[Federal Register Volume 86, Number 237 (Tuesday, December 14, 2021)]
[Notices]
[Pages 71007-71022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26993]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2017-0016]


FSIS Guidelines for Small and Very Small Meat and Poultry 
Establishments Regarding Cooking and Stabilization in Meat and Poultry 
Products (Previously Referred to as Appendices A and B)

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of two updated guidelines for meat and poultry 
establishments concerning the destruction of Salmonella and other 
pathogens during cooking of ready-to-eat (RTE) meat and poultry 
products (lethality) and the control of the growth of spore-forming 
Clostridial pathogens in heat-treated RTE and not-ready-to-eat (NRTE) 
meat and poultry products during cooling and hot-holding 
(stabilization). The updated guidelines reflect changes made in 
response to comments received on the 2017 versions of these guidelines.

DATES: On December 14, 2022, FSIS will verify that establishments that 
had been using the 1999 and 2017 versions of Appendix A and B are 
instead using the 2021 updated versions of the guidance or have 
identified alternative scientific support for their cooking and 
stabilization processes, making changes to their HACCP systems as 
needed.

ADDRESSES: Downloadable versions of the guidelines are available to 
view and print at https://www.fsis.usda.gov/guidelines/2017-0007 and 
https://www.fsis.usda.gov/guidelines/2017-0008 once copies of the 
guidelines have been published.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On June 16, 2017, FSIS announced the availability of and requested 
comments on revisions to two guidance documents, originally published 
in 1999: The FSIS Salmonella Compliance Guideline for Small and Very 
Small Meat and Poultry Establishments that Produce Ready-to-Eat (RTE) 
Products and Revised Appendix A and the FSIS Compliance Guideline for 
Stabilization (Cooling and Hot-Holding) of Fully and Partially Heat-
Treated RTE and NRTE Meat and Poultry Products Produced by Small with 
Very Small Establishments and Revised Appendix B (82 FR 27680). These 
guidelines describe best practices for eliminating Salmonella from RTE 
meat and poultry products (lethality) and for preventing or limiting 
the growth of spore-forming Clostridial pathogens (stabilization) 
during the cooling or hot-holding of RTE and NRTE meat and poultry 
products. After reviewing the comments received, the Agency has again 
revised the guidelines. The revised guidelines are posted at: https://www.fsis.usda.gov/policy/fsis-guidelines. A summarized list of major 
changes to the guidelines appears below.
    Many establishments use these processing guidelines as scientific 
support for the lethality and stabilization procedures in their Hazard 
Analysis and Critical Control Point (HACCP) systems. When adequately 
applied to ensure food safety, FSIS has accepted the use of both of 
these guidelines as scientific support for validating that the 
establishment's HACCP system for these products meets the regulatory 
performance standards for lethality (9 CFR 318.17(a)(1), 9 CFR 318.23, 
381.150(a)(1)) and stabilization (9 CFR 318.17(a)(2), 9 CFR 
318.23(c)(1), 9 CFR 381.150(a)(2), 9 CFR 381.150(b)) in cooked and 
partially-cooked meat and poultry products. In addition, FSIS has 
accepted these guidelines as scientific support for validating that the 
establishment's HACCP system for these products and other RTE and NRTE 
meat and poultry products not covered by the regulations address 
Salmonella and Clostridial pathogens. Therefore, establishments may 
include the guidelines as supporting documentation for decisions in the 
hazard analysis and for validation (9 CFR 417.5(a)(1)) and 9 CFR 
417.4(a)), as well as supporting the selection and development of HACCP 
system controls (9 CFR 417.5(a)(2)). Establishments may choose to adopt 
different procedures than those outlined in the Appendix A and B 
guidelines, but they will need to provide scientific support 
demonstrating why those procedures are effective. Additional types of 
scientific or technical support can consist of other published 
processing guidelines, peer-reviewed scientific or technical data or 
information, expert advice from processing authorities (provided it 
does not rely on expert opinion alone), a challenge or inoculated pack 
study, results of validated pathogen modeling programs, data gathered 
by the

[[Page 71008]]

establishment in-plant, or other best practice guidelines.

Industry Use of the 2021 Guidelines

    Although FSIS accepts the use of these guidelines as validated 
support to achieve adequate lethality and stabilization in certain RTE 
and NRTE poultry products, an establishment's use of the guidelines 
does not exempt it from required ongoing establishment HACCP 
verification activities or expanded FSIS verification or required 
corrective actions should it produce adulterated products. 
Additionally, although an establishment may use the guidelines as 
scientific support for their decisions in developing a HACCP system, 
the establishment still must meet all the regulatory HACCP 
requirements, including those for validation. Therefore, if they use 
the guidelines as scientific support, the establishment needs to follow 
the critical operational parameters in the guidelines applicable to the 
product they are producing and the process they are following.
    FSIS first revised the 1999 guidelines in 2017 and has again 
revised them to clarify requirements, provide new options to meet the 
lethality and stabilization requirements, and to address gaps in the 
scientific knowledge or newly recognized risks. If an establishment has 
been using previous versions of this guidance in support of its 
lethality or stabilization controls, the establishment should review 
the revisions to the guidance and make any adjustments to its HACCP 
system necessary to continue producing safe meat and poultry products. 
Because use of the guidance is voluntary, an establishment can always 
opt to use alternative sources of scientific support for its lethality 
and stabilization controls.
    As stated above, on December 14, 2022, FSIS will verify whether 
establishments that had been using the 1999 and 2017 versions of 
Appendix A and B are instead using the 2021 versions of the guidance or 
have identified alternative scientific support for their cooking and 
stabilization processes, making changes to their HACCP systems as 
needed. At this time, FSIS will consider the older versions of the 
guidance no longer adequate scientific support for HACCP systems 
because they are out of date. Inspection program personnel (IPP) will 
verify establishments are no longer using the 1999 and 2017 versions 
during performance of the next Hazard Analysis Verification (HAV) Task 
after December 14, 2022. If IPP have concerns about a technical aspect 
of the documentation, an Enforcement Investigation and Analysis Officer 
(EIAO) may be assigned to review the scientific support. EIAOs will 
also verify that establishments are maintaining adequate scientific 
support for the design of their HACCP systems during the performance of 
Food Safety Assessments (FSAs). If an establishment continues to use a 
rescinded version of the guidance, FSIS will determine whether the 
establishment has additional supporting documentation that sufficiently 
supports its decisions concerning the controls in its HACCP system, as 
well as the HACCP system in operation. In some cases, an establishment 
may be using portions of the rescinded guidelines that have not changed 
that continue to be adequate for achieving lethality or stabilization 
in the products in question.

Processes Not Covered by the Guidelines and Scientific Gaps

    Many of the critical operating parameters in these guidelines were 
originally published as regulatory requirements in the 1980s, then 
removed from the regulations and revised as guidance in 1999. The 
original research used to support these critical operating parameters 
was performed for only a few processed meat and poultry products and 
was not designed as support for all products and processes. However, 
FSIS has found that establishments have been broadly applying the 
critical operating parameters in the guidelines to many products, 
beyond those they were originally designed to support.
    FSIS has determined that the critical operating parameters in the 
guidelines should not be used as support for some products and 
processes, because research or outbreaks demonstrate they are 
insufficient to result in a safe product or because the guidelines were 
never intended to cover those products (e.g., Fish of the Order 
Siluriformes). These excluded processes are now clearly identified at 
the beginning of each document as ``Products and Processes Not Covered 
by the Guideline.'' For example, FSIS learned through an investigation 
of a 2018 listeriosis outbreak (Recall 084-2018; \1\ CDC: Outbreak of 
Listeria Infections Linked to Deli Ham) \2\ that an establishment was 
cooking country-cured hams in a sealed bag multiple times using 
Appendix A as support for each cooking step. Before being cooked 
multiple times, the ham was salt-cured and dried, thus lowering its 
water activity. The draining of juices may have resulted in drier 
conditions during cooking. The establishment used Appendix A as 
scientific support that the cooking process achieved lethality of 
pathogens, including L. monocytogenes. However, Appendix A guidance was 
not intended for lower water activity products cooked under dry 
conditions or for products cooked multiple times. L. monocytogenes may 
survive cooking under these conditions. Hence, the process may not have 
been lethal to L. monocytogenes.
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    \1\ See: https://www.fsis.usda.gov/recalls-alerts/johnston-county-hams-recalls-ready-eat-ham-products-due-possible-listeria.
    \2\ See: https://www.cdc.gov/listeria/outbreaks/countryham-10-18/index.html.
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    FSIS has stated in the revised Appendix A that the guidance does 
not cover dried products cooked under dry conditions, because of the 
food safety concern. Other products that FSIS has determined should not 
be processed using the critical operating parameters in the Cooking 
Guideline/Revised Appendix A include: Fish of the Order Siluriformes 
(e.g., catfish); pork rind pellets, rendered lard and tallow; partially 
heat-treated not ready-to-eat products; and ready-to-eat products that 
rely on multi-hurdle processes other than cooking such as fermentation, 
salt-curing, or drying to achieve lethality. FSIS has included a 
reference to alternative support establishments may use for many of the 
processes not covered by the guidelines.
    In addition to products clearly not covered by the guidelines, FSIS 
has identified several common cooking and stabilization processes for 
which establishments have used Appendix A and B as support, even though 
these processes cannot achieve the critical operating parameters 
included in the revised guidelines. Therefore, there is insufficient 
evidence showing any imminent food safety concern resulting from the 
continued application of the older recommendations to these processes. 
For example, during the 2018 listeriosis investigation discussed above, 
FSIS determined there were establishments cooking salt-cured and dried 
country cured hams once in the bag without draining the juices. FSIS 
believes the juices in the bag provide sufficient moisture to rehydrate 
the surface of the hams and achieve sufficient lethality of pathogens, 
but there is no research to support this. In addition, FSIS is not 
aware of Salmonella or Lm positives or illnesses associated with 
establishments that use such processes. Therefore, the use of the 
guidelines for these processes are considered by FSIS to be 
``scientific gaps.'' A complete list of the scientific gaps FSIS has 
identified for each

[[Page 71009]]

guideline is included in the Summarized List of Changes below.
    FSIS is working to fill relevant gaps in the scientific support for 
these processes and will update the guidelines as data become 
available. Until such research is complete, an establishment producing 
products using processes that fall under an identified scientific gap 
may continue to use the critical operating parameters from older 
versions of FSIS guidelines that have been included in the revisions. 
However, the establishment should be aware of a few concerns FSIS has 
with doing this:
     Use of these critical operating parameters represents a 
vulnerability because these processes have not been validated to 
address all hazards of concern.
     If a process deviation occurs for a process that is listed 
as a scientific gap, it is unlikely an establishment would be able to 
identify adequate support for product safety without performing product 
testing.
     If FSIS or the establishment collects a RTE product sample 
that is positive for a pathogen or the product is implicated in a food 
safety investigation (i.e., is associated with reports of illness or 
outbreak), FSIS would verify, as part of the corrective actions (9 CFR 
417.3(b)), that the establishment can demonstrate that inadequate 
lethality or stabilization was not the root cause of the positive 
sample or the confirmed illness or outbreak, which it would need to do 
if it wants to continue to use the older recommendation.

Summarized List of Major Changes to the Guidelines

    FSIS made the following changes from the 2017 to the 2021 versions 
of the guidance.
    For Appendix A, FSIS made changes to specify:
     The following products are not covered by the guideline: 
Fish of the Order Siluriformes, pork rind pellets, rendered lard and 
tallow, dried products processed under dry conditions, partially heat-
treated NRTE products, and RTE multi-hurdle products.
     The food safety significance of FSIS's recommendations for 
relative humidity.
     That relative humidity should be addressed for all cooked 
products (including poultry) unless the establishment can support that 
humidity does not need to be addressed. FSIS has not changed the 
relative humidity options other than re-emphasizing that they apply to 
all products.
     Additional resources for selecting a relative humidity 
option when following FSIS's cooking guidance.
     The situations when relative humidity does not need to be 
addressed, including by providing more information about situations 
considered to be direct heating (e.g., by clarifying that relative 
humidity does not need to be addressed for meat patties cooked using 
FSIS's time-temperature table for meat, if the patties are cooked using 
direct heat). Previous guidance indicated it did not need to be 
addressed for meat patties with the assumption all meat patties are 
cooked using direct heat, which is no longer the case.
     That natural casings become semipermeable during cooking, 
maintaining moisture in the product, so that additional documentation 
to address relative humidity is not needed.
     More detailed information for evaluating product safety 
following a heating deviation. The revision also removes the 
recommendation for using the ComBase model for S. aureus growth (which 
was not validated) because of the development and validation of the 
DMRI Staphtox model in 2018.
     Where gaps exist, recommendations from its older cooking 
guidance can be used until research is completed for:
    1. Products cooked for short times at high temperatures.
    2. Products cooked using microwave cooking methods that are not 
designed to control relative humidity.
    3. Products cooked using cooking methods that are not designed to 
control relative humidity.
    4. Other processes that may inherently maintain relative humidity 
around the meat and poultry filling but cannot follow one of the 
relative humidity options.
    5. Processes where the drying step comes before cooking under moist 
conditions.
    6. Products with long heating come-up-times (CUTs).
     That information about a listeriosis outbreak associated 
with a cooked country-cured ham product and recommendations for 
establishments that cook a similar product.
    For Appendix A, FSIS removed:
     Information about how establishments could remove poultry 
rolls from the cooking medium before product has achieved the target 
endpoint temperature and immediately apply another heating or 
processing method. Since FSIS has clarified that limiting heating CUT 
is a critical operating parameter for applying any of FSIS cooking 
guidance (including these older options), the parameter to 
``immediately fully cook'' poultry rolls subject to multiple heating 
mediums and processes has been removed.
     Specific recommendations for conducting a Salmonella 
baseline study on raw source materials as support for using cooking 
critical operating parameters that achieve a 5-Log reduction in 
Salmonella for meat products instead of a 6.5 or 7-Log reduction. This 
information was removed since it was interpreted to apply to all 
establishments when it was only intended for establishments that wanted 
to support a lower level of pathogen reduction from cooking. In 
addition, FSIS is not aware of any establishments that have pursued 
such baseline sampling.
    For Appendix B, FSIS included the following changes and additional 
information:
     Cooling options for products that are cooked to lethality 
(both RTE and NRTE) are now included in a table (Table 1) and 
incorporate the previous options, 1, 2, 3 and 4 as options 1.1, 1.2, 
1.3 and 1.4.
     Cooling options for both RTE and NRTE products that are 
cooked to lethality are included in Table 1.
     Cooling options for partially cooked products are included 
in a separate table and include former Option 1 as Option 2.1 (Table 
2).
     Tables 1 and 2 list the critical operating parameters for 
each option.
     One additional option for partially cooked products, 
Option 2.2.
     That cooling in stage 1 of Option 1.2 from 120 to 80 
[deg]F should occur in <= 1 hour.
     That the heating come-up-time (CUT) in Option 2.1 for 
partially cooked products should be limited to <= 1 hour between 50 and 
130 [deg]F. FSIS extended the CUT up to 3 hours in Option 2.2 for 
partially cooked products, if the product meets the critical operating 
parameters for concentrations of salt, nitrite, and a cure accelerator 
sufficient for purpose.
     New Options 1.5-1.8 that provide additional cooling time 
during the first stage of cooling.
     That to use Option 1.3, establishments should incorporate 
at least 250 ppm sodium erythorbate or ascorbate, along with at least 
100 ppm ingoing sodium nitrite (either from a purified or natural 
source such as celery powder).
     That natural sources of nitrite and ascorbate should not 
be mixed with purified or synthetic sources.
     FSIS removed the recommendation to cool from 120 to 80 
[deg]F in 2 hours in Option 1.4 and replaced it with the critical 
operating parameter that the

[[Page 71010]]

process cause a continuous drop in product temperature.
     To support all the cooling options, additional research 
and modeling results using up-to-date validated cooling models are 
included in Attachment B3, FSIS's Predictive Microbial Modeling Support 
for 1-Log Cooling Options.
     To support common bacon and scrapple processes, FSIS 
updated references to research in Attachment B8, Using Journal Articles 
to Support Alternative Stabilization or Cooling Procedures to address 
comments requesting support for these processes.
     Practical recommendations for improving product cooling in 
Attachment B4, Steps an Establishment Can Take to Cool Products More 
Rapidly.
     Where gaps exist, recommendations from its older cooling 
guidance can be used until research is completed for:
    1. Large mass non-intact products that cannot cool quickly enough 
to follow the new options in Table 1.
    2. Partially heat-treated, smoked products that contain nitrite and 
erythorbate or ascorbate and have long heating come-up and cooling 
times and cannot follow the options in Table 2.
    3. Smoked bacon, that contains nitrite and erythorbate/ascorbate 
that cannot use Option 1.3 because lethal time and temperature 
combination is achieved but relative humidity is not addressed.
    4. Immersion or dry-cured products that contain nitrite and use 
equilibration time instead of erythorbate or ascorbate but cannot meet 
cooling options without nitrite in Table 1 (for products cooked to full 
lethality) or Table 2 (for products not cooked to full lethality).
    5. Products that contain nitrite and use equilibration time instead 
of erythorbate or ascorbate, but do not have a brine concentration of 
>= 6% to meet Option 1.4.
    6. Scalded offal that cannot cool quickly enough to follow the new 
options in Table 2.
    For Appendix B, FSIS removed:
     Specific recommendations for obtaining a waiver to permit 
2-Log growth of C. perfringens during cooling. This information was 
removed since it was interpreted to apply to all establishments when it 
was only intended for establishments that wanted to support a lower 
level of spores in their source product. In addition, FSIS has not 
received any waiver requests, but establishments may request a waiver 
in the future (9 CFR 303.1(h) and 9 CFR 381.3(b)).
    In addition to these specific changes, FSIS reorganized both 
Appendix A and B for clarity. Both guidelines are organized to provide 
establishments with an overview of topics related to the safe cooking 
and cooling of meat and poultry products in the main body of each 
document, with additional details about each topic included in 
attachments. To use the guidelines, FSIS recommends that establishments 
first read the overview of each of the topic areas and then consult 
relevant attachments if more detail is needed.
    The guidelines also are organized so that the main body contains 
critical operating parameters that establishments may choose to use as 
scientific support for their cooking and cooling processes. Additional 
recommendations, including some alternative options, are provided in 
the attachments. The information provided in the attachments is not 
sufficient to use as sole support. Establishments must provide 
additional documentation. For example, both Appendix A and B include 
attachments that summarize alternative support, such as journal 
articles for lethality and stabilization. However, the summaries are 
not adequate scientific support for validation on their own, because 
they do not contain the details of each study. Therefore, 
establishments that choose to use a journal article cited in the 
guidelines as their scientific support must have the full copy of the 
article on file to support decisions in the HACCP System. These changes 
were made so that establishments could more easily find FSIS's cooking 
and cooling recommendations, while also having access to other options 
and details, if needed.

Comments and FSIS Responses

    FSIS received 52 comments and over 250 askFSIS questions on the 
2017 revisions to Appendix A and B from individuals, establishments, 
trade groups, FSIS personnel, academics, a State government, a food 
safety consultant, and a food technology consultant. Following is a 
summary of the issues raised in the comments and FSIS's responses.

General Appendix A and B

    Comment: One individual asked if the 1999 versions of Appendix A 
and B will still be acceptable support for existing HACCP plans and 
requested more information be provided as to why or why not.
    Response: As discussed above, FSIS has rescinded the 1999 and 2017 
versions of Appendix A and B. These versions are no longer available on 
the FSIS website. FSIS will verify, one year from the date of this 
issuance, whether establishments using the guidelines as scientific 
support are using the updated 2021 version. One of the reasons FSIS 
updated the 1999 versions of Appendices A and B was because some of the 
content was out-of-date and could no longer be supported by scientific 
information. In addition, some of the recommendations were vague and 
put establishments at risk of producing unsafe product. FSIS had 
provided clarifications to the recommendations in other documents, but 
all establishments may not have been aware of this information.
    FSIS has incorporated the still valid information from the 1999 
guidance into the 2021 version. Therefore, if an establishment is 
following one of the parts of the 1999 guidance that did not change, 
and it is still supported by the 2021 version, it can continue to use 
the new guidance as scientific support and will not need to make 
changes to its HACCP system or gather new initial in-plant validation 
data (Element 2 to meet validation requirements), because the critical 
operational parameters of its process have not changed. However, in 
some cases, establishments will need to make changes to their HACCP 
system and gather initial validation data, because the critical 
operational parameters of their process will need to change.
    For example, if the establishment is following Option 2 of Appendix 
B and had not been monitoring the time product dwelled between 120 to 
80 [deg]F to meet validation requirements, the establishment would 
need, at a minimum, to gather initial validation data to demonstrate 
that the product could cool between 120 to 80 [deg]F in an hour or 
less. To meet HACCP plan and verification requirements (including in-
plant validation requirements), the establishment should also 
incorporate these parameters into the critical limits of its Critical 
Control Point (CCP) and gather data to support that these parameters 
can continue to be met on an ongoing basis. The one exception is for 
establishments producing large mass non-intact product greater than 4.5 
inches in size or greater than 8 pounds where FSIS has identified a 
scientific gap. For these processes, establishments can continue to 
follow the critical operational parameters FSIS has incorporated from 
the older guidance into the 2021 versions (cooling occurs from 120 to 
55 [deg]F in 6 hours or less and chilling is continuous to 40 [deg]F) 
until additional research is complete.
    Comment: One individual requested that FSIS address the difference 
between guidance and requirements.
    Response: As is stated in the ``Purpose'' sections of the guidance,

[[Page 71011]]

guidance provides best practices establishments can use to produce safe 
food under FSIS regulations. The guidelines do not represent 
requirements that must be met. FSIS has also changed the titles of the 
documents to remove the word ``compliance'' to better indicate that the 
document provides recommendations and validated options, not 
requirements. Therefore, establishments are required to maintain 
scientific support for their HACCP systems. If establishments use the 
guidelines as their scientific support, they need to ensure they follow 
the applicable critical operating parameters in the guidelines.
    Comment: One food safety consultant indicated that the introduction 
should more clearly state what has changed in the revised guidance.
    Response: FSIS has added sections to both documents that summarize 
the changes.

Insufficient Support

    Comment: Comments from eight establishments and a State government 
argue that there is no need for the updated guidelines, as they have 
been operating without problems using the current guidelines. Two of 
these commenters stated that they have been through FSAs with no 
problems. These commenters questioned the need for the updated 
guidelines, considering that there have been few Salmonella outbreaks 
in fully cooked, ready-to-eat meat products.
    Response: As noted above, some of the guidance was outdated and no 
longer provided adequate scientific support for establishments' HACCP 
systems, although establishments have continued to use the guidance as 
scientific support to validate their HACCP systems.
    While it is true that some establishments may have had Food Safety 
Assessments in the past where no issues were found, FSIS determined 
that there may have also been confusion among FSIS EIAOs in determining 
whether establishments were following the recommendations in the 
guidelines. Therefore, FSIS will be providing updated instructions to 
IPP and EIAOs for verifying cooking and stabilization processes at 
establishments producing fully cooked and heat-treated products.
    FSIS has determined that some small and very small establishments 
may not have been applying the recommendations from the 1999 versions 
of the guidelines correctly. Consequently, some products may not have 
been produced in a manner consistent with these original safe harbor 
recommendations. For example, as discussed above, during an 
investigation of a listeriosis outbreak in 2018 that was associated 
with cooked country-cured ham product, FSIS determined the 
establishment applied FSIS Appendix A as support for a cooking step 
when the guidance was not designed for processes where the drying step 
comes before the cooking step (Recall 084-2018; \3\ CDC: Outbreak of 
Listeria Infections Linked to Deli Ham).\4\ FSIS also determined 
through its verification activities that numerous establishments 
following Option 2 in the 1999 version of Appendix B (now Option 1.2) 
were taking two to four hours to cool their product between 120 to 80 
[deg]F. The 1999 version of Appendix B stated that when processes took 
longer than one hour between 120 to 80 [deg]F, ``compliance with the 
performance standard was less certain.'' However, when pathogen 
modeling was performed, processes taking two to four hours to cool 
their product between 120 to 80 [deg]F routinely were found to exceed 
the recommended performance standard of 1-log growth of C. perfringens. 
There has been one outbreak associated with C. perfringens from a 
commercially produced RTE turkey loaf product, the type of product that 
can take an extended time to cool between 120 to 80 [deg]F due to its 
size.\5\ FSIS has updated the guidance to decrease risks of future 
outbreaks associated with these products.
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    \3\ See: https://www.fsis.usda.gov/recalls-alerts/johnston-county-hams-recalls-ready-eat-ham-products-due-possible-listeria.
    \4\ See: https://www.cdc.gov/listeria/outbreaks/countryham-10-18/index.html.
    \5\ Centers for Disease Control and Prevention (CDC). 2000. 
Surveillance of Foodborne-Disease outbreaks--United States, 1993-
1997. Morbidity and Mortality Weekly Report, CDC Surveillance 
Summaries, March 17, 2000. MMWR 49, No. SS-1. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/ss4901a1.htm; personal 
communication, R.F. Woron, N.Y. State Department of Health, August 
2002.
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    Comment: Comments from several establishments and a trade group 
expressed concern that issuing the new guidelines will cause economic 
strain on establishments. Some of the commenters claimed that the 
updated guidelines will cause slaughterhouses to close, increase tax 
burdens, raise unemployment, limit customer choice, reduce the quality 
of products, limit organic and artisanal foods, and harm business 
growth.
    Response: FSIS recognizes the concerns about the economic impact of 
the revisions to its guidance. Some establishments might need to gather 
additional support for lethality and stabilization procedures because 
the guidance did not provide adequate scientific support for their 
processes. In addition, small and very small establishments often do 
not have the resources to perform challenge studies or develop 
additional support on their own. In response to comments on the 2017 
version of the guidelines, FSIS has identified research needs related 
to common procedures and is providing its best recommendations in the 
updated versions of these guidelines, so that establishments may be 
able to attain product safety using the recommendations in the 2021 
version and maintain scientific support for their HACCP systems, while 
scientific gaps are being filled. The Agency continues to work with 
researchers and, once additional research is completed, will provide 
further guidance for those common products with known gaps to assist 
small and very small establishments that do not have the technical 
resources to develop the support on their own.
    Comment: A food safety consultant questioned how FSIS came up with 
the recommendation for 500 samples in Appendix A and B and how it 
applies to small establishments. The commenter also indicated such 
sampling would be excessively expensive for small establishments.
    Response: FSIS removed from Appendix A specific recommendations for 
conducting a Salmonella baseline study on raw source materials as 
support for using cooking critical operating parameters that achieve a 
5-Log reduction in Salmonella for meat products instead of a 6.5 or 7-
Log reduction. In addition, FSIS removed from Appendix B specific 
recommendations for obtaining a waiver to permit 2-Log growth of C. 
perfringens during cooling including by conducting baseline sampling.

Appendix A Comments

FSA Analysis

    Comment: One food safety consultant questioned whether the FSA 
review (from the section titled ``Lessons Learned from RTE Salmonella 
Food Safety Assessments (FSAs)'' in the 2017 guideline) was 
statistically based, since it included only 16 FSAs out of thousands. 
The commenter also questioned whether any of the FSAs reviewed had 
insufficient lethality issues since insufficient lethality was not 
identified in the summary data.
    Response: For the 2017 revision of the guideline, FSIS reviewed a 
large portion (64%) of FSAs that occurred in response to Salmonella-
positives in RTE product during 2009-2014. As stated on page 6 of the 
2017 guideline, there were 25

[[Page 71012]]

positive results for Salmonella during that time. FSIS reviewed 16 of 
the FSAs that were performed in response to the positive results, which 
represented over half of the FSAs and was the number that was available 
for analysis. The goal of the analysis was to identify practices that 
may have been contributing factors to Salmonella contamination of RTE 
products. To look for trends, FSIS categorized practices into broad 
categories such as sanitation issues, HACCP issues, and cross-
contamination issues. Some of the HACCP issues identified included 
inadequate recordkeeping and lack of validation, which may have 
contributed to insufficient lethality. The number reviewed were 
sufficient for purposes of developing the guidance.

6-Hour Come-Up-Time

    Comment: A food safety consultant asked for support for the heating 
come-up-time recommendation and associated illnesses.
    Response: FSIS recommends that the heating come-up-time be limited 
to 6 hours or less between 50 to 130 [deg]F primarily to limit 
outgrowth of Staphylococcus aureus (S. aureus), which could grow to 
high levels and produce a heat-stable enterotoxin that would not be 
destroyed by the cooking step. The six-hour heating come-up-time is 
supported by pathogen modeling using USDA Agricultural Research Service 
(ARS) Pathogen Modeling Program and the Therm 2.0 modeling tool. FSIS 
clarified in the 2021 revision that the six-hour time applies to the 
time the product is between 50 to 130 [deg]F, so the total amount of 
time for product to reach an endpoint time-temperature may be longer. 
The University of Wisconsin also has conducted related research for 
hams but involving the use of antimicrobials in the formulation of the 
product. FSIS has included a reference to this research in the 
revision.
    FSIS is aware that establishments preparing some products (e.g., 
ham or beef brisket) may not be able to follow FSIS's recommendation 
that the heating come-up-time be limited to 6 hours or less between 50 
to 130 [deg]F because of the thermodynamics of the heating process. 
Therefore, FSIS identified long CUT as a Scientific Gap since support 
does not exist for many common processes and the Agency is not aware of 
an imminent public health concern. This gap supports the use of any of 
FSIS's applicable time-temperature combinations and relative humidity, 
without considering CUT as a critical operating parameter until 
research can be complete.
    Comment: Two trade groups indicated FSIS did not provide support 
for the statement that normal levels of S. aureus in meat are 2-log/
gram.
    Response: FSIS based its determination that normal levels of S. 
aureus in meat are 2-log/gram on results from several baseline studies 
conducted from 1994-1998 on market hogs, steers and heifers, cows and 
bulls, broilers, young turkeys, raw ground chicken, ground turkey, and 
ground beef. Additional studies that support that normal levels of S. 
aureus in meat being 2-log/gram include research by Waldroup (1996), 
the Institute of Food Technologists (2003), and Doyle and Buchanan 
(2013). FSIS recognizes that some of these citations use older data.
    The baseline studies used to determine that normal levels of S. 
aureus in meat include:

    1. Nationwide Pork Microbiological Baseline Data Collection 
Program: Market Hogs. June 1996;
    2. Nationwide Beef Microbiological Baseline Data Collection 
Program: Steers and Heifers. January 1994;
    3. Nationwide Beef Microbiological Baseline Data Collection 
Program: Cows and Bulls. February 1996;
    4. Nationwide Broiler Chicken Microbiological Baseline Data 
Collection Program. April 1996;
    5. Nationwide Young Turkey Microbiological Baseline Data 
Collection Program. August 1998;
    6. Nationwide Raw Ground Turkey Microbiological Survey. May 
1996;
    7. Nationwide Federal Plant Raw Ground Beef Microbiological 
Survey. April 1996;
    8. Nationwide Raw Ground Chicken Microbiological Survey. May 
1996;
    9. Doyle, M.P., and R.L. Buchanan (ed.). 2013. Food 
microbiology: Fundamentals and Frontiers--4th ed. ASM Press, 
Washington, DC.;
    10. Institute of Food Technologists (IFT). 2003. Evaluation and 
Definition of Potentially Hazardous Foods. Comprehensive Reviews in 
Food Science and Food Safety. Vol. 2 (Supplement, 2003).; and
    11. Waldroup, A.L. 1996. Contamination of raw poultry with 
pathogens. World's Poultry Science Journal. 52:7-25.

Poultry Time-Temperatures

    Comment: One individual asked if there is a holding time of 160 
[deg]F for cooked poultry rolls and other cooked poultry products (as 
recommended in the Poultry Time-Temperature tables that were 
incorporated into the 2017 Salmonella guideline and Revised Appendix A) 
or if an instantaneous temperature of 160 [deg]F (recommended final 
temperature from the 1999 version of Appendix A, incorporated into the 
2017 Salmonella guideline and revised Appendix A) would meet the 
performance standard to achieve a 7-log reduction in Salmonella 9 CFR 
381.150(a)(1). Also, FSIS has received many questions from FSIS 
personnel and establishments expressing confusion about whether 
temperatures in the Poultry Time-Temperature tables included in the 
2017 revision of the Salmonella Compliance Guideline and Revised 
Appendix A and that have a dwell time of <10 seconds are considered 
instantaneous temperatures.
    Response: The recommendation from the 1999 version of Appendix A to 
cook poultry rolls and other cooked poultry products to an 
instantaneous temperature of 160 [deg]F can be applied to any poultry 
product (not just cooked poultry rolls and breakfast strips). FSIS has 
maintained this option because there have not been any reports of 
illnesses or outbreaks tied to establishments that follow it. However, 
the options in the Poultry Time-Temperature Tables (which include dwell 
times at 160 [deg]F that vary based on species and fat content) have 
been validated with updated research to address species and fat content 
as critical operating parameters to ensure adequate Log reductions of 
Salmonella. Applying the cooked poultry rolls option (160 [deg]F 
instantaneous) may achieve the same Log reductions as the time-
temperature combinations in the Poultry Time-Temperature Tables, 
particularly when applied to a lean product, because the product may be 
maintained at 160 [deg]F for the recommended dwell times (between 13.7 
to 26.9 seconds depending on species and fat) during the time it takes 
to complete temperature monitoring. FSIS recommends establishments 
monitor the dwell time in the Poultry Time-Temperature Tables as 
opposed to relying on the older guidance for cooked poultry rolls (160 
[deg]F instantaneous) to better assure safety. If an establishment is 
using the older guidance for cooked poultry rolls (160 [deg]F 
instantaneous) and FSIS collects a RTE sample that is positive for 
Salmonella or if the establishment is implicated with a food safety 
investigation (i.e., is associated with reports of illness or outbreak, 
FSIS will review and determine the adequacy of the establishment's 
corrective actions (taken under 9 CFR 417.3) to address process 
deviations. The establishment will need to show FSIS that inadequate 
lethality was not the root cause of the process deviation if it wants 
to continue to follow the cooked poultry rolls option. FSIS continues 
to consider the temperatures in the Poultry Time-Temperature table with 
a dwell time of <10 seconds to be instantaneous. To reduce confusion 
and to be consistent with the time-temperature guidance for

[[Page 71013]]

meat products, FSIS has changed the dwell time to zero seconds to 
indicate those temperatures that are instantaneous.

Lethality Performance Standards and Recommendations

    Comment: A trade group, an establishment, and a food safety 
consultant questioned why the guidance recommends that establishments, 
including small and very small processors, identify the reduction of 
generic Salmonella in their process to address foodborne illness 
hazards. The commenters indicated that not all serotypes of Salmonella 
are known to cause illness and Salmonella is naturally occurring in 
poultry and swine. The commenters also mentioned that receiving a 
Salmonella-positive does not necessarily mean there is potential for 
human illness.
    Response: If FSIS finds viable pathogens of concern, including 
Salmonella, in any ready-to-eat product, FSIS considers that product to 
be adulterated. The Agency does not make a distinction among serotypes 
of Salmonella. As stated by the commenters, Salmonella is naturally 
occurring in raw products, such as poultry and swine. RTE meat and 
poultry products should not contain any Salmonella, because they have 
undergone a lethality treatment. As stated in the guideline, finding 
Salmonella in RTE products indicates that under-processing, cross-
contamination, or addition of contaminated ingredients after the 
lethality step may have occurred. Although FSIS has a low rate of 
Salmonella-positives in RTE products, Salmonella spp. are the second 
leading cause of foodborne illness in the United States, and meat and 
poultry products are often associated with outbreaks from Salmonella 
spp.6 7
---------------------------------------------------------------------------

    \6\ Scallan, E., Hoekstra, R.M., Angulo, F.J., Tauxe, R.V., 
Widdowson, M., Roy, S.L., Jones, J.L., and P.M. Griffin. 2011. 
Foodborne Illness Acquired in the United States--Major Pathogens. 
Emerging Infectious Diseases. 17(1): 7-15.
    \7\ Interagency Food Safety Analytics Collaboration. Foodborne 
illness source attribution estimates for 2016 for Salmonella, 
Escherichia coli O157, Listeria monocytogenes, and Campylobacter 
using multi-year outbreak surveillance data, United States. GA and 
DC: U.S. Department of Health and Human Services, CDC, FDA, USDA-
FSIS. 2018.
---------------------------------------------------------------------------

    Comment: A food safety consultant questioned the Agency's 
determination that a 5-log lethality would not be sufficient for all 
products, given pathogen levels in source materials, as stated in the 
guidance. The commenter recommended that FSIS take samples of raw 
source materials to determine appropriate performance standards for RTE 
product and recommended a 5-log lethality for all products types.
    Response: FSIS has established different pathogen reduction 
performance standards, both regulatory and recommended, for different 
products and processes, based on risk assessments. As stated in 
Appendix A, FSIS requires a 6.5-log reduction of Salmonella in cooked 
beef, corned beef, and roast beef per 9 CFR 318.17, and has recommended 
that establishments achieve at least a 6.5 log reduction of Salmonella 
in other cooked meat products. The requirements in 9 CFR 318.17 were 
promulgated based on the results of the 1998 Lethality and 
Stabilization Performance Standards for Certain Meat and Poultry 
Products: Technical Paper. FSIS also supports its recommendations for 
products that do not fall under a performance standard using the ``Risk 
Assessment of the Impact of Lethality Standards on Salmonellosis from 
RTE Meat and Poultry Products, 2005 (Salmonella Risk Assessment),'' \8\ 
which showed that a 5-log reduction of Salmonella (instead of a 6.5 log 
reduction) would result in a greater risk of illness in cooked meat 
products. The FSIS Salmonella Risk Assessment also found that there 
would not be a significant increase in the cases of salmonellosis if 
the processing of jerky and other shelf-stable products achieved a 5.0-
log instead of 7.0-log lethality. Therefore, FSIS recommends a 5.0-log 
reduction of Salmonella in meat and poultry jerky to ensure a safe 
product. In addition, FSIS has identified various options 
establishments may use to show that levels of Salmonella in product 
source materials are lower than those found in the FSIS baseline, 
justifying an alternative lethality other than those required or 
recommended.
---------------------------------------------------------------------------

    \8\ Risk Assessment of the Impact of Lethality Standards on 
Salmonellosis from Ready-to-Eat Meat and Poultry Products. 2005. 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC.
---------------------------------------------------------------------------

    Comment: Two trade groups recommended alternative lethality options 
should be clear in the text and not just a sidebar and that FSIS should 
clarify that the codified performance standard requirements allow for 
an alternative lethality.
    Response: FSIS has made the alternative lethality options clearer 
by moving them from the sidebar into the body of the text. The overview 
of the lethality requirements for specific RTE products in the guidance 
also states that the performance standards allow for an alternative 
lethality.

Ingredients Added Post-Lethality

    Comment: One establishment disagreed with recommendations in the 
guidance related to supporting ingredients added post-lethality are 
safe and not contaminated. Specifically, the commenter stated that if 
the ingredients are inspected, they are considered safe and there 
should be no need for further tests.
    Response: FSIS has identified that a common contributing factor to 
positive pathogen test results, recalls, and outbreaks has been the use 
of non-meat ingredients added post-lethality to ready-to-eat products. 
Some non-meat ingredients, such as frozen vegetables, are considered 
not ready-to-eat by the producing facility and, therefore, should not 
be added to a ready-to-eat product without support for the safety. FSIS 
verifies all ingredients and other articles used in the preparation of 
any meat or poultry product shall be clean, sound, healthful, wholesome 
and otherwise such as will not result in the product being adulterated 
(9 CFR 318.6 9 CFR 424.21). To verify that the non-amenable components 
will not adulterate the product, FSIS verifies that establishments have 
considered any potential food safety hazards at the step in the process 
where the non-meat ingredient is received into the food safety system 
and documents any controls it needs to support its decisions (9 CFR 
417.5(a)(1)) about those hazards.\9\ To provide this support, 
establishments have flexibility and do not have to only rely on 
testing. Alternatively, they can maintain other supporting 
documentation demonstrating that the ingredients, such as spices, have 
been treated by processes to kill pathogens (e.g., irradiation, 
ethylene dioxide, steam treatment of spices), or they can apply a 
lethality treatment to the ingredients (e.g., cook the sauce of a pork 
BBQ).
---------------------------------------------------------------------------

    \9\ FSIS Directive 7111.1--Verification Procedures for Lethality 
and Stabilization (usda.gov).
---------------------------------------------------------------------------

Casing Types

    Comment: Two trade groups questioned FSIS's decision to consider 
natural casings as permeable, therefore requiring humidity during 
cooking. One commenter recommended that FSIS define permeability based 
on water-holding capacity, which would result in natural casings being 
either semi-permeable or impermeable. Another commenter stated that 
both cellulose and natural casings are considered permeable.
    Response: Natural casings made from animal gastrointestinal tracts 
are typically considered permeable, and

[[Page 71014]]

many establishments take advantage of their permeability to produce 
dried products or smoked products. However, FSIS recognizes that the 
permeability of natural casings may be reduced depending on how they 
are used. Most cooking processes likely reduce the permeability of 
natural casings early in the process so that humidity around the 
product is inherently maintained throughout cooking and does not have 
to be added or monitored. According to Sebranek (2010),\10\ 
establishments often apply smoke early in the process while the natural 
casing is still moist and permeable to the smoke. Prior to smoke 
application, the casing surface should be ``tacky'' or ``sticky.'' 
After smoke deposition and color development, further cooking denatures 
the proteins in the casing, reducing permeability to the point that 
later cooking can be applied without great moisture loss from the 
product. However, most drying processes use lower temperatures and 
address relative humidity to maintain casing permeability so that 
moisture can evaporate. This information has been included in the 2021 
guidance. In addition, FSIS revised the 2021 guidance to indicate 
cooking product in any casing that holds moisture (e.g., natural 
casings, cellulose casings, collagen casings, fibrous casings and 
plastic casings (sometimes called ``synthetic'' casings)) is considered 
a situation when relative humidity does not need to be addressed.
---------------------------------------------------------------------------

    \10\ Sebranek (2010). Natural vs. Artificial Casings: Evaluating 
Which is Best for Your Product. Meatingplace.
---------------------------------------------------------------------------

    Although most cooking processes likely result in reduced 
permeability of natural casings early in the cooking process, little 
research has been performed to study the critical operational 
parameters that impact the reduction of permeability, such as the 
length of the initial smoke application step, cooking temperature, 
total cooking time, use of steam, size of casings, composition of 
sausage batter, etc. Therefore, without additional research, the log 
reduction of Salmonella is less certain if meat or poultry products in 
natural casings are cooked using one of the time-temperature parameters 
in Appendix A without following one of the humidity options. Therefore, 
FSIS has identified this issue as a research priority and, if 
additional data becomes available, FSIS may change the recommendation 
that establishments do not need to address relative humidity when 
products are cooked in a natural casing.

Relative Humidity

    Comment: FSIS has received several questions from FSIS personnel 
and establishments concerning the need for adding humidity to the 
process for all products covered in the cooking guideline. Several 
commenters stated that no Salmonella outbreaks have occurred recently, 
so the recommendation to apply relative humidity to all products is 
unfounded.
    Response: FSIS agrees that humidity does not always need to be 
added and identifies situations in the updated guidance where relative 
humidity does not need to be addressed. These situations have now been 
incorporated into the 2021 guidance. For example, establishments 
producing products that weigh 10 pounds or more that are cooked in an 
oven that is 250 [deg]F or higher, or products that are cooked-in-bag 
where moisture is inherently maintained, would not need to apply 
humidity. However, FSIS considers maintaining relative humidity to be 
an important critical operational parameter for many processes to 
achieve surface lethality of pathogens. In the 2021 version of Appendix 
A, the Agency summarizes additional approaches for achieving surface 
lethality of pathogens that establishments can use.
    In the 2017 and 2021 versions of Appendix A and in the FSIS 
Compliance Guideline for Meat and Poultry Jerky Produced by Small and 
Very Small Establishments, FSIS identified the two primary goals of 
relative humidity in the cooking environment. The first goal is to 
reduce surface evaporation and the energy or heat that evaporation 
removes during heating. The second goal is to keep the product surface 
(and any pathogens) moister and prevent unwanted concentration of 
solutes as a result of drying. As water is removed from a product 
because of surface evaporation, remaining solutes become more 
concentrated. As moisture evaporates from the surface, and the 
concentration of solutes increases, the water activity is reduced. 
Consequently, this leads to microbial heat tolerance, especially for 
Salmonella. In response to comments, FSIS has referenced additional 
articles that establishments can use to support their processes.
    Although outbreaks have not occurred recently from Salmonella in 
RTE products, several occurred in the late 1970s and early 1980s, prior 
to the implementation of FSIS's cooking recommendations. Following a 
series of salmonellosis outbreaks in beef in 1977, USDA published an 
emergency rule prescribing a minimum temperature of 145 [deg]F for 
cooked beef and roast beef. In response to comments from industry as 
well as research by Goodfellow and Brown (1978), USDA expanded the 
temperature and time regulations to allow for more combinations 
validated to achieve a 7-log reduction in Salmonella.\11\ At that time, 
the Agency also expanded the regulation to cooked corned beef based on 
Agency testing data and findings suggesting the potential for 
undercooking (47 FR 31856). Following these changes, several additional 
salmonellosis outbreaks were linked to the consumption of roast beef 
produced by four separate establishments in the northeastern United 
States. Epidemiologic investigations revealed that inadequate cooking 
times and temperatures were not the major contributing factors, and 
research at the time identified relative humidity as an important 
parameter during cooking. Outbreaks may have occurred because 
establishments were not adequately accounting for or applying humidity. 
Because of these outbreaks and the scientific research demonstrating 
that Salmonella may become tolerant to heat if low humidity is 
used,12 13 14 15 the guidance continues to recommend that 
establishments apply humidity during the cooking process.
---------------------------------------------------------------------------

    \11\ Goodfellow, S.J. and W.L. Brown. 1978. Fate of Salmonella 
Inoculated into Beef for Cooking. Journal of Food Protection. 
41:598-605.
    \12\ Goodfellow, S.J. and W.L. Brown. 1978. Fate of Salmonella 
Inoculated into Beef for Cooking. Journal of Food Protection. 
41:598-605.
    \13\ Carlson, T.R., Marks, B.P., Booren, A.M., Ryster, E.T., and 
A. Orta-Ramirez. 2005. Effect of Water Activity on Thermal 
Inactivation of Salmonella in Ground Turkey. Journal of Food 
Science: 70(7): 363-366.
    \14\ Goepfert, J.M., I.K. Iskander and C.H. Amundson. 1970. 
Relation of the heat resistance of salmonellae to the water activity 
of the environment. Appl. Microbiol. 19(3):429-33.
    \15\ Gruzdev, N., Pinto, R., and S. Sela. 2011. Effect of 
desiccation on tolerance of Salmonella enterica to multiple 
stresses. App Environ Microbiology 77 (5):1667.
---------------------------------------------------------------------------

    Comment: Six commenters, including a food technology consultant, 
academics, and establishments, questioned the older research used to 
develop Appendix A times/temperatures. Three commenters indicated 
research by Blankenship (1978) \16\ and Goodfellow and Brown (1978) 
should not be used as support for requiring humidity. The commenters 
argued that the paper identified surviving Salmonella on the surface 
and hypothesized that this was due to heat tolerance from drying but 
did not test the humidity options FSIS uses. One

[[Page 71015]]

commenter stated that there is a lack of current research data 
supporting the need for 90% relative humidity. The commenter also 
indicated 90% relative humidity is excessive, is not supported 
scientifically for Salmonella lethality, and cited an article by Mann 
and Brashears (2007) \17\ that supported less humidity.
---------------------------------------------------------------------------

    \16\ Blankenship, L.C., 1978. Survival of a Salmonella 
typhimurium experimental contaminant during cooking of beef roasts. 
Applied Environ Microbiol, 35(6):1160-1165.
    \17\ Mann, J.E. and Brashears, M.M. 2007. Contribution of 
Humidity to the Lethality of Surface-Attached Heat-Resistant 
Salmonella during the Thermal Processing of Cooked Ready-to-Eat 
Roast Beef. Journal of Food Protection (70): 3: 762-765.
---------------------------------------------------------------------------

    Response: New research regularly continues to support the 
underlying concepts found in the research studies used to develop the 
recommendations in Appendix A. FSIS agrees that the research by 
Blankenship and by Goodfellow and Brown hypothesized that Salmonella on 
the surface of the product became more heat tolerant than those in the 
interior of the product. However, their research demonstrated that 
adding steam to the cooking process resulted in no survival of 
Salmonella on the surface of the product, demonstrating the 
effectiveness of moist cooking. Newer research supports that 
dehydration of Salmonella induces tolerance to stressors, including dry 
heat. In addition, research by Boles et al. (2004) \18\ demonstrated 
that sealing the oven (closing dampers) for one hour at the beginning 
of the cooking process was more effective than opening the dampers. 
FSIS is not aware of other newer research supporting the relative 
humidity options; however, newer research has been performed that 
supports the cooking times and temperatures in Appendix A. Therefore, 
FSIS continues to cite the older articles that were used as a basis for 
these recommendations and is continuing to seek additional research to 
add to the relative humidity options.
---------------------------------------------------------------------------

    \18\ Boles, Neary, and Clawson. 2004. New intervention and 
validation for the control of pathogens in the processing of jerky. 
Report available at: https://www.fsis.usda.gov/sites/default/files/media_file/2021-08/C-11_New_Technology_FY2004_Final_Report.pdf.
---------------------------------------------------------------------------

    Specifically, Goodfellow and Brown's research showed greater 
survival of Salmonella inoculated on the surface of dry-roasted beef 
rounds than those in the interior. Research conducted by the 
Agricultural Research Service (ARS) and published by Blankenship in 
1978 and 1980 \19\ substantiated this finding. In response to several 
outbreaks and research findings, FSIS issued an interim final rule in 
1982 and finalized it in 1983 to address the handling, processing, 
cooling times and temperatures, and storage requirements necessary to 
ensure the wholesomeness of cooked roast beef. When the rule was 
finalized, FSIS added two options to the regulations for maintaining 
relative humidity that did not need to achieve 90% relative humidity 
for those products cooked to an internal temperature of 145 [deg]F or 
above. These options were to seal the oven or continuously introduce 
steam for 50% of the cooking time or one hour, whichever was longer. 
Although these exact options were not tested in the literature, FSIS 
used the research conducted by Goodfellow and Brown and Blankenship, 
along with expert opinion, to develop options that were practical and 
could be implemented by small and very small establishments. These 
options were designed to have a safety margin to ensure their 
effectiveness when applied to a wide variety of processes.
---------------------------------------------------------------------------

    \19\ Blankenship, L.C., Davis, C.E., and G.J. Magner. 1980. 
Cooking methods for elimination of Salmonella typhimurium 
experimental surface contaminant from rare dry-roasted beef roasts. 
Journal of Food Science. 45(2): 270-273.
---------------------------------------------------------------------------

    Newer research by McMinn et al. (2018) supports the time-
temperature parameters in Appendix A to achieve sufficient reductions 
of Salmonella.\20\ The research by McMinn et al. (2018) was conducted 
with product cooked in vacuum sealed bags, supporting the importance of 
cooking in a high moisture environment (that is 90% relative humidity). 
However, FSIS agrees 90% relative humidity is not needed in all cases. 
As stated previously, FSIS has provided additional relative humidity 
options for products cooked to an internal temperature of 145 [deg]F or 
above to include sealing the oven or introducing steam for 50% of the 
cooking time or one hour, whichever is longer. Research by Boles et al. 
(2004) supports the use of a sealed oven for maintaining relative 
humidity and other research does continue to support the importance of 
moisture during cooking. For example, research cited by commenters in 
Mann and Brashears (2007) supports the need for at least 30% relative 
humidity during cooking. This is consistent with the minimum amount of 
relative humidity the Agency believes is present when establishments 
seal the oven or introduce steam, based on FSIS's knowledge of 
establishments' processes, suggesting that these practical 
recommendations result in adequate relative humidity. The Agency is 
also not aware of any establishments that have had Salmonella-positives 
or been associated with a salmonellosis outbreak when following FSIS's 
temperature, time, and relative humidity guidance. Therefore, FSIS has 
updated the guidance to include a discussion of the research by Mann 
and Brashears (2007). The discussion outlines how the article supports 
the need for at least 30% relative humidity during cooking of roast 
beef, an amount the Agency believes is maintained when the oven is 
sealed, or steam is introduced suggesting these practical 
recommendations result in adequate humidity.
---------------------------------------------------------------------------

    \20\ McMinn, R.P., King, A.M., Milkowski, A.L., Hanson, R., 
Glass, K., and J.J. Sindelar. 2018. Processed Meat Thermal 
Processing Food Safety Generating D-Values for Salmonella, Listeria 
monocytogenes, and Escherichia coli. Meat and Muscle Biology. 2(1): 
168-179.
---------------------------------------------------------------------------

    Comment: A food technology consultant and an academic referenced 
scientific support for cooking recommendations other than those 
recommended in Appendix A. Specifically, the commenters referenced a 
study by Sindelar et al. (2016) \21\ supporting a wet-bulb time-
temperature combination that may be a suitable replacement for the 
relative humidity recommendations during smokehouse processing.
---------------------------------------------------------------------------

    \21\ Sindelar, J.J., Glass, K., and B. Hanson. 2016. 
Investigating the Development of Thermal Processing Tools to Improve 
the Safety of Ready-to-Eat Meat and Poultry products. NAMIF Final 
Report.
---------------------------------------------------------------------------

    Response: FSIS agrees with the commenters that the research 
conducted by Sindelar et al. (2016) contains scientifically-based 
thermal processing parameters to ensure sufficient reductions of 
Salmonella and other pathogens of concern during cooking. For this 
reason, this reference was included in the revised guideline as a 
journal article that may be used as alternative support. FSIS also 
generally agrees with the concept of a surface lethality step or 
surface lethality treatment that relies on wet-bulb temperature to 
demonstrate how lethality is being achieved on the surface. However, 
FSIS does not consider the research sufficient to support applying a 
single wet-bulb temperature as a replacement for the current relative 
humidity options because of the limited treatments studied.
    The research conducted by Sindelar (2016) provides scientific 
support for alternative processes including use of a wet-bulb 
temperature target. However, the researchers only evaluated reduction 
achieved for limited products under limited conditions. Therefore, 
establishments may choose to use this research as scientific support 
for their process, provided the critical operational parameters are met 
and the parameters chosen were ones that were tested in the laboratory 
to ensure

[[Page 71016]]

sufficient reductions of Salmonella based on the establishment's 
desired target. Critical operational parameters identified in the 
research include the product type, thermal process schedule (dry-bulb 
temperature, wet-bulb temperature, and time at each stage), and final 
internal product temperature and time.
    As stated above, FSIS is not replacing the time-temperature 
recommendations in Appendix A with those identified in the Sindelar 
research. FSIS's recommendations allow for temperatures ranging from 
130 to 160 [deg]F for meat and 136 to 165 [deg]F for poultry and apply 
to all types of products and thermal processing schedules, provided a 
relative humidity option can be met. Because the research conducted by 
Sindelar only applies to certain products and processes, it cannot be 
used by all establishments. In addition, the researchers were not able 
to achieve a 5-log reduction of Salmonella in chicken tenders even at 
the highest internal temperature tested of 175 [deg]F with a wet-bulb 
of 160 [deg]F. FSIS's relative humidity options in Appendix A applies 
to all meat and poultry products covered by the FSIS guidance. For 
these reasons, FSIS has added references to Sindelar's research to the 
guideline but has not used it to replace Appendix A humidity options.
    Comment: One food technology consultant stated that the options for 
products cooked in less than one hour are too restrictive and that a 
low relative humidity process may be more lethal if it has a higher 
wet-bulb, citing research by Buege et al. (2006).\22\ The commenter 
offered an alternative recommendation: Products cooked in less than one 
hour in a high temperature impingement or spiral oven must use a wet-
bulb temperature of 160 [deg]F or higher for the entire process.
---------------------------------------------------------------------------

    \22\ Buege, D.R., G. Searls, and S.C. Ingham. 2006. Lethality of 
commercial whole-muscle beef jerky manufacturing processes against 
Salmonella serovars and Escherichia coli O157:H7. Journal of Food 
Protection. 69: 2091-2099.
---------------------------------------------------------------------------

    Response: FSIS agrees that there may be other approaches for 
demonstrating that surface lethality is achieved for products that are 
cooked for less than one hour. However, the Agency does not believe 
that there is enough data at this time to identify one target wet-bulb 
temperature, due to the wide variety of products and processes that are 
addressed in Appendix A. The Agency also does not believe there is 
enough research at this time to apply FSIS' recommendations that rely 
on less than 90% relative humidity (that is sealing the oven or 
continuously introducing steam) to products that are cooked for less 
than one hour). The Agency is seeking more research related to this 
issue and will consider additional information as it becomes available.
    The relative humidity recommendations were originally intended to 
be options for cooking large mass products such as cooked beef (i.e., 
brisket), roast beef, and cooked corned beef. Cooking time for such 
large mass products typically exceeds one hour, so FSIS's relative 
humidity recommendations were intended to be applied for at least one 
hour or more. However, in response to a series of outbreaks associated 
with beef jerky, including a 2003 outbreak from Salmonella Kiambu, FSIS 
added its recommendation to apply 90% relative humidity throughout 
cooking for processes when the cooking time is one hour or less in the 
2007 Compliance Guideline for Meat and Poultry Jerky Produced by Small 
and Very Small Establishments (updated in 2014)as well as the revised 
Appendix A. FSIS added this recommendation because one potential cause 
of the 2003 Salmonella Kiambu outbreak in jerky was the very slow 
drying process under low humidity conditions (1% Relative Humidity--82 
[deg]C dry-bulb, 30 [deg]C wet-bulb), which allowed Salmonella 
organisms to dehydrate during drying and become tolerant to heat.
    FSIS recognizes that over time, many journal articles have been 
published increasing the scientific understanding of the critical role 
of certain parameters during jerky processing, including relative 
humidity. FSIS also recognizes that many of these articles, including 
that by Buege et al. (2006), support the use of less than 90% relative 
humidity, and the Agency does not object to establishments using these 
articles as scientific support, provided the critical operational 
parameters match the actual process being used. FSIS has included 
several articles establishments may use as scientific support for less 
than 90% humidity in the revised guideline. FSIS did not add the 
specific recommendation for use of wet-bulb to measure the temperature 
of products cooked for less than one hour in a high temperature 
impingement or spiral oven because, as explained earlier, FSIS does not 
believe there is enough information at this time to make a general 
recommendation that a single wet-bulb temperature can be used in 
addition to or in place of its relative humidity options.
    Comment: A food technology consultant stated that the citations 
used by the Agency did not establish the premise that low humidity 
cooking of meats increases concentrations of salt and sugars and will 
lead to increased heat tolerance of pathogens. The commenter also 
contended that the Goepfert research cited by FSIS is of limited use to 
the meat industry because it was conducted with sugar-water solutions 
for the candy industry. The commenter recommended FSIS replace the 
citation with papers by Buege et al. (2006), Boles et al. (2004), and 
Sindelar et al. (2016).
    Response: FSIS agrees that these additional research citations 
support the importance of relative humidity and has added them to the 
revised guidance. In addition to these references, the increase in heat 
tolerance of microorganisms as water activity is reduced is well 
established in the literature.23 24 25 26 While FSIS 
referenced work by Geopfert that was performed with sugar solutions, 
the same findings have been found for meat and poultry products. For 
example, Carlson et al. (2005) found that thermal inactivation of 
Salmonella decreased 64% when decreasing meat water activity from 0.99 
to 0.95.
---------------------------------------------------------------------------

    \23\ Carlson, T.R., Marks, B.P., Booren, A.M., Ryster, E.T., and 
A. Orta-Ramirez. 2005. Effect of Water Activity on Thermal 
Inactivation of Salmonella in Ground Turkey. Journal of Food 
Science: 70(7): 363-366.
    \24\ Goepfert, J.M., I.K. Iskander and C.H. Amundson. 1970. 
Relation of the heat resistance of salmonellae to the water activity 
of the environment. Appl. Microbiol. 19(3):429-33.
    \25\ Blankenship, L.C. 1978. Survival of a Salmonella 
typhimurium experimental contaminant during cooking of beef roasts. 
Appl. Environ. Microbiol. 35:1160.
    \26\ Gruzdev, N., Pinto, R., and S. Sela. 2011. Effect of 
desiccation on tolerance of Salmonella enterica to multiple 
stresses. App Environ Microbiology 77 (5):1667.
---------------------------------------------------------------------------

    Comment: One establishment included a scientific paper by 
Carotenuto and Dell'Isola (1995),\27\ stating that the calibration of 
equipment for relative humidity is poor.
---------------------------------------------------------------------------

    \27\ Carotenuto, A. and Dell'Isola, M. 1995. An Experimental 
Verification of Saturated Salt Solution-Based Humidity Fixed Points. 
International Journal of Thermophysics: 17(6): 1423-1439.
---------------------------------------------------------------------------

    Response: Accurate measurement is critical to ensuring that safe 
products are produced under the critical operational parameters of an 
establishment's HACCP system. Calibration also is important in 
maintaining accuracy over time. Often the owner's manual for humidity 
recorders recommends calibration on an annual basis, and FSIS 
recommends that establishments should follow the manual's instructions 
for calibration. Frequent calibration is the only way to know the 
humidity sensor is accurate. Concerns about lack of calibration have 
contributed to process deviations and recalls in the past. Frequent 
calibration

[[Page 71017]]

and following equipment manufacturer instructions should address any 
concerns about inadequate calibration of equipment for relative 
humidity.

Appendix B Comments

Stabilization Performance Standards and Recommendations

    Comment: Two industry groups contended that parts of the guideline 
were inconsistent, because the Agency stated in some sections that ``no 
growth'' of Clostridium botulinum is acceptable, while other sections 
state that ``net growth <= 0.30'' is acceptable. The commenters 
requested that this aspect of the guideline be clarified.
    Response: The performance standard requirement is that there can be 
no multiplication of toxigenic microorganisms, such as Clostridium 
botulinum (9 CFR 318.17(2), 9 CFR 318.23(b)(3)(ii)(c), 9 CFR 
381.150(a)(2), 9 CFR 318.23(C)(1), and 9 CFR 381.150(b)). However, FSIS 
realizes that existing predictive models, such as the ARS C. botulinum 
in beef broth model, do not predict no (zero) growth. As a practical 
way to evaluate cooling deviations, the Agency has regarded a predicted 
growth of no more than 0.3 logs (an approximate doubling, or one 
generation) as an indication that there has been no growth. FSIS has 
clarified this in the guidance.

Cooling Options

Option 1

    Comment: Thirteen comments from producers, industry groups, a 
consultant, and an academic stated that validation options for 
partially-cooked products have unnecessarily been narrowed in Option 1. 
One commenter expressed concern with the recommendation that the come-
up-time be limited to one hour or less, as the come-up-time is longer 
for partially-cooked smoked sausages. Two commenters asked for 
clarification for what constitutes ``small diameter'' for the purposes 
of following Option 1 and asked for the definition of ``come-up-time.''
    Response: Option 1 was always intended to be the only option for 
partially-cooked products, but this was not clear in the 1999 version. 
Therefore, the Agency made this clarification in the 2021 version. When 
Option 1 was developed, it was primarily for partially-cooked products, 
such as patties and poultry breakfast strips, which have a short come-
up-time of one-hour or less. As establishments used the option for 
other types of partially-cooked products, the Agency determined that 
additional clarification was needed. In the 2021 version, the Agency 
has clarified that the come-up-time should be limited to temperatures 
between 50 to 130 [deg]F, to better define the recommendation. FSIS has 
also removed the mention of ``small diameter,'' since that is not a 
critical operational parameter that effects growth of spore-formers. In 
addition, FSIS has added an option that allows up to three hours come-
up-time between 50 to 130 [deg]F for products that contain at least 150 
ppm nitrite and at least two percent salt. This addition provides more 
time for partially-cooked smoked sausages. This option was designed 
using industry input provided through askFSIS. The Agency believes that 
this option will provide support for many partially-cooked smoked 
sausage processes. Finally, the Agency has provided additional 
information about research by Taormina and Bartholomew (2005) \28\ that 
supports a longer cooling time for partially-cooked smoked bacon.
---------------------------------------------------------------------------

    \28\ Taormina, P.J., and Bartholomew, G.W. 2005. Validation of 
Bacon Processing Conditions to Verify Control of Clostridium 
perfringens and Staphylococcus aureus. Journal of Food Protection. 
68(9): 1831-1839.
---------------------------------------------------------------------------

Option 2

    Comment: A producer and two industry groups requested that FSIS 
clarify why the recommendation in Option 2 to cool from 120 to 80 
[deg]F in one hour or less does not have to be monitored as part of a 
critical limit. The commenters cited a publicly posted askFSIS 
Knowledge Article (``Public Q&A''), that is no longer on FSIS's 
website, as support for this request. Comments from two large 
producers, a university, a small producer, and a food safety consultant 
stated that the recommendation to cool products from 120 to 80 [deg]F 
in one hour or less is too restrictive, too hard to meet for large-
diameter products, and would require new equipment for the product to 
cool fast enough.
    Response: FSIS incorporated the language that had been in the 
askFSIS Knowledge Article (``Public Q&A'') into the guideline. The 
language had been in a note in the 2017 version. To make the 
information clearer, FSIS has moved the text in front of the table 
along with other text that explains how to use FSIS Cooling Options. 
The language states, ``Establishments are not required to demonstrate 
that every lot of product is chilled between 120 [deg]F and 80 [deg]F 
within one hour, if data has been gathered during initial validation 
and as part of ongoing verification to support the critical operational 
parameters can be met.'' This language makes clear that establishments 
do not have to monitor these temperatures as a critical limit. FSIS 
recognizes that cooling large products from 120 to 80 [deg]F in one 
hour or less can be challenging.
    FSIS has added four new options to the 2021 revision to allow for 
more time cooling from 120 to 80 [deg]F. Two of the four cooling 
options consider the pH levels of products to allow even more time 
between 120 to 80 [deg]F. These options are all supported by two 
pathogen modeling programs validated for estimating the growth of 
Clostridium perfringens: (1) The ComBase Perfringens Predictor and the 
Smith-Schaffner Model; and (2) the ARS C. botulinum cooling model. FSIS 
has also identified a scientific gap for establishments producing large 
mass non-intact products greater than 4.5 inches in size or greater 
than 8 pounds that are unable to cool the products between 120 to 80 
[deg]F in one hour or less. For these products, establishments can 
continue to follow the critical operational parameters FSIS has 
incorporated from the older guidance into the 2021 versions (cooling 
occurs from 120 to 55 [deg]F in 6 hours or less and chilling is 
continuous to 40 [deg]F) until additional research is complete.
    Comment: A large producer questioned the use of the article by Ohye 
and Scott (1957) \29\ as support for Option 2, because type E C. 
botulinum, which is a psychotroph and prefers low temperatures for 
growth, is not a microorganism of concern in meat; and is not a 
surrogate for C. perfringens. The producer also questioned whether the 
research supported the guidance because it was not conducted on meat.
---------------------------------------------------------------------------

    \29\ Ohye, D.F. and Scott, W.J. 1957. Studies in the physiology 
of Clostridium botulinum type E. Aust. L. Biol. Sci. 10:85-94.
---------------------------------------------------------------------------

    Response: Option 2 of FSIS Appendix B originated from former 
regulatory requirements promulgated in the 1983 Final Rule, 
``Production Requirements for Cooked Beef, Roast Beef, and Cooked 
Corned Beef'' (48 FR 24314, June 1, 1983). At that time, the primary 
hazard of concern identified by the Agency was C. botulinum. For this 
reason, research by Ohye and Scott (1957) was used as the scientific 
basis of the original recommendation to cool product from 120 to 55 
[deg]F in six hours. However, when Appendix B was developed in 1999, 
the Agency became more aware of the importance of also considering C. 
perfringens growth. Using available research at the time and expert 
opinion, FSIS added the recommendation that establishments consider the 
cooling time between 120 to 80 [deg]F, since C. perfringens grows 
faster than C. botulinum. The 1999 guidance was

[[Page 71018]]

vague in terms of a recommended timeframe, so FSIS added a more 
specific time-frame recommendation to the 2017 revision. The 
recommendation in the 2017 version of Appendix B has been carried over 
into the 2021 version and confirmed using the following up-to-date 
pathogen modeling programs: The ComBase Perfringens Predictor and the 
Smith-Schaffner Model to confirm predicted C. Perfringens outgrowth; 
and the ARS C. botulinum cooling model to confirm predicted C. 
botulinum outgrowth. FSIS has added these additional modeling 
references to the 2021 version.
    Comment: A small producer recommended that the first part of Option 
2 (cooling from 120 to 80 [deg]F in one hour or less) be based on 
surface temperature instead of the internal temperature of the product. 
Additionally, another small establishment requested that the 
recommendation under Option 4 to cool a cured product's internal 
temperature from 120 to 80 [deg]F in two hours or less be applied to 
surface temperature. The commenters argued that these recommendations 
would be consistent with the original recommendation in FSIS Directive 
7110.3 (cancelled by FSIS Directive 7111.1) for slow cooling for some 
cured products (now Option 4), which allowed for monitoring of the 
surface temperature for the first stage of cooling (cooling from 120 to 
80 [deg]F in two hours or less).
    Response: FSIS agrees that for intact products, it is possible to 
monitor the surface temperature of a product to demonstrate that the 
critical operational parameters of Appendix B are met. It would not be 
appropriate to use this approach for non-intact products, since 
pathogens may be internalized and it is important to control the 
internal temperature, as well as the surface temperature. In response 
to comments, FSIS has removed the recommendation to monitor the time 
between 120 to 80 [deg]F from Option 4. The original recommendation in 
FSIS Directive 7110.3 cancelled by FSIS Directive 7111.1) contained an 
option to control the product's surface temperature so that it would 
not stay between 120 to 80 [deg]F for more than two hours or to cause 
``a continuous drop in product temperature.'' However, FSIS has 
determined that the original recommendation was made based on 
controlling S. aureus growth, assuming S. aureus presence is due to 
post-processing contamination and the potential for growth at the 
surface. After further review, FSIS does not recommend that 
establishments consider S. aureus as a hazard during cooling, provided 
they maintain sanitary conditions after cooking. Therefore, as stated 
above, FSIS is removing the recommendation that product be cooled from 
120 to 80 [deg]F in two hours. Establishments may continue to follow 
this option if the product is continuously cooled, without the need to 
demonstrate any timeframe for cooling between 120 to 80 [deg]F. FSIS 
expects that establishments previously following the recommendation 
from FSIS Directive 7110.3 (cancelled by FSIS Directive 7111.1) to 
control the product's surface temperature should be able to meet this 
part of the recommendation instead.

Option 3

    Comment: An individual provided an article by Taormina and 
Bartholomew (2005) and stated that the article provided support for 
Option 3 to be used for not-ready-to-eat products.
    Response: The research by Taormina and Bartholomew (2005) provides 
validated parameters for cooking and cooling partially heat-treated 
bacon. However, the research does not provide sufficient support for 
using Option 3 for all not-ready-to-eat partially heat-treated 
products. This is because the Taormina research included other critical 
operational parameters that may have limited growth of S. aureus and C. 
perfringens, such as smoke, which are not currently part of FSIS's 
Option 3. Establishments are not required to use FSIS guidance as 
scientific support. The article by Taormina and Bartholomew (2005) may 
be used to support the cooking and cooling of partially heat-treated 
bacon, provided the establishment follows the critical operational 
parameters or maintains support to justify any differences in 
parameters. Specifically, the Taormina and Bartholomew research 
supported that bacon smoked with liquid smoke could be heated to 120 
[deg]F with a six-hour heating come-up-time and safely cooled from 120 
to 80 [deg]F in five hours and 80 to 45 [deg]F in 10 hours (15 hours 
total cooling time), without presenting a food safety hazard from 
either C. perfringens or S. aureus. Other critical operational 
parameters of this study include the following product composition 
factors: >=1.6% salt concentration and >=2.9% brine concentration. In 
addition, the brine injected into the bacon contained 0.5% sodium 
phosphate, 547 ppm sodium erythorbate, and 120 ppm sodium nitrite 
(based on email correspondence with Dr. Taormina). Although the 
research was performed with liquid smoke, Dr. Taormina stated that the 
study also represented natural smoking because the phenolic fraction of 
smoked bacon derived from liquid smoke is similar to that of 
traditionally smoked bacon. Therefore, at this time, as indicated in 
Table 15, Time and Temperature Parameters Reported in the Literature 
for Stabilization Processes of the guidance, establishments may follow 
the validated cooling parameters from Taormina and Bartholomew's 
research for bacon that is naturally smoked. FSIS added a reference to 
this research to the guidance.
    In addition to including this reference, the Agency has also 
clarified that establishments producing products that have been fully 
cooked but that they have reclassified into a NRTE HACCP category and 
labeled accordingly, may follow Option 3. FSIS believes this 
clarification may allow for the use of this option by establishments 
that may have previously interpreted the recommendation that the option 
applied to fully cooked products to mean that it could not be applied 
to fully cooked products that are labeled as NRTE.

Use of Natural Sources of Nitrite and Ascorbate

    Comment: A food safety specialist, an industry group, a large 
producer, and a small producer stated there is continued confusion over 
use of natural sources of nitrite. Three industry groups, a small 
producer and an individual consumer recommended that FSIS clarify, in 
Appendix B, that both purified and natural sources of sodium 
erythorbate or ascorbate (e.g., cherry powder) are acceptable to use 
within Option 3. They also recommended that FSIS clarify that any 
natural source containing at least 100 ppm of in-going nitrite may be 
used to replace celery powder. FSIS also received several questions 
through askFSIS asking if establishments can use natural sources of 
nitrite along with synthetic sources of ascorbate or erythorbate.
    Response: After the 2017 version of the guideline published, the 
Agency issued three Knowledge Articles (``Public Q&As'') (Part 1 of 3: 
Use of Celery Powder and Other Natural Sources of Nitrite as Curing 
Agents, Antimicrobials or Flavorings; Part 2 of 3: Revised Appendix B: 
Stabilization Option 3 for Products Containing Natural Sources of 
Nitrite and Natural Sources of Ascorbate or Ascorbic Acid, Part 3 of 3: 
Formulating Products Containing Natural Sources of Nitrite and Natural 
Sources of Ascorbate When Using Revised Appendix B: Stabilization 
Option 3) intended to provide clarification around the use of natural 
sources of nitrite and ascorbate,

[[Page 71019]]

including labeling of products that contain these ingredients, and this 
information has been incorporated into the 2021 version. As part of 
these updates, FSIS revised FSIS Directive 7120.1 ``Safe and Suitable 
Ingredients Used in the Production of Meat, Poultry, and Egg Products'' 
to include any combination of a natural source of nitrite and a natural 
source of ascorbate, provided they are used following the minimum and 
maximum amounts listed in the Directive. In the Knowledge Articles 
(``Public Q&As'', Directive 7120.1, and the updated guidance, FSIS 
states that it is not appropriate to use natural sources of nitrite 
with purified or synthetic sources of erythorbate, as 9 CFR 424.21(c) 
requires that curing accelerators be used with curing agents.
    Comment: FSIS received many questions through askFSIS from 
establishments as to whether using a natural source of nitrite makes a 
product ``cured.'' FSIS has also received questions asking whether 
establishments can select the ``cured'' option, when using the ComBase 
Perfringens Predictor, if natural sources of nitrite and ascorbate are 
used as antimicrobials.
    Response: Adding natural sources of nitrite and ascorbate does not 
make a product ``cured.'' However, if the ingredients are used at the 
minimum levels recommended to be considered antimicrobials, 
establishments may be able to follow the cooling recommendations in 
FSIS's Option 3, originally designed for ``cured'' products, and may 
treat products as ``cured'' for pathogen modeling purposes (i.e., by 
selecting the ``cured meat'' option) as explained in the revised 
Appendix B. Cultured celery powder and other natural sources of nitrite 
are approved for use as antimicrobials and flavorings. Neither celery 
powder (whether in a form containing pre-converted nitrite or when used 
with a nitrate-reducing bacterial culture) nor other natural sources of 
nitrite are approved for use in 9 CFR 424.21(c) as curing agents. As 
with natural sources of nitrite, natural sources of ascorbate (e.g., 
cherry powder) are approved for use as antimicrobials, but not approved 
as cure accelerators. Ingredients approved for use as curing agents and 
cure accelerators are listed in 9 CFR 424.21(c).
    Comment: Two small producers, an individual consumer, a large 
producer, and an industry group contended that Letters of Guarantee 
(LOGs) provided by their suppliers are sufficient to support the amount 
of nitrite and ascorbate added from natural sources as necessary to 
control for C. botulinum and C. perfringens and that a Certificate of 
Analysis (COA) for celery powder should not be needed.
    Response: FSIS agrees it is possible for establishments to support 
that they have adequately addressed C. botulinum and C. perfringens 
using natural sources of nitrite and ascorbate with a LOG, provided it 
supports the amount or concentration of nitrite and ascorbate in each 
lot. Establishments must be able to support the concentrations of 
nitrite from natural sources in their products (9 CFR 417.5(a)(1)) when 
using them as antimicrobials, but they do not necessarily need to have 
a COA. Establishments should be aware that the concentration of nitrite 
and ascorbate or ascorbic acid from natural sources may vary depending 
on the source.
    As stated in the revised Appendix B, FSIS recommends that 
establishments use natural sources of nitrite containing pre-converted 
nitrite, because the quantity of nitrite in the sources is known. When 
using pre-converted nitrite, establishments may need to request 
information from their supplier regarding the nitrite level in each lot 
of product (e.g., through a COA), or they may be able to rely on 
formulation information from their supplier if the concentration is 
standardized from lot to lot. If the concentration of nitrite from 
natural sources is not standardized with each lot and a COA is used, 
establishments should calculate the amount of the natural source needed 
to achieve the appropriate nitrite concentration from each lot, as it 
varies.

Pathogen Modeling

    Comment: An individual stated that FSIS does not recognize ARS 
predictive models and recommended using models that are not from ARS. 
The commenter also recommended that research be sponsored to support 
models.
    Response: ARS is the research arm of the U.S. Department of 
Agriculture. Not all of ARS' models have been validated. A validated 
cooling model is a predictive microbial model whose predictions have 
been found to agree with or be more conservative than actual observed 
results. For establishments to rely on pathogen models alone to support 
decisions in hazard analysis and product disposition, FSIS recommends 
the models be validated for the particular food of interest. For this 
reason, FSIS supports the use of the validated ARS models. FSIS does 
not support the use of models that have not been validated as sole 
support for decisions in hazard analysis and product disposition 
because the predictions of the model have not been found to agree with 
or be more conservative than actual results. If a model has not been 
validated for a particular food of interest, then establishments need 
to provide additional supporting documentation to support the results 
from the model (e.g., sampling data or comparison with other model 
results) meet the requirements of 9 CFR 417.5(a)(1). Those models that 
have not been validated remain on the ARS website because they provide 
useful information to researchers such as initial estimates of growth 
or death of bacteria. FSIS has identified the ARS models that have been 
validated, such as the C. perfringens in the cooked uncured beef model, 
the C. perfringens in cooked uncured pork model, and the C. perfringens 
in cooked uncured chicken model. FSIS recognizes these validated models 
for use in supporting decisions in the hazard analysis and product 
disposition. FSIS has identified one ARS model, the C. perfringens in 
beef broth model, that could not be validated and typically under-
predicted the growth of C. perfringens. Since the model could not be 
validated and was being used by establishments as sole support, it has 
been removed from the ARS website. FSIS continues to work with ARS to 
further research that supports model development and has listed a 
research priority on its website to ``develop or refine cooking and 
cooling models.''

Appendix B Baseline

    Comment: A food safety consultant stated that cooked ready-to-eat 
meat and poultry products are not high-risk foods for C. perfringens 
illness. The commenter argued that the procedures used by industry to 
chill cooked-products and the time-temperatures that ensure C. 
perfringens is controlled have been adequate. The commenter further 
mentioned that subsequent handling and preparation in homes, 
foodservice, and institutions have led to C. perfringens illness.
    Response: FSIS agrees that most outbreaks associated with C. 
perfringens have resulted from the handling of food served in 
restaurants, homes for the elderly, or at large gatherings because the 
products are held at room temperature for too long or cooled in large 
batches, increasing the time it takes for the entire batch of product 
to cool. Outbreaks from C. perfringens associated with commercially 
produced meat and poultry products in the U.S. rarely occur likely 
because of good controls in the commercial setting that have been 
implemented in response to FSIS's requirements and guidance. As 
explained above, FSIS updated

[[Page 71020]]

Appendix B because the Agency determined some of the old guidance 
recommendations were vague, putting establishments at risk of producing 
unsafe product and at risk for recalls. Additionally, some elements of 
the guidance were misunderstood or overlooked, resulting in FSIS 
guidance being applied in ways that increased food safety risks to 
consumers and potential business risks of recalls.
    Comment: A food safety consultant commented that the 2005 C. 
perfringens Risk Assessment \30\ indicated that data from Greenberg et 
al., (1966) \31\ could not be reliably used for quantitative modeling. 
The commenter, a co-author on the Greenberg et al., (1996) article, 
stated that there was a typographical error in the paper on page 789 
under ``Sample Preparation,'' stating that the meat suspensions were 
pasteurized at 60 [deg]C for 15 minutes. According to the commenter, 
the temperature and time actually used throughout the survey was 60 
[deg]C for 50 minutes. The commenter provided documentation to support 
this statement was an error.
---------------------------------------------------------------------------

    \30\ See: https://www.fsis.usda.gov/node/2011.
    \31\ See: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1058416/pdf/applmicro00363-0093.pdf.
---------------------------------------------------------------------------

    Response: FSIS appreciates the commenter sharing this information. 
Because the 2005 C. perfringens Risk Assessment was performed in 
response to comments received on a 2001 proposed rule that FSIS did not 
finalize (66 FR 12589, February 27, 2001), this comment is not relevant 
to this guidance. FSIS did not use the risk assessment to update the 
guidance. FSIS is not addressing comments on the risk assessment 
because it is outside the scope of the guidance.
    Comment: The same food safety consultant also commented that the 
baseline studies FSIS used for its 1998 Lethality and Stabilization 
Performance Standards for Certain Meat and Poultry Products: Technical 
Paper were not designed for estimating the risk of C. perfringens 
illness. The commenter stated that in 1998, FSIS over-estimated the 
number of surviving spores in meat and poultry products after cooking 
to arrive at a worst case of 10\4\ CFU/g of spores and did not consider 
the combined inhibitory effect of salt, nitrite, or other newer 
ingredients that are commonly used for pathogen control. The commenter 
also stated that this led to very conservative time-temperatures being 
recommended for cooling in the 1999 version of Appendix B (i.e., no 
greater than a 1-log increase in C. perfringens as required by 9 CFR 
817.17(a)(2), 318.23(b)(3)(ii)(c), and 381.150(a)(2)). The commenter 
further argued that FSIS does not have credible data on the number of 
C. perfringens spores in raw meat or poultry and that the requirement 
that limits growth of C. perfringens to no greater than a 1-log 
increase during cooling is not valid. The commenter also stated that 
Kalinowski et al. (2003) questioned the need for the performance 
requirement of no more than 1-log growth of C. perfringens and 
suggested that a more appropriate upper limit for growth would be ``no 
greater than a 2-log increase or no greater than 500/g at the time of 
shipment.'' Additionally, the commenter argued that the 2017 revision 
of Appendix B continues to be based on the same assumptions and 
estimates developed in 1998 and that there is a great need for new data 
on the concentration of C. perfringens spores in commercial blends of 
meat and poultry before cooking or after cooling.
    Response: FSIS relied on levels reported in Agency baseline studies 
and surveys of C. perfringens performance standards in the Lethality 
and Stabilization Performance Standards for Certain Meat and Poultry 
Products: Technical Paper. However, Agency cooling requirements in the 
former 9 CFR 318.17(h)(5) and (10) and the cooling recommendations in 
Directive 7110.3 issued in 1988 to industry (cancelled by FSIS 
Directive 7111.1) had the effect of limiting C. perfringens growth to 
1-log even before the 1999 regulation was promulgated. FSIS assumed 
that the baseline studies and surveys either would substantiate the 
regulatory performance standard of 1-log or would indicate a need to 
revise the standard. FSIS assumed that reported C. perfringens levels 
in raw product from the baselines were confirmed, rather than just 
presumptive, and thus validated the proposed growth limitation (no more 
than 1-log growth). Therefore, the Agency may have overestimated worst-
case levels.
    For this reason, FSIS has studied additional data to determine more 
precisely the pre- and post-processing C. perfringens levels in RTE 
products. The Agency tested ground beef samples for C. perfringens and 
found two out of 593 samples collected positive, with one colony at the 
detection limit of 3 cfu/gram.\32\ Also, a survey by industry 
researchers indicates that, while C. perfringens levels in finished 
product occasionally exceed 100-140 cfu/gram, levels higher than 500-
1000 cfu/gram are rare, even after cooling deviations.\33\
---------------------------------------------------------------------------

    \32\ Eblen, D., Cook, V., and Levine, P. (2004). Prevalence and 
levels of Clostridium perfringens spores in raw ground beef from 
federally inspected establishments. Abstract submitted to the 
International Association for Food Protection, 2004--91st Annual 
Meeting, August 8-11, 2004.
    \33\ Kalinowski, R.M.; Tompkin, R.B.; Bodnaruk, P.W.; Pruett, 
W.P. 2003. Impact of cooking, cooling, and subsequent refrigeration 
on the growth or survival of Clostridium perfringens in cooked meat 
and poultry products. Journal of Food Protection 66. Pp. 1227-1232.
---------------------------------------------------------------------------

    In addition, Taormina et al. (2003) reported that that the percent 
of positive for spores was 5.3% and 16.7% for cured ground/emulsified 
meat product mixtures and uncured ground/emulsified meat product 
mixtures, respectively. The average and maximum spore levels were 1.56 
log CFU/g and 2.00 log CFU/g, respectively, for cured ground/emulsified 
meat product mixtures. The average and maximum spore levels were 1.75 
log CFU/g and 2.11 log CFU/g, respectively, for uncured ground/
emulsified meat product mixtures.
    Notably, FSIS also has reviewed data from a large pork processing 
establishment in the Midwest showing that the C. perfringens spore 
counts were close to 1000 CFU/gram in raw sausage batter used to 
produce cooked sausages. In fact, 19 out of the 57 samples collected by 
the company resulted in C. perfringens spore counts ranging from 100 
CFU/g to 760 CFU/g (2.88 log CFU/g) for the raw sausage batter.\34\
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    \34\ Taormina, P.J., Bartholomew, G.W., Dorsa, W.J. 2003. 
Incidence of Clostridium perfringens in Commercially Produced Cured 
Raw Meat Product Mixtures and Behavior in Cooked Products during 
Chilling and Refrigerated Storage. Journal of Food Protection: 
January 2003, Vol. 66, No. 1, pp. 72-81.
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    FSIS continually assesses the state of scientific information and 
overall based on this analysis considers its recommendations to be 
based on the most up-to-date information. FSIS requests data from 
industry related to spore levels in raw formulated products. The Agency 
is also planning to conduct a market basket survey to assess levels of 
C. perfringens vegetative cells and spores in large mass ready-to-eat 
(RTE) meat and poultry products at retail. Although this study will not 
determine the C. perfringens counts in all RTE meat and poultry 
products, it is focusing on large mass, non-intact RTE products because 
industry feedback has indicated that establishments cannot meet current 
cooling requirements for these products. FSIS plans to use the results 
of the study to determine the potential public health issues associated 
with these products and to assess whether changes to its policies are 
needed.
    Lastly, at the time the 1998 FSIS Technical Report (Lethality and 
Stabilization Performance Standards for Certain Meat and Poultry 
Products: Technical Paper) was made available,

[[Page 71021]]

FSIS determined 1-log growth of C. perfringens would provide an 
acceptable level of protection when considering worst-case levels of 4-
logs CFU/g and building in a 1-log safety margin to ensure under worst-
case levels would be below that which can cause human illness (i.e., 6-
logs CFU/gram or higher). FSIS agrees that the worst-case of 4-logs 
CFU/g of spores used in the Technical Paper may have been over-
estimated because of the methodological flaws of the baseline, 
discussed above. However, also discussed above, FSIS has reviewed newer 
data such as that from a large pork processing establishment in the 
Midwest showing that the C. perfringens spore counts were close to 3-
logs CFU/g). Therefore, the Agency now considers 3-logs CFU/g C. 
perfringens in product a worst-case estimate. In addition, in 2010, the 
National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF) recommended building in a 2-log margin of safety to 
performance standards as opposed to the 1-log used in the Technical 
Paper.\35\ Therefore, FSIS still considers allowing up to 1-log of C. 
perfringens in product to be an acceptable level of protection when 
considering worst-case spore counts of 3-log and a 2-log safety margin.
---------------------------------------------------------------------------

    \35\ National Advisory Committee on Microbiological Criteria for 
Foods. 2010. Parameters for Determining Inoculated Pack/Challenge 
Study Protocol. J. Food Prot. 73:140-20.
---------------------------------------------------------------------------

    FSIS acknowledges the Technical Paper did not consider the effect 
of salt and nitrite on the germination of C. perfringens spores. 
However, FSIS cooling options do allow for slower cooling times when at 
least 100 ppm nitrite and at least 250 ppm erythorbate/ascorbate are 
added. By following FSIS recommendations, establishments would meet 
regulatory performance standards. Based on industry feedback, FSIS 
understands that establishments have historically been able to meet the 
time-temperature recommendations for cured ready-to-eat products. 
Finally, FSIS agrees that there is a need for data related to spore 
levels in raw formulated products and again asks industry to provide 
any available data.

Other Appendix B Issues

    Comment: A large producer stated that the lower temperature limit 
for growth of C. perfringens is 53.6 [deg]F, according to Solberg and 
Elkind (1970),\36\ while FSIS guidance states it is 43 [deg]F. The 
commenter also supported this statement with a reference to research by 
Kalinowski et al. (2003) that demonstrated cold storage reduces C. 
perfringens.\37\
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    \36\ Solberg, M., and Elkind, B. 1970. Effect of processing and 
storage conditions on the microflora of Clostridium perfringens-
inoculated frankfurters. Journal of Food Science. 35: 1267-1269.
    \37\ Kalinowski, R.M., Tompkin, R.B., Bodnaruk, P.W., and 
Pruett, P.W. 2003. Impact of Cooking, Cooling, and Subsequent 
Refrigeration on the Growth or Survival of Clostridium perfringens 
in Cooked Meat and Poultry Products. Journal of Food Protection. 
66(7): 1227-1232.
---------------------------------------------------------------------------

    Response: FSIS disagrees that the research by Solberg & Elkind 
(1970) supports a lower temperature limit of 53.6 [deg]F for the growth 
for C. perfringens. Solberg and Elkind (1970) found that C. perfringens 
vegetative cells in frankfurters increased by 3-logs in 5 days when 
held at 53.6 [deg]F, supporting that growth can occur at this 
temperature. The research found it was not until product was held at 50 
[deg]F that growth was restricted. FSIS does recognize that there is a 
range of growth limits of C. perfringens reported in the literature, 
depending on experimental conditions, such as strain(s) used, nutrient 
availability, pH, and growth medium (Labbe, 1989).\38\ However, FSIS 
has reviewed the literature and determined that the most up-to-date 
research supports a minimum temperature of 50 [deg]F to limit growth, 
as opposed to 43 [deg]F that was included in the 2017 guideline. 
Therefore, FSIS has updated the lower growth limit temperature to 50 
[deg]F in the revision. This value is consistent with the research by 
Solberg and Elkind (1970). FSIS also recognizes the growth rate of C. 
perfringens decreases and slows down below 55 [deg]F, but growth is not 
completely limited.
---------------------------------------------------------------------------

    \38\ Labbe, R. ``Clostridium perfringens''. Foodborne Bacterial 
Pathogens. Ed. Michael P. Doyle. New York: Marcel Dekker, Inc. 1989. 
796 pages.
---------------------------------------------------------------------------

    Regarding cold storage reducing C. perfringens, FSIS is aware of 
the research by Kalinowski et al., (2003). However, the reduction 
discussed in the research may be highly variable, product specific, and 
depend upon unstable or changing effects due to temperature and time.
    Comment: A food safety consultant mentioned that FSIS had not 
established science-based upper and lower temperature limits for 
pathogen growth and consistently incorporated the values into their 
cooling options. The commenter noted that the minimum temperature at 
which growth of C. perfringens has been reported to multiply is 53.6 
[deg]F (ICMSF, 1996). Yet, the guidance from FSIS is to chill to 55 
[deg]F, 45 [deg]F, or 40 [deg]F. The commenter also stated that the 
minimum temperature for growth of the proteolytic strains of C. 
botulinum associated with meat in the USA is 50 [deg]F (ICMSF, 1996). 
The commenter stated that the lower critical limit for cooling should 
be 53.6 [deg]F (54 [deg]F) or 50 [deg]F.
    Response: FSIS cooling options in the guidance are focused on 
ensuring cooling time to limit the optimum growth rate for C. 
perfringens and C. botulinum (i.e., between 130 or 120 to 80 [deg]F). 
As previously explained, FSIS has reviewed the literature and 
determined that the most up-to-date research supports a minimum growth 
limit of 50 [deg]F. This value is consistent with the research by 
Solberg and Elkind (1970). FSIS also recognizes the growth rate of C. 
perfringens decreases and slows down below 55 [deg]F, but growth is not 
completely limited. Therefore, the guidance recommends products 
continue to cool to 40 [deg]F to ensure the growth of other pathogens, 
such as Listeria monocytogenes, is limited because FSIS guidance is 
intended to be comprehensive.
    Comment: A small producer requested that FSIS clarify why using 
spore counts alone in cooked products is not appropriate, given how the 
guidance suggests using spore counts in raw products to support the 
option allowing 2-log growth of C. perfringens.
    Response: Although measuring C. perfringens spore counts is 
considered an appropriate method to quantify the initial levels of the 
C. perfringens inoculum, the final measure of bacterial load should 
include a measure of both spore levels and vegetative cells. FSIS 
considers it important for public health to measure the vegetative 
cells in addition to the spore levels because during stabilization, C. 
perfringens spores can germinate and grow into vegetative cells. Once 
vegetative cells reach a critical level and the contaminated food is 
consumed, the cells produce enough toxin in the intestines to cause 
illness. For this reason, FSIS recommends measuring spore counts as 
part of baseline testing to determine whether the initial levels of C. 
perfringens are low and then measuring both spore counts and vegetative 
cells after cooking and cooling to understand the public health risk of 
a product.
    Comment: A food safety consultant commented that, on page five of 
the 2017 version, the mention of the European experience with C. 
botulinum in home-prepared ham raises concerns. The commenter stated 
that there is a long history in Europe of human cases of botulism being 
caused by psychrotrophic strains of C. botulinum in meat products. Such 
cases have not been documented in the U.S.
    Response: There are six distinct Clostridia that produce botulinum 
toxin,

[[Page 71022]]

two of which are associated with food: C. botulinum Group 1 
(proteolytic) and C. botulinum Group II (non-proteolytic). Although 
non-proteolytic C. botulinum is typically associated with fish and 
marine products, there have been several recent outbreaks in Europe 
associated with non-proteolytic C. botulinum and home-prepared (salted) 
ham (Peck et al., 2015).\39\ However, establishments do not need to 
address non-proteolytic C. botulinum during cooling as controls for 
proteolytic C. botulinum during cooling are sufficient to address non-
proteolytic C. botulinum.
---------------------------------------------------------------------------

    \39\ Peck, M., Devlieghere, F., and Membre, J. 2015. Clostridium 
botulinum: a recurrent emerging foodborne pathogen. Symposium 
conducted at the International Association of Food Protection: 
Portland, Oregon. July 26-29, 2015.
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Additional Public Notification

    FSIS will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
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that could affect or would be of interest to our constituents and 
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Through the website, FSIS can provide information to a much broader, 
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information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves and have the option to password protect 
their accounts.

Congressional Review Act

    Pursuant to the Congressional Review Act at 5 U.S.C. 801 et seq., 
the Office of Information and Regulatory Affairs has determined that 
this notice is not a ``major rule,'' as defined by 5 U.S.C. 804(2).

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email: usda.gov">[email protected]usda.gov. USDA is an equal opportunity provider, 
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    Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2021-26993 Filed 12-13-21; 8:45 am]
BILLING CODE 3410-DM-P