[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18605-18609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07032]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0297]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the
[[Page 18606]]
PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's recordkeeping and registration requirements for shell egg
producers.
DATES: Submit either electronic or written comments on the collection
of information by May 28, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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., PI50-400B,
Rockville, MD 20850, 301-796-5733, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
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 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)), 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 at 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 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. 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
FDA 3733 is available for download for registration for submission by
mail or CD-ROM (see http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/ucm217952.htm#cdrom).
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
[[Page 18607]]
eggs to the table egg market, other than directly to the consumer.
We estimate the burden of this collection of information as
follows:
Recordkeeping Burden
Table 1--Estimated Annual Recordkeeping Burden \1\
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No. of No. of records Average
Description and 21 CFR section recordkeepers per Total annual burden per Total hours
\2\ recordkeeper records recordkeeping
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Refrigeration Records, Sec. 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, Sec.
118.10(a)(3)(v) to (a)(3)(viii)
(positive) \3\.................
Egg Testing, Sec. 331 7 2,317 8.3 19,231
118.10(a)(3)(vii)..............
Environmental Testing, Sec. 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, Sec.
118.10(a)(3)(v) to (a)(3)(viii)
(negative) \3\.................
Prevention Plan Review and 331 1 331 10 3,310
Modifications, Sec.
118.10(a)(4)...................
Chick and Pullet Procurement 4,731 1 4,731 0.5 2,366
Records, Sec. 118.10(a)(2)...
Rodent and Other Pest Control, 9,462 52 492,024 0.5 246,012
Sec. 118.10(a)(3)(ii), and
Biosecurity Records, Sec.
118.10(a)(3)(i)................
Prevention Plan Design, Sec. 150 1 150 20 3,000
118.10(a)(1)...................
Cleaning and Disinfection 331 1 331 0.5 166
Records, Sec.
118.10(a)(3)(iii)..............
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Total hours................. .............. .............. .............. .............. 389,857
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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.
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 (118.10(a)(3)(v) to
(a)(3)(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 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) to (a)(3)(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
[[Page 18608]]
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
36,271hours (145,084 x 0.25 hour).
We estimate that records of testing, diversion, and treatment under
Sec. 118.10(a)(3)(v) to (a)(3)(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).
Reporting Burden
Table 2--Estimated Annual Reporting Burden \1\
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No. of
Description and 21 CFR section FDA form No. No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Registrations or Updates, Sec. 118.11... Form FDA 3733 \2\........... 150 1 150 2.3 345
Cancellations, Sec. 118.11.............. Form FDA 3733............... 15 1 15 1 15
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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, 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
[[Page 18609]]
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: March 20, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07032 Filed 3-26-13; 8:45 am]
BILLING CODE 4160-01-P