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
                               ii

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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.
                                IV

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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.
                            vi

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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
                                via.

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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.
                               Vlll

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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.
                                IX

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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
                            xi

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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.
                            xii

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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




                            xiii

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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.
                            xiv

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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).
                                xvi

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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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