United States
                  Environmental Protection
Pollution Prevention
and Toxics
Fall 1996
                  Chemicals in the Environment
                   Public Access Information
                TSCA  at  Twenty
                The Toxic
                Control Act at
This issue of Chemicals in the Environment
commemorates the twentieth anniversary of the
Toxic Substances Control Act (TSCA)  and
provides some of the  highlights about the
programs initiated by this law. In the past twenty
years, TSCA underwent numerous changes, and
EPA faced many challenges in its implementation.
TSCA  evolved  with  the   enactment  of
amendments  and  new  laws,  changes  in
information technology, and changes in the way
government does business. This
issue  will  provide insight to
TSCA's past,  present, and

Chemicals found in nature and
created in laboratories are at the
heart of our highly industrialized,
technology-based society. They
are found in everyday products
used in our homes, businesses.,
and  industry. Chemicals help
protect our health, control pests, manufacture
 clothes, provide shelter and serve many other
 basic functions considered necessary in today's

 The chemical industry plays a vital role in the
 economy of the United States. The production of
 chemicals  and  allied products accounts for
 roughly five percent of the Gross  National
        Product employing about 1.1 million
        people.    Approximately   70,000
        chemical substances are presently
        manufactured  or  processed  for
        commercial use in the United States,
       «. and almost  one thousand more are
        introduced each year.

        Although most chemicals present little
        or no danger to human health or the
        environment when used properly, in the
        past  few decades  some chemicals
 commonly used and widely dispersed have been

Chemicals in the Environment
Fall 1996
      The Toxic Substances Control Act at Twenty
             Tfestefdt®              i
      Events Leading Up to the Passage of TSCA, by Frank Kover
      :The TSCA OtemicalSab&ance Inventory:
      TSCA Sectiott 8(e) Substantial Msfe Reporting and the8(ej CAP, by T«ny O'Bryai
      Evolution of the TSCA Interagency Testing Committee, by 3oha Walker
      The New Chemicals Program*          . A   ,
         A Legaeyof Progress, by Paul Sickart.   '   - ^     '       '  '      *           /**
         A Legacy of Prevention and l^sfc Reduction, bjrT>avM JDI Fiore
      nteOPPTStrattorfeAefivity Team, IsyBsck^ tees                 ,  '    ,
      OPPT's Cfaemical T«s^ng ft-y Matt  Isy S^tt ShWo^s:
      TSCA as a Tool for Integrated EnvironntentalManagenrent, by Ciadj^ FoumiCT
      CAS Nuinbers? Unique IdentiSer^ E-t Oiemlie^s,, t^ Doug SeB^ns

         latortnation CoBectibn, by IMaacy Vosel
         Information Dissemination - Past dad Present, by Etoiis BJocfe

      3WC4 Tomorrow                  ''  " >  »  '                   <,,"*.'
      The Use of Environmental Chemical Databases Witibin OPPT, by Beefy Jones
      ErnerrangRight-to-Know Tite«KS ISadter TSCA, by Steve1'!e«i>ere-<1Sisa
      New- Caemicals Program Embodies PoBntinn Prevention,, fey R<3g?Seid^stBia
      HowOPPT Woits witfe Owtside Partte^<»l»pteiBe»t and Gaia Cwnpaaoce wltb TSCA,
          byKenMoss                    >    »    <  »s      ;
      Perspectives                          '  >                       ^        s .
      The legislative History of TSCA, by Wimm Misr
      No Rose Garden for the Taste Ssbstssaees: Contol Act, by Glesa Selxweitzer
      Ilie Birth ofEPA and TSCA, by Terry Bavfes
      TSCA Consent Ordter Process for Testing, by Robert M. Sassraaa.
      The Program Gatibers Momeatuo*, by DOR it Clay
                                        ^ 5    '. '-^  -"-  » <  V    -
      Chemicals m&eE»wonmfMt^P»b^A£(:^sI^ormMon}sy^^&\^}^^h^&Q^A of Politttioa
      Tftevention aodToxics{OPPT)taiHoreasB^bIjc swareaesssf iautl access to JaformafKHKHi toxic dtatakstis atad
      pollution prevention avaaabJetiHau^bLQPFX. Ifeiesoutoejs a&oayailableoin Sie World Wide Web at
      http^MTVTV^pa,gov/docs/cie/. Maiuing address: Chemietfls in the Envir&nment- Public Access Information,,
      U. S EPA, Office ofPonuSonPreveirficaxand 1oxiKis(7407), 401 MSt, S-.W,*
      Advisory Board                            >   '                 '  -v
      Prefect Manager. {Seorgianae McDi Letty Tabaft, Iffi395; Derase KeamS,
          CMD                                               *       <»,   «

Issue No. 4
                           TSCA Yesterday
TSCA at Twenty (continued)
found to be significantly harmful. In 1971, the
President's  Council on Environmental Quality
developed a legislative proposal, for coping with
the increasing problems of toxic substances. After
five  years of public  hearings  and  debate,
Congress and President Gerald Ford  enacted
TSCA in the Fall of 1976.

By enacting  TSCA,  Congress established a
number of new requirements and authorities for
identifying and controlling toxic chemical hazards
to protect human health and the environment.
Programs now exist  under  TSCA  to gather
information about the toxicity  of particular
chemicals and the extent to which people and the
environment are exposed to them, assess whether
they cause unreasonable risks to humans and the
environment,  and institute appropriate control
actions after weighing then: potential risks against
  their benefits to the Nation's economic and social
  well-being. Eight product categories are exempt
  from TSCA's regulatory authorities: pesticides,
  tobacco,   nuclear   material,   firearms   and
  ammunition,  food,  food additives,  drugs, and
  cosmetics. Many of these product categories are
  regulated under other Federal laws.

  To obtain a copy of TSCA and its amendments,
  as well as other documents that  will assist in
  understanding the scope,of the  law, call the
  TSCA Assistance Inform
Chemicals in the Environment
                                      Fall 1996
 Events Leading Up to TSCA (continued)
 In the summer of 1972, Et^ created the Office of
 Toxic Substances ( OTS ) in anticipation of passage
 of TSCA. The key philosophical question then was
 whether TSCA was an umbrella act or a stop-gap
 measure.  Most thought it would turn out to be a
 catch-all statute.   They   considered the most
 important part of the Act to be the seemingly open-
 ended authority in Section  6 to  address risky
 chemicals with anything ranging from labeling to
 outright banning a chemical.
 OTS was a small staL. opjice under the Assistant
 Administrator for Categorical Programs with about
 ten  people under an acting director.  There were
 chemists,  biologists,  a  toxicologjst,  program
 analysts — one serving almost exclusively as the
 legislative liaison on the E511-- and two support
 staff. The main mission of the group was to support
 legislative efforts • with background and Q  & A
 documents  and to identify  potential  chemical

 EPA used multi-media  assessment  and   other
 analytical efforts to define and investigate potential
 problems.  For example, in May of 1973, a field
 investigation team  was dispatched to Ascension
 Parish,  Louisiana   to  determine  the source  of
 hexachlorobenzene  (HCB) contamination in cattle
 grazing hi Ascension Parish.  They determined a
 quarantine zone and recommended an action level
 for HCB in fat above which the cattle needed to be
 destroyed. (The situation that existed recently in
                     England that  resulted  in
                      cattle being destroyed there
                        was  unrelated  to   HCB

                            In   1974,    OTS
                             initiated    several
                                  efibrts, mainly
                                   to   prepare
                                        u r  e
         fognlafrutom mcroc *ad protect bma*a hu3& «ad ft* environment
       ty requiring totting «ad nocenuiy me re*trictio»« oa e«mia chemical
       xobttULcac, *ad &r other pmpa«M.
                                                        Be it essctod by the Etaute and Howe of Repreuntithw* of the United fitstoc
                                                        Of .Asuric* in Coagnu utMmblcd,
      lfek Aot m«y bo o&d u th* Toxio Snbrttaooc Control Act*.
documents  on chemicals  of potential  concern
(categories  of chemicals in  many  cases).   In
addition, although personal computers were not
available back then, a couple of projects explored
a  then-experimental  analytic tool,  looking  at
chemical structure-biological activity relationships
(SAR)  as  possible tools  for  assessing  "new
chemicals" with little or no hazard data on them.
(Today our scientists perform this complex set of
comparisons using computers at their desks.)

As time passed, TSCA legislative activity continued.
When Congress did not pass TSCA in one session
of Congress after another, the strategy  of OTS
became to perform an early warning service to
identify potential industrial chemical problems. All
the while, the Office anticipated that TSCA would
pass and staff could begin risk management efforts
on those chemical problems identified. OTS devoted
considerable  resources to better define concerns
with  polychlorinated   biphenyls  (PCBs),  the
"showcase" chemical problem designated for action
by Congress in TSCA.

About this same time there was also a project to
create a "toxics agenda" and prepare a small booklet
on this topic.  However, the "filthy fifteen"chemicals
selected  for  the  toxics   agenda  never  really

Issue No. 4
                          TSCA Yesterday
Events Leading Up to TSCA (continued)
became the Office priorities, probably because not
everyone folly accepted the concept.

While awaiting passage of the Act, many tried to
ensure that actions taken by any one of our sister
Offices were  consonant  with actions  taken (or
contemplated) by OTS and other Offices.  This was
done was through active participation on an Agency
Steering Committee.  OTS was often seen to be
meddling in the  process, perhaps because we
thought the Office had license to pursue problem
analysis on a multi-media basis.  However, OTS'
comments were constructive and on balance had a
 salutary effect. A good example of their effect was
the Office of Water's implementation of the Clean
Water Act, Section 301  (Effluent Limitations), as
well as other areas like sewage sludge land disposal
and ocean dumping.

Finally, TSCA passed in October of 1976.  OTS had
grown to about 40 people since March of 1973.
After waiting four years, final passage of TSCA was
somewhat anticlimactic.  Nevertheless, its passage
marked an  important change in the treatment of
toxic chemicals in this country that continues to this
The TSCA Chemical Substance Inventory: An Historical Perspective
       Henry Lau, Economics, Exposure, and Technology Division
Soon after the enactment of TSCA in 1976, one
of EPA's top priorities was  to compile an
inventory of chemical substances, as required
under Section 8(b) of the
Act.       The   primary
objective of the Inventory
was  to define,  from a
regulatory standpoint, the
chemical substances that
existed in U. S. commerce
for  the  purpose   of
implementing  the  New
Chemicals     Program.
Substances that were not
already  included on  the
initial   Inventory  were
considered  "new"  and
were  subject   to   the
P r e m a n u f a c t u r e
Notification      (PMN)
requirements that would become effective on July
1, 1979.

To ensure a complete and reliable Inventory, EPA
promulgated the Inventory Reporting Regulations
  (40 CFR 710) in 1977.  These regulations defined
  the scope of the Inventory. The challenge that
  EPA faced was how to define a workable subset
                 of commercial  chemicals that
                 would ultimately constitute the
                 initial Inventory  out of the
                 several   million   substances
                 known  to  exist.  Although
                 Congress specifically excluded
                 many types of substances (e.g.,
                 pesticides, drugs, food, food
                 additives, cosmetics, mixtures,
                 etc.)   from   the  reporting
                 requirements  under  TSCA,
                 EPA  used   the  Inventory
                 Reporting   Regulations   to
                 further narrow the scope by
                 exempting such substances as
                 impurities,  byproducts,  and
                 chemicals    considered   as
  "incidentally" formed  upon  the manufacture,
  processing,  or  use   of another substance.
  Additionally, to minimize the reporting burden on
  the regulated community,  EPA required  only
  those  persons who  were  considered

Chemicals in the Environment
                                   Fall 1996
 TSCA  Inventory (continued)
 "manufacturers" or  "importers" of commercial
 chemical substances to report.  Generally, most
 chemical processors did not have to report.

 How to represent the various types of commercial
 chemicals that might be reported on the Inventory
 was another major challenge for EPA. Since the
 Inventory was to perform the regulatory function
 of defining what  chemicals  existed in U.S.
 commerce, the chemical listings on the Inventory
 had to accurately and unambiguously define these
 commercial substances. EPA worked closely with
 the regulated community  to  develop specific
 guidelines  that  would  govern how to report
 particularly difficult types  of these substances,
 e.g., petroleum refinery streams, polymers, soap
 and detergent chemicals, and substances with an
 unknown or variable chemical composition. EPA
 recognized that each chemical listing should be
 neither too broad nor too narrow. While a broad
 listing might encompass too many chemicals and
 thus defeat the purpose of the Inventory,  an
 unreasonably narrow listing would impose  an
 unnecessary reporting burden for the regulated
 community. The close interactions with  the
 various segments of the chemical industry enabled
 the Agency to develop an Inventory that satisfied
 the Congressional mandate without imposing an
 unreasonable burden on the submitters.

 The Inventory was originally intended to be only
 a listing of commercial chemicals. However, after
 reviewing  public  comments to the proposed
 Inventory Reporting Regulations, EPA decided to
 expand the scope to also require the reporting of
 plant site location and production volume data for
 each chemical.  In this way, EPA was able to
 develop a more comprehensive profile  of the
 production  characteristics of   the  chemical
industiy.  The Inventory was therefore able to
provide basic information for chemical screening
and  priority  setting  under TSCA.     This
information was so useful that EPA subsequently
promulgated  the Inventory  Update Rule to
require the reporting of current production and
plant site data on a regular basis.

The Inventory is a growing list. EPA adds newly
manufactured  chemicals that have  completed
PMiM  review  to the  Inventory.   Since its
establishment in 1977, the number of chemicals
included  on the  Inventory has increased from
61,000 to over 75,000 today.  The Inventory
continues to function as an important part of
TSCA.  Both EPA and the  chemical industry
routinely rely on the Inventory to determine what
substances  are  reportable  under  the  New
Chemicals Program.   It  has also become the
model for other countries in the development of
their chemical inventories and chemical reporting

For further information on the TSCA Inventory,
contact Henry Lou at (202) 260-1555 or by email
at lau.henry@epamail.epa.gov.

Issue No. 4
                           TSCA Yesterday
TSCA Section 8(e) Substantial Risk Reporting and the 8(e) CAP
       Terry O'Bryan, Chemical Screening and Risk Assessment Division
TSCA Section 8(e) requires  industry to report
information  on  chemicals  or  mixtures  that
reasonably  supports  the  conclusion that  the
chemicals present a "substantial risk" of injury to
health or the environment. The kinds of information
submitted typically include results of toxicity studies
using laboratory animals.  Studies may relate to
reproductive     toxicity,    nervous    system
effects,cancer, mutation, environmental effects and
exposure, among other areas. This information may
be of value to those working with the chemical that
was  the subject of the submission or to others
working with structurally-related chemicals
exhibiting  similar   properties.       If
information has already been published or
submitted to EPA under other
authorities, it  is  exempt from
8(e)  reporting.

The   Section   8(e)  reporting
requirement  began  with  the
effective date of  TSCA on
January 1, 1977. The Agency
published interpretive guidance
in 1978. Since then, EPA has
provided further clarifications
through meetings, question-and-
answer sheets, and other forms
of communication. Up through 1991, the Agency
had received approximately 1,350 new 8(e) notices.

As a result of an enforcement case, EPA suspected
that  a large number of companies may not have
been correctly interpreting  the  8(e) reporting
guidance.  Consequently, in  1991, the Agency
established a voluntary audit program called the
Compliance Audit Program (CAP),  It allowed
companies to submit studies that they should have
provided to EPA earlier at reduced monetary
penalties. One hundred twenty three companies
participated; collectively, they will pay over $20
million in penalties.  EPA received  nearly 11,000
submissions —  a majority of the  13,800  8(e)
submissions received to date — under the CAP.

The CAP was to be  conducted in two phases.
Phase One covered toxic effects data, while the
second  phase was  to focus on environmental
exposure data.   As a result of Phase  One, the
Agency received 10,522  new 8(e)  submissions.
Each submission may contain several stetdle^" so the
number of studies received was substantially higher
than the number of submissions.

        Because  of this large influx  of  8(e)
         submissions, OPPT found it necessary to
         develop a streamlined process to review
                     the  data.    Each  study
                     received  a hazard ranking
                     of high,  medium or  low,
                     and chemicals were further
                     screened     based    on
                     production volume, uses,
                     existing risk management
                     status and other supporting
                     information.  The aim of
                     the  hazard ranking   and
                     screening    was,    and
                     continues to be, to identify
                     candidates  for   further
assessment or referral.   This process  makes it
possible to focus limited Agency resources on those
cases that may present  the greatest  level  of
unmanaged risk.

The unpublished 8(e) data have contributed to the
development  of  risk assessments on a number of
important industrial chemicals, such as glycol ethers,
formaldehyde, acrylamide and 1,3-butadiene. The
assessments, in turn, have prompted a number of
risk reduction activities by EPA, OSHA and the
chemical industry. EPA encourages 8(e) submitters
to  report  all voluntary  risk reductionand  risk
management actions as part of the 8(e) notices.

Chemicals in the Environment
                                     Fall 1996
 The 8(e) CAP Program (continued)
 Data submitted under Section 8(e) ho» also been
 used on a regular basis to support the OPPT New
 Chemicals Program.  It is stored in a data base that
 uses structure-activity relationships to predict the
 toxicity of new chemical substances submitted by
 industry in premanufacture notices required under
 Section 5 of TSCA.

 In June of 1991, EPA suspended it's reporting
 guidance for  exposure data. The guidance and
 requirements for toxic effects dafey representing the
 majority of 8(e) reporting, remained*!? effect. The
 Agency announced that the second phase of the
 CAP  would  be  conducted only after revised
 exposure guidance had been published.  However,
 Phase  Two  was  canceled after the  Agency
 concluded that the submission of old exposure data
 would be duplicative and would most likely have
 little value in identifying or assessing current risks.
 Thus, the Agency is in the process of formally
 closing the CAP.

 In the meantime, EPA proposed revised exposure
 guidance in the Federal Register in July of 1993.
 This guidance tries to avoid duplicative reporting
 without losing the opportunity to obtain information
 on previously unreported situations of widespread
 environmental  contamination.   Based  on  the
 comments received,   EPA revised the proposed
 guidance and provided another opportunity  for
 public comment in March, 1995.  EPA hopes to
 have the new guidance ready for publication in late
 1996 or early 1997. Concurrently, EPA is working
 with industry representatives to develop a question-
 and-answer document that will  further clarify  the
 guidance through the use  of numerous case
 examples.   When  the  final  exposure - related
 guidance is published, it will be prospective; that is,
 information obtained before the guidance was issued
 will not need to be reported.

 Complete copies of all 8(e) studies are available at
 the OPPT Public Docket and on microfiche from
the National Technical Information Service (NTIS).

All 8(e) studies are indexed by a variety of terms,
such as CAS number, chemical name, submitter's
name,  and study type.  They are included in the
TSCA Testing Submissions data base, which is
available  as  part  of  the National Library of
Medicine's TOXNET System and a commercial
data base called  Chemical Information System.
"Status Reports" or "Submission Summaries" were
prepared on all submissions through fiscal year 1991
(approximately 1,350 submissions) and are available
through the  TSCA Public Docket.  Additionally,
bound  volumes of status reports through 1990 are
available from NTIS. The results of "triage" hazard
evaluation and screening of CAP studies and other
recent 8(e) studies are captured in an electronic data
base available to the public.  The current product,
which  contains only a segment of the  CAPs, is
available on diskette and EPA's World Wide Web
Site on the Internet.  Over 500 copies of the  data
base have been distributed  on diskette, and  it is
accessed by  approximately 30 users per month on
the Internet.  The revised version of the  Triage
information   product  will   include   all  CAP
submissions,  in  addition to other  recent  8(e)
submissions. It is expected to be available to the
public by early 1997.

Issue No. 4
                         TSCA Yesterday
Evolution of the TSCA Interagency Testing Committee
       John D. Walker, Office of Pollution Prevention and Toxics
The Interagency Testing Committee (ITC) was
created by the U.S. Congress under Section 4(e)
of TSCA as an independent advisory committee
to the EPA Administrator. Its purpose was to
recommend chemicals to which EPA should give
priority consideration when requiring chemical
testing under TSCA Section 4(a).
       i'Q 16 U.S.  Government organizations
represented on  the  ITC, including the EPA,
Consumer Product Safety Commission, Interior
Department, Food  and  Drug  Administration,
National  Cancer  Institute,  National
Institute of Environmental Health
Sciences, National Institute for
Occupational    Safety    and
Health, and the Occupational
Safety     and      Health
The ITC  is responsible for
establishing the TSCA Section
4(e) Priority  Testing List,
revising the List at least every
six  months,   identifying  and
coordinating     the    Federal
Government's data needs for chemicals
on the List, and recommending these chemicals to
the EPA Administrator for further action.  The
ITC meets monthly as a full Committee to satisfy
its responsibilities under  TSCA Subcommittees
of the ITC form  partnerships with the producers,
processors and users of recommended chemicals
to discuss Federal data needs. The Committee
also reviews and summarizes unpublished data for
recommended chemicals and transmits semiannual
Federal   Register   reports  to   the  EPA

Since its creation,  the ITC has:
>     convened 270 meetings;
*•     issued  testing  decisions  on  40,000
>     recommended 3,500 chemicals for testing;
*     established dialogue groups with 30 trade
*•     reviewed 30,000 unpublished studies;
*•     prepared 1,500 chemical dossiers; and
>     transmitted 39 semiannual reports to the
      EPA Administrator.

The history of the ITC was recently published hi
a peer-reviewed book (Walker, 1993,451-509).

         1970-1976  -
           The ITC was created after several
             years of intense debate hi Congress
             over proposed toxic substances
              control legislation. In 1970, the
              President's     Council     on
              Environmental Quality expressed
              concern about chemicals  that
              were not regulated under the
             Federal Insecticide Fungicide and
            Rodenticide Act  and the Federal
           Food Drug and Cosmetic Act and the
        need for a committee  to coordinate
     interagency concerns on chemical testing.

In 1971, the Nixon Administration proposed toxic
substances legislation. It was passed by the U.S.
House of Representatives and the U.S. Senate,
but compromise could not be reached. Two years
later, hi 1973, the Chemical  Manufacturers
Association (CMA) lobbied Congress for a study
to  address  the need for toxic  substances
legislation.   In 1975, two bills that addressed
chemical testing were proposed.  One proposed
that all  existing chemicals be tested within five
years of TSCA enactment; the other proposed
creation of an independent advisory committee to

Chemicals in the Environment
                                   Fall 1996
 ITC (continued)
 the  EPA  Administrator  to  recommend  a
 prioritized  list of chemicals for testing.   On
 October 11, 1976, TSCA was enacted with an
 effective date of January 1, 1977, and the ITC
 was created.

 When  the  ITC  was established,  the  TSCA
 Inventory from which chemicals could be selected
 for recommendation to the  EPA  Administrator
 had not yet been created. To implement ITC's
 statutory agenda, member organizations provided
 lists of chemicals for which there were concerns
 about  the  adequacy  of test data.  The ITC
 organized  a Chemical Scoring  Workshop to
 prioritize these chemicals for consideration. From
 the ITC's first meeting hi February 1977 to its
 117th meeting hi October 1980, all the chemicals
 that were  deferred or recommended in  ITC
 Reports 1 through 7 were from the first Chemical
 Scoring Workshop.

 Chemicals chosen for consideration from 1981 to
 1988 were selected from Chemical  Storing
 Workshops; chemicals were deferred for testing
 or recommended in ITC Reports 8 through 24.

 Chemicals selected for consideration from 1989
 to  1996 were  nominated by  ITC members
 because their organizations had clearly defined
 data needs for these chemicals.  In addition, the
 ITC  organized  subcommittees  to   review,
 prioritize, and  coordinate these  daiaja?eeds;
 developed a computerized system for idv^Jrying
 potentially  hazardous chemicals  in chemical
 groups; and established partnerships with the
 CMA and other trade associations to discuss the
 needed   data  and  develop   databases   of
 unpublished studies.

 Walker, J.D.  The TSCA Ihterageney Testing Committee,
 1977  to  1992:  Creation,   Structure, Functions  and
 Contributions. In Environmental Toxicology  and Risk
Assessment: Second Volume (ASTM STP 1216). eds.
 Joseph W. Gorsuch, F. James Dwyer, Christopher G.
 Ingersoll, and Thomas, W. La Point, 451 -509. Philadelphia:
 American Society for Testing and Materials, 1993.
                        The New Chemicals Program: A  Legacy of Progress
                            Paul Bickart, Economics, Exposure and Technology Division
 In July of 1979, the first premanufacture notices
 (PMNs) began arriving at EPA These notices
 are required under TSCA for new chemicals that
 manufacturers want to produce for the first time.
 We expected, at most, a few hundred notices a
 year. A study prepared for the Agency projected
 that, if testing and paperwork costs were  kept
 low, the American economy might be able to turn
 out  400 new  chemicals a year. That  was
considered optimistic.   Thus, after receiving
30,000 notices, we are at a fine vantage point for
looking back on the past twenty years.

The initial, few PMNs gave only a few hints of
changes brewing in the chemical industry.  Even
so, in the first year there were suggestions of a
trend toward manufacturing chemicals that were
better from an environmental point of view.

Issue No. 4
                                                                             TSCA Today
 Legacy of Progress (continued)
 Examples included the synthesis of a pesticide
 with  negligible toxicity toward mammals and
 birds, a resin to increase the tread life of tires, and
 a new lubricant derived from a renewable source.

 As the flow of notices increased, we started to
 see other trends emerge. When crude oil prices
 were high, we saw a surge of energy-efficient
 coating materials. When the fear of an oil crisis
 abated, use of some energy-efficient coatings fell
 off in favor of less costly solutions.  At the;
.time; use of other coatings continued to
 Why?  The other coatings met strict  new air
 quality standards to lower the emission^* volatile
 organic compounds.

 Nearly half of all notices werelied for polymers,
 a class  of chemical distinaMied by tfear Mg$l
 molecular  weight  amr  repetitive  ctiessbai
 structure. ^_^After~yljars  of experience*  we
 recognize< i tftat about  hajf of all polymers
 presented  DO  real  risk  to  tbalt&  or
 environmei ft, either because of thek <
 or their pn >|>eities,' We devised chemical <
 to classify feese relatively sde j
 expedited internal, review^ fad IjTl^S^  lot
 exemption  from seme of the rigors of PMM
 steps, we i
          in 1995, the polymer exemption wa&
          6 eliminate PMN reporting altogether
             jyja.ers,  (MotwithsJanding these
            1 get maayaotice^Jfer polymers.)
The PMN^xro^essl^fieettdtie growth of the
microelectronic revolution. Somt
have been created for the semiconductor itself,
                                                while   others   are   for   photolithographic
                                                manufacture of the microchips, like photoresists,
                                                contrast enhancers, and sensitizing dyes.  Still
                                                         : for peripheral devices, such as  liquid
                                                             display devices, dyes  for  inkjet
                                                         \colorants  for  sublimation-transfer
                                                       , an i charge-control agents for toners for
                                                /laser jjrlnt« rs, to name a few.

                                                M tbe las^ couple of years,  we have seen an
                                                           trend   towards  inherently  safer
                                                       is,  design of  safer  and  less waste-
                                                           chemical processing, and greater
                                                recycling of wastes and byproducts.  We are
                                                                       encourage these trends
                                                                             _      such as
                                                             C&engs&y''"' Cfeateage  \and  the
                                                             L Technologies Mtiative.
                                                      trends &st we
                                                     We looked forward to i
                                                                                 we not yet
                                                        would have produced more jPMNs by
                                                                                    icals for
                                                                                 iut we have
                                                                                to see more
                                                                                 but as long
                                                                                      in the
                                                              re supercoi
                                                   jerials from renewable:
                                                     LcaHwek>|^tosee,mfatafePMNs? Asa
                                                          [ a long-time scienee.fiction buff, I am
                                                Jooktag §Mward to self-assembUng molecular
                                                       and eventually, a whole new chemical
                                                  iustry based on nanotechnology - but I am not
                                                holding my breath.
The New Chemicals Program; A Legacy of Prevention and Risk Reduction
      David Di Fiore, Chemical Control Division
As we recognize the 20th anniversary of TSCA,
the New Chemicals Program is nearing a major
milestone of its own—the review of 30,000 new
                                                chemical notifications. Since the implementation
                                                of TSCA, the New Chemicals Program has acted
                                                as gatekeeper for new chemicals seeking to enter

Chemicals in the Environment
                                   Fall 1996
 Legacy of Prevention (continued)
 the commercial marketplace in the U.S.  Only
 those  chemicals  that can  be  manufactured,
 processed, used and disposed of in a safe manner
 are   allowed   unrestricted   market  entry.
 Substances  that present  unacceptable risks to
 human  health  or the  environment  may  be
 restricted entirely from commerce.

 While the vast majority of chemicals proposed for
 manufacture do not pose a concern for human
 health or environmental effects, a significant
 minority do—about 10% of all submissions or
 roughly 200 chemicals per year.  In these cases,
 OPPT raises a cautionary flag by  taking some
 form of regulatory action.  For example, the
 program might  require  testing prior to  any
 nranufacture, to refine the toxicity and risk profile
 of a chemical. Testing might be followed up with
 certain  control  measures,   for  example,  a
 restriction of releases to water. Or,  manufacture
 might be allowed without prior testing only under
 specified conditions, such as restricting discharges
 to a stream or landfill or providing workers with
 protective equipment.

 Requiring chemical manufecturers and processors
 to   implement  protective   measures   limits
 exposures to potentially toxic substances  and
 thereby lessens the risk of harm to people and
 their environment.  The potential beneficiaries of
 these actions are many.  They may include, for
 example,  the  worker who  weighs  or. mixes
 substances at a chemical plant, the  environment
 and aquatic life  surrounding a facility, and the
 individuals living hi a  plant's vicinity who might
          drink water from nearby rivers or wells
                           or  eat fish  from
                           local streams.

                            Many   times  the
                            harm    that    is
                            avoided   involves
                            chronic effects, like
                            cancer  or  lung
disease, which m
Issue No. 4
                               TSCA Today
The OPPT Structure Activity Team
       Becky Jone^; Health and Environmental Review Division
The OPPT Structure Activity Team (SAT) is a team
of expert scientists, including chemists, biologists,
lexicologists, and  information specialists.    The
function of the SAT is to evaluate the potential
health and environmental hazards and environmental
fate  of chemicals  through the use of chemical
structure  -  biological  activity  relationships.
(Chemical structure - biological relationships, or
SAR, refers  tQ^the-link between a  chemical's
structure   and  -ib-  effects   on  people   and
environmental organisms.)  A hazard assessment
developed by the SAT relies on available test data
(although frequently little or nothing is known about
the chemical) and  expert judgment to provide a
preliminary 'assessment of chemical hazards  and
environmental fate.

The health hazard assessment includes a description
of the potential for  a chemical  to be absorbed
through the skin, lungs, and intestinal tract. It also
identifies how the chemical may be changed in the
 body and the potential for the chemical to cause
acute toxicity, neurotoxicity (effects on the brain
and other nerves), effects on internal organs such as
the liver or kidneys, bath defects, infertility, effects
on DNA, and cancer, if exposure to the chemical

The environmental fate profile predicts how quickly
the chemical will  degrade if released into  the
environment. Additionally, the potential transport
of the  chemical  through the  environment is
predicted. The environmental hazard profile judges
how toxic the  chemical will be to plants  and
environmental organisms living in water (such as
fish) or on land (such as birds).

Important factors in developing hazard assessments
are information on the subject chemical, information
for structurally similar chemicals, known toxicity of
chemical classes or parts of a chemical,  and the
knowledge and judgment of SAT members.
                             | Joseph Seifter; MIX* one of &e osgtual members of OPPT's celebrated
                             Stmetare AetiyitjrTeasa, was a remarkable individual and. scientist who
                             -was cental to the earfy technical development and establishmentof the
                             SAT.  Dr. Settler's work with, the SAT eapped1 an eminent career
                             spanning more titan 50 years which produced major eontribatiofls in
                             basic  medical research  and  outstanding service  as-a  teacher,
                             experimentalist (over 200 scientific publications), administrator, and
                             sctefttifie advisor, Br, SeSler*s profound understanding of the cbernksal
                             basis of pharmacology and toxicology was seminal in establishing aad
                             guiding the SAT through; its early years.  His death ia 1982 brought a
                             remarkable career to a. close. Though we mss Mm still, the analytic
    approach, insights* aad technical: excetence wMch. he exemplified., and: freely extended to others as
    botl a coBeagpe and mentor coaHnoe to fesosate ia tiie SAT asd k the  careers of <&e jaany
    ittdividoab i^asejive£ %e fofdied wi enriched; — CfiorfesM. AwrjEwectaf^ Chemical Control

Chemicals in the Environment
                                     Fall 1996
 Structure Activity Team (continued)
 The SAT was originally formed in 1979 to evaluate
 new chemicals (that is, chemicals not currently made
 or used in the U.S.) submitted to OPPT under
 Section 5 of TSCA. Since that time, the SAT has
 evaluated over 30,000 chemicals. Today, the SAT
 reviews over 2,500 new chemicals each year. The
 SAT is also called upon to screen chemicals which
 are already being made or used in the U.S.  Over
 3,500 existing chemicals have been evaluated for
 OPPT and other EPA offices, including regional
 offices and other government agencies.
 During  the  past  year,  the  SAT
 evaluated    approximately    60
 chemicals  in  support of EPA's
 Office of Solid Waste for two of
 their hazardous waste listings. The
 SAT also evaluated over 50 chemicals
 for the Office of Air and Radiation as
 an   early   step   in  identifying
 replacements   for  chlorinated  solvents  and
 chlorofluorocarbons (CFCs) that are being phased
 out because of their  effects on the ozone layer.
 Presently, the SAT is in the process of evaluating
 approximately  1,500 inactive ingredient chemicals
 added to pesticide products.

 The SAT interacted with the U.S. chemical industry
 to share the  SAR  principles routinely used in
 evaluating  chemicals.    Ideally,  this  type  of
 cooperation will result hi the design and use of less
 toxic chemicals.

 The SAT recently participated in a joint study with
 the European Union (EU) to determine how well
 the SAR methods employed by the SAT work. The
 SAT evaluated the chemicals in the usual way and
 then compared the  assessments to the results  of
   studies  that were submitted to the EU.  This'
             exercise  found that  the SAT was
             highly successful both in predicting
              the   environmental   fate   and
                environmental    hazard    and
                identifying potential human health
                effects of the chemicals.   Since
           that time, the methods employed by
           the  SAT have been studied by the
           Canadian, Japanese,  and Australian
  governments,  as  well as the members  of the
 European Union, for possible use hi programs  to
 screen chemicals that  are  of concern in their
 respective countries.

For more information about the SAT and the risk
assessment process for chemicals see the Winter
 1995/1996 issue oj Chemicals in the Environment
 OPPT's Chemical Testing Program
       Dave Williams, Chemical Control Division
 Under the Toxic Substances Control Act (TSCA) of
 1976, EPA is given broad authority to gather
 health/safety and  exposure information on, and
 require testing of,    chemical  substances  and
 mixtures. TSCA states that "it is the policy of the
 United States that adequate  data  should  be
 developed with respect to the effect of chemical
 substances  and  mixtures  on  health and  the
 environment and that the development of such data
 be the responsibility of those who manufacture [and
import] and thosewhoprocess such chemicals and
mixtures." This article provides a brief history of the
TSCA ChenricalJesting Program in EPA's Office of
Pollution Prevention and Toxics (OPPT).

Before requiring companies to test chemicals, EPA
reviews numerous publicly available data sources as
well as the data we collect through our reporting
rules.  Based on this information, we must decide

Issue No. 4
                               TSCA Today
Chemical Testing Program (continued)
 1.     Existing data show that the chemical "may
       present an unreasonable risk of injury to
       health or the environment" and that there is
       probably exposure; and/or
2.     The chemical is produced or imported in
       substantial quantities, and, either enters the
       environment  in substantial  quantities  pi
       results hi significant human exposure; and
3.     Existing data cannot reasonably predict
       human health or environmental effects; and
4.     Testing is necessary to  develop adequate
       data to conduct a risk assessment.

In  the early  years of  TSCA,  EPA used a
complicated  two-phase  rulemaking process  to
require chemical testing under Section 4 of TSCA.
In the first phase, following issuance of a proposed
rule for public comment,  EPA issued a final rule
identifying the chemicals and the type(s) of testing
required. This final rule required industry to submit
test protocols  and study  plans for EPA review.
EPA  accepted  the  protocols  (including  public
comments on them) through a second rulemaking.
This  approach gave  the  chemical industry a
maximum amount of flexibility in developing testing
protocols, but it proved very cumbersome. In fact,
EPA was sued by the Natural Resources Defense
Council (NRDC) in 1980 because the Agency was
not meeting its statutory deadlines for Test Rules on
chemical  designatedfor  testing by the TSCA
Interagency  Testing  Committee   (ITC).  ( See
Walker article this issue.) The Agency launched an
effort to obtain testing via "Negotiated Testing
Agreements" (NTAs) with the chemical industry.
This effort was successful in many ways and
resulted in important dialogue between EPA and the
chemical industry. However, the  NTA process
lacked public input and enforceability under TSCA,
which resulted hi another NRDC lawsuit in  1983.
The court found the NTA process illegal.

In collaboration  with NRDC  and the Chemical
Manufacturers Association (CMA), EPA developed
a formal "Enforceable Consent Agreement/Order"
(EGA) process hi the mid-1980's that encourages
public  participation.  EPA  also streamlined  the
process by  developing  formal  Test  Guidelines,
which allows EPA to simply cite the  appropriate
testing methodology in  Test Rules. In the mid-
1980's, therefore, EPA felt that it was well on its
way to  affecting a strong  Chemical  Testing

The Program had  continuing  legal  challenges,
however. During the mid-1980's, CMA and EPA
agreed that EPA's risk finding (#1 above) is based
on both the toxicity of the substance and exposure
to it. However, CMA and EPA differed over three
specific questions —  whether EPA: (a) must find
that an unreasonable risk is more-probable-than-not,
(b)  must specifically  rebut any industry evidence
suggesting no human exposure by direct evidence of
exposure, and has the authority to issue a test rule
where any individual's exposure is an isolated, non-
recurrent event.  In response to a lawsuit filed by
CMA, the court upheld EPA's views  that a Test
Rule is appropriate  where EPA has substantial
reason for suspecting that some amount of exposure
takes place and the chemical is sufficiently toxic at
that exposure level to present an "unreasonable risk
of injury to health."

In the late 1980's, CMA again sued EPA, charging
that the Agency had not sufficiently developed and
publicized     its
criteria for making
the     substantial
exposure  finding
(#2  above). This
lawsuit delayed the
Program for over
three  years  while
the     Agency
developed    and
announced   its

Chemicals in the Environment
                                     Fall 1996
 Chemical Testing Program (continued)
 criteria in 1993. Although EPA still was able to
 obtain some testing through EGAs, the Agency also
 looked to voluntary industry initiatives to bolster the
 Testing Program. EPA encouraged members of the
 chemical industry to initiate voluntary testing
 activities to develop data needed to protect human
 health and the environment. EPA now has 3 primary
 tools  to obtain testing:  Test Rules,  EGAs, and
 Voluntary Testing Agreements.

 EPA continued to receive much criticism  from the
 U.S. Congress and others about the slow pace of its
 testing program in the early 1990's. Along with the
 issuance of the exposure criteria in 1993, OPPT
 issued  a  Chemical  Testing Program Vision
 Statement with the following goals:

 >•      Increase  the overall productivity of the
        Chemical Testing Program;
 >•      Establish  a  clear  agenda  for  chemical
 »•      Ensure that testing  is  directed  toward
        meeting data needs,  not just  filling data
 *•      Redefine   success  to   recognize   the
        contributions of each of the 3 primary tools
        to fill data needs;
 *•      Emphasize pollution prevention initiatives to
        reduce exposure  or risk  as  a  possible
        substitute for, or adjunct to, testing;
 *•      Promptly review and evaluate test results;
 *•      Improve internal and public  access to test
        data and EPA reviews.

 Finally, OPPT has developed a "Master Testing
 List" (or MTL) to establish the agenda and priorities
 for the Testing  Program  and  to serve as  a
 cornerstone by presenting the universe of existing
 chemicals that have the greatest need for testing.
 The MTL identifies the testing needs of the federal
 government  and international programs  of U.S.
 interest  (e.g.,   Organization  for   Economic
 Cooperation and. Development (OECD) "Screening
Information Data Set" (SIDS) * xogram.  See CIE,
Spring/Summer 1996, pp. 14-15.) Based on broad
public input,  the MTL both focuses on priority
chemical testing needs
and   publicizes  those
priorities, to encourage
voluntary     industry
testing. Listing  on  the
MTL occurs via formal
requests  from  other
EPA  Program Offices,
from    other  Federal
agencies,   from  within
OPPT's Existing Chemicals Program  (see CIE,
Spring/Summer 1996, pp.  11-12), or by way of
designations by the  TSCA Interagency Testing

It is important to note that'OPPT has been using the
MTL since 1990 to set the agenda for the Chemical
Testing Program. Since 1979, about 550 chemicals
have been tested (almost all of these are U.S. High
Production Volume or HPV chemicals), and more
than  50%  of these actions occurred in the  last
several  years.  In  addition,   EPA  has  issued
approximately 250 TSCA  4 Section "Decisions-
Not-To-Test" since 1979; many of these DNTs have
also involved HPV chemicals. The MTL currently
contains over 500 specific chemicals and more than
15 categories - virtually all of these are currently in
testing or a testing action is under development. A
revised MTL, which also contains a list of those
chemicals removed from the MTL (because, e.g.,
testing  has been  completed), was  issued  on
December  13,  1996 (see  61  Federal Register

Today's TSCA Chemical Testing Program can be
characterized by the following attributes:

>      EPA has a clear testing agenda; the MTL
       presents a consolidated public list of the
       priority industrial chemical testing needs of
       EPA and other Federal agencies;

Issue 4
                               TSCA Today
Chemical Testing Program (continued)
»•      More chemical testing is being conducted --
       more than 300  tests are underway, and
       OPPT is developing testing actions on over
       200 chemicals;
>•      EPA will continue to develop testing actions
       by using a mix of Test Rules, Enforceable
       Consent Agreements, and Voluntary Testing
»•      Many U.S.  chemical  companies appear
       willing to conduct testing and to establish
       voluntary product stewardship programs for
       their chemicals;
*•      International efforts such as the voluntary
OiiCD/SIDS  testing program  continue  to  be
integral to OPPT's Testing Program, and we will
continue to encourage U.S. industry participation;
>      Enforceable Test Agreements and Voluntary
       Testing Agreements offer an increased role
       for pollution prevention and risk reduction
       measures as an offset to some testing;
>      Efforts are underway to further improve
       public access to OPPT test data.
Evolution of Risk Management of Existing Chemicals Under TSCA
       Ed Brooks, Chemical Control Division
Birth of Section 6
From  1971  to  1976,  while  several  toxic
substances  control bills were being debated in
Congress, three concerns animated the drive for
an authority to control existing chemicals (i.e.,
commercial chemicals already in production):
»      The  cancer mortality  rate had been
       accelerating since before World War II;
>      Industrial chemicals were believed to be a
       major cause of the increase; and
>      Authorities to control many problems
       posed by industrial chemicals were either
       non-existent or inadequate.

Prevailing  opinion regarding  the first two
concerns  was captured  in  Dan  Rather's
introduction to a CBS documentary, aired at  the
time, entitled The American Way of Cancer:

       "The news tonight is  that the United
       States  is number one  in cancer.  The
       National Cancer Institute estimated that if
       you're living in America your chances of
       getting cancer are higher than anywhere
       else in the world.  Evidence indicates a
       link between rising cancer rates and
         industrialization, and we have  led the
         world in both."

  The third concern was articulated in  a 1971
  Council on Environmental Quality (CEQ) Report
  entitled Toxic Substances, which noted that:
  •>      The Federal Water Pollution Control Act
         had no authority to regulate specific toxic
         chemicals in effluents;
  *•      There was  no Federal authority  to
         regulate disposal of toxic substances; and
  »•      There was  no Federal authority  to
         regulate toxic substances in consumer
         products  that were not food, drugs or

  Moreover, even where adequate authorities did
  exist to control toxic substances, the reach of
  those authorities  was restricted to particular
  environmental media (such as air, water,  or land)
  or to particular settings or applications (such as
  workplaces,  food,  drugs,  or pesticides).   A
  Federal  authority  was  needed  that could
  effectively address risks posed by toxic chemicals
  found in more than one medium or setting or that
  could move from one type to another.

Chemicals in the Environment
                                                              Fall 1996
 Risk Management (continued)
 juased on these concerns, the CEQ recommended
 passage of a Federal authority that would fill the
 regulatory  gap  by,  among  other  things,
 empowering EPA "to restrict or prohibit the use
 or distribution of a chemical sub
 restriction were necessary to prot
 the  environment".   Congress
 enacting Section  6 as  part of TS
 section provided not only the authority,
 restrict production or use of toxic chi
 also to regulate disposal  of such chemi
 require labeling   and  notification
 Following  enactment,  questions
 whether TSCA was actually intend
 regulatory gaps, or whether it was int
 a broader  "umbrella"  role,  when
 become the primary Federal statut
 with toxic substances.   In either
 anticipated that,  at a  minimi
 chemical problems not  effe
 under other statutes would be
 by rules promulgated under S;
 limit use of chemicals that
 risk — where unreasonable
 somewhat  imprecisely
 outweighing the benefits

 To this end, EPA's Offii
 (subsequently  renami
 Prevention and Toxi
 next  several  years
 chemicals that  (1)
 standard, and (2) w;
 other authorities.

 The Early Years
 That goal proved elul
 apparent hurdles to bi
 unreasonable risk standan
 Congress subsequently enacted other statutes that
 essentially closed the void Section 6 was designed
 to fill.
                           With respect to the unreasonable risk issue, after
                           taking action under Section 6 to curb aerosols
                           containing  chlorofluorocarbons  (CFCs),  the
                           Agency came to view Section 6 rulemaking as an
                                         ?pnd complex undertaking that
                                         *'i>ect of resulting in success.
 to  new  legislation,  following
   CEQ report Congress passed

   Conservation and  Recovery
  lorizing  Federal  control of
 of toxic substances;
 ater Act, authorizing, for the first
regulation  of  specific  toxic
 s hi effluents;
      Product    Safety    Act,
    among other things, banning
   iroducts posing unreasonable
      and the
      Water Act, authorizing the
       tent to establish maximum
            ions  of  specific
        lie water supplies.

                 •egulatory gap
                   to address.
                   ;es between
                ctory situation,
                sparsely.   The
                    to ban or
                ;hromium, and
                                                  iis period, successive
                          administrations became increasingly aware  of
                          both the difficulty and the inefficiency — hi an
                          area fraught with uncertainties — of attempting to
                                 risks of
                                 federal g
•w. ipartjibecause of the

Chemicals in the Environment: Public Access Information
(Supplement to Issue No. 4)
Some of the many people instrumental in creating and implementing the Toxic Substances-Control Act have
agreed to share their personal recollections about TSCA.  Chemicals in the Environment thanks them for
sharing their thoughts with us.  <•                             ~                               •'    -
In the Creation of EPA Lay the Seeds of TSCA
  ~ Terry Davies, Director, Center for Risk Management, Resources for the Future
      (Assistant Administrator, Office of Program Planning and Evaluation, »1989-1991)  T
One of the things that makes life both interesting and
confusing is that each of us mentally writes history from our
own unique and sometimes peculiar vantage point. For me, the
creation of EPA and the origins of TSCA are jntertwined.  .
                        *  -v       jf
In 1967, having spent two'years as (ttie first ever) budget
examiner for environmental programs at the Bureau of the
Budget (now the Office of Management and Budget), I
returned to academic life. Like all good academics, I had to
write a book.  Naturally enough, I wrote one entitled The
Politics of Pollution,'-which was published early in  19JO.'
According to the conventions of the day, books of this kind
had to have a concluding chapter that made recommendations
to cure all the ills that had been identified in the previous
chapters. In my concluding chapter I wrote:"*'

   "Each year hundreds of new'chemical
   compounds and new uses for existing chemicals -
   and,metals are being intrbduced'in the United  ^  ,
   States.' And this is done -with little regard for
   their effects on human health or on ecology.... >  "
   What is needed is a Federal agency -with'
    responsibility for determining the health effects
    of all such substances^ setting standards for
    human exposures to them, registering and
    'approving new chemicals, and monitoring the
    ^course ofsuch^substances in the environment,
    thus tracing the sources of human exposure,"

 In 1969, as a consultant to the President's Advisory Council •
 on Executive Organization,  I worked on the new Federal
 -agency which became EPA. When I went to work for the
 Council on Environmental Quality the following year; one of
 my first projects was to draft legislation for "registering and
 approving new chemicals." I was assisted by Charles Lettow,
 a  young lawyer  who was also a chemical  engineer.- The
, ;chemicals legislation was; cfrafted"af-the^ same time that
 Congress was 'considering the reorganization plan to create
 EPA. Forme, the legislation that became TSCA was intended
 to take the same holistic, integrated, balanced approach to
 environmental problems as  the new agency. Neither the
" legislation nor the agency exactly turned out that way - a sad
 commentary on both the pollution control system and my
 ability as a forecaster.        "/
The Passage of TSCA: A Lesson in Compromise  ,
 _  Warren Muir, President, Hampshire Research
      (Director,  Office of Toxic Substances,  1977-1981)
The fact that TSCA, unlike virtually  any -other federal
environmental law, has had no significant amendments since
its original passage in 1976 does not mean that its legislative
history was uneventful. On the contrary, (differences over the
vision of toxic substances control legislation were so great that
  it took three full congresses before a compromise version was

  Competing versions were passed in each House by large
  margins in 1972,1974, and 1976. The Senate wanted all new
                                        TSCA Perspectives
                                       _     P-1      -_

 Chemicals in the Environment
                                         FalM 996
 chemicals registered by EPA after premanufacture review.
 The House of Representatives wanted EPA review limited to
 those new chemicals that EPA, by rule, listed as high priority

 The compromise struck was the current system in which EPA
 is given notice at least 90 days in advance of manufacture and
 supplied with existing information. (No testing is required.)
 If EPA  does not act within the review period, the new
 chemical can be manufactured freely. If EPA finds during the
 review period that the chemical may, pose an unreasonable
 risk,  it can  seek to  prohibit or restrict the  chemical's use
 pending  the development of additional information.  If the
 submitter objects to EPA's finding, EPA must go tojiourt
 before the end of the  review period and obtain a court order to
 impose its determination.

 In the I970's, it was  taking EPA years to register a relatively
 few new pesticides.  Many observers  felt  at the time  of
 enactment that the compromise  would  fail  because of the
 burden on EPA to act  on hundreds or thousands of poorly
characterized chemicals in a 90-day period, requiring this
aspect of TSCA to be revisited quickly.

Even after Congressional action on this compromise, its fate
was uncertain as President Ford seriously considered vetoing
the bill, even though the idea of TSCA was originally aNixon
administration proposal that had been supported by President
Ford. In the end, with the urging of both the Manufacturing
Chemist Association  (now the  Chemical Manufacturers
Association), organized labor,  and  the environmental
community, he signed the bill into law.

Looking back now, it is clear that the new chemical review
program that was the big compromise after contentious debate
has been TSCA's greatest success. More than 20,000 new
chemicals have undergone EPA premanufacture review. On
nearly 10 percent, EPA has acted to restrict use and/or obtain
more data.  No EPA orders have been challenged in court.
And most importantly, none of the environmental problems of
concern today seem to be tied to chemicals that have been
reviewed under the law.
 No Rose Garden for the Toxic Substances Control Act
   [from Glenn Schweitzer, former Director, Environmental Monitoring Systems Laboratory, Office
      of Research and  Development,  in: Borrowed  Earth,  Borrowed  Time, Healing Amen'ca's
      Chemical Wounds (Plenum, 1991)]
 When TSCA finally overcame all the hurdles in the Congress
 and arrived at the White House for signature, President Ford
 delayed his response to the very limit of the time allowed until
 a pocket veto would take effect. Only a few hours remained
 when he finally signed the legislation into law in the privacy
 of his office in October 1976.

 But why did he delay? Why didnt he celebrate the passage of
 this complicated legislation with a signing ceremony in the
 rose  garden?  Environmental  and  industrial  leaders,
 congressional and cabinet officials, and labor and foreign
 trade executives who had repeatedly clashed  during  the
 incubation of the legislation could have joined hands in an
 unusual display  of national consensus. President  Ford's
 campaign for reelection desperately needed demonstrations of
 support from all sides. Perhaps the President's staff correctly
judged that the new legislation was politically insignificant in
 comparison with education, welfare reform, crime, and other
 social and economic issues confronting the nation. Perhaps the
 impassioned congressional  debates,  the intensity of  the
 lobbying efforts, and the media accounts of the cancer crises
 had exaggerated the threat of toxic chemicals. But isn't
 legislation that could affect the daily workings of tens of
 thousands of industrial firms  throughout the country of
 considerable importance?  The White House inner circles
 wanted the chemical problems which regularly punctuated the
 Washington Post and the New York Times to go away. After
 struggling until the last minute to understand the complicated
 provisions which Congress had crafted, they undoubtedly
 concluded that the new legislation would help, even though
 it could hardly be considered monumental in their eyes.

 Meanwhile, the Chemical Manufacturers Association and the
 Chamber of Commerce had advised the White House of their
 desires to have the legislation signed and thereby end the
 regulatory uncertainty that had hung over the chemical
 industry for five years.  The  Sierra Club, the Natural
 Resources Defense Council, and other environmental groups
 assured the presidential aides that their concerns had been
 addressed. The AFL-CIO argued that safety was even more
 important than jobs and that the law should be enacted. The
 Office of Management and Budget, the EPA,  and;other
 agencies endorsed the legislation. Even some of the states
 had become vocal advocates for the law which would shift to
 the federal government many  of the politically charged
 problems of public health threats that they were encountering
 every day. Since no one seemed to object, any need for the
 President to be concerned with the fine print must have
 appeared very unimportant in comparison with the large
 issues of the reelection campaign. In any event, the President
 clearly missed a useful opportunity to enhance his image as
 a responsible advocate of environmental protection by not
 taking center stage in the rose garden.
                                           TSCA Perspectives
                                          _     P-2      	

 issue No. 4 (Supplement)
                       Perspectives on TSCA
 Looking Back: Twenty Years Later
   Marilyn C. Bracken, Ph.D., Bracken Associates, L.L.C. (Deputy Assistant Administrator for Toxics
      Integration, Office of Toxic^Substances, 1980-1983)
 When I reminisce about the early days  of TSCA, L am
 reminded of the youth and enthusiasm of the staff and the
 challenges of implementing ,a new law. In my case, some
 particular challenges were organizing and publishing the
 Inventory of Chemicals, writing Section 8 rules, working with
 member  countries  of the  Organization for • Economic
 Cooperation and Development on .international activities in
 chemicals, and using the integration authorities of TSCA to
 coordinate and disseminate information: We were pushing
"technology trying to get computers to talk to each other.
 'Twenty years later, we can all log on to the Internet and find
 information on chemicals, their uses, exposure data, product
 data,  test data, etc. — much  of  it a byproduct of the^
 information collection and dissemination statutory authority
' of TSCA.

 A real benefit of TSCA was dausing a change hi the way
 companies organize" and track information on chemicals.
 Now companies routinely track exposure, seek ways to
 prevent releases and negative impacts to human health and
 the  environment, and  concern themselves with product
 stewardship.* -There  is  a  new  awareness  of  quality
 management,of chemicals that TSCA clearly impacted,
 perhaps not as explicitly as the original implementers thought
 but nevertheless a pervasive influence.
 The TSCA Program Gathers Momentum
   Don R. Clay, President, Don Clay Associates, Inc.
       (Director, Office of Toxic Substances,  1981-1986),
 From 1981 to 1986 — my tenure as head of the Office of
 Toxic Substances — were exciting and productive years/ We
 established the new" chemical review program without bringing
 the American chemical  industry  to  its  knees, the .first
 Premanufacture Notice (PMN) exemption for polymers was
 developed, and the great debate within the Organization for
 Economic- Cooperation and Development over the use of
 structure activity versus using a base "set of data was raging.
 Section 4 testing rules were being developed at a rapid rate
 and the existing chemicals program was struggling to^regulate
 asbestos." Rules were being written  for polychlorinated
 biphenyls (PCBs), and'a  lot of time was  spent deciding
 whether or not formaldehyde is a,4 (f) chemical. (OTS later
 determined mat formaldehyde is a 4(f) chemical.)

 Unlike many of EPA's offices, the TSGA Office had the
 luxury of being able to devote some resources to looking
 ahead, rather than being driven exclusively by deadlines
 imposed by statute or court order. As a result, we were able
 to  predict that biotechnology  would become  a  growth
 industry and that, at least initially, we would need some level
 of review to assure,, the  public  that  these living products
 would not harm ttiem.  Thus  was ,bom  a  series  of
 biotechnology regulations, a program that continues to this -
 day.      -        .'„                  „  - -
 The TSCA Chemical Inventory
   Bob Hagerman (RegulatoryAssociate, Dow^Chemical, 1955-1995)
 A review of the Toxic Substances Control Act upon its
 enactment twenty years ago demonstrated that it provided the
 EPA powerful, perhaps unique, authority to gather from
 manufacturers, processors, and users  of chemicals  data:
 needed to evaluate and regulate risks associated with industry-
 products and activities.

 The first application of this authority was the development of
 the TSCA Chemical Inventory reporting rule as required by
 Section 8(b) of the Act. A small subgroup of the Chemical
 Manufacturers Association (CMA) Chemical Regulations
 Action Committee (then MCA-CRAC) met with its EPA
 counterparts over an extended period to determine what -
'information would be both useful and practicably obtainable
 for the. purpose of compiling a list of chemicals in U.S.
 commerce: This was a pioneering effort because neither side
 had experience with a law such as TSCA and many of those
 involved at the time had no experience with the regulatory
 process.              '
                                         TSCA Perspectives
                                        _     P-3      	.

Chemicals in the Environment
                                         FalM 996
Initially the effort was aimed at developing a simple list of
chemicals in US commerce. This was complicated following
proposal when, on a brigh» Jkinday morning on May 1977,
Administrator  Charles Quarles appeared on "Meet The
Press." Chagrined by lack of an answer when asked how he
hoped to regulate chemical risks without knowing where they
were produced, by whom and hi what quantity, Mr. Quarles
vowed to rectify the situation.

Very shortly we were involved  in a drastically revised
proposal. In addition to this pivotal issue, in always lively
and frequently spirited discussions we addressed other major
issues including: What information could be treated as
confidential business information? How should quantitative
production data be reported and revealed to the public? How
should polymers be  identified?   How  should  process
intermediates be treated? What about chemicals used for
research and development?       :

The process  illuminated the perspectives of all interested
parties and led, I believe, to a regulation which served at least
the essential needs of each. In addition, the effort provided
a model for cooperation between industry and EPA in
regulation development.
TSCA Consent Order Process for Testing
   Robert M. Sussman, Latham & Watkins (Deputy Administrator, EPA, 1993-1994)
An important milestone in the history of TSCA was the
development of a framework for enforceable consent orders
requiring testing on existing chemicals. This framework has
not been a panacea for all of the shortcomings of the TSCA
testing program but  it has provided a useful and often
effective technique for initiating testing that supplements the
rulemaking process established in the statute itself.

In its early years, the TSCA testing program proceeded in fits
and starts.  EPA was slow to develop proposed test rules, in
part due to uncertainties about its statutory authority, and the
first groups of testing recommendations  issued by the
Interagency Testing Committee (ITC) languished without
follow-up action by the Agency.  (See related article about
the ITC in CIE, no. 4.)

The   Natural   Resources Defense  Council  (NRDC)
successfully sued EPA in 1980 to compel the Agency to
address ITC-designated chemicals within twelve months
either by  proposing  a test rule  or by determining that
rulemaking was unnecessary.  With the support of the
chemical industry, EPA began entering into voluntary testing
agreements responsive to data needs on  several ITC-
designated  substances. However, NRDC filed suit again,
arguing that these agreements could not substitute for test
rules because they were not enforceable and had not been
developed through notice-and-comment rulemaking.

After NRDC  once more prevailed in the courts in 1984,
CMA approached EPA and NRDC representatives to explore
developing a  legally  acceptable  process  that  would
preserve the benefits of negotiated agreements, including
the opportunity for early technical dialogue  between
knowledgeable experts and the ability to minimize delay and
controversy hi launching needed testing. All perceived the
value of a cost-effective alternative to the TSCA rulemaking
process, and productive discussions were soon underway
which led to agreement on a new system  of negotiated
consent  orders under Section  4.   The hallmarks of this
system, which were reflected  in a procedural ;rule  EPA
published in 1986, were a transparent negotiation process
accessible to the public, a strict timetable for developing a
consent  order  or  proceeding  with  rulemaking,  and
enforceability of consent orders on the same basis as test
rules. Simultaneously, the consent order system enabled
EPA to conserve resources by eliminating the need  to
develop and support the findings required for test rules  as
well as the administrative burdens created by the notice-and-
comment process.                 «          :v

The consent order process has shown impressive staying
power: EPA has used it for about fifty chemicals over a ten
year period.  At the same time, EPA has continued to use
rulemaking where  it seeks testing that is complex  or
controversial.             r    "      .,,---"

The Section 4 testing program  is not without critics; many
observers remain disappointed  with the pace and scope  of
EPA's testing activities while others argue that EPA  on
occasion seeks unnecessarily extensive testing. There is little
argument, however, that the availability of consent orders has
enhanced the effectiveness of Section 4 — demonstrating the
wisdom of CMA, NRDC, and EPA in working together to
create an alternative to formal rulemaking ten years ago.
                                           TSCA Perspectives
                                          	      P-4      .	

 Issue 4
                              TSCA Today
 Risk Management (continued)
 coerce  private sector behavior by  regulatory
 edict.   The emphasis gradually shifted from
 adversarial  confrontation  to negotiated  and
 voluntary agreements, and to cooperative efforts
 to  find solutions to toxic chemical problems.
 TSCA Section 6 is now viewed as an option to be
 used only  when private  sector  cooperation is
 lacking, and where there are no other suitable
 regulatory authorities.

 Cgm-sit Operations
 While-"  regulation  remains an  option  when
 circumstances so dictate, management of existing
 chemical  problems   today  more   frequently
 employs    suasive    approaches   involving
 dissemination of information, participation by all
 factions, and multi-party negotiations to arrive at
 consensual  and effective  solutions.   Typical
 specific strategies are highlighted below.

 Assisting other public sector officials - OPPT
 provides technical and analytical expertise to
 Regional, State, and local entities to support their
 counterparts' efforts to reduce toxic chemical
 risks. In a typical example, OPPT's assessment
 of  a serious and continuing toxic chemical
 exposure in Hammond, Indiana enabled Region 5
 and the State authorities  to initiate actions that
 virtually eliminated that risk.

 Preventing pollution - In recent years, the Office
 has  undertaken  several  projects  that  have
 prevented pollution  by:  (1) identifying safer
 substitutes for toxic chemicals used in commerce
 and encouraging  their  use;  (2)  compelling
 removal of toxic chemicals from commercial use,
 often within the context of potential regulation;
 and  (3)  providing   technical   assistance  to
 industries in developing  ways to eliminate or
 reduce emissions of injurious chemicals into the
 surrounding environment.

Empowering communities - Under the authority
 of the Emergency Planning and Community Right
to Know Act, OPPT collects annual data on the
location and amounts of toxic chemicals released
to the environment by industrial facilities.  The
Office has now begun disseminating analyses of
these  industrial  emissions, to  communities
identified  as having  excessive loadings, as  a
means of enabling citizenry to resolve problems at
the local level.

Utilizing  assessments -  In  order  meet  its
regulatory responsibilities, a substantial fraction
of OPPT's resources are devoted to identifying
and assessing  risks  po'sed by specific  toxic
chemicals. These assessments, which may require
two or more years to complete, almost always
entail intensive involvement with the relevant
industries to  obtain and interpret the necessary
information.  While these assessments generally
conclude that the identified risks do not warrant
regulation, they also typically find that the risks
are  nevertheless  not insubstantial.    In these
circumstances, the Office has now started using
the   completed    assessments   to   exhort
manufacturers, processors and commercial users
of the chemicals to  voluntarily find ways to
reduce  the  attendant risks.   As  a further
inducement to action, the assessments are often

Generating consensus - To ensure that issues are
examined  from  the  broadest perspective,  all

Chemicals in the Environment
                                  Fall 1996
 Risk Management (continued)
 potentially affected parties are brought togethei
 at  the outset  of  every  OPPT  regulatory
 assessment, and their collective involvement is
 encouraged throughout the investigation. The
 Office has found that  the  very process  of
 developing a  common understanding of issues
 goes a long way toward achieving consensus
 regarding solutions.  In these instances, industry
 will often voluntarily undertake remedial actions
 that would have taken far more time and effort to
 achieve by regulation.  More importantly, ths*
 interactive process  generates  cohesive  :^
 mutually respectful  relationships that stand in
 stark contrast to the divisive bitterness that often
 accompanies rulemaking.
Establishing accountability - Most contemporary
industries and trade associations have voluntarily
developed and adopted Codes of Conduct or
Product Stewardship programs that  stipulate,
among other things, how member companies
should handle toxic chemical problems prevalent
in their respective areas. OPPT is now beginning
to determine how well individual companies live
up  to these standards, and  to give public
recognition, both to those that excel and to those
that fall below par.
  Interagency Committee Improves Cooperation
        Matt Gillen, Environmental Assistance Division
  Section 9 of TSCA describes the relationship
  between TSCA and other Federal laws.  Under
  this section, if EPA finds that a toxic chemical
  poses  an "unreasonable  risk" that  could be
  reduced  by an action taken by
  another agency, then EPA can file
  a request to the other agency to
  take action. Section 9 also calls
  for EPA to consult and coordinate
  with other  agencies.  Because
  toxic chemical risks  can affect
  consumers  and workers,  EPA
  coordinates  with other agencies
  that have primary  authority for
  protecting     these     groups.
  Employees working directly with
  chemicals typically  have  greater
  opportunity  for  exposure  in
  comparison  to members of the
  public, so this is an area of special
  concern. EPA chemical screening
  activities often lead to questions or concerns
about  the  possibility or  need for reducing
occupational exposures.
In order
       to improve coordination among Federal
                      agencies  on  worker
                      toxics  issues,   EPA
                      entered    into    a
                      memorandum     of
                      understanding with two
                      other     occupational
                      agencies in 1987. The
                      agencies   were   the
                      Occupational   Safety
                      and      Health
                      (OSHA), which is part
                      of the Department of
                      Labor, and the National
                      Institute      for
                      Occupational   Safety
                      and Health (NIOSH),
which is part  of the Department of Health and

Issue 4
                              TSCA Today
Interagency Committee (continued)
                         Human    Services.
                         The     agreement
                         created  a standing
                         committee,   called
                         the ONE (QSHA,
                         MIOSH,      EPA)
                         Committee,      to
                         provide a forum for
                         agency managers to
                         discuss     worker
toxics issues.   In  1990, the Mine  Safety and
Health Administration (MSHA).,also from the
Department of Labor, was added. (The acronym
ONE was retained.)

The ONE  Committee has provided a  useful
vehicle for the agencies to learn more about each
other's authorities, projects, and priorities. Each
agency  has   different,   although   related,
responsibilities  and objectives for  addressing
worker toxics issues. OSHA and MSHA have the
lead role for risk reduction and regulation  of
existing chemicals.  NIOSH has the lead role on
research and on tracking the rates of work-related
disease. EPA has the lead role for regulation of
workplace risks in two areas: new chemicals
(under TSCA)  and field worker exposure  to
pesticides (under other laws). EPA also has the
lead role for testing and collecting information on
existing chemicals.

The ONE Committee meets monthly to discuss
ongoing activities, to initiate joint efforts where
appropriate, to avoid potential  duplication  of
effort, and to plan collaborative projects.  Two
examples illustrate how the agencies can work

>      Skin permeation testing - There are many
       substances without any data as to whether
       or not they can penetrate the skin. This
       important information can be taken into
       account  when establishing  workplace
       exposure standards.  OSHA does not
;,,       have the authority to require testing, but
        EPA does.  The agencies &io working
        together, with EPA using  its testing
        authority   to    require     chemical
        manufacturers to perform tests for 80
        chemicals so that OSHA can use the
        results to inform employers and adjust
        their workplace standards.

 >      Metalworking Fluids - OSHA, NIOSH,
        and EPA  are  working together  with
        industry  and  labor stakeholders to
•. ;.     identify, evaluate, and remittee-risks from
        exposures to these materials.  They are
        used by large numbers of workers during
        metal machining operations.   NIOSH
        pulled together the available information
        and performed-an initial review of the
        issues,   and  OSHA  will   convene
        stakeholders to further evaluate the risks
        and to  recommend approaches for risk
        reduction so  that regulations can be
        developed.  EPA is coordinating  with
        both agencies so that data gaps found to
        pose an obstacle to risk reduction can be
        filled using TSCA testing tools.

 In  summary, our national laws divide up the
 various roles to be played on worker toxics issues
 to different agencies. The ONE Committee is the
 forum by which these agencies coordinate and
 collaborate to help insure that a comprehensive
 approach can be taken where appropriate.

  CJiemicals in the Environment
                                     Fall 1996
 Section 21 Petitions Highlight Citizens' Concerns
        Michelle Price, Environmental Assistance Division
 Section 21 of TSCA provides that any person may petition
 EPA to initiate proceedings for the issuance of rules under
 Sections 4, 6, and 8 of TSCA.  Such a petition must set
 forth the facts which the petitioner believes establish the
 need for the rules requested. EPA is required to grant or
 deny the petition within 90 days.  If EPA grants the
 petition, the Agency must promptly  commence an
 appropriate proceeding.  If EPA denies the petition, the
 Agency must publish its reasons in the Federal Register.

 Since  the  creation of  TSCA,  EPA has  received
 approximatery 60 TSCA Section 21 petitions from states,
 trade  associations, environmental groups,  individual
 citizens, businesses, public interest groups, and unions.
 They  have covered a  wide  range  of issues, from
 polychlorinated  biphenyls  (PCBs)  and  asbestos to
 requesting actions on various individual chemicals.

' One well-publicized action under Section 21 recently
 culminated in a report entitled, "Summary of Information
 Collected from U.S. Parent Companies of Maquiladoras
 Relating to the New River."   (Maquiladora is the
 Mexican term for a foreign-owned factory operating in
 Mexico that uses local labor to manufacture goods for
 export)  The report followed investigation into three
 Section 21 petitions from citizens living in the vicinity of
 New River who expressed concern about the river's
 pollution   and  potential threats  to  health  and  the
Publication of this report in February 1996 marked the
end of information gathering efforts begun in 1994 in
response to the New River petitions.  It describes EPA's
information collection efforts and the pollution of New
River.  It also summarizes information collected from
U.S. parent companies of maquiladoras with facilities in
Mexicali, Mexico in the vicinity of the New River. This
information was provided to EPA in response to both
EPA's April 1994 letter and subpoenas  issued under the
authority  of Section 11 of TSCA.  It was collected to
determine  whether these  subsidiaries  manufacture,
process, or otherwise use, import, export, or dispose of
chemicals that could be  contributing  to  industrial
contamination of the New River.

In the case of New River, EPA denied the initial petition,
and the two subsequent petitions were withdrawn by the
petitioners based on actions taken by EPA to address the
issues raised in the petitions.

Based on the releases reported by U.S. parent companies
of 83 maquiladoras, they do not appear  to be major
contributors to industrial pollution in  the New River.
However, the information contained in the responses from
the U.S. parent companies was insufficient to permit EPA
to  independently  assess  whether  the  data  are
representative of the actual releases of industrial pollutants
from the maquiladoras. Further, EPA does not currently
possess the data necessary to make such a determination
and believes that the continued  monitoring of the New
River is  the  most effective way to provide accurate
information on the pollutants in the river.

Even though the petitions were denied in this instance,
EPA's actions under Section 21 of TSCA have clearly
increased the  community's knowledge about sources of
pollution of the New River.

For information on other TSCA Section 21 petitions and
their disposition, contact the TSCA Non-Confidential
Information Center at (202) 260-7099.

   Issue 4
                             TSCA Today
Evolution of CB! Policy under TSCA
       Scott Sherlock, Information Management Division
      "I  think  the essential element  of this
      legislation is that it has attempted to provide
      the individual - not only who works, but for
      the rest of society - the right to know what is
      in store as far as the toxicity of chemicals is
      concerned."  Senator Pearson, Legislative
      History of the Toxic Substances Control Act
      (1976) Chapter 2, S.3149, Senate debate,

      "(T)he Committee  recognizes that  some
      information which the  Administrator may
      obtain will be of tremendous competitive
      advantage  to the  person  providing  it.
      Accordingly, section 14 contains specific
      prohibitions against  release of such
      information so that the competitive
      position of those supplying information
      will be protected."  Committee
      Report, Legislative History of the
      Toxic  Substances  Control Act
      (1976) Chapter 3, H.R.  14032, 457.

These two comments succinctly summarize  the
competing interests for EPA in implementing TSCA:
right-to-know versus the  obligation to protect
proprietary data. Since 1976, we have struggled to
find a balance between these interests.

In its effort to achieve balance, EPA was hampered
because it operated in essentially uncharted territory.
TSCA was the first statute that allowed the Agency
to address the risks of toxic chemicals from cradle to
grave. TSCA gives EPA the authority to manage
substances from the research and development stage,
to manufacturing, use and, finally, disposal. In order
to adequately address its obligations under TSCA,
EPA required the regulated community to direct an
unprecedented amount of sensitive, confidential data
to the Agency.
One important initiative, little remembered now, was
the effort to secure the confidence of industry that
the we could protect this sensitive information.
Securing  that   confidence  was  an  absolute
precondition to successful implementation of the
statute.   Keeping  that  trust  is  an  ongoing

        The  second  critical  initiative,  which
          continues today, is  addressing EPA's
           statutory obligation to  advise the public
            on the risks of chemicals in commerce.
            This issue  of keeping  the public
             apprised and ensuring opportunities
                for  public   participation  in
                 chemical      management
                 proceedings  under TSCA has
                 always been a cornerstone of the
                 Federal toxics program. It has
                 become  even  more important
                 since 1986 when the Emergency
     Planning and Community Right-to-Know Act
was passed.   This  Act called for creation and
dissemination of the Toxics Release Inventory (TRI).
With the successful implementation of TRI, the
Agency recognized the tremendous power given the
public by requiring chemical  manufacturers and
processors to provide to the public basic information
on chemicals released into the  environment.  As a
result, the public became an indispensable party in
environmental protection and a powerful force in
reducing releases of  toxic substances into the

EPA has struggled to fulfill  the  right-to-know
component of  TSCA.   In  1994, it devised  a
multifaceted strategy to reduce inappropriate CBI
claims and to increase the availability of TSCA data
to the public yet maintain our traditional vigilance to
protect genuine CBI. Efforts have included:

  Chemicals in the Environment
                                    Fall 1996
Evolution of CBI (continued)
Educational Programs:  Cooperative efforts with
industry to advise the regulated community of what
may and may not be claimed as confidential.

TSCA  Information  Products:  By  increasing
availability of TSCA products, OPPT increases the
public's interest in TSCA data.

State Programs:  States are a natural constituency
for TSCA  information and OPPT information
products. Fpsteiing and building this constituency of
state chemical managers encourages the regulated
community to reduce inappropriate CBI claims.

Sculpted Regulations:  Since  1994, the Agency has
proposed a number of regulations that were carefully
  crafted to limit burden but which ensure that CBI
  claims are well thought out and limited to only that
  information which is sensitive and must be claimed as

  These programs have succeeded in limiting some
  inappropriate CBI claims.  We fully  recognize,
  however, that what has been achieved so far is not
  enough. While EPA recognizes the absolute need to
  protect CBI information in a manner consistent with
  the statute, the Agency needs to continue to address
  its obligation to make information on toxic chemicals
  available to the public.  To this end, EPA is strongly
  considering  additional voluntary and  regulatory
  initiatives which will reduce unnecessary CBI claims
  for plant site identities and for ensuring "retirement"
  of older CBI claims.
TSCA as a Tool for Integrated Environmental Management
       Cindy Foumier, Chemical Management Division
A major purpose of TSCA was to fill gaps left by other
media-specific environmental statutes. For example, in
the absence of TSCA,  regulations limiting the air
emissions of a toxic chemical could result in increased
water emissions of that chemical. Now, however, EPA
can consider and manage total human or environmental
exposure of a chemical,  by using TSCA authority to
regulate all aspects of the manufacture, processing,
distribution, use  and disposal   of toxic chemical
substances. If the EPA Administrator determines that
any of these activities pose an unreasonable risk to
health or the environment, Section 6 of TSCA contains
a number of risk management tools that EPA may use.
These tools include:

•      bans or limits on manufacturing, processing, or
•      labeling requirements for products
•      recordkeeping requirements for manufacturers
       and processors
•      bans or limits on commercial uses
•      specific disposal requirements
       hazard communica-
       tion requirements
       for manufacturers
       and processors
Before a TSCA Section 6 rule
can be issued, EPA must consider
health effects, environmental effects,  magnitude of
exposure, the benefits of the substance, the availability
of substitutes for the substance, and the effect that such
a rule will have on the economy.  EPA is also required
to choose the least burdensome regulatory tool that
will adequately address the risks of a substance.

Because Congress was so concerned about the health
and environmental effects of polychlorinated biphenyls
(PCBs), a specific ban on the manufacture, processing,
distribution, and  use of  PCBs was  incorporated
intoTSCA Section 6. PCBs were manufactured as a
fire-resistant insulating fluid for electrical equipment.
They are potential carcinogens that can also cause skin
disorders  and  adversely  affect reproduction and

   Issue 4
                                TSCA Today
 TSCA as a Tool (continued)
 development.  In the environment, PCBs are toxic to
 fish and impair reproduction in mammals and birds.
 The PCB  regulations  cover  the marking of PCB
 transformers and other electrical equipment that are
 still in use, clean up of spills, procedures to be followed
 in the  event of a PCB transformer fires, and disposal

 Another example of comprehensive regulations that
 address a single chemical involves asbestos. Asbestos,
 which is a naturally-occurring fibrous mineral, has been
 extensively used in thermal insulation, fireproofing, and
 acoustical applications. Inhalation of asbestos fibers
 can cause lung and other cancers, as well as asbestosis,
 or  "white lung."   The  emission  of
 asbestos fibers has been regulated by
 the  Clean  Air  Act  since   1973.
 However,  these  regulations  are
 intended to safeguard air quality in
 general, rather than protect workers
 and other building occupants. To address
 these risks in schools, EPA used the authority
 of TSCA  Section 6 to  regulate  asbestos-
 containing materials in school buildings.  This
 1982 rule required  primary and secondary
 schools to inspect their buildings for the types of
 asbestos that are most likely to release fibers into
 the air.  In 1986, Congress superseded the old
 asbestos-in-schools rule with the Asbestos Hazard
 Emergency Response Act, which required schools to
 conduct  thorough inspections, prepare  asbestos
 management plans,  and  respond  appropriately to
 asbestos hazards present in their buildings.  Also in
 1986, EPA issued a regulation to protect the health of
 state and local government employees who perform
 asbestos removals and  who  are  not  otherwise
 coveredby OSHA or an OSHA-approved state plan.

Although   the  asbestos-in-schools  and   worker
protection rules covered serious gaps in the regulations
under the Clean Air Act and the OSHA standards, they
did nothing to prevent future health risks caused by
manufacturing,  processing, use,  and  disposal of
asbestos-containing materials. In 1989, EPA issued the
 Asbestos Ban and Phaseoui Rule, which banned, in
 stages, most of the common uses of asbestos. Nearly
 all aspects of this regulation were overturned by the
 Fifth Circuit Court of Appeals in 1991. The Court's
 decision shows how important it is for EPA to fully
 consider all of the factors required by TSCA § 6, such
 as economic effects and the availability of substitutes.
 According to the Court, EPA had not demonstrated
 that the Asbestos Ban and Phaseout Rule was the least
 burdensome regulation that would address the risks.
 Also, the Court was concerned that EPA  had not
 adequately explored the effects on mqtoi; vehicle safety
       that could result from requiring automobile
7        manufacturers to substitute other materials for
              •     asbestos in brake linings.
            _     J^ EPA has also used TSCA
flp   n         ^Jy Section   6  to   reduce
                         environmental risk!* from
                    chlorofluorocarbons   (CFCs),
                   which  adversely  affect  the
             earth's  ozone layer.  In March 1978,
              EPA  banned  the manufacture and
              processing of CFCs for use as aerosol
              propellants and required annual reports
           from manufacturers and  processors on
           CFCs for these uses. Before TSCA, there
           was no effective way to regulate CFC
        propellant emissions, because CFCs are not air
pollutants in the traditional sense.   They  are  not
considered poisonous and pose no risk to workers.
This rule is a good example of how TSCA § 6 can be
used  to  control  chemical  hazards  where  other
environmental laws cannot.

The broad scope of TSCA § 6 means that actions taken
under its authority can have severe consequences on
the economy and other factors. This explains why EPA
has been so careful in regulating chemicals under this
provisioa  In addition to the three chemicals described
above, EPA has used TSCA §  6 to issue regulations
covering two other situations, the disposal of dioxin-
contaminated  waste   and the  use   of hexavalent
chromium in comfort cooling towers.  EPA also has

   Chemicals in the Environment
                                                     Fall 1996
TSCA as a Tool (continued)
published proposed rules  to  limit acrylamide  in
grouting materials and lead and zinc in fishing sinkers.
While it has been argued that the Court's ruling on the
Asbestos Ban and Phaseout Rule may dissuade EPA
                   from taking future actions under this section of TSCA,
                   it has more likely provided us with valuable lessons in
                   using this powerful tool to protect human health and
                   the environment.
CAS Numbers: Unique Identifiers for Chemicals
      Doug Sellers, Information Management Division
Under TSCA, OPPT  collects  a wide variety of
information on chemicals. These various information
collections are described elsewhere in this publication.
However, with tens of thousands of chemicals on
the Inventory, including  classes of
closely-related  chemicals,   one
critical  question  that  must
always be answered is, "How
can we be sure  we are
referring to precisely the
same     chemical
substance?"    OPPT
does this by relying on
the Chemical Abstract
Service      (CAS)
Registry Numbers.

CAS   numbers   are
assigned    by    the
Chemical    Abstracts
Service  to   identify
unique      chemical
substances. Even different
forms of the  same chemical
structure will have a unique CAS
number.  OPPT needs  this kind of
identification because of the uncertainty
of chemical names. There can be different names for
a single chemical.  Some generic names cover several
substances.  On the other hand, chemical names can be
very specific and complicated, describing the location
and attachment of every atom in the structure. What
Methyl IsobutylKeto
this means is that chemical names are not a useful and
convenient method of specifically identifying a given
chemical substance.Precise chemical nomenclature is
 very important  in  OPPT's chemical information
           activities. The original chemical inventory
              collected under TSCA in 1977 was
                based on CAS numbers. (See Lau
                   article  this  issue).     CAS
                     numbers provide more precise
                      definition for the regulated
                       community, to assure that
                        OPPT requests and they
                        provide information  on
                         the    exact  chemical
                          needed.     Chemical
                          assessments and studies
                          rely    on    correct
                        chemical  identification.
                        OPPT    uses    CAS
                        numbers   to    clearly
                        dentify chemicals in its
                      public    databases   and
                     information products.

                     numbers are easy to locate.
                     re  frequently  included  on
         product labels. Additionally, there are both
printed and computer-based systems available in your
local library that confirm CAS numbers. Including the
CAS number in a request for information will ensure
that OPPT provides you with the information that you
are seeking.

   Issue 4
                              TSCA Today
Changes in Information Technology under TSCA

Information Collection
       Nancy Vogel, Information Management Division
Advances in information technology are underway in
the TSCA docket. The Agency workgroup focusing o n
docket issues is encouraging regulation developers to
submit large support documents (such as meeting
transcripts) to the docket in electronic  (diskette)
format,  as well as on paper.  In addition, we are
working with the  Office's Federal Register staff to
begin uploading docket indices to the Internet. OPPT
is  also  experimenting with  ways to facilitate the
electronic submission of public comments (on rules,
policies, etc.) to the dockets.

In  1994,   OPPTS  began   accepting  comments
electronically on the proposed biotechnology rule and
the lead SNUR. (SNUR means Significant New Use
Rule, which may be issued by EPA when a company
 identifies a new way of using an     "^^K'  exis
 ting chemical.) Beginning in 1995, as ^^^  a
result of these and other pilot projects    throug
hout the Agency, Federal Register notices for all TSCA
rulemaking actions contained instructions for how the
public could submit commentsand data electronically.
Submissions containing no TSCA confidential busifless.
information, in ASCII or WordPerfect format, may
now   be    sent   via   electronic    mail    to
comments received  electronically into hard  copy
format as they are received.  These paper copies are
placed in the  official record, which also includes all
comments submitted directly in writing.  These efforts
should conserve resources as well as increase the speed
and accuracy of handling.
Information Dissemination - Past and Present
      Doris Bloch, Information Management Division
At the inception of TSCA and for  some years
thereafter,  EPA's  information   dissemination
practices  could be  summed up by two types of
outputs: copies of paper documents and products
from large, mainframe systems.

EPA received all information either in paper format
or, a small percentage, on computer-readable tapes
formatted for mainframe use.  The same was true for
dissemination: the majority of information was sent
out as paper, in some cases reports extracted from
              mainframe  systems, or on tapes.
                For instance, EPA published the
                 TSCA   Inventory  in  two
                 formats;  a  five-volume book
                 available from the Government
                 Printing Office and computer
                tapes available for purchase from
  the National Technical Information Service. Other
  major  distribution channels were   individual
  responses to written Freedom Of Information Act
  (FOIA)  requests  and  external  onlinedatabase
  providers such as the Chemical Information System.
  (FOIA responses,  especially, involved only small
  parts of larger data bases or document collections.)

  Only in recent years has EPA used other options for
  sharing  information with  a wider public.   For
  example, EPA publishes  data for chemicals on the
  TSCA Inventory,  Notices  of  Substantial Risk
  submitted by industry under Section 8(e), and other
  data bases on diskettes and CD-ROM; we distribute
  the TSCA Test Submissions data base containing
  various  studies,  test  results  and notices  on

Chemicals in the Environment
                                  Fall 1996
 Dissemination (continued)
 More recently, EPA has begun publishing a wide
 variety of document files on EPA's Internet home
 page.   This change  is  largely due to the
 proliferation of desktop computing in so many
 offices and homes and the expectation that large
 numbers of people can use information in an
 electronic format.

 We  also realize that  the extent of  the  data
 received under TSCA could be unmanageable and
,, overwhelming without an electronic mechanism
jfc»-organize it and assist those who are interested
 in finding  relevant information quickly  and
TSCA data are no longer exclusively mainframe-
based, as that approach was recognized to be too
restrictive.   While  OPPT  is  moving to  an
electronic environment, the Office recognizes that
the change will not occur immediately, either
internally or externally.  And some of our public
clients and customers will prefer to receive paper
copies, even after internal systems are automated.
Paper-based dissemination  through FOIA, the
docket,  and the TSCA Hotline  and for Federal
Register notices will remain as a distribution
option inherited from the past and  projected to
continue far into the foreseeable future.
                       New Chemicals Program Embodies Pollution Prevention
                             Roy Seidenstein, Chemical Control Division
 The Pollution Prevention Act of 1990 ranks the
 preferability of general methods of controlling
 chemical risks  as follows: source  reduction,
 recycling, treatment, and disposal.  The rationale
 for this  ranking  is that it is usually  better,
 environmentally and economically, to
 avoid creation of a pollutant than to
 subsequently control exposures and
 releases which often results in shifting
 a pollutant among environmental
 media (i.e., land, air, water).

 EPA's New Chemicals  Program,
 mandated  under  Section  5  of
 TSCA, plays an important role in
 preventing pollution.   Section 5
 authorizes  EPA  to review  new
 chemicals before they enter  the
 market for the risks they may pose
 to   human   health   and   the
environment. This statutory authority, enacted in
1976 and covering chemicals from cradle to grave
and across all environmental media, embodies the
modem pollution prevention paradigm.
                       Since    the    New
                       Chemicals    Program
                       started in 1979, EPA
                       has  reviewed  almost
                       30,000 new chemicals.
                       In approximately 2,000
                       cases,    EPA   took
                       regulatory  action to
                       prevent  pollution or
                       risks to human health
                       that otherwise might
                       have resulted from the
                       manufacture, process,
                       use  and  disposal of
                       these chemicals.

Issue 4
                                                                          TSCA Tomorrow
 Pollution Prevention (continued)
 Under the New Chemicals Program, anyone who
 plans to manufacture or import a new chemical
 substance   must   provide   EPA  with   a
 premanufacture notice (PMN) at least 90 days
 prior to commencing such manufacture or import.
 To determine whether a substance is "new," the
 company must  consult EPA's  Inventory  of
 Chemical Substances (commonly known as the ,
 TSCA Inventory). If the substance is not listed on
 the TSCA Inventory, it is a "new" chemical.

 EPA scientists from various disciplines
 work   together   to  predict  the
 potential risk to humans and the
 environment  from each new
 substance. The evaluation uses
 data submitted on or with the
 PMN    form,     other
 information  available  to
 EPA, and  exposure  and
 release   modeling.  Since
 EPA revised the PMN form
 in 1991, it has contained a
 page      encouraging
 companies    to   provide
 information telling EPA about
 any    pollution   prevention
 advantages of the new chemical.

 After reviewing the PMN, EPA may take
 a variety, or a combination, of actions:

 (1) If EPA determines that a new chemical may
 pose an unreasonable risk, EPA can enter into a
 consent  order permitting  the  company  to
 manufacture or import the new substance under
 restricted conditions intended  to control exposure
 and releases of the substance. The consent order
 may require a Pollution Prevention Plan for the
 chemical either before production begins or when
 a certain production volume  is reached.

 (2)   Besides regulating risky new chemicals,
EPA has begun sending letters to certain PMN
                                                 submitters recognizing selected new chemicals
                                                 that  may  constitute  safer  substitutes or  be
                                                 developed via pollution prevention processes.
                                                 Only about half of all chemicals that go through
                                                 the PMN process ever go into production, which
                                                 makes  such  encouragement   all  the  more
                                                 important. Criteria include actual test data on the
                                                 PMN substance itself,  less toxicity associated
                                                 with the  new chemical or  related chemicals,
                                                 reduced exposures and releases, conservation of
                                                 energy and water and environmentally beneficial
                                                            uses.     The    letter  to  -the
                                                                 manufacturer  of  such   a
                                                                   chemical   notes   their
                                                                    contribution to preventing
                                                                      pollution.  It  also asks
                                                                       the company to inform
                                                                        EPA    of    the
                                                                        commercial  success
                                                                         of the product over
                                                                         time, and of any new
                                                                         toxicity     and
                                                                        exposure  data  that
                                                                        become available.

                                                                      (3)  Whether or not
                                                                    EPA decides to regulate a
                                                                   PMN substance, EPA may
                                                                suggest  the  use  of "green
                                                             chemistry" to help the company
                                                      identify alternate synthetic pathways that
                                                will  help reduce toxicity and pollution in the
                                                production of the chemical.

                                                Additionally, as an exemption  from the PMN
                                                requirement, EPA has promulgated  a new Low
                                                Exposure/Low Release Exemption Rule that
                                                provides an abbreviated 30-day review period for
                                                substances that  meet  specified  criteria for
                                                negligible exposures and releases.

                                                      For more  information on pollution
                                                prevention in  the New Chemicals Program,
                                                contact Roy Seidenstein at 202/260-2252.

Chemicals in the Environment
                                                                                   Fall 1996
 Emerging Right-to-Know Themes Under TSCA
        Steve Newburg-Rinn, Information Management Division
 From its inception, TSCA addressed regulatory
 control as well as information gathering.  Some
 sections of TSCA (for example, Sections "4 and 5,
 which provide for chemical tesjEmgjatid approval
 of new chemicals) seelTto g^M^iiifermation,
 albeit through regulatory means: "Sections 6 and
In contrast, the intent of Sectioa & off SCA was
               rf   ^M  IT^""*  j  *   w>   *
clearly  informgtioa  gathering.  v  (Section  &
addresses a variety olf activities, inefsding record-
keeping by rndustr&jareatlon of Ifae Inventory,
and submission of^h|alth pad safety studies to
EPA.)  Section l^JcoficWoiag^ exports, was
information dissemination,       r

The Agency, and we |'& individ\Ms.J         ^
the more direct approach; of regulatory control
Staff would study a situation, marshal their fact
and build a record^arkl ultimately" tfee Agenc
would impose sp^Bic  ijeqEarements  on tl
industry sector beitig examidiei But regulatioi
were  not  nearly as'cjean aad aeaf 3$ we had|
anticipated. Toxico^gJistsexamlBiag compounds^
would often disa^^on*Jb^d.egree of risk thejj
posed. Our procedures leelme  drawa out anc
lengthy.   Whett EPA'washable'to fiaafis"
regulations, it founEitself sub^cf'to what seeme
to be an endless round of litigation. The result
was that the hoped-for changes  were  delayed,
and the risks continued.

During TSCA's infancy, we began to realize that
regulatory approaches, while important, were not
necessarily the only way to achieve good public
policy and risk reduction.  As early as 1979, the
Office began  experimenting with negotiation
among EPA and industry scientists to define the
testing needs for particular chemicals.  While
subject to occasional litigation and adjustment,
                                                this basic approach has continued to this day.
                                                The public policy objective of the program was to
                                                obtain all the testing data that was needed on
                                                chemicals ta questioil «s expeditiously and cost-
                                                effectively as posses.* then to assess the results.
                                                EPA also makes the re&uits pubic  Should the
                                                findings be adverse, the testing information
                                                collected woul& jjrobably  sttve  to change
                                                behavior .long befi?^EP4 y^atd  be able to
                                                develop a new^omnaafld-atia** oatrol regulation.
                                                  The initial TSCA Inventory; a»d its successors
                                                  have given EPA staff aftd'fke piblic a better
                                                  understanding of the chemicals, in commerce and
                                                 ^where  tiiey might tie  retasBiifaetured.    The
                                                     ublished health  ami safety todies collected
                                                    jder Sectioa    )  O* T^SCA have proven quite
                                                                ifetors and researchers alike, as
                                                               Icolar chemicals  Substantial risk
                                                    tiees received oifcler Section 8(e) have long
                                                      : used to directly aad immediately influence
                                                     aorafe behavior through the Office's active
                                                    gemination «f the iafonaalian they contain.
                                                     5 Office also issued Letters of Concern under
                                                      existing cfceffiieafe program  as  another
                                                        tive, tdiere a legaktor^ abroach might
                                                    |e too loag ot otherwise be inappropriate.

                                                      the  Office  evolved,   these  information
                                                           and dissemination activities were still at
                                                  the periphery of our conceptualization of our role,
                                                  until the passage  and implementation of the
                                                  Emergency Planning and Community Right-to-
                                                  Know  Act  of 1986.   The  Toxics Release
                                                  Inventory (TRI), with its requirement for the
                                                  active public dissemination of information without
                                                  being  filtered  through  EPA  as regulator,
                                                  fundamentally    changed    the    Agency's
                                                  understanding of the various arrows in its quiver.

                                                  Premanufacture  review  and  regulation  of
                                                  hazardous chemicals under  Sections 5 and 6 of

Issue 4
                         TSCA Tomorrow
Emerging RTK Issues (continued)     *
                                 TSCA are
                                 no     less
                                 than  they
                                 ever were,
                                 and   they
                                 remain  an
                                 ng  of any
                                 effort   to
change behavior.  But OPPT also came to realize
that information, by itself, could be a powerfiil
tool both to the public and to industry itself for
reducing risks from chemicals. When the CEOs
of  large chemical companies suddenly  were
confronted with their own: data showing that a lot
of valuable product was going up into the air
rather than being sold, they began to ask  why.
They also asked their plant managers to do better.
The huge success of EPA's 33/50 program for
reducing releases of selected chemicals would not
have been possible without data collection to set
the initial baseline and as a measure of progress.

TRI provided the Office with a further tool in
examining the issues posed by chemicals which
might present risks. The Pollution Prevention Act
of 1990 added still more information which has
proven important as we seek pollution prevention
solutions. A significant part of programs such as
Design for the Environment or Green Chemistry
is the conceptualization that information and then
the technology transfer of better solutions will
yield  important   risk-reduction results.   By
Executive  Order, Federal facilities  are  now
required to comply with EPCRA.

As  the  Office enters its third decade,  several
right-to-know initiatives  are high on its list of
importance. Last year, the Office doubled the
number of chemicals covered by TRI to include
other chemicals of similar or greater toxicity as
those already in the TRI program.  Secondly,
EPA has proposed that TRI be extended to
several  industrial  sectors  (such as  power
generation)  that  use the TRI chemicals  and
account for a significant amount of toxics loading
to the environment. Once the regulatory process
to add these sectors is finished, expansion to
other sectors will be examined.  The Office has
also  proposed   expanding   the  information
collected to include chemical use and materials
accounting tfajte.' These data additions will allow
more compreB'Sasive understanding of the roles of
chemicals in our lives,  and they will provide
additional opportunities for pollution prevention
and risk reduction.

Finally, the Office has the lead for reinventing
how information is collected  from the many
entities we  regulate.    We  have proposed
collecting a common, consistent set of facility
identification information about each of those
700,000 or so entities.  This would, in the long
term, allow elimination of duplicative reporting,
facilitate consolidation of collection of data from
those entities, and make public access to data
both  easier and  more meaningful.   Thus,
information collection and right-to-know have
become  important  partners   to  regulatory
approaches for OPPT in fulfilling its mission.

Chemicals in the Environment
                                   Fall 1996
 How OPPT Works with Outside Parties to implement and Gain
        Compliance with TSCA
              Ken Moss, Chemical Control Division
 While OPPT's relationship with external constituent
 groups has ebbed and flowed over the 20 years of
 TSCA, there are many at EPA who have believed
 that unless there is some healthy friction between
 the Agency and its numerous public customers, we
 are not doing our job correctly.

 Times change, however, and EPA has increasingly
 shifted to  an approach of actively  working  to
 engage our constituent groups. EPA now strives to
 engage industry 0arge and small businesses), trade
 associations, environmental groups, labor unions,
 environmental justice groups, and others in the
 general  public in cooperative  identification and
 management of risks from exposures to industrial
 chemicals. This improves our mutual understanding
 of chemical exposures and risks and the needs and
 perspectives of all our customers. We have done
 this, for example, by exploring the  relationship
 between the chemical industry's Responsible Care
 and  EPA's TSCA chemical  risk  management
 programs and by recognizing our common need for

 The Agency communicates its belief to industry and
 the environmental community of the importance of
 high quality toxiciry, use, and exposure
 data  for  risk assessment to
 permit a better
 evaluation of
 the   health
 o        r
 tal benefits
 of   new
 This helps
 a   1   1
 parties  to
understand comparative risk assessment and some
of the many choices to be made in the selection of
environmentally preferable products. Toxicity data
are valuable to the Agency as well as industry and
other external groups both for hazard identification
and to help design safer substitutes.

Meeting with the various constituent groups has
resulted in the identification of cross-cutting issues
and shared environmental concerns. We have found
that there is considerable power in pursuing the
many  common   environmental  objectives in
partnership  with these  groups,   rather  than
unilaterally.  The Office has hoped to build and
expand upon dialogue, trust,  and cooperation,
using  forums,  public  meetings,  information
exchange, and product stewardship partnerships.
We have sought to  empower the public  with
knowledge  of pollution prevention and sound
environmental management,  EPA also strives to
provide assistance to chemical users and share tools
and risk  management techniques with others in
efforts to address local environmental concerns.

OPPT  now actively seeks partners within relevant
industry  sectors  to  identify alternatives  to the
          traditional ways we  have gone about
             managing  potential  risks  under
                       TSCA.    This  has
                          ushered in  a  new
                          generation of novel
                           approaches,  such
                           as     consent
                            agreements  with
                            wherein the  legal
                            requirements have
                            been scaled  back
                            in  response to
                            real, voluntary

Issue 4
                          TSCA Tomorrow
How OPPT Works (continued)
steps taken by industry to foster skie handling of
their products by downstream users.  We have
worked to include all levels of the market in formal
product  stewardship  partnerships between the
Agency, companies, and trade groups.  Products of
these efforts  have included the development of
product stewardship guides for select groups of
both new and existing chemicals, coordination of
risk reduction  efforts with the;  environmental
insurance industry, and working with chemical
manufacturers to establish fundaigi'the purchase of
personal protective equipment either technology
that would help  smaller businesses afford the
equipment needed to  reduce exposures in their
As part of our overall effprts to encourage pollution
prevention and the development of safer chemicals
or cleaner industrial processes, OPPT continues to
engage the chemical industry in dialogue to discuss
issues or concerns, jointly develop focused testing
programs or novel risk management approaches,
implement  product  stewardship  programs,  and
encourage innovation in commercially  promising
chemicals.  The future is cooperative and lies in
finding solutions to common problems.
The Use of Environmental Chemical Databases in OPPT
                 Becky Jones, Health and Environmental Review Division
The introduction of chemical databases into OPPT's
workflow dramatically changed and streamlined the
chemical review and  information dissemination
processes. OPPT developed a variety of computer
data bases to manage the  information  that is
submitted under various sections of TSCA.  The
data bases  are used to track the submission of
information, facilitate use of the information in
reviewing individual chemicals, look for similar
effects  for  related chemicals,  and  make  the
information available to the public.

Computer programs have also been developed to
estimate physical/chemical properties of chemicals
(such as water solubility), to predict exposure to
wildlife  and  people  from  releases  to  the
environment,  to  determine  what levels will be
harmful to plants and animals that Eve in water, and
to predict how likely a chemical is to cause cancer.

In the  future, OPPT intends to combine many of
these data bases to further increase the efficiency of
the chemical review processes and provide easier
public access to the non-confidential information.

                         CALL THE TSCA HOTLINE!
       The TSCA Assistance Information Service provides up-to-date information and
       assistance about programs implemented under the Toxic Substances Control Act
       (TSCA), the Asbestos School Hazard Abatement Act (ASHAA), the Asbestos
       Hazard Emergency Response Act (AHERA),  the Asbestos School Hazard
       Abatement Reauthorization Act (ASHARA), the Residential Lead-Based Paint
       Hazard Reduction Act, and the Pollution Prevention Act (PPA).

      The TSCA Hotline is staffed by professionals who are trained to answer technical
      inquiries about TSCA, ASHAA, AHERA, ASHARA, the Lead-Based Paint Hazard
      Reduction Act and some Pollution Prevention activities, including the 33/50

       The TSCA Hotline stocks a variety of documents, including Federal Register
       notices, reports, informational brochures, and booklets. These are available free
       of charge.

For more information or to request a document,
      Call:  (202)554-1404
            TDD (202) 554-0551
            8:30 a.m. - 5:00 p.m. (EST)
      Fax:  (202)554-5603
            7 days, 24 hours


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    Environmental Protection Agency
    Washington, DC 20460

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