Notice2023-09614
Availability of FSIS Ready-To-Eat Fermented, Salt-Cured, and Dried Products Guideline
Primary source
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Published
May 5, 2023
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 87 (Friday, May 5, 2023)</title>
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[Federal Register Volume 88, Number 87 (Friday, May 5, 2023)]
[Notices]
[Pages 29077-29079]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09614]
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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.
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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 <a href="https://www.fsis.usda.gov/policy/fsis-guidelines">https://www.fsis.usda.gov/policy/fsis-guidelines</a>. 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:
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions at that site for
submitting comments.
[[Page 29078]]
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 a<INF>w</INF>) 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-log<INF>10</INF> reduction of Salmonella and at least a
5.0-log<INF>10</INF> 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-log<INF>10</INF> reduction in Listeria
Monocytogenes (Lm), although a 5.0-log<INF>10</INF> 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\
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\1\ See: <a href="https://www.fsis.usda.gov/guidelines/2021-0014">https://www.fsis.usda.gov/guidelines/2021-0014</a>.
\2\ See: <a href="https://www.fsis.usda.gov/guidelines/2014-0010">https://www.fsis.usda.gov/guidelines/2014-0010</a>.
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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-log<INF>10</INF> 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.
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\3\ See: <a href="https://www.fsis.usda.gov/guidelines/2015-0011">https://www.fsis.usda.gov/guidelines/2015-0011</a>.
\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: <a href="https://www.fsis.usda.gov/sites/default/files/media_file/2022-04/FSIS-After-Action-Review-2021-07.pdf">https://www.fsis.usda.gov/sites/default/files/media_file/2022-04/FSIS-After-Action-Review-2021-07.pdf</a>.
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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 <a href="https://www.fsis.usda.gov/news-events/publications/2020-nacmpi-reports">https://www.fsis.usda.gov/news-events/publications/2020-nacmpi-reports</a>.
\8\ See <a href="https://www.fsis.usda.gov/contact-us/state-contacts">https://www.fsis.usda.gov/contact-us/state-contacts</a>.
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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:
<a href="https://www.fsis.usda.gov/federal-register">https://www.fsis.usda.gov/federal-register</a>. 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: <a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. 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 <a href="https://www.usda.gov/forms/electronic-forms">https://www.usda.gov/forms/electronic-forms</a>, 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: <a href="/cdn-cgi/l/email-protection#6c1c1e030b1e0d01420502180d07092c191f080d420b031a"><span class="__cf_email__" data-cfemail="7b0b09141c091a165512150f1a101e3b0e081f1a551c140d">[email protected]</span></a>.
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
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