Food Safety: Agencies' Handling of a Dioxin Incident Caused Hardships for
Some Producers and Processors (Letter Report, 04/10/98, GAO/RCED-98-104).

Pursuant to a congressional request, GAO reviewed the performance of
federal agencies in handling their investigation into elevated dioxin
levels in poultry samples, focusing on: (1) the basis for the agencies'
decisions to require producers to demonstrate their food products did
not contain levels of dioxin above one part per trillion; (2) their
effectiveness in working together to make decisions to address the
problem of dioxin; and (3) the impact of the food safety system on the
handling of this dioxin incident.

GAO noted that: (1) the Food Safety and Inspection Service (FSIS) and
the Food and Drug Administration (FDA) requested the producers and
processors to halt the distribution of food products with dioxin levels
above one part per trillion because of their concern about the potential
risk to human health that these products might present; (2) while
scientists have not yet determined the level of dioxin that poses a
danger to human health, FDA and FSIS believed that one part per trillion
was an appropriate level to use for halting the distribution of these
products; (3) FDA chose the one-part-per-trillion level to distinguish
food products with elevated dioxin levels from those products with
background dioxin levels; (4) the federal agencies worked cooperatively
to identify the source of the dioxin contamination and to decide on the
actions that might be necessary to address any health risks the
contaminated food products posed to consumers; (5) however, their
guidance to the affected producers and processors was sometimes unclear
and impractical, which left the affected producers confused about the
actions they needed to take; (6) for example, FDA, which is responsible
for fish products, told producers they had to test their products, but
the agency did not tell them how to collect their samples for testing;
(7) in addition, the producers expressed concern that the agencies did
not provide them with adequate time to comply with the agencies testing
requirements; (8) in some instances, the testing process took longer
than the time allowed under the deadline; (9) although these regulatory
actions delayed some food products from reaching the market, industry
officials told GAO that FDA and FSIS's actions did not result in the
widespread destruction of affected food products; (10) in addressing the
dioxin incident, the agencies involved had to overcome the inherent
inefficiencies associated with the current food safety system, which
divides responsibility for ensuring food safety among several agencies;
and (11) as GAO has reported on numerous occasions, this fragmented food
safety system necessitates extensive coordination efforts to minimize
wasteful duplication of effort, prevent gaps in regulatory coverage, and
avoid conflicting actions.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  RCED-98-104
     TITLE:  Food Safety: Agencies' Handling of a Dioxin Incident Caused 
             Hardships for Some Producers and Processors
      DATE:  04/10/98
   SUBJECT:  Contaminated foods
             Poultry inspection
             Food inspection
             Safety regulation
             Consumer protection
             Health hazards
             Food industry
             Toxic substances
             Interagency relations
             Safety standards

             
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Cover
================================================================ COVER


Report to Congressional Requesters

April 1998

FOOD SAFETY - AGENCIES' HANDLING
OF A DIOXIN INCIDENT CAUSED
HARDSHIPS FOR SOME PRODUCERS AND
PROCESSORS

GAO/RCED-98-104

Food Safety Agencies' Handling of a Dioxin Incident

(150646)


Abbreviations
=============================================================== ABBREV

  EPA - Environmental Protection Agency
  FSIS - Food Safety and Inspection Service
  FDA - Food and Drug Administration
  CDC - Centers for Disease Control and Prevention
  ARS - Agriculture Research Service

Letter
=============================================================== LETTER


B-279328

April 10, 1998

Congressional Requesters

In May 1997, the Environmental Protection Agency (EPA) discovered
elevated levels of dioxin in poultry samples analyzed as a part of
its reassessment of the health risks of dioxin.\1 This discovery
triggered a joint investigation to determine the source of the
contamination.  This investigation was undertaken by EPA, the U.S. 
Department of Agriculture's Food Safety and Inspection Service
(FSIS), and the Department of Health and Human Services' Food and
Drug Administration (FDA)--each of which has jurisdiction over some
aspect of the food safety system.  By mid-June, the agencies had
traced the contamination to feed distributed to poultry, fish, hog,
and cattle producers in several southern and southwestern states.  At
this point, FDA used its regulatory authority to halt the
distribution of the contaminated feed and requested that the feed be
disposed of by those holding it.  Subsequently, FDA and FSIS required
that the affected food products be tested to demonstrate that they
did not contain elevated dioxin levels--defined by the agencies as
levels above one part per trillion of 2,3,7,8 TCDD, one of the more
potent forms of dioxin--before these products could be distributed. 
Because these elevated levels equated to the concentration levels in
the animals, it was expected that the animals' growth would reduce
the concentration levels over time. 

By mid-September 1997, FDA and FSIS had determined that all the food
products derived from the animals that had consumed the contaminated
feed had only background levels of dioxin and approved them for
commercial distribution.  However, between July and September, large
and small producers and state health officials questioned whether the
levels at which dioxin was found in the food products warranted the
actions taken.  Producers and state officials also reported that the
agencies sometimes issued multiple and unclear directives, resulting
in confusion over the actions producers were to take. 

Concerned about the performance of the federal agencies in handling
this incident, you asked us to determine the (1) basis for the
federal agencies' decisions to require producers to demonstrate that
their food products did not contain levels of dioxin above one part
per trillion; (2) federal agencies' effectiveness in working together
to make decisions to address the problem of dioxin-contaminated feed
and in communicating their decisions to the affected state agencies,
producers, and processors; and (3) impact of the food safety system
on the handling of this dioxin incident. 


--------------------
\1 Dioxins are a class of chemical compounds that are found
throughout the environment at low levels (called background levels)
and are known to be present in the food chain.  The dioxin found in
this incident included a high concentration of 2,3,7,8 TCDD, one of
the more potent forms of dioxin.  In 1997, the World Health
Organization's International Agency for Research on Cancer classified
this form of dioxin as a human carcinogen. 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :1

The Food Safety and Inspection Service and the Food and Drug
Administration requested the producers and processors to halt the
distribution of food products with dioxin levels above one part per
trillion because of their concern about the potential risk to human
health that these products might present.  While scientists have not
yet determined the level of dioxin that poses a danger to human
health, the Food and Drug Administration and the Food Safety
Inspection Service believed that one part per trillion was an
appropriate level to use for halting the distribution of these
products.  The Food and Drug Administration chose the
one-part-per-trillion level to distinguish food products with
elevated dioxin levels from those products with background dioxin
levels. 

The federal agencies worked cooperatively to identify the source of
the dioxin contamination and to decide on the actions that might be
necessary to address any health risks the contaminated food products
posed to consumers.  However, their guidance to the affected
producers and processors was sometimes unclear and impractical, which
left the affected producers confused about the actions they needed to
take.  For example, the Food and Drug Administration, which is
responsible for fish products, told producers they had to test their
products, but the agency did not tell them how to collect their
samples for testing.  In addition, the producers expressed concern
that the agencies did not provide them with adequate time to comply
with the agencies' testing requirements.  For example, the Food and
Drug Administration gave fish producers only a few days' notice that
they could not market their fish unless the affected fish tested free
of elevated dioxin levels.  In some instances, the testing process
took longer than the time allowed under the deadline.  Although these
regulatory actions delayed some food products from reaching the
market, industry officials told us that the Food and Drug
Administration's and the Food Safety and Inspection Service's actions
did not result in the widespread destruction of affected food
products. 

In addressing the dioxin incident, the agencies involved had to
overcome the inherent inefficiencies associated with the current food
safety system, which divides responsibility for ensuring food safety
among several agencies.  As we have reported on numerous occasions,
this fragmented food safety system necessitates extensive
coordination efforts to minimize wasteful duplication of effort,
prevent gaps in regulatory coverage, and avoid conflicting actions.\2


--------------------
\2 Food Safety and Quality:  Uniform, Risk-Based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992);
Food Safety:  Risk-Based Inspections and Microbial Monitoring Needed
for Meat and Poultry (GAO/RCED-94-110, May 19, 1994); Food Safety: 
Changes Needed to Minimize Unsafe Chemicals in Food (GAO/RCED-94-192,
Sep.  26, 1994); and Food Safety:  A Unified, Risk-Based Food Safety
System Needed (GAO/T-RCED-94-223, May 25, 1994). 


   BACKGROUND
------------------------------------------------------------ Letter :2

While studies have shown that dioxin has an adverse effect upon some
animals, the nature of the risk that dioxin poses to human health is
not fully understood.  In a 1990 FDA study, the agency concluded that
the majority of the available epidemiologic studies on the
association of cancer with exposure to dioxin provided little
evidence that dioxin is a potent carcinogen in humans.  Since that
time, EPA, as part of its reassessment of dioxin in the environment,
issued a draft report reconfirming its earlier position that 2,3,7,8
TCDD was a probable human carcinogen.  Subsequently, in 1997, the
World Health Organization's International Agency for Research on
Cancer classified 2,3,7,8 TCDD as a human carcinogen.  However,
researchers from the Centers for Disease Control and Prevention (CDC)
told us that science has not yet determined the level of exposure to
dioxin that may present a danger to human health. 

In early 1997, EPA, as part of its ongoing dioxin reassessment and
its efforts to quantify dioxin levels in foods, analyzed 80 poultry
samples collected from all over the nation to determine the
background level of dioxin.  In analyzing these samples, EPA found
that two contained considerably higher levels of dioxin than the
others.  These samples were traced to two processing plants, one in
Texas and one in Arkansas.  Later sampling of poultry products from
this same general area also revealed elevated levels of dioxin.  The
dioxin levels in these samples tested above 3.5 parts per trillion,
while EPA had determined from the other 78 samples that the
background level for poultry was about 0.14 parts per trillion. 

When the final results for the tested products were received on May
20, 1997, EPA immediately notified the two principal agencies having
regulatory responsibility for food safety of its findings:  (1) FSIS,
which is responsible for the safety of meat and poultry products, and
(2) FDA, which is responsible for the safety of fish, shell eggs, and
animal feed.  FSIS and FDA have the authority to prevent adulterated
products from reaching consumers.\3 Together, EPA, FSIS, and FDA
traced the contaminant to ball clay, an ingredient used as an
anticaking agent in animal feeds sold to some poultry, fish, hog, and
cattle producers in southern and southwestern states.  The
contaminated ball clay came from a single identified mine in
Mississippi. 

As a result of the dioxin contamination, FDA declared that the animal
feed was adulterated.  Subsequently, FDA and FSIS declared that food
products derived from the animals that had consumed this feed were
adulterated.  On July 3, FDA acted to halt the distribution and use
of the adulterated animal feed.  Simultaneously, FDA's Health Hazard
Evaluation Board, in consultation with FSIS and EPA, determined that
the dioxin in the food products did not represent a severe or
life-threatening health risk at these elevated levels.\4 This
determination was primarily based on its conclusion that the duration
of consumers' exposure to the elevated levels of dioxin would be
limited.  FDA officials advised us that the Board, in reaching this
conclusion, considered that exposure would be limited because the
ball clay from the contaminated mine was no longer being used in
animal feed, and products with elevated dioxin levels would be
stopped from reaching the market. 

Therefore, neither FDA nor FSIS requested a voluntary recall of any
food products.  However, both agencies told us they wanted to limit
the public's exposure to elevated dioxin levels, in part because
dioxin accumulates in the body over a lifetime.  On July 8, FSIS and
FDA informed producers and processors that the food products derived
from the animals that had consumed the contaminated feed would need
to be tested before being released into the market.  The agencies
used one part per trillion as a "practical discriminator," or a level
of concern, to distinguish between the food products that they would
allow into the market and those they would not.  Three days later,
FDA suspended its testing requirements for fish because of industry's
and state officials' concerns with the implementation of its sampling
and testing protocol.  Subsequently, a revised implementation plan
was agreed upon and a new deadline established.  By mid-September
1997, FDA and FSIS had determined that all food products derived from
the animals that had consumed contaminated feed had only background
levels of dioxin and approved them for commercial distribution. 

Industry officials with whom we spoke informed us that FDA's and
FSIS' actions did not, to their knowledge, result in the widespread
destruction of beef, pork, poultry, or fish products, but some eggs
had to be destroyed.  We were also informed of several instances in
which fish, poultry, and pork products were delayed in reaching the
market while the dioxin levels in the animals' systems decreased or
while producers awaited test results.  These delays increased
producers' costs.  Furthermore, we were informed that the cost of
testing for some companies totaled more than $100,000. 


--------------------
\3 Food is adulterated if, for example, it bears or contains any
poisonous or deleterious substance that may render it injurious to
human health. 

\4 FDA's Health Hazard Evaluation Board is responsible for evaluating
the risk (actual or potential) presented by contaminated products and
for determining whether the risk warrants a recall. 


   ONE-PART-PER-TRILLION DIOXIN
   CONCENTRATION LEVEL CHOSEN TO
   DISTINGUISH ELEVATED DIOXIN
   LEVELS FROM NORMAL BACKGROUND
   LEVELS
------------------------------------------------------------ Letter :3

FDA and FSIS requested the producers and processors to halt the
distribution of the affected food products with dioxin levels above
one part per trillion because of their concern about the potential
risk to human health.  Although scientists have not yet determined
the level at which dioxin may pose a risk to human health, the
agencies chose a level of dioxin that is somewhat higher than the
background level in food products to distinguish the food products
affected by the use of adulterated feed from other food products. 

The one-part-per-trillion level set by FDA, in consultation with EPA
and FSIS, was a lower concentration level than FDA had used before. 
In an August 1981 letter to the governor of Michigan, FDA provided
advice about the dangers of consuming fish from the Great Lakes
tainted with dioxin.  In this letter, FDA stated that if the dioxin
levels in fish average less than 25 parts per trillion, "there is
little cause for concern." Similarly, FDA's health advisory for fish
stated that dioxin in concentration levels up to 25 parts per
trillion posed "no serious health concerns."\5 This advisory was
included in a 1992 EPA study describing the physical and chemical
properties of dioxin and the potential health effects associated with
exposure to it.  FDA officials said the 1981 guidance was written to
apply to sports fish.  They pointed out that the two situations
differ because the recent dioxin incident involved multiple sources
of food, and consumers might ingest more dioxin through these sources
than they would from sport fish, which are consumed less frequently. 

When FDA and FSIS notified producers and processors that their
products could not be sold for human consumption unless the products
had a dioxin concentration level below one part per trillion,
industry representatives and the Arkansas Department of Health
requested scientific evidence to support the need to restrict food
products with these low dioxin levels because of the risk posed to
consumers.  According to these officials, FDA did not provide any
evidence to support the decision to request that products with a
dioxin level of one part per trillion be halted.  Moreover, industry
representatives were disturbed that FDA and FSIS had acted to halt
the distribution of food products.  They pointed out that neither
agency had requested a voluntary recall of the adulterated products
already in the market, even though these products had higher dioxin
levels than the products they could not distribute and would
potentially pose a greater risk to human health. 

Both FDA and FSIS contend that since the dioxin came from a known,
controllable source, they had the opportunity to reduce consumers'
exposure to it, and therefore they acted to contain it.  FDA
officials informed us that they took these actions to fulfill their
obligation to keep adulterated products from the market.  Both
agencies emphasized that the one-part-per-trillion level should not
be construed as a new standard for dioxin.  They stated that one part
per trillion does not represent a general action level for dioxin in
foods but only the federal government's response to this specific
dioxin incident. 


--------------------
\5 National Study of Chemical Residues in Fish, Volume II, p.  C-1. 


   FEDERAL AGENCIES GENERALLY
   COOPERATED DURING THIS INCIDENT
   BUT DID NOT ADEQUATELY WORK
   WITH PRODUCERS AND PROCESSORS
   TO OVERCOME THEIR PROBLEMS
------------------------------------------------------------ Letter :4

In response to an evolving situation, EPA, FSIS, and FDA worked
cooperatively to identify the source of the dioxin contamination and
to establish restrictions on the sale of adulterated food products. 
However, the agencies did not provide adequate guidance to producers. 
In addition, the producers expressed concern that the agencies did
not allow enough time for them to comply with the requirements.  As a
result, some producers suffered hardships. 


      EPA, FSIS, AND FDA
      COOPERATED TO IDENTIFY THE
      SOURCE OF THE DIOXIN
      CONTAMINATION AND TO DECIDE
      ON THE ACTIONS NECESSARY TO
      ADDRESS POTENTIAL HEALTH
      RISK
---------------------------------------------------------- Letter :4.1

Once EPA confirmed that the dioxin levels in the poultry samples were
higher than naturally occurring background levels, officials from
FSIS and FDA were included in the investigation into the source of
the dioxin.  The agencies coordinated their efforts through daily
conference calls involving numerous officials from the three agencies
participating in the investigation.  Through this arrangement, the
agencies shared responsibility for leading the investigation as the
focus evolved from identifying the source of the dioxin, to disposing
of the adulterated animal feed and, ultimately, to restricting the
sale of adulterated food products.  Because officials from these
agencies were included from the beginning of the investigation, their
decisions were well informed and coordinated.  For example, they were
able to agree on important issues, such as the concentration level of
dioxin that would be used to distinguish food products with elevated
dioxin levels from those products with background dioxin levels.  In
addition, the officials coordinated their efforts by sharing
resources, such as laboratory testing facilities, and by undertaking
joint efforts to collect samples. 


      AGENCIES DID NOT PROVIDE
      ADEQUATE GUIDANCE NOR ALLOW
      SUFFICIENT TIME TO COMPLY
      WITH TESTING REQUIREMENTS
---------------------------------------------------------- Letter :4.2

As the investigation into the source of the dioxin contamination
evolved, the impact on producers' operations changed from simply
stopping the use of contaminated feed to requiring producers to
undergo a complex process for testing dioxin levels in the animals
that had consumed the feed.  Some producers had difficulty complying
with these requirements because the agencies did not always provide
guidance that was clear. 

The confusion caused by FDA's guidance is illustrated by the agency's
handling of the situation with the fish industry.  On July 3, FDA
began notifying fish producers that some of the feed they had been
using was contaminated and that they should dispose of any remaining
contaminated feed in accordance with appropriate regulations. 
However, FDA did not tell the producers to stop distributing their
fish, nor did it tell them about the risk the fish might pose to
consumers' health, even though we were informed that some producers
had asked about these issues.  Five days later, on July 8, FDA
notified these same producers that their fish were subject to a
testing requirement before they could be sold for human consumption. 
However, FDA recognized that it did not provide an adequate
implementation plan for its sampling and testing protocol.  Producers
told us that FDA could not initially tell them whether all fish were
subject to testing; nor did FDA give sufficient guidance on packing
the fish samples for shipment to the laboratories for testing. 
Recognizing these concerns, FDA met with fish producers and discussed
these and other matters.  On July 11, realizing that its sampling and
testing protocol for fish was impractical, FDA temporarily suspended
its implementation.  FDA then held additional meetings with state
regulatory agencies and with industry officials and developed a
revised protocol. 

FDA officials informed us that between July 3 and July 8, they
provided guidance only about the animal feed because, prior to July
8, they had not completed the guidance for the handling of food
products.  In agreeing to revise its fish sampling and testing
protocol, FDA officials said they had been flexible in working with
industry to make its new protocol as effective as possible. 

While the new sampling and testing instructions were clearer than the
original instructions, the producers still were concerned that the
instructions were impractical because they did not allow for a
realistic period of time in which to complete testing.  On July 16,
FDA notified fish producers that any fish that had been fed
contaminated feed could not be sold after July 20 unless the fish had
been tested and shown to have dioxin levels below one part per
trillion.  Therefore, if producers who had used the contaminated feed
wanted to sell their fish after July 20, they had 4 days in which to
collect samples for testing, find a laboratory that could conduct the
tests, send the samples to the laboratory, and receive the test
results back.  However, between July 16 and July 20, producers were
free to market their fish products, regardless of the products'
dioxin levels.  Although many of the producers we spoke with said
they received their results within 7 days, one fish producer informed
us that his testing took 5 weeks to complete.  During this time, his
company could not sell its products.  Furthermore, producers pointed
out that the testing and sampling may have been unnecessary because
their fish had not been fed contaminated feed since at least July 3,
and the dioxin levels were diminishing as the fish grew. 

FSIS allowed 5 days for poultry processors to meet its deadline. 
Although FSIS' testing requirements, issued on July 8, did not take
effect until July 13, poultry processors were not always able to meet
this deadline.  For example, one poultry company was forced to shut
down its processing plant for 2 days while it awaited the results of
the dioxin tests.  The inability to meet the deadline was partly due
to the limited number of laboratories able to perform these very
difficult tests. 


   THE CURRENT FOOD SAFETY SYSTEM
   RESULTED IN INEFFICIENCIES AND
   HARDSHIPS FOR SOME PRODUCERS
   AND PROCESSORS
------------------------------------------------------------ Letter :5

The agencies involved in addressing the dioxin incident had to
overcome the inherent inefficiencies associated with the current food
safety system, in which responsibility for ensuring food safety is
spread among several agencies.  As we have reported on numerous
occasions, this fragmented food safety system necessitates extensive
coordination efforts to minimize wasteful duplication of effort,
prevent gaps in regulatory coverage, and avoid conflicting actions. 

The large number of people that came together to make decisions and
issue guidance in this situation illustrates the inherent
inefficiencies in the current food safety system.  For example,
nearly every day during May, June, and early July, officials from
EPA, FDA, and FSIS participated in conference calls to discuss the
latest developments in the investigation into the source of the
dioxin and to determine what actions, if any, the agencies needed to
take to protect consumers.  At times, over 40 officials participated
in these discussions.  While FDA and FSIS worked together to make
decisions on the preferred course of action, each agency was
responsible for communicating its decisions to producers or
processors under its jurisdiction.  However, complete information was
not always communicated to all affected parties.  For example, FDA,
the agency responsible for regulating animal feed, sent field
officials to inform the purchasers of the contaminated feed that they
should discontinue the use of any remaining contaminated feed.  When
these officials met with meat and poultry producers, their primary
concern was with the feed, not with the animals that had consumed the
contaminated feed.  Thus, the officials did not necessarily tell the
meat and poultry feed purchasers of the actions they should take for
their affected animals.  FSIS, the agency responsible for regulating
meat and poultry processors, sent word of the testing requirements to
meat and poultry processors and to trade associations but also did
not notify meat and poultry producers.  FSIS has jurisdiction over
processing plants, not producers. 

In at least one instance, the fragmented nature of the system
resulted in hardships for a producer because he was not informed in a
timely manner about the actions he had to take to ensure that his
animals could be marketed.  This hardship occurred even though an FDA
official had visited his farm on July 14, the day after FSIS' testing
requirements for poultry and livestock went into effect.  The
producer told us that on this day the FDA official instructed him to
stop using the contaminated feed but did not inform him about FSIS'
testing requirement. 

In the week following the visit by the FDA official, the producer,
who told us he was still not aware of the testing requirement,
shipped his hogs to a processing plant.  While the hogs were in
transit, the producer was informed by the processor that his animals
would not be accepted for processing because his name had been
included on an FSIS list of producers who had purchased feed
contaminated with dioxin.  The producer then had to unload his hogs
en route at a receiving station while he tried to determine the
actions he had to take.  The producer told us that, despite numerous
phone calls to the processor and to FSIS officials in Washington,
D.C., he was not initially told how to resolve this situation.  After
several days, FSIS told him the hogs had to be tested but agreed to
bear the costs of testing.  While awaiting the test results, the
producer shipped the hogs back to his farm.  The producer told us
that at some point, his hogs contracted an illness that spread,
resulting in a tenfold increase in the death rate normally
experienced on his farm.  Ultimately, the test results revealed that
the levels of dioxin in the producer's hogs were below one part per
trillion. 

FSIS officials told us that this producer was the only beef or hog
producer that they knew of who experienced a delay in bringing his
animals to slaughter.  In this instance, they stated that every
effort was made to assist the producer, including purchasing three of
his animals and arranging for their slaughter and testing.  We agree
that once the agency learned of the producer's problems, it was
responsive to his needs.  However, the producer's difficulties arose
because he was not informed of the need for testing prior to his
decision to ship his hogs for slaughter. 


   AGENCY COMMENTS
------------------------------------------------------------ Letter :6

We provided a draft of this report to the Food and Drug
Administration, the Environmental Protection Agency, and the Food
Safety and Inspection Service for review and comment.  Subsequently,
we met with officials from each agency to discuss the information in
this report and to obtain their comments.  The Food and Drug
Administration also provided written comments, which, together with
our responses, appear in appendix I. 

In summary, the Food and Drug Administration commented that the
draft, while factually correct, omitted significant aspects of the
dioxin incident.  The agency pointed out that the report did not
completely discuss the work the agency did to identify and trace back
the dioxin contamination.  In addition, the Food and Drug
Administration wanted to emphasize that it took action because of the
health risk associated with dioxin.  We believe the report describes
the Food and Drug Administration's actions and adequately captures
the agency's reasons for choosing to halt the distribution of food
products with dioxin levels above one part per trillion. 

In commenting on the draft report, the Director of the Environmental
Protection Agency's National Center for Environmental Assessment
expressed concern that the uninformed reader may underestimate the
dangers associated with exposure to dioxin.  He emphasized that while
science has not yet determined the level of exposure to dioxin that
may present a danger to human health, it also has not yet determined
a safe level of dioxin exposure.  We believe we have adequately
represented the known dangers of dioxin in the report. 

In commenting on the draft report, the Acting Deputy Administrator of
the Food Safety and Inspection Service's Office of Management
expressed concern that the report's title and the emphasis given in
the report to some producers' perceptions were misleading.  The Food
Safety and Inspection Service stated that the report did not
adequately reflect the positive efforts the agencies made to quickly
identify the source of the dioxin contamination; to protect consumers
from any potential hazards; and to work effectively with processors
and producers, given the large number of parties affected by this
incident.  In addition, the agency said the report was not completely
accurate because it attributed the hardships producers experienced to
the actions of the federal government and overemphasized one
producer's "perceptions." We believe we have adequately captured the
agencies' efforts to quickly identify the source of the contamination
and to protect consumers from potential hazards.  We agree with the
Food Safety and Inspection Service that the dioxin-contaminated ball
clay caused the incident.  However, as we have stated, the Food
Safety and Inspection Service's guidance to the affected producers
and processors was impractical because it did not provide enough time
for some processors to test and receive results before the agency's
deadline and because it was not delivered to the producers in a
timely manner so that they were aware of the steps that needed to be
taken before they could deliver their products to market. 

Officials from the Environmental Protection Agency, the Food Safety
and Inspection Service, and the Food and Drug Administration also
provided clarifying comments to the report that have been
incorporated where appropriate. 


   OBJECTIVES, SCOPE, AND
   METHODOLOGY
------------------------------------------------------------ Letter :7

To address your concerns about the conduct of the federal food safety
agencies, we spoke with, and obtained studies and other information
from, officials at the U.S.  Department of Agriculture's Agricultural
Research Service (ARS) and FSIS, CDC, EPA, and FDA.  In addition, we
spoke with state officials from Arkansas and Missouri,
representatives of trade associations and industry, and individual
producers.  To determine the basis for the federal agencies' actions
to require producers to demonstrate that the dioxin levels in their
food products were below a specified level, we spoke with officials
from FDA and FSIS and reviewed appropriate statutes and regulations
pertaining to their authority.  We also met with officials from EPA
and CDC to identify and discuss any studies about the health risks
associated with exposure to dioxin. 

To determine federal agencies' effectiveness in working together on
decisions to address the problem of dioxin-contaminated feed, we
reviewed the records of interagency meetings and met with officials
from FDA, FSIS, EPA, and CDC to discuss how frequently officials from
the agencies met, whether officials from one agency took the lead on
certain issues, and how the agencies coordinated their efforts.  To
determine the federal agencies' effectiveness in communicating their
decisions to the affected state agencies, producers, and processors,
we asked officials from the Arkansas Department of Health, the
Arkansas Development Finance Authority, and the Missouri Department
of Agriculture to describe their discussions with FDA, FSIS, and EPA. 
In addition, to discuss whether the federal agencies effectively
communicated their decisions and the consequences of these decisions
to the affected parties, we contacted officials from Tyson Foods,
Inc.; Riceland Foods, Inc.; ARKAT Feeds, Inc.; Cal-Maine Foods, Inc.;
Townsends, Inc.; the United Egg Producers; the Arkansas Cattlemen's
Association; the Arkansas Pork Producers Association; and several
individual fish and pork producers in Arkansas and Missouri. 
Finally, we met with ARS staff in Arkansas and with FDA staff from
the Dallas District Office and the San Antonio Residence Post to
determine how federal regulatory actions were conveyed to affected
producers and feed mills. 

To determine the impact of the current food safety system on the
handling of the dioxin-contaminated feed situation, we discussed the
structure of the current food safety system and its impact upon this
situation with the federal and state agency officials, industry
staff, and the producers listed above. 

We conducted our work from September 1997 through March 1998, in
accordance with generally accepted government auditing standards. 


---------------------------------------------------------- Letter :7.1

We are providing copies of this report to interested congressional
committees; the Secretaries of Agriculture and Health and Human
Services; the Administrator, Environmental Protection Agency; and
other interested parties.  Copies will be made available to others
upon request. 

If you have any questions about this report, I can be reached at
(202) 512-5178.  Major contributors to this report were Robert C. 
Summers, John Nicholson, Natalie Herzog, Stuart Ryba, and Carol
Herrnstadt Shulman. 

Robert A.  Robinson
Director, Food and
 Agriculture Issues


List of Requesters

The Honorable Dale Bumpers
The Honorable Tim Hutchinson
United States Senate

The Honorable Marion Berry
The Honorable Asa Hutchinson
The Honorable Jay Dickey
The Honorable Jo Ann Emerson
The Honorable Roy Blunt
House of Representatives




(See figure in printed edition.)Appendix I
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION
============================================================== Letter 



(See figure in printed edition.)



(See figure in printed edition.)


GAO'S COMMENTS

1.  We believe we have adequately represented the known dangers of
dioxin in the report. 

2.  The Food and Drug Administration (FDA) emphasized that it took
its actions because of its concern that people in the southern and
southwestern states would be exposed to higher levels of dioxin if
the problem was not contained.  We believe that in the report we
adequately captured FDA's reasons for selecting the
one-part-per-trillion level and choosing to stop the flow of
adulterated products to the consumer, as well as FDA's efforts to
work with the fish industry to develop the new sampling plan after
the first plan was determined to be impractical. 

3.  FDA said it was difficult to communicate with the catfish
industry because the industry consists of many small producers who
are neither centrally organized nor represented by a single trade
association.  FDA said that, nonetheless, it worked closely with the
industry to develop a sampling plan that could facilitate a steady
flow of uncontaminated catfish to processors while minimizing or
nearly eliminating the release of contaminated catfish into commerce. 
While we agree that FDA may have attempted to minimize the effects of
their actions, the fact remains that catfish producers had
difficulties complying with FDA's requirements because FDA's guidance
was not always clear, leaving the producers confused about the
actions they needed to take. 


*** End of document. ***