[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Notices]
[Pages 47765-47766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[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.

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 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, fax, or CD-ROM. For more 
information, we invite you to visit our websites at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/shell-egg-producer-registration and http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/ucm217952.htm.
    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 http://www.access.fda.gov 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


