address the urgency of setting standards or
responding to crises. Typically, rotating specialists work in
spurts on toxic substance problems, usually without the opportunity
to evaluate the total hazard posed by a given substance. Communica-
tion among offices working on the same problems has not been good,
coordinated planning scarcely attempted, and the usefulness of the
work of one office to other offices usually minimal.
At present several EPA offices are independently assigning
priorities to problem substances, carrying out in-depth studies, and
promulgating regulations, with minimal attention to coordination
until' most of the work has been completed. With the enactment of
new authorities, the Agency effort may become further fragmented.
Given the constraints on available Agency resources and the complexity
of toxic substance problems, the Agency can ill afford wasted motion
in this area.
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, involves selecting the most appropriate legislative
provisions within these acts for addressing particular problems. The
pesticide act controls the use of certain pesticides while point
source discharges of these same chemicals are being considered for con-
trol under the water act. Further complicating effective choice of
regulatory options is the tendency to search for problems to be con-
trolled under specific authorities, rather than searching for the
best authorities to most effectively control specific problems. This
approach of controlling the "accessible" aspects of the problem,
which may or may not be the "critical" aspects, can hamper efforts to
focus on the core of environmental and health risks posed by the
manufacture, use, and disposal of toxic substances.
38
-------
The setting of standards and tolerances, the issuing of permits,
and the taking of other types of regulatory actions inevitably
involve the balancing of risks and benefits. There are no Agency
guidelines as to how this balancing is to be carried out with regard
to toxic substances -- a particularly difficult area in view of the
uncertainties as to the health and environmental impact of the sub-
stances and the incremental environmental gains which might reasonably
be attributed to actual or proposed EPA actions. This problem is
further complicated by differences in the language of different laws
and uncertainties concerning legislative intent. As a result,
different criteria are being used depending on the specific legislative
framework and the biases of the concerned office.
GENERAL PROGRAM ELEMENT GOAL
To improve the Agency's approach to control of toxic substances
through more effective utilization of statutory authorities and man-
power and financial resources.
PROGRAM COHERENCE
Subgoal
To insure that diverse program efforts designed to clarify
and mitigate the risks associated with toxic substances are con-
sistent and mutually reinforcing.
Strategy
The Steering Committee/Work Group process provides the best
existing mechanism for (a) insuring consistency in the standard
setting and related regulatory approaches of different offices,
and (b) stimulating improved interactions among offices at the
working level. Hov/ever, if this process is to be effective the
following aspects need particular emphasis:
~ better and more comprehensive Development Plans which
are rigorously followed
— greater opportunities through the Work Group process for
interested offices to participate in developing, rather
than merely rubber stamping, proposed standards
— minimizing current tendencies to circumvent the Steering
Committee process
The Toxic Substances Control Act calls for an Annual Report
to Congress on efforts to control toxic substances under a variety
of authorities. Whether or not the legislation is enacted, such
an Annual Report (albeit not necessarily to Congress) should pro-
mote greater coherence to these presently fragmented program
39
-------
activities. At a minimum it can serve as a catalog of on-going
programs. More importantly, it can provide an opportunity to
articulate policies that affect all programs.
An area of particular concern is the apparent gap in a
number of areas between the activities at the EPA research
facilities and program interests. The reality and extent of the
gap are frequently blurred in the welter of bureaucratic documents
surrounding the research process. Therefore, a more systematic
effort by program offices to visit and assess research efforts
on a continuing basis should improve not only the process for
setting research priorities but also foster better working level
interactions between ,program, and research personnel at the working
levels.
Three-Year Milestones
Publication cvf two Annual Reports on EPA activities in toxic
substances.
Completion of two annual in-depth evaluations of current and
potential contributions of EPA research facilities to program
needs in toxic substances.
PROBLEM ASSESSMENT
Subgoal
To improve problem assessments through more deliberate
ordering of priority substances, better problem definition,
and improved interaction among program elements supporting
assessment activities.
Strategy
As a number of EPA offices and other agencies devote an
increasing amount of resources to in-depth analyses of toxic
substances -- particularly in support of regulatory and early
warning activities -- there is a need for more deliberate pro-
cesses for selecting the substances of priority concern. While
each program office must establish its own list of priority
substances to be regulated under different legislative authorities,
each can benefit from a clearer understanding of the criteria
being used by other offices for selecting the substances. Also,
it is important that the results -- both published and un-
published — of such analytical efforts be broadly distributed
on a timely basis within the Agency.
40
-------
An early order of business in implementing the Toxic
Substances Control Act will be selecting the toxic substances
that deserve priority attention and assessing the appropriate-
ness of the new legislation as the regulatory vehicle for
addressing these substances. This activity should serve as a
catalyst in stimulating Agency-wide efforts toward more deliberate
priority ranking of toxic substances.
In addition to activity directed to implementation of the
new legislation, the following steps are planned;
-- a series of seminars on the efforts of EPA and
other agencies, as appropriate, directed to analyzing
for regulatory purposes, specific substances and on
EPA efforts to develop criteria for prioritizing sub-
stances.
— annual summaries of the principal EPA efforts in this
area with appropriate bibliographies.
— more deliberate attention during the Steering
Committee/Work Group process to criteria for selecting
toxic substances for regulatory consideration.
T nree - Y eja r Mi Je s t o ne
Have in place and operating a system of seminars, annual
summaries, and Agency review procedures which will help insure
that selections of toxic substances for in-depth evaluations
are made within the context of the totality of the Agency's
interests and activities.
REGULATORY ACTIONS
Subgoal
To develop and implement control strategies that (a)
address the most critical aspects of toxic substance problems,
and (b) balance in a consistent manner the costs of control
with the reduction in risks from such control.
Strategy
Closely related to problem assessment is the choice of
the most appropriate regulatory authority to reduce the problem.
Insofar as choice among EPA authorities for addressing the
most critical aspects of problems of national dimensions is
41
-------
concerned, the Steering Committee/Work Group process is the
best existing mechanism, subject to the previously noted
caveats. Also, implementation of the Toxic Substances Control
Act should give impetus to a more deliberate selection process.
While different laws set forth differing criteria for
standards, tolerances, and other limitations on toxic substances,
all the existing lav/s give EPA some flexib.lity in this regard,
and there should be some consistency in the Agency's overall
approach. To this end Agency-wide guidelines are needed,
particularly with regard to balancing uncertain health and
environmental impacts of toxic substances w'ith'both direct
and indirect economic impacts of regulations.
Three-Year Milestone
Prepare annually Agency-wide guidance concerning the
balancing of risks and economic impact in setting standards
and tolerances, issuing permits, and imposing other limitations
on toxic substances.
42
-------
IX. RESEARCH NEEDS
PROBLEM
As regulatory activity for toxic substances continues to expand
in scope and complexity, the results of mission-oriented EPA research
efforts take on added significance. Not only is there a need for
research into new areas, but of equal importance is the need to
orient more sharply current research efforts tc program needs. Also,
much of the EPA research effort traditionally identified as related
to toxic substances has been oriented to specific single-media
problems of very limited scope while equally important multimedia
concerns-have -been -largely -neglected.
The most significant gaps in current Agency research programs --
taking into account research activities supported by other organiza-
tions as wel1 — are development of (a) improved test methods that
are more responsive to 'near-term and longer-term regulatory needs,
(b) techniques for estimating the level of human and environmental
exposure to specific chemicals entering the environment, and (c) tech-
niques for assessing economic, technological, and market trends that
will provide insight into the severity of future problems that are
associated with chemical substances entering the environment.
Classical evaluation of toxic effects involves acute, subchronic,
and chronic tests on experimental animals, and extrapolation of results
to 'the effects (or "no effects") on man. This extrapolation relies
very heavily on the incorporation of "safety factors". Such tests
have proven useful in the past and will certainly continue to be in
the immediate future. However, many of them are very expensive and
time consuming. Structuring of tests for specific research purposes
often results in inconsistencies among different investigators so that
applicability to regulatory activity is limited. Similarly, there is
a definite lack of tests optimally designed for generating results
useful in the development of numerical standards. Seldom are animal
and epidemiological investigations conducted on the same materials
to improve the extrapolation process. Finally, the substances being
tested frequently have little relevance to the substances of regula-
tory interest.
The Agency's approach to toxic substances regulation places the
prime responsibility for the testing of substances with the producers
of those substances or others who derive economic benefit from them.
At the same time, the Agency has an interest to insure that tests per-
formed to comply with regulations are meaningful, reliable, and
standardized to the point that the results can be interpreted within the
established regulatory framework. Thus, although a certain amount of
43
-------
testing must still be done by the government, the major responsibility
of EPA in this area is to insure that reliable and practical testing
procedures exist and are being used. Therefore, the primary objective
of the research effort should be the development and verification of
new or improved test methods, rather than the collection of data on a
large number of compounds.
Rapid and relatively low cost testing methods for predicting
chronic effects including carcinogenic, mutagenic, and teratogenic
potential are particularly needed. Such testing would allow for an
initial screening of many more chemicals to identify those chemicals
which require'more elaborate testing.
Similarly, there is an urgent need for development of new test
methods which will indicate environmental effects from chemicals.
Such tests at present are few in number or nonexistent, and substan-
tial research resources will be necessary to close this gap. Given
the potential magnitude of these activities, special efforts must be
made to insure close coupling of research work and priority program
needs.
Extensive efforts have been made to estimate the levels of human
exposure to chemicals which are ingredients in foods, drugs, and
cosmetics. Little serious effort has been made to estimate levels of
human exposure to these or other chemicals via other routes such as
inhalation, drinking water contamination, food contamination, and skin
absorption of pollutants. Even less effort has been directed to
assessing exposure of environmental flora and fauna to chemicals. This
is a difficult area, and meaningful quantification will be the excep-
tion rather than the rule. For example, primitive steps have been made
in considering human exposure to mercury, but only very crude estimates
were possible. Research is needed to develop techniques for estimating
exposure levels of the known problem substances and for signalling high
exposure levels of potential problem substances.
Economic and market forecasts are central to the activities of all
aggressive companies. Similarly, the research for better manufacturing
and related technologies is never ending. However, these industrial
activities are inevitably cast in profit-making and not environmental
impact terms. Economic and technological forecasting techniques which
combine both profit and environmental concerns are particularly impor-
tant in a field dependent on long lead-time R&D requirements. It is
important that the Agency learn how to use such techniques to anticipate
activity that may lead to environmental degradation.
44
-------
GENERAL PROGRAM ELEMENT GOAL
To improve the experimental and analytical techniques and data
base needed to assess the necessity for, character of, and impact
resulting from regulatory and other steps to restrict chemical
substances.
TEST METHODS
Subgoal
To stimulate .development of more .rap.ld, less expensive,
and/or more reliable test methods with particular emphasis on
approaches that provide data needed for specific types of
regulatory actions.
Strategy
The approach to improving toxicological test methods
through EPA research activities should emphasize development of
— short-term and low cost methods for rapidly screening
large number of chemicals and for identifying those
biologically active chemicals which should be subjected
to more detailed testing.
-- improved methods for extrapolating from animal test
results to human health effects, including the design
and execution and toxicological and epidemiological
studies on the same substances.
-- better models for extrapolating toxicological test
results to lower levels on the dose/response curve with
particular attention to orienting the activities at
NCTR more sharply toward regulatory requirements.
— tests for detection of chronic and delayed effects
other than carcinogenesis and mutagenesis.
-- standardization of tests for chronic and delayed
effects such as teratogenesis and mutagenesis.
Environmental test activities should center on improved
methods for assessing (a) the impact of selected chemical
classes on different types of plants and animals, (b) the move-
ment of chemicals through the environment -- and particularly
through the soil and across media interfaces, (c) the ability
-------
of chemical insults to cause serious imbalances in natural eco-
systems, and (d) the utility of micro-ecosystem models to
evaluate the interaction of selected chemicals with the eco-
system. Methods that could be adopted and used by industry
as a basis for predicting environmental fate of toxic substances
should be emphasized. Clearly, cost and reliability will be
central considerations.
Critical to a successful research effort in this field is
participation in selection and design of tests by program
offices -- to help insure their relevance, -and by industry --
to'help insure that the results of the research will be used.
Three-Year Milestone
Have under development three new approaches to testing
that will provide an improved basis for assessing the risks
associated with chemical substances.
ESTIMATION OF EXPOSURE
Subgoal
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, magnification and bioaccumulation, environ-
mental degradation, and retrospective monitoring through
sample banking.
Strategy
The approaches involved are of two types: those more
general approaches which consider factors common to all types
of chemicals for assessing exposure, and specific approaches
which are directed to particular chemicals or classes of
chemicals.
Analytical models which make use of monitoring and other
types of data should be designed and developed for both general
and specific approaches to exposure estimation. Factors such
as production quantity, use patterns, persistence, environmental
transport characteristics, and degradation patterns will be
considered and should form the basis for various proposed
models. Experimental and theoretical techniques for predicting,
-------
assessing, and verifying environmental properties such as per-
sistence and transport characteristics are generally lacking,
and should be developed to support this effort.
The development of analytical models of predictive value
involves relating experimentally obtained values of different
types to one another. For example, a physical-chemical
measurement such as a partition coefficient may have a statistical
correlation to the degree of storage of a compound in certain
biological compartments. This approach can be applied to many
chemicals and chemical classes, but may develop particular
sign.iflcance for a specific group such .as chlorinated hydro-
carbons.
Development of new monitoring methodology and monitoring
data to assess the presence and distribution of chemicals in
the environment is^a vital input to these approaches. Such
activities should involve research on methods to monitor
actual exposures to humans and natural ecosystems to environ-
mental chemicals.
Comparative analysis of theoretical and actual exposure
levels is a concurrent activity which can serve to strengthen
both general and specific approaches to exposure estimation by
revealing the consistencies or inconsistencies of observed
correlations. Verification of analytical models will necessitate
the development of monitoring strategies, and in many cases
will demand extremely sensitive analytical chemical techniques
which may not be readily available. Feedback from this activity
will impact on both monitoring method and analytical model
development.
A sample bank system should be established to provide base-
line information on actual exposures in selected locations.
Initially, the sample bank should be limited to human tissues
but later expanded to environmental samples such as crops, soils,
water, or selected plant and animal tissues.
In addition, these efforts should include some input from
related EPA activities such as the CHESS program and pesticides
community studies.
Three-Year Milestones
Develop and test on a limited number of chemical substances
a system for estimating and/or producting the level of human and
47
-------
environmental exposure to such substances, taking into account
use patterns, environmental transport, degradation, and food
chain effects.
Establish and maintain a sample bank for retrospective
monitoring of selected chemical substances.
TREND ASSESSMENT
Subgoal,
To Improve assessments and forecasts^'of'technoTogical
developments, economic and market trends, and material production
and use patterns which can assist in anticipating environmental
problems resulting from chemical substances entering the environ-
ment.
Strategy
Well established market and related economic forecasting
techniques provide the framework for this activity. Technological
forecasts within this framework can serve as the basis for
estimating the character and direction of the chemical and
allied industries in the years ahead. The major effort should
then be directed to estimating the interaction of these pro-
jected trends with environmental concerns. The following types
of considerations are particularly relevant:
-- At what levels will known problem substances be
entering the environment?
— What currently unsuspected chemicals will be
entering the environment and at what levels?
-- What will be the geographic distribution of
manufacturing and use?
— Which types of manufacturing and use activities
lead to appreciable amounts entering the
environment?
— Which types of technological innovations
heighten environmental concerns and which types
reduce concerns?
-- What risks are involved with substitute and
alternative materials?
48
-------
» To what extent will economic trends and other
market factors influence technological develop-
ments and how will these developments interact
with environmental concerns?
— To what extent can use patterns be predicted
from economic and growth indicators?
Initially, conceptual approaches and analytical techniques
should be developed. They would then be available to assess
specific industries, specific chemical classes, and specific
use classes.
Three-Year Milestone
Develop and apply to a range of selected industrial
classes economic and market indicators that can signal those
chemical substances which should be of particular concern.
49
-------
Appendix 1
EPA REGULATORY AUTHORITIES OF PARTICULAR
RELEVANCE TO TOXIC SUBSTANCES
CLEAN AIR ACT
Ambient Air Quality - National air quality standards based
on geographic regions establish the maximum amount of each
pollutant that will be permitted in the atmosphere consistent
with public health and welfare. Standards have been set for
sulfuroxides, particulate matter, carbon monoxide, hydrocarbons,
photo chemical oxidants, and nitrogenoxides.
New Statipnary^Sources - EPA directly regulates new
stationary sources by setting uniform national standards for
new air polluters. Standards have been devised to require the
application of the best available technology for five sources:
fossil fuel fired steam generators, incinerators, cement plants,
and sulfuric and nitric acid manufacturing operations.
Hazardous Air Pollutants - EPA has the authority to set
national standards for materials discharged into the atmosphere
that have a proven relationship to severe human health problems.
Standards have been set for mercury, asbestos, and beryllium.
Fuel and Fuel Additives - EPA may regulate fuel and fuel
additives which endanger public health, such as leaded gasoline.
FEDERAL WATER POLLUTION CONTROL ACT
Effluent Limitations - EPA is directed to publish regu-
lations establishing guidelines for effluent limitations which
identify the best practicable control technology for various
industrial categories. Industrial discharges must meet these
standards by 1977. Also, EPA must identify the best
available technology which will reduce discharge of
pollutants with industrial discharges obliged to meet these
standards by 1983. Among the industries of particular
relevance to toxic substances are plastics, petroleum, rubber,
organic chemical, asbestos, fertilizers and phospates,
soaps and detergents, and inorganic chemical.
Water Quality Standards - States must submit to EPA'
water quality standards which are consistent >?ith Federally
established water quality criteria, including criteria for
limitations on toxic substances. In addition, where
effluent limitations will not be stringent enough to meet
water quality standards, States are required to establish
50
-------
maximum daily loads of pollutants in waters that will allow
the propagation of fish and wildlife.
New Source Performance Standards - EPA is required to
set standards for nevrindustrial point sources, based on best
available demonstrated control technology.
Toxic and Pretreatment Effluent Standards - EPA is
directed to publish a list of toxic pollutants and effluent
limitations, including prohibition if appropriate, for these
substances.
Oil Spills and Hazardous Substances - EPA is directed to
clean up spills of oil and hazardous substances, make the
polluter pay the cost of clean up, and levy fines and
penalties against him. As a first step in the area of
hazardous substances 5 a list of pollutants is to be promulgated
with subsequent determination of penalty rates.
PUBLIC HEALTH SERVICE ACT
Drinking Water Quality - EPA has responsibility for
drinking water standards for public water supplies used by
interstate carriers.
M&EENE PROTECTION, RESEARCH, AND SANCTUARIES ACT
Ocean Dumping - EPA issues permits for dumping in the
ocean of sewage sludge, garbage, and chemical and construction
wastes and approves permits for dredged materials.
FIFRA, FEPCA, AND FOOD, DRUG, AND COSMETIC ACT
Registration - Under FEPCA, the distribution, sale,
offer or holding for sale, shipment, delivery, or receipt
within any State of any pesticide which is not registered is
prohibited. Additionally, FEPCA calls for labelling of
registered pesticides and the registration of pesticide-
producing establishments.
Certification of Applicators - EPA is authorized to
prescribe applicator certification standards requiring that
the individual to be certified is competent to handle the
pesticide. A related provision is the prohibition against
the use of a pesticide in a manner inconsistent with its
labelling.
51
-------
Tolerances - Under the Food, Drug, and Cosmetic Act, if
the pesticide in normal use leaves residues on crops that
provide food for man and animal, a tolerance must be
established. Where the supporting data is inadequate or a
health hazard may be present, EPA must establish a "zero"
tolerance.
Cancellation - Cancellation is the major tool in imple-
menting the decision that the benefits of using a pesticide
are outweighed by its risks. Cancellation can result in
removal -from -the market. -Other enforcement -sanctions
include: a change in classification from general to
restricted use: stop sale, use, or removal orders; seizures;
and civil and criminal penalties.
52
-------
APPENDIX 2
REGULATORY AUTHORITIES OF OTHER AGENCIES OF PARTICULAR
RELEVANCE TO TOXIC SUBSTANCES
There arc a number of regulatory authorities bearing on
toxic substances administered by other agencies. The most
significant laws and administering agencies are:
Food, Drug, and Cosmetics Act - Department of Health,
Education, and Welfare
Lead Based Paint Poisoning Prevention Act - Department
of Health, Education and Welfare
Federal Meat Inspection Act - Department of Agriculture
Egg Products Inspection Act - Department of Agriculture
Poultry Products Inspection Act - Department of Agriculture
Flammable Fabrics Act - Federal Trade Commission
Occupational Safety and Health Act - Department of Labor
and Department of Health, Education and Welfare
Federal Hazardous Substances Act - Consumer Product
Safety Commission
Consumer Product Safety Act - Consumer Product Safety
Commission
53
-------
Appendix 3
EXAMPLES OF MONITORING NETWORKS SUPPORTED
BY OTHER AGENCIES
Food and Drug Administration:
surveys of raw agricultural products and market basket
purchases
Department of Agriculture:
sampling of livestock feed, livestock, and selected
crops
Forest Service:
surveys of toxic effects on trees and on nearby areas
Geological Survey:
base line monitoring of rivers and streams and periodic
sampling for specific substances
Bureau of Sport Fish £ Wildlife:
analyses of contamination of fish and wildlife, including
sampling for heavy metals
Bureau of Mines:
surveys of mine tailings and related runoffs
National Oceanographic £ Atmospheric Administration:
monitoring of near shore, estuarine, and lake quality
including spot sampling for heavy metals
Smithsonian Institution:
analyses of marine and wildlife biology
Department of Health, Education, and Welfare:
Communicable Disease Center's efforts in epidemiological
monitoring, including diseases related to heavy metals
54
-------
STRATEGY FRAMEWORK
-------
FRAMEWORK FOR AN EPA STRATEGY
FOR THE
CONTROL OF TOXIC SUBSTANCES
July 12, 1973
HMC/OTS
-------
PREFACE
This Report is an early step toward development
of an EPA strategy for controlling toxic substances.
It is intended to serve as the framework for a more
comprehensive and definitive strategy statement to be
prepared during the next several months. Thus, at
this stage the Report is largely descriptive of pro-
blems and activities relevant to such a strategy
statement. In some cases general policy approaches
are suggested although further refinement of these
approaches is clearly in order.
The Report is directed primarily to chemical sub-
stances exhibiting adverse effects on man or the
environment at relatively low concentration levels.
At the same time it is recognized that almost any sub-
stance can be toxic if exposure levels are sufficiently
high, and therefore it is not practical to specify
which chemicals or chemical classes are or are not
included. Additionally, the concern here is only for
toxic effects resulting from sustained chemical or
biological activity, and other hazardous effects, such
as fire, explosions, and radioactivity, are not
considered.
The EPA approach to controlling toxic substances
must be carefully integrated with the myriad of related
activities of other Federal and State agencies --
including regulatory, monitoring, and research activi-
ties. While better integration of all national efforts
is a central concern, this Report does not set forth in
detail the activities of other organizations which are
described in various reports of these organizations.
One purpose of this Report is to provide a broad
perspective for the toxic substance activities of a
number of interested EPA offices, and particularly the
recently established Office of Toxic Substances. There-
fore, the most relevant activities of .these offices and
the additional activities required to implement the
pending Toxic Substance Control Act are briefly outlined,
with more detailed statements of specific activities
presented separately in EPA program documents.
-------
TABLE OF CONTENTS
Page
I. THE PROBLEM OF CONTROLLING TOXIC SUBSTANCES 1
II. AGENCY GOALS 5
III. THE STRUCTURE TO DEAL WITH TOXIC SUBSTANCES 7
A. Regulatory Authorities 7
B. Research, Monitoring, and Data Systems 8
C. Interests of EPA Headquarters Offices 11
D. Role of the Office of Toxic Substances 12
IV. POLICY ISSUES 14
A. The Level of Agency Resources Devoted to
Toxic Substances 14
B. Organizational Responsibilities and
Coordination within EPA 14
C. Selection of Problem Substances for
Detailed Attention 15
D. Selection of Appropriate Regulatory Authority 16
E. Limited Reliance on State Capabilities 17
F. Improved Approaches to Research, Monitoring,
and Data Systems 18
G. Priorities in Implementing the Toxic
Substances Control Act 19
V. FUTURE STEPS 21
Appendix 1 - EPA Regulatory Authorities of
Particular Relevance to Toxic
Substances
Appendix 2 - Regulatory Authorities of Other
Agencies of Particular Relevance
to Toxic Substances
-------
I. THE PROBLEM OF CONTROLLING TOXIC SUBSTANCES
More than 10,000 chemical 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 pro-
ducts, and in specialized uses such as drugs, food addi-
tives, and pesticides. 1972 sales of chemicals and allied
products were about $70 billion, or about eight percent
of total U.S. manufacturing sales.
The problems presented by the presence in the environ-
ment of some of these 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 com-
pletely 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 con-
tamination, 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
chemicals which could adversely affect health and environ-
mental 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 envi-
ronmental stresses. Problem assessment is further compli-
cated by the many unknowns that surround the characteristics
-------
and behaviour in the environment of most toxic sub-
stances, including such aspects as persistence,
dogr-cul.itJon, accumulation, and movement am^ng environ-
mental 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 defi-
ciencies 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 pro-
blems, the Government can draw on three types of regula-
tory 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 environ-
mental 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 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 some-
what 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 appro-
priate 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 chemicals 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 control-
ling 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 employ-
ment of workers in chemical plants must be balanced
against occupational risks; U.S. competitive ability in
world markets weighs against environmental testing costs
or requirement of expensive effluent or emission controls;
and quality of life benefits from chemical substances bear
on the degree of risks which can be tolerated. Restric-
tions 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
product's,, are lost. In short, environmental protection
is not Tree. Care must be exercised in accessing the
impact oF corrective actions on the direction, configu-
ration, and diversity of the chemical industry as well
as on the benefits to society of chemical products.
-------
II. AGENCY GOALS
The overall EPA goal in the toxic substance area
is the prorection of man and his environment from
adverse effects which may result from the manufacture,
use, distribution, and disposal of chemical substances
without unduly jeopardizing the societal benefits
derived from such substances. While this goal is very
broad, and not uniquely the responsibility of EPA, it
can serve as the standard for measuring the success of
EPA efforts in this area.
The following subgoals are directed to an enhanced
EPA capability to assess the risk and benefit aspects
of toxic substances and to take appropriate steps to
control existing or potential problems posed by these
substances:
(1) Development of improved methods to iden-
tify and assess problems, including anticipation of
problems before severe environmental or human health
problems arise. Monitoring and testing data must be
combined with analytical efforts and expert judgements
in forecasting likely problem areas as well as clarify-
ing known problems.
(2) Articulation of actual or potential health
and environmental effects of particular concern. In
individual cases careful consideration must be given to
the concepts of a permissible level vs. a no effects
level, to protection of individual organisms vs. protec-
tion of populations of organisms, and to irreversible vs.
temporary effects.
(3) Improved use and coordination of monitor-
ing and data systems to ensure that maximum benefit is
derived by all concerned program elements from such
activities. Ready access to a broad range of available
scientific, technical, and economic data can greatly
improve and facilitate decisions concerning specific
toxic substance problems.
(4) Stimulation of priority research activi-
ties, both in the public and private sector, to clarify
the problems associated with toxic substances and to
develop less hazardous alternatives to these substances.
-------
(5) Improved understanding of the oconomic
framework surrounding the production, use, distribu-
tion,
-------
IIT. THE STRUCTURE TO DEAL WITH TOXIC SUBSTANCES
A. Regulatory Authorities
There are a variety of existing authorities
which can be used to contro] toxic substances. Some
cover a broad range of pollutants while others have
been specifically designed to address toxic substances.
Appendix 1 describes the relevant provisions of the
following statutes administered by EPA: Clean Air Act;
Federal Water Pollution Control Act; Public Health
Service Act; Marine Protection, Research, and Sanctu-
aries Act; and FIFRA, FEPCA, and Food, Drug, and
Cosmetic Act. Appendix 2 identifies a number of statutes
covering various aspects of the toxic substance problem
which are administered by other agencies.
The proposed Toxic Substances Control Act of
1973 would give EPA new authority for (H~5information
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 unreason-
able 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 stand-
points. 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 sujbstance 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 appro-
priate regulatory action to prevent toxic incidents.
-------
The, proposed Hazardous Waste Management Act
of 1973 would create a joint federal-State program to
regulate the treatment and disposal of hazardous wastes.
This, legislation would authorize EPA to designate waste
substances or waste streams of particular concern and
to specify performance and design standards for disposal
Facilities. Wastes not identified as posing the most
serious hazards, but which still present disposal
problems, would be controlled by State programs
established in accordance with Federal]y specified
guidelines.
This new authority is particularly important
as presently established regulation of air and water
discharges and of ocean dumping makes land disposal of
toxic wastes more attractive. The Agency could require
generators of hazardous wastes to use environmentally
sound disposal techniques and could insure compliance.
The pending Safe Drinking Water Act would
expand Federal coverage of drinking water standards
from the current 700 systems serving interstate carriers
to 40,000 community water supplies and 200,000 non-
community systems serving the travelling public. Manda-
tory national primary standards would apply to all health
related constituents as well as certain operating and
monitoring requirements. Enforcement authority would
rest primarily with the States, subject to EPA support
if State programs fail to meet Federal guidelines. A
more direct Federal role would exist in the presence of
an imminent hazard.
B. Research, Monitoring, and Data Systems
Three EPA research areas of particular signi-
ficance are: Transport Processes, including the fate of
pollutants in ground water and fresh surface water and
the mechanisms of formation and decay, Health Effects,
including development of improved toxicological tests;
and Ecologica] Effects, including the impact of toxic
substances on fish and wildlife. A number of other
Federal agencies also support research on toxic sub-
stances, including the Department of Health, Education,
and Welfare (e.g. Food and Drug Administration and
National Institutes of Health), the Department of
Agriculture (e.g. Agriculture Research Service, Forest
Service), the Department of Interior (e.g. Bureau of
Mines, Bureau of Sport Fish and Wildlife, Geological
-------
Survey), the Department of Commerce (e.g. MOAA, National
Bureau of Standards), and the National Science Foundation.
In a number of cases entire research programs
or laboratories are directed to toxic substances, such
as the NST program on trace metals, the National Center
on Toxicological Research, severs] laboratories of the
National Environmental Research Cent ere., a number of pro-
grams of the National Institute of Environmental Health
Sciences and the National Cancer Institute, and a number
of other Federally supported university programs. In
addition, attention to highly toxic materials is frequently
subsumed in programs encompassing a broader range of pollu-
tion concerns.
Similarly, many Federal and State agencies are
involved in monitoring. For example:
FDA surveys of raw agricultural products and
market basket purchases
USDA sampling of livestock feed, livestock,
and selected crops
Forest Service surveys of toxic effects on
trees and on nearby areas
• -- USGS base line monitoring of rivers and
streams and periodic sampling for specific
substance
Bureau of Sport Fish and Wildlife analyses
of contamination of fish and wildlife,
including sampling for heavy metals
Bureau of Mines surveys of mine tailings and
related runoffs
NOAA monitoring of near shore, estuarine,
and lake quality including spot sampling for
heavy metals
Smithsonian Institution analyses of marine
and wildlife biology
HEW CommunicabDe Disease Center's efforts
iii epidemiological monitoring, including
diseases related to heavy metals.
-------
The objectives, and hence the geographic spread and
data collection requirements, of these networks vary
considerably. Nevertheless, they offer extensive
opportunities for environmental sampling on either a
routine or an ad hoc basis. In some cases toxic
pollutants are a principal concern of the network
collection activities. In other cases, toxic sub-
stances are but a subset of a broader range of
pollutants that are analyzed. Timely access by EPA
to the monitoring data is often difficult, however,
and adjustments of the systems to accommodate quick
responses to short-term EPA needs is usually not
feasible. In short, when the needs of EPA mesh with
the needs of the other agencies, the systems are very
valuable. However, when there is not a good meshing,
there are considerable difficulties in acquiring and
using the needed data.
EPA's highest priority monitoring needs are
currently associated with characterization of known
geographical problem areas and the contributing
pollution sources and with the evaluation of compliance
with standards. Monitoring to assess overall environ-
mental quality, national or regional environmental
trends, and new pollutants emerging as problems is of
secondary priority. Responsibility for the National
Air Sampling Network is being transferred to the
Regions, with emphasis on evaluation of state air
monitoring networks, review of adequacy of state-
collected data, and special surveys. Similarly, the
major responsibility for water quality monitoring is
being placed on the States, with the EPA emphasis on
characterization of water segments where water quality
standards dictate discharge permit conditions. In the
years ahead, the States are expected to begin providing
the majority of information on the overall status and
trends in water quality. None of these efforts are at
present deliberately oriented toward acquiring data on
toxic substances although in specific air or water
bodies where problem substances are suspected, they
obviously are prime targets. With the designation of
toxic pollutants under Section 112 of the Clean Air
Act and Section 307(a) of FWPCA, monitoring for these
substances should increase. Pesticide residue monitor-
ing (for soils, crops, biota, surface runoff, human
tissues) provides data for evaluation of label regula-
tion applications and residue tolerance petitions, rather
than an overall assessment of pesticide levels in the
environment.
10
-------
Many feclei^ally funded data systems potentially
provide a rich reservoir of information on toxic sub-
stances (e.g. TOXICON, SIE, NTIS). A number of data
systems are used in EPA to "handle information collected
through monitoring activities and from other sources (e.g.
ENVIRON, STORET, NEDS, SAROAD, Pesticide Data Base). How-
ever, these systems have been developed largely independ-
ently of one another, and there is little commonality
among them, thus inhibiting integration of data from
various systems. Despite the numerous attempts at
bibliographies, common indexing, and formal and informal
coordination mechanisms, effectively tapping available
data banks remains a formidable task.
C. Interests of EPA Headquarters Offices
Toxic substances currently permeate the activi-
ties of many EPA program offices with responsibilities
for administering existing legislation. They are of major
concern to the Offices of Pesticides, Solid Waste Manage-
ment (and particularly the Division of Hazardous Wastes),
Air Quality Planning and Standards, Mobile Source Air
Pollution Control, Water Programs Operations (and
particularly the Division of Oil and Hazardous Materials),
and -Water Planning and Standards. Each of these offices
is involved in developing control strategies, standards,
and/or guidelines. In addition, these offices are con-
cerned with technical assistance to the states and respond-
ing to emergency problems and inquiries bearing on toxic
substances. Other offices, and particularly the Offices
of Research and Development, Toxic Substances, Technical
Analysis, and Program and Evaluation also devote consider-
able resources to direct support of legislative require-
ments and enforcement activities.
Several examples illustrate the spread of EPA
activities. More than twenty EPA working groups are
currently addressing both policy aspects and technical
details of particularly troublesome toxic substances,
including consideration of unleaded gasoline, fuel
additives, drinking water standards, toxic water pollu-
tants, and spills of hazardous materials. With regard
to crisis response, the Office of Technical Analysis is
currently heavily involved in asbestos problems, the
Pesticides Office in Agent Orange, and the Office of
Toxic Substances in hexachlorobenzene: Two of the longer
range EPA activities involve current analyses of problems
associated with disposal of specific hazardous wastes
11
-------
being conducted by OSWMP and strategy planning of OAWP
for coping with toxic air pollutants, including a
series of supporting studies of specific pollutants
by the National Academy of Sciences.
D. Role of the Office of Toxic Substances
In 1971 several EPA task forces recommended
establishment of a central office to serve as a focal
point for shaping an overall EPA approach to the assess-
ment and control of toxic substance problems. A particu-
lar need was identified for analyzing the effects of
toxic substances on the total environment and relating
these effects to regulatory authorities, strengthened
research and monitoring activities, coordination of the
activities of various EPA offices concerned with toxic
substances, and cooperation with other Government agencies
The initial framework for the Office's activi-
ties reflects these concerns. At present the Office's
efforts are directed to:
supporting the activities of other EPA
offices responsible for regulating toxic
substances under existing statutory
authority with particular attention to
criteria for determining when, and under
what authority, toxic substances should
be controlled.
developing and improving techniques for
anticipating and identifying problem areas,
including monitoring approaches and inves-
tigations of specific chemicals suspected
to pose risks to health and the environment.
improving the analytical base for decision-
making, with particular attention to the
adequacy of existing test methods, the
economic and related framework for the
manufacture, use and distribution of
chemicals, and the timely availability of
technical data to decision makers.
clarifying the most important research
needs including assessment of the value and
uReability of past research efforts and
identification of priority research gaps.
12
-------
support of EPA field units, through provi-
sion of technical information tailored to
specific problems and timely response to
ad hoc requests'.
support for the "Toxic Substances Control
Act. of 1973" with particular attention to
the industrial reporting requirements, the
character and scope of test requirements,
and relationship of the proposed legislation
to existing laws.
response to crisis situations such as the
problems associated with hexachlorobenzene
that do not neatly fall into a single
program area.
Many of these activities are still embryonic,
and the Office's involvement in each area is increasing
rapidly. In particular, the role of supporting other
EPA offices will continue to expand as additional regula-
tions are developed to control toxic substances. Should
the Toxic Substances Control Act be enacted, a major new
dimension will be added to the Office's responsibilities.
13
-------
IV. POLICY ISSUES
A. The Level of Agency Resources Devoted to Toxic
Substances
The increasing frequency of emergency situations
involving toxic substances, as well as the implementation
of the Toxic Substances Control Act and the Hazardous
Waste Management Act, will undoubtedly require resources
beyond those currently devoted to this area. Indeed,
the level of additional resources programmed into the"
area of toxic substances will have a decisive effect on
the character and scope of implementation of an Agency
strategy. Since it is unlikely that a sizeable incre-
ment of new resources will become available to EPA for
toxic substances, the Agency will probably have to
support a significant part of the resultant activities
from within its existing base.
Although a portion of the Agency's resources are
currently directed toward the toxic substances area--in
regulatory and research and supporting activities—the
current commitment is not sufficient to support even
minimal' implementation of either bill. The resource con-
straints dictate that toxic substances related programs
clearly define their priorities and carefully consider
means of making maximum use of existing analytical,
research, and monitoring facilities as well as regulatory
and enforcement personnel and resources.
B. Organizational Responsibilities and Coordination
within EPA
The EPA program offices tend to concentrate on
that portion of the toxic substances problem which
directly relates to their statutory authorities. The
focus of this attention is usually dictated by deadlines
as resources are deployed to address the immediacy of
standard setting or crises. As a result, a number of
rotating specialists are working in spurts on toxic sub-
stance problems usually without the opportunity to
evaluate the total hazard which may be posed by a given
toxic substance. Related to these activities of the
program offices is a myriad of activities of the
Regional Offices, the Enforcement Offices, and ORD,
including the MERCs. Many of these activities are
directly tied to program concerns; others are not. The
-------
disparate nature of EPA toxic substances responsibilities
complicates an already complicated problem, and better
organizational unity seems essential if resources are to
be wisely used, and if the total environmental approach
is to be a reality.
The EPA Regional Offices should further develop
a strong capability to cope with single media problems
and some capability to address a wide range of toxic sub-
stance concerns. Hopefully, this capability will grow as
the Regions gain experience without the necessity of
deploying significant additional resources directed
specifically to toxic substances. However, a strong
centralized system for policy and standard setting and
for assessing highly specialized problems is essential.
Both headquarters personnel and specialists from the NERCs
can play an important role in this regard. The pesticides
program exemplifies how decentralization of enforcement
and local response capabilities are backstopped by
specialized central staffs. Also, in the air monitoring
area, the regions are assuming new responsibility but
much of the specialized analyses will undoubtedly continue
to be guided by centralized staff.
Related to these organizational concerns is the
responsibility within EPA for technical assistance and
for responding to crises, and particularly crises which
involve multi-source and multi-media pollutants. Many
EPA offices -- and particularly the Regional Offices --
are continuously involved. Clearly, an important objec-
tive of an EPA response capability should be to use
efficiently the best available expertise with the minimal
disruption to ongoing activities. Usually, much, but not
all, of the relevant headquarters expertise resides with
the headquarters office that has primary responsibility
for resolving the problem. At the same time the office
is generally so engaged with the problem that it is not
difficult to overlook the interests, capabilities, and
resources of other offices. Toxic substances represent
a formidable and complicated array of problems, and there
are a number of EPA units which can contribute to solving
specific problems.
C. Selection of Problem Substances for Detailed
Attention
Identifying and assigning priority to problem sub-
stances is fundamental to the success of several Agency
programs. At present several EPA offices are independently
15
-------
carrying out studies of various toxic substances with
minimal attention to coordination. With the enactment
of new authorities, the Agency effort may become
further fragmented.
When assessing new chemicals which have not yet
been introduced into commerce, the traditional tools,
such as monitoring and reliance on past human experience,
are not available. Test results and other predictive
measures to assess potential impact must be used. It is
in this area that the Toxic Substances Control Act is
uniquely appropriate, and the Office of Toxic Substances
is a logical focus for such concerns.
With respect to existing chemical substances,
monitoring and epidemiological experience can be used to
complement test and other analytical information for
identifying those substances which are causing health
or environmental problems. Responsibility for identify-
ing and assigning priorities to problem substances in one
of the media or with regard to a specific use rests with
the office responsible for the relevant authority. Never-
theless, a more conscientious effort must be made by all
offices to (1) communicate throughout the Agency their
efforts to identify and establish priorities at an early
date, and (2) define more precisely criteria for identi-
fying hazardous chemicals. The Office of Toxic Substances
and the Office of Research and Development can play strong
supporting roles in this second area.
D. Selection of Appropriate Regulatory Authority
Related to the selection and analyses of specific
substances and problems attendant to the presence of
these substances in the environment is identification of
the best approach in resolving the problems. In many
cases, this relates to a choice of regulatory authorities.
At present the starting point for almost all EPA
efforts to control toxic substances is a legislative
authority, and that authority in large measure dictates
the problem or piece of the problem to be solved. In
many cases, of course, this approach goes to the core of
the problem. In other cases, however, only a small piece
of a tar broader problem posed by a substance can be
addressed. Even with individual laws, such as TWPCA and
the Clean Air Act, there are several routes for control-
ling single media problems. In some instances regulation
under more than one authority may be desirable.
16
-------
In selecting the appropriate authority, a
variety of factors should be kept in mind such as
maximizing reduction of the problem while minimizing
adverse economic impact, ease of enforcement, and
precedents set by the use'of a particular authority.
Schemes developed in addressing one class of problems
may have direct relevance to other classes. Meanwhile,
the current limited efforts to isolate the key elements
of toxic substances problems and then to search out
the most appropriate regulatory authorities should
become a useful complement to the approaches of other
offices.
E. Limited Reliance on State Capabilities
It seems neither wise nor practical to place
primary reliance on the States for controlling toxic
substances -- certainly not in the near term and
probably not in the longer run. While the States are
assuming an ever greater role in monitoring and regu-
lating the activities of many types of polluters,
several of the characteristics of toxic substances
suggest that in this area a program which is in large
measure Federally directed is essential.
The use, sale, and distribution of chemical
substances are generally interstate in
character, and consistency of regulation is
necessary to prevent economic imbalances
and to enable meaningful enforcement.
Given the scientific and technical uncertain-
ties surrounding the behaviour and detection
of many toxic substances, it is highly
unlikely that many States can develop the
capability to address these problems in a
credible fashion.
The hazards associated with toxic substances
are potentially of such magnitude that, the
Federal Government has a special obligation
to take steps to mitigate these hazards.
While State participation in some aspects of
monitoring and enforcement should be encouraged, clearly
the Federal Government must assume the leadership in
these areas as well as in standard setting and general
policy direction.
17
-------
r. Improved Approaches to Research, Monitoring, and
Data Systems ~
There has been relatively little effort to review
the pieces of the total research activity in toxic sub-
stances for determining where duplicative work might be
alleviated, or for identifying neglected areas. The toxic
substances-related research needs of the various EPA pro-
gram offices have not been consolidated into an effective
plan to fill in critical gaps. Both within the Agency
and in the overall federal research effort, a concerted
rather than a fragmentary approach to toxic substances
problems is needed.
Federal record keeping (e.g. Tariff Commission
production data), data gathered through regulatory efforts
(e.g. EPA's pesticides and water permit programs), and the
results of federal monitoring programs (e.g. FDA's market
basket surveys) are all potential sources of valuable
information on the manufacture, use, distribution and dis-
posal of toxic chemicals. To date, however, these sources
have served primarily the parochial interests of the
office conducting the effort. Potential users of such
information are discouraged by specialized systems,
barriers to access to information such as confidentiality
requirements, and general agency reluctance to allow out-
side use of information. Even more fundamentally, it is
often difficult to ascertain what kinds of information
exist within the federal system. At the very least, EPA
must ensure that information collected by one office will
be available to the rest of the Agency. With its own
house in order, the Agency can then call for increased
linking within the overall federal information acquisition
and storage system.
The following approaches should be developed and
articulated in support of further elaboration of the over-
all strategy for controlling toxic substances:
A framework for identifying the highest priority
research needs, including elaboration of the
areas of greatest concern, analysis of the
effectiveness of on-going programs, and esti-
mates of the payoff of new approaches if they
are successful.
A detailed approach to monitoring toxic sub-
stances in the environment, identifying with
some precision specific types of monitoring
18
-------
activities that should be augmented, and
estimating the anticipated usefulness of
the data from such augmentation.
Steps for more effectively utilizing exist-
ing information sources on toxic substances,
with particular emphasis on how one or more
centralized information switching points can
facilitate access to relevant data.
G. Priorities in Implementing the Toxic Substances
Control Act
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 Con-
gressional mandates, severity and urgency of existing
problems which can be alleviated by the new authority,
opportunities to reduce future problems of major dimen-
sions, 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
the 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 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 judgements concern-
ing 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 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 underscores the importance of early
attention to establishing efficient and
decision oriented procedures to be effective
when the first reports arrive.
There are, of course, a considerable number of
other requirements that will require attention from the
outset. However, if choices must be made, less exten-
sive efforts would be devoted to the following:
Development of a detailed system for classi-
fying chemicals.
Analyses of the risks associated with exist-
ing chemicals.
Establishment and meaningful operation of the
Toxic Substances Board.
Analyses of exports of chemicals.
Annual report on coordination of activities
under this legislation with activities under
other authorities.
20
-------
V. FUTURE STEPS
As a step toward a more coherent approach to the
control of toxic substances -- and particularly to
clarify consistency of policy directions of different
offices, to assist in selection of regulatory tools
for addressing specific toxic substance problems, and
to ensure most effective use of limited resources being
devoted to toxic substances -- the strategy described
in previous sections will be further developed during
the coming months. In elaborating the overall approach
careful attention will be directed to (a) various
methodologies currently being used within EPA for
setting tolerances and standards, (b) complimentary
and duplicative efforts within EPA to analyze problems
associated with specific substances, and (c) the
rationale for selecting the appropriate legislative
authority for solving specific problems.
Clearly, the further delineation of needs and
opportunities in research, monitoring, and data systems
that has been described previously should support the
development of a more definitive strategy statement.
Also, the preparation of FY 1975 program documents,
including the program submission for the Office of
Toxic Substances, should assist in further'illuminating
the spread of EPA interests and activities in toxic
substances and in assessing the effectiveness of
current efforts toward more effective meshing of the
efforts of a large number of offices. Meanwhile,
standard,setting through the Steering Group mechanism
can be improved through greater involvement of all
interested offices early in the working group process,
particularly in relation to developing the methodologies
for standard setting.
Should the two pending bills be enacted, major new
dimensions will be added to EPA responsibilities. Thus,
prompt attention should be given to analysis and resolu-
tion of
-- the principal policy and implementation issues
associated with the Toxic Substances Control
Act, including the extent and character of
industrial testing requirements for both new
and existing substances, criteria for determining
whether and how substances should be controlled,
criteria for designating a substance as an
21
-------
"unreasonable threat" and subject to industry
testing, cind criteria for determining whether
the new law is the most appropriate law for
controlling a substance.
-- the principal policy and implementation issues
associated with the Hazardous Waste Management
Act, including clarification of State responsi-
bilities, disposal site standards, and initial
funding requirements.
In addition to the foregoing policy issues there
is need for a better organizational approach which will
add coherence to broadly dispersed regulatory attacks
and supporting activities on pieces of the same problem.
The newly established Office of Toxic Substances — with
responsibility for broad overview of EPA activities in
toxic substances and for coordination of such efforts —
should give high priority to improving such organizational
cohesion.
22
-------
AppendJx
EPA REGULATORY AUTHORITIES OF PARTICUIAR
RELEVANCE TO TOXIC SUBSTANCES
CLEAN AIR ACT
Ambient: Air Quality - National air quality standards based
on geographic regions establish the maximum amount of each
pollutant that will be permitted in the atmosphere consistent
with public health and welfare. Standards have been set for
sulfuroxides, particulate matter, carbon monoxide, hydrocarbons,
photo chemical oxidants, and nitrogenoxides.
New Stationary Sources - EPA directly regulates new
stationary sources by setting uniform national standards for
new air polluters. Standards have been devised to require the
application of the best available technology for five sources:
fossil fuel fired steam generators, incinerators, cement plants,
and sulfuric and nitric acid manufacturing operations.
Hazardous Air Pollutants - EPA has the authority to set
national standards for materials discharged into the atmosphere
that have a proven relationship to severe human health problems.
Standards have been set for mercury, asbestos, and beryllium.
Fuel and Fuel Additives - EPA may regulate fuel and fuel
additives which endanger public health, such as leaded gasoline.
FEDERAL WATER POLLUTION CONTROL ACT
Effluent Limitations - EPA is directed to publish regu-
lations establishing guidelines for effluent limitations which
identify the best practicable control technology for various
industrial categories. Industrial discharges must meet these
standards by 1977. Also, EPA must identify the best
available technology which will reduce discharge of
pollutants with industrial discharges obliged to meet these
standards by 1983. Among the industries of particular
relevance to toxic substances are plastics, petroleum, rubber,
organic chemical, asbestos, fertilizers and phospates,
soaps and detergents, and inorganic chemical.
Water Quality Standards - States must submit to EPA
water1 quality standards which are consistent with Federally
establashed water quality criteria, including criteria for
limitations on toxic substances. In addition, where
effluent limitations will not be stringent enough to meet
water quality standards, States are required to establish
-------
maximum daily loads of pollutants in waters that will allow
the propagation of fish and wildlife.
New Source Performance Standards - EPA is required to
set standards for1 new industrial point sources, based on best
available demonstrated control technology.
Toxic and Pretreatment Effluent Standards - EPA is
directed to publish a list of toxic pollutants and effluent
limitations, including prohibition if appropriate, for these
substances.
Oil Spills and Hazardous Substances - EPA is directed to
clean up spills of oil and hazardous substances, make the
polluter pay the cost of clean up, and levy fines and
penalties against him. As a first step in the area of
hazardous substances, a list of pollutants is to be promulgated
with subsequent determination of penalty rates.
PUBLIC HEALTH SERVICE ACT
Drinking Water Quality - EPA has responsibility for
drinking water standards for public water supplies used by
interstate carriers.
MARINE PROTECTION, RESEARCH, AND SANCTUARIES ACT
Ocean Dumping - EPA issues permits for dumping in the
ocean of sewage sludge, garbage, and chemical and construction
wastes and approves permits for dredged materials.
FIFRA, FEPCA, AND FOOD, DRUG, AND COSMETIC ACT
Registration - Under FEPCA, the distribution, sale,
offer or holding for sale, shipment, delivery, or receipt
within any State of any pesticide which is not registered is
prohibited. Additionally, FEPCA calls for labelling of
registered pesticides and the registration of pesticide-
producing establishments.
Certification of Applicators - EPA is authorized to
prescrj.be applicator certification standards requiring that
the individual to be certified is competent to handle the
pesticide. A related provision is the prohibition against
the use of a pesticide in a manner inconsistent with its
labelling.
-------
Tolerances - Under the Food, Drug, and Cosmetic Act, if
the pesticide in nomial use leaves residues on crops that
provide food for man and animal, a tolerance must be
established. Where the supporting data is inadequate or a
health hazard may be present, EPA must establish a "zero"
tolerance.
Cancellation - Cancellation is the major tool in imple-
ment iJig~the~decTsion that the benefits of using a pesticide
are outweighed by its risks. Cancellation can result in
removal from the market. Other enforcement sanctions
include: a change in classification from general to
restricted use: stop sale, use, or removal orders; seizures;
and civil and criminal penalties.
-------
APPENDIX 2
REGULATORY AUTHORITIES OF OTHER AGENCITS OF PARTICULAR
RELEVANCE TO TOXIC SUBSTANCES
There are a number of regulatory authorities bearing on
toxic sut>stances administered by other agencies. The most
significant laws and administering agencies arc:
Food, Drug, and Cosmetics Act - Department of Health,
Education, and Welfare
Lead Based Paint Poisoning Prevention Act - Department
of Health, Education and Welfare
Federal Meat Inspection Act - Department of Agriculture
Egg Products Inspection Act - Department of Agriculture
Poultry Products Inspection Act - Department of Agriculture
Flammable Fabrics Act - Federal Trade Commission
Occupational Safety and Health Act - Department of Labor
and Department of Health, Education and Welfare
Federal Hazardous Substances Act - Consumer Product
Safety Commission
Consumer Product Safety Act - Consumer Product Safety
Commission
-------
MONITORING STRATEGY
-------
Ed Brooks
Howard Leathers
Glenn Schweitzer
June 19, 1973
TOXIC SUBSTANCES MONITORING STUDY
If not closely and carefully pre-considered, a monitoring
effort can easily become a white elephant. This study will
attempt to realistically determine whether, in fact, there
are any special, significant, and feasibly met monitoring
needs peculiar to toxic substances; special to warrant a
unique effort; significant "to warrant the allocation of
scarce resources; and feasible to avoid a search for the
Holy Grail. The first step, through staff discussions
and studies, will be to enumerate those anticipated infor-
mation requirements that might, at least theoretically,
be met by monitoring.
Presently, several offices within EPA are involved in
monitoring (e.g., Offices of Air, Water, and Pesticides).
This study will seek to clarify and where possible establish
priorities for EPA in the area of toxic substance monitoring,
Short term steps to respond to these needs will be recommend-
ed.
A. Specifically, we will assess the .extent to which
and exactly how, monitoring might:
i
1. Anticipate toxic substance problems by;
i
a. ;Locating substances of possible or
known toxicity in the environment,
Measuring the concentrations of these
substances in the environment,
Signaling changes in the concentrations
of these substances,
d. Measuring accumulated concentrations of
• toxic substances in human and animal
tissue, and
e. Observing biological effects (especially
on "indicator species").
Identify the chemical causes (where unknown)
of observed toxic crises by;
-------
a. Locating substances of possible
toxicity in the environment,
b. Measuring accumulated concentra-
tion levels of known or suspected
toxic substances in human and
animal tissuej
c. Observing anomolies in concentration
levels or trends of these substances.
Provide background data to aid in setting,
justifying, and defending standards and r.egula-
lations by;
a. Correlating observed biologic effects with
concentration levels and trends in tissue
samples and environmental media,
b. Gathering information on use, distribution,
and transport patterns,
c. Discovering sources and paths of toxic
substances into the environment,
d. Gathering specific data regarding physical
and/or chemical properties (e.g., bioaccumu-
lation) of individual substances,
e. Measuring the effectiveness of regulations
and their enforcement -- are the target
concentration levels reached? Do anticipated
environmental effects occur?
Detect violations and enforce compliance by;
a. Frequent trend monitoring near known sources
of toxic substance pollution,
b. General level monitoring to establish when
prescribed concentration levels in "specific
media are being exceeded.
Gain an overview of the extent and components
of toxic substance contamination by;
a. Locating known toxic substances in the
environment,
-------
b. Measuring concentration levels and
trends of these substances,
c. Monitoring for inter-media differences
and trends in the same geographical
area and for inter-areal differences
and trends in the same medium.
B. The alleged potential advantages of each tentatively
indicated monitoring use category will be rigorously
" and critically evaluated. Illustratively, monitoring
has been touted'as an ''early warning" system to
detect emerging toxic threats in the environment.
1. Is this practical - e.g., if such a system
had been in place would it have alerted us
to the NTA, PCB, mercury or HCB problems
any earlier? If so, to what advantage?
2. For such an enterprise to be worthwhile, how
many, and specifically which, chemicals sub-
stances, organisms, media and tissues would it
be necessary to monitor?
3. Assuming an "early warning" system is deemed
both workable and within the bounds of reason,
would it necessarily be our best choice?
a. Are there either more efficient or less
jcostly ways to discover potential toxic
ithreats -- e.g., via the production and
!test data anticipated from industry after
passage of the Toxic Substances Control
Act?
b. How essential is such monitoring? To what
extent would offices and. operations within
EPA be defined differently' in the absence
'of such data? Are the alternative defini-
tions clearly less desirable?
II. Once the priority information requirements of EPA have been
enumerated, and those amenable to monitoring identified, the
next step will be to survey the real world of available
monitoring programs, facilities and activities to determine
their capacity and willingness to meet our needs. This will
involve consultation with, and evaluation of, among others,
the monitoring programs operated by:
-------
A. Within EPA, Offices of;
1. Monitoring,
2. Air,
3. Water, and
4. Pesticides.
B. Other Agencies;
1. National Oceanic and Atmospheric Administration,
2. Bureau of Sport Fisheries and Wildlife,
3. Geological Survey,
4. Department of Agriculture (animal inspection),
and
5. Food and Drug Administration (market basket surveys
and agricultural surveillance).
C. States;
1. Air,
2. Water, and
3. Soil.
These programs will be examined for:
!
D. Comprehensiveness.
1. What chemicals, substances, organisms, media and
tissues are sampled? How extensively and inten-
sively are these samples analysed?
2. How many sampling sites are there in the U.S.,
and how are they distributed geographically'in
the land, air and (ground, surface, navigable,
and contiguous) waters?
-------
E. Consistency and timeliness;
1. Are these sites sampled;
a. Periodically,
b. Consistently,
c. Frequently, and
d. In a standard, prescribed manner?
2. Are the data reasonably current? What is the
typical lapsed time from sample collection
through analysis to data processing and
storage?
F. Comparability and compatibility.
1. Are the data derived from these several
monitoring efforts comparable through time?
2. Are they uniformly collected, analysed,
processed and reported from sampling site
to sampling site?
3. Are the data reported in compatible terms from
one system to another?
G. Availability,
i
1. Are ithe derived data processed and stored on
computer tapes or discs?
a. If so, can EPA have access to these data,
i. via terminal hook-up,
ii. by periodically acquiring copies of
the tapes, discs and related software,
or
iii. in hard copy responses to ad hoc
requests?
b. If not, can the data be made available to
EPA in any form?
-------
2. Assuming the data can be made available in
some form;
a. How long would it take from request to
receipt, and
b. How much would it cost?
H. Form of presentation - is it tailored to decision
makers needs?
III. Environmental Monitoring is a burgeoning field; its
ability to meet information requirements of EPA will
depend not only upon the present state of existing
monitoring systems, but also upon future developments
in these systems. Our survey will therefore try to
anticipate the probable near term qualitative and quantita-
tive increments to currently available monitoring informa-
tion that can be expected to accrue from such factors as;
A. More demanding legislation, as exemplified by the
increased monitoring requirements imposed by;
1. Section 305(a) and (b) of the Federal Water
Pollution Control Act Amendments of 1972, and
2. Section 110(a)(2)(C) and Section lHt(a)(1)(C)
and (D) of the Clean Air Act of 1970, and
B. Improved instrumentation and technology;
C. Implementation of proposals to integrate -- or at
least rerider compatible — the several data systems
established to service the independently operated
monitoring programs.
IV. Once we have a fairly accurate fix on what information EPA
will require, and the existing and probable near term
national monitoring capabilities, means will be sought
to increase, enhance, modify and exploit these capabilities,
Possible avenues to be explored, here, using both staff
and contract resources, include:
A. Encouraging integration of the diverse information
systems into a universal network;
B. Promoting legislation to require the conduct of
autopsies (the result of which would be sent to a
-------
nationally centralized data bank) in all deaths
where toxicity is a suspected cause. Special
emphasis would be placed upon gaining such infor-
matipn in deaths due to diseases of chronic
exposure (such as mesothelioma);
C. Exploring the desirability of collecting and
storing data from regularly reported bioassays
on rats, pigeons, dogs, cats, etc., living in
urban, industrial, and other contaminated environ-
ments. These data would be used to ascertain base
levels and detect changes in the accumulated toxic
bur.den in these animals as means of;
1. Estimating the total doses to man in these
specific locales, and
2: Signaling, early on, potential threats to
man due either to the sudden and inadver-
tent introduction of a toxic substance
into the environment, or to the gradual bio-
accumulation of such a substance, in that
area, to dangerous levels.
D. Establishing a national water, air, soil, food and
tissue "bank: to receive, identify, index, and store
samples that would be regularly collected and sub-
mitted from locations throughout the nation. Samples
from such banks should be 'of inestimable value to
epidemiological studies initiated in the future in
response to toxic catastrophes, by allowing retro-
spective comparative analyses of the toxic exposures
in a particular area, through time;
E. Articulating data needs more carefully in a more
elaborate strategy statement;
F. Encouraging research to improve monitoring techniques,
V. Finally, our estimates of (1) EPA toxic substances informa-
tion needs, (2) the ability of monitoring programs to
meet them, and (3) the likelihood of our favorably
modifying that ability, will all be incorporated into,
an overall Plan for Monitoring Toxic Substances. This
plan will set forth those categories of information to
be addressed through monitoring and, for each such
category, a detailed indication as to:
-------
A. Exactly how the data will be collected, analysed
and reported, and
1. By whom,
2. With what (and whose) resources, and
3. Within what time frame, and
B. Precisely how, and for what purposes, the received
data will be utilized.
------- |