
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40312-40315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14584]


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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) 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 July 
21, 2016.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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) authorizes the Secretary 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)), 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

[[Page 40313]]

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 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 requires that each farm 
covered by Sec.  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 http://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 January 28, 2016 (81 FR 4923), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments in response, both 
of which supported the collection of information by FDA to ensure that 
farms are in compliance with the FD&C Act and regulations, and that 
adequate control measures for prevention of SE are being implemented.
    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.   118.10(a)(3)(iv)             2,600              52         135,200  .5 (30 minutes)                                 67,600
Testing, Diversion, and Treatment Records,                   343              52          17,836  .5 (30 minutes)                                  8,918
 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.   118.10(a)(3)(v)              6,308              23         145,084  .25 (15 minutes)                                36,271
 \3\.
Testing, Diversion, and Treatment Records,                 5,965               1           5,965  .5 (30 minutes)                                  2,983
 Sec.   118.10(a)(3)(v) through (viii)
 (negative) \3\.
Prevention Plan Review and Modifications, Sec.               331               1             331  10                                               3,310
   118.10(a)(4).
Chick and Pullet Procurement Records, Sec.                 4,731               1           4,731  .5 (30 minutes)                                  2,366
 118.10(a)(2).
Rodent and Other Pest Control, Sec.                        9,462              52         492,024  .5 (30 minutes)                                246,012
 118.10(a)(3)(ii), and Biosecurity Records,
 Sec.   118.10(a)(3)(i).
Prevention Plan Design, Sec.   118.10(a)(1)...               300               1             300  20                                               6,000
Cleaning and Disinfection Records, Sec.                      331               1             331  .5 (30 minutes)                                    166
 118.10(a)(3)(iii).
                                               ---------------------------------------------------------------------------------------------------------
    Total hours...............................                                                                                                   392,857
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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 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 are operating 
according to recognized industry or State quality assurance plans are 
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 are members of quality 
assurance plans. Thus, we estimate the number of layer farms incurring 
a new recordkeeping

[[Page 40314]]

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 
percent tests 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 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 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 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 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 x 8.3 
hours).
    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 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 
employs 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 calculated to be 
36,271 hours (145,084 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 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 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 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 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 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 300 new farm registrations annually and we 
assume that this reflects 300 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 6,000 hours (300 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 x 0.5 hour).

[[Page 40315]]



                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
      Description and 21 CFR section                FDA form No.             Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrations or Updates, Sec.   118.11...  Form FDA 3733 \2\...........             300               1             300             2.3             690
Cancellations, Sec.   118.11..............  Form FDA 3733...............              30               1              30               1              30
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............             720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 http://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 300 
registrations or updates per year over the next 3 years. Based on the 
number of cancellations previously received, we estimate that we will 
receive approximately 30 cancellations per year over the next 3 years.
    We estimate 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 690 hours (300 x 2.3 hours).
    We estimate 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).

    Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14584 Filed 6-20-16; 8:45 am]
 BILLING CODE 4164-01-P


