Availability of FSIS Ready-To-Eat Fermented, Salt-Cured, and Dried Products Guideline, 29077-29079 [2023-09614]
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29077
Notices
Federal Register
Vol. 88, No. 87
Friday, May 5, 2023
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
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rulings, delegations of authority, filing of
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DEPARTMENT OF AGRICULTURE
lotter on DSK11XQN23PROD with NOTICES1
Submission for OMB Review;
Comment Request
The Department of Agriculture will
submit the following information
collection requirement(s) to OMB for
review and clearance under the
Paperwork Reduction Act of 1995,
Public Law 104–13 on or after the date
of publication of this notice. Comments
are requested regarding: (1) whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of burden including
the validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Comments regarding these
information collections are best assured
of having their full effect if received by
June 5, 2023. Written comments and
recommendations for the proposed
information collection should be
submitted within 30 days of the
publication of this notice on the
following website www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function.
An agency may not conduct or
sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
VerDate Sep<11>2014
18:07 May 04, 2023
Jkt 259001
the collection of information unless it
displays a currently valid OMB control
number.
National Agricultural Statistics Service
Title: Aquaculture Survey.
OMB Control Number: 0535–0150.
Summary of Collection: The primary
objective of the National Agricultural
Statistics Service is to prepare and issue
State and national estimates of crop and
livestock production, prices, and
disposition. The Aquaculture Surveys
program produces estimates at the
national level on both trout and catfish.
Survey results are used by government
agencies and others in planning farm
programs.
The trout survey includes sales
(dollars, pounds, and quantities),
percent of product sold by outlet at the
point of first sale, distribution (dollars,
pounds, and quantities) of fish raised for
release into open waters, and losses.
The catfish surveys include inventory
counts, water surface acreage used for
production and sales (dollars, pounds,
and quantities).
Need and Use of the Information:
Survey results are used by members of
the Cooperative Extension System and
the National Sea Grant College Program
who research and work in aquaculture.
The information is used to analyze
changing trends in the number of
commercial operations and production
levels by State, as well as to
demonstrate the growing importance of
aquaculture to officials of federal and
State government agencies who manage
and direct policy for programs in
agriculture and natural resources.
Extension specialists use the data to
demonstrate the impact of educational
programs and other efforts to assist in
developing economically viable
aquaculture operations. The type of
information collected and reported
provides extension educators and
research scientists with data that
indicate important areas that require
special educational and/or research
efforts, such as causes for fish loss and
pond inventories of fish of various sizes.
Description of Respondents: Farms;
business or other for-profit.
Number of Respondents: 2,950.
Frequency of Responses: Reporting:
on occasion; annually.
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Total Burden Hours: 551.
Levi S. Harrell,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2023–09625 Filed 5–4–23; 8:45 am]
BILLING CODE 3410–20–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2022–0011]
Availability of FSIS Ready-To-Eat
Fermented, Salt-Cured, and Dried
Products Guideline
Food Safety and Inspection
Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Notice of availability and
request for comments.
AGENCY:
FSIS is announcing the
availability of and requesting comments
on a guidance document for small and
very small meat and poultry
establishments manufacturing ready-toeat (RTE), shelf-stable, fermented, saltcured, and dried meat and poultry
products, that do not use cooking as the
primary lethality step. This guideline
addresses many commonly asked
questions concerning the food safety
hazards associated with these products
and the key steps in each process
needed to ensure safety. This guideline
replaces and expands upon information
previously found in other guidance
documents addressing the safe
production of RTE fermented meat and
poultry products.
DATES: Submit Comments on or before
July 5, 2023.
ADDRESSES: A downloadable version of
the guideline is available to view and
print at https://www.fsis.usda.gov/
policy/fsis-guidelines. No hard copies of
the guideline have been published.
FSIS invites interested persons to
submit comments on this guideline.
Comments may be submitted by one of
the following methods:
• Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field on this web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov. Follow
the online instructions at that site for
submitting comments.
SUMMARY:
E:\FR\FM\05MYN1.SGM
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29078
Federal Register / Vol. 88, No. 87 / Friday, May 5, 2023 / Notices
• Mail: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety
and Inspection Service, 1400
Independence Avenue SW, Mailstop
3758, Washington, DC 20250–3700.
• Hand- or courier-delivered
submittals: Deliver to 1400
Independence Avenue SW, Jamie L.
Whitten Building, Room 350–E,
Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2022–0011. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov.
Docket: For access to background
documents or comments received, call
(202) 937–4272 to schedule a time to
visit the FSIS Docket Room at 1400
Independence Avenue SW, Washington,
DC 20250–3700.
FOR FURTHER INFORMATION CONTACT:
Rachel Edelstein, Assistant
Administrator, Office of Policy and
Program Development; Telephone: (202)
937–4272.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Background
FSIS is announcing the availability of
a guidance document that addresses the
safe production of products that rely on
multiple hurdles, other than cooking
alone, to achieve lethality and shelfstability, and provides an overview of
the scientific support available for these
processes. For these types of products,
no single step, such as cooking, is
responsible for achieving adequate
lethality of pathogens. Rather, a
combination of processing steps such as
fermentation, salt-curing, and drying are
used to kill bacteria and prevent their
outgrowth during storage. Many of these
processing steps use a combination of
factors or hurdles, such as reduction of
pH, a high brine or salt concentration,
or reduction of water activity (also
referred to as aw) over time.
FSIS addressed fermentation and
drying previously in Food Safety
Lessons Learned from the Lebanon
Bologna Outbreak. This document
addressed problems FSIS identified
through an investigation of a 2011
foodborne illness outbreak of E. coli
O157:H7 associated with Lebanon
bologna. FSIS is removing that
document from its web page and has
incorporated information from that
document into this guideline because
information from the earlier document
can be applied to other semi-dry
fermented products.
VerDate Sep<11>2014
18:07 May 04, 2023
Jkt 259001
FSIS has also incorporated into the
new guideline additional information
related to drying. This information
addresses the production of other
fermented products, such as salami that
is fermented and dried and salt-cured
and dried products, as well as those
products that rely on drying alone such
as biltong.
This guideline also provides
information on which fermented, saltcured, and dried products are
considered RTE. FSIS considers a
product to be RTE if there is a standard
of identity in 9 CFR part 319, defining
it as fully cooked (e.g., hotdogs or
barbecue meats) or if it meets the
definition for a RTE product in 9 CFR
430.1, that is, one that is edible without
further preparation for safety.
Not all products described in this
guideline are RTE when the traditional
production process is followed. Often
additional hurdles, such as
antimicrobial interventions or a lowtemperature heat step, need to be
applied along with compliance with the
requirements in 9 CFR part 430 to make
the product safe for consumption
without further preparation. Many of
the products described in this guideline
(e.g., pepperoni, salami, bresaola,
biltong, and droe¨wors) while not
required by standard of identity to be
RTE, are typically considered to have an
intended use of RTE because marketing
materials and recipes commonly
identify them to consumers as RTE.
Other products such as basturma and
country cured ham may be classified as
RTE or not-ready-to-eat (NRTE) by the
establishment. As the guidance
explains, if an establishment identifies
the intended use as NRTE for products
such as pepperoni, salami, bresaola,
biltong, and droe¨wors where the
intended use is typically RTE, the
establishment must have on-file
documentation supporting their
decisions (9 CFR 417.5(a)(1)). This
support must address how the
establishment can ensure the consumer
will properly cook the product (9 CFR
417.5(a)(1)), particularly if there is
evidence such as marketing materials or
recipes commonly indicating the
product is RTE. For example, if an
establishment produces biltong as NRTE
then it must demonstrate how it ensures
consumers will safely prepare the
product, given it is sometimes marketed
as a teething toy for babies and as an onthe-go snack.
This guideline reiterates FSIS’
recommendations that the lethality
treatment of RTE shelf-stable meat and
poultry products should achieve at least
a 5.0-log10 reduction of Salmonella and
at least a 5.0-log10 reduction for Shiga
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Fmt 4703
Sfmt 4703
Toxin-producing Escherichia coli
(STEC) (including E. coli O157:H7) for
products containing beef as
recommended in the Cooking Guideline
for Meat and Poultry Products (Revised
Appendix A).1 In addition to
Salmonella, FSIS recommends the
lethality treatment of RTE shelf-stable
meat and poultry products should
achieve at least a 3.0-log10 reduction in
Listeria Monocytogenes (Lm), although a
5.0-log10 reduction or greater is
desirable for providing an even greater
safety margin for ensuring that Lm does
not grow to detectable levels during
storage, as also recommended in the
FSIS Compliance Guideline for Meat
and Poultry Jerky Produced by Small
and Very Small Establishments.2
Establishments may use scientific
support to demonstrate that the lethality
treatment of fermented/acidified, saltcured, and dried RTE products achieve
at least a 5.0-log10 reduction in
Salmonella without demonstrating
specific reductions in STEC (for
products containing beef) and Lm, as
indicated in the FSIS Hazard Analysis
and Critical Control Point (HACCP)
Systems Validation Guideline.3
However, research has shown that STEC
(including E. coli O157:H7) and Lm are
more tolerant than Salmonella during
the fermentation and drying steps of
dry/semi-dry fermented sausages,4 and
Lm is more tolerant than Salmonella
during the drying step of dried and saltcured meat and poultry products.5
Therefore, if an establishment’s
scientific support is only based on
reductions in Salmonella and the
establishment has a STEC or Lm
positive either through its own testing
or FSIS’ testing or is associated with an
outbreak of these pathogens, the Agency
would require the establishment, as part
of its corrective actions, to validate that
its food safety system effectively
addresses STEC and Lm as intended,
unless it can support the cause of the
positive was post-lethality
contamination.
The guideline also addresses
contributing factors in two Salmonella
outbreaks involving RTE, fermented,
and dried Italian-style meat products
that occurred in 2021. The products
were produced using multiple
interventions (i.e., fermentation and
drying) to control Salmonella. FSIS
1 See: https://www.fsis.usda.gov/guidelines/20210014.
2 See: https://www.fsis.usda.gov/guidelines/20140010.
3 See: https://www.fsis.usda.gov/guidelines/20150011.
4 See: Hussein, et al., 2022; Ihnot et al., 1998;
Porto-Fett et al., 2010; McKinney, 2019.
5 Porto-Fett et al., 2010; Reynolds et al., 2001.
E:\FR\FM\05MYN1.SGM
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Federal Register / Vol. 88, No. 87 / Friday, May 5, 2023 / Notices
found that while the outbreak
establishments used several processing
controls (degree hours parameters for
Staphylococcus aureus control, a
minimum number of drying days for
Trichinella elimination, and a final
water activity level for shelf stability),
none of these processing controls were
validated individually or in
combination to achieve a 5-log
reduction in Salmonella.6
lotter on DSK11XQN23PROD with NOTICES1
NACMPI Recommendations
Finally, the guideline includes several
recommendations made by the National
Advisory Committee on Meat and
Poultry Inspection (NACMPI) in
response to a charge FSIS brought to the
committee in 2020 on the Validation of
Ready-to-Eat Shelf-Stable Multi-hurdle
Lethality Treatments.7 Specifically, in
response to the committee’s
recommendations, FSIS included a link
to the Niche Meat Processors Assistance
Network as a resource in the guidance
document. FSIS also included a link to
its HACCP Coordinator listing 8 that the
Agency updated in 2021 as NACMPI
recommended. In response to another
NACMPI recommendation, FSIS
included guidance for products such as
those that are salt-cured where the
initial validation period may extend
beyond 90 calendar days due to the
nature of the process and the length of
time it takes to implement the critical
operational parameters that impact
lethality. FSIS did not accept NACMPI’s
recommendations to allow
establishments to ‘‘Combine the best
possible combination of available
scientific support documents that may
not exactly match’’ or to ‘‘Use scientific
support that demonstrates a less than
5.0-log reduction’’ as these were
contributing factors in the 2021
outbreaks.
FSIS Verification Activities
FSIS is aware that some
establishments may determine they do
not have adequate scientific support for
the effectiveness of their HACCP system
upon reviewing the recommendations in
the guideline. Therefore, before FSIS
verifies that establishments have
adequately validated their HACCP plans
for these products, FSIS is giving
establishments time to review the
guideline, their hazard analysis, and
scientific support to determine if it is
adequate or to identify new support.
6 See:
https://www.fsis.usda.gov/sites/default/
files/media_file/2022-04/FSIS-After-Action-Review2021-07.pdf.
7 See https://www.fsis.usda.gov/news-events/
publications/2020-nacmpi-reports.
8 See https://www.fsis.usda.gov/contact-us/statecontacts.
VerDate Sep<11>2014
18:07 May 04, 2023
Jkt 259001
Additional time will be provided to
establishments to update their support
unless they have a Salmonella, STEC, or
Lm positive either through their own
testing or FSIS’ testing or are associated
with an outbreak of these pathogens.
FSIS will update instructions to
inspection program personnel (IPP) and
Enforcement, Investigation, and
Analysis Officers (EIAOs) on how to
verify lethality and stabilization
processes at establishments producing
RTE shelf-stable fermented, salt-cured,
and dried meat and poultry products
that do not use cooking as the primary
lethality step. The instructions will
make IPP and EIAOs aware that
establishments will have additional
time to update their support if it is not
adequate and will also include
information for EIAOs when conducting
outreach at establishments producing
these products to provide technical
assistance as part of the compliance
assistance they provide.
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, FSIS will
announce this Federal Register
publication online through the FSIS
web page located at: https://
www.fsis.usda.gov/federal-register. FSIS
also will make copies of this publication
available through the FSIS Constituent
Update, which is used to provide
information regarding FSIS policies,
procedures, regulations, Federal
Register notices, FSIS public meetings,
and other types of information that
could affect or would be of interest to
our constituents and stakeholders. The
Constituent Update is available on the
FSIS web page. Through the web page,
FSIS can provide information to a much
broader, more diverse audience. In
addition, FSIS offers an email
subscription service which provides
automatic and customized access to
selected food safety news and
information. This service is available at:
https://www.fsis.usda.gov/subscribe.
Options range from recalls to export
information, regulations, directives, and
notices. Customers can add or delete
subscriptions themselves and have the
option to password protect their
accounts.
USDA Non-Discrimination Statement
In accordance with Federal civil
rights law and USDA civil rights
regulations and policies, USDA, its
Mission Areas, agencies, staff offices,
employees, and institutions
participating in or administering USDA
programs are prohibited from
discriminating based on race, color,
PO 00000
Frm 00003
Fmt 4703
Sfmt 9990
29079
national origin, religion, sex, gender
identity (including gender expression),
sexual orientation, disability, age,
marital status, family/parental status,
income derived from a public assistance
program, political beliefs, or reprisal or
retaliation for prior civil rights activity,
in any program or activity conducted or
funded by USDA (not all bases apply to
all programs). Remedies and complaint
filing deadlines vary by program or
incident.
Program information may be made
available in languages other than
English. Persons with disabilities who
require alternative means of
communication to obtain program
information (e.g., Braille, large print,
audiotape, American Sign Language)
should contact the responsible Mission
Area, agency, or staff office; the USDA
TARGET Center at (202) 720–2600
(voice and TTY); or the Federal Relay
Service at (800) 877–8339.
To file a program discrimination
complaint, a complainant should
complete a Form AD–3027, USDA
Program Discrimination Complaint
Form, which can be obtained online at
https://www.usda.gov/forms/electronicforms, from any USDA office, by calling
(866) 632–9992, or by writing a letter
addressed to USDA. The letter must
contain the complainant’s name,
address, telephone number, and a
written description of the alleged
discriminatory action in sufficient detail
to inform the Assistant Secretary for
Civil Rights (ASCR) about the nature
and date of an alleged civil rights
violation.
The completed AD–3027 form or
letter must be submitted to USDA by:
(1) Mail: U.S. Department of
Agriculture Office of the Assistant
Secretary for Civil Rights, 1400
Independence Avenue SW, Washington,
DC 20250–9410;
(2) Fax: (833) 256–1665 or (202) 690–
7442; or
(3) Email: program.intake@usda.gov.
USDA is an equal opportunity
provider, employer, and lender.
Paul Kiecker,
Administrator.
[FR Doc. 2023–09614 Filed 5–4–23; 8:45 am]
BILLING CODE 3410–DM–P
E:\FR\FM\05MYN1.SGM
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Agencies
[Federal Register Volume 88, Number 87 (Friday, May 5, 2023)]
[Notices]
[Pages 29077-29079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09614]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2022-0011]
Availability of FSIS Ready-To-Eat Fermented, Salt-Cured, and
Dried Products Guideline
AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Notice of availability and request for comments.
-----------------------------------------------------------------------
SUMMARY: FSIS is announcing the availability of and requesting comments
on a guidance document for small and very small meat and poultry
establishments manufacturing ready-to-eat (RTE), shelf-stable,
fermented, salt-cured, and dried meat and poultry products, that do not
use cooking as the primary lethality step. This guideline addresses
many commonly asked questions concerning the food safety hazards
associated with these products and the key steps in each process needed
to ensure safety. This guideline replaces and expands upon information
previously found in other guidance documents addressing the safe
production of RTE fermented meat and poultry products.
DATES: Submit Comments on or before July 5, 2023.
ADDRESSES: A downloadable version of the guideline is available to view
and print at https://www.fsis.usda.gov/policy/fsis-guidelines. No hard
copies of the guideline have been published.
FSIS invites interested persons to submit comments on this
guideline. Comments may be submitted by one of the following methods:
Federal eRulemaking Portal: This website provides the
ability to type short comments directly into the comment field on this
web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
[[Page 29078]]
Mail: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 1400 Independence
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
Hand- or courier-delivered submittals: Deliver to 1400
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E,
Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2022-0011. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to https://www.regulations.gov.
Docket: For access to background documents or comments received,
call (202) 937-4272 to schedule a time to visit the FSIS Docket Room at
1400 Independence Avenue SW, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 937-4272.
SUPPLEMENTARY INFORMATION:
Background
FSIS is announcing the availability of a guidance document that
addresses the safe production of products that rely on multiple
hurdles, other than cooking alone, to achieve lethality and shelf-
stability, and provides an overview of the scientific support available
for these processes. For these types of products, no single step, such
as cooking, is responsible for achieving adequate lethality of
pathogens. Rather, a combination of processing steps such as
fermentation, salt-curing, and drying are used to kill bacteria and
prevent their outgrowth during storage. Many of these processing steps
use a combination of factors or hurdles, such as reduction of pH, a
high brine or salt concentration, or reduction of water activity (also
referred to as aw) over time.
FSIS addressed fermentation and drying previously in Food Safety
Lessons Learned from the Lebanon Bologna Outbreak. This document
addressed problems FSIS identified through an investigation of a 2011
foodborne illness outbreak of E. coli O157:H7 associated with Lebanon
bologna. FSIS is removing that document from its web page and has
incorporated information from that document into this guideline because
information from the earlier document can be applied to other semi-dry
fermented products.
FSIS has also incorporated into the new guideline additional
information related to drying. This information addresses the
production of other fermented products, such as salami that is
fermented and dried and salt-cured and dried products, as well as those
products that rely on drying alone such as biltong.
This guideline also provides information on which fermented, salt-
cured, and dried products are considered RTE. FSIS considers a product
to be RTE if there is a standard of identity in 9 CFR part 319,
defining it as fully cooked (e.g., hotdogs or barbecue meats) or if it
meets the definition for a RTE product in 9 CFR 430.1, that is, one
that is edible without further preparation for safety.
Not all products described in this guideline are RTE when the
traditional production process is followed. Often additional hurdles,
such as antimicrobial interventions or a low-temperature heat step,
need to be applied along with compliance with the requirements in 9 CFR
part 430 to make the product safe for consumption without further
preparation. Many of the products described in this guideline (e.g.,
pepperoni, salami, bresaola, biltong, and dro[euml]wors) while not
required by standard of identity to be RTE, are typically considered to
have an intended use of RTE because marketing materials and recipes
commonly identify them to consumers as RTE. Other products such as
basturma and country cured ham may be classified as RTE or not-ready-
to-eat (NRTE) by the establishment. As the guidance explains, if an
establishment identifies the intended use as NRTE for products such as
pepperoni, salami, bresaola, biltong, and dro[euml]wors where the
intended use is typically RTE, the establishment must have on-file
documentation supporting their decisions (9 CFR 417.5(a)(1)). This
support must address how the establishment can ensure the consumer will
properly cook the product (9 CFR 417.5(a)(1)), particularly if there is
evidence such as marketing materials or recipes commonly indicating the
product is RTE. For example, if an establishment produces biltong as
NRTE then it must demonstrate how it ensures consumers will safely
prepare the product, given it is sometimes marketed as a teething toy
for babies and as an on-the-go snack.
This guideline reiterates FSIS' recommendations that the lethality
treatment of RTE shelf-stable meat and poultry products should achieve
at least a 5.0-log10 reduction of Salmonella and at least a
5.0-log10 reduction for Shiga Toxin-producing Escherichia
coli (STEC) (including E. coli O157:H7) for products containing beef as
recommended in the Cooking Guideline for Meat and Poultry Products
(Revised Appendix A).\1\ In addition to Salmonella, FSIS recommends the
lethality treatment of RTE shelf-stable meat and poultry products
should achieve at least a 3.0-log10 reduction in Listeria
Monocytogenes (Lm), although a 5.0-log10 reduction or
greater is desirable for providing an even greater safety margin for
ensuring that Lm does not grow to detectable levels during storage, as
also recommended in the FSIS Compliance Guideline for Meat and Poultry
Jerky Produced by Small and Very Small Establishments.\2\
---------------------------------------------------------------------------
\1\ See: https://www.fsis.usda.gov/guidelines/2021-0014.
\2\ See: https://www.fsis.usda.gov/guidelines/2014-0010.
---------------------------------------------------------------------------
Establishments may use scientific support to demonstrate that the
lethality treatment of fermented/acidified, salt-cured, and dried RTE
products achieve at least a 5.0-log10 reduction in
Salmonella without demonstrating specific reductions in STEC (for
products containing beef) and Lm, as indicated in the FSIS Hazard
Analysis and Critical Control Point (HACCP) Systems Validation
Guideline.\3\ However, research has shown that STEC (including E. coli
O157:H7) and Lm are more tolerant than Salmonella during the
fermentation and drying steps of dry/semi-dry fermented sausages,\4\
and Lm is more tolerant than Salmonella during the drying step of dried
and salt-cured meat and poultry products.\5\ Therefore, if an
establishment's scientific support is only based on reductions in
Salmonella and the establishment has a STEC or Lm positive either
through its own testing or FSIS' testing or is associated with an
outbreak of these pathogens, the Agency would require the
establishment, as part of its corrective actions, to validate that its
food safety system effectively addresses STEC and Lm as intended,
unless it can support the cause of the positive was post-lethality
contamination.
---------------------------------------------------------------------------
\3\ See: https://www.fsis.usda.gov/guidelines/2015-0011.
\4\ See: Hussein, et al., 2022; Ihnot et al., 1998; Porto-Fett
et al., 2010; McKinney, 2019.
\5\ Porto-Fett et al., 2010; Reynolds et al., 2001.
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The guideline also addresses contributing factors in two Salmonella
outbreaks involving RTE, fermented, and dried Italian-style meat
products that occurred in 2021. The products were produced using
multiple interventions (i.e., fermentation and drying) to control
Salmonella. FSIS
[[Page 29079]]
found that while the outbreak establishments used several processing
controls (degree hours parameters for Staphylococcus aureus control, a
minimum number of drying days for Trichinella elimination, and a final
water activity level for shelf stability), none of these processing
controls were validated individually or in combination to achieve a 5-
log reduction in Salmonella.\6\
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\6\ See: https://www.fsis.usda.gov/sites/default/files/media_file/2022-04/FSIS-After-Action-Review-2021-07.pdf.
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NACMPI Recommendations
Finally, the guideline includes several recommendations made by the
National Advisory Committee on Meat and Poultry Inspection (NACMPI) in
response to a charge FSIS brought to the committee in 2020 on the
Validation of Ready-to-Eat Shelf-Stable Multi-hurdle Lethality
Treatments.\7\ Specifically, in response to the committee's
recommendations, FSIS included a link to the Niche Meat Processors
Assistance Network as a resource in the guidance document. FSIS also
included a link to its HACCP Coordinator listing \8\ that the Agency
updated in 2021 as NACMPI recommended. In response to another NACMPI
recommendation, FSIS included guidance for products such as those that
are salt-cured where the initial validation period may extend beyond 90
calendar days due to the nature of the process and the length of time
it takes to implement the critical operational parameters that impact
lethality. FSIS did not accept NACMPI's recommendations to allow
establishments to ``Combine the best possible combination of available
scientific support documents that may not exactly match'' or to ``Use
scientific support that demonstrates a less than 5.0-log reduction'' as
these were contributing factors in the 2021 outbreaks.
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\7\ See https://www.fsis.usda.gov/news-events/publications/2020-nacmpi-reports.
\8\ See https://www.fsis.usda.gov/contact-us/state-contacts.
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FSIS Verification Activities
FSIS is aware that some establishments may determine they do not
have adequate scientific support for the effectiveness of their HACCP
system upon reviewing the recommendations in the guideline. Therefore,
before FSIS verifies that establishments have adequately validated
their HACCP plans for these products, FSIS is giving establishments
time to review the guideline, their hazard analysis, and scientific
support to determine if it is adequate or to identify new support.
Additional time will be provided to establishments to update their
support unless they have a Salmonella, STEC, or Lm positive either
through their own testing or FSIS' testing or are associated with an
outbreak of these pathogens. FSIS will update instructions to
inspection program personnel (IPP) and Enforcement, Investigation, and
Analysis Officers (EIAOs) on how to verify lethality and stabilization
processes at establishments producing RTE shelf-stable fermented, salt-
cured, and dried meat and poultry products that do not use cooking as
the primary lethality step. The instructions will make IPP and EIAOs
aware that establishments will have additional time to update their
support if it is not adequate and will also include information for
EIAOs when conducting outreach at establishments producing these
products to provide technical assistance as part of the compliance
assistance they provide.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication online through the FSIS web page located at:
https://www.fsis.usda.gov/federal-register. FSIS also will make copies
of this publication available through the FSIS Constituent Update,
which is used to provide information regarding FSIS policies,
procedures, regulations, Federal Register notices, FSIS public
meetings, and other types of information that could affect or would be
of interest to our constituents and stakeholders. The Constituent
Update is available on the FSIS web page. Through the web page, FSIS
can provide information to a much broader, more diverse audience. In
addition, FSIS offers an email subscription service which provides
automatic and customized access to selected food safety news and
information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information,
regulations, directives, and notices. Customers can add or delete
subscriptions themselves and have the option to password protect their
accounts.
USDA Non-Discrimination Statement
In accordance with Federal civil rights law and USDA civil rights
regulations and policies, USDA, its Mission Areas, agencies, staff
offices, employees, and institutions participating in or administering
USDA programs are prohibited from discriminating based on race, color,
national origin, religion, sex, gender identity (including gender
expression), sexual orientation, disability, age, marital status,
family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Program information may be made available in languages other than
English. Persons with disabilities who require alternative means of
communication to obtain program information (e.g., Braille, large
print, audiotape, American Sign Language) should contact the
responsible Mission Area, agency, or staff office; the USDA TARGET
Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service
at (800) 877-8339.
To file a program discrimination complaint, a complainant should
complete a Form AD-3027, USDA Program Discrimination Complaint Form,
which can be obtained online at https://www.usda.gov/forms/electronic-forms, from any USDA office, by calling (866) 632-9992, or by writing a
letter addressed to USDA. The letter must contain the complainant's
name, address, telephone number, and a written description of the
alleged discriminatory action in sufficient detail to inform the
Assistant Secretary for Civil Rights (ASCR) about the nature and date
of an alleged civil rights violation.
The completed AD-3027 form or letter must be submitted to USDA by:
(1) Mail: U.S. Department of Agriculture Office of the Assistant
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC
20250-9410;
(2) Fax: (833) 256-1665 or (202) 690-7442; or
(3) Email: [email protected].
USDA is an equal opportunity provider, employer, and lender.
Paul Kiecker,
Administrator.
[FR Doc. 2023-09614 Filed 5-4-23; 8:45 am]
BILLING CODE 3410-DM-P