Observations on Aflatoxin Detection and Control Activities of Federal, State, and Private Organizations

Published by the Government Accountability Office on 1990-04-02.

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

                    United States General Accounting OfX’ice      M)w7

 For Release        Observations        on Aflatorin    Detection      and
 on Delivery        Control    Actjtvities      of Federal,     State,   and
 Expected    at     Private    Organizations
 3rOO p.m. EJYI!
 April   2, 1990

                    Statement   of
                    John W. Harman, Director
                    Food and Agriculture    Issues
                    Resources,   Community, and Economic
                    Development    Division
                    Before the
                    Subcommittee  on Wheat, Soybeans,            and
                      Feed Grains
                    House Committee on Agriculture

                                       /                               GAO Form 160 (12/W
Mr.      Chairman               and members of the                         Subcommittee:

          We are pleased                      to be here                today        to discuss              the     preliminary
results             of ongoing              work      we are doing                   at your          request             on aflatoxin
--    a naturally                   occurring           toxin          produced              by a common fungus                      on crops
such      as corn               and peanuts.                   You asked             us to develop                  information              on
(1)      the        relative           food         safety          risk       of    aflatoxin,              (2)     methods          for
detecting                 and controlling                    it,      and (3)          the      extent        of     aflatoxin              in
the    U.S.          corn         crop.

          In summary,                  our       work        shows that               (1)     food       safety           experts
consider             aflatoxin               a serious              food       safety         concern         but         do not
consider             it        as serious            as other              food      safety          risks      and the             Food and
Drug Administration                           (FDA),           the principal                  agency         that         regulates
aflatoxin                 in    food      and feed,                considers           the      overall            food      supply         to
be safe         from            aflatoxin;             (2)         aflatoxin           detection             and control              occurs
through         the            collective            efforts           of various               federal,            state,         and
industry             groups;           and (3)          information                  is      inadequate             to determine                 the
extent         of         aflatoxin           in the          U.S.         corn      crop.
          Aflatoxin                 can enter           the         food       supply         directly             in products              such
as peanut                 butter,         corn       meal,          and corn           grits.            Less potent               forms         of
aflatoxin                 can enter           the     food          supply          indirectly             in the          milk,      meat,
or eggs         of         animals          that      eat          aflatoxin-contaminated                           feeds.          Crops
are    mote          susceptible                 to aflatoxin                  contamination                 when stressed                  by
drought         conditions                  like      those          experienced                in the        midwest          in     1988
and in parts            of      Illinois             and Texas            in     1989.         Aflatoxin          was
subsequently            found             in corn         grown       in those          areas.

          Although           the     presence             of aflatoxin                in food      products          is
undesirable,            aflatoxin              is        not    considered             as serious          as other             food
safety      risks.            Although             there        is    no precise             way to rank            food        safety
risks,      experts           like         FDA and the American                        Association              of Cereal
Chemists         generally            rank         microbial             contaminants             such as salmonella
and listeria            as the            major          health       hazard          associated          with      food
because       of     their         potential              to kill         humans after             one exposure.
Malnutrition            --     the         consumption               of an improper              mix of nutrients,
excessive          amounts           of     fats         and salts,            etc.     --     and environmental
contaminants            such as lead                     and mercury            are     also     considered             more
serious       than      aflatoxin.                  Pesticide             residues           and additives                are
usually       ranked          as less          serious            than      aflatoxin.

         Because        aflatoxin             occurs            naturally             and cannot          be entirely
eliminated,           FDA allows               small           amounts,         referred         to as action               levels,
to be present                in foods          and feeds.                 FDA set        the     action          levels         at 20
parts      per     billion           (ppb)         for     food,         0.5 ppb for            milk      because          infants
and children            drink         large         quantities,                and varying             levels      up to 300
ppb for       feeds.l             If     aflatoxin              exceeds        these       levels,          FDA considers
whether       action        is         needed        to control           the        contaminated            product.2

       Although            FDA's         surveillance                 sampling          of corn-based                products
has shown a small                  number of             instances             where       aflatoxin          made its            way
into   consumer            channels            at levels              exceeding          regulatory           limits,           FDA
does not       consider            the        food     supply          to be at risk.                  At fiscal           year
1990   hearings            before         the        Subcommittee              on Rural           Development,
Agriculture           and Related               Agencies              of the House Committee                         on
Appropriations,              the         FDA Commissioner                     said      that      FDA was confident
that   there         was no risk               associated              with       the    commercial            food       supply
as a result           of the            1988    drought.               He stated           that       occasional
consumption           of    the        very     few corn              products          that      contain       small
amounts       of     aflatoxin            is of        little          lifetime          health        consequence,
because       only      repeated              exposure           to relatively                 high    aflatoxin           levels
over   a number of years                       presents           a significant                 safety       risk.

lHigher     levels  of contamination       in feed are allowed because
research      has shown that animals,        depending    on their    size,
maturity,      or whether they are used for breeding            stock,     can eat
higher    levels   of aflatoxin    without     ill  effects.
  21n 1987, the United States Court of Appeals for the District                      of
Columbia Circuit           found that action      levels,    because they were not
established        through the notice        and comment procedure         of the
Administrative          Procedure   Act (5 U.S.C. 553) were not legally
binding      and that FDA had to establish            new regulatory       limits
through      the notice       and comment process.        Until     FDA establishes  new
limits     it must prove on a case-by-case              basis that the amounts of
aflatoqin       in a food "may be injurious           to health'      in order to take
regulatory        action     such as seizing    the product.         Thus, FDA is now in
the process of establishing             new regulatory       limits.

          FDA's         surveillance                activities                   --     which         increased
significantly                  in     1989 because                     of the          drought          --      showed that           a
small         percentage             of     food         products              exceeded            the        action       levels.
Between          October            1988 and June                      1989,          FDA sampled               2,097      food      products
and found             that         5.5 percent              of the whole                   corn         shipments           and 2.2
percent          of     the milled                corn      products                  contained              aflatoxin        in excess
of      the     20 parts            per     billion              limit.           The products                   in which         aflatoxin
was found             would         have to be further                          processed               or prepared            which
would         further         reduce         the         aflatoxin               levels          before          they      were eaten.

          In comparison,                    for         fiscal          year          1986 (not              a midwest        drought

year 1, FDA sampled                        about         300 food              products            and found             a slightly
higher          incidence            of aflatoxin                   than         in     fiscal          year       1989 (6.8          percent
of the         whole         corn      samples             and 4.3 percent                       of     the milled            corn
products          had levels                exceeding                  20 parts           per      billion).               FDA said
that      the     1986 and 1989                    sample           results             were biased               towards
geographic              areas        suspected              of having                  aflatoxin              and firms        with       a
prior         history         of Food and Drug Law violations.
          Testing            for     aflatoxin,                  particularly                for        corn,         is difficult
because          of the            large     volume              of grain              involved              (about      8 billion
bushels          annually)             and because                  of testing               problems.                 Obtaining
representative                     samples         is      a problem              at all           of the          about      8,000
locations             where whole                 corn      is      traded--including                          whole       corn
deliveries              at mills            because,               (1)        aflatoxin            is    concentrated                in
individual              kernels            of corn,              (2)      infected           kernels             may not       be evenly
distributed             through           a bulk          lot,       (3)     there      are differences                          in the
aflatoxin           level      of       individual                kernels,          and (4)         aflatoxin               is
measured         in exceedingly                     small         quantities.

          Only      about      16 percent                 of the         annual       corn        crop          (about           1.2
billion         bushels)           is     used for               human food          and most            of that            is
processed           at about            100     mills.             Sample variability                      is     less       of a
problem         after       corn        has been milled                    because          it    has been ground                       and
mixed,       and any aflatoxin                       in     it     is more evenly                 distributed.
Consequently,               representative                       samples      are more easily                     obtained.

          Further,          testing           all     corn         marketed,          including              that        used for
commercial           feed,      will          not     always            ensure       that        aflatoxin           will          be

eliminated           from      the       food        supply.             While       recent        USDA research                       shows
that      the meat,          poultry,               and eggs from                animals          eating          aflatoxin              are

not    likely        to be a food                   safety         threat,          the milk            from      dairy           cows
fed aflatoxin               contaminated                  feeds         can contain              aflatoxin           residues             in
excess      of FDA's           action           levels.             Contaminated                 milk     has been traced
to both         commercial              feeds        and those             grown      and fed on farms.

          Despite       these           difficulties,                   aflatoxin           detection             and control
occurs      through          the        efforts           of various             federal,          state,           and private
groups.          Each organization                        has its          own testing             objectives                such as
assuring         food       safety,           market         efficiency,              and profitability.

          FDA does not              monitor           all      affected              foods        and feeds            for
aflatoxin.               Instead,          FDA requires                   food       and feed            manufacturers                to
follow        regulations              commonly             referred             to as good manufacturing
practices.            These      regulations                 require             food      processors               to have
quality        control          procedures             that         ensure          food      products           are         safe,
wholesome,              and suitable            for         human consumption.                           Manufacturers                are
required        to use          only       raw materials                    and ingredients                   that      are within
FDA's      action         levels.           Manufacturers                    may        either          purchase        ingredients
that      are guaranteed                or certified                     to be within              the      action           levels         or
may    test     the       ingredients               themselves.                   As I mentioned,                    FDA annually
samples        a small          number         of     susceptible                 raw materials                and food
products        to monitor              industry             compliance              with         its      regulations               and
obtain        data      on the         level        and frequency                   of     aflatoxin           contamination.

          Food manufacturers                    and firms                 that      mill     corn,          shell       peanuts,             or
otherwise          prepare          raw commodities                       used in          food         manufacturing
contribute            to aflatoxin              detection                 and control              and have economic
incentives            to do so as part                      of their             quality         control        procedures.

          One food         manufacturing                    company's             quality          control           director
told      us his        company requires                     its         suppliers          to have quality                    control
systems        that       ensure        products             are within              FDA's action               levels.               At
the onset          of     the    1988       harvest,               his     company reviewed                    its      suppliers'
sampling        and testing                program           and required                  some         suppliers        to make
changes        to satisfy            his       company's                 requirements.                   Subsequently,                the
manufacturer                 implemented               a program          to sample            and test         dry      milled3
products            for      compliance.                The manufacturer                 did     not      focus         on wet
milled4          food        products          because          research         has shown that                 most of the
aflatoxin             is     removed          during         the wet milling              process.

            Although          we did          not      determine         the extent             of    industrywide
testing,            milling          trade       association             officials          told         us that
aflatoxin             testing          has been standard                  procedure             in their            industry
for     years.             An official               of a dry         milling         industry           organization
said        current          industry          efforts          may involve            testing           of whole         corn      as
it     is    delivered           to plants              or removed            from      storage          for    processing,
as well         as testing              of     finished          products.             An official              of a wet
milling         organization                 said       that,     in     favorable         growing             years,      a
statistical                sampling          plan       may be used to determine                          the     extent       of
testing         needed.              Testing           is    increased          as the     corn          crop     enters       the
market        so that           companies              can identify             and avoid            geographic           areas
producing             aflatoxin-contaminated                          corn.      During        the       drought,         testing
was increased                 to cover           all        incoming      corn.

            At the         federal          level,          FDA works         with     other         federal         agencies        to
extend        its      monitoring              of susceptible                 commodities.                The principal
federal         agencies             with     whom FDA works                  are USDA's Agricultural
Marketing            Service          (AMS) and USDA's Federal                          Grain         Inspection           Service

3Dry milled  products include                                 corn meal,             corn flour,           grits,        alcohol,
and co5n oils for human use,                                  and animal             feeds.
'lWet milled               products          include          starches,         sugars,          oils,         and animal
(FGIS).               AMS oversees                a peanut         marketing            agreement             that      requires
all      peanuts            sold     by farmers             to be sampled                  and visually                inspected
for      the     mold that               produces         aflatoxin,               and all        peanuts,            before       they
are      sold         to food        manufacturers,                   are        sampled      and tested              for
aflatoxin.                  Unlike         the peanut           program,             FGIS's       sampling            and testing
of grain              and grain            products         is on a request                   basis.

          At the            state        level,        aflatoxin            detection           and control
activities              vary        with      state       interests               and for       reasons             such as the
frequency              of     aflatoxin's              occurrence.                 For example,               some states,
such      as Georgia                and North           Carolina,                have annual        programs                to monitor
susceptible                 food     and feed           products            for      aflatoxin.               They I and other
states,          assist            the     AMS by providing                      inspectors        to carry             out    the
detection              and control                program       for        peanuts.           In other              states,
aflatoxin              control           activities          are          less     extensive.

          FDA coordinates                    with       states            to avoid       duplication                 and,     to the
degree          that        FDA has confidence                     in a state's               control          efforts,         FDA
limits          its     activity            to spot         checks.               FDA shares            its    aflatoxin
surveillance                  results        with       state         regulatory            agencies           and encourages
them to reciprocate.                              In this       way,        FDA supplements                   its      information
on the          extent         of    aflatoxin            in food           and feeds.
          Information                on the           incidence            of aflatoxin            in the            corn     crop     is
inadeq;ate              for        determining            whether            aflatoxin          is a widespread
problem.               Although            individual            states           monitor       field         corn      for
aflatoxin            their            results         do not           show how widespread                           aflatoxin            is
because           state         surveys            may not            be     done in         a statistically                       reliable
manner.            Generalizations                       about         the        incidence               of aflatoxin              are
difficult            because              aflatoxin              is    a localized                 problem           even     in years              of
widespread                drought.              For example,                     one state           study          showed that
although           the         average          level         of aflatoxin                  in the          state's          crop      was 21
parts       per      billion,                 65 percent              of the         crop         had no detectable                    level
of      aflatoxin.                However,            limited              state      testing              results          are     sometimes
reported           by      the media               as estimates                   of the          extent       of aflatoxin                 for
the      entire         state          without           recognizing                 the     limitations                of    the      state
study       or the          variability                  of    aflatoxin              across            the    state.

          A recent             proposal             by     the        Iowa Aflatoxin                    Task Force            --
consisting              of representatives                            from        state      government,                producer
organizations,                   grain          trade,         and academia                  --      offers          a proactive
approach           to gathering                  additional                 information                 on the        occurrence               of
aflatoxin            in     the        corn      crop.           The proposal                     calls       for     (1)     a pre-
harvest        weather                monitoring              and early             warning             system        to predict
high-,       medium-,                 and low-risk                areas          of aflatoxin                 formation             and (2)
physical           sampling              at harvest               time       to confirm                 or deny advance
warning        data.             It      is     intended              to alert            regulators                and the         grain
industry          to the              possibility              of aflatoxin                 contamination                    and reduce
its      impacts          by     allowing            (1)       FDA and state                     regulators             to focus            their
aflatoxin            control             efforts           on locations                   with      the       highest         risk;         (2)
dairy       farmers            to decide             whether               the     feeds         they       grow or purchase
should       be tested               for     aflatoxin;           and (3)         food         processors                to select
 locations            from      which        to purchase              their      raw ingredients.

          USDA's National                    Agricultural              Statistics              Service            (Service)
would,       according               to the       Iowa proposal,                 establish               risk      areas          using
temperature             and moisture                information               reported          by the            State      Crop
Reporting             services.              Some additional                  research          would           be required               to
develop          specific            criteria        for     relating            weather           information               to
aflatoxin             formation.                Sampling         to substantiate                  advance            warning             data
would       be accomplished                     by modifying            the      Service's               existing           at-
harvest          crop       sampling            program.          Adding         aflatoxin               testing           would
require       that          larger         samples         be drawn,           dried       immediately                to stop
further       aflatoxin               formation,            and then           sent      for      laboratory                analysis.
Since      the        Service         relies       on farmer            cooperation               for       its     surveys,              it
has turned             down earlier               requests         to estimate                 aflatoxin            in      corn
because          it    is     a controversial                issue        with        farmers,            and may cause                   the
Service       to lose               farmer       cooperation.

          In summary,                aflatoxin        is a serious                food         safety           concern,           but         it
is not       as serious               as several           other        food      safety          risks.            An
infrastructure                 of     federal,        state,          and industry                groups           exist      to test
and control             the     incidence           of aflatoxin                 in the         overall            food      supply.
At this       time,          FDA considers                that     supply         to be safe               from       aflatoxin.
Nevertheless,                the      adequacy        of testing              procedures                 and whether

increase         testing.          If         it    is decided          more testing            is necessary,              a
logical         point     for     additional                 testing     is    the     approximately            100    mills
where      corn      is processed                  into      food.      This      is   at the     point    of
greatest          risk.         The Iowa Aflatoxin                     Task Force's         proposal       also
offers         one approach             for        making      this     testing        and control        process
more proactive              and thereby                   possibly      improving        monitoring        of

          Mr.    Chairman,         this            ends my prepared               statement.         I would          be
glad      to    respond         to any questions.