Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 7285 

1This sampling and testing for Salmonella and 

Campylobacter did not include heat-treated NRTE 

comminuted chicken or turkey. 

2http://www.fsis.usda.gov/wps/portal/fsis/topics/

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

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2014–0023] 

New Performance Standards for 

Salmonella and Campylobacter in NotReady-to-Eat Comminuted Chicken 

and Turkey Products and Raw Chicken 

Parts and Changes to Related Agency 

Verification Procedures: Response to 

Comments and Announcement of 

Implementation Schedule 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS or ‘‘the 

Agency’’) is announcing that it will 

begin assessing whether establishments 

meet the pathogen reduction 

performance standards for Salmonella 

and Campylobacter in raw chicken parts 

and not-ready-to-eat (NRTE) 

comminuted chicken and turkey 

products. It will also begin posting, 

based on FSIS sampling results and 

depending on the standard for the 

particular product, whether an 

establishment meets the FSIS pathogen 

reduction performance standards, or 

what category an establishment is in. 

This notice also responds to comments 

received on the January 2015 Federal 

Register notice that proposed the 

standards and announced changes to 

FSIS’s verification sampling program. 

DATES: FSIS will begin assessing 

whether establishments meet the new 

pathogen reduction performance 

standards for chicken parts and 

comminuted chicken and turkey 

products on May 11, 2016. Also 

beginning no sooner than May 11, 2016, 

FSIS will begin posting on its Web site 

the category status of all eligible 

establishments subject to the existing 

poultry carcass pathogen reduction 

performance standards based on sample 

results from May 2015 (when FSIS 

stopped set-based, consecutive day 

testing and began routine sampling 

throughout the year of broiler and 

turkey carcasses) to the present. See the 

SUPPLEMENTARY INFORMATION section for 

more information about implementation 

dates. 

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. 

SUPPLEMENTARY INFORMATION: 

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. 

As FSIS explained in the January 26, 

2015 (80 FR 3940), Federal Register 

notice (‘‘January 2015 notice’’) in which 

the Agency proposed the new pathogen 

reduction performance standards, 

Salmonella and Campylobacter bacteria 

are among the most frequent causes of 

human foodborne illness in the United 

States. Currently, events that cause 

contamination of raw carcasses cannot 

be eliminated through the commercial 

production and slaughter practices 

employed by the U.S. industry. 

Contamination can be minimized, 

however, with the use of proper sanitary 

dressing procedures and by the 

application of interventions during 

slaughter and fabrication of the 

carcasses into parts and comminuted 

product. 

Significantly, even though FSIS set 

standards for ground turkey and chicken 

in 1996 (61 FR 38806; July 25, 1996), the 

Agency has not set standards for other 

comminuted chicken and turkey 

products. These products have been 

associated with outbreaks (see 77 FR 

72686; December 6, 2012). In addition, 

the Agency has not set a standard for 

chicken parts even though about 80 

percent of chicken product is in the 

form of raw chicken parts fabricated 

from broiler carcasses (80 FR at 3941; 

January 26, 2015). 

In the absence of standards, the 

Salmonella and Campylobacter present 

on raw poultry will survive on that 

product if it is not subjected to a full 

lethality treatment such as thorough 

cooking. In addition, cross 

contamination occurs when bacteria 

(such as Salmonella or Campylobacter) 

are spread from a contaminated 

source—a contaminated food or an 

infected food handler—to other foods or 

objects in the environment (80 FR 3940; 

January 26, 2015). FSIS will monitor the 

sampling results and the Centers for 

Disease Control and Prevention (CDC) 

illness data to evaluate the industry’s 

progress in reducing product 

contamination and reducing illnesses. 

A reduction in illness rates should 

result from the implementation of these 

performance standards because a 

smaller proportion of raw chicken parts 

and NRTE comminuted chicken and 

turkey products will likely be 

contaminated with Salmonella and 

Campylobacter than has been the case 

without standards (80 FR at 3942; 

January 26, 2015). 

Recognizing the need for standards, 

FSIS began sampling and testing NRTE 

comminuted chicken and turkey 

products on June 1, 2013.1 The Agency 

posted the aggregate results of this 

testing as part of its quarterly 

Salmonella report.2

In addition, FSIS conducted the 

Nationwide Microbiological Baseline 

Data Collection Programs: Raw Chicken 

Parts Baseline Survey, 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 

the national prevalence of Salmonella 

and Campylobacter in four pound 

portions of raw chicken parts. An 

overview of the Raw Chicken Parts 

Baseline Survey is available at http://

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

a9837fc8-0109-4041-bd0c-729924a

79201/Baseline_Data_Raw_Chicken_

Parts.pdf?MOD=AJPERES. 

In the January 2015 notice, FSIS also 

announced and requested comment on 

proposed pathogen reduction 

performance standards for Salmonella 

and Campylobacter in raw chicken parts 

and NRTE comminuted chicken and 

turkey products (80 FR at 3946; January 

26, 2015). FSIS developed these 

proposed standards using the baseline 

data for parts and the on-going sampling 

data for NRTE comminuted chicken and 

turkey products. It also factored in what 

reduction in these two pathogens would 

be necessary to meet the Healthy People 

2020 (HP2020) goals. The Agency 

developed Salmonella performance 

standards that would achieve at least a 

30 percent reduction in illness rates 

from Salmonella for chicken parts, 

comminuted chicken, and comminuted 

turkey. FSIS developed a 

Campylobacter standard for chicken 

parts and comminuted chicken that it 

estimated would achieve a 33 percent 

reduction in illness rates. 

Because FSIS found the prevalence 

for Campylobacter in 325 gram samples 

of comminuted turkey to be especially 

low, the highest practical reduction in 

illness rates for this product without 

establishing a zero-tolerance standard 

was estimated to be 19 percent. So, the 

reduction in illness rates estimated for 

the proposed standard for this one 

product-pathogen pair was less than the 

Healthy People goal of a 33-percent 

reduction (80 FR at 3942; January 26, 

2015). 

In the same Federal Register notice, 

for all FSIS-regulated products subject 

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7286 Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 

3 78 FR 53017; Aug. 28, 2013, and 79 FR 32436; 

Jun. 5, 2014. 

4FSIS Notice 16–15; http://www.fsis.usda.gov/

wps/wcm/connect/5233e84c-f4a6-4959-b861- 

926a4d912eff/16-15.pdf?MOD=AJPERES. 

5FSIS Notice 23–15; http://www.fsis.usda.gov/

wps/wcm/connect/41f2bd6b-2c06-4384-935d2ac31e3e77e9/23-15.pdf?MOD=AJPERES. 

6FSIS Notice 22–15; http://www.fsis.usda.gov/

wps/wcm/connect/3379df49-cc8d-47f7-83c3-d4d80

2668f6c/22-15.pdf?MOD=AJPERES. 

7FSIS Notice 32–15; http://www.fsis.usda.gov/

wps/wcm/connect/41a60d0e-060e-479c-a2c0- 

4096d8a542f2/32-15.pdf?MOD=AJPERES. 

8http://www.fsis.usda.gov/wps/portal/fsis/topics/

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

9http://www.fsis.usda.gov/wps/portal/fsis/

newsroom/meetings/newsletters/constituentupdates/archive/2015/ConstUpdate081415. 

10http://www.fsis.usda.gov/wps/wcm/connect/

99b43489-0e14-40c0-b13e-53163d68bf1f/SamplingProgram-Plan-FY2016.pdf?MOD=AJPERES. 

to Salmonella and Campylobacter 

verification testing, FSIS announced 

that it would begin using routine, 

random sampling throughout the year 

rather than the set-based consecutive 

day approach that it had used in the 

past (80 FR at 3945; January 26, 2015), 

and that it would assess performance 

using a moving window of FSIS 

sampling results (80 FR at 3946). FSIS 

explained that it intended to collect 

samples on a weekly basis in high 

volume establishments and less 

frequently in lower volume 

establishments. In addition, FSIS 

announced that it would begin 

exploratory sampling of raw chicken 

parts (80 FR at 3945), raw pork products 

(80 FR at 3942), and imported raw 

poultry products (80 FR at 3944). 

Finally, FSIS announced that it 

intended to post the category status for 

all eligible establishments because webposting provides the public with the 

tools and information it needs to make 

informed food safety decisions (80 FR at 

3948). Because a pathogen reduction 

performance standard already exists for 

young chicken (broiler) and turkey 

carcasses, FSIS announced that it would 

begin web-posting individual 

establishment category information for 

these establishments after it had 

considered the comments it received. 

FSIS stated that it would assess what 

category these establishments are in 

using combined historical set data and 

sample results beginning March 2015. 

In response to a coalition of trade 

associations that requested that FSIS 

extend the comment period to provide 

additional time to formulate meaningful 

comments, FSIS extended the comment 

period by an additional 60 days to May 

26, 2015 (80 FR 12618; March 10, 2015). 

The coalition also requested that FSIS 

extend all implementation dates 

announced in the January 2015 notice. 

The Agency did not delay 

implementation of all actions 

announced in the January 2015 notice 

because FSIS made available much of 

the information in that notice in other 

Federal Register notices.3 Therefore, in 

March 2015, FSIS began sampling raw 

chicken parts to gain information on the 

prevalence of Salmonella and 

Campylobacter (in four pound sample 

units) of those products and to gain 

experience in scheduling, collecting, 

and analyzing raw chicken parts for 

these pathogens.4 In April 2015, FSIS 

began sampling raw pork products for 

pathogens of public health concern, as 

well as for indicator organisms.5 In May 

2015, FSIS began routine sampling, 

rather than set-based consecutive day 

sampling, of young chicken (broiler) and 

turkey carcasses.6 FSIS began sampling 

imported poultry carcasses, imported 

raw chicken parts, and imported NRTE 

comminuted chicken and turkey for 

Salmonella and Campylobacter in July 

2015.7 FSIS has begun posting aggregate 

results from this testing as part of its 

quarterly Salmonella report.8

Because FSIS needed additional time 

to fully evaluate the comments 

submitted on posting information on 

establishment performance under the 

standards, FSIS did delay, and has yet 

to web-post, individual establishment 

information for establishments subject 

to poultry carcass sampling. On August 

14, 2015, FSIS announced that it was 

temporarily removing the Category 3 list 

from its Web site until the new moving 

window sampling procedure is fully 

implemented.9

Final Performance Standards, Followup Sampling, Food Safety Assessments, 

and Establishment Posting 

FSIS will begin assessing whether 

establishments meet the new pathogen 

reduction performance standards on 

May 11, 2016. The new standards are: 

Product 

Maximum acceptable percent 

positive 

Performance 

standard * 

Salmonella Campylobacter Salmonella Campylobacter 

Comminuted Chicken (325 g sample) ............................................................ 25.0 1.9 13 of 52 ......... 1 of 52 

Comminuted Turkey (325 g sample) .............................................................. 13.5 1.9 7 of 52 ........... 1 of 52 

Chicken Parts (4 lb. sample) .......................................................................... 15.4 7.7 8 of 52 ........... 4 of 52 

* FSIS intends to interpret results within a moving window comprising fewer than 52 samples (n) by establishing a number of positive samples 

(s) such that (s–1)/n < p <= s/n, where p is the maximum percent positive that would meet the performance standards. 

These standards are the same as what 

FSIS proposed in the January 2015 

notice. 

Following publication of that notice, 

FSIS continued sampling and testing 

comminuted poultry products for 

Salmonella and Campylobacter. Also, as 

noted above, FSIS implemented ongoing 

sampling and testing of chicken parts 

for Salmonella and Campylobacter. 

FSIS found no notable difference 

between the results from this testing and 

the earlier test results for comminuted 

product and the chicken parts baseline 

results. Therefore, FSIS has made no 

changes to the standards based on these 

additional test results. 

In addition, consistent with the 

January 2015 notice, FSIS will collect 

samples based on the volume of 

production at an establishment. 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. The frequency will be 

determined on the basis of their 

production volume and history of 

sampling results.10 Establishments 

likely to get six samples are those that 

produce high volumes of several 

products. Furthermore, FSIS will 

attempt to collect at least the minimum 

number of samples outlined in the chart 

below per year in order to assess process 

control in all establishments subject to 

performance standards. 

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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 7287 

11From January 1, 2015, through March 31, 2015, 

the percent positive rate for Salmonella in 

mechanically separated chicken was 88.52 percent 

and for mechanically separated turkey was 52.78 

percent. (Available at http://www.fsis.usda.gov/

wps/portal/fsis/topics/data-collection-and-reports/

microbiology/quarterly-reports-salmonella/

quarterly-progress-reports.) 

Product 

Minimum number of samples 

to assess process control in a 

moving window 

Salmonella Campylobacter 

Broiler Carcass ........................................................................................................................................................ 11 10 

Turkey Carcass ....................................................................................................................................................... 14 19 

Comminuted Chicken .............................................................................................................................................. 10 52 

Comminuted Turkey ................................................................................................................................................ 10 52 

Chicken Parts .......................................................................................................................................................... 10 13 

Because the Salmonella performance 

standard for broiler carcasses is 9.8 

percent positive or less, FSIS has 

changed the minimum number of 

Salmonella samples to assess process 

control in a moving window for broiler 

carcasses to eleven. The minimum 

number identified in the January 2015 

notice (10) would have effectively 

allowed zero positives. This would have 

constituted a zero tolerance standard. 

FSIS did not want to create a zero 

tolerance standard but did want to 

maintain the level of precision that 

underlay the proposal. FSIS 

accomplished this by increasing the 

minimum number of samples collected 

for Salmonella on broiler carcasses by 

one. 

Consistent with what FSIS announced 

in the January 2015 Federal Register 

notice, the moving window for all 

products will be 52 weeks. However, the 

number of samples collected in the 

window can vary, depending on the 

volume of the product the establishment 

produces, and depending on whether 

FSIS collects follow up samples in 

response to an establishment not 

meeting the standard. Therefore, FSIS 

will assess establishment performance 

based on the maximum acceptable 

percent positive. 

Because the comminuted chicken and 

turkey pathogen reduction performance 

standards permit only one positive 

result for Campylobacter in order to 

pass the standard, essentially 

eliminating Category 2, FSIS will only 

categorize eligible establishments 

producing these products as either 

passing or failing. FSIS will categorize 

establishments following the criteria 

below: 

I. Category 1. Consistent Process Control: 

Establishments that have achieved 50 percent 

or less of the Salmonella or Campylobacter 

maximum allowable percent positive during 

all completed 52-week moving windows over 

the last three months. 

II. Category 2. Variable Process Control: 

Establishments that meet the Salmonella or 

Campylobacter 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 three months. 

III. Category 3. Highly Variable Process 

Control: Establishments that have exceeded 

the Salmonella or Campylobacter maximum 

allowable percent positive during any 

completed 52-week moving window over the 

last three months. 

IV. Passing. Establishments that meet the 

Campylobacter maximum allowable percent 

positive for NRTE comminuted chicken or 

turkey during all completed 52-week moving 

windows over the last three months. 

V. Failing. Establishments that have 

exceeded the Campylobacter maximum 

allowable percent positive for NRTE 

comminuted chicken or turkey during any 

completed 52-week moving window over the 

last three months. 

Note that when FSIS collects multiple 

samples within a week, all those 

samples will be included in the window 

for that week. 

In the January 2015 notice, FSIS 

stated that it intended to determine 

categories based on moving windows 

over the last six months. FSIS is 

changing this timeframe to every three 

months to provide more timely 

information on the establishment’s 

status. As FSIS explained in the January 

2015 notice, FSIS has determined that a 

6-month time component will have 

minimal impact on the categorization of 

establishments that are most likely to 

meet the standard (80 FR at 3947). 

Similarly, the 3-month time component 

will have minimal effect on 

establishments that are most likely to 

meet the standard. 

As part of its verification sampling 

program, consistent with its exploratory 

sampling program for comminuted 

product, FSIS will collect finished 

NRTE ground chicken and turkey and 

other types of NRTE comminuted 

chicken and turkey products. FSIS will 

not sample dumplings, wontons, egg 

rolls, or other comminuted chicken or 

turkey products wrapped in dough or 

other similar covering at this time. 

However, FSIS will sample raw sausage 

in casing. 

FSIS will continue to sample 

mechanically separated chicken and 

turkey that is not intended to be 

processed into a ready-to-eat (RTE) 

product in a domestic official 

establishment, just as it has done during 

the on-going exploratory testing. At this 

time, mechanically separated poultry 

will not be subject to the pathogen 

reduction performance standard for 

comminuted poultry. Given that 

mechanically separated chicken and 

turkey are not typically added to NRTE 

comminuted poultry products, results 

for these products were not used in 

developing the Salmonella 

contamination distribution used in the 

risk assessment (80 FR at 3943; January 

26, 2015). 

FSIS may consider implementing a 

pathogen reduction performance 

standard for mechanically separated 

poultry in the future, particularly if 

there is evidence that this product is 

being used in domestic NRTE product 

available to consumers, if the FSIS 

results for this product exhibit an 

unchanged or upward trend in 

positives, or if there is evidence that 

industry is not taking steps to reduce 

contamination of source carcass frame 

materials within the year following the 

publication of this notice. FSIS is 

concerned about the ongoing 

wholesomeness of this product if 

establishments do not take steps to 

reduce the high frequency of 

contamination of mechanically 

separated poultry,11 even if it is to be 

used in a finished product that is RTE. 

FSIS recommends that the industry at 

least begin implementing quality control 

procedures for ensuring that extraneous 

materials, including intestinal tract and 

other internal organ fragments, do not 

contaminate the source carcass frames 

regardless of whether or not the product 

is destined for RTE processing. These 

steps, at a minimum, will better ensure 

the wholesomeness of the product. 

Consistent with the January 2015 

notice, FSIS will sample the following 

chicken parts to assess whether they 

meet the standards: legs (comprised of 

the drumstick and thigh portions either 

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7288 Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 

12The 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. 

13FSIS 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. 

separately or combined), wings, and 

breasts. 

Also, consistent with what it 

announced in the January 2015 notice, 

as soon as practical after May 11, 2016, 

FSIS will begin sampling 3–4 times per 

year product that has been excluded 

from Salmonella verification testing: 

chicken in poultry slaughter 

establishments operating under a 

religious exemption; the minor species 

carcasses under FSIS jurisdiction and 

inspection (species other than chicken, 

turkey, pork, and cattle, such as squab, 

ratites, goose and lamb); and product 

otherwise eligible for sampling that 

FSIS has excluded because it is 

produced in low volume establishments 

that produce 1,000 pounds or less per 

day. FSIS expects to eventually 

implement pathogen reduction 

performance standards to assess process 

control for these products. However, 

before FSIS begins using these sample 

results to assess whether establishments 

previously excluded from verification 

sampling meet performance standards, 

it will provide notice and request 

comment on such standards in the 

Federal Register. Meanwhile, FSIS will 

treat these sample results as separate 

populations and report the aggregate 

results quarterly, including such 

information as percentage positive at the 

25th, 50th, and 75th percentile. 

No sooner than May 11, 2016, FSIS 

will begin web-posting the category 

status of all establishments subject to 

the existing poultry carcass pathogen 

reduction performance standards. At 

that time, FSIS will post these 

establishments’ Salmonella and 

Campylobacter category status based on 

sample results from May 2015 (when 

FSIS began routine sampling of broiler 

and turkey carcasses) to the present. 

After completion of the first year of 

sampling (i.e., the first 52-week moving 

window), for chicken parts and 

comminuted poultry products subject to 

sampling under the new pathogen 

reduction performance standards, FSIS 

will begin web-posting whether, based 

on FSIS results, the establishment is 

passing, or what category the 

establishment is in, depending on the 

standard for the particular product. 

However, based on at least the 

minimum number of samples to assess 

process control for that product/

pathogen pair and other available 

information about establishments, such 

as noncompliance rates, if establishment 

performance overall does not improve 

or appears to be worsening before the 

completion of the first moving window, 

FSIS may begin web-posting individual 

establishment category information 

sooner. 

In the January 2015 notice, FSIS 

announced that it intended to web-post 

the categories for all establishments 

subject to the Campylobacter pathogen 

reduction performance standards. 

However, because, as comments pointed 

out, the comminuted chicken and 

turkey pathogen reduction performance 

standards permit only one positive 

result for Campylobacter in order to 

pass the standard, essentially 

eliminating Category 2, FSIS will not, at 

this time, web-post the category status 

of individual establishments that do not 

meet the Campylobacter standard for 

comminuted chicken or turkey products 

(i.e., those in Category 3). Instead, FSIS 

will web-post whether the eligible 

establishment is passing or failing. 

Consistent with the January 2015 notice, 

FSIS will update individual 

establishment postings on a monthly 

basis. 

Starting August 9, 2016, FSIS will 

web-post quarterly aggregate 

information relative to categories for all 

establishments subject to sampling 

under the new performance standards 

for which FSIS has collected the 

minimum number of samples, using the 

most recent sample results. This 

information will be aggregated and will 

not single out any specific 

establishment. This information will 

give industry and other stakeholders 

timely information about progress being 

made to reduce contamination in NRTE 

poultry of all types sampled. FSIS will 

also web-post calendar year prevalence 

estimates in its Salmonella and 

Campylobacter annual report. Results of 

follow-up sampling will be excluded for 

the purposes of these prevalence 

estimates. FSIS will not include followup sampling in prevalence estimates 

because these samples are non-random 

and targeted. 

FSIS will schedule a Public Health 

Risk Evaluation (PHRE), and possibly a 

Food Safety Assessment (FSA), based on 

FSIS test results, for establishments that 

do not meet the pathogen reduction 

performance standards; for 

establishments that have produced 

products with repetitive Salmonella or 

Campylobacter serotypes of public 

health concern or repetitive antibiotic 

resistant Salmonella; and for 

establishments with Salmonella or 

Campylobacter pulsed-field gel 

electrophoresis (PFGE) (or wholegenome sequencing, as it becomes 

available) patterns matching those 

found in recent outbreaks or 

epidemiologically linked to illnesses. 

FSIS intends to do the PHRE because it 

can reasonably be inferred that 

establishments in these categories have 

not adequately addressed Salmonella or 

Campylobacter in their Hazard Analysis 

and Critical Control Point (HACCP) 

systems. Based on PHRE analysis, FSIS 

will determine whether to schedule a 

FSA 12 at the establishment. 

FSIS will collect 16 or 8 follow-up 

samples (depending on the product 

volume) on a daily or per shift basis, as 

soon as possible after an establishment 

has not met a pathogen reduction 

performance standard. The follow-up 

samples will count towards the samples 

collected as part of the moving window 

procedure for that establishment. In the 

January 2015 notice, FSIS stated that it 

did not intend to count the follow up 

samples in the moving window for 

assessing whether establishments are 

meeting the standards. FSIS has decided 

to change its approach so that it can 

more quickly assess whether 

establishments have regained process 

control, and because, when 

establishments have regained control, 

FSIS believes their posted category 

status should reflect that fact. FSIS is 

also making this change in response to 

comments. 

As we currently do for outbreak 

investigations, for at least 90 days after 

an establishment has not met a 

standard, FSIS will monitor CDC 

PulseNet database for matching food 

isolates to those obtained by FSIS in its 

sampling of products produced by the 

establishment. This monitoring will give 

FSIS early warning if an outbreak 

involving the establishment’s products 

is developing. Moreover, as new tools 

such as whole genome sequencing 

become available, FSIS will also search 

for official sequencing databases 

matches between FSIS-regulated NRTE 

products and human illness. FSIS will 

alert its public health partners when an 

establishment does not meet the 

standard, so that they can also be on the 

lookout for an emerging outbreak. In 

addition, FSIS may collect the 

consignee list for product produced 

when an establishment has not met the 

standard so that the Agency can focus 

its attention on the area in which the 

product was distributed. 

Consistent with existing practices,13

after notifying an establishment that it 

has not met a performance standard, 

FSIS will conduct an assessment of the 

establishment’s HACCP plan and 

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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 7289 

Sanitation Standard Operating 

Procedures, through a PHRE, focusing 

on the establishment’s planned 

corrective actions. In addition, FSIS will 

develop a plan to verify whether the 

establishment implemented corrective 

actions. FSIS may also conduct a FSA, 

when it deems it appropriate. If, after 90 

days, the establishment has not been 

able to gain process control, as 

determined from FSIS’s follow-up 

sampling and from the results of the 

PHRE or FSA, and the establishment has 

not taken corrective actions, FSIS will 

likely take enforcement actions, such as 

by issuing a Notice of Intended 

Enforcement (NOIE) or by suspending 

inspection, under the conditions and 

according to the procedures described 

in 9 CFR part 500. FSIS will not issue 

an NOIE or suspend inspection based 

solely on the fact that an establishment 

did not meet a performance standard. 

If the establishment produced product 

associated with an outbreak, even if the 

establishment is in category 1, FSIS will 

scrutinize its corrective actions with 

particular care, including performing an 

Incident Investigation Team review (see 

FSIS Directive 5500.3). 

Generally, if an establishment 

produces product associated with an 

outbreak or has failed to meet a 

pathogen reduction performance 

standard for Salmonella or 

Campylobacter and has not addressed 

those hazards in its HACCP plan, the 

establishment would need to reassess its 

HACCP plan for that product to 

determine whether the plan needs to be 

modified to address the hazard (9 CFR 

417.3(b)). Thus, the establishment, to 

maintain an adequate HACCP system, 

will have to address the pathogen in its 

HACCP plan, rather than through a 

prerequisite program like the Sanitation 

Standard Operating Procedures. 

Finally, consistent with FSIS testing 

of imported beef and poultry products 

for pathogens, FSIS will begin testing 

imported pork for Salmonella later in 

Fiscal Year 2016 (FY2016). 

Summary of Implementation Dates 

FSIS will begin assessing whether 

establishments meet the new pathogen 

reduction performance standards for 

chicken parts and comminuted chicken 

and turkey products on May 11, 2016. 

Also beginning no sooner than May 11, 

2016, FSIS will begin posting on its Web 

site the category status of all eligible 

establishments subject to the existing 

poultry carcass pathogen reduction 

performance standards based on sample 

results from May 2015 (when FSIS 

stopped set-based, consecutive day 

testing and began routine sampling 

throughout the year of broiler and 

turkey carcasses) to the present. After 

completion of the first moving window 

of product sampled under the new 

pathogen reduction performance 

standards for chicken parts, 

comminuted chicken, and turkey 

products (approximately 1 year from 

publication of this notice), FSIS will 

begin web-posting whether individual 

establishments are in Category 1, 2, or 

3, or whether they are passing the 

standards (in the case of NRTE 

comminuted chicken or turkey for 

Campylobacter). However, based on at 

least the minimum number of samples 

to assess process control for that 

product/pathogen pair and other 

available information about 

establishments, such as noncompliance 

rates, if establishment performance 

overall does not improve or appears to 

be worsening before the completion of 

the first moving window, FSIS may 

begin web-posting individual 

establishment category information 

sooner. As soon as practical after May 

11, 2016, FSIS will begin sampling 3– 

4 times per year the following products 

which have been excluded from 

Salmonella verification testing: Broilers 

produced in poultry slaughter 

establishments operating under a 

religious exemption, minor species 

carcasses (minor species are those other 

than classes of chicken, turkey, pork 

and beef for which FSIS has previously 

set pathogen reduction performance 

standards and that are produced and 

consumed in larger quantities than other 

classes of these species or other species 

under FSIS jurisdiction and inspection, 

such as squab, ratites, lamb, and goose), 

and product from low volume 

establishments that produce up to 1,000 

pounds per day of poultry product 

subject to sampling. This fiscal year, 

FSIS will also begin sampling imported 

pork products for Salmonella. 

Summary of Comments and Responses 

In the January 2015 notice, FSIS 

requested comment on specific issues: 

The proposed pathogen reduction 

performance standards for Salmonella 

and Campylobacter in raw chicken parts 

and NRTE comminuted chicken and 

turkey products; sampling of raw 

chicken parts that have been marinated 

or injected; the Agency’s 

implementation strategy, including how 

it plans to assess process control in low 

volume establishments and the planned 

modifications to its categorization 

system; how it plans to web-post the 

category status of eligible 

establishments; and the accuracy of the 

information and assumptions used in its 

cost-benefit analysis. FSIS received 15 

comments in response to these and 

other issues in the notice. The 

comments were from consumer 

advocacy groups, organizations 

representing the meat/poultry industry, 

meat/poultry processors, a food 

ingredient supplier, and an individual. 

FSIS has summarized and responded 

to the relevant issues raised by 

commenters below. 

A. General Comments on Actions 

Announced in the Notice 

Comments: Many comments from 

both industry and consumer groups 

supported FSIS establishing pathogen 

reduction performance standards for 

Salmonella and Campylobacter in NRTE 

chicken parts and comminuted chicken 

and turkey products because the 

commenters agreed that the standards 

are likely to benefit public health. In 

addition, many comments supported 

FSIS replacing set-based, consecutiveday sampling with routine sampling, 

including weekly sampling in high 

volume operations, and using a moving 

window approach for assessing process 

control to gain a better sense of ongoing 

establishment performance. Likewise, 

several comments supported FSIS using 

a more sensitive enrichment-based 

method to analyze samples for 

Campylobacter, sampling imported raw 

chicken products, and sampling raw 

chicken parts other than breasts, legs, 

and wings to better understand the 

incidence of Salmonella and 

Campylobacter in these products and to 

assess whether additional performance 

standards may be needed. Finally, 

several comments supported FSIS’s 

planned action to web-post the 

individual category status of 

establishments subject to FSIS sampling 

to assess whether they meet 

performance standards because it will 

provide the public with specific, 

geographical, and process capability 

information and will provide industry 

with incentives for making changes to 

their operations or from whom they 

purchase source materials. 

Meanwhile, other commenters, mostly 

representing industry interests, 

generally were opposed to the issuance 

of new pathogen reduction performance 

standards and to web-posting individual 

establishment performance. 

Response: FSIS has determined that it 

is prudent to issue of new pathogen 

reduction performance standards and to 

web-post establishment-specific 

performance as noted in detail below. 

B. Proposed Performance Standards 

Comment: An organization 

representing the chicken industry 

objected to the method and scientific 

evidence used to develop the 

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14http://www.fsis.usda.gov/wps/wcm/connect/

afe9a946-03c6-4f0d-b024-12aba4c01aef/EffectsPerformance-Standards-Chicken-PartsComminuted.pdf?MOD=AJPERES. 

15Batz, M.B., et al. 2012. ‘‘Ranking the disease 

burden of 14 pathogens in food sources in the 

United States using attribution data from outbreak 

investigations and expert elicitation.’’ J. Food Prot 

75(7):1278–91. 

16Painter, J.A., et al. 2013. ‘‘Attribution of 

foodborne illnesses, hospitalizations, and deaths to 

food commodities by using outbreak data, United 

States, 1998–2008.’’ Emerg Infect Dis 19(3): 407–15. 

17 Interagency Food Safety Analytics 

Collaboration, 2015. ‘‘Foodborne Illness Source 

Attribution Estimates for Salmonella, Escherichia 

coli O157:H7, Listeria monocytogenes, and 

Campylobacter using Outbreak Surveillance Data.’’ 

18Table 6 in NARMS. 2013. Retail Meat Report 

2011. At: http://www.fda.gov/downloads/

AnimalVeterinary/SafetyHealth/Antimicrobial

Resistance/NationalAntimicrobial

ResistanceMonitoringSystem/UCM334834.pdf. 

19http://www.fsis.usda.gov/wps/wcm/connect/

fsis-archives-content/internet/main/topics/recallsand-public-health-alerts/recall-case-archive/

archives/ct_index295a. 

20http://www.cdc.gov/salmonella/2011/groundturkey-11-10-2011. 

21http://www.cdc.gov/salmonella/heidelberg-10-

13/. 

22Additional data is available at http://

www.fsis.usda.gov/wps/wcm/connect/25bc47add59d-48d6-b90f-4865d1483f4a/Q2-CY2014- 

performance standards. Rather than use 

the Healthy People 2020 (HP2020) goals 

to set the standards, the organization 

argued that FSIS should identify the 

most significant sources of illnesses 

from these pathogens and focus its 

resources on these products. In 

addition, the organization argued that 

chicken and turkey are not the most 

significant sources of illnesses 

associated with these pathogens. 

Response: The Healthy People 

Initiatives have served as a sciencebased framework for public health 

activities by FSIS, CDC, the Food and 

Drug Administration, and across other 

sections of the public health community 

for years. Furthermore, FSIS disagrees 

that the proposed pathogen reduction 

performance standards were not based 

on sufficient valid scientific evidence. 

Using a common analytical 

framework,14 FSIS developed the 

standards based on a variety of data 

sources, including Agency sampling 

data, the CDC foodborne illness and 

outbreak data, and the most recent 

available research, as well as the 

HP2020 national health objectives. 

Recent research supports that poultry 

represents the largest fraction of 

Salmonella and Campylobacter illnesses 

attributed to FSIS-regulated 

products.15 16 17 Furthermore, data from 

the National Antimicrobial Resistance 

Monitoring System (NARMS) show that 

the incidence of Salmonella in poultry 

products is five to ten times higher than 

that in ground beef or pork chops.18

Because FSIS can only directly affect 

those food commodities that fall under 

its jurisdiction, FSIS is addressing the 

product it regulates that poses the 

highest public health risk. 

In addition, evidence of the 

connection of salmonellosis and 

contaminated NRTE comminuted 

poultry products can be found in the 

recent outbreaks that have been 

associated with these products. In 2011, 

there were two outbreaks involving 

ground turkey product. The 2011 

Salmonella Hadar outbreak associated 

with turkey burgers sickened 12 people 

in 10 states and led to a recall of 54,960 

pounds of turkey burger.19 The 2011 

Salmonella Heidelberg outbreak 

associated with ground turkey product 

sickened 136 people in 34 states and led 

to one death. Approximately 36 million 

pounds of ground turkey were 

ultimately recalled.20 The CDC reported 

a 2013–2014 Salmonella Heidelberg 

illness outbreak associated with the 

consumption of chicken parts that 

sickened 634 people in 29 states and 

Puerto Rico.21

In addition, in 2015, the CDC 

investigated two separate outbreaks of 

Salmonella Enteritidis infections linked 

to raw, frozen, stuffed chicken entrees 

associated with two separate 

establishments that produced these 

products. These two outbreaks stemmed 

from poultry product in which the 

source materials were either 

comminuted chicken breast meat or 

whole chicken breast parts and resulted 

in twelve illnesses and five 

hospitalizations. In both outbreaks, the 

establishment involved did not consider 

implementing effective controls for the 

source materials or for the production 

process to know the frequency of 

contamination of source materials with 

Salmonella. 

Thus, FSIS has concluded, using the 

available data and the public health 

science principles contained in a 

quantitative risk assessment, that 

adopting new pathogen reduction 

performance standards for comminuted 

poultry and chicken parts to reduce the 

Salmonella on these types of products 

would reduce consumer exposure to 

this pathogen and thus reduce the 

occurrence of illness. 

Comment: An organization 

representing the turkey industry stated 

that the industry has already made great 

strides in lowering illness that, 

according to the commenter, FSIS did 

not account for in setting the standards. 

This organization also stated that it will 

be very difficult to achieve further 

reduction in illness through the 

proposed NRTE comminuted turkey 

product standards. 

Response: FSIS agrees that the turkey 

industry, particularly, has collectively 

taken steps to reduce the incidence of 

pathogens in comminuted product 

following the Salmonella Heidelberg 

multistate outbreak in 2011 that infected 

more than 100 individuals. Nonetheless, 

setting pathogen reduction performance 

standards is an important tool in 

targeting reductions and in protecting 

public health, and FSIS has decided to 

proceed to do so. 

In setting the performance standards, 

FSIS did not explicitly account for the 

decrease in pathogen contamination 

observed following the Salmonella 

Heidelberg outbreak. To do this, FSIS 

would have needed to use the most upto-date attribution data. Given that there 

is about a two year lag in the CDC 

outbreak data, it was not possible for the 

Agency to do so. FSIS did, however, use 

the most up-to-date published 

attribution data available (Painter et al., 

2013). In addition, FSIS used the most 

recent contamination data available at 

the time it developed the performance 

standards (2013–2014). These 

contamination data reflect some of the 

reduction in pathogen contamination 

seen in comminuted turkey. 

Still, FSIS recognizes that the 

performance standard for 

Campylobacter, allowing only one 

positive sample in the moving window, 

is quite rigorous. Regardless, such a 

performance standard is necessary to 

maintain industry focus on continuous 

improvement. However, as discussed 

later in this document, FSIS has agreed 

that, because the comminuted chicken 

and turkey pathogen reduction 

performance standards permit only one 

positive result for Campylobacter in 

order to pass the standard, there is no 

Category 2. Thus, FSIS will web-post 

these establishments as either passing or 

failing. 

Comment: Several comments 

criticized the proposed pathogen 

reduction performance standards for 

comminuted poultry because they were 

not based on a full year of data. The 

commenters also stated that the 

standards were based on data from the 

high prevalence season for the 

pathogens. 

Response: At the time that the 

pathogen reduction performance 

standards for comminuted poultry were 

developed and subsequently published, 

the standards were based on eight 

months of data. Meanwhile, FSIS has 

analyzed the first twelve months of data 

for NRTE comminuted chicken and 

turkey and compared the results to that 

of the 8-month analysis.22 FSIS found 

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Salmonella-Testing.pdf?MOD=AJPERES (see Table 

8a and 8b). 

23Williams, M.S., et al. (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, 

267–273. 

24Available at http://www.fsis.usda.gov/wps/

wcm/connect/a18d541e-77d2-40cf-a045- 

b2d2d13b070d/Microbiological-Testing-RawPoultry.pdf?MOD=AJPERES 

25Available at http://www.cdc.gov/salmonella/

heidelberg-chickenlivers/011112/index.html. 

26FSIS Notice 16–15; available at http://

www.fsis.usda.gov/wps/wcm/connect/5233e84cf4a6-4959-b861-926a4d912eff/16-15.pdf?

MOD=AJPERES 

no notable difference between these 

results and earlier test results for 

comminuted product. Therefore, FSIS 

made no changes to the standards based 

on these additional test results. 

However, FSIS acknowledges that 

setting the performance standards on 

data from a true high prevalence season 

(i.e., a period in which there was more 

frequent exposure of the public to 

pathogens of public health concern) 

could create an unintended 

consequence of permitting more 

exposure of the public to pathogens of 

public health concern during a true low 

prevalence season. FSIS’s published 

analysis of seasonal patterns of 

Salmonella contamination in FSIS 

regulated products did not identify a 

significant seasonal pattern in ground 

chicken or turkey.23 Therefore, FSIS 

concludes that the performance 

standards have been appropriately 

designed, and that no change is 

necessary. 

Comment: As more data become 

available (and regularly thereafter), 

several consumer advocacy groups 

requested that FSIS re-evaluate the 

performance standards. In addition, 

comments requested that FSIS assess 

whether the performance standards 

need to be updated to account for the 

actual compliance fraction and other 

assumptions made during initial 

calculations. The comments also 

requested that FSIS periodically 

measure the impact of the performance 

standards on public health goals. 

Response: FSIS will periodically 

assess the effect of the performance 

standards. This assessment will include 

an estimation of all the parameters used 

in the risk assessment model and their 

contribution to a potential reduction in 

illnesses. FSIS will assess each 

pathogen reduction performance 

standard on at least a five-year basis to 

determine whether the standard should 

be adjusted. FSIS will calculate ongoing 

pathogen prevalence for all products 

subject to standards and will determine 

whether the pathogen prevalence has 

been significantly reduced in deciding 

whether to revise the performance 

standards. 

Comment: A consumer advocacy 

group requested that FSIS also establish 

a performance standard for live animals 

entering the slaughter facility. 

Response: FSIS disagrees that it 

should establish pathogen reduction 

performance standards for live animals 

because FSIS does not have jurisdiction 

on the farm and has not conducted 

testing on live animals. However, FSIS 

does recommend that establishments 

develop pathogen prevention targets for 

products derived from live animals that 

an establishment would apply as early 

as safely possible in its slaughter 

process. Sampling at this early stage 

would enable an establishment to 

determine whether its food safety 

system is adequately designed to 

mitigate the incoming load of 

pathogens. 

The rehang or pre-evisceration 

sampling point used in the FSIS carcass 

baseline best represents the 

contamination on the carcass before 

there is secondary contamination from 

the evisceration process. FSIS provides 

information to industry on median 

indicator organism values at rehang in 

its compliance guide, ‘‘Modernization of 

Poultry Slaughter Inspection— 

Microbiological Sampling of Raw 

Poultry’’ (June 2015).24 When an 

establishment compares its rehang or 

pre-evisceration sample results to the 

ones in the table in the compliance 

guide, a sample value that is higher than 

the corresponding one listed in the table 

indicates that the incoming bacterial 

load on the bird may be higher than 

expected, and that the establishment 

may not be able to maintain process 

control. As a result, the establishment 

would be less likely to meet the 

applicable performance criteria. 

Comments: An organization 

representing the chicken industry urged 

FSIS to not apply the performance 

standard for raw chicken parts to any 

products not consistently sampled in 

the Raw Chicken Parts Baseline Survey. 

The organization stated that FSIS has no 

basis for concluding that the Raw 

Chicken Parts Baseline Survey is 

applicable to parts that were marinated 

with a clear solution. If the Agency has 

a means to identify which samples in 

the Survey were from marinated parts, 

the organization requested that FSIS 

remove those samples from its 

calculations. 

In addition, the organization stated 

that necks and giblets should not be 

subject to a pathogen reduction 

performance standard because they are 

typically sold to (and used by) 

consumers differently than breasts, legs, 

and wings. However, several consumer 

advocacy groups requested that FSIS 

apply the pathogen reduction 

performance standard for raw chicken 

parts to necks, giblets, half carcasses, 

quarter carcasses, and parts injected or 

marinated with a clear solution until the 

Agency has developed a pathogen 

reduction performance standard specific 

to those items. 

A consumer advocacy group 

requested that FSIS establish a sampling 

program for raw chicken livers. The 

group cited a CDC report detailing 

outbreaks linked to the consumption of 

chicken livers 25 as support for its 

request. The group also requested that 

FSIS sample and develop pathogen 

reduction performance standards for 

raw turkey parts because turkey parts 

are commonly purchased by consumers. 

Response: As FSIS explained in the 

January 2015 Federal Register notice, 

during the baseline some inspection 

personnel sampled parts that were 

injected with a solution or otherwise 

marinated (80 FR at 3943). Because FSIS 

did not identify the samples as injected 

or otherwise marinated at the time of 

collection, FSIS is unable to remove 

these results from its calculations and 

will apply the performance standards to 

marinated, injected, tumbled, or 

tenderized parts. For its ongoing 

exploratory sampling of parts, FSIS 

issued instructions to inspection 

program personnel to make explicit that 

such parts are to be sampled.26 Based on 

the first 3–4 months of exploratory 

chicken parts sampling, Salmonella 

results for injected, tenderized, or 

vacuum tumbled parts were not 

significantly higher than those for intact 

parts. These products are available to 

the consumer and do present a risk of 

exposure. FSIS does not believe it 

appropriate to set a different pathogen 

reduction performance standard for 

these products than for other parts. 

FSIS will not, however, apply the 

pathogen reduction performance 

standard for raw chicken parts to necks, 

giblets, half carcasses, and quarter 

carcasses at this time. In FY2016, FSIS 

will begin exploratory sampling of 

necks, giblets (i.e., gizzards, hearts, and 

livers), half carcasses, and quarter 

carcasses to better understand the 

prevalence of Salmonella and 

Campylobacter in these parts. FSIS will 

post the aggregate results of this testing 

as part of its Salmonella reporting. In 

addition, FSIS plans to analyze these 

data to better understand the potential 

differences in contamination for 

gizzards, hearts, and livers. 

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27http://www.fsis.usda.gov/wps/portal/fsis/

newsroom/meetings/newsletters/constituentupdates/archive/2015/ConstUpdate032015. 

28Though comminuted turkey was not tested in 

this methods comparison, FSIS expects there would 

also be an increase in the Campylobacter percent 

positive using the enrichment-based method. 

29See Chapter VIII, Section II of FSIS Directive 

10,250.1; available at http://www.fsis.usda.gov/wps/ 

wcm/connect/ebf83112-4c3b-4650-8396- 

24cc8d38bf6c/10250.1.pdf?MOD=AJPERES. 

FSIS will use these data to determine 

whether further sampling is needed. 

Such information could then be used by 

the Agency to decide whether pathogen 

reduction performance standards for 

these products are necessary. 

Comment: An organization 

representing the chicken industry 

opposed FSIS using the more sensitive, 

enrichment-based method for 

Campylobacter testing that the Agency 

is using for comminuted product and 

chicken parts because, according to the 

commenter, the method increases the 

likelihood of establishments not 

meeting the performance standard when 

actual prevalence may not have 

changed. 

Several consumer advocacy groups 

requested that the performance standard 

for Campylobacter in NRTE 

comminuted chicken and turkey be 

based on the most sensitive enrichmentbased testing method. 

Response: In 2013, FSIS began testing 

NRTE comminuted poultry for 

Campylobacter using a direct plating 

method (1 mL test portion). Later, in 

August 2015, FSIS began concurrently 

analyzing all NRTE comminuted poultry 

samples for Campylobacter using the 

direct plating method and an 

enrichment-based method (30 mL test 

portion).27 The Agency took this step 

because the enrichment-based method 

can detect a higher percent of positive 

samples, as determined from the results 

of an analysis comparing the direct 

plating method with the enrichmentbased method. 

FSIS found that the 1 mL direct 

plating method identified about 3–4 

percent Campylobacter-positive samples 

for comminuted chicken and about 1 

percent Campylobacter-positive samples 

for comminuted turkey. In contrast, the 

30 mL enrichment-based method 

identified about 15 percent of the 

samples Campylobacter-positive in 

comminuted chicken, i.e. about a 4-fold 

increase in percent positive results 

between the 30 mL enrichment-based 

method and the 1 mL direct plating 

method for comminuted chicken.28 FSIS 

has not completed a similar evaluation 

for comminuted turkey. 

Regardless, FSIS developed the 

pathogen reduction performance 

standards for Campylobacter using a 

direct plating laboratory method of 

analysis with a 1 mL test portion. 

Therefore, FSIS will proceed with 

assessing establishment performance 

relative to those standards based on the 

1 mL portion size. 

The Agency will continue to perform 

the 1 mL direct plating method 

alongside the 30 mL enrichment-based 

method and analyze data generated from 

both analytical approaches. These 

analyses will show whether significant 

differences exist, and whether these 

differences support that there is a need 

to change the combined analytical 

approach, the pathogen reduction 

performance standards, and the 

associated method of analysis for 

Campylobacter in NRTE comminuted 

chicken and turkey. If FSIS determines 

that it needs to changes the standards, 

it will propose changes in the Federal 

Register. 

C. Implementation of Final Performance 

Standards 

Comment: Several industry comments 

requested that FSIS provide at least a 1- 

or 2-year transition period after FSIS 

announces the final performance 

standards, and before FSIS begins 

assessing whether establishments meet 

the standards, to allow industry time to 

adjust to the new standards. 

Response: FSIS does not agree. FSIS 

notes that the poultry industry has been 

aware of the FSIS intent to develop 

pathogen reduction performance 

standards for chicken parts since at least 

2012 when the baseline study got 

underway. Multiple recent outbreaks for 

both chicken parts and comminuted 

poultry heighten the need for industry 

to collectively address more optimal 

process control to limit exposure of the 

public to pathogens of public health 

concern. Thus, FSIS is providing a short 

but practical implementation period 

sufficient for establishments to adjust 

their food safety system. FSIS will begin 

assessing whether establishments meet 

the new Salmonella and Campylobacter 

performance standards for NRTE 

comminuted chicken and turkey and 

raw chicken parts on May 11, 2016. This 

90-day delay is appropriate because 9 

CFR 304.3 provides establishments up 

to 90 days to validate changes to their 

food safety system. Consequently, 

sample results affecting whether 

establishments meet the new standards 

begin with the first sample collected as 

part of a moving window on or after 

May 11, 2016. This 90-day period will 

effectively provide for a sufficient 

period of time for establishments to 

validate that their food safety systems 

can consistently control for enteric 

pathogens of public health concern, in 

accordance with 9 CFR 417.4. 

D. Routine Verification Sampling and 

Testing 

Comment: An individual and several 

consumer advocacy groups stated that 

routine verification sampling should be 

unannounced, unpredictable, and 

completely random to prevent 

establishments from temporarily 

altering their food safety systems to 

‘‘pass’’ tests. 

In addition, two consumer advocacy 

groups noted that antimicrobial agents 

used as interventions in poultry 

establishments may be masking the 

presence of Salmonella (i.e., in the 

neutralizing solution used by the 

Agency during sample collection) 

resulting in ‘‘false negatives.’’ 

Response: The fact that FSIS no 

longer collects samples on consecutive 

days provides establishment less 

awareness about when a sample is to be 

collected. FSIS personnel notify 

establishment management just before 

collecting each sample that a routine 

Salmonella and Campylobacter sample 

is being collected. In addition, FSIS 

personnel use a method for randomly 

selecting specific product for sampling 

such that all product from all shifts, 

rails, chillers, coolers, and grinders have 

an equal chance of being selected for 

sampling. 

FSIS has issued instructions to 

inspection program personnel, directing 

them to report changes in establishment 

practices when FSIS samples are 

collected.29 FSIS has not noted any 

significant concern with changed 

production practices during FSIS 

sampling. Further, based on experience 

in-plant, FSIS does not believe that 

establishments can readily adjust their 

food safety systems to eliminate 

pathogens without such a change being 

obvious and inconsistent with their 

routine food safety system or HACCP 

flow chart. FSIS inspection personnel 

are present every day and are aware of 

the design of the food safety system in 

each establishment. 

FSIS continues to work with USDA’s 

Agricultural Research Service to 

investigate the potential impact of 

carryover of antimicrobial agents on 

sampling results. The findings of this 

research will inform any actions the 

Agency may take. Regardless, in 2016, 

FSIS plans to begin evaluating the use 

of a new buffer solution to reduce the 

potential impact from carryover of 

antimicrobial agents. If an effective 

buffering media is identified, the buffer 

media will be used by inspection 

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30Available at http://www.fsis.usda.gov/wps/

wcm/connect/5233e84c-f4a6-4959-b861- 

926a4d912eff/16-15.pdf?MOD=AJPERES. 

31See Directive 10,250.1 and FSIS Notices 16–15, 

22–15, 23–15, 31–15 and 32–15. 

program personnel when sampling 

poultry carcasses and parts to reduce 

carryover from the common 

antimicrobial interventions that may 

potentially impact sampling results. 

Comment: An organization 

representing the chicken industry and a 

meat and poultry processor requested 

that raw chicken parts only be eligible 

for sampling in the primary producing 

establishment. 

Response: FSIS disagrees with this 

comment. Establishment handling and 

processing of raw chicken parts at 

secondary processing facilities presents 

additional opportunity for 

contamination with pathogens, 

particularly when new source materials 

are incorporated. Thus, FSIS will 

continue sampling finished raw chicken 

parts at slaughter establishments, as 

well as at those that further process the 

product. By doing so, exposure of the 

public to pathogens of public health 

concern will be reduced at each 

practical step in the production process. 

FSIS has issued instructions to its 

inspection program personnel that make 

clear that product that is only 

repackaged and not subject to further 

reprocessing is not subject to sampling 

(see Section V, Part D, of FSIS Notice 

16–15).30

Comment: An organization 

representing the chicken industry 

requested that FSIS provide more detail 

about how each sample will be 

collected, where in the process the 

product will be sampled, and how the 

products will be tested. 

Response: FSIS has issued necessary 

notices and directives 31 on this matter 

and will issue additional instructions as 

necessary. 

Comment: A consumer advocacy 

group requested that FSIS verification 

sampling include raw chicken parts 

derived from carcasses set aside for inplant ‘‘reprocessing’’ and ‘‘salvage’’ 

activities. 

Response: Parts derived from 

‘‘reprocessing’’ and ‘‘salvage’’ activities 

most commonly end up as comminuted 

product or as parts destined for further 

processing—both of which are subject to 

FSIS verification sampling and testing. 

If FSIS finds that these parts are being 

handled in a manner that consistently 

circumvents Agency verification testing, 

FSIS will consider sampling of this 

product. 

Comment: A meat and poultry 

processor requested that FSIS 

enumerate all of its Salmonella results 

and focus its resources on facilities with 

higher levels of Salmonella and not 

focus on presence of the pathogen alone. 

Response: FSIS agrees that high levels 

of pathogens should be considered in 

FSIS sampling considerations and is 

exploring options for enumerating more 

samples. However, because the 

occurrence of any Salmonella poses a 

potential hazard for consumers, FSIS 

will continue to primarily focus upon 

the presence or absence of the pathogen. 

In addition, based on sampling results 

from establishments linked to outbreaks, 

FSIS has found low level but frequent 

contamination does contribute to 

adverse public health outcomes. 

Furthermore, pathogen reduction 

through performance standards results 

in fewer contaminated products overall, 

regardless of the levels of Salmonella 

present. Thus, by setting new 

performance standards for these 

products that are based on presence or 

absence testing, FSIS anticipates 

establishments will adopt practices that 

will reduce all pathogens in their 

products, resulting in a greater overall 

impact on reducing human illnesses 

associated with FSIS-regulated products 

than would result from a focus on 

enumeration. 

Comment: A consumer advocacy 

group suggested that FSIS sample the 

neck skins of several birds in a flock 

(defined as one broiler house) 

immediately after the kill step, as is 

done in Sweden. 

Response: FSIS questions whether 

such a sampling program would derive 

different results than those found 

through other FSIS sampling. Sampling 

of the neck skins immediately after the 

slaughter step is one component of 

Sweden’s Salmonella control program 

which primarily regulates on-farm 

production. The testing of the neck 

skins at the time of slaughter is done to 

verify the effectiveness of on-farm 

screening activities. 

FSIS encourages establishments to 

determine the incoming pathogen load 

on live birds to determine whether its 

processes can effectively address the 

pathogens. For example, these data 

could be used by establishments to 

determine which farms to obtain birds 

from for slaughtering, and how to 

schedule the order of flocks or houses 

of birds to decrease cross contamination 

during slaughter. 

In addition, FSIS requires that 

slaughter establishments sample most 

poultry pre-chill (9 CFR 381.65(g)(1))— 

a valuable source of data about how 

well an establishment is minimizing 

contamination with enteric pathogens 

and fecal material on live birds 

presented for slaughter and on carcasses 

throughout the evisceration and 

dressing process. 

Comment: An organization 

representing the chicken industry 

requested that FSIS share reserve rinsate 

(the solution obtained and sent to FSIS 

laboratories for analysis after mixing/

washing product) with establishments at 

the time of sample collection. 

Response: FSIS does not intend to 

share rinsate with establishments. FSIS 

is satisfied with the competency of its 

laboratory personnel and the procedures 

they implement, which are able to 

reliably detect pathogens. FSIS 

encourages establishments to conduct 

their own sampling rather than rely 

upon FSIS sampling results. In fact, 

FSIS assumes that establishments will 

choose to increase sampling and testing 

as a means of verifying process control, 

and that they are meeting the new 

pathogen reduction performance 

standards. FSIS included additional 

costs associated with increased 

sampling and testing by establishments 

in our cost-benefit analysis posted with 

this notice. 

E. Proposed Moving Window Approach 

for Assessing Process Control 

Comment: In lieu of the moving 

window approach, an organization 

representing the meat/poultry industry 

suggested that FSIS consider other 

alternative approaches to evaluate 

process control in which observations 

are weighted; e.g., the exponentially 

weighted moving average in which 

observations are weighted with the 

highest weight given to the most recent 

data. 

Response: While an exponentially 

weighted moving average could move 

some establishments out of a failing 

status more quickly, it would also move 

some potentially passing establishments 

into a failing status. Thus, FSIS 

concludes the equally weighted 12- 

month moving average is the best 

approach. 

In the January 2015 notice, FSIS 

stated that 10 would be the minimum 

number of samples (over 52 weeks) 

required to assess process control (80 FR 

at 3947). Upon further consideration, 

FSIS has discovered that the proposed 

minimum number of Salmonella 

samples for broiler carcasses (10) would 

effectively equate to a zero tolerance 

standard. Therefore, FSIS has revised 

the minimum number of samples to 11 

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for broiler carcasses only. The following 

table sets out what FSIS has determined 

to be the revised minimum number of 

samples to assess process control for 

each product class by pathogen. 

Product 

Maximum acceptable percent 

positive 

Minimum number of samples 

to assess process control 

Salmonella Campylobacter Salmonella Campylobacter 

Broiler Carcass ................................................................................................ 9.8 15.7 11 10 

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

Comminuted Chicken (325 g sample) ............................................................. 25.0 1.9 10 52 

Comminuted Turkey (325 g sample) ............................................................... 13.5 1.9 10 52 

Chicken Parts (4 lb. sample) ........................................................................... 15.4 7.7 10 13 

Comment: Commenters opposed 

assessing poultry carcass performance 

categories by combining old and new 

samples because the results are 

inconsistent and cannot be compared. In 

addition, a comment noted that some 

poultry carcass data may be relatively 

old and not necessarily indicative of 

current establishment conditions. 

Rather than combining old and new 

sample results to assess performance, 

comments requested that FSIS ‘‘reset’’ 

the performance standards for poultry 

carcasses and begin building new 

datasets. 

Response: FSIS agrees that for 

categorization purposes of individual 

establishments, category status should 

be reflective of the most current sample 

results. Therefore, beginning May 11, 

2016, FSIS will begin web-posting the 

category status of all establishments 

subject to the existing poultry carcass 

pathogen reduction performance 

standards based on sample results from 

May 2015 (when FSIS began routine 

sampling of broiler and turkey 

carcasses) to the present. 

Comment: Several commenters from 

industry stated that assessing process 

control in an establishment over 52 

weeks, based solely on one FSIS 

verification sample per week, will not 

reflect current or very recent conditions 

in the establishment. These commenters 

also requested that FSIS consider 

supplemental establishment test results 

and other establishment measures when 

assessing process control before 

determining individual establishment 

category determinations and 

presumably posting of establishments’ 

name and category. 

To facilitate data sharing between 

establishments and FSIS, several 

comments provided recommendations 

for ‘‘supplemental data’’ that could be 

submitted by establishments, such as 

Salmonella enumeration data, indicator 

organism process control monitoring, or 

corrective actions. If an establishment 

elects to share data to demonstrate 

process control, an organization 

representing the chicken industry 

suggested that FSIS incorporate those 

data into the establishment’s dataset and 

assess the establishment based on the 

most recent 52 samples—whether they 

are FSIS verification samples or 

establishment samples. In addition, if 

FSIS proceeds with web-posting 

establishment-specific data, several 

industry commenters requested that the 

Agency allow establishments to review 

the data and to provide any comments, 

objections, or explanations, which could 

be included with released data. 

Response: The concept of data sharing 

between establishments and FSIS could 

have merit. This approach could 

provide an incentive for establishments 

to gain better process control of 

individual production lots whereby 

microbiological independence and 

improved lotting practices can be 

incorporated. For example, 

establishments performing their own 

robust sampling and testing of 

microbiologically independent lots of 

raw poultry product could use the 

results to assess whether they are 

maintaining ongoing process control. In 

addition, such lotting and sampling 

could provide valuable data for 

establishments when making final 

decisions on product disposition during 

corrective actions and HACCP decisions 

in performing pre-shipment review. 

FSIS intends to find a mechanism for 

ensuring that these data are available to 

the public if FSIS decides to 

supplement its decision making based 

on these data. 

However, there are a number of 

challenges, such as variation in industry 

sampling and testing methodologies, 

collection of on-going establishment 

data, and data interpretation. 

Mechanisms need to be identified and 

implemented to ensure that these nonFSIS data are reliable, and that they 

remain reliable over time. FSIS intends 

to make available compliance guidelines 

for standardizing data collection and 

reporting. 

FSIS, therefore, is considering 

initiating a pilot project using volunteer 

establishments to evaluate the feasibility 

of the concept. As part of the pilot 

project, FSIS may request establishment 

isolates and use them in the same 

manner as it uses FSIS isolates; data on 

how the establishment determines and 

controls risk; and information on 

corrective actions taken by the 

establishment when its risk control 

parameters are not met. If the pilot 

project is successful, FSIS would then 

determine how best to use non-FSIS 

data in Agency decision making. FSIS 

will make information available to the 

public on any pilot or any changes to 

posting as it moves forward. 

Comment: A consumer advocacy 

group requested that FSIS use data 

collected to evaluate whether 

establishment performance for different 

products (e.g., whole carcasses and 

parts) is correlated. 

Response: FSIS disagrees with the 

suggestion that setting performance 

standards requires such data because of 

how samples are collected, and how 

organisms attach to product. 

Attachment of the microorganisms, 

recovery from injury, and other factors 

impact the detection of pathogens 

throughout the production process. 

Consequently, it is appropriate to set 

pathogen reduction performance 

standards on different product types at 

all feasible points in the production 

process where control can be exerted 

and effective (e.g., for carcasses, parts, 

and comminuted products). 

Furthermore, process control 

demonstrated on carcasses may have no 

bearing on the level of process control 

demonstrated for parts or comminuted 

product. 

F. Proposed Changes to Categorization 

System and Web-Posting 

Comment: An organization 

representing the chicken industry stated 

that the proposed categorization system 

will result in categories that fail to 

reflect current conditions in the 

establishment. The commenter stated 

that an establishment could remain in 

categories 2 or 3 up to eighteen months 

after addressing whatever conditions 

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caused the establishment to be classified 

in the category. Instead of recategorizing establishments based on 

their performance over the last six 

months, as FSIS proposed, the 

organization requested that FSIS 

categorize establishments based on the 

results of a continuous moving window 

of the last 52 samples and post 

categories monthly based on the most 

recent 52-sample dataset. If the most 

recent 52-sample dataset indicates that 

the establishment should be moved into 

a lower category (Category 2 or 3), the 

commenter stated that FSIS should 

provide the establishment with an 

additional two months to provide 

supplemental data for FSIS to consider 

before making its final category 

determination. 

An organization representing the 

turkey industry and a meat/poultry 

processor stated that because the 

proposed standards for NRTE 

comminuted turkey product allow for so 

few positive results, there would be very 

little difference between a Category 1 or 

3 turkey establishment. The 

organization also stated that webposting individual turkey establishment 

category information will put turkey 

establishments at a competitive 

disadvantage relative to chicken product 

because the proposed performance 

standards allow for fewer positives for 

turkey establishments. To demonstrate 

this point, the industry comments 

argued that consumers may choose a 

Category 1 chicken product over a 

Category 2 turkey product thinking the 

chicken product is ‘‘safer’’ or ‘‘better,’’ 

when the turkey product may actually 

have lower numbers of Salmonella. If 

FSIS proceeds with web-posting 

establishment-specific data for all 

eligible turkey establishments, the 

comments requested that FSIS also post 

information on the data represented. 

An organization representing the 

turkey industry stated that posting 

individual establishments’ categories 

has not historically been a substantial 

factor in driving industry to reduce 

pathogens. Rather, the organization 

stated that posting individual 

establishments’ categories may be 

harmful to industry and confusing to 

consumers. Likewise, several industry 

comments supported posting aggregate 

data rather than individual 

establishment-specific data to minimize 

unintended consequences to industry. 

An organization representing the 

chicken industry recommended posting 

Category 3 establishments only. 

An organization representing the meat 

industry stated improvements in 

controlling Escherichia coli O157:H7 in 

beef were more the result of industry’s 

implementation of new processes and 

interventions than to public 

accessibility of establishment-specific 

data. In addition, for consistency, the 

organization requested that FSIS outline 

its Category 1/2/3 posting procedures in 

the draft Establishment-specific Data 

Release Strategic Plan. 

An organization representing the 

chicken industry stated that consumers 

are only able to associate web-posting 

with branded products. As a result, the 

organization stated that web-posting 

would disproportionately harm 

establishments producing branded 

products compared to establishments 

producing non-branded product. 

Response: FSIS has decided to recategorize establishments monthly 

based on their performance over the last 

three months. For example, if an 

establishment has exceeded the 

Salmonella or Campylobacter maximum 

allowable percent positive during any 

completed 52-week moving window 

over the last three months, it will be 

placed in Category 3 at least until 

establishments are re-categorized a 

month later. 

In addition, because the comminuted 

chicken and turkey pathogen reduction 

performance standards permit only one 

positive result for Campylobacter in 

order to pass the standard, essentially 

eliminating Category 2, FSIS will 

categorize eligible establishments 

producing these products as either 

passing or failing. Thus, FSIS has 

revised its category classification system 

as follows: 

I. Category 1. Consistent Process Control: 

Establishments that have achieved 50 percent 

or less of the Salmonella or Campylobacter 

maximum allowable percent positive during 

all completed 52-week moving windows over 

the last three months. 

II. Category 2. Variable Process Control: 

Establishments that meet the Salmonella or 

Campylobacter 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 three months. 

III. Category 3. Highly Variable Process 

Control: Establishments that have exceeded 

the Salmonella or Campylobacter maximum 

allowable percent positive during any 

completed 52-week moving window over the 

last three months. 

IV. Passing. Establishments that meet the 

Campylobacter maximum allowable percent 

positive for NRTE comminuted chicken or 

turkey during all completed 52-week moving 

windows over the last three months. 

V. Failing. Establishments that have 

exceeded the Campylobacter maximum 

allowable percent positive for NRTE 

comminuted chicken or turkey during any 

completed 52-week moving window over the 

last three months. 

FSIS disagrees that a delay in webposting should occur if an 

establishment’s performance is trending 

in an adverse direction. One purpose of 

the pathogen reduction performance 

standards is to ensure that industry is 

taking steps to continuously improve its 

food safety system. Therefore, FSIS will 

begin web-posting as follows: 

• No sooner than May 11, 2016, for 

establishments that produce poultry 

carcasses and that have the minimum 

number of samples, FSIS will begin 

posting individual establishment 

category status based on sample results 

from May 2015 (when FSIS began 

routine sampling of broiler and turkey 

carcasses) to the present. Thereafter, 

FSIS will update the category status for 

each eligible establishment monthly. 

• For establishments that produce 

chicken parts and comminuted poultry 

products, FSIS intends to begin webposting quarterly aggregate information 

relative to categories beginning about 

May 11, 2016. This information will 

give industry and other stakeholders 

timely information about progress being 

made to reduce contamination in NRTE 

poultry of all types sampled. 

• For all establishments subject to the 

new pathogen reduction performance 

standards, after completion of the first 

52-week moving window 

(approximately one year), FSIS will 

begin posting whether establishments 

meet the standards, or what category 

establishments are in, depending on the 

standard for the particular product, 

based on FSIS results. However, as is 

discussed above, based on at least the 

minimum number of samples to assess 

process control for that product/

pathogen pair and other available 

information about establishments, such 

as noncompliance rates, if establishment 

performance overall does not improve 

or appears to be worsening before the 

completion of the first moving window, 

FSIS may begin web-posting individual 

establishment category information 

sooner. 

FSIS does not agree that the category 

approach has not been effective. Our 

experience with performance standards 

shows that industry does respond to 

new pathogen reduction performance 

standards. For example, the proportion 

of positive Salmonella carcasses fell 

after implementation of 1996 Pathogen 

Reduction/Hazard Analysis and Critical 

Control Point (PR/HACCP) final rule but 

then began to rise in the mid-2000s. 

FSIS speculates that this rise was 

because there were rarely significant 

consequences to failing a Salmonella 

set. In 2006, this trend of rising 

Salmonella positive carcasses was 

reversed when FSIS instituted 

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32http://www.fsis.usda.gov/wps/wcm/connect/

04cb5fad-c13e-4de7-b391-acd95191a95/Petition_

CSPI_052511.pdf?MOD=AJPERES. 

33http://www.fsis.usda.gov/wps/wcm/connect/

73037007-59d6-4b47-87b7-2748edaa1d3e/FSISresponse-CSPI-073114.pdf?MOD=AJPERES. 

34Available at http://www.fsis.usda.gov/wps/

wcm/connect/6c30c8b0-ab6a-4a3c-bd87- 

fbce9bd71001/5100.4.pdf?MOD=AJPERES. 

categorization and web-posting of 

Category 2 and 3 establishments. In fact, 

the number of establishments not 

meeting the standard fell by 50 percent 

in the 2-year period following the time 

FSIS started posting category 

information. 

On January 15, 2015, FSIS published 

a notice in the Federal Register that 

requested comment on the Agency’s 

draft Establishment-specific Data 

Release Strategic Plan for sharing with 

the public data on federally inspected 

meat and poultry establishments (80 FR 

2092). Although outside the scope of 

this policy initiative, FSIS will consider 

the issue raised by the commenter as it 

considers other comments received on 

the draft Plan. 

Finally, FSIS disagrees that webposting will disproportionately harm 

establishments producing branded 

products compared to those producing 

non-branded product. Any 

establishment could be potentially 

affected by the postings because 

consumers and wholesale buyers in the 

poultry supply chain can equally view 

the Web site. Therefore, it is in any 

establishment’s interest, whether 

branded or non-branded, to put the 

processes in place to ensure that it 

meets or exceeds the pathogen 

reduction performance standards. 

Comment: A consumer advocacy 

group requested that FSIS post aggregate 

data for Campylobacter in imported 

poultry products and post aggregate 

reports showing the Category 1/2/3 

distribution for each product class. 

Response: FSIS disagrees with the 

comment because FSIS does not collect 

enough samples from individual foreign 

establishments to assess whether they 

meet the standards. The foreign 

government conducts verification 

activities at the foreign establishment to 

make that type of determination. 

Through records reviews and audits, 

FSIS verifies that foreign inspection 

systems include these types of 

verification activities. 

FSIS plans to develop and implement 

a voluntary pilot project to explore 

mechanisms for reporting aggregate data 

specific to foreign countries that export 

NRTE poultry to the United States. FSIS 

will continue to verify whether those 

governments assess individual 

establishment process control as part of 

the equivalency process. 

H. Enforcement 

Comment: Several consumer 

advocacy groups stated that certain 

serotypes of Salmonella should be 

considered adulterants. The comments 

cited other actions that FSIS should take 

to enforce the performance standards, 

including suspending inspection at 

facilities that do not meet a performance 

standard until the establishment meets 

the standard and recommending the 

recall of product produced during 

periods when the establishment has 

inadequate process control. 

Response: FSIS disagrees with the 

comment. The pathogen reduction 

performance standards are not lotrelease standards. Product produced by 

an establishment that does not meet the 

standard is not necessarily adulterated. 

However, failing to meet the standard 

provides evidence that the production 

process is not well controlled, and FSIS 

will take steps to ensure that the 

establishment improves its production 

process to reduce variability and to gain 

more consistent process control. FSIS 

does agree that persistent failure to meet 

the pathogen reduction performance 

standards can be used as a rationale to 

progressively encourage the 

establishment to implement more 

effective food safety system controls or 

to discontinue production of product. 

In May 2011, the Center for Science 

in the Public Interest (CSPI) petitioned 

FSIS to issue an interpretive rule to 

declare certain strains of antibioticresistant (ABR) Salmonella to be 

adulterants in raw ground meat and raw 

ground poultry.32 On July 31, 2014, 

FSIS denied the petition without 

prejudice because the Agency 

concluded that the data do not support 

giving the four strains of ABR 

Salmonella identified in the petition a 

different status as an adulterant in raw 

ground meat and raw ground poultry 

than Salmonella strains that are 

susceptible to antibiotics.33 The Agency 

concluded that additional data on the 

characteristics of ABR Salmonella are 

needed to determine whether certain 

strains of ABR Salmonella could qualify 

as adulterants under the Federal Meat 

Inspection Act and Poultry Products 

Inspection Act. On October 14, 2014, 

CSPI refiled its petition to provide 

additional data and requested that FSIS 

declare certain strains of ABR 

Salmonella adulterants in all raw meat 

and raw poultry products. FSIS is 

evaluating the new request. 

Comment: A consumer advocacy 

group requested that FSIS instruct 

inspection personnel on when and how 

to increase enforcement at facilities that 

do not meet the performance standards. 

In addition, the commenter requested 

that FSIS initiate increased enforcement 

action when an establishment 

repeatedly fails to meet the performance 

standard. 

Response: FSIS recently revised FSIS 

Directive 5100.4 34 to provide 

instructions to its personnel on how to 

conduct a PHRE. Enforcement, 

Investigations, and Analysis Officers 

(EIAOs) will conduct a PHRE (in 

priority order) at every establishment 

that does not meet a performance 

standard (i.e., the establishment is in 

Category 3); at establishments that have 

produced products with repetitive 

Salmonella serotypes of public health 

concern, indicating potential higher risk 

for being identified as contributing to an 

outbreak; and establishments with 

Salmonella PFGE patterns matching 

those found in recent outbreaks or 

epidemiological evidence linking them 

to illness to determine the need for a 

FSA. If, during the PHRE, the EIAO 

determines that the establishment is 

shipping or producing adulterated 

product, operating without a HACCP 

plan, or engaging in any other type of 

non-compliance that supports taking a 

withholding or suspension action 

without prior notification (9 CFR 500.3), 

the EIAO will take immediate steps to 

stop the wrongful practice. Next, the 

EIAO will consult with the District 

Office (DO) to determine whether 

additional enforcement action is 

needed. For an EIAO to recommend that 

the DO issue a NOIE, he or she must 

support that the conditions in the 

establishment, or the actions of 

establishment personnel, constitute a 

situation that would justify the action 

under 9 CFR 500.4, and that such 

conditions have resulted in adulterated 

product or create insanitary conditions 

that could cause product to be 

adulterated. 

As stated above, if, after 90 days, the 

establishment has not been able to gain 

process control, as determined from 

FSIS’s follow-up sampling and from the 

results of the PHRE or FSA, and the 

establishment has not taken corrective 

actions, FSIS will likely take 

enforcement actions, such as by issuing 

a NOIE or by suspending inspection, 

under the conditions and according to 

the procedures described in 9 CFR part 

500. FSIS will not issue an NOIE or 

suspend inspection based solely on the 

fact that an establishment did not meet 

a performance standard. 

Comment: A consumer advocacy 

group requested that FSIS refuse entry 

of imported raw poultry product that 

FSIS finds positive for Salmonella. On 

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the other hand, an organization 

representing the chicken industry stated 

that denying entry of imported products 

(or determining foreign country 

equivalency) based on import 

verification sampling results may result 

in international trade ramifications. 

Response: Salmonella is not an 

adulterant in NRTE poultry products. 

Therefore, a positive test result for 

Salmonella in imported NRTE poultry 

product sampled by FSIS import 

inspection personnel would not result 

in regulatory control actions at port-ofentry (i.e., refused entry of the product). 

However, foreign countries that are 

eligible to export poultry products to the 

United States must apply inspection, 

sanitation, and other standards that are 

equivalent to those that FSIS applies to 

poultry products. Thus, in evaluating 

whether a foreign country maintains an 

equivalent inspection system to that of 

FSIS, FSIS considers whether the 

country’s pathogen reduction 

performance standards, testing, and 

other verification procedures related to 

Salmonella or Campylobacter are 

equivalent to those that FSIS uses. 

I. Other Agency Actions 

Comment: A consumer advocacy 

group requested that FSIS make detailed 

testing data available to public health 

officials (e.g., through PulseNet). 

Response: FSIS routinely shares 

subtyping data for positive samples with 

public health officials for data analysis, 

interpretation, and application. This 

sharing includes submission of serotype 

and PFGE data to Pulsenet and 

antimicrobial resistance data to the 

National Antimicrobial Resistance 

Monitoring System for Enteric Bacteria 

(NARMS). FSIS has also recently begun 

using whole genome sequencing to 

analyze positive isolates in certain cases 

and will continue to expand this testing 

as resources allow. FSIS is submitting 

this sequencing data to the National 

Center for Biotechnology Information, a 

publically accessible database. 

Comment: An organization 

representing the meat industry 

requested that FSIS evaluate the 

correlation between higher sanitary 

dressing noncompliances and the 

probability of positive sample results in 

poultry products, as it did for beef 

products. 

Response: FSIS will assess this issue 

and report its findings in FY2016. 

Meanwhile, outbreaks associated with 

Salmonella in raw poultry products 

continue. Improvement in sanitary 

dressing and other process controls can 

reduce the levels of Salmonella and 

other enteric bacteria, such as 

Campylobacter, on poultry carcasses. 

Therefore, FSIS believes that 

establishments should focus more 

closely on their sanitary dressing and 

process control procedures to prevent 

carcass contamination. Importantly, the 

recent final rule on poultry inspection 

modernization mandates that 

establishments prevent contamination 

of poultry product with feces 

throughout the slaughter and dressing 

operation rather than permit carcasses 

to be contaminated and then 

reconditioned (9 CFR 381.45(g)). 

Comment: An organization 

representing the meat/poultry industry 

requested that FSIS explain how the 

Agency intends to assess whether the 

raw beef follow-up sampling model (i.e., 

either 16 or eight follow-up samples 

will be collected when an establishment 

does not meet the standard) is working 

for Salmonella and Campylobacter 

testing, and, if changes are made, how 

FSIS plans to communicate the changes 

to industry. 

Response: FSIS has found follow-up 

sampling to be effective at finding 

additional positives in raw beef 

samples. FSIS will analyze the data and 

information collected during follow-up 

sampling (which will be part of the 

moving window sampling) of poultry 

and make any necessary changes to the 

follow-up sampling procedures based 

on that analysis. 

Comment: A consumer advocacy 

group requested that FSIS include 

improving poultry welfare and living 

conditions and protecting bird health in 

its recommended pre-harvest strategies 

for producers for controlling Salmonella 

and Campylobacter. The group stated 

that research has shown that 

environmental stresses (e.g., depriving a 

bird of feed, overcrowding) can result in 

increased incoming poultry pathogen 

loads. 

Response: FSIS agrees with the 

comment. FSIS has reviewed available 

information, including the information 

provided by the commenter, regarding 

the impact of animal welfare and living 

conditions on food safety. FSIS has 

updated the Compliance Guideline for 

Controlling Salmonella and 

Campylobacter in Raw Poultry to 

include interventions and best practices 

that should assist producers in 

providing for animal welfare, living 

conditions, and bird health at preharvest, which should in turn minimize 

stress in poultry and reduce pathogens 

in birds presented at slaughter. 

Comment: An organization 

representing the chicken industry stated 

that a shift from Category 1 to Category 

2 does not warrant a for-cause FSA 

because Category 2 establishments are 

technically meeting the standard. The 

organization requested that FSIS outline 

situations in which verification 

sampling would trigger a for-cause FSA 

and clarify what the Agency means by 

a ‘‘higher number of positives.’’ 

The same organization also opposed 

FSIS conducting for-cause FSAs when it 

finds serotypes of public health 

significance because, according to the 

organization, doing so would effectively 

impose a zero-tolerance standard for 

these serotypes. The organization 

argued that using this approach would 

encourage establishments to focus only 

on certain serotypes rather than manage 

overall pathogen levels through a 

process control program. 

Response: FSIS will not typically 

schedule an FSA based on an 

establishment moving from Category 1 

to Category 2. As mentioned above, 

during the PHRE, EIAOs use the 

decision-making process outlined in 

FSIS Directive 5100.4 to determine 

whether the DO needs to schedule an 

FSA. 

FSIS will focus on Salmonella 

serotypes of public health concern 

because the incidence rate of infection 

by these serotypes is higher than for 

other serotypes. Moreover, for-cause 

PHREs in response to serotypes of 

public health concern will in fact 

stimulate improvement in industry 

performance in controlling Salmonella 

generally. 

As for ‘‘higher number of positives,’’ 

FSIS intends to analyze results of the 

routine sampling to identify data trends 

indicative of an establishment moving 

in an adverse direction. Once identified, 

these trends may prompt FSIS to 

conduct a PHRE or take other 

appropriate actions, such as additional 

sanitary dressing verification 

procedures, at the establishment that 

produced the product. FSIS provides 

Salmonella serotype results to 

establishments to facilitate their efforts 

in identifying the appropriate 

intervention. 

FSIS is concerned that there is a 

misguided belief that new products do 

not need to be produced in a manner to 

reduce the presence of pathogens of 

public health concern. Since the 1996 

PR/HACCP final rule, FSIS has stressed 

that properly operating food safety 

systems are designed to reduce the 

presence of pathogens of public health 

concern. 

J. Cost-Benefit Analysis 

Comment: Factoring in the costs of 

the additional FSAs and follow-up 

sampling associated with the high 

percentage of establishments not 

expected to initially meet the new 

standards, an organization representing 

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35FSIS Directive 5100.1, Revision 4; available at: 

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

31bb8000-fb33-4b51-964b-1db9dfb488dd/

5100.1.pdf?MOD=AJPERES. 

36Chicken Parts and Not Ready-To-Eat 

Comminuted Poultry Performance Standards 

Preliminary Cost-Benefit Analysis; available at: 

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

e146ef97-c269-44ee-bea2-0c04fcc6f463/CBAChicken-Parts-Comminuted.pdf?MOD=AJPERES . 

the meat industry questioned how FSIS 

does not expect to incur any additional 

costs as a result of setting new 

performance standards. The 

organization requested that FSIS 

calculate the number and cost of FSAs 

and follow-up samples the Agency 

expects to collect for the first three years 

after the changes are implemented. 

Other more general comments stated 

that the proposed changes would be 

overly resource intensive or potentially 

cost prohibitive for FSIS. 

Response: To account for the 

sampling and enforcement actions 

associated with the new performance 

standards, FSIS will realign resources, 

rather than allocating any additional 

resources beyond what it currently 

budgets. FSIS will examine the 

following in a retrospective analysis to 

realign resources: the allocation of 

sampling and outcome of FSAs initiated 

as a result of the new pathogen 

reduction performance standards. 

In addition, FSIS has updated its FSA 

methodology by shortening the timeline 

for completion of most FSAs from 2 to 

4 weeks to 5 to 7 production days.35

This change will enable FSIS personnel 

to perform a greater number of FSAs 

each year, thereby improving Agency 

efficiency. 

Cost-Benefit Analysis 

FSIS has considered the economic 

effects of new pathogen reduction 

performance standards for Salmonella 

and Campylobacter in NRTE chicken 

parts and comminuted poultry. FSIS 

published a preliminary cost-benefit 

analysis in support of the January 2015 

Federal Register notice in which FSIS 

proposed the new performance 

standards and sought comment on the 

estimates and the methodology used.36

After reviewing the comments received, 

FSIS updated the cost benefit analysis to 

reflect a change in a cost assumption. In 

addition to making changes to their 

production processes in order to meet 

the new pathogen reduction 

performance standards, FSIS originally 

assumed that only 30, 40, or 50 percent 

of establishments that fail to meet the 

performance standard would re-asses 

their HACCP plan. However, FSIS now 

assumes that all, or 100 percent, of 

establishments that fail to meet the 

standard will re-assess their HACCP 

plans to comply with 9 CFR 417(3)(b). 

A summary of the analysis follows. The 

full analysis is published on the FSIS 

Web site as supporting documentation 

to this notice. 

Industry Costs 

Establishments will incur costs as 

they make changes to their processes to 

meet the new standards. FSIS estimates 

that approximately 63 percent of raw 

chicken parts producing establishments, 

62 percent of NRTE 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 that choose to do 

so will need to make changes to their 

production processes to lower the 

prevalence of Salmonella and 

Campylobacter in their products. 

Changes made by poultry slaughter 

establishments could include preharvest 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 antimicrobial agents to 

parts and source materials for 

comminuted poultry product, and 

provide additional sanitation training to 

employees. For the purposes of the costbenefit analysis, FSIS used the cost of 

adding antimicrobial agents 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. 

Through FSAs, FSIS has found that the 

majority of establishments added 

antimicrobial agents 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 antimicrobial agents to raw 

poultry parts and source materials for 

comminuted poultry product. FSIS 

accounted for uncertainty in the 

proportion of establishments making 

changes to their production processes 

by providing a range of 30, 40, and 50 

percent (of establishments initially 

falling short of but eventually meeting 

the standards in two years) for cost 

estimates for capital equipment, 

antimicrobial agents, and microbial 

sampling. For HACCP plan reevaluation and training costs, FSIS 

assumes that all establishments (100 

percent) that do not meet the standard 

will re-evaluate their HACCP plan. 

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 Agent ........................................ 6.54 4.61 8.46 

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

HACCP Reassessment & Training ................ * ........................ ........................

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

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

Antimicrobial Agent ........................................ 8.72 6.14 11.28 

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

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Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 7299 

37FSIS Directive 5100.1, Revision 4; available at: 

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

31bb8000-fb33-4b51-964b-1db9dfb488dd/

5100.1.pdf?MOD=AJPERES. 

TABLE 1—TOTAL INDUSTRY COSTS ANNUALIZED 1—Continued 

Compliance level of establishments 

not meeting standard Cost component 

Primary 

estimate 

($mil) 

Low estimate 

($mil) 

High estimate 

($mil) 

HACCP Reassessment & Training ................ * ........................ ........................

Total Costs ............................................... ......................................................................... 21.41 15.52 27.19 

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

Antimicrobial Agent ........................................ 10.89 7.68 14.12 

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

HACCP Reassessment & Training ................ * ........................ ........................

Total Costs ............................................... ......................................................................... 24.88 18.17 31.51 

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

* Approximately $12,216, a value too small to display in table. 

Agency Costs 

FSIS will not request additional 

funding as a result of introducing new 

performance standards. FSIS allocates a 

fixed number of samples by product 

class, sampling project, and pathogen 

each year. The two major components of 

the pathogen reduction performance 

standards—product sampling and 

follow-up actions—will be implemented 

in such a way that they are resource 

neutral. FSIS is not expanding the 

number of samples it will analyze. 

Instead, it will reallocate samples from 

other programs, specifically the young 

chicken and turkey sampling programs 

for Salmonella and Campylobacter, as 

FSIS moves towards assessing 

performance using a moving window 

(described above) of sampling results. 

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 to document 

establishment performance status. 

Furthermore, enforcement actions taken 

as a result of the new performance 

standards, namely FSAs, will not 

require additional FSIS resources. FSIS 

has updated its FSA methodology and 

has shortened the timeline for the 

completion of most FSAs from 2 to 4 

weeks to 5 to 7 production days.37 The 

shortened FSA will enable FSIS 

Enforcement, Investigations and 

Analysis Officers to perform more FSAs 

each year. 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. 

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 

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7300 Federal Register / Vol. 81, No. 28 / Thursday, February 11, 2016 / Notices 

TABLE 3—SUMMARY OF NET BENEFITS 1—Continued 

Compliance level of establishments 

not meeting the standard 

% 

Cost/benefit component 

Primary 

estimate 

($mil) 

Low estimate 

($mil) 

High estimate 

($mil) 

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: February 4, 

2016. 

Alfred V. Almanza, 

Acting Administrator. 

[FR Doc. 2016–02586 Filed 2–10–16; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2015–0047] 

Codex Alimentarius Commission: 

Meeting of the Codex Committee on 

Contaminants in Food 

AGENCY: Office of the Deputy Under 

Secretary for Food Safety, USDA. 

ACTION: Notice of public meeting and 

request for comments. 

SUMMARY: The Office of the Deputy 

Under Secretary for Food Safety, U.S. 

Department of Agriculture (USDA), and 

the Food and Drug Administration 

(FDA), U.S. Department of Health and 

Human Services, are sponsoring a 

public meeting on March 7, 2016. The 

objective of the public meeting is to 

provide information and receive public 

comments on agenda items and draft 

United States (U.S.) positions to be 

discussed at the 10th Session of the 

Codex Committee on Contaminants in 

Food (CCCF) of the Codex Alimentarius 

Commission (Codex), taking place in 

Rotterdam, The Netherlands, April 4–8, 

2016. The Deputy Under Secretary for 

Food Safety and FDA recognize the 

importance of providing interested 

parties the opportunity to obtain 

background information on the 10th 

Session of the CCCF and to address 

items on the agenda. 

DATES: The public meeting is scheduled 

for Monday, March 7, 2016, from 1:00 

p.m.–4:00 p.m. 

ADDRESSES: The public meeting will 

take place at the Food and Drug 

Administration (FDA), Harvey W. Wiley 

Federal Building, Room 1A–001, Center 

for Food Safety and Applied Nutrition 

(CFSAN), 5100 Paint Branch Parkway, 

College Park, MD 20740. Documents 

related to the 10th Session of the CCCF 

will be accessible via the Internet at 

http://www.codexalimentarius.org/

meetings-reports/en/. 

Dr. Lauren Posnick Robin, U.S. 

Delegate to the 10th Session of the CCCF 

invites interested U.S. parties to submit 

their comments electronically to the 

following email address henry.kim@

fda.hhs.gov. 

Call-in-Number: 

If you wish to participate in the 

public meeting for the 10th Session of 

the CCCF by conference call. Please use 

the call-in-number. 

Call-in-Number: 1–888–844–9904. 

The participant code will be posted 

on the Web page below: http://

www.fsis.usda.gov/wps/portal/fsis/

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