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
******************************************************************
** This file contains an ASCII representation of the text of a **
** GAO report. This text was extracted from a PDF file. **
** Delineations within the text indicating chapter titles, **
** headings, and bullets have not been preserved, and in some **
** cases heading text has been incorrectly merged into **
** body text in the adjacent column. Graphic images have **
** not been reproduced, but figure captions are included. **
** Tables are included, but column deliniations have not been **
** preserved. **
** **
** Please see the PDF (Portable Document Format) file, when **
** available, for a complete electronic file of the printed **
** document's contents. **
** **
** A printed copy of this report may be obtained from the GAO **
** Document Distribution Center. For further details, please **
** send an e-mail message to: **
** **
** **
** **
** with the message 'info' in the body. **
******************************************************************
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
GAO/RCED-99-184 Egg Safety Ordering Information The first copy of
each GAO report and testimony is free. Additional copies are $2
each. Orders should be sent to the following address, accompanied
by a check or money order made out to the Superintendent of
Documents, when necessary. VISA and MasterCard credit cards are
accepted, also. Orders for 100 or more copies to be mailed to a
single address are discounted 25 percent. Orders by mail: U.S.
General Accounting Office P.O. Box 37050 Washington, DC 20013 or
visit: Room 1100 700 4th St. NW (corner of 4th and G Sts. NW) U.S.
General Accounting Office Washington, DC Orders may also be placed
by calling (202) 512-6000 or by using fax number (202) 512-6061,
or TDD (202) 512-2537. Each day, GAO issues a list of newly
available reports and testimony. To receive facsimile copies of
the daily list or any list from the past 30 days, please call
(202) 512-6000 using a touchtone phone. A recorded menu will
provide information on how to obtain these lists. For information
on how to access GAO reports on the INTERNET, send an e-mail
message with "info" in the body to: [email protected] or visit
GAO's World Wide Web Home Page at: http://www.gao.gov PRINTED ON
RECYCLED PAPER United States General Accounting Office
Bulk Rate Washington, D.C. 20548-0001 Postage & Fees Paid GAO
Permit No. G100 Official Business Penalty for Private Use $300
Address Correction Requested
*** End of document. ***