oversight

Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety

Published by the Government Accountability Office on 1999-07-01.

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

                  United States General Accounting Office

GAO               RichardtoJ.the
                  Report         Honorable
                              Durbin, U.S. Senate



July   1999       FOOD SAFETY

                  U.S. Lacks a Consistent
                  Farm-to-Table
                  Approach to Egg Safety




                     k
                            Accountability * Integrity * Reliability

?AO/RCED-99-184
      United States

GAO   Washington, D.C. 20548

      Resources, Community, and
      Economic Development Division

      B-282632

      July 1, 1999

      The Honorable Richard J. Durbin
      United States Senate

      Dear Senator Durbin:

      Eggs contaminated by the Salmonella Enteritidis bacteria have been
      recognized as a public health problem since 1988. About 300,000 illnesses
      and between 115 and 229 deaths may have occurred in 1997 as a result of
      Salmonella Enteritidis, according to the Centers for Disease Control and
      Prevention. Illnesses and deaths from Salmonella Enteritidis cost the
      nation approximately $225 million to $3 billion in 1996, according to the
      most current estimates from the U.S. Department of Agriculture (USDA).
      Although not all Salmonella Enteritidis infections are linked to eggs,
      between 1985 and 1998, when a cause could be identified, over
      three-quarters of Salmonella Enteritidis outbreaks were linked to eggs,
      according to the Centers for Disease Control and Prevention.

      No single federal agency has overall responsibility for the policies and
      activities needed to ensure the safety and quality of eggs and egg products.
      These responsibilities are distributed among the Animal and Plant Health
      Inspection Service, the Agricultural Marketing Service, and the Food
      Safety and Inspection Service (FsIs) in USDA and the Food and Drug
      Administration (FDA) in the U.S. Department of Health and Human
      Services. Responsibilities shift among these agencies as eggs make their
      way from the farm to the table. In particular, FDA has the primary
      responsibility for the safe production and processing of eggs still in the
      shell (known in the industry as shell eggs), and Fsis has the responsibility
      for food safety at the processing plants where eggs are broken to create
      egg products. In addition, two agencies in each state generally share egg
      safety responsibilities.

      Concerned about the risks associated with eating eggs contaminated with
      Salmonella Enteritidis, you asked us to review the adequacy of the system
      for ensuring the safety of eggs. Specifically, we examined whether (1) a
      prevention-based approach to food safety has been applied to egg
      production and processing, (2) a new federal policy on egg refrigeration
      will effectively reduce the risks associated with contaminated eggs,
      (3) federal and state policies on serving eggs to vulnerable populations and
      dating egg cartons are consistent, and (4) federal egg safety resources are
      used efficiently and policies are coordinated effectively. As part of our



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                   review, we surveyed state officials responsible for egg regulation in the 50
                   states.


Results in Brief   The Food and Drug Administration has not established a prevention-based
                   approach to shell egg production and processing that would reduce or
                   eliminate Salmonella Enteritidis contamination by identifying, controlling,
                   and monitoring known safety risks. At the state level, 13 states,
                   responsible for about 38 percent of the nation's egg production, have
                   established voluntary prevention-based programs for egg farms. However,
                   because these programs use different approaches to testing for the
                   presence of Salmonella Enteritidis and monitoring the farms, they do not
                   provide a uniform level of risk reduction. Moreover, the Food Safety and
                   Inspection Service does not require a prevention-based approach in
                   processing plants where eggs are broken to create egg products.

                   The first national requirement to refrigerate eggs at 45 degrees Fahrenheit
                   or below from the time they are packed until they reach the consumer may
                   not be as effective as possible in reducing the risks from eggs
                   contaminated with Salmonella Enteritidis. Responsibility for
                   implementing the refrigeration requirement is split between two federal
                   agencies. The Food Safety and Inspection Service has issued regulations
                   that take effect in August 1999-8 years after the Congress passed the
                   legislation-requiring that eggs be refrigerated after packing until they
                   reach retail locations such as restaurants, institutions, and grocery stores.
                   However, once eggs reach these locations, federal regulations will not
                   require that they be refrigerated because the Food and Drug
                   Administration has not yet issued the necessary regulations. In addition,
                   many experts believe greater risk reduction could be achieved by cooling
                   the internal contents of eggs more quickly than the law will require.

                   Inconsistent policies and practices in three areas have weakened the
                   nation's egg safety efforts. Only about half the states have followed the
                   Food and Drug Administration's recommendation that they require food
                   service operators to use pasteurized eggs or egg products when serving
                   populations, such as the elderly in nursing homes, that are more likely to
                   suffer severe health consequences from eating contaminated eggs. In
                   addition, inconsistent policies on returning eggs from grocery stores to
                   processors to be repackaged, redated, and returned to the retail level and
                   inconsistent practices for expiration dating on egg cartons can mislead
                   consumers about the eggs' freshness and may pose a food safety risk.




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             The current organizational and regulatory framework for egg safety makes
             it difficult to ensure that resources are directed to the areas of highest risk
             and that policies are effectively coordinated. For example, the Food Safety
             and Inspection Service provides daily full-time inspection of egg products
             plants where eggs are pasteurized to kill harmful bacteria, whereas the
             Food and Drug Administration almost never inspects egg farms where
             eggs can be contaminated. In addition, although we reported in 1992 on
             the need for better coordination between the Food and Drug
             Administration and the Department of Agriculture on egg safety issues,
             each agency is developing its own labeling requirements for egg cartons
             that will become effective at different times, and the agencies have still not
             agreed on a comprehensive unified approach for improving egg safety.

             We are offering a matter for congressional consideration and
             recommendations to the Secretary of Agriculture and the Commissioner of
             the Food and Drug Administration aimed at improving egg safety.


Background   When Salmonella is found in eggs, Salmonella Enteritidis (SE) is the strain
             most commonly identified. SE was first associated with clean, intact shell
             eggs in 1988. Since that time, in situations in which two or more people
             have become ill and a source could be found, shell eggs have been
             identified as the leading source of SE infection. From 1987 to 1997, reports
             of SE infections increased, as did the proportion of Salmonella cases
             involving SE. Although not necessarily indicative of a national trend, recent
             data from the Centers for Disease Control and Prevention for selected
             counties and states have shown a decrease in SE cases for 1996 through
             1998. SE, as well as other strains of Salmonella, can cause such symptoms
             as abdominal pain, fever, headache, and vomiting and can also lead to
             more severe conditions, such as bloodstream infections, arthritis, and
             meningitis. And it sometimes kills, particularly elderly residents of nursing
             homes. SE in shell eggs is believed to originate from laying hens whose
             ovaries contain the bacteria. Proper refrigeration delays the breakdown of
             the yolk membrane, thereby retarding the growth of Salmonella in eggs,
             and pasteurization or thorough cooking can kill it. (See app. I for
             additional information on the prevalence, causes, and illnesses related to
             SE contamination in eggs.)

             The marked growth in reported bacterial foodborne illnesses, including
             Salmonella, has led to changes in the federal food safety system. One
             notable change has been the introduction over the last few years of
             prevention-based hazard analysis and critical control point (HACCP)



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systems in meat, poultry, and seafood processing. HACCP systems are
designed to actively monitor and control contamination throughout the
food production process by identifying places where the greatest food
safety risks exist, implementing methods to control the risks at those
points, and then monitoring the efficacy of the controls. In May 1998, FDA
and FSIS issued a joint advance notice of proposed rulemaking seeking to
identify actions to decrease the food safety risks associated with eggs as
they move from the farm to the table. This notice requested comments on
several possible actions, including a proposal for a HACCP approach to shell
egg production and processing. As of June 1999, no actions had been taken
on this proposal.

The egg industry in the United States produced about 67 billion eggs in
1998. About 70 percent of those eggs were sold whole as shell eggs. The
production and distribution of shell eggs from the farm to the table is a
multistep process that involves (1) breeding laying hens; (2) producing
eggs on farms; (3) cleaning and packing eggs at processing plants;
(4) transporting eggs from processing facilities to wholesalers and
retailers; and (5) handling and preparing eggs in restaurants, institutions,
and homes. The remaining 30 percent of the eggs produced were broken,
pasteurized, and processed into liquid, frozen, or dried egg products used,
for instance, in commercial baked goods and ice cream. (For more
information on egg production, processing, and distribution see app. II.)

Egg regulatory laws have traditionally assigned responsibilities to federal
agencies based on whether the concern is egg safety or quality and
whether the egg is in the shell or is broken to create an egg product. Under
this fragmented regulatory structure, as eggs move from the farm to the
table, responsibility for egg safety shifts back and forth among several
federal agencies and often two agencies in each state as well. (See fig. 1.)
First, the Animal and Plant Health Inspection Service manages the
National Poultry Improvement Plan that establishes breeding practices to
ensure that at birth laying hens are free from SE. At the next stage, the
farms where eggs are laid, FDA is responsible for egg safety. Once the eggs
arrive at processing plants, where they are either packed as shell eggs or
broken for egg products, the authority is split between two agencies-FDA
for shell eggs and FSIS for egg products. While shell eggs are being
processed, they may also be inspected by the Agricultural Marketing
Service under a voluntary program to ensure shell egg quality. Once
transported to the retail level, both shell eggs and egg products are under
FDA'S authority, but the millions of restaurants, institutions, and other
retail food operations throughout the United States are generally inspected



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by either a state agriculture or health department under state laws. FDA
encourages uniformity among state laws by publishing the Food Code,
which recommends model practices for ensuring safer food, and by
encouraging states to adopt the code's provisions. (See app. III for
additional information on the egg safety and quality responsibilities of
federal and state agencies.)




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Figure 1: Egg Production, Processing, and Distribution and Responsible Federal Regulatory Agencies


Production                                                                   Egg laying
                                          breeding                             on farm
                                           (APHIS)                             (FDA)




Processing              -                                 Shellegg                         i Egg products
                                  t$e               ~    processing                           processing
                                           ,   -.       (FDA, USDA)                             (FSIS)




Transportation                                              Shell egg                              Egg products
                                                         transportation                         transportation
                                                          (USDA,FDA)                                   (FDA)




Storage                                                                   Wholesale        Retail
                                                                      (USDA, FDA)          (FDA)




Preparation and                                                                           Restaurant
consumption                                                        Home                   institutions
                                                                                             (FDA)



                                                                                                               (Figure notes on next page)




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                     Notes: As eggs move from the farm to the table, state governments share egg safety
                     responsibilities with the federal government.

                     USDA will assume responsibility for enforcing refrigeration requirements for shell eggs during
                     storage and transportation in August 1999. FDA will retain overall responsibility for shell egg
                     safety as well as for egg products after they leave the processing plant.



The rFederal         Outbreaks of egg-related illness are sometimes traced to egg production
                     farms where laying flocks have become contaminated with SE. Although
Government and the   prevention-based approaches such as HACCP are generally recognized as
States Have Not      the most effective method for identifying and reducing bacterial
                     contamination, no federal program exists to reduce or eliminate this
Instituted a         contamination during egg production and processing.
Consistent
Prevention-Based     In our 1992 report on SE in eggs, we recommended that the Secretary of
                     Agriculture and the Commissioner of FDA work together to develop a
Approach to Egg      comprehensive program to control SE throughout the production,
Safety               distribution, and consumption of eggs.' Six years later, in May 1998, USDA
                     and FDA published an advance notice of proposed rulemaking in the
                     Federal Register requesting comments by August 1998 on various
                     proposals for improving farm-to-table egg safety, one of which concerned
                     using the HACCP approach on egg farms. The agencies received comments
                     from state agencies, egg industry associations, egg production farms,
                     public interest groups, and individual citizens. Our analysis of the
                     comments found strong support for a uniform, voluntary national
                     HAccP-based program to reduce the risk associated with SE contamination
                     during egg production. The state agencies that commented were the most
                     supportive of the idea. The idea was also supported by the largest egg
                     industry trade association, the United Egg Producers, whose members
                     own approximately 80 percent of all egg-laying hens in the country. As of
                     June 1999, FDA, which has regulatory authority over shell egg production,
                     had not taken any actions based on the comments received. An FDA Official
                     told us that the agency supports a HAccP-based approach for controlling SE
                     but that taking action on this issue is currently not the agency's highest
                     priority.

                     Some states, in cooperation with the egg industry, have established
                     voluntary statewide HAccP-based programs to control or eliminate SE
                     during egg production. These programs are generally known as quality
                     assurance programs even though their objective is to improve egg safety.
                     In our survey of state egg regulatory officials, 13 states, which account for

                     'Food Safety and Quality: Salmonella Control Efforts Show Need for More Coordination
                     (GAO/RCED-92-69, Apr. 21, 1992).


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about 38 percent of the nation's egg production, reported that they have
voluntary quality assurance programs.2 About half of these quality
assurance programs began recently-7 of the 13 states reported starting
their programs in 1997 or 1998. Producers may also choose to participate
in other quality assurance programs, such as the one designed by the
United Egg Producers, or establish HAccP programs on their own. FDA has
entered into partnership agreements to provide guidance and technical
support to some of the states that have adopted quality assurance plans.

Seven elements are commonly found in state quality assurance plans:
(1) purchasing chicks from breeders approved by the National Poultry
Improvement Plan, (2) controlling rodents and pests, (3) using bio-security
procedures, 3 (4) cleaning and disinfecting henhouses, (5) conducting
envirormnental testing for SE, (6) refrigerating eggs after packing, and
(7) keelping records. Although the existing state programs for egg quality
assurance include many of these elements, some significant variations
exist. While 11 of the plans require program participants to use rodent
control and bio-security measures, 2 of the plans do not. All 13 of the plans
require testing the egg-laying environment for the presence of SE. In some
states, if SE is found in the environment, the eggs are immediately diverted
to breaking facilities where they are pasteurized to kill the bacteria. In the
other slates, if environmental contamination is detected, the eggs are
checked. If SE is found in any eggs, all the eggs are diverted to breaking
facilities. Under about half of the plans, environmental testing is only done
8 weeks before the end of a flock's production cycle.4 However, two states
have more extensive testing regimens that start before a chicken begins to
produce eggs and continue periodically throughout the 2-year egg
production cycle. This testing schedule allows problems to be identified
before the chickens begin to produce contaminated eggs, whereas the
testing done in the other states near the end of the egg production cycle
provides less risk reduction.

The reliability and validity of a quality assurance program can be assessed
through third-party oversight. This oversight is generally performed by a
government entity or other organization independent of the egg industry
and provides assurances to the public that the elements in the quality
assurance programs are being performed. Many of the plans we reviewed,

'The 13 states are Alabama, California, Connecticut, Louisiana, Maine, Maryland, Massachusetts,
Michigan, New York, Ohio, Pennsylvania, South Carolina, and Utah.
3
 Bio-secuiity procedures are designed to prevent SE from being carried into poultry houses from
outside sources.
4
    In commercial egg-laying operations, hens generally produce eggs until they are about 2 years old.


Page 8                                                                   GAO/RCED-99-184 Egg Safety
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                         8 of 13, contained provisions for oversight. Under four of the plans, the
                         oversight can be performed in part by groups associated with the industry,
                         not by an independent third party. The frequency and procedures used to
                         conduct the oversight also varied among the plans.

                         After eggs are produced on farms, they are sent to facilities, where they
                         are cleaned, processed, and packed. Egg packers and processors are not
                         required to establish HAccP-based programs to prevent microbial
                         contamination in the plants where shell eggs are processed and packed for
                         consumers. FDA has regulatory authority over these plants and has not
                         proposed HAccP-based requirements in this area. However, the Agricultural
                         Marketing Service, which is primarily responsible for grading the quality of
                         eggs, has recently developed a fee-for-service plant sanitation program for
                         its grading customers that includes some HAccP-like elements. (See app.
                         III.)

                         Eggs that are not sold as shell eggs are sent to egg products plants where
                         they are washed, broken, separated, and pasteurized using automated
                         processes. FSIS, which has regulatory authority over egg products, does not
                         require HACCP programs in these plants. Under the Egg Products Inspection
                         Act, an FSIS inspector is required to be present at each egg products plant
                         every day it is in operation. 5 In public statements, FsIs officials have
                         indicated that the implementation of HACCP programs at egg products
                         plants is appropriate, and the agency has begun taking preliminary actions
                         for a rulemaking to require HACCP, such as researching the scientific and
                         economic issues. However, as of June 1999, the agency had not yet
                         published a rule proposing such a requirement. Despite the absence of a
                         federal requirement, some egg products plants have implemented HACCP
                         plans on their own.


New Federal              A federal egg refrigeration requirement, the nation's first, is soon to be
                         implemented but may not be as effective as possible in reducing the risks
Refrigeration            from SE contamination. In the multistep process used to bring eggs to
Requirements May          consumers, egg safety can be jeopardized at many points by a lack of
Not Be as Effective as    adequate refrigeration. Beginning in August 1999, FSIS will require that eggs
                          destined for the ultimate consumer be refrigerated at an air temperature
Possible                  not to exceed 45 degrees. This requirement-initially mandated in the 1991
                          amendments to the Egg Products Inspection Act-was put into place only
                          after the Congress threatened in 1998 to withhold $5 million of FSIS' annual

                          5
                           There are some minor exceptions to the requirement for continuous inspections. For example, on
                          weekends, plants are permitted to process dried pasteurized egg whites without inspectors present.



                          Page 9                                                               GAO/RCED-99-184 Egg Safety
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appropriation if the agency did not issue implementing regulations. The
1991 amendments authorize USDA to inspect shell egg processors and
packers, including transport vehicles, to ensure that shell eggs destined for
the ultinmate consumer, which FSIS has defined as households, restaurants,
and institutions, meet the temperature requirement and that cartons are
properly labeled to indicate that they require refrigeration. USDA is required
to conduct these inspections on a quarterly basis.

Under the 1991 amendments, FDA is authorized to ensure compliance with
the egg refrigeration and labeling requirements at locations not covered by
FSIS, such as restaurants and institutions, as often as FDA determines
inspections are appropriate. However, FDA has not yet issued regulations
that would require eggs to be refrigerated at these locations or other retail
locations such as grocery stores. In May 1998, FDA announced plans to
propose regulations mandating that shell eggs be stored for retail sale at 45
degrees or less. Given FDA'S limited inspection resources and the large
number of retail establishments, it is not clear how FDA will enforce the
refrigeration requirement at retail locations. States or local jurisdictions
have traditionally conducted the primary regulatory activity at the retail
level, and FDA has supported state activities through training, technical
assistance, and issuing guidance such as the voluntary Food Code. An FDA
official told us the agency plans to propose refrigeration regulations that
will include provisions to encourage the states to enforce the refrigeration
requirement. In the absence of a federal regulation requiring the
refrigeration of eggs at retail locations, responsibility shifts to the states.
Our survey of regulatory officials found that 43 states require that eggs be
kept at 45 degrees or less in retail locations, 3 states have temperature
limits above 45 degrees, and 4 states have no requirements.

While implementing the 1991 amendments is an important first step, FSIS
and other experts have raised concerns about the effectiveness of an air
temperature requirement in improving egg safety. According to FSIS,
maintaining the internal temperature of eggs at 45 degrees or below
throughout processing and distribution would result in a greater reduction
in illnesses from SE than would result from an air temperature
requirement.

In contaminated eggs, SE is unlikely to grow at temperatures under 45
degrees. However, when eggs are processed and packed, according to
USDA, they are often in the 70- to 80-degree temperature range. Because of
the way eggs are packed, even if they are immediately put into a cooler,
research has shown that it may take from 3 to 6 days before the egg's



Page 10                                              GAO/RCED-99-184 Egg Safety
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                             internal temperature is reduced to the air temperature. During this time, SE
                             bacteria may replicate, and the more bacteria an egg contains, the more
                             dangerous it will be if eaten raw or undercooked. A risk assessment study
                             performed by USDA estimated, on average, an 8-percent reduction in human
                             illness when eggs are maintained at an air temperature of 45 degrees. 6 In
                             contrast, the study estimated, on average, a 12-percent reduction in illness
                             if eggs are cooled to an internal temperature of 45 degrees immediately
                             after being laid.

                             New technologies show promise in achieving more rapid cooling at a
                             relatively low cost. Researchers at North Carolina State University have
                             experimented with cryogenic gas to rapidly cool eggs. Their research
                             found that during commercial processing, eggs could be cooled to 38
                             degrees within 12 minutes using cryogenic gases and that this approach
                             would reduce the likelihood of Salmonella growth in or on eggs. One
                             company has developed a prototype cooling method using cryogenic gases
                             that will soon be tested in production. According to the company's
                             estimates, this process will add about 3 cents or less to the cost of a dozen
                             eggs. In addition, other research is being conducted on the use of forced
                             cold air to cool eggs faster, and a process of in-shell pasteurization that
                             has recently begun to be used commercially also includes the rapid
                             cooling of the eggs after they are pasteurized.


Inconsistent Policies        Once eggs reach consumers, federal and state efforts to ensure
                             have been weakened by inconsistencies in three areas. First,
                                                                                            egg safety
                                                                                         provisions in
and Practices Hamper         FDA'S    voluntary Food Code designed to protect populations known to be
Egg Safety Efforts           particularly vulnerable to SE infections, such as the elderly in nursing
                             homes, have not been adopted by all the states. Also, inconsistent federal
                             policies on the repackaging of eggs and how expiration dates are used on
                             egg cartons may mislead consumers and could pose a food safety risk.
                             Although about 30 percent of the nation's eggs are graded for quality by
                             USDA and, therefore, are subject to restrictions on repackaging, the
                             remaining 70 percent are not subject to the same restrictions. In addition,
                             while those eggs inspected by USDA cannot have expiration periods longer
                             than 30 days, all other eggs may have longer expiration periods.


Vulnerable Populations Are   Certain populations-such as the elderly in nursing homes-are more
Not Consistently Protected   likely to experience severe health problems from eating SE-contaminated
                             eggs than the general population. For example, the Centers for Disease

                             6
                                 Salmonella Enteritidis Risk Assessment: Shell Eggs and Egg Products, Final Report (June 12, 1998).



                             Page 11                                                                  GAO/RCED-99-184 Egg Safety
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Control and Prevention reported that 54 of the 79 deaths associated with
outbreaks of SE between 1985 and 1998 were of individuals in nursing
homes. 7 In addition, the agency found that the likelihood of dying from a
foodborne illness contracted in a nursing home was 13 times higher than
from outbreaks in other settings.

Because of the problems associated with SE-contaminated eggs, FDA'S 1993
Food Code contained egg safety provisions for highly susceptible
populations.8 The provisions were revised and expanded in the 1995 and
1997 versions of the code. FDA'S 1997 Food Code recommended that food
service operators serving highly susceptible populations substitute
pasteurized shell eggs or egg products for raw shell eggs (1) in Caesar
salad dressing, mayonnaise, ice cream, and other foods that typically use
raw or undercooked eggs and (2) when eggs are broken, combined in a
container and not cooked immediately or are held for service after
cooking, as with scrambled eggs on a buffet table. In the 1999 version of
the Food Code, FDA modified its provisions for the protection of highly
susceptible populations by allowing the use of shell eggs when eggs are
combined and held for service only if they are prepared under a HACCP plan
that ensures SE growth is controlled before and after cooking and is
destroyed during cooking.

According to our survey of state regulatory officials, many states have not
adopted the 1997 Food Code recommendations on serving pasteurized
shell eggs or egg products to highly susceptible populations. 9 Twenty-four
of the 50 states told us that they did not require food service operators that
serve highly susceptible populations to use pasteurized eggs for any food
item that usually contains raw eggs, such as Caesar salad dressing.
Furthermnore, in 26 states, food service operators are not required to use
pasteurized eggs when they crack, combine, and hold a number of eggs
prior to cooking or after cooking and prior to service. In addition,



7
 An "outbreak" is defined as two or more people having a similar illness that has been traced to eating
a common food. In addition, sporadic cases of illness occur outside of reported outbreaks. According
to the Centers for Disease Control and Prevention, although foodborne diseases are extremely
common, only a fraction of the illnesses are reported. Therefore, the numbers of illnesses and deaths
linked to reported outbreaks of SE are much smaller than the best estimates of the actual prevalence
of illness and death in which SE is a factor.
8
 Highly susceptible populations include the following persons who are in institutional or custodial
care: (1) individuals with impaired immune systems, (2) the elderly in facilities such as nursing homes
or hospitals,, and (3) preschool children in facilities such as day care centers.
9
 When we conducted our survey of regulatory officials, the 1997 Food Code was the most current
version.



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                           according to a 1998 Dietary Managers Association'0 survey of 136 private
                           nursing homes, hospitals, and other care facilities and 23 Air Force
                           hospitals across the nation, 35 percent of these institutions use
                           unpasteurized shell eggs in the preparation of batters for foods that may
                           not be fully cooked, such as French toast.


Rules on Repackaging and   Two key risk factors can affect the growth of SE in eggs-age and
Dating Egg Cartons Are     temperature. Experts agree that an egg's natural defenses to SE can break
Inconsistent               down as an egg ages or is exposed to high or fluctuating temperatures.
                           Therefore, ensuring that eggs are fresh and are maintained under a
                           consistent, appropriate temperature from packing to the table are critical
                           SE reduction measures.

                           Because of these risk factors, concerns have surfaced about the practice
                           of repackaging and redating shell eggs that are about to reach their
                           expiration dates. In April 1998, a national news organization reported that
                           eggs are sometimes removed from grocery stores a few days before their
                           expiration or sell-by dates and returned to an egg processing plant, where
                           they are rewashed, repackaged, placed in cartons with fresh eggs, and
                           given a new expiration date. While FDA, USDA, industry representatives, and
                           several state officials told us that they do not believe this practice is
                           widespread, some officials contend that it may present a food safety
                           hazard. Eggs that are repackaged must be transported to the processing
                           plant and therefore may be subject to temperature fluctuations as well as
                           additional heating during rewashing.

                           USDA  and FDA have reacted differently to these concerns. USDA'S
                           Agricultural Marketing Service announced that, as of April 27, 1998, the
                           practice of repackaging and redating eggs would be temporarily prohibited
                           for the one-third of the nation's eggs graded and packed under its
                           voluntary grading program because the practice can mislead consumers
                           about the eggs' freshness. The Service is currently developing regulations
                           to make this prohibition permanent. FDA, which has regulatory authority
                           over all shell eggs, announced in May 1998 that it was considering
                           appropriate measures to address repackaging but, as of June 1999, had not
                           taken any action to prohibit the practice. The inconsistency in the federal
                           government's approach to repackaging may be misleading to consumers
                           because USDA-graded and non-usDA-graded eggs sit side by side in grocery
                           store coolers. The United Egg Producers has stated that a federal


                           '0The association represents approximately 15,000 dietary managers and food protection professionals
                           nationwide.


                           Page 13                                                             GAO/RCED-99-184 Egg Safety
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prohibition on repackaging eggs should be consistently applied to all eggs,
whether they are packed in cartons bearing the USDA grade shield or not.
Our survey of state regulatory officials found that only 10 of the 50 states
have laws prohibiting repackaging.

With respect to expiration dates, neither the Agricultural Marketing
Service nor FDA requires them on egg cartons. However, according to a
Service official, many producers in its voluntary grading program take this
optional step. If they do, the Service requires that the expiration date be no
more than 30 days from the date the eggs were packed. Egg processors
that do not participate in the agency's grading program typically include
expiration dates of either 30 or 45 days, although some do not provide any
expiration date. Hence, expiration-dating practices are inconsistent.

While the difference in safety between a 30-day-old egg and a 45-day-old
egg may be negligible, according to some experts, inconsistent expiration
dating practices can mislead consumers. For example, when comparing
carton dates, a consumer may be more likely to select the eggs not graded
by USDA because the later date on the carton seems to imply that those
eggs will be fresher for a longer period. But the eggs with the later date
may actually be older than the USDA eggs in the cooler. FDA recognizes that
this inconsistency may be misleading to consumers, and in a May 1998
notice in the Federal Register, the agency sought comments on whether
this practice violates the Federal Food, Drug, and Cosmetic Act's
provisions on misbranding. As of June 1999, FDA had not issued any rules
on expiration dating.

Our survey of state regulatory officials found that only 17 of the 50 states
require either an expiration or a sell-by date on egg cartons sold in their
states. A National Egg Regulatory Officials' committee plans to develop
guidelines for its members for uniform labeling of egg cartons because
many eggs are transported interstate." These officials believe that such
uniformity would help ensure safety and quality.




"The National Egg Regulatory Officials is an organization with members from 35 state departments of
agriculture involved in shell egg and egg products regulations and programs.


Page 14                                                             GAO/RCED-99-184 Egg Safety
                          B-282632




Fragmented Structure      The fragmented regulatory structure for eggs has hampered the federal
                          government's ability to act efficiently and effectively to improve egg
Makes Effective           safety. The government does not assign egg safety resources to the
Resource Allocation       different federal agencies with responsibilities for egg safety based on an
                          overall assessment of risk. Furthermore, although FSIS and FDA are trying
                          to work around the fragmented regulatory structure, the agencies have
Coordination Difficult    been unable to improve egg carton labeling or establish a comprehensive
                          egg safety approach in a timely fashion.


Egg Safety Inspection     The current regulatory and organizational framework does not provide an
Resources Are Not         overall federal focus for ensuring that egg safety resources are used in the
Allocated Based on Risk   most efficient manner. As discussed earlier, responsibility for ensuring the
                          safety of shell eggs and egg products is split between FDA in the
                          Department of Health and Human Services and FSIS in the Department of
                          Agriculture. In approaching its egg safety responsibilities, each agency
                          independently assigns resources for egg inspections based on its own
                          regulatory approach, priorities, and available funding for food safety
                          activities.

                          Under the Federal Food, Drug, and Cosmetic Act, as amended, FDA
                          generally follows a regulatory approach that allows foods to enter the
                          market without preapproval and, therefore, does not inspect foods on a
                          regular schedule. As a result of this approach, and because of limited
                          resources, FDA almost never inspects shell egg production and processing
                          operations. USDA, in contrast, follows a regulatory approach that generally
                          requires inspections before a product reaches the market. For example,
                          FSIS is required by law to conduct daily continuous inspections of all egg
                          products plants in the United States.

                          Egg safety inspection resources are not directed to the areas of highest
                          risk under the current regulatory system. Most of the federal resources are
                          directed toward egg products even though during processing, the eggs are
                          pasteurized to kill harmful bacteria such as SE. In fiscal year 1998, FSIS had
                          102 full-time inspectors dedicated to daily continuous inspection at all egg
                          products plants in the country. In contrast, even though shell eggs
                          generally are not pasteurized, given FDA'S limited inspection resources, the
                          agency almost never inspects egg farms where eggs can be contaminated.

                          As we previously reported, this diverse regulatory approach results in
                          inconsistent oversight and a system that does not base inspection




                          Page 15                                              GAO/RCED-99-184 Egg Safety
                           B-282632




                           frequency on food safety risk. 12 If HACCP systems are implemented in all
                           egg products plants, it may be possible to reduce or eliminate the current
                           requirement for continuous inspection, which could allow inspection
                           resources to be redirected to areas of higher risk. As we have reported in
                           regards to continuous inspections of meat and poultry plants, this type of
                           inspection will be unnecessary to protect food safety after the
                           introduction of HACCP systems.' 3


Actions on Egg Carton      Although USDA and FDA have worked together on various egg safety
Labeling and               activities, including a consumer education campaign, an SE risk
Comprehensive Egg Safety   assessment study, and a foodborne disease monitoring network, progress
Strategy Have Been Slow    on egg carton labeling and a comprehensive egg safety strategy has been
                           slow. In our 1992 report, we found that USDA'S and FDA'S efforts to control
                           illness from SE-contaminated eggs were stymied by questions about
                           jurisdiction, among other things.' 4 Because FSIS and FDA have jurisdiction
                           over different aspects of egg safety, the agencies are each planning to
                           establish egg carton labeling requirements.

                           The 1991 amendments to the Egg Products Inspection Act included a
                           requirement that egg cartons be labeled "keep refrigerated" or words of
                           similar meaning. However, FSIS did not write regulations implementing the
                           1991 amendments until August 27, 1998.'5 The regulations become
                           effective a year later. In commenting on the proposed regulations, some
                           respondents recommended additional food safety labeling requirements.
                           In response, FSIS said that "the statute does not specify any additional
                           labeling provisions, and the Agency is not including additional labeling
                           requirements in these regulations." FDA, however, has begun developing a
                           proposal for an egg safety label that would go beyond the "keep
                           refrigerated" requirement soon to be implemented by FSIS. FDA has not yet
                           made public the language it will propose, although other groups have
                           suggested, for example, advising that eggs should not be eaten raw and
                           should be cooked until firm.

                           Our survey of the states found that while 23 states require at a minimum
                           that egg containers be labeled "keep refrigerated," 27 other states have no

                           '2 Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure Safe Food
                           Supply (GAO/RCED-92-152, June 26, 1992).

                           '3 Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry
                           (GAO/RCED-94-110, May 19, 1994).

                           '4 GAO/RCEI) 92-69, Apr. 21, 1992.

                           '5 FSIS assumed responsibility from USDA's Agricultural Marketing Service in 1995 for the
                           implementation of the 1991 amendments to the Egg Products Inspection Act.

                           Page 16                                                               GAO/RCED-99-184 Egg Safety
              B-282632




              such requirements. In the absence of federal or state requirements, some
              egg producers may voluntarily label egg cartons to show that eggs should
              be kept refrigerated. We asked state regulatory officials whether their
              states require egg cartons to carry words that tell the consumer not to eat
              eggs raw and to cook the eggs thoroughly. Only one state told us that
              either of these consumer warnings is required.

              In our 1992 report on efforts to control SE, we reported that coordination
              difficulties resulted from the split regulatory structure and that
              consequently, the federal government had not agreed on a unified
              approach to addressing the problem of SE in eggs. Now, 11 years after the
              problem of sE-contaminated eggs was first identified, the federal
              government still has not agreed on a unified approach to address the
              problem. In May 1998, FDA and FSIS issued a joint advance notice of
              proposed rulemaking seeking to identify actions that would decrease the
              food safety risks associated with eggs as they move from the farm to the
              table. The notice recognized that eggs contaminated with SE continue to be
              a public health concern and sought comments by August 1998 on a wide
              range of actions that could be taken by the two agencies to improve
              farm-to-table egg safety.

              Little progress has been made by FSIS and FDA in developing a unified
              farm-to-table egg safety approach. Although Fsis received about 70
              comments from state regulatory agencies, industry associations, and other
              interested parties, no official FDA-USDA group has been formed to review
              these comments or to establish a unified regulatory strategy. According to
              FSIS officials, there is no timetable for completing the strategy, and as of
              June 1999, they had not formed a team with FDA to work on the issues.


Conclusions   With responsibilities distributed among four federal agencies, the nation's
              egg safety efforts lack an organizational focus and contain gaps,
              inconsistencies, and inefficiencies. A prevention-based approach to food
              safety involving hazard analysis and critical control point (HACCP)
              principles has not been applied comprehensively to the production and
              processing of eggs and egg products. Moreover, while the states have
              begun to develop HAccP-based safety programs for egg farms, they are not
              based on a set of minimum national standards. A consistent national
              HAccp-based approach to safety on egg farms could reduce the frequency
              of Salmonella Enteritidis contamination in eggs and provide uniform risk
              reduction throughout the country. In addition, if HACCP systems are
              implemented in all egg products plants, it may be possible to reduce or



              Page 17                                              GAO/RCED-99-184 Egg Safety
                  B-282632




                  eliminate the current practice of continuous inspection, which could allow
                  inspection resources to be redirected to areas of higher risk.

                  Controlling an egg's temperature is recognized as one of the most
                  important steps in limiting the growth of Salmonella Enteritidis. However,
                  federal regulations soon to be implemented on the refrigeration of eggs
                  will not control this risk factor as effectively as possible because they
                  address air temperature, not an egg's internal temperature. In addition,
                  raw and undercooked eggs continue to be hazardous, particularly to highly
                  susceptible populations such as those with impaired immune systems or
                  the elderly in nursing homes. Finally, because of the fragmented federal
                  regulatory approach to egg safety, decisions about how to allocate the
                  nation's egg safety inspection resources are not based on risk. Although
                  FDA and FSIS plan to take several actions in the near future to improve egg
                  safety, the fragmented federal regulatory structure we identified in 1992
                  remains an obstacle to a comprehensive, consistent, and effective egg
                  safety strategy.


 Matter for~--    To provide an organizational focus for the nation's egg safety policies and
                  activities, the Congress may wish to consider consolidating responsibility
Congressional     for egg safety in a single federal department.
Consideration
Recommendations   To reduce the threat of Salmonella Enteritidis contamination during egg
                  production and processing, we recommend that the Commissioner of the
                  Food and Drug Administration develop a model HAccP-based program for
                  egg farms and processing plants, that could be adopted by the states. This
                  program should define the minimum national standards, including
                  microbial testing, for egg safety at these locations.

                  To enhance safety protections in egg products processing plants, we
                  recommend that the Secretary of Agriculture develop regulations to
                  require these plants to implement HACCP systems.

                  To reduce the time needed to lower the internal temperature of eggs to 45
                  degrees, we recommend that the Secretary of Agriculture and the
                  Commissioner of the Food and Drug Administration jointly study the costs
                  and benefits of implementing rapid cooling techniques in egg processing
                  and packing operations and, depending on the results, take appropriate
                  action.




                  Page 18                                             GAO/RCED-99-184 Egg Safety
                   B-282632




Agency Comments    We provided   USDA   and FDA with a draft of this report for their review and
                   comment. Both USDA and FDA provided a number of editorial and technical
and Our Response   comments, which have been incorporated into the report as appropriate.
                   The following summarizes their general comments and our responses.
                   USDA'S and FDA'S letters are printed with our responses in appendixes IV
                   and V,respectively.

                   In commenting on the draft report, USDA agreed with all three of our
                   recommendations. While USDA concurred with the intent of our
                   recommendation to implement hazard analysis and critical control point
                   (HACCP) systems in plants, the Department suggested revising the wording
                   of the recommendation. We have made some minor revisions based on the
                   Department's suggestions. USDA also said that the report appeared
                   unbalanced because USDA and FDA were criticized in the body of the report,
                   whereas information about the agencies' positive actions was confined to
                   the appendixes. We do not agree with USDA'S view that the report is
                   unbalanced. The body of the report presents the findings from our review,
                   which identified a number of gaps, inconsistencies, and inefficiencies in
                   the nation's egg safety efforts. Appendix III describes each agency's
                   responsibilities and programs and is not a "listing of what is being done
                   well," as stated by USDA.

                   In commenting on the draft report, FDA agreed with our recommendations.
                   However, FDA said that before it can develop criteria for a HAccP-based
                   program, it must first develop prevention controls for egg production
                   because science has not yet established the optimal strategy to control
                   Salmonella Enteritidis on farms. We agree with FDA that the scientific
                   issues involved in designing and establishing the effectiveness of control
                   measures for Salmonella Enteritidis are complex. However, we believe
                   FDA can take immediate action to develop a model program that contains
                   controls that are based on the best currently available scientific
                   information and the experience of existing state programs. FDA also said
                   that the draft report did not acknowledge that FDA has participated in
                   various meetings and task forces regarding on-farm Salmonella Enteritidis
                   prevention programs. Even though FDA states that it has participated in
                   these activities, our concern remains that FDA has not established a
                   national model program for reducing Salmonella Enteritidis on farms and
                   that existing state programs vary significantly.

                   Both USDA and FDA commented that the draft report did not adequately
                   acknowledge that they have been working together for many years on a
                   coordinated approach to the problem of Salmonella Enteritidis in eggs. We



                   Page 19                                                GAOIRCED-99-184 Egg Safety
              B-282632




              recognize that USDA and FDA have worked together and have added
              information to the report to reflect this. However, we continue to believe
              that progress on developing a comprehensive egg safety strategy has been
              slow. The problem of Salmonella Enteritidis in eggs was first identified in
              1988. Eleven years later, USDA and FDA have yet to establish a
              comprehensive strategy to improve egg safety. Both USDA and FDA said that
              the report did not include any references to ongoing federal research
              efforts to better understand Salmonella Enteritidis. While we are aware
              that federal research on Salmonella Enteritidis is under way, reporting on
              that research was not one of the objectives of our review.


Scope and     To conduct this review, we spoke with and obtained studies, data, and
              other information on egg safety from FDA, the Centers for Disease Control
Methodology   and Prevention, the Animal and Plant Health Inspection Service, the
              Agricultural Marketing Service, and FSIS. We also conducted a telephone
              survey of all 50 states in January and February 1999 and visited egg
              regulatory agencies in four states-California, Georgia, Illinois, and
              Pennsylvania. To obtain answers to all of the survey questions, we
              frequently spoke with several officials from different agencies responsible
              for egg safety in each state. We completed interviews with all 50 states for
              a response rate of 100 percent.

              To determine whether the prevention-based approach to food safety,
              known as HACCP, has been applied to egg production and processing, we
              (1) conducted interviews with USDA, FDA, and state officials; (2) analyzed
              the HAccP-based safety plans being implemented in 13 states; and
              (3) reviewed HACCP regulations for meat, poultry, and seafood. To
              determine whether federal policies on egg refrigeration are effective, we
              discussed with USDA, FDA, and state officials the reasons for their egg
              refrigeration requirements and reviewed the scientific literature on the
              effect of temperature on the growth of Salmonella.

              To determine if federal and state policies on serving eggs to vulnerable
              populations and dating of egg cartons are consistent, we reviewed FDA'S
              Food Code and federal and state egg safety laws and regulations and
              discussed current policies and practices with federal and state officials. To
              determine whether federal egg safety resources are used efficiently and
              policies are coordinated effectively, we interviewed USDA and FDA officials
              regarding the scope and frequency of egg safety inspections for shell egg
              and egg products plants. We also discussed their efforts to coordinate the




              Page 20                                             GAO/RCED-99-184 Egg Safety
B-282632




implementation of labeling requirements for egg cartons and to develop a
farm-to-table egg safety strategy.

We conducted our work from August 1998 through June 1999 in
accordance with generally accepted government auditing standards.


We will send copies of this report to the congressional committees with
jurisdiction over food safety issues; Dan Glickman, Secretary of
Agriculture; Jane Henney, Commissioner of the Food and Drug
Administration; Jacob Lew, 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) 512-5138 or Robert C. Summers at (404) 679-1839. Key contributors
to this report are listed in appendix VI.

Sincerely yours,




Lawrence J. Dyckman
Director, Food and Agriculture Issues




Page 21                                              GAO/RCED-99-184 Egg Safety
Contents


Letter                                                     1
Appendix I                                                24
Salmonella Enteritidis
Contamination in
Eggs
Appendix II                                               28
Egg Production,
Processing, and
Distribution From
Farm to Table
Appendix III                                              30
Federal and State Egg
Safety and Quality
Responsibilities
Appendix IV                                               38
Comments From the
Department of
Agriculture
Appendix V                                                45
Comments From the
Food and Drug
Administration




                         Page 22   GAO/RCED-99-184 Egg Safety
                   Contents




Appendix VI                                                                                 53
GAO Contacts and
Staff
Acknowledgments
Tables             Table I.1: Examples of Salmonella Enteritidis Outbreaks and
                     Egg-Associated Foods, 1990-98
                                                                                            26
                   Table II.1: Top 10 Egg-Producing States in 1998                          28

Figure             Figure 1: Egg Production, Processing, and Distribution and
                     Responsible Federal Regulatory Agencies
                                                                                             6




                   Abbreviations

                   AMS        Agricultural Marketing Service
                   APIms      Animal and Plant Health Inspection Service
                   CDC        Centers for Disease Control and Prevention
                   FDA        Food and Drug Administration
                   FSIS       Food Safety and Inspection Service
                   HACCP      hazard analysis and critical control point
                   SE         Salmonella Enteritidis
                   USDA       U.S. Department of Agriculture


                   Page 23                                           GAO/RCED-99-184 Egg Safety
Appendix I

Salmonella Enteritidis Contamination in
Eggs

                         Over the last decade, shell eggs contaminated with Salmonella Enteritidis
                         (SE) bacteria have increasingly been implicated as the cause of foodborne
                         illness in the United States. According to the best available data from the
                         Centers for Disease Control and Prevention, SE may have caused about
                         300,000 illnesses in 1997, resulting in 115 to 229 deaths. Significant
                         economic costs result from SE illnesses and deaths, with estimates ranging
                         from approximately $225 million to $3 billion in 1996. Although not all SE
                         infections are linked to eggs, according to data from the Centers for
                         Disease Control and Prevention, between 1985 and 1998, 82 percent of SE
                         outbreaks1 6 with an identified cause were associated with eggs. 17


Increasing Reports of    Officials at the Centers for Disease Control and Prevention first cast doubt
                         on the internal safety of shell eggs in a 1988 study of outbreaks of
Salmonella Enteritidis   SE-related foodborne illness that occurred in 1986 and 1987. The research
Infections               in several northeastern states found that 77 percent of illnesses with an
                         identified cause were associated with undercooked, clean, grade A shell
                         eggs. Since this initial connection, reported illnesses related to SE in eggs
                         have been a growing problem through the mid-1990s. SE progressed from
                         an infrequent cause of human illness to one of the most common strains,
                         or serotypes, of Salmonella, growing from 5 percent of total Salmonella
                         cases in 1977 to 15.6 percent in 1987 and 22.9 percent in 1997. Recently
                         released data from the Centers for Disease Control and Prevention for
                          1996 through 1998 indicate a possible change in trends, as SE infections
                         decreased by 44 percent in selected counties and states. SE also fell from
                         being the most common strain of SalmoneUa from 1993 to 1996 to being
                         the second most common strain in 1997. According to agency officials,
                         while these data are encouraging, they are not conclusive evidence of a
                         nationwide reduction in SE.


Factors Contributing     Though no single explanation exists for Salmonella'svirulence and rapid
                         rate of growth in the United States, several contributing factors have been
to Salmonella            identified, including changes in methods of animal food production and
Enteritidis in Eggs      slaughter, increasing centralization of food production, and larger-scale
                         distribution. For example, the increased amount of food produced and
                         consumed outside the home may create an opportunity for incorrect
                         preparation or cross-contamination, which can cause disease.

                         16
                          An "outbreak" is defined as two or more people having a similar illness that can be traced to eating
                         a common fbod. In contrast, sporadic cases involve individuals who report foodborne illnesses outside
                         a recognized outbreak.

                         '7In only 44 percent of cases could a responsible food be identified.


                         Page 24                                                                 GAO/RCED-99-184 Egg Safety
                         Appendix I
                         Salmonella Enteritidis Contamination in
                         Eggs




                         The transmission of SE from the farm environment, to egg-laying flocks,
                         and then to eggs is still not fully understood. However, research at
                         Pennsylvania egg producers during the early 1990s identified several
                         factors that may increase bacterial levels and chicken contamination.
                         These factors included heavy rodent populations, older flocks, and forced
                         molting."8 Once infected, chickens can pass the pathogen directly from
                         their ovaries to the contents of the eggs they lay. Some freshly produced
                         eggs are thus contaminated before the shell forms around their contents.
                         The exact scope and frequency of this problem are not known, but the U.S.
                         Department of Agriculture estimates that 1 in every 20,000 eggs is infected.
                         This means that about 3.4 million of the approximately 67 billion shell eggs
                         produced in 1998 were infected with SE.

                         Eating an egg infected with SE does not always result in illness, though,
                         since proper refrigeration will limit bacterial growth and cooking can
                         ultimately kill it. The site of SE contamination is normally in the egg white.
                         The yolk membrane provides a barrier, which prevents SE from reaching
                         the nutrient-rich yolk where it can quickly multiply. Refrigeration prolongs
                         the life of the yolk membrane and thereby limits the growth of SE in
                         contaminated eggs. Moreover, cooking food at 160 degrees Fahrenheit will
                         rapidly kill SE bacteria. For example, homemade ice cream and eggnog can
                         be made safely only if the egg mixture is cooked to 160 degrees. Similarly,
                         a hard-cooked egg should be safe to eat; however, soft-cooked eggs may
                         not be safe if they are not cooked long enough. In addition, the
                         commercial practice of pooling eggs has played a role in some outbreaks.
                         When hundreds of eggs are pooled in a single bowl and are then used to
                         make scrambled eggs or other dishes, one egg can contaminate the whole
                         batch. For disease to occur, then, eggs usually must be contaminated at
                         the farm or during processing and then be improperly handled,
                         inadequately refrigerated, or undercooked or consumed raw.


Salmonella Enteritidis   Over the years, outbreaks of SE have continued to be associated with a
                         wide variety of egg-related foods, such as Caesar salad dressing,
Outbreaks and            hollandaise sauce, and bread pudding. In many cases, these dishes
Illnesses                contained either raw or undercooked eggs. (See table I.1.)




                         '8Forced molting is done to improve egg production. During a forced molt, chickens are generally
                         deprived of feed or water for a period of time. Following the molt, the birds will produce more eggs
                         than they would have without molting.



                         Page 25                                                               GAO/RCED-99-184 Egg Safety
                                    Appendix I
                                    Salmonella lEnteritidis Contamination in
                                    Eggs




Table 1.1: Examples of Salmonella
Enteritidis Outbreaks and           Year              Food associated with Salmonella Enteritidis outbreaks
Egg-Associated Foods, 1990-98       1990              Undercooked eggs in bread pudding
                                    1991              Undercooked bread stuffing containing pooled raw eggs
                                    1992              Cross contamination of cooked foods from uncooked, pooled eggs
                                                      Banana pudding containing undercooked eggs
                                                      Egg sandwiches
                                    1993              Omelet, egg salad, scrambled eggs
                                                      Hollandaise and bearnaise sauces containing pooled raw eggs
                                                      Sandwiches containing undercooked mayonnaise
                                    1994              Hollandaise sauce containing raw eggs
                                    1995              Jamaican malt beverage (a homemade drink of beer, raw eggs, milk,
                                                      oatmeal, and ice)
                                                      Caesar salad dressing containing raw eggs
                                                      Baked eggs
                                    1996              Coconut cream pie
                                                      French toast using eggs
                                                      Egg salad
                                    1997              Crab fluff
                                                      Bearnaise sauce
                                                      Homemade cheesecake
                                    1998              Cream pies
                                                      Stuffing
                                                      Homemade ice cream
                                    Source: Centers for Disease Control and Prevention.


                                    Human illnesses resulting from SE bacteria can cause a variety of serious
                                    health problems. Short-term reactions, usually beginning 12 to 72 hours
                                    after the contaminated food has been eaten, include abdominal pain,
                                    bloody stools, diarrhea, fever, headache, and vomiting. More severe
                                    conditions associated with Salmonella range from bloodstream infections
                                    to arthritis and meningitis. Patients' symptoms and the severity of their
                                    sickness can vary according to their personal characteristics and extent of
                                    exposure. Individuals with impaired immune systems, young children, and
                                    elderly patients in nursing homes are more susceptible to SE infections and
                                    have more severe symptoms and greater incidence of hospitalization and
                                    death. In SE outbreaks between 1985 and 1998, for example, approximately
                                    68 percent of the deaths occurred among nursing home residents.
                                    Moreover, the death rate for SE outbreaks in nursing homes was
                                    approximately 13 times greater than the rate for all outbreaks. The higher




                                    Page 26                                                     GAO/RCED-99-184 Egg Safety
Appendix I
Salmonella Enteritidis Contamination in
Eggs




death rates among the elderly have been attributed to many causes,
including preexisting illnesses and reduced immunity.




Page 27                                           GAO/RCED-99-184 Egg Safety
Appendix II

Egg Production, Processing, and
Distribution From Farm to Table

                                   Eggs are a significant agricultural commodity and an important part of
                                   most Americans' diets. Americans consume about 245 eggs per capita
                                   annually, fueling a domestic egg industry that produced 67 billion eggs for
                                   human consumption in 1998. These eggs had a retail value of $3.65 billion.

                                   Though eggs are sold and processed in almost every state, over 60 percent
                                   of egg production remains concentrated in the top 10 producing states.
                                   (See table II.1.) Geographically, these states vary widely, from California in
                                   the West; to Iowa, Indiana, Minnesota, and Ohio in the Midwest; to
                                   Pennsylvania and Georgia in the East. From 1985 to 1996, the number of
                                   commercial egg farms declined from approximately 3,000 to 900, and
                                   today most egg production is concentrated on a relatively small number of
                                   large farms. About 340 egg producers have flocks of over 75,000 chickens,
                                   which together represent 97 percent of all domestic egg-laying hens.

Table 11.1: Top 10 Egg-Producing
States in 1998                                                                                 Percentage of               Value of
                                                                       Number of eggs          total U.S. egg            production
                                           States                           (millions)            production              (millions)
                                   1       Ohio                                        7,395               9.3                   $351
                                   2       California                                  6,608               8.3                    309
                                   3       Pennsylvania                                5,983               7.5                    304
                                   4       Iowa                                        5,969               7.5                    225
                                   5       Indiana                                     5,831               7.3                    286
                                   6       Georgia                                     5,126               6.4                    376
                                   7       Texas                                       4,257               5.3                    254
                                   8       Arkansas                                    3,233               4.1                    263
                                   9       Minnesota                                   3,152               4.0                    126
                                   10      Nebraska                                    2,706               3.4                     97
                                           Total                                   50,260                 63.1                $2,591
                                   Note: Total egg production includes both eggs used for consumption and for breeding purposes.
                                   Although exact data are not available, in 1998, about 84 percent of the total eggs produced were
                                   eggs for consumption.

                                   Source: National Agricultural Statistics Service.


                                   Egg production, processing, and distribution is a multistep process. For
                                   eggs that are sold whole, known in the industry as shell eggs, this process
                                   involves five major steps: (1) chick breeding; (2) egg production on farms;
                                   (3) washing and candling; (4) weighing, sorting, and packing; and
                                   (5) transportation and sale. Typically, commercial firms breed chicks for
                                   egg laying and sell them to egg farmers or independent pullet growers. The



                                   Page 28                                                             GAO/RCED-99-184 Egg Safety
Appendix II
Egg Production, Processing, and
Distribution From Farm to Table




chicks then grow for 20 weeks before they mature and begin to lay eggs.
The eggs are processed in either in-line or off-line operations. At in-line
facilities, eggs are transported by conveyor belts from the laying house
directly to an adjacent processing plant. In some cases, in-line facilities
may also process eggs that have been gathered and transported from an
outside location. At off-line facilities, eggs are gathered and stored on a
farm before being transported to the processing facility at another
location.

Upon arrival for processing, eggs are washed and may also be sanitized to
remove dirt, feces, and bacteria collected in the laying house. Following
washing, they are dried to remove the remaining moisture and may be
oiled to seal the pores in the shells. Processing plant employees use a
candling machine, which shines light through the eggs' shells, to ensure
the quality and wholesomeness of the contents by identifying and
removing any eggs that are dirty, cracked, leaking, or rotten as well as
those that contain blood spots. The eggs are then sorted, weighed, and
packed in cartons labeled with their appropriate grade and size. Eggs are
graded for quality as AA, A, or B based on interior and exterior factors,
including the shell, air cell, yolk, and white. Size grades include jumbo,
extra large, large, medium, small, or peewee. The packaged eggs are then
consolidated into boxes and flats and stored in coolers until they are
transported to retail stores and institutions.

While shell eggs are sold whole to consumers, some eggs are broken to
create egg products. These products are sold dried, frozen, or maintained
in liquid form for individual or commercial use. The ability of egg products
to be used separately or combined with other ingredients gives them many
uses. These uses range from frozen egg patties for fast food restaurants to
liquid eggs, yolks, or whites used for cooking. In addition, egg yolks with
sugar added can be used in the commercial production of ice cream, while
egg yolks with salt can be used in producing mayonnaise.

The processing of egg products shares many similarities with the multistep
approach that defines shell egg processing. Upon arrival at an egg
breaking plant, eggs are washed and candled, and eggs that are dirty,
cracked, or have other problems are removed. The eggs are then separated
into yolks and whites by an automated breaking machine. Liquid eggs are
pasteurized to kill any bacteria that may be present. Following
pasteurization, the eggs are chilled, frozen, or dried. At the completion of
the process, egg products are packed into containers or loaded as a chilled
liquid directly into tankers.



Page 29                                              GAO/RCED-99-184 Egg Safety
Appendix III

Federal and State Egg Safety and Quality
Responsibilities

                      From the farm to the table, responsibility for egg safety and quality is
                      distributed among four federal agencies in two departments-in the U.S.
                      Department of Agriculture (USDA), the Animal and Plant Health Inspection
                      Service (APHIS), the Food Safety and Inspection Service (FsIs), and the
                      Agricultural Marketing Service (AMS) and in the U.S. Department of Health
                      and Human Services, the Food and Drug Administration (FDA). These
                      agencies have responsibilities for egg safety and quality under five
                      different laws and, as a result, use different regulatory approaches in
                      addressing these issues.


APHIS Manages a       Producing eggs and bringing them from the      farm to the table is a multistep
                      process. At the first step in this process, USDA offers a program that
Program to Produce    attempts to ensure chicks that will become egg-laying hens are born free
Disease-Free Chicks   of diseases, including Salmonella Enteritidis   (SE).   In 1935, USDA
                      implemented the National Poultry Improvement Plan for the improvement
                      of poultry, poultry products, and hatcheries throughout the country. APHIS
                      currently operates this program under the Department of Agriculture
                      Organic Act of 1944, as amended.

                      The National Poultry Improvement Plan is a program that certifies that
                      poultry breeding stock and hatcheries are free from egg-transmitted and
                      hatchery-disseminated diseases. Participation is open to producers or
                      sellers of poultry and poultry products that demonstrate that their
                      facilities, personnel, and practices adequately carry out the plan's
                      provisions. The states can also implement regulations that further define
                      these provisions or establish higher standards that are compatible with the
                      plan. The program is mandatory for those producers that ship interstate or
                      internationally and voluntary for those that ship intrastate. Although the
                      plan is voluntary for some producers, farms often cannot sell their birds
                      without the plan's certification. According to an APHIS official, during 1998,
                      268 breeding flocks, comprising about 3 million birds, in 22 states
                      participated in the program.

                      APHIS changes the plan's provisions from time to time as new information
                      about poultry diseases becomes available from the industry. For example,
                      in July 1989, APHIS added a component designed to reduce the incidence of
                      SE organisms in egg-laying hens through an effective and practical
                      sanitation program at the breeder farm and in the hatchery. APHIS operates
                      the program through memorandums of understanding with state agencies.
                      Either an APHIS inspector or an authorized state inspector ensures that the
                      plan's standards are implemented by inspecting the farm environment,



                      Page 30                                                  GAO/RCED-99-184 Egg Safety
                        Appendix III
                        Federal and State Egg Safety and Quality
                        Responsibilities




                        collecting samples, and conducting blood tests of participating breeding
                        flocks. Inspectors test breeder farms and henhouses every month for
                        diseases throughout the life of the flock. If initial environmental test
                        samples of the farm show the presence of SE, 60 birds are collected, and
                        their heart, liver, and other organs are cultured for SE. If the birds test
                        positive, the entire breeding flock is destroyed.


                        Federal authority to regulate the safety of eggs and egg products at egg
                        farms and egg processing plants is shared by FDA and FsIS.                     FDA   has
Responsibilities Are    traditionally been responsible for shell eggs' 9 and FsIs for egg products.
Divided Between FDA     Changes soon to be implemented to the Egg Products Inspection Act will
                        give USDA increased enforcement authority over shell eggs while they are
anfd FSIS               being stored at processing plants and transported. FDA and USDA have
                        different regulatory requirements. Based on these requirements, FDA
                        generally allows foods to enter the market without inspection, while USDA
                        generally inspects products before they reach the market.


FDAs Responsibilities   FDA has regulatory authority for shell eggs throughout the farm-to-table
                        process. The agency has responsibility for egg safety at egg farms, egg
                        processing plants where eggs are washed and packed, during
                        transportation, and at the retail level where eggs reach the consumer. The
                        agency's power to regulate egg safety stems from its authority to prevent
                        the spread of communicable diseases, granted by the Public Health
                        Service Act, and the adulteration provisions of the Federal Food, Drug,
                        and Cosmetic Act, as amended.

                        FDA has sole federal authority for regulating food safety on egg farms. The
                        agency currently conducts two main activities at egg farms. First, it
                        conducts egg farm inspections, known as traceback investigations, only
                        when an outbreak of foodborne illness has been identified. Once the
                        source of an outbreak is determined, FDA requires that eggs from
                        SE-positive flocks be diverted from sale to the public and destroyed or sent
                        to egg breaking plants for pasteurization. Second, to help prevent the
                        introduction of SE into the farm environment, FDA has entered into
                        partnership agreements to provide guidance and technical assistance to
                        some of the states that have taken the initiative to adopt egg safety
                        programs for farms based on hazard analysis and critical control point
                        (HACCP) principles and known as quality assurance programs.

                        "9 Shell eggs include whole eggs packed in cartons for individual consumers or packed in bulk for
                        institutional use, as well as cooked shell eggs, such as hard-boiled eggs, which may be sliced or
                        chopped for use at the retail level.



                        Page 31                                                               GAO/RCED-99-184 Egg Safety
Appendix I:I
Federal and State Egg Safety and Quality
Responsibilities




Under the Federal Food, Drug, and Cosmetic Act, as amended, FDA
generally allows foods, including eggs, to leave the processing plant and
enter the market without preapproval. Food firms are generally not
required to register, nor is FDA required to inspect foods or food firms on a
given schedule. According to an FDA official, the agency almost never
conducts inspections at the approximately 700 shell egg processing plants
that wash, grade, and pack eggs in the United States. Under the act, FDA
also has the authority to enforce provisions prohibiting the false or
misleading labeling of foods, including the labels used on egg cartons. In
addition, FDA has authority to regulate egg safety when eggs are
transported.

The Public Health Service Act states that FDA will assist the states in the
prevention and suppression of communicable diseases. State laws and
regulations generally establish food safety requirements for the millions of
restaurants, institutions, and other retail food operations throughout the
United Slttes, and state and local health departments inspect these
establishments to ensure compliance. FDA works with state and local
governments and encourages uniformity among state laws through its
model Food Code. The Food Code is not a federal regulation and only has
the force of law when adopted by a state or local government entity. These
jurisdictions may adopt the entire code or selected provisions. As of
March 2, 1999, 15 states reported to FDA that they had adopted some or all
of the provisions of the 1993 or more recent version of the code, and 23
states reported that they were in the process of doing so. The code
classifies raw shell eggs as a "potentially hazardous food" and sets
requirements for egg handling and preparation, such as proper cooking
temperatures. The code also places restrictions on preparing and serving
shell eggs to persons in institutional or custodial facilities who are highly
susceptible to foodborne illness, such as preschool children, the elderly,
and individuals with impaired immune systems.

The Egg Products Inspection Act, passed in 1970, also gives FDA authority
over shell egg safety at the retail level. Although this act previously
covered mainly egg product safety, the 1991 amendments included
requirements for shell egg safety. The amendments give FDA responsibility
at locations other than those that process and pack eggs, such as
restaurants and institutions, for ensuring that eggs are stored at an air
temperature not to exceed 45 degrees and are appropriately labeled to
show they require refrigeration. This is a departure from FDA'S traditional
role at the retail level under the Public Health Service Act of promoting
egg safety by encouraging states to adopt the Food Code. In addition,



Page 32                                             GAO/RCED-99-184 Egg Safety
                         Appendix III
                         Federal and State Egg Safety and Quality
                         Responsibilities




                         although FDA previously had primary authority over shell eggs, the 1991
                         amendments split enforcement authority for the temperature and labeling
                         requirements between FDA and USDA.


FSIS' Responsibilities   FSIS'responsibility for eggs begins when shell eggs are sent to a plant
                         where they are broken to make egg products. When the Congress passed
                         the Egg Products Inspection Act in 1970, it provided for the mandatory and
                         continuous inspection of the liquid, frozen, and dried egg products of all
                         U.S. egg products plants.20 For the next 25 years, the Poultry Division of
                         USDA'S Agricultural Marketing Service inspected egg products to ensure
                         that they were wholesome, unadulterated, and properly labeled and
                         packaged. However, in May 1995, when food safety responsibilities were
                         reorganized within USDA, FSIS assumed responsibility for inspecting egg
                         products. FSIS now inspects all egg products during production, with the
                         exception of those products that the act exempts, such as egg substitutes
                         and imitation eggs. However, once egg products leave the plant and enter
                         commerce, they become FDA'S regulatory responsibility.

                         To ensure food safety, FSIS follows a regulatory approach of inspecting
                         products before they reach the market. The Egg Products Inspection Act
                         requires that USDA provide continuous supervision while egg processors
                         are operating to ensure that eggs are properly pasteurized and that
                         pasteurized products test negative for Salmonella. In fiscal year 1998, FSIS
                         had 102 full-time inspectors monitoring operations at the 73 egg products
                         plants in the country. In addition, in that same year, the agency had
                         cooperative agreements with six states-Arkansas, Georgia, New Jersey,
                         New York, South Carolina, and Utah-to provide inspections of egg
                         products. Under these agreements, state inspectors conduct inspections
                         under technical supervision by FSIS and are reimbursed for their services.

                         FSIS'inspectors (1) check the eggs' quality and condition as they enter the
                         plant; (2) inspect the plant equipment and facilities to ensure overall
                         sanitation and cleanliness; (3) observe operations as the eggs are washed,
                         sorted, broken, pasteurized, cooled for storage, and properly labeled; and
                         (4) monitor the staffs personal hygiene practices. As a part of the
                         inspection program, all plants must maintain an SE testing program. Under
                         this program, an FSIS inspector or a plant official takes samples from
                         product lots and sends them out for laboratory analysis to identify the
                         presence of Salmonella. If testing shows the presence of Salmonella, the
                         2
                          ┬░Egg products are eggs removed from their shells for processing. Examples of egg products include
                         whole eggs, whites, yolks, and various blends with or without other ingredients that are processed,
                         pasteurized, and available in liquid, frozen, and dried forms.



                         Page 33                                                              GAO/RCED-99-184 Egg Safety
                      Appendix ][II
                      Federal and State Egg Safety and Quality
                      Responsibilities




                      product is repasteurized, destroyed, or diverted to pet food or other
                      products not for human consumption. FSIS also maintains a SalmoneUa
                      monitoring program to check on the testing programs at egg processors.
                      Under this monitoring program, FSIS takes about 3,000 samples a year from
                      the full range of egg products being produced in the 73 plants.

                      USDA'S regulations specify the temperatures required for the storage of egg
                      products at the plant, which depend upon the type of product-liquid,
                      frozen, or dried. However, once pasteurized egg products leave the plant,
                      FDA has responsibility for the temperature requirements for the
                      transportation and storage of these products as well as for inspections to
                      ensure compliance with the requirements.

                      In the 1991 amendments to the Egg Products Inspection Act, the Congress
                      expanded USDA'S authority to include enforcing shell egg refrigeration and
                      labeling safety requirements at processing plants and during
                      transportation. Previously, USDA had authority only for the safety of egg
                      products. Regulations implementing the amendments become effective on
                      August 27, 1999. FSIS and AMS will share responsibility for enforcing these
                      regulations.


AMS Offers Programs                          to assist in the marketing of eggs by ensuring they
                      AMS' traditional role is
                      meet USDA'S quality standards, but the agency has recently offered two
for Egg Quality and   programs that also address egg safety. AMS' long-standing programs are its
Safety                voluntary grading program, which is provided as a service to shell egg
                      processing plants and supported by user fees, and its mandatory Shell Egg
                      Surveillance Program, which provides for periodic monitoring to ensure
                      that eggs are being packed to meet AMS' requirements. In addition, AMS
                      began offering a voluntary HAccP-like sanitation program in August 1998
                      and third-party monitoring services for participants in the United Egg
                      Producers' 5-Star egg safety program in February 1999.

                      The shell egg grading program assists producers in providing quality eggs
                      to consumers. The Agricultural Marketing Act of 1946 authorizes USDA to
                      conduct a voluntary grading program for various commodities. Under this
                      authority, AMS currently grades about one-third of the nation's eggs as AA,
                      A, or B based on internal and external quality factors. For example, the
                      highest quality egg, Grade AA, must have a clean and unbroken shell, an
                      air cell inside the egg of one-eighth inch or less in depth, a clear and firm
                      white, and a slightly defined yolk. Shell egg packers who pay for the
                      grading service can label eggs packed in cartons for retail sale or in bulk



                      Page 34                                              GAOIRCED-99-184 Egg Safety
Appendix III
Federal and State Egg Safety and Quality
Responsibilities




for restaurants and institutions with the official USDA grade shield. USDA
graders are present while eggs are processed and identified with the
official grade shield to confirm that all program requirements are met.
USDA staff grade eggs in some plants, while state employees, working
under cooperative agreements between AMS and their states, grade eggs in
others.

AMS also conducts a Shell Egg Surveillance Program under authority of the
Egg Products Inspection Act to ensure that eggs are wholesome,
unadulterated, and properly labeled. Under this regulatory program, shell
eggs sold to consumers can contain no more restricted eggs than
permitted in U.S. Consumer Grade B and restricted eggs must be disposed
of properly. 2 ' To verify that shell eggs packed for consumer use meet
program requirements, a federal or state shell egg inspector visits each
registered egg packing plant at least four times a year. This inspection
includes product sampling and a review of records, among other things.

AMS developed its new Plant Sanitation and Good Manufacturing Practices
Program as a comprehensive voluntary sanitation service for egg
processors that participate in the shell egg grading program. This
fee-for-service program complements the official quality grade
certification by allowing participating processors to place a USDA shield on
egg cartons verifying that the plant has complied with USDA'S sanitation
and good manufacturing practices. Each participant is required to develop
and implement a "quality manual" of standard operating procedures that
addresses how the plant monitors generally recognized control points in
egg processing and handling. Program requirements include elements that
are quality focused as well as elements that are HAccP-like and focus on
control points, such as suppressing rodents and pests and checking wash
water and cooling room temperatures, among other things. As an
additional step to promote egg safety, participants can request the optional
service of environmental sampling of flocks, equipment, or premises to
identify the presence of SE. AMS has only recently developed the plant
sanitation program, and so far, very few producers are using it.

AMS has recently developed another program that assists the industry in its
efforts to ensure egg safety. Based on a request from the United Egg
Producers, an industry group, AMS is offering a voluntary fee-for-service
program to conduct third-party monitoring for the producers' 5-Star

2t
   Restricted eggs are defined as eggs with cracks or checks in their shells and as dirty, inedible, and
leaking eggs, among others. Cracked and dirty eggs may be shipped to an official egg products plant
for pasteurization; otherwise, restricted eggs must be either destroyed or diverted for use other than
human consumption.



Page 35                                                                  GAO/RCED-99-184 Egg Safety
                       Appendix III
                       Federal and State Egg Safety and Quality
                       Responsibilities




                       program. The United Egg Producers' program is a voluntary HAccP-like
                       program that includes continuous monitoring of critical control points at
                       egg farms and in egg processing plants. The AMS third-party monitoring
                       program. is offered to all egg farms and processing plants that participate
                       in the 5-Star program, including those that do not participate in AMS'
                       voluntary grading service. The monitoring program includes quarterly
                       audits to determine a producer's or packer's compliance with the 5-Star
                       program. and to identify specific areas for improvement. The audits include
                       verification of each of the program's 5-Star points, including (1) cleaning
                       and disinfecting, (2) rodent and pest elimination, (3) egg washing,
                       (4) bio-security, and (5) refrigeration. In addition, auditors review the
                       producer's or packer's environmental sampling program, which is used to
                       validate the effectiveness of the overall program.


States Share           As eggs move from the farm to the table, the states share safety and quality
                       inspection responsibilities with the federal government. State inspectors
Responsibilities for   working under agreements with USDA share responsibility for
Egg Safety and         (1) inspecting the breeding farm environment and testing breeding flocks
                       under APHIS' National Poultry Improvement Plan, (2) conducting
Quality                mandatory inspections at egg products plants for FSIS, and (3) conducting
                       egg quality inspections for AMS under its voluntary grading and mandatory
                       Shell Egg Surveillance programs.

                       Besides sharing these egg safety and quality responsibilities with USDA,
                       some states have their own programs for ensuring shell egg quality and
                       safety. Thirteen states told us they are addressing safety concerns on egg
                       farms using voluntary HAccP-based programs, known as quality assurance
                       programs. These programs generally include measurable control points to
                       prevent the introduction of SE into egg-laying flocks. For instance, the
                       Pennsylvania Department of Agriculture formed a partnership with the
                       state's egg industry to develop the Pennsylvania Egg Quality Assurance
                       Program to provide reasonable assurance to consumers that the state's
                       eggs have a minimal risk of causing foodborne disease from SE. In
                       addition, some states conduct their own inspections of shell egg
                       processing plants. About half of the states told us they conduct inspections
                       of processing plant sanitation, but only one tests for the presence of SE.
                       Also, the states are primarily responsible for conducting food safety
                       inspections at retail locations, including restaurants, grocery stores,
                       hospitals, and other institutions. Finally, one of the states we visited,
                       Pennsylvania, had developed its own egg quality certification program.




                       Page 36                                             GAO/RCED-99-184 Egg Safety
Appendix III
Federal and State Egg Safety and Quality
Responsibilities




States generally model their programs after the federal model of shared
authority by dividing egg quality and safety responsibilities among the
responsible state departments, for example, the agriculture and health
departments. Our state survey found that in 43 of the 50 states,
responsibility for regulating egg quality and safety is shared by two or
more agencies. For example, in California, the State Department of Food
and Agriculture is responsible for periodically spot-checking egg
processing plants to ensure they are packing eggs that meet the state's
quality standards. California's Department of Health Services, meanwhile,
is primarily responsible for food safety inspections at the retail level as
well as for working as a partner on quality assurance programs and
conducting traceback investigations of foodborne illnesses.




Page 37                                             GAO/RCED-99-184 Egg Safety
Appendix IV

Comments From the Department of
Agriculture

Note: GAC) comments
supplementing those in the
report text appear at the
end of this; appendix.       end of this appendix.
                                               DEPARTMENT OF AGRICULTURE
                                                            OFFICE OF THE SECRETARY
                                                              WASHINGTON. D.C. 20250



                                                                                                      1JUN l 719

                             Mr. Lawrence J. Dyckman
                             Director, RCED Division
                             Food and Agriculture Issues
                             U.S. General Accounting Office
                             441 G Street, NW, Room 2T23
                             Washington, DC 20548

                             Dear Mr. Dyclanan:

                             Thank you for the opportunity to review and provide comments on the Draft Report
                             RCED-99-184, "Food Safety: United States Lacks a Consistent, Farm-to-Table Approach
                             to Egg Safety." We have a concern with the report as it is currently written with respect
                             to the degree of coordination between the United States Department of Agriculture
                             (USDA) and the Food and Drug Administration (FDA). Specifically, the report has not
                             adequately acknowledged that USDA and FDA have been working together for many
                             years on a coordinated approach to the problem of Salmonella Enteritidis (SE) in eggs.
                             This coordinated approach is reflected in many joint activities of FDA and USDA such
                             as: "FoodNet" a foodbome diseases active surveillance network begun in 1995 which
                             also includes CDC and shows that the cases of illness due to SE are going down over
                             recent years; Fight Bac! Education campaign begun in 1997 and which also includes EPA
                             and provides information on the safe handling of eggs; quality assurance partnership
                             agreements with several states in 1997 and 1998 which help to support the individual
                             state's Egg Quality Assurance Plan in an animal production food safety program;
                             Advance Notice of Proposed Rulemaking on SE in May 1998 to identify farm-to-table
                             actions that will decrease the food safety risk associated with shell eggs; and an SE risk
                             assessment on shell eggs and egg products in June 1998 to identify possible strategies for
                             enhancing the safety of shell eggs.

                             In general, the report appears unbalanced with all of the criticisms of USDA and HHS in
                             the body of the report and the actual listing of what is being done well by the Federal
See comment 2.               Government (positive things) more or less confined to the appendices. In addition, the
                             report did not include any references to Federal research efforts, which are underway to
                             better understand SE and improve control schemes. For example, the National Animal
See comment 3.               Health Monitoring System 1999 study was not mentioned and there was only limited
                             reference to the fact that there are many unknowns in on-farm SE ecology.




                                Page 38                                                             GAO/RCED-99-184 Egg Safety
                        Appendix IV
                        Comments From the Department of
                        Agriculture




                     GAO RECOMMENDATIONS:

                     Recommendation 1:

                     To reduce the threat of Salmonella Enteritidis contamination during egg production and
                     processing, we recommend that the Commissioner of the Food and Drug Administration
                     develop a model HACCP-based program for egg farms and processing plants, that could
                     be adopted by the states. This program should define the minimum national standards,
                     including microbial testing, for egg safety at these locations.

                     USDA response:

                     We concur.

                     Recommendation 2:
                     To enhance safety protections in plants that break eggs to create egg products, we
                     recommend that the Secretary of Agriculture develop regulations to implement HACCP
                     systems in these plants.

                     USDA response:
See comment 4.   |   We concur with the intent of the recommendation; however, the following is a suggested
                     revision: The Secretary of Agriculture should develop and implement a HACCP-based
                     inspection program in egg products processing plants.

                     Currently, the product inspection regulations specifically identify requirements to be
                     followed by establishments during processing, packaging, and transport to assure that
                     only wholesome egg products enter commerce for human consumption. These
                     requirements, which are monitored by the FSIS food inspectors during processing,
                     include facility and equipment sanitation, personnel hygiene practices, operating
                     conditions, refrigerated storage, minimum pasteurization requirements and sampling
                     pasteurization products for the presence of SE.

                     Recommendation 3:

                     To reduce the time needed to lower the internal temperature of eggs to 45 degrees, we
                     recommend that the Secretary of Agriculture and the Commissioner of the Food and
                     Drug Administration jointly study the costs and benefits of implementing rapid cooling
                     techniques in egg processing and packing operations and, depending upon the results,
                     take appropriate action.

                     USDA response:

                     We concur that USDA will work with FDA to jointly study the costs and benefits of
                     implementing rapid cooling techniques in egg processing and packing operations, and




                        Page 39                                                             GAO/RCED-99-184 Egg Safety
                               Appendix IV
                               Comments From the Department of
                               Agriculture




                           depending upon the results, take appropriate action. USDA and FDA are aware that the
                           lowering of the internal temperature of the egg via methods faster than those currently in
                           use are being studied by researchers in North Carolina and California.

                           TECHNICAL COMMENTS

Now on p. 2.               1. Page 2, second full paragraph:

                           The report states that the "first national requirement to refrigerate eggs at 45 degrees or
                           below from the time they are packed until they reach the consumer may not be as
                           effective as possible in reducing the risks for eggs contaminated with Salmonella
See comment 5.             Enteritidis". We agree that cooling will delay the onset of SE growth. However, the
                           report does not explain that this mandatory temperature requirement is based on statutory
                           language. We have made it clear that the Department has explained the technical
                           weaknesses of this requirement in correspondence, public forums, etc.

Passage deleted from the   2. Page 2, last paragraph:
report.
See comment 6.             The report states that "the Food Safety and Inspection Service has not yet determined
                           how compliance with the law will be monitored". The regulations are not effective until
                           August 27, 1999. USDA resolved most of the implementation issues listed in the GAO
                           report, and the implementation procedure (i.e., FSIS Directive) is expected to be issued
                           before the end of June, well in advance of the August 27 effective date.

Now on p. 3.               3. Page 3, first paragraph:

                           The report states that "each agency (FDA and USDA) is developing its own egg carton
                           labeling requirements that will become effective at different times". As noted in the
                           August 27, 1999, final rule, FSIS published labeling requirements based on statute. The
                           statute enacted by Congress required that section 5 of the Egg Products Inspection Act
                           (21 U.S.C. 103.4) be amended by adding the following:

                                  (e)(1) Subject to paragraphs (2) and (3), the Secretary shall make such inspection
                                  as the Secretary considers appropriate of a facility of an egg handler (including a
                                  transport vehicle) to determine if shell eggs destined for the ultimate consumer-

                                          (A) are being held under refrigeration at an ambient temperature of no
                                          greater than 45 degrees Fahrenheit after packing; and

                                          (B) contain labeling that indicates that refrigeration is required.

                                  (2) In the case of a shell egg packer packing eggs for the ultimate consumer, the
                                  Secretary shall make an inspection in accordance with paragraph (1) at least once
                                  each calendar quarter.




                              Page 40                                                                GAO/RCED-99-184 Egg Safety
                    Appendix IV
                    Comments From the Department of
                    Agriculture




                        (3) The Secretary of Health and Human Services shall cause such inspections to
                        be made as the Secretary considers appropriate to ensure compliance with the
                        requirements of paragraph (1) at food manufacturing establishments, institutions,
                        and restaurants, other than plants packing eggs.

                        (4) A representative of the Secretary (of Agriculture) and the Secretary of Health
                        and Human Services shall be afforded access to places of business referred to in
                        this subsection, including transport vehicles, for purposes of making an inspection
                        required under this subsection.

                 Pursuant to this statutory mandate, and at the risk of losing $5.0 million, FSIS
                 promulgated its final rule. FSIS' rule was coordinated with FDA and will in no way
                 interfere or preclude FDA from developing future regulations. By meeting the FDA
                 requirements, companies would also likely meet the FSIS requirements.
Now on p. 7.
                 4. Page 7, fourth sentence of the second paragraph:

See comment 6.   The focus of a HACCP-based program is to "reduce the risk associated with SE
                 contamination during egg production" rather than "control SE".

Now on p. 11.    5. Page 12, fourth sentence of the first full paragraph:

See comment 6.   For clarification purposes, we suggest the fourth sentence of this paragraph be revised to
                 read: Approximately 30 percent of the nation's eggs, marked for table use are graded by
                 AMS, USDA, in accordance with U.S. Grade Standards, and therefore, subject to
                 restrictions for repackaging. The remaining 70 percent are not subject to the same
                 restrictions.

Now on p. 12.    6. Page 12, citation:

                 There is continuing focus on the elderly as the primary group at greatest risk. The
See comment 8.   citation on pagel2 suggests that the definition of highly susceptible groups come from
                 the Food Code. The first group cited is individuals with impaired immune systems.
                 There should be an expanded definition of"individuals with impaired immune systems"
                 in order to provide more transparency to the reader. Individuals with impaired immune
                 systems include: the elderly, persons undergoing chemotherapy, people with chronic
                 debilitating diseases (including but not limited to acquired immunodeficiency disease),
                 and transplant recipients. Throughout this document, the elderly are cited inappropriately
                 as the only at risk group.

Now on p. 17.    7. Page 18, first paragraph under conclusions:

See comment 9.   There is no mention of the effort by the United States Animal Health Association SE
                 committee to develop the standardized template for all SE risk reduction/quality
                 assurance programs.




                    Page 41                                                              GAO/RCED-99-184 Egg Safety
                     Appendix :[V
                     Comments From the Department of
                     Agriculture




Now on p. 24.     8. Page 24, appendix I, first paragraph:

See comment 10.   The statistics for number of illnesses and deaths should really be referenced. In recent
                  years there have been several citations of these numbers and, as early as a year ago, CDC
                  officials were publicly admitting that those figures were in need of recalculation. Also,
                  the last sentence is rather alarmist in tone and leaves some of the most important
                  information to the reader to lift out of a footnote. It would be more complete and more
                  accurate to reword that last sentence to have all of the pertinent information in it. For
                  example: "In the 44 percent of outbreaks where it was possible to identify a responsible
                  food, 81.7 percent were linked to eggs." This translates to 35.9 percent of outbreaks were
                  linked to egg consumption.
Now on p. 34.     9. Page 36, last paragraph

See comment 6.    " Regulations implementing the amendments become effective on August 27, 1999. As
                  of April 1999, USDA had not announced whether FSIS or AMS will enforce these
                  regulations." As noted in a previous meeting with you, FSIS and AMS share
                  responsibility for enforcing these regulations. We are working with AMS to develop the
                  enforcement protocols.

                  If you have any questions, please contact Mr. Ronald Hicks, Deputy Administrator for
                  Management, at (202) 720-4425.

                  Sincerely,




                  CATHERINE: E. WOTEKI, Ph.D., R.D.
                  Under Secretary
                  Food Safety

                  cc:
                  T. Billy, OA                    J. Riggins, OPPDE                N. Blevins, AMS
                  R. Hicks, OM                    D. Engeljohn, OPPDE              J. Jones, AMS
                  D. Musacchio, OM                R. Edelstein, OPPDE              C. Krenkel, APHIS
                  K. Wachsmuth, OPHS              V. Levine, OPPDE                 G. Frye, APHIS
                  E. Walker, OPHS                 T. Walsh, OGC                    C. Gipson, APHIS
                  A. Baker, OPHS                  D. Bolinger, OGC                 C. Reed, APHIS
                  M. Mina, OFO                    S. Dewhurst, OBPA                E. Figueroa, AMS
                  J. McCutcheon, OFO              A. Ahl, ORACBA                   R. Lake, FDA
                  P. Thompson., TSC               M. McElvaine,                    A. Depman, FDA
                  R. Glasshoff, TSC               ORACBA
                  P. Derfier, OPPDE               D. Lewis, AMS




                     Page 42                                                             GAO/RCED-99-184 Egg Safety
               Appendix IV
               Comments From the Department of
               Agriculture




               The following are GAO'S comments on the Department of Agriculture's
               letter dated June 17, 1999.


GAO Comments   1.We agree that USDA and FDA have worked together on a variety of issues
               related to the problem of Salmonella Enteritidis in eggs and have revised
               the report to reflect this. However, we continue to believe that progress in
               developing and implementing a comprehensive strategy to improve egg
               safety has been slow. The problem of Salmonella Enteritidis in eggs was
               first identified in 1988. Eleven years later, USDA and FDA have yet to
               establish a comprehensive strategy to improve egg safety.

               2. We do not agree with USDA'S view that the report is unbalanced. The
               body of the report presents the findings from our review, which identified
               a number of gaps, inconsistencies, and inefficiencies in the nation's egg
               safety efforts. Appendix III describes agency responsibilities and programs
               and was not intended to be a "listing of what is being done well" as stated
               by USDA.

               3. While we are aware that federal research on Salmonella Enteritidis is
               under way, reporting on that research was not one of the objectives of our
               review.

               4. For purposes of clarification, we made minor revisions to the wording
               of this recommendation.

               5. The draft report explained that a refrigeration requirement for eggs is
               required by statute; therefore, it was not necessary to make this change.

               6. We revised the report to address   USDA'S   remaining technical comments
               where appropriate.

               7. The draft report did not say that FSIS' egg carton labeling requirements
               will interfere with or preclude FDA from developing future regulations.
               Therefore, we made no change in response to this comment.

               8. The definition of highly susceptible populations used in the report
               comes from FDA'S Food Code. Based on FDA'S comments we have revised
               the report to make the definition fully consistent with the code. The report
               does not cite the elderly as the only risk group. Rather it uses the elderly in
               nursing homes as an example of a highly susceptible population that has
               been linked to outbreaks of SalmonellaEnteritidis.



               Page 43                                                GAO/RCED-99-184 Egg Safety
Appendix IV
Comments, From the Department of
Agriculture




9. We are aware of the United States Animal Health Association's efforts to
develop a standardized Salmonella Enteritidis risk reduction program.
However, this does not change our conclusion that a uniform HAccP-based
approach to egg safety has not been applied comprehensively to the
production and processing of eggs.

10. We have revised the report to indicate that these data come from the
Centers for Disease Control and Prevention. We have presented the data
completely and accurately, and officials from the Centers concur with our
presentation. We do not agree that the tone of the presentation is alarmist.




Page 44                                             GAO/RCED-99-184 Egg Safety
Appendix V

Comments From the Food and Drug
Administration

Note: GAO comments
supplementing those in the
report text appear at the
end of this appendix.
                             DEPARTMENT OF HEALTH & HUMAN SERVICES


                                                                                Food and Drug Administration
                                                                                Rodkvile MD 20857




                             Mr. Lawrence J. Dyckman
                             Director, RCED Division
                             Food and Agriculture Issues
                             U.S. General Accounting Office
                             441 G Street, N.W., Room 2T23
                             Washington, D.C. 20548

                             Dear Mr. Dyckman:

                             Enclosed are the Food and Drug Administration's proposed
                             comments on the GAO draft report entitled, "FOOD SAFETY:
                             U.S. Lacks a Consistent, Farm-to-Table Approach to Egg
                             Safety," GAO/RCED-99-184.

                             If we can be of further assistance, please call Lois Adams
                             at (301) 827-0125.

                                                        Sincerely,



                                                        Melinda K. Plaisier
                                                        Interim Associate Commissioner
                                                          for Legislative Affairs

                             Enclosure




                             Page 45                                             GAO/RCED-99-184 Egg Safety
                     Appendix V
                     Comments From the Food and Drug
                     Administration




                 Comments of the Food and Drug Administration on the General Accounting Office Draft
                 Report Entitled, FOOD SAFETY: U.S. Lacks a Consistent Farm-to-Table approach to
                 Egg Safety (GAO/RCED 99-184)

                 GENERAL COMMENTS:

                 The Food and Drug Administration (FDA) appreciates the opportunity to review and
See comment 1.   comment on the draft report. We have a concern with the report as it is currently written
                 with respect to the degree of coordination between FDA and the United States
                 Department of Agriculture (USDA). Specifically, the draft report fails to acknowledge
                 that FDA and USDA have been working together for many years on a coordinated
                 approach to the problem of Salmonella Enteritidis (SE) in eggs. This coordinated
                 approach is reflected in many joint FDA and USDA activities such as: "Food Net," a
                 foodborne diseases active surveillance network begun in 1995 which also includes the
                 Ceniers for Disease Control and Prevention (CDC) and shows that cases of SE have
                 decreased over recent years; the Fight Bac! education campaign begun in 1997 which
                 also includes the Environmental Protection Administration (EPA) and provides
                 information on the safe handling of eggs; quality assurance partnership agreements with
                 several states in 1997 and 1998 which help to support individual state's Egg Quality
                 Assurance Plan in an animal production food safety program; Advance Notice of
                 Proposed Rulemaking on SE in May 1998 to identify farm-to-table actions that will
                 decrease the food safety risks associated with shell eggs; and an SE risk assessment on
                  shell eggs and egg products in June 1998 to identify possible strategies for enhancing the
                  safety of shell eggs.

See comment 2.   In addition, the report did not include any references to Federal research efforts, which
                 are underway tc better understand SE and improve control schemes. For example, the
                 National Animal Health Monitoring System 1999 study was not mentioned and there was
                 only limited reference to the fact that there are many unknowns in on-farm SE ecology.

                 GAO RECOMMENDATION:

                 To reduce the threat of Salmonella enteritidis contamination during egg production and
                 processing, we recommend that the Commissioner of the Food and Drug Administration
                 develop a model HACCP-based program for egg farms and processing plants, that could
                 be adopted by the states. This program should define the minimum national standards,
                 including microbial testing, for egg safety at these locations.

                 FDA COMMENT

                 We concur. In principle, development of a model HACCP-based program for egg farms
See comment 3.   and processing plants that could be adopted by the states is a good approach. The first
                 step will be to develop prevention controls for egg production. Then as the science
                 progresses, FDA will develop criteria for a HACCP-type program.




                      Page 46                                                              GAO/RCED-99-184 Egg Safety
     Appendix V
     Comments From the Food and Drug
     Administration




GAO RECOMMENDATION:

To reduce the time needed to lower the internal temperature of eggs to 45 degrees, we
recommend that the Secretary of Agriculture and the Commissioner of the Food and
Drug administration jointly study the costs and benefits of implementing rapid cooling
techniques in egg processing and packing operations and, depending upon the results,
take appropriate action.

FDA COMMENT:

We concur. FDA will work jointly with USDA to study the costs and benefits of
implementing rapid cooling techniques in egg processing and packing operations, and
depending upon the results, take appropriate action. FDA is aware that researchers in
North Carolina and California are studying methods for lowering the internal
temperature of eggs that may be faster than those currently in use. The speed of cooling
needs to be assessed in conjunction with its overall impact on egg safety.




     Page 47                                                             GAO/RCED-99-184 Egg Safety
                    Appendix V
                    Comments From the Food and Drug
                    Administration




                 TECHNICAL COMMENTS

Now on p. 2.     Page 2, first fill paragraph, line 1-2: FDA has initiated a number of preventative actions
See comment 4.   to reduce the risk of egg-associated Salmonella Enteritidis (SE) infections. Most FDA
                 activities have been directed at controls on the farm and at the retail level. For example,
                 FDA personnel have participated in public meetings to discuss and design proactive
                 preventative programs. FDA has participated in the US Animal Health Association
                 (USAHA) SE task force working on a program to replace the prior USAHA program,
                 which had no testing component. FDA has presented speeches on SE updates and Egg
                 Programs at all 1999 regional meetings of the USAHA, which have strong attendance
                 from state veterinarians. FDA has also spoken with groups from the United Egg
                 Producers (UEP) which resulted in inclusion of testing for the UEP program. FDA has
                 worked with states that have expressed an interest in implementing a farm egg program.

                 Page 2, first full paragraph, lines 1-2: This sentence also suggests that the science FDA
Now on p. 2.     needs to establish a definitive control program is available. In fact, the difficulty with
See comment 3.   establishing specific preventive controls is the technical complexity of the issues and the
                 difficulty in scientifically researching the effectiveness of controls in shell eggs. When a
                 specific feasible universally applicable control (such as pasteurization for milk) is
                 identified, the FDA will rapidly move to establish a performance standard linked to it.
                 However, the optimal control strategy is not clear for shell eggs, thus FDA and USDA
                 have worked to develop and promote the strongest on-farm "egg quality assurance"
                 programs to develop safe production practices on the farm, in distribution, and at retail.

See comment 5.   Page 3, first fill paragraph, line 7: It is misleading to say that "each agency is developing
                 its own egg carton labeling requirements..." While FDA labeling requirements that we
                 intend to propose are designed for a different purpose than USDA's, i.e., to promote for
                 consumers and retail end uses safe handling of eggs, they are completely consistent with
                 USDA's labeling regulations that go into effect in August 1999.

Now on p. 3.     Page 3, last paragraph, lines 4 and 7: There is a disconnect between the two sentences.
See comment 6.   The sentence starting on line 4 states that SE cases increased through 1997 but following
                 sentence states the SE cases declined in 1996-1998.

Now on p. 7.     Page 7, last paragraph, lines 1-3: Creating a HACCP program requires a seven element
See comment 3.   program including a hazard analysis and development of critical controls to prevent,
                 eliminate or reduce the hazards to acceptable levels. As sound science is not available,
                 credible HACCP or HACCP-based programs are difficult to conceive at this time.

                 Page 10, last paragraph, line 5: FDA also announced its intention to publish a proposed
Now on p. 10.    rule on refrigeration and labeling in a Joint FDA/FSIS Advance Notice of Proposed
See comment 7.   Rulemaking of May 19, 1998.

                 Page 11, second full paragraph, lines 5-7: Shell eggs have an internal defense against
Now on p. 11.    outgrowth of bacteria, which is dependent on temperature and time. Once this defense
See comment 8.   breaks down, significant multiplication can occur.




                    Page 48                                                               GAO/RCED-99-184 Egg Safety
                                Appendix V
                                Comments From the Food and Drug
                                Administration




Passage deleted.             Page 12, second full paragraph, line 7: does the 82% relate to all outbreaks or only those
                             involving highly susceptible populations?

For FDA's remaining          Page 12, last paragraph, line 3: after "Food Code" delete "recommended that food
comments, we modified        service operators serving highly susceptible" and replace with, "created a specific,
the report as appropriate.   additional section for highly susceptible populations to clearly establish the
Now on p. 12.                recommendation that facilities serving such"

                             Page 12, footnote: after "include" add "the following persons who are in an institutional
                             or custodial facility:"
Now on p. 12.                Page 13, carry over paragraph, line l: afer "cooking" delete "or" and replace with "and"

                             Page 13, carry over paragraph, line 1: after "held" delete "for service" and replace with
Now on p. 12.
                             "before or"
Now on p. 12.
                             Page 13, carry over paragraph, line 4: after "combined" delete "or" and replace with
                             "and"

Now on p. 12.                Page 13, carry over paragraph, line 4: after " plan" delete "which includes appropriate
                             time and temperature controls" and replace with "that ensure SE growth is controlled
                             before and after cooking and the organism is destroyed during cooking."

Passage deleted.             Page 16, second full paragraph, lines 5-8: FDA has not given high priority to inspection
                             of egg packing facilities because these are frequently under AMS grading or comparable
                             state grading inspection which assures basic sanitation and GMP controls as a condition
                             of grading. FDA generally has not found significant problems with these facilities.

Now on p. 17.                Page 17, second full paragraph, line 4: after "refrigeration" delete "is required" and
                             replace with "is necessary to assure safety."

Passage deleted.             Page 18, second full paragraph, line 5-6: could expand the reference to meat and poultry
                             HACCP plans to include seafood, an FDA program. (See comparable reference to
                             HACCP regulation for meat, poultry, and seafood on page 20, second paragraph, line 4.)
                             Also, when referring to HACCP-type approach for meat and poultry, it must be
                             remembered that this has only been implemented at the processing level - essentially
                             equivalent to egg breaking establishments. HACCP for meat and poultry is not now in
                             effect at farms producing USDA-regulated foods.

                             Page 25, carry over paragraph, line i: Traditional cooking practices had not previously
                             had to contend with an SE organism on the inside of a whole intact shell egg, and
                             culturally acceptable meal items contain raw or under-cooked eggs. It is correct to state
                             that by implementing more rigorous cooking regimes, we may protect ourselves against
                             this new threat; however the implication that the problem of increased illness due to SE
                             in eggs is caused by changed cooking practices is not correct.




                                Page 49                                                               GAO/RCED-99-184 Egg Safety
                   Appendix 'V
                   Comments; From the Food and Drug
                   Administration




Now on p. 32.   Page 34, last paragraph, line 8: after sentence ending with "provisions." Add following
                sentence "Although states generally recognize shell eggs as potentially hazardous foods
                based on interpretive guidance from FDA in 1990, comprehensive and uniform
                requirements :for shell eggs at retail are not in place nationwide."

Now on p. 32.   Page 34, last paragraph, line 9: after "the" delete "code," and replace with "1993 Food
                Code or a more recent edition"

                Page 34, last paragraph, line 13: after "to" delete "highly susceptible populations such as
Now on IP.32.   infants, the elderly and individuals with impaired immune systems." And replace with
                "persons who are in institutional or custodial facilities and are highly susceptible to
                foodborne illness such as the very young, the elderly, and individuals with impaired
                immune systems." This correction is very important from two respects. First, "very
                young," is nol: a term that can be pinned strictly to "infants" and those who are very
                young, elderly, or immunocompromised are only considered "highly susceptible" under
                the Code if they are in a facility to which their care is entrusted.




                   Page 50                                                              GAO/RCED-99-184 Egg Safety
               Appendix V
               Comments From the Food and Drug
               Administration




               The following are GAO'S comments on the Food and Drug Administration's
               letter dated June 10, 1999.


GAO Comments   1.We agree that USDA and FDA have worked together on a variety of issues
               related to the problem of Salmonella Enteritidis in eggs and have revised
               the report to reflect this. However, we continue to believe that progress in
               developing and implementing a comprehensive strategy to improve egg
               safety has been slow. The problem of Salmonella Enteritidis in eggs was
               first identified in 1988. Eleven years later, USDA and FDA have yet to
               establish a comprehensive strategy to improve egg safety.

               2. While we are aware that federal research on Salmonella Enteritidis is
               under way, reporting on that research was not one of the objectives of our
               review.

               3. In commenting on the recommendation to develop a model HAccP-based
               program for egg farms and processing plants and in its technical
               comments, FDA said that the science might not support developing
               prevention controls for egg production. We agree with FDA that the
               scientific issues involved in designing and establishing the effectiveness of
               Salmonella Enteritidis control measures are complex and that a single
               universally applicable control has not been identified. However, research
               and experience in the states have identified a set of controls that generally
               are agreed to help prevent Salmonella Enteritidis contamination on farms.
               We do not believe that FDA should wait to develop criteria for a model
               on-farm Salmonella Enteritidis reduction program until there are scientific
               advances. Rather, FDA can take immediate action to develop a model
               program that contains controls that are based on the best scientific
               information currently available and the experience of existing state
               programs. In addition, we have not recommended that the model program
               should include all the elements of a comprehensive HACCP program.
               Rather, the model should be HAccP-based in the sense that it follows the
               general HACCP principles of identifying the places where the greatest food
               safety risks exist, implementing methods to control the risks at those
               points, and monitoring the efficacy of the controls.

               4. FDA states that the agency has participated in various meetings and task
               forces regarding on-farm Salmonella Enteritidis reduction programs.
               However, our concern remains that FDA has not established a model
               national prevention-based Salmonella Enteritidis reduction program for
               farms and existing state programs vary significantly.



               Page 51                                             GAO/RCED-99-184 Egg Safety
Appendix V
Comments; From the Food and Drug
Administration




5. FDA'S proposed egg labeling regulations have not yet been made publicly
available. Therefore, we are not in a position to comment on whether they
are consistent with USDA'S new labeling regulations. Because each agency
is developing labeling regulations for different purposes and the
regulations will become effective at different times, our report is accurate
in saying that each agency is developing its own labeling requirements.

6. We do not agree with FDA that there is a conflict between the statements
in the report referring to trends in reported Salmonella Enteritidis
infections. The best national data available from the Centers for Disease
Control and Prevention indicate that reports of Salmonella Enteritidis
infections increased through 1997. We also cite new data from selected
cities and counties that indicate a possible change in trends for 1996
through 1998. While these data are encouraging, they are not evidence of a
nationwide reduction in Salmonella Enteritidis. Thus, we did not revise
these statements.

7. We modified the report to address   FDA'S   technical comment as
appropriate.

8. We agree with FDA that eggs have an internal defense against the growth
of bacteria. According to the results of one research study, an egg's
internal defense against the growth of Salmonella Enteritidis would be
intact beyond the 3 to 6 days it takes for an egg's internal temperature to
be reduced to the air temperature. However, this research is based on the
assumption that the Salmonella Enteritidis is deposited in the egg white
and not the yolk. If Salmonella Enteritidis is deposited in the yolk, the
bacteria could grow more quickly. In addition, even if Salmonella
Enteritidis is deposited in the egg white, the research found significant
growth during the first 24 hours after the egg was laid. Given the
uncertainties about the extent of bacterial growth during the first few days
after an egg has been laid, we did not revise the report in response to this
comment. We also recommended that USDA and FDA jointly study the costs
and benefits of implementing rapid cooling techniques.




Page 52                                               GAO/RCED-99-184 Egg Safety
Appendix VI

GAO Contacts and Staff Acknowledgments


GAO Contacts      Lawrence J. Dyckman, (202) 512-5138
                  Robert C. Summers, (404) 679-1839



Acknowledgments   In addition to those named above, Stephen D. Secrist, Kathy R. Alexander,
                  Elyssa M. Back, Mary K. Colgrove-Stone, Fran A. Featherston, and John
                  Nicholson made key contributions to this report.




(150083)          Page 53                                           GAO/RCED-99-184 Egg Safety