Toxic Substances Control Act:
Existing Chemicals Program
October 1982
Office of Toxic Substances
Office of Pesticides and Toxic Substances
United States Environmental Protection Agency
Washington, D.C.
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NOTE
This document is a Supplement to the January 1982
report, Priorities for OTS Operation. The earlier report
is staff guidance for the management and operation of the
TSCA new and existing chemicals program. This document,
Fxisting Chemicals Program, represents further refinement
for improving TPA's effectiveness in protecting the public's
health and environment from unreasonable risks caused
bv existinrr chemicals. It was prepared primarily for
internal office of Toxic Substances Guidance and planning.
It oresents the office Director's current position.
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PROGRAM DESCRIPTION DOCUMENT
EXISTING CHEMICALS PROGRAM
I. INTRODUCTION
II. THE PROGRAM
III. EXPECTED OUTPUTS
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PROGRAM DESCRIPTION DOCUMENT
EXISTING CtiEMICALS PROGRAM
I. INTRODUCTION
The overall goal of the Existing Chemicals Program, under the
Toxic Substances Control Act (TSCA), is to reduce unreasonable
risks of injury to health or the environment from chemicals that
are already in commerce. More specifically, the objectives of the
Program are to:
Identify and evaluate potential risks,
Decide whether specific chemicals need to be tested
for health and environmental effects.
Decide whether action is required to reduce risks;
then define and implement such actions.
Scope
This paper describes how EPA's Office of Toxic Substances is
accomplishing the functions involved in the Existing Chemicals
Program. It does not cover identification of testing needs in
response to recommendations by the Interagency Testing Committee
(ITC), established under section 4 of TSCA. The process for
responding to the ITC recommendations and testing such chemicals
is described in other papers associated with the TSCA section 4
testing program." This program does include the further evaluation
of chemicals after testing in compliance with section 4 of TSCA.
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Priorities
The priorities for considering chemicals in this Program are as
follows:
First Priorj-ty. Chemicals that emerge from the testing
program under section 4 of TSCA, or from other Government or
industry sponsored testing programs.
Second Priority. Chemicals for which there is information
(asreported under TSCA section 8(e)) that reasonably
supports a conclusion of significant risk.
Third Priority. Chemicals that are the subject of citizens'
petitions for action under section 21 of TSCA.
Fourth Priority. Chemicals already in commerce that are
identified, in the course of review of premanufacture notices
on new chemicals under section 5 of TSCA, as possible
problems.
Features
Some of the features of this Program that improve EPA's
effectiveness in protecting the public's health and the
environment from unreasonable risks caused by existing chemicals
are highlighted below.'
The Program focuses on specific effects of concern,
rather than on a more general study of a chemical's
characteristics. Actions are initiated promptly to pursue
or drop a chemical from further consideration based on
specific Program actions and results.
The Program embodies a. project management approach." A
project manager heads up a team of experts, drawn from
several organizational units, and maintains continuity of
management throughout the process. This reduces the
potential for "dropping the ball" between sequential
evaluations conducted by separate organizational units.
The program obtains hazard and exposure data more
efficiently, by being selective and operating in a "step-
wise" manner. The first stages of this new evaluation
process consist almost exclusively of collecting specific
effects and exposure data that fit together in inter-
dependent increments. Acquisition of exposure data under
TSCA has been more complex than for example under the
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pesticides and food and drug laws, which are product
specific. Under those laws, the dose received, the manner
of application, and the exposed population usually have
been known or well estimated at the start of any
evaluation. Because TSCA concentrates on chemicals,
rather than specific products, exposure information can be
available from a wide range of sources. In the past,
effects and exposure evaluations based on such data were
very broad and tended to be developed independently. This
process of evaluation was very difficult to design and
carry out.
The Program emphasizes negotiation and information
exchange among EPA, industry, and the public to reduce
risks. In addition to encouraging early, non-regulatory
preventive action, EPA will require risk reduction
measures whenever necessary or appropriate.
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II. THE PROGRAM
The Existing Chemicals Program consists of a five-phase process of
evaluation and action for risk reduction. These phases (as
depicted in the flow diagram and described below) are:
Phase 1. Entry Review
Phase 2. Problem Characterization & Information Identification
Phase 3. Information Gathering & Risk Analysis
Phase 4. Risk Reduction Analysis
Phase 5. Risk Management
EPA's evaluation begins with an entry review to determine if a
chemical has properties that may result in significant risks.
After a determination has been made that a chemical has such
properties, the process concentrates on hazard and exposure
questions to verify and characterize the risk. The questions to
be answered during the evaluation are:
Is there a verified and significant risk or an
exposure that would require testing?
If so, how should the risk be addressed?
What is the nature of the effect?
What are acceptable exposure limits?
What are cost-effective ways of controlling exposure?
The latter phases of the process address questions concerning
methods and costs of reducing risks where appropriate.
To answer these questions, the evaluation process establishes a
series of evidence thresholds to confirm the validity of the
risk. If the data do not meet these evidence thresholds, the
chemical is dropped from further evaluation. The information
needed for the evaluation is collected incrementally, with
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available information used first to help define and focus any
additional information gathering efforts. This results in more
effective and cost-efficient data collection and analysis and also
more rapid and focused decisionmaking.
For ease of explanation, the following process is described as if
all chemicals proceed fully through all steps and phases.
However, evaluation of many chemicals, such as those for which
tests have been completed under TSCA section 4, or some of the
chemicals described in section 8(e) notices, can progress quickly
to more advanced analysis toward the end of the process. In
addition, at any point in the process where it becomes clear that
a problem should be addressed by another EPA program office or
another agency, that office or agency is contacted to either take
over further evaluation or join Ln the 3TS work.
?"ASE 1. ENTRY REVIEW
This is a two-step review phase during which EPA selects
candidates for evaluation, advances them to the appropriate phase
for further evaluation, and augments the data on the candidates,
as needed, for the next phase. Step 1 is for chemicals that have
not previously been evaluated under TSCA (e.g., section 8(e)
notices, or data from the National Toxicology Program). Step 2 is
both the next step for the above chemicals and the first step for
chemicals previously evaluated (e.g., section 4 test chemicals),
or chemicals referred to TSCA jurisdiction after evaluation by
another regulatory program.
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Step 1. The purpose of this step is to screen candidates for
further evaluation. The main criteria for entry are:
The chemical is on the TSCA Inventory.
Effects data indicate that the chemical may be
capable of causing serious or long-lasting or
irreversible harm to health or the environment.
Production volume and characteristics of use of the
chemical are potentially significant considering the
data on effects.
The potential problem is not likely to be remedied by
another program.
Step 2. In this step, the candidates that are selected by the
above criteria are reviewed to determine whether either a Chemical
Hazard Identification Profile (CHIP) document, summarizing readily
available literature should be prepared as a basis for problem
characterization, or sufficient information is available for
advancing the evaluation to a later phase in the sequence. If a
CHIP is considered necessary, OTS decides on its content and
prepares the document at this point.
Step 2 is the entry point for chemicals that have previously been
evaluated, such as section 4 test chemicals. The review at this
step determines the phase of evaluation at which further analysis
will be done, including analysis for risk reduction.
This entry review usually takes about 10 days. A careful, but
brief, reference record is kept of entry data reviewed and
decisions made.
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PHASE 2. PROBLEM CHARACTERIZATION
This phase of evaluation has two objectives:
To identify the nature of the data and analyses that
need to be added to the information already available
at entry review or from a CHIP. This is needed in
order to verify the available data and to permit a
decision on the seriousness of the apparent risk.
To decide the most cost-effective method and order by
which the identified data can be gathered and
analyzed and to create a plan for data collection to
be carried out in the next phase.
As a simple example, if skin absorption were one of the routes of
exposure of concern, additional data might be needed both on
whether the chemical can be absorbed through skin, and on how much
skin exposure to the chemical actually occurs. Lf testing for
absorption data were less costly than additional exposure data,
this testing generally would precede gathering of exposure data.
However, if more costly testing were needed, exposure
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a relevant factor may be the extent to which occurrence of the
effect is affected by metabolic degradation or bioaccumulation of
the chemical. Another crucial question is whether available data
are sufficient for predicting dose-response relationships, so that
exposure levels of concern can be identified. Identifying the
exposure levels of concern is important not only for estimating
the significance of tVe risk, but also for defining the kinds of
exposure sources on which data are needed.
The time and resources required for this characterization phase of
evaluation depend on the completeness of information already
available. Chemicals that have been evaluated and tested under
section 4 of TSCA may only require a brief evaluation at this
state, or may by-pass it.
This phase takes approximately 3 to 6 months for chemicals not
previously evaluated. The products of evaluation are:
A paper characterizing the problem and recommending
whether the apparent risk is sufficient for continued
evaluation.
A plan for activities in the next phase of
evaluation. Such activities can include discussion
with industry to obtain additional exposure data;
section 8 rulemaking to gather production, use, and
other exposure related information; section 4
rulemaking to require testing: Government funded
testing, or negotiations with industry for testing.
PHASE 3." INFORMATION GATHERING AND RISK ANALYSIS
The scope of the work at this phase of evaluation results from
decisions made in the previous phase. The objective of the work
is to determine the actual character and significance of the risk.
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Data are analyzed from perhaps several, progressive cycles of data
gathering conducted during this phase. The analyses match data on
the types and degrees of exposure with data on dose response, in
order to assess the risk and to decide whether consideration of
risk reduction alternatives is warranted.
In cases where evidence is accumulating that the risk is
significant, it may also be appropriate to obtain a brief profile
analysis of the market for the chemical. This information may
help answer the question of how to approach exposure reduction.
It also may highlight features of the market that need special
attention, such as the existence or non-existence of substitutes
for the chemical.
This phase of evaluation ends 1) at any time that an analysis
shows that no action is needed because significant risk has not
been verified, or 2) with a decision that risk reduction
alternatives will be considered. The decision to end this phase
of evaluation is supported by a risk assessment document that
incorporates the results of the completed analyses on which the
decision was based.
Varying amounts of time will be taken for activities in this
stage. If an information gathering step is a major test program,
it will take months to years. It will take a much shorter period
if, for example, the only need is for the determination of an
exposure level for a well-defined use of the chemical.
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This phase has been described as solely a data collection and
analysis effort. However, whenever it becomes apparent in the
light of the developing picture on a chemical hazard that there
are actions that can be taken to reduce or prevent risks, EPA will
take immediate action to inform industry. The Office of Toxic
Substances uses a Risk Management Advisory (RMA, as described
under Phase 5) or other means to convey such information to
industry and other interested parties.
PHASE 4. RISK REDUCTION ANALYSIS
The objective of the risk reduction analysis phase is to decide
whether to proceed with action to achieve risk reduction and, if
so, how.
Analyses to support this decisionmaking include the estimated
costs of effective alternatives for controlling exposures.
Alternative options include such things as changing to
substitutes, changing practices for handling the chemical, or
product labeling. These analyses also address the economic
impacts of alternatives, apart from the direct costs of exposure
controls. The first analyses performed are short term (2 month)
efforts designed to provide information on the relative costs and
impacts of alternatives. These are intended to be first
approximations rather than complete assessments of any of the
alternatives. More complete analyses are performed later, if
appropriate.
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When the analysis has identified the potential ways of achieving
reduction of risk, discussions with industry and other interested
persons are undertaken. Economic analyses are then further
developed based, in part, on additional information gained from
industry discussions. These kinds of discussions are an important
first step when rulemaking is considered. For proposed rule-
making, OTS expands the risk reduction analysis in order to
support the public proposal for comment.
Another outcome of the risk reduction analysis may be a
recognition that effective action can be taken under the
jurisdiction of other legislation. If so, the next step is to
consult with the program administering that legislation to decide
whether OTS should transfer responsibility to the other program,
or proceed with joint action, as the more appropriate course.
PHASE 5.' RISK MANAGEMENT
EPA undertakes risk management activities in two areas:
Developing basic data about chemical effects and
exposure and informing industry and the public about
the risks.
Developing and implementing methods for risk
reduction.
In both these areas, EPA takes action through discussion and,
where appropriate, negotiation with industry and other interested
parties. (OTS has begun to use a negotiation process for reaching
testing agreements. This process is described in other papers
associated with the testing process.)
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In the course qf the evaluation sequence described earlier, OTS
uses opportunities to bring industry and public interest
representatives into discussions of the exposures to the chemical
being evaluated. When the exposure information needed is
accessible to a small enough number of companies to make a
voluntary information submission feasible, OTS pursues that
course. In other cases, the discussions aid OTS in formulating
more structured approaches to obtaining the necessary data such as
a rulemaking under section 8 of TSCA.
Several approaches are used to achieve risk reduction. The
objective is to effectively and expeditiously control exposures to
chemicals of concern. If exposure controls must be mandatory to
be effective, and the risk is unreasonable, then rulemaking under
section 6 of TSCA is the appropriate approach. In such cases, OTS
considers applying negotiation and consensus-building processes,
such as those currently under study by the Administrative
Conference of the United States, to prepare rules. These
processes hold promise for shortening the overall time required to
adopt controls.
Where opportunities exist to prevent risks or reduce existing
risks by encouraging voluntary adoption of exposure controls,
labeling, or other information practices, these opportunities are
pursued. At present, companies that recognize and report (under
section 8(e)) evidence that a significant risk exists also discuss
with OTS the kinds of steps they can, or have taken to reduce the
potential risk. When appropriate, OTS will broaden these
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discussions to include other companies and the public in order to
encourage the adoption of effective practices.
OTS will also take a very active approach to directly convey
information about risks and risk prevention and control to
chemical manufacturers and users. This may take the form of
making data available, or of convening a public forum for
discussion of the properties and risks of a chemical, or of
issuing Risk Management Advisories on risks to appropriate
segments of industry.
Publication of RMA on chemicals is a new process. An Advisory on
a chemical would contain three kinds of information. It would
first describe the toxic effect of the chemical that is of
concern; second, it would describe the routes and levels of
exposure that result in risks of harm; and third, it would set out
alternatives for reducing exposures to acceptable levels. Each
Advisory would be addressed to the particular group whose action
is needed, e.g., manufacturers, processors, or users. The aim of
publishing an FMA is to influence and encourage exposure reduction
where incentives exist for industry to act.
Advisories would be issued by OTS through public procedures. They
would be issued after discussion with industry and other
interested parties, relying to best advantage on any consensus
that was reached in these discussions. Each issuance of an
Advisory would required a plan for obtaining input from interested
persons prior to issuance.
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The circumstances for publishing an Advisory would vary in scope.
For instance, in one case in the past, a manufacturer reported to
OTS that it had discovered that a particular chemical should not
be used in the presence of HC1 since it would react with the HC1
and the reaction product could cause a hazard. The company had
already advised its customers of the problem. In such a case in
the future, an Advisory on the problem could be issued with
agreement from other manufacturers to distribute it to their
customers. This kind of Advisory of small scope could address a
problem effectively, at minimal cost, and could be negotiated by
letter and telephone. A larger scope Advisory would require more
complicated procedures and more extensive evaluation.
Situations in which Advisories could be used would include, for
instance, those in which the submitter of a notice of evidence of
significant risk, under section 8(e) has taken effective action to
prevent risks, and EPA wants to encourage similarly effective
action on the part of other companies. A parallel situation
occurs occasionally in connection with submission of premanu-
facture notices (PMN's) for new chemicals under section 5 of
TSCA. The PMN submitters report practices they intend to use to
control exposures. OTS could use Advisories to ensure that
subsequent manufacturers are aware of any potential risks and of
methods of avoiding such risks.
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III. EXPECTED OUTPUTS
The evaluation of apparent chemical risks will have several
outputs that meet the goals of TSCA. These outputs will be of
four kinds:
o basic data,
o analyses of risk,
o decisions whether risks merit further action, and
o actions to reduce or avoid risks where appropriate.
This section describes these outputs.
BASIC DATA AND RISK ANALYSIS
The information gathering and analysis phases of the evaluation
process described in Section II produce basic toxicity and
exposure data, and analyses of risk based on these data. These
data and analyses are both valuable as extensions of knowledge for
public and industry use, and necessary for decisions on the need
for further action under TSCA or another authority.
DECISIONS ON RISK AND ACTIONS TO REDUCE RISK
The final outputs of the evaluation process are the decisions that
show the findings of the evaluation plus any resultant actions to
reduce risks. In some cases, the final output is a conclusion
that the existence of the risk originally suspected is not borne
out by the evidence, or that the risk found is not significant or
unreasonable. In other cases, an RMA, developed during the
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information gathering phase, is issued. This can result in
exposure reduction and consequently in a reduction of risk to
reasonable levels, thus making any statutory action unnecessary.
The evaluation may, however, lead to action under TSCA or another
statute to reduce or avoid risks from a chemical. Under TSCA,
action will include rules under section 6 to control unreasonable
risks.
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