Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, 33030-33101 [E9-16119]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 130 (Thursday, July 9, 2009)]
[Rules and Regulations]
[Pages 33030-33101]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16119]



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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

Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Rules 
and Regulations

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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 https://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

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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

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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.
     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)).
     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)).
     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)).
     Shell egg producers are required to use the following SE 
prevention measures:
     Have and implement a written SE prevention plan that 
includes all mandatory SE prevention measures (21 CFR 118.4);
     Procure pullets that are SE-monitored, or raise pullets 
under SE-monitored conditions (Sec.  118.4(a));
     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));
     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
     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)).
     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)).
     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).
     Shell egg producers must conduct egg testing for SE when 
an environmental test is positive for SE (21 CFR 118.6).
     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).
     Shell egg producers must maintain a written SE prevention 
plan and records documenting compliance with the requirements in the 
plan (21 CFR 118.10).
     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)).
     Shell egg producers must make records available within 24 
hours from the time of receipt of the official request (Sec.  
118.10(d)).
     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:
     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.
     Shell egg producers are required to have and implement 
written SE prevention plans.
    The proposed rule did not require that plans be written.
     The requirements for protective clothing and sanitizing 
stations have been removed from biosecurity program requirements.
     The requirement to ``wet clean the positive poultry 
house'' has been removed.
     Egg processors are now permitted to equilibrate 
refrigerated eggs to room temperature just prior to processing.
     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.
     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.
     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).''
     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.
     Shell egg producers must document that pullets were SE-
monitored or raised under SE-monitored conditions.
     ``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.
     Shell egg producers must maintain records documenting 
compliance with each of the SE prevention measures.
     Shell egg producers must maintain records documenting 
review and modifications of the SE prevention plan and corrective 
actions.
     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 8) 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