[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11309-11312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05757]
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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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 28, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0297 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prevention of Salmonella
Enteritidis in Shell Eggs During Production; Recordkeeping and
Registration Provisions.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
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: 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
[[Page 11310]]
existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
With respect to the following collection of information, FDA
invites 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) (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, 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 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 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.
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 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, Sec. 2,600 52 135,200 0.5 (30 67,600
118.10(a)(3)(iv). minutes).
Testing, Diversion, and 343 52 17,836 0.5 (30 8,918
Treatment Records, Sec. minutes).
118.10(a)(3)(v) through (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 (15 36,271
118.10(a)(3)(v) \3\. minutes).
Testing, Diversion, and 5,965 1 5,965 0.5 (30 2,983
Treatment Records, Sec. minutes).
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 4,731 1 4,731 0.5 (30 2,366
Records, Sec. 118.10(a)(2). minutes).
Rodent and Other Pest Control, 9,462 52 492,024 0.5 (30 246,012
Sec. 118.10(a)(3)(ii), and minutes).
Biosecurity Records, Sec.
118.10(a)(3)(i).
Prevention Plan Design, Sec. 350 1 350 20............. 7,000
118.10(a)(1).
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Cleaning and Disinfection 331 1 331 0.5 (30 166
Records, Sec. minutes).
118.10(a)(3)(iii).
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Total...................... .............. .............. .............. ............... 393,857
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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 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 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
[[Page 11312]]
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. 118.11................. \2\ FDA 3733 350 1 350 2.3 805
Cancellations, Sec. 118.11............................ FDA 3733 30 1 30 1 30
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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 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 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: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05757 Filed 3-25-19; 8:45 am]
BILLING CODE 4164-01-P