Rule2022-17247
Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers With Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule; Guidance for Industry; Availability
Primary source
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Published
August 11, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule." The guidance is intended to provide information to egg producers on certain provisions contained in FDA's final rule entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation" (the egg rule) that reference the "poultry house." Specifically, the document provides guidance to shell egg producers whose production systems provide laying hens with access to areas outside of a "poultry house" as that term is defined in the egg rule.
Full Text
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<title>Federal Register, Volume 87 Issue 154 (Thursday, August 11, 2022)</title>
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[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Rules and Regulations]
[Pages 49521-49522]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17247]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 118
[Docket No. FDA-2000-N-0190 (Formerly Docket No. 2000N-0504)]
Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation (Layers With Access to Areas
Outside the Poultry House): Questions and Answers Regarding the Final
Rule; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation (Layers with Access to Areas Outside the Poultry House):
Questions and Answers Regarding the Final Rule.'' The guidance is
intended to provide information to egg producers on certain provisions
contained in FDA's final rule entitled ``Prevention of Salmonella
Enteritidis in Shell Eggs During Production, Storage, and
Transportation'' (the egg rule) that reference the ``poultry house.''
Specifically, the document provides guidance to shell egg producers
whose production systems provide laying hens with access to areas
outside of a ``poultry house'' as that term is defined in the egg rule.
DATES: The announcement of the guidance is published in the Federal
Register on August 11, 2022.
ADDRESSES: You may submit either electronic or written comments on FDA
guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2000-N-0190 for ``Prevention of Salmonella Enteritidis in Shell
Eggs During Production, Storage, and Transportation (Layers with Access
to Areas Outside the Poultry House): Questions and Answers Regarding
the Final Rule.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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.'' We will review
this copy, including the claimed confidential information, in our
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Division of Plant and Dairy Food Safety/Office of Food Safety, Center
for Food Safety and Applied Nutrition, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740. Send two self-addressed
adhesive labels to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1493; or Marquita Steadman, Center for
Food Safety and Applied Nutrition, Office of Regulations and Policy
(HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation (Layers with Access to Areas
Outside the Poultry House): Questions and Answers Regarding the Final
Rule.'' We are issuing this guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The guidance represents our
current thinking on how to interpret the requirements in the egg rule
with regard to production systems that provide laying hens with access
to areas outside of a ``poultry house'' as that term is defined in 21
CFR 118.3, including
[[Page 49522]]
questions and answers on coverage; definitions; Salmonella Enteritidis
(SE) prevention measures; and environmental sampling for SE. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued
the egg rule requiring shell egg producers to implement measures to
prevent SE from contaminating eggs on the farm and from further growth
during storage and transportation, and requiring these producers to
maintain records concerning their compliance with the egg rule and to
register with FDA. The egg rule became effective September 8, 2009,
with a compliance date of July 9, 2010, for producers with 50,000 or
more laying hens. For producers with fewer than 50,000, but at least
3,000 laying hens, the compliance date was July 9, 2012. Producers with
fewer than 3,000 laying hens and those that sell all of their eggs
directly to consumers are exempt from requirements in the egg rule. The
egg rule is codified at part 118 (21 CFR part 118).
In the Federal Register of July 24, 2013 (78 FR 44483), we made
available a draft guidance entitled ``Guidance for Industry: Questions
and Answers Regarding the Final Rule, Prevention of Salmonella
Enteritidis in Shell Eggs During Production, Storage, and
Transportation (Layers with Outdoor Access)'' and gave interested
parties an opportunity to submit comments by September 23, 2013, for us
to consider before beginning work on the final version of the guidance.
We received more than 3,000 comments on the draft guidance and have
modified the content, where appropriate, for this final guidance. In
the draft guidance, we indicated that we consider porches to be part of
the poultry house because we considered them to be part of a structure
used to house poultry. However, comments to the draft guidance
indicated that, from a structural perspective, the difference between a
porch and an outdoor run (whether an outdoor run-row style or an
outdoor run-attached run style) was the presence of a roof, in some
cases concrete flooring, and the height of the fence. We considered
these comments and upon further analysis determined those differences
do not warrant considering one of these systems different from the
other two. We have concluded that our initial interpretation did not
fully consider how the term ``structure'' is used within the context of
21 CFR 118.3, particularly with respect to the goal of housing poultry
and considering factors such as protection from the elements and from
predation and control of temperature, humidity, and lighting.
Accordingly, in this final guidance, we consider a porch to be an area
outside the poultry house rather than part of the poultry house. Other
changes to the guidance include listing additional guidance documents
that egg producers should be aware of, and adding additional references
to support the statement that wild birds are common vectors of SE. In
addition, we made editorial changes to improve clarity and removed
certain recommendations based on practicality. The guidance announced
in this notice finalizes the draft guidance dated July 2013.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required
for this guidance. The previously approved collections of information
are subject to review by OMB under the PRA. The collections of
information in part 118 have been approved under OMB control number
0910-0660.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.
Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17247 Filed 8-10-22; 8:45 am]
BILLING CODE 4164-01-P
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