Federal Register Final Rule (July 9, 2009, 74 FR 33030): Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation

The complete text of this document (including images) is also available at GPO in PDF (489 KB).

[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Rules and Regulations]
[Page 33029-33101]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy09-9]

[[Page 33029]]

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Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 16 and 118

Prevention of Salmonella Enteritidis in Shell Eggs During Production,
Storage, and Transportation; Final Rule

[[Page 33030]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 118

[Docket No. FDA-2000-N-0190] (Formerly Docket No. 2000N-0504)
RIN 0910-AC14

Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
that requires shell egg producers to implement measures to prevent
Salmonella Enteritidis (SE) from contaminating eggs on the farm and
from further growth during storage and transportation, and requires
these producers to maintain records concerning their compliance with
the rule and to register with FDA. FDA is taking this action because SE

is among the leading bacterial causes of foodborne illness in the
United States, and shell eggs are a primary source of human SE
infections. The final rule will reduce SE-associated illnesses and
deaths by reducing the risk that shell eggs are contaminated with SE.

DATES: This final rule is effective September 8, 2009. The Director of
the Office of the Federal Register approves the incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of
certain publications in new 21 CFR 118.8 as of September 8, 2009.

Please see section II.C of this document for the compliance dates of
this final rule. Submit comments on information collection issues under
the Paperwork Reduction Act of 1995 by August 10, 2009 (see the
“Paperwork Reduction Act of 1995” section of this document).

FOR FURTHER INFORMATION CONTACT: John Sheehan, Center for Food Safety
and Applied Nutrition (HFS-315), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1488.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
A. FDA’s Proposed Rule
B. What Are Salmonella and SE Infection?
C. What Is the Connection Between Salmonella and Shell Eggs?
D. The U.S. Egg Industry
E. Current On-Farm Practices
F. Voluntary EQAPs

G. The Food Code
H. Rationale for the Final Rule
II. Highlights of the Final Rule and Summary of Significant
Differences Between the Proposed and Final Rules
A. Highlights of the Final Rule
B. Significant Differences Between the Proposed and Final Rules
C. Compliance Dates
III. Comments on the Proposed Rule
A. General Comments

B. Comments on “Persons Covered by the Requirements in This
Part” (Proposed and Final Sec. 118.1)
C. Comments on “Definitions” (Proposed and Final Sec. 118.3)
D. Comments on “Salmonella Enteritidis (SE) Prevention
Measures” (Proposed and Final Sec. 118.4)
E. Comments on “Environmental Testing for Salmonella
Enteritidis (SE)” (Proposed and Final Sec. 118.5)
F. Comments on “Egg Testing for Salmonella Enteritidis (SE)”
(Proposed and Final Sec. 118.6)

G. Comments on “Sampling Methodology for Salmonella Enteritidis
(SE)” (Proposed and Final Sec. 118.7)
H. Comments on “Testing Methodology for Salmonella Enteritidis
(SE)” (Proposed and Final Sec. 118.8)
I. Comments on “Administration of the Salmonella Enteritidis
(SE) Prevention Plan” (Proposed and Final Sec. 118.9)
J. Comments on “Recordkeeping Requirements for the Salmonella
Enteritidis (SE) Prevention Plan” (Proposed and Final Sec. 118.10)
K. Comments on “Registration Requirements for Shell Egg

Producers Covered by the Requirements of This Part” (Final Sec.
118.11)
L. Comments on “Enforcement and Compliance” (Proposed and
Final Sec. 118.12)
M. Comments on Request for Comments as to Whether FDA Should
Mandate Special Requirements for Certain Food Establishments That
Serve Highly Susceptible Populations
IV. Legal Authority
V. Analysis of Economic Impacts–Final Regulatory Impact Analysis

A. Introduction
B. Need for Regulation
C. Comments on the Preliminary Regulatory Impact Analysis in the
Proposed Rule and Responses
D. Economic Analysis of Potential Mitigations: Overview
E. Summary of Costs and Benefits of Regulatory Options and the
Rule
F. Benefits and Costs of Potential SE Prevention Measures: Detailed
Analysis

G. Summary of Benefits and Costs of the Final Rule
VI. Final Regulatory Flexibility Analysis
A. Introduction
B. Economic Effects on Small Entities
C. Regulatory Options
D. Description of Recordkeeping and Recording Requirements
E. Summary
VII. Unfunded Mandates
VIII. Small Business Regulatory Enforcement Fairness Act

IX. Paperwork Reduction Act of 1995
X. Analysis of Environmental Impact
XI. Federalism
XII. References

 I. Background

 A. FDA’s Proposed Rule

On September 22, 2004, FDA proposed a rule to prevent SE

contamination in shell eggs during production (the proposed rule) (69
FR 56824). The proposed rule set out several measures to be taken by
egg producers to prevent the contamination of shell eggs with SE during
egg production, such as implementation of biosecurity and pest control
programs, environmental and egg testing requirements, and requirements
concerning refrigerated storage of eggs at the farm and diversion from
the table egg market of eggs from flocks in which SE has been detected
(69 FR 56824).
In addition, in the proposed rule we solicited comments on whether

we should include additional requirements in the final rule,
particularly in two areas. First, we asked whether we should expand the
proposed recordkeeping requirements to include a written SE prevention
plan and records documenting compliance with the SE prevention measures
(69 FR 56824 at 56825 and 56841 through 56842). Second, we asked
whether the safe egg handling and preparation practices in FDA’s Food
Code (see http://www.cfsan.fda.gov/~dms/fc05-toc.html (accessed
December 14, 2006)) should be federally mandated for establishments
that specifically serve a highly susceptible population (such as

nursing homes, hospitals, and daycare centers) (69 FR 56824 at 56825
and 56849 through 56852).
The proposed rule had a 90-day comment period, which ended on
December 21, 2004. To discuss the proposed rule and solicit comments
from interested stakeholders, FDA held three public meetings in 2004.
Based on comments received in response to the proposed rule, FDA
reopened the comment period on May 10, 2005, for the limited purpose of
receiving comments and other information regarding industry practices
and programs that prevent SE-monitored chicks from becoming infected by

SE during the period of pullet rearing until placement into laying hen
houses (70 FR 24490). The term “pullet” refers to a chicken less than
20 weeks of age. On May 24, 2005, FDA received a request for an
extension of the reopened comment period from two of the major trade
associations representing egg producers and others affected by this

[[Page 33031]]

rule. We agreed to extend the reopened comment period until July 25,
2005.

 B. What Are Salmonella and SE Infection?

As we described in greater detail in the proposed rule (69 FR 56824
at 56825 through 56827), Salmonella microorganisms are ubiquitous and
are commonly found in the digestive tracts of animals, especially birds
and reptiles. Human illnesses are usually associated with ingesting
food or drink contaminated with Salmonella, although infection also may
be transmitted person-to-person through the fecal-oral route where
personal hygiene is poor or by the animal-to-man route (Ref. 1-2).

All people are at risk for salmonellosis, although the severity of
the infection is influenced by a person’s age and immune status.
Salmonella infections are characterized by diarrhea, fever, abdominal
cramps, headache, nausea, and vomiting. Symptoms usually begin within 6
to 72 hours after consuming a contaminated food or liquid and last for
4 to 7 days. Most healthy people recover without antibiotic treatment;
however, the diarrhea can be severe, and the person may be ill enough
to require hospitalization. In some patients, the infection can spread
into the bloodstream, then to other areas of the body, such as the bone

marrow or the meningeal linings of the brain. This infection can lead
to a severe and fatal illness (Ref. 2). These complications associated
with an infection are more likely to occur in children, the elderly,
and persons with a weakened immune system.
In addition, about 2 percent of those who recover from
salmonellosis may later develop recurring joint pain and reactive
arthritis (Ref. 3, 4).
Salmonellosis is a serious health concern. It is a notifiable
disease, i.e., physicians and health laboratories are required to

report cases (single occurrences of illness) to local health
departments in accordance with procedures established by each State.
These cases are then reported to State health departments, and the
Salmonella isolates are referred to State Public Health laboratories
for serotyping (a method of distinguishing related organisms by their
antigens). Each case and each serotyped isolate is reported to the U.S.
Centers for Disease Control and Prevention (CDC). These reports are
made only for diagnosed cases of Salmonella infection.
A case of illness is confirmed as salmonellosis only if an isolate

is confirmed by a laboratory as being Salmonella. Although all cases
may not be confirmed, all confirmed cases are associated with isolates
of Salmonella. Reported cases are likely to represent only a small
portion of the actual number of illnesses that occur because of the
following reasons: (1) Ill individuals do not always seek care by
medical professionals, especially if the symptoms are not severe; (2)
medical professionals may not establish the cause of the illness but
may simply treat the symptoms; and (3) medical professionals do not
always report Salmonella cases to public health officials. CDC

estimates that there are 38 cases of salmonellosis for every reported
culture-confirmed case (Ref. 5). The overall burden of salmonellosis in
2001 was estimated to be 1,203,650 cases, including 14,000
hospitalizations, and 494 deaths (Refs. 6 and 7). Updated Salmonella
surveillance data for 2004 indicate that the burden of salmonellosis in
2004 was somewhat higher, estimated to be 1,376,514 cases, including
14,264 hospitalizations, and 427 deaths (Refs. 5 and 8).
CDC surveillance data list close to 600 different Salmonella
serotypes that have caused illness in the United States. Since 1995,

Salmonella enterica serotype Enteritidis (SE) has been the second most
frequently reported cause of Salmonella infection (Ref. 9). CDC
reported that in 2008 SE was the leading reported cause of Salmonella
infections, accounting for 20.1% of all of the Salmonella isolates that
were serotyped (Ref. 10). The rate of SE isolates reported to CDC
increased from 0.6 per 100,000 population in 1976 to 3.6 per 100,000
population in 1996 (Ref. 11-12). In 2001 the isolation rate for SE was
2.0 per 100,000 population, and the annual contribution of SE
(corrected for underreporting) to salmonellosis was estimated to be

193,463 illnesses, including 2,004 hospitalizations and 60 deaths
(Refs. 5 and 8). Estimated incidence of Salmonella infection in 2008
did not change significantly compared with estimates for the preceding
3 years, and in particular the apparent increase in Salmonella
infections was not significant. However, the incidence of SE did
increase by 19% (CI = 3%-39%) (Ref. 10). These data confirm the
continued significance of SE as a cause of human infection in the
United States.
In 1985, States reported to CDC 26 SE-related outbreaks (i.e.,

occurrences of 2 or more cases of a disease related to a common
source); by 1990 the number of SE-related outbreaks reported to CDC had
increased to 85. The number of outbreaks began declining in the 1990s;
in 1995 there were 56 confirmed outbreaks of SE infection, in 2000
there were 50, and in 2002 there were 32 (Ref. 13). The number of
outbreaks has remained roughly constant since 2002; in 2004 there were
28, in 2005 there were 35, and in 2006 there were 26 SE outbreaks in
the United States (Ref. 13). Although these data indicate that there
has been a decrease in reported outbreaks (and associated illness)

linked to SE infection since the mid-1990s, the incidence of SE
infection in the United States remains much higher than in the 1970s
(Ref. 14), and the decrease in reported outbreaks of SE illness since
1999 has appeared to slow or stop compared to decreases seen in the
mid-1990s (Ref. 15). CDC recently reported that, of the four pathogens
with HP2010 targets, Salmonella, with 16.2 cases per 100,000 in 2008,
is the farthest from its 2010 target (6.8) (Ref. 10). If current trends
continue, we will fall short of the public health and foodborne illness
gains required to meet the Healthy People 2010 goal of a 50 percent

reduction from the 1997 baseline in both the number of SE foodborne
outbreaks and the rate of isolation in the population of foodborne
Salmonella infections (Ref. 16).

 C. What Is the Connection Between Salmonella and Shell Eggs?

CDC established an epidemiological and laboratory association
between eggs and Salmonella outbreaks in the mid-1980s (see 69 FR 56824
at 56826 through 56827). Shell eggs are the predominant source of SE-
related cases of salmonellosis in the United States where a food

vehicle is identified (a food vehicle is identified in approximately
half of the outbreaks of illness associated with SE). Between 1985 and
2002, a total of 53 percent of all SE illnesses identified through CDC
outbreak surveillance are attributable to eggs. Where a vehicle of
transmission was identified, 81 percent of outbreaks and 79 percent of
illnesses identified through outbreaks were attributed to eggs (Ref.
17). These data are in accord with a published analysis by CDC
researchers reporting that between 1990 and 2001, 78 percent of
vehicle-confirmed SE outbreaks were associated with eggs, primarily raw

or undercooked (Ref. 15). Over that decade, 14,319 illnesses were
attributed to SE associated with shell eggs (Ref. 15). Most of these
attributed illnesses occurred before 1995 (10,406 illnesses), but 3,913
occurred during 1996 through 2001. We believe egg quality assurance
programs (EQAPs), consumer and retailer education, and Federal
regulations requiring egg refrigeration have contributed to the
decrease in SE

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illness since the mid-1990s, but that further reductions in SE illness
and foodborne salmonellosis cannot be accomplished without additional
Federal measures to address SE contamination of shell eggs.
The surface of an egg can become contaminated with any
microorganism that might be excreted by a laying hen or through contact
with contaminated nesting materials, dust, feedstuff, shipping and
storage containers, human beings, and other animals. The likelihood of
trans-shell penetration increases with the length of time that the eggs

are in contact with contaminating materials. This mechanism of
contamination was previously considered the source of all SE
contamination of eggs.
However, while environmental contamination is still a route for
Salmonella contamination, SE experts now believe that the predominant
route through which eggs become contaminated with SE is the
transovarian route. Although the mechanism is still not well
understood, SE will infect the ovaries and oviducts of some egg-laying
hens, permitting transovarian contamination of the interior of the egg

while the egg is still inside the hen (Refs. 18 and 19). The site of
contamination is usually the albumen (the egg white).
Researchers believe that only a small number of hens in an infected
flock shed SE at any given time and that an infected hen may lay many
uncontaminated eggs (Ref. 20). In a farm-to-table risk assessment of SE
in eggs which was conducted by FDA and the U.S. Department of
Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) (“the
1998 joint SE risk assessment”) (Ref. 21), we estimated that of the 47
billion shell eggs consumed annually as table eggs (eggs consumed as

shell eggs, as opposed to eggs that are used to make egg products), 2.3
million are SE-positive, exposing a large number of people to the risk
of illness (Ref. 21). FDA and FSIS updated this risk assessment in 2005
and derived this same estimate (Ref. 22). This figure is based on data
compiled from 1991 to 1995 (Ref. 23).

 D. The U.S. Egg Industry

On a per capita basis, Americans consume about 234 eggs per year
(Ref. 24). U.S. production is relatively stable and has increased only

slightly over time. For example, it was at about 60 billion eggs in
1984 and at 67.3 billion eggs in 1998 (Ref. 25). Generally, about 70
percent of the edible shell eggs produced are sold as table eggs, while
the remainder are processed into liquid, frozen, or dried pasteurized
egg products. The majority of egg products are destined for
institutional use or further processing into foods such as cake mixes,
pasta, ice cream, mayonnaise, and bakery goods.
Geographically, commercial egg production in the western United
States is concentrated in California, and in the eastern United States

is centered in Ohio, Indiana, Iowa, and Pennsylvania. Other States in
which major producers are located include Texas, Minnesota, and
Georgia. Over 4,000 farm sites have 3,000 or more egg-laying hens,
representing 99 percent of all domestic egg-laying hens and accounting
for 99 percent of total egg production. There are an additional 65,000
farms with fewer than 3,000 egg-laying hens, accounting for the balance
of eggs produced (Ref. 26).

 E. Current On-Farm Practices

In the proposed rule we described in detail current farm practices
to address the risk of SE contamination (69 FR 56824 at 56830 through
56831). Most of the information we provided came from a 1999 study (the
Layers 99 study) (Refs. 27, 28, and 29) by USDA’s Animal and Plant
Health Inspection Service (APHIS) National Animal Health Monitoring
System (NAHMS), as well as information on voluntary EQAPs, which are
discussed more fully in section I.G of this document.
The Layers 99 study was designed to include information from States

that account for at least 70 percent of the animal and farm population
in the United States (Refs. 27, 28, and 29). Each operation
participating in the study had more than 30,000 laying hens. The study
found that egg laying operations varied considerably in size and style
of poultry house; approximately 34 percent of the houses had fewer than
50,000 layers, 29 percent had 50,000 to 99,999 layers, 20 percent had
100,000 to 199,999 layers, and 17 percent had 200,000 or more layers.
One-third of farm sites surveyed had only one layer house, while 16.5
percent had six or more layer houses. The study also found wide

variability within the poultry houses with respect to style of housing
and number and level of cages, although less than one percent were
cage-free. Manure handling varied with house style and also varied
regionally.
The study found that, when a poultry house is repopulated with new
laying hens (also known as “layers”), most of the new layers come
from a pullet raising facility. Less than 10 percent of layer farms
raised pullets at the layer farm site, although some layer farms had

their own pullet-raising facilities at other locations. Most (95
percent) of pullets in pullet-raising facilities came as chicks from
National Poultry Improvement Plan (NPIP) monitored breeder flocks.
USDA’s NPIP is a cooperative Federal-State-industry mechanism intended
to prevent and control egg-transmitted, hatchery-disseminated poultry
diseases. NPIP has monitoring programs for many avian diseases and
pathogens, including SE. Chicks are SE-monitored if they are hatched
from eggs from flocks that are certified through NPIP as “U.S. S.
Enteritidis Clean” breeder flocks (9 CFR 145.23(d)).

Many pullet-raising facilities in the Layers 99 study had their own
programs for SE monitoring. In the West region, 83 percent of farms
obtained layers from SE-monitored pullet facilities, and 70 percent of
layers on all farms came from SE-monitored pullet facilities. Pullet
facilities used one or more of the following methods to monitor SE: (1)
Dead chick/chick paper testing, (2) environmental culture, (3) bird
culture, and (4) serology. Some pullet facilities used competitive
exclusion products and/or vaccines to protect pullets against SE.
The study found that in 1997, the average flock was placed for its

first production cycle at 17.5 weeks of age. Flocks in their first
production cycle reached peak production around 29 weeks of age. At
peak production, the average maximum number of eggs produced was 90
eggs per 100 hens per day. Induced molting was used on many farms (83
percent of farm sites). In the West and Southeast regions, 95 percent
or more of farms molted birds, while in the Central region just over
half (57 percent) of the farms molted birds. On average, molted flocks
ended production at 111 weeks of age, while non-molted flocks ended

production at 74 weeks of age.
Approximately two-thirds of farms had biosecurity measures that did
not allow visitors without a business reason to enter poultry houses.
Sixty-two percent of farms that allowed visitors allowed business
visitors provided they had not been on another poultry farm that day.
Of the farms that allowed visitors in the layer house, most farms (76
percent) required that visitors wear clean boots. The majority of farms
prohibited employees from being around other poultry and from owning
their own birds.

With respect to pest control, the Layers 99 study estimated that
rodents and flies had access to feed in feed troughs on nearly all
farms. Fly control was practiced on 90 percent of all farms; baiting
was the most common form of

[[Page 33033]]

fly control (72 percent of farms). Essentially all farms used some type
of rodent control. Chemicals and baits were used for rodent control by
93 percent of farms. Professional exterminators were used on less than

15 percent of farms that used rodent control. Producers rated almost 30
percent of farms as having a moderate or severe problem with mice and
almost 9 percent as having a moderate or severe problem with rats.
The Layers 99 study found essentially all farms emptied feeders, 91
percent emptied feed hoppers, 81 percent flushed water lines, 79
percent dry cleaned cages, walls, and ceilings, and 71 percent cleaned
fans and ventilation systems. Approximately one-third of farm sites
never cleaned or disinfected egg belts/elevators between flocks. Down
time between flocks varied regionally; most farms had a down time of

more than 11 days, although some were down for less than 4 days.
The Layers 99 study showed that, in 1997, 58 percent of farms
tested for SE. The number of farms testing for SE varied by region. The
number and regional distribution of farms doing testing for SE is very
similar to the number and distribution of farms participating in an
EQAP.

 F. Voluntary EQAPs

The Layers 99 study found that 51 percent of all farm sites

participated in an EQAP sponsored by a State or commodity group (e.g.,
United Egg Producers). The Salmonella Enteritidis Pilot Project (SEPP),
begun in 1992 by USDA with special funding from Congress, was one of
the first EQAPs in the United States (in 1994, SEPP became the
Pennsylvania Egg Quality Assurance Program (PEQAP)). Currently, there
are at least nine voluntary EQAPs operated and administered by States
or other organizations (Refs. 30 through 36). In addition, certain egg
companies operate an EQAP within their own facilities (Ref. 28).
Currently, EQAPs are voluntary for producers. These programs have

similar requirements, but vary in how they implement these
requirements. All programs require use of NPIP “U.S. S. Enteritidis
Clean” chicks or equivalent, biosecurity, rodent control, and cleaning
and disinfection of poultry houses. Although most programs require some
environmental testing, the amount varies from once to four or five
times during the life of a flock. If an environmental test is SE-
positive (i.e., SE is detected at any level in any sample), several
programs require egg testing, with diversion if the egg testing is SE-
positive. Several programs also have State government oversight and

recordkeeping requirements. All programs have some educational programs
for participants.

 G. The Food Code

FDA regularly publishes the Food Code, which provides guidance on
food safety, sanitation, and fair dealing that can be uniformly adopted
by State and local governments for the retail segment of the food
industry. The Food Code provisions are not Federal requirements;
however, they are designed to be consistent with Federal food laws and

regulations. The Food Code is written so that all levels of government
can easily adopt its text into a legal requirement.
Beginning with the 1993 edition, the Food Code was issued in its
current format and was revised every 2 years. In 2002, with the support
of the Conference for Food Protection, FDA decided to move to a 4-year
interval between complete Food Code revisions. FDA published the 2005
Food Code, which is the first full edition to publish since the 2001
edition. During the 4-year interim period, a Food Code Supplement that
updated, modified, and clarified certain provisions was made available.

The provisions relevant to egg safety at establishments serving highly
susceptible populations can be found in the 2001 Food Code in sections
3-202.11(C), 3-202.13, 3-202.14(A), 3-401.11(A)(1)(a) and 3-
801.11(B)(1), (B)(2), (D)(1), (D)(2), (E)(1), and (E)(2). These Food
Code provisions include the use of pasteurized eggs in recipes where
eggs are raw or undercooked (e.g., Caesar salad, hollandaise sauce,
eggnog), and if eggs are combined, unless the eggs are cooked to order
and immediately served or combined immediately before baking and
thoroughly cooked. The 2001 provisions all substantively remain the

same in the 2005 Food Code, but sections 3-801.11(D)(1) and (D)(2) are
now designated as 3-801.11(C)(1) and (C)(2), and sections 3-
801.11(E)(1) and (E)(2) are now designated as 3-801.11(F)(1) and
(F)(2). In addition, FDA amended the definitions of “Eggs” and “Egg
Products” in the 2005 edition of the Food Code to clarify the
difference between “egg” (shell egg) and “egg product” (liquid,
frozen, or dry egg). Also, FDA clarified that baluts and reptile eggs
are excluded from the egg-related provisions of the Food Code.
Through careful examination of State retail food codes, FDA has

identified 47 States and territories (out of 56 States and territories)
that have either adopted the 2005 Food Code or provisions that require
the same prevention measures for highly susceptible populations (Ref.
37).

 H. Rationale for the Final Rule

This rule is the most recent in a series of farm-to-table egg
safety efforts begun by FDA and FSIS in the 1990s. These efforts are
described in more detail in the proposed rule (69 FR 56824 at 56827

through 56829). Among these initiatives was the FDA and FSIS 1998 joint
SE risk assessment (Ref. 21), discussed in detail in the proposed rule
(69 FR 56824 at 56829), which concluded that a broad-based policy,
encompassing interventions from farm to table, is likely to be more
effective in eliminating egg-associated SE illnesses than a policy
directed solely at one stage of the production-to-consumption
continuum. In 2004, after FDA’s proposed rule was published, FSIS
published a draft risk assessment for SE in shell eggs and Salmonella
spp. in egg products. This risk assessment was then published as final

in October 2005 (Ref. 22).
There are currently several Federal regulations related to egg
safety at the food service level. These regulations include a final
rule issued by FSIS for refrigeration and labeling of eggs during
transport and storage when packed for the ultimate consumer (63 FR
45663, August 27, 1998) and an FDA final rule that requires labeling of
eggs and refrigeration of eggs at retail establishments (65 FR 76092,
December 5, 2000). However, this is the first and only Federal rule
that addresses the introduction of SE into the egg during production.

Interventions that can reduce the number of SE-contaminated eggs at the
production phase are of particular interest. Because progress in
reducing the number of illnesses and outbreaks appears to have slowed
or stopped, these additional preventive measures are needed to reduce
further the risk of SE illnesses and meet our public health goals.
Because eggs remain the primary source of SE infections, continued
actions to improve egg safety are the most effective way to reduce the
overall number of SE infections and outbreaks and to achieve our public
health goals.

 II. Highlights of the Final Rule and Summary of Significant Differences
Between the Proposed and Final Rules

 A. Highlights of the Final Rule

The provisions in the final rule are described briefly in the
following paragraphs, and are discussed in more detail later in the
preamble of this document.
<bullet> Persons who produce shell eggs from a farm operating with

3,000 or

[[Page 33034]]

more laying hens, unless that farm sells all of its eggs directly to
consumers or does not produce shell eggs for the table market, are
subject to this final rule (21 CFR 118.1(a)).
<bullet> Shell egg producers need only comply with refrigeration
and registration requirements if all of their shell eggs from a

particular farm receive a treatment as defined in the final rule (Sec.
118.1(a)(2)).
<bullet> Persons who transport or hold shell eggs for shell egg
processing or egg products facilities are required to comply with the
refrigeration requirements of this final rule (Sec. 118.1(b)).
<bullet> Shell egg producers are required to use the following SE
prevention measures:

<bullet> Have and implement a written SE prevention plan that
includes all mandatory SE prevention measures (21 CFR 118.4);
<bullet> Procure pullets that are SE-monitored, or raise pullets
under SE-monitored conditions (Sec. 118.4(a));
<bullet> Use a biosecurity program, meaning a program that includes
limiting visitors on the farm and in poultry houses; maintaining

personnel and equipment practices that will protect against cross-
contamination from one poultry house to another; preventing stray
poultry, wild birds, cats, and other animals from entering poultry
houses; and prohibiting employees from keeping birds at home (Sec.
118.4(b));
<bullet> Use a program to control rodents, flies, and other pests
that includes monitoring for pest activity and removing debris and
vegetation that may provide harborage for pests (Sec. 118.4(c)); and

<bullet> Clean and disinfect poultry houses before new laying hens
are added if an environmental or egg test was positive for SE during
the life of the flock; cleaning and disinfecting must include removing
all visible manure, dry cleaning to remove dust, feathers, and old
feed, and disinfecting (Sec. 118.4(d)).
<bullet> Shell eggs being held or transported are required to be
refrigerated at or below 45 degrees Fahrenheit ([deg]F) ambient

temperature beginning 36 hours after time of lay (Sec. 118.4(e)).
<bullet> Shell egg producers must conduct environmental testing for
SE when laying hens are 40 to 45 weeks of age and 4 to 6 weeks after
molt (21 CFR 118.5).
<bullet> Shell egg producers must conduct egg testing for SE when
an environmental test is positive for SE (21 CFR 118.6).
<bullet> Administration of the SE prevention measures requires

having one or more supervisory personnel, who do not have to be onsite
employees, who are responsible for ensuring compliance with each farm’s
SE prevention plan (21 CFR 118.9).
<bullet> Shell egg producers must maintain a written SE prevention
plan and records documenting compliance with the requirements in the
plan (21 CFR 118.10).
<bullet> Shell egg producers must retain records for 1 year after

the flock to which they pertain has been taken permanently out of
production (Sec. 118.10(c)).
<bullet> Shell egg producers must make records available within 24
hours from the time of receipt of the official request (Sec.
118.10(d)).
<bullet> Shell egg producers must register with FDA (21 CFR
118.11).

 B. Significant Differences Between the Proposed and Final Rules

The final rule reflects the following significant changes from the
proposed rule:
<bullet> Persons who transport or hold shell eggs for shell egg
processing or egg products facilities must comply with the
refrigeration requirements. Only shell egg producers were subject to
the proposed refrigeration requirements.

<bullet> Shell egg producers are required to have and implement
written SE prevention plans.
The proposed rule did not require that plans be written.
<bullet> The requirements for protective clothing and sanitizing
stations have been removed from biosecurity program requirements.
<bullet> The requirement to “wet clean the positive poultry

house” has been removed.
<bullet> Egg processors are now permitted to equilibrate
refrigerated eggs to room temperature just prior to processing.
<bullet> The requirement to begin egg testing within 24 hours after
notification of a positive environmental test has been changed to
require that results of egg testing be obtained within 10 calendar days
after receiving notification of the positive environmental test.

<bullet> The required time period to perform environmental testing
for SE after molting has been changed from 20 weeks to 4 to 6 weeks
after molt.
<bullet> Diverted eggs must have labeling on the shipping
container, and all documents accompanying the shipment must state
“Federal law requires that these eggs must be treated to achieve at
least a 5-log destruction of Salmonella Enteritidis or processed as egg

products in accordance with the Egg Products Inspection Act, 21 CFR
118.6(f).”
<bullet> The requirement that one onsite supervisor at each farm be
responsible for administration of the SE prevention measures has been
changed to allow for more than one supervisor and for offsite
supervisors to be responsible.
<bullet> Shell egg producers must document that pullets were SE-

monitored or raised under SE-monitored conditions.
<bullet> “SE monitored” has been defined to mean that pullets are
raised under SE control conditions that prevent SE, including the
following: (1) Procurement of chicks from SE-monitored breeder flocks
that meet NPIP’s standards for “U.S. S. Enteritidis Clean” status (9
CFR 145.23(d)) or equivalent standard, (2) environmental testing, and
(3) cleaning and disinfection of the environment as needed based upon
the results of the environmental testing.

<bullet> Shell egg producers must maintain records documenting
compliance with each of the SE prevention measures.
<bullet> Shell egg producers must maintain records documenting
review and modifications of the SE prevention plan and corrective
actions.
<bullet> Shell egg producers must register with FDA.

 C. Compliance Dates

The compliance date is July 9, 2010; except that, for producers
with fewer than 50,000 but at least 3,000 laying hens, the compliance
date is July 9, 2012. The compliance date for persons who must comply
with only the refrigeration requirements is July 9, 2010.

 III. Comments on the Proposed Rule

FDA received approximately 2,000 timely submissions in response to

the initial comment period on the proposed rule. In addition,
approximately 20 timely submissions were received in response to the
reopened comment period. The majority of submissions came from
individuals and groups advocating animal welfare issues that, for
reasons discussed later in this document, are outside the scope of this
rulemaking. The remaining comments came from various trade
associations, State government agencies, industry, consumer groups,
scientific associations, and individual consumers. These comments
raised approximately 60 major issues. To make it easier to identify

comments and our response to the comments, the word “Comment” will
appear in parentheses before the description of the comment, and the
word “Response” will appear in parentheses before our response. We
have also numbered each comment to make it easier to identify a
particular comment. The number assigned to each comment is purely for
organizational

[[Page 33035]]

purposes and does not signify the comment’s value or importance or the

order in which it was submitted.

 A. General Comments

1. Enforcement by Voluntary EQAPs
(Comment 1) Several comments stated that FDA should implement what
some comments referred to as a “recognition regime,” under which
parts of the final rule would not apply to (or would be presumptively
complied with by) State and industry EQAPs with standards equivalent to
the Federal rule. Some comments suggested that all shell egg producers

should be subject to the testing and diversion requirements of the
final rule, but that egg producers participating in recognized EQAPs
would have to meet only the on-farm SE control measures specified by
the EQAP. The comments suggested that, as part of the recognition of
the EQAPs, FDA should also recognize audits and inspections conducted
by State agencies to measure compliance with those programs, rather
than conducting separate Federal inspections.
(Response) FDA recognizes that existing voluntary EQAPs have been
successful in reducing SE contamination in poultry houses in certain

States (see discussion in section I.G of this document). However, for
several reasons, we do not agree that States with EQAPs that are
recognized by FDA should not be subject to this rule.
First, as discussed, these programs are not uniformly administered
or equally comprehensive in their prevention measures. In addition,
currently the EQAPs that exist are voluntary for shell egg producers.
Although the existing EQAPs all have similar requirements, they vary in
how those requirements are implemented. This rule will establish
uniform, nationwide requirements to prevent SE in shell eggs during

production, storage, and transportation. FDA believes that these
requirements will further reduce SE illness and deaths associated with
egg consumption.
On the other hand, we agree that we can enlist the assistance of
existing EQAP organizations and officials in implementing FDA’s
regulation. The rule provides that a State or locality may, in its own
jurisdiction, enforce this rule by carrying out inspections under Sec.
118.12(b) (21 CFR 118.12(b)) and by using the administrative remedies
in Sec. 118.12(a) unless FDA notifies the State or locality in writing

that its assistance is no longer needed. FDA plans to provide guidance
to States and localities through an enforcement and implementation
guidance subsequent to this final rule.
2. Vaccination of Layers Against SE
(Comment 2) Some comments agreed with FDA’s conclusion, discussed
in the proposed rule, that there is insufficient scientific support for
a requirement that layers be vaccinated against SE (69 FR 56824 at
56847). Some of these comments stated that FDA should encourage
voluntary vaccination efforts by, for example, allowing producers that

can demonstrate the effectiveness of their vaccination programs to
follow an alternative protocol for environmental testing before
depopulation. One comment encouraged the use of SE vaccinations as an
added prevention measure against SE contamination of shell eggs and
recommended that an option of using a vaccination program should be
available to shell egg producers. In support, the comment stated that
data exists from the United States and Europe that the comment said
demonstrates the efficacy of vaccination programs. The comment did not
provide additional data in support of these statements.

Another comment stated that the available research and field
evidence support a conclusion that vaccines used with other SE control
measures will reduce SE.
(Response) FDA agrees with the comments supporting only voluntary
vaccination of layers. As we stated in the proposed rule, there are
insufficient data on the efficacy of vaccines, particularly data
reflecting field trials under “real world” conditions, to support a
mandatory vaccination requirement (69 FR 56824 at 56847). We also
believe that data on the efficacy of vaccines are insufficient to allow

substitution of vaccination for any of the SE prevention measures
required in this final rule. If individual producers have identified
vaccines that are effective for their particular farms, we encourage
the use of the vaccine as an additional SE prevention measure.
3. Delegation of Inspection Responsibilities to Other Federal or State
Agencies
(Comment 3) Two comments urged FDA to delegate farm inspection
responsibilities to USDA’s FSIS and Agricultural Marketing Service
(AMS) or the State Departments of Agriculture, because these agencies

are already involved in oversight of various aspects of egg production.
Similarly, another comment stated that APHIS and FSIS are more
qualified than FDA to address disease and pathogen risk reduction in
live animal production operations.
(Response) FDA disagrees with the suggestion that we should
delegate inspection responsibilities under this rule to USDA or the
States. Although we coordinate our respective egg safety efforts with
FSIS and AMS, each agency has distinct responsibilities and skills, all
of which benefit consumers of shell eggs and egg products. These

responsibilities and skills do not necessarily overlap as a practical
matter (for example, AMS personnel are in certain shell egg packing
plants, but not in the layer houses). Furthermore, the rule provides
that any State or locality that is willing and able to assist FDA in
enforcing the rule may do so in its own jurisdiction.
4. Induced Molting
(Comment 4) Several comments responded to the request in the
proposed rule for comment and data concerning induced molting (69 FR
56824 at 56846 through 56847). We received a number of comments

encouraging FDA to ban induced molting of laying birds. These comments
stated that this practice stresses the immune function of chickens,
resulting in the promotion of SE contamination in shell eggs and egg
products; that it leads to plucking and consumption of feathers that
may be contaminated with Salmonella; and that the plucking may itself
also stress the immune system. The comments provided some references
for these assertions. Another comment stated that USDA supports
elimination of forced molting to reduce SE contamination and that the
American Veterinary Medical Association also opposes the practice.

Other comments supported the absence in the proposed rule of
provisions addressing molting. These comments stated that the research
on which claims about post-molt SE shed are based have primarily been
laboratory, rather than field research, involving large challenge doses
of SE that would not be duplicated in the field and strains of chickens
different from those common in commercial laying operations. The
comments stated that there is only emerging research into how to use a
variety of diets to control the natural process of molting in the egg
production setting.

(Response) We addressed the issue of induced molting at length in
the proposed rule (69 FR 56824 at 56846 through 56847). We discussed
the limitations of studies cited to support the assertion that induced
molting increases SE contamination of eggs and stated that we did not
believe that we had adequate data upon which to rely for a final
decision on the issue of the

[[Page 33036]]

relationship between induced molting and SE contamination of the

environment and of eggs. Although the proposed rule specifically
requested comment and data related to our discussion of induced
molting, we did not receive any new data on the relationship between
induced molting and SE contamination of the laying environment and of
eggs. As a result, we do not have adequate evidence to support
including a prohibition on induced molting in the final rule.
5. Indemnification
(Comment 5) One comment suggested that we research whether the
Public Health Service Act (the PHS Act) would allow us to indemnify

persons whose economic interests are adversely affected by this rule,
for example, as a result of diversion of shell eggs to breaker
facilities. The comment suggested that, should we conclude that we lack
such legal authority, we should consider whether to request it from
Congress. Another comment suggested that a Federal compensation package
may be needed for smaller producers that lack pasteurization
capability.
(Response) Unlike APHIS, FDA is not required or explicitly
authorized by Federal statute to compensate persons whose economic

interests are adversely affected by certain Agency actions.\1\ Further,
FDA notes that although some producers will face economic costs from
the diversion of eggs to the table market, as discussed in section V of
this document (Analysis of Economic Impacts), the economic benefit from
illnesses averted is expected to greatly exceed the cost of this rule.
The suggestion that FDA seek statutory authority to pay compensation to
indemnify producers is outside the scope of this rule.
—————————————————————————

\1\ Under the Animal Health Protection Act, USDA is required to
compensate the owner for any animal, article, or means of conveyance
that the Secretary of Agriculture requires to be destroyed (7 U.S.C.
8306(d)). Under the Plant Protection Act, USDA is authorized to pay
compensation to any person for economic losses incurred as a result
of action taken by the Secretary of Agriculture under a declaration
of extraordinary emergency (7 U.S.C. 7715).
—————————————————————————

 B. Comments on “Shell Egg Producers Covered by the Requirements in
This Part” (Proposed and Final Sec. 118.1)

Exemption of Producers With Small Flocks
(Comment 6) Several comments addressed our proposed exemption of
shell egg producers with small flocks, defined as flocks of less than
3,000 laying hens at a particular farm. Most of these comments argued
that these small flocks are less likely to have adequate SE prevention
measures and that excluding them would be contrary to the public health

goal of the rule. The comments suggested that smaller facilities are
less likely to have adequate refrigeration capacity, effective rodent
control, an effective biosecurity program, measures in place to limit
laying hens’ exposure to manure on building floors and exposure to the
outdoors; that they may pose a greater risk that they will transport
and hold eggs without proper refrigeration; and that they may be less
likely to obtain replacement pullets or chicks from breeders who
participate in the SE prevention programs. One comment similarly
suggested that eggs from these smaller producers might be associated

with a disproportionate share of sporadic illnesses and even some
outbreaks. The comments did not provide data to support these concerns;
one comment from one of the larger trade associations stated that it
was not aware of research that would support any conclusion that
smaller operations would be either more or less likely to have an SE
problem than larger, commercial operations.
One comment proposed that FDA reduce the exemption to producers
with less than 500 chickens or require all producers not selling

directly to consumers to comply with the rule. This comment suggested
that FDA may not be aware of outbreaks associated with eggs from these
producers because the eggs are not likely to be shipped interstate.
One comment cited our $1.01 per hen ($0.05 per dozen) estimate of
the cost to farms with between 3,000-19,999 layers as an illustration
of the large financial burden that the rule imposes on these farms.
(Response) We do not believe that there is at this time sufficient
evidence to warrant extending the rule’s coverage to producers with
fewer than 3,000 laying hens. As we explained in the proposed rule (69

FR 56824 at 56832), because producers with fewer than 3,000 layers do
not contribute significantly to the table egg market, imposing any one
or all of the restrictions on them will have little measurable impact
on the incidence of SE. We have no information documenting that there
is an elevated risk of sporadic illness or outbreaks associated with
eggs sold directly from farmer to consumer or from a producer with
fewer than 3,000 laying hens.
FDA disagrees with the statement that we may be unaware of
outbreaks associated with eggs from small producers because these

producers are less likely to ship eggs interstate. The outbreak data
relied on by FDA is in general submitted by State Departments of Health
to CDC. As noted earlier, cases of salmonellosis must be reported to
local health departments, who in turn provide information to States and
to CDC.
FDA recognizes that the cost per hen is higher for smaller farms.
However, though not specifically broken out in the regulatory impact
analysis, for farms with between 3,000 and 19,999 layers, the public
health benefits of the rule exceed the costs by more than $90 million

annually and costs do not exceed benefits for any of the individual
provisions of the rule. There are a number of features of the rule
itself and in our plans for implementation to facilitate smaller farms’
compliance with the rule. For example, this final rule has a staggered
compliance schedule, which provides smaller egg producers (those with
between 3,000 and 49,999 layers) 3 years to comply with the final rule.
FDA will continue to evaluate the impact of this rule on smaller farms
and will consider taking appropriate steps to mitigate those impacts,
where it is possible to do so without reducing safety. In addition, FDA

intends to provide guidance on the recordkeeping and other provisions
of the rule, including small entity compliance guidance. We plan to use
guidance, to the extent feasible, as a vehicle to identify areas where
compliance could be achieved via flexible approaches that would
mitigate the financial impact while preserving the public health
benefits of the rule. We plan to solicit public and industry input on
this guidance.
Therefore, FDA has retained the exemption from all provisions of
this final rule for farms with fewer than 3,000 layers.

 C. Comments on “Definitions” (Proposed and Final Sec. 118.3)

1. Poultry House
(Comment 7) One comment questioned the proposed definition of a
poultry house, which requires that different sections of a single
building separated by walls be considered as separate houses. The
comment noted that the definition would not address the risk of
airborne transmission of SE. The comment stated that “there is
considerable evidence that SE can be transmitted through dust and other

airborne particles,” citing three references in support. The comment
noted that the proposed rule did not require that separate sections in
a building have separate ventilation systems, but did require
biosecurity

[[Page 33037]]

procedures to ensure that there is no introduction or transfer of SE
from one section to another. The comment suggested that the definition
of a poultry house should clarify that the biosecurity procedures

should include transfer through airborne particles.
(Response) FDA recognizes that SE may be transmitted through dust
and other airborne particles. However, FDA does not believe that
separate ventilation for each section of a house should be mandated
because there is great variation in design and placement of houses and
ventilation systems, and separate ventilation may not be necessary in
every circumstance. Depending on the layout of a farm and the type and
number of houses, a producer should decide whether ventilation needs to
be addressed as part of farm-specific biosecurity measures to prevent

the introduction or transfer of SE from one section to another.
The proposed definition of “poultry house” stated “For
structures comprising more than one section containing poultry, each
section is enclosed and separated from the other sections, and each
section has a biosecurity program in place to ensure that there is no
introduction or transfer of SE from one section to another.” (Emphasis
added.) The final phrase has been removed from this section and added
as an introduction to Sec. 118.4(b) (biosecurity) to make clear that
you must “take steps to ensure that there is no introduction or

transfer of SE into or among poultry houses,” and that “[a]mong such
biosecurity measures you must, at a minimum” include a number of
specific measures in the biosecurity plan. If the design of a farm and
its poultry houses needs an additional measure of ventilation to
prevent cross-contamination, then such a measure should be added to the
biosecurity plan.
In addition, in the final rule we have revised the definition of
“poultry house” to clarify that “[f]or structures comprising more
than one section containing poultry, each section that is separated

from other sections is considered a separate house.”
2. Treatment
(Comment Some comments stated that a survey of egg processors to
determine their current pasteurization practices supports a 5-log
reduction, although many processors achieve a substantially greater
pathogen reduction. The comments stated that the survey indicated that
50 percent of survey respondents reported that they achieve a 5-log
reduction, and the other 50 percent reported a 7-log or greater
reduction. The comments stated that the current 5-log reduction

requirement appears to provide an adequate margin of safety, because
specified temperatures and holding times do not take into account the
additional kill achieved in the product while it is heating up to, and
cooling down from, the pasteurization temperature.
(Response) FDA agrees with the comments that a 5-log reduction in
SE via pasteurization or an alternative approach or the processing of
egg products to achieve an equivalent level of protection is
appropriate to ensure the safety of shell eggs. Therefore, we have
retained the definition for the term “treatment” (or “treated”) in

Sec. 118.3 of the final rule as “a technology or process that
achieves at least a 5-log destruction of SE for shell eggs, or the
processing of egg products in accordance with the Egg Products
Inspection Act. We established this standard in 1997, in response to a
USDA/AMS request to FDA on criteria for shell egg pasteurization. AMS
then published this standard in its Federal Register notice on official
identification of pasteurized shell eggs on September 24, 1997 (62 FR
49955).
Additionally, both FDA and FSIS are evaluating additional measures

to improve egg safety, and FSIS intends to issue proposed rules in the
near future for egg products plants and egg handlers, including egg
handlers who operate in-shell pasteurization treatments. FDA and FSIS
will continue to work closely together to ensure that our egg safety
measures are consistent, coordinated, and complimentary.

 D. Comments on “Salmonella Enteritidis (SE) Prevention Measures”
(Proposed and Final Sec. 118.4)

1. Chicks and Pullets (Sec. 118.4(a))

FDA reopened the comment period on May 10, 2005, to seek further
comment and information on industry practices and programs that prevent
SE-monitored chicks from becoming infected by SE during the period of
pullet rearing until placement into laying hen houses (70 FR 24490). We
received approximately 20 submissions that provided additional
information and data on the specific questions that FDA presented.
(Comment 9) Several comments stated that on-farm prevention
practices must address each stage in the life of laying flocks,
including the pullet-rearing stage. These comments stated that applying

the FDA-mandated practices to layers only after they have been placed
in layer hen houses may be too late to ensure protection against SE, as
the layers’ ovaries may already be contaminated with the pathogen. The
comments urged FDA to make clear in the rule that all of the SE
prevention practices apply to both pullet rearing houses and layer
houses. The comments noted that this approach would be consistent with
the practice of existing EQAPs SE prevention measures that are
applicable specifically to pullets.
Many comments suggested that FDA add a new requirement that

producers certify that pullets they procure have come from a facility
that has an SE-monitoring program. The comments recommended that pullet
houses undergo environmental tests for SE for each flock at
approximately 10 weeks of age. The comments stated that, if the test is
positive, the producer could still accept the pullets, but the producer
should be required to test environmentally after placement. In
addition, the comments suggested that FDA require that pullet houses
should be cleaned and disinfected prior to placement of the next pullet
flock. Finally, the comments suggested that FDA require testing for

layers used to backfill (replacing dead or diseased layers with other
layers) and older flocks that are moved to another facility.
(Response) We agree that SE prevention measures should be in place
during the pullet phase of shell egg production and have modified the
rule accordingly. We believe this will reduce the risk of placing
infected birds into poultry houses. The final rule requires producers
to procure pullets from sources where the environment has been tested
and found environmentally negative prior to introduction into the
laying flock. The environmental testing is required of pullets at 14 to

16 weeks of age and cleaning and disinfection of the pullet environment
is required if the environmental test is positive. The cleaning and
disinfection procedures include removing all manure, dry cleaning the
positive pullet house to remove dust, feathers, and old feed, and
following cleaning, disinfecting of the positive pullet house with
spray, aerosol, fumigation, or another appropriate disinfection method.
Additionally, if the environmental test is positive for SE, producers
must begin egg testing within 2 weeks of the start of egg laying. The
requirements also include procuring chicks from SE-monitored breeder

flocks that meet standards set by NPIP for “U.S. S. Enteritidis
Clean” status or equivalent standard.
FDA does not agree that a specific requirement is needed to test
birds used to backfill and to test older flocks that are moved to
another facility. Section 118.5(a) of the final rule requires

[[Page 33038]]

producers to perform environmental testing for SE in a poultry house
when any group of laying hens constituting the flock within the poultry

house is 40 to 45 weeks of age. Therefore, any layers used to backfill
and older layers moved into a poultry house will be, or would have
been, environmentally tested at 40 to 45 weeks of age, as are all other
layers.
(Comment 10) Several comments supported the proposed requirement
that all pullets and chicks be procured from a hatchery or breeding
flock that participates in NPIP. These comments noted that NPIP
participants have developed effective strategies that have reduced the
prevalence of many poultry diseases including SE.

(Response) We have retained the requirement that pullets that are
purchased be procured as chicks from SE-monitored breeder flocks that
meet NPIP’s standards for “U.S. S. Enteritidis Clean” status or an
equivalent standard.
2. Biosecurity (Sec. 118.4(b))
(Comment 11) Some comments stated that FDA should revise its
biosecurity requirements to allow egg producers greater flexibility. In
addition, some comments challenged specific biosecurity measures as
being insufficiently supported by data demonstrating their

effectiveness in controlling or preventing SE contamination.
Specifically, comments questioned the value of requiring personal
protective equipment and sanitizing stations between houses on one
farm, limiting visitors, controlling movement of workers from house to
house, preventing employees from having poultry at home, and preventing
stray poultry, wild birds, and other animals from entering the grounds.
According to the comments, on a farm it is the presence of mice near
chickens that maintains the SE infection and contributes to SE spread
from building to building. One comment asserted that biosecurity

efforts on the farm should be focused on “rodents and other issues
threatening to introduce or maintain SE.” The comment does not explain
what “other issues” the commenter is referring to. The comment also
asserted that PEQAP does not have a biosecurity requirement.
(Response) FDA agrees with the comments that biosecurity measures
could be more flexible in the final rule without jeopardizing the
effectiveness of the SE prevention measures. Specifically, we believe
egg producers may be able to devise and implement effective means other
than protective clothing and sanitization stations to prevent cross-

contamination between houses. For example, in some circumstances
placing footbaths and farm-specific footwear at the entrance to a
complex, maintaining house specific equipment, or using non-street
clothing in the layer houses may be sufficient to prevent cross-
contamination between houses. Therefore, we have removed from the
biosecurity provisions the requirements for the use of protective
clothing and sanitizing stations between houses. This change addresses
the diverse poultry housing situations that exist throughout the
country by allowing each producer to implement biosecurity practices

and procedures appropriate for a particular farm and situation. We also
agree that it is impractical to require egg producers to prevent stray
animals from entering the grounds. Therefore, we have narrowed the
provision for stray animals to apply only to the poultry houses.
However, FDA disagrees with the comments questioning the value of
other specific biosecurity requirements. As discussed in the proposed
rule (69 FR 56824 at 56835), limiting visitors on the farm and in
poultry houses, maintaining practices that will protect against cross-
contamination when persons move between poultry houses, and prohibiting

employees from keeping birds at home are all vital biosecurity
provisions that are commonly in use. According to the Layers 99 study
(Ref. 29), 66 percent of farm sites already practice some form of
biosecurity; that study found that poultry houses where visitors were
not allowed were less likely to test positive for SE.
Biosecurity is a critical part of a farm’s SE prevention measures.
You must implement these biosecurity measures to prevent the
introduction or transmission of SE into or between poultry houses.
Furthermore, contrary to the comment, PEQAP requires all participants

to maintain an acceptable biosecurity program (Ref. 30). As discussed
in section I.G of this document, all current EQAPs require use of NPIP
“U.S. S. Enteritidis Clean” chicks or equivalent, biosecurity, rodent
control, cleaning and disinfection of poultry houses, and many programs
require some environmental testing as well.
We will make further specific recommendations for biosecurity steps
and options for achieving these steps, based on current science and
best practices, in a guidance that we plan to issue subsequent to this
final rule. We emphasize, however, that biosecurity is an important and

integral part of any poultry farm’s SE prevention program, and that the
biosecurity requirements in the final rule are minimum standards; egg
producers may incorporate additional biosecurity measures into their SE
prevention plans if they believe such measures are warranted.
(Comment 12) One comment stated that if FDA insists on a
biosecurity requirement, it should address the movement of pullets,
spent hens (hens that have permanently ceased egg production), people,
equipment, eggs, flats (a receptacle for storing or transporting eggs
most often constructed of cardboard or plastic), and egg shells.

(Response) The comment was not specific as to how these matters
should be addressed and did not provide any supporting data concerning
the need for particular requirements. However, it was not our intention
that the proposed rule’s biosecurity provisions addressing the risk of
cross-contamination from visitors or the movement of “equipment” be
interpreted as an exclusive list of measures to take to prevent the
introduction of SE into or among poultry houses. We have amended Sec.
118.4(b) to make this clear, by adding general introductory language,
moved from the proposed definition of “poultry house,” that producers

must “take steps to ensure that there is no introduction or transfer
of SE into or among poultry houses.”
(Comment 13) One comment suggested that the proposed rule is
premised on a mistaken belief by FDA that biosecurity alone can prevent
the introduction and spread of SE.
(Response) As reflected in the rule, FDA understands that
biosecurity is only one element of the measures that a producer must
have to prevent SE. Producers must follow additional SE prevention
measures, including pullet measures; rodent, fly and other pest

control; cleaning and disinfection; and refrigeration.
(Comment 14) One comment questioned whether organic poultry
producers would be able to comply with the requirement in the proposed
rule (Sec. 118.4(b)(4)) that requires egg producers to “prevent stray
poultry, wild birds, and other animals from entering grounds and
facilities.” The comment stated that this requirement is in conflict
with a requirement under the USDA National Organic Program (7 CFR part
205) that organic poultry producers must provide outside access for all
livestock. The comment also stated that farms that are based on a

pastured poultry system, which typically provides a substantial
percentage of the birds’ diet from pasture, would have difficulty
complying with this requirement.
(Response) We agree that it would be difficult to prevent stray
poultry and

[[Page 33039]]

other animals from entering the grounds of the farm, and we believe it
is sufficient to keep stray animals out of the poultry house.

Therefore, in the final rule, we have changed the requirement for stray
animals so that it applies only to poultry houses rather than the
entire grounds. Further, we have consulted with AMS, which administers
the National Organic Program, and AMS has informed us that this
requirement would not make it impossible for eggs to qualify as organic
(Ref. 38).
3. Pest Control (Sec. 118.4(c))
(Comment 15) Some comments supported the rodent control program
requirement in proposed Sec. 118.4(c)(1), but questioned the role of

flies in the spread of SE and recommended elimination of the pest
monitoring under proposed Sec. 118.4(c)(2). The comments further
stated that if measured outside the poultry house, the fly count might
reflect flies that are present from external locations, such as animal
housing at adjacent properties.
(Response) FDA disagrees that the provision for monitoring flies in
Sec. 118.4(c)(2) should be removed or modified. In the proposed rule
we described research by FDA and others showing that flies harbor SE
within the poultry house environment (69 FR 56824 at 56835). According

to the Layers 99 study, flies, like rodents, have access to feed
troughs on nearly all farms. Further, the fly monitoring procedure can
be performed inside the layer house, thus creating an accurate
reflection of the presence of flies there.
For clarification, FDA has replaced the term “pest” in Sec.
118.4(c)(2) in the final rule with “flies” because “pest,” which is
defined to mean any objectionable animal including, but not limited to,
rodents, flies, and larvae, is too broad in the context of this
specific provision.

(Comment 16) One comment stated that PEQAP addresses rodent
control, but does not address fly control. The comment recommended that
fly control be included in the FDA regulation, but that the States
individually and independently decide the number of flies allowed for
maintaining compliance with the regulation. The comment suggested that
under State or local requirements or when a farm has a problem, the
spot cards be used to determine the numbers and, therefore, the
appropriate control program.
(Response) FDA disagrees with the comment that the States should

individually and independently decide the number of flies allowed for
maintaining compliance with the regulation. This rule establishes
minimum national standards based on measures that have been shown to
prevent SE. The comment did not provide any rationale for addressing
flies on a State-by-State basis. Further, the rule provides flexibility
in how fly presence is determined, allowing not just spot cards, but
also Scudder grills, sticky traps, or other appropriate monitoring
methods. FDA intends to publish guidance on the requirement to monitor
for flies and on the level of fly activity considered acceptable.

The literature suggests that 50 or fewer hits on a spot card or
sticky trap per week or a count of less than 20 on a Scudder grill
indicate satisfactory fly control ((Refs. 39 and 40).
4. Cleaning and Disinfection (Sec. 118.4(d))
(Comment 17) One comment suggested that mandatory cleaning and
disinfection measures should not require removal of “all visible
manure” in a hen house following a positive environmental test and
depopulation, but should allow for flexibility with respect to manure
removal. The comment stated that complete removal of all manure would

destroy biological controls for flies (such as parasitic wasps). The
comment also argued that this requirement is impractical, because many
producers only remove manure from the houses during those times of year
when they can immediately apply it to fields. Several comments stated
that the requirement to remove all visible manure is impractical for
large, complex poultry farming operations, because commercial in-line,
multi-tiered cage layer houses with related accessories and equipment
for watering, feeding, egg collection, manure deflection, storage, and
removal might be impossible to bring into compliance. The complex

machinery (some electrical) is very difficult to clean at best and is
just not compatible with wet cleaning. It would also be difficult to
accomplish this cleaning in very cold climates because of freezing, in
that the layers were an important source of house heat until they were
removed for replacement. The comment also noted it might be difficult
to enforce a requirement such as “removal of all visible manure.”
(Response) We disagree that flexibility should be allowed with
respect to manure removal after a positive environmental test. First,
even if it is true that complete removal of all manure would “destroy

biological controls for flies” (presumably, by removing parasitic wasp
larvae), the wasp population could be restored by the firm, if
biological controls are an intended and effective component of the
firm’s fly control efforts. Data available to FDA indicate that there
are non-biological methods of control available to producers (i.e.,
chemical and mechanical methods) and that these methods are used by
most laying hen houses. Moreover, the available data indicate that the
role of parasitic wasps in controlling flies is currently being debated
in the scientific literature, with most of the work being done in

cattle feedlots. Meyer et al. (1990) (Ref. 41) and Andress and Campbell
(1994) (Ref. 42) found parasite treatments had no apparent affect on
adult fly populations, while Weinzierl and Jones (1998) (Ref. 43)
concluded that parasitism significantly reduced the fly population. In
the one study we are aware of concerning the use of parasitic wasps to
control flies in the context of poultry facilities, variable results
were obtained (Kaufman et al., 2001) (Ref. 44).
Furthermore, limited data suggest that total cleanout of manure is
feasible even where parasitic wasps are used to control flies. A study

by Hinton and Moon (2003) (Ref. 45) on the effect of a total cleanout
on fly control in chicken houses compared the effect of a total
cleanout of manure from chicken houses to two partial cleanout methods.
Initially, the increase in flies was greatest in those houses with
total cleanout, but subsequent differences between the three cleaning
methods were small and the fly densities remained relatively stable for
3 months in all houses. Although this study did not specifically
evaluate parasitic wasps, it supports a finding that total cleanout of
poultry houses will not adversely affect fly control efforts (Ref. 45).

Second, the fact that manure cannot always be applied to fields
does not mean that it should not be removed from poultry houses. Manure
removed from a house can be composted, stored in a manure barn, or
spread on a field depending on the time of year that it is removed.
Finally, we do not understand why manure removal at a large
operation would be impractical. We acknowledge that a large operation
has more manure to handle, but FDA has visited large operations that do
clean out the manure, and we are unaware of any unique problems for
such operations.

Because manure is a reservoir of SE that has been shed by infected
laying hens, once a poultry house has had an SE-positive environmental
or egg test, it is important that all visible manure be removed.
Removing all visible manure before new laying hens are placed into a
house will help to prevent the SE from

[[Page 33040]]

infecting the replacement flock via the manure and rodents.
Therefore, FDA concludes that, to prevent the spread or

perpetuation of SE from one flock to another, a producer must remove
all visible manure from a poultry house before new laying hens are
added to the house when an environmental test was positive for SE at
any point during the life of the flock that was housed in the poultry
house prior to depopulation. The agency realizes that the floor in a
concrete-floored house could appear light gray, but we do not expect to
see any accumulation of manure in a house that has had the manure
removed, and we do not anticipate practical difficulties in our ability
to enforce this requirement. We plan to publish guidance on acceptable

manure removal subsequent to this final rule.
(Comment 18) Several comments objected to the wet cleaning
requirement in the proposed rule and suggested alternatives such as
allowing flexibility so long as the cleaning and disinfection
procedures are sufficient to eliminate SE. The comments stated that wet
cleaning is impractical during the coldest months in some States; that
it can encourage the growth of SE by creating an environment for growth
of microorganisms in the poultry house; and that wet cleaning will harm
some mechanical and electrical parts of equipment and cages. The

comments argued that there is no scientific consensus in favor of wet
cleaning.
(Response) We agree that wet cleaning may not be practical in all
situations and have removed the requirement from the final rule. As
discussed in the proposed rule (69 FR 56824 at 56836), it is important
that, once a poultry house has had an SE-positive environmental or egg
test, a producer make every effort to rid the environment of SE before
new laying hens are placed into that house to prevent the SE problem
from being perpetuated in the replacement flock. The final rule retains

the requirement in this circumstance to dry clean the poultry house to
remove dust, feathers, and old feed prior to the addition of new laying
hens to the house and following cleaning, to disinfect the positive
poultry house with spray, aerosol, fumigation, or another appropriate
disinfection method.
5. Refrigeration (Sec. 118.4(e))
(Comment 19) Several comments raised concerns about the requirement
in Sec. 118.4(e) of the proposed rule that egg producers should
refrigerate shell eggs if they are held longer than 36 hours. Some

comments urged FDA to change the time at which refrigeration is
required to 72 hours after production. The comments noted that 72 hours
would accommodate shell egg production over weekends and smaller
producers that have pickups less frequent than daily, while at the same
time ensuring that eggs are not accumulated and held over long periods
without refrigeration.
One comment argued that the requirement to refrigerate eggs within
36 hours could actually be counter-productive with respect to the
safety of eggs destined for use in the table market. The comment

reasoned that more checks and cracks will occur when previously
refrigerated eggs are washed due to the greater change in temperature.
The comment recommended that FDA not set a prescriptive time
requirement for refrigeration of table eggs unless further research
justifies the need, but that if a time limit for refrigeration must be
set, it should be set at 72, not 36, hours.
(Response) We disagree that eggs should remain unrefrigerated for
up to 72 hours after laying. Our proposed requirement that eggs be
refrigerated if stored more than 36 hours was based on data indicating

that, although fresh shell eggs provide an inhospitable environment for
Salmonella to multiply, the chemical and physical barriers against
bacterial movement and growth in shell eggs degrade as a result of the
time and temperature of holding (69 FR 56824 at 56836 through 56887).
As they degrade, shell eggs provide an increasingly more hospitable
environment for the growth of SE. Studies have shown that SE, when
inoculated into the albumen (whites) of whole shell eggs, multiplied to
high numbers if the eggs were not properly refrigerated (Refs. 46, 47,
and 48).

The 36-hour limit for unrefrigerated holding is supported by a
model, contained in the 1998 joint SE risk assessment (Ref. 21), which
was developed to examine the relationship among holding time, holding
temperature, and yolk membrane breakdown as an indicator of SE risk.
(The yolk membrane separates the nutrient-rich yolk and any SE bacteria
that might be present in the albumen; breakdown or loss of the yolk
membrane results in rapid growth of SE present in the albumen.) The
model showed that, at 70 to 90 [deg]F (i.e., temperatures that might be
observed in unrefrigerated egg holding areas in farms or warehouses or

in transport vehicles), there was much less breakdown of yolk membrane
in eggs held no longer than 36 hours than in eggs held no longer than
72 hours. According to the model, eggs held at 70 [deg]F will
experience at least a 16-percent breakdown of yolk membrane after 36
hours and a 25-percent breakdown after 72 hours. Eggs held at 80 [deg]F
will suffer at least a 22-percent breakdown after 36 hours and a 39-
percent breakdown in the yolk membrane at 72 hours. At 90 [deg]F, there
is at least a 33-percent breakdown after 36 hours and at least a 62-
percent breakdown of the yolk membrane after 72 hours. In the 2005 FSIS

risk assessment (Ref. 22), refrigeration was modeled again; this risk
assessment found that limiting eggs to just 12 hours without
refrigeration, the shortest timeframe between laying and refrigeration
that was evaluated, provided the greatest public health benefit among
the time frames studied.
Although, as we stated in the proposed rule, we believe that it is
very important that eggs be placed into refrigerated storage as soon as
possible after they are laid, we recognize that this may not be
practical for all producers. It may take several hours or longer after

the eggs are laid before they are collected or picked up for transport.
According to the Layers 99 study (Ref. 28), almost half of the farm
sites surveyed had egg pickups every 1 to 2 days. In light of all of
these data, we are retaining in the final rule the requirement of 36
hours as the maximum amount of time eggs may be held unrefrigerated on
the farm.
(Comment 20) Several comments questioned the proposed refrigeration
temperature requirement of 45 [deg]F. One comment stated that holding
eggs at 45 [deg]F would result in two problems related to egg quality

and safety. First, the comment stated that ambient moisture would
condense on the cold eggs and cause them to “sweat” before they are
washed/sanitized, increasing the chance of surface contamination
penetrating the eggs. Second, the comment stated that when cold eggs
are moved into the egg washer, which uses hot water, checks or cracks
can develop in the shell, lowering the quality of the egg and
increasing the risk of future surface bacterial or fungal contamination
getting into the interior of the eggs.
(Response) FDA does not agree that a 45 [deg]F refrigeration

requirement is too low. This requirement is consistent with FDA’s final
rule on refrigeration of shell eggs at retail (65 FR 76092), and like
that requirement, the rule is based on research demonstrating that
Salmonellae do not grow well or rapidly at temperatures less than or
equal to 45 [deg]F. FDA finds that the scientific evidence on the
growth of SE in eggs shows that control of storage temperature of shell
eggs can significantly reduce the rate of

[[Page 33041]]

multiplication of any SE present (Refs. 46, 47, and 48).
FDA agrees that there can be quality and safety problems such as
thermal checks (hairline cracks in the shell) associated with
refrigerating eggs immediately prior to processing into either table
eggs or egg products. Therefore, FDA is modifying the rule to allow an
equilibration step (a step during which the eggs reach room
temperature) before eggs are processed. Specifically, under Sec.
118.4(e) of the final rule, shell eggs that have been refrigerated may

be held at room temperature for no more than 36 hours just prior to
processing to temper them, which will reduce the risk of hairline
cracks in the shell that could contribute to bacteria entering the egg
during washing if the egg is too cold. We believe the benefits of
refrigeration accompanied by equilibration outweigh any possible risk
associated with sweating of the eggs.
(Comment 21) One comment stated that the rule is silent on the
refrigeration of eggs that are segregated at the grading operation for
processing at egg products plants. These are the eggs that do not meet

grade requirements, are checked (that is, the shell is cracked, but the
shell membrane is intact), or have dirt on the shell. The comment
explained that the last two types of eggs pose a significant food
safety risk if handled improperly and can be processed only in a USDA-
inspected egg products plant. Additionally, the comment stated it may
take several days to accumulate a quantity of checked and dirty eggs
for shipment. Similarly, the comment stated that surplus eggs produced
by hatchery flocks are accumulated and sent to egg products plants for
processing and could present a hazard if not properly refrigerated. The

comment noted that most shell egg packers and hatcheries currently
refrigerate these eggs, but the comment urged FDA to amend the proposed
rule to require that eggs segregated at grading operations and at
hatcheries and intended for further processing also be subject to the
refrigeration requirements proposed for on-farm storage.
Another comment noted that USDA only requires refrigeration at the
packer’s facility after packing for the consumer. The comment stated
that nest run eggs (eggs that are packed as they come from the
production facilities without having been washed, sized, and/or candled

for quality) and restricted eggs, (eggs whose use is limited by FSIS
under the Egg Products Inspection Act because they are, for example,
checked or dirty) are not required to be refrigerated. This comment
further stated that to maintain the maximum benefit of SE illness
reduction from refrigeration, eggs should be refrigerated throughout
the distribution chain.
(Response) We sought comment in the proposed rule on whether to
require refrigerated transport of shell eggs not already required by
regulation or within USDA’s jurisdiction; for example, transport of

shell eggs from a farm or a packer to a food manufacturing facility. We
further stated that we would consider putting into place requirements
similar to those we finalized for refrigerated storage of shell eggs at
retail (i.e., transport of shell eggs at or below 45 [deg]F ambient
temperature).
FDA agrees with the comment that the refrigeration requirement in
the proposed rule only addresses eggs held at the farm for more than 36
hours after time of lay. The proposed requirement does not address
nest-run eggs, surplus hatching eggs sent to the table egg market, eggs

shipped to egg products facilities and then sent to the table egg
market, or any other eggs that are held or transported at locations
other than at the producer’s layer farm. Holding or transporting these
eggs without refrigeration allows growth of any SE that may be present
in the eggs. We also agree with the comment that, to maintain the
maximum benefit of SE illness reduction from refrigeration, eggs should
be refrigerated throughout the distribution chain. Therefore, to reduce
this potential growth of harmful bacteria, we have modified Sec.
118.4(e) in the final rule to require refrigeration during all storage

and transportation beginning at 36 hours after time of lay.
Following are three examples of eggs requiring refrigeration under
the final rule, which would not have required refrigeration previously:
(1) Unwashed eggs more than 36 hours old from a farm with 3,000 or more
layers that have left the producer’s farm and are being transported to
or are at a shell egg processing facility or are being held in a
warehouse; (2) eggs from a farm with 3,000 or more layers that are more
than 36 hours old and are being shipped from an egg products facility
(USDA-inspected plant) to a shell egg processing facility; and (3) eggs

from a hatchery that are more than 36 hours old, were never used for
hatching, and are now being transported to a shell egg processing
facility. For clarification, in the final rule we are defining “egg
products facility” as “a USDA-inspected facility where liquid,
frozen, and/or dried egg products are produced,” and “shell egg
processing facility” as “a facility that processes (e.g., washes,
grades, packs) shell eggs for the table egg market.”
In addition, as discussed in response to comment 20, for those eggs
to be processed as table eggs but which are not processed for the

ultimate consumer within 36 hours from the time of lay and therefore
are required to be held and transported under refrigeration, we are
permitting an equilibration step.

 E. Comments on “Environmental Testing for Salmonella Enteritidis
(SE)” (Proposed and Final Sec. 118.5)

(Comment 22) Several comments challenged the proposed requirement
that egg producers conduct environmental testing when a flock has
reached 40 to 45 weeks of age, and if the flock has molted, 20 weeks

after the end of the molting process. The comments suggested that
instead FDA follow the practice of some EQAPs, which require testing of
the layer house environment at the end of the laying period, prior to
depopulation. One comment stated that environmental samples should be
obtained anytime within the time period of active production, or
between the 40th and 60th week of production. In addition, the comment
stated that if the environmental samples taken at this time are
negative there is no need to conduct additional samples for those birds
that have undergone an induced molt.

Another comment stated that the 1998 joint SE risk assessment (Ref.
21), as well as draft 2004 USDA risk assessment (Ref. 49) support a
revision to the proposed testing time for post-molt layers from 20
weeks, as proposed, to a 4 to 6 week range post-molt. In support of
this suggestion, the comment noted that the 2004 FSIS draft risk
assessment finds the greatest risk of infected eggs immediately after
molt, but at this time hens are laying few eggs. As a result, the
comment estimated that if the increased risk used in the draft risk
assessment is multiplied by expected lay post-molt, the greatest number

of infected eggs from infected molted flocks will occur between 4 to 6
weeks post-molt.
(Response) We do not agree that the timing for environmental
testing of unmolted flocks should be modified. As stated in the
proposed rule, environmental testing for SE is an indicator of whether
SE prevention measures are working effectively. Testing provides an
opportunity for producers to evaluate the SE status of their poultry
houses and to take appropriate action if their prevention measures are
not preventing SE. Information from an EQAP with a testing protocol

indicates that the

[[Page 33042]]

highest numbers of positive environmental samples are found when laying
hens are 40 to 45 weeks of age (Ref. 50). Additionally, the Layers 99
study found that flocks less than 60 weeks of age (younger flocks) were
five times more likely to test positive for SE than older flocks (Refs.
27 through 29). In the absence of any new data, we are retaining in the
final rule the requirement that environmental testing for SE be

conducted for the flock in each poultry house when each group of laying
hens making up that flock is 40 to 45 weeks of age. An SE-positive
environmental test at the 40 to 45 week time period notifies a producer
that there is a problem with SE contamination. At this point, action
can be taken to determine if there are SE-contaminated eggs and to keep
SE-contaminated eggs out of the table egg market. Additionally, a
positive environmental test during the 40 to 45 week period (just after
peak lay) gives a producer sufficient notice to make arrangements for
cleaning and disinfection of the contaminated poultry house at

depopulation.
FDA does, however, agree that the post-molt environmental test
should be moved from 20 weeks post-molt to 4 to 6 weeks post-molt. As
the comment noted, the FSIS 2004 draft risk assessment (Ref. 49) (as
well as the final version of the risk assessment, Ref. 22, published in
2005) described research by Ebel and Schlosser (Ref. 23) that indicated
that “[e]vidence from field studies suggests that molted flocks, in
the first 20 weeks of post-molt production, will produce SE-
contaminated eggs more frequently than non-molted flocks” (Ref. 22 at

page 29). As FSIS explained in the draft and final risk assessments,
“[t]he stress of molting is thought to result in an increased
susceptibility of hens to SE infection” (Id.). FSIS relied in its
analysis on data contained in the “Salmonella Enteritidis Pilot
Project Progress Report” (Ref. 51) and the study by Holt on
immunological factors in laboratory hens (Ref. 52), which were
referenced in the proposed rule. As we stated in our response to
comment 4, the data underlying the FSIS risk assessment, which we
reviewed in the proposed rule, do not support a prohibition on induced

molting. However, these data do suggest that there may be some elevated
risk that hens may become infected with SE in the post-molt period,
before 20 weeks have passed. In light of these studies, we have decided
that it would be prudent to conduct environmental SE testing earlier
post-molt than was proposed. Therefore, to evaluate the status of a
laying hen house post-molt to determine the effectiveness of SE
prevention measures during the post-molt laying cycle, we have amended
Sec. 118.5(b) to require an environmental test at 4 to 6 weeks after
the end of any molting process.

(Comment 23) Several comments suggested that FDA revise the
proposed rule to make the environmental sampling plan flexible.
In support of this suggestion, some comments stated that because
the rule would cover very diverse egg laying facilities in the United
States (e.g., free-range farms and confinement operations using cages
or nesting boxes), one single sampling plan would not be effective. One
comment recommended a different sampling plan requirement for each
operation type. The comment suggested that all confinement “barns”
could be sampled under the same plan, and recommended that for such

operations FDA require that a minimum of one manure drag sample be
obtained from each bank of cages. The comment stated that more research
is needed to determine the most appropriate sample sites for operations
that are cage-free, pasture-raised, or free-range. Another comment
noted that the sampling plan should also be flexible because of
variations in operations within geographic areas and across geographic
regions, for example, difference in manure collection/disposal systems.
(Response) FDA agrees that because the final rule covers very
diverse egg laying facilities, the same sampling plan may not be

practical for all operations and that the sampling plan requirement
should be flexible to accommodate variations in housing styles. The
proposed rule did not specify a particular plan; rather it provided at
Sec. 118.7(a) that “[w]ithin each poultry house, you must sample the
environment using a scientifically valid sampling procedure.” In the
final rule, to make more clear that the appropriateness of a sampling
plan depends on the house being sampled, we have modified the language
in Sec. 118.7(a) to require “a sampling plan appropriate to the
poultry house layout.” Specific sampling instructions have been

incorporated into the environmental testing method, “Environmental
Sampling and Detection of Salmonella in Poultry Houses.”
(Comment 24) One comment questioned whether FDA could appropriately
determine whether a producer is using a “scientifically valid sampling
procedure,” as required in proposed Sec. 118.7(a). The comment
suggested that, for example, there might be no reason to believe that
sampling every cage row is more effective than sampling 32 random sites
in a laying house. Another comment stated that the only ways to
generate drag samples that can be compared across the various types of

poultry house are the two discussed in the proposal: Drag swabbing the
aisles (the “whole aisle” method) and swabbing a certain number of
feet of egg belt (the “limited feet from 32 sites” method) because
eggs are collected by hand in only a few houses. Another comment stated
that while the procedure for sampling manure pits in a high rise
facility with caged layers is fairly straightforward, nonconfinement
operations do not have a clear direction on what is the most
appropriate sampling site. The comment asserted that it would be
unreasonable to expect an operation with 10,000 layers to develop a

scientifically valid sampling program when FDA cannot define what is
scientifically valid.
(Response) In the proposal FDA described the “whole aisle” and
“limited feet from 32 sites” swabbing methods and acknowledged
differences in the types of poultry houses and the challenges involved
in sampling all houses representatively and consistently. We asked for
comments about the appropriateness of different methods of drag
swabbing and received no comments that would support one method over
the other. To specifically acknowledge differences between poultry

houses, the rule now requires “a sampling plan appropriate to the
poultry house layout.” FDA believes that there are sufficient data for
producers to develop sampling plans for all poultry environments. Over
the past ten years, FDA has performed environmental sampling in a
variety of poultry houses, which have contained from 3,500 to 250,000
birds and have varied from high rise to shallow pit to sunken water pit
houses. The results of this sampling indicate that the manure area and
eggbelts are the two best areas to sample (Ref. 53). FDA has
incorporated specific sampling instructions into the environmental

testing method, “Environmental Sampling and Detection of Salmonella in
Poultry Houses.”
(Comment 25) One comment stated that because it is common for
producers in Hawaii to have multi-age flocks in one poultry house, it
would be difficult to perform SE testing for specific flocks that reach
the age at which testing is required. The comment further stated that
if there is an environmental positive test result for a typical farm in
Hawaii (5 to 10 acres), there would be no space to store the eggs to
wait for egg

[[Page 33043]]

test results. The comment argued that a positive environmental test
result could mean depopulation of the entire farm and, even if the egg
tests are negative, it could still mean the end of the farm.
(Response) The comment reflects a misunderstanding of the rule.
Section 118.5 requires environmental testing of the entire poultry
house when any group of laying hens in that house is 40 to 45 weeks of
age. If multi-age flocks are housed in the same poultry house, egg

producers must perform environmental testing on the entire house
whenever any group of laying hens in that house reaches 40 to 45 weeks
of age. Furthermore, upon finding an environmental sample positive for
SE, there is no requirement to store or otherwise hold the eggs. The
eggs from a flock in a house that has tested environmentally positive
for SE may continue to be marketed as table eggs until the producer is
notified that an egg test is determined positive for SE. At that point,
the producer must divert those eggs to treatment.
(Comment 26) One comment argued that a testing regulatory scheme

would not be effective in preventing illnesses from SE. This comment
stated that environmental and egg testing only indicates the status of
the house at the time of the test.
(Response) Environmental and egg testing alone do not prevent SE,
but instead serve as an indicator and verification step that the SE
prevention plan is working properly. Further, a positive egg test can
prevent contaminated eggs from reaching consumers and thereby protect
the public health.
Diversion (Sec. Sec. 118.5 and 118.6)

(Comment 27) We received many comments on our proposed requirement
that eggs from a SE-positive layer house environment must be diverted
to pasteurization, unless testing of four pools of 1,000 eggs each
yields SE-negative results. One comment supported the diversion
requirement as a reasonable way to keep higher-risk eggs out of the
table egg market, but stated that the requirement could pose an
economic risk to shell egg producers that do not have their own egg
pasteurization capabilities. Other comments similarly noted that this
requirement could have an economic impact on egg producers that lack

ready access to egg pasteurization facilities, because they will have
to sell their eggs to “breakers” who already have an adequate supply
of eggs (through ownership of laying houses or pre-existing contacts
with such houses). As a result of this arrangement, egg producers will
have to take whatever price they can get from the breakers and the
price will inevitably be much lower than the price they would have
gotten if the eggs had not come from an SE-positive layer house. Some
comments expressed concern that egg product buyers might not want to
purchase product known to have come from eggs diverted because of SE,

further reducing the breaker’s incentive to buy the diverted eggs.
Thus, these comments expressed concern that this diversion would
result in a cost to the industry much greater than that projected by
FDA in the proposal. One comment stated that, even if they were willing
to buy the diverted eggs, breakers might offer a price too low to make
it economically feasible to retain the flock. That same comment noted
that diversion to the pet food supply chain would not be an option
because SE-positive eggs would have to be run through the processing
plant, and stated that destruction may be the only alternative in most

cases.
(Response) FDA recognizes that diversion of eggs may be expensive
or impracticable. We do not agree that we have underestimated these
costs. Further, these costs are outweighed by the public health benefit
realized by diverting contaminated eggs.
In addition, FDA believes there may be some confusion about the
diversion requirement. Under the rule, diversion is required under the
following three scenarios: (1) When the environment tests positive for
SE, and the producer chooses not to test eggs from that house to

determine whether the eggs are also positive; (2) when the eggs in a
house test positive for SE; and (3) by order of an FDA, State, or local
representative after a finding that shell eggs have been produced or
held in violation of this regulation.
(Comment 28) One comment requested that FDA include hard cooking as
an acceptable method of diversion.
(Response) If diversion is required, you do not necessarily have to
send the eggs to a breaker. You may instead divert them to an
alternative process that achieves at least a 5-log reduction in SE,

using, for example, in-shell pasteurization of shell eggs or hard
cooking of shell eggs.
In the proposed rule, FDA defined treatment as “a technology or
process that achieves at least a 5-log destruction of SE for shell
eggs, or the processing of egg products in accordance with the Egg
Products Inspection Act.” We have retained this definition in the
final rule. Thus, as long as the hard-cooking process achieves at least
a 5-log destruction of SE, it is an acceptable method of diversion.
(Comment 29) One comment stated that Hawaii has no egg breaking

facilities, and that the costs of shipping diverted eggs to breaking
facilities in California or elsewhere in the continental United States
would be prohibitive. The comment also noted that in the past some
breaking facilities on the West coast have refused to accept eggs from
Hawaii. The comment requested that the rule be made more flexible to
address the situation facing Hawaii and other States with inadequate or
no egg diversion capacity.
(Response) FDA recognizes that there is regional variation in the
cost of diversion for eggs. For a full discussion of this variation,

see section V.F of this document. We understand that there are
currently no breaking facilities in Hawaii and that it may not be
economically feasible to ship diverted eggs to the continental United
States or Canada. For egg producers in Hawaii, and for others also
unable to avail themselves of breaker facilities, the cost of diversion
per egg is the lost value of a table egg. In the proposed rule, we
estimated that the price to a producer for one dozen diverted eggs in
Hawaii is $0.53, or $0.044 per egg. We recognize that this cost is more
than double the cost of diversion for egg producers in other regions;

however, per our usual approach for public health regulations
promulgated under the FFDCA and the PHS Act, we are establishing
minimum national standards that will equally apply to all States. We
acknowledge that diversion for egg producers in situations such as
those in Hawaii may be particularly financially challenging. As
discussed above, we will use guidance as appropriate to mitigate the
impacts associated with implementation of the rule.

 F. Comments on “Egg Testing for Salmonella Enteritidis (SE)”

(Proposed and Final Sec. 118.6)

(Comment 30) One comment agreed with the sampling protocol
established in Sec. 118.6(c) for egg testing for SE, but stated that
24 hours is not a practical timeline to begin egg testing after a
positive environment is found. The comment suggested that Sec.
118.6(c) require egg producers to immediately notify the appropriate
state agency of the positive environmental findings and that egg
sampling commence within 2 weeks after the environmental test results

are received. Another comment suggested that FDA revise the time period
allowed between receiving a positive environmental sample and
conducting the required egg testing from

[[Page 33044]]

24 to 72 hours to allow for weekends or holidays when laboratory
facilities would most likely not be available to complete the tests.
Several comments further argued that the 24-hour requirement for
initiating egg testing is impossible, as even collecting the eggs

within 24 hours might be difficult at times. In addition, the comments
argued that to arrange testing for 1,000 eggs requires scheduling of
several items, including people, labs, and media, and cannot be done in
24 hours.
(Response) For the reasons identified in the comments, FDA agrees
that 24 hours may not be practical to begin egg testing. Therefore, we
have modified Sec. 118.5(a)(2)(ii) and (b)(2)(ii) in the final rule.
Rather than setting a time when egg testing must begin, the rule
establishes a deadline for conducting and completing such testing and

receiving the results. The final rule requires that the results of egg
testing for the first 1000 eggs must be obtained within 10 calendar
days of receiving notification of the positive environmental test. This
time period allows for the farm to obtain a laboratory to do the work
and collect the eggs and for the laboratory to perform and complete the
tests.
(Comment 31) Two comments stated that the egg sampling procedure
should be witnessed by a regulatory agency, such as a State Department
of Agriculture.

(Response) FDA disagrees. Other FDA regulations, such as Hazard
Analysis and Critical Control Point (HACCP) Procedures for the Safe and
Sanitary Processing and Importing of Juice (21 CFR part 120) and
Procedures for the Safe and Sanitary Processing and Importing of Fish
and Fishery Products (21 CFR parts 123 and 1240), do not require
sampling and other testing to be overseen by FDA or State officials to
be effective. The egg sampling requirement is expected to be routine
and a regular component of the on-farm plan to prevent SE.
Furthermore, to assist FDA in ensuring compliance, the final rule

requires that each facility establish and maintain records of plan
activities, including egg sampling. Such records will assist FDA in
determining whether sampling was performed appropriately.

 G. Comments on “Sampling Methodology for Salmonella Enteritidis (SE)”
(Proposed and Final Sec. 118.7)

(Comment 32) One comment stated that FDA should distinguish between
a sampling plan used to verify or monitor an on-farm program and a
sampling plan used for an SE outbreak trace back. The comment also

asked for clarification of the scientific justification for the
requirement in Sec. 118.7 that egg producers pull a 1,000 egg sample,
regardless of the size of the operation. The comment questioned whether
sampling for monitoring purposes needs to be as extensive as that
undertaken for outbreak trace back situations.
Another comment noted that due to potential breakage, a sample size
of 1,050 eggs would eliminate the problem of having to use cracked or
broken eggs (i.e., the laboratory can select 1,000 eggs from this 1,050
egg pool).

(Response) The rule requires egg testing after receipt of
notification of a positive environmental test (unless the eggs are
treated). Sampling after a positive environmental test is intended to
effectively detect SE-positive eggs from a flock.
The rule requires that egg producers collect and deliver for
testing a minimum of 1,000 intact eggs representative of a day’s
production four times at 2-week intervals, resulting in a total test of
4,000 eggs over an 8-week period. This sampling scheme is based on data
from the SE risk assessment indicating that an SE-contaminated flock

may be producing SE-contaminated eggs with a prevalence of 1 in 1,400
(Ref. 54). The sampling scheme would result in a 95 percent probability
of accurately detecting an SE-positive egg from a flock producing
contaminated eggs with the prevalence calculated in the risk assessment
(Ref. 54).
We agree with the potential for breakage raised in the comment
concerning the sample size for egg testing and have modified Sec.
118.7(b) in the final rule so that the requirement is to “collect and
deliver for testing a minimum of 1,000 intact eggs representative of a

day’s production” (Emphasis added).
With regard to the comment regarding making a distinction between a
sampling plan for monitoring SE on the farm and for an SE outbreak
trace back, FDA notes that this final rule does not address SE outbreak
trace backs and is solely designed for the prevention of SE in shell
eggs during production, storage and transportation. SE outbreak trace
back is beyond the scope of this regulation and will not be addressed
here.

 H. Comments on “Testing Methodology for Salmonella Enteritidis (SE)”
(Proposed and Final Sec. 118.8)

(Comment 33) One comment recommended that FDA modify its required
environmental testing method to conform to the methods currently being
used by the industry, states and laboratories. One such method is that
used by the NPIP. The comment stated that the proposed environmental
testing method requires the use of an extra selective agar, bismuth
sulfate (BS) agar, which has not been proven to be effective in

isolating SE from environmental samples. The comment argued that BS
agar is the agar of choice for isolating S. Typhi from clinical
samples, but that it is not effective for environmental samples of SE.
The comment suggested that the isolation with BS agar is an unnecessary
step that should be eliminated from the method.
(Response) The method we proposed for environmental testing is set
forth in “Detection of Salmonella in Environmental Samples from
Poultry Houses,” which was proposed for inclusion in FDA’s
Bacteriological Analytical Manual (BAM), or an equivalent method with

respect to accuracy, precision, and sensitivity in detecting SE. The
environmental testing method FDA proposed was very similar to the NPIP
environmental testing method. For example, it included the same pre-
enrichment and enrichment broth. It was different only in that it
specified what specific plating agars should be used, and it required
the use of three, not two, plating agars. The selective plating agars
identified in the proposed rule method were brilliant green with
novobiocin (BGN), xylose-lysine tergitol 4 (XLT4), and BS. BGN and XLT4
are two of the selective plating agars that have been used by some

laboratories using the NPIP method.
With respect to the use of BS, FDA has performed additional plating
with layer house environmental SE colonies on BS agar and has
reconsidered the method for conducting environmental testing. As a
result of this review FDA has eliminated the use of BS for
environmental testing in the final rule and has changed the method to
reflect the elimination of the BS agar. The method specified in the
final rule, “Environmental Sampling and Detection of Salmonella in
Poultry Houses,” requires only two agars, BGN and XLT4.

The comment did not challenge the specification that BGN and XLT4
be the plating agars used, and we have not changed this specific
requirement in the final rule. As in the proposed rule, if other
methods are at least equivalent to the specified method in accuracy,
precision and sensitivity in detecting SE, they may be used instead of
the method specified.
(Comment 34) With respect specifically to environmental testing, a

[[Page 33045]]

comment noted that the test does not allow for pooling of samples,
which the comment stated would reduce the number of samples the
laboratory would have to run with no loss in sensitivity of the test.
The comment stated that pooling would reduce costs by 75 percent.
(Response) Although there are data showing that pooling of food
samples, under specified conditions, does not compromise method
sensitivity, we are not aware of any data, and the comment did not
provide any such data, to support pooling for environmental sampling.

Until such data become available, it would be imprudent of FDA to
specify a test that includes compositing of environmental swabs.
(Comment 35) One comment raised concerns about the proposed egg
testing method. The comment stated that the method proposed by FDA
differs from the method used by APHIS, as well as other methods used by
industry, states and laboratories. In addition to the concern that the
method that we proposed is not the same as that used by APHIS, the
comment identified two other specific concerns with the proposed egg
testing method. First, the comment stated that the proposed egg testing

method requires the use of BS, an isolation media that is the media of
choice for isolating Salmonella Typhi from clinical samples. Second,
the comment stated that only two selective agar plates should be
inoculated (BGN and XLT4) instead of the five proposed in the method
for egg testing.
(Response) Neither the description of the method discussed in the
preamble of the proposed rule nor the reference to the method contained
in the codified portion of the proposed rule are correct for the egg
testing methodology. The method referred to in the codified portion of

the proposed rule was actually a comparison study involving varying
media and pre-enrichment. The method for testing eggs adopted in the
final rule is the method in the BAM, chapter 5, “Salmonella.”
Addressing the comments in turn, we disagree that we should adopt
the APHIS egg testing method. Like the BAM method, the APHIS method
first involves the disinfection of eggs and then the cracking, pooling
and mixing of eggs. The two methods diverge at the third step, which is
incubation: In the BAM method the pools are incubated at room
temperature for 96 hours, while in the APHIS method the pools are

incubated for only 72 hours.
The two methods also are different in subsequent steps. In the BAM
method, there is a pre-enrichment step in which a portion of the egg
pool is enriched with trypticase soy broth supplemented with ferrous
sulfate and incubated for 24 hours, after which the pre-enriched sample
is placed into 2 selective enrichment broths (tetrathionate and
Rappaport-Vassiliades), and subsequent inoculation onto three selective
media: BS, xylose lysine desoxycholate (XLD), and Hektoen enteric (HE).
In the APHIS method, there is no pre-enrichment step. Instead, egg

samples from the incubated eggs are inoculated onto 2 selective agars
(brilliant green and XLD). In both methods colonies that grow on the
agar plates are sampled to characterize the organism as Salmonella by
the reaction on two agar slants.
FDA believes that, for the purposes of this final rule, its method
is preferable to the APHIS “Egg Sampling Method” (58 FR 41048, August
2, 1993). First, the addition of ferrous sulfate at the pre-enrichment
step in FDA’s method provides iron, which is needed by Salmonella for
growth and which may not be present in sufficient quantity in the egg;

thus, this step may increase the likelihood of detection. Second, the
two selective enrichment media (tetrathionate and Rappaport-
Vassiliades) used in FDA’s method contain agents that are selective
(inhibitory) against the non-Salmonella organisms. The inhibition of
non-Salmonella organisms enhances the test by reducing competition and
possible overgrowth from other organisms. Third, the use of three,
rather than two, selective plating agars maximizes the possibility of
detecting as many SE strains as possible. We note that the APHIS egg
sampling method was developed and has been in use since 1993. While it

has been and remains a valid sampling method, the FDA method is more
sensitive and can better detect the presence of Salmonella in food, and
our adoption of this newer and more sensitive test will better support
the public health goals of this rule. In summary, FDA believes that the
specific method prescribed for egg testing in this final rule is
tailored to the goals of the rule.
With respect to the two more specific comments, FDA does not agree
with the recommendation to eliminate BS in the method for egg testing,
for the reasons explained in the previous paragraphs. Nor do we agree

that the other two selective agar plates should be BGN and XLT4, rather
than HE and XLD. In a comparison study of selective plating agars using
selected high moisture foods (Ref. 55), the newer selective plating
agars performed comparably with the BAM recommended agars (BS, HE, and
XLD) but offered no advantage. The BAM is a collection of procedures
preferred by analysts in FDA laboratories for the detection in food and
cosmetic products of pathogens and microbial toxins. With some limited
exceptions, these methods have been used and peer reviewed by FDA
scientists as well as by scientists outside FDA. A new agar such as

that proposed in the comments would be added to the BAM only after
research indicated superior performance in the context of a variety of
foods, and where the agar has been validated by collaborative studies.
Therefore, the final rule does not deviate from the proposal in
recommending the use of the BAM-recommended plating agars. However, we
note that another test that is equivalent to the specified test in
accuracy, precision and sensitivity for detecting SE may be used.
(Comment 36) One comment recommended that FDA allow for
improvements in the methodology for Salmonella testing to be easily and

quickly adopted by the industry upon validation of the new method, and
that FDA work with other Federal agencies with approved testing
methods, such as APHIS and FSIS, to facilitate approval of methods and
to reduce the need for one facility to use several different methods
for Salmonella testing. The comment stated that APHIS, FSIS, and
scientific organizations all have approved methods for detecting
Salmonella and SE. The comment further stated that methods need to
provide consistent results, yet be flexible enough to allow the
industry to adapt quickly when improvements are made. For example,

rapid testing methods are available and approved by some Federal
agencies (e.g., FSIS). The comment argued the current proposed rule
would not allow a producer to use a rapid method for testing of
environmental or egg samples. The comment recommended that FDA conduct
a literature review and, if necessary, additional research to determine
what methods are appropriate to detect SE in the environment and egg
samples, with the goal of identifying methods that are appropriate for
the purpose of the testing and less costly (in both time and money) to
the industry.

(Response) In the final rule, FDA is allowing for other methods to
be used for both environmental and egg testing, provided they are
equivalent to the methods we specify in accuracy, precision, and
sensitivity in detecting SE.

[[Page 33046]]

 I. Comments on “Administration of the Salmonella Enteritidis (SE)
Prevention Measures” (Proposed and Final Sec. 118.9)

(Comment 37) Several comments suggested that FDA modify the
requirement in proposed Sec. 118.9 that one qualified individual at
each farm have training equivalent to a standardized curriculum
recognized by FDA or be otherwise qualified through job experience to
administer the SE prevention measures. The comments proposed instead
that FDA require training of a qualified individual responsible for
each farm, even if that person is not an onsite employee. These
comments noted that many producers employ one individual to oversee
multiple farm locations, and that this person generally has more

experience and training than the onsite employees and can provide
better oversight on developing and implementing SE prevention measures.
(Response) We agree and are amending the language in Sec. 118.9 in
the final rule to allow for one or more supervisory personnel, who do
not have to be onsite employees, to be responsible for ensuring
compliance with each farm’s SE prevention measures.
(Comment 38) One comment expressed concern about the burden small
producers may experience in complying with the proposed requirement
that at least one individual at each farm must successfully complete

standardized FDA-curriculum or equivalent training of up to 2 to 3 days
on SE prevention measures for egg production. The comment requested
that FDA consider developing a training program that could be
implemented without requiring travel from the egg operation. Further,
the comment requested that FDA not impose deadlines for such training
that could be difficult for such small producers to meet.
(Response) FDA plans to work with trade associations, State
regulatory officials, and academia/extension officials to develop and
offer training opportunities at venues that should satisfy the needs of

small, medium, and large size facilities. Further, in the final rule,
FDA has reduced the burden of the training requirement by allowing one
or more supervisory personnel to serve as the trained administrator for
all of the firm’s facilities rather than requiring a dedicated, trained
individual at each facility. FDA believes this will substantially
reduce the burden for small producers to comply. Finally, FDA notes
that the rule provides that equivalent job experience can be
substituted for training.

 J. Comments on “Recordkeeping Requirements for the Salmonella
Enteritidis (SE) Prevention Measures” (Proposed and Final Sec.
118.10)

(Comment 39) In the proposed rule, FDA proposed certain
recordkeeping requirements and solicited comments on whether additional
recordkeeping measures should be required for a comprehensive SE
prevention plan, and whether a written SE prevention plan should be
required. Several comments supported the proposed recordkeeping

requirements but did not comment on expanding them; one comment stated
that there is no need for FDA to expand its recordkeeping requirements
beyond those proposed. In addition, several comments supported
expanding the proposed recordkeeping requirements to include a written
SE prevention plan and records for compliance with SE prevention
measures. Several comments noted that such records have been very
useful in conducting inspections of facilities to determine compliance
with the egg quality assurance program requirements and for identifying
problems in the producer’s SE prevention plan when a test is positive.

Another comment stated that records documenting compliance with all
aspects of the SE prevention plan will be essential for a producer to
determine if their plan is effective and in making adjustments to
improve their plan. One comment opposed the requirement of a written SE
prevention plan, stating that while a written plan would undoubtedly be
an important management tool, and indeed many operations have such a
plan, it is not necessary for FDA to mandate such a document. The
comment stated FDA should not place undue emphasis on paperwork, as
opposed to actual results. The comment suggested that FDA work with

interested parties to develop a model SE prevention plan that could be
provided to egg producers for their use.
(Response) FDA agrees with the comments that the final rule should
require a written SE prevention plan as well as records to document the
effective implementation of that plan. This written SE prevention plan
will set forth a producer’s plan to implement the regulation’s
prevention, testing, and diversion measures. A written plan is
necessary for producers to ensure that they have effectively and
consistently implemented SE prevention measures. Further, a written

plan greatly facilitates FDA inspection. SE prevention measures may be
quite different among farms, given different facility design and size,
and yet be equally effective in preventing SE contamination. Knowledge
of the specific prevention measures taken on a farm, as discussed in an
SE prevention plan, will assist FDA to assess compliance with the
prevention measures.
In addition, reviewing records of implementation of a facility’s
specific SE prevention measures is the best mechanism for FDA to use to
determine whether preventive measures have been implemented over a

period of time. These required documents include records of
implementation and compliance with all SE prevention measures. Such
documents, for example, would include documents that pullets were SE
monitored or raised under SE monitored conditions, records of SE
environmental and egg testing, and records of activities required by
the rule, such as treatment or diversion of eggs, as well as records
indicating review of the plan and any changes or modifications made to
the plan. Keeping careful written records will help producers ensure
that they have effectively and consistently implemented SE prevention

measures and will also assist FDA in determining whether the plan is
being followed and in identifying problems in the producer’s plan when
a test is positive. If changes or modifications need to be made,
recording such changes or modifications will help ensure such changes
are implemented.
Therefore, under Sec. 118.10, FDA is requiring that egg producers
covered by all of the requirements in the rule (Sec. 118.1(a)(1))
maintain the following records documenting their SE prevention
measures: (1) A written SE prevention plan; (2) documentation that

pullets were “SE-monitored” or were raised under “SE-monitored”
conditions, including environmental testing records for pullets; (3)
records documenting compliance with the SE prevention measures; and (4)
records of review and of modifications of the SE prevention plan and
corrective actions taken. FDA intends to issue guidance regarding the
recordkeeping requirement.
(Comment 40) Two comments stated that FDA should require purchasers
of diverted eggs (e.g., egg breaking facilities, shell pasteurization
facilities, hard-cooked operations, or other facilities where the eggs

could be treated) to maintain records indicating that the diverted eggs
have been treated. These comments, submitted by an agricultural
department and poultry and livestock commission of two major shell egg
producing states, argued that without records there would be no

[[Page 33047]]

ability to ensure the purchaser would treat the eggs and not simply
divert them back to the table egg market.
(Response) FDA agrees with the comments’ concern that purchasers of

diverted eggs might resell them for the table egg market without
treating them and that buyers might not know that the eggs must receive
a treatment. To address this concern, FDA has modified this final rule
by adding Sec. 118.6(f), which requires that when shell egg producers
divert eggs, the pallet, case, or other shipping container must be
labeled and all documents accompanying the shipment must contain the
following statement: “Federal law requires that these eggs must be
treated to achieve at least a 5-log destruction of Salmonella
Enteritidis or processed as egg products in accordance with the Egg

Products Inspection Act, 21 CFR 118.6(f).” The statement must be
legible and conspicuous. FDA believes this additional requirement will
help reduce the likelihood that these eggs will end up on the market
without having been treated. We note that USDA-FSIS, not FDA, regulates
egg-breaking facilities under the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).
The costs and benefits of this provision are addressed in section V
of this document, Regulatory Impact Analysis.
(Comment 41) One comment questioned the proposed rule to the extent

it did not require an SE prevention plan until a producer has a
positive environmental test. The comment stated that this delay
increases the risk of producing SE-positive eggs that are distributed
into the table egg market prior to the test and increases the
difficulty of the producer reducing or eliminating SE from the
environment and the flock.
(Response) The assertion in the comment that the proposed rule did
not require an SE prevention plan until a producer has a positive
environmental test is incorrect. Neither the proposed nor final rules

make having an SE prevention plan contingent upon a positive
environmental test.
(Comment 42) One comment commended FDA’s statement that “we intend
to consider records that come into our possession under this rule as
generally meeting the definition of a trade secret or commercial
confidential materials” (69 FR 56824 at 56841). However, the comment
requested that FDA identify in the final rule what information will be
considered confidential commercial information (CCI) or a trade secret,
and under what legal authority FDA will defend this designation against

any legal challenges.
(Response) FDA’s regulations in 21 CFR part 20 govern the
disclosure of information under the Freedom of Information Act (FOIA),
including the disclosure of CCI and trade section information. The
agency’s general policies, procedures, and practices relating to the
protection of confidential information received from third parties
apply to information received under this rule. It is not necessary that
FDA designate information upfront as CCI or trade secret because these
determinations can be made before releasing any information. If FDA

denies a request under FOIA, it will rely on the provisions in that
statute which permit the agency to withhold information.
(Comment 43) One comment questioned FDA’s assertion that section
361 of the PHS Act (42 U.S.C. 264) gives it legal authority to inspect
records. The comment argued that FDA’s reliance upon section 361 of the
PHS Act is misplaced and cannot be used to impose records inspection on
food establishments where, according to the comment, such inspection is
not allowed under section 704(a) of the Federal Food, Drug, and
Cosmetic Act (FFDCA) (21 U.S.C. 374(a)).

(Response) In the final rule, FDA relies on sections 402(a)(4) and
701(a) of the FFDCA (21 U.S.C. 342(a)(4) and 371(a)) and sections 311,
361, and 368 of the PHS Act (42 U.S.C. 243, 264, and 271) to require
access to certain records. FDA does not rely on section 704(a) of the
FFDCA for authority to access records in this rule. Furthermore, the
PHS Act provides authority for records access that is independent of
the FFDCA. Specifically, section 361 of the PHS Act authorizes the
Secretary of Health and Human Services (the Secretary) to make and
enforce such regulations as “are necessary to prevent the

introduction, transmission, or spread of communicable diseases from
foreign countries into the States * * * or from one State * * * into
any other State.” The basis for the recordkeeping requirements in the
final rule is further explained in section IV of this document, Legal
Authority.
(Comment 44) One comment encouraged FDA to incorporate an automated
recordkeeping requirement into the proposed rule. The comment stated
that an automated system would enhance and support the recordkeeping
requirements outlined in the proposed rule. The comment argued that

such a system could provide farm-specific data, and an efficient, cost-
effective way to research compliance. The comment stated that an
automated system would greatly reduce the recordkeeping burden placed
upon egg producers as well as the time, frequency, and cost associated
with FDA inspections.
(Response) FDA believes that the least burdensome way of
implementing the recordkeeping requirements is to specify the
information that must be contained in the records, but not the format
in which the records are kept. Automated technology may not be

available or within the means of all producers covered by the rule. We
note that egg producers may choose to use automated recordkeeping as
long as they maintain all of the required records.

 K. Comments on Registration Requirements for Shell Egg Producers (Final
Sec. 118.11)

(Comment 45) In the proposed rule (69 FR 56841 at 56841 through
56842), FDA solicited comments about whether we should require that
shell egg producers register with FDA. Several comments supported

requiring registrations by egg producers covered by the SE prevention
measures. These comments stated that registration of all producers
covered by any of the SE prevention measures would be the most
efficient method of obtaining the information needed to conduct annual
inspections and allocate resources.
Further, several comments stated that such a requirement should be
consistent with the program developed under the agency’s bioterrorism
regulations. The comments further stated that by identifying each
farm’s location and size, a registration requirement would enable more

efficient inspection, as well as better management and oversight of a
shell egg recall.
One comment stated that, to create a level playing field across the
United States, registering all producers is necessary and that FDA may
be able to cooperate with USDA/APHIS, which is presently developing a
premises identification program for all animal premises in the United
States.
(Response) FDA agrees with the comments and is requiring that egg
producers who must comply with all of the SE prevention measures in

this rule, and also those producers who must comply only with the
refrigeration requirements in this rule, register with FDA and provide
information on the name of each farm, its location, layer capacity, and
the number of houses. Persons who transport or hold shell eggs for
shell egg processing or egg products facilities but who are not egg
producers are not required to register with FDA, although they are
subject to the refrigeration requirements in Sec. 118.4.

[[Page 33048]]

FDA intends to conduct inspections of egg farms to ensure that
shell eggs are being produced under controls that will prevent SE
contamination and reduce the likelihood that SE-contaminated eggs will

cause foodborne illness. We will use the producer registration
information to create a database used to efficiently conduct
inspections and allocate inspection resources. Covered egg producers
must register within 30 days of becoming an egg producer or, if already
an egg producer, by the applicable effective date of the rule.

Additionally, registered egg producers are required to notify FDA
within 120 days of ceasing egg production (excluding seasonal egg
producers or those who temporarily cease operation due to labor
disputes, fire, natural disasters, or other temporary conditions).
Producers can register online via the Internet, by completing a
paper form and mailing or faxing it to FDA, or by sending a CD-ROM
containing the relevant registration information to FDA. If ceasing egg
production, producers can notify FDA either online via the Internet or
by completing a paper form and mailing or faxing it to FDA.

(Comment 46) One comment objected to requiring producers who pack
eggs to register, stating that every producer with packing facilities
is registered with the FDA under the registration rule and should not
be required to register a second time. The comment agreed that
producers that do not pack eggs, but sell eggs that will ultimately go
into the table egg market, should be registered so that FDA can ensure
these firms are following the on-farm production and testing
requirements of the SE rule.
(Response) Farms are not required to register under FDA’s

Registration of Food Facilities regulation (21 CFR 1.226(b)). If a farm
also has a packing or processing facility, then only the packing or
processing facility is required to register under the registration rule
if those packing and processing activities do not qualify under the
farm exemption (see “farm” definition for activities that are covered
in the farm exclusion under 21 CFR 1.227(b)(3)). Because the packing/
processing facility registration information may not fully identify the
farm location, FDA is requiring that information in this regulation. If
the information that would be provided by an egg producer during

registration has already been provided under the registration
regulation, the producer may submit its registration number rather than
registering again.
(Comment 47) One comment objected to the proposed registration
requirement as an unnecessary burden and an unreasonable invasion of
privacy. The comment argued that FDA only should check for compliance.
The comment further argued that “unexpected visits are not appropriate
as a respect for other people and the reality is that no one can hide
what you want to see in 24 hours.” The comment further argued that

registration will result in a loss of privacy for the producer and is
unnecessary for the success of the program.
(Response) FDA disagrees with this comment. As stated above,
registration will aid in the identification of egg producers for
inspection and compliance purposes. We will use the producer
registration information to create a database that we will use to
efficiently conduct inspections and allocate inspection resources. With
regard to “unexpected visits,” section 704 of the FFDCA (21 U.S.C.
374) authorizes FDA inspections without advance notice and FDA’s

practice of making such inspections precedes this rule and is
independent of whether registration is required.
(Comment 48) One comment expressed concern that information
submitted to register facilities would be subject to the Federal
Freedom of Information Act (5 U.S.C. 552), and that public release of
this information could result in a decrease of security at the producer
sites. The comment stated that FDA has other means at its disposal to
learn the site information needed to administer this program and still
respect the need for security at the producer sites.

(Response) FDA recognizes that this information may be subject to
disclosure under FOIA, unless there is statutory authority there or
elsewhere that protects it. However, we disagree that the risk of such
disclosure outweighs the public health benefits of collecting this
information. As stated previously, registration will facilitate FDA’s
identification of egg producers for inspection and compliance purposes.
We will use the producer registration information to create a database
that we will use to efficiently conduct inspections and allocate
inspection resources.

 L. Comments on “Enforcement and Compliance” (Proposed and Final Sec.
118.12)

There were no comments on this section.

M. Comments on Request for Comments as to Whether FDA Should Mandate
Special Requirements for Food Establishments That Specifically Serve
Highly Susceptible Populations

(Comment 49) We received a number of responses to our request in

the proposed rule for comments on whether the current FDA Food Code
system (under which states may adopt and implement provisions of the
FDA Food Code) is adequate to protect highly susceptible populations
from salmonellosis, or whether instead we should establish mandatory
Federal standards for food establishments that serve eggs to highly
susceptible populations, such as the elderly. Several of these comments
supported the Federal codification of the egg-related Food Code
provisions for food establishments specifically serving highly
susceptible populations, and one comment opposed codification.

One comment supporting codification stated that egg producers do
not have full control or responsibility for egg safety, and that food
establishments and consumers must share in the responsibility for egg
safety. The comment opposed to setting Federal standards stated that
the egg safety goal cannot be achieved through mandatory Federal
requirements at the food establishment level. The comment recommended
continuing mandatory on-farm efforts while continuing educational
efforts at retail and consumer levels.
(Response) FDA agrees that food establishments that specifically

serve highly susceptible populations can play an important role in egg
safety As we discussed in section I.H., a majority of states and
territories have adopted into their own retail food codes the relevant
egg-associated provisions of the FDA Food Code (sections 3-202.11(C),
3-202.13, 3-202.14(A), and 3-801.11(B)(1) and (B)(2), (C)(2), (E), and
(F)(1) and (F)(2) of FDA’s 2005 Food Code (see discussion under section
I.H of this document regarding the changes made from the 2001 Food
Code)). In addition, other state, local, Federal, or voluntary
standards applicable to these facilities may have similar egg safety

provisions, although we were not able to identify or quantify all such
standards. We agree with the comment that encouraged us to continue
education efforts at the retail and consumer levels. We also agree that
codification of the FDA Food Code provisions is not a necessary
exercise of our authority. Instead, we have determined that we will
continue to encourage states to adopt the relevant provisions of the
FDA Food Code.

[[Page 33049]]

(Comment 50) One comment suggested that we make mandatory those
parts of the Food Code related to the pooling of eggs in all
institutions, including but not limited to those serving specifically
at-risk populations in section 3-8 of the Food Code. The comment stated
that many of the large outbreaks have been related to commercial or
government institutions that misuse eggs, especially when they break
and pool large numbers of eggs. The comment stated that even if the
eggs are delivered SE-free, the hand breaking and pooling of eggs can

result in a contaminated pool due to inadequate hand washing, unclean
utensils, temperature abuse during the breaking process and cross-
contamination from other raw foods. The comment also stated that the
FDA Food Code should be modified to incorporate a requirement that
pasteurized egg products be substituted for shell eggs if the eggs are
to be pooled, as a model for States to follow.
(Response) FDA has determined that the relevant egg safety
provisions of the Food Code should not be mandatory, for the reasons
discussed in the preceding response, including those provisions related

to the pooling of eggs.
The comment concerning modification of the FDA Food Code is beyond
the scope of this rule.

 IV. Legal Authority

As outlined in section II.B of this document, after considering
comments received in response to the proposal, FDA made changes in the
final rule, including the addition of some requirements. The proposed
rule contained an explanation of its legal basis under authorities in

sections 311, 361, and 368 of the PHS Act (42 U.S.C. 243, 264, and 271)
and sections 402(a)(4) and 701(a) of the FFDCA (21 U.S.C. 342(a)(4) and
371(a)). The PHS Act authorizes the Secretary to make and enforce such
regulations as “are necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the States * * * or from one State * * * into any other State”
(section 361(a) of the PHS Act). This authority has been delegated to
the Commissioner of Food and Drugs. Under section 402(a)(4) of the
FFDCA, a food is adulterated if it is prepared, packed, or held under

insanitary conditions whereby it may have been contaminated with filth
or rendered injurious to health. Under section 701(a) of the FFDCA, FDA
is authorized to issue regulations for the efficient enforcement of the
FFDCA. These authorities, as well as others specified in the following
paragraphs, support the new requirements in the final rule.
Section 118.4(e) requires that persons who transport or hold shell
eggs for shell egg processing or egg products facilities must comply
with refrigeration requirements. It is well documented that shell eggs
may contain Salmonella, including transovarian transmitted SE, which

can result in serious, life-threatening illness. Temperature abuse of
shell eggs, such as by failing to refrigerate eggs as required by the
rule, can lead to the multiplication of SE in shell eggs, and thus,
increase the likelihood of illness if the eggs are not thoroughly
cooked. The refrigeration requirement in Sec. 118.4(e) prohibits food
from being held under insanitary conditions and allows for the
efficient enforcement of the FFDCA (21 U.S.C. 342(a)(4) and 371(a)).
Further, this requirement is necessary to prevent the spread of
communicable disease from one state into another state. (42 U.S.C.

264).
Section 118.10 requires that egg producers have written SE
prevention plans and maintain records documenting compliance, as well
as records of review and modification to the plan and any corrective
actions taken. Through records maintenance and review, an egg producer
can, over time, develop a comprehensive picture of its prevention
measures and identify shortcomings or potential shortcomings. A written
plan and records documenting implementation of that plan are necessary
for producers to ensure that they have effectively and consistently

implemented the plan. For example, without records documenting
environmental sampling procedures, a producer cannot ensure that the
environment was sampled using a plan appropriate to the poultry house
layout.
Similarly, records maintenance and access provide FDA with the
opportunity to oversee, in a comprehensive way, the implementation of
the producer’s SE prevention plan, thereby preventing SE contamination
of eggs. SE prevention measures may be quite different among farms,
given different facility design and size, and yet be equally effective

in preventing SE contamination. Knowledge of the specific prevention
measures taken on a farm, as specified in an SE prevention plan, will
assist FDA to assess compliance with the prevention measures. In
addition, reviewing records is the best mechanism for FDA to use to
determine whether preventive measures have been implemented over a
period of time. Because the preventive measures are essential to the
production of safe eggs as a matter of design, the statutory scheme is
benefited by agency access to records that demonstrate that these
measures are being systematically applied.

By requiring records, we will be able to ensure that producers
follow the SE prevention measures so that eggs are prepared, packed and
held under sanitary conditions (21 U.S.C. 342(a)(4) and 371(a)) and in
a manner designed to prevent the spread of communicable disease via SE-
contaminated eggs (42 U.S.C. 264).
Section 118.11 requires registration by egg producers who must
comply with either all of the SE prevention measures or only with the
refrigeration requirements. It is essential that we know, via
registration, certain information about egg producers, such as whether

a producer has 3,000 or more laying hens at a particular farm, so that
we can identify and inspect those farms subject to the rule. Inspection
is necessary to ensure that shell eggs are being produced in compliance
with SE prevention measures, thereby reducing the likelihood of
foodborne illness. Therefore, the registration requirement is necessary
to prevent the spread of communicable disease from one state into
another state. (42 U.S.C. 264).
Section 118.6(f) requires that for diverted eggs, the pallet, case,
or other shipping container must be labeled and all documents

accompanying the shipment must contain the specified statement to
indicate that the eggs must be treated to destroy SE. This requirement
is supported by sections 201(n), 403(a)(1), and 701(a) of the FFDCA (21
U.S.C. 321(n), 343(a)(1), and 371(a)) and sections 311, 361, and 361 of
the PHS Act. Under section 403(a)(1) of the FFDCA, a food is misbranded
if its labeling is false or misleading in any particular. Section
201(n) of the FFDCA provides that in determining whether labeling is
misleading, the agency shall take into account not only representations
made about the product, but also the extent to which the labeling fails

to reveal facts that are material in light of such representations made
or suggested in the labeling or material with respect to consequences
that may result from use of the product under conditions of use
prescribed in the labeling or under customary or usual conditions of
use. FDA previously has relied on these authorities when it required
label statements on shell eggs not processed to destroy all viable
Salmonella (65 FR 76092, December 5, 2000).
The rule requires eggs to be diverted in certain circumstances,
including after a positive egg test, to ensure that SE will

[[Page 33050]]

be destroyed before the eggs are consumed. Without treatment, these
eggs would present the greatest risk of causing SE illnesses. As
discussed in section V of this document, the eggs that must be diverted
to a treatment are worth less than eggs that may be used for the table
egg market. This creates an economic incentive to send the eggs to the
table egg market. Further, without labeling, a purchaser might not know
that particular eggs are subject to the diversion requirement.

Therefore, the agency concludes that information that the eggs must be
treated to destroy SE is material information that must be provided on
the shipping container and accompanying documentation and that the
requirement is necessary to prevent the spread of communicable disease
from one state into another state. (42 U.S.C. 264).
As explained in the proposal, activities that are intrastate in
character, such as the production and final sale of shell eggs to an
institution for ultimate consumption by a consumer within one State,
are subject to regulation under section 361 of the PHS Act (State of

Louisiana v. Mathews, 427 F. Supp. 174, 176 (E.D.La. 1977)). The
proposed rule explained FDA’s reasoning for tentatively determining
that the SE prevention measures in this rule must apply to producers of
shell eggs who sell their eggs intrastate, other than directly to
consumers. For the reasons discussed therein, we are making that
determination final.

Section V. Analysis of Economic Impacts–Final Regulatory Impact Analysis

 VI. Final Regulatory Flexibility Analysis

 A. Introduction

The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The agency believes that this final rule will have a
significant economic impact on a substantial number of small entities.
The comments received concerning the Initial Regulatory Flexibility

Analysis (IRFA) and Proposed Regulatory Impact Analysis (PRIA) are
contained in Section V.C.

 B. Economic Effects on Small Entities

1. Regulated Entities
a. Number of small entities affected.\93\ The Small Business
Administration (SBA) defines chicken and egg producers to be small if
their total revenues are less than $11.5 million (Ref. 120). A producer
that receives $0.45 per dozen eggs and has layers that produce 265 eggs

per year would have to have over 1,100,000 layers in production to earn
revenues of over $11.5 million. Because only about 400 farms fall into
the category of 100,000 or more layers, more than 99 percent of the
farms with more than 3,000 layers are considered small by SBA
standards, and account for roughly 60 percent of all production.\94\
—————————————————————————

\93\ Please refer to Table 6 for a breakdown of the size of
layer farms affected by the rule.

\94\ FDA does not know the exact percentage of production that
comes from farms with more than 1.1 million layers, since the NASS
Census of Agriculture (Ref. 71) does not include detail on the
industry above 100,000 layers. For the purpose of this calculation,
we assume that half of the eggs produced on farms with more than
100,000 layers are produced on farms that are small by SBA
definition.
—————————————————————————

b. Costs to small entities. The final rule will result in costs to
small businesses. These costs are presented in Table 39 of this
document. For the industry as a whole, the average annual cost of the
final rule is estimated to be about $24,100 per farm site covered by
the rule. This translates into an average cost of $0.30 per layer.
Because almost all farms are defined by SBA to be small, these overall
industry costs are representative of the average costs to small farms.

   Table 39--Distribution of Cost by Farm Size, and as a Percentage of Revenue
-------------------------------------------------------------------------------------
                                        Annual per      Annual per       Cost as a
  Farm size (number of layers)         farm cost of    layer cost of   percentage of
                                        rule \1\          rule         revenue \2\
-------------------------------------------------------------------------------------
Less than 3,000...................           $0              $0              $0
3,000 to 19,999...................       12,295            1.01           7.95%
20,000 to 49,999..................       13,899            0.49           3.86%
50,000 to 99,999..................       25,794            0.36           2.83%
100,000 or more...................       96,847            0.19           1.50%
All farms.........................       24,130            0.30           2.36%
-------------------------------------------------------------------------------------
\1\ These figures are derived from calculations made in the Regulatory Impact
     Analysis (RIA).
\2\ The average revenue between 2001-2008 was $12.40 per hen. For the purposes of
     calculating cost as a percentage of revenue, before dividing categorical costs
     by average revenue, FDA adds the average per hen cost to the average per hen
    revenue. Thus, we implicitly assume that the costs of the rule will be passed
    on to the consumer. Although not quantified, it is possible that revenues
    actually increase after the publication of the rule, as consumers perceive
    eggs to be safer.

2. Other Affected Entities \95\
—————————————————————————

\95\ The costs calculated for layer farms in Table 39 include
the costs to chick and pullet farms, transport companies, and
holding facilities. FDA believes that layer farms will absorb much
of the costs associated provisions affecting these other entities.
—————————————————————————

a. Number of small entities affected. i. Introduction. The final
rule requires that layer farms use layers that were raised in SE-
monitored chick and pullet flocks and that they hold and ship shell
eggs under proper refrigeration. In addition to affecting layer farms,
the final rule will likely have an impact on some small chick and
pullet farmers, trucking companies, and holding facilities.
ii. Chick and pullet farms. As with layer farms, nearly 100 percent
of all chick and pullet farms are considered small by SBA definition.

We were unable to break out the number of chick and pullet farms by
data from NAICS or NASS,\96\ but, based on comments received, we
estimate that there are roughly one third as many pullet-raising farms
and chick-raising farms as there are layer farms affected by the rule.
Also from comments, we learned that pullet farms participate in state
EQAPS at the same rate as layer farms. Accordingly, approximately 1,000
pullet houses will be affected by the rule. Because nearly all chicks
are currently raised as certified SE-monitored (95 percent), some 50 or
fewer of these facilities will be affected.

—————————————————————————

\96\ NASS does not break pullet farms down by size of operation.
The 25,624 pullet farms listed in the 2002 NASS (Ref. 71) are
roughly one fourth the total number of layer farms listed. For the
purposes of this analysis, we used data received from public comment
that indicated there are roughly one third as many pullet farms as
there are farms affected by the rule.
—————————————————————————

iii. Trucking companies and holding facilities. SBA defines
trucking companies and holding facilities for farm products to be small
if their total revenues are less than $23.5 million annually (Ref.
120). By this definition, FDA estimates that over 80 percent of
trucking companies and over 60 percent of holding facilities are small
(Ref. 121). Thus, more than 300 holding facilities that are affected by
the final rule are small by SBA definition.\97\
—————————————————————————

\97\ FDA only estimated the number of new refrigerated shipments
necessary due to the final rule. There are nearly 57,000 general
freight trucking establishments (ref. 121). More than 47,000 of
these are small by SBA definition. We do not have information on the
number of trucking companies that specifically ship eggs from farms
with 3,000 or more layers and will therefore be affected by the
final rule.

—————————————————————————

[[Page 33087]]

b. Costs to small entities. i. Chick and pullet farms. We do not
have data for the cost of monitoring chicks for SE. However, Morales
and McDowell (Ref. 91) estimated that pullets monitored for SE cost
approximately $0.003 to $0.02 more per pullet. If we assume the cost
difference is the same for chicks, the total increased annual cost of
requiring SE-monitored chicks is estimated in the RIA for this rule to
be about $87,000, for a cost of about $1,700 per chick farm if roughly

50 are affected. This cost will be borne by pullet growers but could be
passed on to egg farms depending on market conditions.
In addition, pullet houses must be tested for environmental SE
before the pullets are transferred to the layer houses. If the
environment tests positive, the house must be cleaned and disinfected
before another flock enters the house. Furthermore, upon an
environmental positive in the pullet house, layer farms must begin egg
testing on the positive flock within 2 weeks of the start of egg
laying. Farms that test positive for SE in their eggs would be required

to divert their eggs for treatment until they are able to show via
testing that SE is not present in the eggs produced in the infected
house. The cost of the additional steps, cleaning and disinfecting, and
egg testing and diversion, depends on the prevalence of SE in pullet
houses. From data gathered from comments, FDA estimates that the
prevalence of SE in pullet houses is 0 to 1.5 percent. Based on these
factors, as shown in detail in the RIA for this rule, FDA estimates the
total costs generated by the provisions addressing pullets is about $2
million annually, or about $2,000 per pullet farm, per year. FDA

expects that some of these costs could be passed on to the layer
farms.\98\
—————————————————————————

\98\ To see the effects of the costs if passed completely to
layer farms, please refer to Tables 39 and 33.
—————————————————————————

ii. Trucking companies and holding facilities. Based on the cost
per cubic foot of extra refrigeration necessary to meet the 45 [deg]F

threshold, FDA estimates that the refrigeration requirement will cost
the smallest holding facilities less than $500 annually and the largest
holding facilities (those holding more than 1 million eggs at a time)
more than $18,000 annually, for an industry average of nearly $10,000
in increased costs per facility each year. If we assume that the costs
for increased refrigeration are proportional to revenues (because costs
are directly proportional to the volume of eggs held) the smallest 60
percent of holding facilities will incur increased annual costs of
between $500 and $11,000. The larger numbers in this range will be

incurred by the larger facilities still meeting SBA’s definition of
small.
FDA does not have information on the cost of the refrigeration
provision to trucking companies. However, FDA estimates that the large
majority of eggs are currently shipped in refrigerated trucks. For eggs
that are not currently shipped at 45 [deg]F, FDA estimates that the
provision will cost approximately $0.02 per dozen eggs shipped, or $1.7
million across the industry.

 C. Regulatory Options

1. Exemption for Small Entities
i. One possible approach to reduce the impact on small entities
would be to exempt all small entities from the rule. Although this
would significantly reduce costs, it would also significantly reduce
benefits. As mentioned previously, under the SBA size standards the
vast majority of entities affected by this final rule are small. Small
farms include not only farms with a few hundred layers, but also some

larger farms with over 100,000 layers.
An alternative approach, implemented in the final rule, exempts
producers with fewer than 3,000 layers at a particular farm.\99\ While
over 90 percent of farm sites have fewer than 3,000 layers, less than 1
percent of the eggs produced in the United States are produced on these
farms.
—————————————————————————

\99\ An exemption for farms with fewer than 3,000 birds is

consistent with the exemption given by the EPIA for egg farms that
are also egg processors.
—————————————————————————

FDA has decided to exempt all farms with fewer than 3,000 layers
and those farms that sell all of their eggs directly to consumers.
By exempting these farms, we reduce expected benefits by less than
1 percent while reducing expected costs by more than one half. Table 40
of this document shows a detailed breakdown of the potential costs and

benefits of regulating farms with less than 3,000 layers.

   Table 40--Summary of Annual Costs Averted and Benefits Foregone by Exempting
                    Farms Less Than 3,000 Layers
                                              [Millions of dollars]
-------------------------------------------------------------------------------------
                                                      Illnesses     Total      Net
                                               Costs   averted    benefits  benefits
-------------------------------------------------------------------------------------
Provision
-------------------------------------------------------------------------------------
On-Farm Measures
-------------------------------------------------------------------------------------
Rodent and Pest Control \1\................... $16.0     189         $3.4      -$21.5
Biosecurity...................................   8.3    _ _1         _ _1        _ _1
Cleaning and Disinfecting.....................   0.5    _ _1         _ _1        _ _1
Refrigeration.................................   6.1     147          2.6        -3.5
Environmental Testing (Average)...............   6.8 _ _2, 3      _ _2, 3     _ _2, 3
Egg Testing...................................   0.0    _ _2         _ _2        _ _2
Diversion.....................................   0.3     198          3.6        -3.5
Procurement of SE-Monitored Chicks and Pullets   2.3      21          0.4        -1.9
-------------------------------------------------------------------------------------
On-Farm Administrative Measures
-------------------------------------------------------------------------------------
Plan Design...................................  10.9     -- --      -- --       -- --
Recordkeeping.................................  56.9     -- --      -- --       -- --
Training......................................   6.7     -- --      -- --       -- --
Registration..................................  0.42     -- --      -- --       -- --
-------------------------------------------------------------------------------------

[[Page 33088]]

    Total.....................................   115.3    556         9.9     -105.3
-------------------------------------------------------------------------------------
\1\ Estimated rodent control benefits also include benefits from biosecurity and
cleaning and disinfecting.
\2\ The benefits from all elements of the testing and diversion program are reported
jointly under diversion.
\3\ The environmental testing cost number reported is the average of the costs of the
random swab and row based sampling methods.

The exemption of farms with less than 3,000 layers carries over to
entities potentially affected by, but not directly regulated by, the
rule. Pullet farms supplying layer farms with less than 3,000 layers,
will not necessarily need to prove SE-monitored status. Trucks and
storage facilities holding eggs only for farms with less than 3,000

layers need not be refrigerated at 45 [deg]F.
2. Longer Compliance Periods
We recognize that it may be more difficult for some small farms to
learn about and implement these SE prevention measures than it will be
for other farms. Because of this, FDA is giving farm sites with 3,000
or more, but fewer than 50,000 layers, 3 years (as opposed to 1 year
for larger farm sites) to comply with this rule. The longer compliance
period also affects chick and pullet flocks supplied to farms, and the
shipment and storage of eggs for farms with between 3,000 and 50,000

layers.
FDA will continue to evaluate the impact of this rule on smaller
farms and will consider taking appropriate steps to mitigate those
impacts, where it is possible to do so without reducing safety.
Further, FDA will publish guidance for all covered egg producers, and
small entity compliance guides, which will help inform and educate
small businesses on the requirements of the rule. We plan to use
guidance, to the extent feasible, as a vehicle to identify areas where
compliance could be achieved via flexible approaches that would

mitigate the financial impact while preserving the public health
benefits of the rule. Stakeholder participation in these documents will
be solicited and considered.

 D. Description of Recordkeeping and Recording Requirements

The Regulatory Flexibility Act requires a description of the
recordkeeping required for compliance with this final rule. Each farm
site that sells raw (untreated) eggs to the table egg market, other
than directly to the consumer, must design and monitor an SE-prevention

plan. This prevention plan includes all measures the farm is taking to
prevent SE in its flock. The following elements must be included in the
plan: (1) Chicks and pullets, (2) biosecurity, (3) rodent and other
pest control, (4) cleaning and disinfecting, (5) refrigeration, and (6)
testing and diversion. Records are also required for review and of
modifications of the SE-prevention plan and corrective actions taken.
Farms are required to have a trained or experienced supervisor that
would be responsible for overseeing the plan. Furthermore, all farms
covered by any part of the rule are required to register with FDA. The

cost of recordkeeping is exhibited in Table 41 of this document. We
detail in section V.F of this document how recordkeeping costs are
calculated.

   Table 41--Cost of Recordkeeping by Farm Size
------------------------------------------------------------------------
                                          Per farm  cost     Per layer
      Farm size (number of layers)              of            cost of
                                           recordkeeping   recordkeeping
------------------------------------------------------------------------
Less than 3,000.........................              $0           $0.00
3,000 to 19,999.........................           2,070            0.17
20,000 to 49,999........................           2,070            0.07
50,000 to 99,999........................           3,143            0.04
100,000 or more.........................           8,509            0.02
All Farms...............................           2,941            0.04
------------------------------------------------------------------------

 E. Summary

FDA finds that, under the Regulatory Flexibility Act (5 U.S.C.

605(b)), this final rule will have a significant impact on a
substantial number of small entities. More than 1,000 small farms will
be affected by the final rule.

 VII. Unfunded Mandates

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing “any rule that
includes any Federal mandate that may result in the expenditure by

State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.” The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product.\100\ FDA has determined
that this final rule is significant under the Unfunded Mandates Reform
Act. FDA has carried out the cost-benefit analysis in preceding
sections. The other requirements under the Unfunded Mandates Act of
1995 include assessing the rule’s effects on:

—————————————————————————

\100\ In table 7 of this document, describing the total costs of
the rule, costs are annualized. When costs are not annualized,
particularly the first year costs of refrigeration, the total
initial costs are clearly more than $127 million.
—————————————————————————

<bullet> Future costs;

<bullet> Particular regions, communities, or industrial sectors;
<bullet> National productivity;
<bullet> Economic growth;
<bullet> Full employment;
<bullet> Job creation; and

<bullet> Exports.
The issues listed above are covered in detail in the cost benefit
analysis of the

[[Page 33089]]

preceding sections, with the exception of the trade effects of this
final rule, which we will discuss here.
Given the fragile and highly perishable nature of table eggs and

the restrictions imposed by USDA to ensure safety of imported animals
and animal products (9 CFR part 94), few eggs are imported into the
United States. Only three countries, Canada, Mexico, and New Zealand
are permitted to export shell eggs to the United States. Further, since
2004, only New Zealand continues to send shell eggs to the United
States (Ref. 122). In 2006, a firm from New Zealand shipped 55,112
dozen eggs to the United States. These eggs originated from a single
farm in New Zealand with a little more than 3,000 layers (Ref. 122).
These eggs represent about one one-thousandth of the eggs produced in

the United States annually.
In order to qualify to export eggs to the United States, New
Zealand egg production is already highly regulated. Therefore, it is
unlikely the farm that produces the exports to the United States would
bear even the average cost estimated for a similar sized farm in the
United States. However, if we assume the costs are similar across
countries, the final rule would cost the New Zealand farm, or similar
exporting farms, about $3,000 annually, or about $0.04 per dozen eggs
produced.

 VIII. Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act of 1996
(Public Law 104-121) defines a major rule for the purpose of
congressional review as having caused or being likely to cause one or
more of the following: An annual effect on the economy of $100 million
or more; a major increase in costs or prices; significant adverse
effects on competition, employment, productivity, or innovation; or
significant adverse effects on the ability of United States-based

enterprises to compete with foreign-based enterprises in domestic or
export markets. In accordance with the Small Business Regulatory
Enforcement Fairness Act, the Office of Management and Budget (OMB) has
determined that this final rule is a major rule for the purpose of
congressional review.

 IX. Paperwork Reduction Act of 1995

This final rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (44

U.S.C. 3501-3520). A description of these provisions is given in the
following paragraphs with an estimate of the annual recordkeeping and
reporting burdens. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA’s functions,
including whether the information will have practical utility; (2) the

accuracy of FDA’s estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation–Recordkeeping and Registration

Provisions Under 21 CFR Part 118.
Description: FDA is requiring shell egg producers to implement
measures to prevent SE from contaminating eggs on the farm and from
further growth during storage and transportation. Each farm site with
3,000 or more egg laying hens that sells raw eggs to the table egg
market, other than directly to the consumer, and does not have all of
the eggs treated, must design and monitor an SE prevention plan. This
prevention plan includes all measures the farm is taking to prevent SE
in its flock. Records are also required for each of the provisions

included in the plan and for plan review and modifications if
corrective actions are taken. Furthermore, all farms covered by any
part of the rule are required to register with FDA.
We have concluded that recordkeeping is necessary for the success
of the SE prevention measures. Written SE prevention plans and records
of actions taken due to each provision are essential for farms to
implement SE prevention plans effectively. Further, they are essential
for FDA to be able to determine compliance.
Description of Respondents: Businesses or other for-profit

organizations.
FDA estimates the burden of this collection of information as
follows:

                              Table 42--Estimated Annual Recordkeeping Burden 1, 6
-----------------------------------------------------------------------------------------
                               Number of      Annual
      21 CFR section       recordkeepers  frequency of  Total annual  Hours per   Total
                                   \2\    recordkeeping    records  recordkeeper  hours
-----------------------------------------------------------------------------------------
118.10(a)(1) \5\..............  2,600          1           2,600       20          52,000
118.10(a)(2)..................  4,731          1           4,731      0.5           2,366
118.10(a)(3)(ii)..............  4,731         52         246,012      0.5         123,006
118.10(a)(3)(i)...............  4,731         52         246,012      0.5         123,006
118.10(a)(3)(iii) \5\.........    459          1             459      0.5             230
118.10(a)(3)(iii).............    331          1             331      0.5             166
118.10(a)(3)(iv)..............  2,600         52         135,200      0.5          67,600
118.10(a)(3)(v) through           471         52          24,492      0.5          12,246
 (a)(3)(viii) 3, 4, 5.........
                                5,837          1           5,837        0.5         2,919
118.10(a)(3)(v) through           343         52          17,836        0.5         8,918
 (a)(3)(viii) 3, 4............
                                5,965          1           5,965        0.5         2,983
118.10(a)(4) \5\..............    459          1             459         10         4,590
118.10(a)(4)..................    331          1             331         10         3,310
  Total hours for first year..  .........  ...........  ...........  ..........   387,962
  Total recurring hours.......  .........  ...........  ...........  ..........   331,354
-----------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this
   collection of information.
\2\ Some records are kept on a by-farm basis and others are kept on a by-house basis.
   See section V.F of this document for a detailed description of the breakdown.
\3\ The annual frequency of records kept for this provision depends on whether the house
      actually tests positive for SE.

[[Page 33090]]

\4\ Calculations include requirements for pullet and layer houses.
\5\ First year burden.
\6\ Calculations include the burden on foreign firms. FDA identified a single farm with
    more than 3,000 layers
  in New Zealand that exports shell eggs to the United States.

FDA estimates the recordkeeping burden of this final rule to be
387,962 hours in the first year, and 331,354 each year thereafter, as
shown in table 42 of this document.

The number of recordkeepers estimated in column 2 of table 42 of
this document are based on estimates of the total number of layer and
pullet houses affected by this final rule from statistics obtained from
the Layers study, NASS, and comments to the proposed rule. We assume
that those farms that are currently operating according to recognized
industry or State quality assurance plans are already largely in
compliance with the plan design and recordkeeping provisions discussed
in this section, and therefore would not experience additional costs to
comply with recordkeeping provisions. Using data from the Layers study

(Refs. 27 and 28), we find that 59 percent of farms with more than
50,000 layers are currently members of State or industry quality
assurance plans. Fewer than 8 percent of farms with fewer than 50,000
layers are currently members of quality assurance plans. The estimated
number of layer farms incurring a new recordkeeping burden because of
this rule is 2,600, and the number of houses affected is 4,731. A
detailed breakdown of this estimation is shown in table 29 of this
document.
Plan design (Sec. 118.10(a)(1)) and refrigeration records (Sec.

118.10(a)(3)(iv)) will be kept on a per farm basis, so the number of
recordkeepers for these provisions is 2,600. Plan design is a first
year burden only.
Records of chick and pullet procurement (Sec. 118.10(a)(2)),
rodent and other pest control (Sec. 118.10(a)(3)(ii)), and biosecurity
(Sec. 118.10(a)(3)(i)) will be kept on a per house basis, so the
number of recordkeepers for these provisions is 4,731.
Records of cleaning and disinfection (Sec. 118.10(a)(3)(iii)) will
also be kept on a per house basis, but will only need to be kept in the

event that a layer house tests environmentally positive. Design plan
and review (Sec. 118.10(a)(4)) will also need to be performed every
time a house tests positive. As discussed in section V.F of this
document, FDA estimates that 9.7 percent of houses will test
environmentally positive initially and 7.0 percent will test positive
after the provisions of this rule have taken effect. Therefore, the
number of recordkeepers for these provisions is estimated to be 459
(4,731 houses x 0.097) in the first year and 331 (4,731 houses x 0.070)
annually after the first year.

Records of testing, diversion, and treatment (Sec. 118.10(a)(3)(v)
through (a)(3)(viii)) will be kept on a per house basis and will
include records on flocks from pullet houses. From data provided by
comments, FDA estimates that there are one third as many pullet houses
as there are layer houses. Therefore the total number of recordkeepers
for these provisions is 6,308 (4,731 + (4,731/3)). The number of annual
records kept depends on whether houses test positive for SE or not.
This is further discussed in the following paragraphs.
Because information on the costs of designing the SE prevention

plan for eggs is not available, we base these costs on assumptions used
to analyze the design of HACCP programs (63 FR 24253 at 24275 to
24285). In particular, we assume that each plan component will take
approximately 20 hours to design. In the event of an environmental
positive, the farm must review and modify as necessary its plan design.
FDA estimates this will take roughly half the time (10 hours per
provision) that it took to originally draft the plan.
We assume that the time required for recordkeeping is roughly
equivalent to the time necessary to monitor and document the food

safety provisions of a HACCP plan (63 FR 24253 at 24275 to 24286).
Because the HACCP time estimate upon which we are basing our estimate
involves multiple control points and monitoring, this assumption tends
to overstate the cost of recordkeeping for a provision of this final
rule. In particular, we expect that, for each house affected,
recordkeeping will take one half hour per week per provision that would
require weekly or daily monitoring. Records kept for biosecurity
measures, rodent and pest control, and refrigeration are assumed to be
recorded on a weekly basis.

Records for chick and pullet procurement and cleaning and
disinfection will only have to be collected roughly once per year and
are assumed, as above, to require one half hour to produce each record.
Environmental and egg sampling and testing, diversion and treatment
records together have daily, weekly, and monthly aspects, in the event
of an environmental positive. In the case of an environmental positive,
the record’s annual burden is assumed to be similar to the burden
estimated for the weekly records discussed previously. If a house tests
environmentally negative, the burden is similar to the yearly burden

estimated above. In the first year, 471 layer and pullet houses ((4,731
layer houses x 0.097) + ((4731/3 pullet houses) x 0.0075)) are expected
to test positive and 5,837 are expected to test negative ((4,731 layer
houses x 0.903) + ((4731/3 pullet houses) x 0.9925)). In following
years 343 layer and pullet houses ((4,731 layer houses x 0.070) +
((4731/3 pullet houses) x 0.0075)) are expected to test positive \101\
and 5,965 are expected to test negative ((4,731 layer houses x 0.930) +
((4731/3 pullet houses) x 0.9925)).
—————————————————————————

\101\ As discussed in section V.F.1.i of this document, the
pullet houses are estimated to test positive at only a rate of 0.75
percent.
—————————————————————————

The reporting burden due to the registration requirement is shown
in table 43 of this document.

Table 43–Estimated Annual Reporting Burden 1, 4

———————————————————————————————
Number of Annual frequency Total annual Hours per Total
21 CFR section FDA form No. respondents per response responses response hours
———————————————————————————————
118.11 \3\ FDA 3733 \2\ 3,329 1 3,329 2.3 7,657
———————————————————————————————
\1\ There are no capital costs or operating and maintenance costs associated with this
collection of information.
\2\ The term “Form FDA 3733” refers to both the paper version of the form and the

electronic system known as the Shell Egg Producer Registration
Module, which will be available at http://www.access.fda.gov per
Sec. 118.11(b)(1).
\3\ First year burden.

[[Page 33091]]

\4\ Calculations include the burden on foreign firms. FDA identified a single farm

with more than 3,000 layers in New Zealand that exports shell eggs to the United States.

The registration requirement will be a new, one time reporting
burden for all farms with more than 3,000 layers. FDA used NASS to
estimate that there are 3,329 such farms, as detailed in section V.D of
this document. Using experience gained from implementing section 415 of
the FFDCA (21 U.S.C. 350d), FDA estimates that listing the information
required by the final rule and presenting it in a format that will meet
the agency’s registration regulations will require a burden of

approximately 2.3 hours per average facility registration. As detailed
in section V.F of this document, FDA expects that it will take farms
with access to the Internet 2 hours to register and for farms without
easy access to the Internet it will take 3 hours to register. FDA
assumes the number of farms with easy access to the Internet is similar
to the number used in the BT Registration Rule (68 FR 5378 at 5392 to
5403), that is, 71 percent of farms. The average facility burden hour
estimate of 2.3 hours takes into account that some respondents
completing the registration may not have readily available Internet

access (29 percent).
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the agency has submitted the information collection
provisions of this final rule to OMB for review. Interested persons are
requested to fax comments regarding information collection by (see
DATES), to the Office of Information and Regulatory Affairs, OMB. To
ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

Prior to the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB’s decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

 X. Analysis of Environmental Impact

The agency has determined under 21 CFR 25.30(j) that this action is

of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

 XI. Federalism

FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132 on federalism. We have examined the
effects of the requirements of this rule on the relationship between
the Federal Government and the States. The agency concludes that

preemption of State or local rules that establish requirements for the
prevention of Salmonella Enteritidis (SE) in shell eggs during
production, storage, or transportation that are less stringent than
those in this rule is consistent with this Executive order and has
added Sec. 118.12(d) to the rule to reflect this preemptive effect.
Section 3(b) of Executive Order 13132 recognizes that Federal
action limiting the policymaking discretion of States is appropriate
“where there is constitutional and statutory authority for the action
and the national activity is appropriate in light of the presence of a

problem of national significance.” The constitutional basis for FDA’s
authority to regulate the safety and labeling of foods is well
established.
Section 4(a) of Executive Order 13132 expressly contemplates
preemption where the exercise of State authority conflicts with the
exercise of Federal authority under a Federal statute. Moreover,
section 4(b) of Executive Order 13132 authorizes preemption of State
law by rulemaking when the exercise of State authority directly
conflicts with the exercise of Federal authority under the Federal

statute or there is clear evidence to conclude that Congress intended
the agency to have the authority to preempt State law.
State and local laws and regulations that would impose less
stringent requirements for prevention of SE in shell eggs during
production, storage, and transportation would undermine the agency’s
goal of ensuring that shell eggs are produced, stored, and transported
using measures that will prevent their contamination with SE. These
requirements are the minimal national prevention measures that we
believe are necessary to ensure safety. However, the requirements of

this final rule do not preempt State and local laws, regulations, and
ordinances that establish more stringent requirements with respect to
prevention of SE in shell eggs during production, storage, or
transportation.
Section 4(e) of the Executive order provides that, “when an agency
proposes to act through adjudication or rulemaking to preempt State
law, the agency shall provide all affected State and local officials
notice and an opportunity for appropriate participation in the
proceedings.” As required by the Executive order, FDA provided the

States and local governments with an opportunity for appropriate
participation in this rulemaking when it sought input from all
stakeholders through publication of the proposed rule in the Federal
Register on September 22, 2004 (69 FR 56824 at 56889). In the proposal,
FDA specifically described this preemptive effect. The proposal stated
that, through this notice of proposed rulemaking, State and local
governments have a chance to participate in the proceedings, and that
in addition, “appropriate officials and organizations will be
consulted before this proposed action is implemented; the agency plans

to have public meetings specifically addressing the issue of
implementation of these proposed regulations.”
The agency consulted with a working group comprised of State
officials in developing the provisions of that proposed rule. In
addition, we sent facsimiles of a Federal Register document announcing
a public meeting of egg safety and the availability of egg safety
“current thinking” documents prepared by FDA and USDA to Governors,
State health and agriculture commissioners, State attorneys general,
and State food program coordinators.

Further, subsequent to the publication of the proposed rule, the
agency held three public meetings to discuss the provisions of the
rule, answer questions, and solicit comments from stakeholders.
Meetings were held October 28, 2004, in College Park, MD; November 9,
2004, in Chicago, IL; and November 16, 2004, in Los Angeles, CA.
Additionally, presentations on the proposed rule were made to the
following groups: Iowa Egg Industry Symposium in Ames, IA, on November
10, 2004; Central Atlantic States Association of Food and Drug
Officials Meeting in Laurel, MD, in December 2004; Agricultural

Research Service–Food Safety and Inspection Service Joint Food Safety
Meeting in Shepherdstown, WV, in Spring 2005; National Egg Regulatory
Officials Meeting in Orlando, FL, in March 2005; National Egg Quality
School in Indianapolis, IN, in May 2005; and National Egg Regulatory
Officials Meeting in Oklahoma City, OK, in March 2006. Both State and
local government officials attended and participated in these meetings.

[[Page 33092]]

As a result of the extensive outreach FDA conducted during the

proposed rule notice and comment period to provide State and local
officials with the opportunity for meaningful input, we received
comments from numerous State government agencies. Many of the comments
support FDA in developing a national standard for the prevention of SE
in shell eggs during production, storage, and transportation. In fact,
one State agency commented that “we completely agree with proposed
regulations that make measures already taken by many producers
voluntarily, mandatory for all producers * * *.” Another State agency
stated that, “Overall FDA’s proposal to require SE prevention measures

for egg production would provide for an effective nationwide program to
reduce SE. The prevention measures outlined in the proposal have proven
to be effective in the existing State programs.”
FDA recognizes that existing voluntary State programs using egg
quality assurance plans (EQAPs) have been successful in reducing SE
contamination in poultry houses in certain states, as discussed in
section I.G of this document. However, as discussed in response to
comment 1 in section III of this document, these programs are not
uniformly administered or equally comprehensive in their prevention

measures. In addition, currently the EQAPs that exist are voluntary for
shell egg producers. Although the existing EQAPs have similar
requirements, they vary in how those requirements are implemented. This
rule will establish uniform, nationwide requirements to prevent SE in
shell eggs during production, storage, and transportation. FDA believes
that these uniform, nationwide requirements will further reduce SE
illness and deaths associated with egg consumption.
Although comments received from the State agencies agreed that
uniform, nationwide requirements would be most effective, many States

commented that inspections and enforcement by State Departments of
Agriculture would be the most effective method of implementing these
nationwide requirements. They commented that many States have been
conducting similar inspections to ensure compliance with state EQAPs
and have the expertise and knowledge to conduct inspections for FDA. We
agree that we can enlist the assistance of existing EQAP organizations
and State and/or local officials in implementing FDA’s regulation. The
rule provides that a State or locality may, in its own jurisdiction,
enforce this rule by carrying out inspections under Sec. 118.12(b) and

by using the administrative remedies in Sec. 118.12(a) unless FDA
notifies the State or locality in writing that its assistance is no
longer needed. FDA plans to provide guidance to States and localities
through an enforcement and implementation guidance subsequent to this
final rule.
In conclusion, the agency has determined that the preemptive
effects of this final rule are consistent with Executive Order 13132.

 XII. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web site after this document
publishes in the Federal Register.)

1. Centers for Disease Control and Prevention, “Fact Sheets:
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1999.
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5. Voetsch, A.C., T.J. Van Gilder, F.J. Angulo, M.M. Farley, S.
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Commonly Through Food–10 States, 2008. MMWR 2009; 58:333-337.
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[[Page 33093]]

24. American Egg Board, “Egg Industry Facts Sheet,” February 3,
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Health Inspection Service, United States Department of Agriculture,
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36. United States Animal Health Association, “National Standardized
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37. E-mail Correspondence between J. Bradley Brown, FDA, and Jim
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of Agricultural Marketing Service to John Sheehan of Center for Food
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51. United States Department of Agriculture, PA Poultry Producers,
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List of Subjects

21 CFR Part 16

Administrative practice and procedure.

21 CFR Part 118

Eggs and egg products, Incorporation by reference, Recordkeeping
requirements, Safety.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under the authority delegated to the

Commissioner of Food and Drugs, 21 CFR parts 16 and 118 are amended as
follows:

PART 16–REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for 21 CFR part 16 continues to read as
follows:

Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,

467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. Section 16.5 is amended by adding paragraph (a)(5) to read as
follows:

Sec. 16.5 Inapplicability and limited applicability.

(a) * * *
(5) A hearing on an order for diversion or destruction of shell

eggs under section 361 of the Public Health Service Act (42 U.S.C.
264), and Sec. 118.12 of this chapter.
* * * * *

0
3. Part 118 is added to read as follows:

PART 118–PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

Sec.

118.1 Persons covered by the requirements in this part.
118.3 Definitions.
118.4 Salmonella Enteritidis (SE) prevention measures.
118.5 Environmental testing for Salmonella Enteritidis (SE).
118.6 Egg testing for Salmonella Enteritidis (SE).
118.7 Sampling methodology for Salmonella Enteritidis (SE).
118.8 Testing methodology for Salmonella Enteritidis (SE).
118.9 Administration of the Salmonella Enteritidis (SE) prevention
plan.

118.10 Recordkeeping requirements for the Salmonella Enteritidis
(SE) prevention plan.
118.11 Registration requirements for shell egg producers covered by
the requirements of this part.
118.12 Enforcement and compliance.

Authority: 21 U.S.C. 321, 331-334, 342, 371, 381, 393; 42 U.S.C.
243, 264, 271.

Sec. 118.1 Persons covered by the requirements in this part.

(a) If you are a shell egg producer with 3,000 or more laying hens
at a particular farm that does not sell all of your eggs directly to
consumers and that produces shell eggs for the table market, you are
covered by some or all of the requirements in this part, as follows:
(1) If any of your eggs that are produced at a particular farm do
not receive a treatment as defined in Sec. 118.3, you must comply with
all of the requirements of this part for egg production on that farm.
(2) If all of your eggs that are produced at the particular farm

receive a treatment as defined in Sec. 118.3, you must comply only
with the refrigeration requirements in Sec. 118.4(e) for production of
eggs on that farm and with the registration requirements in Sec.
118.11.
(b) If you transport or hold shell eggs for shell egg processing or
egg products facilities, you must comply with the refrigeration
requirements in Sec. 118.4(e). This section applies only to eggs from
farms with 3,000 or more laying hens.

Sec. 118.3 Definitions.

The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the FFDCA) (21 U.S.C. 321) are
applicable to such terms when used in this part, except where they are
redefined in this part. The following definitions also apply:
Biosecurity means a program, including the limiting of visitors on
the farm and in poultry houses, maintaining personnel and equipment
practices that will protect against cross contamination from one

poultry house to another, preventing stray poultry, wild birds, cats,
and other animals from entering poultry houses, and not allowing
employees to keep birds at home, to ensure that there is no
introduction or transfer of Salmonella Enteritidis (SE) onto a farm or
among poultry houses.
Egg products facility means a USDA-inspected egg products plant
where liquid, frozen, and/or dried egg products are produced.
Farm means all poultry houses and grounds immediately surrounding
the poultry houses covered under a single biosecurity program.

Flock means all laying hens within one poultry house.
Group means all laying hens of the same age within one poultry
house.
Induced molting means molting that is artificially initiated.
Laying cycle means the period of time that a hen begins to produce
eggs until it undergoes induced molting or is permanently taken out of
production and the period of time that a hen produces eggs between
successive induced molting periods or between induced molting and the
time that the hen is permanently taken out of production.

Molting means a life stage during which hens stop laying eggs and
shed their feathers.
Pest means any objectionable animal including, but not limited to,
rodents, flies, and larvae.
Positive flock means a flock that has had an egg test that was
positive for SE. A flock is considered positive until that flock meets
the egg testing requirements in Sec. 118.6(c) to return to table egg
production.
Positive poultry house means a poultry house from which there has

been an environmental test that was positive for SE at any time during
the life of a group in the poultry house until that house is cleaned
and disinfected according to Sec. 118.4(d).
Poultry house means a building, other structure, or separate
section within a structure used to house poultry. For structures
comprising more than one section containing poultry, each section that
is separated from the other sections is considered a separate house.
Producer means a person who owns and/or operates a poultry house
containing laying hens which produce shell eggs for human consumption.

Shell egg (or egg) means the egg of the domesticated chicken.
Shell egg processing facility means a facility that processes
(e.g., washes, grades, packs) shell eggs for the table egg market.
Treatment (or treated) means a technology or process that achieves
at least a 5-log destruction of SE for shell eggs, or the processing of
egg products in accordance with the Egg Products Inspection Act.

Sec. 118.4 Salmonella Enteritidis (SE) prevention measures.

You must follow the SE prevention measures set forth in this

section. In addition, you must have and implement a written SE
prevention plan that is

[[Page 33096]]

specific to each farm where you produce eggs and that includes, at a
minimum, the following SE prevention measures:
(a) Pullets. You must procure pullets that are SE monitored or
raise pullets under SE monitored conditions. “SE monitored” means the
pullets are raised under SE control conditions that prevent SE,

including:
(1) Procurement of chicks. Chicks are procured from SE-monitored
breeder flocks that meet the National Poultry Improvement Plan’s
standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or
equivalent standard;
(2) Environmental testing.
(i) The pullet environment is tested for SE when pullets are 14 to
16 weeks of age;
(ii) If the environmental test required in paragraph (a)(2)(i0029 of

this section is negative, you do not need to perform any additional
testing of those birds or their environment until the environmental
test at 40 to 45 weeks of age specified in Sec. 118.5(a); and
(iii) If the environmental test required in paragraph (a)(2)(i) of
this section is positive, you must begin egg testing, as specified in
Sec. 118.6, within 2 weeks of the start of egg laying.
(3) Cleaning and disinfection. If the environmental test required
in paragraph (a)(2) of this section is positive, the pullet environment
is cleaned and disinfected, to include:

(i) Removal of all visible manure;
(ii) Dry cleaning the positive pullet house to remove dust,
feathers, and old feed; and
(iii) Following cleaning, disinfection of the positive pullet house
with spray, aerosol, fumigation, or another appropriate disinfection
method.
(b) Biosecurity. As part of this program, you must take steps to
ensure that there is no introduction or transfer of SE into or among
poultry houses. Among such biosecurity measures you must, at a minimum:

(1) Limit visitors on the farm and in the poultry houses;
(2) Maintain practices that will protect against cross
contamination when equipment is moved among poultry houses;
(3) Maintain practices that will protect against cross
contamination when persons move between poultry houses;
(4) Prevent stray poultry, wild birds, cats, and other animals from
entering poultry houses; and
(5) Not allow employees to keep birds at home.
(c) Rodents, flies, and other pest control. As part of this

program, you must:
(1) Monitor for rodents by visual inspection and mechanical traps
or glueboards or another appropriate monitoring method and, when
monitoring indicates unacceptable rodent activity within a poultry
house, use appropriate methods to achieve satisfactory rodent control;
(2) Monitor for flies by spot cards, Scudder grills, or sticky
traps or another appropriate monitoring method and, when monitoring
indicates unacceptable fly activity within a poultry house, use
appropriate methods to achieve satisfactory fly control.

(3) Remove debris within a poultry house and vegetation and debris
outside a poultry house that may provide harborage for pests.
(d) Cleaning and disinfection. You must clean and disinfect the
poultry house according to these procedures before new laying hens are
added to the house, if you have had an environmental test or an egg
test that was positive for SE at any point during the life of a flock
that was housed in the poultry house prior to depopulation. As part of
the cleaning and disinfection procedures, you must:
(1) Remove all visible manure;

(2) Dry clean the positive poultry house to remove dust, feathers,
and old feed; and
(3) Following cleaning, disinfect the positive poultry house with
spray, aerosol, fumigation, or another appropriate disinfection method.
(e) Refrigeration. You must hold and transport eggs at or below 45
[deg]F ambient temperature beginning 36 hours after time of lay. If the
eggs are to be processed as table eggs and are not processed for the
ultimate consumer within 36 hours from the time of lay and, therefore,
are held and transported as required at or below 45 [deg]F ambient

temperature, then you may then hold them at room temperature for no
more than 36 hours just prior to processing to allow an equilibration
step to temper the eggs.

Sec. 118.5 Environmental testing for Salmonella Enteritidis (SE).

(a) Environmental testing when laying hens are 40 to 45 weeks of
age. As one indicator of the effectiveness of your SE prevention plan,
you must perform environmental testing for SE (as described in
Sec. Sec. 118.7 and 118.8) in a poultry house when any group of laying

hens constituting the flock within the poultry house is 40 to 45 weeks
of age.
(1) If an environmental test at 40 to 45 weeks is negative and your
laying hens do not undergo induced molting, then you do not need to
perform any additional environmental testing within that poultry house,
unless the poultry house contains more than one group of laying hens.
If the poultry house contains more than one group of laying hens, then
you must perform environmental testing on the poultry house when each
group of laying hens is 40 to 45 weeks of age.

(2) If the environmental test at 40 to 45 weeks is positive, then
you must:
(i) Review and make any necessary adjustments to your SE prevention
plan to ensure that all measures are being properly implemented and
(ii) Begin egg testing (described in Sec. 118.6), unless you
divert eggs to treatment as defined in Sec. 118.3 for the life of the
flock in that poultry house. Results of egg testing must be obtained
within 10-calendar days of receiving notification of the positive
environmental test.

(b) Environmental testing after an induced molting period. If you
induce a molt in a flock or a group in a flock, you must perform
environmental testing for SE in the poultry house at 4 to 6 weeks after
the end of any molting process.
(1) If an environmental test at 4 to 6 weeks after the end of the
molting process is negative and none of your laying hens in that
poultry house is molted again, then you do not need to perform any
additional environmental testing in that poultry house. Each time a
flock or group within the flock is molted, you must perform

environmental testing in the poultry house at 4 to 6 weeks after the
end of the molting process.
(2) If the environmental test at 4 to 6 weeks after the end of a
molting process is positive, then you must:
(i) Review and make any necessary adjustments to your SE prevention
plan to ensure that all measures are being properly implemented; and
(ii) Begin egg testing (described in Sec. 118.6), unless you
divert eggs to treatment as defined in Sec. 118.3 for the life of the
flock in that poultry house. Results of egg testing, when conducted,

must be available within 10-calendar days of receiving notification of
the positive environmental test.

Sec. 118.6 Egg testing for Salmonella Enteritidis (SE).

(a)(1) If the environmental test for pullets at 14 to 16 weeks of
age required by Sec. 118.4(a) is positive, you must divert eggs to
treatment (defined in Sec. 118.3) for the life of any flock or conduct
egg testing within 2 weeks of the start of egg laying, as specified in
paragraphs (b) through (e) of this section.

(2) If you have an SE-positive environmental test at any time
during the life of a flock, you must divert eggs to treatment (defined
in Sec. 118.3) for the life of the flock in that positive poultry

[[Page 33097]]

house or conduct egg testing as specified in paragraphs (b) through (e)
of this section.
(b) Eggs must be sampled as described in Sec. 118.7 and tested
using methodology as described in Sec. 118.8.

(c) You must conduct four egg tests, using sampling and methodology
in Sec. Sec. 118.7 and 118.8, on the flock in the positive poultry
house at 2-week intervals. If all four tests are negative for SE, you
are not required to do further egg testing.
(d) If any of the four egg tests is positive for SE, you must
divert, upon receiving notification of an SE-positive egg test, all
eggs from that flock to treatment (defined in Sec. 118.3) until the
conditions of paragraph (c) of this section are met.
(e) If you have a positive egg test in a flock and divert eggs from

that flock and later meet the negative test result requirements
described in paragraph (c) of this section and return to table egg
production, you must conduct one egg test per month on that flock,
using sampling and methodology in Sec. Sec. 118.7 and 118.8, for the
life of the flock.
(1) If all the monthly egg tests in paragraph (e) of this section
are negative for SE, you may continue to supply eggs to the table
market.
(2) If any of the monthly egg tests in paragraph (e) of this

section is positive for SE, you must divert eggs from the positive
flock to treatment for the life of the flock or until the conditions of
paragraph (c) of this section are met.
(f) If you are diverting eggs, the pallet, case, or other shipping
container must be labeled and all documents accompanying the shipment
must contain the following statement: “Federal law requires that these
eggs must be treated to achieve at least a 5-log destruction of
Salmonella Enteritidis or processed as egg products in accordance with
the Egg Products Inspection Act, 21 CFR 118.6(f).” The statement must

be legible and conspicuous.

Sec. 118.7 Sampling methodology for Salmonella Enteritidis (SE).

(a) Environmental sampling. An environmental test must be done for
each poultry house in accordance with Sec. 118.5 (a) and (b). Within
each poultry house, you must sample the environment using a sampling
plan appropriate to the poultry house layout.
(b) Egg sampling. When you conduct an egg test required under Sec.
118.6, you must collect and test the following number of eggs from the

positive poultry house:
(1) To meet the egg testing requirements of Sec. 118.6(c), you
must collect and deliver for testing a minimum of 1,000 intact eggs
representative of a day’s production. The 1,000-egg sample must be
tested according to Sec. 118.8. You must collect and test four 1,000-
egg samples at 2-week intervals for a total of 4,000 eggs.
(2) To meet the monthly egg testing requirement of Sec. 118.6(e),
you must collect and deliver for testing a minimum of 1,000 intact eggs
representative of a day’s production per month for the life of the

flock. Eggs must be tested according to Sec. 118.8.

Sec. 118.8 Testing methodology for Salmonella Enteritidis (SE).

(a) Testing of environmental samples for SE. Testing to detect SE
in environmental samples must be conducted by the method entitled
“Environmental Sampling and Detection of Salmonella in Poultry
Houses,” April 2008, or an equivalent method in accuracy, precision,
and sensitivity in detecting SE. The April 2008 Environmental Sampling
and Detection of Salmonella Web site is located at

http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htm,
current as of
June 26, 2009. The Director of the Federal Register approves the
incorporation by reference of “Environmental Sampling and Detection of
Salmonella in Poultry Houses,” April 2008, in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. The FDA will request approval to incorporate
by reference any updates to this Web site. The FDA will change the date
of the Web site in this paragraph with each update. You may obtain a

copy from Division of Microbiology (HFS-710), Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-436-2364, or you may examine a copy
at the Center for Food Safety and Applied Nutrition’s Library, 5100
Paint Branch Pkwy., College Park, MD, 301-436-2163, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:

http://www.archives.gov/federal_register/code_of_federal_

regulation/ibr_locations.html.
(b) Testing of egg samples for SE. Testing to detect SE in egg
samples must be conducted according to Chapter 5 of FDA’s
Bacteriological Analytical Manual (BAM), December 2007 Edition, or an
equivalent method in accuracy, precision, and sensitivity in detecting
SE. Chapter 5 of FDA’s Bacteriological Analytical Manual, December 2007
Edition, is located at
http://www.fda.gov/Food/ScienceResearch/

LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm070149.htm,
current as of June 26, 2009. The method is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The FDA will request
approval to incorporate by reference any updates to this Web site. The
FDA will change the date of the Web site in this paragraph with each
update. You may obtain a copy from Division of Microbiology (HFS-710),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-

436-2364, or you may examine a copy at the Center for Food Safety and
Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD,
301-436-2163, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to:
http://www.archives.gov/federal_register/
code_of_federal_regulation/ibr_locations.html.

Sec. 118.9 Administration of the Salmonella Enteritidis (SE)
prevention plan.

You must have one or more supervisory personnel, who do not have to
be on-site employees, to be responsible for ensuring compliance with
each farm’s SE prevention plan. This person must have successfully
completed training on SE prevention measures for egg production that is
equivalent to that received under a standardized curriculum recognized
by the Food and Drug Administration or must be otherwise qualified

through job experience to administer the SE prevention measures. Job
experience will qualify this person to perform these functions if it
has provided knowledge at least equivalent to that provided through the
standardized curriculum. This person is responsible for:
(a) Development and implementation of an SE prevention plan that is
appropriate for your specific farm and meets the requirements of Sec.
118.4;
(b) Reassessing and modifying the SE prevention plan as necessary
to ensure that the requirements in Sec. 118.4 are met; and

(c) Review of records created under Sec. 118.10. This person does
not need to have performed the monitoring or created the records.

Sec. 118.10 Recordkeeping requirements for the Salmonella Enteritidis
(SE) prevention plan.

(a) Records: You must maintain the following records documenting
your SE prevention measures:
(1) A written SE prevention plan required by Sec. 118.4;

[[Page 33098]]

(2) Documentation that pullets were “SE monitored” or were raised
under “SE monitored” conditions, including environmental testing
records for pullets, as required by Sec. 118.4(a)(2);
(3) Records documenting compliance with the SE prevention measures,
as follows:
(i) Biosecurity measures;
(ii) Rodent and other pest control measures;

(iii) Cleaning and disinfection procedures performed at
depopulation, when applicable;
(iv) Refrigeration requirements;
(v) Environmental and egg sampling procedures, when applicable,
performed under Sec. 118.7;
(vi) Results of SE testing, when applicable, performed under Sec.
118.8 as required in Sec. Sec. 118.4(a)(2), 118.5, and 118.6;
(vii) Diversion of eggs, if applicable, as required in Sec. 118.6;
and

(viii) Eggs at a particular farm being given a treatment as defined
in Sec. 118.3, if you are a producer complying with the requirements
of this section as described in Sec. 118.1(a)(2).
(4) Records of review and of modifications of the SE prevention
plan and corrective actions taken.
(b) General requirements for records maintained by shell egg
producers. All records required by Sec. 118.10(a) must include:
(1) Your name and the location of your farm,
(2) The date and time of the activity that the record reflects,

(3) The signature or initials of the person performing the
operation or creating the record. The written SE prevention plan must
be dated and carry the signature(s) (not initials) of the person(s) who
administers the plan as described in Sec. 118.9, and
(4) Data and information reflecting compliance activities must be
entered on records at the time the activity is performed or observed,
and the records must contain the actual values observed, if applicable.
(c) Length of time records must be retained. You must retain all
records required by this part at your place of business, unless stored

offsite under Sec. 118.10(d), for 1 year after the flock to which they
pertain has been taken permanently out of production.
(d) Offsite storage of records. You may store the records required
by this part, except for the written SE prevention plan, offsite. You
must be able to retrieve and provide the records at your place of
business within 24 hours of request for official review. Electronic
records are considered to be onsite if they are accessible from an
onsite location.
(e) Official review of records. You must have all records required

by this part available for official review and copying at reasonable
times.
(f) Public disclosure of records. Records required by this part are
subject to the disclosure requirements under part 20 of this chapter.

Sec. 118.11 Registration requirements for shell egg producers covered
by the requirements of this part.

(a) Shell egg producers covered under Sec. 118.1(a) of this part
are required to register their farms with the FDA within 30 days of

becoming an egg producer or, if already an egg producer, by the
applicable effective date of this regulation.
(b) Shell egg producers may register their farms by any of the
following means:
(1) Electronic registration. To register electronically, you must
register at http://www.access.fda.gov, which will be available for
registration 24 hours a day, 7 days a week beginning May 10, 2010. This
Web site is available from wherever the Internet is accessible,

including libraries, copy centers, schools, and Internet cafes.
(i) An individual authorized by the owner or operator of a farm,
such as an agent in charge, may also register a farm electronically.
(ii) FDA strongly encourages electronic registration for the
benefit of both FDA and the registrant.
(iii) Once you complete your electronic registration, FDA will
automatically provide you with an electronic confirmation of
registration and a permanent registration number.
(iv) You will be considered registered once FDA electronically

transmits your confirmation and registration number.
(2) Registration by mail or by fax. If, for example, you do not
have reasonable access to the Internet through any of the methods
described in paragraph (b)(1) of this section, an individual authorized
by the owner or operator of a farm, such as an agent in charge, may
register by mail or fax.
(i) You must register using FDA Form No. 3733. You may obtain a
copy of this form by writing to the U.S. Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993, or by requesting the

form by phone at 1-888-INFO-FDA (1-888-463-6332).
(ii) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(2)(i) of
this section or fax it to the number on the form.
(iii) If any required information on the form is incomplete or
illegible when FDA receives it, FDA will return the form to you for
revision, provided that your mailing address or fax number is legible
and valid. When returning a registration form for revision, FDA will
use the means by which the form was received by the agency (i.e., by

mail or fax).
(iv) FDA will enter complete and legible mailed and faxed
registration submissions into its registration system, along with CD-
ROM submissions, as soon as practicable, in the order FDA receives
them.
(v) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the registration as entered,
confirmation of registration, and your registration number. When
responding to a registration submission, FDA will use the means by

which the registration was received by the agency (i.e., by mail or
fax).
(vi) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility’s
registration. If any information you previously submitted that was
correct at the time of submission subsequently changes, you must update
your facility’s registration within 60 calendar days.
(vii) Your facility is considered registered once FDA enters your

facility’s registration data into the registration system and the
system generates a registration number.
(3) Registration by CD-ROM for multiple submissions. If, for
example, you do not have reasonable access to the Internet through any
of the methods provided under paragraph (b)(1) of this section, you may
register by CD-ROM.
(i) Registrants submitting their registrations in CD-ROM format
must use ISO 9660 (CD-R or CD-RW) data format.
(ii) These files must be submitted on a portable document format

(PDF) rendition of the registration form (FDA Form No. 3733) and be
accompanied by one signed copy of the certification statement that
appears on the registration form.
(iii) Each submission on the CD-ROM must contain the same preferred
mailing address in the appropriate block on FDA Form No. 3733.
(iv) A CD-ROM may contain registrations for as many facilities as
needed up to the CD-ROM’s capacity.
(v) The registration on the CD-ROM for each separate facility must
have a unique file name up to 32 characters long, the first part of

which may be used to identify the parent company.
(vi) You must mail the CD-ROM to the U.S. Food and Drug
Administration,

[[Page 33099]]

10903 New Hampshire Avenue, Silver Spring, MD 20993.
(vii) If FDA receives a CD-ROM that does not comply with these
specifications, it will return the CD-ROM to the submitter unprocessed.
(viii) FDA will enter CD-ROM submissions that comply with these

specifications into its registration system, along with the complete
and legible mailed and faxed submissions, as soon as practicable, in
the order FDA receives them.
(ix) For each facility on the CD-ROM, FDA will mail to the
preferred mailing address a copy of the registration(s) as entered,
confirmation of registration, and each facility’s assigned registration
number.
(x) If any information you previously submitted was incorrect at

the time of submission, you must immediately update your facility’s
registration. If any information you previously submitted that was
correct at the time of submission subsequently changes, you must update
your facility’s registration within 60 calendar days.
(xi) Your facility is considered registered once FDA enters your
facility’s registration data into the registration system and the
system generates a registration number.
(c) No registration fee is required.
(d) You must submit all registration information in the English

language. All information must be submitted using the Latin (Roman)
alphabet.
(e) Each registrant must submit the following information through
one of the methods described in paragraph (b) of this section:
(1) The name, full address, and phone number of the farm; and
(2) The average or usual number of layers of each house and number
of poultry houses on the farm.
(3) A statement in which the shell egg producer certifies that the
information submitted is true and accurate. If the individual

submitting the form is not the shell egg producer in charge of the
farm, the registration must also include a statement in which the
individual certifies that the information submitted is true and
accurate, certifies that he/she is authorized to submit registration,
and identifies by name, address, and telephone number, the individual
who authorized submission of the registration. Each registration must
include the name of the individual registering the farm submitting the
registration, and the individual’s signature (for paper and CD-ROM
options).

(f) Registered egg producers must submit an update to a
registration within 60-calendar days of any change to any of the
information previously submitted by any of the means as provided in
Sec. 118.11(b).
(g) Registered egg producers must notify FDA within 120 days of
ceasing egg production by completing sections 1b, 1c, and 2 of Form
3733. This notification is not required if you are a seasonal egg
producer or you temporarily cease operation due to labor disputes,
fire, natural disasters, or other temporary conditions.

Sec. 118.12 Enforcement and compliance.

(a) Authority. This part is established under authority of the
Public Health Service Act (the PHS Act). Under the FFDCA, the Food and
Drug Administration (FDA) can enforce the food adulteration provisions
under 21 U.S.C. 331 through 334 and 342. Under the PHS Act (42 U.S.C.
264), FDA has the authority to make and enforce regulations for the
control of communicable diseases. FDA has established the following
administrative enforcement procedures for the diversion or destruction

of shell eggs and for informal hearings under the PHS Act:
(1) Upon a finding that any shell eggs have been produced or held
in violation of this part, an authorized FDA representative or a State
or local representative in accordance with paragraph (c) of this
section may order such eggs to be diverted, under the supervision of
said representative, for processing in accordance with the Egg Products
Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) or by a treatment that
achieves at least a 5-log destruction of SE or destroyed by or under
the supervision of an officer or employee of FDA, or, if applicable, of

the State or locality in accordance with the following procedures:
(i) Order for diversion or destruction under the PHS Act. Any
district office of FDA or any State or locality acting under paragraph
(c) of this section, upon finding shell eggs that have been produced or
held in violation of this regulation, may serve a written order upon
the person in whose possession the eggs are found requiring that the
eggs be diverted, under the supervision of an officer or employee of
the issuing entity, for processing in accordance with the EPIA (21
U.S.C. 1031 et seq.) or by a treatment that achieves at least a 5-log

destruction of SE or destroyed by or under the supervision of the
issuing entity, within 10-working days from the date of receipt of the
order, unless, under paragraph (a)(2)(iii) of this section, a hearing
is held, in which case the eggs must be diverted or destroyed
consistent with the decision of the Regional Food and Drug Director
under paragraph (a)(2)(v) of this section. The order must include the
following information:
(A) A statement that the shell eggs identified in the order are
subject to diversion for processing in accordance with the EPIA or by a

treatment that achieves at least a 5-log destruction of SE or
destruction;
(B) A detailed description of the facts that justify the issuance
of the order;
(C) The location of the eggs;
(D) A statement that these eggs must not be sold, distributed, or
otherwise disposed of or moved except as provided in paragraph
(a)(1)(iv) of this section;
(E) Identification or description of the eggs;

(F) The order number;
(G) The date of the order;
(H) The text of this entire section;
(I) A statement that the order may be appealed by written appeal or
by requesting an informal hearing;
(J) The name and phone number of the person issuing the order; and
(K) The location and telephone number of the office or agency
issuing the order and the name of its Director.
(ii) Approval of District Director. An order, before issuance, must

be approved by FDA’s District Director or the Acting District Director.
If prior written approval is not feasible, prior oral approval must be
obtained and confirmed by written memorandum as soon as possible.
(iii) Labeling or marking of shell eggs under order. An FDA, State,
or local representative issuing an order under paragraph (a)(1)(i) of
this section must label or mark the shell eggs with official tags that
include the following information:
(A) A statement that the shell eggs are detained in accordance with
regulations issued under section 361(a) of the PHS Act (42 U.S.C.

264(a)).
(B) A statement that the shell eggs must not be sold, distributed
or otherwise disposed of or moved except, after notifying the issuing
entity in writing, to:
(1) Divert them for processing in accordance with the EPIA or by a
treatment that achieves at least a 5-log destruction of SE or destroy
them or
(2) Move them to another location for holding pending appeal.
(C) A statement that the violation of the order or the removal or

alteration of the tag is punishable by fine or imprisonment or both
(section 368 of the PHS Act (42 U.S.C. 271)).
(D) The order number and the date of the order, and the name of the
government representative who issued the order.

[[Page 33100]]

(iv) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order must not sell, distribute, or otherwise

dispose of or move any eggs subject to the order unless and until
receiving a notice that the order is withdrawn after an appeal except,
after notifying FDA’s district office or, if applicable, the State or
local representative, in writing, to:
(A) Divert or destroy them as specified in paragraph (a)(1)(i) of
this section, or
(B) Move them to another location for holding pending appeal.
(2) The person on whom the order for diversion or destruction is
served may either comply with the order or appeal the order to the

Regional Food and Drug Director in accordance with the following
procedures:
(i) Appeal of a detention order. Any appeal must be submitted in
writing to FDA’s District Director in whose district the shell eggs are
located within 5-working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing must be
held within 5-working days after the appeal is filed or, if requested
by the appellant, at a later date, which must not be later than 20-
calendar days after the issuance of the order. The order may also be

appealed within the same period of 5-working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order must state the ownership or proprietary interest
the appellant has in the shell eggs.
(ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the Regional Food and Drug Director or his or her
designee determines that no genuine and substantial issue of fact has
been raised by the material submitted in connection with the hearing or

from matters officially noticed. If the Regional Food and Drug Director
determines that a hearing is not justified, written notice of the
determination will be given to the parties explaining the reason for
denial.
(iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing must be conducted by the Regional Food and Drug Director or his
designee, and a written summary of the proceedings must be prepared by
the Regional Food and Drug Director.

(A) The Regional Food and Drug Director may direct that the hearing
be conducted in any suitable manner permitted by law and by this
section. The Regional Food and Drug Director has the power to take such
actions and make such rulings as are necessary or appropriate to
maintain order and to conduct an informal, fair, expeditious, and
impartial hearing, and to enforce the requirements concerning the
conduct of hearings.
(B) Employees of FDA will first give a full and complete statement
of the action that is the subject of the hearing, together with the

information and reasons supporting it, and may present oral or written
information relevant to the hearing. The party requesting the hearing
may then present oral or written information relevant to the hearing.
All parties may conduct reasonable examination of any person (except
for the presiding officer and counsel for the parties) who makes any
statement on the matter at the hearing.
(C) The hearing shall be informal in nature, and the rules of
evidence do not apply. No motions or objections relating to the
admissibility of information and views will be made or considered, but

any party may comment upon or rebut any information and views presented
by another party.
(D) The party requesting the hearing may have the hearing
transcribed, at the party’s expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing
will be included with the Regional Food and Drug Director’s report of
the hearing.
(E) The Regional Food and Drug Director must prepare a written
report of the hearing. All written material presented at the hearing

will be attached to the report. Whenever time permits, the Regional
Food and Drug Director may give the parties the opportunity to review
and comment on the report of the hearing.
(F) The Regional Food and Drug Director must include as part of the
report of the hearing a finding on the credibility of witnesses (other
than expert witnesses) whenever credibility is a material issue, and
must include a recommended decision, with a statement of reasons.
(iv) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the Regional Food and Drug Director

must render a decision on the appeal affirming or revoking the
detention order within 5-working days after the receipt of the appeal.
(v) Regional Food and Drug Director decision. If, based on the
evidence presented at the hearing or by the appellant in a written
appeal, the Regional Food and Drug Director finds that the shell eggs
were produced or held in violation of this section, he must affirm the
order that they be diverted, under the supervision of an officer or
employee of FDA for processing under the EPIA or by a treatment that
achieves at least a 5-log destruction of SE or destroyed by or under

the supervision of an officer or employee of FDA; otherwise, the
Regional Food and Drug Director must issue a written notice that the
prior order is withdrawn. If the Regional Food and Drug Director
affirms the order, he must order that the diversion or destruction be
accomplished within 10-working days from the date of the issuance of
his decision. The Regional Food and Drug Director’s decision must be
accompanied by a statement of the reasons for the decision. The
decision of the Regional Food and Drug Director constitutes final
agency action, subject to judicial review.

(vi) No appeal. If there is no appeal of the order and the person
in possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10-working days, or if the demand is
affirmed by the Regional Food and Drug Director after an appeal and the
person in possession of such eggs fails to divert or destroy them
within 10-working days, FDA’s district office or, if applicable, the
State or local representative may designate an officer or employee to
divert or destroy such eggs. It shall be unlawful to prevent or to
attempt to prevent such diversion or destruction of the shell eggs by

the designated officer or employee.
(b) Inspection. Persons engaged in production of shell eggs must
permit authorized representatives of FDA to make, at any reasonable
time, an inspection of the egg production establishment in which shell
eggs are being produced. Such inspection includes the inspection and
sampling of shell eggs and the environment, the equipment related to
production of shell eggs, the equipment in which shell eggs are held,
and examination and copying of any records relating to such equipment
or eggs, as may be necessary in the judgment of such representatives to

determine compliance with the provisions of this section. Inspections
may be made with or without notice and will ordinarily be made during
regular business hours.
(c) State and local cooperation. Under sections 311 and 361 of the
Public Health Service Act, any State or locality that is willing and
able to assist the agency in the enforcement of Sec. Sec. 118.4
through 118.10, and is authorized to inspect or regulate egg production
establishments, may, in its own jurisdiction, enforce Sec. Sec. 118.4
through

[[Page 33101]]

118.10 through inspections under paragraph (b) of this section and
through administrative enforcement remedies specified in paragraph (a)
of this section unless FDA notifies the State or locality in writing
that such assistance is no longer needed. A state or locality may
substitute, where necessary, appropriate State or local officials for
designated FDA officials in this section. When providing assistance
under paragraph (a) of this section, a State or locality may follow the

hearing procedures set out in paragraphs (a)(2)(iii) through (a)(2)(v)
of this section, or may utilize comparable State or local hearing
procedures if such procedures satisfy due process.
(d) Preemption. No State or local governing entity shall establish,
or continue in effect any law, rule, regulation, or other requirement
regarding prevention of SE in shell eggs during production, storage, or
transportation that is less stringent than those required by this part.

Dated: July 2, 2009.

Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16119 Filed 7-7-09; 1:30 pm]

BILLING CODE 4164-01-P

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APPEAL, CLOSED, TYPE-D

U.S. District Court

District of Columbia (Washington, DC)

CIVIL DOCKET FOR CASE #: 1:09-cv-01575-RCL

SHERLEY et al v. SEBELIUS et al Assigned to: Chief Judge Royce C. Lamberth  Case:  1:01-cv-00502-RCL Case in other court:  U. S. Court of Appeals – DC Circuit, 09-05374 Cause: 05:0706 Judicial Review of Agency Actions

Date Filed: 08/19/2009 Date Terminated: 10/27/2009 Jury Demand: None Nature of Suit: 890 Other Statutory Actions Jurisdiction: U.S. Government Defendant

Plaintiff
JAMES L. SHERLEY Dr.	represented by	Ryan G. Koopmans GIBSON, DUNN & CRUTCHER, LLP 1050 Connecticut Avenue, NW Suite 300 Washington, DC 20036-5306 (202) 887-3565 Email: rkoopmans@gibsondunn.com TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar GIBSON, DUNN & CRUTCHER, LLP 1050 Connecticut Avenue, NW Suite 300 Washington, DC 20036-5306 (202) 955-8558 Fax: 202-530-9555 Email: thungar@gibsondunn.com LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo GIBSON, DUNN & CRUTCHER, LLP 1050 Connecticut Avenue, NW Suite 200 Washington, DC 20036 (202) 887-3681 Fax: 202-530-9683 Email: blingo@gibsondunn.com ATTORNEY TO BE NOTICED Samuel B. Casey ADVOCATES INTERNATIONAL 8001 Braddock Road Suite 300 Springfield, VA 22151 (703) 894-1076 Email: sbcasey@advocatesinternational.org PRO HAC VICE ATTORNEY TO BE NOTICED Steven Henry Aden ALLIANCE DEFENSE FUND 801 G Street, NW Suite 509 Washington, DC 20001 (202)393-8690 Fax: (202)347-3622 Email: saden@telladf.org
Plaintiff
THERESA DEISHER Dr.	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) ATTORNEY TO BE NOTICED Steven Henry Aden (See above for address)
Plaintiff
NIGHT-LIGHT CHRISTIAN ADOPTIONS individually and as next friend for Plaintiff Embryos	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) PRO HAC VICE ATTORNEY TO BE NOTICED Steven Henry Aden (See above for address)
Plaintiff
SHAYNE NELSON	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) PRO HAC VICE ATTORNEY TO BE NOTICED Steven Henry Aden (See above for address)
Plaintiff
TINA NELSON	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY ATTORNEY TO BE NOTICED Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) PRO HAC VICE ATTORNEY TO BE NOTICED Steven Henry Aden (See above for address) ATTORNEY TO BE NOTICED
Plaintiff
WILLIAM FLYNN	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) PRO HAC VICE ATTORNEY TO BE NOTICED Steven Henry Aden (See above for address)
Plaintiff
PATRICIA FLYNN	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) PRO HAC VICE ATTORNEY TO BE NOTICED Steven Henry Aden (See above for address)
Plaintiff
CHRISTIAN MEDICAL ASSOCIATION	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) Steven Henry Aden (See above for address)
Plaintiff
EMBRYOS	represented by	Ryan G. Koopmans (See above for address) TERMINATED: 10/30/2009 LEAD ATTORNEY Thomas G. Hungar (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Bradley Jason Lingo (See above for address) ATTORNEY TO BE NOTICED Samuel B. Casey (See above for address) Steven Henry Aden (See above for address)
V.
Defendant
KATHLEEN SEBELIUS in her official capacity as Secretary of the Department of Health and Human Services	represented by	Eric R. Womack U.S. DEPARTMENT OF JUSTICE 20 Massachusetts Avenue, NW Room 7218 Washington, DC 20530 (202) 514-4020 Fax: (202) 616-8470 Email: eric.womack@usdoj.gov LEAD ATTORNEY Joel L. McElvain U.S. DEPARTMENT OF JUSTICE Civil Division, Federal Programs Branch 20 Massachusetts Ave., NW Room 7332 Washington, DC 20001 (202) 514-2988 Fax: (202) 616-8460 Email: joel.l.mcelvain@usdoj.gov LEAD ATTORNEY Kyle Renee Freeny U.S. DEPARTMENT OF JUSTICE 20 Massachusetts Avenue, NW Washington, DC 20001 (202) 514-5108 Email: kyle.freeny@usdoj.gov
Defendant
DEPARTMENT OF HEALTH AND HUMAN SERVICES	represented by	Eric R. Womack (See above for address) LEAD ATTORNEY Joel L. McElvain (See above for address) LEAD ATTORNEY Kyle Renee Freeny (See above for address)
Defendant
FRANCIS S. COLLINS Dr., in his official capacity as Director of the National Institutes of Health	represented by	Eric R. Womack (See above for address) LEAD ATTORNEY Joel L. McElvain (See above for address) LEAD ATTORNEY Kyle Renee Freeny (See above for address)
Defendant
NATIONAL INSTITUTE OF HEALTH	represented by	Eric R. Womack (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Joel L. McElvain (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED Kyle Renee Freeny (See above for address) ATTORNEY TO BE NOTICED

Date Filed	#	Docket Text
08/19/2009	1	COMPLAINT against KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH ( Filing fee $ 350, receipt number 4616023260) filed by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. (Attachments: # 1 Civil Cover Sheet)(rdj) (Entered: 08/20/2009)
08/19/2009		SUMMONS (6) Issued as to KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH, U.S. Attorney and U.S. Attorney General (rdj) (Entered: 08/20/2009)
08/19/2009	2	NOTICE OF RELATED CASE by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. Case related to Case No. 01-502. (rdj) (Entered: 08/20/2009)
08/19/2009	3	MOTION for Preliminary Injunction by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON (Attachments: # 1 Memorandum in Support, # 2 Declaration Bradley J. Lingo, # 3 Bradley J. Lingo Exhibit A, # 4 Bradley J. Lingo Exhibit B, # 5 Bradley J. Lingo Exhibit C, # 6 Bradley J. Lingo Exhibit D, # 7 Declaration Dr. James Sherley, # 8 Declaration Dr. Theresa Deisher, # 9 Declaration Ronald L. Stoddart, # 10 Declaration Mrs. Tina Nelson, # 11 Declaration William T. Flynn)(rdj) (Entered: 08/20/2009)
08/19/2009	4	MOTION to Appoint Guardian ad Litem by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON (Attachments: # 1 Memorandum in Support, # 2 Declaration Ronald L. Stoddart, # 3 Text of Proposed Order)(rdj) (Entered: 08/20/2009)
08/26/2009	5	NOTICE of Appearance by Bradley Jason Lingo on behalf of all plaintiffs (Lingo, Bradley) (Entered: 08/26/2009)
08/26/2009	6	MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Samuel B. Casey, :Firm- Advocates International, :Address- 8001 Braddock Rd., Suite 300, Springfield, VA 22151. Phone No. – 703-894-1076. by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON (Attachments: # 1 Declaration, # 2 Text of Proposed Order)(Hungar, Thomas) (Entered: 08/26/2009)
08/27/2009	7	NOTICE of Appearance by Steven Henry Aden on behalf of WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON (Aden, Steven) (Entered: 08/27/2009)
08/27/2009	8	Joint MOTION for Extension of Time to File /Set Briefing Schedule by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH (Attachments: # 1 Text of Proposed Order)(Womack, Eric) (Entered: 08/27/2009)
08/27/2009	9	ORDER granting Motion 6 for Leave to Appear Pro Hac Vice. Signed by Chief Judge Royce C. Lamberth on 8/27/2009. (lcrcl2, ) (Entered: 08/27/2009)
08/27/2009	10	ORDER granting the Joint Motion 8 for Extension of Time to File; Set/Reset Deadlines: Opposition briefs are due on or before 9/14/2009. Any reply briefs are due on or before 9/28/2009. Signed by Chief Judge Royce C. Lamberth on 8/27/2009. (lcrcl2, ) (Entered: 08/27/2009)
08/27/2009	11	NOTICE of Appearance by Joel L. McElvain on behalf of all defendants (McElvain, Joel) (Entered: 08/27/2009)
08/28/2009	12	NOTICE of Appearance by Eric R. Womack on behalf of all defendants (Womack, Eric) (Entered: 08/28/2009)
08/28/2009		Set/Reset Deadlines: Opposition briefs due by 9/14/2009. Reply briefs due by 9/28/2009. (rje) (Entered: 08/28/2009)
09/01/2009	13	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to KATHLEEN SEBELIUS served on 8/24/2009, answer due 10/23/2009. (Aden, Steven) (Entered: 09/01/2009)
09/01/2009	14	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to FRANCIS S. COLLINS served on 8/21/2009, answer due 10/20/2009. (Aden, Steven) (Entered: 09/01/2009)
09/01/2009	15	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to DEPARTMENT OF HEALTH AND HUMAN SERVICES served on 8/24/2009, answer due 10/23/2009. (Aden, Steven) (Entered: 09/01/2009)
09/01/2009	16	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on Attorney General. Date of Service Upon Attorney General 8/23/09. (Aden, Steven) (Entered: 09/01/2009)
09/01/2009	17	RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the US Attorney. (Aden, Steven) (Entered: 09/01/2009)
09/02/2009	18	NOTICE of Appearance by Samuel B. Casey on behalf of all plaintiffs (Casey, Samuel) (Entered: 09/02/2009)
09/11/2009	19	NOTICE of Defendants' Objection to Plaintiffs' Related Case Designation by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH re 2 Notice of Related Case (McElvain, Joel) (Entered: 09/11/2009)
09/11/2009	20	Unopposed MOTION for Leave to File Excess Pages by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH (Attachments: # 1 Text of Proposed Order)(Womack, Eric) (Entered: 09/11/2009)
09/14/2009	21	ORDER granting defendants' Unopposed Motion 20 for Leave to File Excess Pages. Signed by Chief Judge Royce C. Lamberth on 9/14/2009. (lcrcl2, ) (Entered: 09/14/2009)
09/14/2009	22	MOTION to Dismiss by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH (Attachments: # 1 Memorandum in Support, # 2 Declaration, # 3 Text of Proposed Order)(Womack, Eric) (Entered: 09/14/2009)
09/14/2009	23	Memorandum in opposition to re 3 MOTION for Preliminary Injunction filed by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH. (Womack, Eric) (Entered: 09/14/2009)
09/14/2009	24	NOTICE of Appearance by Kyle Renee Freeny on behalf of all defendants (Freeny, Kyle) (Entered: 09/14/2009)
09/14/2009	25	Memorandum in opposition to re 4 MOTION to Appoint Guardian ad Litem filed by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH. (Attachments: # 1 Text of Proposed Order)(Freeny, Kyle) (Entered: 09/14/2009)
09/16/2009	26	RESPONSE re 19 Notice (Other) of Defendants' Objection to Plaintiffs' Related Case Designation filed by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. (Lingo, Bradley) (Entered: 09/16/2009)
09/18/2009	27	REPLY re 19 Notice (Other) Defendants' Reply Regarding Their Objection to Plaintiffs' Related Case Designation filed by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH. (McElvain, Joel) (Entered: 09/18/2009)
09/28/2009	28	REPLY to opposition to motion re 4 MOTION to Appoint Guardian ad Litem filed by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. (Hungar, Thomas) (Entered: 09/28/2009)
09/28/2009	29	REPLY to opposition to motion re 3 MOTION for Preliminary Injunction filed by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. (Hungar, Thomas) (Entered: 09/28/2009)
09/28/2009	30	NOTICE of Proposed Order by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON re 3 MOTION for Preliminary Injunction (Hungar, Thomas) (Entered: 09/28/2009)
09/28/2009	31	Memorandum in opposition to re 22 MOTION to Dismiss filed by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. (Attachments: # 1 Declaration of Ronald Stoddart in Support of Opposition to Motion to Dismiss, # 2 Text of Proposed Order Denying Defendants' Motion to Dismiss)(Hungar, Thomas) (Entered: 09/28/2009)
10/08/2009	32	REPLY to opposition to motion re 22 MOTION to Dismiss filed by KATHLEEN SEBELIUS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FRANCIS S. COLLINS, NATIONAL INSTITUTE OF HEALTH. (Womack, Eric) (Entered: 10/08/2009)
10/14/2009		Minute Entry for proceedings held before Chief Judge Royce C. Lamberth: Motion Hearing held on 10/14/2009. Motion on Preliminary Injuction heard and held in abeyance. (Court Reporter Theresa Sorensen.) (rje, ) (Entered: 10/14/2009)
10/15/2009	33	ORDER denying defendants' Objection 19 to Plaintiffs' Related Case Designation. Signed by Chief Judge Royce C. Lamberth on 10/15/2009. (lcrcl2, ) (Entered: 10/15/2009)
10/16/2009	34	NOTICE of Appearance by Ryan G. Koopmans on behalf of all plaintiffs (Koopmans, Ryan) (Entered: 10/16/2009)
10/27/2009	35	ORDER granting defendants' Motion 22 to Dismiss. Signed by Chief Judge Royce C. Lamberth on 10/27/2009. (lcrcl2, ) (Entered: 10/27/2009)
10/27/2009	36	MEMORANDUM AND OPINION re: defendants' Motion 22 to Dismiss. A separate Order shall issue this dte. Signed by Chief Judge Royce C. Lamberth on 10/27/2009. (lcrcl2, ) (Entered: 10/27/2009)
10/27/2009	37	ORDER denying as moot plaintiffs' Motion 3 for Preliminary Injunction, and Motion 4 to Appoint Guardian ad Litem. Signed by Chief Judge Royce C. Lamberth on 10/27/2009. (lcrcl2, ) (Entered: 10/27/2009)
10/28/2009	38	NOTICE OF APPEAL as to 35 Order on Motion to Dismiss, 37 Order by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. Filing fee $ 455, receipt number 4616024999. Fee Status: Fee Paid. Parties have been notified. (rdj) (Entered: 10/29/2009)
10/29/2009	39	Transmission of the Notice of Appeal, Order Appealed, and Docket Sheet to US Court of Appeals. The Court of Appeals fee was paid this date re 38 Notice of Appeal,. (rdj) (Entered: 10/29/2009)
10/29/2009		USCA Case Number 09-5374 for 38 Notice of Appeal, filed by THERESA DEISHER, CHRISTIAN MEDICAL ASSOCIATION, PATRICIA FLYNN, JAMES L. SHERLEY, NIGHT-LIGHT CHRISTIAN ADOPTIONS, WILLIAM FLYNN, EMBRYOS, SHAYNE NELSON, TINA NELSON. (znmw, ) (Entered: 10/29/2009)
10/30/2009	40	NOTICE OF WITHDRAWAL OF APPEARANCE as to WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON. Attorney Ryan G. Koopmans terminated. (Koopmans, Ryan) (Entered: 10/30/2009)
11/02/2009	41	NOTICE of Letter Ordering Transcript by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON (Lingo, Bradley) (Entered: 11/02/2009)
11/04/2009	42	NOTICE of Letter Invoking Statutory Right to Expedited Appeal by WILLIAM FLYNN, PATRICIA FLYNN, CHRISTIAN MEDICAL ASSOCIATION, JAMES L. SHERLEY, EMBRYOS, THERESA DEISHER, NIGHT-LIGHT CHRISTIAN ADOPTIONS, SHAYNE NELSON, TINA NELSON (Lingo, Bradley) (Entered: 11/04/2009)
08/19/2010	43	MANDATE of USCA (certified copy) as to 38 Notice of Appeal, Ordered and Adjudged that the judgement of the District Court be reversed with respect to the dismissal of the plaintiffs' claim for lack of standing insofar as it applies to the Doctors and be affirmed in all other respects; the order dismissing as moot plaintiffs' motion for a preliminary injunction be reversed; and the matter be remanded to the district court for further proceedings, in accordance with the opinion of the court filed herein this date. filed by THERESA DEISHER, CHRISTIAN MEDICAL ASSOCIATION, PATRICIA FLYNN, JAMES L. SHERLEY, NIGHT-LIGHT CHRISTIAN ADOPTIONS, WILLIAM FLYNN, EMBRYOS, SHAYNE NELSON, TINA NELSON ; USCA Case Number 09-5374. (ls, ) (Entered: 08/23/2010)
08/23/2010	44	MEMORANDUM OPINION setting forth the Court's reasoning for GRANTING plaintiffs' motion 3 for a preliminary injunction. A separate order shall issue this date. Signed by Chief Judge Royce C. Lamberth on 8/23/2010. (lcrcl2, ) (Entered: 08/23/2010)
08/23/2010	45	ORDER granting plaintiffs' Motion 3 for Preliminary Injunction. Signed by Chief Judge Royce C. Lamberth on 8/23/2010. (lcrcl2, ) (Entered: 08/23/2010)

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PACER Service Center
Transaction Receipt
08/23/2010 16:47:27
PACER Login:	dn0640	Client Code:
Description:	Docket Report	Search Criteria:	1:09-cv-01575-RCL
Billable Pages:	11	Cost:	0.88

]]> http://journihilism.org/?feed=rss2&p=224 0 http://journihilism.org/?p=220 http://journihilism.org/?p=220#comments Wed, 18 Aug 2010 05:30:33 +0000 admin http://journihilism.org/?p=220 The insane arguments about the insensitivity of putting a community center close to where the World Trade Towers once stood might be applied to this crass emporium – where strippers, lap dancers and the like not considered offensive, but, rather, are central, essential even, to the racist, xenophobic mentality that provoked the controversy in the first place.

NY Dolls strip club near ground zero

This “Gentlemans Club and Sports Cabaret” ‘ whatever that is – is just a block north of Park Place – but on the corner, so, equidistant from Ground Zero as is the proposed Islamic community center.

See Bob Cesca’s piece on the strip club.

]]> http://journihilism.org/?feed=rss2&p=220 0 http://journihilism.org/?p=211 http://journihilism.org/?p=211#comments Wed, 04 Aug 2010 19:22:11 +0000 admin http://journihilism.org/?p=211 Here are the PDFs of the report from the bankruptcy examiner appointed by the Delaware Federal Bankruptcy Court, looking at the possibility of fraud in the Tribune Co. leveraged buyout and bankruptcy. The report was unsealed by the judge on Aug 3, 2010. News accounts follow.

Klee_Tribune_Report_v1.pdf 726 pp., 3.9 MB
Klee_Tribune_Report_v2.pdf 473 pp., 2.9 MB
Klee_Tribune_Report_v2_annexA.pdf 71 pp., 631 KB
Klee_Tribune_Report_v2_annexB.pdf 41 pp., 741 KB
Klee_Tribune_Report_v2_annexC.pdf 4 pp., 106 KB
Klee_Tribune_Report_v3.pdf 83 pp., 463 KB
Klee_Tribune_Report_v4.pdf 27 pp., 119 KB

Judge Unseals Tribune Bankruptcy Report, Again Delaying Its Exit from Chapter 11

By: Randall Chase, AP Business Writer

Published: August 03, 2010

WILMINGTON, Del.

The judge overseeing Tribune Co.’s bankruptcy is granting public access to an independent examiner’s report, which in the already-released summary described the leveraged buyout of the Chicago media giant as bordering on fraud..

The judge granted the examiner’s request to unseal his report, which had been sealed last week because of confidentiality concerns by some parties. (full article here)

Judge Delays Tribune Reorganization Hearings, Releases Examiner’s Report
August 4, 2010 at 4:15 AM (PT)

Reorganization Hearing Delayed

While U.S. Bankruptcy Court Judge KEVIN CAREY delayed the start of hearings on TRIBUNE CO.’s reorganization plan from AUGUST 30th to OCTOBER 4th and creditor voting on the proposed TRIBUNE plan until AUGUST 20th, the full text of the independent examiner’s report on the company’s buyout was released, revealing the names of TRIBUNE executives accused of “intentional fraud.”

The report, announced last week but released in full TUESDAY, was compiled by examiner KENNETH KLEE and alleged that then-Treasurer, later CFO CHANDLER BIGELOW and former SVP of Finance DONALD GRENESKO gave false assurances to the backers of the 2007 leveraged buyout that MORGAN STANLEY had issued an opinion that the company would be able to refinance its debt in 2014. KLEE said that the executives were entitled to $400,000 bonuses each if the deal closed, and GRENESKO was able to sell his shares for $4.47 million.

The examiner also faulted VALUATION RESEARCH CORP., hired to evaluate the company’s solvency, as failing to question a TRIBUNE financial projection, resulting in “highly suspect” work, and the TRIBUNE board, which he said did not sufficiently evaluate the information from management and VALUATION RESEARCH CORP.

(this article from All Access Music Group)

]]> http://journihilism.org/?feed=rss2&p=211 0 http://journihilism.org/?p=203 http://journihilism.org/?p=203#comments Tue, 13 Jul 2010 04:49:36 +0000 admin http://journihilism.org/?p=203

]]> http://journihilism.org/?feed=rss2&p=203 0 http://journihilism.org/?p=190 http://journihilism.org/?p=190#comments Wed, 17 Feb 2010 00:57:16 +0000 admin http://journihilism.org/?p=190 For an excellent monograph of the importance of porridges and gruels in medieval Ireland, read this:

Here is another excellent treatment of GRUELS:

]]> http://journihilism.org/?feed=rss2&p=190 0 http://journihilism.org/?p=188 http://journihilism.org/?p=188#comments Tue, 05 Jan 2010 05:55:10 +0000 admin http://journihilism.org/?p=188 Tested here, with a book on Pinkerton’s role at the Cripple Creek, CO miners’ strike:

]]> http://journihilism.org/?feed=rss2&p=188 0 http://journihilism.org/?p=187 http://journihilism.org/?p=187#comments Mon, 28 Dec 2009 19:52:02 +0000 admin http://journihilism.org/?p=187 NIGHTLINE VIEW POINT: PATRIOTISM, JOURNALISM, & WAR
13862 words
17 January 2003
ABC News: Nightline
NLNE
English
Copyright c 2003 American Broadcasting Companies, Inc. All Rights Reserved.

graphics: ABC NEWS: Special Edition: Nightline
ANNOUNCER
This is an ABC News Special Edition of “Nightline.”
TED KOPPEL, ABC NEWS
(VO) There are times when everyone is expected to pull in the same direction.
GEORGE W. BUSH, US PRESIDENT
Either you are with us or you are with the terrorists.
ARI FLEISCHER, WHITE HOUSE PRESS SECRETARY
Reminders to all Americans that they need to watch what they say, watch what they do.
DONALD RUMSFELD, US DEFENSE SECRETARY
And it strikes me that how the press handles this new conflict will also contribute to the success of it.
TED KOPPEL
(VO) In times of war, is the first duty of a journalist to his profession or to his country?
MALE ONE, POLITICIAN
CNN’s coverage of Peter Arnett being used as a propaganda tool by Iraqi dictator Saddam Hussein is disgusting, if not treasonous.
MALE TWO, US MILITARY
It’s absolutely imperative to deny the enemy any information on the disposition, actions, or plans of our forces.
TED KOPPEL
(VO) What is the proper balance between the public’s right to know and the nation’s need for security?
CHRISTIANE AMANPOUR,
CHIEF INTERNATIONAL CORRESPONDENT, CNN
We war reporters would never in conscience reveal things that were supposed to be war secrets.
MALE THREE, TELEVISION REPORTER
The military will decide which battles are seen, and when.
CHRISTIANE AMANPOUR
What happened during the Gulf War was that the news management was because of image more than because of military security.
TED KOPPEL
(VO) Does it depend on the war?
MALE FOUR, INTERVIEWEE
Censorship was just as important as bullets. Loose lips sink ships.
MALE FIVE, INTERVIEWEE
You never see any problems, you’re never allowed to report, nothing’s ever wrong. And it’s a lie.
TED KOPPEL
(VO) Should press ever hold back? Or is the truth always worth telling?
MALE SIX, INTERVIEWEE
They are worried about the political impact of Americans being able to see what war is like. And I think they have a right to see it, they’re the ones that have to make the decision as to whether to go to war or not.
graphics: View Point: Patriotism, Journalism, & War
ANNOUNCER
This is ABC News “Viewpoint: Patriotism, Journalism, and War.” Reporting live from the National Defense University and Fort McNair in Washington, DC, Ted Koppel.
TED KOPPEL
(OC) If that’s really how this debate is going to be framed, journalist or patriot, where should our allegiance lie, the reporters among us should go home right now. But we crafted the opening to the broadcast deliberately to reflect criticisms that are often leveled against the media, that we put breaking news ahead of national security, that we pretend to occupy some lofty neutral perch between the United States and its enemies as though the two sides were moral equivalents, that criticism of the US military in a time of war gives aid and comfort to the enemy. It’s not that simple. And it’s our hope that over the next 90 minutes or so, a spirited discussion between representatives of the media and the military will generate not just heat by also a little light. We know, believe me, we know, that without the strength and sacrifice of the US military, there would be no press freedom. None of would choose to change places with an Iraqi colleague. We understand that our ability to report events during a war cannot be allowed to jeopardize the security of American troops.
TED KOPPEL (CONTINUED)
(OC) But we will also argue that security cannot be used as a catch- all argument to stifle the reporting of bad news when it happens. A free press can be a source of aid and comfort to our enemies but it is also a potent weapon in democracy’s arsenal. You’ll never find even a hint of a difference between the positions of the Iraqi government and the Iraqi media. But then who, with the freedom to exercise the option, believes either one? We have a lot to talk about this evening and some excellent panelists to engage the issues. General George Joulwan, the former NATO commander and a consultant to ABC News. General Walt Boomer, who commanded the Marine forces during the Gulf War. And Rear Admiral Stephen Pietropaoli, US Navy Chief of Information. To my right, Kate Adie, chief news correspondent, BBC News. Tony Snow, the host of “Fox News Sunday.” David Martin, national security correspondent for CBS News. And David Westin, President of ABC News. And let us begin now with what I suggest, General Boomer, may be one of the most contentious questions. In the course of your long and distinguished military career, how many times did an American journalist jeopardize the security of any troops under your command or to your knowledge?
GEN WALTER BOOMER,
(RETIRED) COMMANDER US MARINE CORPS IN DESERT STORM
Not once.
TED KOPPEL
(OC) Has anyone had another experience? General Joulwan?
GENERAL GEORGE JOULWAN,
(RETIRED), ABC NEWS CONSULTANT
No, I can’t recall when it would jeopardize an operation that I’ve had, both in Vietnam and most recently in the Balkans.
TED KOPPEL
(OC) To what then, Admiral Pietropaoli, do you attribute the tensions that, and I think I can fairly say that they have grown over the past 30 years, particularly after Vietnam?
REAR ADMIRAL STEPHEN PIETROPAOLI,
US NAVY CHIEF OF INFORMATION
I think that the tension is less about real anecdotal evidence that it ever comes that way than that the clash of priorities for the two institutions. For the military, even those like my colleagues here who have had positive experiences and in fact have been very open to access by the press, it’s still about accomplishing the mission first. And accomplishing the mission while you are handling, dealing with, and might be distracted by, the presence of news media is at minimum a distraction and theoretically, a critical distracter at a key time. So I think it’s really just a clash of institutional values that, in practice, most frequently works out just fine.
TED KOPPEL
(OC) Tony Snow, you have served both in an Administration, you were speechwriter I believe, . . .
TONY SNOW, FOX NEWS SUNDAY
That’s right, for the first President Bush.
TED KOPPEL
(OC) For the first President Bush. And you’ve been a journalist for most of your professional career. To what do you attribute the tension? I mean, let’s get to some of the nitty-gritty issues here.
TONY SNOW
Well, I think there are a couple of things. One, there’s a culture at issue. It used to be that young men of an age in America had some military experience. And for the last 30 years that has decreasingly been the case. So, the generation that entered journalism before I did had some military experience, they understood what it was like to be on a base. They understood the parameters of military service and they had a sense of what was involved and they had a certain, sense of what troops were going through. You go back to World War II and Ernie Pyle. Here’s a guy who was the sentinel of the working man, he always talked about the families back home, but he also got kicked out of a couple of theaters of battle for being a little too persistent in seeking out the facts. But there was an understanding. Now, a lot of times, if a journalist goes onto a military base, it’s probably a once in a lifetime experience, they’ve been to zoos more often than they’ve been to military bases. And they don’t see a lot of difference between the two. And I think that, has been one of the problems over the years, is just a clash of cultures, where you have people talking past one another. Now, once somebody gets into a theater of battle, all of a sudden they decide it’s a lot better to be familiar with the soldiers.
TED KOPPEL
(OC) You bet. Kate Adie, we’re not only happy to have a woman on the panel, but since the Brits may be our only allies in this war, we wanted to have a Brit with us here, too. I take it you think that we in the American media are a bunch of pussy cats when it comes to dealing with our military and our government?
KATE ADIE, CHIEF NEWS CORRESPONDENT, BBC NEWS
I think you’re much more concerned with patriotism and you take to it more naturally, in a more open way than we do. Not that we are not patriotic. We haven’t had a war of national survival for over 50 years, and that’s where I think the real problem and tension arises for us. If you go on military adventures, and we go on many, more than the Americans. Give a bunch of small islands down the South Atlantic and we’ll go down and get them back. And we’ll interfere in anybody else’s war. We are rather quite keen at that sort of thing. But we are not in the business of war of national survival and haven’t been for a long time.
TED KOPPEL
(OC) Well, we aren’t either, are we?
KATE ADIE
That’s where the tension arises, that journalists would be totally patriotic in a war of national survival. But would not be, or could not be, if they were doing their journalistic job properly if there were points to be raised, questions to be asked about a military operation or adventure.
TED KOPPEL
(OC) David Westin, let me come to you on a question that neither you nor I have particular expertise on, but you’ve got to deal with it more than I do. And that is the new technology. When we were in Vietnam, 32, 33 years ago, and we were covering what you guys were doing, it wouldn’t get on the air until two and a half days after we had covered it in the field. It had to be shipped from Saigon, from Saigon to Tokyo, from Tokyo to Los Angeles, from Los Angeles to New York. And then it was processed and then it was edited and then it would go on the air. These days, it’s all live. Or much of it is live. And we have new capacities that the American public has barely seen yet, that raise problems that I suspect our friends to my left here have to be very concerned about. Talk about that for a moment and the degree to which it causes you concern about what we do and how we do it.
DAVID WESTIN, PRESIDENT ABC NEWS
I think it’s a problem not just for our friends to your left, but also potentially for us because the fact that we have the capability to go live doesn’t necessarily make it right to go live. We do have an editorial function to fulfill, not just a news gathering function. And I think, first of all, we don’t know whether this new technology’s gonna work, a lot of it. We think it may and we don’t know until we get over there in a true battle situation to know whether it’s going to work. But assuming it does, I think we’re gonna have to make some very difficult judgments about what we’re willing to put on live, as opposed to taking the time to review and decide what’s there, what is news worthy? What do the American people really need to know? What’s important to them? And then air it. And that’s gonna be a big challenge for us.
TED KOPPEL
(OC) You and David Martin and I have a luxury that some of our colleagues on the cable networks don’t have. We can make a decision, or you can make that decision for us, folks, we’re not gonna go live. We’re gonna wait until we’ve had a chance to sort through this material, until we’ve had a chance to separate the wheat from the chaff. David, the folks over, David Martin, the folks over at our colleagues at CNN and MSNBC and Fox Cable, who are on the air 24/seven, they can put it on the air right away and they do. What problems does that raise?
DAVID MARTIN,
NATIONAL SECURITY CORRESPONDENT, CBS NEWS
Well, let’s face it, we would too, in a highly competitive story like war.
TED KOPPEL
(OC) For the first couple of days, until the money started to bite a little bit and then they’d want to put their commercials and their, prime time shows on again.
DAVID MARTIN
And I think we’re all gonna be making those same split-2nd decisions for the first, pick your number of hours, 72 hours. The longer you do it, the greater the chance for error. But the cable networks have gotten pretty good at that, at being pretty calm and judicious about what they put on the air. I think it’s been a long time since I was aware of videotape rolling on the air where nobody knew what it was. It just, they just knew it was coming in from where ever the war was. So, it seems to me, even though the competition to be first is there, people are adding at least a moment’s reflection before they go with it.
TED KOPPEL
(OC) We’re not even talking, Admiral, about tape that is being rolled live on the air, we have little portable satellite dishes now that’s gonna make it possible for us to go on the air live as the action is under way. If I were a, military officer or leader, I would be terribly concerned about what that does.
REAR ADMIRAL STEPHEN PIETROPAOLI
And I think that they’ll have, and we’ve discussed this with the bureau chiefs and the coverage for possible contingencies, there will be controls. It’s not gonna be, if you’re with US forces, that we’ve taken you along, you’re not going to necessarily be able to go live if a tactical situation puts troops at risk. On the other hand, that live communication back to the American people whose support for our efforts and our objectives is pretty critical to an overall success. You can have all the military successes on battlefield you want, if it’s not defined for your public as a, success, you haven’t achieved your political objective. So, it cuts both ways. And we will have, for the journalists that are with us, that are accompanying us, some measure of control over when they go live and when they don’t.
TED KOPPEL
(OC) I’ve got a ton of questions to ask all of you, but I want to involve members of our audience as quickly as possible. Go ahead, sir.
CAPTAIN TOM NEFF, AUDIENCE MEMBER
Evening. My name is Captain Tom Neff. I had a question specifically to the senior military leadership. I’d like to hear their opinion about the public perception, sometimes, that the national media leans a little bit to the left and whether you feel that impacts not only what they report but how they report that?
GENERAL GEORGE JOULWAN
Well, let me take a stab at that. Let me put it this way, I think there’s always, you have to consider there’s always, let me use the word “adversarial” relationship between the media and the military. And I think that’s good, I think that’s healthy in a democracy. Whether that’s leaning to the left or right or whatever side of political spectrum you want to go on, but I think you have to consider that you could be friends but you could always, you must always remember that there is this adversarial relationship and I think it’s good. I’ve always said, the first report as a military commander is always wrong, or normally wrong. The media normally gets that report and goes with it. And sometimes it is wrong. Whether that’s left or right, I just say that’s part of the technology we have today, the 24/seven of cable news, and that we and you all that are coming up in the military need to recognize that’s what you’re gonna have to live with. It’s not gonna go away and what you need to is develop the sort of relationship with the media that you can work together whenever you get committed, . . .
TED KOPPEL
(OC) We’ve got to go to a commercial break, but before we do Captain, maybe I’m drawing an inference you didn’t mean to imply. There’s sort of a suggestion here, you know, 20, 30 years ago we might have said, those “pinko liberals with their agenda.” What do you mean when you’re talking about the left these days in the current political climate?
CAPTAIN TOM NEFF
Well, I think, you know, I’ve heard a lot that, you know, that there’s certain, you know, polls that have been taken, that a certain, great percentage of the media tend to vote Democratic.
TED KOPPEL
(OC) Let’s say for the sake of argument you’re absolutely right.
CAPTAIN TOM NEFF
And whether that would impact their reporting or not.
TED KOPPEL
(OC) Let’s say for the argument you’re right, what impact does that have on the relationship between the press and the military? All right. We’ll go to a commercial break and come back a little later.
commercial break
graphics: Patriotism, Journalism, & War
TED KOPPEL
(OC) With characteristic media sneakiness I asked the Captain, a question he wasn’t prepared for. But you got a couple of folks here who, one wants to throw you a lifeline, I don’t know what General Boomer wants to do, go ahead, General.
GEN WALTER BOOMER
Part of the problem, Captain, is that we don’t know each other very well and there’s very little opportunity to get to know each other. And I’m talking about the media and the military. What I’ve found is that once we get to know each other a little better, some of those perceived differences go away. Now, we’re a pretty conservative group in the military, but from my perspective it really doesn’t make any difference if the media’s a little to the left of us, if you want to use that term. We just have to, as General Joulwan said, learn how to work together, because we’re gonna have to, whether you like it or not.
TED KOPPEL
(OC) Tony?
TONY SNOW
Yeah, a couple points, Captain. Number one, right now in the United States, we’re not that deeply divided on partisan lines about whether people are gonna support the military should it come to a war in Iraq. Now, as Kate pointed out, in times when you don’t have a war of national survival, the debate rages whether it’s a justifiable war, whether it’s in the national interest, whether it’s vital, whether it’s worth risking blood and treasure. That’s when you get a partisan divide. We haven’t reached that point yet. The other interesting thing is, there is talk now of imbedding journalists in military forces in Iraq. Well, that changes things as well, because I guarantee you, when the firing starts journalists aren’t gonna be thinking, now, what are they thinking on Capitol Hill? They’re thinking, I’m going to get with somebody who knows what the hell they’re doing and I’m gonna hide, you know. I mean, the fact is, you will suddenly see new relationships because, unlike the Gulf War where a lot of times people were worried about their hair and the camera angle and all that, you’re gonna have folks instead, they’re gonna be on the ground, they’re going to be in military shape. Chances are they’re going to be, you know, they’re gonna be in military dress and there is going to be a much greater understanding. Now, reporters are not always going to be the friends of people who are on the battlefield, in the sense that they may in fact report bad news. But I don’t think the partisan issues are nearly as clear cut on the battlefield as they are here in Capitol Hill. Mainly because, sort of like the joke about faculty lounges, the fighting’s so nasty because the stakes are so small. The stakes are a lot larger in a theater of war.
TED KOPPEL
(OC) Captain, do you have anything you want to add?
CAPTAIN TOM NEFF
No. You know, I’m paid to think on my feet and I think I failed in that.
TED KOPPEL
(OC) Well, in that case, you’d better retreat to another part of your anatomy. Yes, ma’am?
LT COMMANDER LISA BRACKENBERRY,
AUDIENCE MEMBER
Good evening, sir. Lieutenant Commander Lisa Brackenberry. I think everyone here recognizes that disseminating the news is a very important part of journalism, but you also have to sell the news and it makes it a very competitive business. How, much does the need for sensationalism determine the impact of the quality of news reporting?
TED KOPPEL
(OC) Do you, mind if I qualify what you said just a little bit so that I can throw it to my boss because, rather than the need for sensationalism, the need to attract a large and eager audience, how does that grab you? Okay? How much does that affect what we do, David?
DAVID WESTIN
Well, listen, it’s a competitive business and it is a business. And so, no one would believe me if I said it’s simply irrelevant. I think, particularly when we’re talking about the possibly of going to war, which we’re talking about now, that really recedes into the background, in all honesty. I mean, we all, whatever our individual missions are, and we have somewhat different missions, we all realize the importance of a nation going to war and our respective roles in that. And I think we all step it up a notch and we take that very seriously and, that really triumphs over anything else. The other thing I would say is, we shouldn’t underestimate the American people. Our role as journalists in this constitutional democracy is to give people the information they need know in deciding whether we go to war and how we execute a war and things like that. Because, ultimately, it’s up to the people to decide what to do. The American people are interested in these issues. I mean, they care about them and you don’t need to sensationalize them, you don’t need to tart them up somehow. And so, I don’t think we should underestimate our audience, by any means. I don’t think we’ll have any problems having people watching us and listening to us and reading the newspapers and things, if we in fact go to war.
TED KOPPEL
(OC) David Martin, do you ever feel any pressure at all to tart it up a little bit? David covers the Pentagon, it’s a little difficult to tart that up, but go ahead.
DAVID MARTIN
Don’t ask, don’t tell. The pressures on me are strictly competitive. Find it out first, ahead your competition. Get it right, get it on the air. And it has zero to do with sensationalism or even making it particularly spiffy so it will attract a large audience. But I recognize I live in a very circumscribed universe over there. And I’m just, I got my head down and I’m going straight ahead on the story, trying to get there before anybody else. And presentation and stuff like that, all falls way, way behind.
TED KOPPEL
(OC) Kate?
KATE ADIE
I think there’s one new element coming with the new technology. Everybody wants to get their live dish into position. And so much now is done on the live 2-way of somebody standing in front of a camera saying, I’m here, as if that is an achievement in journalism in itself. And this comes particularly when you insert someone into the enemy base, or capital, or the enemy territory. The fact of being there is trumpeted by the network as a great triumph. The fact that you may have nothing to say or that you have little information is rather secondary. And we’re seeing quite an increase in that. And the 24-hour channels are very keen on saying, our guy there. You know, the fact that he’s just riveting over the same old stuff he’s done for the last 24 hours is really a secondary matter. And it is a cosmetic kind of television coverage. And it is coming with 24-hour coverage.
TED KOPPEL
(OC) Let me go back, General Boomer, to that sound bite that we heard in our opening where a member of Congress, who shall remain mercifully anonymous, was accusing Peter Arnett, who was then sitting in Baghdad during the war, of traitorous behavior. You were out there, you were fighting that war. I don’t know if you saw Peter’s reports, but did you, find them traitorous?
GEN WALTER BOOMER
My view was that if he was stupid enough to be there, it was okay with me. I really didn’t care. I, had so much to think about, as did my colleagues, that it didn’t worry us. And there wasn’t anything that he was doing that was impacting us one way or the other. Plus the fact that he was there really seemed to alienate a lot of people and he was reporting the obvious, so there goes a cruise missile. Well.
TED KOPPEL
(OC) Let me suggest an alternative theory here, that at a time when I suspect you didn’t have a lot of human intelligence on the ground, doesn’t anything that you’re getting out of Baghdad help you just a little bit?
GEN WALTER BOOMER
I’m not sure that Peter offered us very much, but that could be the case. And you’re always craving more intelligence. You never have enough.
TED KOPPEL
(OC) Okay. Lady in the back?
LISA ANDERSON, AUDIENCE MEMBER
I’m Lisa Anderson from the Army Management Staff College. I’d like to address this question to anyone on the panel. It seems to me that the national press has access to critical information about military operations and we often, as military journalists, have the same information but we’re prevented from releasing it to our own people. Don’t you think the soldier, sailors, airmen, Marines, and civilian employees have the same right to that information?
TED KOPPEL
(OC) General Joulwan?
GENERAL GEORGE JOULWAN
I don’t think so. I think coming from a source that’s inside the military is much different than coming from, I believe, a national television network. I think we do have certain responsibilities and I’d like to bring up the word “accountability” on all sides here. And accountability on the military side for protecting the lives of our troops as we’re gonna go into deployments. And I think there’s also accountability on the media side that needs to be recognized and I don’t we, say enough about that. So, I would say there is a difference, in my opinion, between what would be reported by, say, military, journalists and by the national media. But accountability, to me, is very important.
TED KOPPEL
(OC) George, just, beat on that drum a little more, when you talk about accountability, you talk to me, what’s my accountability to you in this regard or to the American public?
GENERAL GEORGE JOULWAN
I think David said it, to get it right. If you don’t get it right, what is the accountability on the part of, . . .
DAVID MARTIN
Oh, I’ll give you quick answer on that George, you get toasted in the ratings. It’s terrible, if you go on and you get a war story wrong and you are perceived as a reporter or a network that has placed Americans in harm’s way and has jeopardized national security and people’s lives, it’s gonna blow up on you. People are not gonna say, oh, man, I wanna watch that and see if they screw up again. What they’re gonna do is they’re gonna turn to a source of news that they think is more reliable. In time of war, when you have a lot of things happening, people are interested in news. They’re interested in hard news, they’re not interested in somebody prancing around, we’ve got somebody there. That maybe part of it, but they want to figure out what’s going on. They want to know what’s going on on the ground and whoever wins that fight, as David was saying, who ever gets the facts right, they’re gonna win that ratings battle. Now when the war’s done, you can do, you know, “Joe millionaire,” or whatever, I mean, you can do that kind of stuff because it’s a different game.
TED KOPPEL
(OC) Hold it one second, we’ve got to take another short break. We wanna milk that one a little bit more. And I’ll come back to you, David, in a moment.
graphics: Nightline Poll
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ANNOUNCER
This is ABC News “View Point: Patriotism, Journalism, and War.” Reporting live from the National Defense University, once again, Ted Koppel.
TED KOPPEL
(OC) David Westin, we were talking about accountability and the question was asked earlier on, you know, so in the interests of getting a sexy story on the air somebody gets it wrong, how much chances do we get to get it wrong before you say, try some other place?
DAVID WESTIN
Well, that was the point I wanted to make. I certainly agree with General Joulwan, that we need to be accountability, as the military needs to be accountable. But this is the flip side of the Lieutenant Commander’s point earlier, where she asked the question about the competition. Because that very competition means that every time we go on the air, we are painfully conscious, particularly as Tony says, at a time when we’re at war, that we need to get it right. Because in some ways, what’s happened in America is amazing democratization of the media. People get to vote constantly all night long and all day long with their remote controls about what they want to watch. And at a time of the war, they’re gonna go to the places that they feel are offering them something substantively and that is right, fundamentally. So, I think, actually, there’s very healthy and very rigorous accountability for the media right now.
TED KOPPEL
(OC) David Martin?
DAVID MARTIN
There’s another kind of accountability, too, which is, if I constantly go on the air with bum information or information that gives away legitimate secrets, nobody’s gonna talk to me. They’re going to shut me down and then I’m going to be nowhere.
TED KOPPEL
(OC) Kate?
KATE ADIE
Well, I think no journalist wants to be in a position of putting out the wrong information. But what if you are with the military and you are not putting out the information that is embarrassing, the informations that the military would rather you didn’t mention? And the facts that, it is the sin of omission. There was a good example during the Gulf War where patriot missiles were used against incoming scuds. It was never mentioned that a very large percentage of these never hit their target.
TED KOPPEL
(OC) Let me stop you on that one, Kate. All right, so here we have a situation where the Iraqis are targeting Israel in particular with scuds, and the word is out, the patriots are doing great. They’re knocking them down, you know, one after another. Would you really have wanted to convey, as a journalist, I’m putting it now in your lap, you got the story, they’re actually not working very well. They’re not doing the job.
KATE ADIE
Well, if I don’t put it out, somebody else will. It is wrong to believe just one nation is reporting. And this is one of the myths that knocks around these days. And with global communication, the idea that one nation is in charge of the world’s media is just, does not hold water. You have got other people, they will be putting out things and to say that you can discount everybody else’s journalism is neither practical nor realistic these days.
TED KOPPEL
(OC) No, but the fact of the matter is, there are also a lot of people putting crap out right now, I don’t feel the obligation to match them on it point for point. What I’m asking you, with regard to the scud missiles is, here is an instance where one can say that the information that you would be conveying to the Iraqis might cause a great many casualties.
KATE ADIE
No journalist, and this is, everybody has it as a given, can possibly be responsible for causing or in any way allowing death or injury to occur knowingly because of what they have said. Except of course to the enemy. And therefore we are not being entirely humane people.
TED KOPPEL
(OC) Well, war is, war is not a humane exercise, I mean, let’s set that aside immediately.
KATE ADIE
The real problem in all of this is whether it’s a full all-out war with the whole of your nation on side, totally committed. If there are questions to be asked about the actual intent of the war, the reason why you’ve gone to it, whether you think it is fully justified and a just war, if there are those questions, there are going to be major questions raised, I think they have to be raised by the journalists.
TED KOPPEL
(OC) Kate has raised an interesting question, Admiral, and let me pose it to you because you have to deal with it. You’re not just getting requests from American journalists who want to be embedded, you’re getting requests from journalists from how many different nations?
REAR ADMIRAL STEPHEN PIETROPAOLI
I’m sure it’s dozen scores. And indeed, on the first night of the strikes into Afghanistan, there were 12 international outlets among the 26 news outlets we had on the carriers and the ships at sea.
TED KOPPEL
(OC) Well, let me take an example and let me say at the outset, I’m not going to criticize al-Jazeera, it is the best broadcasting that has come out of the Middle East ever. It may not be as friendly to some of our interests, or the interests of our allies as we’d like it to be, but nothing quite like it has ever come out of the Middle East. Al-Jazeera comes to you, as I’m sure they have, and they say, we want to be embedded, are you gonna let them?
REAR ADMIRAL STEPHEN PIETROPAOLI
You know, we’ve actually had this debate, because frankly, while there is somebody of anecdotal information that al-Jazeera has, we haven’t done a very good job, frankly, of studying the product. And as long as, you know, our basic philosophy in the US military, and I think I speak for all the services in this regard is, we crave press coverage, day in and day out. And frankly, there’s fewer embarrassing stories out there with the all-volunteer force today than there was 20 years ago. You get out to the, front lines, you get outside Washington, you got some pretty eye-watering kids out there doing a great job. Getting people out there among those troops is great for their morale, it’s good for public support. And by and large, we want it. And that includes al-Jazeera because, frankly, coalition support, international support, is important as well. But it is really difficult to ask a Commander to take an organization, if in fact you can demonstrate that they have not been responsible and balanced in the way they’ve presented the stories. That doesn’t mean they’re, lap dogs, that means that they’ve been responsible and balanced. And we don’t have a good system in the US military for judging international media. We know the BBC, it’s a got a terrific reputation, never a problem with putting BBC out there. Al-Jazeera presents a challenge and we’re trying to gather some data. Right now we’re gonna put them out there.
TED KOPPEL
(OC) Admiral Boomer, you were in a position of command during Desert Storm. If al-Jazeera had existed back then, would you have wanted an al-Jazeera team with you?
GEN WALTER BOOMER
I’m not sure. Because what, really happened on the ground was that I took with me people that I trusted and knew. And I invited people to come with us that I trusted and knew because I was gonna open it all up to them. And I really expected them to exercise some accountability and they did. You see, I’d take the David Martins of the world anywhere, any time. And show them practically anything. But I’ve got a problem with someone that I, don’t know, particularly if I’m worried about them potentially endangering some of our troops.
TED KOPPEL
(OC) We, I mean, I began this broadcast by asking you whether you were aware of a single instance in all your years in the military of a report by an American reporter jeopardizing American troops. And you gave me a very succinct and honest answer, no, you said. So, why is that such a grave concern? How many years were you in the marines?
GEN WALTER BOOMER
We were talking about American reporters and I’d throw in the BBC as well because there’s a certain affinity there.
TED KOPPEL
(OC) I won’t stretch your tolerance by asking about the French or Germans.
GEN WALTER BOOMER
No, please don’t, please don’t stretch me. My experience is with American reporters. And I said, not once, and that was true. But I would have to think very, very carefully about reporters from other countries that didn’t know. It would be an issue.
TED KOPPEL
(OC) Let me just, before we go on to another question, we’re gonna come to you in a moment, give you an example, a recent example of where having critical reporters on a story can be helpful. You remember when the, Israelis moved into the West Bank and there were the stories of the massacre, the alleged massacre. The Israelis, of course, denied it. The Palestinians, I’m talking about Janine here, the Palestinians claimed there had been a massacre. The Israeli denials didn’t account for much, the Palestinian charges were taken at face value by a lot of reporters. And it was only when reporters went in, the same ones who had previously been critical of the Israelis, and said, you know something, we’ve dug into this for the last two weeks, we can’t find any evidence of a massacre. My point to you, gentlemen and then I’ll ask my colleagues to pick up on it, is, the fact that we are known as being critical, the fact that we may not always give you the kind of spin on a story that you want to get, I would argue, is in the long run going to be tremendously helpful to you.
GEN WALTER BOOMER
I wouldn’t disagree with that. I would not disagree with that.
REAR ADMIRAL STEPHEN PIETROPAOLI
The main issue for us, as I said, besides thinking that you’re not gonna find nearly as much bad as you think, an independent witness to history in military operations is a critical element of credibility. If we’d had a journalist in some of these instances in Afghanistan where it was, who shot first, when it was a wedding party and mistaken identity, if there had been a journalist taking the fire first with our troops, there wouldn’t have been a question. As opposed to us coming back retroactively and reporting, he said, she said.
TED KOPPEL
(OC) Go ahead, Kate, I’m sorry.
KATE ADIE
You’re assuming that there is an independence of a journalist who goes with the military. A deal has been done. The fact that you are with the military means a compromise has been reached. That is a fact of life for a journalist. You are not a totally independent, completely objective journalist. You have thrown in your lot with the military. You may be wearing the uniform. And you will have agreed, either formally or informally, that there are parameters, there are ground rules, there are some things off limits. I have never known an instance where journalists formally with a military unit have had anything other than that. So, you are not the independent voice. And after the Gulf War, in the early ’90s, I remember endless criticisms of journalists who went with the military, both the US and the UK pool as lapdogs, as poodles who swallowed everything, who’d been censored and who did not deliver, “the full truth.” So, I think we’re talking slightly mythically about independent journalists with the military. They are seen by large numbers of people as trotting behind the military.
GEN WALTER BOOMER CONSULTANT
That sounds like your problem, not ours.
TED KOPPEL
(OC) David?
DAVID WESTIN
As much affinity as we all feel, and I certainly do, with our friends in Great Britain and the BBC, I couldn’t disagree more, I don’t think, with Kate. And it goes back, to some extent, to the question that the Captain asked earlier. What we do as professional journalists is do our best to set aside whatever personal views or biases or preferences we might have to try to go out and get the information we think the American people need and want, and make sure it’s right and report it. And that is without regard to what we might personally think, good, bad, or indifferent, about the policies of the United States government or anything else. We, all the time as journalists, have a relationship with sources, quite apart from the military, quite apart from the Army, quite apart from war, in which there are compromises made. In a sense, you go and meet with them a certain way, sometimes there are ground rules and things like that. We do that all of the time. That doesn’t mean that we become biased witnesses if we’re doing our job. Now, sometimes we don’t do our job well enough, absolutely right. But as professional journalists, that’s what we do, we set aside all that to try to get to the truth and present it to the American people so that they can make up their minds what is right, wrong, or indifferent. So, I don’t see the notion of embedding with the military, at all as compromising what we report.
TED KOPPEL
(OC) Tony, you’re, make it relatively brief, if you will.
TONY SNOW
Well, once again, I’ll go back to the Ernie Pyle example which is, good reporters are gonna write or report what they see and sometimes they’re gonna get in trouble. That’s the way it works. Yes, there’s a deal struck. You are within, you are within a military unit, obviously in some ways they’re gonna be protecting your life. But on the other hand, you have no obligation to report something that’s not true. And I think reporters are pretty good sticklers about that, for the most part.
KATE ADIE
I keep coming back to this idea, it’s not the idea that you get it wrong or you actually tell lies. It is the massive sins of omission. What you fail to tell people about what is going on. The silence, the silence, the complicity.
TONY SNOW
In order to make the judgment, . . .
TED KOPPEL
(OC) Tell you what, hold on to the thought, Tony, we’ll come back to it. Obviously we haven’t finished this one yet. We’ll be back in a moment.
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“Patriotism, Journalism, and War,” and ABC News “View Point”, brought to you by . . .
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BOB PEARSON, AGENCE FRANCE-PRESSE PHOTOGRAPHER
I think the Vietnam War was probably the last time you would ever see total access to war coverage. In a lot of ways, that was a good thing, but I think the military probably saw that as a, lot of bad publicity for them. And after that, you just did not see any type of close-in coverage made available on a day-to-day basis ever again. And I’m sure you never will again. It’s just too controlled. And while the DOD does not really call it censorship and I guess in the strictest sense of the words, it’s not censorship, the access they give you really does act as a form of censorship.
CHRISTIANE AMANPOUR
We war reporters would never in conscience reveal things that were supposed to be war secrets or military security, et cetera. But what happened during the Gulf War was that the news management was because of image more than because of military security. And I think that had a very, very, very negative and profoundly bad effect on the coverage and on the subsequent war coverage and on the subsequent deals that the Pentagon has tried to snare us into.
TED KOPPEL
(OC) Those voices of correspondents come from a recent exhibition called “War Stories at the Museum.” Our thanks to our friends as the Museum. Very quickly, I want to finish off on the co-opting part of this discussion. Tony, you wanted to add something and I know Kate did.
TONY SNOW
Just a couple of quick points. What Kate was saying is, somehow people will commit sins of omission. A lot of times, requires almost a God’s eye view to figure out what constitutes a sin of omission that may in fact be journalistic dereliction. Sorry I’m rhyming so much. Now, the other thing is that in the Gulf War, we had a lot of people who tried to cover it from a hotel suite. And, you know Arno, an old boss of mine, went out, and he made the point that too few reporters back then got their hair cut, got into shape, hitched a ride with a tank and developed trust with the military and actually got into the action. And so we had the scene where people were doing these briefings and, at Riyadh and saying, now, where are we going to head tomorrow and “Saturday Night Live” is doing skits about it. The failings in the Gulf War were those of reporters who really didn’t know how to get in with troops and didn’t get to the front. And so, there was a certain, I think, lack of experience that plagued American reporters. It appears that it’s gonna be a little different this time around.
TED KOPPEL
(OC) Although, for example, David, your CBS colleague Bob Simon ended up in an Iraqi prison because he didn’t allow himself to be led around by the nose.
DAVID MARTIN
That’s the danger of breaking away. 40 days in an Iraqi jail.
KATE ADIE
It’s both a danger but it is considered that it’s another part of journalism as valid as going with the military., It has to happen. It may be dangerous, you will hear the military say, but we can protect you, that’s why you should stay with us. So you say, well, actually there may be another angle, there may be another way of reporting this war. The military always say that. They’re terribly nice. I mean, they’re kind and they genuinely do. I’ve been hoisted into the back of an armored vehicle more than once, and saved my life. I have no argument and I am grateful to my own military for doing that. But, there’s another way of seeing a war and it doesn’t have to be just with the military. So, do you consider that there are going to be people on the battlefield who are not with you?
GENERAL GEORGE JOULWAN
Sure.
KATE ADIE
Do you mind?
GENERAL GEORGE JOULWAN
Not at all. That’s this adversarial relationship I’m talking about.
KATE ADIE
What if they get in the way?
GEN WALTER BOOMER CORPS IN DESERT STORM
They may report that we’ve had a very successful, in our mind, engagement. We’ve taken, the mission is accomplished and what the lead story is, two Americans were killed. That is your prerogative to report it that way. We may not like it, but to me, that is the environment we’re in. That doesn’t mean we want to brainwash you or not have you report the story, but we have to accept that, that that may be their headline, the report that you make.
TED KOPPEL
(OC) Let me just jump to the gentleman in the back. Go ahead, sir.
SPECIALIST RYAN WOOD, AUDIENCE MEMBER
Specialist Ryan Wood with the Defense Information School. My question is more to the media. With today’s modern technology, how do we retain our objectivity when, by the very act of reporting, we are affecting the events of the story?
TED KOPPEL
(OC) Well, let me, before one of my colleagues here tries to answer that, let me ask you, when you thought it was ever different? I mean it’s faster now, no question about it. We can do it, more easily, more quickly, but that’s always been the case, hasn’t it?
SPECIALIST RYAN WOOD
Coming through the military side of being trained in journalism, right now I’m in that school, we see chances where, in Vietnam, like you said, you had two and a half days in between getting something from the front to the people at home. Now you’ve got two and a half seconds of getting something from the front to the people at home. If someone on the other side happens to be watching saying, oh, look, here comes a column of tanks, I recognize that street and that street sign, I’m gonna remove my people from that area or I’m going to move them for a counterattack, suddenly the reporter becomes part of the action by the very virtue of reporting on the story.
TED KOPPEL
(OC) I think it’s a legitimate question, but if I may, let me direct it over here, because I think, if I was listening carefully, Admiral, you told me that if we are in those kinds of circumstances in active combat, we’re not gonna be able to use that equipment live.
REAR ADMIRAL STEPHEN PIETROPAOLI
This goes to Kate’s point, if you are with us, we are not gonna let you transmit that. And if you are not with us and we think it’s gonna put us at risk, you may not be with anyone for long.
KATE ADIE
Would you actually take out reporters? Would you actually do something about them if they were perhaps going to do that?
REAR ADMIRAL STEPHEN PIETROPAOLI
I suppose we’d try persuasion first.
KATE ADIE
Describe persuasion. How far would you take persuasion?
REAR ADMIRAL STEPHEN PIETROPAOLI
I mean, I think that a Commander, and I’m not, these guys have got more time in a latrine on the battlefield than I do, so, but I think that a Commander has the legitimate right to remove, from the battlefield, things that will provide real time intelligence to the enemy. Now, this not gonna be, I’ve been out there for all my career arguing against having base guards seize cameras and tapes. I mean, we don’t like to do this sort of thing, but the stakes are a little different when you are in the circumstances our specialist described here. I don’t think that’s gonna happen a lot, but if it happens, for these Commanders that are out there, whose priorities are protecting their people and accomplishing the mission, whether or not you broadcast that real time or whether you put that in the can and transmit that compelling video 20 minutes later is not a reason to put the mission at risk.
TED KOPPEL
(OC) And let me lose my lifetime fraternity ring in journalism by suggesting, what the hell is wrong with that, Kate? If you are a Commander and you know that a piece of video that is being sent all around the world, that can be picked up as easily in Baghdad or in Kuwait City or in Doha as it can in Washington or in Los Angeles, if you know that that piece of video being broadcast in real time is jeopardizing the lives of your men, yours, you’re gonna tell me you’re not gonna confiscate that until that particular danger is over?
KATE ADIE
They may not be just Americans on that battlefield reporting, other journalists. So you treat them as the enemy?
TED KOPPEL
(OC) As an annoyance, as a nuisance, as a danger to my troops.
KATE ADIE
I’ve had that in one or two places and, not dealing with Americans, but with other nations. And it’s why so many journalists are murdered these days on battlefields, because Generals wish to own battlefields. They wish to take over entire areas, declare them military zones where they only rule. Fine, if it’s a just war and it’s your people but we are actually looking further afield these days.
TED KOPPEL
(OC) I don’t think I’ve heard quite that Draconian suggestion coming from this side of the, . . .
KATE ADIE
Yeah, but Generals were looking pretty determined while you were saying that. I’m a realist about this, I have seen journalists killed by the military.
TED KOPPEL
(OC) By the American military?
KATE ADIE
Not by the American military but by other military.
TED KOPPEL
(OC) David?
DAVID WESTIN
There’s a very important point here that the Admiral referred to. There is a profound difference between whether we get the information and when the information is disclosed. The fact is, as I said earlier, it’s terribly important the American people know what is going on to a degree that they need to make decisions about what we should be doing. Often, they don’t need to know it this moment. They can wait a few hours or even a day or two. And this comes up, I mean, this is not that rare. I mean, a year or so ago, and I think David Martin was involved in this as well, in the early stages of the Afghanistan conflict, we had a report from inside the Pentagon that the United States had special forces who were on a raid into an airfield outside of Kandahar. And the military, the Pentagon said to us, please hold off on reporting it for a few hours because we’re concerned if that’s broadcast before those guys come back out, they could be put in danger. And we sat on it. And, it made neither of our evening broadcasts that evening, our newscasts. And afterwards, our Pentagon person was concerned that I would be upset because we didn’t get it. And somebody else actually got it and got it first. And I said, it’s not that important. I mean, I don’t want to jeopardize our people’s lives for a few hour’s time. Now, if the military comes to us and says, we never want you to report something, that’s a very different matter. That’s very, troubling. But if there’s an independent record from a journalist that’s there, that can be disclosed to the American people at some point, then I think, largely we’ve accomplished what we need to accomplish.
TED KOPPEL
(OC) Why did we, ever get away from, I mean, I’m not saying this in a wistful sense, but why did we ever get away from the sort of formal censorship that existed in World War II? Or World War I, for that matter? Is it because we don’t declare wars any more, or at least our presidents don’t bother going to Congress any more? Is that why?
DAVID MARTIN
It’s a pain in the neck for everyone. The military has got to administer the darn thing and we’ve got to live with it. Nobody likes it.
TONY SNOW
We’ve also, take a look at the wars in which the United States has been involved in the last dozen or so years. They’ve been swift, they’ve been almost clinical. I mean, the big concern is whether anybody dies. And so, somehow I think we’re talking about a much different kind of situation than Vietnam or World War II. And here’s something that’s maybe worth considering is that, the assumption in a lot of quarters is, go to war in Iraq, it’s no big deal. You know, you do, the air first and then you bring everybody in, it’s clean, it’s fast. There are no guarantees of that. But there does seem to be a certain cockiness, maybe on the part of reporters and also the pundit class here in Washington, that somehow it’s just gonna be a kind of clean thing conducted at arm’s length.
TED KOPPEL
(OC) I mean, Kate forgive me, you’re, waging a valiant and slightly lonely battle here, but let me just, remind you of what your own government did, for example, during the many years of recent unpleasantness in Northern Ireland.
KATE ADIE
Absolutely.
TED KOPPEL
(OC) And, you know, I don’t have any recollection of British forces in Northern Ireland having any reluctance to stop coverage. And if they couldn’t stop it in Northern Ireland they slapped a “D notice” on it? Isn’t that what it’s called?
KATE ADIE
Yes. But there’s a deep reservoir, and maybe my discomfort comes from that, that the press were less than honorable, that we did not challenge a great number of abuses which occurred in the security forces. Things which, as citizens, and people upholding human rights, we should not have tolerated, that were done by the military in the government’s name. And there is a sense of considerable bitterness that this was allowed to gone on. And I think all journalists who’ve been in military situations have known later that there were things they should have challenged. And maybe I, we feel it a little more strongly because we were so close to it.
TED KOPPEL
(OC) Terrific point. Let me, take another quick break and then we’ll be back with our panelists and our audience.
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graphics: View Point: Patriotism, Journalism, & War
PETER ARNETT, FORMER CNN CORRESPONDENT
I was at a American special forces camp in, north of Saigon. There had been an attack the previous night, 2-thirds of the Americans had been killed, seven or eight had been killed, there were only four left. They welcomed us there and they said, well, you can stay with us tonight, on the condition that you help defend the camp and we’re expecting an attack. So through the night, I was manning a machine gun at a mortar pit and was told, if the VC come up that ravine, your job is to make sure they don’t make it to the wire. It was the most uncomfortable frightening night I ever spent in my life. But I was ready to shoot that machine gun, if only to defend myself. But fortunately I didn’t have to do it.
TED KOPPEL
(OC) Survival is a pretty strong instinct. David, I take you never had, never faced that particular problem?
DAVID MARTIN
No. Nothing like that.
TED KOPPEL
(OC) But, you know, I, think it illustrates, Kate, what you have been talking about here, too. You have been holding forth for us, and I’m grateful to you for doing that, a sort of idealized version of the fearless combat correspondent. Actually, I’m reminded of that wonderful World War I rhyme, one cannot hope to bribe or twist thank God the British journalist that seen what the man will do unbribed has no occasion to. We’re all human.
KATE ADIE
Yes.
TED KOPPEL
(OC) Peter Arnett is one of the best war correspondents that ever was. He was certainly one of the best who was with us over there in Vietnam. And for Peter to acknowledge that, you know, on that particular occasion, sitting in special forces camp and if the Vietcong are about to overrun the camp and some guy hands you a machine gun and says, use it.
KATE ADIE
Survival. Absolutely understandable. I hold forth the ideal because I think you have to have the ideal, otherwise you might all just sign up with the military and go with them. Be paid by them to put this stuff out. You have to have the ideal. I am an absolute realist. What I would always argue is that if you go with the military, you make very public the deal you have done. You tell what the limits are. You don’t pretend you’re reporting the full stuff. I think there’s a great desire to just sort of suggest that if you are somewhere in that battle zone, there are guys with military uniform around you, you’re really telling it all. I think you have to be utterly honest. I was when I was in uniform in the Gulf, with 7th Armored Brigade. I said, I’m wearing uniform because I done a deal, this is it, I’m only telling you a certain amount. And I think you have to be absolutely practical in that sense. But you have to push it forward, have the other reporters who are not with the military, it may be horrendously risky and I think even more so these days, but you have to have those ideals. If you don’t, well, as I said, let’s just all sign up.
TED KOPPEL
(OC) General Boomer?
GEN WALTER BOOMER
Well, the deal is sort of a mystery to me because I never cut one with anybody, anyone that was accompanying us.
TED KOPPEL
(OC) Oh, come on, it’s sort of, I mean, it’s sort of an implicit deal. Let’s face it. I think Kate has a point. If I am going to ask for the protection of your men, if I’m going to ride in your humvees or on your helicopters, to get to the location, if I’m expecting your guys to pull me out of trouble if I get into trouble, isn’t there a certain expectation that I’m, gonna give you the fairest possible shake that I can?
REAR ADMIRAL STEPHEN PIETROPAOLI
That’s the expectation with the journalist from the, I mean, if you don’t have that expectation you’re gonna get a fair shake, you shouldn’t be bringing them.
GEN WALTER BOOMER
I think that’s all you want is a fair shake. But my, you know, my interpretation of what Kate was saying is that we can’t live with the facts. And I don’t think that’s true. We can live with the good and the bad.
REAR ADMIRAL STEPHEN PIETROPAOLI
I’ll tell you, Sir, the only thing that is, you can talk about implicit deals and maybe, maybe this journalist is gonna self-censor and say, I really don’t want to report negative things about the guys because they are my buddies and I want to make sure they come out in that mine field and get me. But that’s not part of what we have them sign up for. There are restrictions on, you’re gonna have, by nature of being with our forces, access to information that is sensitive and can’t be reported in real time. We’re going to tell what you that is and, you know, to prevent you from getting access to it would be to leave you behind, and you agree that you’re not gonna report that. It has nothing to do with not reporting, if you choose to, the malcontent in the ranks or the fact that the water is, you know, skanked or the chem-biosuits nobody’s got confidence in or they do, that’s all fair game.
KATE ADIE
I mean, winging goes on all the time in armies, you know, it’s a matter of morale as to how you handle that. But what do you do if see a soldier commit an illegal act?
REAR ADMIRAL STEPHEN PIETROPAOLI
Report it.
KATE ADIE
Is that going to be allowed by you?
REAR ADMIRAL STEPHEN PIETROPAOLI
Absolutely.
KATE ADIE
During a push forward or maybe a reverse, where it may affect what is going to happen?
REAR ADMIRAL STEPHEN PIETROPAOLI
I mean, we’re getting pretty deep in theory here.
TED KOPPEL
(OC) Go ahead, David.
DAVID WESTIN
On the specifics of the so-called deal, I actually just happened, a week ago, to be in Kuwait City and I went to camp Doha where the, men and women and the equipment’s coming in. And I met with a senior Army officer and he said the deal, as far as he’s concerned, with the embeds in the ground forces is very simple. Don’t give away my specific location. Don’t give away my plans and don’t get in the way. That’s all I ask. Other than that, it’s up to you, you can do anything you want. Those are the three, and I a agree entirely with Kate, as always, in television journalism it’s critical we disclose to our public what we are saying, what we’re not saying, if there is some understanding, and then they can decide whether they want to believe what we’re saying or not. I agree entirely. But this officer was very clear, that’s the deal and that’s it. That’s the full extent of it. Other than that, report everything you want.
TED KOPPEL
(OC) Let me focus on something that I suspect our viewers at home have seen more than those of us who are facing out here. That’s your little flag. You’re wearing the little flag, David isn’t. David Martin isn’t. I’m not. Well, you’re a Brit but you’re not wearing, . . .
KATE ADIE
I would not wear the British one if I were not signed up with forces. It would be considered, it’s a very different attitude to patriotism that you people have, the Brits do not do it overtly.
TED KOPPEL
(OC) This is a, you know, this is a sensitive issue in this country. Tony, why do you wear it?
TONY SNOW
Tonight did it out of sheer perversity, ’cause I knew the topic would come up. But, there was an interesting debate early on in the Gulf War, I mean, after September 11th, about whether you should wear an American flag. I see no reason not to do it. Because the presumption that somehow you’re taking sides if you’re wearing the flag, I think, makes the mistake of equating the flag with the government or a political party. In our neighborhood, we buried a guy. And there were a number of other people very close by who were in the Pentagon. We had firemen who were working in there. It hit people close to home. And after September 11th, what a lot of Americans realized is what an extraordinary country we are. And I think it is something that is worth remembering, because it is at the core of who we are. It explains why we are a nation that is constantly agonizing over the moral propriety of what we do, where we go, why we do it. It’s one of the glories. It’s why we are constantly arguing about everything and anything, on this stage and elsewhere.
TED KOPPEL
(OC) David Martin, you know it’s coming, so why aren’t you wearing the flag?
DAVID MARTIN
I wouldn’t wear it because it looks too much like part of a uniform. I mean, the Vice President wears one. And you just look a little too much like an Administration “suit” when you’re up there on television. If I wore one, I wouldn’t do anything differently. It’s strictly an appearance factor. The day we started bombing in Afghanistan, October 7th, when I left home that morning, I put an American flag up outside my house. Had no problem with that, a personal show of patriotism. But I wouldn’t wear one in public appearing on television.
TED KOPPEL
(OC) Gentlemen, actually I, . . .
GENERAL GEORGE JOULWAN
Yes, I’m wearing one.
TED KOPPEL
(OC) You’ve got one. Well, hell, you’re an ex, four star, right? I mean, . . .
GENERAL GEORGE JOULWAN
Well, I think there’s much more than that. I think it’s a symbol of unity within our country. I don’t think it applies, you belong to one political group or another. I think it’s very much what unites all Americans. We have certain symbols that I think represent that. I don’t think it’s in a negative or, something that you side with one group. I think it’s very proud statement, on my part at least, that I represent not just military but Americans. And Americans are something very special, if I may say that.
TONY SNOW
Ted let just me add on, David’s argument. I know it’s, a lot of people are concerned about this being an Administration suit. Again, I think it’s a big mistake to say, this represents an Administration, it represents a government. Because it doesn’t, that’s not what I thought when I started wearing the flag.
TED KOPPEL
(OC) No, and I certainly don’t, I don’t question anybody’s individual motive. I’ll tell you the one thing that troubles me about it, is that because you wear it on the air, David and David and I and my colleagues who choose not to wear it on the air, are in some eyes then regarded as less patriotic. I understand, not your problem.
TONY SNOW
I look on that as, for anybody to draw assumptions about your patriotism about whether you wear a lapel pin or not, to me is nuts.
TED KOPPEL
(OC) It’s surprising how people make their judgments. But go ahead.
DAVID WESTIN
I mean, I was involved in this not only because I do not have one on tonight. I mean, as David said, I fly one on the Fourth of July, I put one on the antenna of my car and drive through the main street of my hometown, parade and things like that. And I think the flag represents everything General Joulwan says. But after 9/11, the question came up and we, as a matter of policy at ABC News, tell our people on the air, you shall not wear an American flag or any other symbol on the air.
TED KOPPEL
(OC) Because?
DAVID WESTIN
Because, as I said before, I think, and this is where I may differ just slightly with what Kate said earlier, I think our patriotic duty as journalists in the United States is to try to be independent and objective and present the facts to the American people and let them decide all the important things. Now, I respect Tony’s right to wear one. I respect any other news organization taking a different tack, but for me, part of the symbolism of the fact that what we’re doing in our constitutional democracy, what we’re doing to right to help “the cause of the country overall” is to be objective and give just the straight facts to the American people and let them decide what they want to do about it.
TED KOPPEL
(OC) Tell you what guys, Tony, we’re down to our last five minutes, and I want to see if we can’t get, oh, wait a second, we got to take a break. We’ll be right back and I promise we’ll come to you.
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graphics: ABC News: View Point
ANNOUNCER
ABC News “View Point.” Once again, Ted Koppel.
TED KOPPEL
(OC) And let’s go right to a question, the Marine in the back.
FIRST LIEUTENANT KNOT, AUDIENCE MEMBER
Good evening my name is First Lieutenant Knot. It seems to me that one of the central issues, . . .
TED KOPPEL
(OC) You can pull that thing up, you know. You don’t have to bend over like that.
FIRST LIEUTENANT KNOT
Thank you. Seems to me that one of the central issues in this panel is the potential, from the military perspective, is a, potential danger the media poses to military units operating in a combat environment. Now, we certainly would not expect the military to react well to the media putting any of its combat units in danger. How does media react to the potential of putting its own reporters in danger?
TED KOPPEL
(OC) David, actually we were talking about this in my office this afternoon because it must weigh heavily on your shoulders.
DAVID WESTIN
Yeah, Kate and I were talking about this at the break. And I think this is a place where, actually, it’s a bit harder for those of us sitting back in nice comfortable offices in New York than some of the people in the field. Because our people in the field are very eager and brave and a number of them are experienced, thank goodness, and have training and we’ve put through a lot of training with the military. But for me, one of the things I say, I’m not sure our people always believe it is, as serious as I take our mission, as I’ve tried to say, and as important as I think what we do, it’s not worth losing your life over. I don’t want any journalists putting themselves in a position where they’re going to lose their life. Now, let’s be serious, if you’re over there in a combat situation, there’s risks. And there’s more risks, probably, than taking the west side highway somewhere in New York City. But we try to give our people the counseling and the protection and the advice that they need and try to supervise them. But I’m very, very concerned about the safety. As Kate said, I think that this conflict, if there is a conflict, may be much more dangerous for journalists, as well as perhaps the military, than others we’ve seen. Particularly if there is actually a move toward Baghdad to actually take over the regime and we have the possibility of weapons of mass destruction, of chemical or biological. I think that this could be very, very dangerous for our people and it weighs heavily on me.
TED KOPPEL
(OC) Let’s go to the lady in the back.
KARA CHEETHAM, AUDIENCE MEMBER
Kara Cheetham(PH) from Richmond, Virginia. My question is directed towards our military leadership. Soon after 9/11, the Pentagon explored the idea of creating an office whose mission was psychological operations or strategic deception. How do you feel about the military deliberately feeding misinformation to reporters, knowing that they’ll get the story wrong, but also knowing that perhaps the enemy will also get a hold of that story?
TED KOPPEL
(OC) And if we were gonna do it, why would you believe whatever answer they’re going to go give you? Go ahead, Admiral.
REAR ADMIRAL STEPHEN PIETROPAOLI
I was involved in that, and I can tell you, leaving aside what the stated mission of the office of strategic influence or strategical situational integrity, whatever it was going to be, the one a thing that was not acceptable to Secretary Rumsfeld to the Assistant Secretary of Defense for PA, public affairs, was deception of journalists, the American public, et cetera. Will we let journalists make mistake if it’s to a tactical advantage, let them? We’ve done so. Is there a arc of military deception designed to fool the enemy about our intentions? Yes. Do media sometimes pick up on that and report it, as they did in the Gulf War when we conducted amphibious exercises to demonstrate our capability to do an amphibious assault on Kuwait, even though we never intended to do one? Yes. Did that hold Iraqi divisions in Kuwait? Yes. But there was never going to happen under this Secretary of Defense, or I think any of us that have done public affairs, where we will deliberately lie to US or international press in order to influence the enemy. Will we lie to the adversary? You bet.
TED KOPPEL
(OC) And let me suggest, there’s also a certain amount of self- interest involved in that, as I’m sure the Admiral will agree. Because, if you lie us to for those reasons, there will come a time when they want us to believe them and we won’t.
REAR ADMIRAL STEPHEN PIETROPAOLI
Well, it’s in a sense, why we don’t, why we really don’t want to do censorship, besides the bureaucratic difficulty. The credibility of not having copy or broadcast stuff, having to say, “cleared by American censors” or “cleared by the US military,” that’s what we’re seeking, we want that credibility. I think we do, without mortgaging too much of your independence, but that’s the key for us. We have nothing more valuable in maintaining the support of the American public than the credibility of the men and women in uniform.
KATE ADIE
Is there not, very much at the heart of all of this, that between journalists and the military, those who’ve actually been in combat and know what it’s about and the awfulness of war, do have an understanding about these things. The people who are one step removed always, and where these suggestions come from, are the politicians.
TED KOPPEL
(OC) Let me just give you an example from something that’s not too distant in our memories. When US forces landed on the beach in Somalia and much was made, the media was mocked for being there as they came aboard because there we were with our lights and our cameras, you know who put us there? The UN command, for crying out loud. They’re the one who showed us where these guys were gonna land. You know, the media, God knows we do enough stupid things in our lives, but we don’t try to make a habit of it. And particularly not when lives are at stake. But go ahead.
JENNIFER CHESICK, AUDIENCE MEMBER
I’m Jennifer Chesick (PH) with the, School of Journalism. And my question is directed towards the military. Since, you know, the media may not always be working with the military or the government’s agenda, how much obligation do you feel to actually protect the media when they’re out there in the battlefield with you?
GEN WALTER BOOMER
I’m always a little worried about them.
REAR ADMIRAL STEPHEN PIETROPAOLI
You’ll sleep soundly tonight, huh?
TED KOPPEL
(OC) Try, to contain your emotions there, General Boomer, will you?
GEN WALTER BOOMER
But you know, truthfully, these folks are professionals, the vast majority. They, know what they are in for. They recognize the danger. They’re not stupid. So you really don’t need to worry about them too much, quite frankly. They tend to take care of themselves. So it’s never been a real, issue. I had a, woman with me in Vietnam that I thought, as I think back on it, I thought she was just incredibly dumb the way she exposed herself, and not personally, but to the enemy. And finally, I just gave up, you know. And I can’t remember her name, but I said, you know, if you want to get killed, go ahead, I’m not going to worry about you anymore, so. But generally speaking, from my perspective, it’s never been a problem.
TED KOPPEL
(OC) General Boomer that will have to be the last word. I’m afraid we are out time. I propose to you at home tonight that you ought to be quite encouraged by what you’ve seen here this evening, a unified military and bunch of journalists who can’t agree on much of anything. I suggest that both are healthy for American freedoms. And I thank all of our guests here this evening and those of us who have welcomed us here. Thanks to you to all of you. I’m Ted Koppel in Washington, for all of us here at ABC News, good night.
ANNOUNCER
From the National Defense University, this has been an ABC News “View Point: Patriotism, Journalism, and War.”
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]]> http://journihilism.org/?feed=rss2&p=187 0 http://journihilism.org/?p=184 http://journihilism.org/?p=184#comments Tue, 01 Dec 2009 03:54:06 +0000 admin http://journihilism.org/?p=184

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KPFK, located in Los Angeles, is one of the five radio stations that make up the Pacifica network. KPFK’S Interim Program Director, Alan Minsky, has been given an order to change programming in an effort to increase revenue. (Attached is a copy of his semi-apologetic rationale) The program changes Minsky has proposed further reveals the long range intentions and direction of the new Pacifica National Board (PNB) majority. I am not adverse to change. Change is necessary if Pacifica is going to survive. However this proposal is based on an enormously flawed premise.

Over the years I also have been approached by dozens of untutored media watchers who make pronouncements about what Pacifica, more specifically what WBAI, should do to increase audience and revenue. Their claims were made without any real investigation, study or experience in organizing a creative and diverse program grid that actively pursues the Pacifica mandate. To these prognosticators their proposals appear to be a perfectly logical and obvious solution. But without the benefit of study and research, what they are actually expressing are their personal feelings. Although personal feelings cannot be totally disregarded in formulating a schedule, they can neither be the sole nor the primary consideration in evaluating or changing a program grid. Among other things, a radio station’s program schedule reflects its identity, ideals, direction and how it perceives its role in society. To organize a compelling program grid for a listener-sponsored radio station is an extremely important task. To be successful requires a deeper analysis and a more comprehensive discussion. However, these are activities that for this writing will have to wait.

It is very important that we understand what this seemingly innocent action portends for the future of the Pacifica Foundation. There is an indisputable way to characterize the changes: the renegade PNB majority is “imposing” a corporate commercial model on the network and the first victim is KPFK. And next in line will be occupied WBAI.

If they are successful with their plan, it will surely mean certain death for the nation’s only listener-sponsored community radio network. The corporate commercial model is not neutral; it has predictable consequences. You cannot impose a right-wing commercial media model and maintain left credentials.

The corporate model is based on profit – not people, community issues or community struggles. It is intrinsically racist and exclusionary in its construction, and this is certainly true for its outcomes. The goal of this model is to fashion a broadcast schedule that targets a white middle class listenership with the goal of capturing a portion of their discretionary capital.
Pursuing this course of action represents the adoption and projection of the philosophical change that the new leadership has brought to Pacifica. The new leadership is led by Scientologist, Grace Aaron on the West coast and multimillionaire junk mail marketer Steve Brown on the east coast. This top-down corporate monetarist model is incapable of supporting genuine people’s concerns and movements. One of the more odious aspects of this format is the incentive to severely restrain giving voice to the voiceless, the marginalized and people of color as a fundamental part of its on-air product. The primary focus for this model is the accumulation of capital, not the amplification of marginalized voices residing in our community and in other countries. The adoption of this path necessitates the abandonment of Pacifica’s historical mission and the decimation of local autonomy.

The corporate model is based on the belief that poor people don’t have any money and therefore they can’t monetarily support the stations; thus, it follows, broadcasting to them is a waste of precious airtime. Of course, that is not true. Poor people in the aggregate are by far the major donors to Pacifica and comprise the largest percentage of listeners to the Pacifica network. Pacifica has no way of accurately measuring their presence. Poor people are routinely ignored by audience measuring devices like Arbitron and its latest incarnation, the Personal People Meter (PPM) because the system isn’t designed to track their listening habits. This under-monitored group comprises a major portion of the listenership who relies on Pacifica stations for news, information and entertainment. However they will not be a part of discussions about changes, and their presence will not be factored into the new strip programming time slots. The audience rating system has become the new bible, providing an unchallengeable rationale to selectively eliminate progressive programmers and hosts with close ties to community struggles. The schedule will of necessity become have a “whiter” presence as it reshapes itself to appeal to a richer, wider, whiter audience. Alan Minsky is already using the language of Arbitron and PPM as he refers to KPFK’s potential listeners as the “Southern California Metro Radio Market.”

All of this is being done under the rubric of increasing audience and revenue. The twin questions of “what kind of audience is being sought?” and “how much is Pacifica willing to dilute its programming to acquire audience and increase revenue?” will soon be revealed.

I am speculating that this action kicks open the door wider for further impositions. Will we soon see the imposition of multimillionaire Steve Brown’s multimillionaire business partner Gary Null on the entire network so that jointly they can make multimillions of dollars from our listeners. When the broom gets to WBAI, will Robert Knight be one of the strippers imposed on New York’s program grid? Is that why he has been hanging around the station lately?

Anyone can see clearly that Minsky’s announcement marks a dangerous shift in Pacifica policy and that in order to sell this plan he has begun to make promises that the Interim Progam Director knows he can’t insure will be kept. After all, this entire action isn’t even his idea. It came down to him by fiat from on high. It is the Pacifica National Board majority and their ACE allies who are the architects of this major step away from Pacifica’s history and its mission.

You must join in the effort to stop them. If not they will surely destroy the network. For additional information check out the following websites: www.takebackwbai.org, http://www.facebook.com/pages/takebackwbaiorg, http://www.livestream.com/wbix, http://bernardwhite.blogspot.com/

First they came for KPFK, but I lived on the east coast…

Please read Minsky’s email several times and pay close attention to what he says and how he frames it.

Bernard

——– Original Message ——–
Subject: About KPFK’s Programming Changes
Date: Sun, 25 Oct 2009 17:24:35 -0700
From: Alan Minsky Error! Reference source not found.
To: Error! Reference source not found., “staff” Error! Reference source not found.

Dear KPFK Programmers, Staff, and LSB Members,

I will be releasing the new KPFK Programming Grid tomorrow. I am writing in advance of announcing these changes, which commence on Monday, to explain some of my thinking that has informed the moves being made.

My primary responsibility at this time is to increase KPFK’s audience; and I feel this is an urgent need. KPFK has the most powerful FM signal in Southern California ; and I believe, because of KPFK’s uniquely humane mission, it is the most important media outlet in the region. Yet, all evidence suggests that few people even know about the station, and very few are listening. This has to change.

In order to achieve this, I will be taking what in my mind are some drastic measures. I will be introducing three new “stripped” shows on the week-day grid at prime hours: 7am, 5pm, and Noon (which will be shifting to a new 10am public affairs slot in three weeks). While all three of these stripped shows will actually be partial strips (i.e. not five days a week), I am doing this because every radio professional I’ve consulted with suggests that stripping popular programmers at key (previously un-stripped) hours is the quickest way to reverse the downward trend in listenership.

I want to be clear to the KPFK community that these moves – especially in the form they’re taking – runs counter to the vision of KPFK that I hope can be achieved in the coming years. But, as a measure to draw people to KPFK, I think they are necessary – and, unless KPFK increases its audience, the station is in serious jeopardy of having no future.

What I, personally, hope KPFK can evolve into is something that is both a journalistically responsible media outlet and a vibrant social center, a hub for the expression of the political, social, and cultural needs of the people of Southern California . I recognize that handing key stretches of programming over to a small handful of people will not achieve that. Therefore, I want to explain clearly to you how I plan to proceed.

If these moves prove spectacularly successful (e.g. a doubling of our audience at the stripped hours), at most what I will do is create one more mini-strip in February. If the success is more moderate, I will cut back the days of one of the new strips and try a talk-radio mini-strip in the 3pm hour. If they fail to build audience, it’s back to the drawing board.

If strip programming proves a success for KPFK (building audience, raising funds etc.), then I will work to make sure that the format evolves into a more participatory, community model than our current talk-shows. This will be achieved by having regularly appearing co-hosts and non-host segment producers on the stripped shows. In this manner, KPFK should be able to have many more people regularly producing on-air content, than is the case with the model of “one host for one hour” that is the standard for most of our current talk shows.

I very much believe in expanding the number of people regularly involved in producing content on KPFK, and following this round of programming changes, I will see to it that KPFK’s programming trends in that direction – if it doesn’t, I expect to be held accountable as iPD.

Lastly, I truly want to hear from as many people as possible about the direction they hope the station will take. There are 12 to 15 million people in the Southern California Metro Radio market – and given the strength of our signal, perhaps as many as 20 million people within our range – and that doesn’t even take into account the internet. Given the global significance of Southern California as one of the world’s greatest and most influential population centers – it’s not an overstatement to say that KPFK, which stands apart from every other media enterprise in SoCal, can profoundly influence the course of history. But what it will take, moving forward, is a clear sense and a solid dialogue about how to organize this station so that it truly serves the needs of the people of this region.

KPFK’s current situation requires immediate measures, and bold experimentation. While changes this sweeping understandably evoke apprehension, they also represent an opportunity for us to revitalize our programming and attract new audiences. I ask for your patience, participation, and insight as we proceed.

sincerely,

Alan Minsky
KPFK interim Program Director