Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 37995 

1The 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. 

analysis as a basis for the NSIS 

rulemaking, to draw conclusions on 

worker safety in HIMP or non-HIMP 

establishments, or to determine whether 

there is an associated impact on food 

safety. Had FSIS developed the analysis 

for any of these reasons, it would have 

more thoroughly addressed data 

limitations and uncertainty, as 

recommended by OIG. 

Instead, FSIS published the 

preliminary worker safety analysis 

solely to solicit comments for use by 

OSHA and the National Institute for 

Occupational Safety and Health 

(NIOSH) in examining worker safety in 

swine slaughter establishments. OSHA 

and NIOSH are the Federal agencies 

with jurisdiction over meat and poultry 

establishment worker safety. Notably, 

FSIS stated this immediately following 

the discussion of the preliminary 

analysis in the preamble to the proposed 

rule (83 FR 4796): 

FSIS is requesting comments on the effects 

of faster line speeds on worker safety. 

Specifically, FSIS is requesting comments on 

whether line speeds for the NSIS should be 

set at the current regulatory limit of 1,106 

hph or some other number. The Agency is 

also interested in comments on the 

availability of records or studies that contain 

data that OSHA or the National Institute for 

Occupational Safety and Health (NIOSH) 

may be able to use in analyzing the effects 

of increased line speed on the safety and 

health of employees throughout the 

establishment, including effects prior to and 

following the evisceration line. 

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-aprogram-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: program.intake@usda.gov. 

USDA is an equal opportunity 

provider, employer, and lender. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, FSIS will 

announce this Federal Register 

publication online through the FSIS 

web page located at: https://

www.fsis.usda.gov/federal-register. 

FSIS also will announce and provide 

a link to it 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 is able to 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. 

Done at Washington, DC. 

Paul Kiecker, 

Administrator. 

[FR Doc. 2021–15291 Filed 7–16–21; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2018–0033] 

Availability of Two Revised Guidelines 

for Minimizing the Risk of Shiga ToxinProducing 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. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

that it has updated two of its guidelines 

for minimizing the risk of Shiga toxinproducing 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/regulatorycompliance/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 1 the availability 

of the FSIS Compliance Guideline for 

Minimizing the Risk of Shiga Toxinproducing 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 ToxinProducing 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 


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37996 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 

3The FSIS guidance web page can be found at: 

https://www.fsis.usda.gov/wps/portal/fsis/topics/ 

regulatory-compliance/guidelines. 

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. 

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. 

Summary of Changes to the Guidelines 

Beef Slaughter Guideline 

• FSIS clarified that the Agency’s 

recommendations are not regulatory 

requirements; 

• 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; 

• FSIS removed best practice 

recommendations on the use of 

chlorophyll to detect contamination on 

carcasses and air inflation for bunging; 

• FSIS clarified the Agency’s 

recommendations on washing cattle to 

reduce pathogen transfer and added 

more information on humane handling 

during cattle washing; 

• FSIS added more information on 

pre-harvest interventions; 

• FSIS clarified the Agency’s 

recommendations about when feet, 

eardrums, and bruises should be 

removed; 

• FSIS provided more information to 

support its recommendations on 

chilling and storage of carcasses and 

parts; 

• 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 

• FSIS added a section on how ‘‘dry 

aging’’ can be used as an intervention to 

reduce pathogens, including STEC. 

Beef Processing Guideline 

• FSIS clarified throughout the 

document that the recommendations in 

the guideline are not regulatory 

requirements; 

• FSIS removed the section on lymph 

node removal; 

• FSIS removed all references to 

Salmonella; 

• FSIS added additional examples 

and scenarios using supplier-based 

verification programs to illustrate 

additional verification options for 

establishments; 

• 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 

• 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 bestpractices document specific for veal 

slaughter sanitary dressing procedures 


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Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 37997 

4Antimicrobial 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. 

5The link to the CSPI petitions and the Agency’s 

responses is located at https://www.fsis.usda.gov/ 

policy/petitions. 

6The link to the FSIS Petitions web page is 

located at: https://www.fsis.usda.gov/policy/ 

petitions. 

7The link to the January 18, 2020 petition can be 

found at: https://www.regulations.gov/document/ 

FSIS-2020-0007-0001. 

8Changes 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-verificationtesting-program-proposed-performance-standardsfor-salmonella. 

9The 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. 

10The 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. 

11FSIS Microbiology Laboratory Guidebook: 

https://www.fsis.usda.gov/news-events/ 

publications/microbiology-laboratory-guidebook. 

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. 

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

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 hostspecific 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. 

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. 

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. 

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 


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12The 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. 

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. 

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. 


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13ComBase 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. 

14The Tompkin paper can be found at: https://

meathaccp.wisc.edu/Model_Haccp_Plans/assets/ 

raw_ground/TompkinPaper.pdf. 

15Tompkin, R.B. 1996. The Significance of Timetemperature to Growth of Foodborne Pathogens 

During Refrigeration at 40–50 °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. 

16Available at: https://www.fsis.usda.gov/ 

guidelines/2015-0011. 

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 bleedout 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 onehour 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

Comment: An industry group opposed 

the guideline’s recommendations that 

hot-boning rooms be maintained at 50 °F 

or lower and that product should be 

chilled and maintained at 40 °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 °F 

or lower is based on the Tompkin 

paper 14 that shows STEC and 

Salmonella will not grow at product 

temperatures of 40 °F or less. 

The recommendation for maintaining 

a temperature of 50 °F or less for a hotboning 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. 

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. 

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 


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38000 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 

17The 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-PolicyBook.pdf?MOD=AJPERES. 

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. 

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 ongoing verification rather than providing 

detailed options for processors. The 

commenters stated that this overemphasis may lead to FSIS inspectors 

concluding that product testing is 

mandatory or is the best and only option 


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Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 38001 

18Beef 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. 

19BIFSCO 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. 

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 ongoing 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 nonintact 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). 

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. 

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 ongoing verification frequencies based on 

past industry practices that provide a 

safe harbor and starting point for 

establishments and support for their ongoing 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 


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38002 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 

20E. coli O157:H7 Contamination of Beef 

Products can be found at: https://www.govinfo.gov/ 

app/details/FR-2002-10-07/02-25504. 

21Beef Products Contaminated with Escherichia 

coli O157:H7 can be found at: https://

www.govinfo.gov/app/details/FR-1999-01-19/99- 

1123. 

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 nonintact 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 nonintact 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 endproduct. 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. 

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


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Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 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 threefourths of an inch to exhibit the same 

food safety characteristics as raw nonintact beef products. Similar to ground 

beef, when cubes are made smaller-andsmaller, 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. 

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: program.intake@usda.gov. 

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 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Modoc County Resource Advisory 

Committee 

AGENCY: Forest Service, Agriculture 

(USDA). 

ACTION: Notice of meeting. 

SUMMARY: The Modoc County Resource 

Advisory Committee (RAC) will hold a 

virtual meeting by phone and/or 

teleconference. The committee is 

authorized under the Secure Rural 

Schools and Community SelfDetermination Act (the Act) and 

operates in compliance with the Federal 

Advisory Committee Act. The purpose 

of the committee is to improve 

collaborative relationships and to 

provide advice and recommendations to 

the Forest Service concerning projects 

and funding consistent with Title II of 

the Act as well as make 

recommendations on recreation fee 

proposals for sites on or benefitting the 

Modoc National Forest within Modoc 

County, California, consistent with the 

Federal Lands Recreation Enhancement 

Act. RAC information and virtual 

meeting information can be found at the 

following website: https://

www.fs.usda.gov/main/modoc/ 

workingtogether/advisorycommittees. 

DATES: The meeting will be held on 

August 25, 2021 at 4:00 p.m., Pacific 

Daylight Time. 

All RAC meetings are subject to 

cancellation. For meeting status prior to 

attendance, please contact the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

ADDRESSES: The meeting will be held 

virtually. Attendees can join via 

telephone conference by dialing 323– 

886–7051 with pass code 993916790# 

and/or via video conference link: 

https://teams.microsoft.com/l/meetupjoin/19%3ameeting_

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0?context=%7b

%22Tid%22%3a%22ed5b36e7-01ee4ebc-867e-e03cfa0d4697%22%

2c%22Oid%22%3a%22acedd9e6-fe59- 

4fec-8e11-244c6d1d8148%22%7d. 

Written comments may be submitted 

as described under SUPPLEMENTARY

INFORMATION. All comments, including 

names and addresses when provided, 

are placed in the record and are 

available for public inspection and 

copying. The public may inspect 

comments received upon request. 

FOR FURTHER INFORMATION CONTACT: 

Chris Christofferson, Designated Federal 

Officer (DFO), by phone at 530–233– 

8700 or email at chris.christofferson@

usda.gov or Ken Sandusky at 530–233– 

8713 or email at kenneth.sandusky@

usda.gov. 

Individuals who use 

telecommunication devices for the 

hearing-impaired (TDD) may call the 

Federal Information Relay Service 

(FIRS) at 1–800–877–8339 between 8:00 

a.m. and 8:00 p.m., Eastern Daylight 

Time, Monday through Friday. 

SUPPLEMENTARY INFORMATION: The 

purpose of the meeting is to: 

1. Hear from possible Title II project 

proponents and discuss project 

proposals; 

2. Plan for project solicitation and 

replacment member recruitment; 

3. Review old projects’ meeting 

minutes; and 

4. Schedule the next meeting. 

The meeting is open to the public. 

The agenda will include time for people 

to make oral statements of three minutes 

or less. Individuals wishing to make an 

oral statement should make a request in 

writing by August 16, 2021, to be 

scheduled on the agenda. Anyone who 

would like to bring related matters to 

the attention of the committee may file 


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