United States
Environmental Protection
Agency
Office of Pesticides
and Toxic Substances
Washington, DC 20460
Toxic Substances
December 198'
Section 4 of the
Toxic Substances
Control Act:
An Overview
Test Rules
Development Branch
Office of
Toxic Substances
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SECTION 4 OF THE TOXIC SUBSTANCES
CONTROL ACT: AN OVERVIEW
Test Rules Development Branch
Office of Toxic Substances
U.S. Environmental Protection Agency
Washington, D.C. 20460
December 1983
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SECTION 4 OF THE TOXIC SUBSTANCES CONTROL ACT; AN OVERVIEW*
A. INTRODUCTION
Section 4 of the Toxic Substances Control Act (TSCA) was
enacted by Congress in response to the concern that, in many
cases, the effects of chemical substances and mixtures on
human health and the environment were not adequately
documented or understood. Under this section of TSCA, the
Administrator of the Environmental Protection Agency (EPA) is
given the authority to require the development of adequate
test data on the health and environmental effects of
potentially hazardous chemicals. These data are taken into
account by the Administrator in determining whether, and in
what ways, to regulate or control potentially hazardous
chemicals under other sections of TSCA or other statutes.
The primary purpose of this overview is to inform
interested parties about EPA's policies and procedures for
implementing its section 4-related responsibilities. It
provides a general introduction to: the objectives and
requirements of section 4; the constraints affecting EPA's
decision-making process; and selected key points and
opportunities for public involvement in the section 4
process. This overview only presents a limited and fairly
*Mucn 6£ the material contained in this Overview Package was
developed by S'chwartz and Connolly, Inc., Washington, D.C., under
the supervision of the Test Rules Development Branch pursuant to
EPA Contract No. 68-01-6527.
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broad description of the Agency's decision-making process
under section 4. More complete, detailed information on the
process is provided in a separate information package
entitled, "Guide to the TSCA Section 4 Process."
B. OBJECTIVES AND REQUIREMENTS OF SECTION 4
Section 4 of TSCA was designed to assure that: (1) those
chemicals which may pose "unreasonable" risks of health or
environmental damage receive priority attention for testing
from EPA, (2) that EPA has the authority to require chemical
manufacturers and processors to perform testing when it is
needed to assess risk, and (3) that EPA does not require
testing when such testing would not be useful or is not
necessary. To these ends, the Act requires that EPA make
three findings before requiring the manufacturers and
processors of a chemical to test it for the potential effects
of concern to the Agency.
Specifically, EPA must make all of the following findings
with respect to the chemical:
(1) that the chemical may pose an "unreasonable risk" of
harm to health or the environment; or that the
chemical is produced in "substantial" quantities
which may result in substantial or significant human
exposure or substantial environmental release; and
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(2) that insufficient data or knowledge exist about the
health or environmental effects of the chemical to
reasonably determine or predict the impacts of its
manufacturing, processing, distribution, use, and
disposal; and
(3) that testing is needed to develop such data.
In addition to making the above findings, EPA must
consider the potential economic impacts of required testing
before issuing such requirements under section 4.
If EPA makes all of the above findings with regard to a
given chemical, EPA must assure that necessary testing is
performed. This can be accomplished through the issuance of a
rule requiring industry testing of the substance.
Alternatively, if EPA can reach agreement with industry on a
satisfactory testing program and testing schedule to be
conducted by industry, then no test rule is needed.
EPA has found that industry testing conducted according
to an agreed-upon program often offers several advantages.
Because this approach tends to be less time consuming and more
efficient than promulgating test rules, it offers all parties
who participate in the section 4 process as well as the public
the potential for saving resources. Moreover, such
"negotiated" test programs mav expedite the conduct of desired
testing and, in turn, may lead to earlier resolution of
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uncertainties for the public and for industry concerninq a
qiven chemical. If the test results indicate the need for
control measures, such measures may be initiated more
expeditiously than may be possible if testing is delayed until
issuance of a test rule. Expeditinq the use of control
measures results in improved protection of public health.
Thus, EPA believes that, when testing is necessary, pursuit of
a negotiated testing agreement with industry is an important
option for implementing section 4 that should be explored.
EPA recognizes, however, that negotiations may not always
be feasible or may not be completed successfully within the
limited time period available.* In cases in which development
of a negotiated program proves to be infeasible or proceeds at
a pace that is unsatisfactory, the Agency will issue a
proposed rule seeking to require that the necessary testing
for the health and environmental effects of concern be
performed.**
*The time period for publication of a notice which announces a
negotiated testing agreement is one year in the case of a chemical
"designated" by the Interagency Testing Committee for priority
consideration by EPA. For further details, see discussion under
part "C".
**The Agency may choose to issue an Advance Notice of Proposed
Rulemaking (ANPR) rather than a Notice of Proposed Rulemakinq
(NPRM). This alternative is generally used when an ITC-desiqnated
chemical presents complicated issues on which the Agency seeks
public comment early in the rulemaking process. The ANPR
generally follows the same schedule as an NPR.
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C. CONSTRAINTS UNDER WHICH EPA'S SECTION 4 PROCESS OPERATES
TSCA established a mechanism to assist EPA in determining
which chemicals, if any, should be given priority attention
under the testing provisions of the Act. Specifically,
section 4(e) created the Interagency Testing Committee (ITC),
composed of representatives of several federal agencies
involved in regulation and research related to environmental
and health issues. The function of the ITC is to review
readily available data on a variety of chemicals and to
recommend for EPA's priority consideration those substances
which the ITC believes may require additional testing.
The Committee's recommendations to EPA are in the form of
a list of chemical substances and mixtures known as the
"Priority List". The ITC is required under section 4(e) to
"designate" those recommendations on the list to which the EPA
should respond within one year. If the ITC has designated a
chemical for priority consideration, the law gives EPA only
one year to independently perform a more comprehensive/ in-
depth analysis of available information on the chemical and
either to initiate rulemaking to require testing of the
chemical, or to publish its reasons for not doing so. This
statutory one-year deadline has been reinforced by a court
order compelling the Agency to meet the law's deadline.*
EPA's Test Rules Development Branch (TRDB) of the Office
of Toxic Substances (OTS) is the EPA office with lead
*NRDC v. Costle, 14 ERC 1858 (S.D.N.Y. , 1980)
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responsibility for coordinating the Agency's section 4-related
activities. During the one-year period after tne ITC's
designation of a chemical, OTS must analyze available
information, obtain additional information, recommend a
testing program if appropriate, obtain peer review of the
testing program from other Agency offices and coordinate and
respond to the Agency's and, in certain cases, the Office of
Management and Budget's review of the testing program. For
these reasons, OTS has established very tight deadlines for
obtaining and evaluating relevant information, and for
arriving at preliminary testing decisions for approval by
upper-level Agency management.
In order to meet the statutory deadline, EPA's section 4
process has been carefully designed to include a series of
interim deadlines and decision points. These interim steps
help ensure both that the statutory one-year deadline will be
met and that sufficient opportunity will be provided for
public input as well as for the Agency's internal review of
proposed testing decisions. For example, one critical
milestone occurs approximately 14 weeks after EPA's receipt of
the ITC's designations. At this time, a preliminary decision
must be made by EPA staff as to whether, and for what effects,
testing of a given chemical is needed. Thus, it is crucial
that all data relevant to this "course-setting" decision be
submitted to the Agency substantially earlier than the 14th
week. Such data may include information regarding the
production, use, exposure, environmental release, health
effects, or environmental effects of a chemical.
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Two other key points in the process are when EPA must
decide whether to pursue negotiated testing or a test rule to
obtain the necessary testing for a chemical. Week 25 in the
process is the deadline by which a preliminary agreement must
be reached between EPA and industry on an appropriate testing
program if EPA is to decide to seek the necessary testing
through a negotiated testing agreement in lieu of a test
rule. Between weeks 31 and 33, EPA reviews industry's draft
test program and decides whether a satisfactory negotiated
agreement has been reached. If preliminary agreement has not
been reached by week 25 or actual agreement by week 33 on a
negotiated testing program, EPA will focus its resources on
development and issuance of a proposed test rule. These
deadlines are necessary to ensure that EPA can respond to ITC
designations within the statutory one-year deadline.
The following section describes, in chronological order,
some of the key interim decision points and deadlines in EPA's
section 4 process as well as points at which public input as
to EPA's decisions is sought.
D. KEY DECISION POINTS AND OPPORTUNITIES FOR PUBLIC INVOLVEMENT
IN EPA'S SECTION 4 PROCESS
This section presents information that is intended to
assist interested parties in most effectively participating in
EPA's section 4 process. Specifically, it outlines the points
in the process both where the Agency's critical interim
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decisions are made (decision points), and the times when
comments on EPA's approach or its tentative decisions are
solicited .* Tne interim decision points are highlighted by a
double asterisk {**) because they represent deadlines by which
interested parties must submit their views and relevant
information in order for these to receive consideration prior
to Agency decisions. A chart that identifies the major
milestones in EPA's section 4 process is included at the end
of this paper.
Week Number
0-2 Receipt and Publication by EPA of the ITC
Recommendations on a Given Chemical.
EPA's receipt of the ITC's recommendations
initiates the one-year period available for the
Agency to respond to designated chemicals.
Approximately two weeks after receipt of the ITC
recommendations, EPA publishes a Federal Register,
notice which:
o announces EPA's receipt of the ITC report;
*It should also be noted that the opportunity exists for public
input during the ITC's consideration of chemicals for the
Priority List, at the time a preliminary list of chemicals being
considered by the ITC for addition to the Priority List is
published in the Federal Register.
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o establishes a four-week period for submission
of public comments on the ITC's recommendations
(the first of several opportunities for public
input); and
o invites the public to attend Focus Meetings
(see week 10 below) as well as subsequent
public meetings (see week 16 below)*.
In addition, the submission of specific
exposure and healtn and safety information on
many of the ITC-designated chemicals is
required by the TSCA sections 8(a) and 8(d)
rules.
2-13 Public Submission of Relevant Information.
,>
During these weeks prior to EPA's tentative
decision on the need to require testing {see week 14
below) , specific information is requested from alJT
interested parties regarding the need for further
testing and the types of tests, if any, which should
be required for the chemical in question. These
early weeks are the best time for the public to
submit information relevant to EPA's testing
decisions.
* The date and location of the Focus Meetings for each chemical
are indicated in this notice. In addition, the notice states
that parties interested in attending subsequent public meetings
should contact EPA in order to be notified in advance of these
meetings.
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10 Public Focus Meeting .
A public meeting is held with representatives
of the affected industry(s) and other interested
parties for the purpose of exchanging information on
the chemical. The meeting helps focus and narrow
the Agency's inquiry and highlights the issues of
greatest importance to EPA and to other interested
parties. Usually, EPA makes further, more focused
requests for data submissions from knowledgeable
parties at this point, based upon the comments
made. A summary of the focus meeting is placed in
the public docket.
**14-15 Course-Setting Decision Made.
At this point, preliminary decisions are made
by EPA about whether further testing of the chemical
is warranted, and for what effects. These preliminary
decisions are known as "course-setting." The
information on which these decisions are based
includes the ITC recommendations, public data
submissions, information received during and after
the public focus meeting, and the Agency's own
preliminary evaluation of production, use, exposure,
health and environmental data.
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16 Public Meetings on Course-Setting .
EPA discusses the rationale and invites public
comment on its preliminary decisions.
After consideration of public comments, EPA may determine
that no testing is necessary. In this case, the Agency will
publish a Federal Register notice at about week 38 which
describes why EPA has determined that further testing is not
required. If, on the other hand, EPA determines that testing
is necessary, the Agency may seek testing under either a
negotiated testing agreement or under a test rule. In such a
case, EPA will welcome industry initiation of negotiations for
the purpose of developing a negotiated testing program. In
cases where test program negotiations are not feasible or are
not progressing on schedule, EPA will pursue development of a
rule to require testing of the chemical. (EPA may choose to
pursue a test rule at any time during the negotiations.) The
remainder of this outline applies only to the latter two
possibilities (negotiated testing program or test rule).
**16-24 EPA/Industry Discussions; Opportunity for
Separate Meetings with Interested Parties.
EPA may hold informal meetings with industry to
attempt to reach an agreement regarding needed
testing [a negotiated testing agreement]. The
opportunity will also be provided, upon request, for
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separate meetings with other interested parties who
wish to present their views on testing needs and
negotiation issues. Summaries of all meetings will
be placed in the public docket after the
negotiations are completed.
*24-25 Preliminary Agreement on Test Program,
EPA and industry must reach preliminary
(conceptual) agreement on a testing program by this
date. If no agreement is reached, EPA proceeds with
preparation of a test rule proposal. EPA management
considers whether negotiated testing is a viable
option during week 25.
31 Draft Industry Test Program Submitted.
If preliminary agreement is reached at week 24,
industry must submit to EPA its draft test program
by week 31. This will need to include detailed
testing protocols, explanations and/or
justifications for the testing approach taken,
descriptions of the decision-making process during
the testing (including provisions for interaction
with EPA) and provisions for release of test data.
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**33 Negotiated Testing vs. Test Rule Development.
After review of industry's proposed test
program, EPA decides whether it is likely that a
satisfactory negotiated test agreement will be
reached. If an agreement has not been reached which
substantially addresses most of the testing details
with only minor matters to clarify, EPA proceeds
with preparation of a test rule proposal.
49 Publication of a Proposed Test Rule.
If a satisfactory negotiated test agreement
cannot be reached, EPA publishes a proposed rule on
which the public is invited to comment. (EPA also
?
issues a proposed rule in the event that public
comments on the proposed Negotiated Test Agreement
notice raise significant issues about the adequacy
of the proposed testing program and EPA and industry
fail to resolve these issues. In this case, EPA is
committed to issuing a proposed rule as soon as
practicable.)
52 Publication in Federal Register of Proposed
Negotiated Test Agreement Notice (NTA notice) and
EPA's Decision Not to Initiate Rulemaking.
If a negotiated test agreement has been reached
which appears to be satisfactory to EPA, a proposed
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Negotiated Test Agreement notice is published in the
Federal Register. This notice announces EPA's
intent not to initiate rulemaking under section 4 of
TSCA. The notice also requests public comment on
industry's proposed test program during a 60-day
period.
66 Final Industry Test Program Submitted.
In response to public comments on the proposed
NTA notice and to any additional concerns raised by
EPA, industry revises its proposed test program and
submits the final negotiated test program. If the
final program is significantly different from the
proposed negotiated test program, a public meeting
is held to discuss the final program.
83 Publication in the Federal Register of the Final
Negotiated Test Agreement Notice.
If agreement is reached on a final negotiated
test program, EPA publishes a final negotiated test
agreement notice in the Federal Register noting its
acceptance of the industry program in lieu of
mandating testing by rule. The final test program
is placed in the public record.
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93 Publication in the Federal Register of the Final
Test Rule.
If a proposed rule was published in the Federal
Register (week 49), after consideration of public
comments, EPA publishes a final test rule. This
rule requires each manufacturer subject to the rule
to submit within 60 days after publication of the
rule either a letter of intent to perform the
testing or an application for exemption (week
102) . Test sponsors are required to submit study
plans for the required tests within 120 days after
publication of the rule (week 106).
127 Publication of Notice of Proposed Study Plans.
The study plans submitted by industry are
proposed for comment in the Federal Register at
approximately week 127.
158 Publication of Follow-Up Rule Adopting Final Test
Standards.
After providing a 45-day comment period and an
opportunity for a public meeting on the sponsors'
proposed test study plans, EPA will adopt the study
plans, as proposed or modified, as specific test
standards for the test rule.
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After EPA publishes a final negotiated test agreement notice
(week 83) or a final rule adopting test standards for a test rule
(week 158), industry is required to perform the testing according
to the schedule specified in the agreement or rule. EPA will
announce in the Federal Register the receipt and availability of
data from testing performed under negotiated testing agreements
and test rules.
E. FURTHER INFORMATION ON THE SECTION 4 PROCESS
For specific information on EPA's section 4 activities on
particular chemicals and on the section 4 process, interested
parties should contact the Test Rules Development Branch
(TS-778), Office of Toxic Substances, Environmental Protection
Agency, 401 M Street, SW, Washington, D.C. 20460; (703-475-
8130).
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MILESTONES: SECTION 4 PROCESS
NOTIFICATION AND INFORMATION GATHERING, EXCHANGE AND ANALYSIS
Week Event
0 Receive ITC Report
*2 Publish ITC Report & 8(a) & 8(d) Notices
6 Complete Preliminary Exposure Analysis
*10 Public Focus Meeting
14-15 Course-Setting Recommendations
*16 Public Meeting on Course-Setting Decision
, Decision Not to Test vs. Test Decision
DECISION NOT "TO TEST
19 Prepare DOT Notice
23-36 Agency Review
38 Publish in FR
TEST DECISION
16-23
*16-24
Draft Support Documents
EPA/Industry Discussions/Negotiations,
Public Discussions
**24-25 Preliminary Agreement on Test Program
AGREEMENT
NO AGREEMENT
NEGOTIATED TESTING
26-31 EPA/Industry Test Negotiations
31 Industry Submits Draft Test Program
32 OTS Reviews Draft Test Program
**33 OTS Decision:
Negotiated Testing vs. Rule
>TEST ROLE DEVELOPMENT
34-37
38-50
*52
52-61
62-64
66
*67-68
66-69
70-82
83
Prepare Proposed NTA Notice
Agency Review
Publish in FR
Comment Period
OTS Reviews Comments/Discussions
with Industry
Industry Submits Final Test Program
OTS Reviews/Approves Final Test Program
Prepare Final NTA Notice
Agency Review
Publish in FR
26-31 Prepare Proposed Rule/ANPR.
32-43 Agency Review
44-45 OMB Review
46-48 Administrator Signs
*49 Publish in FR
49-57 Comment Period
57-73 OTS Reviews Comments/
Prepares Final Test Rule
74-87 Agency Review
88-90 OMB Review
91-92 Administrator Signs
93 Publish in FR
102 Industry Submits Letters of
Intent
106 Industry Submits Study Plans
*127 Propose Study Plans in FR
127-136 Comment Period
137-142 OTS Reviews Comments/Prepares
Final Test Standards Rule
143-156 Agency Review
155-157 Administrator Signs
153 Publish in FR
DMT = Decision Not To Test NTA = Negotiated Test Agreement
FR = Federal Register ANPR * Advance Notice of Proposed Rulemaking
* Points in the process when public comment is solicited.
** Major decision points concerning negotiations versus test rules.
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