0660 Eggs SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Production, Storage, and Transportation of Shell Eggs:
21 CFR part 118
OMB Control No. 0910-0660
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
Shell eggs contaminated with Salmonella Enteritidis (SE) are responsible for more than
140,000 illnesses per year. The Public Health Service Act (PHS Act) authorizes the
Secretary of Health and Human Services to make and enforce such regulations as “are
necessary to prevent the introduction, transmission, or spread of communicable diseases
from foreign countries into the States . . . or from one State . . . into any other State”
(section 361(a) of the PHS Act). This authority has been delegated to the Commissioner
of Food and Drugs. Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 342(a)(4)), a food is adulterated if it is prepared, packed,
or held under insanitary conditions whereby it may have been contaminated with filth or
rendered injurious to health. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)),
the Food and Drug Administration (FDA or we) is authorized to issue regulations for the
efficient enforcement of the FD&C Act.
Accordingly, regulations are established under part 118 (21 CFR part 118), requiring
shell egg producers to implement measures to prevent SE from contaminating eggs on the
farm and from further growth during storage and transportation. Shell egg producers also
are required to maintain records concerning their compliance with part 118 and to register
with FDA. As described in more detail with regard to each information collection
provision of part 118, each farm site with 3,000 or more egg-laying hens that sells raw
shell eggs to the table egg market, other than directly to the consumer, must refrigerate,
register, and keep certain records. Farms that do not send all of their eggs to treatment
are also required to have an SE prevention plan and to test for SE.
Form FDA 3733
As provided for in the regulations, respondents must use Form FDA 3733, “DHHS/FDA
Shell Egg Producer Registration,” to complete the required registration under § 118.1(a).
The term “Form FDA 3733” refers to both the paper version of the form and the
electronic system known as the Shell Egg Producer Registration Module, which is
available at http://www.access.fda.gov.
We therefore request extension of OMB approval for the information collection
provisions found in the regulations at 21 CFR part 118, and associated Form FDA 3733,
as discussed in this supporting statement.

2. Purpose and Use of the Information Collection
Section 118.10 of FDA’s regulations requires recordkeeping for all measures a farm takes
to prevent SE in its flocks. Since many existing farms participate in voluntary egg
quality assurance programs, those respondents may not have to collect any additional
information. Records are compiled and retained at each farm site and examined there
periodically by FDA inspectors.
Section 118.10 also requires each farm site with 3,000 or more egg-laying hens that sells
raw shell eggs to the table egg market, other than directly to the consumer, and does not
have all of the shell eggs treated, to design and implement an SE prevention plan.
Section 118.10 requires recordkeeping for each of the provisions included in the plan and
for plan review and modifications if corrective actions are taken.
We strongly encourage electronic registration because it provides for more efficient
processing. The system the agency has developed can accept electronic registrations 24
hours a day, 7 days a week. A registering shell egg producer will receive confirmation of
electronic registration instantaneously once all the required fields on the registration
screen are completed. However, paper registrations will also be accepted. Form FDA
3733 is available for download for registration for submission by mail, fax, or CD-ROM
(see
http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProduc
erRegistration/ucm217952.htm.)
Recordkeeping and registration are necessary for the success of the SE prevention
measures. Written SE prevention plans, and records of actions taken due to each
provision are essential for farms to implement SE prevention plans effectively. Further,
they are essential for us to be able to determine compliance. Information provided under
these regulations helps us to quickly notify the facilities that might be affected by a
deliberate or accidental contamination of the food supply. In addition, data collected
through registration is used to support our enforcement activities.
Description of Respondents: Respondents to this information collection include farm sites
with 3,000 or more egg-laying hens that sell raw eggs to the table egg market, other than
directly to the consumer. Respondents are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
Companies are free to use whatever forms of information technology that best assist them
in retaining the appropriate records. We encourage, but do not mandate, the use of
electronic recordkeeping.
As noted above, the term “Form FDA 3733” refers to both the paper version of the form
and the electronic system known as the Shell Egg Producer Registration Module, which
is available at http://www.access.fda.gov. The agency strongly encourages electronic
registration because it is faster and more convenient for both FDA and the registrant. In

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addition, registration updates and cancellations may be accomplished electronically. The
system the agency has developed can accept electronic registrations 24 hours a day, 7
days a week, 365 days a year. The individual registering a facility will receive
confirmation of electronic registration and the facility’s registration number
instantaneously once all the required fields on the registration screen are completed.
However, we will continue to accept paper registrations. Form FDA 3733 is available for
download for registration by mail, fax, or CD-ROM. Registration by mail may take
several weeks to several months, depending on the speed of the mail system and the
number of paper registrations that we will have to enter manually.
Based on submissions received during the past three years, the agency estimates that
about ninety percent (90%) of registrations will be submitted electronically in the next
three years.
4. Efforts to Identify Duplication and Use of Similar Information
There is no duplication of recordkeeping requirements as a result of FDA’s regulation
and regulations issued by the U.S. Department of Agriculture (USDA). USDA requires
records on some of the egg products it regulates, but these will not overlap in information
with the records required by FDA’s regulation of shell egg production.
Farms that have packing facilities integrated on the farm will already be registered by
USDA under the Egg Product Inspection Act (EPIA) and by FDA under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002 (the
Bioterrorism Act), which added section 415 of the act (21 U.S.C. 350d), and §§ 1.230 1.235 of FDA’s regulations (21 CFR 1.230 - 1.235). However, these two registration
programs are not a substitute for the Shell Eggs Registration information collection
because information required by this regulation, namely the size of operation, including
the number of houses on the farm and the number of layers per house, are not provided
under EPIA or the Bioterrorism Act. Farms already registered under EPIA or the
Bioterrorism Act will need to fully reregister under this regulation.
5. Impact on Small Businesses or Other Small Entities
We estimate that ninety-nine percent (99%) of respondents are small businesses. Farms
with more than 3,000 layers are considered small by Small Business Administration
(SBA) standards. The SBA defines chicken and egg producers to be small if their total
revenues are less than $11.5 million. A producer that receives $0.45 per dozen eggs and
has layers that produce 265 eggs per year would have to have over 1,100,000 layers in
production to earn revenues of over $11.5 million. Because only about 400 farms fall
into the category of 100,000 or more layers, more than 99 percent of the farms with more
than 3,000 layers are considered small by SBA standards, and account for roughly 60
percent of all production. We assist small businesses by providing small farms (farms
with between 3,000 and 49,999 laying hens) up to three years to comply with the
recordkeeping and registration provisions of the regulation; and by exempting very small

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farms (farms with fewer than 3,000 layers) from the recordkeeping and registration
provisions of this regulation.
We also provide assistance with the registration requirements to small businesses through
the CFSAN small business office. In addition, the FDA Industry Systems Help Desk can
answer computer system and technical questions, as well as general questions about
registration and will attempt to assist small businesses to register. The Help Desk is
available Monday through Friday from 7:00 a.m. to 11:00 p.m. Eastern Time. We
strongly encourage electronic registration, but provides registration through postal mail,
which can reduce the burden on small entities. We aid small businesses in complying
with its requirements through the agency’s Regional Small Business Representatives and
through the scientific and administrative staffs within the agency. We also provide a
Small Business Guide on the agency’s website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
There are no legal obstacles to reduce the burden. Data collection occurs occasionally. If
a farm is not registered or the registration for a farm is not updated when necessary, we
may not be able to contact the farm in case of a known or potential threat to the food
supply or other food-related emergency. Written SE prevention plans, and records of
actions taken due to each provision are essential for farms to implement SE prevention
plans effectively. Without written plans and records of actions taken due to each
provision, the SE prevention plan would not be effective. Further, recordkeeping and
registration are essential for FDA to be able to determine compliance.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this information collection.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment
in the Federal Register of March 26, 2019 (84 FR 11309). Two comments were
received, however only one was responsive to the four information collection topics
solicited and is discussed here.
One comment suggested that farms could save money by pooling samples while
conducting environmental testing, proffering a 2015 research article. While we are aware
of the referenced study, we decline to adopt the alternative methodology.
The comment also suggested adjusting the egg testing protocol to two 1,000-egg samples
instead of four 1,000-egg samples. Testing four 1,000-egg samples over an 8-week
period results in 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. Testing fewer than 4,000 eggs over a period of 8 weeks, as required by § 118.7,

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would result in less than a 95 percent probability that a positive egg would be detected
from a flock that is producing SE-contaminated eggs at that rate.
We find that the required testing established under 21 CFR 118.7 and 118.8 best protects
the public health and that relaxing the current testing requirements, whether or not in an
effort to reduce costs, would not provide the same level of protection necessary to ensure
the public health.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
The regulation does not specify confidentiality. However, records that may be consulted
during FDA farm inspections are subject to FDA’s regulations on the release of
information, 21 CFR part 20. Confidential commercial information is protected from
disclosure under FOIA under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by
part 20 of the agency’s regulations (21 CFR part 20). To the extent 21 CFR 20.64
applies, we will honor the confidentiality of any data in investigation records compiled
for law enforcement purposes.
Privacy Act
This ICR does not request any personally identifiable information. It does include a
form, but that form does not require a Privacy Act Statement under 5 U.S.C. § 552a(e)(3).
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:

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Table 1. --Estimated Annual Recordkeeping Burden1
No. of
Total
Average
Records per
Annual
Burden per
Total
No. of
Description and 21 CFR Section
Recordkeepers2 Recordkeeper Records Recordkeeping Hours
Refrigeration Records,
0.5
§ 118.10(a)(3)(iv)
2,600
52
135,200
(30 mins.) 67,600
Testing, Diversion, and Treatment
Records, § 118.10(a)(3)(v) to
0.5
(a)(3)(viii) (positive)3
343
52
17,836
(30 mins.)
8,918
Egg Testing, § 118.10(a)(3)(vii)
331
7
2,317
8.3 19,231
Environmental Testing,
0.25
§ 118.10(a)(3)(v)3
6,308
23
145,084
(15 mins.) 36,271
Testing, Diversion, and Treatment
Records, § 118.10(a)(3)(v) to
0.5
(a)(3)(viii) (negative)3
5,965
1
5,965
(30 mins.)
2,983
Prevention Plan Review and
Modifications, § 118.10(a)(4)
331
1
331
10
3,310
Chick and Pullet Procurement
0.5
Records, § 118.10(a)(2)
4,731
1
4,731
(30 mins.)
2,366
Rodent and Other Pest Control,
§ 118.10(a)(3)(ii), and
Biosecurity Records,
0.5
§ 118.10(a)(3)(i)
9,462
52
492,024
(30 mins.) 246,012
Prevention Plan Design,
§ 118.10(a)(1)
350
1
350
20
7,000
Cleaning and Disinfection
0.5
Records, § 118.10(a)(3)(iii)
331
1
331
(30 mins.)
166
TOTAL
804,169
393,857
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
2
Some records are kept on a by-farm basis and others are kept on a by-house basis.
3
Calculations include requirements for pullet and layer houses.

We are basing our estimates for the recordkeeping burden and the reporting burden on
our experience with similar recordkeeping activities and the number of registrations and
cancellations received in the past 3 years.
The number of recordkeepers estimated in column 2 of Table 1 is drawn from estimates
of the total number of layer and pullet houses affected by part 118. We assume that those
farms that were operating according to recognized industry or State quality assurance
plans prior to their compliance date under 21 CFR part 118 were already largely in
compliance with the plan design and recordkeeping provisions discussed in this section,
and therefore are not experiencing additional costs to comply with recordkeeping
provisions. We found that 59 percent of farms with more than 50,000 layers are
members of State or industry quality assurance plans. Fewer than 8 percent of farms with
fewer than 50,000 layers were members of quality assurance plans. Thus, we estimate
the number of layer farms incurring a new recordkeeping burden because of part 118 to
be 2,600, and the number of houses affected to be 4,731.

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Prevention plan design (§ 118.10(a)(1)) records are kept on a per farm basis, so we
assume that new prevention plan design is only undertaken by new entrants to the
industry. Refrigeration records (§ 118.10(a)(3)(iv)) are also kept on a per farm basis so
the estimated number of recordkeepers for this provision is 2,600.
Records of chick and pullet procurement (§ 118.10(a)(2)), rodent and other pest control
(§ 118.10(a)(3)(ii)), and biosecurity (§ 118.10(a)(3)(i)) are kept on a per house basis, so
the estimated number of recordkeepers for these provisions is 4,731.
Records of cleaning and disinfection (§ 118.10(a)(3)(iii)) are also kept on a per house
basis, but only need to be kept in the event that a layer house tests environmentally
positive for SE. Prevention plan review and modifications (§ 118.10(a)(4)) also need to
be performed every time a house tests positive, which we estimate that 7.0 percent tests
positive. Therefore, the number of recordkeepers for these provisions is estimated to be
331 (4,731 houses x 0.070) annually.
Records of testing, diversion, and treatment (118.10(a)(3)(v) to (a)(3)(viii)) are kept on a
per house basis and include records on flocks from pullet houses. We estimate that there
are one-third as many pullet houses as there are layer houses. Therefore, the total number
of recordkeepers for these provisions is 6,308 (4,731 + (4,731/3)). The number of annual
records kept depends on whether or not houses test positive for SE. Annually, 343 layer
and pullet houses ((4,731 layer houses x 0.070) + ((4731/3 pullet houses) x 0.0075)) are
expected to test positive and 5,965 are expected to test negative ((4,731 layer houses x
0.930) + ((4731/3 pullet houses) x 0.9925)).
We assume that refrigeration records are kept on a weekly basis on a per farm basis under
§ 118.10(a)(3)(iv)). We estimate that 2,600 recordkeepers maintain 52 records each for a
total of 135,200 records and that it takes approximately 0.5 hour per recordkeeping.
Thus, the total annual burden for refrigeration records is estimated to be 67,600 hours
(135,200 x 0.5 hour).
We assume that records of testing, diversion, and treatment under § 118.10(a)(3)(v) to
(a)(3)(viii)) are kept weekly in the event a layer house tests environmentally positive for
SE. We estimate that 343 layer and pullet houses test positive and thus 343
recordkeepers maintain 52 records each for a total of 17,836 records and that it takes
approximately 0.5 hour per recordkeeping. Thus, the total annual burden for testing,
diversion, and treatment records in the event of a positive test result is calculated to be
8,918 hours (17,836 x 0.5 hour).
Given a positive environmental test for SE, we estimate the weighted average number of
egg tests per house under § 118.10(a)(3)(vii)) to be 7. We estimate that 331
recordkeepers maintain 7 records each for a total of 2,317 records and that it takes
approximately 8.3 hours per recordkeeping. Thus, the total annual burden for egg testing
is calculated to be 19,231 hours (2,317 x 8.3 hours).

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We estimate that all 1,577 pullet and 4,731 layer houses not currently testing (6,308
recordkeepers) incur the burden of a single environmental test annually under
§ 118.10(a)(3)(v)). The number of samples taken during the test depends on whether a
farm employs the row-based method (an average of 12 samples per house) or the random
sampling method (32 samples per house). We estimate that roughly 50 percent of the
houses affected employ a row-based method and 50 percent employ a random sampling
method, implying an average of 23 samples per house. Thus, we estimate that 6,308
recordkeepers take 23 samples each for a total of 145,084 samples. The time burden of
sampling is estimated on a per swab sample basis. We estimate that it takes
approximately 15 minutes to collect and pack each sample. Thus, the total annual burden
for environmental testing is estimated to be 36,271 hours (145,084 records x 0.25 hour).
We estimate that records of testing, diversion, and treatment under § 118.10(a)(3)(v) to
(a)(3)(viii)) are kept annually in the event a layer house tests environmentally negative
for SE. We estimate that 5,965 layer and pullet houses test negative and thus 5,965
recordkeepers maintain one record of that testing that take approximately 0.5 hour per
record. Thus, the total annual burden for testing, diversion, and treatment records in the
event of a negative test result is estimated to be 2,983 hours (5,965 records x 0.5 hour).
Prevention plan review and modifications under § 118.10(a)(4)) need to be performed
every time a house tests positive. We estimate that 331 layer houses test positive
requiring plan review and modifications and that it takes 10 hours to complete this work.
Thus, the total annual burden for prevention plan review and modifications in the event
of a positive test result is calculated to be 3,310 hours (331 records x 10 hours).
We estimate that chick and pullet procurement records under § 118.10(a)(2) is kept
roughly once annually per layer house basis. We estimate that 4,731 layer houses
maintain 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus,
the total annual burden for chick and pullet procurement recordkeeping is calculated to be
2,366 hours (4,731 records x 0.5 hour).
We estimate that rodent and other pest control records under § 118.10(a)(3)(ii)) and
biosecurity records under § 118.10(a)(3)(i) are kept weekly on a per layer house basis.
We assume that 4,731 layer houses maintain a weekly record under each provision.
Thus, we estimate 9,462 recordkeepers maintain 52 records each for a total of 492,024
records. We estimate a recordkeeping burden of 0.5 hours per record for a total of
246,012 burden hours (492,024 records x 0.5 hour).
New prevention plan design required by § 118.10(a)(1) is only undertaken by new farms
and records are kept on a per farm basis. We estimate that there are 350 new farm
registrations annually and we assume that this reflects 350 new farms requiring
prevention plan design. This is an increase from our previous estimate based on new
registrations received. We estimate that it takes 20 hours to complete this work. Thus,
the total annual burden for prevention plan design is calculated to be 7,000 hours (350
records x 20 hours).

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Cleaning and disinfection recordkeeping under § 118.10(a)(3)(iii) needs to be performed
every time a house tests positive. We estimate that 331 layer houses will test positive
requiring 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus,
the total annual burden for cleaning and disinfection recordkeeping in the event of a
positive test result is calculated to be 166 hours (331 records x 0.5 hour).
Table 2. --Estimated Annual Reporting Burden1
Description and 21
CFR Section

Form
FDA

No. of
Respondents

Total
Annual
Responses

350

No. of
Responses
per
Respondent
1

Registrations or
Updates, § 118.11
Cancellations,
§ 118.11
Total

37332
3733

Total
Hours

350

Average
Burden
per
Response
2.3

30

1

30

1

30

380

805

835

1

There are no capital costs or operating and maintenance costs associated with this collection of information.
The term “Form FDA 3733” refers to both the paper version of the form and the electronic system known as the
Shell Egg Producer Registration Module, which is available at http://www.access.fda.gov per § 118.11(b)(1).

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This estimate is based on the average number of new shell egg producer registrations and
cancellations received in the past 3 years under § 118.11. We estimate that we will
receive 350 registrations or updates per year over the next 3 years and that it takes the
average farm approximately 2.3 hours to register, taking into account that some
respondents completing the registration may not have readily available Internet access.
Thus, the total annual burden for new shell egg producer registrations or updates is
estimated to be 805 hours (350 respondents x 2.3 hours).
We estimate that we will receive approximately 30 cancellations per year over the next 3
years and that cancelling a registration, on average, requires a burden of approximately 1
hour, taking into account that some respondents may not have readily available Internet
access. Thus, the total annual burden for cancelling shell egg producer registrations is
calculated to be 30 hours (30 cancellations x 1 hour).
We estimate that the burden for this information collection will increase since the last
OMB approval due to the estimated annual increase of 50 new farm registrations and
recordkeeping. As a result, the total annual recordkeeping burden will increase from
392,857 to 393,857 hours, and the total annual reporting burden will increase from 720 to
835 hours.
12b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $12,002,584 per year. We
estimate that the average hourly wage for the employee engaged in recordkeeping,
testing, and registration would be equivalent to a GS-6/Step-1 level in the locality pay
area of Washington-Baltimore in 2019, approximately $20.27/hour. Adding fifty percent
(50%) to this wage to account for overhead costs, we estimate the average hourly cost to

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respondents to be $30.41/hour. Thus, the overall estimated cost incurred by the
respondents is $11,122,486 (394,692 burden hours x $30.41/hr = $12,002,584).
Type of
Respondent
Support Employee

Total Burden
Hours
394,692

Hourly Wage Rate
$30.41

Total Respondent
Costs
$12,002,584

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.
14. Annualized Cost to the Federal Government
Our review of the registration documents would generally occur as part of the registration
process. We devote approximately 2 hours per registration to the inspection of the
documents; cancellations require only a nominal amount of processing time, which has
been factored in to the registration process. We estimate the annualized cost to the
Federal Government for the review of records retained by a firm to be $119.88 per
review. In this calculation of cost, we estimate the hourly cost for review and evaluation
at a base GS-12, step 1 salary for the locality pay area of Washington-Baltimore-Northern
Virginia for 2019 of $39.96/hour. Two hours multiplied by $39.96 per hour equals
$79.92. To account for overhead, this cost is increased by 50 percent, making the cost to
the Federal Government $119.88 per review. As noted above, we estimate that we will
receive an average of 350 registrations per year over the next 3 years, and an average of
30 registration cancellations. Thus, the cost to the government to review the registration
documents is estimated to be $41,958 per year (350 registrations per year x $119.88 per
review).
15. Explanation for Program Changes or Adjustments
This information collection reflects adjustments. We have increased our estimate based
on an increase in registrations, resulting in 100 additional responses and 1,115 additional
burden hours. We have also uploaded cost information to appear at www.reginfo.gov,
and have changed the title of the collection to align with the underlying regulations.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans to publish data from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We will display the OMB expiration date as required by 5 CFR 1320.5.

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18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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