[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to our constituents and
stakeholders. The Constituent Update is available on the FSIS website.
Through the website, FSIS can provide information to a much broader,
more diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves and have the option to password protect
their accounts.
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).
USDA Non-Discrimination Statement
In accordance with Federal civil rights law and U.S. Department of
Agriculture (USDA) civil rights regulations and policies, the USDA, its
Agencies, offices, and employees, and institutions participating in or
administering USDA programs are prohibited from discriminating based on
race, color, national origin, religion, sex, gender identity (including
gender expression), sexual orientation, disability, age, marital
status, family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Persons with disabilities who require alternative means of
communication for program information (e.g., Braille, large print,
audiotape, American Sign Language, etc.) should contact the responsible
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or
contact USDA through the Federal Relay Service at (800) 877-8339.
Additionally, program information may be made available in languages
other than English.
To file a program discrimination complaint, complete the USDA
Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and
at any USDA office or write a letter addressed to USDA and provide in
the letter all of the information requested in the form. To request a
copy of the complaint form, call (866) 632-9992. Submit your completed
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture,
Office of the Assistant Secretary for Civil Rights, 1400 Independence
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3)
email: usda.gov">program.intake@usda.gov. USDA is an equal opportunity provider,
employer, and lender.
Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2021-26993 Filed 12-13-21; 8:45 am]
BILLING CODE 3410-DM-P