8774 Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 

1FSIS defines ‘‘comminuted pork’’ as pork that 

has been ground, mechanically separated, or 

otherwise processed to reduce particle size; an 

‘‘intact pork cut’’ as a smaller cut derived from a 

pork primal cut that has not been subjected to 

processing that renders it non-intact; and a ‘‘nonintact pork cut’’ also as a smaller cut but that has 

been injected, mechanical tenderized, 

reconstructed, vacuum-tumbled, scored and 

marinated, or otherwise processed to render it nonintact. 

2As noted in Table 2 at 9 CFR 310.25(b), FSIS 

intended to add a pathogen reduction performance 

standard for fresh pork sausage. FSIS collected data 

in 1998 and 1999 but a performance standard for 

fresh pork sausage was never finalized. 

3At the time, FSIS estimated the prevalence of 

Salmonella in market hogs was 1.66% with a 95% 

confidence interval between 0.82% and 2.51%. See 

the Nationwide Microbiological Baseline Data 

Collection Program: Market Hogs Survey August 

2010–August 2011; available at https://

www.fsis.usda.gov/sites/default/files/media_file/ 

2020-07/Baseline_Data_Market_Hogs_2010- 

2011.pdf#:∼:text=The%20Market%20

Hogs%20Baseline%20Survey%20

%28MHBS%29%20was%20conducted,at%20preevisceration%20and%20postchill%20and%20between%20production%20shifts. 

4Painter, J.A., Ayers, T., Woodruff, R., Blanton, 

E., Perez, N., Hoekstra, R.M., Griffin, P.M., Braden, 

C., 2009. Recipes for foodborne outbreaks: A 

scheme for categorizing and grouping implicated 

foods. Foodborne Pathogens and Disease 6, 1259– 

1264. 

5Painter, J.A., Hoekstra, R.M., Ayers, T., Tauxe, 

R.V., Braden, C.R., Angulo, F.J., Griffin, P.M., 2013. 

Attribution of foodborne illnesses, hospitalizations, 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2019–0023] 

Changes to the Salmonella Verification 

Testing Program: Proposed 

Performance Standards for Salmonella 

in Raw Comminuted Pork and Intact or 

Non-Intact Pork Cuts and Related 

Agency Verification Procedures 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice and request for 

comments. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

and requesting comment on proposed 

pathogen reduction performance 

standards for Salmonella in raw 

comminuted pork and raw intact or 

non-intact pork cuts. The Agency is also 

announcing how it plans to assess 

whether establishments producing these 

products are effectively addressing 

Salmonella using a moving window of 

FSIS sampling results. Approximately 

one year (52 weeks) after the new 

performance standards are made final, 

the Agency plans to post online each 

establishment’s performance category, 

based on the most recent 52 Salmonella 

sample results. The notice discusses 

other verification activities related to 

FSIS Salmonella sampling and testing of 

raw pork products. Finally, the notice 

provides a brief summary of the 

Agency’s recent announcements 

concerning Salmonella in poultry 

products. FSIS will consider comments 

received on this notice before 

announcing the final performance 

standards in the Federal Register and 

assessing whether pork establishments 

meet them. 

DATES: Submit comments on or before 

April 18, 2022. 

ADDRESSES: FSIS invites interested 

persons to submit comments on this 

notice. Comments may be submitted by 

one of the following methods: 

• Federal eRulemaking Portal: This 

website provides commenters the ability 

to type short comments directly into the 

comment field on the web page or to 

attach a file for lengthier comments. Go 

to https://www.regulations.gov. Follow 

the on-line instructions at that site for 

submitting comments. 

• Mail: Send to Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, 1400 

Independence Avenue SW, Mailstop 

3758, Washington, DC 20250–3700. 

• Hand- or courier-delivered 

submittals: Deliver to 1400 

Independence Avenue SW, Jamie L. 

Whitten Building, Room 350–E, 

Washington, DC 20250–3700. 

Instructions: All items submitted by 

mail or electronic mail must include the 

Agency name and docket number FSIS– 

2019–0023. Comments received in 

response to this docket will be made 

available for public inspection and 

posted without change, including any 

personal information, to https://

www.regulations.gov. 

Docket: For access to background 

documents or comments received, call 

(202) 720–5627 to schedule a time to 

visit the FSIS Docket Room at 1400 

Independence Avenue SW, Washington, 

DC 20250–3700. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Edelstein, Assistant 

Administrator, Office of Policy and 

Program Development by telephone at 

(202) 205–0495. 

SUPPLEMENTARY INFORMATION: FSIS 

administers a regulatory program under 

the Federal Meat Inspection Act (FMIA) 

(21 U.S.C. 601 et seq.) that is intended 

to ensure that meat and meat food 

products distributed in commerce are 

wholesome; not adulterated; and 

properly marked, labeled, and packaged. 

As part of its inspection program, FSIS 

collects samples of these products for 

laboratory analysis (21 U.S.C. 642(a)). 

Salmonella bacteria are among the 

most frequent causes of foodborne 

illness. These bacteria reside in the 

gastrointestinal tract and hide or hair of 

food animals; therefore, they also are 

good indicators for food product 

contamination with enteric pathogens. 

Salmonella are often introduced during 

the rearing of live animals (e.g., 

Salmonella may contaminate the 

exterior of an animal on the farm, 

remain attached to the animal’s hide or 

hair, or be transferred to the carcass, and 

can contaminate raw products during 

slaughter and subsequent fabrication 

and further processing). Currently, 

events that cause contamination of pork 

carcasses cannot be completely 

eliminated from commercial slaughter, 

fabrication, or further processing 

operations. Contamination can be 

minimized, however, with the use of 

proper sanitary dressing procedures and 

through the application of antimicrobial 

interventions during the slaughter, 

fabrication, and further processing of 

pork carcasses into products, including 

raw comminuted pork and raw intact or 

non-intact pork cuts.1

FSIS began its Salmonella verification 

testing program with the final rule 

entitled, ‘‘Pathogen Reduction; Hazard 

Analysis and Critical Control Point 

Systems’’ (PR/HACCP Rule), published 

on July 25, 1996 (61 FR 38805). Among 

other things, the PR/HACCP Rule 

established Salmonella pathogen 

reduction performance standards for 

establishments that slaughter selected 

classes of food animals and/or that 

produce selected classes of raw meat 

products, including pork carcasses, 

based on FSIS baseline study data (9 

CFR 310.25(b)).2 In 2012, FSIS stopped 

sampling and testing for Salmonella in 

pork carcasses because percent positive 

findings were very low 3 and the carcass 

sampling was not a good use of Agency 

resources. In the 2019 rule to modernize 

swine slaughter, FSIS removed the 

Salmonella pathogen reduction 

performance standards associated with 

pork carcasses and sausages from the 

regulations (84 FR 52300; Oct. 1, 2019). 

In that rule, FSIS also noted that it is 

testing pork cuts and comminuted pork 

products for Salmonella and expected to 

decide in 2019 whether to develop new 

pathogen performance standards for 

these products (82 FR 52318). 

The Centers for Disease Control and 

Prevention (CDC) first estimated the role 

of pork products in salmonellosis cases 

by analyzing outbreak data collected 

between 1998 and 2008.4 The estimated 

percentage of foodborne illnesses 

attributed to pork for this time period 

was 6.2 percent, with lower- and upperbound estimates of 3.6 and 11.4 percent, 

respectively.5 In 2011, the CDC, Food 


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Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 8775 

and deaths to food commodities, United States, 

1998–2008. Emerging Infectious Diseases 19, 407– 

415. 

6 IFSAC, 2019; available at https://www.cdc.gov/ 

foodsafety/ifsac/pdf/P19-2017-report-TriAgency508-revised.pdf. 

7FSIS Salmonella Action Plan; available at 

https://www.fsis.usda.gov/sites/default/files/media_

file/2020-10/SAP-120413.pdf. 

8Available at https://health.gov/healthypeople. 

9https://www.fsis.usda.gov/news-events/newspress-releases/special-alert-constituent-updateusda-launches-new-effort-reduce. 

10USDA FSIS Constituent Update, Dec. 3, 2021, 

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

news-press-releases/constituent-update-december3-2021. 

11Available at https://www.cdc.gov/ 

norsdashboard/. 

12Available at https://www.cdc.gov/salmonella/ 

pork-08-15/index.html. 

13FSIS Recall 110–2015; available at Kapowsin 

Meats Recalls Pork Product Due To Possible 

Salmonella Contamination | Food Safety and 

Inspection Service (usda.gov). 

14Available at Kapowsin Meats Inc. Recalls Pork 

Products Due To Possible Salmonella 

Contamination | Food Safety and Inspection Service 

(usda.gov). 

15Available at https://www.cdc.gov/ 

norsdashboard/. 

16Williams, M.S., Ebel, E.D., Golden, N.J., 

Schlosser, W.D. (2014). Temporal patterns in the 

occurrence of Salmonella in raw meat and poultry 

products and their relationship to human illnesses 

in the United States. Food Control 35(1): 267–273. 

17FSIS Notice 41–19, Raw Pork Products 

Sampling Program; Oct. 28, 2019. 

and Drug Administration, and FSIS 

teamed up to form the Interagency Food 

Safety Analytics Collaboration (IFSAC). 

Using outbreaks between 1998 and 

2017, the IFSAC estimates suggest pork 

is responsible for 10.3 percent of 

domestic cases of salmonellosis among 

all foods, with lower- and upper-bound 

estimates of 7.7 and 13.1 percent, 

respectively.6 This represents about 30 

percent of all domestic foodborne 

Salmonella illnesses among FSISregulated products. This makes pork the 

second highest contributor to 

Salmonella illnesses associated with 

products regulated by FSIS, behind 

chicken. 

In 2013, FSIS committed to a 25- 

percent reduction in annual 

salmonellosis illnesses attributed to the 

products it regulates.7 The 25-percent 

reduction goal was set to meet Healthy 

People 2020 objectives. FSIS will 

continue to use a 25-percent reduction 

as its intended target for salmonellosis 

illness reductions to meet Healthy 

People 2030, under which the objectives 

are unchanged.8 FSIS requests comment 

on this intended target for salmonellosis 

illness reductions and whether the 

Agency should consider a more 

stringent reduction (e.g., 30 percent). 

Recent Announcements Concerning 

Salmonella in Poultry 

On October 19, 2021, USDA 

announced that FSIS would be 

mobilizing a stronger and more 

comprehensive effort to reduce 

Salmonella illnesses associated with 

poultry products.9 A key component of 

this effort is identifying ways to 

incentivize use of preharvest controls to 

reduce Salmonella contamination 

coming into the slaughterhouse. 

In November 2021, FSIS held 

roundtable listening sessions with 

industry and consumer groups to 

answer questions about establishment 

pilot projects. On December 3, in its 

Constituent Update, FSIS invited 

poultry slaughter and processing 

establishments to submit proposals for 

pilot projects that will test different 

control strategies for Salmonella 

contamination in poultry products.10

FSIS explained that Pilot projects will 

last for a defined period of time, during 

which establishments will experiment 

with new or existing pathogen control 

and measurement strategies and share 

data collected during the pilots with 

FSIS. FSIS also explained that data will 

be analyzed by FSIS to determine 

whether it supports changes to FSIS’ 

existing Salmonella control strategies. 

In this notice, FSIS is proposing 

Salmonella performance standards for 

certain pork products. If we adopt a 

revised approach to performance 

standards for Salmonella in poultry, the 

Agency may also propose future 

changes to the pork standards. 

Public Health Concerns 

There have been multiple outbreaks 

attributed to the consumption of pork in 

recent years. Between 2014 and 2016, 

CDC identified a total of approximately 

772 persons sickened and 93 persons 

hospitalized with Salmonella resulting 

from 19 pork associated outbreaks. One 

individual died.11 Two of these 

outbreaks resulted in recalls. In 2015, 

the CDC confirmed a multi-state 

outbreak of Salmonella I 4,[5],12:i:- and 

Salmonella Infantis that resulted in 192 

illnesses and 30 hospitalizations.12 This 

outbreak led to a recall of approximately 

523,000 pounds of pork products.13 In 

2016, the CDC confirmed a single-state 

outbreak of Salmonella I 4,[5],12:i:- that 

resulted in 15 illnesses. This outbreak 

led to a recall of approximately 11,700 

pounds of pork products.14 Between 

2017 and 2019, a total of approximately 

475 persons were sickened and 93 

persons hospitalized with Salmonella 

resulting from 15 pork associated 

outbreaks. One individual died.15

The outbreaks referenced here suggest 

that Salmonella in raw pork is a 

continuing public health concern. The 

changes described below will apply to 

most of the pork consumed in the 

United States and will likely improve 

FSIS’ ability to detect Salmonella by 

focusing increased sampling on the 

largest establishments that produce the 

greatest amount of product. Also 

discussed below, FSIS has developed 

performance standards that will likely 

lead establishments producing raw pork 

products to strengthen their own 

Salmonella control measures. Such 

changes at establishments will likely 

have a positive impact on public health. 

Moving Window Approach 

On February 11, 2016, the Agency 

explained how it would assess 

performance using a moving window of 

FSIS sampling results in poultry 

establishments subject to Salmonella 

and Campylobacter pathogen reduction 

performance standards (81 FR 7285). 

FSIS stated that the moving window 

would be 52 weeks and that the Agency 

would collect samples more frequently 

in higher-volume establishments and 

less frequently in lower-volume 

establishments. The 52-week window 

obviates the need to account directly for 

seasonal fluctuations in contamination 

frequency.16 FSIS intends to use this 

moving window approach for pork 

establishments that produce raw 

comminuted pork and/or raw intact or 

non-intact pork cuts that will be subject 

to the new Salmonella performance 

standards. 

In preparation for the implementation 

of the new performance standards, FSIS 

has begun Salmonella sampling in all 

pork establishments that produce 

greater than 1,000 pounds of raw 

comminuted pork and greater than 

1,000 pounds of raw intact or non-intact 

pork cuts per day.17 FSIS currently 

assigns samples five times per month in 

pork establishments producing greater 

than 6,000 pounds per day of raw 

comminuted pork and/or greater than 

50,000 pounds per day of raw intact or 

non-intact pork cuts. FSIS samples less 

frequently in the lower-volume 

establishments. 

FSIS will use the results of this 

sampling to gain additional information 

on the prevalence of Salmonella in 

these products and to make sure the 

data continue to support the standards. 

FSIS ensures that result information is 

made available to establishments. Note 

that FSIS does not recognize Salmonella 

in raw pork products as a pathogen that 

would ordinarily render the product 

injurious to health, and thus an 

adulterant within the meaning of 21 

U.S.C. 601(m)(1). As such, currently and 


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18Scallan, et al., 2011; IFSAC 2019. 

19 Data collected during Phase 2 of the RPPESP 

showed the percentage of positive samples for raw 

comminuted pork, intact pork cuts, and non-intact 

cuts was 16.4, 9.4, and 6.3, respectively. However, 

FSIS found no significant difference in the 

percentage of positive samples from intact pork cuts 

and non-intact pork cuts, so the two product classes 

were combined into a single product class. The 

percentage of Salmonella-positive samples for the 

combined product class was 8.7%. 

when new standards are in place, 

individual Salmonella sample results 

will not result in regulatory control 

actions. 

Illness Reduction Goals 

As explained above, FSIS has 

committed, with its public health 

partners, to a 25-percent reduction in 

annual cases of salmonellosis. Using 

published results,18 FSIS estimates a 

median of about 122,000 annual cases of 

salmonellosis associated with the 

consumption of raw pork contaminated 

with Salmonella. FSIS estimates that 

approximately 34,000 of these illnesses 

are associated with raw comminuted 

pork and 88,000 of these illnesses are 

associated with raw intact or non-intact 

pork cuts. Thus, to meet the 25-percent 

reduction goal, there would need to be 

about 8,300 and 21,600 fewer annual 

Salmonella illnesses from raw 

comminuted pork and raw intact or 

non-intact pork cuts, respectively. 

Pathogen Reduction Performance 

Standards 

With the goal of reducing Salmonella 

in raw pork products, the Agency is 

proposing two new pathogen reduction 

performance standards—one for 

Salmonella in raw comminuted pork 

and another for Salmonella in raw intact 

or non-intact pork cuts.19

Sampling evidence suggests that these 

two pork product classes differ with 

respect to Salmonella contamination 

occurrence. The prevalence of 

Salmonella in raw comminuted is about 

30% while the combined percent 

positive for raw intact or non-intact 

pork cuts is about nine percent. 

Therefore, FSIS is proposing separate 

performance standards for each of these 

product classes. 

The modeling methods for developing 

the proposed pathogen reduction 

performance standards and predictions 

for the public health effect of those 

standards are described in FSIS’ Public 

Health Effects of Performance Standards 

for raw Comminuted Pork and raw Pork 

Cuts (2020 Pork Risk Assessment)(cite 

when posts). 

Because the pork product industry is 

relatively concentrated by production 

volume, that is, a relatively small 

number of establishments produce most 

of the raw pork, FSIS developed 

pathogen reduction performance 

standards for each of the above product 

classes based on an average daily 

production volume threshold. The 

proposed performance standards would 

be applicable to establishments 

producing greater than 6,000 pounds 

per day in the case of raw comminuted 

pork and/or greater than 50,000 pounds 

per day in the case of raw intact and/ 

or non-intact pork cuts. This approach 

would account for approximately 96 

percent of raw comminuted pork and 91 

percent of raw intact and non-intact 

pork cuts produced annually. And as 

further explained in the 2020 Pork Risk 

Assessment, the approach would also 

focus Agency resources on that part of 

the pork industry where Salmonella 

contamination is most clustered. 

FSIS intends to collect and analyze 52 

samples per year for each establishment 

subject to the performance standards. 

Analyzing this number of samples 

would provide strong evidence that an 

establishment is meeting the 

performance standard. 

FSIS has opted at this time not to 

propose pathogen reduction 

performance standards in lower-volume 

establishments (i.e., those producing 

less than or equal to 6,000 pounds per 

day of raw comminuted pork and/or less 

than or equal to 50,000 pounds per day 

of raw intact or non-intact pork cuts). A 

summary of the new performance 

standards is provided in Table 1. 

TABLE 1—NEW PERFORMANCE STANDARDS FOR SALMONELLA IN RAW COMMINUTED (GROUND) PORK AND RAW INTACT

OR NON-INTACT PORK CUTS

Product 

(establishment volume (pounds/day)) 

Maximum 

number of 

allowable 

positive 

samples 

Minimum number 

of samples 

needed 

to assess 

establishment 

performance * 

Raw Comminuted Pork (>6,000) ............................................................................................................. 13 of 52 ................. 52 

Raw Intact or Non-Intact Pork Cuts (>50,000) ....................................................................................... 6 of 52 ................... 52 

* Any establishment with more than the maximum number of allowable positive samples for that product class in a 52-week window would be 

categorized as Category 3 even when less than the minimum number of samples (52) are collected/analyzed. 

Raw Comminuted Pork 

For raw comminuted pork, FSIS is 

proposing a pathogen reduction 

performance standard for Salmonella of 

13 allowable positives out of 52 

samples. This standard would be 

applied to establishments producing 

greater than 6,000 pounds of raw 

comminuted pork per day 

(approximately 10 percent of 

establishments that produce this 

product class, 138 establishments). As 

mentioned above, FSIS would continue 

to assign samples five times per month 

in all establishments producing greater 

than 6,000 pounds of eligible product 

per day with the intention of collecting 

and analyzing 52 samples in a 52-week 

window. 

FSIS predicts that approximately 44 

percent of establishments (about 61 

establishments) would initially not meet 

this performance standard. Once 

implemented, if about half (45%) of the 

establishments producing greater than 

6,000 pounds of raw comminuted pork 

per day that are not meeting the 

proposed performance standard 

subsequently begin to meet this 

standard, this should result in about a 

25-percent reduction in Salmonella 

illnesses from that product. The median 

expected number of illnesses avoided 

per year would be about 8,300 (95% 

uncertainty interval: 3,600–16,300). 

Raw Intact or Non-Intact Pork Cuts 

For both raw intact and non-intact 

pork cuts, FSIS is proposing a single 

pathogen reduction performance 

standard for Salmonella of 6 allowable 

positives out of 52 samples in a 52-week 

window. This standard would be 

applied to establishments producing 

greater than 50,000 pounds of these 

products per day (approximately 4 

percent of establishments producing 


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20See also FSIS Notice 17–19, Follow-up 

Sampling in Raw Poultry Establishments Not 

Meeting Salmonella Performance Standards; June 4, 

2019. 

21 Information about the 20 most frequently 

reported Salmonella serotypes reported to the 

CDC’s Laboratory-based Enteric Disease 

Surveillance system is available at https://

www.cdc.gov/nationalsurveillance/pdfs/2016- 

Salmonella-report-508.pdf. 

22The purpose of an FSA is to assess and analyze 

an establishment’s food safety system to verify that 

the establishment is able to produce safe and 

wholesome meat or poultry products in accordance 

with FSIS statutory and regulatory requirements. 

this product class, 38 establishments). 

Approximately 39 percent of these 

establishments (about 15 

establishments) are predicted to initially 

not meet this performance standard (i.e., 

would be categorized as Category 3). 

Once implemented, if about half (45%) 

of the establishments producing greater 

than 50,000 pounds of raw intact or 

non-intact pork cuts per day that are not 

meeting the proposed performance 

standard subsequently begin to meet 

this standard, this should result in about 

a 25-percent reduction in Salmonella 

illnesses from that product. The median 

expected number of illnesses avoided 

per year would be about 21,600 (95% 

uncertainty interval: 10,000–40,000). 

Specifics of the 52-Week Window 

Approach and Categorizing 

Establishments 

As stated, the performance standard is 

intended to apply to 52 samples in a 52- 

week window. If FSIS analyzes more 

than 52 samples in a 52-week window, 

the most recent 52 sample results in that 

52-week window would be used to 

categorize the establishment. Although 

unlikely, there may be rare occasions 

when fewer than 52 samples are 

analyzed in these establishments within 

a 52-week window. If fewer than 52 

samples are analyzed, the 

establishment’s status would be 

reported as ‘‘N/A,’’ provided the 

establishment has fewer than the 

minimum number of allowable 

Salmonella positives for that product 

class in that window. Any 

establishment with more than the 

minimum number of allowable 

Salmonella positives for that product 

class in a 52-week window would be 

categorized as Category 3 (outlined 

below), regardless of the number of 

samples collected/analyzed in that 

window. 

Web-Posting Establishment 

Performance 

Should FSIS move forward with 

finalizing the proposed pathogen 

reduction performance standards for 

Salmonella in raw comminuted pork 

and raw intact or non-intact pork cuts, 

FSIS would announce the final 

standards and the sample dates FSIS 

will use to assess whether 

establishments meet the standards in a 

subsequent Federal Register notice. 

About one year after FSIS starts 

assessing whether establishments meet 

the standards, FSIS would determine 

individual establishment performance 

based on the last 52 FSIS Salmonella 

sample results and then report on the 

FSIS website the category of each 

establishment subject to the 

performance standard using the 

following criteria: 

• Category 1: Establishments with 

50% or less of the allowable number of 

positive Salmonella sample results for 

that product class during the most 

recent 52-week window, based on the 

last 52 FSIS Salmonella sample results. 

• Category 2: Establishments with 

greater than 50% but not more than the 

allowable number of positive 

Salmonella sample results for that 

product class during the most recent 52- 

week window, based on the last 52 FSIS 

Salmonella sample results. 

• Category 3: Establishments with 

more than the allowable number of 

positive Salmonella sample results for 

that product class during the most 

recent 52-week window, based on the 

last 52 FSIS Salmonella sample results. 

During the period after FSIS begins to 

make performance assessments based on 

the proposed standards, and before the 

performance standards are 

implemented, FSIS intends to make 

available monthly aggregate information 

relative to status (i.e., Category 1, 

Category 2, or Category 3) for all 

establishments subject to sampling 

under the final performance standards, 

using the most recent FSIS Salmonella 

sample results. This information will be 

aggregated and will not identify any 

specific establishment. FSIS would 

make this information available to give 

industry and other stakeholders timely 

information about progress being made 

to reduce Salmonella contamination in 

raw comminuted pork and raw intact or 

non-intact pork cuts. 

Related Agency Verification Actions 

An establishment that does not meet 

a pathogen reduction performance 

standard or produces product that has 

been associated with an outbreak may 

not have adequately addressed the food 

safety hazard, Salmonella, in its HACCP 

system. If the establishment considers 

Salmonella reasonably likely to occur 

and addresses Salmonella in its HACCP 

plan, it must take corrective actions as 

required in 9 CFR 417.3(a). If the 

establishment considers Salmonella not 

reasonably likely to occur, it must take 

corrective actions and reassess its 

HACCP plan for that product to 

determine whether the plan needs to be 

modified to address Salmonella as a 

hazard reasonably likely to occur (9 CFR 

417.3(b)). To maintain an adequate 

HACCP system, the establishment may 

need to address the pathogen 

Salmonella in its HACCP plan, rather 

than through Sanitation Standard 

Operating Procedures (Sanitation SOPs) 

or another prerequisite program. 

Corrective actions taken in response to 

exceeding a pathogen reduction 

performance standard would need to be 

documented in records subject to 

verification by FSIS as required in 9 

CFR 417.3(c)). 

When a pork establishment does not 

meet a Salmonella performance 

standard (i.e., when the number of 

positive samples within a specified 

timeframe exceeds the number of 

allowable positives for that product 

class), FSIS may conduct follow-up 

sampling after the establishment is 

categorized as Category 3 to verify the 

adequacy of corrective actions taken by 

the establishment. The follow-up 

samples would not count towards the 

samples collected as part of the moving 

window procedure for assessing 

whether the establishment meets the 

standard. Follow-up sampling for 

establishments that do not meet the raw 

comminuted pork and/or raw pork cuts 

performance standard for an extended 

period of time, or that fluctuate between 

meeting or not meeting one or both of 

these performance standards, would 

occur at a frequency determined by 

FSIS.20

In addition, FSIS may conduct a 

Public Health Risk Evaluation (PHRE), a 

decision-making process that is used by 

Agency enforcement and investigation 

personnel, for any pork establishment 

that (a) does not meet a Salmonella 

pathogen reduction performance 

standard; (b) has produced products 

with repetitive Salmonella serotypes of 

public health concern 21 or repetitive 

antibiotic-resistant Salmonella; and/or 

(c) has Salmonella whole-genome 

sequencing (WGS) matching those 

found in recent outbreaks or 

epidemiologically linked to illnesses 

(see FSIS Directive 5100.4 at https://

www.fsis.usda.gov/wps/wcm/connect/ 

6c30c8b0-ab6a-4a3c-bd87- 

fbce9bd71001/ 

5100.4.pdf?MOD=AJPERES). FSIS 

would use the results of the PHRE to 

determine whether to schedule a Food 

Safety Assessment (FSA) 22 at the 

establishment. 

As explained above, and also 

consistent with existing FSIS 


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23FSIS stated in a Federal Register notice 

published April 16, 2003 (68 FR 18593), that it was 

using Salmonella sample-set failures ‘‘as an 

indication that there is something wrong in the 

establishment’s HACCP system, and that the system 

needs to be carefully evaluated by the Agency.’’ 

More recently, FSIS announced the same course of 

action for poultry products subject to pathogen 

reduction performance standards on February 11, 

2016 (81 FR 7288). 

24FSIS Notice 41–19, Raw Pork Products 

Sampling Program; Oct. 28, 2019. 

25 In microbiology, the term ‘‘isolates’’ refers to 

strains of microorganisms isolated for study. 

practices,23 after notifying a pork 

establishment that it is in Category 3 

(has not met a pathogen reduction 

performance standard), FSIS would 

conduct an assessment of the 

establishment’s HACCP plan and 

Sanitation SOPs, through a PHRE and 

possible subsequent FSA, focusing on 

the establishment’s corrective actions, 

HACCP plan reassessment (if 

applicable), and the effectiveness of the 

establishment’s system for controlling 

Salmonella in raw pork products. In 

addition, when necessary, FSIS would 

develop a plan to verify whether the 

establishment implemented corrective 

actions. If, after 120 days from not 

meeting the standard, the establishment 

has not been able to demonstrate 

reduced variability of process control, as 

determined from FSIS’ follow-up and 

routine sampling and in some cases 

from the results of a PHRE or an FSA, 

and the establishment has not taken 

corrective actions, FSIS would likely 

take an enforcement action, such as 

issuing a Notice of Intended 

Enforcement (NOIE) or suspending 

inspection, under the conditions and 

according to the procedures described 

in 9 CFR part 500. FSIS would not issue 

an NOIE or suspend inspection based 

solely on the fact that an establishment 

did not meet a pathogen reduction 

performance standard for Salmonella. 

Although establishments producing 

less than or equal to 6,000 pounds per 

day of raw comminuted pork and/or less 

than or equal to 50,000 pounds per day 

of raw intact or non-intact pork cuts 

would not be subject to the proposed 

performance standards, FSIS may 

initiate follow-up sampling and/or 

conduct a PHRE or a FSA in these 

establishments when there is evidence 

of a high level of Salmonella 

contamination and for any of the 

reasons listed above, other than failing 

to meet the performance standard. 

Establishments producing less than or 

equal to 1,000 pounds per day would 

not be sampled and are not eligible for 

performance standards. However, 

recognizing that establishments 

producing greater than 1,000 pounds 

per day but less than or equal to 6,000 

pounds per day of raw comminuted 

pork, and greater than 1,000 pounds per 

day but less than or equal to 50,000 

pounds per day of raw intact or nonintact pork cuts, would not be subject to 

the proposed performance standards, 

FSIS would continue the current 

sampling program discussed above to 

monitor this population of lower 

volume establishments.24 FSIS would 

sample and test product from these 

establishments at a yearly rate that 

would allow the Agency to determine 

whether there has been a significant 

change in Salmonella prevalence at 

these establishments by +/¥5 percent. 

FSIS would review changes in 

prevalence over time in aggregate for 

this population of establishments and 

determine whether it is improving. If 

not, FSIS may increase sampling at that 

volume class in order to assess what is 

happening at the establishment level. 

As previously announced in a 2012 

Federal Register notice on Agency 

verification procedures, if any livestock 

establishment produces product 

associated with a Salmonella illness 

outbreak identified through 

epidemiological and/or traceback 

investigations, FSIS likely will consider 

the product to be adulterated under 21 

U.S.C. 601(m)(3) because the product is 

‘‘unsound, unhealthful, unwholesome, 

or otherwise unfit for human food’’ (77 

FR at 72689; Dec. 6, 2012). In such 

cases, the Agency would request that 

the establishment recall the product if it 

is still in commerce. Additionally, in 

such situations, even if the 

establishment is meeting a Salmonella 

performance standard, FSIS will 

scrutinize its corrective actions closely 

and may conduct an Incident 

Investigation Team review (see FSIS 

Directive 5500.3 at https://

www.fsis.usda.gov/wps/wcm/connect/ 

bf3095f8-c6aa-4ed7-b819-

45668c05c44b/5500.3.pdf?MOD

=AJPERES). 

FSIS monitors relevant databases (e.g., 

those maintained by the CDC and the 

National Institutes of Health) for clinical 

isolates 25 that match (via WGS) food 

isolates obtained by FSIS in its sampling 

of products produced by official 

establishments. This monitoring gives 

FSIS early warning that an outbreak 

involving an establishment’s product 

could be developing. FSIS may alert its 

public health partners if it appears there 

are human illness (clinical isolates) and 

food isolate matches indicating a 

potential emerging outbreak. In such 

situations, FSIS may also collect 

distribution information (e.g., the 

consignee list) for product produced, so 

as to focus its attention on the 

geographic area in which the affected 

product was distributed. 

Cost-Benefit Analysis 

FSIS has considered the economic 

effects of the proposed pathogen 

reduction performance standards for 

Salmonella in raw comminuted pork 

and raw intact or non-intact pork cuts. 

The full analysis is published on the 

FSIS website as supporting 

documentation to this notice ([insert 

link]). FSIS is seeking comment on the 

information and assumptions used in 

the cost-benefit analysis. A summary of 

the analysis follows. 

Industry Costs 

FSIS predicts that approximately 44 

percent of the medium and highervolume raw comminuted pork 

establishments (about 61 

establishments) and 39 percent of the 

higher-volume intact or non-intact pork 

cuts establishments (about 15 

establishments) would not initially meet 

the standards. Establishments meeting 

the performance standards would not 

have any cost associated with these 

standards. In order to ensure their 

HACCP systems are functioning 

correctly, establishments not meeting 

the performance standards would incur 

cost associated with a HACCP plan 

reassessment and possibly with an 

Agency Food Safety Assessment (FSA), 

the associated primary industry costs 

being $18,203 and $1,361, respectively, 

annualized at the 7 percent discount 

rate over 10 years. 

Establishments that initially do not 

meet the proposed standards but aspire 

to do so, would incur additional cost. 

For those establishments initially not 

meeting the performance standards, 

FSIS assumes approximately 45 percent 

would start making changes after one 

year and eventually would meet the 

standards in two years by making 

changes to their production process. 

Based on available information, FSIS 

expects that these establishments would 

most likely add antimicrobial 

interventions and equipment to their 

production process to meet the 

performance standard, with an 

associated primary cost of $1,236,391, 

annualized at the 7 percent discount 

rate over 10 years. These establishments 

may also add Salmonella testing to their 

existing sampling program or start 

Salmonella sampling and testing, with 

an associated primary cost of $122,451, 

annualized at the 7 percent discount 

rate over 10 years. These establishments 

would also likely validate their HACCP 

plans, and/or conduct training, with an 

associated total primary industry cost of 

$114,903 and $11,097, annualized at the 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 8779 

26FSIS Annual Sampling Plan FY2021: Table A3: 

FY 2020 and FY 2021 Sample Numbers for Raw 

Pork; available at https://www.fsis.usda.gov/sites/ 

default/files/media_file/2021-02/fsis-annualsampling-plan-fy2021.pdf. 

27FSIS Notice: Raw Pork Parts Sampling 

Program; available at https://www.fsis.usda.gov/wps

/wcm/connect/e2176090-7257-4d6e-9964- 

e9b8a512d8b5/41-19.pdf?MOD=AJPERES. 

28EIAO Public Health Risk Evaluation (PHRE) 

methodology Implementation of FSIS Directive 

5100.4 (September 2016) report. The FSA cost 

estimate includes travel cost to the establishment. 

29FSIS defined the following categories for 

broiler and turkey slaughter establishments in 2006: 

Category 1: Consistent Process Control: 

Establishments that have achieved 50 percent or 

less of the Salmonella maximum allowable percent 

positive during all completed 52-week moving 

windows over the last 3 months. Category 2. 

Variable Process Control: Establishments that meet 

the Salmonella maximum allowable percent 

positive for all completed 52-week moving 

windows but have results greater than 50 percent 

of the maximum allowable percent positive during 

any completed 52-week moving window over the 

last 3 months. Category 3. Highly Variable Process 

Control: Establishments that have exceeded the 

Salmonella maximum allowable percent positive 

during any completed 52-week moving window 

over the last 3 months. Changes to the Salmonella 

and Campylobacter Verification Testing Program, 

Federal Register, Vol. 80, No. 16, January 26, 2015. 

Docket No. FSIS–2014–0023. 

30Marsh, T.L., T.C. Schroeder, J. Mintert. (2004). 

Impacts of Meat Product Recalls on Consumer 

Demand in the USA. Applied Economics. 

36(9):897–909. URL accessed on July 1, 2020; 

available at http://ses.wsu.edu/publication/impactsof-meat-product-recalls-on-consumer-demand-inthe-usa/. 

7 percent discount rate over 10 years, 

respectively. 

Total industry cost ranges from 

$1,163,796 to $1,842,518, with a 

primary estimate of $1,504,406, 

annualized at the 7 percent discount 

rate over 10 years, table 2. The majority 

of these costs are associated with 

antimicrobial equipment maintenance 

and labor incurred by establishments 

that initially do not meet the 

performance standards but attempt to 

meet the standards. Establishments that 

meet the performance standards would 

incur minimal cost associated with lost 

product due to FSIS Salmonella 

sampling. 

Agency Costs 

The raw comminuted pork and raw 

intact or non-intact performance 

standards would require FSIS sampling, 

which would incur Agency cost for 

follow-up sampling. FSIS estimates that 

total sampling for the performance 

standards, including follow-up 

sampling and lower-volume sampling, 

would be 12,232 samples. However, in 

2021 FSIS planned for 8,640 raw 

comminuted pork Salmonella samples 

and 2,400 raw intact or non-intact pork 

cuts samples for a total of 11,040 

samples 26 for the Raw Pork Sampling 

Program.27 The raw comminuted pork 

and raw intact or non-intact 

performance standards would replace 

the Raw Pork Sampling Program, 

leading to a net increase of 1,192 

samples, which are attributed to followup sampling. The primary cost estimate 

for the additional 1,192 follow-up 

samples is $81,508, annualized at the 7 

percent discount rate over ten years. 

FSIS would also incur costs from 

PHREs and FSAs. Pork establishments 

that do not meet the Salmonella 

pathogen reduction performance 

standards would be prioritized for a 

PHRE. A portion of the establishments 

that receive a PHRE would also have an 

FSA.28 The combined PHRE and FSA 

primary cost estimate is $20,988, 

annualized at the 7 percent over 10 

years. 

The total Agency cost for follow-up 

sampling, PHREs and FSAs ranges from 

$0.06 million to $0.18 million, with a 

primary estimate of $0.10 million, 

annualized at the 7 percent over 10 

years, table 2. 

Public Health Benefits 

As pork establishments subject to the 

proposed performance standards make 

changes to their production processes 

and reduce the prevalence of 

Salmonella in raw comminuted pork 

and intact or non-intact pork cuts, 

public health benefits would be realized 

in the form of averted illnesses. The 

Agency’s policy of web-posting 

establishments’ process control 

performance may stimulate 

improvement in industry performance. 

FSIS data show that sharing this 

information provides an incentive for 

establishments to further reduce 

Salmonella levels, which is necessary to 

reduce foodborne illness due to 

salmonellosis and protect consumers. 

For instance, in the poultry industry, 

after the Agency’s announcement in 

2006 that it was considering posting the 

names of broiler and turkey slaughter 

establishments with their respective 

performance standard categories based 

on Salmonella verification testing, the 

number of broiler slaughter 

establishments that had been in 

Category 3 decreased by 55 percent.29

As discussed in the 2020 Risk 

Assessment, FSIS estimated the annual 

Salmonella foodborne illnesses 

associated with pork products. FSIS 

then estimated the number of annual 

illnesses attributed to products subject 

to the updated or new performance 

standards. Finally, FSIS estimated the 

number of illnesses averted if 45 percent 

of the establishments that do not 

initially meet the standards, meet the 

standards over the course of two years. 

Additionally, FSIS estimated the cost 

savings associated with the percentage 

reduction in human illnesses as 

calculated in the 2020 Risk Assessment. 

The estimated public health benefits 

from the illnesses averted because of the 

proposed Salmonella pork performance 

standards ranges from $49.09 million to 

$203.24 million, with a primary 

estimate of $107.94 million, annualized 

at the 7 percent discount rate over 10 

years, table 2. 

Industry Benefits 

FSIS expects that industry would 

benefit from reduced outbreak-related 

recalls. The negative impacts of recalls 

on industry include the loss of sales 

revenue, the loss of consumer 

confidence and consumers shifting 

away from meat products.30 Recalls 

negatively impact consumers by 

creating anxiety and time-consuming 

inconveniences (e.g., looking for recall 

information, checking the products 

purchased, returning or disposing of 

products identified by the recalls, and 

so on). FSIS expects the proposed raw 

comminuted pork and intact or nonintact pork cuts performance standards 

would lead to fewer contaminated 

products, because of industry actions 

taken to reduce Salmonella in these 

products to meet the proposed 

performance standards. The reduction 

in Salmonella would result in less 

exposure to Salmonella for consumers 

that eat pork products and fewer 

illnesses, outbreaks, and recalls. 

Summary of Net Benefits 

Table 2 displays the total costs and 

benefits expected from the 

implementation of the performance 

standards for raw comminuted pork and 

raw intact or non-intact pork cuts 

establishments. There would be 138 

establishments subject to the raw 

comminuted pork performance standard 

and 38 establishments subject to the 

intact or non-intact pork cuts 

performance standard. These 

establishments represent 96 and 91 

percent of total production volume, 

respectively. The proposed performance 

standards would lead to industry cost 

for these establishments and FSIS 

would incur Agency cost implementing 

these standards. Benefits would occur 

once establishments who initially do 

not meet the standard make changes to 

meet the performance standards. The 

net benefits are the public health 

benefits minus the industry and agency 

cost. The estimated net benefits 

associated with the proposed 

Salmonella pork performance standards 

range from $47.87 million to $201.22 


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8780 Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 

million, with a primary estimate of 

$106.33 million, annualized at the 7 

percent discount rate over 10 years, 

table 2. 

TABLE 2—SUMMARY OF ESTIMATED NET BENEFITS 1

Compliance rate 2 Cost/benefit component 

Low 

estimate 

($mil) 

Primary 

estimate 

($mil) 

High 

estimate 

($mil) 

45% .................................................. Industry Costs ............................................................... $1.16 $1.50 $1.84 

Agency Cost .................................................................. 0.06 0.10 0.18 

Public Health Benefits ................................................... 49.09 107.94 203.24 

Net Benefits 3 ................................................................ 47.87 106.33 201.22 

1All costs (savings) annualized at a discount rate of 7 percent over 10 years. Numbers in table may not sum to totals due to rounding. 2 Compliance rate for establishments initially not meeting the proposed standards, but then meeting the proposed standards over 2 years. 

3 Numbers in the table may not sum to totals due to rounding. 

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. 

Paul Kiecker, 

Administrator. 

[FR Doc. 2022–03301 Filed 2–15–22; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food and Nutrition Service 

Child Nutrition Programs: Income 

Eligibility Guidelines 

AGENCY: Food and Nutrition Service, 

USDA. 

ACTION: Notice. 

SUMMARY: This notice announces the 

Department’s annual adjustments to the 

Income Eligibility Guidelines to be used 

in determining eligibility for free and 

reduced price meals and free milk for 

the period from July 1, 2022 through 

June 30, 2023. These guidelines are used 

by schools, institutions, and facilities 

participating in the National School 

Lunch Program (and Commodity School 

Program), School Breakfast Program, 

Special Milk Program for Children, 

Child and Adult Care Food Program and 

Summer Food Service Program. The 

annual adjustments are required by 

section 9 of the Richard B. Russell 

National School Lunch Act. The 

guidelines are intended to direct 

benefits to those children most in need 

and are revised annually to account for 

changes in the Consumer Price Index. 

DATES: Applicable Date: July 1, 2022. 

FOR FURTHER INFORMATION CONTACT: J. 

Kevin Maskornick, Program Monitoring 

and Operational Support Division, 

Child Nutrition Programs, Food and 

Nutrition Service, United States 

Department of Agriculture, 1320 

Braddock Place, Suite 401, Alexandria, 

Virginia 22314, 703–305–2537. 

SUPPLEMENTARY INFORMATION: This 

action is not a rule as defined by the 

Regulatory Flexibility Act (5 U.S.C. 

601–612) and thus is exempt from the 

provisions of that Act. 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

no recordkeeping or reporting 

requirements have been included that 

are subject to approval from the Office 

of Management and Budget. 

This notice has been determined to be 

not significant and was not reviewed by 

the Office of Management and Budget in 

conformance with Executive Order 

12866. 

The affected programs are listed in the 

Assistance Listings (https://

beta.sam.gov/) under No. 10.553, No. 

10.555, No. 10.556, No. 10.558, and No. 

10.559 and are subject to the provisions 


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