[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]


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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 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\
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    \1\ See: https://www.fsis.usda.gov/guidelines/2021-0014.
    \2\ See: https://www.fsis.usda.gov/guidelines/2014-0010.
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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-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.
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    \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