This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

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rulings, delegations of authority, filing of

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examples of documents appearing in this

section.

Notices Federal Register

3940 

Vol. 80, No. 16 

Monday, January 26, 2015 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2014–0023] 

Changes to the Salmonella and 

Campylobacter Verification Testing 

Program: Proposed Performance 

Standards for Salmonella and 

Campylobacter in Not-Ready-to-Eat 

Comminuted Chicken and Turkey 

Products and Raw Chicken Parts and 

Related Agency Verification 

Procedures and Other Changes to 

Agency Sampling 

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 new 

pathogen reduction performance 

standards for Salmonella and 

Campylobacter in raw chicken parts and 

not-ready-to-eat (NRTE) comminuted 

chicken and turkey products. 

The Agency is also announcing its 

plans to begin sampling raw chicken 

parts to gain additional information on 

the prevalence and the microbiological 

characteristics of Salmonella and 

Campylobacter in those products. In 

addition, FSIS intends to begin an 

exploratory sampling of raw pork 

products for pathogens of public health 

concern, as well as for indicator 

organisms. 

Finally, FSIS is announcing that it 

plans to use routine sampling 

throughout the year rather than 

infrequently sampling on consecutive 

days to assess whether establishments’ 

processes are effectively addressing 

Salmonella and, where applicable, 

Campylobacter on poultry carcasses and 

other products derived from these 

carcasses, including chicken parts and 

comminuted chicken and turkey 

product. FSIS intends to perform this 

assessment using a moving window of 

sampling results. 

FSIS will proceed with implementing 

the routine sampling of raw chicken 

parts and the changes to specified 

verification procedures on the dates 

announced in this notice. However, 

FSIS is seeking comments on its 

implementation strategy as part of its 

effort to continuously assess and 

improve the effectiveness of Agency 

policy. 

DATES: Submit comments on or before 

March 27, 2015. In March 2015, the 

Agency plans to begin routine sampling 

of raw chicken parts as one of the 

several routine verification testing 

programs. Also, in March 2015, the 

Agency plans to begin using the moving 

window approach (explained below) 

rather than the consecutive day 

approach for assessing all verification 

testing. 

In March 2015, FSIS intends to begin 

exploratory sampling of raw pork 

products. In March 2015, FSIS also 

intends to begin sampling imported 

poultry carcasses, imported raw chicken 

parts, and imported NRTE comminuted 

chicken and turkey for Salmonella and 

Campylobacter. Finally, in March 2015, 

FSIS will start posting aggregate reports 

showing the category distribution for 

comminuted chicken and turkey using 

historical data and new results based on 

the proposed standards for comminuted 

product. As data become available 

following the new testing that FSIS will 

begin in March, FSIS will also begin 

posting aggregate reports showing the 

category distribution for chicken parts, 

based on the proposed standards for 

parts. 

After reviewing the comments 

received on this notice, beginning July 

1, 2015, the Agency plans to begin 

posting individual establishment 

category information for poultry 

carcasses. 

ADDRESSES: FSIS invites interested 

persons to submit comments on the new 

performance standards and other issues 

identified in the notice for comment. 

FSIS is not requesting comment on the 

new testing of imported product, 

chicken parts, or pork products because 

FSIS needs to begin this testing to gather 

additional information, and because 

FSIS is not assessing whether 

establishments producing these product 

meet performance standards at this 

time. Comments may be submitted by 

one of the following methods: 

Federal eRulemaking Portal: This 

Web site provides the ability to type 

short comments directly into the 

comment field on this Web page or 

attach a file for lengthier comments. Go 

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

the on-line instructions at that site for 

submitting comments. 

Mail, CD–ROMs: Send to Docket 

Clerk, U.S. Department of Agriculture, 

Food Safety and Inspection Service, 

Patriots Plaza 3, 355 E Street SW., 

Mailstop 3782, Room 8–163B, 

Washington, DC 20250–3700. 

Hand- or courier-delivered submittals: 

Deliver to Patriots Plaza 3, 355 E Street 

SW., Room 8–163A, Washington, DC 

20250–3700. 

Instructions: All items submitted by 

mail or electronic mail must include the 

Agency name and docket number FSIS– 

2014–0023. Comments received in 

response to this docket will be made 

available for public inspection and 

posted without change, including any 

personal information, to http://

www.regulations.gov. 

Docket: For access to background 

documents or to comments received, go 

to the FSIS Docket Room at Patriots 

Plaza 3, 355 E Street SW., Room 164– 

A, Washington, DC 20250–3700 

between 8:00 a.m. and 4:30 p.m., 

Monday through Friday. 

FOR FURTHER INFORMATION CONTACT: 

Daniel L. Engeljohn, Ph.D., Assistant 

Administrator, Office of Policy and 

Program Development; Telephone: (202) 

205–0495, or by Fax: (202) 720–2025. 

Background 

FSIS is responsible for verifying that 

the nation’s commercial supply of meat, 

poultry, and egg products is safe, 

wholesome, and properly labeled and 

packaged. 

Salmonella and Campylobacter 

bacteria are among the most frequent 

causes of foodborne illness. These 

bacteria can reside in the intestinal tract 

of animals, including birds. Salmonella 

and Campylobacter contamination of 

raw poultry products occurs during 

slaughter operations, as well as during 

the live-animal rearing process (e.g., onfarm contamination can coat the exterior 

of the bird and remain attached to the 

skin). Currently, events that cause 

contamination of raw carcasses cannot 

be eliminated through the commercial 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 3941 

1ERS, http://www.ers.usda.gov/data-products/

food-availability-(per-capita)-data-system.aspx. 

2NCC, 2011. Broiler Industry Marketing Survey 

Report, http://

members.www.nationalchickencouncil.org/wpcontent/uploads/2013/02/2011-Broiler-IndustrySurvey-Report.pdf. 

3FSIS, 2009. The nationwide microbiological 

baseline data collection program: Young chicken 

survey: July 2007– June 2008. U. S. Department of 

Agriculture, Washington D.C. 

4FSIS, 2010. The nationwide microbiological 

baseline data collection program: Young turkey 

survey. August 2008—July 2009. U. S. Department 

of Agriculture, Washington D.C. 

5FSIS considers ‘‘NRTE comminuted poultry’’ to 

be any NRTE chicken or turkey product that has 

been ground, mechanically separated, or hand- or 

mechanically deboned and further chopped, flaked, 

minced or otherwise processed to reduce particle 

size (77 FR 72687). 

6This sampling and testing for Salmonella and 

Campylobacter did not include heat-treated NRTE 

comminuted chicken or turkey. 

7http://www.fsis.usda.gov/wps/portal/fsis/topics/

data-collection-and-reports/microbiology/quarterlyreports-salmonella. 

8http://www.fsis.usda.gov/salmonella. 

production and slaughter practices 

employed in the United States. 

Contamination can be minimized, 

however, with the use of proper sanitary 

dressing procedures and by the 

application of antimicrobial 

interventions during slaughter and 

thereafter during fabrication of the 

carcasses into parts and comminuted 

product. 

Salmonella and, to a lesser extent, 

Campylobacter may increase on raw 

poultry if the product is improperly 

stored at temperatures conducive to 

their growth. Moreover, if these 

pathogens are present on raw poultry, 

they will survive on the product if the 

product is not subjected to a full 

lethality treatment such as thorough 

cooking before being presented for 

human consumption. Also, if raw 

poultry is improperly handled during 

food preparation, Salmonella and 

Campylobacter can cross-contaminate 

other foods or food contact surfaces. 

The Salmonella verification testing 

program began with the Agency’s final 

rule ‘‘Pathogen Reduction; Hazard 

Analysis and Critical Control Point’’ 

(PR/HACCP Rule), which was issued on 

July 25, 1996 (61 FR 38805). Among 

other things, the PR/HACCP Rule set 

Salmonella pathogen reduction 

performance standards for 

establishments that slaughter selected 

classes of food animals or that produce 

selected classes of raw ground products. 

FSIS uses the pathogen reduction 

performance standards to ensure that 

eligible establishments are consistently 

controlling or reducing harmful bacteria 

on raw meat and poultry products. 

The microbiological performance 

standards for the reduction of 

Salmonella in raw products allow FSIS 

to verify whether establishments have 

effective process controls to address 

Salmonella. The sample sets were 

designed to assess the presence of 

Salmonella in a specified number of 

samples collected daily for a sufficient 

number of days to discern an 

establishment’s capability to sustain 

long term process control. For example, 

the 2011 broiler carcass pathogen 

reduction performance standard 

consisted of 51 samples with 5 positive 

samples being the acceptable limit in 

the set positive for Salmonella. 

Additionally, FSIS set criteria for which 

establishments were to be included in 

the verification testing program. Only 

broiler establishments that slaughter at 

least 20,000 birds annually are currently 

subject to FSIS Salmonella sampling 

and testing. A lower volume of birds 

would likely be slaughtered 

intermittently throughout the year 

rather than daily, and thus it would 

likely take a year or more to complete 

a set. 

FSIS conducted the Nationwide 

Microbiological Baseline Data 

Collection Programs: Raw Chicken Parts 

Baseline Survey (RCPBS) from January 

2012 to August 2012 to estimate the 

percent positive of various raw chicken 

parts sampled and the levels of 

Salmonella, Campylobacter, and 

indicator bacteria on these products. 

FSIS used this information to estimate 

national prevalence of the two 

pathogens on raw chicken parts. An 

overview of the RCPBS is available at 

http://www.fsis.usda.gov/wps/wcm/

connect/a9837fc8-0109-4041-bd0c729924a79201/Baseline_Data_Raw_

Chicken_Parts.pdf?MOD=AJPERES. 

Based on available data, about 85 

percent of poultry products available to 

consumers are chicken,1 and about 80 

percent of the chicken product is in the 

form of raw chicken parts fabricated 

from broiler carcasses.2 The amount of 

chicken parts available from fabricated 

broiler carcasses is larger than that of 

turkey carcasses that are fabricated into 

raw turkey parts and available to 

consumers. Also, there is more 

contamination of broiler carcasses with 

Salmonella and Campylobacter 

compared to turkey carcasses. For 

example, in 2008, FSIS found that 

broiler carcasses had a Salmonella 

prevalence of 7.5 percent,3 while in 

2009 turkey carcasses had Salmonella 

prevalence of 1.7 percent.4 Given the 

higher percentages of these positives in 

broiler carcasses and higher volume of 

raw chicken parts produced, FSIS 

conducted its baseline on chicken parts 

only. 

In the Federal Register notice of 

December 6, 2012, (77 FR 72686), FSIS 

informed establishments producing 

NRTE comminuted poultry products 5

that they were required to reassess their 

Hazard Analysis and Critical Control 

Point (HACCP) plans for these products. 

In that same notice, FSIS announced 

that it would expand its Salmonella 

sampling beyond ground chicken and 

turkey to include all forms of nonbreaded, non-battered comminuted 

NRTE chicken or turkey products not 

destined for further processing into 

ready-to-eat (RTE) products. In addition, 

FSIS announced that it was moving its 

microbiological testing for Salmonella 

and Campylobacter for these products 

from a 25-gram test portion to 325 

grams. Finally, FSIS explained that it 

would use the sampling results to 

determine the prevalence of Salmonella 

and Campylobacter in NRTE 

comminuted chicken and turkey and to 

develop pathogen reduction 

performance standards for these 

products. 

FSIS began sampling and testing 

NRTE comminuted chicken and turkey 

products on June 1, 2013.6 FSIS has 

posted the aggregate results of this 

testing for all finished products as part 

of its quarterly Salmonella report.7

On April 21, 2014, FSIS responded to 

all relevant comments received on the 

December 2012 notice. As the April 

2014 notice explains, after carefully 

considering all of the comments, FSIS 

decided that it would proceed as 

announced with analyzing the 

comminuted product testing data to 

establish pathogen reduction 

performance standards for NRTE 

comminuted chicken and turkey as 

originally planned. FSIS also provided 

other updates, including the status of 

HACCP plan reassessments, information 

on Food Safety Assessments (FSAs) in 

establishments producing comminuted 

poultry product, and details on how 

FSIS intends to evaluate the exploratory 

testing data and information gathered 

from surveying its poultry inspection 

program personnel. A summary report 

of this survey, the FSIS Poultry 

Checklist, which also showed that the 

majority of establishments are not 

currently applying antimicrobials to raw 

poultry parts and NRTE comminuted 

poultry product components, is 

available on FSIS’s Web site at http://

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

902e9de8-712c-4d74-a223- 

c9ef4b37464a/poultrychecklist.pdf?MOD=AJPERES. 

FSIS announced its Salmonella 

Action Plan (SAP) on December 4, 

2013.8 In the plan, FSIS announced that 


emcdonald on DSK67QTVN1PROD with NOTICES
3942 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 

9 76 FR 15282. 

10Available at http://www.healthypeople.gov/

2020/topicsobjectives2020/

objectiveslist.aspx?topicId=14. 

11Public Health Effects of Raw Chicken Parts and 

Turkey Performance Standards, 2014. FSIS. 

12 76 FR 15282; Mar. 14, 2011. 

13http://www.cdc.gov/mmwr/pdf/wk/

mm6315.pdf. These surveillance data are for all 

foods, not just FSIS-regulated foods. 

14Painter, et al., 2013 available at http://

wwwnc.cdc.gov/eid/article/19/3/11–1866_article. 

15Available at http://

www.nationalchickencouncil.org/about-theindustry/statistics/how-broilers-are-marketed/. 

it would complete a risk assessment and 

develop pathogen reduction 

performance standards for NRTE 

comminuted chicken and turkey and 

raw chicken parts. FSIS also announced 

in the SAP that it would explore 

developing a Salmonella sampling 

program for pork products. In March 

2015, FSIS intends to begin an 

exploratory sampling of raw pork 

products for pathogens of public health 

concern, as well as for indicator 

organisms. 

Pathogen Reduction Performance 

Standards 

In general, illnesses should be 

reduced as establishments reduce the 

occurrence of pathogens on their 

products. Thus, consistent with the 

rationale discussed in the March 21, 

2011 Federal Register notice,9 reduced 

illnesses should result from the 

implementation of pathogen reduction 

performance standards to reduce the 

occurrence of pathogens on chickens 

and turkeys. 

The Healthy People 2020 (HP2020) 

goal is to reduce human illness from 

Salmonella by about 25 percent by the 

year 2020.10 In order to meet this 

objective for all poultry products, the 

Agency is proposing a pathogen 

reduction performance standard 

designed to achieve at least a 30 percent 

reduction in illnesses from Salmonella 

for chicken parts, comminuted chicken, 

and comminuted turkey. 

The HP2020 goal for Campylobacter is 

to achieve a 33 percent reduction in 

human illnesses from this pathogen. For 

chicken parts and comminuted chicken, 

FSIS is proposing a pathogen reduction 

performance standard designed to 

reduce illness from Campylobacter by 

about 33 percent. However, because 

FSIS found the prevalence for 

Campylobacter in comminuted turkey to 

be especially low,11 the highest practical 

reduction for this product was estimated 

to be 19 percent. Therefore, for this one 

product-pathogen pair, comminuted 

turkey and Campylobacter, FSIS is 

proposing a reduction less than its 

stated goal. The methods for developing 

the pathogen reduction performance 

standards and predictions for the public 

health effect of those standards are 

described in Public Health Effects of 

Raw Chicken Parts and Comminuted 

Chicken and Turkey Performance 

Standards (2015 Risk 

Assessment)(http://www.fsis.usda.gov/

wps/wcm/connect/afe9a946-03c6-4f0db024-12aba4c01aef/EffectsPerformance-Standards-Chicken-PartsComminuted.pdf?MOD=AJPERES). FSIS 

used the same methodology to estimate 

the public health effects for the young 

chicken and turkey performance 

standards in 2011.12

The 2015 Risk Assessment describes 

how Salmonella- and Campylobacterpositive samples will be used to 

categorize establishments as either 

meeting or not meeting the applicable 

performance standard for chicken parts 

or comminuted chicken or turkey. FSIS 

used a common analytical framework to 

estimate the improvements in public 

health (illnesses averted) associated 

with six separate pathogen reduction 

performance standards discussed as 

options considered in this notice. FSIS, 

based on the risk assessment 

predictions, estimated the reductions in 

salmonellosis and campylobacteriosis 

cases that would result if establishments 

made changes in their processes that 

would reduce the occurrence of these 

pathogenic bacteria in their products. 

Should FSIS finalize these pathogen 

reduction performance standards, once 

the Agency begins testing to implement 

the standards, the risk assessment 

model presents different scenarios 

under which the desired percent 

reduction in salmonellosis cases could 

be achieved across both chicken parts 

and comminuted poultry products. The 

risk assessment model also describes 

different scenarios under which 

reductions in Campylobacter illnesses 

could occur. 

Furthermore, despite a significant 

drop (a 9 percent decrease) in human 

illnesses from Salmonella in recent 

years, salmonellosis remains high in the 

U.S.13 About 33 percent of all food 

related salmonellosis cases are 

associated with products regulated by 

FSIS. Of these FSIS-associated illnesses, 

poultry represents about 58 percent of 

the cases with 85 percent being 

associated with chicken and 15 percent 

being associated with turkey.14 Of the 

illnesses from consuming chicken, FSIS 

estimates that 81 percent were 

associated with parts, 13 percent were 

associated with whole carcasses, and 6 

percent were associated with 

comminuted product.15

FSIS considered the results of the 

2015 Risk Assessment and selected 

performance standards for specified 

product-pathogen pairings based on the 

most likely within-establishment 

contamination distributions and a 50- 

percent compliance fraction for 

establishments not initially meeting the 

performance standard. Furthermore, 

FSIS chose, where feasible, performance 

standards expected to accomplish a 

reduction in Salmonella and 

Campylobacter illnesses on a productpathogen pair basis of at least 30 percent 

and 33 percent, respectively. 

FSIS chose this objective for productpathogen pairs for addressing 

Salmonella in FSIS-regulated products 

as it will help increase the likelihood 

that the HP2020 national goal of 

reducing human illness by 25 percent 

can be met across all poultry products. 

The proposed pathogen reduction 

performance standards for 

Campylobacter are also expected to 

achieve greater than a 30 percent 

reduction in campylobacteriosis from 

chicken parts and comminuted chicken, 

and a 19 percent reduction in illnesses 

from comminuted turkey. 

In combination, FSIS estimates that 

the implementation of performance 

standards for chicken products (existing 

and those proposed in this notice) may 

result in about a 31 percent reduction in 

salmonellosis. The estimated combined 

impact of implementing performance 

standards for turkey products (existing 

and those proposed in this notice) is 

about a nine percent reduction in 

salmonellosis. The overall estimated 

impact on salmonellosis is about a 28 

percent reduction for chicken and 

turkey products, thus satisfying the HP 

2020 objective of 25 percent. 

After it has considered comments 

received on this notice, FSIS will 

announce the final standards in the 

Federal Register. 

NRTE Comminuted Poultry— 

Salmonella 

For the purpose of developing a 

pathogen reduction performance 

standard for Salmonella in NRTE 

comminuted chicken and turkey 

products, FSIS evaluated the first eight 

months of data generated by the new 

sampling and testing program. FSIS 

chose to initiate development of a 

proposed standard now, using the first 

eight months of data, in order to 

expedite the process for proposing a 

new standard and for realizing the 

projected public health benefits from a 

final standard. FSIS does not expect 

there to be substantive differences in the 

first eight months of data compared to 

the overall outcome of a baseline testing 


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16MLG 4.08 is described at http://

www.fsis.usda.gov/wps/wcm/connect/700c05fe06a2-492a-a6e1-3357f7701f52/MLG4.pdf?MOD=AJPERES. 

17Uncertainty about total illnesses attributed to 

poultry is simulated to generate 5th and 95th 

quantile values. These values are multiplied by the 

predicted effects of the performance standards to 

generate 5th and 95th percentile values for the 

annual number of illnesses avoided by the 

performance standard. 

18http://www.sciencedirect.com/science/article/

pii/S0956713512002393. 

19AMS, Northeast & Southern States Monthly 

Report Data CY2013. 

period lasting at least one full year to 

more fully assess seasonal variation. 

However, if substantial differences are 

seen, FSIS could determine the effects 

of those differences on the standard 

prior to implementation. 

FSIS utilized its MLG 4.08 16 method 

to analyze samples of NRTE 

comminuted chicken and turkey 

products and parts for Salmonella. FSIS 

also used the 2015 Risk Assessment, 

which took into account the 

establishment by establishment 

incidence of Salmonella in NRTE 

comminuted chicken and turkey 

products and the predicted illnesses 

averted as a consequence of reducing 

the percentage positive of these 

pathogens. Because it is using an ongoing sampling approach, FSIS will be 

able to calculate national prevalence for 

Salmonella and Campylobacter at least 

on an annual basis. 

To obtain a better estimate of the 

overall prevalence of Salmonella and 

Campylobacter than a simple percent 

positive estimate, FSIS weighted the 

Salmonella and Campylobacter percent 

positive estimates by the production 

volume of each establishment for which 

there were sampling results. Using the 

first eight months of data, the national 

prevalence for Salmonella in NRTE 

comminuted chicken is about 49 

percent and in NRTE comminuted 

turkey is about 20 percent. The national 

prevalence for Campylobacter in NRTE 

comminuted chicken is about three 

percent, and in NRTE comminuted 

turkey is about one percent. 

Given that mechanically separated 

chicken and turkey are typically not 

added to NRTE comminuted poultry 

products, results for these products 

were not used in developing the 

Salmonella contamination distribution 

used in the risk assessment or the 

volume-weighted percent positive 

prevalence (VWPP) estimates above. It is 

important to note that the prevalence 

estimates were determined using the 

larger 325-gram analytical portion—a 

13-fold increase in size from the 25- 

gram portion used to make prior 

prevalence determinations. 

FSIS is proposing pathogen reduction 

performance standards that would 

achieve at least a 30-percent reduction 

in salmonellosis on a product-pathogen 

basis as a result of a reduction in 

exposure of the public to this pathogen 

when handling and preparing the 

product for consumption. To achieve 

this result for NRTE comminuted 

chicken, FSIS is proposing a pathogen 

reduction performance standard for 

Salmonella of 13 positives out of 52 

samples. 

Under this standard, the expected 

number of illnesses avoided would be 

about 3,100 (uncertainty interval (UI): 17

2,000–4,700). Based on the initial eight 

months of data collected, FSIS estimates 

that approximately 62 percent of 

establishments will initially fail the 

performance standard. As 

establishments make changes to meet 

the new performance standard, FSIS 

estimates that the VWPP of 49 percent 

from Salmonella in comminuted 

chicken would be reduced to 34 

percent. Evidence regarding FSIS’s 

testing to assess whether establishments 

met the chicken carcass Salmonella 

performance standard suggested an 

approximate 50-percent increase in the 

share of industry that met the 

performance standard after 24 months 

under the new performance standard.18

Therefore, FSIS estimates that 50 

percent of establishments that initially 

do not meet the new performance 

standard will meet it in about two years. 

FSIS expects the same for all products 

under the new standards announced in 

this notice, as further elaborated in the 

2015 Risk Assessment. 

For NRTE comminuted turkey, FSIS is 

proposing a performance standard that 

would achieve at least a 30- percent 

reduction in salmonellosis. FSIS is, 

therefore, proposing a pathogen 

reduction performance standard for 

Salmonella of seven positives out of 52 

samples for NRTE comminuted turkey. 

With that standard, FSIS estimates that 

the expected number of illnesses 

avoided would be about 2,400 (UI: 

1,500–3,600). Based on the initial eight 

months of data collected, approximately 

58 percent of establishments are 

predicted to initially fail the 

performance standard. As 

establishments make changes to meet 

the new performance standard, FSIS 

estimates that the VWPP of 20 percent 

of Salmonella in NRTE comminuted 

turkey will be reduced to 14 percent. 

Raw Chicken Parts—Salmonella 

FSIS developed the Salmonella 

pathogen reduction performance 

standard for raw chicken parts using the 

RCPBS data. Based on the baseline 

results, FSIS estimates that the national 

prevalence of Salmonella in four pound 

portions of raw chicken parts is about 

24 percent with a 95-percent confidence 

interval between 19 percent and 29 

percent. 

As stated above, FSIS is proposing at 

least a 30- percent reduction in 

salmonellosis from raw chicken parts. 

To achieve this reduction, FSIS is 

proposing a pathogen reduction 

performance standard for Salmonella of 

eight positives out of 52 samples for raw 

chicken parts. The expected number of 

illnesses avoided would be about 29,000 

(UI: 18,900—45,400). Based on the 2012 

chicken parts baseline data, 

approximately 63 percent of 

establishments are predicted to initially 

not meet the performance standard. As 

establishments make changes to meet 

the new performance standard, FSIS 

estimates that the VWPP of 28 percent 

of Salmonella in four pound portions of 

raw chicken parts (breasts, legs, and 

wings) will be reduced to 18 percent. 

The RCPBS expressly excluded 

chicken parts that were marinated or 

injected. The sampling of such products 

was not originally planned for under the 

new performance standards. Although 

during the period of test sampling 

before the baseline survey began (the 

shakedown period), FSIS did respond to 

questions about injected product and 

identified that products should not be 

sampled as part of the RCPBS. However, 

during the baseline survey, inspectors at 

multiple establishments confirmed that 

they collected sample parts that had 

been injected. In addition, since the 

shakedown, FSIS has determined that 

the additional handling of injected 

products marinated in a clear solution 

likely could cause additional 

contamination, particularly of the 

exterior surface of the poultry and that 

these products look no different to the 

consumer than products not injected or 

marinated (when done with a clear 

solution that may not be evident to the 

individual preparing the product) other 

than through the ingredient statement. 

FSIS will clarify that such products will 

be sampled as part of the exploratory 

chicken parts sampling that will start in 

March 2015 (detailed below). In 

addition, when the new performance 

standard for chicken parts is 

implemented, such products would be 

subject to sampling. FSIS invites 

comment on this issue. 

Breasts, legs, and wings are the most 

frequently produced chicken parts in 

the U.S. (>90 percent).19 During the 


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20More details about the analytical method are 

available at http://www.fsis.usda.gov/wps/wcm/

connect/0273bc3d-2363-45b3-befb-1190c25f3c8b/

MLG-41.pdf?MOD=AJPERES. 

21FSIS chose not to reduce the standard to three 

positives out of 52 samples because it would exceed 

the HP2020 national goal in excess of 10 percent. 

RCPBS, FSIS sampled additional parts, 

including necks, giblets, quarter 

carcasses, and half carcasses. Because of 

their high production representation, 

only breasts, legs, and wings were 

included in the risk assessment, and the 

draft performance standard will only 

apply to these parts. However, because 

the other types of chicken parts are 

available to consumers and present an 

exposure potential for both Salmonella 

and Campylobacter, FSIS recommends 

that industry put process controls in 

place to reduce contamination on these 

products. In cases where FSIS is 

concerned about the sanitary conditions 

in establishments, such as when an 

establishment is implicated in a foodborne outbreak, FSIS may collect 

samples of these other chicken parts to 

ascertain the level of process control in 

the establishment. When FSIS 

determines that there is reason to 

believe that the establishment is failing 

to maintain sanitary conditions, FSIS 

will require the establishment to 

demonstrate improved process control 

as evidenced by lower contamination 

incidence in these other chicken parts. 

In March 2015, the Agency plans to 

begin sampling raw chicken parts on an 

on-going basis. As with all of the 

pathogen reduction performance 

standards announced in this notice, 

FSIS will not begin applying the 

pathogen reduction performance 

standard for raw chicken parts until 

after it has considered comments 

received on this notice. Meanwhile, 

FSIS will gain experience in scheduling, 

collecting, and analyzing raw chicken 

parts for Salmonella and 

Campylobacter. In addition, FSIS will 

report back to establishments 

periodically information about the 

samples collected and found to be 

positive for Salmonella or 

Campylobacter. 

FSIS does not expect that data will 

change substantially and, therefore, 

does not expect to re-propose the 

standards based on the new data. 

However, FSIS will analyze the data and 

will discuss it in the Federal Register 

notice announcing the final standards. If 

the data change substantially based on 

the new testing so that FSIS determines 

it should change the standards, FSIS 

would re-propose the standards. 

As stated above, FSIS intends to 

establish its standards for parts based on 

its sampling of breasts, legs, and wings 

in the RCPBS and thus to focus its ongoing sampling on those parts. However, 

because some other parts were sampled 

very infrequently during the 2012 

RCPBS, FSIS has decided to also sample 

additional parts not only to ascertain the 

level of process control in individual 

establishments but to estimate that 

part’s contribution to Salmonella and 

Campylobacter illnesses. FSIS may 

ultimately decide that it is necessary to 

propose additional pathogen reduction 

performance standards for these other 

chicken parts, particularly if there is 

evidence that establishments are not 

effectively controlling sanitary 

conditions associated with the 

production of these parts. 

NRTE Comminuted Poultry— 

Campylobacter 

FSIS developed the new standards 

using the 2015 Risk Assessment, which 

took into account the establishment by 

establishment prevalence of 

Campylobacter in NRTE comminuted 

chicken and turkey products and 

predicted illnesses averted as a 

consequence of reducing the prevalence 

of these pathogens. For the purpose of 

developing these pathogen reduction 

performance standards, as stated above, 

FSIS analyzed the first eight months of 

data generated from the new sampling 

program. 

For NRTE comminuted chicken, a 

pathogen reduction performance 

standard for Campylobacter of one 

positive out of 52 samples should result 

in about a 37-percent reduction in 

Campylobacter illnesses from that 

product. The expected number of 

illnesses avoided would be about 1,300 

(UI: 700–2,000). Approximately 24 

percent of establishments are predicted 

to initially not meet the performance 

standard. As establishments make 

changes to meet the new performance 

standard, FSIS estimates that the VWPP 

of Campylobacter of 3.4 percent in 

NRTE comminuted chicken will be 

reduced to 2.1 percent. 

For NRTE comminuted turkey, the 

current Campylobacter prevalence is so 

low that the Agency determined a 33- 

percent reduction could not be feasibly 

met. Thus, FSIS is proposing a pathogen 

reduction performance standard for 

Campylobacter for NRTE comminuted 

turkey of one positive out of 52 samples, 

which is estimated to result in about a 

19-percent reduction in Campylobacter 

illnesses. The expected number of 

illnesses avoided as a result of such a 

reduction would be about 500 (UI: 300– 

700). The risk assessment estimates 

approximately nine percent of 

establishments will initially fail the 

performance standard. As 

establishments make changes to meet 

the new performance standard, FSIS 

estimates that the VWPP of 

Campylobacter of 1.2 in NRTE 

comminuted turkey will be reduced to 

about one percent. 

FSIS developed the above pathogen 

reduction performance standards for 

Campylobacter using a direct plating 

laboratory method of analysis with a 1 

ml test portion. FSIS plans to assess 

establishment performance relative to 

those standards based on the 1 ml 

portion size. However, given the lower 

sensitivity of this test, this fiscal year 

FSIS will begin concurrently analyzing 

a subset of NRTE comminuted poultry 

samples it collects for verification 

testing using an enrichment method of 

analysis with a larger test portion, a 30 

ml test portion for chickens (MLG 

41.03).20 By increasing the potential for 

growth and recovery of injured cells, 

FSIS anticipates the enrichment method 

of analysis will detect more 

contamination. FSIS expects to analyze 

testing data generated from both 

analytical approaches. This analysis 

will allow FSIS to determine whether 

the pathogen reduction performance 

standards for Campylobacter in NRTE 

comminuted chicken and turkey should 

be revised from the above proposed 

standards to standards based on an 

enrichment method, such as with a 30 

ml test portion. 

Raw Chicken Parts—Campylobacter 

The stated HP2020 national goal for 

percent reduction in campylobacteriosis 

cases is 33 percent. Based on the 

baseline results, FSIS estimates that the 

national prevalence of Campylobacter in 

four pound portions of raw chicken 

parts is about 22 percent with a 95- 

percent confidence interval between 19 

percent and 25 percent. To meet a 32- 

percent reduction in 

campylobacteriosis, the 2015 Risk 

Assessment estimated that a pathogen 

reduction performance standard for 

Campylobacter in raw chicken parts of 

four positives out of 52 samples 21

would be sufficient. The expected 

number of illnesses avoided would be 

about 14,300 (UI: 8,400–23,100). Based 

on data generated from the 2012 RCPBS, 

approximately 46 percent of 

establishments are predicted to fail the 

performance standard. As 

establishments make changes to meet 

the new performance standard, FSIS 

estimates that the VWPP of 15.5 percent 

for Campylobacter in four pound 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 3945 

22http://www.fsis.usda.gov/wps/wcm/connect/

56b2ccbd-ad57-4311-b6df-289822d28115/

Prevalence_Estimates_Report.pdf?MOD=AJPERES. 

portions of raw chicken parts (breasts, 

legs, and wings) will be reduced to 10 

percent. 

legs, and wings) will be reduced to 10 

percent. 

Product 

Salmonella 

prevalence 

(percent) 

Campylobacter 

prevalence 

(percent) 

Maximum acceptable percent 

positive 

Performance standard 

Salmonella Campylobacter Salmonella Campylobacter 

Broiler Carcasses ........... 7 .5 10 .4 9.8 15.7 5 of 51 .............. 8 of 51. 

Turkey Carcasses .......... 1 .7 0 .79 7.1 5.4 4 of 56 .............. 3 of 56. 

Comminuted Chicken ..... ∧* 49 ∧* 3 .4 25.0 1.9 13 of 52 ............ 1 of 52. 

Comminuted Turkey ....... ∧* 19 .9 ∧* 1 .2 13.5 1.9 7 of 52 .............. 1 of 52. 

Chicken Parts ................. ∧* 28 ∧* 15 .5 15.4 7.7 8 of 52 .............. 4 of 52. 

∧ volume-weighted percent positive 

* based on eight months of data 

Changes to Related Verification 

Sampling Procedures 

On August 28, 2013, FSIS published 

in the Federal Register a notice 

announcing changes to its Salmonella 

sampling program for raw beef products 

(78 FR 53017). In the August 2013 

notice, FSIS also announced that it was 

considering alternatives to set-based 

sampling for Salmonella, including 

routine sampling (similar to what FSIS 

uses for Shiga toxin-producing 

Escherichia coli (STEC) sampling) with 

a moving window approach to assess 

process control. 

On June 5, 2014, in the Federal 

Register notice responding to comments 

received on the August 2013 Federal 

Register notice, FSIS reiterated that it 

was considering using on-going 

scheduled sampling with a moving 

window approach to assess process 

control for all Salmonella performance 

standards (79 FR 32436). FSIS is 

affirming those plans for addressing 

Salmonella and will proceed with 

implementing those plans. Below, FSIS 

is providing more explanation of how 

the change will work when scheduling 

samples and assessing process control 

in establishments. 

FSIS does not collect imported raw 

poultry products for Salmonella and 

Campylobacter analysis. However, on 

June 29, 2014, FSIS began analyzing for 

Salmonella all imported raw beef 

samples it collects for STEC analysis (79 

FR 32436; Jun 5, 2014). 

Thus, in March 2015, FSIS will begin 

analyzing for Salmonella (and 

Campylobacter) imported raw broiler 

and turkey carcasses, NRTE 

comminuted chicken and turkey 

products, and raw chicken parts. FSIS 

will use enumeration and serotype data 

of this testing to identify trends within 

the sampling data, to determine whether 

an isolate has a historical association 

with human illness, and to identify 

clusters of patterns. In addition, FSIS 

will post aggregate results of this testing 

on the FSIS Web site as part of its 

quarterly report on Salmonella. 

Salmonella is not an adulterant in raw 

poultry products. Therefore, a positive 

test result for Salmonella in imported 

raw poultry product sampled by FSIS 

import inspection personnel would not 

result in regulatory control actions at 

port-of-entry. However, consistent 

findings of Salmonella would raise 

concern about the effectiveness of the 

country’s food safety system, which 

could influence the focus and timing of 

the next audit of the country or result 

in other appropriate action. 

Routine Sampling 

Consistent with what it announced in 

its August 2013 Federal Register notice, 

FSIS will replace its existing Salmonella 

sampling set-approach with a routine 

sampling approach for all FSISregulated products subject to 

Salmonella and Campylobacter 

verification testing. This includes for 

broiler and turkey carcasses and chicken 

parts. FSIS has already moved to routine 

sampling for comminuted poultry, 

ground beef, and beef manufacturing 

trimmings. 

FSIS has determined that its current 

set-based Salmonella sampling program 

cannot be used to estimate prevalence 

for several reasons.22 First, FSIS’s 

scheduling algorithm disproportionately 

focuses sample collection based on past 

performance under the Salmonella 

performance standards. As a result, FSIS 

may not sample from establishments 

maintaining consistent process control 

(Category 1—establishments 

continuously achieving 50 percent or 

less of the pathogen reduction 

performance standard, i.e., meeting or 

surpassing the standard) for a year or 

more, while those with highly variable 

process control (Category 3— 

establishments that have exceeded the 

pathogen reduction performance 

standard, i.e., not meeting the standard) 

could be scheduled quite often. An 

establishment with variable process 

control (Category 2—establishments that 

have not continuously achieved 50 

percent or less of the pathogen 

reduction performance standard, nor 

have they exceeded the standard) could 

be sampled at least annually. Such 

disproportionate sample collection 

results in not all establishments having 

a known probability of being selected 

for sampling. 

Second, once a sample set begins, an 

establishment is aware that it will be 

sampled every day the product is 

produced over the next few months (or 

longer for smaller plants that produce 

less frequently) until the set is complete. 

This knowledge might create a bias 

because establishments may, 

intentionally or not, adhere more 

conscientiously to proper sanitary 

procedures during this time. This 

adherence could result in lower 

numbers of positive Salmonella results 

than would occur otherwise, and any 

prevalence calculation would be 

underestimated. 

By sampling establishments with a 

proper frequency and continuously 

throughout the year, FSIS would be able 

to calculate the national prevalence of 

Salmonella and Campylobacter. FSIS 

intends to use the ongoing estimation to 

monitor changes in prevalence over 

time and to correlate those changes with 

the effectiveness of Agency policies and 

procedures. 

FSIS will begin using, in lieu of setbased sampling, routine sampling for all 

products that it samples as part of its 

Salmonella verification sampling 

program, such as broiler and turkey 

carcasses, as well as those products for 

which new standards are contemplated, 

such as ground beef at the 325-gram 

sample size and beef manufacturing 

trimmings. Taking into account risk 

factors including production volume 

and past establishment testing 


emcdonald on DSK67QTVN1PROD with NOTICES
3946 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 

23Available at http://www.fsis.usda.gov/wps/

wcm/connect/cb091bde-4900-45ec-8bf5- 

980dc9496bd1/Sampling-Program-PlanFY2015.pdf?MOD=AJPERES. 

performance (i.e., positive Salmonella 

and Campylobacter test results), FSIS 

will sample eligible product from the 

largest-volume establishments four or 

five times per month (once per week), 

on average, and will decrease 

incrementally the number of samples it 

collects from establishments producing 

less volume. FSIS may sample a small 

number of establishments up to six 

times per month because the risk factor 

for that particular volume category/

product combination is much higher 

than that for other combinations. FSIS 

has described its overall strategy for 

directing its Salmonella and 

Campylobacter sampling resources in its 

FY 2015 Annual Sampling Program 

Plan.23

Some large volume establishments, in 

particular young turkey slaughter 

establishments, may produce eligible 

product for only a few months of the 

year. Under the existing set-based 

Salmonella sampling program, these 

establishments rarely complete a 

sampling set within the year. To assess 

process control in establishments with 

concentrated seasonal production, FSIS 

will intensify sampling at these 

establishments when in production to 

obtain the samples needed to assess 

process control using the moving 

window. FSIS will use historical 

sampling data collected from the 

particular establishment to determine 

the frequency of sampling. 

FSIS does not currently sample 

eligible product for Salmonella from 

poultry establishments that produce less 

than 1,000 pounds per day (i.e., very 

small establishments) or from poultry 

slaughter establishments that operate 

under a religious exemption. Therefore, 

FSIS does not have Salmonella or 

Campylobacter data from these 

establishments for young chickens, 

turkeys, NRTE comminuted chicken or 

turkey, and raw chicken parts. At the 

time that the new pathogen reduction 

performance standards are 

implemented, FSIS intends to begin 

sampling eligible product 3–4 times per 

year from these establishments. FSIS 

anticipates that it will begin sampling 

eligible product that had been exempted 

from Salmonella verification testing in 

approximately 95 poultry slaughter 

establishments operating under a 

religious exemption, and approximately 

580 poultry establishments that produce 

less than 1,000 pounds per day. FSIS 

expects to eventually implement 

pathogen reduction performance 

standards to assess process control at 

these poultry establishments. 

Before FSIS begins using these 

samples to assess process control at 

establishments previously excluded 

from verification sampling, it will 

provide notice in the Federal Register. 

Meanwhile, FSIS expects to treat the 

low volume establishments as separate 

populations and to report how well the 

population of establishments is 

performing, including such information 

as percentage positive, 25th, 50th, and 

75th percentile. 

Moving Window Approach 

Without discrete sampling sets, a 

different approach is needed to assess 

process control in establishments within 

a routine sampling program. When 

assessing process control under a 

moving window approach, FSIS intends 

to evaluate, over a certain period of 

time, a number of sequential results 

from a single establishment. Thus, given 

the fixed timeframe of one year (52 

weeks) for which an establishment has 

been sampled, FSIS would assess the 

first moving window by evaluating the 

number of positive samples out of the 

number of samples taken within the 52- 

week period. As an example, if an 

establishment has five Salmonella 

positives within 52 samples (one sample 

per week for a year), then the 

establishment passed the performance 

standard if the performance standard 

allows five positive samples among 52 

samples. When the next sample is taken 

(week 53, in this example), the moving 

window would shift forward the fixed 

timeframe of one year (52 weeks); that 

is, the original week 1 (and the original 

first sample) is excluded, while the most 

recent week is included in the new 52- 

week moving window. This shifting is 

repeated with each new week and 

allows FSIS to continuously assess the 

process control of an establishment. 

FSIS chose a 52-week moving 

window because it will appropriately 

average expected fluctuations, for 

example, those that result from seasonal 

variation. Nevertheless, FSIS intends to 

periodically assess its results to 

determine if adjustments to the 52-week 

moving window are appropriate. 

For highest-volume establishments, 

FSIS expects to collect 52 samples 

within the 52-week moving window. In 

this case, to assess process control (at 

establishments producing products with 

performance standards measured in 52 

samples), one need only to count the 

number of positives test results within 

the 52-week moving window. So, as an 

example, the proposed performance 

standard for Salmonella in raw chicken 

parts is eight positives out of 52 

samples. Assuming 52 samples were 

collected from the establishment within 

a 52-week moving window, if the 

establishment has eight or fewer 

Salmonella positives within that 52- 

week timeframe, then it would pass the 

performance standard. If, on the other 

hand, the establishment has nine or 

more Salmonella positives within that 

same 52-week timeframe, then it would 

fail the performance standard. 

The following table demonstrates 

what FSIS has determined to be the 

minimum number of samples for each 

product class by pathogen. 

Product 

Max Acceptable percent positive Minimum number of samples 

Salmonella Campylobacter Salmonella Campylobacter 

Broiler Carcass ................................................................................ 9.8 15.7 10 10 

Turkey Carcass ................................................................................ 7.1 5.4 14 19 

Comminuted Chicken ...................................................................... 25.0 1.9 10 52 

Comminuted Turkey ........................................................................ 13.5 1.9 10 52 

Chicken Parts .................................................................................. 15.4 7.7 10 13 

Previously, FSIS held the same 

standard to all eligible establishments 

within a product class. However, FSIS 

found that some lower volume 

establishments would take over a year 

and sometimes two years to complete a 

set. Thus, to assess process control in 

establishments that FSIS samples less 

often than weekly (i.e., lower volume 

establishments), FSIS will assess 

establishment performance (as percent 

positive) based on the (likely variable) 

number of samples collected and 

positive results within the 52-week 

moving window. 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 3947 

To illustrate this point, if a small 

establishment producing raw chicken 

parts is sampled fewer than 52 times in 

the 52-week moving window, only 26 

times, for example, with three of those 

samples testing positive for Salmonella, 

26 will be the denominator while three 

would be the numerator. This gives the 

establishment a percent positive of 11.5 

percent ((3⁄26) × 100 = 11.5%). In this 

example, the resulting percent positive 

is less than 15.4 percent, the acceptable 

percent positive for the proposed 

performance standard for Salmonella in 

raw chicken parts ((8⁄52) × 100 = 15.4%). 

As such, the establishment would pass 

the performance standard. 

Given that Salmonella is not an 

adulterant in raw product, FSIS 

determined that any performance 

standard for Salmonella or 

Campylobacter should use one or 

greater as the acceptable number of 

positives results. A performance 

standard of zero maximum acceptable 

positives is actually a zero-tolerance 

standard. With one acceptable positive 

as the numerator, FSIS used the 

following formula to estimate the 

minimum number of samples (n) 

needed to assess process control at an 

establishment: 

n = (1/percent positive allowed) ¥ 100. 

So, for example, if the performance 

standard is 5 percent (the percent 

positive allowed), then (1⁄5.0) ¥ 100 = 20 

samples is the minimum number of 

samples required to assess process 

control. Although, as another example, 

if the performance standard is 20 

percent then (1/20.0) ¥ 100 = 5 samples 

is the minimum number of samples 

required to assess process control. 

However, to decrease the margin of 

error, FSIS has deemed 10 as the 

minimum number of samples required 

to assess process control in an 

establishment. 

FSIS acknowledges that less-thanweekly sampling plans may result in a 

higher probability of miscategorizations. However, FSIS chose 

the above method for assessing process 

control in lower volume establishments 

to limit the duration these 

establishments would remain in 

Category 2 or 3, if effective corrective 

actions are taken by the establishment. 

FSIS requests comment on how it plans 

to assess process control in lower 

volume establishments. 

A 52-week moving window does not 

necessarily mean that FSIS must wait 

one year before it can determine 

whether an establishment has met a 

performance standard. Using the broiler 

carcass performance standard as an 

example (5 acceptable positives or fewer 

constitute passing while 6 or more is 

failing), if a high volume chicken 

slaughter establishment that is sampled 

weekly gets six positives in less than 52 

weeks, FSIS can deem that 

establishment to have failed the 

performance standard no matter how 

many uncollected samples remain in the 

establishment’s 52-week moving 

window. 

Defining Categories 

Under the existing set-based 

Salmonella verification sampling 

program, FSIS classifies establishment 

performance relative to the pathogen 

reduction performance standard (by 

product class) using the 3-category 

establishment classification system 

announced on February 27, 2006 (71 FR 

9772). FSIS will continue using this 

classification system under routine 

sampling. However, for all products 

sampled under routine Salmonella 

verification sampling, FSIS plans to 

modify the time component of those 

definitions as follows: 

I. Category 1. Consistent Process Control: 

Establishments that have achieved 50 percent 

or less of the performance standard during all 

completed 52-week moving windows over 

the last six months. 

II. Category 2. Variable Process Control: 

Establishments that meet the standard for all 

completed 52-week moving windows but 

have results greater than 50 percent of the 

standard during any completed 52-week 

moving window over the last six months. 

III. Category 3. Highly Variable Process 

Control: Establishments that have exceeded 

the performance standard during any 

completed 52-week moving window over the 

last six months. 

Because of the potential for frequent 

changes in category status once the first 

moving window is complete, FSIS felt a 

time component was needed to provide 

stability. Upon completion of their first 

52-week moving window, FSIS intends 

to update the category status for each 

eligible establishment, after the 

pathogen reduction performance 

standards are finalized and 

implemented for that product category. 

Thereafter, FSIS expects to re-categorize 

establishments monthly based on their 

performance over the last six months. 

Finally, FSIS expects to categorize 

establishments for Campylobacter 

process control similarly as for 

Salmonella. 

With the addition of the 6-month time 

period, establishments can expect to 

remain in Category 2 or 3 no shorter 

than 26 weeks. This lower bound is 

based on a scenario where an 

establishment’s positive results are 

clustered at the beginning of the 52- 

week moving window. Alternatively, if 

an establishment’s positive results are 

clustered at the end of the 52-week 

moving window, it would take a 

minimum of 69 weeks to move out of 

that category. However, based on 

analysis of its current set-based 

verification sampling results, FSIS does 

not believe these extreme scenarios are 

likely. FSIS data suggests that positive 

results would be more evenly 

distributed throughout the moving 

window and not clustered. 

FSIS has analyzed the 6-month time 

period and determined it to have 

minimal impact on the categorization of 

establishments that are most likely to 

meet the standard. Our analysis suggests 

that, depending on the underlying 

pathogen prevalence at an 

establishment, the impact could range 

from no increase in probability to about 

a 7-fold increase. However, the higherend increase is predominantly for those 

establishments already with a low 

probability of not meeting the standard, 

so the absolute probability of not 

meeting the standard remains low. For 

example, if an establishment had a 0.1 

percent chance of not meeting a 

standard during a 52-week moving 

window, its probability of not meeting 

the standard during the 6 months after 

completion of that moving window 

would be about 0.7 percent. FSIS 

requests comment on its planned 

modifications and the impact of the 6- 

month time period on the categorization 

of establishments. 

Web-Posting 

The Agency’s policy of web-posting 

establishments’ process control 

performance has stimulated 

improvement in industry performance, 

as was shown in the Agency’s 

experience after announcing in 2006 

that it was considering posting the 

names of broiler and turkey slaughter 

establishments in Category 2 and 3. 

Within two years after the 

announcement, but before names were 

actually posted, the number of broiler 

slaughter establishments that had been 

in Category 3 decreased by 

approximately 55 percent. Furthermore, 

the percentage of broiler slaughter 

establishments in Category 1 increased 

by nearly 40 percent. Once FSIS began 

posting establishment names and their 

process control performance, the turkey 

slaughter establishments responded 

particularly to the challenge that FSIS 

identified for the industry. The Agency 

said that if 90 percent of the broiler or 

turkey industry attained Category 1 

status with no establishments in 

Category 3, FSIS would no longer 

publish the names or process control 

performance of the establishments. The 


emcdonald on DSK67QTVN1PROD with NOTICES
3948 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 

24http://www.sciencedirect.com/science/article/

pii/S0956713512002393; http://

online.liebertpub.com/doi/abs/10.1089/

fpd.2011.0951. 

25The Compliance Guideline for Controlling 

Salmonella and Campylobacter in Poultry, Third 

Edition, May 2010, is available at http://

www.fsis.usda.gov/wps/wcm/connect/6732c082- 

af40-415e-9b57-90533ea4c252/Compliance_Guide_

Controling_Salmonella_Campylobacter_Poultry_

0510.pdf?MOD=AJPERES. 

turkey slaughter establishments met the 

challenge proffered by FSIS, and FSIS 

stopped publishing the names of the 

turkey slaughter establishments. 

Another example of how the 

categorization of establishments was 

used by the industry involved those 

establishments that produced a product 

referred to as NRTE stuffed chicken 

breast that appeared as RTE, such as 

Chicken Kiev. Multiple illnesses were 

traced to this product containing raw 

chicken. As a mitigation strategy for 

reducing the likelihood of the product 

being contaminated with Salmonella, 

establishments that produced the 

product cited a purchase specification 

requirement for using only chicken 

breast meat supplied by Category 1 

establishments. Because FSIS was not 

posting the Category 1 status of 

establishments, industry internally 

worked out how to address this issue, 

but there was no verification of this 

specification provision by FSIS. FSIS 

noted at the time that without posting 

Category 1 status, there was confusion 

by consumers and industry as to 

whether establishments not listed as 

Category 2 or Category 3 establishments 

were actually Category 1 or had not yet 

been categorized. 

Consequently, FSIS intends to post 

the category status for all eligible 

establishments because web-posting 

provides greater transparency, thereby 

providing the public with the tools and 

information that it needs to make 

informed food safety decisions. After 

reviewing the comments received on 

this notice, beginning July 1, 2015, the 

Agency plans to begin web-posting 

individual establishment category 

information for chicken and turkey 

carcasses. FSIS will finish sample sets 

begun before February 2015 and will not 

begin any new sampling until March, at 

which time FSIS will begin sampling 

chicken and turkey carcasses using the 

moving window approach, rather than 

the set approach. FSIS will assess what 

category establishments are in as of July 

1, using combined historical set data 

and sample results beginning March 

2015. In July, FSIS will then post the 

category establishments are in. For 

example, once FSIS begins the new 

sampling approach in March, FSIS may 

collect 24 samples from March 1 

through June 30, 2015, at some 

establishments. In July, FSIS will assess 

those 24 results and the previous 28 

results assessed under the set approach. 

Based on those most recent 52 samples, 

FSIS will assess which category the 

establishment is in and post that 

category. FSIS will then monthly recategorize establishments, based on the 

last 52 samples, until sufficient data is 

available to look at the previous six 

months of windows as described above. 

Until July, FSIS will continue to webpost existing Category 3 poultry carcass 

establishments. In addition, the Agency 

will post aggregate reports quarterly 

showing the Category 1/2/3 distribution 

for each relevant product class subject 

to FSIS Salmonella and Campylobacter 

testing, as applicable. Therefore, FSIS 

will continue to post aggregate reports 

for chicken and turkey slaughter 

establishments showing category 

distribution for current performance 

standards for carcasses. In addition, 

starting in March, FSIS will begin 

posting aggregate reports showing the 

category 1/2/3 distribution for chicken 

parts as data become available, and 

comminuted chicken and turkey using 

historical data and new results 

beginning in March based on the 

proposed standards. FSIS invites 

comments on how it plans to web-post 

establishments. 

Agency Actions 

FSIS has used the results from its 

verification testing program as a 

measure of establishment process 

control for reducing exposure of the 

public to pathogens. Under the HACCP 

regulations, establishments need to 

control their processes to ensure that 

public exposure to pathogens is 

minimized. The Agency has found that 

using pathogen reduction performance 

standards in this way is effective in 

encouraging improved establishment 

control of pathogens, and that it has 

resulted in reduced human illnesses.24

Under the new standards and under 

the new moving window approach, 

when an establishment does not meet a 

performance standard (i.e., the number 

of positive samples within a specified 

timeframe exceeds the maximum 

acceptable for that product class), FSIS 

will immediately conduct follow-up 

sampling. Follow-up samples will be 

analyzed for both Salmonella and 

Campylobacter, where applicable. 

Because FSIS has experience with 

follow-up samples associated with the 

Escherichia coli O157 testing program, 

FSIS will assess whether this approach 

will work for Salmonella and 

Campylobacter testing. In essence, 

either 16 or eight follow-up samples are 

collected depending upon the size and 

production volume of the establishment. 

FSIS will analyze follow-up sampling 

data independent of the moving 

window approach to assess whether the 

establishment is making or has made 

changes to its food safety system to 

improve its process control. 

As FSIS does now when 

establishments do not meet performance 

standards, FSIS will conduct a for-cause 

FSA at the establishment that produced 

the product. In addition, even when 

establishments meet the performance 

standards, if FSIS Salmonella or 

Campylobacter verification testing data 

from an establishment show a high 

number of positives or serotypes of 

human health significance, FSIS may 

perform Incident Investigation Team 

testing or conduct a for-cause FSA that 

includes collection of samples or take 

other appropriate actions, such as 

additional sanitary dressing verification 

procedures, at the establishment that 

produced the product. 

In May 2010, FSIS issued guidance on 

how establishments can address 

Salmonella and Campylobacter in 

poultry.25 FSIS is updating this 

guidance to include additional 

suggested pre-harvest and post-harvest 

controls. The Agency intends to make 

the updated guidance available to the 

establishments soon. In response to a 

Government Accountability Office 

recommendation, FSIS will include 

information in the guidance on the 

effectiveness of pre-harvest controls to 

reduce pathogens in live poultry (USDA 

Needs to Strengthen its Approach to 

Protecting Human Health from 

Pathogens in Poultry Products, 

September 2014 at http://www.gao.gov/ 

assets/670/666231.pdf). 

Cost-Benefit Analysis 

FSIS has considered the economic 

effects of new pathogen reduction 

performance standards for Salmonella 

and Campylobacter in raw chicken parts 

and NRTE comminuted poultry. The 

full analysis is published on the FSIS 

Web site as supporting documentation 

to this notice. FSIS is seeking comment 

on the accuracy of the information and 

assumptions used in the cost-benefit 

analysis. A summary of the analysis is 

below. 

Industry Costs 

Establishments will incur costs as 

they make changes to their processes in 

order to meet the new standards. FSIS 

estimates that approximately 63 percent 

of raw chicken parts producing 

establishments, 62 percent of NRTE 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 3949 

comminuted chicken producing 

establishments, and 58 percent of NRTE 

comminuted turkey producing 

establishments will not meet the new 

Salmonella standards. FSIS estimates 

that approximately 46 percent of raw 

chicken parts producing establishments, 

24 percent of NRTE comminuted 

chicken producing establishments, and 

9 percent of NRTE comminuted turkey 

producing establishments will not meet 

the new Campylobacter standards. 

Establishments that initially do not 

meet the standard but aspire to do so 

will need to make changes to their 

production processes to lower the 

prevalence of Salmonella and 

Campylobacter in their products. 

Changes could include pre-harvest 

interventions, such as vaccination 

programs, well-timed feed withdrawal, 

clean and dry litter and transportation, 

and supplier contract guarantees of 

pathogen-free flocks. During processing, 

establishments could add additional 

cleaning procedures, apply chemical 

antimicrobials to parts and source 

materials for comminuted poultry 

product and provide additional 

sanitation training to employees. For the 

purposes of the cost-benefit analysis, 

FSIS used the cost of adding 

antimicrobial solutions to poultry parts 

as a proxy for the costs of interventions 

and changes that could be implemented. 

FSIS used this approach based on 

information from FSAs in response to 

broiler Salmonella sets not meeting the 

standards and information from the 

FSIS Poultry Checklist explained above. 

Through FSAs, FSIS found that the 

majority of establishments added 

antimicrobials to the production process 

as a corrective action, suggesting that an 

antimicrobial intervention would be the 

most likely response should an 

establishment not meet the proposed 

performance standards. Also, 

information from the FSIS Poultry 

Checklist showed that the majority of 

establishments are not applying 

antimicrobials to raw poultry parts and 

source materials for comminuted 

poultry product. 

To account for uncertainty in the 

proportion of establishments making 

changes to their production processes in 

order to meet the new standards, FSIS 

provided cost estimates for a range (30, 

40, and 50 percent) of establishments 

initially falling short of but eventually 

meeting the standards in two years. 

These costs are summarized and 

annualized over 10 years at a discount 

rate of 7 percent in Table 1. 

TABLE 1—TOTAL INDUSTRY COSTS ANNUALIZED 1

Compliance level of establishments not meeting standard Cost component 

Primary estimate 

($mil) 

Low estimate 

($mil) 

High estimate 

($mil) 

30% ................................................................. Capital Equipment .......................................... 2.15 ........................ ........................

Antimicrobial Solution ..................................... 6.54 4.61 8.46 

Microbiological Sampling ............................... 9.27 6.18 12.36 

HACCP Validation & Training ........................ (*) ........................ ........................

Total Costs ............................................... 17.96 .............................................................. 12.94 22.97 

40% ................................................................. Capital Equipment .......................................... 2.86 ........................ ........................

Antimicrobial Solution ..................................... 8.72 6.14 11.28 

Microbiological Sampling ............................... 9.82 6.52 13.05 

HACCP Validation & Training ........................ (*) ........................ (*) 

Total Costs ............................................... 21.40 .............................................................. 15.52 27.19 

50% ................................................................. Capital Equipment .......................................... 3.58 ........................ ........................

Antimicrobial Solution ..................................... 10.89 7.68 14.12 

Microbiological Sampling ............................... 10.40 6.91 13.81 

HACCP Validation & Training ........................ (*) ........................ ........................

Total Costs ............................................... ......................................................................... 24.87 18.17 31.51 

1 Costs annualized at a discount rate of 7 percent over 10 years. 

* Approximately $3,800 at 30% compliance, $5,100 at 40% compliance, and $6,400 at 50% compliance—values too small to display in table. 

Agency Costs 

FSIS does not expect to incur any 

additional costs as a result of 

introducing new performance standards. 

FSIS allocates a fixed number of 

samples by product class, sampling 

project, and pathogen each year. FSIS 

does not anticipate the need to exclude 

any of the other testing programs 

allocated to other product classes. FSIS 

intends to test carcasses at the level that 

is needed. In order to accommodate the 

proposed sampling programs, FSIS will 

adjust the currently allotted young 

chicken (‘‘Broiler’’) and young turkey 

sampling programs for Salmonella and 

Campylobacter to include testing of raw 

chicken parts and not-ready-to-eat 

comminuted chicken and turkey. In this 

case, samples that could be allocated to 

test carcasses will be moved closer to 

the consumer and be used on parts and 

NRTE comminuted poultry products. 

Therefore, FSIS will not expend 

additional resources to implement the 

proposed performance standards. 

Public Health Benefits 

As establishments make changes to 

their production processes and reduce 

the prevalence of Salmonella and 

Campylobacter in chicken parts and 

NRTE comminuted poultry, public 

health benefits will be realized in the 

form of averted illnesses. For each 

assumed compliance level FSIS 

estimated the cost savings associated 

with the percentage reduction in human 

illnesses as calculated in the 2015 Risk 

Assessment. The results of this 

calculation were annualized over 10 

years at a discount rate of 7 percent, and 

are displayed in Table 2. 


emcdonald on DSK67QTVN1PROD with NOTICES
3950 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 

TABLE 2—PUBLIC HEALTH BENEFITS ANNUALIZED 1

Compliance 

level of establishments not 

meeting the 

standard 

(%) 

Primary estimate 

($mil) 

Low estimate 

($mil) 

High estimate 

($mil) 

30 ................. 50.87 31.84 79.89 

40 ................. 79.66 50.43 125.89 

50 ................. 109.10 68.80 171.24 

1Benefits annualized over 10 years at a discount rate of 7 percent. 

Summary of Net Benefits 

Table 3 displays the total costs and 

benefits expected from the 

implementation of performance 

standards for chicken parts and 

comminuted poultry. All values have 

been annualized over 10 years at a 7 

percent discount rate. For all 

compliance levels considered, the 

performance standards result in net 

benefits. 

TABLE 3—SUMMARY OF NET BENEFITS 1

Compliance level of establishments not 

meeting the standard 

(%) 

Cost/benefit component 

Primary 

estimate 

($mil) 

Low estimate 

($mil) 

High estimate 

($mil) 

30 ................................................................. Industry Costs ............................................. (18.0 ) (12.9 ) (23.0 ) 

FSIS Costs .................................................. .......................... .......................... ..........................

Public Health Benefits ................................. 50.9 31.8 79.9 

Net Benefits .......................................... ...................................................................... 32.9 18.9 56.9 

40 ................................................................. Industry Costs ............................................. (21.4 ) (15.5 ) (27.2 ) 

FSIS Costs .................................................. .......................... .......................... ..........................

Public Health Benefits ................................. 79.7 50.4 125.9 

Net Benefits .......................................... ...................................................................... 58.3 34.9 98.7 

50 ................................................................. Industry Costs ............................................. (24.9 ) (18.2 ) (31.5 ) 

FSIS Costs .................................................. .......................... .......................... ..........................

Public Health Benefits ................................. 109.1 68.8 171.2 

Net Benefits .......................................... ...................................................................... 84.2 50.6 139.7 

1All costs and benefits annualized over 10 years at a 7 percent discount rate. 

USDA Nondiscrimination 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. 

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). 

Additional Public Notification 

FSIS will announce this notice online 

through the FSIS Web page located at 

http://www.fsis.usda.gov/federalregister. 

FSIS will also make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, and other types of 

information that could affect or would 

be of interest to constituents and 

stakeholders. The Update is 

communicated via Listserv, a free 

electronic mail subscription service for 

industry, trade groups, consumer 

interest groups, health professionals, 

and other individuals who have asked 

to be included. The Update is also 

available on the FSIS Web page. In 

addition, FSIS offers an electronic mail 

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 to regulations, directives, 

and notices. Customers can add or 

delete subscriptions themselves, and 

have the option to password protect 

their accounts. 

Done at Washington, DC on: January 21, 

2015. 

Alfred V. Almanza, 

Acting Administrator. 

[FR Doc. 2015–01323 Filed 1–23–15; 8:45 am] 

BILLING CODE 3410–DM–P 


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