EPA's Chemical Testing Program Has Made Little Progress

Published by the Government Accountability Office on 1990-06-20.

Below is a raw (and likely hideous) rendition of the original report. (PDF)


                     United     !States General    Accounting    Omce

:   GAO

    For   Release    EPA ' : Chemicsi         Testing        Program
    on Delivery      Ha2 Made Little              Progress
    Expected at
    9:30 a.;n. EDT
    Zune 2C. 1990

                     Statezer.:    by RlcharZ       L. HeAxa,     Director
                     E?.7:;ronoental    Protcctlor,     Issiies
                     Resources,      Comw-.~ty,      and Ecczorr.ic Deve1oix.tnt
                        ii : '.' i S i Of,
Mr.   Chairman     and Members       of the   Subcommittee:

    We are pleased to be here today to discuss the Environmental
Protection       Agency's    (EPA) chemical      testing   program for toxic
substances.        The chemical     testing     program was established        to
develop      data on the health       and environmental       effects   of
potentially       harmful   chemicals     in commerce 10 that toxic          chemicals
can be identified         and regulated.        Wy testimony     is based on our
report      on the testing     program,     which is being released        today.l

     Werall,        our work showed that EPA has made little               progress    in
identifying         chemicals     that should be tested to determine            their
health      and environmental          effects.    In fact,     EPA's testing     program
has considered          for testing       about 386 chemicals       or less than 1
percent      of the more than 60,000 chemicals               currently    used in the
United     States.        Although     not all  60,000 chemicals may need to be
tested,      EPA has not produced a list             of those that do not require
testing.        As of the end of fiscal          year 1989, EPA had obtained
complete      test data for only six chemicals even though the program
had been in existence             about 12 years.       What is even more
disturbing        is that EPA has not finished            assessing    any of those six
chemicals       to determine,        from a toxicity      standpoint,     whether they
should be regulated.

    Specifically,        we identified      three major       program  deficiencies
which,    if not corrected,         will   only further       impede the testing
program's      progress.

       --   The first    area relates to the Interagency Testing   Committee
            (ITC) , which was established   to recommend chemicals   to EPA
            for testing.     We found that ITC continues to lack crucial

lTOXIC SUBSTANCES: EPA's Chemical Testins                     Prosram Has Made Little
Prosress (GAO/RCED-90-112, Apr. 25, 1990).
            data it needs to identify       potentially   toxic chemicals  t.i?d
            to justify     its recommendations     for EPA action.   In
            addition,    ITC's efforts    have not been made easier becaMe
            of members' poor attendance        at meetings set       up
                                                                   to make
            those critical     decisions.

       --   Secondly,  even after    ITC recommends the chemicals    and EPA
            publishes  proposed test rules,     EPA continues  to drag its
            feet in issuing    final  test rules to begin testing--a
            critical  point  in the testing    process.

      --    Finally,    we found that although    EPA has established      various
            policies    and procedures   for implementing    the chemical
            testing    program,  it has not developed overall      objectives
            for the    program or a strategy   for achieving    then,.

        The remainder     of my statement  discusses    these three
deficiencies       in more detail.    However, before I begin,      I would
like    to briefly    provide  SOIW background    information.


     The chemical       testing     program for toxic       substances was
authorized     under section         4 of the Toxic Substances Control          Act
 (TSCA) . The Congress enacted TSCA in October 1976 to provide
regulatory     authority        over chemicals      not covered at that time by
existing    legislation.          The act applies      to all chemicals     except
those in eight product            categoriescovered         by other laws--
pesticides,      tobaccG,       nuclear   material,    firearms    and ammunition,
food, food additives,            drugs,   and cosmetics.

     Our review focused on chemicals      already   in commerce, which are
listed   in TSCAls inventory   of @vexisting     chemicals."    All chemicals
not listed    in the inventory  are "new chemicals"        and are subject   to

premanufacture   notification          requirements  established under another
section   of TSCA. Our report            does not address new chemicals.

      Section    4 authorized     EPA to require     chemical manufacturers      and
processors       to test potentially      harmful    chemicals   that are already
in the marketplace         for the purpose of developing         adequate data on
their     health   and environmental      effects.     To start    this process,    EPA
must show that existing          data are insufficient        to determine   whether
the chemicals       in fact    have toxic     consequences and that testing       is
needed to make that determination.

     To assist      EPA, section     4 created     ITC.   The committee      was
established      to recommend to EPA chemicals            that should receive
priority     attention     for testing.       Composed    of representatives         from
eight    federal     agencies    involved    in environmental     and health
matters,     1°K must report        semiannually     to EPA and include       a list     of
no more than 50 chemicals            recommended for testing.         By law, EPA
must respond within         1 year by proposing         a test rule or explaining
its reasons       for not doing so in the Federal Register.2                 TSCA
established      no time requirements          for EPA to issue a final        test


    Let    me now elaborate      on problems      ITC has encountered  in making
chemical     recommendations      to EPA for      action.  At the time of our

2EPA proposes    a test rule when it determines     that testing    is
necessary.     A proposed rule specifies     the chemical  to be tested                  and
such things    as the type of testing    required,  test standards     to
follow,    and schedules  for submission    of test data.    A primary
purpose of the proposed rule is to allow for public          comment.
3After     EPA reviews      the public     comments on a proposed test rule,             it
iss-ues    either   a final    test    rule to require     industry to begin
testing     or a decision      not to require     testing.
review,      ITC had recommended to EPA a total          of 386 chemicals    for
testing.       This number represents       less   than 1 percent    of the more
than 60,000 chemicals           in TSCA's existing     chemical  inventory   and an
average of approximately           32 chemicals    recommended per year.       About
80 percent       of these 386 chemicals       were recommended by ITC almost 10
years ago.         ITC believes    that its lack of production       and e-sure
data     has prevented      it from making more recommendations         in more
recent      years.

     To recommend chemicals           to EPA for testing,        ITC    needs data on
their     production     and exposure     levels.     Xn addition        to being
legislatively        required    to consider      such data, ITC        needs this
information       to determine      the chemicals'     potential        harm to humans
and the environment           and to determine      whether the        chemicals   should
be given priority          for testing.

      Throughout      its chemical      reviews,      ITC has had to use outdated
production      data.      Before     1979, ITC was able to obtain            only limited
production      data from whatever           existing     chemical   databases      were
available     because complete          data for the more than 60,000 chemicals
in the TSCA inventory            did not exist.         In 1979, EPA created          its
first     TSCA inventory,        which included        production    data that ITC
subsequently        used.     However, in the process,            ITC found that
production       levels    for a number of chemicals            had changed
significantly        since    the data were obtained.             For example, methyl-
tert-butyl      ether,     a chemical      additive     to unleaded     gasoline,       went
from virtually          no production      in 1979 to approximately           2 billion
pounds in 1985.

    Consequently,      ITC could not rely with any confidence     on the
1979 inventory      data.   EPA updated the TSCA inventory    data with 1985
production     data, and, according    to an EPA official  responsible    for
the inventory,      EPA thereafter   decided to update the inventory     about
every five years and is currently         working on a 1990 update.     Thus,

ITC's    production data will     still        be outdated since       production
levels    can change dramatically           from year to year.

      ITC has also had difficulty            obtaining     adequate exposure data.
In general,      such data are not readily             available     from chemical
manufacturers      and processors         unless specifically          requested.      In
1980, EPA and ITC identified              2,226 chemicals        that they believed
might be harmful.          To help ITC, EPA proposed a rule under section                    8
of TSCA requiring        chemical      manufacturers       to submit this
information.        (Section     8 authorizes       EPA to require        manufacturers
and processors       to maintain       records     and submit any information            EPA
needs to effectively          enforce     the act.)      However, in the 1982 final
rule,    EPA required      data for only 250 chemicals.                EPA reduced the
number of chemicals          by almost      90 percent,      in part,     because of the
reporting     burden on industry.            Thus, over 1,700 potentially            toxic
chemicals     are not being tested           because of the lack of sufficient
data about them.

    Because    ITC's review was limited             by the reduced number of
chemicals    covered in the final           rule,    ITC chose to obtain    the
additional     information     it needed on its own by researching             whatever
was available       in published     literature.         In this way, ITC obtained
data on an additional         250 chemicals.          HrJwever, as of November 1989,
ITC still    did not have exposure            information     for more than 1,700 of
the original      2,226 chemicals        EPA and ITC had identified        10 years
ago as being potentially          harmful.

    In addition    to having data problems,     ITC has low membership
turnout   for its meetings.      ITC members meet monthly to decide which
chemicals    are of most concern and should be recommended to EPA.
Members are needed, among other things,         to provide their specific
expertise    on chemicals   under consideration    and vote on which
chemicals    should be recommended to EPA for testing.

   We found  that between January 1986 and April         1989, attendance
by members at ITC's    monthly   meetings averaged about 61 percent.         We
also found that reviews     of chemicals   had to be postponed      several
times because members were not present        to provide   the needed input.
ITC members who were often absent were representatives           from the
Council  on Environmental     Quality  and the Department     of Comexce.

           HUES TO BE SLOW

   Let  me now turn to EPA's continued          slowness in issuing       final
test rules.    Unless final  test rules        are issued,   testing     dG;as not
begin and the health    and environmental         effects  of potentially
harmful  chemicals   remain unknown.

     In 1984, we first  reported   EPA's slowness in issuing          final   test
rules.4    At that time, we stated    that EPA had issued no final            test
rules   and was taking  over 3 years to make a proposed rule final.
Based on our analysis,     we then recommended that,      after     proposing
test rules,   EPA make them final    within  a reasonable       time, such as
12 to 18 months.

    EPA has proposed  15 test rules in response to chemical
recommendations   ITC made since our 1984 report.     EPA took an
average of more than 27 months in completing      12 of these test
rules.   It met the 12- to la-month   time frame for only 1 of the                   12
rules.   As of November 1389, EPA had not completed     the remaining
three proposed rules:   two of these were over 2 years old.

    In addition,   as of the end of fiscal    year 1989, EPA still
needed to complete     four rules  that it initiated   before June 1984.
These four rules    covered   134 chemicals,   or more khan one-third of

4EPA's Efforts    to Ce
(GAO/RCED-84-100,    June 13,     1964).
the j86 chemicals  recommended by ITC for testing.                       Since   the end Of
fiscal  year 1989, EPA has made final  one of these                    rules,    which
covered about 40 of the 134 chemicals.

    According        to the Chief of the Test Rules Development Branch,
EPA continued          to be slow in issuing           final     test rules because         of
recent high staff           turnover.      He stated that the testing              program had
a turnover      of 30 percent         in fiscal      year 1988 and 40 percent             in
fiscal    year    1989.       As a result,       the completion         of rules   had to be
postponed      until      experienced     staff     members were available           to work on
them.     The Branch Chief acknowledged                  that under normal
circumstances          12 to 18 months is a reasonable                time for making a
proposed test rule final.                Furthermore,        the Branch Chief noted that
EPA is placing           a high priority        on issuing       proposed rules,       rather
than final      rules.        He said that EPA does this to ensure that it
responds to ITC's recommendations                   within     the l-year     statutory

    Because EPA has been slow to issue final             test rules,      chemicals
that have not yet been tested          include    aryl phosphates      and glycidol
and its derivatives.         Aryl phosphates       (used as plasticizers,       in
hydraulic     fluids,   and in lubricants)       are produced in quantities
exceeding    millions    of pounds per year and have the potential              for
substantial      human exposure and environmental          release.     Aryl
phosphates      are suspected    of producing     damage to the central       nervous
system and paralysis.         Glycidol    and its derivatives       (used in epoxy
glues)    are produced in quantities         exceeding   1,000 pounds per year
and have exposure estimates          of over 100,000 workers:        they are
suspected    of causing cancer and gene mutations.

     ITC recommended aryl phosphates and glycidol           and its
derivatives    for testing       more than 10 years ago.     They represent   84
of the 386 chemicals         recommended by ITC.    EPA initiated   test rules
for these chemicals        in 1983 but has still    not issued final    rules
to begin their    testing.
     ING Pm      LACKS

     The two deficiencies           I've just discussed         appear to have
resulted     from the lack of overall              program objectives         and strategy.
Establishing       clear     program direction          and priorities      are key
elements     in any federal         program.       Although    EPA has established
various    policies       and procedures        for implementing       the chemical
testing    program,       it has not established           any overall       objectives     or a
strategy     for achieving        those objectives.           In particular,        it has not
identified      the universe        of chemicals       that it needs to address or
the pace at which it plans to address these chemicals.                            Without
these matters        defined,     EPA officials         remain unclear       about the
chemical     testing     program's      direction      and priorities.

     Federal programs need objectives              and strategies      for adequate
internal    control.       They provide       focus and direction        and help
establish    priorities.         In addition,      they provide     the agency a
perspective     on the magnitude of the tasks it faces and help
identify    resource      needs.     They can also provide        timing    for expected
results    and benchmarks for measuring              a program's    performance,
Furthermore,      specified      objectives      and a strategy     can provide the
Congress with a sense of what can be achieved with the level of
resources    committed.

     In 1983, GAO issued internal          control     standards    to be followed
by executive      agencies,5     as required    by the Federal Managers'
Financial    Integrity     Act of 1982.      Internal      controls     are the
combination     of policies      and procedures      managers use to help ensure
that their     agencies,     programs,    or fUnCtiOnS       are effective     and
efficient.      GAO's document specifically            identified     the

5Standards     For   Internal     Controls        in the   Federal   Government,      1983.
establishment        of objectives     and strategies      as internal     control

     In a 1988 draft        report    on its chemical     review program, EPA
acknowlzdgeci       its own lack of clear direction           in its overall      review
of existing        chemicals     under TSCA, which includes        the chemical
tasting      program.6      The draft    report   discussed     the differences      among
staff    and management about the goals of the program.                   It also
stated     that the absence of explicit           written    documentation
concerning       such matters      as program direction       has contributed
significantly         to the lack of productivity         and misdirection      of the
program - The report           iS still    not final.


     In conclusion,       unless EPA corrects         ITC's insufficient         data and
low member participation           problems,      places increased       attention      to
issuing    final    test rules in a timely           manner, and establish         clear
program direction         and priorities,       the chemical    testing      program will
continue     to make little       progress.       The program will       continue     not
only to lack adequate internal              controls    to ensure that it is
implemented      effectively      and efficiently,        but, more importantly,
will   not be identifying        harmful     chemicals     that may be presenting
risks    to our health       or the environment.

     Accordingly,      in our report       being released     today, we are
recommending      that EPA exercise         its data-gathering      authority   under
section     8 of TSCA to obtain the data that ITC needs to make
recommendations        and that it work with ITC to improve its member's
participation,         In addition,       we are recommending that EPA place a
high priority       on issuing      final   test rules by ensuring       that
adequate staff       resources     are devoted to completing         test rules
within     a reasonable    time, such as the 12- to 18-month time frame

6Fxistinq       Chemical   Review    Prosram:    Ouerations     Manua_l.
that we recommended in 1984.         We are also recommending that       EPA
develop overall   objectives     for the chemical   testing program      and a
strategy  for achieving     those objectives.

     Furthermore,     we stated    in our report     that the Congress may want
to require      EPA to develop a comprehensive          plan for the chemical
testing     program that sets forth       its objectives,       a strategy, and
time frames,      and submit the plan to the Congress for approval.             We
believe     the plan will    provide   the Congress with a sense of what can
be achieved      with the level of resources         committed.

   That concludes     my testimony.      We would   be happy to answer     any