Contains Nonbinding Recommendations 
Questions and Answers Regarding the 
Final Rule, Prevention of Salmonella 
Enteritidis in Shell Eggs During 
Production, Storage, and 
Transportation: Guidance for Industry
Additional copies are available from: 
Office of Food Safety 
Division of Dairy, Egg and Meat Products, HFS-315 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive
College Park, MD  20740 
(Tel) 240-402-4187 
http://www.fda.gov/FoodGuidances 
You may submit either electronic or written comments regarding this guidance at any 
time.  Submit electronic comments to  http://www.regulations.gov.  Submit written 
comments on the guidance to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All 
comments should be identified with Docket No. FDA-2011-D-0398. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Revised 
July 2015 
1  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction 
II.  Background 
III.  Questions and Answers 
A.  Compliance Dates for the Egg Final Rule 
B.  Coverage of the Egg Rule 
C.  Definitions 
   Farm 
D.  SE Prevention Measures 
   SE Prevention Plan 
   Cleaning and Disinfection 
   Refrigeration 
E.  Environmental Testing for SE 
F.  Egg Testing for SE 
G.  Sampling Methodology for SE 
H.  Testing Methodology for SE 
I.  Registration Requirements 
J.  Enforcement and Compliance 
K.  Other 
  2  Contains Nonbinding Recommendations 
Questions and Answers Regarding the Final Rule, Prevention of 
Salmonella Enteritidis in Shell Eggs During Production, Storage, 
1
and Transportation:  Guidance for Industry
 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or we) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of 
the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff responsible for this guidance as listed on the title page. 
1.  Introduction 
This document provides guidance to egg producers and other persons who are covered by 
FDAs final rule Prevention of Salmonella Enteritidis in Shell Eggs During Production, 
Storage, and Transportation (74 FR 33030 (July 9, 2009) (codified at 21 CFR part 118)). 
The guidance document revises our previous guidance (regarding questions FDA has 
received on the final rule since its publication) by removing text pertaining to 
Competitive Exclusion Products, providing citations for regulatory requirements, and 
making a few editorial changes. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements 
are cited.  The use of the word should in FDA guidances means that something is 
suggested or recommended, but not required. 
2.  Background 
FDA regulations at 21 CFR part 118 require shell egg producers and certain other persons 
to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs 
on the farm and from further growth during storage and transportation.  The rule also 
requires shell egg producers to maintain records concerning their compliance with the 
rule and to register with FDA.  FDA took this action because SE is among the leading 
1 This guidance has been prepared by the Division of Dairy, Egg and Meat Products in the Center for Food 
Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
  3    Contains Nonbinding Recommendations 
 
bacterial causes of foodborne illness in the United States, and shell eggs are a primary 
source of human SE infections.  The final rule will reduce SE-associated illnesses and 
deaths by reducing the risk that shell eggs are contaminated with SE. 
This guidance document contains questions and answers relating to the requirements 
contained in 21 CFR Part 118, Production, Storage, and Transportation of Shell Eggs, 
including (1) compliance dates; (2) coverage; (3) definitions; (4) SE prevention 
measures; (5) sampling and testing for SE; (6) registration; and (7) enforcement and 
compliance. 
3.  Questions and Answers 
A.  Compliance Dates for the Egg Final Rule 
1. Is the compliance date determined by the number of layers on a farm, the 
number of layers in a poultry house, or the number of layers one producer owns, 
even if those layers are spread out over many farms? 
As stated in the preamble to the final rule, the compliance date for the rule is July 9, 
2010; except that, for producers with fewer than 50,000 but at least 3,000 laying hens, 
the compliance date is July 9, 2012.  The compliance date for persons who must 
comply with only the refrigeration requirements is July 9, 2010 (74 FR 33030, 33034). 
The compliance date is determined by the number of layers a producer has at a 
particular farm.  The rule defines a farm as all poultry houses and grounds 
immediately surrounding the poultry houses covered under a single biosecurity 
program (21 CFR  118.3).  If you are a producer and you own and/or operate many 
farms, only those farms with 50,000 or more layers must be in compliance with the 
egg rule by July 9, 2010.  If you also own and/or operate some farms with at least 
3,000 but fewer than 50,000 layers, you have until July 9, 2012, to bring those farms 
into compliance with the egg rule. 
2. Must all layers on my farm be in compliance with all provisions of the egg rule on 
my applicable compliance date (July 9, 2010, or July 9, 2012) if layers in one 
house are 30 weeks of age on my compliance date and layers in another house are 
10 weeks post-molt? 
No.  On your applicable compliance date (see response to question A-1), you must be 
in compliance with only those requirements of the egg rule that have not yet passed for 
layers in each house.  For example, if layers in one house are 30 weeks old, you do not 
need to comply with the pullet requirements for those layers, but you must comply 
with all other applicable requirements.  Similarly, if layers in another house are more 
than six weeks post-molt, you do not need to comply with the pullet requirements for 
those layers.  You also do not need to comply with any of the environmental or egg 
testing requirements for those layers, unless they are molted again. 
B.  Coverage of the Egg Rule 
  4 Contains Nonbinding Recommendations 
1. If I am a shell egg producer with 3,000 or more laying hens at a particular farm, 
must I follow all of the requirements of the egg rule if I send eggs from four of my 
houses to treatment and eggs from my other four houses (on the same farm) to 
shell egg processing? 
Yes.  Under  118.1(a)(1), if any of your eggs that are produced at a particular farm do 
not receive a treatment (as defined in  118.3), you must comply with all of the 
requirements of the egg rule for all eggs produced on that farm. 
2. If I am a shell egg producer with 3,000 or more laying hens at a particular farm, 
must I follow all of the requirements of the egg rule if I usually send all of the 
eggs from my farm to treatment and only occasionally send surplus eggs (from 
the same farm) to shell egg processing? 
Yes.  Under  118.1(a)(1), if any of your eggs that are produced at a particular farm do 
not receive a treatment, you must comply with all of the requirements of the egg rule 
for all eggs produced on that farm. 
3. Am I covered by the egg rule if I am an owner of broiler breeder flocks (breeding 
hens that supply hatching eggs) and I occasionally send surplus eggs to either the 
table egg market or to an egg products facility for breaking? 
Yes.  Under  118.1(a), you are covered by some or all of the requirements of the egg 
rule if you own 3,000 or more layers at a particular farm and do not sell all your eggs 
directly to consumers.  Under  118.1(a)(2), if all of your surplus eggs receive a 
treatment (as defined in  118.3), you must comply only with the refrigeration 
requirements in  118.4(e) and with the registration requirements in 118.11.  Under  
118.1(a)(1), if any of your surplus eggs do not receive a treatment, you must comply 
with all of the requirements of the rule for that farm. 
4. Am I covered by the egg rule if I have fewer than 3,000 layers on my farm, but I 
am a member of an egg cooperative that is made up of several farms, and the 
total number of layers at all farms within the cooperative is greater than 3,000? 
No.  Producers with fewer than 3,000 layers at a particular farm are exempt from the egg 
rule.  See the response to question A-1, above. 
C.  Definitions 
   Farm (21 CFR 118.3) 
In  118.3, FDA defines farm as all poultry houses and grounds immediately 
surrounding the poultry houses covered under a single biosecurity program.  Can I 
separate my existing farm into several smaller farms, each with fewer than 3,000 
layers and each with its own biosecurity program, so that each new (smaller) farm 
will be exempt from the rule? 
  5  Contains Nonbinding Recommendations 
No.  We are not aware of any circumstances where it would be appropriate for poultry 
houses located in close proximity to one another to have different biosecurity programs. 
D.  SE Prevention Measures (21 CFR 118.4) 
   SE Prevention Plan (21 CFR 118.4) 
1. What additional preventive measures can I implement during egg production to 
reduce the potential contamination of eggs with SE? 
In addition to the SE prevention measures required by the egg rule, there are several 
other measures that producers can incorporate into their SE prevention plans.  If 
producers have identified a vaccination program that is effective for their particular 
farms, they should consider including SE vaccination.  Other intervention measures 
might include treatment of feed and/or water, e.g., FDA permits ionizing radiation for 
the treatment of poultry feed and poultry feed ingredients (21 CFR 579.40).     
2.  What SE vaccines are available for layers? 
There are a number of different SE vaccines available, both killed (bacterins) and live 
attenuated, and numerous vaccination programs that use a combination of one or both 
types.  Individual producers who choose to use a vaccine should determine which 
program is most effective for the particular set of circumstances that exist at their 
farm. 
3. How effective are SE vaccines? 
Vaccines can be a very effective component of an SE prevention program.  However, 
the efficacy of a vaccination program depends on various parameters, some of which 
include the vaccination program used, effectiveness of administration by the 
vaccination crew, age of the birds when the vaccine is administered, and the 
environmental load of SE in pullet or layer houses. 
4. Can vaccines be used in lieu of any of the SE preventive measures required by 
the egg rule? 
No.  As was discussed in the preamble to the final rule (74 FR 33030 at 33035), FDA 
believes that data on the efficacy of vaccines are not sufficient to allow substitution of 
vaccination for any of the SE prevention measures required in the egg rule. 
Vaccination against SE is most effective when it is one part of a larger SE prevention 
plan which includes SE-monitored pullets, effective biosecurity measures, effective 
rodent and fly control, thorough cleaning and disinfection procedures, and a 
monitoring program for SE in the environment and eggs.  If individual producers have 
  6  Contains Nonbinding Recommendations 
identified a vaccination program that is effective for their particular farms, FDA would 
encourage the use of the program as an additional SE prevention measure. 
 
5.  How can I treat feed for my layers as an additional SE prevention measure? 
 
Feed can be treated with heat, a combination of heat and pressure, the chemical 
formaldehyde (see 21 CFR 573.460(b)), and/or irradiation (see 21 CFR 579.40) to 
reduce contamination with SE.  Producers should determine if feed treatment is an 
appropriate addition to their SE prevention plan.  If feed treatment is incorporated, 
it is the producers responsibility to determine the appropriate type of treatment 
and equipment requirements necessary for treatment of feed. 
 
6. How does treating feed help minimize SE contamination of eggs? 
 
Treating feed helps reduce the environmental load of SE within the pullet or layer 
house and is an added measure that may help prevent the introduction of SE into the 
rodent and fly populations, which are the predominant vectors for its spread across 
layer farms. 
 
7. How can I treat water used for my layers as an additional SE prevention 
measure? 
 
There are several chemical treatments available to reduce or eliminate SE in water.  A 
producer may consider water treatment particularly when a non-municipal water 
source is used, such as well water.  It is up to individual producers to determine if 
water treatment should be part of their SE prevention plans.  Producers considering 
water treatment should consult the appropriate local, state and federal agencies before 
treating any water source to ensure the specific treatment being considered is 
approved. 
 
 
   Cleaning and Disinfection (21 CFR 118.4(a)(3)) 
 
Under certain circumstances, the egg rule requires the removal of all visible 
manure.  What can I do with manure I remove from my poultry houses during 
the winter in cold climates when I cannot apply it to fields? 
 
The egg rule requires removal of manure regardless of whether it can be applied to 
fields.  FDA notes that other possible options in some circumstances include 
composting and storage in manure barns. 
 
   Refrigeration (21 CFR 118.4(e)) 
 
1. How will I determine when the "36-hour clock" for refrigeration starts when it is 
impossible to determine when each individual egg is laid? 
 
Under  118.4(e), you must hold and transport eggs at or below 45F ambient 
temperature beginning 36 hours after time of lay.  FDA considers that the 36-hour 
  7   Contains Nonbinding Recommendations 
clock for refrigeration begins at the end of the egg collection shift.  For example, if 
you collect eggs from 6:00 a.m. until 5:00 p.m., the 36-hour clock will begin at 5:00 
p.m. on Tuesday for all eggs laid between 5:00 p.m. on Monday and 5:00 p.m. on 
Tuesday.  Thus, those eggs will have to be refrigerated no later than 5:00 a.m. on 
Thursday. 
 
2. Once eggs are at an official egg products facility, must they be refrigerated at 45 
degrees F ambient temperature until they are broken? 
 
Once eggs are at an official egg products facility, they are under the jurisdiction of the 
U.S. Department of Agriculture, which will determine the proper procedures to be 
followed.  However, pursuant to  118.4(e), they must be refrigerated prior to arriving 
at the official egg products facility if they are more than 36 hours old. 
 
3.  If I am not a shell egg producer who is covered under  118.1(a), but instead I 
run a hard-cooking or in-shell pasteurization facility, must I comply with the 
refrigeration requirements of  118.4(e)? 
 
No.  The refrigeration requirements of  118.4(e) apply to certain shell egg producers 
and to persons who transport or hold shell eggs for shell egg processing or egg 
products facilities ( 118.1(a) and (b)).  You state that you are not a producer covered 
under  118.1(a).  Further, hard-cooking facilities and in-shell pasteurization facilities 
are neither shell egg processing facilities (facilities that process (e.g., wash, grade, 
pack) shell eggs for the table egg market) nor egg products facilities (USDA-inspected 
egg products plants where liquid, frozen, and/or dried egg products are produced). 
Therefore, you do not have to comply with the refrigeration requirements in  
118.4(e). 
 
4. If I am a shell egg producer with 3,000 or more laying hens at a particular farm, 
I do not sell all of my eggs directly to consumers, and I produce shell eggs for the 
table market, must I refrigerate eggs that I am going to send directly from my 
farm to a hard-cooking operation or an in-shell pasteurization facility? 
 
Yes, beginning 36 hours after time of lay, you must refrigerate them as set forth in  
118.4(e). Hard-cooking and in-shell pasteurization methods that achieve at least a 5- 
log destruction of SE for shell eggs, or that are carried out in accordance with the Egg 
Products Inspection Act, meet the definition of "treatment" in  118.3.  Under  
118.1(a)(2), if you have 3,000 or more layers at a particular farm, you do not sell all 
your eggs directly to consumers, and you produce shell eggs for the table market, you 
must comply with the refrigeration requirements in  118.4(e), even if all of your eggs 
receive a treatment as defined in  118.3. 
 
5. How can I prevent thermal checks (hairline cracks in the shell caused by too 
great of a difference between the temperature of the wash water and the 
temperature of the eggs being washed) when I wash eggs that have been 
refrigerated? 
 
The equilibration step, a process allowed for in  118.4(e) to bring the internal 
temperature of refrigerated eggs up to room temperature just prior to washing,  is 
  8    Contains Nonbinding Recommendations 
designed to prevent thermal checks. 
6. If I refrigerate eggs destined for a shell egg processing facility within 36 hours of 
time of lay, must they be refrigerated a minimum amount of time before I can 
remove them from refrigeration and store them at room temperature for up to 36 
hours to temper them (i.e., perform the equilibrium step, as discussed in question 
D-5)? 
No.  There is no minimum amount of time eggs destined for shell egg processing must 
be refrigerated before they may be tempered.  However, the reason FDA is allowing 
these eggs to be tempered prior to washing is to reduce the risk of thermal checks (see 
question D-5 above).  If the eggs have not been refrigerated long enough to reduce 
their internal temperature to the point where there is a risk of thermal checks, then 
there is no need to temper those eggs. 
7. If I am a shell egg processor and I refrigerate eggs that are not processed for the 
ultimate consumer within 36 hours of time of lay, the egg rule allows me to 
remove eggs from refrigeration and store them at room temperature for up to 36 
hours just prior to processing to temper them.  Is the 36 hours (for tempering) 
cumulative, e.g., may I remove them from refrigeration for several hours in 
anticipation of processing, then return them to refrigeration if they are not 
processed, then remove them again in anticipation of processing and again return 
them to refrigeration if they are not processed, as long as the total time they are 
removed from refrigeration does not exceed 36 hours? 
No.  Section 118.4(e) states If the eggs are to be processed as table eggs and are not 
processed for the ultimate consumer within 36 hours from the time of lay and, 
therefore, are held and transported as required at or below 45 oF ambient temperature, 
then you may then hold them at room temperature for no more than 36 hours just prior 
to processing to allow an equilibration step to temper the eggs [emphasis added]. 
The reason FDA allows eggs to be tempered prior to washing is to reduce the risk of 
thermal checks (see question D-5 under the Refrigeration bullet above).  Therefore, 
the tempering process is only allowed just prior to processing. 
8. If eggs are washed and/or graded and then loose-packed and transferred to a 
second location to be placed in containers (overwrapped trays, sleeves, boxes, 
etc.) for sale to the ultimate consumer, must the eggs be refrigerated during 
  9  Contains Nonbinding Recommendations 
transport to the second location and while being held and repacked at the second 
location, under  118.4(e)? 
Yes (beginning 36 hours after time of lay), if the eggs originate from farms with 3,000 
or more laying hens.  Section 118.1(b) states (in part), If you transport or hold shell 
eggs for shell egg processing or egg products facilities, you must comply with the 
refrigeration requirements in  118.4(e).  Shell egg processing facility is defined in 
 118.3 as a facility that processes (e.g., washes, grades, packs) shell eggs for the 
table egg market.  In the above situation, the location to which the washed and/or 
graded eggs are transferred to be placed in containers (overwrapped trays, sleeves, 
boxes, etc.) is considered a shell egg processing facility under the rule.  The 
refrigeration requirements in  118.4(e) state, You must hold and transport eggs at or 
below 45 oF ambient temperature beginning 36 hours after time of lay.  The only 
exception to these refrigeration requirements is the equilibration allowance in  
118.4(e) that allows the eggs to be held at room temperature for no more than 36 hours 
just prior to processing to temper them (see response to question D-7 above). 
9. Must I refrigerate surplus eggs from broiler breeder flocks (breeding hens that 
supply hatching eggs) that are destined for an official egg products facility? 
Yes, unless they reach the official egg products facility within 36 hours of time of lay, 
per  118.4(e).  Under  118.1(a), your surplus eggs are covered by some or all of the 
requirements of the egg rule if you have 3,000 or more layers at a particular farm and 
do not sell all your eggs directly to consumers.  Pursuant to  118.1(a)(2), even if all 
of your surplus eggs receive a treatment, such as processing into egg products at an 
official egg products facility, you still must comply with the refrigeration requirements 
in  118.4(e) for those eggs. 
E.  Environmental Testing for SE (21 CFR 118.5) 
1. When does FDA consider the end of any molting process ( 118.5) to have 
occurred? 
FDA considers that the molting process has ended when the layers have reached 50 
percent of production.  Although there are other possible indicators, FDA considers 
that this standard is the most objective, easy to apply indicator.  Further, FDA notes 
that many of the State egg quality assurance programs use this standard. 
2. If an environmental test comes back positive for SE, and I choose to begin egg 
testing instead of diverting eggs to treatment for the life of the flock, as set forth 
at  118.5(a)(2)(ii), must I hold eggs until the first egg test results come back? 
No.  As was discussed in the preamble to the final rule (74 FR 33030 at 33042-43), 
producers in this situation are not required to hold eggs until test results are received. 
3. Is a positive environmental test result cause for a voluntary recall or market 
withdrawal? 
  10  Contains Nonbinding Recommendations 
An egg producer should assess the implications of a positive environment test result 
for any product in the marketplace to determine if a voluntary recall or market 
withdrawal is appropriate.  Not all SE positive environmental test results lead to SE 
contaminated eggs, and so FDA does not expect that most findings of positive 
environmental test results will result in recalls.  Some factors egg producers should 
consider when making a decision whether to withdraw product from the marketplace 
include the extent of the positive findings (for example, several positives throughout 
the farm, or one positive remote from the eggs), whether the farm has had positive 
environmental test results previously, and whether it is likely that impacted eggs 
remain on the market. 
F.  Egg Testing for SE (21 CFR 118.6) 
1. Is a positive egg test result cause for a voluntary recall or market withdrawal? 
FDA considers eggs containing SE to be adulterated.  An egg producer obtaining a 
positive egg test result should take appropriate action to determine if a voluntary recall 
or market withdrawal is the appropriate response to a positive finding of SE in an egg 
sample.  FDA expects that most findings of positive egg test results will result in 
recalls in situations where eggs produced by the flock on or after the day the eggs were 
sampled have been placed in the table egg market. 
2. If I initiate a voluntary recall or market withdrawal based on a positive egg test 
result, which eggs should be subject to the recall/withdrawal? 
An egg producer who determines that a voluntary recall or market withdrawal is 
necessary in light of a positive finding of SE in an egg sample (see response to 
question F-1) should take appropriate action to determine what the scope of that recall 
or market withdrawal should be.  If an egg test result is positive, all eggs produced by 
that flock on or after the day those eggs were sampled would be considered SE- 
positive by FDA.  Eggs that were produced before the day on which the positive 
sample was taken would not automatically be considered SE-positive by FDA.  For 
example, for a producer conducting a series of four egg tests following an 
environmental positive test result as set forth in  118.6(c), if the first egg test were 
negative and the second egg test were positive, absent other factors, FDA generally 
would only consider the eggs produced by the flock on or after the day on which the 
second sample was taken to be SE-positive. 
3. Would all my eggs produced between the time I receive a positive environmental 
test result and the time I receive a positive egg test result for SE always be 
considered SE-positive by FDA? 
No.  All eggs produced between the time a positive environmental test result is 
received and the time a positive egg test result is received would not automatically be 
considered SE-positive by FDA.  Only those eggs produced on or after the day eggs 
are sampled would automatically be considered SE-positive by FDA (when the egg 
sample leads to a positive egg test result).  However, under some circumstances, FDA 
  11 Contains Nonbinding Recommendations 
may consider the conditions under which the eggs were produced to be such that the 
earlier produced eggs may be rendered injurious to health.  As an example, if the firm 
had a positive environmental test and had a major rodent infestation, FDA may 
consider the eggs produced between the time of the positive environmental test and the 
positive egg test to be adulterated because of the conditions under which the eggs were 
produced. 
4. What can I do with my eggs after I receive a positive egg test result? 
Under  118.6(d), eggs from positive flocks must be diverted to treatment.  Treatment 
is defined in  118.3 to refer 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 (21 U.S.C. 1031 et seq.).  As was discussed above at 
question E-2, there is no obligation to hold eggs until the results of an egg test are 
received.  Therefore, the obligation to begin diverting eggs to treatment does not begin 
until a positive egg test result is received.  See 74 FR 33030, 33043.  However, as was 
discussed above at questions F-1 through F-3, if an egg test result is positive, all eggs 
produced by that flock on or after the day those eggs were sampled would be 
considered SE-positive by FDA, and a recall or market withdrawal of those eggs 
would likely be appropriate. 
G.  Sampling Methodology for SE (21 CFR 118.7) 
Whom may I designate to collect environmental and egg samples at my farm? 
You may designate any individual who is capable of following the sampling 
requirements in 118.7. 
H.  Testing Methodology for SE (21 CFR 118.8) 
1. How can I determine whether the test methods I use for environmental and egg 
samples are equivalent in accuracy, precision, and sensitivity to the testing 
methods specified in the egg rule for detecting SE? 
Under  118.8(a), testing to detect SE in environmental samples must be conducted by 
the method entitled Environmental Sampling and detection of Salmonella in Poultry 
Houses, April 2008, or an equivalent method in accuracy, precision, and sensitivity in 
detecting SE.  Under  118.8(b), testing to detect SE in egg samples must be conducted 
according to Chapter 5 of FDAs Bacteriological Analytical Manual (BAM), 
December 2007 Edition, or an equivalent method in accuracy, precision, and 
sensitivity in detecting SE.  Alternative methods used to analyze environmental or egg 
samples for SE do not require a formal determination of equivalency or prior approval 
by FDA.  If you have information that you believe demonstrates that a method is 
equivalent to a method specified in the egg rule and want to obtain FDA's view 
regarding the method, you may contact FDAs Microbial Methods Development 
Branch (MMDB).  Methods that have undergone a validation process through the 
Association of Official Analytical Chemists (AOAC International) Research Institute 
  12 Contains Nonbinding Recommendations 
(RI) or the AOAC International Official Methods of Analysis (OMA) Program and 
that have been certified by that body as being equivalent to the FDA methods 
specified in the egg rule are not automatically considered equivalent by FDA.  To 
obtain FDA's view regarding whether such a method is equivalent to a method 
specified in the egg rule, you may contact MMDB, as set forth above. MMDB can be 
reached by phone at 240-402-2408, or by mail at: MMDB, Division of Microbiology, 
Office of Regulatory Science, CFSAN, HFS-711, 5001 Campus Drive, College Park, 
MD 20740.  All methods ultimately determined by FDA to be equivalent to the 
methods cited in the rule will be listed on FDAs website here: http://www.fda.gov/
food/guidanceregulation/guidancedocumentsregulatoryinfor mation/eggs/
ucm228796.htm. 
2. Is FDA evaluating any alternative test methods for SE, specifically any rapid test
methods?
Yes.  As of the date of this guidance, FDA is evaluating a rapid method for detection
of SE in eggs.  FDA encourages the industry to evaluate rapid methods as well, using
the protocol described in the response to question H-1, above.
3. Can I use any laboratory for testing my environmental and egg samples?
You may use any laboratory that is capable of properly carrying out the testing
methods specified in the egg rule.
4. Do laboratories need to register with FDA or be acknowledged or authorized by
FDA as a compliant tester for environmental and/or egg samples for SE under
this regulation?
No.
I.  Registration Requirements (21 CFR 118.11) 
1. If I buy eggs from a producer and then sell them to a processor, am I required to
register with FDA?
No.  Only shell egg producers covered under  118.1(a) must register with FDA.
2. Must I register my farm with FDA if I send all of my surplus eggs from broiler
breeder operations (as defined at question B-3) to an official egg products
facility?
Yes, you must comply with the registration requirements in  118.11.  Under 
118.1(a), you are covered by some or all of the requirements of the egg rule if you
have 3,000 or more layers at a particular farm and do not sell all your eggs directly to
consumers.  As set forth in  118.1(a)(2), even if all of your surplus eggs receive a
treatment, such as processing into egg products at an official egg products facility, you
still must comply with the registration requirements in  118.11.
13 Contains Nonbinding Recommendations 
3. Who must register contract flocks? 
The registration requirements of  118.11 apply to [s]hell egg producers covered 
under  118.1(a).  Producer is defined in  118.3 as a person who owns and/or 
operates a poultry house containing laying hens which produce shell eggs for human 
consumption.  It is the producer who must comply with the registration 
requirements, regardless of who owns the flock. 
J.  Enforcement and Compliance (21 CFR 118.12) 
1. How will FDA determine that eggs are in compliance with the rule? 
FDA will inspect both domestic and foreign egg producers as necessary to ensure that 
eggs distributed in the United States are produced in compliance with the rule. 
2. What biosecurity measures will FDA inspectors follow when inspecting a farm? 
FDAs Investigations Operations Manual, the primary source regarding FDA policy 
and procedures for field investigators and inspectors, discusses biosecurity measures 
for FDA inspectors in Chapter 5.2.10, Routine Biosecurity Procedures for Visits to 
Facilities Housing or Transporting Domestic or Wild Animals (available at: 
http://www.fda.gov/ICECI/Inspections/IOM/ucm122530.htm#5.2.10). FDA 
inspectors will follow these procedures. 
3. In those States that contract with FDA to enforce the egg rule, how will FDA 
ensure that individuals doing the inspections have received proper training? 
Inspectors from States that contract with FDA to enforce the egg rule will first be 
trained by FDA using the same training module used to train FDA field staff.  This 
will ensure consistency among inspectors and inspections. 
K.  Other 
FDA held two public meetings to discuss the egg rule.  Where can I obtain copies 
of the transcripts from these meetings and the presentations that were given? 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRe
gulatoryInformation/Eggs/ucm195536.htm. 
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