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

Thursday,
July 9, 2009
Part II
Department of
Health and Human
Services
Food and Drug Administration
21 CFR Parts 16 and 118

Prevention of Salmonella Enteritidis in
Shell Eggs During Production, Storage,
and Transportation; Final Rule
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33030 Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Rules and Regulations
DEPARTMENT OF HEALTH AND G. The Food Code IX. Paperwork Reduction Act of 1995
HUMAN SERVICES H. Rationale for the Final Rule X. Analysis of Environmental Impact
II. Highlights of the Final Rule and Summary XI. Federalism
Food and Drug Administration of Significant Differences Between the XII. References
Proposed and Final Rules
A. Highlights of the Final Rule I. Background
21 CFR Parts 16 and 118 B. Significant Differences Between the A. FDA’s Proposed Rule
[Docket No. FDA–2000–N–0190] (Formerly Proposed and Final Rules
Docket No. 2000N–0504) C. Compliance Dates On September 22, 2004, FDA
III. Comments on the Proposed Rule proposed a rule to prevent SE
RIN 0910–AC14 A. General Comments contamination in shell eggs during
B. Comments on ‘‘Persons Covered by the production (the proposed rule) (69 FR
Prevention of Salmonella Enteritidis in Requirements in This Part’’ (Proposed
Shell Eggs During Production, and Final § 118.1)
56824). The proposed rule set out
Storage, and Transportation C. Comments on ‘‘Definitions’’ (Proposed several measures to be taken by egg
and Final § 118.3) producers to prevent the contamination
AGENCY: Food and Drug Administration, D. Comments on ‘‘Salmonella Enteritidis of shell eggs with SE during egg
HHS. (SE) Prevention Measures’’ (Proposed production, such as implementation of
ACTION: Final rule. and Final § 118.4) biosecurity and pest control programs,
E. Comments on ‘‘Environmental Testing environmental and egg testing
SUMMARY: The Food and Drug for Salmonella Enteritidis (SE)’’ requirements, and requirements
Administration (FDA) is issuing a final (Proposed and Final § 118.5)
F. Comments on ‘‘Egg Testing for
concerning refrigerated storage of eggs at
rule that requires shell egg producers to the farm and diversion from the table
Salmonella Enteritidis (SE)’’ (Proposed
implement measures to prevent egg market of eggs from flocks in which
and Final § 118.6)
Salmonella Enteritidis (SE) from G. Comments on ‘‘Sampling Methodology SE has been detected (69 FR 56824).
contaminating eggs on the farm and for Salmonella Enteritidis (SE)’’ In addition, in the proposed rule we
from further growth during storage and (Proposed and Final § 118.7) solicited comments on whether we
transportation, and requires these H. Comments on ‘‘Testing Methodology for should include additional requirements
producers to maintain records Salmonella Enteritidis (SE)’’ (Proposed in the final rule, particularly in two
concerning their compliance with the and Final § 118.8)
areas. First, we asked whether we
rule and to register with FDA. FDA is I. Comments on ‘‘Administration of the
Salmonella Enteritidis (SE) Prevention should expand the proposed
taking this action because SE is among recordkeeping requirements to include a
Plan’’ (Proposed and Final § 118.9)
the leading bacterial causes of written SE prevention plan and records
J. Comments on ‘‘Recordkeeping
foodborne illness in the United States, Requirements for the Salmonella documenting compliance with the SE
and shell eggs are a primary source of Enteritidis (SE) Prevention Plan’’ prevention measures (69 FR 56824 at
human SE infections. The final rule will (Proposed and Final § 118.10) 56825 and 56841 through 56842).
reduce SE-associated illnesses and K. Comments on ‘‘Registration Second, we asked whether the safe egg
deaths by reducing the risk that shell Requirements for Shell Egg Producers handling and preparation practices in
eggs are contaminated with SE. Covered by the Requirements of This
FDA’s Food Code (see http://
Part’’ (Final § 118.11)
DATES: This final rule is effective www.cfsan.fda.gov/∼dms/fc05-toc.html
L. Comments on ‘‘Enforcement and
September 8, 2009. The Director of the Compliance’’ (Proposed and Final (accessed December 14, 2006)) should
Office of the Federal Register approves § 118.12) be federally mandated for
the incorporation by reference in M. Comments on Request for Comments as establishments that specifically serve a
accordance with 5 U.S.C. 552(a) and 1 to Whether FDA Should Mandate highly susceptible population (such as
CFR part 51 of certain publications in Special Requirements for Certain Food nursing homes, hospitals, and daycare
new 21 CFR 118.8 as of September 8, Establishments That Serve Highly centers) (69 FR 56824 at 56825 and
2009. Please see section II.C of this Susceptible Populations 56849 through 56852).
document for the compliance dates of IV. Legal Authority
V. Analysis of Economic Impacts—Final
The proposed rule had a 90-day
this final rule. Submit comments on comment period, which ended on
Regulatory Impact Analysis
information collection issues under the A. Introduction December 21, 2004. To discuss the
Paperwork Reduction Act of 1995 by B. Need for Regulation proposed rule and solicit comments
August 10, 2009 (see the ‘‘Paperwork C. Comments on the Preliminary from interested stakeholders, FDA held
Reduction Act of 1995’’ section of this Regulatory Impact Analysis in the three public meetings in 2004. Based on
document). Proposed Rule and Responses comments received in response to the
FOR FURTHER INFORMATION CONTACT: John D. Economic Analysis of Potential proposed rule, FDA reopened the
Sheehan, Center for Food Safety and Mitigations: Overview comment period on May 10, 2005, for
E. Summary of Costs and Benefits of
Applied Nutrition (HFS–315), Food and the limited purpose of receiving
Regulatory Options and the Rule
Drug Administration, 5100 Paint Branch F. Benefits and Costs of Potential SE comments and other information
Pkwy., College Park, MD 20740, 301– Prevention Measures: Detailed Analysis regarding industry practices and
436–1488. G. Summary of Benefits and Costs of the programs that prevent SE-monitored
SUPPLEMENTARY INFORMATION: Final Rule chicks from becoming infected by SE
VI. Final Regulatory Flexibility Analysis during the period of pullet rearing until
Table of Contents A. Introduction placement into laying hen houses (70
I. Background B. Economic Effects on Small Entities FR 24490). The term ‘‘pullet’’ refers to
A. FDA’s Proposed Rule C. Regulatory Options a chicken less than 20 weeks of age. On
B. What Are Salmonella and SE Infection? D. Description of Recordkeeping and
C. What Is the Connection Between Recording Requirements
May 24, 2005, FDA received a request
Salmonella and Shell Eggs? E. Summary for an extension of the reopened
D. The U.S. Egg Industry VII. Unfunded Mandates comment period from two of the major
E. Current On-Farm Practices VIII. Small Business Regulatory Enforcement trade associations representing egg
F. Voluntary EQAPs Fairness Act producers and others affected by this
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Rules and Regulations 33031
rule. We agreed to extend the reopened Salmonella. Although all cases may not outbreaks of SE infection, in 2000 there
comment period until July 25, 2005. be confirmed, all confirmed cases are were 50, and in 2002 there were 32 (Ref.
associated with isolates of Salmonella. 13). The number of outbreaks has
B. What Are Salmonella and SE
Reported cases are likely to represent remained roughly constant since 2002;
Infection?
only a small portion of the actual in 2004 there were 28, in 2005 there
As we described in greater detail in number of illnesses that occur because were 35, and in 2006 there were 26 SE
the proposed rule (69 FR 56824 at 56825 of the following reasons: (1) Ill outbreaks in the United States (Ref. 13).
through 56827), Salmonella individuals do not always seek care by Although these data indicate that there
microorganisms are ubiquitous and are medical professionals, especially if the has been a decrease in reported
commonly found in the digestive tracts symptoms are not severe; (2) medical outbreaks (and associated illness) linked
of animals, especially birds and reptiles. professionals may not establish the to SE infection since the mid-1990s, the
Human illnesses are usually associated cause of the illness but may simply treat incidence of SE infection in the United
with ingesting food or drink the symptoms; and (3) medical States remains much higher than in the
contaminated with Salmonella, professionals do not always report 1970s (Ref. 14), and the decrease in
although infection also may be Salmonella cases to public health reported outbreaks of SE illness since
transmitted person-to-person through officials. CDC estimates that there are 38 1999 has appeared to slow or stop
the fecal-oral route where personal cases of salmonellosis for every reported compared to decreases seen in the mid-
hygiene is poor or by the animal-to-man culture-confirmed case (Ref. 5). The 1990s (Ref. 15). CDC recently reported
route (Ref. 1–2). overall burden of salmonellosis in 2001 that, of the four pathogens with HP2010
All people are at risk for was estimated to be 1,203,650 cases, targets, Salmonella, with 16.2 cases per
salmonellosis, although the severity of including 14,000 hospitalizations, and 100,000 in 2008, is the farthest from its
the infection is influenced by a person’s 494 deaths (Refs. 6 and 7). Updated 2010 target (6.8) (Ref. 10). If current
age and immune status. Salmonella Salmonella surveillance data for 2004 trends continue, we will fall short of the
infections are characterized by diarrhea, indicate that the burden of public health and foodborne illness
fever, abdominal cramps, headache, salmonellosis in 2004 was somewhat gains required to meet the Healthy
nausea, and vomiting. Symptoms higher, estimated to be 1,376,514 cases, People 2010 goal of a 50 percent
usually begin within 6 to 72 hours after including 14,264 hospitalizations, and reduction from the 1997 baseline in
consuming a contaminated food or 427 deaths (Refs. 5 and 8). both the number of SE foodborne
liquid and last for 4 to 7 days. Most CDC surveillance data list close to 600 outbreaks and the rate of isolation in the
healthy people recover without different Salmonella serotypes that have population of foodborne Salmonella
antibiotic treatment; however, the caused illness in the United States. infections (Ref. 16).
diarrhea can be severe, and the person Since 1995, Salmonella enterica
may be ill enough to require serotype Enteritidis (SE) has been the C. What Is the Connection Between
hospitalization. In some patients, the second most frequently reported cause Salmonella and Shell Eggs?
infection can spread into the of Salmonella infection (Ref. 9). CDC CDC established an epidemiological
bloodstream, then to other areas of the reported that in 2008 SE was the leading and laboratory association between eggs
body, such as the bone marrow or the reported cause of Salmonella infections, and Salmonella outbreaks in the mid-
meningeal linings of the brain. This accounting for 20.1% of all of the 1980s (see 69 FR 56824 at 56826
infection can lead to a severe and fatal Salmonella isolates that were serotyped through 56827). Shell eggs are the
illness (Ref. 2). These complications (Ref. 10). The rate of SE isolates predominant source of SE-related cases
associated with an infection are more reported to CDC increased from 0.6 per of salmonellosis in the United States
likely to occur in children, the elderly, 100,000 population in 1976 to 3.6 per where a food vehicle is identified (a
and persons with a weakened immune 100,000 population in 1996 (Ref. 11– food vehicle is identified in
system. 12). In 2001 the isolation rate for SE was approximately half of the outbreaks of
In addition, about 2 percent of those 2.0 per 100,000 population, and the illness associated with SE). Between
who recover from salmonellosis may annual contribution of SE (corrected for 1985 and 2002, a total of 53 percent of
later develop recurring joint pain and underreporting) to salmonellosis was all SE illnesses identified through CDC
reactive arthritis (Ref. 3, 4). estimated to be 193,463 illnesses, outbreak surveillance are attributable to
Salmonellosis is a serious health including 2,004 hospitalizations and 60 eggs. Where a vehicle of transmission
concern. It is a notifiable disease, i.e., deaths (Refs. 5 and 8). Estimated was identified, 81 percent of outbreaks
physicians and health laboratories are incidence of Salmonella infection in and 79 percent of illnesses identified
required to report cases (single 2008 did not change significantly through outbreaks were attributed to
occurrences of illness) to local health compared with estimates for the eggs (Ref. 17). These data are in accord
departments in accordance with preceding 3 years, and in particular the with a published analysis by CDC
procedures established by each State. apparent increase in Salmonella researchers reporting that between 1990
These cases are then reported to State infections was not significant. However, and 2001, 78 percent of vehicle-
health departments, and the Salmonella the incidence of SE did increase by 19% confirmed SE outbreaks were associated
isolates are referred to State Public (CI = 3%–39%) (Ref. 10). These data with eggs, primarily raw or
Health laboratories for serotyping (a confirm the continued significance of undercooked (Ref. 15). Over that
method of distinguishing related SE as a cause of human infection in the decade, 14,319 illnesses were attributed
organisms by their antigens). Each case United States. to SE associated with shell eggs (Ref.
and each serotyped isolate is reported to In 1985, States reported to CDC 26 SE- 15). Most of these attributed illnesses
the U.S. Centers for Disease Control and related outbreaks (i.e., occurrences of 2 occurred before 1995 (10,406 illnesses),
Prevention (CDC). These reports are or more cases of a disease related to a but 3,913 occurred during 1996 through
made only for diagnosed cases of common source); by 1990 the number of 2001. We believe egg quality assurance
Salmonella infection. SE-related outbreaks reported to CDC programs (EQAPs), consumer and
A case of illness is confirmed as had increased to 85. The number of retailer education, and Federal
salmonellosis only if an isolate is outbreaks began declining in the 1990s; regulations requiring egg refrigeration
confirmed by a laboratory as being in 1995 there were 56 confirmed have contributed to the decrease in SE
illness since the mid-1990s, but that frozen, or dried pasteurized egg other locations. Most (95 percent) of
further reductions in SE illness and products. The majority of egg products pullets in pullet-raising facilities came
foodborne salmonellosis cannot be are destined for institutional use or as chicks from National Poultry
accomplished without additional further processing into foods such as Improvement Plan (NPIP) monitored
Federal measures to address SE cake mixes, pasta, ice cream, breeder flocks. USDA’s NPIP is a
contamination of shell eggs. mayonnaise, and bakery goods. cooperative Federal-State-industry
The surface of an egg can become Geographically, commercial egg mechanism intended to prevent and
contaminated with any microorganism production in the western United States control egg-transmitted, hatchery-
that might be excreted by a laying hen is concentrated in California, and in the disseminated poultry diseases. NPIP has
or through contact with contaminated eastern United States is centered in monitoring programs for many avian
nesting materials, dust, feedstuff, Ohio, Indiana, Iowa, and Pennsylvania. diseases and pathogens, including SE.
shipping and storage containers, human Other States in which major producers Chicks are SE-monitored if they are
beings, and other animals. The are located include Texas, Minnesota, hatched from eggs from flocks that are
likelihood of trans-shell penetration and Georgia. Over 4,000 farm sites have certified through NPIP as ‘‘U.S. S.
increases with the length of time that 3,000 or more egg-laying hens, Enteritidis Clean’’ breeder flocks (9 CFR
the eggs are in contact with representing 99 percent of all domestic 145.23(d)).
contaminating materials. This egg-laying hens and accounting for 99 Many pullet-raising facilities in the
mechanism of contamination was percent of total egg production. There Layers 99 study had their own programs
previously considered the source of all are an additional 65,000 farms with for SE monitoring. In the West region,
SE contamination of eggs. fewer than 3,000 egg-laying hens, 83 percent of farms obtained layers from
However, while environmental accounting for the balance of eggs SE-monitored pullet facilities, and 70
contamination is still a route for produced (Ref. 26). percent of layers on all farms came from
Salmonella contamination, SE experts SE-monitored pullet facilities. Pullet
now believe that the predominant route E. Current On-Farm Practices
facilities used one or more of the
through which eggs become In the proposed rule we described in following methods to monitor SE: (1)
contaminated with SE is the detail current farm practices to address Dead chick/chick paper testing, (2)
transovarian route. Although the the risk of SE contamination (69 FR environmental culture, (3) bird culture,
mechanism is still not well understood, 56824 at 56830 through 56831). Most of and (4) serology. Some pullet facilities
SE will infect the ovaries and oviducts the information we provided came from used competitive exclusion products
of some egg-laying hens, permitting a 1999 study (the Layers 99 study) (Refs. and/or vaccines to protect pullets
transovarian contamination of the 27, 28, and 29) by USDA’s Animal and against SE.
interior of the egg while the egg is still Plant Health Inspection Service (APHIS) The study found that in 1997, the
inside the hen (Refs. 18 and 19). The National Animal Health Monitoring average flock was placed for its first
site of contamination is usually the System (NAHMS), as well as production cycle at 17.5 weeks of age.
albumen (the egg white). information on voluntary EQAPs, which Flocks in their first production cycle
Researchers believe that only a small are discussed more fully in section I.G reached peak production around 29
number of hens in an infected flock of this document. weeks of age. At peak production, the
shed SE at any given time and that an The Layers 99 study was designed to average maximum number of eggs
infected hen may lay many include information from States that produced was 90 eggs per 100 hens per
uncontaminated eggs (Ref. 20). In a account for at least 70 percent of the day. Induced molting was used on many
farm-to-table risk assessment of SE in animal and farm population in the farms (83 percent of farm sites). In the
eggs which was conducted by FDA and United States (Refs. 27, 28, and 29). West and Southeast regions, 95 percent
the U.S. Department of Agriculture’s Each operation participating in the or more of farms molted birds, while in
(USDA’s) Food Safety and Inspection study had more than 30,000 laying hens. the Central region just over half (57
Service (FSIS) (‘‘the 1998 joint SE risk The study found that egg laying percent) of the farms molted birds. On
assessment’’) (Ref. 21), we estimated operations varied considerably in size average, molted flocks ended
that of the 47 billion shell eggs and style of poultry house; production at 111 weeks of age, while
consumed annually as table eggs (eggs approximately 34 percent of the houses non-molted flocks ended production at
consumed as shell eggs, as opposed to had fewer than 50,000 layers, 29 percent 74 weeks of age.
eggs that are used to make egg had 50,000 to 99,999 layers, 20 percent Approximately two-thirds of farms
products), 2.3 million are SE-positive, had 100,000 to 199,999 layers, and 17 had biosecurity measures that did not
exposing a large number of people to the percent had 200,000 or more layers. allow visitors without a business reason
risk of illness (Ref. 21). FDA and FSIS One-third of farm sites surveyed had to enter poultry houses. Sixty-two
updated this risk assessment in 2005 only one layer house, while 16.5 percent percent of farms that allowed visitors
and derived this same estimate (Ref. 22). had six or more layer houses. The study allowed business visitors provided they
This figure is based on data compiled also found wide variability within the had not been on another poultry farm
from 1991 to 1995 (Ref. 23). poultry houses with respect to style of that day. Of the farms that allowed
housing and number and level of cages, visitors in the layer house, most farms
D. The U.S. Egg Industry although less than one percent were (76 percent) required that visitors wear
On a per capita basis, Americans cage-free. Manure handling varied with clean boots. The majority of farms
consume about 234 eggs per year (Ref. house style and also varied regionally. prohibited employees from being
24). U.S. production is relatively stable The study found that, when a poultry around other poultry and from owning
and has increased only slightly over house is repopulated with new laying their own birds.
time. For example, it was at about 60 hens (also known as ‘‘layers’’), most of With respect to pest control, the
billion eggs in 1984 and at 67.3 billion the new layers come from a pullet Layers 99 study estimated that rodents
eggs in 1998 (Ref. 25). Generally, about raising facility. Less than 10 percent of and flies had access to feed in feed
70 percent of the edible shell eggs layer farms raised pullets at the layer troughs on nearly all farms. Fly control
produced are sold as table eggs, while farm site, although some layer farms had was practiced on 90 percent of all farms;
the remainder are processed into liquid, their own pullet-raising facilities at baiting was the most common form of
fly control (72 percent of farms). have State government oversight and for highly susceptible populations (Ref.
Essentially all farms used some type of recordkeeping requirements. All 37).
rodent control. Chemicals and baits programs have some educational
H. Rationale for the Final Rule
were used for rodent control by 93 programs for participants.
percent of farms. Professional This rule is the most recent in a series
G. The Food Code of farm-to-table egg safety efforts begun
exterminators were used on less than 15
percent of farms that used rodent FDA regularly publishes the Food by FDA and FSIS in the 1990s. These
control. Producers rated almost 30 Code, which provides guidance on food efforts are described in more detail in
percent of farms as having a moderate safety, sanitation, and fair dealing that the proposed rule (69 FR 56824 at 56827
or severe problem with mice and almost can be uniformly adopted by State and through 56829). Among these initiatives
9 percent as having a moderate or severe local governments for the retail segment was the FDA and FSIS 1998 joint SE
problem with rats. of the food industry. The Food Code risk assessment (Ref. 21), discussed in
The Layers 99 study found essentially provisions are not Federal requirements; detail in the proposed rule (69 FR 56824
all farms emptied feeders, 91 percent however, they are designed to be at 56829), which concluded that a
emptied feed hoppers, 81 percent consistent with Federal food laws and broad-based policy, encompassing
flushed water lines, 79 percent dry regulations. The Food Code is written so interventions from farm to table, is
cleaned cages, walls, and ceilings, and that all levels of government can easily likely to be more effective in eliminating
71 percent cleaned fans and ventilation adopt its text into a legal requirement. egg-associated SE illnesses than a policy
systems. Approximately one-third of Beginning with the 1993 edition, the directed solely at one stage of the
farm sites never cleaned or disinfected Food Code was issued in its current production-to-consumption continuum.
egg belts/elevators between flocks. format and was revised every 2 years. In In 2004, after FDA’s proposed rule was
Down time between flocks varied 2002, with the support of the published, FSIS published a draft risk
regionally; most farms had a down time Conference for Food Protection, FDA assessment for SE in shell eggs and
of more than 11 days, although some decided to move to a 4-year interval Salmonella spp. in egg products. This
were down for less than 4 days. between complete Food Code revisions. risk assessment was then published as
The Layers 99 study showed that, in final in October 2005 (Ref. 22).
FDA published the 2005 Food Code,
1997, 58 percent of farms tested for SE. There are currently several Federal
which is the first full edition to publish
The number of farms testing for SE regulations related to egg safety at the
since the 2001 edition. During the 4-
varied by region. The number and food service level. These regulations
year interim period, a Food Code
regional distribution of farms doing include a final rule issued by FSIS for
Supplement that updated, modified,
testing for SE is very similar to the refrigeration and labeling of eggs during
and clarified certain provisions was
number and distribution of farms transport and storage when packed for
participating in an EQAP. made available. The provisions relevant
to egg safety at establishments serving the ultimate consumer (63 FR 45663,
F. Voluntary EQAPs highly susceptible populations can be August 27, 1998) and an FDA final rule
found in the 2001 Food Code in sections that requires labeling of eggs and
The Layers 99 study found that 51
3–202.11(C), 3–202.13, 3–202.14(A), 3– refrigeration of eggs at retail
percent of all farm sites participated in
401.11(A)(1)(a) and 3–801.11(B)(1), establishments (65 FR 76092, December
an EQAP sponsored by a State or
(B)(2), (D)(1), (D)(2), (E)(1), and (E)(2). 5, 2000). However, this is the first and
commodity group (e.g., United Egg
These Food Code provisions include the only Federal rule that addresses the
Producers). The Salmonella Enteritidis
use of pasteurized eggs in recipes where introduction of SE into the egg during
Pilot Project (SEPP), begun in 1992 by
USDA with special funding from eggs are raw or undercooked (e.g., production. Interventions that can
Congress, was one of the first EQAPs in Caesar salad, hollandaise sauce, reduce the number of SE-contaminated
the United States (in 1994, SEPP became eggnog), and if eggs are combined, eggs at the production phase are of
the Pennsylvania Egg Quality Assurance unless the eggs are cooked to order and particular interest. Because progress in
Program (PEQAP)). Currently, there are immediately served or combined reducing the number of illnesses and
at least nine voluntary EQAPs operated immediately before baking and outbreaks appears to have slowed or
and administered by States or other thoroughly cooked. The 2001 provisions stopped, these additional preventive
organizations (Refs. 30 through 36). In all substantively remain the same in the measures are needed to reduce further
addition, certain egg companies operate 2005 Food Code, but sections 3– the risk of SE illnesses and meet our
an EQAP within their own facilities 801.11(D)(1) and (D)(2) are now public health goals. Because eggs
(Ref. 28). designated as 3–801.11(C)(1) and (C)(2), remain the primary source of SE
Currently, EQAPs are voluntary for and sections 3–801.11(E)(1) and (E)(2) infections, continued actions to improve
producers. These programs have similar are now designated as 3–801.11(F)(1) egg safety are the most effective way to
requirements, but vary in how they and (F)(2). In addition, FDA amended reduce the overall number of SE
implement these requirements. All the definitions of ‘‘Eggs’’ and ‘‘Egg infections and outbreaks and to achieve
programs require use of NPIP ‘‘U.S. S. Products’’ in the 2005 edition of the our public health goals.
Enteritidis Clean’’ chicks or equivalent, Food Code to clarify the difference II. Highlights of the Final Rule and
biosecurity, rodent control, and cleaning between ‘‘egg’’ (shell egg) and ‘‘egg Summary of Significant Differences
and disinfection of poultry houses. product’’ (liquid, frozen, or dry egg). Between the Proposed and Final Rules
Although most programs require some Also, FDA clarified that baluts and
environmental testing, the amount reptile eggs are excluded from the egg- A. Highlights of the Final Rule
varies from once to four or five times related provisions of the Food Code. The provisions in the final rule are
during the life of a flock. If an Through careful examination of State described briefly in the following
environmental test is SE-positive (i.e., retail food codes, FDA has identified 47 paragraphs, and are discussed in more
SE is detected at any level in any States and territories (out of 56 States detail later in the preamble of this
sample), several programs require egg and territories) that have either adopted document.
testing, with diversion if the egg testing the 2005 Food Code or provisions that • Persons who produce shell eggs
is SE-positive. Several programs also require the same prevention measures from a farm operating with 3,000 or
more laying hens, unless that farm sells do not have to be onsite employees, who for administration of the SE prevention
all of its eggs directly to consumers or are responsible for ensuring compliance measures has been changed to allow for
does not produce shell eggs for the table with each farm’s SE prevention plan (21 more than one supervisor and for offsite
market, are subject to this final rule (21 CFR 118.9). supervisors to be responsible.
CFR 118.1(a)). • Shell egg producers must maintain • Shell egg producers must document
• Shell egg producers need only a written SE prevention plan and that pullets were SE-monitored or raised
comply with refrigeration and records documenting compliance with under SE-monitored conditions.
registration requirements if all of their the requirements in the plan (21 CFR • ‘‘SE monitored’’ has been defined to
shell eggs from a particular farm receive 118.10). mean that pullets are raised under SE
a treatment as defined in the final rule • Shell egg producers must retain control conditions that prevent SE,
(§ 118.1(a)(2)). records for 1 year after the flock to including the following: (1)
• Persons who transport or hold shell which they pertain has been taken Procurement of chicks from SE-
eggs for shell egg processing or egg permanently out of production monitored breeder flocks that meet
products facilities are required to (§ 118.10(c)). NPIP’s standards for ‘‘U.S. S. Enteritidis
comply with the refrigeration • Shell egg producers must make Clean’’ status (9 CFR 145.23(d)) or
requirements of this final rule records available within 24 hours from equivalent standard, (2) environmental
(§ 118.1(b)). the time of receipt of the official request testing, and (3) cleaning and
• Shell egg producers are required to (§ 118.10(d)). disinfection of the environment as
use the following SE prevention • Shell egg producers must register needed based upon the results of the
measures: with FDA (21 CFR 118.11). environmental testing.
• Have and implement a written SE B. Significant Differences Between the • Shell egg producers must maintain
prevention plan that includes all Proposed and Final Rules records documenting compliance with
mandatory SE prevention measures (21 each of the SE prevention measures.
CFR 118.4); The final rule reflects the following • Shell egg producers must maintain
• Procure pullets that are SE- significant changes from the proposed records documenting review and
monitored, or raise pullets under SE- rule: modifications of the SE prevention plan
monitored conditions (§ 118.4(a)); • Persons who transport or hold shell
and corrective actions.
• Use a biosecurity program, meaning eggs for shell egg processing or egg • Shell egg producers must register
a program that includes limiting visitors products facilities must comply with the with FDA.
on the farm and in poultry houses; refrigeration requirements. Only shell
egg producers were subject to the C. Compliance Dates
maintaining personnel and equipment
practices that will protect against cross- proposed refrigeration requirements. The compliance date is July 9, 2010;
• Shell egg producers are required to except that, for producers with fewer
contamination from one poultry house
have and implement written SE than 50,000 but at least 3,000 laying
to another; preventing stray poultry,
prevention plans. hens, the compliance date is July 9,
wild birds, cats, and other animals from The proposed rule did not require that
entering poultry houses; and prohibiting 2012. The compliance date for persons
plans be written. who must comply with only the
employees from keeping birds at home • The requirements for protective
(§ 118.4(b)); refrigeration requirements is July 9,
clothing and sanitizing stations have
• Use a program to control rodents, been removed from biosecurity program
2010.
flies, and other pests that includes requirements. III. Comments on the Proposed Rule
monitoring for pest activity and • The requirement to ‘‘wet clean the
removing debris and vegetation that FDA received approximately 2,000
positive poultry house’’ has been timely submissions in response to the
may provide harborage for pests removed. initial comment period on the proposed
(§ 118.4(c)); and • Egg processors are now permitted to
• Clean and disinfect poultry houses rule. In addition, approximately 20
equilibrate refrigerated eggs to room
before new laying hens are added if an timely submissions were received in
temperature just prior to processing.
environmental or egg test was positive • The requirement to begin egg response to the reopened comment
for SE during the life of the flock; testing within 24 hours after notification period. The majority of submissions
cleaning and disinfecting must include of a positive environmental test has came from individuals and groups
removing all visible manure, dry been changed to require that results of advocating animal welfare issues that,
cleaning to remove dust, feathers, and egg testing be obtained within 10 for reasons discussed later in this
old feed, and disinfecting (§ 118.4(d)). calendar days after receiving document, are outside the scope of this
• Shell eggs being held or transported notification of the positive rulemaking. The remaining comments
are required to be refrigerated at or environmental test. came from various trade associations,
below 45 degrees Fahrenheit (°F) • The required time period to perform State government agencies, industry,
ambient temperature beginning 36 hours environmental testing for SE after consumer groups, scientific
after time of lay (§ 118.4(e)). molting has been changed from 20 associations, and individual consumers.
• Shell egg producers must conduct weeks to 4 to 6 weeks after molt. These comments raised approximately
environmental testing for SE when • Diverted eggs must have labeling on 60 major issues. To make it easier to
laying hens are 40 to 45 weeks of age the shipping container, and all identify comments and our response to
and 4 to 6 weeks after molt (21 CFR documents accompanying the shipment the comments, the word ‘‘Comment’’
118.5). must state ‘‘Federal law requires that will appear in parentheses before the
• Shell egg producers must conduct these eggs must be treated to achieve at description of the comment, and the
egg testing for SE when an least a 5-log destruction of Salmonella word ‘‘Response’’ will appear in
environmental test is positive for SE (21 Enteritidis or processed as egg products parentheses before our response. We
CFR 118.6). in accordance with the Egg Products have also numbered each comment to
• Administration of the SE Inspection Act, 21 CFR 118.6(f).’’ make it easier to identify a particular
prevention measures requires having • The requirement that one onsite comment. The number assigned to each
one or more supervisory personnel, who supervisor at each farm be responsible comment is purely for organizational
purposes and does not signify the implementation guidance subsequent to (Response) FDA disagrees with the
comment’s value or importance or the this final rule. suggestion that we should delegate
order in which it was submitted. inspection responsibilities under this
2. Vaccination of Layers Against SE
rule to USDA or the States. Although we
A. General Comments (Comment 2) Some comments agreed coordinate our respective egg safety
1. Enforcement by Voluntary EQAPs with FDA’s conclusion, discussed in the efforts with FSIS and AMS, each agency
proposed rule, that there is insufficient has distinct responsibilities and skills,
(Comment 1) Several comments stated scientific support for a requirement that
that FDA should implement what some all of which benefit consumers of shell
layers be vaccinated against SE (69 FR eggs and egg products. These
comments referred to as a ‘‘recognition 56824 at 56847). Some of these
regime,’’ under which parts of the final responsibilities and skills do not
comments stated that FDA should necessarily overlap as a practical matter
rule would not apply to (or would be encourage voluntary vaccination efforts (for example, AMS personnel are in
presumptively complied with by) State by, for example, allowing producers that certain shell egg packing plants, but not
and industry EQAPs with standards can demonstrate the effectiveness of in the layer houses). Furthermore, the
equivalent to the Federal rule. Some their vaccination programs to follow an rule provides that any State or locality
comments suggested that all shell egg alternative protocol for environmental that is willing and able to assist FDA in
producers should be subject to the testing before depopulation. One enforcing the rule may do so in its own
testing and diversion requirements of comment encouraged the use of SE jurisdiction.
the final rule, but that egg producers vaccinations as an added prevention
participating in recognized EQAPs measure against SE contamination of 4. Induced Molting
would have to meet only the on-farm SE shell eggs and recommended that an (Comment 4) Several comments
control measures specified by the option of using a vaccination program responded to the request in the
EQAP. The comments suggested that, as should be available to shell egg proposed rule for comment and data
part of the recognition of the EQAPs, producers. In support, the comment concerning induced molting (69 FR
FDA should also recognize audits and stated that data exists from the United 56824 at 56846 through 56847). We
inspections conducted by State agencies States and Europe that the comment received a number of comments
to measure compliance with those said demonstrates the efficacy of encouraging FDA to ban induced
programs, rather than conducting vaccination programs. The comment did molting of laying birds. These
separate Federal inspections. not provide additional data in support comments stated that this practice
(Response) FDA recognizes that of these statements. stresses the immune function of
existing voluntary EQAPs have been Another comment stated that the chickens, resulting in the promotion of
successful in reducing SE available research and field evidence SE contamination in shell eggs and egg
contamination in poultry houses in support a conclusion that vaccines used products; that it leads to plucking and
certain States (see discussion in section with other SE control measures will consumption of feathers that may be
I.G of this document). However, for reduce SE. contaminated with Salmonella; and that
several reasons, we do not agree that (Response) FDA agrees with the the plucking may itself also stress the
States with EQAPs that are recognized comments supporting only voluntary immune system. The comments
by FDA should not be subject to this vaccination of layers. As we stated in provided some references for these
rule. the proposed rule, there are insufficient assertions. Another comment stated that
First, as discussed, these programs are data on the efficacy of vaccines, USDA supports elimination of forced
not uniformly administered or equally particularly data reflecting field trials molting to reduce SE contamination and
comprehensive in their prevention under ‘‘real world’’ conditions, to that the American Veterinary Medical
measures. In addition, currently the support a mandatory vaccination Association also opposes the practice.
EQAPs that exist are voluntary for shell requirement (69 FR 56824 at 56847). We Other comments supported the
egg producers. Although the existing also believe that data on the efficacy of absence in the proposed rule of
EQAPs all have similar requirements, vaccines are insufficient to allow provisions addressing molting. These
they vary in how those requirements are substitution of vaccination for any of the comments stated that the research on
implemented. This rule will establish SE prevention measures required in this which claims about post-molt SE shed
uniform, nationwide requirements to final rule. If individual producers have are based have primarily been
prevent SE in shell eggs during identified vaccines that are effective for laboratory, rather than field research,
production, storage, and transportation. their particular farms, we encourage the involving large challenge doses of SE
FDA believes that these requirements use of the vaccine as an additional SE that would not be duplicated in the field
will further reduce SE illness and prevention measure. and strains of chickens different from
deaths associated with egg those common in commercial laying
consumption. 3. Delegation of Inspection operations. The comments stated that
On the other hand, we agree that we Responsibilities to Other Federal or there is only emerging research into
can enlist the assistance of existing State Agencies how to use a variety of diets to control
EQAP organizations and officials in (Comment 3) Two comments urged the natural process of molting in the egg
implementing FDA’s regulation. The FDA to delegate farm inspection production setting.
rule provides that a State or locality responsibilities to USDA’s FSIS and (Response) We addressed the issue of
may, in its own jurisdiction, enforce this Agricultural Marketing Service (AMS) induced molting at length in the
rule by carrying out inspections under or the State Departments of Agriculture, proposed rule (69 FR 56824 at 56846
§ 118.12(b) (21 CFR 118.12(b)) and by because these agencies are already through 56847). We discussed the
using the administrative remedies in involved in oversight of various aspects limitations of studies cited to support
§ 118.12(a) unless FDA notifies the State of egg production. Similarly, another the assertion that induced molting
or locality in writing that its assistance comment stated that APHIS and FSIS increases SE contamination of eggs and
is no longer needed. FDA plans to are more qualified than FDA to address stated that we did not believe that we
provide guidance to States and localities disease and pathogen risk reduction in had adequate data upon which to rely
through an enforcement and live animal production operations. for a final decision on the issue of the
relationship between induced molting SE prevention measures and that outbreak data relied on by FDA is in
and SE contamination of the excluding them would be contrary to general submitted by State Departments
environment and of eggs. Although the the public health goal of the rule. The of Health to CDC. As noted earlier, cases
proposed rule specifically requested comments suggested that smaller of salmonellosis must be reported to
comment and data related to our facilities are less likely to have adequate local health departments, who in turn
discussion of induced molting, we did refrigeration capacity, effective rodent provide information to States and to
not receive any new data on the control, an effective biosecurity CDC.
relationship between induced molting program, measures in place to limit FDA recognizes that the cost per hen
and SE contamination of the laying laying hens’ exposure to manure on is higher for smaller farms. However,
environment and of eggs. As a result, we building floors and exposure to the though not specifically broken out in
do not have adequate evidence to outdoors; that they may pose a greater the regulatory impact analysis, for farms
support including a prohibition on risk that they will transport and hold with between 3,000 and 19,999 layers,
induced molting in the final rule. eggs without proper refrigeration; and the public health benefits of the rule
that they may be less likely to obtain exceed the costs by more than $90
5. Indemnification
replacement pullets or chicks from million annually and costs do not
(Comment 5) One comment suggested breeders who participate in the SE exceed benefits for any of the individual
that we research whether the Public prevention programs. One comment provisions of the rule. There are a
Health Service Act (the PHS Act) would similarly suggested that eggs from these number of features of the rule itself and
allow us to indemnify persons whose smaller producers might be associated in our plans for implementation to
economic interests are adversely with a disproportionate share of facilitate smaller farms’ compliance
affected by this rule, for example, as a sporadic illnesses and even some with the rule. For example, this final
result of diversion of shell eggs to outbreaks. The comments did not rule has a staggered compliance
breaker facilities. The comment provide data to support these concerns; schedule, which provides smaller egg
suggested that, should we conclude that one comment from one of the larger producers (those with between 3,000
we lack such legal authority, we should trade associations stated that it was not and 49,999 layers) 3 years to comply
consider whether to request it from aware of research that would support with the final rule. FDA will continue
Congress. Another comment suggested any conclusion that smaller operations to evaluate the impact of this rule on
that a Federal compensation package would be either more or less likely to smaller farms and will consider taking
may be needed for smaller producers have an SE problem than larger, appropriate steps to mitigate those
that lack pasteurization capability. commercial operations. impacts, where it is possible to do so
(Response) Unlike APHIS, FDA is not One comment proposed that FDA without reducing safety. In addition,
required or explicitly authorized by reduce the exemption to producers with FDA intends to provide guidance on the
Federal statute to compensate persons less than 500 chickens or require all recordkeeping and other provisions of
whose economic interests are adversely producers not selling directly to the rule, including small entity
affected by certain Agency actions.1 consumers to comply with the rule. This compliance guidance. We plan to use
Further, FDA notes that although some comment suggested that FDA may not guidance, to the extent feasible, as a
producers will face economic costs from be aware of outbreaks associated with vehicle to identify areas where
the diversion of eggs to the table market, eggs from these producers because the compliance could be achieved via
as discussed in section V of this eggs are not likely to be shipped flexible approaches that would mitigate
document (Analysis of Economic interstate. the financial impact while preserving
Impacts), the economic benefit from One comment cited our $1.01 per hen
the public health benefits of the rule.
illnesses averted is expected to greatly ($0.05 per dozen) estimate of the cost to
We plan to solicit public and industry
exceed the cost of this rule. The farms with between 3,000–19,999 layers
input on this guidance.
suggestion that FDA seek statutory as an illustration of the large financial Therefore, FDA has retained the
authority to pay compensation to burden that the rule imposes on these exemption from all provisions of this
indemnify producers is outside the farms. final rule for farms with fewer than
scope of this rule. (Response) We do not believe that
3,000 layers.
there is at this time sufficient evidence
B. Comments on ‘‘Shell Egg Producers to warrant extending the rule’s coverage C. Comments on ‘‘Definitions’’
Covered by the Requirements in This to producers with fewer than 3,000 (Proposed and Final § 118.3)
Part’’ (Proposed and Final § 118.1) laying hens. As we explained in the
proposed rule (69 FR 56824 at 56832), 1. Poultry House
Exemption of Producers With Small
Flocks because producers with fewer than (Comment 7) One comment
3,000 layers do not contribute questioned the proposed definition of a
(Comment 6) Several comments significantly to the table egg market, poultry house, which requires that
addressed our proposed exemption of imposing any one or all of the different sections of a single building
shell egg producers with small flocks, restrictions on them will have little separated by walls be considered as
defined as flocks of less than 3,000 measurable impact on the incidence of separate houses. The comment noted
laying hens at a particular farm. Most of SE. We have no information that the definition would not address
these comments argued that these small documenting that there is an elevated the risk of airborne transmission of SE.
flocks are less likely to have adequate risk of sporadic illness or outbreaks The comment stated that ‘‘there is
associated with eggs sold directly from considerable evidence that SE can be
1 Under the Animal Health Protection Act, USDA
is required to compensate the owner for any animal, farmer to consumer or from a producer transmitted through dust and other
article, or means of conveyance that the Secretary with fewer than 3,000 laying hens. airborne particles,’’ citing three
of Agriculture requires to be destroyed (7 U.S.C. FDA disagrees with the statement that references in support. The comment
8306(d)). Under the Plant Protection Act, USDA is we may be unaware of outbreaks noted that the proposed rule did not
authorized to pay compensation to any person for
economic losses incurred as a result of action taken
associated with eggs from small require that separate sections in a
by the Secretary of Agriculture under a declaration producers because these producers are building have separate ventilation
of extraordinary emergency (7 U.S.C. 7715). less likely to ship eggs interstate. The systems, but did require biosecurity
procedures to ensure that there is no current 5-log reduction requirement contaminated with the pathogen. The
introduction or transfer of SE from one appears to provide an adequate margin comments urged FDA to make clear in
section to another. The comment of safety, because specified the rule that all of the SE prevention
suggested that the definition of a poultry temperatures and holding times do not practices apply to both pullet rearing
house should clarify that the biosecurity take into account the additional kill houses and layer houses. The comments
procedures should include transfer achieved in the product while it is noted that this approach would be
through airborne particles. heating up to, and cooling down from, consistent with the practice of existing
(Response) FDA recognizes that SE the pasteurization temperature. EQAPs SE prevention measures that are
may be transmitted through dust and (Response) FDA agrees with the applicable specifically to pullets.
other airborne particles. However, FDA comments that a 5-log reduction in SE Many comments suggested that FDA
does not believe that separate via pasteurization or an alternative add a new requirement that producers
ventilation for each section of a house approach or the processing of egg certify that pullets they procure have
should be mandated because there is products to achieve an equivalent level come from a facility that has an SE-
great variation in design and placement of protection is appropriate to ensure monitoring program. The comments
of houses and ventilation systems, and the safety of shell eggs. Therefore, we recommended that pullet houses
separate ventilation may not be have retained the definition for the term undergo environmental tests for SE for
necessary in every circumstance. ‘‘treatment’’ (or ‘‘treated’’) in § 118.3 of each flock at approximately 10 weeks of
Depending on the layout of a farm and the final rule as ‘‘a technology or age. The comments stated that, if the
the type and number of houses, a process that achieves at least a 5-log test is positive, the producer could still
producer should decide whether destruction of SE for shell eggs, or the accept the pullets, but the producer
ventilation needs to be addressed as part processing of egg products in should be required to test
of farm-specific biosecurity measures to accordance with the Egg Products environmentally after placement. In
prevent the introduction or transfer of Inspection Act. We established this addition, the comments suggested that
SE from one section to another. standard in 1997, in response to a FDA require that pullet houses should
The proposed definition of ‘‘poultry USDA/AMS request to FDA on criteria be cleaned and disinfected prior to
house’’ stated ‘‘For structures for shell egg pasteurization. AMS then placement of the next pullet flock.
comprising more than one section published this standard in its Federal Finally, the comments suggested that
containing poultry, each section is Register notice on official identification FDA require testing for layers used to
enclosed and separated from the other of pasteurized shell eggs on September backfill (replacing dead or diseased
sections, and each section has a 24, 1997 (62 FR 49955). layers with other layers) and older
biosecurity program in place to ensure Additionally, both FDA and FSIS are flocks that are moved to another facility.
that there is no introduction or transfer evaluating additional measures to (Response) We agree that SE
of SE from one section to another.’’ improve egg safety, and FSIS intends to prevention measures should be in place
(Emphasis added.) The final phrase has issue proposed rules in the near future during the pullet phase of shell egg
been removed from this section and for egg products plants and egg production and have modified the rule
added as an introduction to § 118.4(b) handlers, including egg handlers who accordingly. We believe this will reduce
(biosecurity) to make clear that you operate in-shell pasteurization the risk of placing infected birds into
must ‘‘take steps to ensure that there is treatments. FDA and FSIS will continue poultry houses. The final rule requires
no introduction or transfer of SE into or to work closely together to ensure that producers to procure pullets from
among poultry houses,’’ and that our egg safety measures are consistent, sources where the environment has
‘‘[a]mong such biosecurity measures you coordinated, and complimentary. been tested and found environmentally
must, at a minimum’’ include a number negative prior to introduction into the
of specific measures in the biosecurity D. Comments on ‘‘Salmonella laying flock. The environmental testing
plan. If the design of a farm and its Enteritidis (SE) Prevention Measures’’ is required of pullets at 14 to 16 weeks
poultry houses needs an additional (Proposed and Final § 118.4) of age and cleaning and disinfection of
measure of ventilation to prevent cross- the pullet environment is required if the
1. Chicks and Pullets (§ 118.4(a))
contamination, then such a measure environmental test is positive. The
should be added to the biosecurity plan. FDA reopened the comment period on cleaning and disinfection procedures
In addition, in the final rule we have May 10, 2005, to seek further comment include removing all manure, dry
revised the definition of ‘‘poultry and information on industry practices cleaning the positive pullet house to
house’’ to clarify that ‘‘[f]or structures and programs that prevent SE- remove dust, feathers, and old feed, and
comprising more than one section monitored chicks from becoming following cleaning, disinfecting of the
containing poultry, each section that is infected by SE during the period of positive pullet house with spray,
separated from other sections is pullet rearing until placement into aerosol, fumigation, or another
considered a separate house.’’ laying hen houses (70 FR 24490). We appropriate disinfection method.
received approximately 20 submissions Additionally, if the environmental test
2. Treatment that provided additional information is positive for SE, producers must begin
(Comment 8) Some comments stated and data on the specific questions that egg testing within 2 weeks of the start
that a survey of egg processors to FDA presented. of egg laying. The requirements also
determine their current pasteurization (Comment 9) Several comments stated include procuring chicks from SE-
practices supports a 5-log reduction, that on-farm prevention practices must monitored breeder flocks that meet
although many processors achieve a address each stage in the life of laying standards set by NPIP for ‘‘U.S. S.
substantially greater pathogen flocks, including the pullet-rearing Enteritidis Clean’’ status or equivalent
reduction. The comments stated that the stage. These comments stated that standard.
survey indicated that 50 percent of applying the FDA-mandated practices to FDA does not agree that a specific
survey respondents reported that they layers only after they have been placed requirement is needed to test birds used
achieve a 5-log reduction, and the other in layer hen houses may be too late to to backfill and to test older flocks that
50 percent reported a 7-log or greater ensure protection against SE, as the are moved to another facility. Section
reduction. The comments stated that the layers’ ovaries may already be 118.5(a) of the final rule requires
producers to perform environmental houses. For example, in some egg producers may incorporate
testing for SE in a poultry house when circumstances placing footbaths and additional biosecurity measures into
any group of laying hens constituting farm-specific footwear at the entrance to their SE prevention plans if they believe
the flock within the poultry house is 40 a complex, maintaining house specific such measures are warranted.
to 45 weeks of age. Therefore, any layers equipment, or using non-street clothing (Comment 12) One comment stated
used to backfill and older layers moved in the layer houses may be sufficient to that if FDA insists on a biosecurity
into a poultry house will be, or would prevent cross-contamination between requirement, it should address the
have been, environmentally tested at 40 houses. Therefore, we have removed movement of pullets, spent hens (hens
to 45 weeks of age, as are all other from the biosecurity provisions the that have permanently ceased egg
layers. requirements for the use of protective production), people, equipment, eggs,
(Comment 10) Several comments clothing and sanitizing stations between flats (a receptacle for storing or
supported the proposed requirement houses. This change addresses the transporting eggs most often constructed
that all pullets and chicks be procured diverse poultry housing situations that of cardboard or plastic), and egg shells.
from a hatchery or breeding flock that exist throughout the country by (Response) The comment was not
participates in NPIP. These comments allowing each producer to implement specific as to how these matters should
noted that NPIP participants have biosecurity practices and procedures be addressed and did not provide any
developed effective strategies that have appropriate for a particular farm and supporting data concerning the need for
reduced the prevalence of many poultry situation. We also agree that it is particular requirements. However, it
diseases including SE. impractical to require egg producers to was not our intention that the proposed
(Response) We have retained the prevent stray animals from entering the rule’s biosecurity provisions addressing
requirement that pullets that are grounds. Therefore, we have narrowed the risk of cross-contamination from
purchased be procured as chicks from the provision for stray animals to apply visitors or the movement of
SE-monitored breeder flocks that meet only to the poultry houses. ‘‘equipment’’ be interpreted as an
NPIP’s standards for ‘‘U.S. S. Enteritidis However, FDA disagrees with the exclusive list of measures to take to
Clean’’ status or an equivalent standard. comments questioning the value of prevent the introduction of SE into or
other specific biosecurity requirements. among poultry houses. We have
2. Biosecurity (§ 118.4(b))
As discussed in the proposed rule (69 amended § 118.4(b) to make this clear,
(Comment 11) Some comments stated FR 56824 at 56835), limiting visitors on by adding general introductory
that FDA should revise its biosecurity the farm and in poultry houses, language, moved from the proposed
requirements to allow egg producers maintaining practices that will protect definition of ‘‘poultry house,’’ that
greater flexibility. In addition, some against cross-contamination when producers must ‘‘take steps to ensure
comments challenged specific persons move between poultry houses, that there is no introduction or transfer
biosecurity measures as being and prohibiting employees from keeping of SE into or among poultry houses.’’
insufficiently supported by data birds at home are all vital biosecurity (Comment 13) One comment
demonstrating their effectiveness in provisions that are commonly in use. suggested that the proposed rule is
controlling or preventing SE According to the Layers 99 study (Ref. premised on a mistaken belief by FDA
contamination. Specifically, comments 29), 66 percent of farm sites already that biosecurity alone can prevent the
questioned the value of requiring practice some form of biosecurity; that introduction and spread of SE.
personal protective equipment and study found that poultry houses where (Response) As reflected in the rule,
sanitizing stations between houses on visitors were not allowed were less FDA understands that biosecurity is
one farm, limiting visitors, controlling likely to test positive for SE. only one element of the measures that
movement of workers from house to Biosecurity is a critical part of a a producer must have to prevent SE.
house, preventing employees from farm’s SE prevention measures. You Producers must follow additional SE
having poultry at home, and preventing must implement these biosecurity prevention measures, including pullet
stray poultry, wild birds, and other measures to prevent the introduction or measures; rodent, fly and other pest
animals from entering the grounds. transmission of SE into or between control; cleaning and disinfection; and
According to the comments, on a farm poultry houses. Furthermore, contrary refrigeration.
it is the presence of mice near chickens to the comment, PEQAP requires all (Comment 14) One comment
that maintains the SE infection and participants to maintain an acceptable questioned whether organic poultry
contributes to SE spread from building biosecurity program (Ref. 30). As producers would be able to comply with
to building. One comment asserted that discussed in section I.G of this the requirement in the proposed rule
biosecurity efforts on the farm should be document, all current EQAPs require (§ 118.4(b)(4)) that requires egg
focused on ‘‘rodents and other issues use of NPIP ‘‘U.S. S. Enteritidis Clean’’ producers to ‘‘prevent stray poultry,
threatening to introduce or maintain chicks or equivalent, biosecurity, rodent wild birds, and other animals from
SE.’’ The comment does not explain control, cleaning and disinfection of entering grounds and facilities.’’ The
what ‘‘other issues’’ the commenter is poultry houses, and many programs comment stated that this requirement is
referring to. The comment also asserted require some environmental testing as in conflict with a requirement under the
that PEQAP does not have a biosecurity well. USDA National Organic Program (7 CFR
requirement. We will make further specific part 205) that organic poultry producers
(Response) FDA agrees with the recommendations for biosecurity steps must provide outside access for all
comments that biosecurity measures and options for achieving these steps, livestock. The comment also stated that
could be more flexible in the final rule based on current science and best farms that are based on a pastured
without jeopardizing the effectiveness of practices, in a guidance that we plan to poultry system, which typically
the SE prevention measures. issue subsequent to this final rule. We provides a substantial percentage of the
Specifically, we believe egg producers emphasize, however, that biosecurity is birds’ diet from pasture, would have
may be able to devise and implement an important and integral part of any difficulty complying with this
effective means other than protective poultry farm’s SE prevention program, requirement.
clothing and sanitization stations to and that the biosecurity requirements in (Response) We agree that it would be
prevent cross-contamination between the final rule are minimum standards; difficult to prevent stray poultry and
other animals from entering the grounds regulation. This rule establishes intended and effective component of the
of the farm, and we believe it is minimum national standards based on firm’s fly control efforts. Data available
sufficient to keep stray animals out of measures that have been shown to to FDA indicate that there are non-
the poultry house. Therefore, in the prevent SE. The comment did not biological methods of control available
final rule, we have changed the provide any rationale for addressing to producers (i.e., chemical and
requirement for stray animals so that it flies on a State-by-State basis. Further, mechanical methods) and that these
applies only to poultry houses rather the rule provides flexibility in how fly methods are used by most laying hen
than the entire grounds. Further, we presence is determined, allowing not houses. Moreover, the available data
have consulted with AMS, which just spot cards, but also Scudder grills, indicate that the role of parasitic wasps
administers the National Organic sticky traps, or other appropriate in controlling flies is currently being
Program, and AMS has informed us that monitoring methods. FDA intends to debated in the scientific literature, with
this requirement would not make it publish guidance on the requirement to most of the work being done in cattle
impossible for eggs to qualify as organic monitor for flies and on the level of fly feedlots. Meyer et al. (1990) (Ref. 41)
(Ref. 38). activity considered acceptable. and Andress and Campbell (1994) (Ref.
The literature suggests that 50 or 42) found parasite treatments had no
3. Pest Control (§ 118.4(c)) fewer hits on a spot card or sticky trap apparent affect on adult fly populations,
(Comment 15) Some comments per week or a count of less than 20 on while Weinzierl and Jones (1998) (Ref.
supported the rodent control program a Scudder grill indicate satisfactory fly 43) concluded that parasitism
requirement in proposed § 118.4(c)(1), control ((Refs. 39 and 40). significantly reduced the fly population.
but questioned the role of flies in the In the one study we are aware of
spread of SE and recommended 4. Cleaning and Disinfection (§ 118.4(d))
concerning the use of parasitic wasps to
elimination of the pest monitoring (Comment 17) One comment control flies in the context of poultry
under proposed § 118.4(c)(2). The suggested that mandatory cleaning and facilities, variable results were obtained
comments further stated that if disinfection measures should not (Kaufman et al., 2001) (Ref. 44).
measured outside the poultry house, the require removal of ‘‘all visible manure’’ Furthermore, limited data suggest that
fly count might reflect flies that are in a hen house following a positive total cleanout of manure is feasible even
present from external locations, such as environmental test and depopulation, where parasitic wasps are used to
animal housing at adjacent properties. but should allow for flexibility with control flies. A study by Hinton and
(Response) FDA disagrees that the respect to manure removal. The Moon (2003) (Ref. 45) on the effect of a
provision for monitoring flies in comment stated that complete removal total cleanout on fly control in chicken
§ 118.4(c)(2) should be removed or of all manure would destroy biological houses compared the effect of a total
modified. In the proposed rule we controls for flies (such as parasitic cleanout of manure from chicken houses
described research by FDA and others wasps). The comment also argued that to two partial cleanout methods.
showing that flies harbor SE within the this requirement is impractical, because Initially, the increase in flies was
poultry house environment (69 FR many producers only remove manure greatest in those houses with total
56824 at 56835). According to the from the houses during those times of cleanout, but subsequent differences
Layers 99 study, flies, like rodents, have year when they can immediately apply between the three cleaning methods
access to feed troughs on nearly all it to fields. Several comments stated that were small and the fly densities
farms. Further, the fly monitoring the requirement to remove all visible remained relatively stable for 3 months
procedure can be performed inside the manure is impractical for large, complex in all houses. Although this study did
layer house, thus creating an accurate poultry farming operations, because not specifically evaluate parasitic
reflection of the presence of flies there. commercial in-line, multi-tiered cage wasps, it supports a finding that total
For clarification, FDA has replaced layer houses with related accessories cleanout of poultry houses will not
the term ‘‘pest’’ in § 118.4(c)(2) in the and equipment for watering, feeding, adversely affect fly control efforts (Ref.
final rule with ‘‘flies’’ because ‘‘pest,’’ egg collection, manure deflection, 45).
which is defined to mean any storage, and removal might be Second, the fact that manure cannot
objectionable animal including, but not impossible to bring into compliance. always be applied to fields does not
limited to, rodents, flies, and larvae, is The complex machinery (some mean that it should not be removed
too broad in the context of this specific electrical) is very difficult to clean at from poultry houses. Manure removed
provision. best and is just not compatible with wet from a house can be composted, stored
(Comment 16) One comment stated cleaning. It would also be difficult to in a manure barn, or spread on a field
that PEQAP addresses rodent control, accomplish this cleaning in very cold depending on the time of year that it is
but does not address fly control. The climates because of freezing, in that the removed.
comment recommended that fly control layers were an important source of Finally, we do not understand why
be included in the FDA regulation, but house heat until they were removed for manure removal at a large operation
that the States individually and replacement. The comment also noted it would be impractical. We acknowledge
independently decide the number of might be difficult to enforce a that a large operation has more manure
flies allowed for maintaining requirement such as ‘‘removal of all to handle, but FDA has visited large
compliance with the regulation. The visible manure.’’ operations that do clean out the manure,
comment suggested that under State or (Response) We disagree that flexibility and we are unaware of any unique
local requirements or when a farm has should be allowed with respect to problems for such operations.
a problem, the spot cards be used to manure removal after a positive Because manure is a reservoir of SE
determine the numbers and, therefore, environmental test. First, even if it is that has been shed by infected laying
the appropriate control program. true that complete removal of all hens, once a poultry house has had an
(Response) FDA disagrees with the manure would ‘‘destroy biological SE-positive environmental or egg test, it
comment that the States should controls for flies’’ (presumably, by is important that all visible manure be
individually and independently decide removing parasitic wasp larvae), the removed. Removing all visible manure
the number of flies allowed for wasp population could be restored by before new laying hens are placed into
maintaining compliance with the the firm, if biological controls are an a house will help to prevent the SE from
infecting the replacement flock via the change the time at which refrigeration is °F will experience at least a 16-percent
manure and rodents. required to 72 hours after production. breakdown of yolk membrane after 36
Therefore, FDA concludes that, to The comments noted that 72 hours hours and a 25-percent breakdown after
prevent the spread or perpetuation of SE would accommodate shell egg 72 hours. Eggs held at 80 °F will suffer
from one flock to another, a producer production over weekends and smaller at least a 22-percent breakdown after 36
must remove all visible manure from a producers that have pickups less hours and a 39-percent breakdown in
poultry house before new laying hens frequent than daily, while at the same the yolk membrane at 72 hours. At 90
are added to the house when an time ensuring that eggs are not °F, there is at least a 33-percent
environmental test was positive for SE accumulated and held over long periods breakdown after 36 hours and at least a
at any point during the life of the flock without refrigeration. 62-percent breakdown of the yolk
that was housed in the poultry house One comment argued that the membrane after 72 hours. In the 2005
prior to depopulation. The agency requirement to refrigerate eggs within 36 FSIS risk assessment (Ref. 22),
realizes that the floor in a concrete- hours could actually be counter- refrigeration was modeled again; this
floored house could appear light gray, productive with respect to the safety of risk assessment found that limiting eggs
but we do not expect to see any eggs destined for use in the table to just 12 hours without refrigeration,
accumulation of manure in a house that market. The comment reasoned that the shortest timeframe between laying
has had the manure removed, and we do more checks and cracks will occur when and refrigeration that was evaluated,
not anticipate practical difficulties in previously refrigerated eggs are washed provided the greatest public health
our ability to enforce this requirement. due to the greater change in benefit among the time frames studied.
We plan to publish guidance on temperature. The comment Although, as we stated in the
acceptable manure removal subsequent recommended that FDA not set a proposed rule, we believe that it is very
to this final rule. prescriptive time requirement for important that eggs be placed into
(Comment 18) Several comments refrigeration of table eggs unless further refrigerated storage as soon as possible
objected to the wet cleaning research justifies the need, but that if a after they are laid, we recognize that this
requirement in the proposed rule and time limit for refrigeration must be set, may not be practical for all producers.
suggested alternatives such as allowing it should be set at 72, not 36, hours. It may take several hours or longer after
flexibility so long as the cleaning and (Response) We disagree that eggs the eggs are laid before they are
disinfection procedures are sufficient to should remain unrefrigerated for up to collected or picked up for transport.
eliminate SE. The comments stated that 72 hours after laying. Our proposed According to the Layers 99 study (Ref.
wet cleaning is impractical during the requirement that eggs be refrigerated if 28), almost half of the farm sites
coldest months in some States; that it stored more than 36 hours was based on surveyed had egg pickups every 1 to 2
can encourage the growth of SE by data indicating that, although fresh shell days. In light of all of these data, we are
creating an environment for growth of eggs provide an inhospitable retaining in the final rule the
microorganisms in the poultry house; environment for Salmonella to multiply, requirement of 36 hours as the
and that wet cleaning will harm some the chemical and physical barriers maximum amount of time eggs may be
mechanical and electrical parts of against bacterial movement and growth held unrefrigerated on the farm.
equipment and cages. The comments in shell eggs degrade as a result of the (Comment 20) Several comments
argued that there is no scientific time and temperature of holding (69 FR questioned the proposed refrigeration
consensus in favor of wet cleaning. 56824 at 56836 through 56887). As they temperature requirement of 45 °F. One
(Response) We agree that wet cleaning degrade, shell eggs provide an comment stated that holding eggs at 45
may not be practical in all situations increasingly more hospitable °F would result in two problems related
and have removed the requirement from environment for the growth of SE. to egg quality and safety. First, the
the final rule. As discussed in the Studies have shown that SE, when comment stated that ambient moisture
proposed rule (69 FR 56824 at 56836), inoculated into the albumen (whites) of would condense on the cold eggs and
it is important that, once a poultry whole shell eggs, multiplied to high cause them to ‘‘sweat’’ before they are
house has had an SE-positive numbers if the eggs were not properly washed/sanitized, increasing the chance
environmental or egg test, a producer refrigerated (Refs. 46, 47, and 48). of surface contamination penetrating the
make every effort to rid the environment The 36-hour limit for unrefrigerated eggs. Second, the comment stated that
of SE before new laying hens are placed holding is supported by a model, when cold eggs are moved into the egg
into that house to prevent the SE contained in the 1998 joint SE risk washer, which uses hot water, checks or
problem from being perpetuated in the assessment (Ref. 21), which was cracks can develop in the shell,
replacement flock. The final rule retains developed to examine the relationship lowering the quality of the egg and
the requirement in this circumstance to among holding time, holding increasing the risk of future surface
dry clean the poultry house to remove temperature, and yolk membrane bacterial or fungal contamination getting
dust, feathers, and old feed prior to the breakdown as an indicator of SE risk. into the interior of the eggs.
addition of new laying hens to the (The yolk membrane separates the (Response) FDA does not agree that a
house and following cleaning, to nutrient-rich yolk and any SE bacteria 45 °F refrigeration requirement is too
disinfect the positive poultry house that might be present in the albumen; low. This requirement is consistent with
with spray, aerosol, fumigation, or breakdown or loss of the yolk membrane FDA’s final rule on refrigeration of shell
another appropriate disinfection results in rapid growth of SE present in eggs at retail (65 FR 76092), and like
method. the albumen.) The model showed that, that requirement, the rule is based on
at 70 to 90 °F (i.e., temperatures that research demonstrating that
5. Refrigeration (§ 118.4(e)) might be observed in unrefrigerated egg Salmonellae do not grow well or rapidly
(Comment 19) Several comments holding areas in farms or warehouses or at temperatures less than or equal to 45
raised concerns about the requirement in transport vehicles), there was much °F. FDA finds that the scientific
in § 118.4(e) of the proposed rule that less breakdown of yolk membrane in evidence on the growth of SE in eggs
egg producers should refrigerate shell eggs held no longer than 36 hours than shows that control of storage
eggs if they are held longer than 36 in eggs held no longer than 72 hours. temperature of shell eggs can
hours. Some comments urged FDA to According to the model, eggs held at 70 significantly reduce the rate of
multiplication of any SE present (Refs. comment further stated that to maintain grades, packs) shell eggs for the table
46, 47, and 48). the maximum benefit of SE illness egg market.’’
FDA agrees that there can be quality reduction from refrigeration, eggs In addition, as discussed in response
and safety problems such as thermal should be refrigerated throughout the to comment 20, for those eggs to be
checks (hairline cracks in the shell) distribution chain. processed as table eggs but which are
associated with refrigerating eggs (Response) We sought comment in the not processed for the ultimate consumer
immediately prior to processing into proposed rule on whether to require within 36 hours from the time of lay and
either table eggs or egg products. refrigerated transport of shell eggs not therefore are required to be held and
Therefore, FDA is modifying the rule to already required by regulation or within transported under refrigeration, we are
allow an equilibration step (a step USDA’s jurisdiction; for example, permitting an equilibration step.
during which the eggs reach room transport of shell eggs from a farm or a E. Comments on ‘‘Environmental
temperature) before eggs are processed. packer to a food manufacturing facility. Testing for Salmonella Enteritidis (SE)’’
Specifically, under § 118.4(e) of the final We further stated that we would (Proposed and Final § 118.5)
rule, shell eggs that have been consider putting into place
refrigerated may be held at room (Comment 22) Several comments
requirements similar to those we
temperature for no more than 36 hours challenged the proposed requirement
finalized for refrigerated storage of shell
just prior to processing to temper them, that egg producers conduct
eggs at retail (i.e., transport of shell eggs
which will reduce the risk of hairline environmental testing when a flock has
at or below 45 °F ambient temperature).
cracks in the shell that could contribute reached 40 to 45 weeks of age, and if the
FDA agrees with the comment that the flock has molted, 20 weeks after the end
to bacteria entering the egg during refrigeration requirement in the
washing if the egg is too cold. We of the molting process. The comments
proposed rule only addresses eggs held suggested that instead FDA follow the
believe the benefits of refrigeration at the farm for more than 36 hours after
accompanied by equilibration outweigh practice of some EQAPs, which require
time of lay. The proposed requirement testing of the layer house environment
any possible risk associated with does not address nest-run eggs, surplus
sweating of the eggs. at the end of the laying period, prior to
hatching eggs sent to the table egg depopulation. One comment stated that
(Comment 21) One comment stated
market, eggs shipped to egg products environmental samples should be
that the rule is silent on the refrigeration
facilities and then sent to the table egg obtained anytime within the time period
of eggs that are segregated at the grading
operation for processing at egg products market, or any other eggs that are held of active production, or between the
plants. These are the eggs that do not or transported at locations other than at 40th and 60th week of production. In
meet grade requirements, are checked the producer’s layer farm. Holding or addition, the comment stated that if the
(that is, the shell is cracked, but the transporting these eggs without environmental samples taken at this
shell membrane is intact), or have dirt refrigeration allows growth of any SE time are negative there is no need to
on the shell. The comment explained that may be present in the eggs. We also conduct additional samples for those
that the last two types of eggs pose a agree with the comment that, to birds that have undergone an induced
significant food safety risk if handled maintain the maximum benefit of SE molt.
improperly and can be processed only illness reduction from refrigeration, eggs Another comment stated that the 1998
in a USDA-inspected egg products should be refrigerated throughout the joint SE risk assessment (Ref. 21), as
plant. Additionally, the comment stated distribution chain. Therefore, to reduce well as draft 2004 USDA risk
it may take several days to accumulate this potential growth of harmful assessment (Ref. 49) support a revision
a quantity of checked and dirty eggs for bacteria, we have modified § 118.4(e) in to the proposed testing time for post-
shipment. Similarly, the comment the final rule to require refrigeration molt layers from 20 weeks, as proposed,
stated that surplus eggs produced by during all storage and transportation to a 4 to 6 week range post-molt. In
hatchery flocks are accumulated and beginning at 36 hours after time of lay. support of this suggestion, the comment
sent to egg products plants for Following are three examples of eggs noted that the 2004 FSIS draft risk
processing and could present a hazard requiring refrigeration under the final assessment finds the greatest risk of
if not properly refrigerated. The rule, which would not have required infected eggs immediately after molt,
comment noted that most shell egg refrigeration previously: (1) Unwashed but at this time hens are laying few eggs.
packers and hatcheries currently eggs more than 36 hours old from a farm As a result, the comment estimated that
refrigerate these eggs, but the comment with 3,000 or more layers that have left if the increased risk used in the draft
urged FDA to amend the proposed rule the producer’s farm and are being risk assessment is multiplied by
to require that eggs segregated at grading transported to or are at a shell egg expected lay post-molt, the greatest
operations and at hatcheries and processing facility or are being held in number of infected eggs from infected
intended for further processing also be a warehouse; (2) eggs from a farm with molted flocks will occur between 4 to 6
subject to the refrigeration requirements 3,000 or more layers that are more than weeks post-molt.
proposed for on-farm storage. 36 hours old and are being shipped from (Response) We do not agree that the
Another comment noted that USDA an egg products facility (USDA- timing for environmental testing of
only requires refrigeration at the inspected plant) to a shell egg unmolted flocks should be modified. As
packer’s facility after packing for the processing facility; and (3) eggs from a stated in the proposed rule,
consumer. The comment stated that nest hatchery that are more than 36 hours environmental testing for SE is an
run eggs (eggs that are packed as they old, were never used for hatching, and indicator of whether SE prevention
come from the production facilities are now being transported to a shell egg measures are working effectively.
without having been washed, sized, processing facility. For clarification, in Testing provides an opportunity for
and/or candled for quality) and the final rule we are defining ‘‘egg producers to evaluate the SE status of
restricted eggs, (eggs whose use is products facility’’ as ‘‘a USDA-inspected their poultry houses and to take
limited by FSIS under the Egg Products facility where liquid, frozen, and/or appropriate action if their prevention
Inspection Act because they are, for dried egg products are produced,’’ and measures are not preventing SE.
example, checked or dirty) are not ‘‘shell egg processing facility’’ as ‘‘a Information from an EQAP with a
required to be refrigerated. This facility that processes (e.g., washes, testing protocol indicates that the
highest numbers of positive status of a laying hen house post-molt be no reason to believe that sampling
environmental samples are found when to determine the effectiveness of SE every cage row is more effective than
laying hens are 40 to 45 weeks of age prevention measures during the post- sampling 32 random sites in a laying
(Ref. 50). Additionally, the Layers 99 molt laying cycle, we have amended house. Another comment stated that the
study found that flocks less than 60 § 118.5(b) to require an environmental only ways to generate drag samples that
weeks of age (younger flocks) were five test at 4 to 6 weeks after the end of any can be compared across the various
times more likely to test positive for SE molting process. types of poultry house are the two
than older flocks (Refs. 27 through 29). (Comment 23) Several comments discussed in the proposal: Drag
In the absence of any new data, we are suggested that FDA revise the proposed swabbing the aisles (the ‘‘whole aisle’’
retaining in the final rule the rule to make the environmental method) and swabbing a certain number
requirement that environmental testing sampling plan flexible. of feet of egg belt (the ‘‘limited feet from
for SE be conducted for the flock in each In support of this suggestion, some 32 sites’’ method) because eggs are
poultry house when each group of comments stated that because the rule collected by hand in only a few houses.
laying hens making up that flock is 40 would cover very diverse egg laying Another comment stated that while the
to 45 weeks of age. An SE-positive facilities in the United States (e.g., free- procedure for sampling manure pits in
environmental test at the 40 to 45 week range farms and confinement operations a high rise facility with caged layers is
time period notifies a producer that using cages or nesting boxes), one single fairly straightforward, nonconfinement
there is a problem with SE sampling plan would not be effective. operations do not have a clear direction
contamination. At this point, action can One comment recommended a different on what is the most appropriate
be taken to determine if there are SE- sampling plan requirement for each sampling site. The comment asserted
contaminated eggs and to keep SE- operation type. The comment suggested that it would be unreasonable to expect
contaminated eggs out of the table egg that all confinement ‘‘barns’’ could be an operation with 10,000 layers to
market. Additionally, a positive sampled under the same plan, and develop a scientifically valid sampling
environmental test during the 40 to 45 recommended that for such operations program when FDA cannot define what
week period (just after peak lay) gives a FDA require that a minimum of one is scientifically valid.
producer sufficient notice to make manure drag sample be obtained from (Response) In the proposal FDA
arrangements for cleaning and each bank of cages. The comment stated described the ‘‘whole aisle’’ and
disinfection of the contaminated poultry that more research is needed to ‘‘limited feet from 32 sites’’ swabbing
house at depopulation. determine the most appropriate sample methods and acknowledged differences
sites for operations that are cage-free, in the types of poultry houses and the
FDA does, however, agree that the pasture-raised, or free-range. Another challenges involved in sampling all
post-molt environmental test should be comment noted that the sampling plan houses representatively and
moved from 20 weeks post-molt to 4 to should also be flexible because of consistently. We asked for comments
6 weeks post-molt. As the comment variations in operations within about the appropriateness of different
noted, the FSIS 2004 draft risk geographic areas and across geographic methods of drag swabbing and received
assessment (Ref. 49) (as well as the final regions, for example, difference in no comments that would support one
version of the risk assessment, Ref. 22, manure collection/disposal systems. method over the other. To specifically
published in 2005) described research (Response) FDA agrees that because acknowledge differences between
by Ebel and Schlosser (Ref. 23) that the final rule covers very diverse egg poultry houses, the rule now requires ‘‘a
indicated that ‘‘[e]vidence from field laying facilities, the same sampling plan sampling plan appropriate to the
studies suggests that molted flocks, in may not be practical for all operations poultry house layout.’’ FDA believes
the first 20 weeks of post-molt and that the sampling plan requirement that there are sufficient data for
production, will produce SE- should be flexible to accommodate producers to develop sampling plans for
contaminated eggs more frequently than variations in housing styles. The all poultry environments. Over the past
non-molted flocks’’ (Ref. 22 at page 29). proposed rule did not specify a ten years, FDA has performed
As FSIS explained in the draft and final particular plan; rather it provided at environmental sampling in a variety of
risk assessments, ‘‘[t]he stress of molting § 118.7(a) that ‘‘[w]ithin each poultry poultry houses, which have contained
is thought to result in an increased house, you must sample the from 3,500 to 250,000 birds and have
susceptibility of hens to SE infection’’ environment using a scientifically valid varied from high rise to shallow pit to
(Id.). FSIS relied in its analysis on data sampling procedure.’’ In the final rule, sunken water pit houses. The results of
contained in the ‘‘Salmonella Enteritidis to make more clear that the this sampling indicate that the manure
Pilot Project Progress Report’’ (Ref. 51) appropriateness of a sampling plan area and eggbelts are the two best areas
and the study by Holt on immunological depends on the house being sampled, to sample (Ref. 53). FDA has
factors in laboratory hens (Ref. 52), we have modified the language in incorporated specific sampling
which were referenced in the proposed § 118.7(a) to require ‘‘a sampling plan instructions into the environmental
rule. As we stated in our response to appropriate to the poultry house testing method, ‘‘Environmental
comment 4, the data underlying the layout.’’ Specific sampling instructions Sampling and Detection of Salmonella
FSIS risk assessment, which we have been incorporated into the in Poultry Houses.’’
reviewed in the proposed rule, do not environmental testing method, (Comment 25) One comment stated
support a prohibition on induced ‘‘Environmental Sampling and that because it is common for producers
molting. However, these data do suggest Detection of Salmonella in Poultry in Hawaii to have multi-age flocks in
that there may be some elevated risk Houses.’’ one poultry house, it would be difficult
that hens may become infected with SE (Comment 24) One comment to perform SE testing for specific flocks
in the post-molt period, before 20 weeks questioned whether FDA could that reach the age at which testing is
have passed. In light of these studies, appropriately determine whether a required. The comment further stated
we have decided that it would be producer is using a ‘‘scientifically valid that if there is an environmental
prudent to conduct environmental SE sampling procedure,’’ as required in positive test result for a typical farm in
testing earlier post-molt than was proposed § 118.7(a). The comment Hawaii (5 to 10 acres), there would be
proposed. Therefore, to evaluate the suggested that, for example, there might no space to store the eggs to wait for egg
test results. The comment argued that a producers will have to take whatever destruction of SE, it is an acceptable
positive environmental test result could price they can get from the breakers and method of diversion.
mean depopulation of the entire farm the price will inevitably be much lower (Comment 29) One comment stated
and, even if the egg tests are negative, than the price they would have gotten that Hawaii has no egg breaking
it could still mean the end of the farm. if the eggs had not come from an SE- facilities, and that the costs of shipping
(Response) The comment reflects a positive layer house. Some comments diverted eggs to breaking facilities in
misunderstanding of the rule. Section expressed concern that egg product California or elsewhere in the
118.5 requires environmental testing of buyers might not want to purchase continental United States would be
the entire poultry house when any product known to have come from eggs prohibitive. The comment also noted
group of laying hens in that house is 40 diverted because of SE, further reducing that in the past some breaking facilities
to 45 weeks of age. If multi-age flocks the breaker’s incentive to buy the on the West coast have refused to accept
are housed in the same poultry house, diverted eggs. eggs from Hawaii. The comment
egg producers must perform Thus, these comments expressed requested that the rule be made more
environmental testing on the entire concern that this diversion would result flexible to address the situation facing
house whenever any group of laying in a cost to the industry much greater Hawaii and other States with inadequate
hens in that house reaches 40 to 45 than that projected by FDA in the or no egg diversion capacity.
weeks of age. Furthermore, upon finding proposal. One comment stated that, (Response) FDA recognizes that there
an environmental sample positive for even if they were willing to buy the is regional variation in the cost of
SE, there is no requirement to store or diverted eggs, breakers might offer a diversion for eggs. For a full discussion
otherwise hold the eggs. The eggs from price too low to make it economically of this variation, see section V.F of this
a flock in a house that has tested feasible to retain the flock. That same document. We understand that there are
environmentally positive for SE may comment noted that diversion to the pet currently no breaking facilities in
continue to be marketed as table eggs food supply chain would not be an Hawaii and that it may not be
until the producer is notified that an egg option because SE-positive eggs would economically feasible to ship diverted
test is determined positive for SE. At have to be run through the processing eggs to the continental United States or
that point, the producer must divert plant, and stated that destruction may Canada. For egg producers in Hawaii,
those eggs to treatment. be the only alternative in most cases. and for others also unable to avail
(Comment 26) One comment argued (Response) FDA recognizes that themselves of breaker facilities, the cost
that a testing regulatory scheme would diversion of eggs may be expensive or of diversion per egg is the lost value of
not be effective in preventing illnesses impracticable. We do not agree that we a table egg. In the proposed rule, we
from SE. This comment stated that have underestimated these costs. estimated that the price to a producer
environmental and egg testing only Further, these costs are outweighed by for one dozen diverted eggs in Hawaii
indicates the status of the house at the the public health benefit realized by is $0.53, or $0.044 per egg. We recognize
time of the test. diverting contaminated eggs. that this cost is more than double the
(Response) Environmental and egg In addition, FDA believes there may cost of diversion for egg producers in
testing alone do not prevent SE, but be some confusion about the diversion other regions; however, per our usual
instead serve as an indicator and requirement. Under the rule, diversion approach for public health regulations
verification step that the SE prevention is required under the following three promulgated under the FFDCA and the
plan is working properly. Further, a scenarios: (1) When the environment PHS Act, we are establishing minimum
positive egg test can prevent tests positive for SE, and the producer national standards that will equally
contaminated eggs from reaching chooses not to test eggs from that house apply to all States. We acknowledge that
consumers and thereby protect the to determine whether the eggs are also diversion for egg producers in situations
public health. positive; (2) when the eggs in a house such as those in Hawaii may be
test positive for SE; and (3) by order of particularly financially challenging. As
Diversion (§§ 118.5 and 118.6)
an FDA, State, or local representative discussed above, we will use guidance
(Comment 27) We received many after a finding that shell eggs have been as appropriate to mitigate the impacts
comments on our proposed requirement produced or held in violation of this associated with implementation of the
that eggs from a SE-positive layer house regulation. rule.
environment must be diverted to (Comment 28) One comment
pasteurization, unless testing of four F. Comments on ‘‘Egg Testing for
requested that FDA include hard
pools of 1,000 eggs each yields SE- Salmonella Enteritidis (SE)’’ (Proposed
cooking as an acceptable method of
negative results. One comment and Final § 118.6)
diversion.
supported the diversion requirement as (Response) If diversion is required, (Comment 30) One comment agreed
a reasonable way to keep higher-risk you do not necessarily have to send the with the sampling protocol established
eggs out of the table egg market, but eggs to a breaker. You may instead in § 118.6(c) for egg testing for SE, but
stated that the requirement could pose divert them to an alternative process stated that 24 hours is not a practical
an economic risk to shell egg producers that achieves at least a 5-log reduction timeline to begin egg testing after a
that do not have their own egg in SE, using, for example, in-shell positive environment is found. The
pasteurization capabilities. Other pasteurization of shell eggs or hard comment suggested that § 118.6(c)
comments similarly noted that this cooking of shell eggs. require egg producers to immediately
requirement could have an economic In the proposed rule, FDA defined notify the appropriate state agency of
impact on egg producers that lack ready treatment as ‘‘a technology or process the positive environmental findings and
access to egg pasteurization facilities, that achieves at least a 5-log destruction that egg sampling commence within 2
because they will have to sell their eggs of SE for shell eggs, or the processing of weeks after the environmental test
to ‘‘breakers’’ who already have an egg products in accordance with the Egg results are received. Another comment
adequate supply of eggs (through Products Inspection Act.’’ We have suggested that FDA revise the time
ownership of laying houses or pre- retained this definition in the final rule. period allowed between receiving a
existing contacts with such houses). As Thus, as long as the hard-cooking positive environmental sample and
a result of this arrangement, egg process achieves at least a 5-log conducting the required egg testing from
24 to 72 hours to allow for weekends or clarification of the scientific being used by the industry, states and
holidays when laboratory facilities justification for the requirement in laboratories. One such method is that
would most likely not be available to § 118.7 that egg producers pull a 1,000 used by the NPIP. The comment stated
complete the tests. Several comments egg sample, regardless of the size of the that the proposed environmental testing
further argued that the 24-hour operation. The comment questioned method requires the use of an extra
requirement for initiating egg testing is whether sampling for monitoring selective agar, bismuth sulfate (BS) agar,
impossible, as even collecting the eggs purposes needs to be as extensive as which has not been proven to be
within 24 hours might be difficult at that undertaken for outbreak trace back effective in isolating SE from
times. In addition, the comments argued situations. environmental samples. The comment
that to arrange testing for 1,000 eggs Another comment noted that due to argued that BS agar is the agar of choice
requires scheduling of several items, potential breakage, a sample size of for isolating S. Typhi from clinical
including people, labs, and media, and 1,050 eggs would eliminate the problem samples, but that it is not effective for
cannot be done in 24 hours. of having to use cracked or broken eggs environmental samples of SE. The
(Response) For the reasons identified (i.e., the laboratory can select 1,000 eggs comment suggested that the isolation
in the comments, FDA agrees that 24 from this 1,050 egg pool). with BS agar is an unnecessary step that
hours may not be practical to begin egg (Response) The rule requires egg should be eliminated from the method.
testing. Therefore, we have modified testing after receipt of notification of a (Response) The method we proposed
§ 118.5(a)(2)(ii) and (b)(2)(ii) in the final positive environmental test (unless the for environmental testing is set forth in
rule. Rather than setting a time when eggs are treated). Sampling after a ‘‘Detection of Salmonella in
egg testing must begin, the rule positive environmental test is intended Environmental Samples from Poultry
establishes a deadline for conducting to effectively detect SE-positive eggs Houses,’’ which was proposed for
and completing such testing and from a flock. inclusion in FDA’s Bacteriological
receiving the results. The final rule The rule requires that egg producers Analytical Manual (BAM), or an
requires that the results of egg testing for collect and deliver for testing a equivalent method with respect to
the first 1000 eggs must be obtained minimum of 1,000 intact eggs accuracy, precision, and sensitivity in
within 10 calendar days of receiving representative of a day’s production four detecting SE. The environmental testing
notification of the positive times at 2-week intervals, resulting in a method FDA proposed was very similar
environmental test. This time period total test of 4,000 eggs over an 8-week to the NPIP environmental testing
allows for the farm to obtain a period. This sampling scheme is based method. For example, it included the
laboratory to do the work and collect the on data from the SE risk assessment same pre-enrichment and enrichment
eggs and for the laboratory to perform indicating that an SE-contaminated broth. It was different only in that it
and complete the tests. flock may be producing SE- specified what specific plating agars
(Comment 31) Two comments stated contaminated eggs with a prevalence of should be used, and it required the use
that the egg sampling procedure should 1 in 1,400 (Ref. 54). The sampling of three, not two, plating agars. The
be witnessed by a regulatory agency, scheme would result in a 95 percent selective plating agars identified in the
such as a State Department of probability of accurately detecting an proposed rule method were brilliant
Agriculture. SE-positive egg from a flock producing green with novobiocin (BGN), xylose-
(Response) FDA disagrees. Other FDA contaminated eggs with the prevalence lysine tergitol 4 (XLT4), and BS. BGN
regulations, such as Hazard Analysis calculated in the risk assessment (Ref. and XLT4 are two of the selective
and Critical Control Point (HACCP) 54). plating agars that have been used by
Procedures for the Safe and Sanitary We agree with the potential for some laboratories using the NPIP
Processing and Importing of Juice (21 breakage raised in the comment method.
CFR part 120) and Procedures for the concerning the sample size for egg With respect to the use of BS, FDA
Safe and Sanitary Processing and testing and have modified § 118.7(b) in has performed additional plating with
Importing of Fish and Fishery Products the final rule so that the requirement is layer house environmental SE colonies
(21 CFR parts 123 and 1240), do not to ‘‘collect and deliver for testing a on BS agar and has reconsidered the
require sampling and other testing to be minimum of 1,000 intact eggs method for conducting environmental
overseen by FDA or State officials to be representative of a day’s production’’ testing. As a result of this review FDA
effective. The egg sampling requirement (Emphasis added). has eliminated the use of BS for
is expected to be routine and a regular With regard to the comment regarding environmental testing in the final rule
component of the on-farm plan to making a distinction between a and has changed the method to reflect
prevent SE. sampling plan for monitoring SE on the the elimination of the BS agar. The
Furthermore, to assist FDA in farm and for an SE outbreak trace back, method specified in the final rule,
ensuring compliance, the final rule FDA notes that this final rule does not ‘‘Environmental Sampling and
requires that each facility establish and address SE outbreak trace backs and is Detection of Salmonella in Poultry
maintain records of plan activities, solely designed for the prevention of SE Houses,’’ requires only two agars, BGN
including egg sampling. Such records in shell eggs during production, storage and XLT4.
will assist FDA in determining whether and transportation. SE outbreak trace The comment did not challenge the
sampling was performed appropriately. back is beyond the scope of this specification that BGN and XLT4 be the
regulation and will not be addressed plating agars used, and we have not
G. Comments on ‘‘Sampling changed this specific requirement in the
here.
Methodology for Salmonella Enteritidis final rule. As in the proposed rule, if
(SE)’’ (Proposed and Final § 118.7) H. Comments on ‘‘Testing Methodology other methods are at least equivalent to
(Comment 32) One comment stated for Salmonella Enteritidis (SE)’’ the specified method in accuracy,
that FDA should distinguish between a (Proposed and Final § 118.8) precision and sensitivity in detecting
sampling plan used to verify or monitor (Comment 33) One comment SE, they may be used instead of the
an on-farm program and a sampling recommended that FDA modify its method specified.
plan used for an SE outbreak trace back. required environmental testing method (Comment 34) With respect
The comment also asked for to conform to the methods currently specifically to environmental testing, a
comment noted that the test does not with trypticase soy broth supplemented preferred by analysts in FDA
allow for pooling of samples, which the with ferrous sulfate and incubated for laboratories for the detection in food
comment stated would reduce the 24 hours, after which the pre-enriched and cosmetic products of pathogens and
number of samples the laboratory would sample is placed into 2 selective microbial toxins. With some limited
have to run with no loss in sensitivity enrichment broths (tetrathionate and exceptions, these methods have been
of the test. The comment stated that Rappaport-Vassiliades), and subsequent used and peer reviewed by FDA
pooling would reduce costs by 75 inoculation onto three selective media: scientists as well as by scientists outside
percent. BS, xylose lysine desoxycholate (XLD), FDA. A new agar such as that proposed
(Response) Although there are data and Hektoen enteric (HE). In the APHIS in the comments would be added to the
showing that pooling of food samples, method, there is no pre-enrichment
BAM only after research indicated
under specified conditions, does not step. Instead, egg samples from the
compromise method sensitivity, we are superior performance in the context of
incubated eggs are inoculated onto 2
not aware of any data, and the comment selective agars (brilliant green and XLD). a variety of foods, and where the agar
did not provide any such data, to In both methods colonies that grow on has been validated by collaborative
support pooling for environmental the agar plates are sampled to studies. Therefore, the final rule does
sampling. Until such data become characterize the organism as Salmonella not deviate from the proposal in
available, it would be imprudent of FDA by the reaction on two agar slants. recommending the use of the BAM-
to specify a test that includes FDA believes that, for the purposes of recommended plating agars. However,
compositing of environmental swabs. this final rule, its method is preferable we note that another test that is
(Comment 35) One comment raised to the APHIS ‘‘Egg Sampling Method’’ equivalent to the specified test in
concerns about the proposed egg testing (58 FR 41048, August 2, 1993). First, the accuracy, precision and sensitivity for
method. The comment stated that the addition of ferrous sulfate at the pre- detecting SE may be used.
method proposed by FDA differs from enrichment step in FDA’s method (Comment 36) One comment
the method used by APHIS, as well as provides iron, which is needed by
recommended that FDA allow for
other methods used by industry, states Salmonella for growth and which may
and laboratories. In addition to the improvements in the methodology for
not be present in sufficient quantity in
concern that the method that we the egg; thus, this step may increase the Salmonella testing to be easily and
proposed is not the same as that used by likelihood of detection. Second, the two quickly adopted by the industry upon
APHIS, the comment identified two selective enrichment media validation of the new method, and that
other specific concerns with the (tetrathionate and Rappaport- FDA work with other Federal agencies
proposed egg testing method. First, the Vassiliades) used in FDA’s method with approved testing methods, such as
comment stated that the proposed egg contain agents that are selective APHIS and FSIS, to facilitate approval
testing method requires the use of BS, (inhibitory) against the non-Salmonella of methods and to reduce the need for
an isolation media that is the media of organisms. The inhibition of non- one facility to use several different
choice for isolating Salmonella Typhi Salmonella organisms enhances the test methods for Salmonella testing. The
from clinical samples. Second, the by reducing competition and possible comment stated that APHIS, FSIS, and
comment stated that only two selective overgrowth from other organisms. scientific organizations all have
agar plates should be inoculated (BGN Third, the use of three, rather than two, approved methods for detecting
and XLT4) instead of the five proposed selective plating agars maximizes the Salmonella and SE. The comment
in the method for egg testing. possibility of detecting as many SE further stated that methods need to
(Response) Neither the description of strains as possible. We note that the provide consistent results, yet be
the method discussed in the preamble of APHIS egg sampling method was flexible enough to allow the industry to
the proposed rule nor the reference to developed and has been in use since adapt quickly when improvements are
the method contained in the codified 1993. While it has been and remains a
portion of the proposed rule are correct made. For example, rapid testing
valid sampling method, the FDA
for the egg testing methodology. The methods are available and approved by
method is more sensitive and can better
method referred to in the codified some Federal agencies (e.g., FSIS). The
detect the presence of Salmonella in
portion of the proposed rule was food, and our adoption of this newer comment argued the current proposed
actually a comparison study involving and more sensitive test will better rule would not allow a producer to use
varying media and pre-enrichment. The support the public health goals of this a rapid method for testing of
method for testing eggs adopted in the rule. In summary, FDA believes that the environmental or egg samples. The
final rule is the method in the BAM, specific method prescribed for egg comment recommended that FDA
chapter 5, ‘‘Salmonella.’’ testing in this final rule is tailored to the conduct a literature review and, if
Addressing the comments in turn, we goals of the rule. necessary, additional research to
disagree that we should adopt the With respect to the two more specific determine what methods are
APHIS egg testing method. Like the comments, FDA does not agree with the appropriate to detect SE in the
BAM method, the APHIS method first recommendation to eliminate BS in the environment and egg samples, with the
involves the disinfection of eggs and method for egg testing, for the reasons goal of identifying methods that are
then the cracking, pooling and mixing of explained in the previous paragraphs. appropriate for the purpose of the
eggs. The two methods diverge at the Nor do we agree that the other two testing and less costly (in both time and
third step, which is incubation: In the selective agar plates should be BGN and money) to the industry.
BAM method the pools are incubated at XLT4, rather than HE and XLD. In a
room temperature for 96 hours, while in comparison study of selective plating (Response) In the final rule, FDA is
the APHIS method the pools are agars using selected high moisture foods allowing for other methods to be used
incubated for only 72 hours. (Ref. 55), the newer selective plating for both environmental and egg testing,
The two methods also are different in agars performed comparably with the provided they are equivalent to the
subsequent steps. In the BAM method, BAM recommended agars (BS, HE, and methods we specify in accuracy,
there is a pre-enrichment step in which XLD) but offered no advantage. The precision, and sensitivity in detecting
a portion of the egg pool is enriched BAM is a collection of procedures SE.
I. Comments on ‘‘Administration of the equivalent job experience can be size, and yet be equally effective in
Salmonella Enteritidis (SE) Prevention substituted for training. preventing SE contamination.
Measures’’ (Proposed and Final § 118.9) Knowledge of the specific prevention
J. Comments on ‘‘Recordkeeping
measures taken on a farm, as discussed
(Comment 37) Several comments Requirements for the Salmonella
in an SE prevention plan, will assist
suggested that FDA modify the Enteritidis (SE) Prevention Measures’’
FDA to assess compliance with the
requirement in proposed § 118.9 that (Proposed and Final § 118.10)
prevention measures.
one qualified individual at each farm (Comment 39) In the proposed rule, In addition, reviewing records of
have training equivalent to a FDA proposed certain recordkeeping implementation of a facility’s specific
standardized curriculum recognized by requirements and solicited comments SE prevention measures is the best
FDA or be otherwise qualified through on whether additional recordkeeping mechanism for FDA to use to determine
job experience to administer the SE measures should be required for a whether preventive measures have been
prevention measures. The comments comprehensive SE prevention plan, and implemented over a period of time.
proposed instead that FDA require whether a written SE prevention plan These required documents include
training of a qualified individual should be required. Several comments records of implementation and
responsible for each farm, even if that supported the proposed recordkeeping compliance with all SE prevention
person is not an onsite employee. These requirements but did not comment on measures. Such documents, for
comments noted that many producers expanding them; one comment stated example, would include documents that
employ one individual to oversee that there is no need for FDA to expand pullets were SE monitored or raised
multiple farm locations, and that this its recordkeeping requirements beyond under SE monitored conditions, records
person generally has more experience those proposed. In addition, several of SE environmental and egg testing,
and training than the onsite employees comments supported expanding the and records of activities required by the
and can provide better oversight on proposed recordkeeping requirements to rule, such as treatment or diversion of
developing and implementing SE include a written SE prevention plan eggs, as well as records indicating
prevention measures. and records for compliance with SE review of the plan and any changes or
(Response) We agree and are prevention measures. Several comments modifications made to the plan. Keeping
amending the language in § 118.9 in the noted that such records have been very careful written records will help
final rule to allow for one or more useful in conducting inspections of producers ensure that they have
supervisory personnel, who do not have facilities to determine compliance with effectively and consistently
to be onsite employees, to be the egg quality assurance program implemented SE prevention measures
responsible for ensuring compliance requirements and for identifying and will also assist FDA in determining
with each farm’s SE prevention problems in the producer’s SE whether the plan is being followed and
measures. prevention plan when a test is positive. in identifying problems in the
Another comment stated that records producer’s plan when a test is positive.
(Comment 38) One comment
documenting compliance with all If changes or modifications need to be
expressed concern about the burden
aspects of the SE prevention plan will made, recording such changes or
small producers may experience in
be essential for a producer to determine modifications will help ensure such
complying with the proposed
if their plan is effective and in making changes are implemented.
requirement that at least one individual adjustments to improve their plan. One Therefore, under § 118.10, FDA is
at each farm must successfully complete comment opposed the requirement of a requiring that egg producers covered by
standardized FDA-curriculum or written SE prevention plan, stating that all of the requirements in the rule
equivalent training of up to 2 to 3 days while a written plan would (§ 118.1(a)(1)) maintain the following
on SE prevention measures for egg undoubtedly be an important records documenting their SE
production. The comment requested management tool, and indeed many prevention measures: (1) A written SE
that FDA consider developing a training operations have such a plan, it is not prevention plan; (2) documentation that
program that could be implemented necessary for FDA to mandate such a pullets were ‘‘SE-monitored’’ or were
without requiring travel from the egg document. The comment stated FDA raised under ‘‘SE-monitored’’
operation. Further, the comment should not place undue emphasis on conditions, including environmental
requested that FDA not impose paperwork, as opposed to actual results. testing records for pullets; (3) records
deadlines for such training that could be The comment suggested that FDA work documenting compliance with the SE
difficult for such small producers to with interested parties to develop a prevention measures; and (4) records of
meet. model SE prevention plan that could be review and of modifications of the SE
(Response) FDA plans to work with provided to egg producers for their use. prevention plan and corrective actions
trade associations, State regulatory (Response) FDA agrees with the taken. FDA intends to issue guidance
officials, and academia/extension comments that the final rule should regarding the recordkeeping
officials to develop and offer training require a written SE prevention plan as requirement.
opportunities at venues that should well as records to document the (Comment 40) Two comments stated
satisfy the needs of small, medium, and effective implementation of that plan. that FDA should require purchasers of
large size facilities. Further, in the final This written SE prevention plan will set diverted eggs (e.g., egg breaking
rule, FDA has reduced the burden of the forth a producer’s plan to implement the facilities, shell pasteurization facilities,
training requirement by allowing one or regulation’s prevention, testing, and hard-cooked operations, or other
more supervisory personnel to serve as diversion measures. A written plan is facilities where the eggs could be
the trained administrator for all of the necessary for producers to ensure that treated) to maintain records indicating
firm’s facilities rather than requiring a they have effectively and consistently that the diverted eggs have been treated.
dedicated, trained individual at each implemented SE prevention measures. These comments, submitted by an
facility. FDA believes this will Further, a written plan greatly facilitates agricultural department and poultry and
substantially reduce the burden for FDA inspection. SE prevention livestock commission of two major shell
small producers to comply. Finally, measures may be quite different among egg producing states, argued that
FDA notes that the rule provides that farms, given different facility design and without records there would be no
ability to ensure the purchaser would legal authority FDA will defend this greatly reduce the recordkeeping burden
treat the eggs and not simply divert designation against any legal challenges. placed upon egg producers as well as
them back to the table egg market. (Response) FDA’s regulations in 21 the time, frequency, and cost associated
(Response) FDA agrees with the CFR part 20 govern the disclosure of with FDA inspections.
comments’ concern that purchasers of information under the Freedom of (Response) FDA believes that the least
diverted eggs might resell them for the Information Act (FOIA), including the burdensome way of implementing the
table egg market without treating them disclosure of CCI and trade section recordkeeping requirements is to specify
and that buyers might not know that the information. The agency’s general the information that must be contained
eggs must receive a treatment. To policies, procedures, and practices in the records, but not the format in
address this concern, FDA has modified relating to the protection of confidential which the records are kept. Automated
this final rule by adding § 118.6(f), information received from third parties technology may not be available or
which requires that when shell egg apply to information received under this within the means of all producers
producers divert eggs, the pallet, case, rule. It is not necessary that FDA covered by the rule. We note that egg
or other shipping container must be designate information upfront as CCI or producers may choose to use automated
labeled and all documents trade secret because these recordkeeping as long as they maintain
accompanying the shipment must determinations can be made before all of the required records.
contain the following statement: releasing any information. If FDA denies
a request under FOIA, it will rely on the K. Comments on Registration
‘‘Federal law requires that these eggs
provisions in that statute which permit Requirements for Shell Egg Producers
must be treated to achieve at least a 5-
the agency to withhold information. (Final § 118.11)
log destruction of Salmonella Enteritidis
or processed as egg products in (Comment 43) One comment (Comment 45) In the proposed rule
accordance with the Egg Products questioned FDA’s assertion that section (69 FR 56841 at 56841 through 56842),
Inspection Act, 21 CFR 118.6(f).’’ The 361 of the PHS Act (42 U.S.C. 264) gives FDA solicited comments about whether
statement must be legible and it legal authority to inspect records. The we should require that shell egg
conspicuous. FDA believes this comment argued that FDA’s reliance producers register with FDA. Several
additional requirement will help reduce upon section 361 of the PHS Act is comments supported requiring
the likelihood that these eggs will end misplaced and cannot be used to impose registrations by egg producers covered
records inspection on food by the SE prevention measures. These
up on the market without having been
establishments where, according to the comments stated that registration of all
treated. We note that USDA–FSIS, not
comment, such inspection is not producers covered by any of the SE
FDA, regulates egg-breaking facilities
allowed under section 704(a) of the
under the Egg Products Inspection Act prevention measures would be the most
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 1031 et seq.). efficient method of obtaining the
(FFDCA) (21 U.S.C. 374(a)).
The costs and benefits of this (Response) In the final rule, FDA information needed to conduct annual
provision are addressed in section V of relies on sections 402(a)(4) and 701(a) of inspections and allocate resources.
this document, Regulatory Impact the FFDCA (21 U.S.C. 342(a)(4) and Further, several comments stated that
Analysis. 371(a)) and sections 311, 361, and 368 such a requirement should be consistent
(Comment 41) One comment of the PHS Act (42 U.S.C. 243, 264, and with the program developed under the
questioned the proposed rule to the 271) to require access to certain records. agency’s bioterrorism regulations. The
extent it did not require an SE FDA does not rely on section 704(a) of comments further stated that by
prevention plan until a producer has a the FFDCA for authority to access identifying each farm’s location and
positive environmental test. The records in this rule. Furthermore, the size, a registration requirement would
comment stated that this delay increases PHS Act provides authority for records enable more efficient inspection, as well
the risk of producing SE-positive eggs access that is independent of the as better management and oversight of
that are distributed into the table egg FFDCA. Specifically, section 361 of the a shell egg recall.
market prior to the test and increases PHS Act authorizes the Secretary of One comment stated that, to create a
the difficulty of the producer reducing Health and Human Services (the level playing field across the United
or eliminating SE from the environment Secretary) to make and enforce such States, registering all producers is
and the flock. regulations as ‘‘are necessary to prevent necessary and that FDA may be able to
(Response) The assertion in the the introduction, transmission, or cooperate with USDA/APHIS, which is
comment that the proposed rule did not spread of communicable diseases from presently developing a premises
require an SE prevention plan until a foreign countries into the States * * * identification program for all animal
producer has a positive environmental or from one State * * * into any other premises in the United States.
test is incorrect. Neither the proposed State.’’ The basis for the recordkeeping (Response) FDA agrees with the
nor final rules make having an SE requirements in the final rule is further comments and is requiring that egg
prevention plan contingent upon a explained in section IV of this producers who must comply with all of
positive environmental test. document, Legal Authority. the SE prevention measures in this rule,
(Comment 42) One comment (Comment 44) One comment and also those producers who must
commended FDA’s statement that ‘‘we encouraged FDA to incorporate an comply only with the refrigeration
intend to consider records that come automated recordkeeping requirement requirements in this rule, register with
into our possession under this rule as into the proposed rule. The comment FDA and provide information on the
generally meeting the definition of a stated that an automated system would name of each farm, its location, layer
trade secret or commercial confidential enhance and support the recordkeeping capacity, and the number of houses.
materials’’ (69 FR 56824 at 56841). requirements outlined in the proposed Persons who transport or hold shell eggs
However, the comment requested that rule. The comment argued that such a for shell egg processing or egg products
FDA identify in the final rule what system could provide farm-specific data, facilities but who are not egg producers
information will be considered and an efficient, cost-effective way to are not required to register with FDA,
confidential commercial information research compliance. The comment although they are subject to the
(CCI) or a trade secret, and under what stated that an automated system would refrigeration requirements in § 118.4.
FDA intends to conduct inspections (Comment 47) One comment objected M. Comments on Request for Comments
of egg farms to ensure that shell eggs are to the proposed registration requirement as to Whether FDA Should Mandate
being produced under controls that will as an unnecessary burden and an Special Requirements for Food
prevent SE contamination and reduce unreasonable invasion of privacy. The Establishments That Specifically Serve
the likelihood that SE-contaminated comment argued that FDA only should Highly Susceptible Populations
eggs will cause foodborne illness. We check for compliance. The comment (Comment 49) We received a number
will use the producer registration further argued that ‘‘unexpected visits of responses to our request in the
information to create a database used to are not appropriate as a respect for other proposed rule for comments on whether
efficiently conduct inspections and people and the reality is that no one can the current FDA Food Code system
allocate inspection resources. Covered hide what you want to see in 24 hours.’’ (under which states may adopt and
egg producers must register within 30 The comment further argued that implement provisions of the FDA Food
days of becoming an egg producer or, if registration will result in a loss of Code) is adequate to protect highly
already an egg producer, by the privacy for the producer and is susceptible populations from
applicable effective date of the rule. unnecessary for the success of the salmonellosis, or whether instead we
Additionally, registered egg producers program. should establish mandatory Federal
are required to notify FDA within 120 standards for food establishments that
days of ceasing egg production (Response) FDA disagrees with this
comment. As stated above, registration serve eggs to highly susceptible
(excluding seasonal egg producers or populations, such as the elderly. Several
those who temporarily cease operation will aid in the identification of egg
producers for inspection and of these comments supported the
due to labor disputes, fire, natural Federal codification of the egg-related
disasters, or other temporary compliance purposes. We will use the
producer registration information to Food Code provisions for food
conditions). establishments specifically serving
Producers can register online via the create a database that we will use to
efficiently conduct inspections and highly susceptible populations, and one
Internet, by completing a paper form comment opposed codification.
and mailing or faxing it to FDA, or by allocate inspection resources. With
One comment supporting codification
sending a CD–ROM containing the regard to ‘‘unexpected visits,’’ section
stated that egg producers do not have
relevant registration information to 704 of the FFDCA (21 U.S.C. 374)
full control or responsibility for egg
FDA. If ceasing egg production, authorizes FDA inspections without safety, and that food establishments and
producers can notify FDA either online advance notice and FDA’s practice of consumers must share in the
via the Internet or by completing a making such inspections precedes this responsibility for egg safety. The
paper form and mailing or faxing it to rule and is independent of whether comment opposed to setting Federal
FDA. registration is required. standards stated that the egg safety goal
(Comment 46) One comment objected (Comment 48) One comment cannot be achieved through mandatory
to requiring producers who pack eggs to expressed concern that information Federal requirements at the food
register, stating that every producer with submitted to register facilities would be establishment level. The comment
packing facilities is registered with the subject to the Federal Freedom of recommended continuing mandatory
FDA under the registration rule and Information Act (5 U.S.C. 552), and that on-farm efforts while continuing
should not be required to register a public release of this information could educational efforts at retail and
second time. The comment agreed that result in a decrease of security at the consumer levels.
producers that do not pack eggs, but sell producer sites. The comment stated that (Response) FDA agrees that food
eggs that will ultimately go into the FDA has other means at its disposal to establishments that specifically serve
table egg market, should be registered so learn the site information needed to highly susceptible populations can play
that FDA can ensure these firms are administer this program and still respect an important role in egg safety As we
following the on-farm production and the need for security at the producer discussed in section I.H., a majority of
testing requirements of the SE rule. sites. states and territories have adopted into
(Response) Farms are not required to their own retail food codes the relevant
(Response) FDA recognizes that this
register under FDA’s Registration of egg-associated provisions of the FDA
information may be subject to disclosure
Food Facilities regulation (21 CFR Food Code (sections 3–202.11(C), 3–
under FOIA, unless there is statutory
1.226(b)). If a farm also has a packing or 202.13, 3–202.14(A), and 3–801.11(B)(1)
authority there or elsewhere that and (B)(2), (C)(2), (E), and (F)(1) and
processing facility, then only the
packing or processing facility is protects it. However, we disagree that (F)(2) of FDA’s 2005 Food Code (see
required to register under the the risk of such disclosure outweighs discussion under section I.H of this
registration rule if those packing and the public health benefits of collecting document regarding the changes made
processing activities do not qualify this information. As stated previously, from the 2001 Food Code)). In addition,
under the farm exemption (see ‘‘farm’’ registration will facilitate FDA’s other state, local, Federal, or voluntary
definition for activities that are covered identification of egg producers for standards applicable to these facilities
in the farm exclusion under 21 CFR inspection and compliance purposes. may have similar egg safety provisions,
1.227(b)(3)). Because the packing/ We will use the producer registration although we were not able to identify or
processing facility registration information to create a database that we quantify all such standards. We agree
information may not fully identify the will use to efficiently conduct with the comment that encouraged us to
farm location, FDA is requiring that inspections and allocate inspection continue education efforts at the retail
information in this regulation. If the resources. and consumer levels. We also agree that
information that would be provided by L. Comments on ‘‘Enforcement and codification of the FDA Food Code
an egg producer during registration has Compliance’’ (Proposed and Final provisions is not a necessary exercise of
already been provided under the § 118.12) our authority. Instead, we have
registration regulation, the producer determined that we will continue to
may submit its registration number There were no comments on this encourage states to adopt the relevant
rather than registering again. section. provisions of the FDA Food Code.
(Comment 50) One comment in the following paragraphs, support the as a matter of design, the statutory
suggested that we make mandatory new requirements in the final rule. scheme is benefited by agency access to
those parts of the Food Code related to Section 118.4(e) requires that persons records that demonstrate that these
the pooling of eggs in all institutions, who transport or hold shell eggs for measures are being systematically
including but not limited to those shell egg processing or egg products applied.
serving specifically at-risk populations facilities must comply with refrigeration By requiring records, we will be able
in section 3–8 of the Food Code. The requirements. It is well documented that to ensure that producers follow the SE
comment stated that many of the large shell eggs may contain Salmonella, prevention measures so that eggs are
outbreaks have been related to including transovarian transmitted SE, prepared, packed and held under
commercial or government institutions which can result in serious, life- sanitary conditions (21 U.S.C. 342(a)(4)
that misuse eggs, especially when they threatening illness. Temperature abuse and 371(a)) and in a manner designed to
break and pool large numbers of eggs. of shell eggs, such as by failing to prevent the spread of communicable
The comment stated that even if the refrigerate eggs as required by the rule, disease via SE-contaminated eggs (42
eggs are delivered SE-free, the hand can lead to the multiplication of SE in U.S.C. 264).
breaking and pooling of eggs can result shell eggs, and thus, increase the Section 118.11 requires registration by
in a contaminated pool due to likelihood of illness if the eggs are not egg producers who must comply with
inadequate hand washing, unclean thoroughly cooked. The refrigeration either all of the SE prevention measures
utensils, temperature abuse during the requirement in § 118.4(e) prohibits food or only with the refrigeration
breaking process and cross- from being held under insanitary requirements. It is essential that we
contamination from other raw foods. conditions and allows for the efficient know, via registration, certain
The comment also stated that the FDA enforcement of the FFDCA (21 U.S.C. information about egg producers, such
Food Code should be modified to 342(a)(4) and 371(a)). Further, this as whether a producer has 3,000 or more
incorporate a requirement that requirement is necessary to prevent the laying hens at a particular farm, so that
pasteurized egg products be substituted spread of communicable disease from we can identify and inspect those farms
for shell eggs if the eggs are to be one state into another state. (42 U.S.C. subject to the rule. Inspection is
pooled, as a model for States to follow. 264). necessary to ensure that shell eggs are
(Response) FDA has determined that Section 118.10 requires that egg being produced in compliance with SE
the relevant egg safety provisions of the producers have written SE prevention prevention measures, thereby reducing
Food Code should not be mandatory, for plans and maintain records the likelihood of foodborne illness.
the reasons discussed in the preceding documenting compliance, as well as Therefore, the registration requirement
response, including those provisions records of review and modification to is necessary to prevent the spread of
related to the pooling of eggs. the plan and any corrective actions communicable disease from one state
The comment concerning taken. Through records maintenance into another state. (42 U.S.C. 264).
modification of the FDA Food Code is and review, an egg producer can, over Section 118.6(f) requires that for
beyond the scope of this rule. time, develop a comprehensive picture diverted eggs, the pallet, case, or other
of its prevention measures and identify shipping container must be labeled and
IV. Legal Authority all documents accompanying the
shortcomings or potential shortcomings.
As outlined in section II.B of this A written plan and records shipment must contain the specified
document, after considering comments documenting implementation of that statement to indicate that the eggs must
received in response to the proposal, plan are necessary for producers to be treated to destroy SE. This
FDA made changes in the final rule, ensure that they have effectively and requirement is supported by sections
including the addition of some consistently implemented the plan. For 201(n), 403(a)(1), and 701(a) of the
requirements. The proposed rule example, without records documenting FFDCA (21 U.S.C. 321(n), 343(a)(1), and
contained an explanation of its legal environmental sampling procedures, a 371(a)) and sections 311, 361, and 361
basis under authorities in sections 311, producer cannot ensure that the of the PHS Act. Under section 403(a)(1)
361, and 368 of the PHS Act (42 U.S.C. environment was sampled using a plan of the FFDCA, a food is misbranded if
243, 264, and 271) and sections appropriate to the poultry house layout. its labeling is false or misleading in any
402(a)(4) and 701(a) of the FFDCA (21 Similarly, records maintenance and particular. Section 201(n) of the FFDCA
U.S.C. 342(a)(4) and 371(a)). The PHS access provide FDA with the provides that in determining whether
Act authorizes the Secretary to make opportunity to oversee, in a labeling is misleading, the agency shall
and enforce such regulations as ‘‘are comprehensive way, the take into account not only
necessary to prevent the introduction, implementation of the producer’s SE representations made about the product,
transmission, or spread of prevention plan, thereby preventing SE but also the extent to which the labeling
communicable diseases from foreign contamination of eggs. SE prevention fails to reveal facts that are material in
countries into the States * * * or from measures may be quite different among light of such representations made or
one State * * * into any other State’’ farms, given different facility design and suggested in the labeling or material
(section 361(a) of the PHS Act). This size, and yet be equally effective in with respect to consequences that may
authority has been delegated to the preventing SE contamination. result from use of the product under
Commissioner of Food and Drugs. Knowledge of the specific prevention conditions of use prescribed in the
Under section 402(a)(4) of the FFDCA, measures taken on a farm, as specified labeling or under customary or usual
a food is adulterated if it is prepared, in an SE prevention plan, will assist conditions of use. FDA previously has
packed, or held under insanitary FDA to assess compliance with the relied on these authorities when it
conditions whereby it may have been prevention measures. In addition, required label statements on shell eggs
contaminated with filth or rendered reviewing records is the best mechanism not processed to destroy all viable
injurious to health. Under section 701(a) for FDA to use to determine whether Salmonella (65 FR 76092, December 5,
of the FFDCA, FDA is authorized to preventive measures have been 2000).
issue regulations for the efficient implemented over a period of time. The rule requires eggs to be diverted
enforcement of the FFDCA. These Because the preventive measures are in certain circumstances, including after
authorities, as well as others specified essential to the production of safe eggs a positive egg test, to ensure that SE will
be destroyed before the eggs are FDA estimates that more than 99 provide the incentives necessary for
consumed. Without treatment, these percent of all egg farms are small. optimal egg safety.
eggs would present the greatest risk of Though more than 45,000 farms with With sufficient information for
causing SE illnesses. As discussed in less than 3,000 layers are exempt from consumers and producers, a legal
section V of this document, the eggs that all provisions of the rule, the agency system that awards compensation for
must be diverted to a treatment are certifies that the rule will have a harm done due to SE-contaminated eggs
worth less than eggs that may be used significant economic impact on a has the potential to remedy market
for the table egg market. This creates an substantial number of small entities. imperfections by providing producers
economic incentive to send the eggs to This is discussed further in section VI with incentives to provide the level of
the table egg market. Further, without of this document. safety that is best for society. The legal
labeling, a purchaser might not know system does not ensure the optimum
Section 202(a) of the Unfunded
that particular eggs are subject to the level of shell egg safety because
Mandates Reform Act of 1995 requires
diversion requirement. Therefore, the consumers who become ill due to SE
that agencies prepare a written
agency concludes that information that contamination often do not know the
statement, which includes an
the eggs must be treated to destroy SE reason for, or source of, their illness.
assessment of anticipated costs and
is material information that must be Even in cases where consumers are
benefits, before finalizing ‘‘any rule that
provided on the shipping container and aware that their illness was contracted
includes any Federal mandate that may from eggs, imperfect information makes
accompanying documentation and that result in the expenditure by State, local,
the requirement is necessary to prevent it difficult to determine who is
and tribal governments, in the aggregate, ultimately responsible for their illness,
the spread of communicable disease or by the private sector, of $100,000,000
from one state into another state. (42 since the particular source of the SE
or more (adjusted annually for inflation) contamination of the eggs is not known
U.S.C. 264). in any one year.’’ The current threshold
As explained in the proposal, in many circumstances.
after adjustment for inflation is $130 In sum, the imperfect information
activities that are intrastate in character, million, using the most current (2007)
such as the production and final sale of about the risk associated with SE from
Implicit Price Deflator for the Gross particular shell eggs means that neither
shell eggs to an institution for ultimate Domestic Product. FDA expects this
consumption by a consumer within one the legal system nor the marketplace
final rule to result in 1-year may be able to provide adequate
State, are subject to regulation under expenditures that would meet or exceed
section 361 of the PHS Act (State of economic incentives for the production
this amount. This is discussed further in of eggs sufficiently free of SE
Louisiana v. Mathews, 427 F. Supp. 174, section VII of this document.
176 (E.D.La. 1977)). The proposed rule contamination. The Government may
explained FDA’s reasoning for B. Need for Regulation therefore be able to improve social
tentatively determining that the SE welfare through targeted regulation. In
prevention measures in this rule must Private markets operating within the what follows, we will look at the costs
apply to producers of shell eggs who framework of the legal system promote and benefits of the provisions in the rule
sell their eggs intrastate, other than the health and safety of consumers. and comments addressing the benefits
directly to consumers. For the reasons Limitations of both the marketplace and and costs of options presented in the
discussed therein, we are making that the legal system, however, can result in proposed rule. We will also look at the
determination final. inadequate control of some health and costs and benefits of other measures to
safety hazards, and reduce societal control SE that we considered, but did
V. Analysis of Economic Impacts— welfare. not include in this final rule.
Final Regulatory Impact Analysis
In a perfectly competitive market in C. Comments on the Preliminary
A. Introduction which consumers and producers both Regulatory Impact Analysis in the
FDA has examined the impacts of the have sufficient information, the optimal Proposed Rule and Responses
final rule under Executive Order 12866, level of production of eggs will be (Comment 51) One comment agreed
the Regulatory Flexibility Act (5 U.S.C. provided at an optimal level of safety. that FDA should exempt small
601–612), and the Unfunded Mandates In the egg market, however, consumers producers generally from the final rule,
Reform Act of 1995 (Pub. L. 104–4). and producers do not have sufficient but suggested that the proposed testing
Executive Order 12866 directs agencies information on the SE status of and diversion requirements should
to assess all costs and benefits of particular eggs. In the case of SE- apply to all egg producers, regardless of
available regulatory alternatives and, contaminated eggs, although farmers size. The comment argued that testing of
when regulation is necessary, to select and producers do have an incentive to the environment and shell eggs provides
regulatory approaches that maximize put safety programs into place, the lack verification that on-farm sanitation
net benefits (including potential of awareness and information about the programs are effective in controlling SE
economic, environmental, public health risk suggests that an inefficiently high and allows for preventive measures
and safety, and other advantages; demand exists for eggs that are including diversion if a positive test
distributive impacts; and equity). The produced without using adequate occurs, which could prevent illnesses
agency believes that this final rule is an measures to prevent SE.2 Because the and outbreaks. The comment suggested
‘‘economically significant’’ regulatory demand for specific eggs is not that imposing testing and diversion
action as defined by Section 3(f)(1) of sufficiently affected by safety requirements on small producers would
the Executive Order. considerations, the farmer’s incentive to limit the burden on these small
The Regulatory Flexibility Act invest in safety measures is diminished. businesses without reducing the public
requires agencies to analyze regulatory Consequently, the market does not health benefit from the final regulation.
options that would minimize any (Response) Some benefits would be
2 For example, although many consumers may be
significant impact of a rule on small derived by requiring farms with less
generally aware of the association between shell
entities. Using the Small Business eggs and SE, they may not know that a few common
than 3,000 layers to divert potentially
Administration (SBA) definitions of methods of preparing eggs for consumption will not positive eggs upon both a positive
small for chicken and egg producers, eliminate SE in a contaminated egg. environmental and a positive egg test.
However, the cost per case averted on coolers for a relatively short period of § 118.5(a) and (b). Within each poultry
farms with less than 3,000 layers, time; that there is evidence that any low house, you must sample the
producing less than 1 percent of the level of SE within a naturally infected environment using a sampling plan
shell eggs on the market (accounting for egg will not undergo significant appropriate to the poultry house layout.
300 to 1,000 SE-related illnesses per multiplication until the albumen begins We agree that sites/houses are the
year and less than 1 death per year), is to degrade; and that, even at room appropriate sampling location. Costs
approximately $205,000 per case temperature, significant growth may and benefits of environmental sampling
averted, which would not be a cost- take several weeks. The comment stated are calculated on a per house basis.
effective public health intervention on that the cost involved in remodeling and (Comment 55) Several comments
over 45,000 very small egg farms. operating on-farm coolers to maintain a stated that breaker eggs will sell for a
(Comment 52) One comment noted 45-degree ambient temperature, rather lower price than table eggs, that
that, over the last several years, than a 55-degree ambient temperature, diversion costs will vary by region, and
numerous shell egg production facilities would not show a reasonable cost/ that breaker eggs from SE-positive flocks
in the United States were built to benefit ratio. will sell for even less than normal
produce eggs only for processing into (Response) Not all farms will need to breaker eggs. One comment stated that
egg products; these facilities may divert remodel their on farm coolers to the cost estimated for normal breaker
eggs for sale as table eggs when market maintain a 45-degree ambient eggs is underestimated in the analysis of
conditions or seasonal production temperature. However, many will, and the proposed rule. Data were provided
patterns warrant. The comment stated the costs associated with that to support the comment. One comment
that this diversion is done when remodeling are significant. In the stated that processors are likely to refuse
demand for egg products is weak and analysis detailed in section V.F of this eggs from SE-positive flocks.
the producer can avoid or minimize document, FDA estimates annualized (Response) We agree with the
potential economic loss by moving costs for farms that build cooling comments and recognize differences
temporary surpluses to the table egg facilities from scratch, remodel existing exist regionally in the price received for
market. The comment stated that, cooling facilities, use extra power to eggs, in the price of breaker eggs, and in
although under the proposed rule reduce temperature, use refrigerated the price of eggs from SE-positive flocks.
producers whose entire production will shipping, and use refrigerated All of these costs, including regional
be processed into egg products need preproduction storage, to be $20.1 differences in diversion costs, and the
comply only with the refrigeration million using a 7 percent discount rate adverse effects of bad publicity, are
requirements for on-farm storage, these and $16.4 million using a 3 percent
discussed in the analysis. The
producers who may divert their eggs to discount rate. Using the 2005 FSIS risk
additional data the comment provides
the table egg market must comply with assessment (Ref. 22), FDA estimated that
are considered in the final rule. The
all of the egg production requirements the refrigeration at 45 degrees within 36
expected cost of a diverted egg has
when any part of their production is not hours of lay through the preproduction
increased in the new analysis to $0.23
processed into egg products or does not stage, in the absence of the other
per dozen eggs (drawn from a uniform
receive a treatment that achieves at least provisions in the final rule, would
range of $0.13 to $0.33 per dozen eggs)
a 5-log destruction of SE. The comment reduce the number of annual SE related
from the proposed rule’s estimate of
stated that, while many firms that illnesses by nearly 45,000. With all
$0.17 per dozen (drawn from a uniform
produce shell eggs for use primarily in provisions in the final rule fully
the manufacture of egg products now implemented, refrigeration would range of $0.13 to $0.21 per dozen). The
have extensive on-farm programs to reduce the number of SE related analysis and new results are detailed in
ensure the safety of eggs and egg illnesses by nearly 29,000. Including all table 22 and section V.F of this
products, some of these producers will costs of egg-related SE illnesses (i.e., document.
need to impose additional food safety both mild cases and the less frequent FDA does not agree with the comment
measures at the production site in order though more severe ones including that processors will refuse eggs from
to be able to continue to occasionally hospitalization, chronic arthritis, or positive flocks. FDA is aware of at least
divert eggs to the table egg market. The even death), FDA estimated the average one processor that will purchase eggs
comment questions whether the agency cost of an SE illness to be $17,900. This from SE-positive flocks, and FDA
considered these expenditures in provision, when implemented with the believes others will as well because the
determining total costs of the proposed rest of the final rule, is estimated to pasteurization process for breaker eggs
rule on the egg industry. provide nearly $520 million in benefits is designed to achieve at least a 5-log
(Response) Those farms that produce annually and nearly $500 million in reduction in any SE that may be in eggs.
only a portion of their eggs for sale on annual net benefits. However, because of the restrictions
the table egg market have been covered (Comment 54) One comment stated placed on eggs from SE-positive flocks,
within the scope of this rule and their that, for environmental testing, these eggs are intrinsically less valuable
costs are included in the costs and the consideration should be given to the than normal shell eggs. This decrease in
benefits analysis of the final rule. sampling of a given proportion of value, and cost burden likely to be
(Comment 53) One comment states available sites as opposed to a given transferred from egg processor to
that the requirement that eggs be number of samples regardless of the size producer through a discount on eggs
refrigerated at a temperature of no of the flock or the number of houses. purchased from SE-positive flocks, is
greater than 45 °F within 36 hours of The comment stated that a farm may considered a cost of this rulemaking and
laying is not realistic. The comment have a single age group in more than is accounted for in the analysis and
recommended instead that the rule one house. detailed in section V.F of this
require that eggs held at the farm be (Response) This comment reflects a document.
refrigerated at a temperature no greater misunderstanding of the proposal. (Comment 56) One comment stated
than 55 degrees, provided the eggs are Sampling is performed on a per house that, to replace diverted eggs for a farm’s
not to be stored on the farm for more basis. Section 118.7(a) requires that an existing markets, other eggs would need
than 4 days. The comment states that environmental test must be done for to be purchased, probably at an inflated
eggs are generally held in on-farm each poultry house in accordance with price.
(Response) Although FDA recognizes by five plates for each enrichment broth This cost includes medical costs, the
this effect is possible in the rulemaking, and then inoculation onto two value of lost production, and the loss of
it is a within-industry transfer of burden differential media. welfare the individual experiences due
One comment stated that there would to pain and suffering and lost leisure
and is not counted as a cost in the time.
analysis (the costs net out between be start up costs for new labs entering
producers). the market due to increased demand for We write the risk reduced component
(Comment 57) One comment testing as a result of the rule. of the benefits equation in a general
questioned the presumed number of (Response) FDA agrees that the costs functional form rather than an additive
houses on the ‘‘larger than 3,000 hens’’ estimated in the proposed rule analysis form because combinations of the rule’s
farms, although the comment refer to the costs of the testing regime components (C1, C2, C3, * * *) will
recognized that the number was outlined in the pilot project, a less usually not result in linear, proportional
estimated using the National Animal intensive regime than the one required reductions of risk. Instead, we assume
Health Monitoring System (NAHMS) in the proposed and final rules. These that some components are partial
study. cost estimates have been corrected in substitutes for one another while others
(Response) The number of houses was the analysis of the final rule. A detailed complement each other.3 The total risk
estimated using the best data available, description of the analysis is located in reduction will not be the sum of the
which the comment correctly identified section V.F of this document. individual components; the
as the NAHMS study. We do not include start up costs for effectiveness of the rule could be less
(Comment 58) One comment stated labs that enter the market or increase than or greater than the sum of its parts.
that all cost calculations are broken capacity due to increased testing b. Base line risk from SE in eggs. We
down by house capacities. Results are demand as a result of the rule. The lab estimated the reduction in SE illnesses
applied to each size category with no fees are set up by these firms to cover by applying the percentage prevention
acknowledgement that within each both the initial set up costs and the to the base line number of illnesses. We
category, considerable variation still costs of each test. Counting these costs estimated the base line levels of egg
exists. in addition to lab fees charged to egg contamination and the number of
(Response) FDA agrees. There will be producers would be double counting. human illnesses that result from such
considerable variation of costs within contamination.
groups. Costs in most cases will be D. Economic Analysis of Potential The Centers for Disease Control and
smaller than average for the smaller Mitigations: Overview Prevention (CDC) passive surveillance
than average farms within a size We considered many possible SE system recorded 6,740 illnesses due to
category and larger than average for prevention measures. Because of the SE in 2006. Using the CDC multiplier
larger than average farms. For rodent large number of provisions considered (used to estimate total cases based on
and other pest control, within group (and the large number in the rule) we ratio of total to reported cases) derived
variation from the mean estimation is begin our analysis in this section with by Voetsch, et al. (Ref. 5) of 38 (with a
due to uncertainty about the extent to an overview of our methods of 90 percent confidence interval of 23 to
which current farm practices are estimating the benefits and costs of the 61), we estimated the number of
adequate to meet the rule’s requirements various measures to control SE in shell illnesses due to SE to have been 256,120
and costs of inputs, and due to variation eggs. In section V.F of this document, in 2006 (ranging between 155,020 and
in the number of houses. The variation we summarize the benefits and costs of 411,140).4 Because SE is not unique to
is driven by the number of houses on a the rule and regulatory options. In eggs, not all of the 256,120 illnesses due
farm, so larger farms within a given size section V.G of this document, we to SE in 2006 can be attributed to
category will incur higher costs. The present the detailed analysis of SE domestic shell eggs. CDC estimates that
same is true for the biosecurity and prevention measures we considered 16 percent of the cases reported were
cleaning and disinfecting provisions. (including both those included and not acquired outside of the United States.
Within group variation for the included in the final rule). Consequently, the base line level of
refrigeration provision is driven domestic SE cases is 215,140 (ranging
1. Measuring Benefits
primarily by the variance in egg between 130,220 and 345,360). Between
production and compliance. Farms that a. Modeling benefits. The primary 1985 and 2002, a total of 53 percent of
produce more eggs will require the benefit of the provisions in this rule all SE illnesses identified through CDC
construction of larger and more costly (and the other possible measures) would outbreak surveillance are attributable to
egg rooms than average. For testing and be an expected decrease in the eggs. Where a vehicle of transmission
diversion, the within group variation is incidence of SE-related illnesses. The was identified, 81 percent of outbreaks
driven by the number of houses and egg benefits will be calculated using the and 79 percent of illnesses identified
production. Farms with more houses following model: through outbreaks were attributed to
will have higher environmental testing Benefits = base line risk × % risk eggs (Ref. 17). The midpoint between
costs, and farms with higher egg reduced (C1, C2, C3, * * *) × value the lower bound (53 percent) and upper
production per house will have a higher of risk reduced
3 An example of substitute components would be
cost of diversion. Where: rodent poisons and traps. By themselves rodent
(Comment 59) Several comments • Benefits = annual health benefits realized poisons and traps may reduce the problem of SE
stated that the cost of testing eggs is due to this rule. contamination by X percent and Y percent,
underestimated in the proposed rule • Base line risk = the base line level of risk respectively. However, when used together the
analysis. One comment noted that, facing consumers today, expressed as the effect on SE contamination will be somewhat less
number of SE cases attributable to shell than X percent + Y percent (though still higher than
although in the proposal FDA estimated each component alone). When prevention measures
lab costs at $30, the pilot project lab cost eggs consumption
are complements, the total prevention from using
relied on in developing that estimate • Risk reduced (C1, C2, C3, * * *) = the % the two measures that reduce risk by A percent and
of risk reduced from the baseline due to B percent separately is greater than A percent + B
were for direct plating from the egg pool changes in production (C1, C2, C3, percent.
onto two plates, not for the testing * * *) 4 All data for the calculations in this paragraph
proposed of one pre-enrichment • Value of risk reduced = the social cost of and the following paragraph are from Meade (Ref.
followed by two enrichments followed one representative case of salmonellosis. 6) and CDC (Refs. 8, 11, 15, and 56).
bound (79 percent) estimates is 66 69,020 (53 percent × 130,220) and an 215,140) cases for 2006.5 Table 1 of this
percent, which we assume to be the upper bound estimate of 218,260 (79 document illustrates how we arrived at
mean percent of domestic SE illnesses percent × 345,360) cases due to SE in our base line.
attributable to eggs. Using these figures eggs. The CDC method generates a mean
we calculate a lower bound estimate of point estimate of 141,990 (66 percent ×
TABLE 1—BASE LINE EGG-RELATED Salmonella Enteritidis (SE) CASES

Low estimate Mean High estimate
2006 Passive Surveillance Cases ................................................................................... 6,740
Multiplier ........................................................................................................................... 23 38 61
Estimated SE Cases in 2006 .......................................................................................... 155,020 256,120 411,140
Cases from Outside the United States ............................................................................ ¥16%
130,220 215,140 345,360
Percent of SE cases from eggs ...................................................................................... 53% 66% 79%

Egg Related SE cases in 2006 ....................................................................................... 69,020 141,990 272,830
c. Measuring the health benefits from nonmonetary losses and are both acute The acute illness that accompanies SE
preventing salmonellosis. and chronic in nature. generally causes gastrointestinal
i. The economic impact of illness from ii. The consequences of SE illness. We symptoms, which might be mild.
SE in eggs. In measuring the economic outline the consequences of SE illnesses However, SE infections can be severe
impact of illness due to the in table 2 of this document. Table 2 and result in death, especially for the
includes the medical outcomes of SE elderly, immunocompromised, and
consumption of SE-contaminated eggs,
illness, the duration of conditions children (Ref. 58). Finally, a small
it is important that we include all of the
acquired due to SE illness, and the percentage of all SE infections result in
effects of SE on human health. These probability of occurrence for each
effects include both monetary and chronic reactive arthritis (Ref. 4).
condition with a given level of severity.6
TABLE 2—CONSEQUENCES OF SE INFECTION

Duration
Condition and severity Outcome Percent of cases
(days per year)
Gastrointestinal Illness:
Mild ................................................................... No physician visit ..................................................... 1 to 3 ................ 90.7
Moderate ........................................................... Physician visit .......................................................... 2 to 12 .............. 8.1
Severe ............................................................... Hospitalized .............................................................. 11 to 21 ............ 1.2
Arthritis:
Short-term ......................................................... Waxing and waning, eventually resolved ................ 1 to 121 ............ 1.3
Long-term .......................................................... Chronic arthritis ........................................................ 365 ................... 2.4
Death ........................................................................ Death ........................................................................ ........................... 0.04
We classify the gastrointestinal illness We do not have direct estimates of the visits, a rate of 8.1 percent (113,000 ÷
caused by SE illness as mild, moderate, distribution of outcomes of SE illnesses 1,400,000) (Ref. 15). CDC also has
or severe. A mild case of SE is defined separate from the outcomes of illnesses estimated that foodborne Salmonella
as a case that causes gastrointestinal for all nontyphoidal Salmonella. In the cases lead to about 15,600
symptoms, but is not severe enough to absence of better information we assume hospitalizations per year, which is about
warrant visiting the doctor. An that all Salmonella serovars will result 1.2 percent (15,600 ÷ 1,340,000) of
individual with a mild case of SE illness in similar distributions of illness annual foodborne cases (Ref. 6). Based
will be ill for 1 to 3 days. A moderate severity. We therefore use information on this we can calculate that the
case of SE illness lasts for 2 to 12 days that applies either to all 1,400,000 remaining 90.7 percent of
and is characterized as a case severe estimated annual cases of salmonellosis gastrointestinal illness cases occur
enough to necessitate a trip to the doctor or to the 1,340,000 estimated annual without a visit to the doctor; that is,
or other health care professional. A foodborne cases of salmonellosis. Using they are mild.
severe case of SE illness results in general results for all diarrheal illnesses, SE may also result in reactive
CDC has estimated that 113,000 of the arthritis. This illness can manifest itself
hospitalization and typically lasts from
1,400,000 Salmonella illnesses in 1997 either as a relatively short-term bout of
11 to 21 days.
could have resulted in physician office joint pain or as a chronic condition.
5 In the proposed rule, we adjusted the estimated However, since then the rate has remained 6 We use recent data from CDC to estimate the
number of cases downward to account for the relatively steady, implying that at least the short relative prevalence of illnesses of different
projected effects of the refrigeration and labeling term effects of the refrigeration and labeling rule severities (Ref. 57). The expected duration of illness
rule. After that rule took effect in 2001, the have been realized. We therefore do not adjust for for each category of severity is taken from Zorn and
estimated number of SE illnesses in the United the effects of the refrigeration and labeling rule in
Klontz (Ref. 4).
States in 2002 decreased by nearly 9 percent. this final rule.
Studies of outbreaks imply that short- One approach to estimating health 59). In our analysis, we use both
term reactive arthritis may last from 1 benefits involves the use of QALYs. methods where appropriate.9
day to a total of 121 days. Chronic QALYs can be used to measure the loss In table 3 of this document, we
reactive arthritis can last from the time of well-being that an individual suffers present estimates of the number of
of onset until death. Overall, we due to a disease or condition. QALYs do quality adjusted life days (QALDs) lost
estimate that 1 to 10 percent of SE not include the value of health due to SE. Total QALDs lost are derived
infections lead to some form of reactive expenditures caused by the condition in by dividing the estimated number of
arthritis. We expect two-thirds of these question; we estimate health QALYs lost by 365. Then, to calculate
to be long-term and one-third to be expenditures separately.8 QALYs range the disutility per day, or 1 QALD, we
short-term (Ref. 4).
from 0 to 1 where 0 is equivalent to multiply by the average duration of the
The most severe potential result of SE
infection is death. CDC estimated in death and 1 is equivalent to perfect illness. Like QALYs, QALDs range from
1999 that 553 deaths occur annually due health for 1 year. 0 to 1 where 0 is equivalent to death and
to foodborne Salmonella (Ref. 6). The A number of methods have been 1 is equivalent to perfect health for 1
estimate suggests that about 0.04 constructed to measure QALYs. One day. We report the loss in QALDs
percent (553 ÷ 1,340,000) of foodborne class of methods uses surveys to ask because most of the illnesses associated
cases of Salmonella result in death.7 doctors and the general population to with SE last days rather than years. The
iii. Quality adjusted life years use a QALY scale to estimate how much QALD values listed for mild, moderate,
(QALYs). The benefits from this someone else who is afflicted with a and severe cases of SE infection were
regulation will be presented in both estimated by Zorn and Klontz using data
given symptom or condition will suffer.
monetary and nonmonetary terms. In from Kaplan, Anderson, and Ganiats
This direct survey approach has been
section V.G of this document, the (Ref. 4). This approach calculated that
used widely, partly because surveys of
benefits will be expressed in illnesses the acute effects of food poisoning
QALY values for a large variety of (vomiting, diarrhea, and general
and deaths averted by each regulatory
symptoms and functional limitations gastrointestinal illness) lead to a loss of
provision under consideration. In the
summary of benefits due to the have been published (Ref. 4). An QALDs greater than 0.5 for each day of
regulation, we present both a cost alternative method used by Cutler and illness. Furthermore, these lost QALDs
effectiveness framework (cost per illness Richardson uses regression analysis to persist for 2 to 16 days. Thus, the total
averted and cost per QALY saved) and estimate the effect of particular loss of QALDs from gastrointestinal
a monetary benefits estimation. conditions on overall health status (Ref. illness is calculated to be 1 to 10.
TABLE 3—LOST QUALITY ADJUSTED LIFE DAYS DUE TO SE

Disutility per day (QALDs lost)
Total QALDs
Severity Average days lost per illness
Functional Symptom Total Ill
Illness:
Mild ............................................................................... 0.44 0.08 0.053 2 1
Moderate ....................................................................... 0.44 0.08 0.053 7 4
Severe ........................................................................... 0.53 0.09 0.062 16 10
Reactive Arthritis:
Short-term ..................................................................... ........................ ........................ 0.22 25 5
Long-term ...................................................................... ........................ ........................ 0.14 18,250 2,613
For reactive arthritis, we used the ‘‘illnesses averted’’ metric for each morbidity effects. Benefit estimates not
regression approach of Cutler and option and provision. This practice relying on QALY estimates will
Richardson (Ref. 59). The regression allows us to calculate cost per illness necessarily be significantly lower than
approach yields estimates of losses per averted by each provision. In the estimates with QALYs. The results of all
day of 0.22 for short-term reactive summary we present the result of methods of valuation are presented in
arthritis and 0.14 for long-term reactive alternate valuation methods that do and section V.F of this document.
arthritis. We estimate that short-term do not rely on QALY estimates. Because iv. Valuation of SE illnesses. Table 4
reactive arthritis results in a loss of 5.4 a large portion of the loss due to chronic of this document illustrates how we
to 10.8 QALDs while long-term reactive calculate the dollar value of a typical
reactive arthritis is due to pain and
arthritis results in a loss of 2,613 to case of SE. The first column of table 4
suffering not associated with direct
5,223 QALDs. lists the type of ailment. The second and
We do not present the estimated medical expenditures, it is difficult to
third columns of table 4 are taken from
QALYs saved for each provision capture the full economic loss due to SE tables 2 and 3 of this document. The
considered in this analysis. Instead, we related reactive arthritis without using health loss per case is calculated by
present benefits by provision in an QALYs or some other measure of multiplying the value of a QALD by the
7 CDC updated the estimate of the overall burden from 44 to 32. Mean estimated annual benefits approach. However, it is not clear that this
of salmonellosis in 2004. The rates of death for both would decrease by roughly $35 million. approach is appropriate for valuing acute illnesses.
salmonellosis and SE were estimated to be 0.03 8 Although some QALY estimates include the Therefore the Kaplan, Anderson, and Ganiats
percent, a decrease of one one-hundredth of a approach is used for acute illnesses and the Cutler
value of medical expenditures, particularly QALY
percent from the 1999 estimate. The rate of death
estimates derived from survey data, the QALY and Richardson approach is used for chronic
may vary slightly from year to year. A decrease in
the rate of death from SE by 0.01 percent would estimates used in this study do not. conditions. See Scharff and Jessup for a discussion
decrease the baseline mean estimated number of 9 The Cutler and Richardson approach has several of the pros and cons of each approach (Ref. 60).
deaths related to consumption of eggs containing SE advantages over the Kaplan, Anderson, and Ganiats
actual number of QALDs lost, and then 4 shows the annual medical costs of given outcome (column 2) is multiplied
discounting where appropriate (only each condition that is caused by SE by the sum of the average health and
values of chronic cases of reactive infection (long term reactive arthritis is medical costs per case. The weighted
arthritis are affected by the discount the only condition where the afflicted dollar values in column 6 are summed
rate). The values in this column will will incur medical costs for more than to calculate the total expected loss
vary depending upon the particular a single year). The sixth column of table associated with a typical case of SE. We
estimates of the value of a statistical life 4 shows the weighted dollar loss per present the range of estimates of dollar
(VSL), the value of a QALY, and the outcome caused by SE. The probability losses per case in table 5 of this
discount rate. The fifth column of table that a case of SE infection results in a document.
TABLE 4—VALUING OF A TYPICAL CASE OF SE1, 2

Case Weighted
Total QALDs Health loss Medical costs
Type and severity breakdown dollar loss
lost per illness per case per case
(percent) per case
Illness:
Mild ............................................................................. 90.7 1.05 $864 $0 $780
Moderate ..................................................................... 8.1 3.68 3,025 92 250
Severe ......................................................................... 1.2 9.99 8,208 9,257 210
Arthritis:
Short-Term .................................................................. 1.26 5.41 4,442 139 60
Long-Term .................................................................. 2.40 2,613.12 592,411 9,536 14,460
Death .................................................................................. 0.04 18,250.00 5,000,000 ........................ 2,140
Total expected loss per case .............................. .......................... ........................ ........................ ........................ 17,900
1 The value of a typical case will actually vary widely depending on the values used for the VSL, QALY, and the discount rate. The figures pre-
sented here are based on VSL = $5 million, QALY = $300,000, and a discount rate of 7%.
2 ‘‘Health Loss per Case’’ and ‘‘Weighted Dollar Loss per Case’’ for ‘‘Death’’ are calculated using a VSL = $5 million. If we use the QALD cal-
culation, assuming the average decedent loses 50 years of life, the Health Loss per Case is $4.14 million and the Weighted Dollar Loss per
Case is $1,773.
Cost of illness estimates usually reactive arthritis are based on Zorn and family income in 2002 was about
include the medical costs associated Klontz (Ref. 4). Zorn and Klontz $51,000 (Ref. 65). Moreover, this
with SE. For example, Buzby et al. estimated that short-term reactive estimate is close to the estimate used in
produced a summary of medical and arthritis medical costs were FDA’s economic analysis of the
other costs for U.S. salmonellosis cases approximately $100 per case in 1998. regulations implementing the Nutrition
(Ref. 58).10 The figures they estimated We adjust these numbers to account for Labeling and Education Act of 1990. To
include the lost productivity of workers the increased cost of medical care since reflect other underlying literature, and
due to salmonellosis. Because we 1998. We estimate that long-term following suggestions from other
account for lost productivity separately, reactive arthritis costs had a present Federal agencies, we begin with an
we must net out these costs. value of $5,370 in 1992.11 We use the estimate of the VSL of $6.5 million. This
For mild SE illnesses, we assume that CPI for medical care in general to estimate is consistent with the survey by
most persons will not obtain medical update this cost to current dollars. Aldy and Viscusi (Ref. 66) on the
services. The cost estimated for this Between 1992 and 2005, the CPI for premium for risk observed in labor
category chiefly reflects lost medical services rose from 190.1 to markets. Annualizing this value over 35
productivity (Ref. 58). 323.8. years at 3 percent and at 7 percent
For medical costs for those who FDA uses a range to estimate the discount rates implies estimates of a
contract moderate illnesses, we use value of an additional year of life to value of an additional year of life of
figures from Williams (Ref. 61) updated reflect the uncertainty in the literature. about $300,000 and $500,000.
with medical cost indices. In 1996, the As a low estimate, FDA uses $100,000 Therefore, calculations for estimated
average total cost of treatment for a non- per QALY. Cutler and Richardson (Ref. benefits will reflect three estimates of
urgent medical problem, including 59) use a similar estimate, and Garber the value of a statistical life year
physician’s fees and medication, was and Phelps (Ref. 64) conclude that (VSLY): $100,000, $300,000 and
$62. We adjust these numbers to estimates of the value of a life year are $500,000, for both of the methods of
account for the increased cost of about twice the level of income, though estimating gains in life years. Total
medical care since 1996. The consumer they present a broad range to reflect benefits differ from mortality-related
price index (CPI) for medical services uncertainty associated with risk benefits by including the value of
rose from 228.2 in 1996 to 323.8 in 2005 aversion and discount rates. Updating reduced morbidity and health care
(Ref. 62). Garber and Phelps’ estimates suggests costs. Furthermore, FDA uses values of
The data for the medical cost of a that $100,000 per life year is a a statistical life of $5 million and $6.5
severe case of SE was obtained from the reasonable estimate, given that median million. This range of VSL estimates is
consistent with a reasonable
Health Cost and Utilization Project’s

Nationwide Inpatient Sample (Ref. 63) 11 This is based on the fact that in 1992 there were interpretation of studies of willingness
and updated to 2005 constant dollars $64.8 billion in costs due to arthritis, 24 percent of to pay to reduce mortality risks (Refs. 66
using the CPI. Medical costs due to these costs were medical costs, and there were 40 and 67). FDA uses the lower value to
million arthritis sufferers. This yields $389 per reflect the fact that many of the
arthritis sufferer in direct medical costs. Discounted
10 As with the CDC data, we assume that the at 7 percent, the present value of medical
estimates of willingness to pay to reduce
characteristics of SE-related illnesses are similar to expenditures for 50 years with reactive arthritis is mortality risk from papers not surveyed
those of Salmonella in general. $5,370. by Aldy and Viscusi are relatively low.
In table 5 of this document the value

of a typical case of SE under different
assumptions is shown.
TABLE 5—VALUE OF A TYPICAL CASE OF SALMONELLA ENTERITIDIS UNDER DIFFERENT ECONOMIC ASSUMPTIONS1, 2, 3
Discount rate = 3 percent Discount rate = 7 percent
VSL = $5 million VSL = $6.5 million VSL = $5 million VSL = $6.5 million
VSLY = $100 thousand ........................................... $11,900 .................................. $7,600 ..................................

VSLY = $300 thousand ........................................... 30,400 31,000 17,900 18,500
VSLY = $500 thousand ........................................... .................................. 49,500 .................................. 28,800
1 VSLmeans value of a statistical life.
2 VSLYmeans value of a statistical life year.
3 Values
are only reported for most likely combinations. A VSLY of $100,000 is not consistent with a VSL of $6.5 million, and likewise, a VSLY
of $500,000 is not consistent with a VSL of $5 million.
The expected value of a typical case 2. Measuring Costs consumers include sales of a farmer’s
of SE varies greatly depending on the We measure costs based on the best own eggs to neighbors, at farmers
estimates used. The lowest expected available information from government, markets, and at roadside stands.
value for a case of SE, $7,600, occurs industry, and academic sources. Farmers that sell their eggs to another
when we use a VSL of $5 million, QALY Furthermore, we assume that total costs person for distribution or resale are not
of $100,000, and a discount rate of 7 are typically the sum of the costs of assumed to be exempt from the listed
percent. The highest expected value for individual provisions. What this provisions. We do not anticipate any
a case of SE, $49,500, occurs when we assumption means is that, unlike control measures for farms that sell all
use a VSL of $6.5 million, a QALY of benefits, the cost of one provision is of their eggs directly to consumers, so
generally independent of the cost of we exclude them from the analysis.
$500,000, and a discount rate of 3
other provisions. Where economies of We estimate that approximately 3,300
percent. For purpose of this analysis, we farm sites with roughly 7,400 poultry
have chosen to use $17,900 per case as scope 14 with respect to SE mitigation
exist, we adjust the costs downward to houses will be covered by some or all
a central estimate. This value parts of the rule. These figures are
corresponds to where the VSL is $5.0 account for the economies.15
calculated as follows:
million, a QALY is valued at $300,000, 3. Coverage of the Analysis • We use the National Agricultural
and the discount rate is 7 percent. Two major sectors are affected by this Statistics Service (NASS) 2002 Census
d. Other benefits. Pathogens other rule: Farms that produce eggs for the of Agriculture to determine the number
than SE have been associated with eggs. retail markets and farms that raise of farm sites with layers on hand. NASS
In particular, Campylobacter (Ref. 68) pullets that become layers. We estimate estimated that there are 98,315 farms
and non-SE Salmonella (Ref. 20) have costs and benefits of changing practices with layers over 20 weeks old in their
been found on the shells of eggs. The in each of these sectors separately. inventory (Ref. 71).
We estimate costs and benefits of • Next, we adjust for the fact that a
presence of pathogens on the eggshell large portion of farms with fewer than
may be harmful to humans if one of two potential prevention measures for all
farms that produce eggs for distribution 3,000 layers either sell their eggs
scenarios occurs. First, under certain directly to consumers or do not sell
conditions, pathogens may migrate in retail markets. Because the rule
exempts very small farms (< 3,000 their eggs at all. We estimate that, of the
through the shell of the egg to infect the approximately 94,300 farms with fewer
layers) from all provisions, wherever the
egg’s contents (Ref. 69). Second, than 3,000 layers,17 over 48,600 of these
data permit, we calculate costs and
eggshell contamination could result in benefits separately for both very small farms sell their eggs, but not directly to
the contamination of egg contents if eggs farms and for larger farms (≥ 3,000 consumers.18
are broken in such a way that the shell layers). The separation of costs and • NASS data suggested that 83
of the egg comes into contact with the benefits by size of farm allows us to percent of layers are table egg layers
contents of the egg (Ref. 69).12 Pathogen measure the regulatory relief provided 17 The NASS Census of Agriculture uses farms
migration is unlikely given current by the exemption for very small farms.16 with 3,200 birds as its cutoff point for
USDA standards and industry Farmers who sell all of their eggs categorization. FDA uses 3,000 birds as its cutoff
practices.13 Regarding egg breaking, directly to consumers are exempt from point for small versus large farms, because this is
current USDA washing and sanitizing all provisions. Sales of eggs directly to the measure that is used in other egg and poultry
regulations. To adjust the NASS data, FDA assumes
standards are designed to reduce that all flocks are uniformly distributed across the
pathogens on the exterior of the egg. 14 Economies of scope occur when more than one
400 to 3,200 bird category. Using this assumption,
Consequently, we do not expect benefits activity can be more efficiently performed at the 7.1 percent (200 ÷ 2,800) of these farms fall in the
same time, rather than one at a time. over 3,000 bird category while the remaining 92.9
from the reduction of illnesses due to 15 Where economies of scope with regard to SE percent fall in the small farm category.
pathogens other than SE to be large. mitigation occur, we observe that the incremental 18 Based on assumptions that industry experts
cost of one provision decreases with the (Refs. 72, 73, and 74) validated as plausible, we
implementation of another provision. For example, have calculated that approximately 2,860 farms sell
12 The use of centrifuges would cause this to if rodent control decreases the chance of SE eggs via retail channels other than farmers markets,
occur. detection through environmental testing, we would roadside stands, and neighborhood sales. Many of
13 Most modern egg washing machines are spray-
expect the amount (and the cost) of follow-up egg the remaining 91,400 very small farms sell their
testing to decline. eggs to consumers indirectly at roadside stands or
washers (63 FR 27502 at 27505, May 19, 1998). 16 A detailed breakdown of the estimated impact farmers markets (Ref. 71). In the absence of better
Migration of SE through the eggshell is more of each provision were they required for farms with information, we assume that half of those remaining
commonly associated with immersion washing (Ref. less than 3,000 birds can be found in section VII 91,400 very small farms sell eggs indirectly to
70). of this document. consumers.
(Ref. 75). For those farms with more category in table 6 of this document. We • We calculate the total number of
than 3,000 layers, we adjust the use data from the 1999 Table Egg Layer poultry houses that will be affected by
estimated number of farms affected by Management in the U.S. Survey (Refs. this rule by multiplying the adjusted
the NASS estimate. The resulting 27 and 28) to estimate the number of number of farm sites by the expected
estimated number of farm sites is houses per farm site for those farms number of houses per farm site.
illustrated in the first column of table 6 with more than 3,000 layers.19 For those As Table 6 of this document
of this document. farms with fewer than 3,000 layers, we demonstrates, the majority of the houses
• The estimated number of houses assume that there is only one house per are on farm sites with fewer than 3,000
per farm site is broken down by size farm site. layers.
TABLE 6—FARMS POTENTIALLY COVERED BY THE RULE

Total number
Adjusted Number of Total number of eggs
Farm size (number of layers) number of houses per of houses produced
farm sites site (in millions)
3,000 to 19,999 ................................................................................................ 1,746 1.4 2,445 5,607

20,000 to 49,999 .............................................................................................. 925 1.4 1,295 6,886
50,000 to 99,999 .............................................................................................. 248 2.4 595 4,662
100,000 or more .............................................................................................. 409 7.4 3,024 54,958
Total potential coverage ........................................................................... 3,328 2.2 7,359 72,113
We also estimate the costs and 1. No New Regulatory Action prevent the initial contamination of eggs
benefits of prevention measures on with SE.
One possible alternative to the rule is
farms that raise pullets. Comments to Several of the large egg-producing
to rely on current Federal, State, and
the proposed rule stated that there are industry efforts to control SE in shell States and industry groups have
roughly one third as many pullets as eggs. These efforts include relying on an encouraged producers of eggs to follow
there are layers at any given time. FDA final rule for labeling and on-farm practices aimed at preventing
Further, there are roughly one third as refrigerating shell eggs, FDA educational SE in their flocks. One of the first States
many pullet houses as there are layer programs, and the growth of to implement a structured quality
houses. FDA therefore estimates that membership in State and industry assurance program was Pennsylvania.
2,453 pullet houses (7,359 layer quality assurance programs. We believe Though voluntary, the implementation
houses/3) will be covered under this these methods of control, while of the PEQAP has been accompanied by
provision.20 Some of the pullet houses valuable, are unable to fully address the a significant decrease in SE-related
are located onsite at layer farms and problem of SE contamination of shell illnesses in those areas where eggs from
others are located on pullet growing eggs. Pennsylvania are marketed. Industry
facilities. FDA issued a related rule designed to groups also have drawn up quality
help prevent the growth of SE in eggs by assurance plans as guidelines for their
E. Summary of Costs and Benefits of
requiring refrigeration of shell eggs at members to follow. The voluntary
Regulatory Options and the Rule
retail and by requiring shell egg labeling programs have achieved some success
In this section we summarize the (65 FR 76092, December 5, 2000). As in reducing SE contamination in eggs,
costs and benefits of the rule and the part of that rule, we set refrigeration and the more comprehensive plans
regulatory options. In section V.F of this temperatures to reduce the potential contain many preventive measures
document, we provide a detailed growth of SE inside shell eggs at the similar to those in this rule (Ref. 76).
analysis of the costs and benefits of all retail level, and, to inform consumers,
These voluntary programs have now
of the SE prevention measures we required safe handling instructions on
been in operation for many years and
all cases and cartons of shell eggs.
considered, both those in and those not are well-known throughout the
Nevertheless, labeling and refrigeration
in the final rule. industry. Although the State and
standards do not prevent or limit the
We considered a number of regulatory growth of SE while eggs are in industry programs are potentially
options that may be used to prevent the production. effective, many producers choose not to
problem of SE in eggs, including no new FDA also is pursuing a program participate. As data from CDC show, SE
regulatory action, classification of SE- designed to inform consumers about illnesses continue to be associated with
positive eggs as restricted or SE- microbial hazards in egg preparation. shell eggs even in those areas where
positive, HACCP, the final rule, more The nationally distributed ‘‘Fight BAC!’’ voluntary programs are in place (Ref.
extensive on-farm prevention measures, program targets children in schools and 56). Option 1, relying on current
less extensive on-farm prevention television audiences with a more Federal, State, and industry efforts to
measures, and the inclusion of general food safety message that likely control SE in shell eggs, will be used as
mandatory food establishment results in better egg handling practices. a baseline for the rest of the analysis.
prevention measures. This program, although useful, does not

19 Data from the Layers study are used throughout 20 Comments received on the number of pullet less than 3,000 layers) or will be covered by virtue
this document. We acquired the data either directly houses came primarily from large farm of selling to larger farms. Therefore, FDA uses the
from the NAHMS Web site or through direct representatives. Farms with less than 3,000 layers number of houses located on farms with 3,000
correspondence with Lindsey Garber, Centers for are not covered by this provision, so the pullet layers or more to calculate the number of pullet
Epidemiology and Animal Health, Veterinary houses from which they procure their layers will
houses affected by the provision.
Services, APHIS, USDA. either not be covered (if they sell only to farms with
2. HACCP on egg farms, either voluntarily 3. The Final Rule

We could, in theory, require that a developed by individual businesses or
required by states, and we note that The rule includes the following
HACCP system be implemented on layer requirements for farms with 3,000 or
farms. Although the general sanitation FDA did not receive any comment
suggesting that it attempt to apply a more layers that do not have all of their
and hazard control measures in the rule
are similar to aspects of existing HACCP HACCP approach to egg farms. eggs treated or do not sell all of their
programs in other areas, the agency has eggs directly to consumers: Rodent and
FDA considers that the level of other pest control, biosecurity, cleaning
decided not to mandate HACCP on layer scientific and technical knowledge
farms. To be effective, a HACCP system and disinfecting, use of SE-monitored
needed to identify the range of possible chicks and pullets, testing and
must be based on a foundation of hazards reasonably likely to occur and
prerequisite programs that provide basic diversion, refrigeration during holding
the critical control points needed for
environmental and operating and transport, registration, and records
eliminating those hazards from shell
conditions. Thus, to be technically and with respect to compliance with each
eggs may not always be readily available
scientifically feasible for egg provision. Farms where all eggs are
on layer farms. Moreover, we believe
production, a HACCP system would treated need only comply with the
that the HACCP plans that most layer
require adoption of basic measures such refrigeration requirements.
as those required in this final rule, as farms would develop, if required to do
so, would contain many if not all of the The benefits from the SE prevention
well as several additional measures. measures in the rule would take time to
Even if FDA were to provide less detail measures in this rule. We believe the
targeted SE-prevention measures be fully realized, but the costs would be
as to its expectations for compliance in
required by this final rule are as more immediately incurred. Table 7 of
the regulation and to require a HACCP
plan rather than an SE prevention plan, effective as any conceivable HACCP this document shows the initial costs
these measures would certainly be system, and avoid imposing on each and benefits and the eventual costs and
required for producers to effectively layer farm the burden of developing benefits following implementation of
prevent SE contamination of eggs. scientific and technical knowledge the rule.21 Following are the detailed
Furthermore, we are not aware of any required to develop an individualized calculations underlying table 7, in
precedent for use of a HACCP approach HACCP system. section V.F. of this document.
TABLE 7—FINAL RULE ANNUAL COSTS AND BENEFITS

Total costs Illnesses Cost per ill- Total benefits
(in millions) averted ness averted (in millions)
Initially (first four years):1

Discount Rate = 3% ................................................................................. $83 68,790 $1,200 $1,231
Discount Rate = 7% ................................................................................. 88 68,790 1,300 1,231
Eventually (after four years):1
Discount Rate = 3% ................................................................................. 76 79,170 1,000 1,417
Discount Rate = 7% ................................................................................. 81 79,170 1,000 1,417
1 As explained in the detailed analysis in section V.F., some of the provisions, particularly rodent and pest control, will take up to 4 years to be-
come fully effective. The effectiveness of the provisions affects the prevalence rate and thus affects both benefits and costs of each provision.
Therefore, the costs and benefits are presented over two time frames: ‘‘initially’’ assuming an average effectiveness over the first 4 years, and
‘‘eventually’’ assuming full effectiveness after 4 years.
4. More Extensive On-Farm SE controls would result in a marginal cost- number of these farms. For these
Prevention Measures effectiveness of more than $315,000 per reasons, FDA has decided not to pursue
FDA could issue a rule that is broader additional illness averted and a decrease this option.
in scope and has more extensive in net benefits of over $100 million. The
main reason for the small increase in 5. Less Extensive On-Farm SE
provisions including: (1) Does not Prevention Measures
exempt farms with fewer than 3,000 benefits relative to costs is that much of
layers from any provisions and (2) the increase in costs comes from adding We could also require fewer controls
includes more on-farm provisions than farms with fewer than 3,000 layers. The than are in the rule. Several provisions
those in the rule. Additional on-farm large number of such farms (over could be combined to provide a less
provisions include requiring the use of 45,000) means that requiring them to extensive set of controls than in the
SE-negative feed and vaccinating flocks comply with all provisions of the rule rule. Many of the prevention measures
against SE. would greatly increase costs. These
could be put forth as stand-alone
Such extensive controls would lead to farms, however, account for less than 1
regulations. We have not presented each
total eventual costs of $274.0 million percent of egg production. Requiring
of these prevention measures as a
per year and eventual expected number them to comply with all of the SE
prevention measures would have a separate option, but the reader can see
of illnesses averted of 80,777, per year.
small effect on the volume of shell eggs the individual effects of the various on-
This approach increases costs by more
farm prevention measures in table 28 of
than $175 million, while only that could be contaminated with SE. In
increasing the number of illnesses addition, including these very small this document. As documented in table
averted by 556 cases (valued at a total farms likely would result in the 28, the various individual measures
of $10.0 million). These more extensive cessation of egg production at a large would, by themselves, generate lower
21 The discount rate is used here to annualize the will only include figures reflecting the discount rate subtract roughly $5 million from the calculations
costs of refrigeration equipment, plan designs, and of 7 percent. Those interested in the total cost performed with a 7-percent discount rate. The exact
training. For simplicity, subsequent summary tables number reflecting a 3-percent discount rate should difference is shown in section F of this document.
net benefits than the integrated program 1. On-Farm SE Prevention Measures correlated with lower prevalence of SE
outlined in the rule. a. Interdependence of on-farm may understate the effectiveness of the
measures. Rodent and other pest practice. For example, a group of farms
6. Include Mandatory Provisions
control, biosecurity, and cleaning and may have practices in place because
Applicable to Food Service
disinfecting all have a role in they are part of a voluntary SE
Establishment Serving Highly
eliminating SE in the poultry house. prevention plan, which may have been
Susceptible Populations
Although the actions taken under each put in place in areas because they had
We could require certain safe egg heading may be distinct, the effects of higher than average prevalence of SE. In
handling and preparation practices for each action are related. For example, a this case the practices would appear to
food establishments that serve highly biosecurity plan may include provisions be correlated with higher than average
susceptible populations as part of to limit standing water and high grass in prevalence.
custodial care, health care, assisted areas adjacent to the poultry house. b. Organization of economic analysis
living, or nutritional or socialization Although categorized as biosecurity of potential provisions. FDA has
services. These provisions would affect measures, these practices also help considered a number of on-farm,
nearly 40,000 such establishments. In control both rodents and pests. administrative, and institutional SE
place with the other provisions of the Similarly, cleaning and disinfecting prevention measures. The provisions
final rule, the provisions pertaining to remove not only SE, but also rodents that we considered are examined below.
food service establishments serving a and pests. We have included some, but not all, of
highly susceptible population would This interdependence means that the these provisions in the rule.
prevent 1,052 illnesses annually at a total efficacy of on-farm controls cannot Marginal costs and benefits are
cost of $16,700 per illness and $1.2 be determined by adding the effects of calculated for farms with less than 3,000
million in annual net benefits (Ref. 77). each provision (as determined by layers, although these farms are exempt
As we discussed in section I.G., a studies that focus on each provision from the final rule. These results are
majority of states and territories have separately). The measurement difficulty presented in section VI of this
adopted into their own retail food codes arises for two reasons. First, when two document, where relief for small
the relevant egg-associated provisions of practices substitute or complement one businesses is discussed.
the FDA Food Code. With most states another, the efficacy of the first practice The costs and benefits of the
adopting as mandatory the relevant is affected by the introduction of a provisions of the final rule as written
sections of the FDA Food Code (or second. Throughout the analysis, results are summarized in table 34 in section
similar safety standards), FDA believes for benefits calculations are presented V.G of this document.
it would be an unnecessary exercise of for each provision standing alone as c. Control of rodents and other pests,
authority to codify the FDA Food Code. well as in the presence of all other biosecurity, and cleaning and
We will continue education efforts at provisions. Therefore, a provision that disinfection.—i. Rodent and other pest
the retail and consumer levels. Further, occurs later in the production chain control provisions. One requirement of
we will continue to encourage states to than a provision that has already this final rule is that each layer house
adopt the relevant provisions of the reduced the prevalence of SE will have be under a pest control program. Such
FDA Food Code. less of an impact on total illnesses a program could include the use of traps
F. Benefits and Costs of Potential SE averted than if that provision stood or poisons to reduce rodents and other
Prevention Measures: Detailed Analysis alone. The hierarchy of provisions (first pests. Each farm must have a written
in production chain to last) is as control plan for rodents and other pests,
In this section, we describe the SE follows: and pest control records must be kept to
prevention measures that we (1) Chicks and pullets procurement. verify that the program is accomplishing
considered, including provisions that (2) Testing, cleaning, disinfection of its goals.
were not included as requirements or chicks and pullets. ii. Current industry practices—rodent
that were only required for certain (3) Rodent control, biosecurity, and other pest control. Most farms
producers in the rule. cleaning and disinfection in layer currently address rodent and pest
For the costs and benefits of the houses. control problems to some extent.
provisions of the rule, we examine a (4) Testing and diversion in layers. However, if SE-positive eggs are
number of on-farm measures including (5) Refrigeration. required to be diverted, there will be a
the following: Second, a simple comparison of farms financial incentive to find ways to
• Rodent and other pest control, that use one given practice with farms prevent SE in poultry houses. As a
• Biosecurity measures, that do not use that practice is result, the effectiveness of rodent and
• Cleaning and disinfecting of layer insufficient in measuring the pest control in eliminating SE in the
houses between flocks, effectiveness of that individual practice. poultry house will lead many farms to
• Refrigeration of eggs, The use of one good practice tends to be institute rodent and pest control
• Layer house environmental testing, positively correlated with the use of programs that are more stringent than
• Follow-up egg testing, other good practices, and therefore a those currently in place in order to
• The diversion of SE-positive eggs, simple comparison between farms will achieve a higher level of rodent and
• The use of SE monitored chicks or overstate the effectiveness of any one other pest control.
pullets, and practice. For example, those houses that Currently, 99.2 percent of all
• Other provisions, including the use use the best rodent control practices are commercial farms with more than
of SE negative feed, and vaccinating also likely to be using other SE controls 30,000 layers use some form of rodent
flocks against SE. as well, so a measure of rodent control control, but not all methods of rodent
For each of these on-farm measures effectiveness is likely to pick up the control are compatible with the goal of
we estimate the costs of the following effects of good biosecurity, pest control, eliminating SE in poultry houses.22 In
administrative measures: Registration, and cleaning and disinfecting practices.
training, plan design, and On the other hand, a simple farm to 22 Only operations with 30,000 or more layers are
recordkeeping. farm comparison of practices that are included in the Layers study (Refs. 27 and 28).
particular, we believe that biological use cats as a rodent control measure) are positive eggs will encourage farmers
predators, such as cats, should not be counted as having unacceptable rodent currently using a level of rodent control
used as a method of rodent control control programs. Based on data from that would satisfy the provision to
because cats can be vectors for SE the Layers study (Refs. 27 and 28), we increase their rodent control efforts.
contamination. estimate that the number of farms with Without better information about the
Table 8 of this document illustrates, unacceptable rodent control programs number of farms that would increase
by farm size, the number of programs will range from 1.8 percent for farms rodent control efforts, we assume the
that would satisfy the rodent control with over 100,000 layers to 21.0 percent true number will lie between 0 percent
provisions in the rule. Farms that do not for farms with 20,000 to 49,999 layers.23 and 100 percent of those currently using
use rodent controls as specified in this Furthermore, we believe that the an acceptable level of rodent control.
provision (e.g., many farms primarily potential costs of diversion of SE-
TABLE 8—RODENT CONTROL

Unacceptable Number of farms Number of farms
Farm size (number of layers) rodent control with unacceptable increasing effort
(in %) rodent control
3,000 to 19,999 .......................................................................................................... 19 328 709

20,000 to 49,999 ........................................................................................................ 21 194 365
50,000 to 99,999 ........................................................................................................ 4 9 119
100,000 or more ........................................................................................................ 2 7 201
All farms with 3,000 layers or more ................................................................... .............................. 539 1,394
We assume that between 25 percent the presence of flies and fly control 3,000 layers use some form of fly
and 75 percent of very small farms because they have been implicated in control. Some of these methods,
(those with fewer than 3,000 layers) are the transmission of Salmonella (Ref. however, are not permitted by the final
using an acceptable level of rodent 79).24 rule. In particular, the rule does not
control. The survey used to develop the Layers allow the use of biological predators,
Pests, other than rodents, commonly study asked questions about on-farm fly such as wild birds, for fly control
found in poultry houses include flies, control practices (Refs. 27 and 28). because these predators may themselves
mites, beetles, and ants (Ref. 78). Using these data, we estimate that over be vectors for SE transmission (Ref. 79).
However, we chiefly are interested in 90 percent of those farms with over
TABLE 9—FLY CONTROL

Unacceptable Number of farms Number of farms
Farm size (number of layers) fly control with unacceptable increasing effort
(in %) fly control
3,000 to 19,999 .......................................................................................................... 27 470 638

20,000 to 49,999 ........................................................................................................ 18 162 382
50,000 to 99,999 ........................................................................................................ 12 29 109
100,000 or more ........................................................................................................ 22 89 160
All farms ..................................................................................................................... .............................. 750 1,289
All farms with 3,000 or more layers ................................................................... .............................. 750 1,289
Table 9 of this document shows the The actual number of farms that are estimate the costs, we assume that the
number of farms with unacceptable (not using unacceptable methods of fly number of farms using acceptable fly
sufficient to satisfy the rule) fly control control is likely to be higher than the control methods but will increase their
programs. Farms that do use fly control estimates in table 9 of this document fly control efforts is uniformly
or that use biological predators, such as would suggest. The fact that a particular distributed between 0 and 100 percent.
birds, as their primary method of fly method is used does not automatically Consequently, at the mean estimate of
control, are not using acceptable guarantee that it is used at its optimal 50 percent, an additional 1,289 farms
methods. We estimate that a total of 750 level. As with rodent control, even will increase their fly control efforts.
farms with 3,000 or more layers are farmers in compliance with the
using unacceptable methods of fly provision would be likely to increase iii. Costs of rodent and other pest
control. their use of fly controls. In order to control.25 We estimate the cost of rodent
23 Our primary source for on-farm practices 30,000 layers were included in the survey. manure upon a house cleaning, the costs and
related to SE prevention measures is the Layers Consequently, we approximate the practices of benefits of which are discussed later in this
study (Refs. 27 and 28). As the only major current smaller farms based on a limited amount of document. Other costs of control, as well as
survey of the industry, this study has provided us information. Nonetheless, the Layers study has benefits, are assumed to be accounted for in the
with data that has allowed us to characterize the
added greatly to our understanding of the industry analysis of fly control.
industry. The study, however, does not fully
represent the industry. A total of 526 farm sites and its practices. 25 All cost estimates in this section are from data
24 Beetles have also been shown to be a reservoir supplied to the FDA through a contract with
responded to the first part of the survey and 252
responded to the second part of the survey. for SE (Refs. 80 and 81). Beetle populations can be Research Triangle Institute. Derivations of estimates
Furthermore, only operations with more than controlled primarily by the removal of all visible are described more fully in a memorandum to the
and other pest control to farms in table control ranges from $680 for the average Pest control measures include the cost
10 of this document. We assume that a farm with between 3,000 and 20,000 of sprays, baits, fly monitoring, and
farm with an adequate control program layers to $5,860 for the typical farm manure pit fans. We expect the annual
for rodents and other pests will be using with over 100,000 layers. The costs of cost of pest control to range from $4,600
a combination of control measures. limiting rodent access to feed and for farms with between 3,000 and
Included in the cost of rodent control patching holes in the walls of poultry 20,000 layers to $77,660 for farms with
are the costs of setting up and houses are not included in our more than 100,000 layers.
maintaining bait stations and of rodent estimates.
indexing. The annual cost of rodent
TABLE 10—COST OF RODENT AND OTHER PEST CONTROL

[In thousands]
Rodent control Pest control

Farm size (number of layers) Total
Unacceptable Increased Unacceptable Increased
controls effort controls effort
3,000 to 19,999 .................................................................... $222 $240 $2,160 $1,467 $4,089

20,000 to 49,999 .................................................................. 157 148 1,355 1,597 3,256
50,000 to 99,999 .................................................................. 12 76 460 859 1,408
100,000 or more .................................................................. 43 588 6,887 6,212 13,730
All farms with 3,000 or more layers ..................................... 434 1,052 10,861 10,136 22,483
The total cost of rodent and other pest provision results in costs of $22.5 the rodent problem on farms. The first
control shown in table 10 of this million for the effected farms. four rows of table 11 of this document
document, is found by multiplying the iv. Benefits of rodent control. Rodent show the percentages of farms in four
cost per farm by the number of farms control appears to be effective in size categories with four severities of
affected. Some farms are already using controlling SE. As a critical vector, mouse or rat infestation.26 Table 11
acceptable rodent and other pest control rodents may spread SE throughout a shows that larger farms are generally
methods, but they will increase their given poultry house and between more likely to experience moderate or
rodent and other pest control efforts in houses. Rodents spread the disease severe rodent problems. The greater
order to reduce the subsequent expected through their droppings, which often prevalence in the larger houses means
are consumed by layers. In this section
costs of testing and diversion. We that, while only 17 percent of houses
of the document, we merge field data
estimate that their cost of rodent and have moderate or severe rodent
with estimates of the current level of
other pest control enhancements will be rodent infestation on farms to assess the problems, 33 percent of all layers are
approximately half of the cost of farms benefits from increased rodent control. currently in houses with moderate or
with unacceptable controls. This We used the Layers study (Refs. 27 severe problems.27
and 28) to determine the magnitude of
TABLE 11—SEVERITY OF RODENT PROBLEM
Severity in % Number of
houses in
Severe Moderate Slight None category
Farm Size (Number of Layers):

< 20,000 ................................................................ 0 14.8 81.7 3.5 48,145
20,000 to 49,999 ................................................... 9.1 13.2 70.1 7.6 1,295
50,000 to 99,999 ................................................... 1.2 28.4 52.3 18.1 595
100,000 or more ................................................... 1.5 32.1 60.1 6.3 3,024
Percent of houses affected .......................................... 0.5 16.9 78.7 3.8
Percent of layers affected ............................................ 2.9 31.4 60.2 5.5
Risk ratio ...................................................................... 4.2 3.1 2.1 1 Total
Percent of layers in houses with positive environ-
ments ........................................................................ 19.2 14.3 9.5 4.6 11
Maximum expected SE reduction from increased ro-
dent control 1 ............................................................ 38.1 34 25.8 0 27.3
1 These values are calculated using the following equations:
Severe: [( 19.2¥4.6) ÷ 2] ÷ 19.2 = 38.1%.
Moderate: [( 14.3¥4.6) ÷ 2] ÷ 14.3 = 34.0%
Slight: [( 9.5¥4.6) ÷ 2] ÷ 9.5 = 25.8%.

None: [( 4.6¥4.6) ÷ 2] ÷ 4.6 = 0.0%.
record (Ref. 82). Where applicable, costs are 27 To determine the percent of houses affected, a given rodent problem in each size category by the
changed to year 2005 constant dollars using the the percent of farms with a given rodent problem number of birds in each size category.
Gross Domestic Product (GDP) deflator. was weighted using the number of houses in each
26 Severity level is self-assessed by respondents to size category. The number of birds affected was
the survey. determined by weighting the percent of farms with
Henzler (Ref. 83) examined the link effective, we would assume that it other control measures) would be
between rodents and SE, and found that would result in a drop in SE from smaller than our estimates suggest.
environmental tests of manure in houses current levels to 4.6 percent, the level v. Benefits of other pest control. Pests
with large rodent populations were 4.2 associated with no rodent problem. For other than rodents also have been
times more likely to be positive for SE a severe rodent infestation, rodent shown to be vectors in the spread of SE.
than similar tests in houses with small control would therefore result in a 76.2 In particular, Davies and Wray showed
rodent populations.28 We assume that percent decline in SE, but such a large that the ingestion of SE-contaminated
the risk ratio for SE can be linearly decline is not likely for most farms. maggots by a chicken protects
extrapolated between 1 for those farms Severe rodent infestations are probably Salmonella from the stomach acids of
with no rodent problem and 4.2 for caused by more than just the failure to the chicken and aids in the
those farms with a severe rodent control have a rodent control program. House establishment of SE in the chicken’s gut
problem. This extrapolation is presented design (open walls, dirt floors, and other (Ref. 84).31 Beetles and wild birds have
in table 11 of this document along with features), unfavorable location (near also been implicated in the transmission
the estimated level of rodent infestation other rodent-infested entities, climate, of SE (Ref. 79). Wild birds currently
for farms of different sizes. and so on), and lack of knowledge have access to layer feed troughs on 23.5
The third section of the Layers study regarding proper rodent control percent, and flies have access to layer
(Ref. 29) 29 supports the Henzler study. techniques are additional factors likely feed troughs on 91.3 percent, of farms
The Layers study finds that farms with to diminish the effectiveness of rodent (Refs. 27 and 28).
a rodent index of at least 20 mice have control. Consequently, we assume that Despite the high prevalence of pests
an SE prevalence rate of 10.1 percent, the effectiveness of rodent control for a other than rodents on farms, most farms
while farms with a rodent index of less particular farm will be uniformly attempt to limit their presence. For
than 20 mice have a prevalence of SE of distributed between no reduction and example, approximately 82 percent of
only 2.0 percent.30 This difference is reduction to an SE risk of 4.6 percent. farms currently use fly control methods
statistically significant. Overall, this leads to an estimated other than the use of biological
Using data from the Henzler study, we average 27.3 percent reduction in SE, as predators (Refs. 27 and 28).32
estimate the base level of environmental shown in table 11. The third section of the Layers study
SE prevalence for houses without rodent Based on information from the egg (Ref. 29) illustrates the effect of other
problems to be 4.6 percent when the industry, we believe that rodent control pest control. On those farms in which
overall prevalence of SE-positive houses may take up to 4 years to be fully pests have access to feed storage sites,
is 11 percent. We calculated the base as: effective. During the 4-year transition the prevalence of SE is estimated to be
Base = Overall ÷ [(preventionSEV × period, we assume that the effectiveness higher than on farms where pests do not
BirdsSEV) + (preventionMOD × of rodent control will average 13.7 have access to feed in storage. Because
BirdsMOD) + (preventionSLT × percent, half of the eventual the practices and effects of other pest
BirdsSLT) + (preventionNON × effectiveness. control are highly correlated with
BirdsNON)]; We use the baseline number of SE rodent control we do not estimate the
Where: cases due to eggs and the value of a benefits separately.
typical case of salmonellosis to estimate vi. Other benefits of rodent and other
• ‘‘Base’’ is the base level of prevalence for
a rodent free house, the value of rodent and other pest pest control. The rodent control
• ‘‘Overall’’ is the total prevalence for all control benefits. On the affected farms, provisions are expected to decrease the
houses, rodent and other pest control results in rodent population in poultry houses.
• ‘‘prevention’’ is the risk ratio for each level expected annual benefits of 19,433 Because rodents consume large amounts
of rodent infestation, and illnesses averted initially to 38,954 of feed, this reduction will benefit
• ‘‘Birds’’ is the percentage of layers in illnesses averted eventually. producers by lowering their feed costs.
houses with a given rodent problem. The narrow definition of rodent The Cooperative Extension Service of
The subscripts SEV, MOD, SLT, and control is limited to direct methods of Oklahoma State University estimated
NON refer to the cases of severe, catching, killing, and blocking rodents that each rat in a poultry house
moderate, slight, and no rodent from entering a poultry house. Measures consumed $2.18 worth of feed annually
problems, respectively. such as pest control, biosecurity, and (Ref. 86) in 1987. This amount is
The percentage of layers in houses cleaning and disinfecting also affect equivalent to $3.75 in the year 2005
with environments positive for SE is rodent control. Cleaning and constant dollars.33 Because mice eat 5 to
found by multiplying the SE risk ratio disinfecting a house, when done 10 percent as much as rats (Ref. 78), the
times the base level of risk. Houses with properly, removes rodents and their expected annual loss of feed for each
severe rodent control problems are 4.2 nests from an infested house. Similarly, mouse in a house is estimated to cost
times more likely to be positive for SE biosecurity makes rodent penetration of $0.19 to $0.38.
than houses with no problems (19.2 a house more difficult. As a result, the We estimate that an infested house
percent versus 4.6 percent). benefits estimated for rodent control are may have over 1,000 mice (Ref. 83). This
In the last row of table 11 of this partly due to the adoption of other infestation will cost a farmer
document, we estimate the expected measures that may be required. We approximately $285 for that house
reduction in SE due to increased rodent therefore believe that the expected effect (1,000 × $.285). A house infested with
control. If rodent control were wholly of rodent control by itself (assuming no rats may have as many as 700 rats (Ref.
28 A total of 84 flocks were examined in 30 The standardized rodent index is calculated as predators may themselves become a vector for SE
Pennsylvania (Ref. 83). (number of rodents trapped) × (7 ÷ number of days) transmission.
29 The third part of the Layers study (Ref. 29) × (12 ÷ number of functional traps). The index 33 Nominal 1987 dollars are converted to 2005
standardizes the number of rodents trapped to the
provides estimates for the prevalence of SE on 200 constant dollars by multiplying the amount as
equivalent of having 12 traps function for 7 days
farm sites with different management practices. For (Ref. 29). estimated in 1987 by the ratio of the GDP deflator
many of the variables analyzed, however, the 31 See also Olsen (2000) (Ref. 85). in 2005 to the GDP deflator in 1987 ($2.18 ×
sample size was too small for statistically 32 Use of biological predators is not seen as an 113.386/65.958).
significant differences to be measured. effective pest control technique because the
87). In this case, the infestation costs the

farmer $2,625 (700 × $3.75).
TABLE 12—FEED SAVINGS FROM RODENT CONTROL

Cost to
Rodents in a Feed savings Houses in
Problem % of houses 1 classifiction 2
houses in
house per house classification
Mice:
Severe ................................................................. 1,000 $285 2.4 105 $30,000
Moderate ............................................................. 500 143 25.5 1,118 159,800
Slight ................................................................... 250 71 62.4 2,735 194,200
None ................................................................... 0 0 9.7 425 0
Rats:
Severe ................................................................. 700 2,625 1.6 70 184,100
Moderate ............................................................. 350 1,313 6.9 302 397,100
Slight ................................................................... 175 656 43.7 1,915 1,256,500
None ................................................................... 0 0 47.8 2,095 0
Total cost of rodents .......................................................................................................................................................................... 2,221,700
Expected savings from control (assumes 50% reduction) ................................................................................................................ 1,110,850

1 Thepercentages are from the Layers study (Refs. 27 and 28).
2 Becauserodent populations are estimated for large houses only (over 54,000 layers), we estimate the number of houses to be the number of
large house equivalents. This implies that two 27,000-bird houses are counted as one house in this analysis.
The total feed savings from rodent site on a given day. Although it is 32.0 percent require persons to change
control are illustrated in table 12 of this impossible to predict what measures clothes or wear coveralls.
document. If rodent control leads to just each farm will take to guarantee the Many farms use biosecurity measures
half of all rodents being eliminated, the hygiene of persons moving between aimed at keeping stray poultry, birds,
savings in lost feed from rodent control houses, for the purposes of calculating and other animals away from the
are estimated to be more than $1.1 the costs of this provision, discussed in poultry houses. While data on the
million annually. detail in the following paragraphs, we number of farms that trim grass and
vii. Biosecurity provisions. We have assume that farms will use footbaths discourage standing pools of water are
examined the effects of several and have visitors wear protective not available, the Layers study did
biosecurity provisions. These include clothing. estimate that fencing is currently used at
the following effects: (1) Limiting visitor Stray poultry, wild birds, cats, and 26.7 percent of farms.
access; (2) avoiding the movement of other animals must also be prevented Finally, 75.7 percent of farms do not
contaminated equipment between from entering the farm’s poultry houses. allow employees to keep their own
poultry houses; (3) ensuring that This may be done by keeping grass and layers at home.
employees are hygienic; (4) keeping weeds cut, minimizing the existence of ix. Costs of biosecurity. It is difficult
stray poultry, birds, and other animals standing pools of water near poultry to quantify many of the costs of
from entering poultry houses; and (5) houses, repairing holes on poultry biosecurity. This is especially true
prohibiting employees from keeping houses, and keeping doors closed on because the biosecurity measures may
birds at home. poultry houses. be implemented in different ways,
The first biosecurity measure we allowing each farm to adapt the
examine is the limitation of visitors’ Finally, biosecurity precludes measures to their operation, as
access on poultry farms. Limiting a employees of the farm from keeping any appropriate. However, a few of the costs
visitor’s access may include prohibiting birds as domestic animals at home. can be quantified.
a visitor from entering a house on one viii. Current industry practices; First, the cost of restricting visitors
farm if that person has already entered biosecurity. Most farms already practice can be estimated as the cost of
a house on another farm. Also, visitors some form of biosecurity.34 Roughly monitoring and providing protective
may be banned from entering poultry 68.1 percent of farms do not allow clothing to visitors who are allowed on
houses altogether. nonbusiness visitors and 22.1 percent the farm. The cost of monitoring visitors
Contaminated equipment can also do not allow business visitors into includes the cost of posting signs asking
spread SE on a farm. One way to poultry houses. Of those that do allow visitors to check in, the cost of having
mitigate this problem is to ensure that visitors to enter, 65.6 percent have visitors sign in, and the cost of
equipment that is used in multiple biosecurity rules for nonbusiness accompanying visitors around the farm.
houses (such as forklifts and manure visitors and 69.5 percent have One estimate of protective clothing
removing equipment) is kept clean. biosecurity rules for business visitors. found costs of $102.75 for a box of 25
The hygiene of persons moving Farms use different methods to keep disposable coveralls and $112.97 for a
between houses affects the likelihood of employee, contract crew, and visitor box of 200 plastic shoe covers (Ref. 88).
cross-contamination. To protect against hygiene at an acceptable level. The Because farms will choose to implement
cross-contamination, farms may require Layers study estimates that 24.5 to 24.6 this part of biosecurity in different
that employees and visitors use percent use footbaths, 3.9 to 4.8 percent ways, it is impossible to determine what
footbaths, change their clothing, or use require showers to be taken, and 17.6 to the actual cost will be.
protective clothing when on the farm. The cost of cleaning contaminated
Farms also may choose to require that 34 All data in this section are from the Layers equipment is uncertain because we do
their employees work on only one farm study (Refs. 27 and 28). not know how individual farmers will
choose to do this. We assume that the percent) × 7,359 houses × $360 per We include the benefits from
amount of equipment that needs to be house = $2.0 million. biosecurity with those of rodent control,
kept clean increases linearly with the Finally, the cost of preventing stray because the practices and effects are
number of houses on a farm. In poultry, wild birds, cats and other highly correlated and cannot be
particular, we assume that a farm with animals from entering poultry houses estimated separately.
two houses requires 1 hour of cleaning already is accounted for under rodent
xi. Cleaning and disinfecting
per week, a farm with three houses and other pest control costs. The
provisions. Specific cleaning and
requires 2 hours, and so on. Using data estimated cost for a complete rodent and
disinfecting provisions include the
from the Layers study, we find that the other pest control program includes all
removal of all visible manure, and a dry
average farm will devote 69 labor hours biosecurity measures that contribute to
clean and disinfection of the house.
annually to cleaning equipment. At a rodent and other pest control.
labor rate of $9.56 per hour (Ref. 89), The total measured costs of xii. Current industry practices;
plus 50 percent to include overhead biosecurity provisions are $5.3 million cleaning and disinfecting. To a large
costs, the total expected labor cost of for affected farms. extent the layer industry already
this provision is $990 per farm, or $3.3 x. Benefits of biosecurity. The performs adequate cleaning and
million for all affected farms. importance of biosecurity in the disinfecting procedures. For larger
The cost of chlorine footbaths also can reduction of disease transmission is houses, the Layers study (Refs. 27 and
be estimated. We calculate the cost of a well established.36 For example, the 28) estimates that, every year or two,
footbath as the sum of the cost of the Layers study (Ref. 29) estimates that manure is removed from 100 percent of
plastic vessel, the cost of bleach, and the farms allowing nonbusiness visitors houses, 80.5 percent of houses are dry
cost of the labor needed to fill footbaths. onsite are five times more likely to test cleaned annually, 53.6 percent of
We estimate the total cost per house to positive for SE than farms that ban such houses are wet cleaned annually, and
be $360 per year.35 Because only 24.6 visitors. Farms allowing nonbusiness 65.1 percent of houses are disinfected.
percent of houses currently use visitors have a prevalence of SE of 17.0 The prevalence of these practices on
footbaths, the total annual cost of percent while farms that do not only affected farms is illustrated in table 13
footbaths is estimated to be (100 ¥ 24.6 have an SE prevalence of 3.6 percent. of this document.
TABLE 13—CURRENT CLEANING AND DISINFECTING PRACTICES

Manure Dry clean (%) Wet clean (%) Disinfect (%)
removal (%)
Between each flock (cleaned annually) ........................................................... 96.6 79.4 30.6 44.5
After two or more flocks (cleaned occasionally) .............................................. 3.4 1.1 23 20.6
Never ............................................................................................................... 0 19.5 46.4 34.9
xiii. Costs of cleaning and number of houses that this provision practice in table 14 of this document),
disinfecting. The cost of cleaning and will affect each year times the cost per the probability of a positive flock, and
disinfecting houses is illustrated in table house. We calculate the number of the number of affected houses (7,359,
14 of this document. For each houses affected as the product of the calculated from data in table 6 of this
component of cleaning and disinfecting, percent of houses not using a practice document).
we estimate the annual cost as the (100 minus the percent using the
TABLE 14—COST OF CLEANING AND DISINFECTING HOUSES ON AFFECTED FARMS

Probability of a Number of
Houses using positive envi- Cost per Cost to
houses
practice (%) ronmental test house industry
affected
(%)
Dry clean .............................................................................. 79.8 8.4 125 $1,200 $130,300

Disinfect ............................................................................... 51.4 8.4 300 600 152,300
Total cost ...................................................................... ........................ ........................ ........................ ........................ 282,600
The percentages of houses engaged in CA is the percent of farms that are cleaned environmental test. We assume that PC
the different cleaning and disinfecting and disinfected annually, (see table 13 of is distributed uniformly between 0 and
practices (the first column of numbers this document) 0.667, with a mean value of 0.333.
in table 14 of this document) is based on CO is the percent of farms that are cleaned
and disinfected occasionally, (see table The per-house cost for each
the first two rows of table 13 of this component is taken from Morales and
13), and
document. In table 14 we calculate the McDowell (Ref. 91) and is converted to
PC is the probability that a farm that is
percent as follows: cleaned occasionally would have been year 2005 constant dollars using the
CA + (CO × PC), where cleaned in a year that it had a positive GDP deflator. We assume that the true
35 This estimate is based on the following labor costs $9.56 an hour (Ref. 89) plus 50 percent 36 A number of State extension services have
assumptions: (1) The plastic vessel costs $5 and is to include overhead; and (5) changing the bleach- written extensively about the importance of
replaced annually; (2) bleach costs $1 a gallon; a water mixture takes 10 minutes. The estimate in the biosecurity (Refs. 79, 80, and 90).
gallon is used per footbath, and it is changed once text is calculated as 2 × [($5 × 1) + ($1 × 52) +
a week; (3) there are two footbaths per house; (4) ($14.34 × 0.167 × 52)] = $360 per year.
cost of each component is distributed xv. Total and net benefits of rodent 0.0023) × 39,000 illnesses). Costs would
uniformly between the low and the high and other pest control programs, only decrease slightly, as cleaning and
estimates given. biosecurity, and cleaning and disinfecting costs are the only ones that
xiv. Benefits of Cleaning and disinfecting. The total annual cost for all are a function of SE prevalence. In place
Disinfecting. Cleaning and disinfecting three provisions is $28.1 million. with the other provisions of the final
is another tool that may decrease or As discussed in detail under rodent rule, these three provisions will cost
eliminate SE in an infected house. control, the benefits of these provisions about $700 per illness averted and have
Schlosser et al. estimate that cleaning are highly correlated. The data net benefits of about $674.3 million.
and disinfecting a house reduces by 50 attributing a correlation between any d. Refrigeration.—i. Refrigeration
percent the probability that a previously one practice and a decrease in SE provisions. This rule requires that shell
prevalence is probably overstating the
infected house will test positive (Ref. eggs being held or transported must be
effect because, for instance, farms with
92). Because they do not address cross- refrigerated at or below 45 °F ambient
a good biosecurity system tend to have
contamination, the 50 percent reduction temperature beginning 36 hours after
good rodent and other pest control
is likely to be an overestimate of the time of lay.
programs. In order to avoid the double
actual efficacy of cleaning and ii. Current industry practices;
counting of benefits, we use only the
disinfecting. Furthermore, the same refrigeration. Because eggs packed on
benefits estimated for rodent control as
study estimates that 28 percent of the farm do not have to be transported
a proxy for the benefits of all three
negative houses tested positive after to a packing plant, we assume that eggs
provisions implemented correctly.
cleaning and disinfecting. on these farms are packed for sale
Therefore all three provisions
The Layers study (Ref. 29) finds that implemented together are estimated to within 36 hours of lay. Accordingly, we
farms that are cleaned and disinfected reduce the number of SE related assume that this provision would
are less likely to be contaminated with illnesses every year by nearly 39,000 for impose additional costs only on those
SE. No surveyed farms that performed total estimated annual benefits of more farms that do not pack their eggs for the
washes of houses between flocks were than $697.3 million. The provisions ultimate consumer, are currently storing
found to be positive. By contrast, houses would cost about $690 per illness their eggs for longer than 36 hours, and
that neither wash nor fumigate between averted and have net benefits of about currently do not refrigerate their eggs at
flocks had SE prevalence rates of 12.2 $675.9 million. an ambient temperature at or below 45
percent. These results suggest that If we account for estimated reductions °F, either on-farm, during shipment, or
cleaning and disinfecting a layer house in SE prevalence due to the chick and during holding before shell egg
is negatively correlated with SE pullet provisions (an estimated decrease processing or entering egg products
prevalence. However, because the of 0.23 percent, discussed in detail in facilities. We use data from the Layers
practices and effects of cleaning and section V.F.1.i), occurring earlier in the study (Refs. 27 and 28), shown in table
disinfecting are highly correlated with production cycle, these three provisions 15 of this document, to determine the
rodent control we do not estimate the would prevent about 90 less illnesses percentage of farms affected by the on-
benefits separately. than they would standing alone ((1– farm storage temperature requirements.
TABLE 15—FARMS AFFECTED BY ON-FARM EGG STORAGE TEMPERATURE REQUIREMENTS

Stored
Packed Temp > Percent of Number of
longer than
Farm size (number of layers) off-farm 45 °F farms farms
36 hours
(%) (%) affected affected
(%)
3,000 to 19,999 ........................................................................................ 98.3 98.2 78.1 75.4 1,317

20,000 to 49,999 ...................................................................................... 96.3 100 75.8 73.0 675
50,000 to 99,999 ...................................................................................... 83.1 83.4 92.1 63.8 158
100,000 or more ...................................................................................... 65.6 75 72.6 35.7 146
Total .................................................................................................. 81.2 87.3 81.2 57.6 2,296
The first three columns of table 15 of further processed.37 Farms with more not in compliance with the on-farm
this document are taken directly from than 10,000 layers are likely to be refrigeration part of this provision (all
data collected for the Layers study. The currently in compliance with this farms with less than 3,000 layers and
percentage of farms affected (fourth provision. Some smaller farms, those 75.4 percent of farms with between
column) is the product of multiplying with 10,000 layers or less, which 3,000 and 20,000 layers) 38 are not in
the first three columns. The number of account for roughly 5 percent of current compliance with the refrigerated
farms affected (final column) is egg production, may be out of shipping requirement.
estimated by multiplying the percent of compliance. It is unlikely that even the There are 514 producers, packers, and
farms affected by this provision by the smallest farms that are currently grading stations that will be affected by
refrigerating eggs onsite would ship eggs this provision (Ref. 93). While the
total number of farms covered by the
on unrefrigerated trucks. As a high majority of eggs in the United States are
provision.
estimate of the costs of this provision, processed within 2 to 3 days, some
Due to current rules on refrigeration, FDA assumes that producers with cases arise where eggs are held longer.
most farms currently ship eggs from the 10,000 layers or less, who are currently Seasonal fluctuations in demand or
farm in refrigerated freight at 45 °F, even within industry egg trading, at times
though they are not required to do so 37 Current industry practices and the costs of egg
causes eggs to be held for more than 36
transportation are based on information gained from
until the eggs have been packaged or telephone conversations between FDA, an egg
processor, and a shipper. 38 See table 16 of this document.
hours between lay and processing 39 have any refrigeration installed on their temperature is 7.5 °F. If the electricity
(Ref. 94). farms. We assume that those farms that rate is $0.057 per kilowatt-hour (Ref.
There is currently no regulation report storing their eggs between 45 and 96), farms will spend between about
requiring a specific temperature for 60 °F already have refrigeration $130 for farms with between 3,000 and
preprocessed eggs. Eggs are typically installed. For these farms, the cost of 20,000 layers to a little over $1,400 for
held between 55 and complying with the refrigeration farms with more than 100,000 layers.
60 °F (Ref. 94). FDA believes most provision is the cost of increasing These estimates are based on the
producers will have to decrease the electricity usage to further cool their assumption that refrigeration must be
holding temperature for their eggs. eggs. For farms that store their eggs at run 18 hours a day to achieve the 45 °F
iii. Cost of on-farm refrigeration.40 a temperature greater than or equal to mark, while it must be run 15 hours a
The refrigeration provision will cause 60 °F, we assume that no refrigeration day to achieve the 60 °F mark. We
producers to choose to perform one of is currently installed. The cost to these estimate that the average farm with
the following tasks: (1) Turn down the farms includes the cost of installing an
thermostats in their coolers, (2) install 20,000 to 50,000 layers would need to
insulated egg room with refrigeration
new refrigeration, or (3) renegotiate their run one 5-horsepower refrigeration unit
units.
shipping contracts to require more In table 16 of this document, we use and one 1-horsepower unit to
frequent pickup of unpacked eggs. In data from the Layers study to determine sufficiently cool its egg room. A 5-
addition, producers that do not how many farms will have to install horsepower unit uses 4.83 kilowatt
currently ship in refrigerated freight will refrigeration and how many will only hours per hour of operation, while a 1-
need to do so. Furthermore, producers, have to reduce the temperatures in their horsepower unit only uses 1.73 kilowatt
packers, and egg grading stations will egg rooms. The majority of smaller hours. Therefore, the cost of cooling to
have to refrigerate eggs at no more than farms lack refrigeration facilities, while 60 °F is about $168 per month, or about
45 °F if they hold the eggs for more than larger farms are more likely to use $2,020 per year.42 The cost of cooling to
36 hours prior to processing. refrigeration at an inadequate level. 45 °F is about $202 per month, or about
In table 15 of this document, we The cost of this provision to farms $2,420 per year.43 The resulting cost of
estimate that almost 2,300 farms do not that are using refrigeration at an decreasing the ambient temperature in
meet the on-farm standards set by the inadequate level is assumed to be the the egg cooler by 15 °F is approximately
refrigeration provision. Of these farms, cost of increased energy usage.41 If $400. Using a linear relationship
some are currently using refrigeration, temperatures in egg rooms on these between refrigeration and cost gives us
albeit at higher temperatures than the farms are uniformly distributed between an estimate of approximately $200 for a
provision would permit. Others do not 45 and 60 °F, the average reduction in 7.5 °F reduction.44
TABLE 16—ANNUAL COST OF ON-FARM REFRIGERATING AFFECTED FARMS

No refrigeration Inadequate refrigeration Total cost
(in thousands)
Farm size (number of Cost per farm Cost per farm
layers) Number (7% discount (3% discount Number Cost per farm (7% discount (3% discount
rate) rate) rate) rate)
3,000 to 19,999 ............ 720 $6,979 $5,074 597 $128 $5,102 $3,730
20,000 to 49,999 .......... 201 13,793 9,779 474 203 2,868 2,062
50,000 to 99,999 .......... 65 26,359 18,500 93 352 1,746 1,235
100,000 or more .......... 32 112,681 78,595 114 1,413 3,767 2,676
The fixed cost of new refrigeration The cost of constructing an egg room estimated to be between $50 and $75.
includes the cost of constructing an egg equals the number of square feet Therefore, for the average farm with
room, insulating that room, and required times the construction cost per 20,000 to 50,000 layers the cost of
installing refrigeration units. Storage square foot. The number of square feet construction is $125,000. The amortized
rooms and their insulation are assumed required is estimated as the number of cost over 30 years at 7 percent is
to last 30 years. Refrigeration units last square feet required per 1,000 dozen approximately $10,050.
from 10 to 20 years. Using these values, eggs (294 square feet) times the number The cost of insulating an egg room
along with a 7 percent discount rate, we of eggs produced in a 24-hour period equals the number of square feet to be
estimate that the annualized cost of (1,700 dozen eggs) times the number of covered times the insulation cost per
installing new refrigeration would be days the eggs are expected to be stored square foot. Insulation costs $13.38 for
about $1,300 for a farm with 20,000 to (about 4 days). The average cost of a 32 square foot sheet. For a farm with
50,000 layers. construction per square foot has been 20,000 to 50,000 layers requiring 3,670
39 Within industry egg trading refers to trading estimate how many farms fall into this category, we 42 (4.83 + 1.73) kilowatt hours used per hour × 15
between firms to meet unexpected demand or get assume that the only cost facing farms that use an hours of operation × $0.057 per kilowatt hour used
rid of excess supply. inadequate level of refrigeration will be the cost of × 30 days.
increased energy usage. As such, actual
40 All cost estimates regarding on farm storage are 43 (4.83 + 1.73) kilowatt hours used per hour × 18
from data supplied to FDA through a contract with refrigeration costs will be higher than estimated. As
most farms currently using refrigeration will simply hours of operation per day × $0.057 per kilowatt
the Research Triangle Institute. Derivation of hour × 30 days.
have to increase their energy usage, we believe the
estimates is more fully described in a memorandum difference between actual costs and costs estimated 44 In actuality, the relationship between
to the record (Ref. 95). using energy usage as a proxy is small. Furthermore refrigeration and cost is increasing at an increasing
41 We recognize that some of these farms may
the underestimate will be at least somewhat offset rate, so that our use of a linear relationship
require additional refrigeration units to achieve the by the use of newer, more efficient equipment, and somewhat overstates the cost of lowering
45 °F threshold. However, because we do not overestimates in other parts of this calculation (see
refrigeration temperatures.
currently have information that allows us to footnote 44 of this document).
square feet of insulation, the expected Unrefrigerated shipments cost 20 model designed, in part, to estimate the
cost of insulation is therefore $1,540. percent less than refrigerated shipments. effects of refrigeration on the number of
The annualized cost of insulation Therefore, the difference in cost SE illnesses. The FSIS risk assessment
(amortized over 30 years at 7 percent) is between refrigerated and unrefrigerated estimates that if all eggs on farms
$125. shipments is $0.024 per dozen eggs. affected by the final rule are refrigerated
The fixed cost of refrigeration for an Since farms with 10,000 layers or less at 45 °F within 36 hours of lay to the
egg room is the cost of buying and produce roughly 1.5 percent of the eggs time they were processed, we would see
installing refrigeration units. We assume sold annually (93 million dozen eggs), a 31 percent decline in annual SE
that installation costs are approximately the additional cost of refrigerated illnesses. This translates to nearly
5 percent of the purchase price of the shipping on these farms is $1.7 million 45,000 illnesses avoided annually, or
unit. For a farm with 20,000 to 50,000 (93 million dozen eggs × $0.024 × 0.754 about $800.6 million in annual benefits.
layers, the cost of refrigeration is the not in compliance). Standing alone, the refrigeration
purchase price for needed refrigeration v. Cost of preprocessing storage. The provisions would cost about $450 per
units ($10,300) plus the cost of cost of this provision to facilities illness avoided and provide $780.4
installation ($10,300 × 5 percent) for a holding eggs at above 45 °F for shell egg million in net benefits.
total of $10,816. Amortizing this cost processing or before entering egg If we account for estimated reductions
over 15 years at 7 percent yields an products facilities is assumed to be the in SE prevalence due to the provisions
annual cost of $1,190. cost of increased energy usage. If pertaining to chicks and pullets, rodent
The total annualized cost of installing temperatures in egg rooms at these and pest control, biosecurity, cleaning
a refrigerated egg room on a farm with facilities are uniformly distributed and disinfecting, and testing and
20,000 to 50,000 layers is estimated to between 55 and 60 °F, the average diversion (a 35 percent reduction in
be approximately $11,350. Including the reduction in temperature is 7.5 °F. If the prevalence when all provisions are in
cost of energy increases the total cost to electricity rate is $0.057 per kilowatt- place and fully effective), all occurring
$13,800. hour, facilities holding 100 dozen eggs earlier in the production cycle, the
For all types of refrigeration, there at a time will spend $35 annually while refrigeration provisions would provide a
also will be a cost associated with the facilities holding 1,000 dozen eggs at a 20 percent decline in SE illness,
use of electricity to run the cooling time will spend nearly $20,000 preventing about 29,000 illnesses
units. Given that electricity costs $0.057 annually. Using calculations similar to annually ((1–0.35) × 45,000 illnesses).
per kilowatt-hour, we estimate that those described previously for on-farm Costs of refrigeration are not a function
farms not currently using refrigeration holding, it is estimated that the average of SE prevalence and remain constant.
will spend an additional $1,500 to annual cost of additional refrigeration is In place with the other provisions of the
$17,000 annually for power.45 Farms about $9,700 per facility. The total final rule, the cost per illness averted on
that currently use refrigeration, but at annual cost for the 514 facilities holding farms with more than 3,000 layers is
higher temperatures than 45 °F, will eggs at above 45 °F is expected to be $5 estimated to be roughly $700.48 The
spend an additional $130 to $1,400 million. annual net benefit of the provision is
vi. Total cost of refrigeration $496.9 million.
annually for power.46
provisions. The total cost of the e. Routine environmental testing.
The cost of this provision to a farm
refrigeration provision, using a 7 Environmental testing does not serve
without any refrigeration in place is
percent discount rate, is approximately directly as an SE prevention measure.
estimated to range from about $7,000 for
$20.2 million.47 Using a 3 percent Testing serves primarily as an indicator
farms with between 3,000 and 20,000
discount rate, the cost is approximately of the effectiveness of the SE prevention
layers to over $112,600 for farms with
$16.4 million. However, some farms measures.
more than 100,000 layers. The cost of will choose to increase the frequency of i. Environmental testing provision.
this provision to a farm with adequate egg pickups instead of installing This provision would require every farm
refrigeration is simply the cost of the additional refrigeration to remain in to routinely test the environment of
additional energy, ranging from about compliance with the provision. If more their layers for SE. For flocks that do not
$130 for farms with between 3,000 and frequent egg pickups are a lower cost undergo a molt, this requirement would
20,000 layers to over $1,400 for farms alternative to refrigeration installation, be limited to a test for SE in the
with more than 100,000 layers. the previously mentioned figures may environment when each group of layers
iv. Cost of refrigerated shipping. The overstate the actual cost of increased in the flock is 40 to 45 weeks of age. For
average cost of refrigerated shipment at refrigeration. those flocks that do undergo a molt,
45 °F is $0.12 per dozen eggs. vii. Benefits of refrigeration. The testing would be required when each
45 As noted previously, for a farm with 20,000 to
probability that an individual will group of layers is 40 to 45 weeks of age
50,000 layers the annualized cost of cooling an egg
become ill from an SE-contaminated egg and 4 to 6 weeks after molting for each
room to 45 °F is (4.83 + 1.73) kilowatt hours used depends, among other things, on the group is completed.49
per hour × 18 hours of operation per day × $0.057 number of bacteria within the infected Environmental sampling would be
per kilowatt hour × 30 days ≈ $202 per month, or egg. Refrigeration of eggs at 45 °F accomplished by a method such as
about $2,420 per year. Using similar calculations, significantly slows the reproduction of
average annual energy costs for refrigeration on swabbing manure piles in the poultry
farms that previously did not use refrigeration are the SE bacteria (Ref. 22). This provision
estimated to be $1,540 on farms with 3,000 to would require that eggs that are stored 48 This estimate assumes a 7-percent discount
19,999 layers, $4,230 on farms with 50,000 to for more than 36 hours after laying be rate.
99,999 layers, and $16,950 on farms with 100,000 refrigerated at 45 °F through the 49 In the proposed rule, molted flocks were to
layers or more. undergo environmental testing at 20 weeks post

46 Using a calculation similar to the one
preproduction stage. We use the USDA molt. Changing the time from 20 weeks to 4 to 6
illustrated in the discussion of the costs of SE risk assessment model (Ref. 22), a weeks post molt increases the costs to farms that
inadequate refrigeration for farms with 20,000 to test environmentally positive, egg positive, and
50,000 layers, average annual energy costs for farms 47 For ease of explanation, the total new burden continue to test egg positive. For these farms, earlier
with inadequate refrigeration are estimated to be of the refrigeration requirement is assumed to be testing means more eggs diverted over the life of the
$130 on farms with 3,000 to 19,999 layers, $350 on carried by the farmers. In reality, this burden, flock and more egg tests. However, the benefit of
farms with 50,000 to 99,999 layers, and $1,400 on although equal in total, might be spread among the diverting more potentially positive eggs is greater
farms with $100,000 layers or more. farmer, shipper, producer, retailer, and consumer. than the additional costs.
house and then culturing those swabs samples would have to be taken. Many before depopulation (Refs. 27 and 28).
using a primary enrichment testing other State quality assurance plans, Industry molting practices, however,
method. We consider variants of including Pennsylvania’s, require the vary by region and by farm size.
sampling protocols that are currently in span of each row of the layer house to Farms in the Central and Great Lakes
use. The California Quality Assurance be swabbed with one swab, regardless of
regions are least likely to molt their
program currently requires a sampling row length (Ref. 92).
ii. Current industry molting practices. flocks while farms in the Southeast and
plan that relies on randomly swabbing
30-foot sections of the poultry house Molted flocks face additional testing West are most likely to use molting as
(Ref. 97). To obtain a 95 percent under this provision. Overall, 62 a practice. See table 17 of this
probability of finding a house that is 10 percent of all large flocks are molted document.
percent infected, we estimate that 32 once and 12 percent are molted twice
TABLE 17—REGIONAL MOLTING PRACTICES 1

Times molted
Region
0 1 2
Great Lakes ............................................................................................................................................. 30% 65% 5%

Southeast ................................................................................................................................................. 7% 80% 13%
Central ..................................................................................................................................................... 49% 51% 0%
West ......................................................................................................................................................... 18% 50% 32%
1 Layers study data provided by APHIS.
Molting practices also vary by farm farms. While almost 85 percent of all flocks. This disparity plays a significant
size. As table 18 of this document farms with 50,000 or more layers molt role in the determination of the
illustrates, smaller farms are less likely their layers, only 28 percent of farms expected cost of testing and diversion.
to molt their layers than are larger with fewer than 20,000 layers molt their
TABLE 18—MOLTING PRACTICES BY FARM SIZE 1

Times molted
Farm size (number of layers)
0 1 2
Fewer than 20,000 ................................................................................................................................... 72% 28% 0%

20,000 to 49,999 ...................................................................................................................................... 35% 54% 11%
50,000 to 99,999 ...................................................................................................................................... 14% 68% 18%
100,000 or more ...................................................................................................................................... 16% 72% 12%
1 Layers Study data provided by APHIS.
iii. Current environmental testing assume that a swab, with its packing To determine the testing cost of the
practices. According to the Layers material, weighs approximately 1 row-based plan, we multiply the cost
study, approximately 52 percent of all pound. To calculate the cost of per test by the estimated number of
farms with more than 30,000 layers shipping, we estimate the average rows that will have to be swabbed. We
currently conduct some routine number of swabs sent per shipment and assume that all farms that are currently
environmental tests for SE (Refs. 27 and use rate tables (Ref. 98) to determine the conducting routine testing (52 percent)
28). The vast majority of these cost of shipment. (Refs. 27 and 28) are using a row-based
producers are also members of formal We estimate the laboratory cost of plan.
quality assurance programs. testing for SE that has been collected
iv. Environmental testing costs. The The number of rows that will have to
from the environment to be be swabbed in larger houses is estimated
cost of routine environmental testing
approximately $36.00 per sample (Ref. in table 19 of this document.
depends on how many samples are
99). Information for the first three columns
tested, the labor cost of collecting the
samples, the cost of shipping the The average cost of routine testing for is drawn from the Layers study (Refs. 27
samples to a laboratory, and the SE in a given house is determined by and 28). We estimate the number of
laboratory cost per sample tested. multiplying the number of tests required houses affected by the provision (the
We estimate that it will take for that house by the expected cost per fourth column) by multiplying the
approximately 15 minutes to collect and test. For any plan that is used, the per number of large houses (7,315) by the
pack each sample. Because the wage for house cost of testing is estimated to be percent of houses affected by the
a typical livestock and poultry worker is
Cost = SWABS × (LABOR + MAIL + provision (48 percent), and then
approximately $9.56 per hour (Ref. 89),
LAB) multiplying the product by the percent

after adding 50 percent to reflect of houses in the given category. We
overhead costs, we assume that the cost Where:
estimate the number of rows that will
of labor is $3.59 per sample collected.50 SWABS is the number of required swabs,
The cost of shipping samples will LABOR is the cost of labor per test,
have to be swabbed because of the
vary by the weight of the shipment. We MAIL is the cost of shipping samples to a lab, provision as the number of rows per
and house times the number of houses
50 (15 ÷ 60) × $14.34. LAB is the laboratory costs of testing for SE. affected by the provision. We estimate
that a total of 21,325 rows would have

to be swabbed due to this provision.
TABLE 19—NUMBER OF ROWS TO BE SWABBED

[Houses with 3,000 or more layers]
Average Percent of Number of Number of

Number of rows or batteries of cages number of houses houses rows affected
rows 1 affected
1 ....................................................................................................................... 1.0 1.9 67 67

2 to 3 ................................................................................................................ 2.5 12.5 442 1,105
4 to 5 ................................................................................................................ 4.5 50.8 1,794 8,073
6 or more ......................................................................................................... 10.0 34.2 1,208 12,080
Total .......................................................................................................... 6.1 ........................ 3,511 21,325

1 The average number of rows per house is estimated as the midpoint of the range estimated by Layers study. For the ‘‘6 or more’’ category
we assume that these houses have an average of 10 rows each.
Because each row has two sides, each testing may be pooled in samples of 20 Specifically, this provision would
of which we assume will have to be eggs each. If pooled into samples of 20 require that batches of 1,000 eggs be
swabbed, the total number of swabs eggs each, a total of 200 egg tests are tested if egg testing is required, while
required is estimated to be conducted. If any of these egg tests are the Pennsylvania and Maryland plans
approximately 42,650. On average, 12.2 positive, the farm will be required to only require 480 eggs to be tested in
swabs will be used for each house with divert its eggs until four consecutive each batch. Farms on either the
more than 3,000 layers. The total cost of rounds of egg tests are found to be Pennsylvania or the Maryland plans are
testing the average large house is $532 negative. Furthermore, a farm that has only 48 percent (480 ÷ 1000) in
(12.2 swabs × ($3.59 labor + $3.98 had a positive egg test must continue to compliance with the provision.
shipping + $36.00 lab culture)) when test 1,000 eggs each month for the life Furthermore, the testing protocol used
two swabs are used per row.51 of the flock. in Pennsylvania and Maryland is less
The random swabbing plan requires If the cost of egg testing is high rigorous than the one prescribed by
that 32 samples be taken per house. enough, however, the farmer may FDA. Therefore, farms currently testing
Although 52 percent of houses conduct simply choose to forego egg testing and under the Pennsylvania and Maryland
some routine environmental testing, far divert all eggs for the life of the flock.53 plans will also have to change their
fewer are likely to follow the random ii. Current industry practices; Follow- testing protocol. Because these farms are
swabbing plan. In the absence of better up egg testing. We assume that those already paying for egg testing, however,
information, we assume that between 0 farms currently under a recognized not all costs of the new testing plan will
and 52 percent (uniformly distributed) quality assurance plan that mandates be new costs. The tests under the
of large houses that are currently testing egg testing following a positive Pennsylvania plan cost about 71 percent
use random swabbing plans. The cost environmental test are currently in as much as the test required under the
per swab under the random swabbing partial compliance with this provision. FDA plan.
sampling plan is about $42 ($3.59 labor Of the major plans, only the These numbers suggest that the
+ $2.42 shipping 52 + $36.00 lab Pennsylvania and Maryland plans have current net level of compliance with the
culture). The total cost of one round of follow-up testing provisions that are provision is 2.8 percent (8.2 percent
testing under the random swabbing plan largely the same as this provision (Ref. under state quality control plans × 48
is calculated to be $1,344 per house, 76). According to ‘‘Chicken and Eggs’’ percent as many eggs tested as required
regardless of size (32 swabs per house (Ref. 75), egg production in Maryland by this rule × 71 percent the cost of FDA
× $42 cost per swab). and Pennsylvania accounted for 9.7 test) for farms with more than 3,000
f. Follow-up egg testing.—i. Egg percent of the U.S. total. Only 85 layers.
testing provisions. Follow-up egg testing percent of the eggs in these States fall iii. Egg testing costs. The cost of
would occur if an environmental test is under the State quality assurance follow-up egg testing is composed of the
positive for SE. If egg testing is programs. We therefore estimate that 8.2 following: (1) The labor cost of
triggered, the following protocol must percent (9.7 percent × 85 percent) of all collecting the eggs, (2) the value of the
be followed. First, the farmer must eggs are currently in partial compliance. eggs being tested, (3) the cost of
submit 1,000 eggs to a lab both initially Because farms with fewer than 3,000 shipping the eggs to a qualified
and subsequently every 2 weeks for a layers are not currently in these quality laboratory, and (4) the lab costs of
total of 4,000 eggs. Consistent with the assurance programs, we assume that no testing the eggs. The cost of collecting
method described in chapter 5 of FDA’s farms with fewer than 3,000 layers the eggs is the hourly cost of labor times
Bacteriological Analytical Manual conduct follow-up egg tests. the number of hours spent collecting the
(BAM) the eggs that are submitted for Farms using the number of eggs for eggs. We estimate that it will take the
sampling required by the Pennsylvania typical farmhand approximately one-
51 The cost of shipping 12 swabs (12 pounds)
and Maryland plans are sampling fewer half minute per egg to select eggs for
overnight is estimated to be between $25.58 and

$70.73, including pickup charges (Ref. 98). We
eggs than are required by this rule. testing, so the labor cost of egg testing
divide the average cost of shipping by 12 to obtain is $119.50 per 1,000 eggs tested (50
the cost per swab ($3.98). 53 Under the provision on diversion, farms that
samples × 20 eggs per sample × 0.0083
52 The cost of shipping 32 swabs (32 pounds) test positive for SE in their eggs would be required hours per egg × $14.34 dollars per hour)
overnight is estimated to be between $42.10 and to divert their eggs for treatment until they are able
$114.65, including pickup charges (Ref. 98). We to show via testing that SE is not present in the eggs (Ref. 89).
divide the average cost of shipping ($77.44) by 32 produced in the infected house. This is discussed The lost value of the eggs used for
to obtain the cost per swab ($2.42). in detail in the following section on diversion costs. testing is the number of eggs tested
times the producer price of an egg.54 To shipping these eggs in two 60-pound of diversion and the expected cost of
avoid double counting of the cost of packages (including packing) to the diversion will vary by each operation’s
diversion (for those eggs being tested), laboratory is approximately $260.56 location and size.
we modify this value to account for the The largest cost of egg testing is the
ii. Regional differences in the cost of
fact that as many as 26 percent of eggs laboratory; we estimate the average lab
diversion. Regional differences in the
being tested may be required to be cost for 1 batch of 20 eggs to be
cost of production have led to the
diverted at the time of testing. The price $35.16.57 Hence, for 50 tests the
laboratory cost of eggs testing is $1,758 centralization of the breaker industry in
that the typical producer receives for
per 1,000 eggs tested (50 batches × the North Atlantic and North Central
table eggs is about $0.43 per dozen,
$35.16 per test). regions of the United States. As table 20
while the price a producer receives for
diverted eggs is about $0.26 per dozen The total cost of egg testing is the sum of this document shows, these regions
eggs (see table 21 of this document). The of each of the previously stated costs. are responsible for only 52 percent of
expected value of a tested egg is the Therefore, the cost of egg testing is overall egg production, but over 86
weighted average of the value of a table $2,169 per 1,000 eggs tested ($119.50 percent of breaker eggs.58 The
egg and a diverted egg, or about $0.03 collection costs + $32.37 lost income centralization of the breaker industry is
per egg.55 The value of the eggs tested from egg sales + $259.05 shipping costs even more clearly illustrated in the
is the value per egg times the number + $1,758 lab costs). fourth column of table 20. While 36 to
of eggs tested. The value of every 1,000 g. Diversion.—i. Diversion provisions. 44 percent of eggs make it to breaker
eggs tested is $32.15. Under this provision, farms that test plants in the northern regions, the
Eggs that are collected will have to be positive for SE in their eggs would be corresponding figures for the West and
shipped to a laboratory for analysis. The required to divert their eggs for South are only 10 percent and 6 to 7
cost of shipping these eggs depends on treatment until they are able to percent. The primary purpose of breaker
the weight of the eggs being shipped. determine via testing that SE is not plants outside of the North appears to be
We estimate that 1,000 large eggs weigh present in the eggs produced in the as an outlet for eggs not suitable for
approximately 111 pounds. The cost of infected house. Both the expected level retail sale as table eggs.
TABLE 20—PRODUCTION AND BREAKING OF EGGS

Eggs produced Eggs broken Percent of
eggs produced
Region Millions of Thousands of that are
Percent Percent
eggs1 dozens 2 broken
North Atlantic ....................................................................... 10,106 12.3 300,406 17.1 35.7

North Central ........................................................................ 32,869 40.0 1,212,758 69.1 44.3
South Atlantic ....................................................................... 13,979 17.0 69,774 4.0 6.0
South Central ....................................................................... 14,512 17.7 84,071 4.8 7.0
West ..................................................................................... 10,636 13.0 87,662 5.0 9.9
Total .............................................................................. 82,102 100.0 1,754,671 100.0 25.7

1 National Agricultural Statistical Services (NASS) (Ref. 75).
2 NASS (Ref. 101).
To predict how the industry will eggs than it is to transport egg products. will locate there. Consequently, it makes
respond to a provision mandating Shell eggs are relatively bulky and are sense to locate breaker plants in this
diversion, it is important to consider the susceptible to breakage in transit. region as well.
following information: (1) Why the Second, shell eggs are ultimately If centralization of breaker plants is
breaker egg industry is regionally delivered directly to consumers in their going to occur, it will likely occur in the
concentrated while the shell egg natural state, while egg products are northern regions, for several reasons.
industry is distributed more evenly often used as ingredients in large-scale The cost of egg production is lowest in
throughout the United States and (2) food manufacturing operations. Because the north, partly because feed grains
Why the concentration has occurred in processed foods are less costly to (such as corn and wheat) are locally
the northern regions of the United transport than are their ingredients, it available at low prices in this region.59
States. makes sense to locate processed food Also, farms in the north are more likely
There are several reasons why the facilities in areas where ingredients are to be characterized by large in-line
breaker industry is centralized and the locally available. To the extent that houses (up to 250,000 layers). These
shell egg industry is not. First, it is these ingredients are available in the houses take advantage of economies of
much more expensive to transport shell northern regions, processed food plants scale to produce more eggs more
54 Using the producer price of the egg may pickup charges (Ref. 98). We multiply the average expected cost of a test is $35.16 (($35 × 0.9945) +
slightly underestimate the value of the lost egg. cost of shipping ($129.52) by 2 to obtain the total ($65 × 0.0055)).
Although much of the price increase between cost of $259.05. 58 In table 20 of this document, the number of
producer and consumer includes transfers, there is 57 For the testing method FDA prescribes, the lab
eggs produced includes hatching eggs as well as
real value added during some processing. cost per 20 egg pool is $35 initially and an
55 The following calculation is used to reach this
table eggs. Because most hatching eggs are
additional $30 for confirmation if the pool tests
produced in the South and hatching eggs do not go
figure. [(74 percent of eggs not diverted × $0.43 per positive (Ref. 100). Upon an environmental
dozen table eggs) + (26 percent of eggs diverted × positive, eggs will test positive at a rate of 2.75 per to breaker plants, the percentages of eggs going to
$0.26 per dozen diverted eggs)] ÷ 12 eggs in a dozen 10,000 (Ref. 92). Therefore the probability of a pool breaker plants are biased downward for the
= $0.03215 per egg. of 20 eggs testing negative is 99.45 percent ((1 ¥ southern regions.
59 Shipping grains from the Midwest to the West
56 The cost of shipping a 60-pound package (2.75/10,000))¥20). Conversely the probability of a
overnight is between $67.35 and $191.70, including pool testing positive is 0.55 percent. So the Coast by rail car cost over $1 per bushel (Ref. 102).
cheaply. Furthermore, because the Pennsylvania was estimated to be treated to achieve at least a 5-log
demand for egg products is higher in the insignificant while the diversion cost in destruction of Salmonella Enteritidis or
northern regions, breaker plants can California was estimated to be $0.21 to processed as egg products in accordance
avoid the high transportation costs of $0.42 per dozen. with the Egg Products Inspection Act’’
shipping to food processors by locating iii. Effect of operation size on will be insubstantial.61 However,
closer to their customers. diversion costs. Operation size can have because these eggs are limited in how
The implication of the industry a significant effect on average diversion they may be used, SE-positive eggs are
structure is that there are likely to be costs for a given producer. A large intrinsically less valuable than SE-
regional disparities in the cost of producer is less likely to be affected by negative eggs.
diversion. Egg products and, hence, an individual house that tests positive,
breaker egg prices are not expected to because the cost is generally spread v. Cost of a diverted egg. Given all of
vary regionally by as much as shell egg across many houses and farm sites. the factors stated in the previous
prices. Where the cost of egg production Furthermore, in areas where it is paragraphs, we estimate that, on
and freight for diverted eggs is relatively economically feasible to produce eggs average, breaker eggs from an SE-
high (such as in California), the cost of that are dedicated to breaker plants, positive flock will command a price
diversion is likely to be high. Similarly, large operations are less likely to have below that received for shell eggs. Table
where the price of egg production and contract problems 60 because they can 21 of this document illustrates the
freight is low (such as in Ohio and substitute SE-positive eggs for the eggs prices that producers receive for shell
Pennsylvania), the cost of diversion is that originally were contracted to go to and breaker eggs by region. As expected,
likely to be low. Furthermore, there are the breaker plant. By contrast, the the north-central region, with its
some remote areas, such as Hawaii, economic losses from a positive house proximity to inexpensive feed and a
where the absence of breaker plants may cause a small farm with one house large food processing industry, has the
makes local diversion impossible. to incur significant losses for that farm. highest level of production, the lowest
Because it is not economical to ship iv. Effect of SE-positive status on prices for eggs, and the lowest cost for
these eggs to breaker plants in the diversion costs. It has been suggested diversion. The West, with its higher
continental United States, the cost of that eggs from an SE-positive flock will feed costs and smaller layer houses, has
diversion is simply the lost value of a command a lower price at the breaker the highest prices for eggs and the
clean table egg. than will other eggs. The pasteurization highest cost of diversion. We find the
FDA met with industry process for breaker eggs is designed to weighted average cost of diversion to be
representatives in each of the previously achieve at least a 5-log reduction in any between $0.13 and $0.23 per dozen
mentioned regions and was given SE that may be in eggs. Further, the eggs. If there is an additional discount
estimates of diversion costs that are actual cost of marking the shipments for those eggs with SE, the total cost
consistent with the above reasoning. and stamping documents accompanying could rise as high as $0.33 per dozen
The diversion cost per dozen eggs in diverted eggs as ‘‘these eggs must be eggs.
TABLE 21—TOTAL COST OF DIVERTING EGGS

Regional weight Shell egg price Breaking eggs Cost of diversion
Region (in %) to producer 1 (nest run) 2 (nest run)
North-Atlantic ................................................................................. 12.3 $0.42 $0.31 $0.11

North-Central ................................................................................. 40 0.39 0.30 0.09
South-Atlantic ................................................................................. 17 0.43 0.31 0.12
South-Central ................................................................................. 17.7 0.47 0.30 0.17
West ............................................................................................... 13 0.53 0.31 0.22
Average Cost of Diverting Eggs 3 .................................................................................................................................................... 0.13–0.23

Additional Discount for SE+ Eggs 4 ................................................................................................................................................. 0.00–0.10
Total Cost of Diverting Eggs ........................................................................................................................................................... 0.13–0.33
1 The shell egg price paid to producers for the north-central region was estimated as equivalent to the prices AMS reported as paid in Iowa,
Minnesota, and Wisconsin. For regions other than the north-central region, the shell egg price to the producer was calculated by discounting the
price to retailer by a percentage equal to the percent difference between the price to the producer and the price to retailer in the north-central re-
gion. All figures were taken from AMS data accessed through The Institute of Food and Agricultural Services at the University of Florida (Ref.
103).
2 All figures are from AMS data accessed through the North Carolina Department of Agriculture (Ref. 104).
3 The lower bound of this range is the average cost of diverting eggs calculated as described above, and is weighted by regional production
(Ref. 75). The upper bound of this range is calculated using data from comments to the analysis of the proposed rule, suggesting that the dif-
ference between the value of shell eggs and breakers has been greater recently. Because prices tend to fluctuate, and therefore differences in
the price between shell eggs and breaker eggs fluctuate, the full range of estimated price differences is used in the calculation of the total cost of
diverting eggs.
4 Ref. 91 and comment to analysis of the proposed rule.
60 Filling orders for table eggs when eggs from one detail in section F.1.h of this document), between industry, or less than two one-thousandths of a cent
house must be diverted. 45,000 and 60,000 labels would have to be affixed additional cost per egg. Each farm will need to buy
61 Eggs are typically shipped on palates holding to palates each year. This estimate accounts for the a label gun for a one time cost of approximately
fact that some shipments may use partially full $100. Amortized over 10 years, this cost is less than
900 dozen eggs. The palates are shrink-wrapped.
palates. The labels themselves will cost about
Diverted eggs will need to be marked somewhere $15 per year, per farm. The cost of stamping the
$0.025 each and require less than 30 seconds to
on the shrink wrapping. Based on FDA’s estimate apply. Thus, a conservative estimate puts the cost accompanying documents is discussed in the
of 474 million eggs diverted annually (discussed in at less than $8,000 annually across the entire recordkeeping section F.2.a of this document.
vi. Expected cost of diversion. The of Pennsylvania is representative of the statistical probability that each scenario
expected cost of diversion is determined nation as a whole. In the absence of will occur.62
by the cost of diverting an egg, the better information, we use the In the final stage of the testing cost
number of eggs in commerce affected by Pennsylvania figure. model, we insert logical operators into
the provision, and the probability that a In the next stage of the dynamic the model in such a way that farmers are
given egg will be diverted. model, the expected cost of testing and given the choice of diverting rather than
h. A model of testing and diversion diversion is calculated for farms in each testing eggs when it is cost-efficient to
costs.—i. The model. We use a dynamic of the five size categories used do so. Failure of the model to give the
model for estimating testing and throughout this analysis. There are two farmer this choice may lead to estimated
diversion costs. We model these costs as reasons why this is a necessary step. costs that are up to double the actual
depending on the probability of SE First, the estimation of cost for different expected costs.63
detection, farm size, molting practices,
size categories allows for the explicit ii. The costs of testing and diversion.
and the farmer’s choice between
representation of the fact that both the The model described in the previous
conducting follow-up egg tests and
number of tests required and the cost of paragraph produces estimates of the
diverting until depopulation of the
diversion are directly related to the annual expected cost of testing and
contaminated house.
In the first stage of the model, we number of layers on the farm. Second, diversion for layer houses. Estimates are
estimate the probabilities associated using different size categories facilitates obtained for each of the size categories
with environmental and egg tests. For an algebraic model design that uses by molting practice.
environmental tests, we estimate that logical operators to allow farmers (in the As tables 22 and 23 of this document
9.7 percent of all flocks currently test model) to make the low cost choice illustrate, the expected costs of testing
positive. We then adjust this estimate between egg testing and diversion. and diversion for a poultry house range
downwards to 8.4 percent initially and Molting practices are accounted for in from $160 to over $5,500, depending on
7.0 percent eventually to account for the the next stage. The different testing house size, environmental testing
expected reduction of SE on the farm protocols for molted and non-molted protocol, and molting practices.64 The
due to the adoption of other provisions layers make it necessary to look at the low figures in the environmental testing
of the rulemaking to reduce SE. In the cost of testing and diversion separately and total cost columns represent costs
experience of Pennsylvania, a flock with for each of these types of flocks. At this given the row-based sampling scheme,
at least one environmental positive is stage of the model, we set out the while the high estimates represent the
likely to have at least one egg test possible scenarios for testing and random swab sampling method. The
positive 26 percent of the time (Ref. diversion, derive the expected cost of costs for molted houses are annualized
105). We do not know if the experience each scenario, and calculate the for the purpose of comparison.
TABLE 22—COST PER HOUSE

[Non-molted flocks]
Farm size Environmental Dynamic total

Egg testing Diversion Static total cost
(number of layers) testing cost
Fewer than 3,000 .................................................. $150 to $1,340 ... $0 $6 $156 to $1,346 ... $1,313 to $2,503.
3,000 to 19,999 ..................................................... $530 to $1,340 ... 843 311 $1,684 to $2,494 $1,885 to $2,695.
20,000 to 49,999 ................................................... $530 to $1,340 ... 843 722 $2,095 to $2,905 $2,140 to $2,950.
50,000 to 99,999 ................................................... $530 to $1,340 ... 1,124 556 $2,210 to $3,020 $2,352 to $3,162.
Over 100,000 ......................................................... $530 to $1,340 ... 1,124 1,288 $2,942 to $3,752 $3,223 to $4,033
TABLE 23—COST PER HOUSE

[Molted flocks]
Farm size Environmental Dynamic total

Egg testing Diversion Static total cost
(number of layers) testing cost
3,000 to 19,999 ..................................................... $530 to $1,340 ... $1,378 $537 $2,454 to $3,314 $2,522 to $3,332.
20,000 to 49,999 ................................................... $530 to $1,340 ... 1,597 766 $2,893 to $3,703 $2,955 to $3,765.
50,000 to 99,999 ................................................... $530 to $1,340 ... 1,597 1,129 $3,256 to $4,066 $3,315 to $4,125.
Over 100,000 ......................................................... $530 to $1,340 ... 1,597 2,618 $4,745 to $5,555 $4,793 to $5,603
The inclusion of a choice to opt out significantly increases diversion costs dynamic total costs and static total
of egg testing also results in egg testing for smaller farms while having a limited costs. If the option to switch from egg
costs that increase with farm size. The effect on larger farms.65 This difference testing into diversion were removed, the
choice to opt out of egg testing is apparent in the comparison between costs incurred would be the static total
62 For a detailed look at the mathematical model Therefore, we did not include this option in our estimate that reflects the expected prevalence
for this stage, see Ref. 106. analysis. We invited comment on the feasibility of following the full implementation of this rule.
63 A further refinement of the model would be to this option in the analysis of the proposed rule but 65 It is never in the interest of the smallest farms
include the option of depopulating the flock and did not receive any responses.
to test eggs because the expected cost of testing
starting over with a new flock. There is a large 64 Tables 22 and 23 of this document present the
exceeds the revenue loss from simply diverting all
degree of uncertainty over whether this is feasible cost estimates for houses based on the current
given that the growing cycle of chicks and pullets estimated prevalence of SE. In the total cost tables eggs for the life of the flock.
must be coordinated with the laying cycle of flocks. (24 and 25 of this document), we also present an
costs. Nonetheless, diversion costs also secondary effect of increasing egg- expected costs may fall by over 60
generally rise with farm size. testing costs due to the high expected percent.66 On the largest farms, it is less
Whether or not a farmer chooses to cost of opting out. economical to divert, and thus the cost
molt the flock also has an effect on cost. For comparison with dynamic costs, savings can be insignificant.
The annual cost of testing and diversion the static cost of testing and diversion To obtain the total cost of testing and
for a molted flock is greater than that for is included in the final column of tables diversion for all houses on all farms we
a non-molted flock, largely because a 22 and 23 of this document. As multiply the cost per house in each
molted flock forced to divert for the life expected, when the producer is given category by the number of houses in
of the flock is expected to experience the choice of opting out of egg testing each category and the percentage of
diversion for a longer time. In the the total cost of testing and diversion houses that would be affected by the
dynamic model, where the farmer can falls. The savings to the farmer are provision. These costs are summarized
opt out of testing, molting has a greatest on the smallest farms, where in tables 24 and 25 of this document.
TABLE 24—TOTAL COST OF TESTING AND DIVERSION: ROW-BASED SAMPLING

[Thousands of dollars]
Number of Percent Environmental

Farm size (number of layers) Egg testing Diversion Total cost
houses molted testing
Fewer than 3,000 ..................................... 45,700 0 $6,798 $0 $271 $7,069

3,000 to 19,999 ........................................ 2,445 28 617 2,357 839 3,813
20,000 to 49,999 ...................................... 1,295 65 327 1,675 892 2,894
50,000 to 99,999 ...................................... 595 86 150 886 574 1,610
Over 100,000 ........................................... 3,024 84 763 4,476 6,687 11,926
Farms with ≥ 3,000 layers, Initially .................................................................. 1,857 9,393 8,992 20,242
Farms with ≥ 3,000 layers, Eventually ............................................................ 1,857 6,812 6,512 15,181
TABLE 25—TOTAL COST OF TESTING AND DIVERSION: RANDOM SWAB SAMPLING

Number of Percent Environmental

houses molted testing
Fewer than 3,000 ..................................... 45,700 0 $61,425 $0 $271 $61,696

3,000 to 19,999 ........................................ 2,445 28 2,432 2,357 839 5,627
20,000 to 49,999 ...................................... 1,295 65 1,288 1,675 892 3,855
50,000 to 99,999 ...................................... 595 86 592 886 574 2,051
Over 100,000 ........................................... 3,024 84 3,008 4,476 6,687 14,171
Farms with ≥ 3,000 layers, Initially .................................................................. 7,319 9,393 8,992 25,704
Farms with ≥ 3,000 layers, Eventually ............................................................ 7,319 7,319 7,319 21,958
As shown in table 24 of this benefits from diversion using the example, those that chose to participate
document, the estimated eventual total experience of the states. may be a biased sample who are more
cost of testing and diversion is The first key measure to be likely to have cleaner houses).
approximately $15.2 million when row- determined is the probability that the Regional quality assurance programs
based sampling is used. When we environment of a flock will test positive.
have also collected data on SE
assume that a random swab method of We used two sources to estimate the
prevalence on farms. As an upper
environmental sampling is used, as in current prevalence of SE-positive
houses. Our first source is the Layers bound, Pennsylvania experienced a
table 25 of this document, the eventual prevalence of 40 percent in the early
estimated costs increase to $22.0 study (Ref. 29), which recruited 200
farm sites to be tested across the United 1990’s (Ref. 107). As a lower bound, we
million. use 1 to 3 percent, which is the current
States. We also use estimates based on
iii. Benefits of testing and diversion. the experience of testing under quality prevalence of houses with SE-positive
While the primary purpose of testing is assurance plans. environments in Maine (Ref. 108). We
to obtain an indication of the The Layers study estimates that 7.1 believe that Pennsylvania’s current
effectiveness of the farm’s SE prevention percent of all houses are positive for SE. prevalence of 7 to 9 percent (Ref. 105)
measures, the testing and diversion Regionally, SE prevalence ranges from a is a mode for the nation as a whole.67
program would also directly reduce SE low of 0 percent in the Southeast to a When we put this data into a Beta-Pert
infection by preventing SE-positive eggs high of 17.2 percent in the Great Lakes probability distribution using a uniform
from reaching consumers. To the extent region. Nonetheless, because only 200 of distribution over 1 to 3 percent as the
that SE-positive eggs are diverted for an original sample of 526 farm sites lower bound, 40 percent as the upper
treatment, the number of these eggs that chose to participate in this phase of the bound, and a uniform distribution over
reach the consumer in an untreated study, we are hesitant to rely solely on 7 to 9 percent as the mode, or most
form will decline. We estimate the this figure for SE prevalence (for
66 This conclusion assumes that the farmer will be 67 This assumption is based on the fact that the Pennsylvania is located) has fallen to a level
paying all of the costs of testing and diversion. number of outbreaks in the Northeast (where equivalent with the rest of the nation (Ref. 11).
likely value, we estimate a national testing and diversion are about $189.6 is relatively low.72 Between 1994 and
prevalence rate of 12.3 percent. million per year. 1996 only 2 out of 847 breeder flocks
We consider that the Layers study and i. SE-Monitored chicks and pullets.— (0.2 percent) had layers that tested
quality assurance program estimates are i. Chick and pullet provisions. Under positive for SE. For our estimate of
equally likely to be valid. Therefore, we the final rule, farms must procure benefits, we used this figure because
put these values in a uniform pullets that are SE monitored or raise breeders under the NPIP program must
distribution (7 to 12.3 percent) to pullets under SE monitored conditions. destroy their flocks when layers test
estimate that an expected 9.7 percent of Pullets to be used as layer hens must be positive.73
farms would currently test SE-positive. raised under SE control conditions that The 0.2 percent estimate understates
Based on the experience of prevent SE, including (1) procurement the probability that a farm not currently
Pennsylvania, we estimate that 26 of chicks from SE-monitored breeder using NPIP SE-monitored layers will
percent of houses that are flocks,70 (2) cleaning and disinfection, test positive. To the extent that farmers
environmentally positive also will have and (3) environmental testing at 14 to 16 obtain their chicks from multiple
eggs that test positive (Ref. 105). weeks of age. If the environmental test sources,74 we would expect the
is negative, the farm will not need to probability that a farm obtains SE-
These figures imply that 469 million
perform any additional testing of those positive chicks to be greater than the
eggs from affected farms,68 or 0.5
birds or their environment until the underlying prevalence of SE in hatchery
percent of all shell eggs,69 would be
environmental test at 40 to 45 weeks of flocks.75
diverted initially following the initial
age. If the 14 to 16 week environmental
effective date of the provision. Of these We calculated the expected benefit of
test is positive, farms must begin egg
eggs, we expect eggs to be positive at a this provision using the percentage of
testing within 2 weeks of the start of egg
rate of 2.75 per 10,000 (Ref. 92). farms affected by the provision
laying. A positive egg test triggers
Consequently, we estimate that an diversion. multiplied by the probability of a
average of 129,000 SE-positive eggs ii. SE-Monitored chicks. Farms must positive test. Because only 5.5 percent
would be diverted annually. Given a procure pullets that have been raised of farms receive birds from breeder
total estimated number of positive eggs from chicks from SE-monitored breeder flocks that are not SE monitored, the
of 1.5 million, we estimate that flocks that meet the NPIP’s standards for expected effect of this provision on SE
diversion would initially decrease the ‘‘U.S. S. Enteritidis Clean’’ status (9 CFR contamination on the farm and, hence,
number of SE-related illnesses by 10.8 145.23(d)) or equivalent standard. human illness, is projected to be slightly
percent. This translates to potentially iii. Current industry practices—SE- greater than 0.01 percent (5.5 percent ×
15,300 illnesses (valued at $274.1 monitored chicks. According to the 0.2 percent). This percent translates into
million) prevented each year. Standing Layers study (Refs. 27 and 28), 94.6 an expected benefit of 14 illnesses
alone, the testing and diversion percent of farm sites representing 94.5 averted on affected farms (valued at
provisions would cost about $1,300 per percent of layers received their chicks about $0.3 million). This provision
illness avoided and provide about from flocks that were bred under the attempts to bar the introduction of SE
$261.6 million in net benefits. NPIP program. Furthermore, NPIP has onto the farm. SE can be difficult to
If we account for estimated reductions successfully integrated all of these control once it has been introduced onto
in SE prevalence due to the provisions layers into the NPIP U.S. Salmonella a farm, but if SE is never introduced, it
pertaining to chicks and pullets, rodent Enteritidis monitored program (Ref. is impossible for it to spread. For this
and pest control, biosecurity, and 109). reason, effective SE control in chick
cleaning and disinfecting, (a 28 percent NASS estimates that a total of populations has been cited as critical.
reduction in prevalence when all 138,292,380 chicks were sold in 1997 vi. Cleaning and disinfecting, and
provisions are in place and fully (Ref. 26). If 94.5 percent of these birds environmental testing in pullet houses.
effective), all occurring earlier in the were purchased from breeder facilities To ensure that pullets about to begin the
production cycle, the refrigeration that are NPIP SE monitored, then 5.5 laying cycle are SE free, egg producers
provisions would provide a nearly 8 percent (7,606,080) of chicks are not must only use pullets whose
percent decline in SE illness, preventing currently monitored for SE. environments were tested for SE when
about 11,000 illnesses annually ((1– iv. Costs of SE-monitored chicks. We the pullets were 14 to 16 weeks old.
0.28) × 15,300 illnesses). Because the do not have data for the cost of There are two consequences to a
baseline SE prevalence will be reduced monitoring chicks for SE. However, positive environmental test. First, an egg
by other provisions, FDA expects that Morales and McDowell (Ref. 91) producer who uses those pullets must
over 40 million less eggs will be estimated that pullets monitored for SE begin egg testing on the positive flock
diverted once the rule is fully effective. cost approximately $0.003 to $0.02 more within 2 weeks of the start of egg laying.
Furthermore, less egg tests will be per pullet. If we assume the cost Second, the pullet house must have all
necessary. Therefore we expect annual difference is the same for chicks, the manure removed, and be cleaned and
costs to decrease by $3.5 million once total increased annual cost of requiring disinfected before a new flock is added.
all provisions are fully effective. In SE-monitored chicks is estimated to be
place with the other provisions of the about $87,000.71 This cost would be 72 The data for this paragraph is drawn from
final rule, the cost of testing and borne by pullet growers but could be Rhorer (Ref. 110).
diversion is about $1,900 per SE case passed on to egg farms depending on 73 Under the NPIP program a flock only loses its
market conditions. certification as a NPIP SE-monitored flock if birds

prevented. The eventual net benefits of test positive.
v. Benefits of SE-monitored chicks.
74 The Layers study estimates that 38.2 percent of

68 The total cost of diversion is divided by the The prevalence of SE in breeder flocks farms obtain pullets from multiple sites (Refs. 27
cost of diversion per egg to obtain the number of and 28).
eggs diverted. 70 NPIP
certified or the equivalent. 75 The following example illustrates this point. If
69 The percent of shell eggs that are diverted is 71 If
monitoring costs $0.003 per layer, the total a farmer obtains pullets from two different flocks,
determined by dividing the number of eggs diverted cost is 7,606,080 layers × $0.003 = $22,820. If each of which has a 0.2 percent chance of having
by the total number of shell eggs produced (90,772 monitoring costs $0.02 per layer, the total cost is SE-positive birds, the probability that the farm will
million) as published in the USDA’s Chicken and 7,606,080 layers × $0.02 = $152,120. The average of obtain SE-positive birds is 0.2 percent + 0.2 percent
Eggs report (Ref. 75). these two figures is $87,470. ¥0.04 percent = 0.36 percent.
vii. Current industry practices— laboratory cost per sample tested.76 The xii. Cost of egg testing and diversion.
Cleaning and disinfecting, and total annual cost of environmental Total costs are estimated once again
environmental testing in pullet houses. testing in pullet houses is estimated to using the testing and diversion model
FDA does not have detailed information be $1.3 million. described in section V.F.1.l of this
on SE monitoring practices in pullet ix. Costs of cleaning and disinfecting document. The model takes into
houses. However, comments from state in pullet houses. The rule requires a account prevalence of SE in the
run programs and industry stated that similar cleaning and disinfecting environment and the farmer’s decision
pullet houses are typically subject to the routine for both pullet houses and layer between egg testing and immediate
same provisions as layer houses under houses. Therefore, the per house costs diversion to minimize costs.78 The
state Egg Quality Assurance Programs and the number of houses affected are prevalence of SE in pullet flocks is
(EQAPs) and other programs for egg calculated similarly to the costs for
relatively low compared to layer flocks.
farmers. Therefore, FDA estimates that cleaning and disinfecting a layer house.
Data gathered from comments, citing
pullet houses will be in compliance We calculate the number of houses
PEQAP and CEQAP databases, show
with these provisions at the same rate as affected as the product of the percent of
houses not using a practice (100 minus that the environmental prevalence of SE
estimated for layer houses in previous
the percent using the practice in Table in pullet houses ranges from 0 to 1.5
sections of this analysis.
FDA does not have specific data on 14 of this document), the probability of percent. We use a uniform distribution
the number of pullets and pullet houses a positive flock, and the number of bound between 0 and 1.5 percent to
there are in the United States. However, pullet houses.77 The total annual cost of estimate that 0.75 percent of pullet
multiple comments stated that there are cleaning and disinfecting pullet houses houses would currently test
roughly one-third as many pullets as that test environmentally positive is environmentally positive.
there are layers at any given time. $226,000. The per test cost of egg testing is
Further, there are roughly one-third as x. Follow-up egg testing and discussed in detail in section V.F.1.f of
many pullet houses as there are layer diversion. Upon an environmental this document. The cost of diverted eggs
houses. FDA therefore estimates that positive, farms must begin egg testing on is discussed in detail in section V.F.1.g
2,453 pullet houses (7,359 layer houses the positive flock within 2 weeks of the of this document. To summarize, we
covered/3) will be covered under this start of egg laying. Farms that test find the weighted average cost of
provision. Some of the pullet houses are positive for SE in their eggs would be diversion to be between $0.13 and $0.23
located onsite at layer farms and others required to divert their eggs for per dozen eggs. If there is an additional
are located on pullet growing facilities. treatment until they are able to show via discount for those eggs with SE, the
viii. Costs of environmental testing in testing that SE is not present in the eggs total cost could rise as high as $0.33 per
pullet houses. Because the requirements produced in the infected house. dozen eggs.
for tests will be the same for both pullet xi. Current Industry Practices—
and layer houses, per house costs are Follow-up egg testing and diversion. To obtain the total cost of testing and
calculated the same way. As in layer Comments to the proposed rule suggest diversion for all houses on all farms, we
houses, the cost of routine that farms do not typically test eggs multiplied the cost per house in each
environmental testing in pullet houses when a pullet house tests positive for category by the number of houses in
depends on how many samples are SE. FDA therefore estimates that all each category and the percentage of
tested, the labor cost of collecting the pullet flocks in houses that test houses that would be affected by the
samples, the cost of shipping the environmentally positive will be provision. These costs are summarized
samples to a laboratory, and the affected by this provision. in tables 26 and 27 of this document.
TABLE 26—TOTAL COST OF TESTING IN PULLET HOUSES, FOLLOW-UP EGG TESTING, AND DIVERSION: ROW-BASED
SAMPLING
Number of Environmental
houses testing
3,000 to 19,999 .................................................................... 815 $58 $53 $50 $161

20,000 to 49,999 .................................................................. 432 31 47 18 96
50,000 to 99,999 .................................................................. 198 14 22 12 48
Over 100,000 ....................................................................... 1,008 72 111 144 326
Farms with ≥ 3,000 layers ............................................................................... 174 233 225 632

76 For a detailed breakdown of per house 78 The choice on whether to destroy the flock or production, is much greater than the costs of egg
environmental testing costs, see section V.F.1.e of move it to the layer house is also included in the testing and diversion. Therefore, FDA believes
this document. pullet section of the testing and diversion model. nearly all farms covered by this rule will choose to
77 For a detailed discussion of cleaning and However, except for very small flocks not covered test eggs rather than destroying the flock upon and
disinfecting costs, see previous section on cleaning by this rule, the cost of flock destruction, including environmental positive in the layer flock.
and disinfecting costs for layer houses. the cost of disposal, bird replacement costs, and lost
TABLE 27—TOTAL COST OF TESTING IN PULLET HOUSES, FOLLOW-UP EGG TESTING, AND DIVERSION: RANDOM SWAB
SAMPLING
Number of Environmental
houses testing
3,000 to 19,999 .................................................................... 815 $811 $53 $50 $914

20,000 to 49,999 .................................................................. 432 429 47 18 495
50,000 to 99,999 .................................................................. 198 197 22 12 231
Over 100,000 ....................................................................... 1,008 1,003 111 144 1,258
Farms with ≥ 3,000 layers ............................................................................... 2,440 233 225 2,897
Table 26 of this document shows that These figures imply that 12 million of these summary estimates. First,
the estimated eventual total cost of eggs from affected farms would be because the effectiveness of rodent and
testing in the pullet house and diversion diverted due to environmental testing in other pest control is strongly linked to
is approximately $0.6 million when the pullet house and follow-up eggs biosecurity and cleaning and
row-based sampling is used. If a random testing and diversion. We expect eggs to disinfecting practices, we estimated the
swab method of environmental be positive at a rate of 2.75 per 10,000 benefits of these provisions jointly.
sampling is used, as in table 27 of this in an SE-positive house (Ref. 92). Second, we derive benefits without
document, the estimated costs increase Therefore, we estimate that an average taking into account the interdependence
to $2.9 million. of 3,200 SE-positive eggs would be of all provisions. Therefore, table 28
xiii. Benefits of SE-monitored chicks diverted annually. Given a total
reflects the incremental effects of each
and pullets. While the primary purpose estimated number of positive eggs of 1.5
of an SE monitoring program is to provision starting from a baseline of no
million, we estimate that diversion
ensure that pullets entering layer houses would decrease the number of SE- new regulation. The benefits reported
producing table eggs are SE free, testing related illnesses by 0.2 percent. This for the provisions in table 28 can be
and diversion will also directly reduce translates to potentially 306 illnesses added together, mixed and matched, to
SE infection by preventing SE-positive (valued at about $5.5 million) prevented achieve a rough upper bound estimate
eggs from reaching consumers. annually. of the effectiveness of different
Furthermore, cleaning and disinfecting The chick and pullet program will combinations of provisions. Because
a house after an environmental positive potentially prevent 320 illnesses per some of the provisions are substitutes in
will help ensure SE does not spread and year, for a total benefit of about $5.7 benefits, particularly diversion and
infect current and future flocks on the million. The total annual cost per illness rodent and other pest control, the actual
same farm. of the program is $6,500. The annual net benefits of combinations of provisions,
As stated in the previous section, FDA benefits for the chick and pullet as well as the final rule, will be
estimates that the national prevalence of provisions are $3.6 million.79 somewhat smaller than what is reflected
SE in pullet houses varies uniformly j. Summary of costs and benefits of in table 28. A rough lower bound
from 0 to 1.5 percent, for an average of on-farm SE prevention measures. Table estimate of the incremental effect of
0.75 percent. As with layer houses, we 28 of this document summarizes the each provision when combined with
estimate that 26 percent of houses that costs and benefits of the on-farm SE another is shown in table 33 of this
are environmentally positive also will prevention measures. In this paragraph document.
have eggs that test positive (Ref. 105). we emphasize some of the key features
TABLE 28—SUMMARY OF ANNUAL COSTS AND BENEFITS OF ON-FARM MEASURES

Cases of SE Total benefits Net benefits
Costs (millions Cost per case
averted (millions of (millions of
of dollars) of SE averted
(eventual) dollars) dollars)
Rodent and Pest Control 4 ................................................. $21.4 38,954 $529 $697.3 $675.9
Biosecurity .......................................................................... .......................... _ _1 _ _1 _ _1 _ _1
Cleaning and Disinfecting .................................................. 0.3 _ _1 _ _1 _ _1 _ _1
Refrigeration ....................................................................... 20.2 44,727 451 800.6 780.4
Environmental Tests (average) .......................................... 4.6 _ _2, 3 _ _2, 3 _ _2, 3 _ _2, 3
Egg Tests ........................................................................... 9.7 _ _2 _ _2 _ _2 _ _2
Diversion ............................................................................ 12.5 15,312 1,343 274.1 261.6
SE Monitored Chicks and Pullets ...................................... 2.1 320 6,494 5.7 3.6
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.
4 This calculation nets out feed savings.
79 These figures are correct if the chick procurement provisions alone only reduce
procurement provisions and the pullet provisions prevalence by about 0.01 percent, the difference, if
are put in place simultaneously, so the costs and calculated separately, is less than 1 illness per year.
benefits of the pullet provisions are net the effect
of the change in SE prevalence due to the chick
procurement provision. Because the chick
k. Other on-farm prevention measures that the collection and preparation of If finished feed is contaminated with
considered. This section analyzes the each subsample will take approximately SE, the consequences for human health
costs and benefits of two prevention 10 minutes. Given an hourly wage of are potentially large. A feed mill that
measures, SE-monitored feed, and flock $15.51 for production inspectors at does not test feed for SE and becomes
vaccination, considered by the FDA, but grain and feed mills (Ref. 113), plus 50 contaminated with SE could deliver a
not required by the final rule. percent to include overhead costs, we large number of shipments of
i. SE-negative feed provisions. We estimate the cost of labor to be $38.78 contaminated feed before the problem is
considered requiring the use of feed that ($23.27 x 1.667 hours) for each full uncovered. The potential financial
meets the standards for SE-negative sample. The cost of shipping each consequences to the farms using the
feed, as defined by FDA’s Center for sample to a lab is estimated to be feed include costs due to increased
Veterinary Medicine (CVM). CVM $30.20.82 The total cost per composite cleaning and disinfecting, egg testing,
defines SE-negative as 10 subsamples sample is about $130 ($61.00 + $38.78 and diversion of eggs. Also, there likely
that are negative for SE (measured using + $30.20). would be adverse health effects from the
the BAM method) collected for a lot of Samples must be taken for each lot of consumption of SE-positive eggs.
feed (60 FR 50098, September 28, 1995). feed. We expect that, because of limited v. Vaccination provision. Inoculating
Composite samples may be used to storage space for finished feed, a lot of layers with vaccines is another potential
reduce testing costs. We received feed will not exceed 3 days worth of way of preventing the growth of SE in
comments that SE-negative feed is not production for most large mills. For layers. FDA could mandate that all
currently available commercially. some small mills, however, a lot may be layers be inoculated against SE.
ii. Current industry practices—SE a week’s worth of production; for some vi. Current industry practices;
monitoring of feed. The layer industry large mills a lot may be a day’s worth vaccination of flocks. The Layers study
obtains feed from both independent feed of production. Given these parameters, (Refs. 27 and 28) estimates that at least
mills and from egg farmers that produce we assume that the frequency of feed 14.6 percent of all layers on farms with
feed in their own mills. The Economic testing will be distributed uniformly 3,000 or more layers are vaccinated
Research Service report on the feed between once a week and five times a against SE.
manufacturing industry estimates that week with a mean frequency of three vii. Cost of vaccinating flocks.
egg producers operated a total of 144 times a week. Consequently, the Estimation of vaccination costs range
feed mills in 1984 (Ref. 111). In the expected annual cost of testing for a from approximately $0.13 per layer (Ref.
absence of more recent data, we assume typical feed mill is calculated to be 115) to $0.15 per layer 83 for an
that they operated the same number in approximately $20,300 ($130 per inoculation. The average of these
2006. To isolate the number of sample × 52 weeks × 3 times a week). estimates is an expected vaccination
independent feed mills operating in the The cost of testing all of the cost of $0.14 per layer for an
United States, we used the July 2000 approximately 1,450 entities that inoculation.84 Given 272.1 million
version of Dun’s Market Identifiers (Ref. produce feed is estimated to be $29.4 layers on larger farms and 1.4 million
112). Using this database, we were able million. If these costs are passed on to layers on smaller farms, we expect that
to isolate 210 mills that primarily farmers at a rate proportional to the this provision would result in 232.2
produce poultry and chicken feeds. This number of layers on the farm, the total million new vaccinations on larger
figure is our low estimate of the number cost to affected farms would be $29.2 farms and 1.4 million new vaccinations
of independent feed mills producing million. on smaller farms. Consequently, the cost
layer feed. For a high estimate, we In the event of a positive feed test, of vaccination on farms with at least
assume that all 2,459 establishments feed mills would have to treat or destroy 3,000 layers would be $31.2 million.
that Dun’s Market Identifiers reports as the suspect feed. It is also likely that the viii. Benefits of vaccinating flocks.
producers of animal feed produce layer mill would take action to address the While vaccines have shown some
feed.80 This estimate is similar to the problem at its source. Furthermore, we promise in the lab, there is insufficient
1984 Economic Research Service assume that the mill would recall this evidence from field trials about their
estimate of 2,432 primary feed feed and treat or dispose of it, which efficacy to estimate any benefit from
manufacturers. Assuming that the true could be very costly. their use.
number of feed mills producing layer iv. Benefits of monitoring feed for SE.
In a controlled environment vaccines
feed is uniformly distributed between Feed contaminated with SE is
were found to reduce incidence of
the low and high estimates, we estimate theoretically also a vehicle for the
intestinal colonization and mean
that approximately 1,300 feed mills introduction of SE on the farm. Testing
number of SE shed in the feces. Further,
produce layer feed. for SE in finished layer feed at mills has
in a controlled setting, the same
iii. Costs of monitoring feed for SE. almost never yielded positive results.
vaccines have been shown to reduce the
The cost of this provision to a feed mill However, SE has been isolated in
number of SE-positive eggs laid when
would be the sum of the labor, ingredients at feed mills so SE
compared to non-vaccinated controls
laboratory, and shipping costs for contamination of feed is a potential
(Ref. 116). Hens were vaccinated at 38
testing, multiplied by the number of lots problem (Ref. 114).
weeks of age followed by a booster 4
tested. In addition, SE-positive feed
weeks later and subsequently
would have to be treated or destroyed. option that mills have is to initially test for the
The laboratory cost per test has been genus of Salmonella ($28.00) and then, if the test challenged intravaginally 2 weeks later.
estimated to be approximately $61.00 is positive, follow through with a test for the Despite the high level of SE recovery
per sample.81 In addition, we estimate
serotype enteritidis ($33.00). We assume that mills from cloacal and vaginal swabs of
will not choose this option because Salmonella vaccinated and unvaccinated hens,
positive feed is considered adulterated and firms
80 The low estimate is likely to underreport the will not want to test to see if their feed is vaccination resulted in a significant
number of mills producing layer feed because most adulterated unless mandated to do so by FDA.
firms did not report to Dun’s Market Identifiers 82 The cost of shipping a 2-pound package 83 This is based on a per layer cost of $0.035 for
what kinds of feeds they produced. overnight in the United States ranges from $21.15 vaccine plus $0.10 for labor (Ref. 115), adjusted for
81 This is the cost of an Association of Official to $39.25. These figures include a $6 pickup charge. inflation.
Analytical Chemists test for Salmonella genus and The average charge is estimated to be $30.20 (Ref. 84 These costs are recalculated in terms of year
a serotype test at Silliker Laboratories (Ref. 99). One 98). 2005 constant dollars using the GDP deflator.
decrease in the number of SE-positive transmission to eggs in the future. taken. Farms are required to have a
eggs when compared to non-vaccinated However, currently, there is no vaccine trained or experienced supervisor that
controls (19 percent versus 37 percent, that has been shown to be efficacious in would be responsible for overseeing the
respectively). The degree of protection the field. Therefore, FDA is not plan.
was only partial though, because more requiring vaccination in this final rule. ii. Current industry practices; plan
than half the population was still design and recordkeeping. We assume
2. Administrative Measures
shedding SE at a high rate (Ref. 116). that those farms that are currently
However, the primary test for efficacy a. Plan design and recordkeeping.—i. operating according to recognized
of a vaccine is a field trial, and it is Plan design and recordkeeping industry or State quality assurance
common for vaccines to be effective in provisions. Each farm site with 3,000 or plans are already largely in compliance
the laboratory but fail to perform up to more layers that sells raw eggs to the with the plan design and recordkeeping
expectations under field conditions. In table egg market, other than directly to provisions discussed in this section, and
a series of Pennsylvania field studies, the consumer, and does not have the therefore would not experience
despite the use of SE vaccine, 63.6 eggs treated, must design and monitor additional costs to comply with record
percent of the houses had SE-positive an SE prevention plan. This prevention keeping provisions. Using data from the
environmental cultures and 100 percent plan includes all measures the farm is Layers study (Refs. 27 and 28), we find
of the flocks had SE organ positive taking to prevent SE in its flock. The that 59 percent of farms with more than
birds. With regard to all parameters following information includes 50,000 layers are currently members of
tested, there were no statistical potential components of the plan: (1) State or industry quality assurance
differences between vaccinated or Chicks and pullets, (2) biosecurity, (3) plans. Fewer than 8 percent of farms
unvaccinated controls—indicating the rodent and other pest control, (4) with fewer than 50,000 layers are
ineffectiveness of either commercially cleaning and disinfecting, (5) currently members of quality assurance
available bacterins or autogenously refrigeration, and (6) testing and plans.85 The estimated number of farms
manufactured SE vaccines (Ref. 117). diversion. Records are also required for and houses affected by plan design and
Lab results show promise for vaccines to review and of modifications of the SE recordkeeping provisions is shown in
become a useful tool in fighting SE prevention plan and corrective actions table 29 of this document.
TABLE 29—FARMS AFFECTED BY PLAN DESIGN AND RECORDKEEPING PROVISIONS

Percent of Houses
Number of Houses per farms on a Farms affected
Farm size (number of layers) affected by the
farms farm quality assur- by the rule rule
ance program
3,000 to 19,999 .................................................................... 1,746 1.4 4.9 1,661 2,325

20,000 to 49,999 .................................................................. 925 1.4 27.7 669 936
50,000 to 99,999 .................................................................. 248 2.4 58 104 250
100,000 or more .................................................................. 409 7.4 59.7 165 1,219
All farms ............................................................................... 3,328 1.4 21.9 2,599 4,730
As table 29 of this document shows, 24275 to 24285, May 1, 1998). In 10 years at 3 percent, the total cost of
we expect that a total of 2,598 farm sites particular, we assume that each plan plan design for all farms will be about
with 4,730 poultry houses would be component will take approximately 20 $171,000 ($66 per farm) per provision.
affected by plan design and labor hours to design. We add 50 For six provisions (rodent and other
recordkeeping provisions. percent to the cost of labor for designing pest control, biosecurity, cleaning and
iii. Plan design costs. The per the plan to account for overhead. The disinfecting, chick and pullet
provision plan design cost is calculated cost of designing a plan with one procurement, refrigeration, and testing
in table 30 of this document. Because component is expected to be $560 and diversion), the total cost of the plan
information on the costs of designing
($27.98 × 20) (Ref. 89). Amortized over design would be $1.2 million when
the SE prevention plan for eggs is not
10 years at 7 percent, the total cost of amortized over 10 years at 7 percent
available, we base these costs on
plan design will be about $207,000 ($80 ($1.0 million when amortized over 10
assumptions used to analyze the design
of HACCP programs (63 FR 24253 at per farm) per provision. Amortized over years at 3 percent).
TABLE 30—COST OF PLAN DESIGN PER PROVISION

Farms affected Total costs
Farm size (number of layers) by the Cost per farm (in thousands
proposal of dollars)
3,000 to 19,999 ............................................................................................................................ 1,661 $560 $930

20,000 to 49,999 .......................................................................................................................... 669 560 375
50,000 to 99,999 .......................................................................................................................... 104 560 58

100,000 or more .......................................................................................................................... 165 560 92
All farms ....................................................................................................................................... 2,599 560 1,455
Amortized over 10 years at 7% ................................................................................................... ........................ ........................ 207
85 We do not have data on participation by farms of these farms are currently members of recognized
with fewer than 3,000 layers. We assume that none quality assurance programs.
iv. Recordkeeping costs. We assume environmental positive, the records’ In the event of an environmental
that the time required for recordkeeping annual cost is assumed to be similar to positive, the farm must review and
is roughly equivalent to the time the cost estimated for the weekly modify as necessary its plan design.
necessary to monitor and document the records discussed previously, $727 per FDA estimates this will take roughly
food safety provisions of a HACCP plan record, per house. However, as half the time (10 hours per provision)
(63 FR 24253 at 24275 to 24286). discussed previously in this document than it took to originally draft the plan.
Because the HACCP time estimate upon FDA estimated that 9.7 percent of To calculate how many farms will need
which we are basing our estimate houses will test environmentally to review their plans, the estimation of
involves multiple control points and positive initially and 7.0 percent will 9.7 percent of houses testing positive
monitoring, this assumption tends to test positive after the provisions of this initially and 7.0 percent of houses
overstate the cost of recordkeeping for a rule have taken effect. Additionally, testing positive eventually is applied.88
provision of this final rule. In particular, farms would have to keep records of egg The initial total expected cost of the
we expect that, for each house affected, testing, diversion, and treatment if they
plan design review and modification
recordkeeping will take one half hour receive pullets from a house that has
records is $0.8 million (0.097 × ($280 ×
per week per required provision for tested environmentally positive; FDA
provisions that would require weekly or estimated that pullet houses will test 6 provisions) × 4,730 houses). The
daily monitoring. Records kept for positive 0.75 percent of the time. The eventual total expected cost of the plan
biosecurity measures, rodent and other cost for houses that test negative would design review and modification records
pest control and refrigeration are be similar to keeping an annual is $0.6 million (0.070 × ($280 × 6
assumed to be recorded on a weekly record 87; at a half hour per record the provisions) × 4,730 houses).
basis. annual cost would be $14 per record, We assume that pullet growers will
The cost of weekly recordkeeping for per house. The initial total annual cost keep a record of each environmental test
biosecurity and rodent and other pest of the environmental and egg testing, performed on a per house, per flock
control, assuming $18.65 an hour for diversion, and treatment records is $0.4 basis. Each house can hold
labor, plus 50 percent to reflect million (((0.097 × $727) + (0.903 × $14) approximately 3 flocks per year and, as
overhead costs, would be $727 ($27.98 + (0.0075 × $727)) × 4,730 houses). The comments to proposed rule state, there
× 0.5 hours × 52 weeks) per record, per eventual total expected cost of the are roughly one third as many pullet
house. The total annual cost for all environmental and egg testing, houses as there are layer houses. At a
houses for these two records is $3.4 diversion, and treatment records is half hour per record, the annual cost
million ($27.98 × 0.5 hours × 52 weeks about $0.3 million (((0.070 × $727) + would be $42 per pullet house ($14 × 3
× 4,730 houses). Refrigeration records, (0.930 × $14) + (0.0075 × $727)) × 4,730 records annually). The total annual
collected weekly on a farm-by-farm houses). expected cost of environmental testing
basis, rather than by-house, will cost Records of chick and pullet
records for pullet houses is $66,200 ($42
$1.9 million annually ($27.98 × 0.5 procurement and records of cleaning
× 1,577 houses).
hours × 52 weeks × 2,598 farms). and disinfection will take one half hour
Environmental and egg sampling and each, per year, per house. At a half hour The calculation of the initial and
testing, diversion and treatment per record, the annual cost will be $14 eventual costs of $10.2 million and $9.8
records 86 together have daily, weekly, per record, per house. These two million, respectively, for all records for
and monthly aspects, in the event of an records will cost farms $0.1 million (2 affected farms is shown in table 31 of
environmental positive. In the case of an records × $14 × 4,730 houses). this document.
TABLE 31—TOTAL COST OF ON-FARM RECORDKEEPING

Total cost
(in thousands of dollars)
Record kept
Initial Eventual
Chick and pullet procurement .......................................................................................................................... $66 $66

Rodent and pest control .................................................................................................................................. 3,440 3,440
Biosecurity ....................................................................................................................................................... 3,440 3,440
Cleaning and disinfection ................................................................................................................................ 66 66
Refrigeration .................................................................................................................................................... 1,890 1,890
Testing, diversion, and treatment .................................................................................................................... 419 328
Design plan review and modification ............................................................................................................... 770 556
Environmental testing for pullet houses .......................................................................................................... 66 22
Total .......................................................................................................................................................... 10,158 9,809
b. Training. The person responsible SE prevention measures on more than that, on average, one person will need
for overseeing the SE prevention one farm. Alternatively, more than one to be trained to oversee preventions
measures will have to be trained or have person may be trained to oversee a measures on each farm covered by the
equivalent job experience. Under the single farm. The latter is likely on some rule. A training course would last 2 to
final rule, one person may oversee the of the larger operations. FDA assumes 3 days. The cost of taking a course
86 Including stamping documents accompanying 88 This may tend to overstate costs because farms positive at roughly the same time as one or more
diverted egg shipments. The cost of the actual with 3,000 layers or more have on average more other SE-positive houses. This would require only
rubber stamp is assumed to be negligible. than one house per farm. Some of the 459 (0.097 one review and modification of the entire plan.
87 The cost of environmental tests to pullet houses × 4,730 houses) houses expected to test positive
is discussed in a separate paragraph. initially could be located on the same farm and test
consists of tuition, the cost of the enable more efficient inspection, as well access. The total one-time cost to the
supervisor’s labor while in class as better management and oversight of industry is $0.2 million (($27.98 × 3,328
(opportunity cost), and any travel a shell egg recall. farms) × ((0.71 × 2) + (0.29 × 3))).
related expenditures that may be ii. Current industry practices— Amortized at 7 percent, the annual cost
incurred. registration. FDA assumes that no farms of one-time registration is $30,400.
The cost of a recent 3-day HACCP are currently registered with the FDA.91 Amortized at 3 percent, the annual cost
training course was advertised to be Therefore, this provision will affect all of registration is expected to be $25,000.
$600 to $650 (Ref. 118).89 The cost of farms with 3,000 or more layers. d. Summary of costs and benefits of
the supervisor’s labor is estimated to be iii. Registration costs. We assume that administrative provisions. The costs of
$895 (32 hours 90 × $27.98 an hour). the time required for registration under administrative provisions are
Travel expenditures consist of this rule is roughly equivalent to the summarized in table 32 of this
transportation, hotel, and miscellaneous time necessary to register a domestic document. These provisions do not have
expenses. These costs range from facility under the Registration of Food independently quantifiable benefits.
insignificant (reimbursement for Facilities under the Public Health The provisions would be likely to
minimal mileage) to $1,000 ($400 airfare Security and Bioterrorism Preparedness generate benefits because administrative
+ $400 hotel expenses + $200 expenses). and Response Act of 2002 rule (68 FR provisions are essential for farmers to
We believe that most training will be 5378 at 5392 to 5403, February 3, 2003) effectively implement SE prevention
relatively close to where producers are (BT registration rule). In particular, FDA measures. Further, the administrative
located. In addition, training is likely to expects that it will take farms with measures are critical for FDA to be able
take place in rural areas where lodging access to the Internet, either through to ensure compliance, and thus for the
is relatively inexpensive. Therefore, we their own computer, or through a friend, benefits of the SE prevention measures
estimate that the most likely travel public library, or internet café, 2 hours to be realized.
expense will be roughly $200 to $300. to research the requirements, fill out the
We use a Beta-Pert distribution to form and send it in. We expect that for TABLE 32—ANNUAL COST OF
estimate that the expected cost of travel farms without easy access to the
is $330. Internet, due to increased time for
ADMINISTRATIVE PROVISIONS
The average cost of attending a research and to send the documents, the [Thousands of dollars]
training class is estimated to be $1,850 process will take 3 hours.
($625 tuition + $895 labor + $330). Not FDA assumes the number of farms Plan design ........................... $1,243
all producers will have to send a with easy access to the Internet is Recordkeeping ...................... 9,809
supervisor to a class. The 12 percent of similar to the number used in the BT Training ................................. 343
Registration ........................... 30
large farms with established quality Registration Rule (68 FR 5378 at 5392 to
assurance programs will have a trained 5403), that is, 71 percent of farms. This Total ............................... 11,425
supervisor already running the program. number has two potential biases. The
Of the remaining farms, some have first is that the 71 percent of farms used G. Summary of Benefits and Costs of the
experienced personnel who do not need in the BT Registration Rule is related to Final Rule
formal training. Without better small businesses in general, not
information, we assume that the true specifically to farms. Because farms are In the previous section of this
number of establishments that will need typically rural, whereas small business document, we described and estimated
to formally train a supervisor will be in general may be rural or urban, the the benefits and costs of all of the SE
uniformly distributed between 0 and estimate for all small businesses may prevention measures we have
100 percent for all sizes of farms. overstate the Internet access for farmers. considered. Here, we summarize and
Therefore, we expect 1,299 farms with That being said, FDA believes that the estimate the benefits and costs of the
3,000 or more layers to incur training small business estimate is a good proxy final rule.
expenses. This cost will have to be for farms, and it is the most detailed 1. Coverage
incurred only at the outset of the data available. The second bias comes
program, and then again when a farm from the fact that the survey data used All of the on-farm SE prevention
loses a trained supervisor. The total cost in the BT regulations is relevant to the measures in the final rule apply to farms
for all farms training a supervisor every year 2002. Internet access has certainly with at least 3,000 layers that do not
10 years, whether amortized at 7 percent increased since that particular data was have all of their eggs treated, do not sell
or 3 percent, is estimated to be $0.3 published. all of their eggs directly to consumers,
million. We estimate that approximately 3,328 and produce shell eggs for the table
c. Registration.—i. Registration farms with 3,000 or more layers are market. Only the refrigeration and
provision. Under this provision, all covered by a registration provision. We registration requirements apply to farms
farms covered by any part of the rule are assume the value of labor is $18.65 per whose eggs all receive a treatment to
required to register with FDA. hour, plus 50 percent for overhead destroy SE. Only the refrigeration
Registration of all producers covered by costs, for a total cost of $55.95 per requirement applies to persons who
any of the SE prevention measures will producer with Internet access and transport and supply shell eggs for shell
$83.93 for producers with no Internet egg processing or egg products facilities.
89 The cost of a similar 3-day HACCP training
course for egg processors was advertised to be $450 91 Farms are not required to register under FDA’s
2. Provisions of the Final Rule
to $550 in 2000 (Ref. 119) and was offered through Registration of Food Facilities regulation (68 FR a. On-Farm preventive controls. Many
the U.S. Poultry and Egg Association. It is no longer 5378 at 5392 to 5403). If a farm also has a packing
offered. The course sited above is a course geared or processing facility, then only the packing or
of the on-farm preventive controls
towards meat processors. In a conversation with the processing facility is required to register under the examined previously are included in
International HACCP Alliance, FDA confirmed that registration rule (68 FR 5378 at 5392 to 5403). If the this final rule. Provisions included in
a similar course geared towards egg farmers, if information that would be provided by an egg the final rule are rodent and other pest
offered today, would cost roughly the same amount producer during registration has already been
($600 to $650). provided under the registration regulation, the
control, biosecurity, cleaning and
90 The number of hours is estimated as 24 hours producer may submit its registration number rather disinfecting, and procurement of chicks
of class time plus 8 hours of travel time. than registering again. and pullets from SE-monitored breeders.
b. On-Farm SE prevention measures. otherwise qualified individual to table 34 shows the cost per estimated
The rule also contains most of the on- administer the prevention measures QALY saved. Assuming a 7-percent
farm SE prevention measures described required by the final rule. discount rate, we estimate the rule will
previously. In particular, the Furthermore, all farms covered by any save approximately 5,055 QALYs
refrigeration, sampling, testing, and part of the rule are required to register annually. Assuming a 3-percent
diversion provisions are included in the with FDA. discount rate, the estimated number of
final rule. 3. Summary of Costs and Benefits QALYs saved annually is 8,708. This
c. Administrative provisions. All of In table 33 of this document, we translates to $16,100 per QALY saved
the administrative provisions discussed summarize the costs and illnesses using a 7-percent discount rate and
in this analysis are required by the final averted of this final rule and its $9,300 per QALY saved using a 3-
rule. In particular, the rule requires that provisions. After the on-farm percent discount rate.92 Either estimate
producers maintain records for chick adjustment phase (up to 4 years), we falls well below our most conservative
and pullet procurement, biosecurity, expect costs to fall and illnesses averted estimate of $100,000 for the value of a
rodent and other pest control, cleaning to increase. Eventually, the final rule quality adjusted statistical life year.
and disinfecting, refrigeration, and will prevent approximately 79,170 cases
testing and diversion. of SE per year at a cost of $1,000 per 92 QALDs were converted back to QALYs for each
Farms are required to use SE illness averted. This value is less than possible outcome by multiplying by 365. Annual
QALYs lost for a case of chronic arthritis (0.14) and
prevention measures and are required to the lowest estimate of the expected for death (1.0) were summed and subsequently
have a written SE prevention plan. Each value of an SE related illness, shown in discounted (at 3 percent and 7 percent) over 50
farm is required to have a trained or table 5 of this document. Furthermore, years.
BILLING CODE 4164–01–C
TABLE 34—COSTS PER QALY SAVED

Eventual costs QALYs saved Cost per QALY saved
(millions of (thousands of dollars)
dollars)
Discount rate 3% 7% 3% 7%
Provision
On-Farm Measures
Rodent and Pest Control 1 ................................................... $21.4 4,275 2,481 $6.3 $10.9
Biosecurity ............................................................................ 5.3 _ _1 _ _1
Cleaning and Disinfecting .................................................... 0.3 _ _1 _ _1

ER09JY09.001</GPH>
TABLE 34—COSTS PER QALY SAVED—CONTINUED

Eventual costs QALYs saved Cost per QALY saved
(millions of (thousands of dollars)
dollars)
Discount rate 3% 7% 3% 7%
0.0
Refrigeration ......................................................................... 20.2 3,177 1,844 6.3 10.9
Environmental Testing (Average) ........................................ 4.6 _ _2, 3 _ _2, 3
Egg Testing .......................................................................... 7.0 _ _2 _ _2
Diversion .............................................................................. 9.0 1,221 708 16.9 29.0

Procurement of SE-Monitored Chicks and Pullets .............. 2.1 35 20 59.0 101.7
On-Farm Administrative Measures
Plan Design .......................................................................... 1.2
Recordkeeping ..................................................................... 9.8
Training ................................................................................ 0.3
Registration .......................................................................... 0.0
Total .............................................................................. 81.2 8,708 5,055 9.3 16.1

The mean estimated dollar values of to illustrate the costs and lower uncertainty intrinsic to the underlying
the benefits, the complete range and incremental benefits of individual analysis. In table 35 of this document,
discussion of which is shown in table provisions or combinations of we present the results of a Monte Carlo
37 of this document, range from $228 provisions. Because table 33 shows the simulation of uncertainty for the
million to over $9.5 billion, depending effects of each provision when all are eventual annual costs of the rule.
on the uncertainty in the efficacy of the enacted, and the interdependence of Results are reported for the 5th and 95th
provisions and baseline number of each is accounted for, these estimates percentiles, as well as for the mean
illnesses, and the assumptions made can be added together, or mixed and value. Because many uncertainties
about VSL, QALY, and the discount matched, to achieve a rough estimate of could not be measured, this table should
rate. The lowest estimate of annual the lower bound effects of different not be seen as a complete
benefits is well above the high estimate combinations of provisions. Between characterization of the uncertainty
of $117 million estimated annual costs table 28 of this document and table 33, underlying the analysis. Nonetheless,
of the rule. Using the assumption set a bounded estimate of the incremental table 34 is a good illustration of the
resulting in our central estimate (VSL of effect of each provision is achieved. effect of the uncertainties we know to
$5 million, a VSLY of $300,000, and a Table 33 illustrates that we have not exist. Based on the data for which we
discount rate of 7 percent) gives us explicitly determined the benefits for have been able to characterize
estimated benefits of $1.5 billion, or net the administrative provisions. The uncertainty, we believe that the
benefits in excess of $1.4 billion. administrative provisions enhance the eventual annual cost of the final rule
Considering the widest range of benefits effectiveness of the SE prevention will lie between $57.5 million and
and costs, net benefits of the final rule measures mandated by the rule, and the $116.5 million. A complete description
could be as low as $111 million benefits are therefore embedded in the of the distributions underlying the
annually and as high as $9.4 billion benefits estimates for each control estimates of uncertainty can be found in
annually. measure. Ref. 106. While some of the range is
The benefits of some provisions in the driven by uncertainty in unit costs of
4. Analysis of Uncertainty
final rule are slightly lower in table 33 adopting the provisions, much of the
of this document than are the benefits In table 33 of this document and range is a product of uncertainty in
listed in the analysis of potential elsewhere we present the expected baseline practices. Indeed, the largest
provisions. This difference arises from effects of the final rule as point contributor to the range in total cost, the
the fact that each provision in the rule estimates. While this is a convenient uncertainty in the cost of the rodent and
reduces the base line number of way to summarize the effects of pest control provisions, is due in large
illnesses that is used to estimate the individual provisions and alternative part to the uncertainty in the current
benefits of the next provision in the list. regulatory options, the use of point baseline practices and extent of current
In this way, table 33 can also be used estimates neglects the large degree of rodent and pest problems.
TABLE 35—COSTS OF THE FINAL RULE: ANALYSIS OF UNCERTAINTY

[Millions of dollars] 1
On-farm measures 5th Percentile Mean 95th Percentile
Rodent and Pest Control ............................................................................................................. $12.0 $22.5 $36.1

Biosecurity ................................................................................................................................... 4.9 5.3 5.7
Cleaning and Disinfecting ............................................................................................................ 0.1 0.3 0.5
Refrigeration ................................................................................................................................ 15.6 20.2 24.7
Environmental Testing ................................................................................................................. 3.4 4.6 5.7
Egg Testing .................................................................................................................................. 4.6 7.0 12.1
Diversion ...................................................................................................................................... 4.9 9.0 16.1
SE Monitoring of Chicks and Pullets ........................................................................................... 1.9 2.1 2.2
On-Farm Administrative Measures .............................................................................................. 10.0 11.3 13.2
Total Costs of Final Rule ...................................................................................................... 57.5 82.2 116.5

1 See Ref. 106 for a description of the distributions underlying this table.
In tables 36 and 37 of this document, rule. The expected annual benefits in illnesses averted to over 191,000 cases
we characterize the uncertainties terms of illness averted from the final of SE illnesses averted.
associated with the benefits of the final rule range from nearly 30,000 SE
TABLE 36—ILLNESSES AVERTED BY THE FINAL RULE: ANALYSIS OF UNCERTAINTY1

Provision on-farm measures 5th Percentile Mean 95th Percentile
Rodent and Pest Control ............................................................................................................. 6,405 38,866 123,772
Biosecurity ................................................................................................................................... Included in Rodent and Pest Control
Cleaning and Disinfecting ............................................................................................................ Included in Rodent and Pest Control
Refrigeration ................................................................................................................................ 9,305 28,888 73,724

Testing and Diversion .................................................................................................................. 3,382 11,096 46,634
SE Monitoring of Chicks and Pullets ........................................................................................... 21 320 1,233
Total ...................................................................................................................................... 29,853 79,170 191,273

Table 37 of this document shows the baseline illnesses. The range is also economic assumptions, the expected
estimated annual benefits in constant affected by the uncertainty that benefits of the final rule exceed the
2005 dollars range from $228 million to expected target efficacies are met (e.g.: expected costs, regardless of uncertainty
$9.5 billion. A complete description of rodent and pest control, biosecurity, and in efficacy of the provisions, the
the distributions underlying the cleaning and disinfecting, and underlying prevalence of SE on farms,
estimates of uncertainty can be found in refrigeration), the underlying prevalence baseline practices, or even the
Ref. 106. The large range is due in great of SE (e.g.: testing and diversion), and uncertainty inherent in the estimation of
part to the uncertainties underlying the the uncertainty in baseline practices of baseline number of illnesses.
economic assumptions and number of all provisions. Under very reasonable
TABLE 37—ESTIMATED VALUE OF ALL ILLNESSES AVERTED, GIVEN DIFFERENT ECONOMIC ASSUMPTIONS
[Millions of dollars] 1, 2, 3, 4
Discount rate = 3%
VSL = $5 million VSL = $6.5 million
5th Percentile Mean 95th Percentile 5th Percentile Mean 95th Percentile
VSLY = $100 thousand ........................... $355.9 $943.8 $2,280.2 __ __ __

VSLY = $300 thousand ........................... 907.5 2,406.7 5,814.6 926.7 2,457.6 5,937.5
VSLY = $500 thousand ........................... __ __ __ 1,478.3 3,920.5 9,471.9
Discount rate = 7%
VSLY = $100 thousand ........................... $227.6 $603.5 $1,458.1 __ __ __

VSLY = $300 thousand ........................... 534.4 1,417.1 3,423.8 553.6 1,468.0 3,546.7
Discount rate = 7%
VSLY = $500 thousand ........................... __ __ __ 860.4 2,281.7 5,512.5

2 VSL means Value of a Statistical Life.
3 VSLY means Value of a Statistical Life Year.
4 VSL and effects of long term arthritis are annualized over 50 years.
Tables 35 through 37 of this used to value the health effects of 5. Rule as Final Versus Rule as Proposed
document show that the range of chronic reactive arthritis, the higher the
potential costs is much narrower than estimated monetary benefits of this final Table 38 of this document shows the
the range of potential benefits. The rule. estimated costs and benefits of the final
monetary estimates of benefits cover a Even the lowest 5th percentile of rule versus the proposed rule. The
broad range largely because of the estimated benefits, under the most proposed rule estimates have been
different values placed on cases of conservative reasonable assumptions, updated to correct model errors, add
chronic reactive arthritis that result exceeds the 95th percentile of estimated new data, and express costs and benefits
from SE illness. The higher the VSLY costs. in terms of 2005 constant dollars.
TABLE 38—SUMMARY OF ANNUAL COSTS AND BENEFITS AS ESTIMATED FOR THE FINAL AND PROPOSED RULES
[Millions of dollars]
Costs Illnesses averted Total benefits Net benefits

Provision
Final Proposed Final Proposed Final Proposed Final Proposed
On-Farm Measures
Rodent and Pest Control 1 ............................... $21.4 $21.4 38,866 38,950 $695.7 $697.2 $668.7 $659.3
Biosecurity ........................................................ 5.3 13.7 _ _1 _ _1 _ _1
Cleaning and Disinfecting ................................ 0.3 2.8 _ _1 _ _1 _ _1
Refrigeration ..................................................... 20.2 13.5 28,888 20,286 517.1 363.1 496.9 349.6
Environmental Testing (Average) .................... 4.6 4.6 _ _2, 3 _ _2, 3 _ _2, 3
Egg Testing ...................................................... 7.0 6.9 _ _2 _ _2 _ _2
Diversion .......................................................... 9.0 8.0 11,096 9,541 198.6 170.8 178.1 151.4
Procurement of SE-Monitored Chicks and Pul-

lets ................................................................ 2.1 0.1 320 14 5.7 0.3 3.6 0
Plan Design ...................................................... 1.2 1.2 __ __ __
Recordkeeping ................................................. 9.8 9.8 __ __ __
Training ............................................................ 0.3 0.3 __ __ __
Registration ...................................................... 0.03 0 __ __ __
Total .......................................................... 81.2 82.2 79,170 68,791 1,417.1 1,231.4 1,335.9 1,149.1
The annual costs are about $1.0 proposed and final rule. Cost decreased provisions and the earlier required
million higher for the final rule, as because, as suggested by comments to environmental test for flocks post-molt.
provisions were added that were not the proposed rule, some of the more We estimate that the final rule will avert
included in the proposed rule; the most prescriptive or less effective elements of about 10,400 additional illnesses
notable additions are the additional the provisions were removed. annually and provide for more than
refrigeration provisions. However, some Illnesses averted (and therefore total $185 million in additional annual net
costs associated with the biosecurity benefits) as well as net benefits are benefits, when compared to the
and cleaning and disinfecting much higher in the final rule, due proposed rule.
provisions decrease between the mainly to increased refrigeration
Table 38 of this document shows the options that would minimize any $11.5 million. Because only about 400
benefits of the rules, with all provisions significant impact of a rule on small farms fall into the category of 100,000 or
in place simultaneously. This is worth entities. The agency believes that this more layers, more than 99 percent of the
noting because it appears that the rodent final rule will have a significant farms with more than 3,000 layers are
and other pest control, biosecurity, and economic impact on a substantial considered small by SBA standards, and
cleaning and disinfecting provisions are number of small entities. The comments account for roughly 60 percent of all
less effective in the final rule. However, received concerning the Initial production.94
this is simply because the chick and Regulatory Flexibility Analysis (IRFA)
pullet provision is more effective in the and Proposed Regulatory Impact b. Costs to small entities. The final
final rule, so the baseline SE prevalence Analysis (PRIA) are contained in rule will result in costs to small
in flocks upon entry to the layer house Section V.C. businesses. These costs are presented in
is lower in the final rule than in the Table 39 of this document. For the
B. Economic Effects on Small Entities industry as a whole, the average annual
proposed rule. For the same reason,
table 38 likely understates the 1. Regulated Entities cost of the final rule is estimated to be
effectiveness of the refrigeration, and a. Number of small entities affected.93 about $24,100 per farm site covered by
testing and diversion, and other The Small Business Administration the rule. This translates into an average
provisions if they were implemented on (SBA) defines chicken and egg cost of $0.30 per layer. Because almost
their own. producers to be small if their total all farms are defined by SBA to be
VI. Final Regulatory Flexibility revenues are less than $11.5 million small, these overall industry costs are
Analysis (Ref. 120). A producer that receives representative of the average costs to
$0.45 per dozen eggs and has layers that small farms.
A. Introduction produce 265 eggs per year would have
The Regulatory Flexibility Act to have over 1,100,000 layers in
requires agencies to analyze regulatory production to earn revenues of over
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 di-
viding 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 publi-
cation of the rule, as consumers perceive eggs to be safer.
2. Other Affected Entities 95 unable to break out the number of chick some 50 or fewer of these facilities will
a. Number of small entities affected. i. and pullet farms by data from NAICS or be affected.
Introduction. The final rule requires that NASS,96 but, based on comments iii. Trucking companies and holding
layer farms use layers that were raised received, we estimate that there are facilities. SBA defines trucking
in SE-monitored chick and pullet flocks roughly one third as many pullet-raising companies and holding facilities for
and that they hold and ship shell eggs farms and chick-raising farms as there farm products to be small if their total
under proper refrigeration. In addition are layer farms affected by the rule. Also revenues are less than $23.5 million
to affecting layer farms, the final rule from comments, we learned that pullet annually (Ref. 120). By this definition,
will likely have an impact on some farms participate in state EQAPS at the FDA estimates that over 80 percent of
small chick and pullet farmers, trucking same rate as layer farms. Accordingly, trucking companies and over 60 percent
companies, and holding facilities. approximately 1,000 pullet houses will of holding facilities are small (Ref. 121).
ii. Chick and pullet farms. As with be affected by the rule. Because nearly Thus, more than 300 holding facilities
layer farms, nearly 100 percent of all all chicks are currently raised as that are affected by the final rule are
chick and pullet farms are considered certified SE-monitored (95 percent), small by SBA definition.97
small by SBA definition. We were
93 Please refer to Table 6 for a breakdown of the 95 The costs calculated for layer farms in Table 39 as many pullet farms as there are farms affected by
size of layer farms affected by the rule. include the costs to chick and pullet farms, the rule.
transport companies, and holding facilities. FDA
94 FDA does not know the exact percentage of 97 FDA only estimated the number of new
believes that layer farms will absorb much of the
production that comes from farms with more than refrigerated shipments necessary due to the final
costs associated provisions affecting these other
1.1 million layers, since the NASS Census of entities. rule. There are nearly 57,000 general freight
Agriculture (Ref. 71) does not include detail on the 96 NASS does not break pullet farms down by size trucking establishments (ref. 121). More than 47,000
industry above 100,000 layers. For the purpose of of operation. The 25,624 pullet farms listed in the of these are small by SBA definition. We do not
this calculation, we assume that half of the eggs 2002 NASS (Ref. 71) are roughly one fourth the total have information on the number of trucking
produced on farms with more than 100,000 layers number of layer farms listed. For the purposes of companies that specifically ship eggs from farms
are produced on farms that are small by SBA this analysis, we used data received from public with 3,000 or more layers and will therefore be
definition. comment that indicated there are roughly one third affected by the final rule.
b. Costs to small entities. i. Chick and pullet houses is 0 to 1.5 percent. Based provision will cost approximately $0.02
pullet farms. We do not have data for on these factors, as shown in detail in per dozen eggs shipped, or $1.7 million
the cost of monitoring chicks for SE. the RIA for this rule, FDA estimates the across the industry.
However, Morales and McDowell (Ref. total costs generated by the provisions
C. Regulatory Options
91) estimated that pullets monitored for addressing pullets is about $2 million
SE cost approximately $0.003 to $0.02 annually, or about $2,000 per pullet 1. Exemption for Small Entities
more per pullet. If we assume the cost farm, per year. FDA expects that some
difference is the same for chicks, the i. One possible approach to reduce the
of these costs could be passed on to the
total increased annual cost of requiring impact on small entities would be to
layer farms.98
SE-monitored chicks is estimated in the ii. Trucking companies and holding exempt all small entities from the rule.
RIA for this rule to be about $87,000, for facilities. Based on the cost per cubic Although this would significantly
a cost of about $1,700 per chick farm if foot of extra refrigeration necessary to reduce costs, it would also significantly
roughly 50 are affected. This cost will be meet the 45 °F threshold, FDA estimates reduce benefits. As mentioned
borne by pullet growers but could be that the refrigeration requirement will previously, under the SBA size
passed on to egg farms depending on cost the smallest holding facilities less standards the vast majority of entities
market conditions. than $500 annually and the largest affected by this final rule are small.
In addition, pullet houses must be holding facilities (those holding more Small farms include not only farms with
tested for environmental SE before the than 1 million eggs at a time) more than a few hundred layers, but also some
pullets are transferred to the layer $18,000 annually, for an industry larger farms with over 100,000 layers.
houses. If the environment tests average of nearly $10,000 in increased An alternative approach,
positive, the house must be cleaned and costs per facility each year. If we assume implemented in the final rule, exempts
disinfected before another flock enters that the costs for increased refrigeration producers with fewer than 3,000 layers
the house. Furthermore, upon an are proportional to revenues (because at a particular farm.99 While over 90
environmental positive in the pullet costs are directly proportional to the percent of farm sites have fewer than
house, layer farms must begin egg volume of eggs held) the smallest 60 3,000 layers, less than 1 percent of the
testing on the positive flock within 2 percent of holding facilities will incur eggs produced in the United States are
weeks of the start of egg laying. Farms increased annual costs of between $500 produced on these farms.
that test positive for SE in their eggs and $11,000. The larger numbers in this FDA has decided to exempt all farms
would be required to divert their eggs range will be incurred by the larger with fewer than 3,000 layers and those
for treatment until they are able to show facilities still meeting SBA’s definition farms that sell all of their eggs directly
via testing that SE is not present in the of small. to consumers.
eggs produced in the infected house. FDA does not have information on the By exempting these farms, we reduce
The cost of the additional steps, cost of the refrigeration provision to expected benefits by less than 1 percent
cleaning and disinfecting, and egg trucking companies. However, FDA while reducing expected costs by more
testing and diversion, depends on the estimates that the large majority of eggs than one half. Table 40 of this document
prevalence of SE in pullet houses. From are currently shipped in refrigerated shows a detailed breakdown of the
data gathered from comments, FDA trucks. For eggs that are not currently potential costs and benefits of regulating
estimates that the prevalence of SE in shipped at 45 °F, FDA estimates that the 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
Illnesses
Costs Total benefits Net benefits
averted
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
Plan Design ....................................................................................................... 10.9 __ __ __

Recordkeeping ................................................................................................... 56.9 __ __ __

Training .............................................................................................................. 6.7 __ __ __
Registration ........................................................................................................ 0.42 __ __ __
98 To see the effects of the costs if passed 99 An exemption for farms with fewer than 3,000
completely to layer farms, please refer to Tables 39 birds is consistent with the exemption given by the
and 33. EPIA for egg farms that are also egg processors.
TABLE 40—SUMMARY OF ANNUAL COSTS AVERTED AND BENEFITS FOREGONE BY EXEMPTING FARMS LESS THAN 3,000
LAYERS—Continued
Illnesses
Costs Total benefits Net benefits
averted
Total ............................................................................................................ 115.3 556 9.9 ¥105.3

The exemption of farms with less than FDA will continue to evaluate the sells raw (untreated) eggs to the table
3,000 layers carries over to entities impact of this rule on smaller farms and egg market, other than directly to the
potentially affected by, but not directly will consider taking appropriate steps to consumer, must design and monitor an
regulated by, the rule. Pullet farms mitigate those impacts, where it is SE-prevention plan. This prevention
supplying layer farms with less than possible to do so without reducing plan includes all measures the farm is
3,000 layers, will not necessarily need safety. Further, FDA will publish taking to prevent SE in its flock. The
to prove SE-monitored status. Trucks guidance for all covered egg producers, following elements must be included in
and storage facilities holding eggs only and small entity compliance guides, the plan: (1) Chicks and pullets, (2)
for farms with less than 3,000 layers which will help inform and educate biosecurity, (3) rodent and other pest
need not be refrigerated at 45 °F. small businesses on the requirements of
control, (4) cleaning and disinfecting,
the rule. We plan to use guidance, to the
2. Longer Compliance Periods (5) refrigeration, and (6) testing and
extent feasible, as a vehicle to identify
We recognize that it may be more areas where compliance could be diversion. Records are also required for
difficult for some small farms to learn achieved via flexible approaches that review and of modifications of the SE-
about and implement these SE would mitigate the financial impact prevention plan and corrective actions
prevention measures than it will be for while preserving the public health taken. Farms are required to have a
other farms. Because of this, FDA is benefits of the rule. Stakeholder trained or experienced supervisor that
giving farm sites with 3,000 or more, but participation in these documents will be would be responsible for overseeing the
fewer than 50,000 layers, 3 years (as solicited and considered. plan. Furthermore, all farms covered by
opposed to 1 year for larger farm sites) any part of the rule are required to
to comply with this rule. The longer D. Description of Recordkeeping and
register with FDA. The cost of
compliance period also affects chick Recording Requirements
recordkeeping is exhibited in Table 41
and pullet flocks supplied to farms, and The Regulatory Flexibility Act of this document. We detail in section
the shipment and storage of eggs for requires a description of the V.F of this document how
farms with between 3,000 and 50,000 recordkeeping required for compliance recordkeeping costs are calculated.
layers. with this final rule. Each farm site that
TABLE 41—COST OF RECORDKEEPING BY FARM SIZE

Per farm Per layer
Farm size (number of layers) cost 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 result in the expenditure by State, local, Mandates Reform Act. FDA has carried
FDA finds that, under the Regulatory and tribal governments, in the aggregate, out the cost-benefit analysis in
Flexibility Act (5 U.S.C. 605(b)), this or by the private sector, of $100,000,000 preceding sections. The other
final rule will have a significant impact or more (adjusted annually for inflation) requirements under the Unfunded
on a substantial number of small in any one year.’’ The current threshold Mandates Act of 1995 include assessing
entities. More than 1,000 small farms after adjustment for inflation is $127 the rule’s effects on:
will be affected by the final rule. million, using the most current (2006) • Future costs;
Implicit Price Deflator for the Gross • Particular regions, communities, or
VII. Unfunded Mandates Domestic Product.100 FDA has industrial sectors;
Section 202(a) of the Unfunded determined that this final rule is • National productivity;
Mandates Reform Act of 1995 requires significant under the Unfunded • Economic growth;
that agencies prepare a written • Full employment;
statement, which includes an 100 In table 7 of this document, describing the
• Job creation; and
total costs of the rule, costs are annualized. When
assessment of anticipated costs and costs are not annualized, particularly the first year
• Exports.
benefits, before proposing ‘‘any rule that costs of refrigeration, the total initial costs are The issues listed above are covered in
includes any Federal mandate that may clearly more than $127 million. detail in the cost benefit analysis of the
preceding sections, with the exception $100 million or more; a major increase use of automated collection techniques,
of the trade effects of this final rule, in costs or prices; significant adverse when appropriate, and other forms of
which we will discuss here. effects on competition, employment, information technology.
Given the fragile and highly productivity, or innovation; or Title: Prevention of Salmonella
perishable nature of table eggs and the significant adverse effects on the ability Enteritidis in Shell Eggs During
restrictions imposed by USDA to ensure of United States-based enterprises to Production, Storage, and
safety of imported animals and animal compete with foreign-based enterprises Transportation—Recordkeeping and
products (9 CFR part 94), few eggs are in domestic or export markets. In Registration Provisions Under 21 CFR
imported into the United States. Only accordance with the Small Business Part 118.
three countries, Canada, Mexico, and Regulatory Enforcement Fairness Act, Description: FDA is requiring shell
New Zealand are permitted to export the Office of Management and Budget egg producers to implement measures to
shell eggs to the United States. Further, (OMB) has determined that this final prevent SE from contaminating eggs on
since 2004, only New Zealand continues rule is a major rule for the purpose of the farm and from further growth during
to send shell eggs to the United States congressional review. storage and transportation. Each farm
(Ref. 122). In 2006, a firm from New site with 3,000 or more egg laying hens
IX. Paperwork Reduction Act of 1995
Zealand shipped 55,112 dozen eggs to that sells raw eggs to the table egg
the United States. These eggs originated This final rule contains information
market, other than directly to the
from a single farm in New Zealand with collection provisions that are subject to
consumer, and does not have all of the
a little more than 3,000 layers (Ref. 122). review by OMB under the Paperwork
eggs treated, must design and monitor
These eggs represent about one one- Reduction Act of 1995 (44 U.S.C. 3501–
an SE prevention plan. This prevention
thousandth of the eggs produced in the 3520). A description of these provisions
plan includes all measures the farm is
United States annually. is given in the following paragraphs
taking to prevent SE in its flock. Records
In order to qualify to export eggs to with an estimate of the annual
are also required for each of the
the United States, New Zealand egg recordkeeping and reporting burdens.
provisions included in the plan and for
production is already highly regulated. Included in the estimate is the time for
plan review and modifications if
Therefore, it is unlikely the farm that reviewing instructions, searching
corrective actions are taken.
produces the exports to the United existing data sources, gathering and
Furthermore, all farms covered by any
States would bear even the average cost maintaining the data needed, and
part of the rule are required to register
estimated for a similar sized farm in the completing and reviewing each
with FDA.
United States. However, if we assume collection of information.
the costs are similar across countries, FDA invites comments on: (1) We have concluded that
the final rule would cost the New Whether the proposed collection of recordkeeping is necessary for the
Zealand farm, or similar exporting information is necessary for the proper success of the SE prevention measures.
farms, about $3,000 annually, or about performance of FDA’s functions, Written SE prevention plans and
$0.04 per dozen eggs produced. including whether the information will records of actions taken due to each
have practical utility; (2) the accuracy of provision are essential for farms to
VIII. Small Business Regulatory FDA’s estimate of the burden of the implement SE prevention plans
Enforcement Fairness Act proposed collection of information, effectively. Further, they are essential
The Small Business Regulatory including the validity of the for FDA to be able to determine
Enforcement Fairness Act of 1996 methodology and assumptions used; (3) compliance.
(Public Law 104–121) defines a major ways to enhance the quality, utility, and Description of Respondents:
rule for the purpose of congressional clarity of the information to be Businesses or other for-profit
review as having caused or being likely collected; and (4) ways to minimize the organizations.
to cause one or more of the following: burden of the collection of information FDA estimates the burden of this
An annual effect on the economy of on respondents, including through the collection of information as follows:
TABLE 42—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1, 6

Number of Annual Total annual Hours per
21 CFR section record- frequency of Total hours
records recordkeeper
keepers 2 recordkeeping
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 (a)(3)(viii) 3, 4, 5 ................................ 471 52 24,492 0.5 12,246
5,837 1 5,837 0.5 2,919
118.10(a)(3)(v) through (a)(3)(viii) 3, 4 .................................. 343 52 17,836 0.5 8,918
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 descrip-
tion of the breakdown.
3 The annual frequency of records kept for this provision depends on whether the house actually tests positive for SE.
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 a per house basis, but will only need to 24286). Because the HACCP time
burden of this final rule to be 387,962 be kept in the event that a layer house estimate upon which we are basing our
hours in the first year, and 331,354 each tests environmentally positive. Design estimate involves multiple control
year thereafter, as shown in table 42 of plan and review (§ 118.10(a)(4)) will points and monitoring, this assumption
this document. also need to be performed every time a tends to overstate the cost of
The number of recordkeepers house tests positive. As discussed in recordkeeping for a provision of this
estimated in column 2 of table 42 of this section V.F of this document, FDA final rule. In particular, we expect that,
document are based on estimates of the estimates that 9.7 percent of houses will for each house affected, recordkeeping
total number of layer and pullet houses test environmentally positive initially will take one half hour per week per
affected by this final rule from statistics and 7.0 percent will test positive after provision that would require weekly or
obtained from the Layers study, NASS, the provisions of this rule have taken daily monitoring. Records kept for
and comments to the proposed rule. We effect. Therefore, the number of biosecurity measures, rodent and pest
assume that those farms that are recordkeepers for these provisions is control, and refrigeration are assumed to
currently operating according to estimated to be 459 (4,731 houses × be recorded on a weekly basis.
recognized industry or State quality 0.097) in the first year and 331 (4,731
assurance plans are already largely in houses × 0.070) annually after the first Records for chick and pullet
compliance with the plan design and year. procurement and cleaning and
recordkeeping provisions discussed in Records of testing, diversion, and disinfection will only have to be
this section, and therefore would not treatment (§ 118.10(a)(3)(v) through collected roughly once per year and are
experience additional costs to comply (a)(3)(viii)) will be kept on a per house assumed, as above, to require one half
with recordkeeping provisions. Using basis and will include records on flocks hour to produce each record.
data from the Layers study (Refs. 27 and from pullet houses. From data provided Environmental and egg sampling and
28), we find that 59 percent of farms by comments, FDA estimates that there testing, diversion and treatment records
with more than 50,000 layers are are one third as many pullet houses as together have daily, weekly, and
currently members of State or industry there are layer houses. Therefore the monthly aspects, in the event of an
quality assurance plans. Fewer than 8 total number of recordkeepers for these environmental positive. In the case of an
percent of farms with fewer than 50,000 provisions is 6,308 (4,731 + (4,731/3)). environmental positive, the record’s
layers are currently members of quality The number of annual records kept annual burden is assumed to be similar
assurance plans. The estimated number depends on whether houses test positive to the burden estimated for the weekly
of layer farms incurring a new for SE or not. This is further discussed records discussed previously. If a house
recordkeeping burden because of this in the following paragraphs. tests environmentally negative, the
rule is 2,600, and the number of houses Because information on the costs of burden is similar to the yearly burden
affected is 4,731. A detailed breakdown designing the SE prevention plan for estimated above. In the first year, 471
of this estimation is shown in table 29 eggs is not available, we base these costs layer and pullet houses ((4,731 layer
of this document. on assumptions used to analyze the houses × 0.097) + ((4731/3 pullet
Plan design (§ 118.10(a)(1)) and design of HACCP programs (63 FR houses) × 0.0075)) are expected to test
refrigeration records (§ 118.10(a)(3)(iv)) 24253 at 24275 to 24285). In particular,
positive and 5,837 are expected to test
will be kept on a per farm basis, so the we assume that each plan component
negative ((4,731 layer houses × 0.903) +
number of recordkeepers for these will take approximately 20 hours to
((4731/3 pullet houses) × 0.9925)). In
provisions is 2,600. Plan design is a first design. In the event of an environmental
following years 343 layer and pullet
year burden only. positive, the farm must review and
Records of chick and pullet modify as necessary its plan design. houses ((4,731 layer houses × 0.070) +
procurement (§ 118.10(a)(2)), rodent and FDA estimates this will take roughly ((4731/3 pullet houses) × 0.0075)) are
other pest control (§ 118.10(a)(3)(ii)), half the time (10 hours per provision) expected to test positive 101 and 5,965
and biosecurity (§ 118.10(a)(3)(i)) will be that it took to originally draft the plan. are expected to test negative ((4,731
kept on a per house basis, so the number We assume that the time required for layer houses × 0.930) + ((4731/3 pullet
of recordkeepers for these provisions is recordkeeping is roughly equivalent to houses) × 0.9925)).
4,731. the time necessary to monitor and The reporting burden due to the
Records of cleaning and disinfection document the food safety provisions of registration requirement is shown in
(§ 118.10(a)(3)(iii)) will also be kept on a HACCP plan (63 FR 24253 at 24275 to table 43 of this document.
TABLE 43—ESTIMATED ANNUAL REPORTING BURDEN 1, 4

Number of Annual frequency Total annual Hours per
21 CFR section FDA form No. Total hours
respondents per response responses response
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 Reg-
istration Module, which will be available at http://www.access.fda.gov per § 118.11(b)(1).
3 First year burden.
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.
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 XI. Federalism agency shall provide all affected State
new, one time reporting burden for all FDA has analyzed this final rule in and local officials notice and an
farms with more than 3,000 layers. FDA accordance with the principles set forth opportunity for appropriate
used NASS to estimate that there are in Executive Order 13132 on federalism. participation in the proceedings.’’ As
3,329 such farms, as detailed in section We have examined the effects of the required by the Executive order, FDA
V.D of this document. Using experience requirements of this rule on the provided the States and local
gained from implementing section 415 relationship between the Federal governments with an opportunity for
of the FFDCA (21 U.S.C. 350d), FDA Government and the States. The agency appropriate participation in this
estimates that listing the information concludes that preemption of State or rulemaking when it sought input from
required by the final rule and presenting local rules that establish requirements all stakeholders through publication of
it in a format that will meet the agency’s for the prevention of Salmonella the proposed rule in the Federal
registration regulations will require a Enteritidis (SE) in shell eggs during Register on September 22, 2004 (69 FR
burden of approximately 2.3 hours per production, storage, or transportation 56824 at 56889). In the proposal, FDA
average facility registration. As detailed that are less stringent than those in this specifically described this preemptive
in section V.F of this document, FDA rule is consistent with this Executive effect. The proposal stated that, through
expects that it will take farms with order and has added § 118.12(d) to the this notice of proposed rulemaking,
access to the Internet 2 hours to register rule to reflect this preemptive effect. State and local governments have a
and for farms without easy access to the Section 3(b) of Executive Order 13132 chance to participate in the proceedings,
Internet it will take 3 hours to register. recognizes that Federal action limiting and that in addition, ‘‘appropriate
FDA assumes the number of farms with the policymaking discretion of States is officials and organizations will be
easy access to the Internet is similar to appropriate ‘‘where there is consulted before this proposed action is
the number used in the BT Registration constitutional and statutory authority implemented; the agency plans to have
Rule (68 FR 5378 at 5392 to 5403), that for the action and the national activity public meetings specifically addressing
is, 71 percent of farms. The average is appropriate in light of the presence of the issue of implementation of these
facility burden hour estimate of 2.3 a problem of national significance.’’ The proposed regulations.’’
hours takes into account that some constitutional basis for FDA’s authority The agency consulted with a working
respondents completing the registration to regulate the safety and labeling of group comprised of State officials in
may not have readily available Internet foods is well established. developing the provisions of that
access (29 percent). Section 4(a) of Executive Order 13132 proposed rule. In addition, we sent
In compliance with the Paperwork expressly contemplates preemption facsimiles of a Federal Register
Reduction Act of 1995 (44 U.S.C. where the exercise of State authority document announcing a public meeting
3507(d)), the agency has submitted the conflicts with the exercise of Federal of egg safety and the availability of egg
information collection provisions of this authority under a Federal statute. safety ‘‘current thinking’’ documents
final rule to OMB for review. Interested Moreover, section 4(b) of Executive prepared by FDA and USDA to
persons are requested to fax comments Order 13132 authorizes preemption of Governors, State health and agriculture
regarding information collection by (see State law by rulemaking when the commissioners, State attorneys general,
DATES), to the Office of Information and exercise of State authority directly and State food program coordinators.
Regulatory Affairs, OMB. To ensure that conflicts with the exercise of Federal Further, subsequent to the publication
comments on information collection are authority under the Federal statute or of the proposed rule, the agency held
received, OMB recommends that written there is clear evidence to conclude that three public meetings to discuss the
comments be faxed to the Office of Congress intended the agency to have provisions of the rule, answer questions,
Information and Regulatory Affairs, the authority to preempt State law. and solicit comments from stakeholders.
OMB, Attn: FDA Desk Officer, FAX: State and local laws and regulations Meetings were held October 28, 2004, in
202–395–6974. that would impose less stringent College Park, MD; November 9, 2004, in
Prior to the effective date of this final requirements for prevention of SE in Chicago, IL; and November 16, 2004, in
rule, FDA will publish a notice in the shell eggs during production, storage, Los Angeles, CA. Additionally,
Federal Register announcing OMB’s and transportation would undermine presentations on the proposed rule were
decision to approve, modify, or the agency’s goal of ensuring that shell made to the following groups: Iowa Egg
disapprove the information collection eggs are produced, stored, and Industry Symposium in Ames, IA, on
provisions in this final rule. An agency transported using measures that will November 10, 2004; Central Atlantic
may not conduct or sponsor, and a prevent their contamination with SE. States Association of Food and Drug
person is not required to respond to, a These requirements are the minimal Officials Meeting in Laurel, MD, in
collection of information unless it national prevention measures that we December 2004; Agricultural Research
displays a currently valid OMB control believe are necessary to ensure safety. Service—Food Safety and Inspection
number. However, the requirements of this final Service Joint Food Safety Meeting in
rule do not preempt State and local Shepherdstown, WV, in Spring 2005;
X. Analysis of Environmental Impact laws, regulations, and ordinances that National Egg Regulatory Officials
The agency has determined under 21 establish more stringent requirements Meeting in Orlando, FL, in March 2005;
CFR 25.30(j) that this action is of a type with respect to prevention of SE in shell National Egg Quality School in
that does not individually or eggs during production, storage, or Indianapolis, IN, in May 2005; and
cumulatively have a significant effect on transportation. National Egg Regulatory Officials
the human environment. Therefore, Section 4(e) of the Executive order Meeting in Oklahoma City, OK, in
neither an environmental assessment provides that, ‘‘when an agency March 2006. Both State and local
nor an environmental impact statement proposes to act through adjudication or government officials attended and
is required. rulemaking to preempt State law, the participated in these meetings.
As a result of the extensive outreach carrying out inspections under Through Food—10 States, 2008. MMWR
FDA conducted during the proposed § 118.12(b) and by using the 2009; 58:333–337.
rule notice and comment period to administrative remedies in § 118.12(a) 11–12. Centers for Disease Control and
Prevention, ‘‘Outbreaks of Salmonella
provide State and local officials with the unless FDA notifies the State or locality
Serotype Enteritidis Infection Associated
opportunity for meaningful input, we in writing that its assistance is no longer with Eating Raw or Undercooked Shell
received comments from numerous needed. FDA plans to provide guidance Eggs—United States, 1996–1998’’,
State government agencies. Many of the to States and localities through an MMWR 2000; 49:73–79.
comments support FDA in developing a enforcement and implementation 13. CDC memorandum, Frederick J. Angulo
national standard for the prevention of guidance subsequent to this final rule. to the Record, July 10, 2007.
SE in shell eggs during production, In conclusion, the agency has 14. Mishu, B., J. Koehler, L.A. Lee, D.
storage, and transportation. In fact, one determined that the preemptive effects Kodrigue, F., Hickman Brenner, P. Blake,
State agency commented that ‘‘we of this final rule are consistent with and R.V. Tauxe, ‘‘Outbreaks of
Salmonella Enteritidis infections in the
completely agree with proposed Executive Order 13132. United States’’, 1985–1991, Journal of
regulations that make measures already Infectious Disease 169: 547–552, 1994.
XII. References
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mandatory for all producers * * *.’’ The following references have been Prevention, ‘‘Outbreaks of Salmonella
Another State agency stated that, placed on display in the Division of Serotype Enteritidis Infection Associated
‘‘Overall FDA’s proposal to require SE Dockets Management (see ADDRESSES) with Eating Shell Eggs—United States,
prevention measures for egg production and may be seen by interested persons 1999–2001’’, MMWR 2003; 51:1149–
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Hydrotaea aenescens (Wiedemann) Department of Agriculture, January 4, 119. U.S. Poultry & Egg Association
(Diptera: MU.S.C.idae), at Caged-Layer 2000. Educational Programs, U.S. Poultry and
Egg Association, accessed online August 118.8 Testing methodology for Salmonella Farm means all poultry houses and
8, 2000. Enteritidis (SE). grounds immediately surrounding the
120. Small Business Association, ‘‘Small 118.9 Administration of the Salmonella poultry houses covered under a single
Business Size Standards by NAICS Enteritidis (SE) prevention plan. biosecurity program.
Industry’’, United States Small Business 118.10 Recordkeeping requirements for the
Association, accessed online via GPO Salmonella Enteritidis (SE) prevention
Flock means all laying hens within
Access, October 4, 2007. plan. one poultry house.
121. Small Business Association, ‘‘U.S. 118.11 Registration requirements for shell Group means all laying hens of the
receipt size of firm by major industry egg producers covered by the same age within one poultry house.
group, 1997 & 2002’’, United States requirements of this part. Induced molting means molting that
Small Business Association, accessed 118.12 Enforcement and compliance. is artificially initiated.
online, October 4, 2007. Authority: 21 U.S.C. 321, 331–334, 342, Laying cycle means the period of time
122. FDA Memorandum, On U.S. shell and 371, 381, 393; 42 U.S.C. 243, 264, 271. that a hen begins to produce eggs until
egg product imports, November 20, 2007. it undergoes induced molting or is
List of Subjects § 118.1 Persons covered by the permanently taken out of production
requirements in this part. and the period of time that a hen
21 CFR Part 16 (a) If you are a shell egg producer with produces eggs between successive
Administrative practice and 3,000 or more laying hens at a particular induced molting periods or between
procedure. farm that does not sell all of your eggs induced molting and the time that the
directly to consumers and that produces hen is permanently taken out of
21 CFR Part 118 shell eggs for the table market, you are production.
Eggs and egg products, Incorporation covered by some or all of the Molting means a life stage during
by reference, Recordkeeping requirements in this part, as follows: which hens stop laying eggs and shed
requirements, Safety. (1) If any of your eggs that are their feathers.
produced at a particular farm do not Pest means any objectionable animal
■ Therefore, under the Federal Food, receive a treatment as defined in including, but not limited to, rodents,
Drug, and Cosmetic Act and the Public § 118.3, you must comply with all of the flies, and larvae.
Health Service Act, and under the requirements of this part for egg Positive flock means a flock that has
authority delegated to the Commissioner production on that farm. had an egg test that was positive for SE.
of Food and Drugs, 21 CFR parts 16 and (2) If all of your eggs that are A flock is considered positive until that
118 are amended as follows: produced at the particular farm receive flock meets the egg testing requirements
a treatment as defined in § 118.3, you in § 118.6(c) to return to table egg
PART 16—REGULATORY HEARING must comply only with the refrigeration production.
BEFORE THE FOOD AND DRUG requirements in § 118.4(e) for Positive poultry house means a
ADMINISTRATION production of eggs on that farm and poultry house from which there has
■ 1. The authority citation for 21 CFR with the registration requirements in been an environmental test that was
part 16 continues to read as follows: § 118.11. positive for SE at any time during the
(b) If you transport or hold shell eggs life of a group in the poultry house until
Authority: 15 U.S.C. 1451–1461; 21 U.S.C. for shell egg processing or egg products that house is cleaned and disinfected
141–149, 321–394, 467f, 679, 821, 1034; 28 facilities, you must comply with the
U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.
according to § 118.4(d).
refrigeration requirements in § 118.4(e). Poultry house means a building, other
■ 2. Section 16.5 is amended by adding This section applies only to eggs from structure, or separate section within a
paragraph (a)(5) to read as follows: farms with 3,000 or more laying hens. structure used to house poultry. For
structures comprising more than one
§ 16.5 Inapplicability and limited § 118.3 Definitions.
section containing poultry, each section
applicability. The definitions and interpretations of that is separated from the other sections
(a) * * * terms in section 201 of the Federal is considered a separate house.
(5) A hearing on an order for Food, Drug, and Cosmetic Act (the Producer means a person who owns
diversion or destruction of shell eggs FFDCA) (21 U.S.C. 321) are applicable and/or operates a poultry house
under section 361 of the Public Health to such terms when used in this part, containing laying hens which produce
Service Act (42 U.S.C. 264), and except where they are redefined in this shell eggs for human consumption.
§ 118.12 of this chapter. part. The following definitions also Shell egg (or egg) means the egg of the
* * * * * apply: domesticated chicken.
Biosecurity means a program, Shell egg processing facility means a
■ 3. Part 118 is added to read as follows: including the limiting of visitors on the facility that processes (e.g., washes,
farm and in poultry houses, maintaining grades, packs) shell eggs for the table
PART 118—PRODUCTION, STORAGE,
personnel and equipment practices that egg market.
AND TRANSPORTATION OF SHELL
will protect against cross contamination Treatment (or treated) means a
EGGS
from one poultry house to another, technology or process that achieves at
Sec. preventing stray poultry, wild birds, least a 5-log destruction of SE for shell
118.1 Persons covered by the requirements cats, and other animals from entering eggs, or the processing of egg products
in this part. poultry houses, and not allowing in accordance with the Egg Products
118.3 Definitions. employees to keep birds at home, to
118.4 Salmonella Enteritidis (SE) Inspection Act.

ensure that there is no introduction or
prevention measures. § 118.4 Salmonella Enteritidis (SE)
transfer of Salmonella Enteritidis (SE)
118.5 Environmental testing for Salmonella prevention measures.
Enteritidis (SE). onto a farm or among poultry houses.
118.6 Egg testing for Salmonella Enteritidis Egg products facility means a USDA- You must follow the SE prevention
(SE). inspected egg products plant where measures set forth in this section. In
118.7 Sampling methodology for liquid, frozen, and/or dried egg products addition, you must have and implement
Salmonella Enteritidis (SE). are produced. a written SE prevention plan that is
specific to each farm where you produce glueboards or another appropriate laying hens. If the poultry house
eggs and that includes, at a minimum, monitoring method and, when contains more than one group of laying
the following SE prevention measures: monitoring indicates unacceptable hens, then you must perform
(a) Pullets. You must procure pullets rodent activity within a poultry house, environmental testing on the poultry
that are SE monitored or raise pullets use appropriate methods to achieve house when each group of laying hens
under SE monitored conditions. ‘‘SE satisfactory rodent control; is 40 to 45 weeks of age.
monitored’’ means the pullets are raised (2) Monitor for flies by spot cards, (2) If the environmental test at 40 to
under SE control conditions that Scudder grills, or sticky traps or another 45 weeks is positive, then you must:
prevent SE, including: appropriate monitoring method and, (i) Review and make any necessary
(1) Procurement of chicks. Chicks are when monitoring indicates adjustments to your SE prevention plan
procured from SE-monitored breeder unacceptable fly activity within a to ensure that all measures are being
flocks that meet the National Poultry poultry house, use appropriate methods properly implemented and
Improvement Plan’s standards for ‘‘U.S. to achieve satisfactory fly control. (ii) Begin egg testing (described in
S. Enteritidis Clean’’ status (9 CFR (3) Remove debris within a poultry § 118.6), unless you divert eggs to
145.23(d)) or equivalent standard; house and vegetation and debris outside treatment as defined in § 118.3 for the
(2) Environmental testing. a poultry house that may provide life of the flock in that poultry house.
(i) The pullet environment is tested harborage for pests. Results of egg testing must be obtained
for SE when pullets are 14 to 16 weeks (d) Cleaning and disinfection. You within 10-calendar days of receiving
of age; must clean and disinfect the poultry notification of the positive
(ii) If the environmental test required house according to these procedures environmental test.
in paragraph (a)(2)(i) of this section is before new laying hens are added to the (b) Environmental testing after an
negative, you do not need to perform house, if you have had an induced molting period. If you induce a
any additional testing of those birds or environmental test or an egg test that molt in a flock or a group in a flock, you
their environment until the was positive for SE at any point during must perform environmental testing for
environmental test at 40 to 45 weeks of the life of a flock that was housed in the SE in the poultry house at 4 to 6 weeks
age specified in § 118.5(a); and poultry house prior to depopulation. As after the end of any molting process.
(iii) If the environmental test required (1) If an environmental test at 4 to 6
part of the cleaning and disinfection
in paragraph (a)(2)(i) of this section is weeks after the end of the molting
procedures, you must:
positive, you must begin egg testing, as process is negative and none of your
(1) Remove all visible manure;
specified in § 118.6, within 2 weeks of (2) Dry clean the positive poultry laying hens in that poultry house is
the start of egg laying. house to remove dust, feathers, and old molted again, then you do not need to
(3) Cleaning and disinfection. If the
feed; and perform any additional environmental
environmental test required in
(3) Following cleaning, disinfect the testing in that poultry house. Each time
paragraph (a)(2) of this section is
positive poultry house with spray, a flock or group within the flock is
positive, the pullet environment is
aerosol, fumigation, or another molted, you must perform
cleaned and disinfected, to include:
(i) Removal of all visible manure; appropriate disinfection method. environmental testing in the poultry
(ii) Dry cleaning the positive pullet (e) Refrigeration. You must hold and house at 4 to 6 weeks after the end of
house to remove dust, feathers, and old transport eggs at or below 45 °F ambient the molting process.
feed; and temperature beginning 36 hours after (2) If the environmental test at 4 to 6
(iii) Following cleaning, disinfection time of lay. If the eggs are to be weeks after the end of a molting process
of the positive pullet house with spray, processed as table eggs and are not is positive, then you must:
aerosol, fumigation, or another processed for the ultimate consumer (i) Review and make any necessary
appropriate disinfection method. within 36 hours from the time of lay adjustments to your SE prevention plan
(b) Biosecurity. As part of this and, therefore, are held and transported to ensure that all measures are being
program, you must take steps to ensure as required at or below 45 °F ambient properly implemented; and
that there is no introduction or transfer temperature, then you may then hold (ii) Begin egg testing (described in
of SE into or among poultry houses. them at room temperature for no more § 118.6), unless you divert eggs to
Among such biosecurity measures you than 36 hours just prior to processing to treatment as defined in § 118.3 for the
must, at a minimum: allow an equilibration step to temper life of the flock in that poultry house.
(1) Limit visitors on the farm and in the eggs. Results of egg testing, when conducted,
the poultry houses; must be available within 10-calendar
(2) Maintain practices that will § 118.5 Environmental testing for days of receiving notification of the
Salmonella Enteritidis (SE).
protect against cross contamination positive environmental test.
when equipment is moved among (a) Environmental testing when laying
poultry houses; hens are 40 to 45 weeks of age. As one § 118.6 Egg testing for Salmonella
indicator of the effectiveness of your SE Enteritidis (SE).
(3) Maintain practices that will
protect against cross contamination prevention plan, you must perform (a)(1) If the environmental test for
when persons move between poultry environmental testing for SE (as pullets at 14 to 16 weeks of age required
houses; described in §§ 118.7 and 118.8) in a by § 118.4(a) is positive, you must divert
(4) Prevent stray poultry, wild birds, poultry house when any group of laying eggs to treatment (defined in § 118.3) for
cats, and other animals from entering hens constituting the flock within the the life of any flock or conduct egg
poultry houses; and poultry house is 40 to 45 weeks of age. testing within 2 weeks of the start of egg
(5) Not allow employees to keep birds (1) If an environmental test at 40 to 45 laying, as specified in paragraphs (b)
at home. weeks is negative and your laying hens through (e) of this section.
(c) Rodents, flies, and other pest do not undergo induced molting, then (2) If you have an SE-positive
control. As part of this program, you you do not need to perform any environmental test at any time during
must: additional environmental testing within the life of a flock, you must divert eggs
(1) Monitor for rodents by visual that poultry house, unless the poultry to treatment (defined in § 118.3) for the
inspection and mechanical traps or house contains more than one group of life of the flock in that positive poultry
house or conduct egg testing as collect and deliver for testing a Methods/BacteriologicalAnalytical
specified in paragraphs (b) through (e) minimum of 1,000 intact eggs ManualBAM/ucm070149.htm, current
of this section. representative of a day’s production. as of June 26, 2009. The method is
(b) Eggs must be sampled as described The 1,000-egg sample must be tested incorporated by reference in accordance
in § 118.7 and tested using methodology according to § 118.8. You must collect with 5 U.S.C. 552(a) and 1 CFR part 51.
as described in § 118.8. and test four 1,000-egg samples at 2- The FDA will request approval to
(c) You must conduct four egg tests, week intervals for a total of 4,000 eggs. incorporate by reference any updates to
using sampling and methodology in (2) To meet the monthly egg testing this Web site. The FDA will change the
§§ 118.7 and 118.8, on the flock in the requirement of § 118.6(e), you must date of the Web site in this paragraph
positive poultry house at 2-week collect and deliver for testing a with each update. You may obtain a
intervals. If all four tests are negative for minimum of 1,000 intact eggs copy from Division of Microbiology
SE, you are not required to do further representative of a day’s production per (HFS–710), Center for Food Safety and
egg testing. month for the life of the flock. Eggs must Applied Nutrition, Food and Drug
(d) If any of the four egg tests is be tested according to § 118.8. Administration, 5100 Paint Branch
positive for SE, you must divert, upon Pkwy., College Park, MD 20740, 301–
§ 118.8 Testing methodology for
receiving notification of an SE-positive Salmonella Enteritidis (SE). 436–2364, or you may examine a copy
egg test, all eggs from that flock to at the Center for Food Safety and
(a) Testing of environmental samples
treatment (defined in § 118.3) until the Applied Nutrition’s Library, 5100 Paint
for SE. Testing to detect SE in
conditions of paragraph (c) of this Branch Pkwy., College Park, MD, 301–
environmental samples must be
section are met. 436–2163, or at the National Archives
(e) If you have a positive egg test in conducted by the method entitled
‘‘Environmental Sampling and and Records Administration (NARA).
a flock and divert eggs from that flock For information on the availability of
Detection of Salmonella in Poultry
and later meet the negative test result this material at NARA, call 202–741–
Houses,’’ April 2008, or an equivalent
requirements described in paragraph (c) 6030, or go to: http://www.archives.gov/
method in accuracy, precision, and
of this section and return to table egg federal_register/code_of_federal_
sensitivity in detecting SE. The April
production, you must conduct one egg regulation/ibr_locations.html.
2008 Environmental Sampling and
test per month on that flock, using
Detection of Salmonella Web site is § 118.9 Administration of the Salmonella
sampling and methodology in §§ 118.7
located at http://www.fda.gov/Food/ Enteritidis (SE) prevention plan.
and 118.8, for the life of the flock.
ScienceResearch/LaboratoryMethods/ You must have one or more
(1) If all the monthly egg tests in
ucm114716.htm, current as of June 26, supervisory personnel, who do not have
paragraph (e) of this section are negative
2009. The Director of the Federal to be on-site employees, to be
for SE, you may continue to supply eggs
Register approves the incorporation by responsible for ensuring compliance
to the table market.
(2) If any of the monthly egg tests in reference of ‘‘Environmental Sampling with each farm’s SE prevention plan.
paragraph (e) of this section is positive and Detection of Salmonella in Poultry This person must have successfully
for SE, you must divert eggs from the Houses,’’ April 2008, in accordance completed training on SE prevention
positive flock to treatment for the life of with 5 U.S.C. 552(a) and 1 CFR part 51. measures for egg production that is
the flock or until the conditions of The FDA will request approval to equivalent to that received under a
paragraph (c) of this section are met. incorporate by reference any updates to standardized curriculum recognized by
(f) If you are diverting eggs, the pallet, this Web site. The FDA will change the the Food and Drug Administration or
case, or other shipping container must date of the Web site in this paragraph must be otherwise qualified through job
be labeled and all documents with each update. You may obtain a experience to administer the SE
accompanying the shipment must copy from Division of Microbiology prevention measures. Job experience
contain the following statement: (HFS–710), Center for Food Safety and will qualify this person to perform these
‘‘Federal law requires that these eggs Applied Nutrition, Food and Drug functions if it has provided knowledge
must be treated to achieve at least a 5- Administration, 5100 Paint Branch at least equivalent to that provided
log destruction of Salmonella Enteritidis Pkwy., College Park, MD 20740, 301– through the standardized curriculum.
or processed as egg products in 436–2364, or you may examine a copy This person is responsible for:
accordance with the Egg Products at the Center for Food Safety and (a) Development and implementation
Inspection Act, 21 CFR 118.6(f).’’ The Applied Nutrition’s Library, 5100 Paint of an SE prevention plan that is
statement must be legible and Branch Pkwy., College Park, MD, 301– appropriate for your specific farm and
conspicuous. 436–2163, or at the National Archives meets the requirements of § 118.4;
and Records Administration (NARA). (b) Reassessing and modifying the SE
§ 118.7 Sampling methodology for For information on the availability of prevention plan as necessary to ensure
Salmonella Enteritidis (SE). this material at NARA, call 202–741– that the requirements in § 118.4 are met;
(a) Environmental sampling. An 6030, or go to: http://www.archives.gov/ and
environmental test must be done for federal_register/code_of_federal_ (c) Review of records created under
each poultry house in accordance with regulation/ibr_locations.html. § 118.10. This person does not need to
§ 118.5 (a) and (b). Within each poultry (b) Testing of egg samples for SE. have performed the monitoring or
house, you must sample the Testing to detect SE in egg samples must created the records.
environment using a sampling plan be conducted according to Chapter 5 of
appropriate to the poultry house layout. FDA’s Bacteriological Analytical § 118.10 Recordkeeping requirements for
(b) Egg sampling. When you conduct Manual (BAM), December 2007 Edition, the Salmonella Enteritidis (SE) prevention
an egg test required under § 118.6, you or an equivalent method in accuracy, plan.
must collect and test the following precision, and sensitivity in detecting (a) Records: You must maintain the
number of eggs from the positive SE. Chapter 5 of FDA’s Bacteriological following records documenting your SE
poultry house: Analytical Manual, December 2007 prevention measures:
(1) To meet the egg testing Edition, is located at http://www.fda. (1) A written SE prevention plan
requirements of § 118.6(c), you must gov/Food/ScienceResearch/Laboratory required by § 118.4;
(2) Documentation that pullets were (e) Official review of records. You FDA receives it, FDA will return the
‘‘SE monitored’’ or were raised under must have all records required by this form to you for revision, provided that
‘‘SE monitored’’ conditions, including part available for official review and your mailing address or fax number is
environmental testing records for copying at reasonable times. legible and valid. When returning a
pullets, as required by § 118.4(a)(2); (f) Public disclosure of records. registration form for revision, FDA will
(3) Records documenting compliance Records required by this part are subject use the means by which the form was
with the SE prevention measures, as to the disclosure requirements under received by the agency (i.e., by mail or
follows: part 20 of this chapter. fax).
(i) Biosecurity measures; (iv) FDA will enter complete and
(ii) Rodent and other pest control § 118.11 Registration requirements for legible mailed and faxed registration
measures; shell egg producers covered by the
requirements of this part.
submissions into its registration system,
(iii) Cleaning and disinfection along with CD–ROM submissions, as
procedures performed at depopulation, (a) Shell egg producers covered under soon as practicable, in the order FDA
when applicable; § 118.1(a) of this part are required to receives them.
(iv) Refrigeration requirements; register their farms with the FDA within (v) FDA will then mail to the address
(v) Environmental and egg sampling 30 days of becoming an egg producer or, or fax to the fax number on the
procedures, when applicable, performed if already an egg producer, by the registration form a copy of the
under § 118.7; applicable effective date of this registration as entered, confirmation of
(vi) Results of SE testing, when regulation. registration, and your registration
applicable, performed under § 118.8 as (b) Shell egg producers may register number. When responding to a
required in §§ 118.4(a)(2), 118.5, and their farms by any of the following registration submission, FDA will use
118.6; means:
(vii) Diversion of eggs, if applicable, the means by which the registration was
(1) Electronic registration. To register received by the agency (i.e., by mail or
as required in § 118.6; and electronically, you must register at
(viii) Eggs at a particular farm being fax).
http://www.access.fda.gov, which will (vi) If any information you previously
given a treatment as defined in § 118.3, be available for registration 24 hours a
if you are a producer complying with submitted was incorrect at the time of
day, 7 days a week beginning May 10, submission, you must immediately
the requirements of this section as 2010. This Web site is available from
described in § 118.1(a)(2). update your facility’s registration. If any
wherever the Internet is accessible, information you previously submitted
(4) Records of review and of including libraries, copy centers,
modifications of the SE prevention plan that was correct at the time of
schools, and Internet cafes. submission subsequently changes, you
and corrective actions taken. (i) An individual authorized by the
(b) General requirements for records must update your facility’s registration
owner or operator of a farm, such as an within 60 calendar days.
maintained by shell egg producers. All
agent in charge, may also register a farm (vii) Your facility is considered
records required by § 118.10(a) must
electronically. registered once FDA enters your
include:
(1) Your name and the location of (ii) FDA strongly encourages facility’s registration data into the
your farm, electronic registration for the benefit of registration system and the system
(2) The date and time of the activity both FDA and the registrant. generates a registration number.
that the record reflects, (iii) Once you complete your (3) Registration by CD–ROM for
(3) The signature or initials of the electronic registration, FDA will multiple submissions. If, for example,
person performing the operation or automatically provide you with an you do not have reasonable access to the
creating the record. The written SE electronic confirmation of registration Internet through any of the methods
prevention plan must be dated and carry and a permanent registration number. provided under paragraph (b)(1) of this
the signature(s) (not initials) of the (iv) You will be considered registered section, you may register by CD–ROM.
person(s) who administers the plan as once FDA electronically transmits your (i) Registrants submitting their
described in § 118.9, and confirmation and registration number. registrations in CD–ROM format must
(4) Data and information reflecting (2) Registration by mail or by fax. If, use ISO 9660 (CD–R or CD–RW) data
compliance activities must be entered for example, you do not have reasonable format.
on records at the time the activity is access to the Internet through any of the (ii) These files must be submitted on
performed or observed, and the records methods described in paragraph (b)(1) of a portable document format (PDF)
must contain the actual values observed, this section, an individual authorized by rendition of the registration form (FDA
if applicable. the owner or operator of a farm, such as Form No. 3733) and be accompanied by
(c) Length of time records must be an agent in charge, may register by mail one signed copy of the certification
retained. You must retain all records or fax. statement that appears on the
required by this part at your place of (i) You must register using FDA Form registration form.
business, unless stored offsite under No. 3733. You may obtain a copy of this (iii) Each submission on the CD–ROM
§ 118.10(d), for 1 year after the flock to form by writing to the U.S. Food and must contain the same preferred mailing
which they pertain has been taken Drug Administration, 10903 New address in the appropriate block on FDA
permanently out of production. Hampshire Ave., Silver Spring, MD Form No. 3733.
(d) Offsite storage of records. You may 20993, or by requesting the form by (iv) A CD–ROM may contain
store the records required by this part, phone at 1–888–INFO–FDA (1–888– registrations for as many facilities as
except for the written SE prevention 463–6332). needed up to the CD–ROM’s capacity.
plan, offsite. You must be able to (ii) When you receive the form, you (v) The registration on the CD–ROM
retrieve and provide the records at your must fill it out completely and legibly for each separate facility must have a
place of business within 24 hours of and either mail it to the address in unique file name up to 32 characters
request for official review. Electronic paragraph (b)(2)(i) of this section or fax long, the first part of which may be used
records are considered to be onsite if it to the number on the form. to identify the parent company.
they are accessible from an onsite (iii) If any required information on the (vi) You must mail the CD–ROM to
location. form is incomplete or illegible when the U.S. Food and Drug Administration,
10903 New Hampshire Avenue, Silver to any of the information previously Regional Food and Drug Director under
Spring, MD 20993. submitted by any of the means as paragraph (a)(2)(v) of this section. The
(vii) If FDA receives a CD–ROM that provided in § 118.11(b). order must include the following
does not comply with these (g) Registered egg producers must information:
specifications, it will return the CD– notify FDA within 120 days of ceasing (A) A statement that the shell eggs
ROM to the submitter unprocessed. egg production by completing sections identified in the order are subject to
(viii) FDA will enter CD–ROM 1b, 1c, and 2 of Form 3733. This diversion for processing in accordance
submissions that comply with these notification is not required if you are a with the EPIA or by a treatment that
specifications into its registration seasonal egg producer or you achieves at least a 5-log destruction of
system, along with the complete and temporarily cease operation due to labor SE or destruction;
legible mailed and faxed submissions, disputes, fire, natural disasters, or other (B) A detailed description of the facts
as soon as practicable, in the order FDA temporary conditions. that justify the issuance of the order;
receives them. (C) The location of the eggs;
(ix) For each facility on the CD–ROM, § 118.12 Enforcement and compliance. (D) A statement that these eggs must
FDA will mail to the preferred mailing (a) Authority. This part is established not be sold, distributed, or otherwise
address a copy of the registration(s) as under authority of the Public Health disposed of or moved except as
entered, confirmation of registration, Service Act (the PHS Act). Under the provided in paragraph (a)(1)(iv) of this
and each facility’s assigned registration FFDCA, the Food and Drug section;
number. Administration (FDA) can enforce the (E) Identification or description of the
(x) If any information you previously food adulteration provisions under 21 eggs;
submitted was incorrect at the time of U.S.C. 331 through 334 and 342. Under (F) The order number;
submission, you must immediately the PHS Act (42 U.S.C. 264), FDA has (G) The date of the order;
the authority to make and enforce (H) The text of this entire section;
update your facility’s registration. If any (I) A statement that the order may be
information you previously submitted regulations for the control of
communicable diseases. FDA has appealed by written appeal or by
that was correct at the time of requesting an informal hearing;
submission subsequently changes, you established the following administrative
enforcement procedures for the (J) The name and phone number of
must update your facility’s registration the person issuing the order; and
within 60 calendar days. diversion or destruction of shell eggs
and for informal hearings under the PHS (K) The location and telephone
(xi) Your facility is considered number of the office or agency issuing
registered once FDA enters your Act:
(1) Upon a finding that any shell eggs the order and the name of its Director.
facility’s registration data into the (ii) Approval of District Director. An
registration system and the system have been produced or held in violation
of this part, an authorized FDA order, before issuance, must be
generates a registration number. approved by FDA’s District Director or
(c) No registration fee is required. representative or a State or local
the Acting District Director. If prior
(d) You must submit all registration representative in accordance with
written approval is not feasible, prior
information in the English language. All paragraph (c) of this section may order
oral approval must be obtained and
information must be submitted using such eggs to be diverted, under the
confirmed by written memorandum as
the Latin (Roman) alphabet. supervision of said representative, for
soon as possible.
(e) Each registrant must submit the processing in accordance with the Egg (iii) Labeling or marking of shell eggs
following information through one of Products Inspection Act (EPIA) (21 under order. An FDA, State, or local
the methods described in paragraph (b) U.S.C. 1031 et seq.) or by a treatment representative issuing an order under
of this section: that achieves at least a 5-log destruction paragraph (a)(1)(i) of this section must
(1) The name, full address, and phone of SE or destroyed by or under the label or mark the shell eggs with official
number of the farm; and supervision of an officer or employee of tags that include the following
(2) The average or usual number of FDA, or, if applicable, of the State or information:
layers of each house and number of locality in accordance with the (A) A statement that the shell eggs are
poultry houses on the farm. following procedures: detained in accordance with regulations
(3) A statement in which the shell egg (i) Order for diversion or destruction issued under section 361(a) of the PHS
producer certifies that the information under the PHS Act. Any district office Act (42 U.S.C. 264(a)).
submitted is true and accurate. If the of FDA or any State or locality acting (B) A statement that the shell eggs
individual submitting the form is not under paragraph (c) of this section, must not be sold, distributed or
the shell egg producer in charge of the upon finding shell eggs that have been otherwise disposed of or moved except,
farm, the registration must also include produced or held in violation of this after notifying the issuing entity in
a statement in which the individual regulation, may serve a written order writing, to:
certifies that the information submitted upon the person in whose possession (1) Divert them for processing in
is true and accurate, certifies that he/she the eggs are found requiring that the accordance with the EPIA or by a
is authorized to submit registration, and eggs be diverted, under the supervision treatment that achieves at least a 5-log
identifies by name, address, and of an officer or employee of the issuing destruction of SE or destroy them or
telephone number, the individual who entity, for processing in accordance (2) Move them to another location for
authorized submission of the with the EPIA (21 U.S.C. 1031 et seq.) holding pending appeal.
registration. Each registration must or by a treatment that achieves at least (C) A statement that the violation of
include the name of the individual a 5-log destruction of SE or destroyed by the order or the removal or alteration of
registering the farm submitting the or under the supervision of the issuing the tag is punishable by fine or
registration, and the individual’s entity, within 10-working days from the imprisonment or both (section 368 of
signature (for paper and CD–ROM date of receipt of the order, unless, the PHS Act (42 U.S.C. 271)).
options). under paragraph (a)(2)(iii) of this (D) The order number and the date of
(f) Registered egg producers must section, a hearing is held, in which case the order, and the name of the
submit an update to a registration the eggs must be diverted or destroyed government representative who issued
within 60-calendar days of any change consistent with the decision of the the order.
(iv) Sale or other disposition of shell permitted by law and by this section. held in violation of this section, he must
eggs under order. After service of the The Regional Food and Drug Director affirm the order that they be diverted,
order, the person in possession of the has the power to take such actions and under the supervision of an officer or
shell eggs that are the subject of the make such rulings as are necessary or employee of FDA for processing under
order must not sell, distribute, or appropriate to maintain order and to the EPIA or by a treatment that achieves
otherwise dispose of or move any eggs conduct an informal, fair, expeditious, at least a 5-log destruction of SE or
subject to the order unless and until and impartial hearing, and to enforce destroyed by or under the supervision of
receiving a notice that the order is the requirements concerning the an officer or employee of FDA;
withdrawn after an appeal except, after conduct of hearings. otherwise, the Regional Food and Drug
notifying FDA’s district office or, if (B) Employees of FDA will first give Director must issue a written notice that
applicable, the State or local a full and complete statement of the the prior order is withdrawn. If the
representative, in writing, to: action that is the subject of the hearing, Regional Food and Drug Director affirms
(A) Divert or destroy them as together with the information and the order, he must order that the
specified in paragraph (a)(1)(i) of this reasons supporting it, and may present diversion or destruction be
section, or oral or written information relevant to accomplished within 10-working days
(B) Move them to another location for the hearing. The party requesting the from the date of the issuance of his
holding pending appeal. hearing may then present oral or written decision. The Regional Food and Drug
(2) The person on whom the order for information relevant to the hearing. All Director’s decision must be
diversion or destruction is served may parties may conduct reasonable accompanied by a statement of the
either comply with the order or appeal examination of any person (except for reasons for the decision. The decision of
the order to the Regional Food and Drug the presiding officer and counsel for the the Regional Food and Drug Director
Director in accordance with the parties) who makes any statement on constitutes final agency action, subject
following procedures: the matter at the hearing. to judicial review.
(i) Appeal of a detention order. Any (C) The hearing shall be informal in (vi) No appeal. If there is no appeal
appeal must be submitted in writing to nature, and the rules of evidence do not of the order and the person in
FDA’s District Director in whose district apply. No motions or objections relating possession of the shell eggs that are
the shell eggs are located within 5- to the admissibility of information and subject to the order fails to divert or
working days of the issuance of the views will be made or considered, but destroy them within 10-working days,
order. If the appeal includes a request any party may comment upon or rebut or if the demand is affirmed by the
for an informal hearing, the hearing any information and views presented by Regional Food and Drug Director after
must be held within 5-working days another party. an appeal and the person in possession
after the appeal is filed or, if requested (D) The party requesting the hearing of such eggs fails to divert or destroy
by the appellant, at a later date, which may have the hearing transcribed, at the them within 10-working days, FDA’s
must not be later than 20-calendar days party’s expense, in which case a copy of district office or, if applicable, the State
after the issuance of the order. The order the transcript is to be furnished to FDA. or local representative may designate an
may also be appealed within the same Any transcript of the hearing will be officer or employee to divert or destroy
period of 5-working days by any other included with the Regional Food and such eggs. It shall be unlawful to
person having an ownership or Drug Director’s report of the hearing. prevent or to attempt to prevent such
proprietary interest in such shell eggs. (E) The Regional Food and Drug diversion or destruction of the shell eggs
The appellant of an order must state the Director must prepare a written report of by the designated officer or employee.
ownership or proprietary interest the the hearing. All written material (b) Inspection. Persons engaged in
appellant has in the shell eggs. presented at the hearing will be attached production of shell eggs must permit
(ii) Summary decision. A request for to the report. Whenever time permits, authorized representatives of FDA to
a hearing may be denied, in whole or in the Regional Food and Drug Director make, at any reasonable time, an
part and at any time after a request for may give the parties the opportunity to inspection of the egg production
a hearing has been submitted, if the review and comment on the report of establishment in which shell eggs are
Regional Food and Drug Director or his the hearing. being produced. Such inspection
or her designee determines that no (F) The Regional Food and Drug includes the inspection and sampling of
genuine and substantial issue of fact has Director must include as part of the shell eggs and the environment, the
been raised by the material submitted in report of the hearing a finding on the equipment related to production of shell
connection with the hearing or from credibility of witnesses (other than eggs, the equipment in which shell eggs
matters officially noticed. If the expert witnesses) whenever credibility are held, and examination and copying
Regional Food and Drug Director is a material issue, and must include a of any records relating to such
determines that a hearing is not recommended decision, with a equipment or eggs, as may be necessary
justified, written notice of the statement of reasons. in the judgment of such representatives
determination will be given to the (iv) Written appeal. If the appellant to determine compliance with the
parties explaining the reason for denial. appeals the detention order but does not provisions of this section. Inspections
(iii) Informal hearing. Appearance by request a hearing, the Regional Food may be made with or without notice and
any appellant at the hearing may be by and Drug Director must render a will ordinarily be made during regular
mail or in person, with or without decision on the appeal affirming or business hours.
counsel. The informal hearing must be revoking the detention order within 5- (c) State and local cooperation. Under
conducted by the Regional Food and working days after the receipt of the sections 311 and 361 of the Public
Drug Director or his designee, and a appeal. Health Service Act, any State or locality
written summary of the proceedings (v) Regional Food and Drug Director that is willing and able to assist the
must be prepared by the Regional Food decision. If, based on the evidence agency in the enforcement of §§ 118.4
and Drug Director. presented at the hearing or by the through 118.10, and is authorized to
(A) The Regional Food and Drug appellant in a written appeal, the inspect or regulate egg production
Director may direct that the hearing be Regional Food and Drug Director finds establishments, may, in its own
conducted in any suitable manner that the shell eggs were produced or jurisdiction, enforce §§ 118.4 through
118.10 through inspections under under paragraph (a) of this section, a regarding prevention of SE in shell eggs
paragraph (b) of this section and State or locality may follow the hearing during production, storage, or
through administrative enforcement procedures set out in paragraphs transportation that is less stringent than
remedies specified in paragraph (a) of (a)(2)(iii) through (a)(2)(v) of this those required by this part.
this section unless FDA notifies the section, or may utilize comparable State Dated: July 2, 2009.
State or locality in writing that such or local hearing procedures if such
assistance is no longer needed. A state Jeffrey Shuren,
procedures satisfy due process.
or locality may substitute, where (d) Preemption. No State or local Associate Commissioner for Policy and
necessary, appropriate State or local governing entity shall establish, or Planning.
officials for designated FDA officials in continue in effect any law, rule, [FR Doc. E9–16119 Filed 7–7–09; 1:30 pm]
this section. When providing assistance regulation, or other requirement BILLING CODE 4164–01–P

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Thursday,

21 CFR Parts 16 and 118

1 Under the Animal Health Protection Act, USDA

TABLE 1—BASE LINE EGG-RELATED Salmonella Enteritidis (SE) CASES

2006 Passive Surveillance Cases ................................................................................... 6,740

Cases from Outside the United States ............................................................................ ¥16%

130,220 215,140 345,360

Percent of SE cases from eggs ...................................................................................... 53% 66% 79%

TABLE 2—CONSEQUENCES OF SE INFECTION

TABLE 3—LOST QUALITY ADJUSTED LIFE DAYS DUE TO SE

TABLE 4—VALUING OF A TYPICAL CASE OF SE1, 2

Health Cost and Utilization Project’s

In table 5 of this document the value

VSLY = $100 thousand ........................................... $11,900 .................................. $7,600 ..................................

TABLE 6—FARMS POTENTIALLY COVERED BY THE RULE

3,000 to 19,999 ................................................................................................ 1,746 1.4 2,445 5,607

Total potential coverage ........................................................................... 3,328 2.2 7,359 72,113

prevention measures. This program, although useful, does not

2. HACCP on egg farms, either voluntarily 3. The Final Rule

TABLE 7—FINAL RULE ANNUAL COSTS AND BENEFITS

Initially (first four years):1

TABLE 8—RODENT CONTROL

3,000 to 19,999 .......................................................................................................... 19 328 709

TABLE 9—FLY CONTROL

3,000 to 19,999 .......................................................................................................... 27 470 638

TABLE 10—COST OF RODENT AND OTHER PEST CONTROL

Rodent control Pest control

3,000 to 19,999 .................................................................... $222 $240 $2,160 $1,467 $4,089

Farm Size (Number of Layers):

Slight: [( 9.5¥4.6) ÷ 2] ÷ 9.5 = 25.8%.

87). In this case, the infestation costs the

TABLE 12—FEED SAVINGS FROM RODENT CONTROL

Total cost of rodents .......................................................................................................................................................................... 2,221,700

Expected savings from control (assumes 50% reduction) ................................................................................................................ 1,110,850

TABLE 13—CURRENT CLEANING AND DISINFECTING PRACTICES

TABLE 14—COST OF CLEANING AND DISINFECTING HOUSES ON AFFECTED FARMS

Dry clean .............................................................................. 79.8 8.4 125 $1,200 $130,300

Total cost ...................................................................... ........................ ........................ ........................ ........................ 282,600

TABLE 15—FARMS AFFECTED BY ON-FARM EGG STORAGE TEMPERATURE REQUIREMENTS

3,000 to 19,999 ........................................................................................ 98.3 98.2 78.1 75.4 1,317

Total .................................................................................................. 81.2 87.3 81.2 57.6 2,296

TABLE 16—ANNUAL COST OF ON-FARM REFRIGERATING AFFECTED FARMS

layers or more. undergo environmental testing at 20 weeks post

TABLE 17—REGIONAL MOLTING PRACTICES 1

Great Lakes ............................................................................................................................................. 30% 65% 5%

TABLE 18—MOLTING PRACTICES BY FARM SIZE 1

Fewer than 20,000 ................................................................................................................................... 72% 28% 0%

LAB) multiplying the product by the percent

that a total of 21,325 rows would have

TABLE 19—NUMBER OF ROWS TO BE SWABBED

Average Percent of Number of Number of

1 ....................................................................................................................... 1.0 1.9 67 67

Total .......................................................................................................... 6.1 ........................ 3,511 21,325

overnight is estimated to be between $25.58 and

TABLE 20—PRODUCTION AND BREAKING OF EGGS

North Atlantic ....................................................................... 10,106 12.3 300,406 17.1 35.7

Total .............................................................................. 82,102 100.0 1,754,671 100.0 25.7

TABLE 21—TOTAL COST OF DIVERTING EGGS

VSLY = $100 thousand ........................... $355.9 $943.8 $2,280.2 __

VSLY = $100 thousand ........................... $227.6 $603.5 $1,458.1 __

VSLY = $500 thousand ........................... __ 860.4 2,281.7 5,512.5

Plan Design ...................................................... 1.2 1.2 __

Recordkeeping ................................................. 9.8 9.8 __

Training ............................................................ 0.3 0.3 __

Registration ...................................................... 0.03 0 __