oversight

EPA Lacks Assurance That Disinfectants Kill Germs

Published by the Government Accountability Office on 1990-10-02.

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

                            United    States General Accounting                Office
                            Testimony




For    Release               EPA     Lacks     Assurance          That        Disinfectants         Kill    Germs
on   Delivery
Expected         at
9:30     a.m.       EDT
Tuesday
October       2,     1990




                             Statement        of
                             Richard       L.    Hembra,         Director
                             Environmental            Protection              Issues
                             Resources,          Community,            and      Economic      Development
                             Division

                             Before        the
                             Environment,             Energy,       and       Natural
                             Resources          Subcommittee
                             Committee          on Government                Operations
                             House      of     Representatives




  GAO/T-RCED-91-l
Mr.   Chairman     and Members of the Subcommittee:

        We are pleased to be here today to discuss                        how well the
Environmental         Protection      Agency (EPA) reassures              doctors,    nurses,
and consumers that disinfectants                   are effective.          EPA regulates       the
efficacy      of disinfectants          because users cannot see whether they
kill    germs, and the use of ineffective                   disinfectants        could threaten
public      health.      Moreover,      ineffective        disinfectants        waste consumer
dollars.        About $1 billion          per year is spent on disinfectants                 to
kill     disease-causing         microorganisms         on surfaces       and objects     in
hospitals,        schools,     restaurants,        offices,      homes, and at many other
locations.          My testimony      is based on our report              on EPA's
disinfectant         program,     which is being released              today.1

        In summary, we found that EPA lacks sufficient    assurance                          that
disinfectants     kill germs as claimed for four reasons.

       --    First,     the validity    of test methods and pass/fail
             performance      standards   used to assess the efficacy      of
             disinfectants       have been embroiled     in scientific   controversy
             over the last decade.          However, EPA has made little
             progress      in resolving   the controversies.

        --   Second, EPA has contributed         to these controversies       by
             accepting      test methods and modifications        to these methods
             without    criteria    and independent    laboratory    data for
             evaluating       their validity.

        --   Third,    EPA lacks sufficient        internal controls    to ensure the
             quality    and integrity       of the data that registrants     submit
             on disinfectant      efficacy.

        --   Fourth,     EPA lacks      an enforcement        strategy      to ensure      that,


IDisinfectants:   EPA Lacks Assurance                   They Work (GAO/RCED-90-139,
August 30, 1990).
           once registered,    disinfectants              sold    and distributed         in the
           marketplace    work as claimed.

       Although     the true extent to which ineffective                     disinfectants
are marketed      is unknown, evidence from EPA, the                    states,      and others
indicates     that up to 20 percent   of disinfectants                    on the market may
be ineffective.

       I will     address each of these major program deficiencies           in
more detail,       but first      I would like to provide    some background
information       on disinfectant      efficacy  regulation.

BACKGROUND

        EPA regulates        disinfectants         as pesticides       under the Federal
Insecticide,        Fungicide,       and Rodenticide        Act (FIFRA).         Under FIFRA,
disinfectants        generally       must be registered          or licensed       by EPA
before they may be marketed.                  EPA may register         a disinfectant        only
after     determining      that it is effective            when used as claimed and
does not cause an unreasonable                  risk to public       health     or the
environment.          EPA requires        registrants      of disinfectants          intended     to
protect      public    health     to submit efficacy          data substantiating           each
claim about a product's               performance      and use.       By contrast,       EPA
allows     the marketplace          to regulate       product    performance       for most
other pesticides          because users can see whether the pesticide                       is
effective       against    the target        pest.

        As defined     by EPA, "disinfectant"          refers    to only one of
several     types of antimicrobial         pesticides,       which,    with some
exceptions,       are substances      intended     to inhibit      or destroy
microorganisms        (bacteria,    fungi,    and viruses).         However, we have
used the term disinfectant            to broadly     describe      all antimicrobial
pesticides      intended     to protect     public   health.



                                                2
       At the time of our review,              about 4,100 disinfectants               were
registered     by EPA for a variety            of uses in many areas of the
inanimate    (i.e.,    nonliving)        environment.         Disinfectant         types and
uses range from products            intended      to kill     bacteria      on hard surfaces
in bathrooms to products            intended      to chemically        sterilize       medical
instruments      in hospitals      and doctors'        offices.        We focused on EPA'S
regulation     of disinfectants          registered       for use on hard surfaces
because over 75 percent           of all disinfectants,             or 3,200, were
registered     for such use.          In addition,        these disinfectants           are most
affected    by the scientific           controversies        surrounding        the test
methods used to substantiate              efficacy.

       Infection      control    is a serious        concern for health-care
providers,       the food industry,         and consumers.            In fact,     health-care
organizations        recommend, and many public               health    ordinances       require,
the use of disinfectants.               About 5 percent           of all patients        acquire
an infection        while hospitalized,         according        to the Centers for
Disease Control.          Although      medical    experts        generally     believe     that
most hospital-acquired,            or nosocomial,          infections       are transmitted
from person to person rather than from the inanimate                            environment,
the role of the inanimate             environment        in transmitting         infections
has not been completely            defined.       However, research            has linked      at
least some infections,           including      fatalities,         to contaminated
medical     instruments.

EPA LACKS ASSURANCE THAT EFFICACY
TEST METHODS AND STANDARDS ARE VALID

        Almost all of the EPA-recommended efficacy               test methods and
performance     standards      have been embroiled     in scientific         controversy
for over a decade.           Various   scientists   and officials        from EPA,
state governments,         academia,     industry,  commercial      laboratories,
scientific     associations,        and user groups disagree        over whether (1)
the test methods produce inconsistent              and nonreproducible          results;
 (2) the existing       laboratory     test methods adequately         simulate
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performance      of a disinfectant          in actual      use; and (3) the
performance      standards,      or pass/fail      criteria,      for existing        methods
are valid     or are too stringent.             Nevertheless,       EPA officials
believe    that the existing         disinfectant        efficacy    test methods and
performance      standards      are acceptable       for registration         and
enforcement      purposes.       Most of the EPA-recommended methods were
developed      under the auspices of the Association                 of Official
Analytical      Chemists      (AOAC).     The AOAC is an independent              standard-
setting    organization        whose primary      purpose is to develop and
validate     standardized       chemical      and biological      analytical       methods
that are generally          recognized     as "official."

        EPA officials        have acknowledged       that the existing          disinfectant
efficacy     methods and standards           need to be improved;           yet the agency
has made limited         progress     in resolving      the controversies          because of
problems     in conducting         needed research.        Between 1983 and 1989, EPA
spent about $384,000 on two consecutive                   cooperative       agreements with
the University         of North Carolina        at Chapel Hill        (UNC) to update and
improve certain         disinfectant      test methods, but this work did not
accomplish      EPA's intended        objectives.       EPA officials         and the UNC
researchers       have disagreed        over UNC's research         results     and
conclusions.          Our review indicated        that EPA did not manage and
monitor    the UNC cooperative           agreements well.         In addition,         the
dispute    between EPA and UNC over the research                  may have been
compounded by a lack of communication                  and coordination         within     EPA
and a lack of top management involvement                    in the early years of the
agreements.

        We do not know whether EPA's criticisms                   of UNC's research are
valid,     reflect     reasonable    differences       in scientific           judgment,     or
reflect      a lack of acceptance         of research       results      critical       of an
existing      program.       However, if EPA is ever to resolve                   the
scientific       controversies,      it must do a better            job of managing the
research.         In April    1990,  EPA announced that it would spend
$600,000 for research           on certain     disinfectant         efficacy        methods.
                                              4
However, EPA believes            it may need to spend an additional                     $1.2
million      to completely       research the alleged problems    with                  the
disinfectant      methods       and standards.

         Over the years,           EPA has contributed        to the controversies               by
accepting        test methods and modifications               to methods that have not
been independently              validated    through laboratory           evaluation.           EPA
has accepted the methods and modifications                       on the basis of
internal,       and in some cases external,              scientific        peer review and
regulatory         judgment.         However, EPA lacks criteria             for assessing          the
validity       of proposed test methods or significantly                      modified        test
methods.         For example,         EPA accepts three different              test methods to
demonstrate          that disinfectants         kill tuberculosis          bacteria.          In
effect,      the registrants            may choose which of the three              methods they
will     use to support          the registration      of their        products,       even though
the test,        such as the length of time a surface                    is exposed to the
disinfectant           (referred      to as contact    time),      differ      significantly.

       We found that one product was tested          under two of the test
methods and was deemed to be effective          after    10 minutes   under one
method and effective        after  55 minutes  under a second method.
Naturally,     the registrant     chose to maintain    the product's
registration      by using the method that produced the shorter          contact
time.      However, EPA was unable to explain        to us the differences      in
the test results      between the methods for this product.

CONTROLS OVER QUALITY/INTEGRITY
OF EFFICACY DATA QUESTIONABLE

        Even with improvements       in its programs to ensure the validity
of the test methods used to support the efficacy                of disinfectants,
EPA would continue         to lack assurance that disinfectants          work as
claimed.     This is because of problems with the quality               and
integrity    of registrant-submitted         disinfectant    efficacy    data.    EPA
relies    on registrant-submitted       efficacy      data to register
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disinfectants          and on its data review,            lab inspection,        and data
audit programs to ensure the quality                     and integrity      of the data.
However, we found weaknesses in each of these programs.                              We also
found that a pre-registration                  testing    program is needed to
supplement        these programs because they generally                   do not enable EPA
to identify         cases in which registrants              have selectively        submitted
incomplete        disinfectant        efficacy      data or have deliberately
submitted       invalid      data.     We believe       EPA's lack of sufficient
control      over the quality          and integrity        of registrant-submitted
disinfectant         efficacy      data is a material         weakness in EPA's internal
controls      that should be, but has not been, reported                      to the
President,        as required       by the Federal        Managers'     Financial      Integrity
Act of 1982.

         Specifically,       we found that (1) EPA had inspected/audited
only about 10 percent            of all the labs that performed           disinfectant
efficacy     studies      submitted    to EPA over a period         of about     4 years
and had identified          only about       13 percent    of all the labs that
performed     these studies;        (2) EPA's inspectors         and auditors      may be
unable to evaluate          adequately      the capability      of labs to perform
these studies;         (3) EPA has been slow to prepare             and process reports
from inspections          and audits     at labs performing       these studies;        and
(4) EPA lacks program guidance for conducting                    data reviews,       lab
inspections,        and data audits        relating    to these studies.         I will
now discuss       just    one of the weaknesses we found to illustrate                  the
extent    of the problems.

       We found that EPA had not inspected               most of the labs that
performed    disinfectant        efficacy  studies.        Between January 1, 1985,
and September 30, 1989, EPA's lab division                  inspected      labs and
audited   studies      at 9 individual     labs,     representing       only 10 percent
of the 92 labs that had generated             disinfectant        efficacy     data EPA
received   over about       this same time period.            What is distressing       is
that the lab division           was unaware of most of the labs,              including
some high-volume        labs.      The lab division      had identified         only 12 of
                                               6
the 92 labs because it had not used a readily        available                       EPA data
system that contains  a central archive     of studies     that                     registrants
submit to EPA to support  their registrations.

        Even if-EPA corrected             the weaknesses we found in its data
review,     lab inspection,           and data audit programs,               it would be
unable to identify            cases in which registrants                have selectively
submitted       incomplete       disinfectant       efficacy       data.       EPA's position       is
that registrants           are required       by FIFRA to submit all data
indicating        that a disinfectant           may not be effective              as registered
when they are aware that such data exist.                          However, evidence
indicates       that registrants          have submitted         to EPA efficacy           test data
indicating        that their      disinfectants         work but may have withheld
other test data indicating                that these disinfectants                do not work.
Furthermore,         if a registrant         deliberately        submitted        invalid     data to
EPA, or a commercial             lab deliberately           submitted      invalid      data to a
registrant,         EPA'S data reviewers,           lab inspectors,            and data auditors
probably      would be unable to tell.                Neither      lab inspectors          nor data
auditors      can practically          observe these tests            in progress,         and no
physical      evidence       remains from the tests            once they are completed.
As a result,         EPA relies       on a registrant's          word about the procedures
followed      in a test,       the disinfectant           formulation        tested,      and the
test results         reported.

        During our review we also found evidence                    that registrants       had
submitted      selective     data to EPA. For example,                by chance, one data
auditor     found evidence        of selective         data-- passing    and failing      data
on a high-volume,          household      disinfectant       whose registration       file
contained      only passing data.            In addition,      representatives       of two
registrants       told us that they had obtained               both passing and
failing     results      on disinfectants         but had submitted        only passing
results     to EPA.

      The belief    that        registrants submit selective                 data to EPA is
widespread.      In fact,        members of the disinfectant                 industry openly
                                                 7
joked about submitting        selective   data to EPA at a widely       attended
national     meeting on disinfectant      efficacy     test methods that we and
EPA officials       attended.    Industry   representatives     and others
explained     that the disinfectants      are "effective,"      but selective
data had been submitted        to EPA because EPA's performance         standards
are too stringent.

        What can EPA do to fix this situation?                      We believe         that the
only way for EPA to determine                   whether a registrant           has submitted
selective      data or has deliberately                 submitted    invalid       data is for
EPA to sponsor independent                 testing      of the disinfectants.             Although
EPA tested       selected       product claims at one time,                it no longer does
so.     EPA discontinued           testing      disinfectants      primarily        because of
competing      program priorities.                However, remaining          records from
EPA's limited        testing       program show that,           in at least        some cases,
federal     government        testing      before registration           led to more
protective       label    claims.        We are not suggesting             that EPA test all
disinfectants         for efficacy         before registering          them.       Instead,     EPA
could target        such a program to those disinfectant                      claims of
greatest      importance        to public       health     and/or products         with suspected
efficacy      problems.

LIMITED MONITORING/ENFORCEX'lENT
OF REGISTERED DISINFECTANTS

        I would now like         to turn to our last point--EPA               lacks an
enforcement        strategy    to ensure that,          once registered,
disinfectants         sold and distributed           in the marketplace         work as
claimed.       Even if EPA were to implement                improvements      in its
processes       for registering       efficacy       claims and for ensuring            the
quality      and integrity       of registrant-submitted            data,   these
improvements         would not provide        sufficient      assurance     that
disinfectants         on the market work as claimed.                Registrants       could,
intentionally         or inadvertently,        manufacture        and sell     ineffective
batches of disinfectants            after     registering       them.
                                                8
        Until    1982, EPA operated            a limited     post-registration          testing
program to verify          certain      efficacy      claims of marketed          disinfectants
at its laboratory          facilities        in Beltsville,         Maryland.       According     to
previous      EPA congressional           testimony,       EPA discontinued         the program
primarily       because (1) the level of testing                  was inadequate         and was
creating      a false     sense of security           among users and the public               about
the efficacy        of disinfectants           on the market and (2) budget
constraints       prevented        EPA from conducting           what it considered          to be
an adequate level          of testing.          Since it stopped testing
disinfectants,          EPA has looked to the states,                 the user community,
and the disinfectants              industry     to ensure the efficacy            of marketed
disinfectants.           However, we found that few states                   and no user
groups were routinely              monitoring      disinfectants         and that industry
self-regulation          was ineffective.            Furthermore,        EPA lacks a strategy
to channel complaints              about potentially          ineffective      disinfectants
from various        sources to take appropriate                 enforcement     action      against
disinfectants         found to be ineffective.

        We identified        only three states--Florida,            North Carolina,       and
Mississippi--       that were monitoring           the efficacy     of disinfectants       in
the marketplace          under their      pesticide     enforcement     programs,     and
these states        have decreased the amount of testing                they have
performed      in recent years.           Only two states --Wisconsin           and
Virginia--     were testing       disinfectants        under other state programs.
These five states          test for only a limited            number of efficacy
claims.       Other states       have been reluctant          to start    testing    programs
because they too lack the resources                   needed to establish         and operate
a testing      facility,      according     to selected       state officials       we
interviewed.

        Also,   states     do not have the authority       to regulate       the
efficacy      of disinfectants       in the marketplace      outside    of their
boundaries.        In at least two cases, registrants             have responded               to
state enforcement          action  by recalling   disinfectants       from the
marketplace      within     the state or by deleting        specific    efficacy
                                                9
claims     from disinfectant     labels while continuing           to market the
disinfectants        or make the claims     in other states.          For example, a
producer      agreed to recall     from a single      state market a disinfectant
marketed      under nine different      brand names after        the product    failed
state efficacy        tests.   However, the disinfectant,            which is
registered       for use on floors,     walls,   and other hard surfaces          in
hospitals,       nurseries,  rest rooms, telephone          booths,    and elsewhere,
continues      to be sold in all other states,           according     to the
registrant's        customer service    representative.

        Individuals       and organizations          both within      and outside     of the
health-care        industry       told us that they were not aware of any
hospitals,       doctors,       or dentists      that test disinfectants          for
efficacy.        Likewise,        the restaurant      and food-processing         industries
generally      do not test the efficacy              of disinfectants      on the market.
Some researchers          affiliated       with users and others         have tested
disinfectants,         or are planning         to test disinfectants,          but have not
established       monitoring         programs.

        Although     several     researchers        and others   have complained        or
submitted      data to EPA indicating             that specific     disinfectants       do not
work as claimed,          EPA has not established           the system for processing
these complaints,          a system that it proposed as part of its 1987
disinfectant        strategy     to improve its program.            Furthermore,       EPA
lacks an adequate          laboratory      facility     or provision       to contract     for
laboratory       services     to verify      the complaints      and take appropriate
enforcement       action     against    disinfectants       found to be ineffective.

          Market forces      cannot be relied       upon to control         disinfectant
efficacy     problems      because users cannot visually           identify
ineffective       products.      Furthermore,     although    registrants         can test
competitors'       products     and have challenged        competitors'        claims,   EPA
has been unable to resolve            conflicting      claims  because it lacks the
laboratory      facilities      necessary to do so.


                                             10
        Although      the scientific          controversies       cloud the issue
somewhat, historical            data on specific           products     from EPA and the
states,     along with data from industry,                  academia,      and other sources,
indicate      that some disinfectants              on the market do not work.                The
true percentage           of ineffective        disinfectants        on the market is
unknown.        Although     historical        data on product        failure      rates from
EPA and the states           are not comparable            because of differences            in
sampling      schemes, performance             standards,      and testing       procedures,
EPA officials         and others believe            that up to 20 percent           of marketed
disinfectants         may be ineffective.              Some disinfectants          have failed
enforcement        tests    by a wide margin,           and some have failed           repeatedly
in a single        state,    in multiple         regulatory     labs,     or in tests
performed       by registrants         themselves        at regulatory       labs.     For
example, one registered              disinfectant         used in hospitals,          nursing
homes, and schools           failed      efficacy      tests on multiple         occasions      in
EPA's lab and in two state labs.

        Without    an enforcement          strategy     to channel complaints          about
potentially      ineffective        disinfectants         from industry,      users, and
others and to take appropriate                  enforcement      action   against    the
producers      of disinfectants          found to be ineffective,           EPA may be
jeopardizing       public     health     and wasting        consumer money.       In light           of
federal     budget constraints,            EPA may need to explore          options     for
pooling     resources      from the states,           user groups,      and industry      to
implement      such a strategy.

         Although       there are other options,            a federal       or federally
supported         independent      laboratory      facility     could conduct post-
registration          testing    to verify      selective      disinfectant       efficacy
claims and assist             in enforcement       cases.      However, EPA's existing
facility        in Beltsville,        Maryland,      is obsolete       and in disrepair.
Options exist           for operating       an independent        laboratory      facility;
however,       EPA has not explored           these options.           EPA officials         have
objected       to reopening        a federal     facility      because they claim EPA
cannot afford           to test disinfectants            because of its limited             budget
                                                11
and competing     pesticide   program priorities,        and they do not believe
the federal    government    should test these products.             Although      fees
charged for the privilege        of obtaining     a disinfectant        registration
could help offset       the costs of a disinfectant         laboratory      facility,
the Congress would need to provide EPA with additional                   authority      to
establish   these fees.

CONCLUSIONS AND RECOMMENDATIONS

        Our work shows that EPA does not know whether disinfectants
work and that its disinfectant                efficacy      program needs a major
overhaul.        When consumers purchase disinfectants                  with EPA
registered        labels     to use in their       homes, they expect that the
products      will     kill    the germs claimed on the labels.                When people
are admitted         to hospitals      or go to their        doctors'     offices      for
treatment,        they expect that their           doctors      and nurses will        use
disinfectants          that work and that their           treatment     will    not expose
them to germs that disinfectants                  should have killed.
Unfortunately,           these expectations        are not being fully           realized
because of deficiencies              in EPA's efforts         to regulate      disinfectant
efficacy.          In short,      EPA's policy     of "let      the buyer beware" for
disinfectants          may be compromising         public     health   and wasting
consumer dollars.              It is clear to us that EPA needs to exercise
greater     leadership         to resolve    these problems.

         Our report    makes several         recommendations        to EPA to correct
the deficiencies         we identified        and restore       credibility        to the
disinfectant       program,     including       (1) developing        a plan to resolve
the scientific        controversies        that surround       disinfectant          efficacy
test methods and performance               standards;       (2) developing         and
publishing      a policy     that establishes         criteria       for evaluating           the
validity     of new test methods and modifications,                      including       criteria
for determining        when independent          laboratory      data are needed for
validation;      (3) improving        internal      controls     over its current
programs to ensure the quality                 and integrity       of registrant-
                                                12
submitted      efficacy       data and conducting          preregistration        tests to
selectively        verify     registrant     claims;     (4) establishing         an
enforcement        strategy       in conjunction      with the states,         user groups,
and industry        to ensure that marketed disinfectants                    work as claimed;
and (5) preparing            a cost-benefit       analysis     of alternatives         for a
laboratory      facility        to research and test the efficacy                of
disinfectants,          including      the option of charging            fees to register
disinfectants         to help finance        such a facility.

      Mr. Chairman,        this concludes my prepared  statement. I would
be glad to respond         to any questions that you or members of the
Subcommittee   might       have.




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