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, 49521-49522 [2022-17247]
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Federal Register / Vol. 87, No. 154 / Thursday, August 11, 2022 / Rules and Regulations
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.
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:
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
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
VerDate Sep<11>2014
16:33 Aug 10, 2022
Jkt 256001
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
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
49521
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-201509-18/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 selfaddressed 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
E:\FR\FM\11AUR1.SGM
11AUR1
lotter on DSK11XQN23PROD with RULES1
49522
Federal Register / Vol. 87, No. 154 / Thursday, August 11, 2022 / Rules and Regulations
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
VerDate Sep<11>2014
16:33 Aug 10, 2022
Jkt 256001
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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2022–0645]
Special Local Regulation; Olympia
Harbor Days Tug Boat Races, Budd
Inlet, WA
AGENCY:
PO 00000
Coast Guard, DHS.
Frm 00014
Fmt 4700
Sfmt 4700
Notification of enforcement of
regulation.
ACTION:
The Coast Guard will enforce
special local regulations for the Olympia
Harbor Days Tug Boat Races, Budd,
Inlet, WA, from 11 a.m. until 4 p.m. on
September 3, 2022. This action is
necessary to limit vessel movement
within the specified race area
immediately prior to, during, and
immediately after racing activity in
order to ensure the safety of
participants, spectators, and the
maritime public. During the
enforcement periods, the operator of any
vessel in the regulated area must
comply with directions from the Patrol
Commander or any Official Patrol
displaying a Coast Guard ensign.
DATES: The regulations in 33 CFR
100.1309 will be enforced from 11 a.m.
until 4 p.m. on September 3, 2022.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email Lieutenant
Peter McAndrew, Sector Puget Sound
Waterways Management Division, U.S.
Coast Guard; telephone 206–217–6051,
email SectorPugetSoundWWM@
uscg.mil.
SUMMARY:
The Coast
Guard will enforce special local
regulations for the Olympia Harbor Days
Tug Boat Races, Budd Inlet, WA
regulated area detailed in 33 CFR
100.1309(a), which encompasses
approximately 2 nautical miles of the
navigable waters in Budd Inlet south of
Big Tykle Cove to west of Priest Point.
Under the provisions of 33 CFR
100.1309, the regulated area shall be
closed immediately prior to, during, and
immediately after the event to all
persons and vessels not participating in
the event and authorized by the event
sponsor. This action is necessary to
ensure the safety of participants,
spectators, and the maritime public.
During the enforcement periods, if you
are the operator of a vessel in the
regulated area you must comply with
directions from the Patrol Commander
or any Official Patrol displaying a Coast
Guard ensign. All persons or vessels
who desire to enter the race area while
it is enforced must obtain permission
from the on-scene patrol craft on VHF–
FM channel 13.
In addition to this notice of
enforcement in the Federal Register, the
Coast Guard will provide notification of
this enforcement period via the Local
Notice to Mariners. If the Captain of the
Port determines that the regulated area
need not be enforced for the full
duration stated in this notice, he may
use a Broadcast Notice to Mariners to
SUPPLEMENTARY INFORMATION:
E:\FR\FM\11AUR1.SGM
11AUR1
Agencies
[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]
[[Page 49521]]
=======================================================================
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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.
-----------------------------------------------------------------------
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
[[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
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