Food Safety: Federal Oversight of Shellfish Safety Needs	 
Improvement (09-JUL-01, GAO-01-702).				 
								 
Molluscan shellfish--oysters, clams, mussels, and scallops--cause
over 100,000 illnesses annually, according to the most recent	 
available estimates made by the Food and Drug Administration	 
(FDA). Unlike meat and most other seafood products, which are	 
normally cooked before consumption, shellfish are frequently	 
eaten raw, heightening the risk of illness. The severity of	 
illnesses that occur from contaminated shellfish varies from mild
gastrointestinal discomfort to death. The vibrio vulnificus (V.  
vulnificus) bacteria in shellfish, primarily raw oysters, have	 
been the cause of 275 reported illnesses resulting in 143 deaths 
since 1989, according to FDA. In 1982, FDA, state regulators, and
shellfish industry representatives formed the Interstate	 
Shellfish Sanitation Conference (ISSC) to promote uniform	 
shellfish policies for the safe harvesting, processing, and	 
distribution of fresh and frozen shellfish. In December 1997, FDA
required processors of seafood, including shellfish, to implement
Hazard Analysis Critical Control Point (HACCP) systems. 	 
Processors of raw molluscan shellfish are required to identify	 
safety hazards that are reasonably likely to occur and to	 
establish controls to prevent or reduce contamination to	 
acceptable levels. This report reviews (1) FDA's approach to	 
oversight of state and foreign shellfish safety programs and (2) 
the ISSC's strategy for reducing the illnesses and deaths	 
associated with V. vulnificus bacteria. GAO found that several	 
weaknesses exist in FDA's approach to oversight of domestic and  
foreign safety programs. FDA does not use existing information,  
including shellfish production and illness data, to make	 
risk-based decisions about which programs should receive the most
oversight. FDA's ability to fully assess relative risk and	 
allocate its limited oversight resources is limited by weaknesses
in the compliance and effectiveness information it gathers on	 
state and foreign country shellfish safety programs. FDA also	 
does not have objective, measureable data on the effectiveness of
HAACP requirements and other state and foreign country efforts to
reduce the amount of bacteria in shellfish and associated	 
illnesses. Despite various actions, the ISSC's efforts to reduce 
V. vulnificus-related illnesses and deaths have not been	 
effective. The ISSC is now developing a strategy that would rely 
primarily on educating at-risk consumers to reach the goal of	 
reducing the number of V. vulnificus-related illnesses and deaths
by 60 percent by 2008.						 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-01-702 					        
    ACCNO:   A01127						        
  TITLE:     Food Safety: Federal Oversight of Shellfish Safety Needs 
             Improvement                                                      
     DATE:   07/09/2001 
  SUBJECT:   Contaminated foods 				 
	     Data collection					 
	     Food inspection					 
	     Importing						 
	     Health hazards					 
	     Safety standards					 
	     Product safety					 
	     Federal/state relations				 
	     Shellfish						 
	     State programs					 
	     Safety regulation					 
	     FSIS Hazard Analysis and Critical			 
	     Control Point System				 
								 
	     Florida						 
	     Louisiana						 
	     National Shellfish Sanitation Program		 
	     New Jersey 					 
	     New York						 
	     Texas						 
	     Washington 					 

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GAO-01-702
     
Report to the Committee on Agriculture, Nutrition, and Forestry, U. S.
Senate

United States General Accounting Office

GAO

July 2001 FOOD SAFETY Federal Oversight of Shellfish Safety Needs
Improvement

GAO- 01- 702

Page i GAO- 01- 702 Shellfish Safety Letter 1

Appendix I Scope and Methodology 30

Appendix II Comments From the Food and Drug Administration 31

Appendix III Comments From the Interstate Shellfish Sanitation Conference 39

Appendix IV GAO Contacts and Staff Acknowledgements 50

Tables

Table 1: Principal Pathogens and FDA's Estimates of Associated Cases of
Shellfish- Related Illnesses, 1995 7 Table 2: 1995 NSSP Post- harvest
Refrigeration Requirements for

States Subject to Shellfish Temperature Controls 17 Table 3: V. vulnificus-
related Illnesses and Deaths From Shellfish

Reported to FDA, 1994- 2000 20

Figures

Figure 1: Map of Shellfish Harvesting and Processing States 5 Figure 2: U.
S. Shellfish Production by Type of Shellfish, 1999 6 Figure 3: V.
vulnificus- related Illnesses and Deaths From Shellfish

Reported to FDA, 1989- 2000 8 Figure 4: Known Sources of V. vulnificus-
related Illnesses From

Shellfish Reported to FDA, 1989- 2000 9 Figure 5: Annual U. S. Oyster
Production, 1994- 99 21 Contents

Page 1 GAO- 01- 702 Shellfish Safety

July 9, 2001 The Honorable Tom Harkin Chairman The Honorable Richard G.
Lugar Ranking Minority Member Committee on Agriculture, Nutrition, and
Forestry United States Senate

Molluscan shellfish- oysters, clams, mussels, and scallops- cause over
100,000 illnesses annually, according to the most recent available estimates
from the Food and Drug Administration (FDA). 1 Unlike meat and most other
seafood products, which are normally cooked before consumption, molluscan
shellfish (hereafter, shellfish) are frequently eaten raw, heightening the
risk of illness from a variety of pathogens that may be present. The
severity of the illnesses that occur from contaminated shellfish varies. On
one end of the spectrum, Norwalk and Norwalk- like viruses, which cause the
vast majority of illnesses, result in mild gastrointestinal discomfort. On
the other end, Vibrio vulnificus (hereafter V. vulnificus) bacteria cause
severe illnesses and, frequently, death, generally in persons with weakened
immune systems because of adverse health conditions, such as liver disease.
V. vulnificus bacteria in shellfish, primarily raw oysters, have been the
cause of 275 reported illnesses resulting in 143 deaths since 1989,
according to FDA.

FDA is the federal agency responsible for ensuring the safety of shellfish.
In 1982, FDA, state regulators, and shellfish industry representatives
formed the Interstate Shellfish Sanitation Conference (ISSC) to promote
uniform shellfish safety policies. The ISSC develops policies for the safe
harvesting, processing, and distribution of fresh and frozen shellfish. FDA
must concur with the ISSC's proposed policy changes before they are
incorporated into the National Shellfish Sanitation Program?s (NSSP)
catalogue of safety procedures, referred to as the model ordinance. When

1 FDA defines molluscan shellfish as all edible species of oysters, clams,
mussels, and whole or roe- on scallops; either shucked or in the shell,
fresh or frozen, whole or in part. Scallops are excluded from the definition
when the final product is the shucked abductor muscle only, the most
commonly eaten part of the scallop. FDA issued its estimate of shellfish-
related illnesses in its December 1995 final rule on the procedures for the
safe and sanitary processing and importing of fish and fishery products.
Neither FDA nor the Centers for Disease Control and Prevention have current
estimates of the number of shellfish- related illnesses that occur annually.

United States General Accounting Office Washington, DC 20548

Page 2 GAO- 01- 702 Shellfish Safety

new policies are adopted into the model ordinance, the participating states
and foreign countries incorporate them into their own program requirements
and are responsible for enforcing them. All 30 of the states that harvest
and/ or process shellfish commercially participate in the ISSC. In addition,
four foreign countries- Canada, Chile, South Korea, and New Zealand- have
memorandums of understanding with FDA in which they agree to abide by NSSP's
shellfish safety policies. Raw shellfish from countries that have not signed
such memorandums are not permitted to enter U. S. commerce. The ISSC member
states and foreign countries are responsible for inspecting their shellfish
processing plants, classifying shellfish growing areas to limit harvesting
to areas that meet water quality standards, and patrolling shellfish growing
areas to prevent illegal harvesting. FDA oversees ISSC member states? and
foreign countries? shellfish safety programs primarily by (1) conducting
evaluations to ensure they comply with NSSP policy and applicable federal
regulations and (2) providing technical assistance, such as helping conduct
water quality studies or helping implement new shellfish safety policies.

A significant change to shellfish safety policy occurred in December 1997,
when FDA required processors of seafood, including shellfish, to implement
Hazard Analysis Critical Control Point (HACCP) systems. Under the HACCP
regulations, which were also incorporated into the NSSP, processors of raw
molluscan shellfish are required to identify safety hazards that are
reasonably likely to occur and to establish controls to prevent or reduce
contamination to acceptable levels. FDA and ISSC do not require shellfish
processors to treat V. vulnificus as a hazard that must be controlled under
their HACCP plans because the bacteria occurs naturally in oysters, the
general population is not susceptible to illness from it, and the amount of
V. vulnificus needed to cause illness in susceptible individuals is unknown.
According to the ISSC, these characteristics distinguish V. vulnificus from
other known hazards associated with shellfish and pose challenges in
determining the appropriate public health intervention strategies. As such,
the ISSC has adopted various strategies, such as educating at- risk
consumers, and continues to propose new strategies aimed at reducing V.
vulnificusrelated illnesses.

Concerned about shellfish safety, you requested that we evaluate (1) FDA's
approach to oversight of state and foreign shellfish safety programs and (2)
the ISSC's strategy for reducing the illnesses and deaths associated

Page 3 GAO- 01- 702 Shellfish Safety

with V. vulnificus bacteria. 2 To conduct this review we visited six states-
Florida, Louisiana, New Jersey, New York, Texas, and Washington- to gather
information on state implementation of shellfish safety requirements. During
1999, these six states collectively produced about 65 percent of the
nation's shellfish, and shellfish from Florida, Texas, and Louisiana was the
source of almost all reported shellfish- related illnesses caused by V.
vulnificus bacteria that could be traced to a particular state. Appendix I
provides additional details on our scope and methodology.

Several weaknesses exist in FDA's approach to overseeing domestic and
foreign shellfish safety programs. First, FDA does not use existing
information, including shellfish production and illness data, to make
riskbased decisions about which programs should receive the most oversight.
For example, in 2000, FDA devoted essentially the same amount of staff time
to annual evaluation activities in Louisiana, a very large oyster producer
and one of the major sources of reported V. vulnificus- related illnesses,
as it did in Delaware which produces relatively few oysters and has not been
the source of any reported V. vulnificus- related illnesses. As a result,
FDA's resources are not being used efficiently to achieve the greatest level
of shellfish safety. FDA officials said that they have not yet moved to a
risk- based approach to overseeing shellfish safety programs in part because
the states wanted to receive uniform FDA oversight. Second, FDA's ability to
fully assess relative risk and allocate its limited oversight resources is
limited by weaknesses in the compliance and effectiveness information it
gathers on states? and foreign countries? shellfish safety programs.
Currently, FDA does not have sufficient information, such as the results of
all plant inspections in the 30 states and the four exporting countries, to
assess the extent of compliance with some safety requirements. FDA also does
not have objective, measurable data on the effectiveness of HACCP
requirements and other efforts by states and foreign countries to reduce the
amount of bacteria in shellfish and associated illnesses. FDA officials
acknowledged the desirability of having better data on compliance and
effectiveness. However, they believe it is not currently possible to
directly assess the effectiveness of shellfish safety efforts because of
problems in accurately measuring reductions in shellfish- related pathogens
and illnesses.

2 The safety of all other seafood, excluding molluscan shellfish, is
discussed in our report, Food Safety: Federal Oversight of Seafood Does Not
Sufficiently Protect Consumers (GAO- 01- 204, Jan. 31, 2001). Results in
Brief

Page 4 GAO- 01- 702 Shellfish Safety

The ISSC's efforts to reduce V. vulnificus- related illnesses and deaths
have not been effective. Despite various actions by the ISSC, the annual
number of reported illnesses and deaths associated with V. vulnificus has
remained relatively constant since 1994. The ISSC is now developing a
strategy that, if adopted, would rely primarily on educating at- risk
consumers, to reach the goal of reducing the rate of V. vulnificus related
illnesses and deaths by 60 percent by 2008. If the states do not meet this
goal, one of several potential controls designed to achieve the desired
outcome, such as postharvest treatment to kill bacteria, will be
implemented. However, if the states rely on education alone, it is
questionable whether significant illness reductions will be achieved prior
to 2008 because the ISSC's past education efforts have not demonstrated that
education is likely to have this effect. Two strategies- mandating
refrigeration of oysters shortly after harvest and requiring immediate
phase- in of post- harvest treatment- may reduce V. vulnificus- related
illnesses and deaths more quickly than the proposed ISSC strategy. However,
these options have disadvantages as well, such as the potential for negative
economic impacts on some segments of the shellfish industry.

We are making several recommendations to the Commissioner of the Food and
Drug Administration aimed at improving federal oversight of the shellfish
safety program and at providing consumers with increased protections against
illnesses resulting from V. vulnificus. In commenting on a draft of this
report, FDA and the ISSC generally concurred with our recommendations.
However, in response to our recommendation that FDA gather data, such as
microbial test results, to measure program effectiveness, FDA and the ISSC
said that while they recognize the importance of effectiveness data, they
are uncertain what the most appropriate measures would be. Nonetheless, the
agencies said they will work together to investigate the development of
program effectiveness measures.

Molluscan shellfish- oysters, clams, mussels, and scallops- have been a part
of the American diet for several centuries. Today, domestic shellfish are
commercially harvested from the waters of the Atlantic, Pacific, and Gulf of
Mexico and shipped to consumers throughout the United States. Twenty- two
coastal states harvest shellfish from their waters and 8 other states
process shellfish that were harvested elsewhere, as shown in figure 1.
Background

Page 5 GAO- 01- 702 Shellfish Safety

Figure 1: Map of Shellfish Harvesting and Processing States

Source: Interstate Shellfish Sanitation Conference.

During 1999, the United States commercially harvested and processed about
165 million pounds of clams, oysters, scallops, and mussels. Figure 2 shows
the amount and percentage of each type of shellfish harvested. Production
varied by state- New Jersey and Massachusetts fishermen

Page 6 GAO- 01- 702 Shellfish Safety

harvested most of the nation's clams, whereas Washington, Louisiana, and
Texas were the main oyster- harvesting states. Massachusetts and Virginia
were the two top scallop- harvesting states, and mussels were harvested
primarily in Maine.

Figure 2: U. S. Shellfish Production by Type of Shellfish, 1999

Source: National Marine Fisheries Service.

In addition, some foreign countries export molluscan shellfish to the United
States. While any foreign country may export cooked shellfish to the United
States, only certified shippers from countries that have memorandums of
understanding with FDA and have agreed to abide by the shellfish safety
policies incorporated into the NSSP are permitted to export fresh or frozen
uncooked shellfish into the country. Four countries- Canada, Chile, Korea,
and New Zealand- have such agreements. The amount of fresh and frozen
uncooked shellfish that these countries export to the United States is not
known. The National Marine Fisheries Service tracks total shellfish imports
but does not have data on the percent of shellfish imports that are uncooked
and destined to be sold for raw consumption.

Page 7 GAO- 01- 702 Shellfish Safety

Unlike meat, and most other seafood products, which are normally cooked
before consumption, shellfish, particularly oysters, are frequently eaten
raw, thus potentially exposing consumers to a variety of pathogens. In 1995,
FDA estimated that shellfish caused over 100,000 illnesses and cost the
nation about $201. 9 million annually. Many of these illnesses are not
reported because the symptoms are mild and the individuals affected do not
seek medical attention. However, the ISSC believes FDA?s estimate
significantly overstates the actual number of annual illnesses related to
shellfish.

As shown in table 1, FDA estimated that the greatest number of
shellfishrelated illnesses are attributable to the Norwalk virus, which
occurs primarily in feces- contaminated growing waters. 3 The virus can
cause nausea, vomiting, diarrhea, abdominal cramps, and occasionally fever
in humans, but the symptoms usually persist for less than 48 hours.

Table 1: Principal Pathogens and FDA's Estimates of Associated Cases of
ShellfishRelated Illnesses, 1995

Pathogens Cases of illness

Norwalk virus 100,000 Hepatitis A virus 1,000

Vibrio vulnificus 60 Other marine toxins 20 Paralytic shellfish poisoning 10
Other Unknown a

Total 101,090

a Additional pathogens, such as Campylobacter jejuni, Giardia, and other
Vibrios affect fish as well as shellfish. FDA did not estimate the number of
illnesses from these pathogens linked to shellfish alone. Source: FDA.

FDA also estimated that about 60 percent of the cost of shellfish- related
illnesses, or about $120. 5 million annually, is the result of V. vulnificus
bacteria. Although the number of V. vulnificus- related illnesses is small,
the costs of the disease are high because of the high mortality rate- about
52 percent of those who become ill eventually die. V. vulnificus is a
naturally occurring bacterium found in all coastal waters and is more
abundant in oysters and clams during the warm- weather months of April

3 Because individuals suffering from this illness generally do not seek
medical help, the Centers for Disease Control and Prevention has no data on
the number of reported cases of shellfish- related Norwalk illness.

Page 8 GAO- 01- 702 Shellfish Safety

through October. Most healthy people do not become ill from V. vulnificus,
but certain medical conditions put some people at risk of developing a
potentially fatal infection known as septicemia. These conditions include,
alcohol- related liver disease, hemachromatosis, cancer, chronic kidney
disease, and HIV/ AIDS, among other conditions. FDA has estimated that
between 12 million and 30 million Americans have conditions that put them at
increased risk for V. vulnificus- related illness.

According to FDA data, from 1989 through 2000, 275 reported illnesses
resulting in 143 deaths were linked to shellfish containing V. vulnificus.
The annual number of reported illnesses and deaths is somewhat higher at the
end of this time period than at the beginning, as shown in figure 3. It is
not known whether this increase is due to better reporting, greater
shellfish consumption, or an actual increase in the rate of shellfish-
related illnesses.

Figure 3: V. vulnificus- related Illnesses and Deaths From Shellfish
Reported to FDA, 1989- 2000

Source: FDA

Almost all of the V. vulnificus- related illnesses that could be traced to a
particular state between 1989 and 2000 were associated with eating raw
oysters harvested in Louisiana, Texas, and Florida, as shown in figure 4.

Page 9 GAO- 01- 702 Shellfish Safety

Figure 4: Known Sources of V. vulnificus- related Illnesses From Shellfish
Reported to FDA, 1989- 2000

Source: FDA.

The shellfish safety program is one of four FDA- state cooperative programs
where FDA's role is primarily oversight of state programs rather than direct
enforcement of safety requirements. 4 FDA has delegated to the ISSC the
primary responsibility for developing shellfish safety policy. FDA, each of
the 30 states that produces and/ or processes shellfish, the four countries
that have active shellfish agreements with the United States, and
representatives of the shellfish industry are members of the ISSC. The ISSC
has met annually to discuss and adopt new shellfish safety policies, which
are then compiled in the NSSP model ordinance. 5 Only the state
representatives may vote on changes to shellfish safety policy. Federal
agencies, including FDA, industry, and foreign country representatives do

4 The other three FDA- state programs are radiological health, retail food
protection, and milk safety. 5 Beginning in 2001, the ISSC will meet
biennially instead of annually.

Page 10 GAO- 01- 702 Shellfish Safety

not vote, but FDA must concur with new policies before they are formally
adopted.

Once new shellfish safety policies have been incorporated into the NSSP,
member states and foreign countries are responsible for adopting them into
law and taking necessary enforcement actions. States and foreign countries
manage shellfish safety by taking the following required actions:

 Classify growing areas. States and foreign countries divide their coastal
shellfish growing waters into distinct geographic regions. For each area,
states and foreign countries must identify potential sources of pollution
and test the water regularly for bacteriological or other contamination.
Pathogens may naturally occur in the growing water or result from human
activities, such as discharges of human sewage and chemicals. States and
foreign countries use these tests to determine limitations on shellfish
harvesting for each growing area. Each area is classified as approved,
conditionally approved, restricted, conditionally restricted, or prohibited.
Growing areas are then designated as either open or closed. Prohibited areas
are never open and restricted areas are only open for special harvesting.
The other classified areas are normally open, subject to the limitations of
their classifications. All harvest areas, regardless of classification, are
subject to closure in emergency situation that have the potential to make
the water unsafe.

 Patrol shellfish growing areas. States and foreign countries conduct
patrols of growing areas to prevent harvest of shellfish from closed areas
and to check that boats are not dumping their waste overboard into shellfish
growing areas. Harvesting from closed areas and overboard discharge of waste
into shellfish growing areas have been identified as sources of shellfish-
related illnesses in the past.

 Inspect shellfish processing plants. States and foreign countries conduct
regular, comprehensive, on- site, inspections of shellfish processing plants
and issue annual certifications that permit processors to sell their
shellfish products in interstate commerce. The regular inspections and
annual certification provide notice to consumers and health officials in
other states that the shellfish products purchased from the processor have
been grown, harvested, processed, and shipped in accordance with NSSP safety
requirements. These requirements include implementing general sanitation
procedures commonly used throughout the food industry, such as ensuring the
safety of the water and ice that come into contact with food or food contact
surfaces, preventing crosscontamination from unsanitary objects, and
excluding pests from the processing plant. Since December 1997, processors
have also been required to implement HACCP systems under which they must
identify

Page 11 GAO- 01- 702 Shellfish Safety

safety hazards that are reasonably likely to occur and establish control
procedures to prevent or reduce contamination from such hazards to
acceptable levels.

 Operate laboratories. States and foreign countries operate laboratories to
test growing waters and shellfish meats for the presence of pathogens, among
other purposes.

FDA oversees states' and foreign countries' shellfish safety programs to
ensure that they comply with all shellfish safety requirements. FDA carries
out this responsibility primarily by (1) evaluating states? and foreign
countries? programs and (2) providing technical assistance, such as helping
conduct water quality studies or helping implement new shellfish safety
policies. In fiscal year 2001, FDA expects to use about 8 staff years to
conduct evaluations of states? and foreign countries? programs and 6 staff
years to provide technical assistance and training to states? and foreign
countries? staff. 6 In evaluating these programs FDA, among other things,
assesses whether the state or foreign country is properly classifying and
patrolling shellfish growing areas and inspecting processing plants to
identify those that are not fully meeting the applicable safety
requirements.

Several weaknesses exist in the way FDA oversees states' and foreign
countries' efforts to ensure shellfish safety. First, FDA has not adopted a
risk- based approach to overseeing states? and foreign countries? shellfish
programs. Although risk- based approaches are generally recognized as the
most effective method for targeting limited resources, FDA's oversight
approach is based on essentially equal treatment of all participants in the
shellfish safety program. Second, FDA lacks sufficient information on
states' and foreign countries' compliance with some NSSP safety requirements
and has no data on the effectiveness of states? and foreign countries?
shellfish safety programs. Both of these weaknesses limit FDA's ability to
allocate its oversight resources to most effectively reduce the risk of
consumers becoming ill from eating unsafe shellfish.

6 Overall, in fiscal year 2000, FDA used 54. 3 staff years to administer the
molluscan shellfish program. This number includes program evaluation,
research laboratory, policy, and administrative personnel. Weaknesses Exist
in

FDA's Oversight of Domestic and Foreign Shellfish Programs

Page 12 GAO- 01- 702 Shellfish Safety

The level of food safety risk in a state's or foreign country's shellfish
program principally depends on the size and type of the shellfish industry,
the public's rate of consumption of shellfish, and the state's or foreign
country's compliance with safety requirements, such as properly classifying
growing waters. For example, the risk of shellfish- related illnesses is
likely greater for a state or foreign country that contains a larger number
of firms selling raw oysters, and that does not fully comply with NSSP
safety requirements, than it would be for one that sells significantly fewer
raw oysters and fully complies with the requirements. (Raw oyster
consumption has been associated with the most serious shellfish- related
illnesses.) Changes in the organization of a state's or foreign country's
shellfish safety program, the officials implementing the program, or its
funding, can also affect a program's compliance with NSSP requirements and,
consequently, the level of food safety risk. Although much of this
information is currently available, FDA does not use the information to
target its program oversight and thus does not make the most effective use
of its limited resources.

FDA seeks to provide essentially equal oversight to each shellfish safety
program, regardless of differences among the programs that could affect
their relative food safety risks, such as the amount and type of shellfish
produced and the shellfish- related illnesses that have occurred. To
illustrate, from fiscal years 1998 through 2000,

 FDA devoted approximately the same level of resources to evaluate the
Delaware program as it did to evaluate the Louisiana program, although
Delaware produces substantially less shellfish and has experienced far fewer
reported cases of shellfish- related illnesses than Louisiana; and

 FDA used slightly fewer resources to assess growing areas, processing
plants, and other aspects of New Zealand's shellfish program than it used to
assess Chile's program, although New Zealand exports tons of oysters to the
United States each year and has reported cases of shellfish- related
illnesses from local toxins, while Chile exports about one- seventh as many
oysters to the United States and has reported fewer shellfish- related
illnesses.

Similarly, FDA does not use the results of its previous state program
evaluations to help allocate its shellfish oversight resources. In a summary
of its fiscal year 1999 evaluations, FDA identified several states that had
significant deficiencies in aspects of their shellfish safety programs. For
example, FDA reported that seven states did not have the legal authority to
enforce HACCP requirements, four states had failed to collect and/ or
analyze the required number of growing area water samples, and one state
FDA's Oversight of States?

and Foreign Countries? Shellfish Programs Is Not Risk- Based

Page 13 GAO- 01- 702 Shellfish Safety

had not developed an education program to limit illegal harvesting of
shellfish in closed growing areas. Several states were deficient in multiple
areas. However, the following year (fiscal year 2000), FDA devoted
essentially the same level of oversight resources to evaluate each state's
program, regardless of the degree of problems the state had previously had
in implementing the shellfish safety requirements.

We and other organizations, such as the National Academy of Sciences, have
previously reported that including risk as one of several decisionmaking
factors can help an agency more efficiently target its oversight resources
to activities that have the greatest potential for enhancing food safety. 7
FDA officials said the agency plans to adopt a more risk- based approach to
its oversight of states? and foreign countries? shellfish programs. In this
regard, they said that near the end of fiscal year 2001, they would begin
discussing alternatives for redesigning the program to more effectively
target oversight resources. However, at this time, FDA has neither developed
a plan nor budgeted resources to study alternative program designs.

The states currently maintain paper records of shellfish processing plant
inspections that show the extent to which processors comply with sanitation
and HACCP requirements. However, most states do not enter such information
into an electronic database. The lack of electronic data on the results of
states? inspections of processing plant limits the states' and FDA's ability
to identify statewide and/ or national trends in compliance. In the absence
of electronic compliance data, FDA relies on its own limited number of plant
visits to estimate statewide and national trends in compliance with safety
requirements. Despite large differences in the number of processing plants
in each state, with some states having more than 150 processing plants, FDA
estimated compliance with sanitation and HACCP requirements based on, on
average, eight processing plants in each state. 8 According to an FDA
official, the agency assessed approximately the same limited number of
processing plant inspections in each state because (1) the agency does not
have sufficient

7 See Food Safety: U. S. Needs a Single Agency to Administer a Unified,
Risk- Based Inspection System (GAO/ T- RCED- 99- 256, Aug. 4, 1999) and
Ensuring Safe Food from Production to Consumption (National Academy Press,
1998). 8 The actual number of plants visits in any one state ranged from 3
to 14. FDA evaluated fewer than eight plants only in those states that had
fewer than eight commercial plants. FDA Lacks Electronic

Access to Information on State Compliance With Some Safety Requirements and
Has No Data on the Effectiveness of State Programs

Page 14 GAO- 01- 702 Shellfish Safety

resources to evaluate more and (2) the states requested that FDA use a
uniform system of evaluation. FDA has developed electronic systems for
recording inspection results in another FDA- state cooperative program and
agrees that a similar system for shellfish processors would be beneficial.
According to an FDA official, the agency has developed and is currently
testing electronic templates and storage capability so that, in the retail
foods program, state inspectors using laptop computers can complete
inspection reports electronically. The results of individual plant
inspections can then easily be compiled electronically into a summary
database. FDA plans to wait until this program is fully implemented in the
retail foods program before considering adapting it for use in shellfish
plant inspections.

Some states also lack sufficient tracking systems for patrols of growing
waters. As a result, FDA does not have the data it needs to verify states?
compliance with patrol requirements. At its 1999 annual meeting, the ISSC
adopted new minimum frequency requirements for patrols that are based on the
risk of illegal harvesting from each growing area. In fiscal year 2000, FDA
assessed states? compliance with the patrol requirements and found that 14
of the 22 shellfish- harvesting states- including 9 of the top 10 oyster-
harvesting states- did not have adequate tracking systems in place to
document the frequency of growing water patrols. FDA believes that most
states met or exceeded the required patrol frequencies, but without an
adequate tracking system in each state, FDA does not have the data needed to
verify this belief. Furthermore, without a tracking system, a state?s
noncompliance will likely remain undetected if it reduces its patrol
frequency to a level below the minimum requirement for any reason, such as
budget constraints.

In addition to limited access to information on state compliance with
shellfish safety requirements, FDA does not collect any data to measure the
overall effectiveness of states? and foreign countries? programs in reducing
bacteria or illness levels. For example, FDA has no direct measure of
whether (1) the growing water classification or processing plant sanitation
requirements actually result in safer shellfish or (2) taken as a whole,
some states' or foreign countries' programs are more effective in producing
safe shellfish than others. Furthermore, although FDA justified HACCP
implementation in shellfish processing plants by citing expected reductions
in shellfish- related illnesses, the agency has not evaluated HACCP
effectiveness either in terms of illness or pathogen reduction.

Page 15 GAO- 01- 702 Shellfish Safety

In our January 2001 report on seafood safety, we reached a similar
conclusion- that FDA lacked objective, measurable data to determine whether
its HACCP program for seafood is effectively reducing hazards. 9 In that
report, we noted that a guiding principal of the Government Performance and
Results Act is the use of objective, measurable data to assess how well an
organization is achieving its goals. For example, prior to implementing its
HACCP program, the U. S. Department of Agriculture determined the prevalence
of salmonella bacteria, among others, in meat and poultry so that it could
evaluate whether HACCP requirements were effective in lowering bacterial
levels and thus lowering risks to consumers.

According to FDA officials, the agency has not attempted to directly measure
effectiveness because it has not found reliable and meaningful ways to
measure either reductions in bacteria or illness for shellfish. FDA
officials said the agency relies on its compliance assessments to determine
whether states? and foreign countries? shellfish safety programs are
effective in protecting consumers' health. However, compliance data show
only what actions were taken by shellfish processors, not whether these
actions had the desired impact- safer shellfish. Despite the difficulties
associated with measuring reductions in bacteria or illnesses, we continue
to believe that such measurements can and should be made. In response to a
recommendation in our report on seafood safety, FDA noted that it had tested
seafood for salmonella, and plans to test for the presence of other
pathogens. In addition, the ISSC plans to measure reductions in illness to
determine the effectiveness of its V. vulnificus control strategy for raw
oysters.

9 Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect
Consumers (GAO- 01- 204, Jan. 31, 2001).

Page 16 GAO- 01- 702 Shellfish Safety

V. vulnificus- related illnesses and deaths have continued throughout the
past decade despite the ISSC's efforts to reduce them. The ISSC is now
developing a strategy that, if adopted, would principally rely on consumer
education to meet an illness reduction goal of 60 percent by 2008. If the
goal is not met, controls such as subjecting harvested oysters to treatments
that will reduce bacteria to nondetectable levels will be implemented.
However, past education efforts have not shown any demonstrable reductions
in V. vulnificus- related illnesses. As a result, it is unlikely that
education alone will significantly reduce illnesses by 2008. Options exist
that may reduce V. vulnificus- related illnesses and deaths more quickly
than the proposed ISSC strategy, but each option has advantages and
disadvantages.

During the past 6 years, the ISSC has employed two main strategies to reduce
illnesses and deaths associated with V. vulnificus. The ISSC has required
that oysters be refrigerated within certain time frames after harvest and
has implemented programs to educate those at- risk of V. vulnificus illness
on the dangers of eating raw shellfish. The biggest health concern about V.
vulnificus is with oysters because they are the type of shellfish that are
most often eaten raw and have been associated with most of the reported
illnesses and deaths.

Regarding refrigeration, in August 1995 FDA informed the ISSC that
additional controls were urgently needed to reduce the risk of illness from
V. vulnificus in Gulf Coast oysters. Because the level of V. vulnificus can
increase 10- fold in 3-ï¿½ hours and can reach its maximum 100- fold growth in
14 hours at summer temperatures, FDA concluded refrigeration following
harvesting is likely to be effective in controlling illnesses if they result
from bacterial growth after harvest. Although the amount of V. vulnificus
bacteria needed to cause illness is unknown, limiting its growth is
considered desirable because it may lower the risk of illness. As FDA has
demonstrated, immediate refrigeration maintains "at harvest" levels of V.
vulnificus in oysters. According to FDA, "while immediate refrigeration is
probably not practical for many small harvesting vessels, a maximum time at
uncontrolled temperatures of 2 hours would allow small harvesting vessels to
move their catch to larger vessels with onboard refrigeration."

Shortly after FDA's notification, the ISSC amended the NSSP to include an
interim control plan that required oysters to be under refrigeration at 45
degrees Fahrenheit within certain time frames, depending on the water
temperature, if the oysters were harvested from a state that was the source
of two or more confirmed cases of V. vulnificus illness. The The ISSC's
Efforts to

Reduce V. VulnificusRelated Illnesses and Deaths Have Not Been Effective,
and the Success of Its Proposed Strategy in the Near Term Is Questionable
Initiatives to Reduce Vibrio vulnificus- Related Illnesses

Have Been Ineffective

Page 17 GAO- 01- 702 Shellfish Safety

refrigeration time frames, as shown in table 2, ranged from 36 hours when
the water temperature was at its lowest- below 65 degrees Fahrenheit- to 6
hours when the water temperature was at its highest-- 84 degrees Fahrenheit
or greater.

Table 2: 1995 NSSP Post- harvest Refrigeration Requirements for States
Subject to Shellfish Temperature Controls

Action level Water temperature Maximum hours from

harvest to temperature control

Level 1 Less than 65 degrees Fahrenheit 36 Level 2 65 to 74 degrees 14 Level
3 Greater than 74 to 84 degrees 12 Level 4 Greater than 84 degrees 6

Source: National Shellfish Sanitation Program Model Ordinance.

A 1996 ISSC- commissioned evaluation of the refrigeration requirements found
that the action level 4, 6- hour requirement reduced bacteria levels in
shellfish subjected to it, but refrigeration occurring 12 or more hours
after harvest (i. e. levels 1, 2, and 3) did not lower the bacterial levels
in shellfish subject to these requirements.

Nonetheless, in 1997, the ISSC modified the temperature control requirement
for action level four. The change increased the time from harvest to
refrigeration from 6 hours to 10 hours when the water temperature is greater
than 84 degrees Fahrenheit. All of the other requirements remained the same.
According to the ISSC Executive Director, the modification was made to
accommodate concerns from the shellfish industry about difficulties in
implementing the 6- hour requirement and because no evidence existed that a
6- hour requirement would be any more effective in reducing illnesses than a
10- hour one. Because the amount of V. vulnificus bacteria needed to cause
illness is unknown, according to the ISSC, there is no conclusive evidence
that the refrigeration controls had any impact on reducing the number of V.
vulnificus- related illnesses.

According to a September 2000 survey by the Gulf Oyster Industry Council of
the five Gulf states- Alabama, Florida, Louisiana, Mississippi, and Texas-
all the states have implemented the NSSP's refrigeration controls or have
more stringent requirements. For example, Florida limits the time from
harvest to refrigeration to 6 hours in June, July, August, and September.
However, only Louisiana responded that harvesters were

Page 18 GAO- 01- 702 Shellfish Safety

taking the additional step of voluntarily icing shellfish on harvest boats.
Louisiana estimated that 5 percent of its harvesters take this step. Four of
the five states said they had no plans to work with harvesters to obtain
voluntary icing or refrigeration of shellfish on harvest boats or to offer
incentives to add refrigeration capacity to boats. 10

In addition to refrigeration requirements, the ISSC initiated education
programs aimed at reducing V. vulnificus- related illnesses and deaths.
Beginning in 1996, the ISSC developed and distributed education materials
designed to increase the number of high- risk consumers who (1) receive and
understand the health message regarding the dangers of eating uncooked
shellfish (comprehension) and (2) say they would not eat raw oysters
(behavior change). The information was distributed to physicians who were to
provide the educational materials to their at- risk patients and counsel
them on the potential impacts of eating raw shellfish.

In 1999, the ISSC evaluated the effectiveness of the V. vulnificus education
campaign. 11 To evaluate the educational materials, the ISSC sent
questionnaires to both medical providers and patients. The ISSC received a
total of 880 responses- 641 from medical providers and 239 from patients.
The response rate was 5 percent from providers and less than 1 percent for
patients. The report concluded that "if these respondents are representative
of persons with liver disease who enjoy eating raw shellfish, then these
educational materials, presented by physicians, were effective in persuading
those at high- risk to change their behavior." However, because of the very
low response rate, statistically valid conclusions cannot be drawn about the
effectiveness of the education effort. That is, the survey results cannot be
interpreted as providing evidence that the educational materials were an
effective way to change high- risk behavior and by so doing reduce the
number of illnesses associated with V. vulnificus. Furthermore, the ISSC
discontinued its efforts to use physicians as the primary means for
disseminating educational materials because (1) the process was difficult
for states to administer and (2) it was impossible to determine how often
the educational material actually reached patients.

10 Mississippi said it is investigating this issue. 11 Vibrio Vulnificus
Model Education Campaign: ISSC Final Report, Interstate Shellfish Sanitation
Conference, April 1999.

Page 19 GAO- 01- 702 Shellfish Safety

Between March 1999 and September 2000, the ISSC tried several different
approaches to educating high- risk individuals on the dangers of eating raw
shellfish. The ISSC (1) printed and disseminated educational materials to
at- risk individuals and health care providers, (2) conducted a pilot
educational conference on V. vulnificus for state and national agencies, and
(3) produced and broadcast a 30- second television message on the dangers of
eating raw oysters, which reached an audience estimated at 5 million people
in Florida, Louisiana, and Texas. The ISSC distributed educational materials
to individuals through partnerships with various organizations linked to
those at- risk, such as the American Liver Foundation. (Certain diseases,
such as liver disease, are very common among those affected by V.
vulnificus.) For example, the Foundation's Gulf Coast Chapter, located in
Florida, distributed over 12,400 brochures through patient support groups,
liver transplant centers, and health fairs. However, the ISSC did not
measure whether these education activities improved the awareness of the at-
risk target population or whether the education efforts led to any
behavioral changes.

A September 2000 study by the Gulf Oyster Industry Council also examined the
status of some of the V. vulnificus public education programs in the five
Gulf Coast states. The Council found that all five states required warnings
about the risks of eating raw oysters to be posted in restaurants, bars, and
similar establishments and that in three states the warning must be on the
menu. However, none of the states have studied whether these warnings have
had any impact on changing the behavior of at- risk consumers. Despite
requiring the consumer warning for the past 2 years, according to FDA data,
Texas experienced more reported V. vulnificus- related illnesses in 2000
than it had in the past several years.

Even with the NSSP's refrigeration requirements and the ISSC's education
efforts, V. vulnificus- related illnesses and deaths remain a problem.
Between 1994 and 2000, 30 illnesses and 16 V. vulnificus- related deaths
were reported annually, on average, to FDA. Although fluctuations in
reported illnesses and deaths occurred from one year to the next, they have
remained relatively constant overall during this period, as shown in table
3. Nearly all of these illnesses and deaths were associated with eating raw
oysters.

Page 20 GAO- 01- 702 Shellfish Safety

Table 3: V. vulnificus- related Illnesses and Deaths From Shellfish Reported
to FDA, 1994- 2000

Year Illnesses Deaths

1994 24 11 1995 32 14 1996 33 23 1997 21 11 1998 40 19 1999 34 20 2000 29 17

Source: FDA.

If the number of illnesses remained relatively constant, but the production
and consumption of raw oysters increased, then the rate of illness per pound
of oysters would be declining. However, while the level of raw oyster
consumption during this time is unknown, between 1994 and 1999 the annual
production of oysters remained about the same or declined slightly, as shown
in figure 5. Therefore, the available data do not show a reduction in the
number or the rate of V. vulnificus- related illnesses from 1994 to 1999.

Page 21 GAO- 01- 702 Shellfish Safety

Figure 5: Annual U. S. Oyster Production, 1994- 99

Source: National Marine Fisheries Service.

Recognizing that its efforts have not significantly affected V.
vulnificusrelated illnesses, the ISSC began developing a V. vulnificus
control plan in 1999. The plan required that states develop a risk
management plan for oysters if they have had two or more confirmed V.
vulnificus- related illnesses since 1995, traced to the consumption of
commercially harvested raw or undercooked oysters originating from their
waters. The goal of the plan was to reduce the rate of V. vulnificus-
related illnesses, as measured in certain states (Florida, Texas,
California, Louisiana, Georgia, South Carolina, and Alabama), by 40 percent
collectively by the end of 2005 and 60 percent collectively by the end of
2007. A consumer education program to convince at- risk individuals to
reduce or stop their consumption of raw oysters was the only required
activity aimed at achieving the illness reduction goals. The plan also
included a number of other elements, such as suggested activities to provide
incentives for the shellfish industry to increase its capacity to treat
oysters after harvest to reduce V. vulnificus bacteria levels. The ISSC's
Proposed

Strategy Is Unlikely to Reduce V. vulnificusRelated Illnesses and Deaths in
the Near Term

Page 22 GAO- 01- 702 Shellfish Safety

If the states collectively failed to meet the 60- percent goal by the end of
2007, one of several potential controls, or equivalent measures, considered
necessary to achieve the illness reduction goal would have to be
implemented. These potential controls include, among others, requiring that
during the months of May through September, when V. vulnificus levels are
known to be highest, (1) all oysters be subjected to post- harvest treatment
to reduce V. vulnificus bacteria to a nondetectable level, (2) all oysters
be labeled "for shucking by a certified dealer," or (3) shellfish growing
areas be closed for the purpose of harvesting oysters intended for the raw
market.

FDA supported the plan, but on a very close vote, the plan was not adopted
by the ISSC at its 2000 annual meeting. Instead, the plan was returned to
the ISSC's V. vulnificus subcommittee to revise and present it for
reconsideration at the July 2001 ISSC annual meeting. The revised plan
changed the states in which progress in meeting the illness reduction goal
will be measured to California, Florida, Louisiana, and Texas. In addition,
the revised plan states that if inadequate progress is being made toward
meeting the illness reduction goal, the ISSC's Vibrio Management Committee
will propose policy alternatives to be considered at the 2005 meeting, such
as a reduction in time from harvest to refrigeration and phased- in post-
harvest treatment requirements. However, like last year's version, the
proposed 2001 control plan contains only one activity the states are
required to implement- educate at- risk consumers to reduce or stop their
consumption of raw oysters. The plan also allows the states to take whatever
other actions they believe are needed to meet the illness reduction goal.

Even if the revised control plan is approved in 2001, it is questionable
whether education initiatives alone will result in significant illness
reduction because the ISSC has not demonstrated that education has been or
will be effective. FDA is also concerned about the ISSC's relying on
education alone to achieve its illness reduction goals. According to a
letter from FDA to the Chairman of the ISSC, "while we believe that
education of consumers and health care professionals should be part of such
a strategy, we do not believe that the illness reduction goal (60% reduction
by the end of 2007) is likely to be achieved through education efforts
alone."

The effectiveness of educating at- risk individuals is also questionable
because some individuals may not be aware they are at increased risk. For
example, FDA noted that individuals may be at increased risk from eating raw
oysters if they have liver disease, which may have no symptoms. Furthermore,
according to the Center for Science in the Public Interest, a

Page 23 GAO- 01- 702 Shellfish Safety

consumer advocacy group, alcoholics with liver damage, a significant portion
of the at- risk population, are frequently in denial about their condition
and therefore unresponsive to consumer education efforts.

Under the ISSC's revised V. vulnificus control plan, the date that the
states must meet the 60- percent goal for reducing illnesses has been
changed from 2007 to 2008. 12 If the plan is approved in 2001, and the
states do not meet the goal by 2008, they will be required to implement
post- harvest treatment, or equivalent controls, for oysters. As such, the
plan includes the goal of providing industry with incentives to help develop
post- harvest treatment capacity. The plan calls for developing the capacity
by the end of the third year of plan implementation to treat 20 percent of
the oysters from certain Gulf Coast states that are harvested between May
and September and are intended to be eaten raw. However, the plan does not
provide any details on which post- harvest treatment technologies have been
shown to be capable of reducing the levels of V. vulnificus bacteria to
nondetectable levels, what type of incentives, if any, are needed to develop
adequate post- harvest capacity, and what actions will be taken should the
20- percent goal not be achieved. Without a detailed plan for developing
adequate post- harvest treatment capacity that addresses these issues, among
others, the ISSC runs the risk that, come 2008, adequate postharvest
treatment capacity may not exist to meet the illness reduction goal. As
such, the states would be required to implement one of the other alternative
controls, closing growing areas or diverting oysters to be shucked rather
than sold for raw consumption. While these controls would achieve the
illness reduction goal, they would have a greater negative economic impact
on the oyster industry than post- harvest treatment.

According to an ISSC official, the ISSC plans to create a separate, detailed
plan for how states can develop adequate post- harvest treatment capacity
after the passage of the proposed V. vulnificus control plan. Furthermore,
according to an FDA official, the prospect of closing states' shellfish
growing waters or requiring shellfish to be shucked instead of sold for raw
consumption if the illness reduction goals are not met by 2008 should
provide a significant incentive for states to promote, and industry to
voluntarily adopt, post- harvest treatment technology well before the
deadline.

12 The date was changed because the ISSC had agreed to a 7 year timeframe
for meeting its final illness reduction goal from the year of plan approval.
To leave the date as originally proposed in 2000 would have meant reducing
the amount of time for meeting the plan's goals.

Page 24 GAO- 01- 702 Shellfish Safety

Two primary options offer the potential for reducing illnesses and deaths
more quickly than the proposed ISSC strategy while still maintaining a
market for raw oysters- more stringent refrigeration requirements and
phasing in mandated post- harvest treatment. Both of these options have a
number of advantages and disadvantages.

As mentioned previously, FDA has demonstrated that immediate refrigeration
maintains "at harvest" levels of V. vulnificus in oysters. Even though a
control strategy, such as immediate refrigeration, may prevent the growth of
V. vulnificus in an oyster, FDA cannot determine whether this will be
sufficient to reduce the illness rate because it has no information on the
infectious dose of V. vulnificus- that is the risk of illness in relation to
different levels of exposure to V. vulnificus. It is possible that the
amount of bacteria present at the time of harvest will be sufficient to
cause illness. However, if illnesses are due to the growth of bacteria after
harvest, limiting or reducing bacteria growth at that point would clearly
reduce illnesses.

While the impact of immediate refrigeration on V. vulnificus- related
illnesses is not known, a recent FDA study concluded more rapid
refrigeration would reduce illnesses associated with a different species of
Vibrio bacteria. According to FDA's December 2000 draft assessment of the
risks posed by Vibrio parahaemolyticus in raw shellfish, 13 the most
important factor related to the risk of illness caused by V.
parahaemolyticus is the level of the bacteria found in oysters at the time
of harvest. 14 The second most important risk factor- for the Gulf Coast
states only- is the amount of time oysters are left unrefrigerated after
harvest. FDA's analysis indicated a significant reduction in the probability
of illness when oysters are cooled immediately after harvest and kept
refrigerated. For the Gulf Coast states, FDA estimated that if oysters were
iced or refrigerated aboard ship while harvesting operations continued, the
probable number of annual illnesses from V. parahaemolyticus would decrease
from 3, 000 to about 240.

13 Draft Risk Assessment on the Public Health Impact of Vibrio
Parahaemolyticus in Raw Molluscan Shellfish, Center for Food Safety and
Applied Nutrition, FDA, December, 2000. 14 Unlike potential victims of V.
vulnificus, those at risk of illness from V. parahaemolyticus are not
limited to persons with underlying health conditions. V. parahaemolyticus
can cause diarrhea, vomiting, or abdominal cramps, but the symptoms usually
end without treatment and are of moderate severity and short duration.
Options for Reducing

Illnesses and Deaths Related to V. vulnificus in Shellfish

Page 25 GAO- 01- 702 Shellfish Safety

The disadvantages of requiring more rapid refrigeration include (1) no
guarantee that illnesses from V. vulnificus in shellfish would be reduced,
(2) logistical challenges associated with equipping oyster- harvesting boats
with manual or mechanical refrigeration, and (3) costs to the oyster
industry to comply with the requirements.

Regarding post- harvest treatment, three different processes designed to
reduce V. vulnificus bacteria to nondetectable levels are currently in
limited, voluntary, commercial use in the Gulf region: (1) hydrostatic
pressure, (2) a mild heat treatment known as cool pasteurization, and (3)
cryogenic individual quick freezing. Mandating post- harvest treatment of
all oysters destined for the raw market may result in a quicker reduction in
V. vulnificus- related illnesses than would be achieved under the ISSC's
proposed plan. 15 Such a plan could be phased in and include incentives to
build up treatment capacity over time. Furthermore, according to a March
2000 report by the Research Triangle Institute on the economic impacts of
requiring post- harvest treatment of oysters, oyster processors would
benefit from such treatment because "revenues are estimated to rise more
than the increase in costs associated with the treatment technologies." 16
The report estimated that the cost of treatment of raw half- shell oysters
would range from 3. 3 cents to 17.7 cents per oyster, and the cost for
treatment of shucked oysters would range from a decrease of 2. 9 cents to an
increase of 0.2 cents per oyster, depending on the technology used and the
region of the country. Net revenues are estimated to increase because (1)
two of the treatment processes, hydrostatic pressure and cool
pasteurization, actually reduce the costs of producing shucked oysters and
(2) companies that use post- harvest treatment reported obtaining between 1
and 2 cents more for treated shucked oysters and between 3 and 7 cents more
for treated, raw, half- shell oysters.

This approach's disadvantages include, according to the March 2000 Research
Triangle Institute report, (1) a potential decrease in demand for treated
oysters by some types of consumers, which could have a negative economic
impact on the industry, and (2) the potential shutdown of some processing
plants because they lack the resources to install and maintain

15 Post- harvest treatment requirements could be applied only to those
states that have had V. vulnificus- related illnesses linked to their
shellfish and/ or to certain times of the year when V. vulnificus levels are
known to be highest. 16 Economic Impacts of Requiring Post- Harvest
Treatment of Oysters: Final Report,

Research Triangle Institute, March 2000.

Page 26 GAO- 01- 702 Shellfish Safety

post- harvest treatment equipment or because revenues are not sufficient to
cover production and treatment costs. In addition, some industry groups are
concerned that mandating post- harvest treatment would eliminate the option
for consumers to purchase raw, untreated oysters. While the production of
untreated oysters would not be eliminated throughout the United States if
post- harvest treatment was required only in certain states during certain
months of the year, consumers in those states required to treat oysters may
find it more difficult or expensive to purchase untreated, raw oysters.

By providing uniform and equal oversight of the 30 states and four countries
that produce shellfish for the U. S. market, FDA is not using its limited
resources wisely. States? and foreign countries? shellfish programs pose
different levels of risk for consumers, requiring more intensive oversight
for some states and countries than for others. However, FDA has not made use
of available data on compliance with safety requirements by states and
foreign countries and has not developed data on the effectiveness of states?
and foreign countries? programs in reducing bacteria levels in shellfish or
related illnesses. Such information would enable FDA to target its resources
on those areas presenting the highest level of risk.

V. vulnificus- the most deadly of shellfish- related illnesses- continues to
pose a significant risk for some individuals. The ISSC's proposed strategy,
yet to be formally adopted, may not significantly reduce V.
vulnificusrelated illnesses until after 2008, when proven control measures
will be required. However, even then, capacity to implement one such
control, post- harvest treatment, may not be available, and the ISSC does
not yet have detailed plans for ensuring such capacity. Without adequate
capacity, alternate control measures, such as eliminating the sale of raw
oysters during certain months, would be required. The fact that such
alternatives would have a greater negative economic impact on the oyster
industry could create pressure to postpone their implementation.

To better ensure the safety of domestic and imported shellfish consumed in
the United States, we recommend that the Commissioner of FDA

 adopt a risk- based approach to overseeing states? and foreign countries?
shellfish safety programs that includes Conclusions

Recommendations for Executive Action

Page 27 GAO- 01- 702 Shellfish Safety

 a standardized, automated system to capture the results of states' and
foreign countries' inspections of processing plant and patrols of growing
water; and

 baseline data, such as the results of regular shellfish microbial tests,
to assess over time the effectiveness of states' and foreign countries'
shellfish safety programs, including HACCP.

 work with the ISSC to prepare and implement a detailed plan for developing
adequate post- harvest treatment capacity to help achieve the ISSC's goals
for reducing illnesses

We provided FDA and the ISSC a draft of this report for their review and
comment. Both FDA and the ISSC generally concurred with the draft report?s
recommendations. However, the ISSC raised concerns about the draft report?s
characterization of some information. FDA?s and the ISSC?s written comments
and our responses are contained in appendixes II and III, respectively. FDA
and the ISSC also provided technical comments, which we incorporated into
the report as appropriate.

FDA generally concurred with our recommendations, although it said that in
some cases additional study and/ or consultation with the ISSC would be
necessary to determine the feasibility of implementing them. Specifically,
FDA concurred with our recommendation that the agency adopt a riskbased
approach to overseeing states? and foreign countries? shellfish safety
programs. FDA also acknowledged the merits of our recommendation that it
develop and implement an automated system for capturing the results of
states? shellfish plant inspections and growing water patrols. FDA said it
will assess the costs and benefits of such a system for the shellfish
program when information about similar projects it already has under way for
other programs has been evaluated. Regarding our recommendation that it
gather data to assess the effectiveness of state and foreign country
shellfish safety programs, such as the results of microbial tests, FDA
responded that additional testing for Norwalk- like viruses, the most common
sources of illnesses from molluscan shellfish, is not feasible at this time,
although the agency is working on new testing procedures. Nonetheless, FDA
said it will review, in consultation with the ISSC, whether testing (1) of
shellfish growing waters for other pathogens, such as salmonella, and (2) of
shellfish meats, as the Europeans now do, should be added to the program.
Finally, FDA agreed with our recommendation that it work with the ISSC to
prepare and implement a detailed plan for developing enough post- harvest
treatment capacity to help achieve the ISSC?s illness reduction goals.
Agency Comments

and Our Evaluation

Page 28 GAO- 01- 702 Shellfish Safety

The ISSC concurred with the draft report?s recommendation that FDA (1) adopt
a risk- based approach to overseeing states? and foreign countries?
shellfish safety programs, (2) develop and implement an automated system for
capturing the results of states? shellfish plant inspections and growing
water patrols, and (3) work with the ISSC to prepare and implement a
detailed plan for developing adequate post- harvest treatment capacity to
help achieve the ISSC?s goals for reducing illnesses. In response to our
recommendation that FDA gather data, such as microbial test results, to
measure program effectiveness, the ISSC said that while it welcomes
meaningful effectiveness measures, it questions the practicality of using
bacterial levels in shellfish to measure effectiveness. Nonetheless, the
ISSC said it will investigate with FDA the development of program
effectiveness measures. We recognize the difficulties inherent in obtaining
effectiveness data but believe it is critical to identifying program
shortcomings and strengths and making required changes over time.
Effectiveness measures may be the results of microbial tests or other
indicators that the ISSC and FDA believe are appropriate.

The ISSC did not agree with some information or characterizations of issues
made in the draft report. For example, the ISSC did not agree with the draft
report?s citation of FDA?s estimate that shellfish cause over 100,000
illnesses each year. The draft report clearly states that FDA?s shellfish-
related illness figure is an estimate made in 1995. Norwalk viruses
associated with shellfish consumption make up the vast majority of FDA?s
estimate and are frequently not reported. CDC has no data on the level of
such nonreporting and thus has not made any estimate of such illnesses.
Nonetheless, we modified the report to note that the ISSC believes FDA?s
estimate significantly overstates the annual number of shellfish- related
illnesses.

The ISSC was also concerned about, among other issues, the draft report?s
characterization of its proposed strategy as relying primarily on education
to reach its V . vulnificus illness reduction goal by 2008. The ISSC said
education is only one of the components of its strategy and that the plan
includes intermediate goals and assessments prior to 2008. However, it
acknowledged that education is the only mandatory component of its plan. Our
draft report states that the proposed plan establishes an interim illness
reduction goal and allows the states to adopt additional controls beyond
education. Nonetheless, because education is the only required activity
contained in the proposed plan, we continue to believe that at this time the
plan relies primarily on education to meet the illness reduction

Page 29 GAO- 01- 702 Shellfish Safety

goals. Whether any additional actions are taken by the states or the ISSC in
the future remains to be seen.

We conducted out review from August 2000 through June 2001 in accordance
with generally accepted government auditing standards.

As agreed with your offices, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days from
the date of this letter. At that time, we will send copies to congressional
committees with jurisdiction over food safety issues; the Secretary of
Health and Human Services; the Director, Office of Management and Budget;
and other interested parties. We will also make copies available to others
on request.

If you have any questions about this report, please contact me at (202) 512-
3841. Major contributors to this report are listed in appendix IV.

Lawrence J. Dyckman Director, Natural Resources and Environment

Appendix I: Scope and Methodology Page 30 GAO- 01- 702 Shellfish Safety

To evaluate the Food and Drug Administration's (FDA) approach to oversight
of state and foreign country shellfish safety programs, we reviewed the
existing shellfish safety policies contained in the National Shellfish
Sanitation Program Guide for the Control of Molluscan Shellfish, and the
Hazard Analysis and Critical Control Point regulations that apply to
shellfish processing plants, among other relevant shellfish safety policy
and guidance documents. We visited six states- Florida, Louisiana, New
Jersey, New York, Texas, and Washington- to gather information on the
state's implementation of shellfish safety requirements and FDA's approach
to oversight of the states. During 1999, these six states collectively
produced about 65 percent of the nation's shellfish. In each of these states
we interviewed state officials responsible for shellfish safety, gathered
documentation regarding program implementation, and visited shellfish
processing plants. We reviewed FDA's evaluation reports of states? and
foreign countries? shellfish safety programs for fiscal years 1998, 1999,
and 2000 and discussed the findings with state and FDA officials. We
interviewed officials in FDA's Center for Food Safety and Applied Nutrition,
Office of Seafood and Office of Field Programs. In addition, we interviewed
officials in FDA's Office of Regulatory Affairs, Division of Federal- State
Relations, including FDA staff who conduct the evaluations of the state and
foreign country shellfish safety programs. We also interviewed officials and
reviewed documents from the Interstate Shellfish Sanitation Conference
(ISSC) and the shellfish industry.

To evaluate the ISSC's strategy for reducing illnesses and deaths associated
with V. vulnificus bacteria, we reviewed scientific information regarding
the bacteria's prevalence and impact on human health. We reviewed
documentation of the ISSC's efforts to educate those at risk from V.
vulnificus to avoid eating raw shellfish as well as policies regarding
temperature control of harvested shellfish to reduce bacterial growth. We
visited the three states- Florida, Texas, and Louisiana- that have been the
source of nearly all of the reported V. vulnificus- related illnesses from
shellfish that could be traced to a particular state. In each of these
states we met with state officials responsible for shellfish safety as well
as shellfish industry officials, including some who have begun to treat
oysters post- harvest to kill bacteria. We also interviewed ISSC and FDA
officials regarding the history of the policy initiatives designed to reduce
V. vulnificus- related illnesses. Appendix I: Scope and Methodology

Appendix II: Comments From the Food and Drug Administration

Page 31 GAO- 01- 702 Shellfish Safety

Appendix II: Comments From the Food and Drug Administration

Note: GAO comments supplementing those in the report text appear at the end
of this appendix.

Appendix II: Comments From the Food and Drug Administration

Page 32 GAO- 01- 702 Shellfish Safety

Appendix II: Comments From the Food and Drug Administration

Page 33 GAO- 01- 702 Shellfish Safety

See comment 1.

Appendix II: Comments From the Food and Drug Administration

Page 34 GAO- 01- 702 Shellfish Safety

See comment 2.

Appendix II: Comments From the Food and Drug Administration

Page 35 GAO- 01- 702 Shellfish Safety

Appendix II: Comments From the Food and Drug Administration

Page 36 GAO- 01- 702 Shellfish Safety

Appendix II: Comments From the Food and Drug Administration

Page 37 GAO- 01- 702 Shellfish Safety

Appendix II: Comments From the Food and Drug Administration

Page 38 GAO- 01- 702 Shellfish Safety

1. Our draft report does not conclude that FDA has inadequate information on
the status of the New Zealand program. We mention the New Zealand program
only as an example of a foreign program that receives essentially the same
level of FDA oversight as other foreign programs, despite the fact that it
is a much bigger oyster exporter to the United States and has reported more
shellfish- related illnesses than, for example, Chile.

2. While it may be possible for FDA to assess compliance with patrol
frequency requirements through a manual review of documents maintained for
other purpose, we continue to believe that an automated system for tracking
patrol frequencies would provide more accurate, timely information that
would be more easily accessible to FDA?s shellfish specialists. GAO?s
Comments

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 39 GAO- 01- 702 Shellfish Safety

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Note: GAO comments supplementing those in the report text appear at the end
of this appendix.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 40 GAO- 01- 702 Shellfish Safety

See comment 1.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 41 GAO- 01- 702 Shellfish Safety

Now on p. 4. See comment 4. See comment 3.

See comment 2.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 42 GAO- 01- 702 Shellfish Safety

Now on p. 11. Now on p. 8.

Now on p. 7. Now on p. 7.

See comment 6. See comment 1.

See comment 5. See comment 1.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 43 GAO- 01- 702 Shellfish Safety

Now on p. 15. Now on p. 14.

Now on p. 13. Now on p. 13.

See comment 9. See comment 8.

See comment 7.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 44 GAO- 01- 702 Shellfish Safety

Now on p. 22. Now on p. 19 Now on p. 18.

Now on p. 16. See comment 4. See comment 10. See comments 6 and 9.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 45 GAO- 01- 702 Shellfish Safety

Now on p. 22. Now on p. 22.

See comment 13. See comments 6 and 9.

See comment 12. See comment 11.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 46 GAO- 01- 702 Shellfish Safety

See comment 9.

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 47 GAO- 01- 702 Shellfish Safety

1. Our draft report acknowledges that FDA?s figure for shellfish- related
illnesses is an estimate made in 1995 and that neither FDA nor the CDC have
current estimates. Given the fact that many shellfish- related illnesses
from Norwalk viruses are not reported, the FDA estimate is the best
available data on this issue. However, we revised the draft report to note
that the ISSC believes FDA?s estimate significantly overstates the actual
number of annual illnesses related to shellfish.

2. According to FDA, one of the reasons for its current oversight approach
was that the states wanted uniform FDA oversight. The ISSC does not agree
that this is the case. Nevertheless, both FDA and the ISSC agree that in the
future FDA should adopt a risk- based approach to overseeing states? and
foreign countries? programs.

3. While FDA could review the paper records from all state plant inspections
if it chose to, the fact remains that it has not done so. As a result, we
continue to believe that FDA does not have sufficient information to assess
the extent of statewide and national compliance with some safety
requirements and that automated systems for recording the results of state
activities would help alleviate this problem.

4. The draft report states that the ISSC?s proposed plan establishes an
interim illness reduction goal and allows the states to adopt additional
controls beyond education. However, as the ISSC acknowledges, education is
the only required activity contained in the proposed plan. While additional
actions may be taken by the states or the ISSC in the future, at present
such actions remain to be seen.

5. We disagree. The draft report clearly states that the number of reported
illnesses has increased but the reason for the increase is not known.

6. See comment 3 for our response regarding whether FDA has sufficient
information on compliance. FDA told us that it assesses states, and foreign
countries? compliance with shellfish safety requirements but had not
attempted to directly measure the effectiveness of these program
requirements in lowering bacterial levels or reducing illnesses and deaths.
While compliance data are helpful in determining whether safety requirements
have been implemented, they do not provide any measure of whether those
requirements effectively reduce illnesses associated with shellfish
consumption. The ISSC appears to believe GAO Comments

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 48 GAO- 01- 702 Shellfish Safety

that data on program compliance is an appropriate measure of effectiveness.
We do not agree.

7. We agree that FDA reviews some states? processing plant inspection files
as a part of its evaluation process. However, the limited number of plant
visits and file reviews conducted by FDA only allows the agency to draw
conclusions on the plants it visited or reviewed, not to project statewide
or national trends in compliance.

8. The concern we raised in the draft report was not whether FDA could
assess the states? ability to implement the requirements of the NSSP. Rather
our concern was that FDA relied on a limited number of plant visits to
estimate statewide and national trends in compliance with safety
requirements. See comment 7.

9. We recognize the difficulties inherent in developing meaningful measures
of the effectiveness of states? and foreign countries? shellfish safety
activities. Nonetheless, as our recommendation suggests, we believe it is
critical to identify measures of program effectiveness and to gather data on
these measures over time. These measures may be the results of microbial
tests or other indicators that the ISSC and FDA believe are appropriate.

10. While the response rate may not be unusual for this type of survey, the
low response rate still precludes any assumptions from being made about the
at- risk population as a whole. As such, the survey results do not provide
statistically sound evidence for the conclusion that this education effort
was effective in changing the behavior of at- risk individuals.

11. We recognize that demonstrating the effectiveness of consumer education
in reducing shellfish- related illnesses and deaths is not a simple task.
However, the ISSC has evaluated only one of its education initiatives.
Because of the low response rate to the evaluation survey, no conclusions
can be drawn regarding the at- risk population as a whole, as we discussed
in comment 10. As such, we do not believe the ISSC has demonstrated that
education has been or will be effective.

12. We revised the report to reflect FDA?s current position on this issue.
13. The likely impact of education on reducing V. vulnificus- related

illnesses and deaths is uncertain, other possible controls are voluntary, a
detailed plan to ensure adequate post- harvest treatment capacity

Appendix III: Comments From the Interstate Shellfish Sanitation Conference

Page 49 GAO- 01- 702 Shellfish Safety

does not exist, and proven controls will not be required until after 2008.
As such, we believe our conclusion that V. vulnificus- related illnesses and
deaths may not be significantly reduced until after 2008 is fair and
reasonable. In addition, while the shellfish industry may be under
considerable pressure at this time to develop controls to reduce V.
vulnificus- related illnesses, if the ISSC?s illness reduction goals are not
reached by 2008 and post- harvest treatment capacity is not available,
industry members may press for additional time to obtain such capacity.

Appendix IV: GAO Contacts and Staff Acknowledgements

Page 50 GAO- 01- 702 Shellfish Safety

Lawerence J. Dyckman (202) 512- 3841 Keith W. Oleson (415) 904- 2218

In addition to those named above, Stephen D. Secrist, Katherine B. Mannen,
Robert P. Lilly, and Fran A. Featherston made key contributions to this
report. Appendix IV: GAO Contacts and Staff

Acknowledgements GAO Contacts Acknowledgments

(150195)

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