Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety
(Letter Report, 07/01/1999, GAO/RCED-99-184).

On average, each American eats about 245 eggs annually. During the last
decade, eggs contaminated with Salmonella Enteritidis bacteria have
increasingly been implicated as a cause of foodborne illness in the
United States. The bacteria may have sickened about 300,000 people in
1997, killing about 230 of them. More than three-quarters of the
Salmonella Enteritidis outbreaks between 1985 and 1998 were linked to
eggs, according to the Centers for Disease Control and Prevention. This
report reviews the adequacy of the system for ensuring the safety of
eggs. Specifically, GAO 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. GAO summarized this report in
testimony before Congress; see: Food Safety: U.S. Needs a Consistent
Farm-to-Table Approach to Egg Safety, by Lawrence J. Dyckman, Director,
Food and Agriculture Issues, before the Subcommittee on Oversight of
Government Management, Restructuring and the District of Columbia,
Senate Committee on Governmental Affairs. GAO/T-RCED-99-232, July 1 (13
pages).

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

 REPORTNUM:  RCED-99-184
     TITLE:  Food Safety: U.S. Lacks a Consistent Farm-to-Table
	     Approach to Egg Safety
      DATE:  07/01/1999
   SUBJECT:  Food inspection
	     Safety regulation
	     Interagency relations
	     Contaminated foods
	     Health hazards
	     Consumer protection
	     Quality control
	     Safety standards
	     Product safety
	     Poultry industry
IDENTIFIER:  Salmonella Enteritidis Bacteria
	     APHIS National Poultry Improvement Plan

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    United States General Accounting Office GAO                Report
    to the Honorable Richard J. Durbin, U.S. Senate July 1999
    FOOD SAFETY U.S. Lacks a Consistent Farm-to-Table Approach to Egg
    Safety GAO/RCED-99-184 GAO    United States General Accounting
    Office 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 Page 1
    GAO/RCED-99-184 Egg Safety B-282632 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. Page 2
    GAO/RCED-99-184 Egg Safety B-282632 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) Page 3
    GAO/RCED-99-184 Egg Safety B-282632 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
    Page 4                                               GAO/RCED-99-
    184 Egg Safety B-282632 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.) Page 5
    GAO/RCED-99-184 Egg Safety B-282632 Figure 1: Egg Production,
    Processing, and Distribution and Responsible Federal Regulatory
    Agencies Production                                  Chick
    Egg laying breeding                            on farm (APHIS)
    (FDA) Processing                                             Shell
    egg                              Egg products processing
    processing (FDA, USDA)                                    (FSIS)
    Transportation                                            Shell
    egg                              Egg products transportation
    transportation (USDA, FDA)
    (FDA) Storage
    Wholesale         Retail (USDA, FDA)         (FDA) Preparation and
    Restaurants/ consumption
    Home                   institutions (FDA)
    Joe's Diner (Figure notes on next page) Page 6
    GAO/RCED-99-184 Egg Safety B-282632 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 Federal
    Outbreaks of egg-related illness are sometimes traced to egg
    production Government and the    farms where laying flocks have
    become contaminated with SE. Although prevention-based approaches
    such as HACCP are generally recognized as States Have Not
    the most effective method for identifying and reducing bacterial
    Instituted a          contamination, no federal program exists to
    reduce or eliminate this contamination during egg production and
    processing. Consistent Prevention-Based      In our 1992 report on
    SE in eggs, we recommended that the Secretary of Approach to Egg
    Agriculture and the Commissioner of FDA work together to develop a
    comprehensive program to control SE throughout the production,
    Safety                distribution, and consumption of eggs.1 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 1Food Safety and Quality:
    Salmonella Control Efforts Show Need for More Coordination
    (GAO/RCED-92-69, Apr. 21, 1992). Page 7
    GAO/RCED-99-184 Egg Safety B-282632 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
    environmental testing for SE, (6) refrigerating eggs after
    packing, and (7) keeping 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 states, 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, 2The 13 states are Alabama, California, Connecticut,
    Louisiana, Maine, Maryland, Massachusetts, Michigan, New York,
    Ohio, Pennsylvania, South Carolina, and Utah. 3Bio-security
    procedures are designed to prevent SE from being carried into
    poultry houses from outside sources. 4In commercial egg-laying
    operations, hens generally produce eggs until they are about 2
    years old. Page 8
    GAO/RCED-99-184 Egg Safety B-282632 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 Refrigeration
    implemented but may not be as effective as possible in reducing
    the risks 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 5There 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 B-282632 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 ultimate 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 B-282632 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 egg safety and
    Practices Hamper have been weakened by inconsistencies in three
    areas. First, provisions in 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 6Salmonella Enteritidis Risk Assessment: Shell
    Eggs and Egg Products, Final Report (June 12, 1998). Page 11
    GAO/RCED-99-184 Egg Safety B-282632 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. Furthermore, 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, 7An "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. 8Highly 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. 9When we
    conducted our survey of regulatory officials, the 1997 Food Code
    was the most current version. Page 12
    GAO/RCED-99-184 Egg Safety B-282632 according to a 1998 Dietary
    Managers Association10 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 eggsage 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 10The association
    represents approximately 15,000 dietary managers and food
    protection professionals nationwide. Page 13
    GAO/RCED-99-184 Egg Safety B-282632 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.11 These
    officials believe that such uniformity would help ensure safety
    and quality. 11The 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 Makes Effective                 government's ability to
    act efficiently and effectively to improve egg safety. The
    government does not assign egg safety resources to the Resource
    Allocation             different federal agencies with
    responsibilities for egg safety based on an and Policy
    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.13
    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.14 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, 1998.15 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 12Food Safety and Quality:
    Uniform, Risk-Based Inspection System Needed to Ensure Safe Food
    Supply (GAO/RCED-92-152, June 26, 1992). 13Food Safety: Risk-Based
    Inspections and Microbial Monitoring Needed for Meat and Poultry
    (GAO/RCED-94-110, May 19, 1994). 14GAO/RCED 92-69, Apr. 21, 1992.
    15FSIS 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 Congressional      activities,
    the Congress may wish to consider consolidating responsibility 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 and Our Response    comment. Both USDA and FDA provided a
    number of editorial and technical 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
    GAO/RCED-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
    Methodology    other information on egg safety from FDA, the
    Centers for Disease Control 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
    26 Egg-Associated Foods, 1990-98 Table II.1: Top 10 Egg-Producing
    States in 1998                              28 Figure
    Figure 1: Egg Production, Processing, and Distribution and
    6 Responsible Federal Regulatory Agencies Abbreviations AMS
    Agricultural Marketing Service APHIS         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 outbreaks16
    with an identified cause were associated with eggs.17 Increasing
    Reports of            Officials at the Centers for Disease Control
    and Prevention first cast doubt Salmonella Enteritidis on the
    internal safety of shell eggs in a 1988 study of outbreaks of 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 Salmonella 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's virulence and rapid to Salmonella
    rate of growth in the United States, several contributing factors
    have been 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. 16An "outbreak" is defined as two or more people having a
    similar illness that can be traced to eating a common food. In
    contrast, sporadic cases involve individuals who report foodborne
    illnesses outside a recognized outbreak. 17In 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.18 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 Outbreaks and                    wide variety of
    egg-related foods, such as Caesar salad dressing, hollandaise
    sauce, and bread pudding. In many cases, these dishes Illnesses
    contained either raw or undercooked eggs. (See table I.1.)
    18Forced 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 Enteritidis
    Contamination in Eggs Table I.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 barnaise 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 Barnaise 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 II.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 Program to Produce     process. At the first step in
    this process, USDA offers a program that 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. Egg Safety                     Federal
    authority to regulate the safety of eggs and egg products at egg
    Responsibilities Are           farms and egg processing plants is
    shared by FDA and FSIS. FDA has traditionally been responsible for
    shell eggs19 and FSIS for egg products. Divided Between FDA
    Changes soon to be implemented to the Egg Products Inspection Act
    will and FSIS                       give USDA increased
    enforcement authority over shell eggs while they are 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. FDA's 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.
    19Shell 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 III 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 States, 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 staff's 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 20Egg 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 III 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 Salmonella 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    AMS' traditional role is to
    assist in the marketing of eggs by ensuring they for Egg Quality
    and    meet USDA's quality standards, but the agency has recently
    offered two 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
    GAO/RCED-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.21 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 21Restricted 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 Responsibilities for    inspection
    responsibilities with the federal government. State inspectors
    working under agreements with USDA share responsibility for Egg
    Safety and          (1) inspecting the breeding farm environment
    and testing breeding flocks Quality                 under APHIS'
    National Poultry Improvement Plan, (2) conducting 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: GAO comments supplementing those
    in the report text appear at the end of this appendix. See comment
    1. See comment 2. See comment 3. Page 38      GAO/RCED-99-184 Egg
    Safety Appendix IV Comments From the Department of Agriculture See
    comment 4. Page 39                            GAO/RCED-99-184 Egg
    Safety Appendix IV Comments From the Department of Agriculture Now
    on p. 2. See comment 5. Passage deleted from the report. See
    comment 6. Now on p. 3. Page 40
    GAO/RCED-99-184 Egg Safety Appendix IV Comments From the
    Department of Agriculture See comment 7. Now on p. 7. See comment
    6. Now on p. 11. See comment 6. Now on p. 12. See comment 8. Now
    on p. 17. See comment 9. Page 41
    GAO/RCED-99-184 Egg Safety Appendix IV Comments From the
    Department of Agriculture Now on p. 24. See comment 10. Now on p.
    34. See comment 6. 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 Salmonella Enteritidis. 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. Page 45
    GAO/RCED-99-184 Egg Safety Appendix V Comments From the Food and
    Drug Administration See comment 1. See comment 2. See comment 3.
    Page 46                            GAO/RCED-99-184 Egg Safety
    Appendix V Comments From the Food and Drug Administration Page 47
    GAO/RCED-99-184 Egg Safety Appendix V Comments From the Food and
    Drug Administration Now on p. 2. See comment 4. Now on p. 2. See
    comment 3. Now on p. 3. See comment 5. Now on p. 3. See comment 6.
    Now on p. 7. See comment 3. Now on p. 10. See comment 7. Now on p.
    11. See comment 8. Page 48                            GAO/RCED-99-
    184 Egg Safety Appendix V Comments From the Food and Drug
    Administration Passage deleted. For FDA's remaining comments, we
    modified the report as appropriate. Now on p. 12. Now on p. 12.
    Now on p. 12. Now on p. 12. Now on p. 12. Now on p. 12. Passage
    deleted. Now on p. 17. Passage deleted. Now on p. 24. Page 49
    GAO/RCED-99-184 Egg Safety Appendix V Comments From the Food and
    Drug Administration Now on p. 32. Now on p. 32. Now on p. 32. 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
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