[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34191-34194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0297]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prevention of 
Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping 
and Registration Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
16, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0660. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Prevention of Salmonella Enteritidis in Shell Eggs During Production--
Recordkeeping and Registration Provisions--21 CFR 118.10 and 118.11

OMB Control Number 0910-0660--Extension

    Shell eggs contaminated with Salmonella Enteritidis (SE) are 
responsible for more than 140,000 illnesses per year. The Public Health 
Service Act (PHS Act) (42 U.S.C. 264) authorizes the Secretary of 
Health and Human Services to make and enforce such regulations as ``are 
necessary to prevent the introduction, transmission,

[[Page 34192]]

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))). 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 (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)), FDA is authorized to issue regulations for 
the efficient enforcement of the FD&C Act.
    Under part 118 (21 CFR part 118), shell egg producers are required 
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.
    Section 118.10 of FDA's regulations (21 CFR 118.10) requires 
recordkeeping for all measures the 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 maintained on file 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.
    Finally, Sec.  118.11 of FDA's regulations (21 CFR 118.11) requires 
that each farm covered by 21 CFR 118.1(a) register with FDA using Form 
FDA 3733. 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 https://www.access.fda.gov. 
We strongly encourage electronic registration because it is faster and 
more convenient. The system can accept electronic registrations 24 
hours a day, 7 days a week. A registering shell egg producer receives 
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 by mail or CD-ROM.
    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 notify quickly 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.
    In the Federal Register of March 26, 2019 (84 FR 11309), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received, however only one 
was responsive to the four information collection topics solicited. 
Specifically, the comment suggested that farms could save money by 
pooling samples while conducting environmental testing, proffering a 
2015 research study. The comment continued by suggesting that the 
testing protocol be adjusted from four 1,000-egg samples to two 1,000 
egg samples. We note, however, that 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, while testing fewer 
than 4,000 eggs over a period of 8 weeks, as required by 21 CFR 118.7, 
results 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. While we are aware of the referenced research, we decline to 
relax the current requirements provided for under 21 CFR 118.7 and 
118.8 as doing so may reduce certain associated costs that would not 
provide the same level of protection necessary to ensure the public 
health. The comment did not suggest a revision to our estimated burden.
    We estimate the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                             Number of        Number of
     Description and 21 CFR section        recordkeepers     records per      Total annual       Average  burden per  recordkeeping        Total hours
                                                \2\          recordkeeper       records
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Refrigeration Records, Sec.                         2,600               52          135,200  0.5 (30 minutes)..........................           67,600
 118.10(a)(3)(iv).
Testing, Diversion, and Treatment                     343               52           17,836  0.5 (30 minutes)..........................            8,918
 Records, Sec.   118.10(a)(3)(v) through
 (viii) (positive) \3\.
Egg Testing, Sec.   118.10(a)(3)(vii)...              331                7            2,317  8.3.......................................           19,231
Environmental Testing, Sec.                         6,308               23          145,084  0.25 (15 minutes).........................           36,271
 118.10(a)(3)(v) \3\.
Testing, Diversion, and Treatment                   5,965                1            5,965  0.5 (30 minutes)..........................            2,983
 Records, Sec.   118.10(a)(3)(v) through
 (viii) (negative) \3\.
Prevention Plan Review and                            331                1              331  10........................................            3,310
 Modifications, Sec.   118.10(a)(4).
Chick and Pullet Procurement Records,               4,731                1            4,731  0.5 (30 minutes)..........................            2,366
 Sec.   118.10(a)(2).
Rodent and Other Pest Control, Sec.                 9,462               52          492,024  0.5 (30 minutes)..........................          246,012
 118.10(a)(3)(ii), and Biosecurity
 Records, Sec.   118.10(a)(3)(i).

[[Page 34193]]

 
Prevention Plan Design, Sec.                          350                1              350  20........................................            7,000
 118.10(a)(1).
Cleaning and Disinfection Records, Sec.               331                1              331  0.5 (30 minutes)..........................              166
  118.10(a)(3)(iii).
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    Total...............................  ...............  ...............  ...............  ..........................................          393,857
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
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\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 base 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 part 118 were already largely in 
compliance with the plan design and recordkeeping provisions discussed 
in this section, and therefore did not experience 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 are 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.
    Prevention plan design (Sec.  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 
(Sec.  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 (Sec.  118.10(a)(2)), 
rodent and other pest control (Sec.  118.10(a)(3)(ii)), and biosecurity 
(Sec.  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 (Sec.  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 (Sec.  118.10(a)(4)) also need to be 
performed every time a house tests positive, which we estimate that 7.0 
percent test positive. Therefore, the number of recordkeepers for these 
provisions is calculated to be 331 (4,731 houses x 0.070) annually.
    Records of testing, diversion, and treatment (Sec.  118.10(a)(3)(v) 
through (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 houses test positive 
for SE. Annually, 343 layer and pullet houses ((4,731 layer houses x 
0.070) + (4,731/3 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) + (4,731/3 pullet houses) x 0.9925)).
    We assume that refrigeration records are kept on a weekly basis on 
a per farm basis under Sec.  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 calculated to be 
67,600 hours (135,200 records x 0.5 hour).
    We assume that records of testing, diversion, and treatment under 
Sec.  118.10(a)(3)(v) through (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 records x 
0.5 hour).
    Given a positive environmental test for SE, we estimate the 
weighted average number of egg tests per house under Sec.  
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 records 
x 8.3 hours).
    We estimate that all 1,577 pullet and 4,731 layer houses not 
testing prior to their compliance date under part 118 (6,308 
recordkeepers) incur the burden of a single environmental test annually 
under Sec.  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. The time burden of 
sampling is estimated on a per swab sample basis. We assume it takes 15 
minutes to collect and pack each sample. Thus, the total annual burden 
for environmental testing is calculated to be 36,271 hours (145,084 
records x 0.25 hour).
    We estimate that records of testing, diversion, and treatment under 
Sec.  118.10(a)(3)(v) through (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 1 record of that testing that takes 
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 calculated to be 2,983 hours (5,965 records x 0.5 hour).
    Prevention plan review and modifications under Sec.  118.10(a)(4)) 
need to be performed every time a house tests positive. We estimate 
that 331 layer

[[Page 34194]]

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 Sec.  
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 Sec.  
118.10(a)(3)(ii) and biosecurity records under Sec.  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 Sec.  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).
    Cleaning and disinfection recordkeeping under Sec.  
118.10(a)(3)(iii) needs to be performed every time a house tests 
positive. We estimate that 331 layer houses 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 Burden \1\
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                                                                                         Number of
    Description and 21 CFR section                 Form                 Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Registrations or Updates, Sec.         FDA 3733 \2\                              350                1              350              2.3              805
 118.11.
Cancellations, Sec.   118.11.........  FDA 3733                                   30                1               30                1               30
                                      ------------------------------------------------------------------------------------------------------------------
    Total............................  ............................  ...............  ...............  ...............  ...............              835
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration
  Module, which is available at https://www.access.fda.gov per Sec.   118.11(b)(1).

    This estimate is based on the average number of new shell egg 
producer registrations and cancellations received in the past 3 years 
under Sec.  118.11. We estimate that we will receive an average of 350 
registrations or updates per year over the next 3 years and that it 
takes the average farm 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 calculated to be 805 hours 
(350 respondents x 2.3 hours).
    We estimate that we will receive 30 cancellations per year over the 
next 3 years and that cancelling a registration, on average, requires a 
burden of 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 have increased our burden estimate for the information 
collection based on an increase in annual new farm registrations.

    Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15162 Filed 7-16-19; 8:45 am]
 BILLING CODE 4164-01-P