Comment period extended - June 8, 2005 FR
Comment period re-opened - May 10, 2005 FR
This document, including the omitted image on p. 56902, is also available in PDF (559 KB).
[Federal Register: September 22, 2004 (Volume 69, Number 183)]
[Proposed Rules]
[Page 56823-56906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se04-25]
[[Page 56823]]
-----------------------------------------------------------------------
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;
Proposed Rule
[[Page 56824]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 118
[Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203, and 2000N-0504]
RIN 0910-AC14
Prevention of Salmonella Enteritidis in Shell Eggs During
Production
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to require
shell egg producers to implement measures to prevent Salmonella
Enteritidis (SE) from contaminating eggs on the farm. We are taking
this action because of the number of outbreaks of foodborne illnesses
and deaths caused by SE that are associated with the consumption of
shell eggs that have not been treated to destroy this pathogen. We
expect that the requirements that we are proposing in this rule, if
finalized as proposed, will result in a significant decrease in the
number of SE-contaminated eggs produced on farms. Ultimately, we expect
that the proposed requirements in this rule will generate public health
benefits through a decrease in the numbers of SE-associated illnesses
and deaths caused by consumption of shell eggs.
DATES: Submit written or electronic comments by December 21, 2004.
Submit written comments on the information collection provisions by
October 22, 2004. See sections III.C and VI.C of this document for the
proposed compliance dates of a final rule based on this document.
ADDRESSES: You may submit comments, identified by [Docket Nos. 1996P-
0418, 1997P-0197, 1998P-0203, and 2000N-0504], by any of the following
methods:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
<bullet> E-mail: fdadockets@oc.fda.gov. Include [Docket Nos. 1996P-
0418, 1997P-0197, 1998P-0203, and 2000N-0504 and RIN number 0910-AC14]
in the subject line of your e-mail message.
<bullet> FAX: 301-827-6870.
<bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://www.fda.gov/dockets/ecomments, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Rebecca Buckner, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
5100 Paint Branch Pkwy. College Park, MD 20740, 301-436-1486.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Highlights of the Proposed Rule
II. Background
A. Salmonella and SE Infection
1. Salmonellosis
2. SE
3. SE and Eggs
4. Mechanism of Salmonella Contamination in Eggs
5. Infectious Dose
B. U.S. Egg Industry
C. Federal Egg Safety Regulatory Agencies and Authorities
D. Current Federal Egg Safety Measures for Shell Egg Production and
Retail
1. Refrigeration of Shell Eggs
2. Labeling of Shell Eggs
3. The FDA Food Code
4. Egg Safety Education Efforts
E. The SE Risk Assessment
F. Advanced Notice of Proposed Rulemaking on SE in Eggs
G. Egg Safety Public Meetings
H. Current On-Farm Practices
1. The Layers Study
2. Voluntary Egg Quality Assurance Programs (QA)
I. Petitions to the Agency
1. Center for Science in the Public Interest
2. Rose Acre Farms, Inc.
3. United Poultry Concerns, Inc., and the Association of
Veterinarians for Animal Rights
III. The Proposal to Require SE Prevention Measures for Egg Production
A. Rationale for Proposal
B. Shell Egg Producers Covered by Proposed 21 CFR Part 118
C. Proposed Compliance Dates for Shell Egg Producers of Various
Sizes
D. Definitions
E. The SE Prevention Measures
1. Chicks and Pullets
2. Biosecurity
3. Rodents, Flies, and Other Pest Control
4. Cleaning and Disinfection
5. Refrigeration of Shell Eggs Stored More Than 36 Hours
F. Indication of the Effectiveness of the SE Prevention Measures:
Testing
1. Environmental Testing for SE
2. Egg Testing for SE
G. Sampling and Testing Methodology for SE
1. Sampling of the Poultry House Environment
2. Egg Sampling
H. Laboratory Methods for Testing for SE
I. Administration of the SE Prevention Measures
J. Recordkeeping Requirements for the SE Prevention Measures
1. Records That Egg Producers Are Required to Maintain
2. General Requirements for Records Maintained by Egg Producers
3. Length of Time Records Must Be Retained
4. Offsite Storage of Records
5. Official Review of Records
6. Public Disclosure of Records
7. Comment Solicitation on Recordkeeping Measures
K. Enforcement of On-Farm SE Prevention Measures for Shell Eggs
L. Legal Authority
M. Response to Comments Related to On-Farm SE Prevention Measures
N. Transportation of Shell Eggs
IV. Handling and Preparation of Eggs by Retail Establishments
A. Inappropriate Handling of Raw Shell Eggs by Food Preparers
B. SE and Highly Susceptible Populations
C. The FDA Food Code
D. Request for Comments
E. Response to Comments Related to Retail Standards
V. Preliminary Regulatory Impact Analysis (PRIA)
A. Introduction
B. Need for Regulation
C. Economic Analysis of Potential Mitigations: Overview
1. Measuring Benefits
2. Measuring Costs
3. Coverage of the Analysis
D. Summary of Costs and Benefits of Regulatory Options and the
[[Page 56825]]
Proposed Rule
1. No New Regulatory Action
2. Classification of SE-Positive Eggs as Restricted or SE Positive
3. HAACP
4. The Proposed Rule
5. More Extensive On-Farm SE Prevention Measures
6. Less Extensive On-Farm SE Prevention Measures
7. Retail SE Prevention Measures
E. Benefits and Costs of Potential SE Prevention Measures: Detailed
Analysis
1. On-Farm SE Prevention Measures
2. Administrative Measures
3. Summary of On-Farm SE Prevention and Administrative Measures
4. Retail Provisions
F. Summary of Benefits and Costs of the Proposed Rule
1. Coverage
2. Provisions in the Proposed Rule
3. Summary of Costs and Benefits
4. Analysis of Uncertainty
VI. Initial Regulatory Flexibility Analysis
A. Introduction
B. Economic Effects on Small Entities
1. Number of Small Entities Affected
2. Costs to Small Entities
C. Regulatory Options
1. Exemption for Small Entities
2. Longer Compliance Periods
D. Description of Recordkeeping and Recording Requirements
E. Summary
VII. Unfunded Mandates
VIII. Federalism
IX. Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Comments
XII. References
Appendix to the PRIA A: Costs of Alternative Testing and Diversion
Scenarios
Appendix to the PRIA B: The Expected Cost of Testing and Diversion
Appendix to the PRIA C: Distributions Used in the Analysis of
Uncertainty
I. Highlights of the Proposed Rule
In this proposed rulemaking, FDA is proposing egg safety SE
prevention measures for egg production. This proposal is significant
because a farm-to-table risk assessment of Salmonella Enteritidis (SE)
in eggs identified implementation of on-farm prevention measures as a
very important step that could be taken to reduce the occurrence of SE
infections from eggs. Voluntary quality assurance programs for egg
production have led to meaningful reductions in SE illnesses already.
However, these programs are not always uniformly administered or
uniformly comprehensive in their prevention measures.
Moreover, the most recent data from the Centers for Disease Control
and Prevention (CDC) show that SE illnesses have essentially remained
steady for the past several years. In 2001, CDC estimated that 118,000
illnesses were caused by consumption of SE-contaminated eggs.
Accordingly, we believe that additional interventions are warranted.
The proposed on-farm SE prevention measures and a more detailed
rationale for these measures are found in section III of this document.
Following are the proposed SE prevention measures: (1) Provisions
for procurement of chicks and pullets, (2) a biosecurity program, (3) a
pest and rodent control program, (4) cleaning and disinfection of
poultry houses that have had an environmental sample or egg test
positive for SE, and (5) refrigerated storage of eggs at the farm.
Moreover, a cornerstone of the proposal is a requirement that producers
test the environment for SE in poultry houses. If the environmental
test is positive, we are proposing that egg testing for SE be
undertaken, and that if an egg test is positive, eggs be diverted from
the table egg market to a technology or process that achieves at least
a 5-log destruction of SE for shell eggs, or the processing of egg
products in accordance with the Egg Products Inspection Act. As part of
the SE prevention measures, we are proposing that producers identify a
responsible person to administer the prevention measures at each farm.
We also are proposing recordkeeping requirements for environmental and
egg sampling and testing and for egg diversion. Finally, we are
proposing that if a producer has 3,000 or more laying hens and all eggs
at a farm are to be given a treatment that will achieve at least a 5-
log destruction of SE or processed into egg products, then only the
proposed refrigeration requirements would apply. The proposed rule
would not apply to producers who sell all of their eggs directly to
consumers or producers with fewer than 3,000 laying hens.
We also are soliciting comment on whether we should include
additional requirements in the final rule, particularly in two areas.
First, should we expand the recordkeeping requirements to include a
written SE prevention plan and records for compliance with the SE
prevention measures? Second, should the safe egg handling and
preparation practices in FDA's 2001 Model Food Code (as outlined in
section IV.D of this document) be federally mandated for retail
establishments that specifically serve a highly susceptible population
(e.g., nursing homes, hospitals, day care centers)? These issues are
discussed in more detail in the following relevant sections of this
document.
II. Background
A. Salmonella and SE Infection
1. Salmonellosis
Salmonella microorganisms are ubiquitous and are commonly found in
the digestive tracts of animals, especially birds and reptiles. Human
illnesses are usually associated with ingesting food or drink
contaminated with Salmonella, although infection also may be
transmitted person to person through the fecal-oral route where
personal hygiene is poor or by the animal-to-man route (Ref. 1).
The disease salmonellosis is the result of an intestinal infection
with Salmonella and is characterized by diarrhea, fever, abdominal
cramps, headache, nausea, and vomiting. Symptoms of salmonellosis
usually begin within 6 to 72 hours after consuming a contaminated food
or liquid and last for 4 to 7 days. Most healthy people recover without
antibiotic treatment; however, the infection can spread into the
bloodstream, then to other areas of the body such as the bone marrow or
the meningeal linings of the brain. This infection can lead to a severe
and fatal illness (Ref. 2). The complications associated with an
infection are more likely to occur in children, the elderly, and
persons with weakened immune systems. In addition, about 2 percent of
those who recover from salmonellosis may later develop recurring joint
pains and arthritis (Ref. 3).
Salmonellosis is a serious health concern. It is a notifiable
disease, i.e., physicians and health laboratories are required to
report cases (single occurrences of illness) to local health
departments in accordance with procedures established by each State.
These cases are then, in turn, reported to State health departments,
and the Salmonella isolates\1\ are referred to State Public Health
laboratories for serotyping. Each case and each serotyped isolate is
reported to CDC. These reports are made only for diagnosed cases of
Salmonella infection.
---------------------------------------------------------------------------
\1\ When a physician sees a patient and suspects that the
patient has a case of salmonellosis, the physician may obtain a
patient's specimen (e.g. stool) for analysis. The specimen is sent
to the laboratory to be tested to identify and confirm any
Salmonella that may be present. Thus, the laboratory obtains the
actual specimen of Salmonella.
---------------------------------------------------------------------------
A case of illness is confirmed as salmonellosis only if an isolate
is confirmed by a laboratory as being
[[Page 56826]]
Salmonella. Although all cases may not be confirmed, all confirmed
cases are associated with isolates of Salmonella. Reported cases are
likely to represent only a small portion of the actual number of
illnesses that occurred because of the following reasons: (1) Ill
individuals do not always seek care by medical professionals,
especially if the symptoms are not severe; (2) medical professionals
may not establish the cause of the illness but may simply treat the
symptoms; and (3) medical professionals do not always report Salmonella
cases to public health officials. CDC used updated information and data
from a FoodNet population study to estimate that there are 38 cases of
salmonellosis for every one that is reported (Ref. 4). This estimate
was central to updating an estimate of the burden of salmonellosis. The
overall burden of salmonellosis in 2001 was estimated to be 1,203,650
cases, including 14,000 hospitalizations, and 494 deaths (Refs. 4 and
5).
CDC surveillance data list close to 600 different Salmonella
serotypes (a group of related microorganisms distinguished by their
antigens) that have caused illness in the United States. Following are
the four serotypes most frequently reported as causing illness: (1)
Salmonella enterica serotype Typhimurium, (2) Salmonella enterica
serotype Enteritidis (Salmonella Enteritidis or SE), (3) Salmonella
enterica serotype Newport, and (4) Salmonella enterica serotype
Heidelberg (Ref. 6). These microorganisms are found in poultry, eggs,
and other foods.
2. SE
Currently, SE is one of the most commonly reported serotypes of
Salmonella. SE accounted for only about 5 percent of the number of all
reported Salmonella isolates in 1976. However, in 1985, 1990, 1994, and
1999, SE constituted 9.8 percent, 20.6 percent, 26.3 percent, and 16.3
percent, respectively, of all Salmonella isolates (Ref. 6). The rate of
SE isolates reported to CDC increased from 0.6 per 100,000 population
in 1976 to 3.6 per 100,000 in 1996 (Ref. 7). In 2001, the isolation
rate of SE was 2.0 per 100,000 population and the contribution of SE
(corrected for underreporting) to total salmonellosis was estimated to
have been 213,046 illnesses, including 2,478 hospitalizations, and 87
deaths (Refs. 4 and 5).
In 1985, the States reported 26 SE-related outbreaks (i.e.,
occurrences of 2 or more cases of a disease related to a common source)
to CDC; by 1990 the number of SE-related outbreaks reported to CDC had
increased to 85. In 1995 there were 56 confirmed outbreaks of SE
infection, in 2000 there were 50 and in 2002 there were 32 (Ref. 8).
3. SE and Eggs
In the mid-1980s, CDC made an epidemiological and laboratory
association between eggs and Salmonella outbreaks. Shell eggs are now
the predominant source of SE-related cases of salmonellosis in the
United States where a food vehicle is identified. A food vehicle is
identified in approximately half of the outbreaks of illness associated
with SE. Between 1990 and 2001, an average of 78 percent of vehicle-
confirmed SE outbreaks were egg associated (Ref. 9). These eggs were
typically raw or undercooked. Although CDC can estimate the number of
egg-associated SE illnesses as a percentage of all SE illnesses, the
proportion of domestically acquired salmonellosis that is attributable
to SE in eggs is difficult to estimate. The estimates have a broad
range of uncertainty around them because of the variable nature of both
foodborne disease outbreaks and investigations. However, the basic
surveillance information on the number of reported SE cases and
outbreaks is readily available and does not require further estimation.
Although there are other sources of SE, actions to improve egg safety
are the single most effective way to reduce the overall number of SE
infections and outbreaks.
CDC has described several SE outbreaks that occurred between 1996
and 1998 and were associated with raw or undercooked eggs (Ref. 7).
<bullet> In November 1997, 91 persons who consumed broccoli with
Hollandaise sauce at a Las Vegas restaurant became ill. Investigation
showed that the Hollandaise sauce was prepared with pooled shell eggs,
cooked to a temperature inadequate to kill SE, and then held at room
temperature for several hours prior to service.
<bullet> In August 1997, 12 persons developed culture-confirmed
cases of SE after consuming cheesecake prepared in a private residence
in Los Angeles, CA. The cheesecake contained raw egg whites and egg
yolks that were heated in a double boiler until slightly thickened. The
California Department of Health Services and Department of Food and
Agriculture investigated the farm that supplied the eggs and isolated
SE from manure samples and from pooled egg samples.
<bullet> In October 1997, 75 persons at 7 different events in the
District of Columbia developed salmonellosis after consuming lasagna
supplied by the same commercial manufacturer. Cultures of leftover
lasagna yielded SE. Investigation revealed that all of the lasagnas
consumed at the different events were prepared from the same egg-cheese
mixture. A traceback investigation led to farms at which 5 of 13
poultry houses had environmental samples positive for SE.
From 1990 to 2001, 14,319 illnesses were attributed to SE
associated with shell eggs. Of those illnesses, 10,406 occurred during
1990 through 1995 and 3,913 occurred during 1996 through 2001 (Ref. 9).
In 2002, there were 32 outbreaks of SE illness, and the SE isolation
rate (illnesses per 100,000 population) was 1.77 (Ref. 8). Progress has
been made and there has been a decrease in SE incidence since the mid-
1990s, in part due to egg quality assurance (QA) programs, informing
and educating consumers and retailers on proper handling, and
nationwide regulations to keep eggs refrigerated. However, these gains
are still far short of the public health and foodborne illness gains
required to meet Healthy People 2010 goals. Healthy People 2010 sets
forth significant and achievable goals, namely a 50 percent reduction
in both outbreaks and salmonellosis from foodborne contamination
(corresponding to a 50 percent reduction from the 2000 goals for SE
outbreak reduction and a 50 percent reduction in salmonellosis in
general) (Ref. 10). We estimate that the largest gains towards our
public health goals will be achieved through implementation of this
rule. The incidence of SE in the United States remains much higher than
in the 1970s (1976 SE isolation rate = 0.56) (Ref. 11), and the
decrease in reported cases of SE illness since 1999 has appeared to
slow or stop compared to decreases seen in the mid-1990s (Ref. 9).
Because progress in reducing the number of illnesses and outbreaks
appears to have greatly slowed or stopped, we believe the additional
preventive measures, proposed herein, for shell eggs may be needed to
reduce further the incidence of SE illnesses and meet our public health
goals.
4. Mechanism of Salmonella Contamination in Eggs
Previously, Salmonella contamination of shell eggs was thought most
likely to be caused by trans-shell penetration of bacteria present in
the egg's environment. The surface of an egg can become contaminated
with any microorganism that is excreted by the laying hens. In
addition, contact with nesting materials, dust, feedstuff, shipping and
storage containers, human beings and other animals may be a source of
shell contamination. The
[[Page 56827]]
likelihood of trans-shell penetration increases with the length of time
that the eggs are in contact with contaminating materials.
While environmental contamination is still a route for Salmonella
contamination, SE experts now believe that the predominant route
through which eggs become contaminated with SE is the ``transovarian''
route. Though the mechanism is still not well understood, SE will
infect the ovaries and oviducts of some egg-laying hens, permitting
transovarian contamination of the interior of the egg while the egg is
still inside the hen (Refs. 12 and 13). The site of contamination is
usually the albumen (the egg white).
It is believed that only a small number of hens in an infected
flock shed SE at any given time and that an infected hen may lay many
uncontaminated eggs (Ref. 14). Nonetheless, it has been estimated that
of the 47 billion shell eggs consumed annually as table eggs (eggs
consumed as shell eggs, as opposed to eggs that are used to make egg
products), 2.3 million are SE-positive, exposing a large number of
people to the risk of illness (Ref. 15).
5. Infectious Dose
In general, the greater the numbers of microorganisms ingested, the
greater the likelihood of disease. The likelihood of disease also is
contingent on the virulence of the microorganism and the susceptibility
of the host (Ref. 16). However, there is evidence that the infectious
dose (i.e., amount of microorganisms capable of causing disease) for SE
can be very low. For example, in a 1994 outbreak attributed to
consumption of SE-contaminated ice cream, the highest level of
contamination found in the implicated ice cream was only six
microorganisms per half-cup (65 gram) serving (Ref. 17). Another
report, using a different method of measurement, determined that the
infective dose per serving was 25 microorganisms (Ref. 18). These
reports indicate that low-level contamination of some foods with SE can
lead to illness. It is generally believed that SE-contaminated eggs
initially contain only a few SE microorganisms (less than 20 (Ref.
19)), which may be sufficient to cause illness.
B. U.S. Egg Industry
On a per capita basis, Americans consume about 234 eggs per year
(Ref. 20). U.S. production is relatively stable and has increased only
slightly, from about 60 billion eggs in 1984 to 67.3 billion eggs in
1998 (Ref. 21). Generally, about 70 percent of the edible shell eggs
produced are sold as table eggs while the remainder are processed into
liquid, frozen or dried pasteurized egg products. The majority of egg
products are destined for institutional use or further processing into
foods such as cake mixes, pasta, ice cream, mayonnaise, and bakery
goods.
Geographically, commercial egg production in the western United
States is concentrated in California, and in the eastern United States
is centered in Ohio, Indiana, Iowa, and Pennsylvania. Other States in
which major producers are located include Texas, Minnesota, and
Georgia. Over 4,000 farm sites have 3,000 or more egg-laying hens,
representing 99 percent of all domestic egg-laying hens and accounting
for 99 percent of total egg production. There are an additional 65,000
farms with fewer than 3,000 egg-laying hens, accounting for the balance
of eggs produced (Ref. 22).
C. Federal Egg Safety Regulatory Agencies and Authorities
Federal authority to regulate egg safety is shared by FDA and the
U.S. Department of Agriculture's Food Safety and Inspection Service
(USDA's FSIS). In addition, USDA's Animal and Plant Health Inspection
Service (APHIS) conducts a control program that certifies poultry
breeding stock and hatcheries as SE-monitored and USDA's Agricultural
Marketing Service (AMS) conducts a surveillance program to ensure
proper disposition of restricted shell eggs.
FDA has jurisdiction over the safety of foods generally, including
shell eggs, under section 201 of the Federal Food, Drug, and Cosmetic
Act (the FFDCA) (21 U.S.C. 321). The Public Health Service Act (the PHS
Act) (42 U.S.C. 201 et seq.) authorizes the FDA to make and enforce
such regulations as ``are necessary to prevent the introduction,
transmission or spread of communicable diseases from foreign countries
into the States * * * or from one State * * * into any other State''
(section 361(a) of the PHS Act (42 U.S.C. 264(a)). Thus, under the
FFDCA and the PHS Act, FDA has the authority to regulate a food when
the food may act as a vector of disease, as in the case of SE-
contaminated eggs.
USDA has primary responsibility for implementing the Egg Products
Inspection Act (EPIA) (21 U.S.C. 1031 et seq.). Under the EPIA, FSIS
has primary responsibility for the inspection of processed egg products
to prevent the distribution of adulterated or misbranded egg products.
This proposed rule is part of a joint and coordinated strategy by
FDA and FSIS to more effectively address egg safety. Pursuant to this
coordinated strategy, FDA is focusing its efforts on farm practices,
and on food manufacturing plants, institutions, and restaurants. FSIS,
in turn, is focusing its efforts on egg products plants and egg
handlers. Both agencies are evaluating additional measures to improve
egg safety, and FSIS intends to issue proposed rules in the near future
for egg products plants and egg handlers, including egg handlers who
operate in-shell pasteurization treatments. FDA and FSIS will continue
to work closely together to ensure that our egg safety measures are
consistent, coordinated, and complementary.
D. Current Federal Egg Safety Measures for Shell Egg Production and
Retail
Currently, there are no Federal regulations to reduce the presence
of SE in eggs during production. However, we recognize that some State
or local agencies may have requirements in place addressing egg safety
during production.
There are several Federal activities related to egg safety at the
retail level. FSIS issued a final rule for refrigeration and labeling
of eggs during transport and storage when packed for the ultimate
consumer (63 FR 45663, August 27, 1998). In addition, FDA issued a
final rule that requires labeling of eggs and refrigeration of eggs at
retail establishments (65 FR 76092, December 5, 2000). Further, FDA's
Food Code provides guidance to retail establishments on the handling
and storage of potentially hazardous foods, such as shell eggs. Also,
there have been egg safety education campaigns specifically tailored
for the retail sector. The following sections describe these egg safety
measures.
1. Refrigeration of Shell Eggs
The EPIA was amended in 1991 (Public Law 102-237) to require that
shell eggs packed for the ultimate consumer be stored and transported
under refrigeration at an ambient temperature (i.e., the air
temperature maintained in an egg storage facility or transport vehicle)
not to exceed 45 [deg]F. The 1991 Amendments to the EPIA also require
that labels on egg containers indicate that refrigeration of eggs is
required. Subsequently, USDA's FSIS amended its regulations to require
shell egg handlers to store and transport shell eggs packed in
containers destined for the ultimate consumer under refrigeration at an
ambient temperature of no greater than 45 [deg]F (7.2 [deg]C) (63 FR
45663). In the FSIS regulation, an egg handler is defined as any
person, excluding the ultimate consumer, who engages in any business in
commerce that involves buying or selling any eggs
[[Page 56828]]
(as a poultry producer or otherwise), or processing any egg products,
or otherwise using any eggs in the preparation of human food. In 9 CFR
590.5, FSIS defines an ultimate consumer as any household consumer,
restaurant, institution, or other party who has purchased or received
shell eggs or egg products for consumption. This regulation became
effective August 27, 1999.
FSIS' regulation does not require the ultimate consumer, including
restaurants and institutions, to maintain shell eggs under
refrigeration. Consequently, we concluded that it was necessary to
require that shell eggs be kept refrigerated throughout retail
distribution. On December 5, 2000, we published a final rule requiring
that retail establishments, such as grocery stores, farm stands,
restaurants, schools, and nursing homes, promptly refrigerate eggs upon
receipt and store and display eggs at an ambient temperature of 45
[deg]F (7.2 [deg]C) or less (65 FR 76092).
2. Labeling of Shell Eggs
In an effort to inform consumers of the risks associated with
consuming raw or undercooked eggs, we require that egg cartons carry
safe handling instructions (21 CFR 101.17(h)). All eggs not
specifically processed to destroy Salmonella must carry the following
safe handling statement: ``SAFE HANDLING INSTRUCTIONS: To prevent
illness from bacteria: keep eggs refrigerated, cook eggs until yolks
are firm, and cook foods containing eggs thoroughly.''
3. The FDA Food Code
Through the Food Code, FDA endeavors to assist those local, State,
tribal, and Federal governmental jurisdictions assuming primary
responsibility for preventing foodborne illness and for licensing and
inspecting establishments within the retail segment of the food
industry. The Food Code, published by FDA, is not Federal law or
regulation, and is not preemptive. Rather, it represents our best
advice to States and local authorities to ensure that food at the
retail level is safe, properly protected, and properly represented
(i.e., is what it is purported to be). The Food Code provides guidance
on food safety, sanitation, and fair dealing that can be uniformly
adopted for the retail segment of the food industry. The document is
the cumulative result of the efforts and recommendations of many
contributing individuals with years of experience. These individuals
represent a diverse group of regulators, educators, industry leaders,
and consumer representatives acting through their agencies, companies,
professional groups, or trade organizations.
Although the Food Code provisions are not Federal requirements,
they are designed to be consistent with Federal food laws and
regulations. The Food Code is written so that all levels of government
can easily adopt the language of the Food Code into a legal
requirement.
All segments of the food industry and Federal, State, and local
governments share the responsibility to ensure food provided to the
consumer is safe and does not become a vehicle for a disease outbreak
or the transmission of communicable disease. By sharing in this
responsibility, government and industry can ensure consumer
expectations are met, and food is prepared in a sanitary environment,
properly presented, and not adulterated.
The Food Code provides advice on how to prevent foodborne illness
based on information obtained from CDC investigations. CDC has
identified risk factors, such as unsafe sources, inadequate cooking,
improper holding, contaminated equipment, and poor personal hygiene,
which may lead to foodborne outbreaks. CDC further established five key
public health interventions to protect consumer health: (1)
Demonstration of knowledge, (2) employee health controls, (3)
controlling hands as a vehicle of contamination, (4) time and
temperature parameters for controlling pathogens, and (5) consumer
advisories.
FDA revises sections of the Food Code every 2 years, and publishes
the revision either as a supplement (most recently in 2003) to the
existing edition or as a new edition (most recently in 2001), based on
the extent of revision. Each new edition incorporates the provisions of
supplements issued between editions. The next revision of the Food Code
will be in 2005. Provisions relevant to egg safety can be found in the
2001 Food Code in sections 3-202.11, 3-202.13, 3-202.14, 3-302.13, 3-
401.11, 3-603.11, and 3-801.11.
4. Egg Safety Education Efforts
Consumer food safety surveys conducted in 1993, 1998, and 2001 by
FDA and FSIS suggested that consumers are less aware of or concerned
about risks associated with eggs than they are of risks associated with
other foods (Refs. 23 and 24). The data indicate that people are most
likely to follow recommended practices when handling fish, somewhat
less likely when handling meat or chicken, and much less likely to
follow recommended practices when breaking eggs. In fact, the majority
of people (65 percent) do not wash their hands with soap after breaking
raw eggs (Refs. 23 and 24).
Comparing the 1998 survey findings with those of 1993, improvement
in the safe handling of eggs by people 61 and older lagged considerably
behind that of people 18 to 25 years old. The younger group showed a 42
percent improvement versus 9 percent for the older group. The 2001
survey showed no significant difference in consumers' egg-handling
behavior from 1998 (Ref. 24).
In consideration of the survey findings, we developed a strategy
for an education campaign on egg safety that targeted both the general
public and at-risk populations. We began the campaign with the July 1,
1999, release of FDA's egg labeling and refrigeration proposed rule to
take advantage of media and public interest in safe handling
instructions for shell egg labels and refrigeration requirements for
eggs at retail establishments. We prepared a video news release (VNR)
to inform consumers of the proposed regulations and to alert them to
the potential risks of, and steps to take to avoid, undercooked eggs.
The VNR was released in conjunction with the July 1999 announcement of
the proposed egg labeling and refrigeration rule.
To provide a basic source of print information for consumers on
eggs and egg safety, we developed a fact sheet, ``Food Safety Facts for
Consumers: Playing It Safe With Eggs,'' which was released in July
1999. The fact sheet covers safe buying, handling, preparation, and
storage of eggs and egg dishes, as well as information on how to avoid
the hidden risks in foods that contain raw or lightly cooked eggs. A
corresponding fact sheet was developed for food service personnel,
entitled ``Food Service Safety Facts: Assuring the Safety of Eggs and
Egg Dishes Made From Raw, Shell Eggs,'' and was released in September
1999.
The consumer fact sheet was targeted to general consumers,
especially parents of young children and older Americans. The food
service fact sheet was targeted to institutional preparers of food for
children, the elderly, and immunocompromised individuals. To reach the
target audience, the fact sheets were distributed to the print and
electronic media, 83,000 day care centers, 13,000 nursing home
directors, school nurses, FDA field staff, extension agents, State and
local health agencies, and food preparation trade associations. Both
fact sheets are posted on FDA's Web site http://www.foodsafety.gov.
Egg safety information also is incorporated into other food safety
[[Page 56829]]
education initiatives. For example, the widely distributed English and
Spanish Fight BAC! brochures produced by the public-private Partnership
for Food Safety Education, of which FDA is a member, include safe egg
cooking information. The Partnership's Virtual Toolbox, available on
the fightbac.org Web site, features egg safety information prominently
among a wide range of other education materials for use by health
educators.
We initiated a second phase of the egg safety education campaign
after publishing the final rules on safe handling labels and
refrigeration at retail. Our strategy remained unchanged; we targeted
the general public and at-risk populations. Our campaign message
focused attention on the new labels on eggs, the potential for human
sickness caused by bacteria from fresh eggs from any source, and the
safety of eggs if selected, stored, and prepared properly.
In addition to the press information FDA distributed about the
regulations, we prepared and distributed a range of consumer education
materials, including a video news release; a public service
announcement/flier sent to 600 publications specializing in health,
food, elderly issues and parenting, as well as specialized health
information providers, such as the National AIDS Clearinghouse and
Hotline, the American Cancer Society and National Cancer Hotline, and
the Arthritis Foundation; a consumer brochure; and a drop-in feature
article in English and Spanish. All consumer education materials are
available on our Web site.
We currently are distributing educational materials we developed
for food service and food retail personnel incorporating existing FDA
regulations and recommendations pertaining to egg safety. These
materials consist of a brochure entitled ``Assuring the Safety of Eggs
and Menu and Deli Items Made From Raw, Shell Eggs--Information for
Retail Food Stores and Food Service Operations,'' and a poster, ``Key
Temperatures for Egg Safety in Food Service Operations and Retail Food
Stores.'' Initially, 250 copies each of the brochure and the poster
were sent to State Egg Program Directors, State Food Service Program
Directors, FDA Regional Food Specialists, and FDA Public Affairs
Specialists in the field to use in generating demand for the
information.
Since the initial mailing, orders have been steady. As of August
2004, approximately 202,000 posters and 246,000 brochures had been
distributed. At least one State, Kentucky, ordered enough (22,000) to
provide copies to each retail food store, food service establishment
and food manufacturing firm in the State. In addition, the brochure,
``Assuring the Safety of Eggs and Menu and Deli Items Made from Raw
Shell Eggs--Information for Retail Food Stores and Food Service
Operations,'' was mailed to 70,300 restaurants in September 2002.
Consumer information on safe handling of eggs is also included in
two widely distributed FDA consumer publications, To Your Health: Food
Safety for Seniors and the Fight BAC! Flyer (originally developed as a
patient handout for the AMA/ANA/FDA/CDC/USDA health professional
education kit, Kiagnosis and Management of Foodborne Illnesses).
Distribution of consumer and foodservice educational materials
continues at professional meetings and conferences, most recently the
2003-2004 meetings of the American Dietetic Association, American
Public Health Association, Food Safety Summit, National WIC
Association, American College of Physicians, National Restaurant
Association, American Nurses Association, National Association of Area
Agencies on Aging, National Wellness Conference, and International
Association for Food Protection.
E. The SE Risk Assessment
In December 1996, FSIS and FDA, with representatives from other
government agencies and academia, began a comprehensive risk assessment
in response to an increasing number of human illnesses associated with
the consumption of eggs (Ref. 15). Following are the objectives of the
risk assessment: (1) Establish the unmitigated (without any SE-
prevention measures risk of foodborne illness from SE, (2) identify and
evaluate potential prevention strategies, (3) identify data needs, and
(4) prioritize future data collection efforts.
A team of scientists developed a quantitative model to characterize
the risks associated with the consumption of eggs contaminated
internally with SE, using information obtained from academic,
government, and industry sources, along with scientific literature. The
risk assessment model consists of five discrete modules (Egg Production
Module, Shell Egg Module, Egg Products Module, Preparation and
Consumption Module, and Public Health Module) that may be used
independently to evaluate the effect of variable changes during a
particular stage of the farm-to-table continuum. However, the overall
model encompasses the entire continuum, from the chicken through egg
production, to egg consumption and human illness. The model predicted
that using any one intervention (e.g., egg refrigeration or consumer
egg safety education) could achieve a modest reduction in human SE
illnesses, while using multiple interventions could achieve a more
substantial reduction for those interventions tested (Ref. 15). Though
on-farm mitigations, as such, were not specified in the risk
assessment, various inputs to the model were tested for cooling and
refrigeration of eggs, including cooling eggs immediately after lay.
The SE risk assessment concluded that a broad-based policy,
encompassing interventions from farm to table, is likely to be more
effective in eliminating egg-associated SE illnesses than a policy
directed solely at one stage of the egg production-to-consumption
continuum.
F. Advance Notice of Proposed Rulemaking on Salmonella Enteritidis in
Eggs
In the Federal Register of May 19, 1998 (63 FR 27502), FDA and USDA
jointly published an advance notice of proposed rulemaking (ANPRM)
seeking to identify farm-to-table actions that would decrease the food
safety risks associated with eggs. The agencies requested comment on
these egg safety actions. In section III.M of this document, we respond
to comments related to on-farm measures to prevent SE contamination of
eggs. We respond to comments related to retail standards to reduce the
risk of egg-associated SE illnesses in section IV.E of this document.
G. Egg Safety Public Meetings
To address the public health problem of SE, FDA and FSIS decided to
coordinate efforts in a farm-to-table approach. Consistent with each
agency's legislative authority, FDA would address egg safety issues at
the producer and retail levels and FSIS would address these issues at
egg packers and processors. On March 30, 2000, and April 6, 2000, FDA
and FSIS held public meetings in Columbus, OH, and Sacramento, CA,
respectively, to gather information for reducing or eliminating the
risk of SE in eggs. Comments on specific egg safety questions were
solicited in a Federal Register document (65 FR 15119, March 21, 2000).
Interested persons were given until April 20, 2000, to comment.
In an effort to expand the public process and build upon the two
public meetings, FDA and FSIS held a public meeting (65 FR 42707, July
11, 2000) on July 31, 2000, in Washington, DC. The purpose of this
meeting was to obtain
[[Page 56830]]
comments on the agencies' current thinking on approaches to ensure egg
safety from farm to table. A document outlining the agencies' current
thinking on on-farm egg safety standards, packer/processor egg safety
standards, and retail egg safety standards was made available at the
public meeting and on the agencies' food safety Web site
http://www.foodsafety.gov. Interested persons were given until August 14,
2000, to comment.
We are responding to comments from the public meetings in Columbus,
OH, and Sacramento, CA, and the current thinking meeting in Washington,
DC in this document. We have responded to comments related to on-farm
measures to prevent SE contamination of eggs in section III.M of this
document and to comments on retail standards to prevent egg-associated
SE illnesses in section IV.E of this document.
H. Current On-Farm Practices
Most of the information on current on-farm practices comes from the
APHIS National Animal Health Monitoring System (NAHMS) Layers '99 Study
(the Layers study) and information on voluntary egg QA programs.
1. The Layers Study
In 1999, NAHMS conducted a study addressing national table egg
layers and SE (Refs. 25, 26, and 27). The aim of the study was to
include information from States that account for at least 70 percent of
the animal and farm population in the United States. Fifteen States
(Alabama, Arkansas, California, Florida, Georgia, Indiana, Iowa,
Minnesota, Missouri, Nebraska, North Carolina, Ohio, Pennsylvania,
Texas, and Washington) were chosen to participate in the study. These
15 States represented 82 percent of the 1997 U.S. table egg layers. The
States, and the operations surveyed within those States, were chosen
from a ranking of table egg layers summarized in a 1997 National
Agricultural Statistics Service (NASS) survey of egg layers and egg
production. NASS maintains information on laying operations that have
more than 30,000 hens; therefore, each operation participating in the
Layers study had more than 30,000 laying hens, although all hens may
not have been on one farm.
a. Production facilities. Egg laying operations varied considerably
in size and style of poultry house. Of the farm sites surveyed by the
Layers study, approximately 34 percent had fewer than 50,000 layers, 29
percent had 50,000 to 99,999 layers, 20 percent had 100,000 to 199,999
layers, and 17 percent had 200,000 or more layers. One-third of farm
sites surveyed had only one layer house, while 16.5 percent had 6 or
more layer houses.
Within a poultry house, style also varied. Approximately one-third
of all poultry houses had six or more banks of cages. A bank is all
cages between two walkways or between a walkway and a wall.
Approximately 40 percent of houses had 4 or more vertical levels of
cages, while approximately 25 percent had only one level. Less than 1
percent of all poultry houses were cage-free.
Manure handling varied with house style and also varied regionally.
Houses with a manure pit at ground level with the house above (high
rise) accounted for 63 percent of houses in the Great Lakes region and
48 percent of houses in the Central region. In the Southeast, 40
percent of farm sites flushed manure to a lagoon. Nonflush scraper
systems were used on 44 percent of farms in the West region.
b. Chicks and pullets. When a poultry house is repopulated with new
laying hens, most of the new layers come from a pullet raising
facility. A pullet is defined in the Layers study as a chicken less
than 20 weeks of age. Less than 10 percent of layer farms raised
pullets at the layer farm site, although some layer farms had their own
pullet raising facilities at other locations.
The vast majority (95 percent) of pullets in pullet raising
facilities came as chicks from National Poultry Improvement Plan (NPIP)
monitored breeder flocks. USDA's NPIP is a cooperative Federal-State-
industry mechanism intended to prevent and control egg-transmitted,
hatchery-disseminated poultry diseases. NPIP has different monitoring
programs for many avian diseases and pathogens, including SE, and all
flocks in the program must meet the qualifications for ``U.S. Pullorum-
Typhoid Clean'' classification (9 CFR 145.23(b)). Therefore, the fact
that the chicks were from NPIP-monitored breeder flocks does not mean
that they were from certified ``U.S. S. Enteritidis Monitored'' breeder
flocks (9 CFR 145.23(d)).
Many pullet raising facilities in the Layers Study had their own
programs for SE monitoring. In the West region, 83 percent of farms
obtained layers from SE-monitored pullet facilities, and 70 percent of
layers on all farms came from SE-monitored pullet facilities. Pullet
facilities used one or more of the following methods to monitor SE: (1)
Dead chick/chick paper testing, (2) environmental culture, (3) bird
culture, and (4) serology. Some pullet facilities used competitive
exclusion products\2\ and/or vaccines to protect pullets against SE.
---------------------------------------------------------------------------
\2\ Competitive exclusion is a strategy in which benign bacteria
are introduced into the gut to prevent a pathogen from colonizing
the gut by blocking all of the sites on the walls of the intestines
where the pathogen would attach.
---------------------------------------------------------------------------
c. Production. In 1997, the average flock was placed for its first
production cycle at 17.5 weeks of age. Flocks in their first production
cycle reached peak production around 29 weeks of age. At peak
production, the average maximum number of eggs produced was 90 eggs per
100 hens per day. Induced molting was used on many farms (83 percent of
farm sites) to increase the laying cycles of the hens. In the West and
Southeast regions, 95 percent or more of farms molted birds, while in
the central region just over half (57 percent) of the farms molted
birds. On average, molted flocks ended production at 111 weeks of age,
while nonmolted flocks ended production at 74 weeks of age.
d. Feed and water. Approximately half (48 percent) of layer houses
used a chain feed delivery system. Well water was used for watering
birds by 66 percent of farms. The percentage of farms that tested feed
for SE varied regionally. For example, finished feed was tested for SE
by 26 percent of farms in the central region, and 68 percent of farms
in the West. Approximately 75 percent of farms in both the West and
Southeast regions tested feed ingredients for SE.
e. Biosecurity. Approximately two-thirds of farms instituted
biosecurity measures that did not allow visitors without a business
reason to enter poultry houses. Sixty-two percent of farms allowed
business visitors provided they had not been on another poultry farm
that day. Most farms (76 percent) required that visitors wear clean
boots. At the majority of farms, employees were required not to be
around other poultry and not to own their own birds.
f. Pest control. The Layers study estimated that rodents and flies
had access to feed in feed troughs on nearly all farms. Fly control was
practiced on 90 percent of all farms; baiting was the most common form
of fly control (72 percent of farms). Essentially all farms used some
type of rodent control. Chemicals and baits were used by 93 percent of
farms for rodent control. Professional exterminators were used on less
than 15 percent of farms that used rodent control. Producers rated
almost 30 percent of farms as having a moderate or severe problem with
mice and almost 9 percent as having a moderate or severe problem with
rats.
[[Page 56831]]
g. Depopulation practices. Depopulation of a poultry house is the
most opportune time for a producer to thoroughly clean and disinfect
the house. Most farms did some sort of cleaning between flocks.
Essentially all farms emptied feeders, 91 percent emptied feed hoppers,
81 percent flushed water lines, 79 percent dry cleaned cages, walls,
and ceilings, and 71 percent cleaned fans and ventilation systems.
Approximately one-third of farm sites never cleaned or disinfected egg
belts/elevators between flocks. Down time between flocks varied
regionally; most farms had a down time of more than 11 days, although
some were down for less than 4 days.
h. Testing for SE. A 1994 NAHMS survey of farms revealed that
almost 16 percent of farms tested for SE. The Layers study showed that,
in 1997, 58 percent of farms tested for SE. The number of farms testing
for SE varied by region. In the Southeast, almost 84 percent of farms
had an SE testing program, while in the West only 26 percent had an SE
testing program. The number and regional distribution of farms doing
testing for SE is very similar to the number and distribution of farms
participating in an egg quality assurance (QA) program.
i. NAHMS Study Testing for SE. In 1994, NAHMS undertook its own
survey for SE in layer houses. It found that 7 percent of layer houses
were positive for SE, based on environmental sampling. Only 4 percent
of houses with fewer than 100,000 laying hens were positive for SE,
while 16 percent of houses with greater than 100,000 laying hens were
SE-positive. The study indicated that the number of rodents, cleaning
and disinfection procedures, biosecurity, and the age of the flock were
all related to the SE status of the layer house.
2. Voluntary Egg QA Programs
The Layers study found that 51 percent of all farm sites
participated in an egg QA program sponsored by a State or commodity
group (e.g., United Egg Producers (UEP)). Based on this information, we
estimate that approximately 50 percent of the eggs in the United States
are produced under an egg QA program.
In 1992, Congress provided special funding to USDA to begin the SE
Pilot Project (SEPP). The SEPP was one of the first egg QA programs in
the United States. The pilot project phase operated for 2 years and
then, in 1994, the SEPP became the PA Egg QA Program (PEQAP).
Currently, there are several voluntary egg QA programs operated and
administered by states or other organizations (Refs. 28, 29, 30, 31,
and 32). The states that have programs include PA, MD, NY, OH, SC, AL,
OR, CA and the New England region. The UEP has a program called the UEP
``Five Star'' Total QA Program (Ref. 33) and the United States Animal
Health Association has a protocol entitled ``National Standardized
Salmonella Enteritidis Reduction Program for Eggs'' (Ref. 34). In
addition, certain egg companies operate an egg QA program within their
own facilities (Ref. 26).
Currently the egg QA programs that exist are voluntary for
producers. All programs have similar requirements but vary in how they
implement these requirements. All programs require use of chicks from
NPIP ``U.S. S. Enteritidis Monitored'' breeders or equivalent,
biosecurity, rodent control, and cleaning and disinfection of poultry
houses. Most programs require some environmental testing; the amount
varies among programs from once to four or five times during the life
of a flock. If an environmental test is SE-positive, several programs
require egg testing, with diversion if the egg testing is SE positive.
Several programs also have State government oversight and recordkeeping
requirements. All existing QA programs have some educational programs
for participants. There is data indicating that QA programs have been
effective in reducing SE contamination in poultry houses (see
discussion in section III) and the provisions in this proposal are
modeled on those successful programs.
I. Petitions to the Agency
FDA has received several citizen petitions relevant to this
proposed rulemaking.
1. Center for Science in the Public Interest
We received a petition from the Center for Science in the Public
Interest (CSPI) (filed May 14, 1997, Docket No. 97P-0197) requesting,
among other things, that FDA require programs to reduce the risk of SE
for all egg producers. In support of its request, CSPI stated that SE
in eggs is a serious health problem, illnesses caused by SE in the
United States have increased, and consumers are at risk of illness from
SE in raw or undercooked eggs. CSPI requested that producers be
required to implement on-farm SE prevention programs using Hazard
Analysis and Critical Control Point (HACCP) principles and modeled
after the PEQAP program. CSPI also requested the following program
components: (1) Chicks from SE-monitored breeder flocks, (2)
environmental sampling for SE of chicks, pullets, and twice during the
life of layers, (3) cleaning and disinfection of poultry houses if
environmental tests are SE positive, (4) egg testing if the environment
is positive with diversion of SE-positive eggs to pasteurization
plants, (5) biosecurity, (6) rodent control program, (7) program to
control SE in feed, and (8) refrigerated storage of eggs at 41[deg]F to
ensure that SE cannot multiply. In addition, CSPI requested that
producers be required to keep records that would be verified by FDA to
indicate compliance with SE prevention programs.
2. Rose Acre Farms, Inc.
We received a petition from Rose Acre Farms, Inc. (filed November
4, 1996, Docket No. 96P-0418) requesting, among other things, that we
issue a regulation requiring ``Best Practices'' of egg producers. The
petitioner stated that ``best practices'' are a set of procedures used
by egg producers to control the presence of SE to the lowest level
practical. Rose Acre Farms, Inc. suggested that the ``best practices''
might include: (1) Environmental testing of a poultry house for SE, (2)
egg testing if the environmental testing is SE-positive, (3) cleaning
and disinfection of poultry houses, (4) a program to reduce SE in feed,
(5) vaccines, (6) rodent control, (7) biosecurity, (8) egg washing, (9)
recordkeeping requirements, and (10) use of appropriate third parties
to audit compliance with program elements. The petitioner requested
that ``best practices'' programs be accredited individually by FDA and
USDA. The petitioner also requested that eggs produced under an
accredited program could never be deemed adulterated, regardless of the
outcome of environmental testing or implication of a flock in a
traceback.
In addition, Rose Acre Farms, Inc. requested that the agency place
greater emphasis on consumer education and retail foodservice. The
petitioner suggested that FDA revise the FDA Food Code to prohibit
pooling of more than three shell eggs by any restaurant or foodservice
institution. For egg dishes requiring pooling of more than three eggs,
pasteurized product would have to be used.
3. United Poultry Concerns, Inc. and the Association of Veterinarians
for Animal Rights
We received a petition from United Poultry Concerns, Inc., and the
Association of Veterinarians for Animal Rights (filed April 14, 1998,
Docket No. 98P-0203/CP1) requesting that FDA eliminate forced molting
of laying birds in the United States. The petitioners requested that
forced molting be
[[Page 56832]]
stopped because it is cruel. The petitioners also stated that the
stress of forced molting promotes a systemic disease in birds in the
form of SE that renders products derived from these birds a health risk
to consumers.
In support of the request to stop forced molting because it
promotes SE-infection in layers and renders products from these birds a
health risk to consumers, the petitioners stated that forced molting
impairs the immune response of laying hens, which invites colonization
of the intestine and other organs by SE. The petitioners also cited
studies that they believe demonstrate SE is shed in large numbers in
the feces of infected, molted birds and spreads more rapidly among
molted laying hens than among nonmolted ones. The petitioners stated
that molted birds are more susceptible to SE infection from rodents,
which have been shown to harbor SE in the poultry house environment.
The petitioners also cited information that indicates feathers can
carry SE and that molted birds engage in abnormal feather pecking
because of the molting conditions.
United Poultry Concerns, Inc. and the Association of Veterinarians
for Animal Rights also requested that forced molting be eliminated
because the living conditions under which forced molting is conducted
are inherently disease producing. The petitioners cited studies that
indicate that concentrated confinement of birds in cages allows 48
square inches of living space per bird. The petitioners stated that the
confined living space puts an additional stress on birds that lowers
immune response and exacerbates an SE infection if present.
III. The Proposal to Require SE Prevention Measures for Egg Production
A. Rationale for Proposal
The incidence and geographical distribution of egg-associated SE
illnesses have made SE a significant public health concern. Although
there are Federal rules requiring refrigeration of shell eggs packed
for the ultimate consumer (FSIS) and at retail (FDA) to limit the
growth of SE that may be present, there are no Federal requirements to
address the introduction of SE into the egg during production. The
Salmonella Enteritidis Risk Assessment Team (Ref. 15) estimated that 1
in 20,000 eggs are contaminated with SE. Based on annual egg production
(Ref. 20), this means that 3.3 million SE-contaminated shell eggs may
be produced annually. Thirty percent of total egg production is used in
egg products (Ref. 20), leaving an estimated 2.3 million SE-
contaminated shell eggs that may reach the consumer. Therefore,
interventions that can reduce the number of SE-contaminated eggs
produced are warranted from a public health standpoint.
As discussed in section II.I of this document, several States and
organizations have established voluntary egg QA programs that show
great promise in reducing the incidence of egg-associated SE illnesses
in specific regions of the country. Data from the PEQAP program show
that after three years on the program the number of poultry houses that
had environmental samples positive for SE decreased from 38 percent in
1992 to 13 percent in 1995 (Refs. 35 and 36). PEQAP data initially
indicated that approximately 50 percent of the flocks in the program
had environmental samples positive for SE at some time during flock
life, whereas in 1996 approximately 15 percent of PEQAP flocks had
environmental samples positive for SE at some time during flock life
(Ref. 36). From 1992 to 1995, there was a decrease in the SE isolation
rate in humans in the three-State region (NY, NJ, PA) that constitutes
the market for PA's eggs. This decrease in isolation rate has been
attributed to the PEQAP program and consumer education (Refs. 35 and
36).
Currently in the United States, only 50 percent (Ref. 26) of shell
eggs are produced under voluntary egg QA programs and the regions that
have voluntary egg QA programs are not necessarily the regions that
have had recent outbreaks of SE illnesses (Ref. 9). Therefore, we have
tentatively concluded that a proposal to require that producers of
shell eggs for the table market, other than those producers whose eggs
are treated or sold directly to consumers or who have fewer than 3000
laying hens, comply with all of the proposed SE prevention measures
would exclude SE on the farm and, thus, remove sources of SE
contamination of shell eggs.
B. Shell Egg Producers Covered by Proposed 21 CFR Part 118
The proposed requirements for SE prevention measures do not apply
to producers who sell all of their eggs directly to consumers (e.g.,
roadside stand operators) or producers with fewer than 3,000 laying
hens. Although we could have proposed to require these producers to
implement SE prevention measures, we opted not to do so because the
sales by these producers do not contribute significantly to the table
egg market. In addition, we have no information indicating that an
outbreak of SE illness has ever been caused by eggs sold directly from
farmer to consumer or from a producer with fewer than 3,000 laying
hens. We are soliciting comment on the exemption for producers with
fewer than 3,000 laying hens and producers who sell all of their eggs
directly to consumers. Specifically, should these producers be covered
by some or all of the SE prevention measures?
We are proposing in Sec. 118.1(a) (21 CFR 118.1(a)) that if you
are a producer with 3,000 or more laying hens at a particular farm
whose eggs are going to the table egg market (eggs consumed as shell
eggs, rather than eggs used in egg products), and not all of your eggs
receive a treatment as defined in Sec. 118.3, then you must comply
with all of the requirements in proposed part 118 for eggs produced on
that farm. You may be selling your eggs to restaurants or other
foodservice establishments where the presence of SE-contaminated eggs
could cause a severe public health threat by striking many people at
one time. In establishments where eggs are combined to make food items,
one SE-contaminated egg can contaminate a dish that will be served to
many people. Thus, it is necessary for you to use SE prevention
measures on your farm to prevent SE contamination of your eggs and
illness in consumers.
It is our understanding that it would be difficult for a producer
to keep eggs produced from individual poultry houses on a farm separate
from other eggs that may be handled differently. For example, a
producer could not easily segregate eggs destined for a breaking plant
from three poultry houses, which would not have to comply with the SE
prevention measures, from eggs not destined for a breaking plant from
two other poultry houses, which would have to follow all of the SE
prevention measures. Furthermore, it would be difficult for the
producer to maintain proper biosecurity for the two poultry houses
subject to all of the SE prevention measures if there were three other
poultry houses on the farm not employing the same biosecurity measures.
Therefore, we have tentatively concluded that, unless all of the eggs
from a particular farm receive a treatment as defined in Sec. 118.3 or
are sold directly to consumers, producers who have 3000 or more laying
hens on that farm must comply with all of the requirements of proposed
part 118 if the eggs are produced for the table egg market.
We are proposing in Sec. 118.1(b) that if you are a producer who
produces eggs on a farm that will all receive a treatment as defined in
Sec. 118.3 and you
[[Page 56833]]
have 3,000 or more laying hens, you must comply only with the
refrigeration requirements for on-farm storage found in proposed Sec.
118.4(e). As defined in proposed Sec. 118.3, ``treatment'' means a
technology or process that achieves at least a 5-log destruction of SE
for shell eggs, or the processing of egg products in accordance with
the Egg Products Inspection Act. It is important that the load of SE
within a contaminated egg be kept low prior to treatment so that the
level of kill given to that egg by the treatment will be sufficient.
For example, if the in-shell pasteurization process for eggs is
designed to reduce the level of SE in an egg by ``x'' logs, then the
incoming SE load of that egg must be less than ``x'' logs for the
treatment to be successful.
Refrigeration at 45 [deg]F within 36 hours of laying has been shown
to slow the multiplication of SE within an egg substantially and is
discussed in section III.E.5 of this document. We have tentatively
concluded that, prior to treatment for SE destruction, producers who
have 3,000 or more laying hens must keep eggs under refrigeration at 45
[deg]F maximum if they are held at the farm for more than 36 hours.
Although we are not proposing to require that producers who treat all
of their eggs to achieve the required destruction of SE comply with all
of the SE prevention measures, we strongly encourage all egg producers
to follow non-mandatory SE prevention measures during egg production.
C. Proposed Compliance Dates for Shell Egg Producers of Various Sizes
We are proposing that, if a producer has 50,000 or more laying
hens, according to the requirements of proposed part 118, compliance
would be required 1 year after the date of publication of the final
rule in the Federal Register. Although producers who currently
participate in voluntary QA programs may already have some of the
provisions in place, we recognize that producers will need time to
implement SE prevention measures, train individuals to implement the
measures, and begin to incorporate them in their farm practices. We
believe that 1 year from the date that any final rule is published is a
realistic timeframe for producers that have 50,000 or more laying hens
on farm to put measures in place.
We recognize that smaller producers (those with fewer than 50,000
but at least 3,000 laying hens) may need more time to comply with the
requirements of proposed part 118. We tentatively have concluded that
it is reasonable to allow for extended compliance periods for smaller
producers. For smaller producers, compliance would be required 2 years
after the date of publication of the final rule in the Federal
Register.
D. Definitions
We are proposing in the introductory paragraph of Sec. 118.3 that
the definitions and interpretations of terms in section 201 of the
FFDCA, unless these terms are redefined in this part, are applicable to
these terms when used in proposed part 118.
We are proposing in Sec. 118.3 that the term ``biosecurity'' means
a program to ensure that there is no introduction or transfer of SE
onto a farm or among poultry houses. As specified in proposed Sec.
118.4(b), a biosecurity program includes, but is not limited to,
limiting visitors to a farm, keeping animals and wild birds out of
poultry houses, requiring personnel to wear protective clothing, and
ensuring that equipment is not moved among poultry houses or, if it is
so moved, that it is adequately cleaned before it is moved.
We are proposing in Sec. 118.3 that the term ``farm'' means all
poultry houses and the grounds immediately surrounding the poultry
houses covered under a single biosecurity program. We intend the term
``farm'' to encompass an entire farming operation at a single
geographic location. We do not intend to allow, by this definition,
multiple ``farms'' covered by multiple biosecurity programs at a
particular geographic site. If we did allow multiple farms at a
geographic location, a producer could have part of the operation under
SE prevention measures for eggs going to the table egg market and part
of the operation under no such measures for eggs going to treatment.
Such an outcome is contrary to our rationale set forth for proposed
Sec. 118.1(a).
We are proposing in Sec. 118.3 that the term ``flock'' means all
laying hens within one poultry house. We recognize that laying hens of
different ages sometimes are placed in the same poultry house. Research
has indicated that once SE is introduced into a poultry house it
spreads among the laying hens in that house (Refs. 37 and 38).
We are proposing in Sec. 118.3 that the term ``group'' means all
laying hens of the same age within one poultry house. This term
particularly applies to laying hens of the same age that comprise part
of a multi-aged flock of laying hens within one poultry house.
We are proposing in Sec. 118.3 that the term ``induced molting''
means molting that is artificially initiated. Induced molting is done
to improve egg production and egg quality.
We are proposing in Sec. 118.3 that the term ``laying cycle''
means: (1) The period of time that a hen begins to produce eggs until
it undergoes induced molting or is permanently taken out of production;
and (2) the period of time that a hen produces eggs between successive
induced molting periods or between induced molting and the time that
the hen is permanently taken out of production.
We are proposing in Sec. 118.3 that the term ``molting'' means a
life stage during which a hen stops laying eggs and sheds its feathers.
We are proposing in Sec. 118.3 that the term ``pest'' means any
objectionable animals or insects, including, but not limited to, birds,
rodents, flies, and larvae. This is also the definition of ``pest''
found in 21 CFR part 110.
We are proposing in Sec. 118.3 that the term ``positive flock''
means a flock that produced eggs that tested positive for SE and
applies until that flock meets the egg testing requirements in proposed
Sec. 118.6 to return to table egg production.
We are proposing in Sec. 118.3 that the term ``positive poultry
house'' means a poultry house from which there has been an
environmental test that was positive for SE during a laying cycle. A
poultry house would be considered positive until it had been cleaned
and disinfected, even if an environmental test is positive for SE prior
to a molt and then is SE-negative at the post-molt environmental test.
A negative environmental test after a molt does not invalidate the
initial positive environmental test or necessarily indicate that SE is
no longer present. Data from the PEQAP program have indicated that
cleaning and disinfection procedures can decontaminate an SE-positive
poultry house (Ref.39). Therefore, we have tentatively concluded that a
poultry house that has had an SE-positive environmental test must be
considered positive until it has been cleaned and disinfected according
to proposed Sec. 118.4(d).
We are proposing in Sec. 118.3 that the term ``poultry house''
means a building, other structure, or separate section within one
structure used to house poultry. We have also tentatively concluded
that, for structures comprising more than one section containing
poultry, each section must have biosecurity procedures in place to
ensure that there is no introduction or transfer of SE from one section
to another. In addition, each section must be enclosed and separated
from the other sections. We interpret ``enclosed and separated'' to
mean that sections must be separated from one another by walls. Thus,
under this proposed
[[Page 56834]]
definition, producers would have to limit their designation of
``sections'' representing separate poultry houses to areas that are
physically separate from one another. It would not be acceptable under
this proposed rule to designate areas that are separated, for example,
only by a walkway or a gate as separate poultry houses.
We are proposing in Sec. 118.3 that the term ``producer'' means a
person who maintains laying hens for the purpose of producing shell
eggs for human consumption.
We are proposing in Sec. 118.3 that the term ``shell egg (or
egg)'' means the egg of the domesticated chicken. This differs from the
definition of ``shell egg'' in the EPIA, because, unlike the EPIA
definition, FDA's definition does not cover shell eggs of the
domesticated turkey, duck, goose, or guinea. FDA is focusing its
resources on domesticated chicken eggs because they have been
associated with numerous outbreaks of foodborne illness.
We are proposing in Sec. 118.3 that the term ``treatment'' means
technologies or processes that achieve at least a 5-log destruction of
SE for shell eggs or the processing of egg products in accordance with
the EPIA. In 1997, we recommended to AMS, in response to an AMS request
to FDA on criteria for shell egg pasteurization, that processors attain
a 5-log reduction in Salmonella in shell eggs in order for the eggs to
be considered ``pasteurized.'' We recommended the 5-log lethality based
on literature available at the time on naturally infected shell eggs
that indicated, under most storage conditions, an intact shell egg
could contain between 10\2\ and 10\3\ Salmonella organisms (Ref. 19).
FDA then added a 2-log safety factor to arrive at the recommendation
for a 5-log lethality. AMS published this standard in its Federal
Register notice on official identification of pasteurized shell eggs
(62 FR 49955, September 24, 1997).
We are soliciting comment on whether a 5-log reduction or an
alternative approach to achieve an equivalent level of protection is
still appropriate to ensure the safety of shell eggs. We intend to work
with USDA to ensure that shell eggs and egg products are given adequate
treatments to destroy SE.
E. The SE Prevention Measures
Data indicate that voluntary egg QA programs have contributed to a
decrease in SE in poultry houses and a decrease in SE illnesses. The
particular program (PEQAP) from which the data were gathered includes
provisions for chick and pullet procurement, biosecurity, rodent
control, refrigeration, cleaning and disinfection of poultry houses,
and monitoring of the poultry house environment through testing for SE
(Ref. 28). Although the individual provisions were not evaluated for
their relative importance, the PEQAP results indicate that, when used
together, the provisions resulted in a decrease in the prevalence of SE
within a poultry house (Ref. 35). Thus, the agency tentatively
concludes that SE prevention measures are necessary to reduce the
incidence of SE illness from consumption of shell eggs, when the eggs
are not treated to destroy SE.
All of the provisions of proposed Sec. 118.4 apply to you if you
are a producer with at least 3,000 laying hens, you produce shell eggs
for the table market, and you do not sell all of your eggs directly to
consumers or treat all of your eggs to destroy SE as defined in
proposed Sec. 118.3 (Sec. 118.1(a)). We are proposing in Sec. 118.4
that shell egg producers described in Sec. 118.1(a) develop and
implement the following SE prevention measures: Provisions for
procurement of chicks and pullets, a biosecurity program, rodent, fly
and other pest control, cleaning and disinfection of poultry houses
that have had an environmental or egg test positive for SE, and
refrigerated storage of eggs at the farm.
We also are proposing in Sec. 118.4 that the particular form that
SE prevention measures take be specific to each farm and poultry house
where eggs are produced. Depending upon whether there are multiple
poultry houses on a farm and whether the poultry houses vary in house
style and location, the SE prevention measures may vary among poultry
houses. For example, one poultry house may require certain rodent and
pest control measures that another poultry house may not require.
Further, we are proposing that if you are a producer under section
Sec. 118.1(a), you must comply with the environmental and egg testing
requirements in Sec. Sec. 118.5 and 118.6, the sampling and testing
methodology requirements in Sec. Sec. 118.7 and 118.8, the
administration requirements in Sec. 118.9, and the recordkeeping
requirements in Sec. 118.10. We will discuss our rationale for
compliance with these requirements in the relevant sections of this
proposed rule.
1. Chicks and Pullets
We are proposing in Sec. 118.4(a) that you must procure chicks and
pullets that came as chicks from breeder flocks that meet NPIP's
standards for ``U.S. S. Enteritidis Monitored'' status or equivalent
standards. The fact that SE can be transmitted via the transovarian
route means that chicks can be born SE-positive (Refs. 35 and 40).
Therefore, they may remain infected as pullets and be placed into
poultry houses as layers already carrying SE and then contaminate their
eggs and, in addition, pass SE on to other layers within the poultry
house (Refs. 38, 41, and 42). We tentatively have concluded that it is
necessary for you to procure chicks and pullets that came as chicks
from breeding flocks that meet NPIP's standards for ``U.S. S.
Enteritidis Monitored'' status (9 CFR 145.23(d)) or equivalent
standards in order to prevent SE contamination of shell eggs from SE-
positive chicks. Producers that procure pullets from a pullet-raising
facility need to have an assurance that those pullets came as chicks
from a breeder flock that meets NPIP's standards for ``U.S. S.
Enteritidis Monitored'' status or equivalent standards.
USDA's NPIP is a cooperative Federal-State-industry mechanism for
controlling certain pathogens and poultry diseases. NPIP has
established ``U.S. S. Enteritidis Monitored'' standards (9 CFR
145.23(d)) from which the breeding-hatching industry may conduct a
program for the prevention and control of SE. Participation in the plan
is voluntary, except under 9 CFR part 82, subpart C, no hatching eggs
or newly-hatched chicks from egg-type chicken breeding flocks may be
moved interstate unless they are classified ``U.S. S. Enteritidis
Monitored'' under NPIP or meet equivalent standards.
To be classified ``U.S. S. Enteritidis Monitored,'' under 9 CFR
145.23(d), a flock and the hatching eggs and chicks produced must come
from a ``U.S. S. Enteritidis Monitored'' flock, or meconium (first
bowel movement) from chick boxes and a sample of chicks that died
within 7 days after hatching must be examined and test negative for
Salmonella. Throughout the life of a ``U.S. S. Enteritidis Monitored''
flock, environmental and blood samples are taken at specified times and
examined for group D Salmonella (the group that includes SE). Breeder
flocks may be vaccinated with an SE bacterin, provided that 350 birds
remain unvaccinated until the flock is at least 4 months of age.
Hatching eggs produced by the flock are collected as quickly as
possible, sanitized or fumigated, and incubated in an approved
hatchery. The flock must also meet feed, facilities, and transport
requirements.
A flock is not eligible for the ``U.S. S. Enteritidis Monitored''
classification if SE is isolated from a specimen taken from a bird in
the flock. Isolation of SE
[[Page 56835]]
from an environmental sample of a vaccinated or nonvaccinated flock
necessitates bird testing. If bird testing reveals no SE contamination,
then the flock qualifies for the classification. The classification may
be revoked at any time if procedures are not followed.
We are aware that most producers purchase pullets from a pullet-
raising facility to repopulate a poultry house. Some of these pullet-
raising facilities have SE-monitoring programs (Ref. 25). We
specifically request comment on whether we should include in any final
rule based on this proposal, a requirement that producers certify that
pullets they procure have come from a facility that has an SE-
monitoring program. If so, what requirements should producers certify
that a pullet-raising facility has met in order to ensure that the
pullet raising facility has an adequate SE-monitoring program?
2. Biosecurity
We are proposing in Sec. 118.4(b) that you develop and implement a
biosecurity program. Biosecurity refers to procedures that must be
instituted on farms to prevent SE from being transferred from the
environment into the poultry house or among poultry houses. Biosecurity
is a routine part of all existing egg QA programs and is aimed at
preventing the horizontal spread of SE. According to the Layers study
(Ref. 26), 66 percent of farm sites already practice some form of
biosecurity, and poultry houses where visitors were not allowed were
less likely to test positive for SE. The Swiss have identified control
of the horizontal spread (i.e., cross contamination from layer to layer
or poultry house to poultry house) of SE as a major success of their SE
control program (Ref. 42). We have tentatively concluded that producers
need to develop and implement a biosecurity program covering the
grounds and all facilities, including poultry houses, for each egg farm
in order to prevent the horizontal spread of SE.
As part of your biosecurity program, you must take measures to
prevent cross-contamination among poultry houses and contamination of
poultry houses from the environment. This includes, where practical,
purchasing separate equipment for each poultry house within a farm
because shared equipment can cause SE cross-contamination between
poultry houses. For certain large pieces of equipment (e.g., manure
removing equipment), we recognize that it is not practical to purchase
separate pieces of equipment for each house. We also recognize that
certain pieces of equipment are common to all houses (e.g., egg belts).
In the Layers study, approximately one-half of the positive
environments were identified by egg belt or elevator sampling (Ref.
27). You must keep egg belts, manure-removing equipment, and other
similar pieces of equipment clean and ensure that these pieces of
equipment are not sources of SE contamination that can be spread from
one house to another.
A comprehensive biosecurity program must also include provisions to
limit visitors to the farm and poultry houses and to ensure proper
hygiene of personnel who do move among poultry houses. Proper hygiene
includes the use of protective clothing that is changed as employees
move between poultry houses and foot sanitizing stations or other
appropriate means to protect against contamination. In addition, you
must prevent stray poultry, wild birds, or other animals from entering
into poultry houses or on the grounds. You must not allow employees to
keep poultry at home. You must implement the biosecurity measures
stated above to prevent spreading SE from one poultry house to another
on contaminated clothing or spreading SE from the environment into a
poultry house by allowing stray animals entrance into a poultry house
or allowing employees to keep their own poultry, which may be carrying
SE, at home.
3. Rodents, Flies, and Other Pest Control
We are proposing in Sec. 118.4(c) that you must develop and
implement a pest and rodent control program to control rodents, flies
and other pests. Many of the comments that we received after the egg
safety public meetings in Columbus, OH (March 30, 2000), and
Sacramento, CA (April 6, 2000), stated that the most important SE
prevention measure that can be taken within a poultry house is rodent
and pest control.
Several investigators have found strong indications that mice are
carriers of invasive SE in the poultry house (Refs. 43 and 44). Kreager
(Ref. 45) has stated that the SE status of rodents in a poultry house
is thought to be indicative of the status of the flock. In fact, data
indicate that the environments of SE-contaminated flocks are usually
infected with the same phage type of SE found in mice and eggs also in
that environment (Ref. 39). According to Davison et al. (Ref. 46), a
single mouse can produce 100 droppings per day, and each dropping can
contain up to 230,000 SE organisms. Wray and Davies (Ref. 47) have
stated that mice may shed Salmonella intermittently for up to 18 weeks
and may infect chickens consuming the fecal matter. Mice may become
infected with SE from contaminated manure and then may spread it to
other poultry houses that were previously SE free (Refs. 46 and 47). A
few mice in one house can proliferate to 10,000 or more during the life
of a flock.
Henzler and Opitz (Ref. 48) found that a poultry house with a large
rodent population was approximately four times more likely to have an
SE-positive environment as a poultry house with a small rodent
population. In the Layers study (Ref. 26), producers reported that they
had a moderate to severe problem with mice on 30 percent of farms and a
moderate to severe problem with rats on 9 percent of farms. Rats have
also been shown to harbor SE and are important vectors because they can
travel long distances (Ref. 47). Environmental testing for the Layers
study (Ref. 27) indicated that poultry houses in which 20 or more mice
were captured (equals a rodent index of 2 or 3, see discussion of
rodent indexing later in this section) were 9 times more likely to
contain SE than poultry houses with a lower rodent index.
In addition to rodents, flies have been shown to harbor SE within
the poultry house environment. Several Salmonella species were found in
houseflies and bronze dump flies collected at caged-layer facilities
that produced eggs that were implicated as the food vehicle in two
recent outbreaks of SE infections. SE was isolated from 2 of 15 pools
of houseflies from these facilities (Ref. 49). Both flies and rodents
are attracted to feed within the poultry house and, according to the
Layers study, flies and rodents have access to feed troughs on nearly
all farms.
These studies indicate that rodents and pests can harbor SE that
can be transmitted to layers and possibly to their eggs, potentially
resulting in SE illnesses from consumption of shell eggs. We
tentatively have concluded that producers must develop and implement a
program to control rodents, flies and other pests.
We are proposing to require, under Sec. 118.4(c)(1), that you must
monitor rodent populations through visual inspection and use of
mechanical traps or glueboards or another appropriate method. The use
of traps and glueboards is appropriate if placed at regular intervals
throughout each poultry house, or wherever rodents are most likely to
be caught (Ref. 46). Davison et al. (Ref. 46) recommend that 12 traps
be set per poultry house, left for a week, and checked twice during
that week. If no mouse is caught at the first check, the trap should be
moved, but no more than 15 feet. One week of trapping gives
[[Page 56836]]
a good indication of the level of rodent infestation in a poultry
house; this is called rodent indexing (Ref. 46). If 0 to 10 mice (less
than 2 mice/day) are caught, the rodent index is low or equal to 1; if
11 to 25 mice are caught, the rodent index is moderate or equal to 2;
if 26 or more mice are caught, the rodent index is high or equal to 3.
A low rodent index indicates acceptable rodent control.
We are proposing to require that when monitoring indicates
unacceptable rodent activity (a rodent index of 2 or higher as
described in Davison et al. (Ref. 46)) within a poultry house, you must
take appropriate action to reduce the rodent population. We are
proposing that baiting and trapping are possible methods to reduce a
rodent population, but may not be effective in all situations.
Producers, aware of rodent situations in their individual poultry
houses, should choose a method that will be effective in their houses.
If rodenticides are used, you should take care to prevent chickens or
other nonrodents from consuming the bait.
We also are proposing to require under Sec. 118.4(c)(2) that you
monitor for flies and other pests through spot cards, Scudder grills,
sticky traps or some other appropriate method that indicates pest
activity. Spot cards are index cards used to enumerate the number of
flies that land within the card area by counting fly specks (Ref. 50).
Sticky traps are used to count the number of flies stuck to the trap
(Ref. 51). A Scudder grill or a fly grill is a wooden grill that is
placed over natural fly concentrations. The number of flies that land
on the grill in 30 seconds is counted (Ref. 52). Spot cards and sticky
traps should be checked weekly, while Scudder grills give an instant
measure of fly activity within a poultry house.
Axtell (Ref. 50) has suggested that 50 or fewer hits on a spot card
or sticky trap per week indicates satisfactory fly control. A count of
less than 20 on a Scudder grill likewise indicates satisfactory fly
control (Ref. 52). If monitoring indicates pest infestation (i.e.,
levels that do not indicate satisfactory pest control, as described
above) within a poultry house, producers must use appropriate methods
to reduce the pest population within a poultry house.
You would be required, under proposed Sec. 118.4(c)(3), to remove
debris within a poultry house and vegetation and debris outside of a
poultry house that may harbor rodents and pests. Maintenance of a
section of crushed rock around the perimeter of a poultry house helps
prevent rodents from burrowing near poultry house foundations. Where
possible, poultry houses should be sealed against entrance by rodents
and pests.
4. Cleaning and Disinfection
We are proposing in Sec. 118.4(d) that you must develop procedures
for cleaning and disinfection of a poultry house that include removal
of visible manure, dry cleaning, followed by wet cleaning using
disinfectants, and finally, disinfecting. Further, we are proposing to
require that you clean and disinfect a positive poultry house prior to
the addition of new laying hens to the house. It is important, once a
poultry house has had an SE-positive environmental or egg test, that
you make every effort to rid the environment of SE before new laying
hens are placed into that house to prevent the SE problem from being
perpetuated in the replacement flock. Schlosser et al. (Ref. 39)
reported that 50 percent of the SE-positive houses that were cleaned
and disinfected according to PEQAP specifications were SE-negative when
subsequently sampled. PEQAP cleaning and disinfection procedures
consist of dry cleaning, wet cleaning (soaking, washing, rinsing),
disinfection, and possibly fumigation with formaldehyde (Ref. 39). In
addition, the Layers study found that no poultry house tested positive
for SE after wet cleaning (i.e., where cages, walls, and ceilings were
washed) (Ref. 27). We tentatively have concluded that, if an
environmental test or an egg test is positive for SE during the life of
a group in a poultry house, producers must clean and disinfect that
poultry house before new laying hens are added to the house.
You must develop procedures for cleaning and disinfection in case
they should ever need to be implemented. The cleaning and disinfection
must include removal of all visible manure from the poultry house.
Manure is a reservoir of SE that has been shed by infected laying hens.
You must begin the cleaning procedure with dry cleaning of the house to
remove dust, feathers, and old feed. Then, you must wet clean the
poultry house, including washing with detergents. Detergents must be
used according to label instructions, followed by recommended rinsing
procedures. Following cleaning, you must disinfect the poultry house
with spray, aerosol, fumigation or another appropriate disinfection
method.
We are aware of studies that indicate that wet cleaning may have a
detrimental effect on the SE status of a poultry house. In the report
by Schlosser et al. (Ref. 39) mentioned in the first paragraph of this
section, it is noted that, while 50 percent of the houses went from SE-
positive to SE-negative after wet cleaning, 28 percent of the houses
went from SE-negative to SE-positive. It is not known whether this was
a testing error or a result of the wet cleaning. In addition, a Danish
study found a relationship between wet cleaning procedures and SE-
positive pig herds (Ref. 53). The authors were unsure whether the
cleaning procedures were actually contributing to the presence of SE in
the pigs or if the study was biased. Because there is some evidence,
though inconclusive, suggesting that wet cleaning may result in an SE-
positive poultry house environment, we specifically request comment and
data on this subject. Although we are requiring cleaning and
disinfection only for houses that have had an environmental or egg test
that was positive for SE, we recommend that you remove manure and dry
clean poultry houses as a general management practice every time you
depopulate a house, even when no SE was detected in the house or eggs.
5. Refrigeration of Shell Eggs Stored More Than 36 Hours
We are proposing in Sec. 118.4(e) that you must store eggs at or
below 45[deg]F (7.2[deg]C) ambient temperature if you hold them at the
farm for more than 36 hours after laying. This proposed requirement is
the only SE prevention measure that applies to all producers with 3,000
or more laying hens regardless of whether your eggs will receive a
treatment.
As we described in the shell egg refrigeration and labeling
proposed rule (64 FR 36492 at 36495, July 6, 1999), although fresh
shell eggs provide an inhospitable environment for Salmonella and other
microorganisms to multiply, the chemical and physical barriers against
bacterial movement and growth in shell eggs degrade as a result of the
time and temperature of holding. Consequently, as a result of
degradation, SE, if present, has access to the nutrient rich yolk,
which provides a favorable environment for growth of SE.
Studies have shown that SE, when inoculated into the albumen of
whole shell eggs, multiplied to high numbers if the eggs were not
properly refrigerated (Refs. 54, 55, and 56). One study investigated
the effect of holding inoculated whole eggs at five different
temperatures in the range of 4 [deg]C (39 [deg]F) to 27 [deg]C (81
[deg]F). The investigators found that the SE growth response was
proportional to the temperature at which the inoculated eggs were held.
The study demonstrated that SE inoculated in shell eggs can multiply to
substantial levels if held at 10 [deg]C (50 [deg]F)
[[Page 56837]]
or higher for up to 30 days. The authors concluded that ``because the
number of SE present at the time an infected egg is laid is probably
very low, egg storage at 4 [deg]C (39 [deg]F) could be expected to
result in a smaller risk to the public health than higher storage
temperatures'' (Ref. 54). In studies by Humphrey (Ref. 55) and Bradshaw
et al. (Ref. 56), no growth was observed in SE inoculated into whole
shell eggs at 8 [deg]C (46 [deg]F) and 7 [deg]C (45 [deg]F),
respectively. We find that the scientific evidence on the growth of SE
in eggs shows that control of storage temperature of shell eggs can
effectively prevent the multiplication of any SE present. We seek
comment and data on the impact of refrigeration on eggs after they
leave the farm, such as the possibility that the eggs may ``sweat''
when removed from refrigeration.
Although we believe that it is very important that eggs be placed
into refrigerated storage as soon as possible after they are laid, we
realize that this may not be practical for all producers. It may be
several hours or longer after the eggs are laid before they are
collected or picked up for transport. It may not be practical for
producers to place eggs under refrigeration within several hours after
they are laid. It would be reasonable, based on what we know about
current practices and the risk of SE growth in unrefrigerated eggs, to
establish a time limit for holding eggs under ambient temperature
conditions. According to the Layers study (Ref. 26), almost half of the
farm sites surveyed had egg pick-ups every 1 to 2 days. We believe that
holding eggs under ambient temperature conditions for up to 36 hours
would not result in excessive growth of any SE, if present (Ref. 54).
If eggs will be held at the farm for more than 36 hours after they are
laid, it is important to place them in an environment that will protect
the yolk membrane from degradation and, thereby, prevent any SE that
may be present from multiplying. We have tentatively concluded that if
eggs will be stored for more than 36 hours after they are laid,
producers, with 3,000 or more laying hens, must store them at an
ambient temperature of 45 [deg]F (7.2 [deg]C) or lower.
We are soliciting comment and data on the 36-hour threshold that
eggs may be held unrefrigerated at a farm. Is this time frame practical
for producers with daily egg pickup? Is it practical to refrigerate
eggs held at farms for less than 36 hours?
F. Indication of the Effectiveness of the SE Prevention Measures:
Testing
In addition to implementing SE prevention measures in the poultry
house environment, we have tentatively concluded it is also important
that you do environmental testing as an indicator of whether your
measures are working effectively.
1. Environmental Testing for SE
Under proposed Sec. 118.1(a), Sec. 118.5 would apply to you if
you are a shell egg producer with 3,000 or more laying hens, you
produce shell eggs for the table market but do not sell all of your
eggs directly to consumers, and any of your eggs that are produced at a
particular farm do not receive a treatment as defined in Sec. 118.3.
We are proposing in Sec. 118.5 that you must conduct environmental
testing for SE as an indicator of whether your SE prevention measures
are working effectively. According to Schlosser et al. (Ref. 39), the
Northeast Conference on Avian Diseases recommended that the poultry
house environment (e.g., manure pits and egg machinery) be sampled by
swabbing. This recommendation was made with the assumption that, if SE
was found in the environment, there was a high probability that the
laying hens in the house were infected. Sampling of manure in a poultry
house is a simple screening method for determining if laying hens are
shedding SE. Some studies have shown that manure sampling gives more
consistent results than sampling of egg machinery (Ref. 39), although
we recognize that sampling egg machinery may be preferable in certain
poultry houses, and the Layers study identified almost one-half of
environmental positives through sampling of egg machinery (Ref. 27). We
tentatively have determined that environmental testing of the manure or
egg machinery in a poultry house is an appropriate method for screening
the environment for SE and should be used as one indicator of the
effectiveness of your SE prevention measures.
Testing provides an opportunity for you to evaluate the SE status
of your poultry houses and to take appropriate action if your measures
are not preventing SE. Many of the comments we received in response to
the public meetings in Columbus, OH, and Sacramento, CA, stated that
environmental testing was an appropriate indicator of whether SE
prevention measures are working effectively. In addition, most of the
voluntary egg QA programs contain some level of environmental testing
for SE to evaluate the effectiveness of the programs.
Information from an egg QA program with a testing protocol
indicates that the highest numbers of positive environmental samples
are found when laying hens are 40 to 45 weeks of age (Ref. 57). The
Layers study (Ref. 27) found that flocks less than 60 weeks of age
(younger flocks) were 5 times more likely to test positive for SE than
older flocks. Accordingly, we are proposing in Sec. 118.5(a) that
environmental testing for SE be conducted for the flock in each poultry
house when each group of laying hens making up that flock is 40 to 45
weeks of age. We are proposing in Sec. 118.5(b) that environmental
testing for SE also be conducted approximately 20 weeks after the end
of any induced molting process. We propose to do this because the egg
industry considers the time period approximately 20 weeks after the end
of a molting process to be equivalent to the time period when layers
are 40 to 45 weeks of age in an initial laying cycle.
An SE-positive environmental test at the 40 to 45 week time period
notifies a producer that there is a problem with SE contamination. At
this point, action can be taken to determine if there are SE-
contaminated eggs and to keep SE-contaminated eggs produced by an SE-
positive flock out of the table egg market. Additionally, a positive
environmental test during the 40 to 45 week period (just after peak
lay) gives a producer sufficient notice to make arrangements for
cleaning and disinfection of the contaminated poultry house at
depopulation. Therefore, we have tentatively concluded that you must
perform environmental testing for SE on a poultry house when each group
of laying hens in the flock in that house are 40 to 45 weeks of age
and, if molted, approximately 20 weeks after the end of any molting
process.
We tentatively have concluded in proposed Sec. 118.5(a)(1) that,
if an environmental test at 40 to 45 weeks for SE is negative, and your
laying hens do not undergo induced molting, then you do not need to
perform additional environmental testing on the poultry house, unless
the flock in that poultry house contains multi-aged laying hens. If the
flock contains multi-aged laying hens, you must test the environment of
the poultry house when each group of hens in the flock is 40 to 45
weeks of age. We are establishing minimum testing requirements to serve
as one indication of whether your SE prevention measures are working
effectively, and we believe that one test per laying cycle is
sufficient for that purpose. In addition, a representative
[[Page 56838]]
from the PEQAP program stated at a recent FDA/FSIS public meeting on
egg safety (Washington, DC, July 31, 2000) that 75 percent of
environmental positives will be caught with one environmental test
(Ref. 58).
If an environmental test for SE is positive, we have tentatively
concluded, under proposed Sec. 118.5(a)(2), that you must review
implementation of your SE prevention measures and begin egg testing
within 24 hours of receiving notification of the positive environmental
test, unless you divert eggs to treatment for the life of the flock in
that poultry house. Review of the SE prevention measures is critical to
ensure that they are being implemented properly and to eliminate
improper implementation as a contributor to the SE-positive
environment. We are proposing that you begin egg testing within 24
hours of receiving notification of an SE-positive environmental test in
order to determine as quickly as possible whether SE-contaminated eggs
are being marketed to consumers.
Further, we tentatively have concluded, in proposed Sec. 118.5(b),
that you must perform an environmental test for SE at approximately 20
weeks after the end of the molting process. Under proposed Sec.
118.5(b)(1), if an environmental test is negative approximately 20
weeks after the end of a molting process, and your laying hens are not
molted again, you do not need to perform additional environmental
testing, for the reasons previously stated, on that poultry house,
unless the flock in the poultry house contains multi-aged laying hens.
If the flock contains multi-aged laying hens, the environment of the
poultry house must be tested approximately 20 weeks after the end of
the molting process of each group of hens in the flock in each poultry
house.
Under proposed Sec. 118.5(b)(2), if the environmental test for SE
is positive at approximately 20 weeks after the end of a molting
process, you must proceed in the same manner as described when the
environmental test performed when laying hens are 40 to 45 weeks of age
is positive for SE.
2. Egg Testing for SE
Under proposed Sec. 118.1(a), Sec. 118.6 would apply to you if
you are a shell egg producer with 3,000 or more laying hens, you
produce shell eggs for the table market but do not sell all of your
eggs directly to consumers, and any of your eggs that are produced at a
particular farm do not receive a treatment as defined in Sec. 118.3.
We are proposing in Sec. 118.6 that if you have an environmental test
that is positive for SE at any point during the life of a flock, you
must perform egg testing for SE, unless you divert eggs to treatment as
defined in Sec. 118.3 for the life of the flock in the positive
poultry house. If an environmental test is SE-positive, the flock in
that environment may be producing SE-positive eggs. Studies have shown
that infected laying hens that are shedding SE into the environment are
not necessarily producing SE-contaminated eggs (Ref. 14). However, data
from the SE Pilot Project (Ref. 39) showed that 50 percent of flocks
with an SE-positive environment produced at least one positive egg in
the time period studied. The prevalence of SE-positive eggs from flocks
in SE-positive environments was estimated to be approximately 1 in
3,600 from data from the SE Pilot Project (Ref. 39). The SE Risk
Assessment (Ref. 15) estimated the prevalence of contaminated eggs to
be as high as 1 in 1,400 from ``high risk'' flocks with SE-positive
environments. We have tentatively concluded that, in order to protect
public health, you must begin testing eggs within 24 hours of receiving
notification that you have an environmental test that is positive for
SE, unless you choose to divert eggs to treatment as defined in Sec.
118.3 for the life of the flock in the positive poultry house.
We are proposing in Sec. 118.6(c) that you must conduct 4 egg
tests on the positive poultry house; you must collect and test eggs as
required by Sec. Sec. 118.7 and 118.8, respectively, at 2-week
intervals for a total of 4 tests. We are also proposing in Sec.
118.6(c) that if all four tests are negative for SE, then you may
continue to supply eggs to the table egg market. However, if any one of
the four egg tests is positive for SE, we are proposing in Sec.
118.6(d) that, upon receiving notification of an SE-positive egg test,
you must divert all eggs from the positive flock for treatment as
defined in Sec. 118.3 until the provisions of Sec. 118.6(c) are met.
You may divert eggs from the positive flock to egg products processing
or to a treatment that will achieve at least a 5-log destruction of SE
for shell eggs. You may return to providing eggs to the table egg
market if they have met the provisions of proposed Sec. 118.6(c) (see
discussion in section III.G.2 of this document) and continue to meet
the provisions of proposed Sec. 118.6(e), described in the following
paragraph.
We are proposing in Sec. 118.6(e) that, if you have had a positive
egg test in a flock and later meet the number of negative egg tests
required in Sec. 118.6(c) and return to table egg production, you must
conduct one egg test per month on that flock (see discussion in section
III.G.2 of this document) for the life of that previously positive
flock. Humphrey (Ref. 14) has suggested that laying hens that are
infected with SE will produce SE-contaminated eggs sporadically.
Therefore, we believe that it is important that a flock that previously
has produced positive eggs be monitored throughout its life for
production of SE-contaminated eggs. Under proposed Sec. 118.6(e)(1),
if the monthly egg test in paragraph (e) is negative for SE, you may
continue to supply eggs to the table market. If any of the monthly egg
tests in paragraph (e) are positive for SE, under proposed Sec.
118.6(e)(2), you must divert eggs from the positive flock to treatment
for the life of the flock or until the conditions in paragraph (c) of
proposed Sec. 118.6 are met.
The testing schemes described in the previous paragraphs could be
the basis for a performance based regulatory scheme. We are soliciting
comment and data on alternative regulatory schemes that would achieve
the same public health protection as the set of measures we are
currently proposing. One possibility is a requirement for a specified
frequency of environmental testing for all producers, followed, if
necessary, by egg testing and diversion. As long as producers were
maintaining poultry houses that tested negative for SE, the SE
prevention measures would be recommended but not required. However,
some or all of the measures may be required of producers whose houses
were contaminated with SE. We solicit comment on a testing-based
regulatory scheme and combinations of the prevention measures that
might achieve the same public health goals as the current proposal.
G. Sampling and Testing Methodology for SE
We are proposing in Sec. 118.7 to require that you follow a
scientifically valid sampling procedure when sampling for SE in the
poultry house environment and in eggs. Your ability to accurately
assess the SE status of a flock and its eggs is a factor of the
sampling methodology used to detect SE in the environment and in eggs.
To protect public health, it is important that when you perform
environmental testing for SE, you take representative samples of the
manure or other appropriate material in poultry houses and, when you
perform egg testing, you randomly collect 1,000 eggs from a day's
production.
[[Page 56839]]
1. Sampling of the Poultry House Environment
We are proposing in Sec. 118.7(a) that you use a scientifically
valid sampling procedure for conducting environmental sampling within
each poultry house. Currently, drag swabbing methods are being used to
sample manure in poultry houses in the voluntary State QA programs
(Refs. 28, 29, 30, 31, and 32). Drag swabbing has been reported to be
an effective and convenient method for determining the SE status of a
flock in a poultry house (Ref. 59). Drag swabbing involves pulling a
square gauze pad (approximately 4 x 4 inches) that has been moistened
with canned, evaporated milk across the surface of manure. Information
on drag swabbing generated for the CA Egg QA Program (CEQAP) indicates
that a swab becomes saturated with manure after being dragged
approximately 30 linear feet (Ref. 60) and, therefore, in that program
an individual swab is only dragged for 30 feet. Most other State
programs drag a single swab the entire length of a row of cages within
a poultry house regardless of the length of that row (Refs. 28, 30, 31,
and 32). As only the one CEQAP study has been done on saturation of a
drag swab, there is very little information on this subject.
Currently, two different sampling plans are being used to drag swab
manure in poultry houses among the voluntary State egg QA programs.
CEQAP has developed a statistical sampling plan for drag swabbing a
poultry house based on an assumed level of contamination within that
house. Based on this assumed level of contamination, the number of
swabs necessary to give a particular probability of detecting SE can be
determined. For example, if 10 percent of the area of a poultry house
is contaminated with SE, taking 32 swabs would give a 96 percent
probability of detecting SE in that house. For the CEQAP program, the
total area of a poultry house is divided into 30-foot sections (the
distance that they have determined it is valid to drag a single swab)
and, in our example, 32 of those 30-foot sections would be randomly
selected to be drag swabbed for SE. In this sampling plan, the assumed
area of contamination can be altered to fit the conditions in a
particular poultry house with consequent changes in the number of swabs
that must be taken to retain a 95 percent or better probability of
detecting any SE that may be present.
Alternatively, many of the other voluntary egg QA programs drag
swab the entire length of every row of cages within a poultry house.
Rows or banks of cages typically have a right and left side. Each side
of a row is dragged with a fresh swab until all the rows have been
sampled. One swab is used per side regardless of the length of that
row. The number of drag swabs taken per house equals twice the number
of rows in that house. In addition, there are houses with cages that
are stair-stepped and can be eight cages high with a large manure pit
beneath them. In houses such as these, the manure belts are usually
sampled. In houses where the floors are constantly flushed with water,
the floor in general is swabbed.
We are aware of the differences in the types of poultry houses
within the United States and the challenges involved in sampling all
houses representatively and consistently. We are specifically
soliciting comment on the appropriateness of different methods of drag
swabbing, including manure belt and floor swabbing, and egg machinery
swabbing. We would like comments on the distance an individual swab
should be dragged and whether or not it is necessary to drag every row
of every house. We would also like comments on alternative methods of
sampling (e.g., sampling of the air in a poultry house to detect SE)
that could be utilized more uniformly in different styles of poultry
houses. Based on comments received, we will consider what poultry house
environmental sampling methods should be required in any final rule.
2. Egg Sampling
In Sec. 118.5(a)(2)(B) and (b)(2)(B), we are proposing to require
that you begin egg testing within 24 hours of receiving notification of
a single SE-positive environmental test unless you divert eggs to
treatment for the life of the flock in the poultry house. In Sec.
118.7(b)(1), we are proposing that, when you conduct an egg test
required under Sec. 118.6, you randomly collect and test 1,000 eggs
from a day's production. The 1,000-egg sample must be tested according
to proposed Sec. 118.8. You must randomly collect and test 4 1,000-egg
samples at 2-week intervals for a total test of 4,000 eggs over an 8-
week period. With this sampling scheme, there is approximately a 95
percent probability that a positive egg will be detected from a flock
that is producing SE-contaminated eggs with a prevalence of 1 in 1,400
(Ref. 61). As mentioned previously, data have indicated that an SE-
contaminated flock may be producing SE-contaminated eggs with a
prevalence of 1 in 1,400 (Ref. 15). We are proposing that eggs be
tested in 2-week intervals because infected flocks shed SE
intermittently (Ref. 14). However, the false negative rate of the
sampling scheme is sensitive to the assumption regarding the prevalence
of SE-contaminated eggs (Ref. 61). We are soliciting comment on this
assumption, as well as other scientifically valid egg sampling
procedures.
In proposed Sec. 118.7(b)(2) we have tentatively concluded that
1,000 eggs from a day's production should be tested per month for the
life of a flock that has had an SE-positive egg test and then met the
provisions of Sec. 118.6(c) and returned to table egg production. We
are requiring this monthly egg test for the life of the flock because
infected layers shed SE intermittently (Ref. 14).
H. Laboratory Methods for Testing for SE
We are proposing in Sec. 118.8(a) that you must test for SE in
environmental samples according to the method ``Detection of Salmonella
in Environmental Samples from Poultry Houses'' and in Sec. 118.8(b)
that you must test for SE in egg samples according to the preenrichment
method described by Valentin et al. (Ref. 62). These methods, which are
incorporated by reference, are required unless you test for SE in
environmental and egg samples using other methods that are at least
equivalent in accuracy, precision, and sensitivity in detecting SE. In
the future, we intend to place the specified methods in FDA's
Bacteriological Analytical Manual. After publication of this proposed
rule, the environmental sampling method will be available on FDA's
Internet Web site at http://www.cfsan.fda.gov.
The method for detecting SE in the environment that we are
specifically proposing to allow, ``Detection of Salmonella in
Environmental Samples from Poultry Houses,'' is a pre-enrichment method
followed by primary enrichment method. The basic procedure for
culturing samples involves incubating pre-enriched samples in
enrichment broth and then streaking samples of broth onto selective
media. Following incubation of the samples on the selective media, any
suspect colonies that have grown on the media are identified
biologically and serologically. In general, this procedure should give
results in 5 days following receipt of samples by the laboratory.
The method for detecting SE in egg samples that we are specifically
proposing to allow is a pre-enrichment method. The basic procedure for
culturing involves incubation of pools of 20 eggs, followed by
enrichment in modified tryptic soy broth. Following incubation and
enrichment, samples are subcultured and streaked onto media and any
suspect colonies that have
[[Page 56840]]
grown on the media are identified biochemically and serologically. We
specifically request comment on appropriate options for conducting and
funding testing of SE detection methods through State and Federal
programs.
I. Administration of the SE Prevention Measures
We are proposing in Sec. 118.9 that one individual at each farm
must be responsible for administration of the SE prevention measures.
Oversight by one qualified individual is essential to the effective
implementation of SE prevention measures for egg production. Because
egg production operations tend to be small and may have frequent
turnover in staff, it is particularly important that one individual
have training equivalent to a standardized curriculum recognized by FDA
(discussed in the following paragraphs) or be otherwise qualified
through job experience to administer the SE prevention measures.
Proposed Sec. 118.9 requires an individual to have the requisite
training or experience to administer SE prevention measures. Training
on SE prevention measures for egg production must be at least
equivalent to that received under a standardized curriculum recognized
by FDA. We anticipate that 2- or 3-day training sessions will be
provided by an egg safety training alliance, modeled after the Seafood
HACCP Alliance. The Seafood HACCP Alliance is a consortium consisting
of representatives from Federal and State agencies, industry, and
academia who have worked to create a uniform training program that will
meet the requirements of the seafood HACCP regulations with minimal
cost. It is our intention to develop an Egg Safety Alliance to create a
core curriculum and training materials on SE prevention measures for
egg production. It also is our intention to use the Egg Safety Alliance
curriculum and materials as the standard against which other course
curricula and materials may be judged.
We also are proposing in Sec. 118.9 that job experience will
qualify an individual to administer the SE prevention measures if such
experience has provided knowledge at least equivalent to that provided
through the standardized curriculum. We acknowledge that a course on SE
prevention measures for egg production might not be necessary for an
individual who has experience working on an egg farm and is well-versed
in SE prevention during egg production. Where job experience has
imparted a level of knowledge at least equivalent to what an individual
would receive through the standardized curriculum, that individual
would be considered qualified to administer the prevention measures
under proposed Sec. 118.9.
We are proposing in Sec. Sec. 118.9(a) through (c) that the
qualified individual designated under Sec. 118.9 must develop and
implement SE prevention measures for each farm, reassess and modify the
prevention measures as necessary to ensure that the requirements of
Sec. 118.4 are met, and review all records created under Sec. 118.10.
We also are proposing that the individual does not need to have
performed the monitoring or created the records being reviewed. We have
tentatively concluded that the prevention measures need to be
implemented and, if necessary, modified and reassessed by an individual
who not only is knowledgeable about egg production but who also has
been trained or is experienced specifically in SE prevention measures
for egg production so that the individual will be able to recognize
potential problems.
J. Recordkeeping Requirements for the SE Prevention Measures
We are proposing recordkeeping requirements related to
environmental testing and egg testing for SE, diversion, and eggs going
to treatment.
1. Records that Egg Producers Are Required to Maintain
Under proposed Sec. 118.1(a), Sec. 118.10 would apply to you if
you are a shell egg producer with 3000 or more laying hens, you produce
shell eggs for the table market but do not sell all of your eggs
directly to consumers, and any of your eggs that are produced at a
particular farm do not receive a treatment as defined in Sec. 118.3.
We are proposing in Sec. 118.10(a)(1) that you must keep records
indicating compliance with environmental and egg sampling performed
under proposed Sec. 118.7 and results of environmental and egg testing
performed under proposed Sec. 118.8 as required in proposed Sec. Sec.
118.5 and 118.6. If applicable, you must also keep records indicating
compliance with the egg diversion requirements of proposed Sec. 118.6.
These records may be handwritten logs, invoices, documents reporting
laboratory results, or other appropriate records.
Maintenance of appropriate records is fundamental to evaluating the
effectiveness of your SE prevention measures. As stated in section
III.A of this document, the combined SE prevention measures, when
implemented properly, have been shown to result in a decrease in the
number of poultry houses with SE-positive environments (Ref. 39). We
have tentatively concluded that in order for you and FDA to evaluate
whether these measures are being effective, it is necessary for you to
keep records documenting the results of environmental testing and, if
applicable, egg testing. We are proposing in Sec. 118.10(a)(2) that if
egg testing reveals SE-positive eggs you must maintain records
indicating compliance with the diversion requirements in Sec. 118.6.
Records of diversion will provide assurance to both you and FDA that
eggs required to be diverted are not being marketed to consumers and,
thereby, putting consumers at risk of illness from SE.
We are proposing in Sec. 118.10(a)(3) that you must keep records
indicating that all of the eggs at a particular farm will be given a
treatment as defined in Sec. 118.3, if you have 3,000 or more laying
hens and you are not complying with the SE prevention measures other
than refrigeration (i.e., you are a producer described in Sec.
118.1(b)). These records may include a contract with an in-shell
pasteurization facility or an egg-breaking facility. It is necessary
that these records be maintained so that both you and FDA will have an
assurance that the potential for SE contamination in eggs is being
addressed through a treatment or through the SE prevention measures.
2. General Requirements for Records Maintained by Egg Producers
In proposed Sec. 118.10(b), we describe general requirements for
records that must be maintained. Proposed Sec. 118.10(b)(1) and (b)(2)
require that records contain your name, the location of your farm, and
the date and time of the activity that the record reflects. Proposed
Sec. 118.10(b)(3) requires that the record include the signature or
initials of the person performing the operation or creating the record.
The record signing requirement will assure responsibility and
accountability by the individual who performed the activity. Also, a
signature or initials ensure that the source of the record will be
known if any questions regarding the record arise.
Proposed Sec. 118.10(b)(4) requires that data reflecting
compliance activities be entered on a record by the person performing
or observing the activity at the time it is performed or observed in
order to increase accuracy. The record must contain the actual values
observed, if applicable.
[[Page 56841]]
3. Length of Time Records Must Be Retained
Proposed Sec. 118.10(c) requires you to maintain all records in
accordance with proposed part 118 at your place of business, unless
stored offsite under Sec. 118.10(d), for 1 year after the flock to
which the records pertain has been taken permanently out of production.
You must maintain records for 1 year after a flock is no longer
producing eggs for consumption to allow for annual inspection and to
facilitate investigation if the eggs from that flock are implicated in
an outbreak of a foodborne illness.
4. Offsite Storage of Records
Proposed Sec. 118.10(d) allows for o