xvEPA
United States
Environmental Protection
Agency
Office of Pesticides
and Toxic Substances
Washington, DC 20460
Toxic Substances
June 1987
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
June 1987
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A. INTRODUCTIOH
Section 4 of the Toxic Substances Control Act (TSCA) was enacted by
Congress to respond to the concern that effects of chemical substances and
mixtures on human health and the environment were frequently inadequatel'y
documented and understood. This section of TSCA gives the Administrator
of the Environmental protection Agency (EPA) the authority to require the
development of adequate test data on the health and environmental effects
of potentially hazardous chemicals. These data help the Administrator,
other Federal agencies, and state and local governments, to determine both
whether and how to regulate or control potentially hazardous chemicals.
The primary purpose of this overview is to describe EPA'a policies and
procedures for implementing its section 4-related responsibilities. It
provides a general introduction to: the objectives and requirements of
section 4; the statutory constraints affecting EPA's decisionmaking
process; the alternative processes by which EPA may ensure necessary
testing is done) and the key opportunities for public involvement in the
section 4 process.
1Much of the material contained in this Overview package was developed
'by Jellinek, Schwartz, Connolly & Freshman, Inc., Washington, D.C., under the
supervision of the Test Rules Development Branch, pursuant to EPA Contract No.
68-02-4214.
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B. OBJECTIVES AND REQUIREMENTS OF SECTION 4
Section 4 of TSCA was designed to ensure the following: (1) Chemicals
which may pose "unreasonable" risks of health or environmental damage, or
may involve substantial production or exposure, receive priority attention
for testing. (2) EPA has the authority to require chemical manufacturers
and processors to perform testing on such chemicals. This section of the
Act requires that EPA make three findings before requiring the
manufacturers and/or processors of a chemical to test it for the potent^
effects of concern to the Agency.
Specifically, EPA must make all of the following findings:
(1) that the chemical may pose an "unreasonable risk" to health or to the
environment; or that the chemical is produced in "substantial"
quantities, which could result in substantial or significant human
exposure or substantial environmental release; and
(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 manufacture, processing, distribution, use
and/or disposal; and
(3) that testing is needed to develop such data.
Additionally, EPA considers the potential economic impacts of the required
testing before issuing requirements under section 4*
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C. EPA'S ALTERNATIVES FOR ENSURING THE NECESSARY TESTING IS POKE
If EPA makes all of the above findings for a specific chenical or category
of chemicals, EPA nay issue a test rule requiring industry to test the
substance(s).
Alternatively, if EPA finds that affected Manufacturers and processors,
and interested members of the public agree with the Agency regarding the
need for and scope of testing requirements, EPA may issue an enforceable
consent order to expedite the testing.
If a consensus of the interested parties cannot be reached, e.g., because
testing issues are in dispute or are too complicated to be resolved in the
limited time available, the Agency will initiate rulemaking.
D. CONSTRAINTS IMPOSED BY INTERftGENCY TESTING COMMITTEE'S RECOMMENDATIONS
TSCA established the Interagency Testing Committee (ITC) to help EPA
determine which chemicals should receive priority attention under the
testing provisions of the Act. The ITC is comprised of representatives of
EPA and several other federal agencies that are involved in
regulation and research related to environmental and health issues. The
ITC reviews readily available data on a variety of chemicals; it also
recommends substances which may require additional testing for EPA's
priority consideration. The ITC presents these recommendations in the
form of the TSCA Section 4(e) priority list ("priority List").
The priority List of chemicals is divided into three parts: 1) those
designated for EPA response within 12 months; 2) those recommended with
intent-to-designate; and 3) those recommended without being designated for
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response within 12 months. (Chemicals in the first part are called
designated chemicals; chemicals in the second and third parts are non-
designated chemicals.)
When the ITC designates a chemical for priority consideration, TSCA
requires that EPA must either initiate rulemaking to require testing of
the chemical, or publish its reasons for not so doing within one year.
(No more than fifty chemical substances may be designated at any one
time.)
The ITC recommends with intent-to-designate chemical substances or
mixtures which it believes should receive expedited testing consideration,
by means of the second part of the priority List. The ITC nay designate
these chemicals later, after EPA's review of the Committee's testing
recommendations, and after the iTC's own review of the data collected
under TSCA sections 8(a) and 8(d) and other relevant information. The
intent-to-designate recommendation does not require EPA to respond to the
ITC by a certain deadline. Should these chemicals be subsequently
designated, a one-year statutory deadline for EPA response would be
imposed at that time.
The third part of the priority List includes chemical substances or
mixtures that the ITC believes warrant testing consideration, but not
expedited review of testing needs. The ITC adds the chemical substance or
mixture to the Priority List, and recommends it for testing without
designating the substance or mixture for EPA review within any statutory
deadline. These chemicals may be evaluated by EPA as tine and resources
permit.
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E. EPA'S RESPONSE TO ITC RECOMMENDATIONS
The Test Rules Development Branch (TRDB) of EPA's Office of Toxic
Substances (OTS) has the lead responsibility for carrying out the Agency's
section 4-related activities. After the ITC's recommendation of chemicals
for testing, OTS analyzes the available information, obtains additional
information, determines whether additional testing is needed and whether
the available data support the required section 4 regulatory findings,
(obtains both technical and policy review of a consent agreement or a
proposed testing program, and prepares the necessary Federal Register
notices. Because of the many tasks involved in testing decisions, OTS has
found it necessary to establish very tight deadlines for obtaining and
evaluating relevant information, and for arriving at preliminary testing
decisions for approval by upper-level Agency management.
If the ITC designates a chemical for consideration by EPA, the Agency must
respond within the one-year statutory deadline. EPA's section 4 process
has been carefully designed to include a series of interim deadlines and
decision points. This schedule is intended to ensure that the statutory
one-year deadline will be met, and to provide sufficient opportunity for
both public input and for the Agency's internal review of proposed testing
decisions. One critical milestone occurs approximately 18 to 20 weeks
after EPA's receipt of the ITC's designations. At that time, a
preliminary decision must be made by EPA staff as to whether testing of a
given chemical is needed, and for what effects. If EPA determines that
testing is needed, it will proceed with the development of a proposed test
rule for the chemical. EPA does not use the consent agreement process for
designated chemicals because of the short time frame available to meet the
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statutory deadline. It is therefore crucial that all data relevant to
this "course-setting" decision be submitted to the Agency considerably
earlier than the 18th week. Such data may include information on the
production, use, exposure, environmental release, health effects, or
environmental effects of a chemical.
If the ITC recommends with intent-to-designate a chemical (or mixture),
EPA conducts a similar evaluation of the chemical. However, in addition.
to the rulemaking procedures described above, EPA has the consent
agreement2 option for chemicals that nave been recommended with intent-to-
designate. to use the consent agreement process, EPA determines whether a
consensus exists among the Agency, industry, and other interested
individuals, regarding the need for and scope of testing.
A major milestone of the consent agreement process is the deadline by
which a tentative consent agreement must be established. By week 32, EPA,
industry, and interested public groups must reach a consensus regarding
the need for and scope of required testing. This deadline is particularly
important, because if there is no consensus, the consent agreement option
is extinguished and EPA must proceed with the issuance of a proposed test
rule. Chemicals in the recommended with intent-to-designate category may
also proceed directly to rulemaking when EPA believes individual chemical
substance or mixture testing requirements cannot be successfully
negotiated through the consent agreement process.
A consent agreement is an agreement between EPA and interested
parties, who agree either to conduct testing or to a test program. Once t
agreement is signed by all parties, it is known as a consent order, which
legally binding and enforceable.
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If the ITC recommends a chemical or mixture for testing consideration by
EPA without designating it for EPA response within one year, the Agency
will evaluate the chemical according to its relative priority versus that
of all other ITC chemicals. There is no deadline for response by EPA for
these chemicalsi both ruleraaking and consent agreement options are
available.
EPA also develops testing requirements under the Act for cheoicals that
warrant testing even though they have not been recommended by the ITC.
These non-ITC chemicals are considered for test rules or consent
agreements in cases where the Office of Toxic Substances, or another EPA
program, needs test data to assess the risks of the chemical. The
schedules for the development of test rules and consent agreements for
non-designated ITC chemicals are generally followed for these chemicals.
The following section chronologically presents some of the key interim
decision points and deadlines in EpA's section 4 process, as well as
points at which public input to the process is sought.
F. KEY DECISION POINTS AND OPPORTUNITIES FOR PUBLIC INVOLVEMENT IK EPA'S
SECTION 4 PROCESS
This section will enable interested parties to effectively participate in
EPA's section 4 process by detailing where in the process critical interim
decisions are made, and when public comments on the approach or on
tentative decisions are solicited.3 The course-setting decision point is
^An opportunity also exists for public input during the iTC's
sideration of chemicals for the priority List, i.e., when the preliminary
t of chemicals being considered by the ITC for addition to the priority
List is published in the Federal Register.
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highlighted by a double asterisk (**), The end of the reporting period
for public submission of section 8(a) and section B(d) information is the
deadline by which interested parties must submit their views and any
relevant information, in order to receive consideration prior to the
Agency's preliminary decisions. The week numbers represent target
dates. A summary chart of section 4 process target dates is located at
the end of this booklet.
Week Number
O-2 Receipt and Publication by EPA of the ITC Recommendation on a Given
Chemical
EPA's receipt of the ITC's recommendations initiates the section 4
process. For those chemicals designated by the ITC for testing
consideration, a one-year deadline is established for the Agency to
respond with a regulatory decision.
Approximately two weeks after receipt of the ITC recommendations, EPA
publishes a Federal Register notice which:
° announces EPA's receipt of the ITC report;
° establishes a four-week period for submission of public comments
on the ITC's recommendations (the first of several opportunities
for public input);
° invites the public to attend Focus Meetings (see week 6 below) as
well as subsequent public meetings (see week 22 below)4; and
in cases of chemicals under consideration for consent agreements,
The date and location of the Focus Meeting for each chemical is
indicated in the Federal Register notice. The notice states that parties
interested in attending subsequent public meetings should contact EPA to
request notification of the dates and locations of these meetings.
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invites persons interested in participating in or monitoring the
negotiations of the consent agreement to contact the Agency in
writing.
In addition to publishing the ITC report, EPA issues TSCA section
8(a) and 8(d) reporting rule amendments in the Federal Register,
under the automatic reporting rule promulgation procedures of 40 CFR
part 712, and 40 CFR part 716, respectively. The TSCA section 8(a>
preliminary Assessment information rule requires manufacturers to
submit specific production and exposure information on the ITC-
designated and ITC-recommended chemicals within 90 days of
publication of the amendment. The TSCA section 8(d) Health and
Safety Data Reporting rule requires manufacturers, processors, and
distributers who possess or know of such studies to submit copies or
lists of unpublished health and safety studies on the iTC-designated
and ITC-recommended chemicals within 90 days of publication of the
amendment. The section 8(d) rule also requires such persons to
notify EPA if they subsequently initiate a health or safety study on
a listed chemical. Persons subject to these reporting requirements
are urged by EPA to submit such information as early as possible in
the reporting period. The public docket for the chemical is also
established at this time; its location and the public hours for
review are announced in the Federal Register.
3-6 Comment Period on the ITC Report
The public is invited to submit comments on the ITC Report during
this time.
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6-19 Discussion Phase
At this point, EPA begins discussions with the affected
industry and other interested parties to exchange information
and to allow an opportunity for the public to provide input to
the Agency's decision-making process. Usually EPA holds a
public focus meeting to begin these discussions. This meeting
helps focus the Agency's inquiry and highlights the issues of
greatest importance to EPA and other interested parties.
7-14 public Submission of Relevant Information/Section 8(a) and 8(d)
Reporting period
During the weeks prior to EPA's tentative decision on the need to
require testing (see week 18 below), specific information is
requested from all interested parties regarding the need for further
testing and, if appropriate, what types of tests should be required
for the chemical in question. These early weeks are the critical
time for the public to submit information relevant to EPA's testing
decisions, and for industry to submit information in response to
section 8(a) and 8(d) reporting requirements.
** 18-20 Course-Setting Decision
At this point, EPA makes preliminary internal decisions, known as
"course-setting" decisions, as to whether testing of the chemical is
warranted, and for what effects. These preliminary decisions are
based on the ITC recommendations, public data submissions,
information received as a result of the public focus meeting, and
Agency's own preliminary evaluations of production, use, exposure,
health, and environmental data.
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22 Public Meeting on Course-Setting and Deadline for Requests to
Participate in Consent Agreement Negotiations
EPA holds a public meeting to announce its preliminary course-setting
decisions and the basis for those decisions. The public is invited
to comment on EpA's preliminary decisions. These preliminary
decisions may be altered, if necessary, based on additional analysis
resulting from public comment. In addition, for non-designated
chemicals, individuals interested in participating in any consent
agreement negotiations must also notify EPA in writing by this
time. For designated chemicals, EPA does not initiate negotiations,
but proceeds directly to preparation of a proposed rule to require
the necessary testing (see week 52 below).
22-30 Negotiation of Consent Agreement (Non-Designated Chemicals Only)
During this period, EPA meets with affected manufacturers and
processors, and other interested parties, to determine whether a
preliminary agreement on a testing program can be reached.
Individuals and groups who have responded by week 22 to EPA's initial
Federal Register notice (see weeks 0-2 above) are designated
"interested parties" and are afforded an opportunity to participate
in the negotiation process at their own expense. All negotiation
meetings are open to members of the public, who may observe. EPA
advises interested parties of meeting dates and circulates meeting
minutes, testing proposals, background documents, and other relevant
materials.
32 EPA Decision point: Consent Agreement or Test Rule
By week 32, EPA determines whether a tentative agreement can be
reached on a testing program acceptable to EPA, and whether continued
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negotiation is likely to result in a draft agreement within an
additional 4 weeks. If both stipulations are affirmative, EPft
proceeds with the development of an agreeaent. If a tentative
agreement has not been reached and it appears unlikely that
additional negotiation will result in such an agreement by week 36,
EPA proceeds with the development and preparation of a proposed test
rule (to be published by week 62).
32-36 preparation of Consent Agreement
If a consensus is reached, EPA prepares a draft agreement that
reflects the apparent consensus, which contains suitable guidelines
as the required testing standards. The agreement is then distributed
to the interested parties for comment.
42 Optional Meeting to Address Comments on the Draft Consent Agreement
If necessary, EPA will hold a public meeting to address comments
received in response to the draft consent agreement.
42-44 Preparation of the Consent Order and Federal Register Notice
After the comment period for the agreement, EPA prepares the consent
order (which incorporates the consent agreement). Each consent order
is accompanied by a support document which explains the basis for the
original agreement, summarizes any ITC testing recoramendations for
the chemical, describes the objectives of the testing to be conducted
and the rationale for the selection of tests, and briefly outlines
the use and exposure characteristics of the test chemical. This
support document will become a part of the record and will serve as
the basis for the consent order.
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48 Signature of Consent Order
The consent order is circulated for signature by the Agency and the
interested parties. The consent order becoaes legally enforceable as
of its effective date.
50 publication of Oonsent Order notice in Federal Register
When a consent order has been issued, the document explaining the
basis for the consent order and a notice of availability of the
consent order itself is published in the Federal Register. This
notice serves as the statement of EPA's reason for not initiating
rulenaking under section 4 of TSCA.
52-62 publication of Decision Hot to Require Testing
If EPA determines that no testing of a chemical is necessary, the
Agency will prepare a Federal Register notice to respond to the ITC,
which describes why El* has determined that further testing is not
required.
52-62 publication of proposed Rule
If EPA determines that testing of a designated chenical is necessary
(or that tinely consensus will not be reached for a non-designated
chemical), the Agency pursues development of a rule to require
testing of the chemical. A proposed test rule is signed by week 52
to initiate rulenaking for designated chemicals, or by week 62 for
chemicals recomended with intent-to-designate. The proposed test
rule specifies the chemical to be tested, health and environmental
effects for which testing will be required, proposed test standards
for the development of test data, schedules for the submission of
test data, and who ia responsible for conducting the testing. The
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Agency usually proposes the TSCA Test Guidelines, or other suitable
guidelines, as the required test standards for the rule. The
guidelines are modified as necessary, to allow for specific
characteristics of the chemical to be tested. The public is invited
to comment on the proposed rule during a 60-day period.'
To initiate rulemaking, the Agency nay choose in some cases to issue
an Advance Notice of proposed Rulemaking (ANPR) rather than a pro-
posed rule, this alternative is generally used when an ITC-designa-
ted chemical or chemical category presents complicated issues on
which the Agency seeks public comment early in the rulemaking pro-
cess. EPA publishes the ANPR at approximately week 52 (or 62),
following receipt of the initial ITC report, This is followed by a
For certain test rules, EPA may use a two-phase rulemaking process.
Generally, EPA uses the two-phase process in cases where no well-accepted test
methodology is available for inclusion in a proposed test rule. Under two-
phase rulemaking, the Agency issues a proposed rule at week 52 or 62
specifying the chemical to be tested, the effects for which testing is
required, and who is responsible for conducting testing. This is a phase I
proposed test rule. The public is invited to comment on the proposed rule
during a 60-day period. After consideration of public comments, EPA publishes
a Phase I final test rule at week 1O8. The rule becomes effective
approximately 44 days after its publication in the Federal Register. The rule
requires each person subject to it to submit, within 30 days after the
effective date of the rule, either a letter of intent to conduct the testing
or an application for exemption. Test standards and schedules are developed
in a second phase of rulemaking. in the second phase of two-phase rulemaking,
test sponsors are required to submit proposed study plans for the required
tests within 90 days after the effective date of the phase I final test
rule. The study plans submitted by industry in response to a phase I test
rule, with any modifications considered necessary by the Agency, are proposed
for comment in the Federal Register. After providing a 45-day comment period
and an opportunity for a public meeting on the sponsors' proposed test study
plans, EPA adopts the study plans, as proposed or modified, as specific test
standards and schedules for the test rule. This is a Phase II test rule.
After EPA publishes a phase II final rule that adopts test standards and
schedules for a test rule, industry is required to perform the testing
according to the schedule specified in the rule. EPA announces in the Federal
Register the receipt and availability of data from testing performed under a
test rule.
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proposed rule or decision-not-to-test which is published by' week
108. A final rule or notice teminating the rulemaking process is
published by week 154.
70-106 preparation cf Final Rule or Decision Mot to Teat
in response to public comments received on the proposed rule, EBV
prepares either a final test rule or a decision not to require
testing.
08 publication of the Final Test Rule in the Federal Register
Once EPA publishes a final test rule, each person subject to the rule
ust submit either a letter of intent to conduct the testing or an
application for exemption within 30 days after the effective date of
the rule. Test sponsors are required to commence testing and to sub-
lit test data according to the schedule specified in the rule. Study
plans oust be submitted to BFA at least 45 days before the start of
each test. EFA will inspect the testing laboratory and audit the
study data as appropriate to ensure that the study is conducted in
' confonance with the study plan and El* Good Laboratory practice
standards.
G. TEST OMA SUBMITTED IN COMPLIANCE WITH A CONSENT ORDER OR TEST ROLE
When the Agency receives data which are submitted in compliance with a
consent order or test rule, EPA publishes a Receipt of Data Notice in the
Federal Register, this notice appears within 15 days of receipt of the
data to announce their availability. The notice identifies the type of
test data received, when they were received, and the El* action in
response to which they were submitted.
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Test data are reviewed by EPA to determine their completeness and
reliability, and to ensure that the data were submitted in compliance with
the test rule requirements. After this preliminary review, the data are
further evaluated to assess their adequacy for use in an evaluation of the
risks associated with the chemical. Should some regulatory or other
action appear warranted, the data on the chemical are referred to the
appropriate office within EPA.
B. FURTHER INFORMATION OH THE SECTION 4 PROCESS
For specific information on EPA'a section 4 activities on particular chem-
icals, and for more information on the section 4 process, interested
parties should contact the TSO Assistance Office (TS-799), Office of
Toxic Substances, Environmental protection Agency, Rm. E-543, 401 M
Street, S.W., Washington, D.C. 20460. Toll Free: (800-424-9065)i in
Washington, D.C.i (544-1404)> outside the United States: (Operator-202-
554-1404).
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TARGET SCHEDULE FOR EPA ACTION: SECTION 4 PROCESS
NOTIFICATION AND INFORMATION GATHERING, EXCHANGE, AND ANALYSIS
Week" Event
0 Receive ITC Report
2 publish ITC Report fi B(a) C 8(d) Notices;
Invite public participation in Negotiations
3-6 Consent period on ITC Report
*6-18 Discussion Phase
7-14 8(a) and 8(d) Reporting Period
*22 public Meeting on Course-Setting Decision;
Deadline for Request to Participate in Negotiations
22-30 Negotiation of Enforceable Consent Agreement7
32 Decision Point: Consent Agreement or Test Rule
CONSENT AGREEMENT TEST RULE
36-40 Comment Period 32-60 Prepare Test Rule; Agency
42 Meeting to Address Review and Signing
Comments (if necessary) 52-62 publish proposed Rule in
48 Signing of Consent PR
Order and FR Notice 70-106 Agency Review of Comments;
50 Publish FR Notice prepare Final Rule or No-
Test Decision; Agency
Review of Rule; Signing of
Rule
108 publish Final Rule or No-
Test Decision in FR
FR - Federal Register
Points in the process when public comment is solicited.
6The dates contained in the left-hand column are calculated from the
date EPA leceives the ITC report recommending a chemical for testing.
Designated chemicals do not go through the negotiation process, but
broceed directly from week 22 to test rule preparation, and are signed by week
52.
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