ASSESSMENT AND CONTROL OF CHEMICAL PROBLEMS
An Approach To Implementing the
Toxic Substances Control Act
U.S. Environmental Protection Agency
Washington,-D.C.
February 1977
Draft £3
Office of Toxic Substances/February 17, 1977
-------
PREFACE
miis draft. document describes a possible approach to the implementation
of the" Toxic Substances Control Act (TSCA). It represents the first
step in the development of an overall strategy for implementation of the
new
The purpose of this draft document is to stimulate comments from
the many parties interested in implementation of the Act. These comments,
together with estimates currently being developed concerning the resources
required by EPA to carry out alternative levels of TSCA activities, will
be considered in preparing a strategy document later this spring.
In an effort to help focus public discussion, the draft document
proposes a general goal and two purposes in implementing TSCA. It
suggests the initial emphasis and priority to be given to different
program activities and addresses some of the major policy issues. The
first three years of implementation are highlighted, and timetables for
program activities during this period are proposed.
Comments on the draft document are invited. They would be particularly
helpful if received by April~T57 1977. They should be sent to Mrs. Vickie
Briggs, Environmental Protection Agency, Office of Toxic Substance~sT~~
Room 715 East Tower (WH-557). 401 "M" Street, SW, Washington, DC,
20460. (To-f acfli tate hand! ing and disposition of comments, please
refer teTOTS-000002 in the cover letter.)
-------
TABLE OF CONTENTS
Preface i
Executive Summary , 1
Background 2
The Problem and TSCA
Legislative Interests
Highlights of TSCA
Overall Program Direction 4
General Goal in Implementing TSCA
Purposes of TSCA Implementation Activities
Major Functional Areas
Initial Priorities
Protecting Against Unreasonable Risk
Supporting Functional Activities
Acquisition of Information and Assessment of
Risks to Health and the Environment . 18
General Policy Framework
Disclosure of Data
TSCA Information Gathering Authorities
Risk Assessments
Testing Requirements
Industrial Reporting and Retention of Information
Use of TSCA Regulatory Authorities when Necessary
To Control New Chemicals 29
TSCA Authorities To Control New Chemicals
Preparation of the Inventory of Existing Chemicals
Data Requirements for the Review of New Chemicals
Limiting Manufacture or Marketing of New Chemicals
Review Procedures for New Chemicals
Use of TSCA Regulatory Authorities when Necessary To
Control Existing Chemicals -.' ; 36
General Regulatory Approach
Policy Considerations
'Orientation of Initial Activities
Responses to Urgent Problems
-------
JRAFT
TABLE OF CONTENTS (cont.)
Dissemination of Information and Assessments To
Other Programs and Interested Parties 41
The Broad Interests in Toxic Substances
Policy Considerations
The Establishment and Operation of Data Systems
***»
Types of Anticipated Impacts from Implementation
Activities ..... 47
Health and Environment
Commerce and the Economy
Industrial Research and Development
The Scientific Base
Social Concerns
111
-------
1
EXECUTIVE SUMMARY
The goal of the Toxic Substances Control Act (TSCA) is to protect
human health and the environment from unreasonable risks now and in
future generations. To achieve this goal, TSCA implementation activities
will emphasize not only control of specific problems under TSCA regulatory
provisions, but also use of TSCA authorities to support other Governmental
and non-Governmental programs to control toxic substances. These programs
include other activities of EPA and other Federal and State agencies,
activities of environmental and public interest groups and or professional
societies, policies of the financial and investment communities, and
efforts of individual companies and trade associations.
During the first several years, EPA will give top priority to the
following implementation activities:
Establishment and Implementation of a Premarket Review System. The
system will emphasize (a) the responsibility of industry to develop
adequate data for meaningful chemical assessments, (b) categorization of
new chemicals by broad chemical classes and broad uses with particular
attention to those categories of greatest environmental concern, and (c)
procedures for rapid decisions and adequate documentation of these
decisions. '
Establishment of Initial Testing Requirements. Testing will be
required in a hierarchical manner on selected categories of both new and
existing chemicals. Industry will be required to develop data concerning
both toxicity and exposure and to conduct risk assessments of the data.
Quality assurance of the data that are developed will be stressed.
Regulatory Actions to Control a Limited Number of Environmental
Problems Associated with Existing Chemicals. In addition to early
action on PCB's and selected chlorofluorocarbons, a limited number of
serious chemical problems for which adequate data are currently available
will be selected for intensive review and for regulatory action as
appropriate. Concurrently, a systemmatized approach for identifying,
characterizing, and controlling toxic substances under TSCA will be
developed and implemented as rapidly as possible.
Assessment and Control of Unanticipated Problems of Urgent Concern..
Unexpected problems will inevitably arise and provisions w,ill be made to
respond to such problems without unduly disrupting other priority activities.
In these four priority areas, as well as in other areas, continuing
attention will be directed to several overarching concerns. Activities
will be oriented to serve the interests of both EPA and other organizations,
particularly with regard to data dissemination. Data will be gathered
on a highly selective basis to serve specific purposes. Confidentiality
aspects will be a major factor influencing data collection, use, and
dissemination strategies and activities.
-1-
-------
BACKGROUND
The Problem and TSCA
AFT
An estimated IjQOO new chemical substances^ are introduced into
commerce each year in addition to the 30,000 or more which are currently
used in many ways. The problems posed by the presence of some of these
chemicals in the environment are too well known. Assessing and dealing
with chemical problems involves the complex tasks of measuring their'
presence, estimating their effects, and evaluating the economic and
social costs and benefits of their use and control. At the same time,
there exists a wide variety of often overlapping and uncoordinated.
regulatory authorities and support activities directed to toxic substances
at the national, State, and local levels. TSCA is designed to help
reduce scientific uncertainties concerning toxic substances and to add
coherence to the national effort to protect man and the environment from
unreasonable risks without unnecessarily blunting a dynamic sector of
our economy.
The Congressional Interest
V
Summary of the Legislative Deliberations
Early in 1971, the Administration transmitted to Congress a proposal
for toxic substances legislation. The report of the Council on Environmental
Quality accompanying the proposal, Toxic Substances, documented some of
the environmental problems which such legislation"should address. The
two Houses of the 92nd Congress passed different versions of the legislation
late in the session. However, there was not time to appoint a conference
committee to resolve the differences prior to adjournment.
Five different bills were introduced during the 93rd Congress, and
by July 1973, the two Houses had passed different versions. However,
the conference committee could not resolve several of the key differences
between the two bills, including provisions concerning premarket screening
and the relationship of TSCA to other laws.
In March 1976, in the 94th Congress, the Senate passed a somewhat
revised version of the bill it had considered previously. In August
1976, the House passed still a different version. A conference com-
mittee met in early September, and the compromise bill that it developed
was passed by both the House and the Senate in September 1976, with an
effective date of .January 1, 1977. The President signed the legislation
on October 11, 1976.
"Chemicals" and "chemical substances" are us^d interchangeably
in this document in addressing those substances subject to TSCA.
In general, pesticides, foods, food additives, drugs, and cosmetics
are excluded from TSCA coverage. The problems associated with
mixtures and formulations are given special attention in the law.
-2-
-------
During the deliberations of both the House and Senate in the 94th
Congress, a number of technical aspects of the legislation were con-
sidered 'in detail. Thus, the committee reports of both houses, together
with the report of the conference committee, provide considerable guidance
concerning Congressional intent.
Findings
In proposing toxic substances legislation, the Congress found that
human beings and the environment are exposed to many chemicals, some of
which may present unreasonable risks due to their manufacture, processing,
distribution, use, or disposal and that to address this problem, regula-
tion of both interstate and intrastate commerce is necessary [2(a)].
Policy and Intent
The Policy of the United States enunciated in the Toxic Substances
Control Act is that (a) adequate data on the effects of chemical substances
should be developed as the responsibility of those who manufacture and
process them; (b) authority should exist to regulate such chemicals
which pose unreasonable risks and act on those which are imminent hazards;
and (c) exercising this authority should assure that chemical substances
will not present unreasonable risks yet not unduly impede technological
innovation [2(b)]. The Congress intends that the Act be carried out in
a reasonable manner, taking into account the environmental, economic,
and social impact of actions taken under the law [2(c)].
Highlights of TSCA
TSCA authorizes EPA to obtain information about existing and new
chemicals and take appropriate action against those which may present
unreasonable risks. Manufacturers or processors of chemicals may be
required to conduct tests and submit to EPA data on the effects and
behavior of chemicals. EPA must be notified 90 days in advance of the
manufacture of new chemicals and supplied with information necessary to
evaluate their effects. When necessary, EPA is authorized to take steps
to limit manufacturing, processing, use, or disposal of a chemical
substance which may present an unreasonable risk.
TSCA contains several explicit authorities to promote better coordination
among Federal agencies in identifying, assessing, and controlling toxic
substances. If the Administrator determines that an unreasonable risk
may be prevented or sufficiently reduced under a law not administered by
EPA, he will request the relevant agency to evaluate the problem and
take appropriate action. Similarly, other laws administered by EPA will
be used in preference to TSCA when these authorities can adequately
address the problems. ' c
-3-
-------
OVERALL PROGRAM DIRECTION
General Goal in Implementing TSCA
The-general goal in implementing TSCA can be stated as follows:
TO PROTECT HUMAN HEALTH AND THE ENVIRONMENT FROM.
UNREASONABLE RISKS PRESENTED BY CHEMICAL SUBSTANCES.
The program to be implemented pursuant to TSCA is one of a number
of efforts, within and outside Government, directed toward this common
goal. These other efforts include not only other programs of EPA and
other Federal agencies, but also programs of the States, activities of
environmental and public interest groups and of professional societies,
policies of the financial and investment communities, and efforts of
individual companies and trade associations.
However, the TSCA implementation program is somewhat unique in view
of its breadth of coverage and its wide ranging authorities as contrasted
to the narrower scope of other programs in the toxic substances area.
Thus, there are greater expectations that the program will be able to
work toward the common goal on a far broader basis than has been possible
in the past.
The number of adverse chemical incidents can and must be reduced.
But accidents will continue to occur, and chemicals posing environmental
problems will undoubtedly slip through the net of assessment and control.
Development of efficient and effective means to minimize the likelihood
that such adverse incidents will occur now and in the future ~ is
the challenge of this legislation.
Purposes of TSCA Implementation Activities
The purposes in implementing the regulatory and non-regulatory
provisions of TSCA are two-fold, namely
TO CONTROL TOXIC SUBSTANCES DIRECTLY, and
~ TO SUPPORT OTHER GOVERNMENTAL AND NON-GOVERNMENTAL PROGRAMS
TO CONTROL TOXIC SUBSTANCES.
Inherent in the concept of control is the necessity to match the
control requirements with the problems. In many cases, chemicals do not
pose a threat to health or the environment, and no control is warranted.
At the other extreme, there may be a necessity to ban a chemical altogether.
In each case, judicious use of control alternatives must undergird
successful implementation.
The dual Purposes of direct control through the regulatory author-
ities of TSCA on the one hand and, on the other hand, indirect control
through the use of TSCA authorities to support the efforts of other
-4-
-------
programs .in a position to control toxic chemicals reflect the clear
intent of Congress. Implementation of this legislation must rely on
achieving a "multiplier effect" through the efforts of many organizations
if a significant number of commercial chemicals are to be addressed in
the near future. Furthermore, the dual Purposes recognize the many
common interests among a large variety of public and private organizations
and the necessity to share and conserve resources whenever possible in
addressing similar problems. Indeed, more than any other environmental
legislation, TSCA should be considered as a mechanism to serve the
interests of many organizations.
Several principles will guide implementation activities directed to
these dual Purposes.
The Environmental Protection Agency will assume a position of
national leadership in the field of toxic substances control. At the
same time, other organizations will be encouraged to utilize the full
range of their authorities and capabilities to control toxic substances.
In those cases when there are overlapping authorities or capabilities,
EPA will encourage the use of the most expeditious and effective approach
for addressing urgent environmental problems.
Information obtained under the law will be made available as promptly
and as widely as feasible to enable the expertise of other Federal,
State, and local agencies and of the private sector to be utilized as
fully as practical in meeting the purposes of the Act. Similarly,
relevant information will be actively solicited from all available
sources and used appropriately. International exchange of experiences"
and of data concerning toxic substances assessment and control, will be
strongly supported.
. All interested parties will have adequate opportunity to partici-
pate in development of regulatory requirements. The basis for regulatory
decisions will be clearly stated at the time the decisions are made. To
the extent possible, such statements will distinguish among scientific
facts and uncertainties, scientific judgements, and value judgements.
Operationally, it may be desirable to establish formal agreements
with other Federal agencies, and perhaps with other Governments and with
international organizations. Also, systemmatic approaches to regularly
obtaining up-to-date views on the priorities of other organizations will
be developed.
Major Functional Areas
The activities to be conducted under TSCA have been divided into
four major functional areas and several supporting areas (see Figure 1),
recognizing that all of these areas are'interrelated as discussed below.
In particular, the acquisition and assessment of information provides
the basis for regulatory and related decisions by both EPA and other
organizations.
-5-
-------
V GOAL-
PROTECT AGAINST UNREASONABLE RISK
PURPOSES
Use TSCA to Control
foxic Substances Directly
Under TSCA
Use TSCA to Support Other
. Governmental and Non-
Governmental Programs to
Control Toxic Substances
MAJOR
FUNCTIONAL
ACTIVITY
AREAS
Use TSCA Regulatory Authorities
When Necessary to Control Existing
Chemicals
Use TSCA Regulatory Au-
thorities When Necessary
to Control New Chemicals
Disseminate Information and
Assessments ;to Other Pro-
grams and Interested Parties
Responses to
Information Needs
Acquire Information and Assess
Risks to Health and the
Environment
SUPPORTING
ACTIVITY
AREAS
Conduct Research
Assist Interested
Parties
Implement TSCA
Procedural Aspects
FIGURE 1
-------
Major Functional Area #1: Acquire Information and Assess Risks to
Health and the Environment
TSCA provides several new authorities by which EPA may require
industry to develop and provide to EPA information concerning chemical
substances. These activities include submittal of information concerning
the production, by-products of production, uses, and effects of chemicals.
In some cases, such data may be readily available to industry. Sometimes,
it will be necessary for industry to develop the data.
EPA will obtain information from other sources as well, including
other Governmental organizations and private institutions. Also, EPA
wiTT;- a's 'necessary, carry out laboratory and field studies to supplement
or to confirm data available from external sources. However, the emphasis
will be on requiring industry to develop data necessary to assess the
environmental acceptability of chemicals since TSCA explicitly places
this responsibility squarely on'industry [2(b)(l)].
The Agency considers that industry has the responsibility not only
of gathering and assembling data but also of assessing the data to
determine possible environmental risks. This responsibility is particularly
important with regard to test data. Industry will be expected to prepare
risk assessments in accordance with guidelines issued by EPA on data
submitted pursuant to premarket notification and testing requirements.
Obviously, the Agency will review such assessments and also conduct
independent assessments when necessary.
In some cases when EPA is using TSCA authorities to acquire for
other agencies data which are not of priority interest to EPA, the
assessment process will be left to the other agencies. More often,
there will probably be a congruence among the interests of EPA and other
agencies in the same environmental problems and joint risk assessments
among agencies will be in order.
Major Functional Area #2: Use of TSCA Regulatory Authorities wfien
Necessary To Control Nea Chemicals
TSCA calls for establishment from scratch by the end of 1977 of a '
premarket review system for considering the environmental acceptability
of all new commercial chemicals. The system includes (a) final regulations
clarifying which chemicals are subject to premarket notification and the
notification requirements, (b) an appropriately trained staff to receive
and assess the notifications, and (c) an internal EPA policy and procedural
framework to help insure consistency, efficiency, and objectivity of the
reviews.
The following regulatory mechanisms are available to control new
chemicals when appropriate:
-7-
-------
Premarket notifications will not be accepted by EPA unless they
include-all information required by regulations [5(a) and 5(b)].
If additional information is needed to conduct an adequate assessment,
and such information is not available, the manufacture of the chemical
will be delayed pending development of the information [5(e)].
Should a proposed new chemical be determined to present a significant
risk, regulatory steps may be taken to control the manufacture, use, or
disposal of the chemical [5(f)].
Major Functional Area #3: Use of TSCA Regulatory Authorities when Necessary
To Control Existing Chemicals
Among the types of regulatory actions provided for in TSCA are
[6(a) and 6(b)]:
banning or limiting manufacture, processing, distribution, or use
of a chemical.
requiring warning labels.
requiring specified disposal methods.
requiring specified quality control measures during the manufacturing
process.
There are many other statutes available for controlling toxic
chemical problems. The rather comprehensive authority of TSCA is intended
to be used when necessary to fill the gaps among these other authorities.
Thus, the starting point in determining when and how TSCA regulatory
authorities are to be used is an overall assessment of environmental
problems associated with a chemical or group of chemicals and a determination
as to which regulatory approach will most effectively reduce the problems.
If the most appropriate statute is administered by another Agency,
EPA may request the other Agency to take action or explain the basis
for non-action within a specified period of time [9(a)]. Close collaboration
with the other regulatory agencies beginning with the initial discovery
of a chemical problem is essential to insure that this system of formal
"referrals" does not unnecessarily disrupt the priority activities of
these agencies.
Mador Functional Area §4: Disseminate Information and Assessments To
Other Programs and Interested Parties
A key to achieving "indirect" control of toxic chemicals through
other programs is an effective system to aggressively disseminate to the
broadest possible audience information obtained through TSCA.' To the
extent possible the quality and reliability of the data should be clear,
and information should be in a format that will be most meaningful to
the users [10(b) and 25(b)].
-8-
-------
An effective dissemination program is intimately linked to an
earlier determination of the information needs of the users and the
timing of these needs so tha£ the appropriate data can be generated in
the first place. Thus, the first step is a continuing program to
assess user interests and needs and, to the extent possible, to shape
the data collection efforts to meet their needs.
Much of the data collected for one user, including EPA, will undoubtedly
be of interest to many other users as well. Thils, information will be
placed in the public domain as rapidfy as possible after receipt by EPA.
Some of the data collected under'TSCA possibly will be subject to
claims of confidentiality. Rapid and efficient mechanisms for segregating
data which are confidential from other data are essential if the user
community is to be adequately serviced.
Interrelationships Among the Major Funat-iandl Areas-
As shown in Figure 2, the four major functional areas are integral
components of the overall system of assessing and controlling toxic
substances. Figure 3 shows in more detail crosswalks among specific
provisions of TSCA and indicates the reinforcing character of these
provisions.
In general, the information acquisition activities (Area #1) are
determined by the needs for data to (a) provide a basis for decisions
concerning the control of new or existing chemicals under TSCA (Areas #2
and #3) and (b) service the interests of others (Area #4). In some
cases, the. data lead directly to risk assessments within EPA; in other
cases, the raw data are forwarded for assessment to other programs.
Initial Priorities
During the initial implementation phase, it will be necessary to
establish priorities among the many possible TSCA activities. These
priorities should reflect continuing concerns of the Congress, the
Agency, and the public that there may be a large number of currently
unattended environmental problems which should be addressed very promptly.
At the same time, early action must be taken to establish the policy and
procedural framework for a long-term program, with the groundrules
clearly understood by all interested parties. This is particularly true
with regard to the premarket review system which should be environmentally
meaningful and administratively efficient from the outset. And, of
course, the legislative deadlines should be met.
With regard to regulatory activities, newly identified problems
that present a significant risk to health or the environment must be
dealt with immediately. Also, the chemical problems cited during the
five years of legislative hearings should be promptly reviewed to determine
whether regulatory action is needed. Finally, selection of early regulatory
-9-
-------
INFORMATION
FLOW AMONG FUNCTIONAL AREAS
Information Acquisition, Processing,
and Storage
Risk Assessment
by EPA
Regulation by EPA
When Necessary
New
Chemicals
Under
TSCA
Existing
Chemicals
Under
TSCA
Under
Other
Authorities
Dissemination of Information
and Assessments
Federal,
State,Local/
Int'l Orga-
nizations
Private
Sector
Other
Interested
Parties
Figure 2
-10-
-------
SELECTED CROSSWALKS AMONG PREMARKET TESTING,
REPORTING, AND REGULATORY REQUIREMENTS
Test Chemicals
Selected for
Risk List
Test Requirements incl.
Toxicity and Environmental
Behavior
Appro-
priate
Controls
Data Concerninn
Toxicity and Exposure
Data Concerninq
Toxicity and Exposure
Premarket
Assessments of
Mew Chemicals
Test Chemicals
Selected for
Reporting]
New Chemicals
Selected for
Post-market Reportinn
Assessments of
Selected Existing
Chemicals
Data Related to
Exposure and Economic
Impact
Discretionary Reporting
Requirements incl. produc-
tion use, byproducts
Significant New Uses
of Selected
Existino Chemicals
Appro-
priate
Controls
-------
activities should include consideration of utilizing a variety of approaches
that will not only reduce environmental risks but also clarify the
dimensions, the strengths, and the weaknesses of TSCA.
Information is the lifeblood of the overall system. Early development
of policies and procedures to establish a broadly based and technically
sound data base, drawing on domestic and foreign sources and readily
accessible to all interested parties, is essential if future regulatory
actions are to be soundly conceived. Given the lead time necessary to
develop health and environmental data, steps should be promptly initiated
to begin to develop such data on those chemicals which could present
serious problems. The information on the health and environmental
aspects of commercial chemicals which is currently available only to
individual agencies or companies should be promptly made more widely
available.
In view of the unusual opportunity provided by TSCA to respond to
these general concerns, EPA will give top priority to the following
operational activities during the initial three years of TSCA implementation:
Establishment and Implementation of a Premarket Review System. The
system will emphasize the (a) responsibility of industry to develop
adequate data for meaningful chemical assessments, (b) categorization of
new chemicals by broad chemical classes and broad uses with particular
attention to those categories of greatest environmental concern, and (c)
procedures for rapid decisions and adequate documentation of these
decisions.
Establishment of Initial Testing Requirements. Testing will be
required in a hierarchical manner on selected categories of both new and
existing chemicals. Industry will be required to develop data concerning
both toxicity and exposure and to conduct risk assessments of the data.
Quality assurance of the data that are developed will be stressed.
Regulatory Actions To Control a Limited Number of Environmental
Problems Associated with Existing Chemicals. In addition to early
action on PCB's and selected chlorofluorocarbons, a limited number of
serious chemical problems for which adequate data are currently available
will be selected for intensive review and for regulatory action as
appropriate. Concurrently, a systemmatized approach for identifying,
characterizing, and controlling toxic substances under TSCA will be
developed and implemented as rapidly as possible.
Assessment and Control of Unanticipated Problems of Urgent Concern.
Unexpected problems will inevitably arise and provisions will be made to
respond to such problems without unduly disrupting other priority programs.
In these four priority activity areas, as well as in other areas,
continuing attention will be directed to several overarching concerns.
Activities will be oriented to serve the interests of both EPA and other
organizations, particularly with regard to data dissemination. Data will
-12-
-------
LFKAI-I
be gathered on a highly selective basis to serve specific purposes.
Confidentiality aspects will be a major factor influencing data collection,
use, and dissemination strategies and activities.
There are many uncertainties as' to the number of chemicals subject
to premarket notifications and the availability of data concerning these
chemicals, the number and extent of unanticipated problems associated
with existing chemicals that will emerge, and the difficulties in gaining
a scientific consensus concerning the most appropriate approaches to
testing. Thus, there is little basis foY estimating at this time the
relative emphases that should be placed on each of these four types of
activities. However, in setting priorities among the many types of
potential environmental problems falling within these activities, the
following principles will be considered:
Toxic substance problems of national or global dimensions, and
particularly those problems affecting many people or extensive ecological
resources, will receive priority over localized problems which affect
smaller populations.
Special attention will be given to the effects of toxic substances
on human health, recognizing that ecological impacts can also directly
and indirectly affect human health.
Toxic chemicals which are discharged into the environment in significant
quantities and which persist.and/or bioaccumulate will be of particular
concern.
Protecting against Unreasonable Risk
The concept of unreasonable risk is the central element in relating
TSCA implementation activities to the overall goal of TSCA. This concept
recognizes that some level of risk must be accepted in our activities
involving chemicals. Also, the welfare of future generations as well as
our present population must be of concern.
In general, the most severe risks trigger the imminent hazard
provision of TSCA [7(a)], and the possibility of less severe risks may
trigger testing or other information gathering activities. In some
instances the term "unreasonable risk" is used in the Act, in one case
"substantial risk" is used [8(e)], and in other cases elaborations of
"unreasonable risk" are presented.
The burden of proof for establishing the degree of risk varies in
different lections. For example, the proponent of use must establish
that selected new chemicals which are on a "risk" list [5(b))4)(A)] do
not present an unreasonable risk. On the other hand, EPA must make
explicit findings on risk to take regulatory actions [6(a)]. Meanwhile,
there is an overarching requirement on EPA to consider social and economic
impacts, as well as environmental impacts, in taking action under any
provision of TSCA [2(c)].
-13-
-------
The most detailed elaboration in the Act as to the types of considerations
involved in assessing risk is set forth in the guidance provided to the
Interagency Testing Committee, but this guidance is still very general
[4(e)(l)(A)]. Several other provisions of the law, as well as the
legislative history, also emphasize the importance of considering carcinogenesis,
teratogenesis, and mutagenesis when evaluating risks. While there are
no explicit references in the law to acute toxicity concerns, there is
no reason for not considering such risks.
Recent court opinions, such as those concerning lead in gasoline
and asbestos in drinking water, provide some indication as to the
important factors in risk assessment. The 1975 NAS report Decision
Making for Regulating Chemicals in the Environment also makes some
observations concerning those factors that should be considered in
assessing risks and in balancing costs, risks, and benefits in decision-
making.
To-foster a degree of consistency in the approach to risk assessments,
the following steps will be taken:
Minimum data requirements for conducting risk assessments will be
developed for selected categories of chemicals (e.g., chemical classes,
use categories).
Guidelines for use by industry and the agency concerning risk
assessments and the factors involved in cost-risk-benefit decisions will
be developed and used.
Risk assessments of the same chemical or same environmental problems
by different programs and different agencies will to the extent feasible
be consistent even though the determination as to whether regulatory
action is warranted may vary depending on the differing requirements of
different statutes.
Summaries of relevant court opinions related to unreasonable risk
will be'prepared periodically and made available to risk assessors and
decision makers.
The feasibility of developing criteria for triggering different
types of TSCA actions when the chemicals meet the criteria will be
explored in detail.
Supporting Functional Activities
Research
TSCA authorizes a broad range of research activities [10 and 27],
and explicitly calls for EPA to direct attention to:
development of screening techniques to help assess health and
ecological effects [10(c)]»
-14-
-------
development of monitoring techniques and instruments [10(d)]t
basic research to provide the scientific basis for screening and
monitoring developments [10(e)]» and
training of Federal personnel to utilize the new techniques [10(f)].
HEW and other agencies are expected to intensify their research efforts
directed to toxic substances as well. t
EPA will be developing a more detailed framework for its initial
five-year research program during the next few months. EPA intends to
give high priority to research both in its own programs and in encouraging
a more broadly based and more effectively coordinated national effort
involving research by many organizations. Also, the Agency will encourage
efforts to expand the pool of technical manpower needed by many organizations
to carry out TSCA requirements.
Assistance to Interested Organizations
Given the limited authorization of $1.5 million for each of the
first three years of TSCA for support of a program of state grants (28),
the initial grants will be limited to programs in only a few states.
The states will be selected on the basis of the likelihood that the
proposed programs will significantly upgrade local capabilities to
address environmental problems. Should the initial grants prove to be
successful in providing an important new dimension to toxic substances
control, EPA will consider seeking additional funding in later years and
will assess the desirability of incorporating the program into the
broader concept of bloc grants.
The Agency will not be in a good position for some time to provide
responses to petitions from industry requesting specification of test
requirements for individual new chemicals [4(g)]. Within a few years
the Agency should have available testing guidelines covering a broad
range of chemicals, effects, environmental behavior patterns, and routes
of exposure. At that time, authoritative responses to such petitions
should be relatively easy to provide. In the interim, heavy reliance
will be placed on using, whenever possible, the relevant portions of
testing guidelines already prepared by EPA and other agencies for other
programs such as those directed to pesticides, food additives, and
drugs, taking into account the different types of exposures involved
with industrial chemicals.
With regard to EPA assistance in defraying the costs of certain
attorneys and witnesses in regulatory proceedings [6(c)(4)(A)], only
limited funding will be available in FY 1977, but significant additional
funding will be sought in FY 1978. Meanwhile, the criteria for determining
eligibility are being developed. Available resources will be distributed
on an equitable basis among all bona fide claimants at the end of each
fiscal quarter for services rendered during that quarter.
-15-
-------
a
An area of Congressional concern has been the capability of small
and medium industrial firms to understand the legal and policy complexities
of toxic substances control in relation to specific chemical concerns.
Thus, in addition to exempting small business from certain reporting
requirements, TSCA calls for an EPA Assistance Office to provide clarification
on regulatory and related requirements [26(d)]. The Office has been
established. In addition, each of the ten EPA Regional Offices will
have an appropriate contact point to help clarify TSCA requirements for
the small businessman in particular, and the public in general. The
Assistance Office will not be in a position in the near future to provide
advice on the environmental acceptability of specific commercial chemicals
of interest to individual parties. However, the Office will help identify
some of the parameters that 'should be considered in such assessments and
will of ^course assist in obtaining available information relevant to the
particular chemicals of interest.
Procedural Aspects
A number of TSCA provisions call for development of procedural
rules. Also, more explicit guidance will help facilitate implementation
of other provisions. Some of EPA's earliest activities will be directed
to:
procedures governing the hearings to be conducted under' TSCA and
particularly with regard to regulatory actions [6(a)].
the requirements for selected EPA and HEW employees to disclose
their financial interests [26(e)J.
clarification of the requirements concerning claims of confidentiality
and requests for information under the Freedom of Information Act [14].
preemption of State laws [18].
Several TSCA provisions are of special interest to another Federal
agency and will receive attention in the near future. For example:
national defense waivers (Department of Defense) [22]
employee protection (Department of Labor) [23]
definition of small manufacturers and processors (Small Business
Administration) [8(a) (3) (B)] .......
~ notice to foreign governments of exports (Department of State) [12]
imports (Department of Treasury) [13]
reimbursement for use of test data generated by another party
(FTC/Department of Justice) [4(b)(3) and'4(c)l
Finally, special studies and reports are called for as follows:
-16-
-------
' study of the indemnification aspects of all laws administered by
EPA [25(a)]
annual reports to Congress on TSCA actions [30]
-17-
-------
ACQUISITION OF INFORMATION AND ASSESSMENT OF RISKS
TO HEALTH AND THE ENVIRONMENT
General Policy Framework
The gathering, processing, and storing of information will be
designed to support specific requirements of EPA and other organizations
and will not be considered an end in itself. Data requirements may be
very specific or quite broad. For example, information activities may
be oriented to:
Development of specific regulations to control new or existing
chemicals under TSCA or other EPA authorities;
Identification and prioritization of problem chemicals for attention
under TSCA or other authorities;
Supporting specific activities of other agencies and other organizations
to assess and control problem chemicals.
Informing the public of chemical activities and associated problems.
The intended use of the information will determine the type and
extent of data that are needed, the timing, the sources, and the most
appropriate mechanisms for acquiring the data. When appropriate, data
already available in Government files will be used. When industrial
data are required, data already available to industry should be used to
the extent possible. However, in a number of cases, and particularly
with regard to new chemicals, additional data must be developed by
industry on a routine basis.
Given the interests of many parties in data that can be developed
under TSCA, and the multiplicity of data acquisition efforts already in
place, the development of new TSCA data requirements will be coordinated
widely within and outside the Government. Such coordination should
assist in (a) reducing the likelihood of gaps in information needed for
regulatory purposes, (b) conserving resources of EPA and other agencies,
and (c) limiting the total reporting burden on industry.
Particular attention will be given to assuring that information
that is acquired, and particularly industrial data, is accurate, complete,
and current. Among the steps to be considered are:
Clarity and precision of record keeping and data submission requirements;
Procedures for assuring appropriate quality control in the acquisition
and reporting of information;
Interim reports of progress in fulfilling long-term data requirements
to avoid discovery only at a very late date that unacceptable data have
been generated;
Spot checks and audits of data generation activities conducted in
the United States or abroad;
-18-
-------
._ Development of confirmatory data to check on accuracy and reliability
of submissions;
Prompt and vigorious enforcement against violators of data requirements;
Encouragement of open communication with industry to discuss
implementation problems in satisfying data requirements.
Disclosure of Data
Assertions of trade secrecy and related confidentiality matters
could cause many implementation problems and must be addressed promptly.
Prior to gathering information which is likely to include confidential
data, the need for the information should be very clear. Submitters
will be afforded the opportunity to make confidentiality claims at the
time of submission. A clear explanation of the consequences of failing
to assert confidentiality and the procedure for resolving disputes will
be a part of the request for information.
TSCA specifically excludes from claims of confidentiality health
and safety studies on chemicals offered for commercial distribution and
on chemicals subject to premarket notification and/or testing requirements
[14(b)]> Other data which the manufacture, processor, or distributor
consider confidential may be so designated but must be segregated from
other non-confidential data. Thus, EPA reporting forms will require
confidentiality designations for individual items, and a general confidential
stamp for an entire form will not be accepted.
If there is a Freedom of Information request or other action concerning
release o-f data designated as confidential, the originator of the data
will be given an opportunity to justify the claim of confidentiality in
detail prior to the Administrator's decision on the release of the data.
Also, he will have an opportunity to seek judicial relief if there is
disagreement with the Administrator's determination. However, if the
release of data is necessary to protect health or the environment against
an imminent, unreasonable risk, the advance notice of release can be as
short as 24 hours [14(c)].
The information system for receiving and storing TSCA data will
insure appropriate protection of confidential information.
TSCA Information Gathering Authorities
Figure 4 identifies some of the information that will be received
as a result of both non-discretionary and discretionary provisions of
TSCA. Non-discretionary provisions include:
Reporting of chemicals to be included on the initial inventory of
existing chemicals [8(a) and 8(b)]
Premarket notifications [5(a)]
Industrial reporting of substantial risks associated with commercial
chemicals [8(e)]
Citizen's petitions [21]
-19-
-------
Information Acquisition (illustrative)
Non-Discretionary
Premarket Notices [5(a)J
Not1ce_of Substantial
Risk [8(e)J
Citizens Petitions C2T)
Initial
Inventory
Discretionary
Testing Requirements [4]
Industrial Reporting [B(a)]
Inspections/Subpoenas [11]
Decisions
That Data
Are Needed
Action
Required
Requests for
Data
Collection
Data
Data
Data Evaluation
Risk Assessment
Priority Setting
Selection of Action Modes
Data and
Recommendations
Regulatory and Related Actions by EPA
Support for Activities of Other Organizations
Storage
and
i
Retrieval
Data
FIGURE 4
-20-
-------
Some of the provisions to be implemented at the discretion of EPA are:
Testing requirements [4(a) and 4(b|]
Industrial reporting of production and related activities [3(a}]
Industrial submission of records of adverse reactions to health
or the environment [8(c)j
Industrial submission of health and safety studies [8(d)]
Inspections and subpoenas [11]
Acquisition of information from other Agencies [10(b)(2)] \
Figure 5 sets forth the implementation timetable for the principal
activities related to TSCA testing provisions and the provisions concerning
industrial recordkeeping and reporting. These activities are also
discussed below.
Risk Assessments
Risk assessments are required under a number of TSCA provisions.
Risk assessments are inevitably conducted with less than optimal data
either in terms of quantity or quality. However, a minimum level of
data is essential if assessments are to be meaningful, and EPA will
develop guidelines concerning such minimum data requirements.
Manufacturers will be expected to conduct and submit risk assessments,
prepared in accordance with EPA guidelines, when developing data under
TSCA testing regulations and when submitting premarket notices. Also,
risk assessments may be required in connection with information provided
under other TSCA provisions. The assessments will utilize not only data
developed by the manufacturer but also other available data on the
chemicals, and when appropriate, on closely related chemicals. In
addition to providing a better basis for EPA evaluation of the likely
environmental problems associated with toxic substances, this requirement
should stimulate a much broader industrial effort to better understand
the environmental acceptability of many chemicals being produced and
used.
While much remains to be done to clarify, even in a preliminary
way, what is involved in risk assessments, the following types of considerations
are important:
Chemical structure, physical properties, contaminants
Source assessment and exposure potential: quantities produced,
production processes, uses, reactions involved in uses, and types
and frequency of environmental discharges
Environmental behavior and fate, including degradation rates
and products, chemical reactions in the environment and inadvertent
products, bioaccumulation and biomagnification potential, and
possible synergistic effects
Acute, chronic, and subacute effects on man; absorption, excretion,
and metabolism
. Effects on vertebrates, invertebrates, microorganisms, and plants
Effects on inanimate objects and structures
-21-
-------
1977
1978
General Testing Framework
Policies
Forms and Procedures
Test Requirements [4(a) and 4(b)]
First Generation
Second Generation
Third Generation
Advisory Committee [4(e)]
Reimbursement Formula [4(b)(3) and 4(c)]
1_.
1979
Elaborate
Develop
Propose
nal
A
Develop
Propose 1 Final 1
Develop
Propose
Final
Develop Propose Final
A
Recommend
* 1
A A
*
0^& JWi
Develop
Propose \ Final
Recordkeeping and Discretionary
Reporting [8(a)]
Recordkeeping and Health
and Safety Studies [8(c) and
8(d)]
Substantial Risk [8(e)]
Disclosure of Data [14]
Propose
Final
Specific Chemical Requirements
Propose
Guidance
| Final
A
Propose I Final]
I P >t ' »" 'I I I
KEY:
- Revise or Update
FIGURE 5
-22-
-------
1
Testing Requirements
Almost all agencies and organizations in a position to assess and .
control'toxic substances have stressed the need for more timely and more
reliable test data on a wide range of chemicals. Test data will be used
to support specific regulatory actions and to identify problems that
need attention. TSCA test requirements that are developed can be pacesetters
for the entire field of environmental assessment techniques. Thus,
priority will be given to implementation of the testing provisions of
TSCA, recognizing that scientific uncertainties and overlapping organizational
interests will complicate rapid progress in this area.
The initial implementation activities related to testing will
involve (a) establishing the procedures and format for submitting test
data under a variety of TSCA provisions, including premarket notifications
which will begin to arrive in December 1977, (b) determining general
policies which will provide the framework for TSCA test requirements for
determining specific effects of specific chemicals, including procedures
for assuring the quality of test data, and (c) developing the initial
TSCA test requirements for selected categories of both new and existing
chemicals.
In view of the number of chemicals of potential interest, test
requirements directed to categories of chemicals is the most appropriate
approach. The categories will be based on similarities in chemical
structure, chemical use, and/or levels and routes of likely exposure,
recognizing that production volume may often be an appropriate surrogate
for exposure potential. Not only will such an approach simplify the
sorting of priorities, but it will also provide a means for anticipating
problems with new chemicals and new uses. In general, EPA will develop .
general testing requirements for each selected category of chemicals and
the manufacturer will in turn propose a detailed protocol for each
chemical for EPA approval.
Given the current limitations on the availability of testing facilities
and personnel and the scientific uncertainties concerning some types of
test methods, the testing requirements during the'first several years
will be developed on a selective basis directed to some of those chemical -
effects, types of chemical behavior, and routes of exposure of immediate
concern. At the same time, a more comprehensive effort will be undertaken
to develop testing approaches on a much wider range of chemicals, effects,
behavior, and exposure routes. The recommendations of the Interagency
Testing Committee and of other interested parties will be considered
within this framework. In short, the categorization scheme can be
"tuned", in terms of number and breadth of categories and types of
effects and exposure, in accordance with the capability to generate
sound data and to use the data effectively.
-23-
-------
In general, TSCA testing requirements will:
require only such data as are necessary to reach regulatory and
related decisions.
provide the flexibility to enable initial state-of-the-art protocols
to be effected immediately while permitting modifications and improvements
to be made as the science of testing progresses. EPA will update protocols
when appropriate without jeopardizing the acceptability of testing
already underway in accordance with earlier protocols.
document the laboratory analytical procedures and the requirements
for estimating risks so that industry will clearly know what is required
and how the information will be assessed. Industry should be able to
conduct the same assessments of their data as EPA.
provide an approach for developing test protocols in a hierarchical
manner so that the degree of testing and evaluation is related to the likely
exposure and the projected economic and social benefit.
Consistency of test requirements issued by different programs
directed to the same classes of chemicals is important. Also, compatability
with recommendations of international organizations and with requirements
of other Governments is important. However, two pitfalls must be avoided.
First, overstandardization of requirements could stifle advances in the
state-of-the-art. Secondly, the types and levels of exposures associated
with industrial chemicals usually differ significantly with the exposures
associated with drugs, food additives, and pesticides. Therefore, the
types and extent of testing of industrial chemicals may differ greatly
from the more comprehensive approaches used in these other programs.
In developing the near-term requirements, as well as the more
comprehensive long term approach, the Congressional concern with the
following aspects will be kept in mind:
carcinogenicity, mutagenicity, teratogenicity
levels of environmental exposure
behavioral effects
synergistic and cumulative effects
With regard to assuring the quality of data that are submitted by
industry, EPA will explore the feasibility of expanding the FDA laboratory
inspection program and the use of the-FDA Good Laboratory Practices
manual to encompass TSCA concerns. A counterpart system for environmental
testing will be explored within EPA. In the longer term, other approaches
may be more appropriate to assure that data are obtained and presented
in a technically credible manner [3(12)(B)].
-24-
-------
ORIGIN OF TEST REQUIREMENTS
Premarket
Screening
C5(e)]
EPA Review of
Existing
Chemicals
Test Petition
4(9)
Rulemaklng
[4(a) &
Citizen's
Petitions
[21]
EPA Determination of Testing Need
Informal Persuasion for
Industrial Testing
Interagency
Requests
Government
Testing
FIGURE 6
-25-
-------
During 1977 the Interagency Advisory Committee will designate up to
50 priority chemicals for testing. The Agency will have up to one year
to respond to these recommendations [4(e)(l)]. Meanwhile, as indicated
in Figure 6, other testing recommendations will be received from a
variety of sources. A sorting of the various recommendations, taking
into account the availability of testing facilities, will be a major
activity during 1977-78. While such prioritizing is important, promulgation
of initial test requirements will not be delayed pending development of
an elaborate sorting system which may never be feasible. Early EPA
action will demonstrate the Agency's intent to consider all suggestions
but then to move in the direction of the priorities as viewed by the
Agency.
Policies and procedures will be prepared for enabling the developer
of test data to receive fair reimbursement from another party who wishes
to use the data [4(b)(3) and 4{c)].
Industrial Reporting and Retention of Information
The recordkeeping and reporting provisions of TSCA are illustrated
in Figure 7.
Discretionary acquisition of industrial data concerning production,
by-products, and uses [8(a)] will be used for a number of purposes,
.including: .
to keep track of the commercial development of new chemicals after
they have been marketed for the first time. Although the initial production.
and use patterns might not warrant regulatory intervention in the premarket
period, changes in these patterns could become of environmental concern.
to provide information related to likely types of exposure on
existing chemicals which are subject to testing requirements.
to provide data related to exposure and also related to economic
impact of controls on those chemicals which are being considered for
regulatory action.
to provide information on the impact of controls which limit but do "
not ban chemicals.
to help pinpoint the types.and locations of exposure potential when
unexpected chemical problems of urgent concern arise.
to provide trend data concerning newly emerging chemical technologies
which should be of special concern.
The initial emphasis will be on requirements for the establishment
within individual industrial firms of complete, up-to-date, and easily
accessible records concerning each of the individual chemicals which is
used by the firm. Such records will include information concerning the
chemical identity, production levels, uses, by-products, health and
safety studies, alleged adverse reactions, and other factors of environmental
significance [8(aj and 8(c)]. These records will be available for on-
-26-
-------
«..
r..
Health and Safety. Studies
C8(d)]
Production and
Related Records
C8(a)]
Overlaps in
Records
Adverse Reaction
Records
[8(c)3
f
Reports
to
EPA
'.- ... Health and
Safety Studies
Production Information Information Lists
id Related on on C8(d)(l)]
iformation Inventory Adverse
[8 (a)] [8(b)] Reactions
C8(c)J
Copies Notices of
[8(d)(2)T Substantial
Risk
FIGURE 7
-27-
-------
UKAH"
sfte reviews which might trigger requests for the data to be reported to
EPA. Also, as individual chemicals are being analyzed in detail by EPA
and other agencies, information concerning these chemicals will be
requested. In order to know which manufacturers to approach concerning
specific chemicals, EPA will require each manufacturer to identify all
the chemicals he manufacturers in connection with compiling the initial
inventory of existing chemicals [8(b)].
The responsibilities of importers and their suppliers concerning
recordkeeping require special attention.
The general procedural requirements for reporting will also be
established promptly with the specific chemicals to be subject to reporting
identified subsequently [8(a)]. Data on specific chemicals could then
be obtained with a minimum of delay. In the early years, this authority
will be used selectively to help assess chemical problems under active
investigation. At a later date, it may be desirable to build up within
EPA a broader base of industrial data. However, before comprehensive
reporting requirements are developed, more thorough investigations of
the availability of comparable data through other Governmental and non-
Governmental mechanisms will be carried out to avoid duplicative reporting.
During the Congressional hearings, concern was repeatedly voiced
that considerable amounts of data related to the health and 'environmental
acceptability of commercial chemicals were available in industry files.
While the value of such data are unknown, the extent of the backlog of
data will be promptly ascertained [8(d)]. Should a manufacturer become
aware of data generated by himself or others concerning the likelihood
of substantial risks due to chemical exposures [8(e)]» notifications to
EPA of this data-will trigger the activities described under the response
section below.
-28-
-------
USE OF TSCA REGULATORY AUTHORITIES
WHEN NECESSARY TO CONTROL NEW CHEMICALS
TSCA Authorities To Control New Chemicals
Priority will be given to establishing the program for premarket
screening which must be in place by the end of 1977. TSCA requires
notification of all new chemicals at least 90 days prior to their manufacture
to provide the Agency an opportunity for determining whether such chemicals
pose a risk. If the Agency believes that a new chemical poses an unreasonable
risk, or if information is lacking to make an evaluation, the Agency may
initiate action leading to the following:
delay in the manufacture of the new chemical pending development of
additional information needed to evaluate the risk [5(e)],
ban or marketing limitation on the new chemical to protect against
an unreasonable risk [5(f)], or
requirements to track the commercial development of the new chemical
after initial marketing through periodic reporting by industry of its
production levels, uses, by-products, and related aspects [8(a)].
Also linked to the premarket review are several TSCA authorities
which can be used to require certain types of information to be submitted
at the time of notification, namely:
production, use, by-product and related data [5(a)(l)]
data required by testing regulations [5(b)(l)]
health and environmental data on chemicals on a "risk" list [5(b)(4)]
If required data are not submitted, the notification will not be accepted.
Preparation of the Inventory of Existing Chemicals
The first order of business to implement premarket screening for
new chemicals is the compilation of an inventory of existing chemicals.
This inventory will be regularly updated and will serve as the baseline
for determining which chemicals to be manufactured after publication of
the inventory are "new" and, therefore, subject to premarket notification.
Each manufacturer will be required to report for inclusion in the
inventory all chemicals produced after January 1, 1977. Manufacturers
may report other chemicals produced between July 1, 1974, and January 1,
1977, if they wish to have these chemicals included; chemicals which are
not reported will be subject to premarket notification requirements. To
-29-
-------
a
assist in standardizing the nomenclature used in reporting for the
inventory," the Agency will publish a candidate list of about 30,000
chemicals, with appropriate names and CAS registry numbers. Also,
instructions will be provided for reporting other chemicals not on the
candidate list.
The initial inventory will not differentiate among various technical
grades of chemicals. The problems related to impurities will be addressed
at a later date. The initial inventory will include some categories of
chemicals since it is not practical in the short time available, and it
may not be de'sirable, to list every variation of all existing chemicals.
Raw agricultural products, for example, will be considered as a single
category. Also, minerals will be included on the basis of relatively
broad categories.
The exemption from the inventory and from premarket notification of
"small" quantities for research purposes will include those amounts no
greater than what is reasonably necessary for scientific experimentation,
testing, analysis, or research, including such research or analysis
necessary for the development of a product [5(h){3)]. "Test marketing"
will be limited to distribution of a chemical to a defined number of
potential customers for purposes of'evaluating particular uses of that
chemical during a predetermined evaluation period [5(h)(l)].-
Many intermediate chemicals are often involved in the synthesis of
industrial chemicals and are subject to TSCA. Only those intermediate
chemicals which cannot be isolated in a practical sense from the immediate
vicinity of the reaction process will be exempt from inclusion on the
initial inventory and from premarket notification. Thus, for example,
those chemicals which normally exist in only a pipeline would be included. .
The Agency is considering requiring that all premarket notifications
be accompanied by a fee [26(b)]. This requirement would not only help
defray costs of administration but would also help insure that Agency
efforts are directed to environmental assessments of serious commercial
endeavors and are not diverted to address theoretical curiosities submitted
by parties who have no intention to manufacture the chemicals commercially.-
Also, the Agency is considering placing a limit of perhaps one year on
the time between premarket notification and initiation of manufacture of
the chemical. If the time is exceeded, a second notification would be
required. -^
Data Requirements for the Review of New Chemicals
A meaningful review of new chemicals requires adequate data to
review. Thus, EPA reviewers will be provided with internal guidance on
minimum data requirements for new chemicals based on chemical categorization
considerations. Data requirements will vary among categories. This
guidance will be made publicly available.
-30-
-------
The guidance for each category will identify the types of data
which should normally accompany notification of a new chemical in that
category including in some instances data not explicitly required by
regulations. A notification submitted without the data will be a candidate
for possible action to delay its commercialization. In that event, the
Administrator may issue a proposed order to delay manufacture, based on
insufficiency of information to "permit a reasoned evaluation of the
health and environmental effects" of the new chemical [5(e)]. The
guidance will merely serve to alert Agency reviewers to possible problems,
and the absence of data will not automatically cause the Agency to issue
a proposed order. The Agency is prepared, however, to issue proposed
orders when appropriate.
In some cases, it may be appropriate to convert portions of the
internal guidance into formal testing requirements. In that event,
premarket notifications would not be accepted in the absence of such
data. As the guidance is developed, the desirability of such testing
requirements will be actively explored.
The Agency does not plan to establish a risk list of new chemicals
which pose "an unreasonable risk of injury to health or the environment"
at the outset [5(b)(4)]. The internal guidance by chemical categories
will help insure a meaningful review of premarket notices, and in a
sense perform much of the same function as a risk list. Also, the
Agency does not plan to activate reporting of significant new uses of
existing chemicals in the short term because of the urgency and complexity
of the task of instituting premarket notification for new chemicals and
the difficulty of preparing a meaningful categorization of uses of
environmental significance [5(a)(2)].
Limiting Manufacture or Marketing of New Chemicals
The internal guidance on data needs will also assist in determining
the key factors underlying decisions as to whether to restrict new
chemicals [5(f)]. However, each regulatory decision must be made on a
case-by-case basis, and decision-making criteria beyond a check list of
the factors to be considered does not appear feasible at this time.
There are often many uncertainties about the commercial viability
of new chemicals. In some cases, the likelihood that the potential
environmental problems uncovered during premarket review will become
actual problems may be questionnable. Therefore, alternatives to the
resource-intensive process of formal rulemaking and, when necessary,
court intervention to limit manufacture or marketing will be considered.
For example, simply releasing adverse data to interested parties may in
certain instances result in limitations on the type of commercialization
which poses environmental problems. However, when necessary, EPA will
intervene in a regulatory mode. If worker exposure is the principal
concern, referral to OSHA might be the most appropriate course [9(a)].
-31-
-------
_
'Review Procedures for New Chemicals
As indicated in Figure 8, tire Agency will initially determine if
the premarket notification contains the information required by regulations.
If such information is missing, the notification will not be accepted.
An FR notice indicating receipt of a complete notification will be
published within five days [5(d)]. The notification will be accepted
even if it is not accompanied by the additional data specified in the
internal EPA guidance for the ndw chemical's category.
/
The internal guidance will'also indicate (a) those categories of
chemicals which should in all cases be subjected to in-depth reviews,
and (b) those categories which £hould be screened to determine if in-
depth reviews are warranted. In the latter case, technical reviewers
will identify the specific chemicals for which no action appears warranted
and those that deserve in-depth'review, along with all the new chemicals
in the first group. . :)
The in-depth review will routinely be completed in 30 days and will
include consideration of: :
Physical and chemical properties of the chemical and its byproducts;
Health and ecological effects;
Environmental behavior and fate including persistence and bioaccumulation;
Likely sources of environmental discharges and exposed populations;
Technological and economic factors;
Industry's risk assessment.
In addition to the data included in the premarket notice, other
data on the same chemical and, when appropriate, on chemical relatives
which may not have been available to the manufacturer will be reviewed.
Criteria will be developed for triggering extensions of up to 90 days of
the in-depth review period. These criteria might include the necessity
to validate questionable data.
At the completion of the in-depth review, including the supplementary
review when appropriate, recommendations will be prepared as to the
action that should be taken on each chemical. The recommendations and
supporting justification will be concisely summarized in a short decision-
making document.
A policy decision body including representatives from appropriate
Agency offices will meet on a regular basis and decide the disposition
of each of the recommendations of the technical reviewers. The decision
will be appropriately documented so that at a later date the basis for
the decision is clear. The following types of decisions are envisaged:
-32-
-------
ivbi-i*uuvci x cua v A rat a x a U..&J.T.
Premarket
Notice
I Notice of
Receipt
(5 days)
EPA Receint of Notices
Cor !identiality
Problems
Rejection of
Incomplete
Not i ces__
TECHNICAL REVIEW
Screening of Selected
Categories (3 days)
Detailed Analysis
(30 days)
Extension of Detailed
Analysis
(Up to 90 days?
Recommendations
Selected
Audits of
No Action
Cases
Policy Decisions
(10 Days)
Decision Documentation
No Action
FR Notice
of No Action
risk list
testing
-- new uses
Delay
Manufacture
for More
Data
Restrict
limit
label
ban
Designate
for Future
Tracking
8 (a)
Rulemaking
When
Appropriate
FIGURE 8
-33-
-------
'1. No action is warranted.
2. , No action is warranted but an FR notice of the decision is
required if the chemical is subject to testing requirements. Also, at a
later date an FR notice will be required if the chemical is on the risk
list or is subject to significant new use reporting [5(g)].
3. Manufacture will be delayed pendinq development of additional
data [5(e)].
4. Manufacturing and marketing will be regulated [5(f)].
5. While no action is taken during the premarket period, the
chemical will be ear-marked for future reporting after it becomes commercialized
C8(a)].
"No action" can be decided by technical"screeriers on chemicals in
selected categories and by the policy body on other chemicals. All "no
action" decisions will be subject to a later audit on a selective basis
to help insure that the necessity to screen out quickly the less worrisome
problems does not result in inappropriate chemicals inadvertently slipping
through the review process.
The Agency will give prompt attention to development of a data
recovery system for premarket submissions. This will allow use of the
Agency reviewers' comments and prior analysis of one new chemical when
later reviewing a different4 although similar new chemical. The data
system will also permit use of premarket data for other purposes under
TSCA.
The premarket screening implementation timetable is set forth in
Figure 9.
-34-
-------
1977
1978
1979
INVENTORY [8(b)]
PREMARKET NOTIFICATION
REQUIREMENTS [5(a).]
EPA INTERNAL
REVIEW SYSTEM
EPA INTERNAL
GUIDANCE ON DATA
NEEDS
Propose
r!ON
>3
Final
A A
Propose
,
Final
A A
Develop
T
Implement
Develop
A , Jk
SIGNIFICANT NEW USES
r
Propose
Final
Key:
-------
USE OF TSCA REGULATORY AUTHORITIES WHEN NECESSARY
TO CONTROL EXISTING CHEMICALS
General Regulatory Approach
TSCA is designed to fill the void in the regulatory span of other
authorities. It is intended both to prevent problems and to correct
problems.
As indicated in Figure 10, EPA plans to initiate a limited number
of regulatory actions directed to existing chemicals in the near future.
In addition to addressing important environmental problems, such early
actions should stimulate a greater degree of introspection within industry
concerning preventive and corrective measures in anticipation of future
environmental problems or additional regulatory actions. Also, this
early attention to specific problem chemicals should enable EPA to play
a lead role in establishing regulatory priorities rather than having
external developments become the dominant factor in determining the
Agency's priorities. Finally, initial actions directed to a variety of
environmental situations should help clarify the scope and limitations
of TSCA and its interfaces with other regulatory programs.
The regulatory strategy will emphasize overall assessments of the
causes of the environmental problems associated with chemicals and the
most effective measures to address these underlying causes. A key
factor will be a determination of the most effective regulatory approach
using TSCA, another statute, or a combination of statutes. In many
cases, authorities other than TSCA will provide the appropriate means
for reducing the problems. If the most appropriate statute is administered
by another Agency, EPA may request the other Agency to take action or
explain non-action within a specified time [9(a)]. However, a collaborative
rather than adversarial interagency approach is essential, and close
interaction with other agencies beginning with the initial discovery of
a chemical problem will help insure that this system of formal referrals
does not unnecessarily disrupt the priority activities of these agencies.
When formally referring chemical problems to other agencies for
action, EPA will provide all available information concerning potential
risk. While EPA may not have in hand complete documentation concerning
all aspects of the risk, there should be a reasonably good indication
that preventive or corrective action in the near term deserves serious
attention. EPA will follow up with the other agencies. If additional
data are subsequently developed, and the follow through by the other
agency appears inadequate, EPA will not hesitate to review again the
situation and to determine appropriate additional actions.
-36-
-------
PCBs: Labelling
Disposal
PCBs: Other
[6(e)(2) & 6(e)(3)]
Chlorofluorocarbons
Aerosols
Other Uses
Proposed! Final
Proposed
Final
i
Proposed
Final
Proposed
Other Regulatory Action:
Second Generation
Develop
Data
Third Generation
Fourth Generation
Submission of
Citizen's Petitions
[21]
Submission of
Notice of Substan-
tial Risk [8(e)]
Final
Analysis
Proposed
Final
Develop Data
Analysis
Proposed
Final
Develop Data
Analysis
Pro-
posed
Internal
Guidance
Proposed
Guidelines
Final
Interim
Guidance
Pronosed
Rules
Final
FIGURE 10
-37-
-------
Policy Considerations
The basic consideration for all regulatory decisions is the risk to
man or the environment of the problems being addressed. The appropriateness
and character of the regulation must then take into account the possibility
of actions under other laws [6(c) and 9(a)], the least burdensome approach
under TSCA [6(a)], and the overarching requirement to take economics and
social factors, as well as environmental concerns, into consideration
[2(c)]. The environmental acceptability of the substitute chemicals or
alternative technologies that are likely to emerge as the result of the
regulatory action will be given special attention. Sometimes, the
likely alternatives may be less than optimal from the environmental
viewpoint and the incremental environmental gains in adopting the substitutes
will be considered.
Often the regulatory action taken under TSCA will be in addition to
regulatory actions that have been or could be taken by other programs.
Different programs must by law give different weights to the economic
and to some of the other factors concerning regulations, and there may
be some differences in the orientation of the regulatory decisions made
by different programs.
Regulatory actions directed to existing chemicals will not be
limited only to correcting problems which are known or believed to be
having adverse health and ecological effects but will also be directed
to preventing such problems in the future.. On occasion, TSCA action may
address only a portion of the environmental problem posed by a chemical.
Nevertheless, such limited steps can be important, and TSCA action to
correct a piece of the problem need not be delayed until the entire
problem can be effectively addressed.
Orientation of Initial Activities
Polychlorinated biphenyls and selected chlorofluorocarbons have
been of special concern to the Congress for several years, and work is
well underway to develop appropriate regulations for limiting their
discharge into the environment. The other unattended chemical problems
cited during the Congressional hearings are also being examined to
determine whether additional regulatory actions are needed immediately.
Many agencies already have lengthy lists of chemicals of particular
environmental concern. These lists are being reviewed before reaching a
judgement as to whether they can provide useful guidance or whether they
should be supplemented with still additional lists. Also, the list to
be developed by the Interagency Testing Committee on priorities for
testing may be useful in determining regulatory priorities as well.
Expanded efforts will be directed to more systemmatic procedures
for screening and establishing priorities among chemical problems for
regulatory attention. While establishing priorities will inevitably
involve a number of judgmental decisions, it may be possible to develop
improved techniques for assisting in the setting or priorities. Also,
the utilization of chemical classes or categories of chemical use might
assist in narrowing the vast array of chemicals to a more manageable
number.
-3R-
-------
Underpinning the entire regulatory effort must be a technically
sound program of chemical assessment. Chemical assessments have traditionally
involved (a) hazard assessment, (b) source assessment, (c) identification
of substitutes and alternative technologies, (d) development of control
options, and (e) evaluation of the environmental, economic, and related
impacts of controls. In some cases, much of the needed data is at hand;
more often, supplementary data must be developed. The assessment program
will include anlayses of individual chemicals, categories of chemicals,
chemical technologies, and geographic problems.
Responses to Urgent Problems
Response to the uncovering of chemical problems which might pose
urgent risks to health or ecological resources will receive the highest
priority, and an on-call response capability will help minimize diversion
of resources from other priority activities. In the past such problems
have usually come to light as the result of new toxicity test results,
new monitoring data, or identification of human or ecological victims of
chemical exposure. The discovery of real or alleged urgent problems
often results from the conduct of Government programs (e.g., PCB's in
the milk of nursing mothers), findings of the scientific community
(e.g., nitrosamines in the atmosphere), industrial revelations (e.g.,
worker deaths from vinyl chloride), and press investigations (e.g.,
cancer death rates in the Little Elk Valley of Maryland).
TSCA provides additional mechanisms for bringing to light urgent
problems. Two of these mechanisms citizens' petitions [21] and risks
uncovered by test data [4(f)] require a response within a specified
time limit. A third principal TSCA mechanism notification by industry
of substantial risk [8(ej] ~ doesn't have a mandated response time.
Regardless of the source of the discovery, the urgency of the problem
must drive the response timing.
TSCA also provides several new regulatory mechanisms for limiting
chemical exposures quickly if warranted (e.g., imminent hazard [7],
regulatory action immediately effective [6(d)(2)], referral to other
agency with short deadline for action by the other agency [9(a)]). In
the past, local agencies and industry itself have often been willing to
take immediate corrective steps in the face of chemical crises. In any
event, prompt and effective action to prevent additional damage using
TSCA or other programs will be the immediate objective.
The EPA response capability will include available technical
specialists to assess the discovery, on-call field and laboratory capability
to confirm and supplement the data concerning the discovery, and coordinative
and organizational mechanisms involving a variety of programs within
and outside EPA for implementing prompt and effective corrective
actions.
-39-
-------
While each new problem will have its own pecularities, there are
usually some common concerns relating to toxicity, exposure, chemical
behavior, related commercial activities, and routes of environmental
discharges. Generalized checklists of typical concerns are being developed
to help insure that technical and policy analyses do not overlook important
factors in the face of tight timetables. Also, steps will be taken to
insure that interested parties are continuously informed of developments
and particularly acquisition of additional data in view of the broad
political interests in these types of problems.
A very general framework for the response activity is:
(a) Identification of problems associated with chemical activities
as the result of
Systemmatic screening of available information
Monitoring, toxicological, and epidemiological screening
programs
Ad hoc environmental incidents, research findings, and allega-
tions
Discoveries submitted under TSCA
(b) Characterization of the problems with particular attention to
Health and ecological effects and environmental behavior
Current and projected sources, environmental levels, and
exposed population
Substitutes, control technology, and related cost and economic
factors
Actions to date and actions underway to clarify and control
the problems . -
(c) Development and stimulation of preventive and corrective
approaches including consideration of
Role of relevant authorities of EPA and other agencies
Alternative approaches to voluntary or regulatory redress *
Environmental and economic impact of approaches
Implementation of appropriate approach
-40-
-------
DISSEMINATION OF INFORMATION AND ASSESSMENTS TO OTHER PROGRAMS
AND INTERESTED PARTIES
The Broad Interests in Toxic Substances
Throughout the Congressional consideration of TSCA, there was a
recognition of a TSCA role for many of the regulatory and non-regulatory
programs of a number of organizations that were in place directed to the
assessment and control of toxic substances. Since the enactment of the
new law, such programs have already- increased in number and in the scope
of their interests.
***- * At :t he Federal level, for example, a large number of chemicals will
be explicitly regulated under the Federal Water Pollution Control Act.
Many more will be affected by more general standards under that authority
and also under the Clean Air Act. The National Academy of Sciences will
recommend a large number of chemicals to be considered for possible
regulation under the Safe Drinking Water Act. NIQSH has several hundred
criteria documents completed or in preparation which will add to the
list of chemicals already regulated by OSHA. The Department of Transportation
and the Mining Enforcement and Safety Administration similarly have
regulations in place or under development affecting many toxic substances.
All of these activities must be based on assessments of environmental
and related data.
A number of states have taken steps in the toxic substances area.
Virginia and Illinois, for example, are particularly interested in data
reporting systems. Several states in the Great Lakes area have taken
steps concerning PCB's and phosphates. Several states are concerned with
chlorofluorocarbons. New Jersey, Texas, and California have very broad
concerns over the heavy concentrations of the chemical industry and can
be expected to expand efforts in the near future.
Central to the way industry does business are the policies and the
attitudes of the financial community concerning investment capital.
TSCA, in effect, adds one more risk dimension in the investment world.
As this community begins to focus on toxic substances, it needs access
to reliable and timely data. The information must be packaged in an
understandable and usable form. Meanwhile, the insurance industry is
rapidly expanding its interests in toxic substances, particularly with
regard to product liability. The issue of substitutes for PCB's also
sharpened concern over hazards associated with acceptability of substitutes.
Both access to data and early awareness of possible TSCA regulatory
actions are important to this side of the commercial community.
Other forces influencing the future directions of the chemical
industry are the labor unions, environmental and public interest groups,
and the consumer. In all of these cases the specter of possible harmful
effects of chemicals can have a direct impact on industrial behavior.
TSCA can provide important "early warnings" to these groups who in turn
can provide the Government with other early warning signals.
-41-
-------
A handful of the larger chemical companies who are responsible for
a large proportion of chemical sales have for a number of years conducted
sizeable programs to assess the environmental aspects of industrial
chemicals. Although there have been many soft spots in these efforts,
they nevertheless provide a good foundation for expanded activities.
Complimentary efforts have also been supported by industry through a
number of trade associations and most recently through the Chemical
Industry Institute of Toxicology.
However, relatively few companies have adequate data available to
conduct environmental assessments of the chemicals they buy and sell.
Despite these shortcomings of the past, the greatest potential impact
resulting from TSCA in terms of the number of chemicals that are addressed
may lie in the expanded internal assessments and procedures of individual
companies, activities that must rest on a solid base of environmental
data. .
Finally, as the Congress and the courts deepen their involvement in
this area, the availability of experts that they can call upon and the
credibility of scientific data take on added importance. TSCA will be
an important tool for developing the information base which will undergird
many major decisions of the future.
Policy Considerations
Several explicit TSCA mechanisms enable interested parties to
obtain information. Perhaps the most far-reachjng mechanism is the
Interagency Testing Committee which provides for seven agencies, in
addition to EPA, to set forth the highest priority needs for testing
[4(e)]. The provision for citizen's petitions allows any interested
party to seek information under the testing and reporting sections of
the law [21]. The requirement to place in the Federal Register notices
of receipt of premarket data will alert parties concerned with new
chemicals reaching the marketplace [5(e)]. The provision concerning
disclosure of data clarifies some of the uncertainties concerning the
public access to health and safety studies [14(b)]. Of course the
overarching requirements of the Freedom of Information Act are designed
to enable all interested parties to obtain information collected under
TSCA and other laws. All of these explicit provisions of TSCA underscore
the clear intent of the Congress that this legislation service the
interests of many organizations in a variety of ways, and particularly
with regard to acquisition and dissemination of data.
Therefore, EPA will emphasize coordinated approaches with other Federal
agencies to the assessment and control of toxic substances, with particular
attention to identifying common information requirements that can be
best satisfied through TSCA. The Agency will actively solicit the views
of other interested parties as well ,as to information needs. Information
-42-
-------
UO" U
acquired under TSCA will be made available as widely and as promptly as
"possible.- In this regard the interests of the international community
are particularly important as we consider the possibility of an international
'convention to deal on a global basis with the control of toxic substances.
A major effort will be made at the outset to insure that sound
procedures are in place which will facilitate a flow of data to all
interested parties. Since establishment of these procedural aspects
will take priority, it will not be possible to respond to all requests
for information to be collected under TSCA until adequate systems are in
place to handle the flow. Even in the long run, it will continue to be
necessary to prioritize the competing claims from many parties for
information services under TSCA.
The Establishment and Operation of Data Systems
System for Receiving and Storing TSCA Data
Data received pursuant to TSCA will be retained in a discrete data
system module with entry into and withdrawal from the system controlled,
at least initially, by the Office of Toxic Substances. The TSCA data
module obviously will be but one additional component to the much larger
Governmental data systems covering toxic substances. To the extent
feasible, the TSCA module will be made compatible with and linked to the
other existing systems. Figure 11 sets forth the implementation timetable
for data systems.
While the volume of data received under TSCA may be relatively
small at the outset, this volume will probably grow rapidly. Therefore,
from the outset the system will incorporate automated components as
rapidly as possible. The system will be designed and time-phased so that
data received in the initial implementation stages are compatible with
data received several years into the future, thus avoiding the potential
problem of receding. Development in sub-modules is envisaged, with
components (personnel, hardware, and software) added as implementation
progresses and data volumes grow. At the outset, however, methods for
coding, cataloging, and retrieving data will be established so that
consistent ground rules will guide data requirements resulting from
rulemaking activities.
The chemicals included in the initial inventory of existing chemicals
[8(b)] will provide a core index for the system which will be expanded
as the number of chemicals in the system'grows. In general, production
and use data obtained pursuant to premarket notification [5(a)l and
discretionary reporting [8(a)] requirements will be entered from the
outset into an automated system. Initially, test data will be retained
-43-
-------
1977
1978
1979
System for Receiving and
Storing TSCA Data
System
Def.
System
Design
System
Implementation L
A
Making TSCA Data
Available [10(b)(l)]
Manual Searches
Routine Standardized Searches
Analytical
Searches
Retrieval of Data From
Other Systems
Search By s ten] System
Stra- 'pef1- Develop-
teqy jriitiorl ment
System Implementation
CEQ
lompilation
Dissemination of Non-TSCA
Data to Interested
Parties
Retrieval of Some Types of Data
A
Provide Direction to
Appropriate System
Standardization of Govern-
ment-Wide Data Activities
[25(b)]
Feasibility Study
Pilot Effort on Effects Data
-44-
Implementation Program
KEY A- Evaluation, Update, Refinement
-------
in hard copy with a locator tag incorporated into the automated system.
A test data summary format which could be automated is currently being
explored with the National Library of Medicine.
With regard to coding, CAS numbers and manufacturer identification
will provide two keys. A chemical use coding system is currently under
development to provide another key.
Access to confidential data will be strictly controlled and initially
limited to the examination by authorized officials of available information
in situ.
Making TSCA Data Available .
EPA plans to aggressively develop and carry out procedures for
disseminating to the public information obtained under TSCA. For example,
test data will be submitted to EPA in sufficient copies so that one copy
can be made publicly available without delay through the National Technical
Information Service or other appropriate mechanism. Studies of the
feasibility of establishing on-line terminal access to non-confidential
data and of periodically publishing such data will be soon initiated.
Retrieval of Data from Other Systems
There are many sources of external technical, scientific, and
economic data which should be utilized in implementing TSCA. These
sources are located both within and outside the Federal government. CEQ
is presently conducting a survey of such data bases. Meanwhile, some .
states are initiating additional toxic materials data banks. These data
activities in particular will be examined in some detail with an eye
toward reducing reporting requirements, on the one hand, and avoiding
duplicate data searches during examinations of chemical for potential
hazards, on the other.
Dissemination of Non-TSCA Data to Interested Parties
Many parties are interested in improved ways for tapping the multiplicity
of Governmental data banks concerning chemicals. As part of the overall .
data system effort, practical means for facilitating such access will be
explored. Initially, an inventory of existing data bases is being
conducted. Hopefully, meaningful road maps to Governmental data can be
provided to all interested users in the future.
Standardization of Government-Vide Data Activities
Data standardization is particularly important when considering
interlocking data systems. Data required by TSCA rulemakinq should be
requested in a format which can be used readily by a multiplicity of
interested parties. As an initial step towards improved standardization
of Government-wide approaches, emphasis will be given to standardizing
-45-
-------
the formatting and dissemination of newly collected data on health and
ecological effects. At a later date, the effort will be expanded to
include other types of data, and as time and resources permit, efforts
will be directed to achieving compatibility of data already in the files
of many agencies with the newly collected and standardized data.
-46-
-------
TYPES OF ANTICIPATED IMPACTS FROM IMPLEMENTATION ACTIVITIES
The types and extent of the impacts that will result from implementation
activities are speculative at best, given the many uncertainties concerning
the effects of chemicals and their behavior in the environment, the
large number and variety of chemical products, and the continuing rapid
growth of the chemical industry. The five years of Congressional testimony
included many general statements concerning the environmental benefits
that are likely to ensue. A number of unfortunate chemical incidents
were cited as examples of the types of problems that can be avoided. On
the economic side, the EPA report Draft Economic Assessment of the Impact
of the Toxic Substances Control Act of June 1975, as well as economic
assessments prepared by industry and by the General Accounting Office,
attempted to identify some of the types of direct impact that will
undoubtedly occur. However, those discussions were very limited, and
little effort was made to address indirect impacts.
The following discussion provides but a very superficial framework
for the impact evaluation effort that will accompany implementation
activities.
Health and Environment
A primary legislative concern is reducing adverse health effects,
and particularly chronic effects. The legislation should offer an
opportunity to clarify the health effects of many chemicals and, over
time, to reduce the number of deaths and the disease rates attributable
to such effects. Also, the possibility of preventing acute effects will
be addressed.
Data obtained under TSCA should enhance the capability of OSHA,
MESA, and state authorities to reduce the incidence of worker deaths and
diseases. Other agencies and organizations which obtain information and
support under this legislation should also assist in preventing adverse
health impacts at the national and local levels.
The likely impact of TSCA on reducing ecological damage is even
more difficult to predict. The early experience in addressing PCB's
(i.e., destruction of aquatic resources) and chlorofluorocarbons (i.e., .
depletion of the ozone layer) clearly demonstrates the importance of
the legislation in this regard. A number of toxic chemicals end up in
the aquatic environment where ecological damage can he extensive. Prevention
of such damage will largely depend on the specific regulatory actions.
Ecological test requirements should assist in clarifying the impact of
chemicals on the eco-system and in setting quality standards for water
and other media under other authorities. This aspect of environmental
assessment has been largely neglected by industry in the past.
-47-
-------
Commerce and the Economy
Implementation requirements will add a new dimension in financial
planning within industry for the development, manufacture, and marketing
of chemicals. For example, there will be far greater reluctance to
expand commercial investments in chemicals of questionable toxicity, and
the search for broader applications of chemicals which are environmentally
acceptable will intensify. Some marginal products for which testing is
required may give way to substitutes which become commercially competitive.
Many firms will be far more cautious in purchasing or selling products
of unknown chemical composition. The ripple effect of such adjustments
in current marketing practices will impact on a broad range of downstream
processors and users.
There will probably be a tendency among some of the larger companies
toward greater self reliance on in-house chemical assessments of old and
new chemicals and on conducting their own synthesis of small batches of
highly reactive chemicals previously purchased from small suppliers.
Given the concern over quality control of test data and the shortage of
laboratory facilities, in-house toxicological and ecolog-ical testing
laboratories should become more commonplace. Meanwhile, small firms may
tend to move away from product lines that become targets for TSCA attention.
The international development and marketing strategies' of multi-
national firms will also be impacted. Test marketing may be more heavily
concentrated in countries where premarket requirements are minimal.
Also, there may be a surge of new chemical imports into the United
States to establish them as "existing" chemicals and, thus, eliminate
the notification period for future imports. In general, more careful
planning of international shipment of chemicals will be required.
Industrial Research and Development
Premarket notification requirements and premarket testing requirements
will cause some adjustments in the R&D cycle. In a few cases, the
testing requirements may in large measure codify existing industrial
practices. In most cases, however, the new requirements will alter
substantially the time phasing, the types of expertise, and the review
processes involved in developing new chemicals. These adjustments will
in turn impact on (a) the decisions as to which new chemicals and products
should be explored and then developed, (b) the criteria for investing in
R&D when there is an increased risk for commercial introductions, and
(c) the efforts to "design around" potentially troublesome chemicals
from the environmental viewpoint.
The number and quality of environmental assessments conducted by
industry should increase markedly. More qualified technical personnel
will be attracted to the field, methodological approaches will be significantly
-48-
-------
upgraded, and the quality assurance procedures will be improved. However,
should Governmental requirements "over-standardize" assessment techniques,
there is a danger that industrial creativity in improving the state-of-
the-art of environmental assessment could be stifled.
In the early years of implementation, the number of new chemicals
reaching the marketplace may decline due to uncertainties as to future
regulatory requirements, technical and financial difficulties in adjusting .
to the new procedural requirements, and the increased R&D costs and lead
times for some products with limited market potential. However, in the
longer run innovation in introducing new products need not be stifled.
More intensive investigations of environmentally acceptable chemicals,
coupled with incorporation of premarket requirements into a routine R&D
cycle, should continue to allow ever expanding benefits to the consumer
from the uses of chemicals.
The Scientific Base .
The heavy emphasis in the legislation on improving the scientific
methodologies undergirding chemical assessments, and the attendant
implications for strengthening the technical manpower base, should have
a major impact on the chemical and biological sciences. Not only will
the legislation give impetus to the advancement of these individual
disciplines, but it should stimulate a closer coupling of these disciplines
with engineering, economics, and other areas of imporance to toxic
substances control. This general impetus to the broad spectrum of
sciences may far overshadow the scientific impact of individual regulatory
actions.
The inadequacy of science to provide clear answers for regulatory
decisions will probably be subject to frequent criticism by many impatient
parties. However, carefully documented scientific investigations will
be a key to many actions. There is no doubt that the importance of
credible technical data, albeit inconclusive, will be widely recognized.
All should benefit from the expanded sharing of scientific data.
The importance of common procedures and common formats in carrying out
and reporting scientific investigations will take on added importance as .
the problems involved in exchanging noncompatible data bases become
clear.
Social Concerns
Many of the impacts cited above are tied to social concerns, such
as employment effects, increased costs of products, and rights of inspection.
However, there are even more fundamental social concerns which will be
affected by TSCA implementation such as:
-49-
-------
How much effort should be directed to protecting the welfare of
future generations?
To what extent should the public participate in decision-making
that has previously been the exclusive domain of private industry?
How are health concerns to be balanced with economic costs in
determining "unreasonable risk"?
There is little experience in measuring the types of social impact
that could far outweigh in importance the other more narrow impacts of
this legislation. A continuing effort to identify and understand these
impacts is the key to determining the value of TSCA as an instrument of
public policy.
-50-
------- |