Notice2022-16686
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Production, Storage and Transportation of Shell Eggs (Preventing Salmonella Enteritidis (SE))
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 149 (Thursday, August 4, 2022)</title>
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[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Notices]
[Pages 47765-47766]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16686]
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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; Production, Storage
and Transportation of Shell Eggs (Preventing Salmonella Enteritidis
(SE))
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: Submit written comments (including recommendations) on the
collection of information by September 6, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0660. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#38686a796b4c595e5e785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="c797958694b3a6a1a187a1a3a6e9afafb4e9a0a8b1">[email protected]</span></a>.
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.
Production, Storage and Transportation of Shell Eggs (Preventing
Salmonella Enteritidis (SE))
OMB Control Number 0910-0660--Extension--21 CFR 118.10 and 118.11
This information collection supports Agency regulations in part 118
(21 CFR part 118), Production, Storage, and Transportation of Shell
Eggs, and Form FDA 3733, Shell Egg Producer Registration Form. 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, 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 about
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 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 <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. 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, fax, or CD-ROM. For more
information, we invite you to visit our websites at: <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration</a> and <a href="http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/ucm217952.htm">http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/ucm217952.htm</a>.
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 quickly notify 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 19, 2022 (87 FR 2797), FDA
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.
The comment suggested that farms could save money by pooling
samples while conducting environmental testing, proffering a 2015
research article. FDA reviewed the 2015 research article by Kinde et
al. and had additional questions about the equivalency of pooled versus
non-pooled samples. This
[[Page 47766]]
led to a subsequent 2020 study conducted and published by Jones et al.,
which found that analysis of pooled samples was not equivalent to that
of single samples. In environmental samples, the level of background
microflora plays a role in the ability to detect SE, if present. When
samples are pooled, the amount of background microflora is amplified,
potentially causing the inability to detect SE by masking its presence.
This is further exacerbated based on the number of pooled samples
(e.g., two vs. four samples per collection bag) and could result in
false negative test results. After consideration of the science, FDA
determined that at this time, there is not sufficient data to consider
pooled samples equivalent to single samples, as required by the
reference methods cited in Sec. 118.8. While we understand cost
considerations are important, the primary concern should always be the
ability to detect SE if it is present.
The comment also suggested adjusting the egg testing protocol to
two 1,000-egg samples instead of four 1,000-egg samples. 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.
Testing fewer than 4,000 eggs over a period of 8 weeks, as required by
Sec. 118.7, would result 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.
We find that the required testing established under 21 CFR 118.7
and 118.8 best protects the public health and that relaxing the current
testing requirements, whether or not in an effort to reduce costs,
would not provide the same level of protection necessary to ensure the
public health.
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
Activity; 21 CFR section recordkeepers records per Total annual Average burden per Total
\2\ recordkeeper records recordkeeping hours
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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 343 52 17,836 0.5 (30 minutes).. 8,918
Treatment Records; Sec.
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 minutes). 36,271
118.10(a)(3)(v) \3\.
Testing, Diversion, and 5,965 1 5,965 0.5 (30 minutes).. 2,983
Treatment 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 4,731 1 4,731 0.5 (30 minutes).. 2,366
Records; Sec. 118.10(a)(2).
Rodent and Other Pest Control; 9,462 52 492,024 0.5 (30 minutes).. 246,012
Sec. 118.10(a)(3)(ii), and
Biosecurity Records, Sec.
118.10(a)(3)(i).
Prevention Plan Design; Sec. 350 1 350 20................ 7,000
118.10(a)(1).
Cleaning and Disinfection 331 1 331 0.5 (30 minutes).. 166
Records; Sec.
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.
Table 2--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR section Form Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
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Registrations or Updates; Sec. 118.11..... FDA 3733 \2\.................. 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 <a href="http://www.access.fda.gov">http://www.access.fda.gov</a> per Sec. 118.11(b)(1).
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. Our estimates for the recordkeeping burden and the reporting
burden are based on our experience with similar recordkeeping
activities and the number of registrations and cancellations received
in the past 3 years.
Dated: July 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16686 Filed 8-3-22; 8:45 am]
BILLING CODE 4164-01-P
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