[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 37995-38003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15274]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0033]


Availability of Two Revised Guidelines for Minimizing the Risk of 
Shiga Toxin-Producing Escherichia Coli (STEC) in Beef Slaughter and 
Processing Operations

AGENCY: Food Safety and Inspection Service, Agriculture (USDA).

ACTION: Notice of availability and response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that it has updated two of its guidelines for minimizing the risk of 
Shiga toxin-producing Escherichia coli (STEC) in beef slaughter 
(including veal) and processing operations. Additionally, FSIS is 
responding to comments on the guidelines.

ADDRESSES: Downloadable versions of the guidelines are available to 
view and print at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines. No hard copies of the guidelines have 
been published.

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

SUPPLEMENTARY INFORMATION:

Background

    On March 3, 2017, FSIS announced in the Constituent Update 
<SUP>1</SUP> the availability of the FSIS Compliance Guideline for 
Minimizing the Risk of Shiga Toxin-producing Escherichia coli (STEC) 
and Salmonella in Beef (including Veal) Slaughter Operations (hereafter 
referred to as the beef slaughter guideline). On September 6, 2017, 
FSIS announced in the Federal Register the availability of the FSIS 
Compliance Guideline for Minimizing the Risk of Shiga Toxin-Producing 
Escherichia coli (STEC) in Raw Beef (including Veal) Processing 
Operations (hereafter referred to as the beef processing guideline).\2\ 
FSIS published these guidelines to advise small and very small 
establishments on the best practices for beef slaughter and processing 
to prevent, eliminate, or

[[Page 37996]]

reduce levels of fecal and associated microbiological contamination. 
The guidelines provided information on addressing contamination with 
STEC and Salmonella in raw non-intact beef products and beef products 
intended for non-intact use. FSIS requested comments on these 
guidelines.
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    \1\ The March 3, 2017 Constituent Update is located at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-march-3-2017.
    \2\ FSIS Compliance Guideline for Minimizing the Risk of Shiga 
Toxin-Producing Escherichia coli (STEC) in Raw Beef (including Veal) 
Processing Operations can be found at: https://www.govinfo.gov/app/details/FR-2017-09-06/2017-18847.
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    After review and consideration of all comments, FSIS has made 
changes to and clarified certain aspects of the guidelines. For 
example, FSIS removed the word ``compliance'' from the titles of the 
guidelines to help clarify that the guidelines are recommendations and 
do not create any new regulatory requirements. The other revisions are 
summarized below and are discussed in more detail in the Agency's 
responses to comments. The revised guidelines are available at the FSIS 
guidance web page.\3\ Although comments on these guidelines will no 
longer be accepted through www.regulations.gov, FSIS will continue to 
update these documents, as necessary.
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    \3\ The FSIS guidance web page can be found at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines.
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Summary of Changes to the Guidelines

Beef Slaughter Guideline

    <bullet> FSIS clarified that the Agency's recommendations are not 
regulatory requirements;
    <bullet> FSIS removed the information pertaining to lymph node 
harborage of Salmonella and will make that information available in 
other Agency documents that focus on controlling Salmonella as a 
foodborne hazard;
    <bullet> FSIS removed best practice recommendations on the use of 
chlorophyll to detect contamination on carcasses and air inflation for 
bunging;
    <bullet> FSIS clarified the Agency's recommendations on washing 
cattle to reduce pathogen transfer and added more information on humane 
handling during cattle washing;
    <bullet> FSIS added more information on pre-harvest interventions;
    <bullet> FSIS clarified the Agency's recommendations about when 
feet, eardrums, and bruises should be removed;
    <bullet> FSIS provided more information to support its 
recommendations on chilling and storage of carcasses and parts;
    <bullet> FSIS emphasized that it considers the presence of certain 
STEC strains to be adulterants when they are present in raw non-intact 
beef products and raw intact beef source materials intended for use in 
such non-intact beef products or when the intended use is unclear. 
These adulterant STEC strains include E. coli O157:H7 as well as 
strains that have certain O groups (O26, O45, O103, O111, O121, and 
O145) and contain two specific virulence genes (stx and eae). This 
addition was created to clarify FSIS policy regarding STEC in relation 
to product recalls; and
    <bullet> FSIS added a section on how ``dry aging'' can be used as 
an intervention to reduce pathogens, including STEC.

Beef Processing Guideline

    <bullet> FSIS clarified throughout the document that the 
recommendations in the guideline are not regulatory requirements;
    <bullet> FSIS removed the section on lymph node removal;
    <bullet> FSIS removed all references to Salmonella;
    <bullet> FSIS added additional examples and scenarios using 
supplier-based verification programs to illustrate additional 
verification options for establishments;
    <bullet> FSIS added a brief question and answer section addressing 
antimicrobial interventions and retained water in beef trim intended 
for grinding, based on concerns expressed by stakeholders to Agency 
leadership; and
    <bullet> FSIS added language from FSIS' Microbiology Laboratory 
Guidebook (MLG), stating that, when testing for STEC, if the initial 
screen test result is negative for the Shiga toxin gene (stx) or the 
intimin gene (eae), then the test result is considered to be negative 
for an adulterant. This addition was created to clarify FSIS policy 
regarding STEC in relation to product recalls.

Comments and Responses

    FSIS received three comments on the beef slaughter guideline from 
an industry group, a consumer group, and a consumer. FSIS received six 
comments on the beef processing guideline from three industry groups, 
two consumers, and a very small establishment. Comment summaries and 
Agency responses follow.

General

    Comment: Multiple industry groups suggested that FSIS revise the 
guidelines to clarify that the recommendations in the guidelines are 
not regulatory requirements. The same industry groups stated that FSIS 
inspectors could incorrectly interpret the guidelines as regulatory 
requirements instead of best practice recommendations. These same 
commenters requested that FSIS change the titles of the guidelines to 
remove the phrase ``compliance guidelines'' and replace it with 
``guidance'' or ``industry guidance'' to avoid potential misuse.
    Response: As FSIS mentioned above, the Agency removed the word 
``compliance'' from the guidelines' titles. FSIS also included 
additional text throughout the documents to clarify that the best 
practices in the documents are not regulatory requirements.
    Comment: Multiple industry groups expressed concern regarding the 
mention of cooking non-intact raw beef products to a level of 
``doneness'' (i.e., rare, medium rare, and well-done), instead of 
listing recommended internal cooking temperatures. The commenters 
argued that doneness is not a reliable indicator for food safety and 
that the guideline would be improved if the levels of doneness were 
replaced with temperatures and descriptions.
    Response: The Agency agrees that visual observation is not a 
scientifically reliable indicator of food safety. The use of the term 
``doneness'' is to explain to the reader, using plain language, why 
STEC is an adulterant in some, but not all beef products. Because 
``rare'' and ``medium rare'' are common descriptive terms describing 
levels of doneness that indicate non-intact beef products have not been 
cooked to a validated time/temperature combination sufficient to 
destroy STEC throughout a product, FSIS did remove the term from the 
guidance. When describing products that are customarily cooked by the 
consumer to a well-done state, FSIS made specific reference to 
validated time and temperature combinations sufficient to destroy STEC 
throughout the product.

STEC Slaughter Guideline

    Comment: One consumer group suggested that the beef slaughter 
guideline should include more information on veal products and that 
FSIS should develop outreach materials that focus on the challenges 
associated with preparing veal products. The consumer group cited 
recent recalls of veal products to support their argument that FSIS 
should provide more guidance on veal products.
    Response: The Agency maintains that minimizing contamination of the 
carcass and maximizing decontamination efforts during the slaughter 
process are the best ways to reduce STEC and Salmonella contamination 
in all classes of beef, including veal. Many of the examples in the 
beef slaughter guideline should be helpful to establishments that 
slaughter veal.
    FSIS has already published a best-practices document specific for 
veal slaughter sanitary dressing procedures

[[Page 37997]]

and antimicrobial interventions.\4\ A reference to the veal slaughter 
sanitary dressing document has been added to the beef slaughter 
guideline. FSIS believes that information provided in the beef 
slaughter guideline and the 2015 best practices document properly 
addresses concerns over recent recalls associated with STEC in veal. 
FSIS is not revising the guideline in response to this comment.
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    \4\ Antimicrobial Intervention Implementation and Veal Slaughter 
Establishments: Identified Issues and Best Practices can be found 
at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines/2015-0018.
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Salmonella

    Comment: A consumer group argued that FSIS should do more to 
protect consumers from Salmonella in beef. The same consumer group 
argued that FSIS should declare antibiotic resistant (ABR) Salmonella 
strains to be adulterants, just as it declared the six strains of STEC 
to be adulterants in 2011. Additionally, the consumer group suggested 
that FSIS update its performance standards for Salmonella in ground 
beef because the current standards are based on outdated studies.
    Response: In 2011, the Agency received a petition from the Center 
of Science in the Public Interest (CSPI) requesting that the Agency 
declare certain strains of ABR Salmonella to be per se adulterants, 
i.e. adulterants in all meat and poultry products, including raw 
products. FSIS denied the petition without prejudice after determining 
that the data submitted with the petition was insufficient to support 
CSPI's request. In 2014, CSPI submitted another petition on the same 
matter, which FSIS also denied without prejudice.\5\
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    \5\ The link to the CSPI petitions and the Agency's responses is 
located at https://www.fsis.usda.gov/policy/petitions.
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    In the Agency's final response to the 2014 petition, FSIS explained 
that while the 2014 petition included expanded factual and legal 
support, the data did not support giving any of the ABR Salmonella 
strains identified in the petition a different status as adulterants 
than is given to Salmonella strains that are susceptible to antibiotics 
under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) 
and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 453 et seq.). 
FSIS also explained in the petition response that the data show that 
numerous factors, including genetic, environmental, and host-specific 
factors interact to make a particular strain pathogenic and virulent. 
Because of this complexity, FSIS concluded that antibiotic resistance 
alone is not an appropriate basis for determining whether a strain of 
Salmonella should be considered an adulterant in raw meat and poultry 
products. FSIS further explained that the Agency does not consider ABR 
Salmonella to be an ``added substance'' within the meaning of the 
adulteration provisions of the FMIA or PPIA.
    More recently, on January 18, 2020, FSIS received a petition 
submitted on behalf of consumer advocacy groups and private individuals 
requesting that FSIS issue an interpretive rule to declare certain 
Salmonella serotypes to be per se adulterants in meat and poultry 
products. The petition is available on FSIS' website.\6\ FSIS requested 
that interested persons submit comments on the petition.\7\ The comment 
period closed on May 22, 2020. FSIS is analyzing the comments and 
developing a response to the petition, which it will post on its 
website.
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    \6\ The link to the FSIS Petitions web page is located at: 
https://www.fsis.usda.gov/policy/petitions.
    \7\ The link to the January 18, 2020 petition can be found at: 
https://www.regulations.gov/document/FSIS-2020-0007-0001.
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    Regarding the comment on Salmonella performance standards for 
ground beef, FSIS published a Federal Register notice on October 28, 
2019, to announce and request comments on proposed pathogen reduction 
performance standards for Salmonella in raw ground beef and beef 
manufacturing trimmings.\8\ The comment period closed January 27, 2020. 
The Agency is currently reviewing the comments it received on the 
notice and intends to respond to comments and announce the final 
performance standards in a future Federal Register document. FSIS is 
not revising the guidance documents in response to this comment.
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    \8\ Changes to the Salmonella Verification Testing Program: 
Proposed Performance Standards for Salmonella in Raw Ground Beef and 
Beef Manufacturing Trimmings and Related Agency Verification 
Procedures can be found at https://www.federalregister.gov/documents/2019/10/28/2019-23473/changes-to-the-salmonella-verification-testing-program-proposed-performance-standards-for-salmonella.
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Sampling

    Comment: An individual consumer submitted questions about FSIS' 
sampling and testing methods for STEC and Salmonella.
    Response: FSIS did not address these topics in the beef slaughter 
guideline. However, more information on sampling and testing 
methodologies can be found in the FSIS Compliance Guideline for 
Controlling Meat and Poultry Products Pending FSIS Test Results,\9\ 
Foodborne Pathogen Test Kits Validated by Independent 
Organizations,\10\ and the FSIS Microbiology Laboratory Guidebook 
(MLG).\11\ FSIS is not revising the guidance documents in response to 
this comment.
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    \9\ The FSIS Compliance Guideline for Controlling Meat and 
Poultry Products Pending FSIS Test Results can be found at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines/2013-0003.
    \10\ The list of test kits that have been validated for 
detection of relevant foodborne pathogens can be found at: https://www.fsis.usda.gov/guidelines/2019-0008.
    \11\ FSIS Microbiology Laboratory Guidebook: https://www.fsis.usda.gov/news-events/publications/microbiology-laboratory-guidebook.
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    Comment: Multiple establishments have sent inquiries to the askFSIS 
questioning whether the required generic E. coli testing under 9 CFR 
310.25 is equivalent to STEC testing conducted for HACCP verification. 
Although these questions were not submitted specifically as comments on 
the guidelines, we have addressed the issue in the revisions to the 
guidelines, as they are the best vehicle to communicate guidance to 
industry stakeholders.
    Response: FSIS has added a text box to the verification sections of 
the slaughter and processing guidelines to explain the differences 
between STEC testing conducted for HACCP verification and the required 
generic E. coli testing under 9 CFR 310.25. The text box explains how 
each serves a separate function, and neither is a supportable 
substitute for the other.

Best Practices

    Comment: One consumer group suggested that the beef slaughter 
guideline emphasize the importance of preventing aerosolization of 
contamination during ``up-pulling'' of hides, which is the action 
generated by a machine that pulls the hide away from the carcass.
    Response: The beef slaughter guideline's best practice section on 
dehiding as posted on September 6, 2017 already included information on 
preventing aerosolization due to the excessive forces that occur when 
using mechanical hide pullers. During this process, best practices in 
preventing cross-contamination include establishing a maintenance 
program for the mechanical pullers that involves monitoring pullers on 
an on-going basis for proper adjustment, installing shields or devoting 
an employee to holding up a shield, and directing air flow away from 
the carcasses being skinned to prevent contamination of carcasses with 
the aerosols created at this step. Because

[[Page 37998]]

the requested information is already in the guideline, FSIS did not 
make additional changes to the guidance in response to this comment.
    Comment: An industry group argued that the recommendation in the 
``Best Practices during Cattle Transport, Receiving and Holding'' 
section on washing incoming cattle is flawed. The commenter agreed that 
washing cattle reduces visual contamination but argued that the 
guideline provides no support showing that the practice effectively 
reduces Salmonella and STEC contamination.
    Response: FSIS has revised the beef slaughter guideline to clarify 
that washing cattle may be considered a means to reduce visible 
contamination, but this practice may not necessarily reduce pathogen 
transfer to the carcass. In addition, FSIS specified that if an 
establishment decides to wash livestock pre-slaughter, it should ensure 
the washing is done in a humane manner.
    Comment: An industry group questioned language in the beef 
slaughter guideline suggesting that industry-source cattle from ``farms 
or feedlots that employ one or more production system or feedlot 
controls [are] shown to reduce the carriage of STEC and Salmonella.'' 
The commenter also opposed language in the guideline stating that 
``effective farm and feedlot management and control can reduce fecal 
shedding of the organism, as well as reduce the microbial load on the 
animals in the intestinal tract.'' The commenter pointed out that FSIS 
does not cite any data to support the conclusion that sourcing such 
cattle will cause a meaningful reduction in the overall prevalence of 
Salmonella and STEC on carcasses or their final products and stated 
that FSIS should remove the section from the guideline.
    Response: FSIS has revised the beef slaughter guideline to add a 
reference to the 2014 FSIS guideline on preharvest controls for 
STEC.\12\ The 2014 guideline addresses the commenter's concerns, 
including the concern about FSIS' supporting data for its 
recommendations on pre-harvest interventions.
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    \12\ The 2014 guideline, Pre-Harvest Management Controls and 
Intervention Options for Reducing Shiga Toxin-Producing Escherichia 
coli Shedding in Cattle: An Overview of Current Research can be 
found at: https://www.fsis.usda.gov/guidelines/2014-0012.
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    Comment: An industry group expressed concern about language in the 
beef slaughter guideline about removing the front and hind feet before 
making any incisions to remove the hide. The industry group stated that 
the practice is unnecessary if cattle are not being cradled for 
skinning. The industry group stated that FSIS inspectors may consider 
that the best practice recommendation is a regulatory requirement.
    Response: FSIS revised the ``Best Practices during Hide Removal'' 
section of the beef slaughter guideline to clarify that establishments 
are not required to remove an animal's feet first. However, FSIS 
continues to recommend that when establishments use a bed or cradle for 
hide removal, establishments remove the front and hind feet before 
making any other incisions through the hide. These procedures should 
reduce the potential for cross-contamination of the carcass.
    Comment: An industry group expressed concern regarding recommended 
practices in the beef slaughter guideline related to clamping, bagging 
tails, bunging before hide removal, and using paper towels to protect 
the exposed carcass surfaces. While the commenter agreed that it is 
important to ensure the hide, tail, and bung do not contact the carcass 
surface, the commenter noted that the recommendations appear to be 
regulatory requirements and that there are additional methods to 
protect carcasses from insanitary conditions than FSIS provides in the 
guideline.
    Response: FSIS revised the beef slaughter guideline to convey that 
FSIS' recommendations are not regulatory requirements and that there 
are more ways to prevent insanitary conditions than were mentioned in 
the 2017 guideline. For example, FSIS revised the guideline to state 
that using hide clips is just one way to prevent hide flaps from 
contacting the carcass.
    Comment: An industry group mentioned that using chlorophyll 
detection equipment to identify fecal material is outdated and most 
equipment used for this purpose is no longer commercially available.
    Response: FSIS removed the best practice recommendations on the use 
of chlorophyll to detect contamination on carcasses from the beef 
slaughter guideline.
    Comment: An industry group pointed out that in the ``Best Practices 
during Bunging'' section, FSIS recommends that establishments remove 
the bung during the final part of rumping. While the commenter 
acknowledged that it is important to ensure the bung is not a source of 
fecal contamination to the carcass, the commenter questioned why FSIS 
recommends that bunging be performed at this step. The commenter argued 
that bunging should happen whenever an establishment can best minimize 
the risk of contamination.
    Response: FSIS modified the beef slaughter guideline to reflect 
that an establishment could do bunging at other points in the process, 
besides the final part of rumping, if the establishment minimized the 
contamination.
    Comment: An industry group opposed the guideline's recommendation 
of using air inflation around the anus/vulvar area to assist in 
bunging, because, according to the commenter, this practice is not 
typically performed and could cause greater contamination.
    Response: FSIS removed the recommendation of using air inflation.
    Comment: An industry group expressed concern regarding the ``Best 
Practices during Head Removal'' section of the guideline. The commenter 
pointed out that FSIS suggests removing the eardrums before head 
washing but provides no explanation or documentation as to why any 
establishment should perform this process before washing and not after.
    Response: FSIS revised the text in the beef slaughter guideline to 
state, ``remove horns, pieces of hide and ear drums in a manner to 
minimize contamination.''
    Comment: An industry group expressed concern regarding the ``Best 
Practices during Carcass Splitting'' section of the guideline. 
According to the commenter, FSIS recommends removing bruises before 
carcass splitting, but provides no justification for how removing this 
material before or after splitting minimizes the risk of STEC and 
Salmonella contamination. The commenter suggested that bruises should 
be removed at the step in the harvest process most suitable to each 
individual facility.
    Response: In the Agency's experience during inspection, removing 
organic material, bruises, grubs, and tissue damaged by grubs from the 
middle area of the back before splitting reduces potential 
contamination to the split saw, bone, and surrounding tissues. 
Therefore, FSIS is not making the requested revision.
    Comment: An industry group opposed FSIS' recommendation that 
industry ``sanitize saws and knives between each carcass,'' because, 
according to the commenter, FSIS provides no explanation as to why this 
practice effectively reduces STEC and Salmonella contamination.
    Response: FSIS modified the guideline to clarify that the practice 
should be done as necessary instead of between each carcass. FSIS 
recommends that establishments disinfect the splitting saw after each 
use on suspect, retained, or diseased carcasses to prevent 
contamination.

[[Page 37999]]

    Comment: An industry group stated that the best practices in the 
chilling section of the beef slaughter guideline are outdated and lack 
a scientific foundation. The commenter noted that the guideline asserts 
a carcass should begin chilling within one hour of bleed-out to limit 
pathogen multiplication but does not provide an explanation or 
supporting data to demonstrate that this practice will effectively 
minimize STEC or Salmonella contamination.
    Response: FSIS revised the guideline to clarify that the one-hour 
timeline is a recommendation and not a regulatory requirement. The 
recommended one-hour period from bleed-out to the start of chilling 
corresponds to a period of slower bacterial growth due to new 
environmental conditions and is based on the ComBase Growth Predictor 
Model for generic E. coli. According to the ComBase Growth Predictor 
Model for E. coli, if the establishment begins chilling the carcass 
within this time period, then the establishment may be able to minimize 
microbial growth during the overall chilling process.\13\
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    \13\ ComBase Growth Predictor Model for E. coli was used to 
predict the growth of E. coli. if the bacterium was deposited onto 
the sterile carcass surface during the hide removal/dressing steps. 
The Growth Predictor Model predicts the response of a range of 
pathogens and spoilage microorganisms characterizing the food 
environment. The parameters selected were left at the ComBase 
default values of initial level = 3 log10, pH 7, physiological state 
as recommended by ComBase, and either water activity at 0.997, or 
0.6% NaCl.
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    Comment: An industry group opposed the guideline's recommendations 
that hot-boning rooms be maintained at 50 [deg]F or lower and that 
product should be chilled and maintained at 40 [deg]F or lower. The 
industry group argued that both recommendations are provided without 
scientific justification and should be removed from the guideline.
    Response: FSIS revised the ``Best Practices During Chilling'' 
section of the guideline to clarify that establishments may choose to 
maintain temperatures other than those recommended in the guideline if 
they have supporting documentation for their chosen temperature limit. 
The temperature recommended in the guideline of chilling and storage of 
product at 40 [deg]F or lower is based on the Tompkin paper \14\ that 
shows STEC and Salmonella will not grow at product temperatures of 40 
[deg]F or less.
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    \14\ The Tompkin paper can be found at: https://meathaccp.wisc.edu/Model_Haccp_Plans/assets/raw_ground/TompkinPaper.pdf.
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    The recommendation for maintaining a temperature of 50 [deg]F or 
less for a hot-boning room is based on minimizing the potential for 
bacterial growth during processing. Common industry practice has shown 
that the colder the temperature, the more the risk of bacterial growth 
decreases. FSIS is not aware of any specific scientific research on 
environmental temperatures during hot-boning. Establishments are not 
required to follow this specific temperature recommendation and can use 
any temperature as long as bacterial growth is prevented.
    Comment: An industry group argued that FSIS did not provide a 
scientific basis for the beef slaughter guideline's recommendation that 
packers should not hold aged-beef for longer than seven days. The 
commenter argued that the best practice ignores several considerations 
(e.g., weekends and holidays), and opens the door for an inspector to 
conclude product held more than seven days is out of compliance.
    Response: FSIS revised the guideline to clarify that holding beef 
for no more than seven days is a recommendation and not a requirement. 
FSIS chose seven days based on industry practice and Dr. Bruce 
Tompkin's estimates of the combined effect of temperature and bacterial 
content on time of spoilage of beef.\15\ The revised guideline explains 
that establishments may hold carcasses for longer than seven days in 
the cooler before fabrication if they maintain scientific supporting 
documentation for cooler parameters that take the holding time into 
account, which may include: Temperature, humidity, and air flow (see 9 
CFR 417.5(a)(1) or 417.5(a)(2)). In addition, FSIS added a section on 
``dry aging'' of beef to the guideline.
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    \15\ Tompkin, R.B. 1996. The Significance of Time-temperature to 
Growth of Foodborne Pathogens During Refrigeration at 40-50 [deg]F. 
Presented during the Joint FSIS/FDA Conference on Time/Temperature. 
November 18, 1996 Washington, DC. Available at: https://meathaccp.wisc.edu/Model_Haccp_Plans/assets/raw_ground/TompkinPaper.pdf.
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    Comment: An industry group suggested that FSIS remove references to 
antimicrobial interventions, Hazard Analysis and Critical Control 
Points (HACCP) verification, and HACCP validation. The commenter argued 
that FSIS should reference FSIS' HACCP systems validation guideline as 
essential and complementary to help reduce the risk of Salmonella and 
STEC contamination.
    Response: The beef slaughter guideline provides a link to FSIS' 
Compliance Guideline on HACCP Systems Validation.\16\ The validation 
information provided in the beef slaughter guideline is included as a 
convenience to the reader and is not a replacement of the HACCP systems 
validation guideline. No revision was made in response to this comment.
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    \16\ Available at: https://www.fsis.usda.gov/guidelines/2015-0011.
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STEC Processing Guideline

General

    Comment: An industry group opposed FSIS' recommendation that 
establishments use a single supplier for each lot. The commenter argued 
that this is impractical, lacks a scientific basis, and that it does 
not represent typical or practical industry practices. The commenter 
argued that this recommendation was included in the guideline to 
simplify Agency traceback investigations.
    Response: FSIS revised the text in the beef processing guideline 
and removed the wording that suggests using single source material is a 
``best practice.'' However, it is important to emphasize that this 
practice does help in traceback and could limit the scope of a recall.
    Comment: A very small establishment stated that it would be too 
difficult for small and very small establishments to implement the 
testing recommendations in the guideline because of the costs of lot-
by-lot testing. The same commenter also stated that using antimicrobial 
interventions on a day-to-day basis would be difficult because often 
the amount of product that needs to be produced is unknown.
    Response: The beef processing guideline does not create any new 
regulatory requirements. Instead, the beef processing guideline 
presents supportable recommendations that establishments can use to 
address STEC, including having a purchase specification program to get 
a Certificate of Analysis (COA) on each lot received. If a COA is not 
available, then FSIS recommends testing each lot of incoming product, 
testing each lot of finished product, applying a validated 
antimicrobial intervention, or treating or washing the product and then 
trimming the outer surface. There is not one ``superior'' antimicrobial 
intervention for STEC. When searching for an antimicrobial treatment to 
use as an intervention for STEC, establishments should review the 
supporting documentation available and choose an intervention based on 
its overall HACCP system. Establishments must effectively control STEC 
in their production of non-intact beef products. The financial impact 
of a recall or illness outbreak associated with a failure to control 
STEC at the establishment could be much greater than the cost of 
implementing the recommended prevention strategies. FSIS is not

[[Page 38000]]

revising the guideline in response to this comment.
    Comment: An industry group requested that FSIS consider expanding 
the usability of the guideline for all beef processing operations, 
regardless of size.
    Response: FSIS has developed these guidelines to help small and 
very small establishments meet best practice recommendations by FSIS, 
based on the best scientific and practical considerations. The 
guidelines are focused on small and very small establishments; however, 
all FSIS regulated beef slaughter and processing establishments may be 
able to apply the recommendations in the guidelines. As written, larger 
establishments may use the guideline. FSIS is not revising the 
guideline in response to this comment.
    Comment: Multiple establishments have sent inquiries to FSIS 
questioning whether establishments can send product that is positive or 
presumptive positive for STEC to pet food manufacturers to be processed 
into animal food product. Although these questions were not submitted 
specifically as comments on the guidelines, FSIS has addressed the 
issue in the revisions to the beef processing guideline, as it is the 
best vehicle to communicate guidance to industry stakeholders.
    Response: FSIS has revised the beef processing guidance to clarify 
that product that is positive or presumptive positive for STEC is 
eligible to be sent to a pet food manufacturer. FSIS recommends that 
FSIS-inspected establishments communicate with pet food manufacturers 
before sending products containing STEC to a pet food manufacturer, so 
that the pet food manufacturer is aware that the ingredient they are 
receiving contains a pathogen that will need to be controlled in their 
finished pet food.
    Pet food facilities operate under the jurisdiction of the Food and 
Drug Administration (FDA). Pet food facilities required to register 
with the FDA as food facilities must comply with the Preventive 
Controls for Animal Food (PCAF) regulation, at 21 CFR part 507, unless 
an exemption applies. Under the PCAF regulation, registered facilities 
are required, in part, to identify and control any hazards requiring a 
preventive control that are associated with their incoming ingredients 
(21 CFR 507.33 and 507.34). As a result, if a pet food facility is 
receiving ingredients that are or may be positive for STEC, it would be 
required to identify and evaluate that food safety hazard and implement 
a preventive control that has been validated to prevent or 
significantly minimize the hazard (21 CFR 507.34 and 507.47). Pet food 
facilities exempt from FDA registration requirements or otherwise not 
subject to the PCAF regulations also have an obligation under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 and 342) not to 
introduce adulterated pet food into interstate commerce. As a result, 
FDA expects such facilities to put in place appropriate processes and 
procedures to ensure that any animal food they produce using 
ingredients containing microbiological pathogens is not adulterated.

Lymph Nodes and Salmonella

    Comment: Three industry groups commented that the beef processing 
guideline should focus on STEC, not Salmonella. These industry groups 
suggested that all references to Salmonella, including the section on 
lymph node removal, be removed from the document, because they may 
detract from the purpose of the document and confuse the reader.
    Response: While Salmonella is a pathogen of public health 
significance and is associated with raw beef products, FSIS agrees with 
the commenters that the beef processing guideline is designed to 
describe the best practices for controlling STEC, not Salmonella. 
Therefore, references to controlling Salmonella, including the section 
on lymph nodes, have been removed from this guideline. Salmonella 
control is still addressed in the beef slaughter guideline and 
additional information may be incorporated into future Salmonella 
specific guidance materials.
    Comment: A consumer group asked if FSIS will continue to allow 
establishments to use lymph nodes taken from meat products for ``beef 
patties'' where the ingredients statement discloses that the patties 
contain byproducts. The commenter urged FSIS to entirely eliminate the 
exception, or at least require additional disclosure, such as an 
asterisk on the ingredients statement that is linked to the statement: 
``beef byproducts have been shown to contain high levels of pathogenic 
Salmonella. Cook thoroughly.''
    Response: FSIS is not changing its labeling policy. FSIS clarifies 
in its Food Standards and Labeling Policy Book \17\ that beef patties 
may contain beef byproducts if the byproducts are included in the 
ingredients statement and the ingredients statement immediately follows 
the product name. Additionally, FSIS already requires establishments to 
label not ready-to-eat inspected product with safe-handling 
instructions that state ``Cook Thoroughly'' (9 CFR 317.2(l)). FSIS is 
not adopting the commenter's requested warning statement because it 
could confuse consumers.
---------------------------------------------------------------------------

    \17\ The FSIS Food Standards and Labeling Policy Book can be 
found at: https://www.fsis.usda.gov/wps/wcm/connect/7c48be3e-e516-4ccf-a2d5-b95a128f04ae/Labeling-Policy-Book.pdf?MOD=AJPERES.
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Lymph Nodes

    Comment: One consumer group suggested that FSIS should conduct more 
inspection tasks to verify that processors do not mix highly pathogenic 
lymphatic tissue into beef products because, according to the consumer 
group, there is research showing that lymphatic tissue harbors high 
concentrations of Salmonella bacteria. One industry group argued that 
``suggesting/requiring'' the removal of ``major'' lymph nodes lacks 
sound scientific reasoning, and that a ``one size fits all'' approach 
will not work. Rather, the industry group suggested that each packing 
establishment should use its data to determine the appropriate best 
practices regarding lymph nodes.
    The industry group further argued that there is currently no 
research showing that lymph nodes are a source of STEC contamination 
and therefore, requiring their removal would not reduce STEC 
contamination on carcasses and final products. Additionally, the 
industry group argued that multiple peer-reviewed scientific studies 
illustrate that the prevalence of Salmonella is not consistent 
geographically, seasonally, across production stages, or across 
individual lymph nodes within each animal. Therefore, the commenter 
argued that requiring all establishments to remove the six peripheral 
lymph nodes in all carcasses at all times is not a prudent best 
practice.
    Response: FSIS determined that the inclusion of lymph node removal 
procedures to assist in the control of Salmonella is out of the scope 
of this document's overall focus on STEC control. Therefore, the Agency 
removed this section from this document and intends to include it in 
future guidance materials that focus on Salmonella control.

On-Going Verification

    Comment: Multiple industry groups suggested that the beef 
processing guideline over-emphasizes the importance of product testing 
for on-going verification rather than providing detailed options for 
processors. The commenters stated that this over-emphasis may lead to 
FSIS inspectors concluding that product testing is mandatory or is the 
best and only option

[[Page 38001]]

for on-going verification and that FSIS should clarify, in the 
guideline, that testing is not a regulatory requirement. One commenter 
suggested that information about alternatives to testing may be helpful 
to small and very small establishments and should be included in the 
guideline. Additionally, the same commenters argued that the guideline 
should provide more examples of on-going verification besides product 
testing in the ``Scenarios'' section of the guideline. Multiple 
industry groups commented that supplier verification programs should be 
mentioned as an alternative to on-going verification.
    Response: FSIS did not intend to suggest that testing by the 
receiving establishment is the only option available. The beef 
processing guideline was developed to assist small and very small 
establishments understand STEC controls and verification procedures. 
The guideline includes detailed discussions on sampling and testing 
procedures based on the many askFSIS questions that FSIS receives.
    In response to comments, FSIS has revised the beef processing 
guideline to include options for on-going verification other than 
testing and added an example of on-going verification procedures, other 
than receiving establishment testing, to Scenario 4. FSIS has modified 
the ``On-going Verification'' section and the flowchart to include 
supplier verification programs as a form of verification.
    Comment: An industry group argued that the customary cooking 
section on page four of the beef processing guideline is confusing and 
recommended that the words ``customary'' and ``customarily'' be 
removed, as the words have not been adequately defined. The commenter 
also recommended that the section be segmented into two parts: (1) How 
the two classes of non-intact products (ground beef and non-intact 
steak) should be considered regarding cooking instructions and (2) the 
processing establishment's HACCP plan.
    Response: FSIS has revised this section of the guideline, and has 
divided it into two sections, one on validated cooking instructions and 
one on customary cooking practices. The Agency did not remove the words 
``customary'' or ``customarily'' from the guideline, because they are 
adequately defined. Additionally, the discussion of customary cooking 
practices is consistent with the Agency's discussion of customary 
cooking practices in the January 19, 1999 Federal Register notice Beef 
Products Contaminated with Escherichia coli O157:H7.\18\ The customary 
preparation of raw ground beef and non-intact steaks (i.e., cooking to 
a rare or medium state) does not destroy STEC throughout the product or 
render the product safe. However, FSIS recognizes that there are some 
non-intact raw beef products (e.g., raw corned beef) that are 
customarily cooked by the consumer to a well-done state (i.e., cooked 
to a time and temperature combination sufficient to destroy STEC 
throughout the product).
---------------------------------------------------------------------------

    \18\ Beef Products Contaminated with Escherichia coli O157:H7 
can be found at: https://www.govinfo.gov/content/pkg/FR-1999-01-19/pdf/99-1123.pdf.
---------------------------------------------------------------------------

    Comment: An industry group suggested that FSIS rewrite the section 
on outside suppliers to include a more comprehensive discussion of the 
importance of processing establishments ensuring that their HACCP plans 
adequately address the use of incoming product for producing non-intact 
product.
    Response: FSIS disagrees with the commenter. The guideline already 
thoroughly discusses STEC control options for establishments that 
purchase product slaughtered off-site. For example, the guideline 
recommends that the receiving establishment have knowledge of the STEC 
controls applied to the product they are purchasing, as that affects 
decisions being made in the receiving establishment's HACCP system. 
FSIS is not revising the guideline in response to this comment.
    Comment: Multiple industry groups recommended that FSIS incorporate 
and reference in the beef processing guideline the recommendations 
outlined in the November 2016 Beef Industry Food Safety Council 
(BIFSCO) Guidance for Purchasers of Raw Beef for Non-Intact Use. The 
commenters stated that the BIFSCO Guidance, developed by industry, 
provides practical guidance to processing establishments producing non-
intact product on how to maximize the food safety of raw materials and 
finished products, as well as how to meet FSIS regulatory requirements. 
It also includes the components of a supplier verification program.
    Response: The beef processing guideline represents FSIS' best 
practice recommendations and are based on the best scientific and 
practical considerations. Establishments may choose to adopt different 
procedures than those outlined in the guideline, such as practices 
recommended by BIFSCO.\19\ FSIS' best practice recommendations are 
generally consistent with the BIFSCO recommendations. FSIS is not 
revising the guideline in response to this comment.
---------------------------------------------------------------------------

    \19\ BIFSCO Guidance for Purchasers of Raw Beef for Non-Intact 
Use: https://www.bifsco.org/Media/BIFSCO/Docs/guidance_for_purchasers_of_raw_beef_for_non-intact_use_final.pdf.
---------------------------------------------------------------------------

    Comment: One industry group stated that FSIS should cite the 
appropriate scientific articles that support the testing frequencies 
recommended throughout the guideline.
    Response: Establishments determine their frequencies for on-going 
verification procedures based on their specific individual HACCP 
system. However, the Agency recognizes that small and very small 
establishments routinely have difficulty in finding scientific support 
for the frequency of on-going verification procedures as required by 9 
CFR 417.5(a)(2). Therefore, the Agency has provided on-going 
verification frequencies based on past industry practices that provide 
a safe harbor and starting point for establishments and support for 
their on-going verification frequency. If an establishment chooses to 
select an alternative frequency, they may do so if they have supporting 
documentation for their chosen frequency (see 9 CFR 417.5(a)(2)). As is 
explained in the guideline, in the absence of an STEC control or 
preventive measures, establishments cannot rely solely on testing at 
the frequencies listed in the verification section. FSIS rejects this 
comment.
    Comment: An industry group recommended that FSIS remove the 
following language from page nine of the beef processing guideline: 
``Testing of product provides a statistical confidence that the product 
is not contaminated with STEC. However, negative test results do not 
provide 100 percent certainty that the product is not contaminated. For 
that reason, testing is a verification activity that demonstrates that 
a HACCP system is functioning as intended rather than a control for 
pathogens.'' The commenter argued that this language is not pertinent 
to the discussion on verification testing.
    Response: FSIS disagrees with the commenter. The Agency included 
the information to help small and very small establishments understand 
that testing alone is not a sufficient control for STEC. FSIS is not 
revising the guideline in response to this comment.
    Comment: An industry group suggested that, on page 10 of the beef 
processing guideline, FSIS should remove the green call-out box that 
stated that ``In the absence of a control or prevention measures, it is 
not appropriate for establishments to apply the recommended minimum 
frequencies. Without a control or

[[Page 38002]]

preventive measure in place, sampling should occur on a lot-by-lot 
basis.'' The commenter argued that there are many options to conduct 
on-going verification activities that do not include product testing 
for non-intact products.
    Response: The green box was revised to emphasize that, in the 
absence of an STEC control or preventive measures, establishments 
cannot rely solely on testing at the frequencies listed in the 
verification section.
    Comment: Multiple industry groups opposed FSIS' recommendation of 
``frequent sampling at multiple points in the process (e.g., before and 
after the non-intact processing).'' According to the commenters, 
testing at this frequency may cause confusion or render lotting 
documentation null and void. The commenters stated that this approach 
conflicts with downstream verification testing, conducted to verify 
that the systems in place have been effective in reducing the pathogens 
of concern to undetectable levels before the materials are received at 
the further processor. The commenters further argued that it is unclear 
how testing before and after non-intact processing provides 
meaningfully different feedback on supply-side intervention processes 
and that the establishment should have the flexibility to determine 
when and where sampling should occur within their HACCP plan to 
demonstrate process control.
    Response: FSIS revised the language in the beef processing 
guideline to emphasize that sampling and testing should provide 
evidence regarding the effectiveness of the establishment's HACCP 
controls.
    Comment: An industry group suggested that FSIS revise the last 
paragraph on page 15 of the beef processing guideline on lotting. The 
commenter suggested the following revision: ``Following the 
identification of the affected lot, the establishment is required to 
ensure that no product that is injurious to health or otherwise 
adulterated enters commerce. The amount of any additional affected 
product will be determined based on the establishment's lotting and 
food safety systems. The implemented corrective actions will depend on 
whether the positive finding represents a critical control point (CCP) 
deviation requiring corrective actions per 9 CFR 417.3(a) or an 
unforeseen hazard requiring corrective actions per 9 CFR 417.3(b).''
    Response: FSIS agreed with the commenter and revised the guideline 
to reflect the commenter's suggestion.

Scenarios

    Comment: An industry group recommended that FSIS rewrite Scenario 1 
on page 18 to clarify whether the boxed subprimals in the scenario were 
vacuum packaged and whether the processing establishment went to the 
supplier's website to determine what food safety documents were 
available. The commenter argued that these are key points that must be 
included in the scenario because they reflect the current information 
the processing establishment would have to consider as they ensure 
their food safety system is appropriate and meets regulatory 
requirements. Furthermore, the commenter stated that each of these 
details would more completely explain the scenario and possibly provide 
direction to the processing establishment.
    Additionally, the same industry group recommended that FSIS should 
rewrite Scenario 2 on page 18 to clarify whether the boxed beef primals 
were vacuum packed as it would indicate the supplier did not intend the 
use to be for non-intact products and whether the certificate of 
analysis (COA) was received. The industry group noted that intended use 
of products must be considered by the receiving establishment. The same 
industry group recommended that FSIS explain in the scenario that no 
intervention was used. Furthermore, the same industry group stated that 
if the finished ground beef that tested positive contained trim from 
these non-intact primals and there was no intervention used to 
microbially differentiate the non-intact subprimals from the ground 
beef, FSIS should explain that the Agency may also investigate the need 
to recall the non-intact subprimals.
    Response: FSIS agreed with the commenter and revised Scenario 1 and 
Scenario 2 to clarify that the boxed subprimals were vacuum packaged 
and that the receiving establishment was able to obtain a letter of 
guarantee from each supplier. FSIS did not specifically mention that 
the receiving establishment obtained the letter of guarantee from a 
website because producing establishments can also provide the letter 
via mail or email.
    In Scenario 2, FSIS added additional information indicating that 
the establishment did not apply any antimicrobial interventions. 
Lotting and microbiological independence are already addressed in the 
guideline. The focus of Scenario 2 is on establishments developing a 
HACCP system that addresses materials from multiple sources used in 
ground beef product and not the response to positive product or recall 
potential. The guideline contains a separate section on how 
establishments should respond to positive product.

Non-Intact Classification

    Comment: An industry group requested that the beef processing 
guideline be revised to include cube steak on the list of non-intact 
products that are ``customarily cooked by the consumer to a well-done 
state.'' The commenter argued that cubed steak is customarily cooked by 
consumers to a well-done state and should be included alongside 
products like meatballs and ``Philly'' style steak.
    Response: As FSIS explained in the October 7, 2002 Federal Register 
notice E. coli O157:H7 Contamination of Beef Products, there is a lack 
of data on industry and consumer practices for cooking pinned, needled, 
and blade tenderized steaks and a lack of data on the proportion of 
industry outlets and consumers that prepare these products according to 
each of these different methods.\20\ However, establishments have the 
option of providing support for how their establishment uses the end-
product. The HACCP regulations provide establishments the flexibility 
to design their HACCP system to fit their procedures, processes, and 
products. Ultimately, the regulations require the establishment to 
conduct the hazard analysis (9 CFR 417.2(a)), determine the hazard(s) 
reasonably likely to occur (9 CFR 417.2(a)(1)), conduct on-going 
verification (9 CFR 417.4), and support the decisions made (9 CFR 
417.5(a)(1)). FSIS is not revising the guideline in response to this 
comment.
---------------------------------------------------------------------------

    \20\ E. coli O157:H7 Contamination of Beef Products can be found 
at: https://www.govinfo.gov/app/details/FR-2002-10-07/02-25504.
---------------------------------------------------------------------------

    Comment: An industry group opposed FSIS categorizing diced beef 
smaller than three-fourths of an inch in any one dimension as non-
intact, putting it into a higher risk category. The commenter argued 
that FSIS did not conduct an assessment to determine the higher risk 
surrounding diced products smaller than three-fourths of an inch in any 
one dimension, and that FSIS should not classify this product as non-
intact.
    Response: The guideline did not create a new classification for 
diced beef. In 1999, FSIS published the Federal Register notice Beef 
Products Contaminated with Escherichia coli O157:H7, which 
differentiated intact beef cuts from non-intact products.\21\

[[Page 38003]]

The meat interior of intact beef cuts remains protected from pathogens 
migrating below the exterior surface. Pathogens may be introduced below 
the surface of non-intact beef cut as a result of the processes by 
which they are made. FSIS considers diced beef products (beef cubes) of 
less than three-fourths of an inch to exhibit the same food safety 
characteristics as raw non-intact beef products. Similar to ground 
beef, when cubes are made smaller-and-smaller, the cubes begin to stick 
(or clump) together, allowing pathogens previously restricted only to 
the exterior of the meat to be distributed throughout the mass (or 
clump) of cubes. FSIS is not revising the guideline in response to this 
comment.
---------------------------------------------------------------------------

    \21\ Beef Products Contaminated with Escherichia coli O157:H7 
can be found at: https://www.govinfo.gov/app/details/FR-1999-01-19/99-1123.
---------------------------------------------------------------------------

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register. FSIS also will make copies 
of this publication available through the FSIS Constituent Update, 
which is used to provide information regarding FSIS policies, 
procedures, regulations, Federal Register notices, FSIS public 
meetings, and other types of information that could affect or would be 
of interest to our constituents and stakeholders. The Constituent 
Update is available on the FSIS web page. Through the web page, FSIS 
can provide information to a much broader, more diverse audience. In 
addition, FSIS offers an email subscription service which provides 
automatic and customized access to selected food safety news and 
information. This service is available at: http://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

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination, any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: <a href="/cdn-cgi/l/email-protection#9ceceef3fbeefdf1b2f5f2e8fdf7f9dce9eff8fdb2fbf3ea"><span class="__cf_email__" data-cfemail="4333312c2431222e6d2a2d3722282603363027226d242c35">[email protected]</span></a>.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done in Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2021-15274 Filed 7-16-21; 8:45 am]
BILLING CODE 3410-DM-P


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