[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32400-32403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12790]


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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

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 1, 
2013.

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 Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 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) 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.
    On July 9, 2009, FDA published in the Federal Register a final rule 
that established a regulation part 118 (21 CFR part 118) entitled 
``Prevention of Salmonella Enteritidis in Shell Eggs During Production, 
Storage, and Transportation'' (74 FR 33030) (the Shell Eggs final 
rule''). Part 118 requires shell egg producers to implement measures to 
prevent SE from contaminating eggs on the farm and from further growth 
during storage and transportation, and requires these producers to 
maintain records concerning their compliance with the rule 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 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. 
The Agency strongly encourages electronic registration because it is 
faster and more convenient. 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

[[Page 32401]]

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 27, 2013 (78 FR 18605), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one letter in response to the 
notice; however, the letter did not contain comments responsive to the 
four information collection topics specified in the 60-day notice.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                     Number of       Number of                    Average burden
 Description and 21 CFR Section    recordkeepers    records per    Total annual         per         Total hours
                                        \2\        recordkeeper       records      recordkeeping
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Refrigeration Records,                     2,600              52         135,200            0.5           67,600
 118.10(a)(3)(iv)...............
Testing, Diversion, and                      343              52          17,836            0.5            8,918
 Treatment Records,
 118.10(a)(3)(v-viii) (positive)
 \3\............................
Egg Testing, 118.10(a)(3)(vii)..             331               7           2,317            8.3           19,231
Environmental Testing,                     6,308              23         145,084            0.25          36,271
 118.10(a)(3)(v) \3\............
Testing, Diversion, and                    5,965               1           5,965            0.5            2,983
 Treatment Records,
 118.10(a)(3)(v-viii) (negative)
 \3\............................
Prevention Plan Review and                   331               1             331           10              3,310
 Modifications, 118.10(a)(4)....
Chick and Pullet Procurement               4,731               1           4,731            0.5            2,366
 Records, 118.10(a)(2)..........
Rodent and Other Pest Control,             9,462              52         492,024            0.5          246,012
 118.10(a)(3)(ii) and
 Biosecurity
 Records,118.10(a)(3)(i)........
Prevention Plan Design,                      150               1             150           20              3,000
 118.10(a)(1)...................
Cleaning and Disinfection                    331               1             331            0.5              166
 Records, 118.10(a)(3)(iii).....
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............         389,857
----------------------------------------------------------------------------------------------------------------
\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.

    FDA is retaining most of the estimates published in the Shell Eggs 
final rule with regard to the estimated number of respondents and the 
average burden per recordkeeping (74 FR 33030 at 33089 to 33091). FDA 
bases the remaining recordkeeping burden estimates and the reporting 
burden estimates on its experience implementing the final rule and the 
number of registrations and cancellations received in the past 3 years.
    The number of recordkeepers estimated in column 2 of Table 1 and 
all other estimates discussed in this section are drawn from estimates 
of the total number of layer and pullet houses affected by the Shell 
Eggs final rule (74 FR 33030 at 33078 to 33080). In the final rule, we 
assumed that those farms that were operating according to recognized 
industry or State quality assurance plans were already largely in 
compliance with the plan design and recordkeeping provisions discussed 
in this section, and therefore would not experience additional costs to 
comply with recordkeeping provisions. We found that 59 percent of farms 
with more than 50,000 layers were 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 estimated the 
number of layer farms incurring a new recordkeeping burden because of 
the Shell Eggs final rule to be 2,600, and the number of houses 
affected to be 4,731. A detailed breakdown of this estimation is shown 
in Table 29 of the Shell Eggs final rule (74 FR 33030 at 33078).
    Prevention plan design (Sec.  118.10(a)(1)) records will be kept on 
a per farm basis but because the Shell Eggs final rule has been fully 
implemented, FDA assumes that new prevention plan design will only be 
undertaken by new entrants to the industry. Refrigeration records 
(Sec.  118.10(a)(3)(iv)) will also be 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)) will be 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)) will 
also be kept on a per house basis, but will 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)) will also 
need to be performed every time a house tests positive. As discussed in 
Section V.F. of the Shell Eggs final rule (74 FR 33030 at 33078 to 
33080), FDA estimated that 7.0 percent will test positive after the 
provisions of the rule took effect. 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 (Sec.  118.10(a)(3)(v-
viii)) will be kept on a per house basis and will include records on 
flocks from pullet houses. In the Shell Eggs final rule, FDA estimated 
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

[[Page 32402]]

houses x 0.930) + ((4731/3 pullet houses) x 0.9925)).
    We assume that refrigeration records will be kept on a weekly basis 
on a per farm basis under Sec.  118.10(a)(3)(iv)). We estimate that 
2,600 recordkeepers will maintain 52 records each for a total of 
135,200 records and that it will take 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 
Sec.  118.10(a)(3)(v-viii)) will be kept weekly in the event a layer 
house tests environmentally positive for SE. We estimate that 343 layer 
and pullet houses will test positive and thus 343 recordkeepers will 
maintain 52 records each for a total of 17,836 records and that it will 
take 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 estimated 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 will 
maintain 7 records each for a total of 2,317 records and that it will 
take approximately 8.3 hours per recordkeeping. Thus, the total annual 
burden for egg testing is estimated to be 19,231 hours (2,317 x 8.3 
hours).
    FDA estimates that all 1,577 pullet and 4,731 layer houses not 
currently testing (6,308 recordkeepers) will 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). For the purposes of 
this analysis we estimate that roughly 50 percent of the houses 
affected will employ a row based method and 50 percent will employ a 
random sampling method, implying an average of 23 samples per house. 
Thus, we estimate that 6,308 recordkeepers will 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 will take 
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 x 0.25 hour).
    We estimate that records of testing, diversion, and treatment under 
Sec.  118.10(a)(3)(v-viii)) will be kept annually in the event a layer 
house tests environmentally negative for SE. We estimate that 5,965 
layer and pullet houses will test negative and thus 5,965 recordkeepers 
will maintain one record of that testing that will 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 x 0.5 hour).
    Prevention plan review and modifications under Sec.  118.10(a)(4)) 
will need to be performed every time a house tests positive. As 
discussed, we estimate that 331 layer houses will test positive 
requiring plan review and modifications and that it will take 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 
estimated to be 3,310 hours (331 x 10 hours).
    We estimate that chick and pullet procurement records under Sec.  
118.10(a)(2) will be kept roughly once annually per layer house basis. 
We estimate that 4,731 layer houses will maintain 1 record each and 
that it will take approximately 0.5 hour per recordkeeping. Thus, the 
total annual burden for chick and pullet procurement recordkeeping is 
estimated 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) 
will be kept weekly on a per layer house basis. We assume that 4,731 
layer houses will maintain a weekly record under each provision. Thus, 
we estimate 9,462 recordkeepers will 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) will only 
be undertaken by new farms and records will be kept on a per farm 
basis. We estimate that there are 150 new farm registrations annually 
and we assume that this reflects 150 new farms requiring prevention 
plan design. We estimate that it will take 20 hours to complete this 
work. Thus, the total annual burden for prevention plan design is 
estimated to be 3,000 hours (150 x 20 hours).
    Cleaning and disinfection recordkeeping under Sec.  
118.10(a)(3)(iii) will need to be performed every time a house tests 
positive. As discussed, we estimate that 331 layer houses will test 
positive requiring 1 record each and that it will take 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 estimated to be 166 hours (331 x 0.5 hour).

                                                     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
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Registrations or Updates, 118.11.........  Form FDA 3733 \2\...........             150               1             150              2.3             345
Cancellations, 118.11....................  Form FDA 3733...............              15               1              15              1                15
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  ............................  ..............  ..............  ..............  ...............             360
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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 http://www.access.fda.gov per Sec.   118.11(b)(1).

    This estimate is based on FDA's experience implementing the Shell 
Eggs final rule and the average number of new Shell Egg Producer 
registrations and cancellations received in the past 3 years under 
Sec.  118.11. Based on FDA experience with implementing the 
registration provisions of the Shell Eggs final rule, which had 
staggered compliance dates and gave producers with fewer than 50,000 
but at least 3,000 laying hens until July 9, 2012, to register (74 FR 
33030 at 33034), FDA expects that it will receive fewer registrations 
or updates each year over the next 3 years,

[[Page 32403]]

reflecting compliance with the final rule's registration deadlines. FDA 
estimates that it will receive 200 registrations or updates in 2013, 
150 registrations or updates in 2014 and 100 registrations or updates 
in 2015, for an average of 150 registrations or updates per year over 
the next 3 years. FDA received 12 cancellations in 2011 and 19 
cancellations in 2012. Based on this experience, FDA estimates that it 
will receive approximately 15 cancellations per year over the next 3 
years.
    FDA estimated in the Shell Eggs final rule that listing the 
information required by the final rule and presenting it in a format 
that will meet the Agency's registration regulations will require a 
burden of approximately 2.3 hours per average registration. As detailed 
in section V.F. of the final rule (see 74 FR 33030 at 33080), FDA 
estimates that it will take 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 estimated 
to be 345 hours (150 x 2.3 hours).
    FDA estimates cancelling a registration will, on average, require 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 
estimated to be 15 hours (15 cancellations x 1 hour).

    Dated: May 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12790 Filed 5-29-13; 8:45 am]
BILLING CODE 4160-01-P