[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 [www.gpo.gov]
[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:
     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-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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 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.govinfo.gov/content/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, 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

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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 
https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. 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


