Office of Pesticides
             and Toxic Substances
             Washington, DC 20460
             Toxic Substances
                          December j19S'
Section 4 of the
Toxic Substances
Control Act:
An Overview
             Test Rules
             Development Branch
             Office of
             Toxic Substances

   Test Rules Development  Branch
     Office of Toxic Substances
U.S.  Environmental Protection Agency
      Washington, D.C.  20460

            December 1983



         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
'MucTT 6F~Yhe~mat~erial contained in this Overview Package was
 developed by Schwartz and Connolly,  Inc., Washington, D.C., under
 the supervision of the Test Rules Development Branch pursuant to
 EPA Contract No. 68-01-6527.

    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."


         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

     (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

    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

    expeditious ly  than may be possible if testing is delayed until

    issuance of  a  test rule.   Expediting 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

*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 Rulemaking
(NPRM).  This alternative is generally used when an ITC-designated
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.


         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)

responsibility for coordinating the Agency's section 4-related

activities.  During the one-year period after the 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.

         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.

         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

    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.

              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)


    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 all

              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

c  The  date  andlocation  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
me e t i ng s .

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.

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

          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.

**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

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


          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

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.

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

               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.

     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 .


         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-

                             MILESTONES:  SECTION  4  PROCESS

               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

    19   Prepare DNT Notice
 23-36  Agency Review
    38  Publish in FR
                                        TEST DECISION
         Draft Support Documents
         EPA/Industry Discuss ions/Negotiations,
           Public Discussions
**24-25  Preluninary Agreement on Test Program
                                               NO AGREEMENT

 26-31  EPA/Industry Test Negotiations
    31  Industry Submits Draft Test Program
    32  CTS Reviews Draft Test Program
  **33  OTS Decision:
          Negotiated Testing vs.  Rule 	
                                             •TEST RULE DEVELOPMENT

Prepare Proposed NTA Notice              57-73
Agency Review
Publish in FR                            74-87
Comment Period                           88-90
OTS Reviews Comments/Discussions         91-92
  with Industry                             93
Industry Submits Final Test Program        102
OTS Reviews/Approves Final Test Program
Prepare Final NTA Notice                   106
Agency Review                             *127
Publish in FR                          127-136

                     Prepare Proposed Rule/ANPR
                     Agency Review
                     OMB Review
                     Administrator Signs
                     Publish in FR
                     Comment Period
                     OTS Reviews Comments/
                       Prepares Final Test Rule
                     Agency Review
                     OMB Review
                     Administrator Signs
                     Publish in FR
                     Industry Submits Letters of
                     Industry Submits Study Plans
                     Propose Study Plans in FR
                     Comment Period
                     OTS Reviews Comments/Prepares
                       Final Test Standards Rule
                     Agency Review
                     Administrator Signs
                     Publish iii FR
 DNT - 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.