15282 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 

Dated: March 14, 2011. 

Julia Paradis, 

Administrator, Food and Nutrition Service. 

[FR Doc. 2011–6494 Filed 3–18–11; 8:45 am] 

BILLING CODE 3410–30–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2010–0029] 

New Performance Standards for 

Salmonella and Campylobacter in 

Young Chicken and Turkey Slaughter 

Establishments: 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) published a 

Federal Register Notice on May 14, 

2010 (75 FR 27288) in which it 

announced the forthcoming 

implementation of new performance 

standards for the pathogenic microorganisms Salmonella and 

Campylobacter for chilled carcasses in 

young chicken (broiler) and turkey 

slaughter establishments. The new 

performance standards were developed 

in response to a charge from the 

President’s Food Safety Working Group 

and based on recent FSIS Nationwide 

Microbiological Baseline Data 

Collection Programs. The standards will 

be applied to sample sets collected and 

analyzed by the Agency to evaluate 

establishment performance with respect 

to requirements of the Hazard Analysis 

and Critical Control Points (HACCP) 

Rule. The Agency received detailed 

comments submitted in response to the 

notice. This notice responds to those 

comments submitted and explains the 

changes adopted by the Agency after 

carefully evaluating comments. These 

changes include: 

1. Updated Salmonella and new 

Campylobacter performance standards for 

young chickens and turkeys will take effect 

with Agency verification sample sets 

scheduled for July 2011 

2. All young chicken and turkey 

establishments will move to the highest 

scheduling priority due to the initiation of 

Campylobacter testing for these product 

classes 

3. All sample sets scheduled for young 

chicken and turkey establishments will be 

analyzed for both Campylobacter and 

Salmonella, and follow-up sample sets 

responding to sample set failure for either 

organism will be analyzed for both organisms 

4. Effective with sample sets begun in July 

2011, the new Salmonella standards will 

accept five positive samples in a 51-sample 

set for young chickens and four positive 

samples in a 56-sample set for turkeys 

5. Effective July 2011 Salmonella 

performance Categories 1 and 2 for young 

chicken and turkey establishments, based on 

the new performance standards, will be 

applied exclusively for Agency internal 

analysis and quarterly aggregate reporting 

6. Web-posting of young chicken and 

turkey establishments that fail the new 

Salmonella standards (‘‘Category 3’’) for their 

last set will begin as sample sets scheduled 

for July 2011 are completed 

7. Campylobacter performance standards 

and sample set criteria for tracking and 

reporting to establishments will be applied to 

results from the smaller of the two laboratory 

Campylobacter sample portions (1 mL), 

which detects higher levels of contamination, 

making the performance standards 10.4 

percent for young chickens and 0.79 percent 

for turkeys 

8. Campylobacter sample set criteria for 

tracking and reporting 1 mL results are eight 

positive samples acceptable per 51-sample 

set for young chickens and three positive 

samples acceptable per 56-sample set for 

turkeys 

9. Campylobacter results from the larger of 

the two laboratory Campylobacter sample 

portions (30 mL for chickens, 24 mL for 

turkeys), which detects lower levels of 

contamination, will be used for Agency 

internal analysis 

10. Agency responses to Campylobacter 

sample set results will follow current 

Salmonella procedures for immediate followup testing for both organisms and for Food 

Safety Assessments when necessary 

11. Category 1/2/3 results will be posted in 

quarterly aggregate reports for all 

establishments producing raw products 

subject to FSIS Salmonella testing, including 

young chickens and turkeys under the new 

standards 

Docket: For access to background 

documents, go to the FSIS Docket Room 

at Room 2–2127, George Washington 

Carver Center, 5601 Sunnyside Avenue, 

Mailstop 5474, Beltsville, MD 20705– 

5474 between 8:30 a.m. and 4:30 p.m., 

Monday through Friday. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Engeljohn, PhD, Assistant 

Administrator for Office of Policy and 

Program Development, FSIS, USDA, 

Room 349–E, Jamie Whitten Building, 

14th and Independence, SW., 

Washington, DC 20250–3700; telephone 

(202) 205–0495, fax (202) 720–2025; 

daniel.engeljohn@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS is the public health regulatory 

agency in USDA that is responsible for 

ensuring that the nation’s commercial 

supply of meat, poultry, and processed 

egg products is safe, wholesome, and 

appropriately labeled and packaged. 

FSIS is a participant in the President’s 

Food Safety Working Group (FSWG), 

which was created by President Obama 

in March 2009 to recommend 

improvements to the U.S. food safety 

system. The FSWG is chaired by 

Secretary of Agriculture Tom Vilsack 

and Health and Human Services 

Secretary Kathleen Sebelius. In July 

2009, the FSWG published Key 

Findings recommending a new, public 

health-focused approach to food safety 

based on three core principles: 

Prioritizing prevention, strengthening 

surveillance and enforcement, and 

improving response and recovery. 

The FSWG specifically charged FSIS 

with ‘‘cutting Salmonella risk in Poultry 

Products’’ by ‘‘develop[ing] new 

standards to reduce the prevalence of 

Salmonella in turkey and poultry’’ and 

by ‘‘establish[ing] a Salmonella 

verification program with the goal of 

having 90 percent of poultry 

establishments meeting the new 

standards by the end of [calendar year] 

2010.’’ (FSWG) These new Salmonella 

standards are to be applied to sample 

sets from establishments included in the 

Agency’s Salmonella Verification 

Program in the place of the performance 

standards for young chickens (as 

broilers) codified at 9 CFR 381.94 and 

the standards for turkeys announced in 

a Federal Register Notice of February 

17, 2005. The Agency intends to issue 

a proposed rule that would formally 

rescind the codified standards that are 

no longer in effect. In consultations with 

the FSWG, the Agency committed to a 

number of other food safety initiatives 

to prevent illness, among them 

developing a new performance standard 

for Campylobacter for young chickens 

and turkeys. 

The Agency accordingly published a 

Federal Register Notice on May 14, 

2010 (75 FR 27288) in which it 

announced the July 2010 

implementation of new performance 

standards for the pathogenic microorganisms Salmonella and 

Campylobacter for chilled carcasses in 

young chicken and turkey slaughter 

establishments. The May 14, 2010 

notice announced that FSIS had 

developed such performance standards 

and predicted the public health impact 

that might result if, after two years of 

implementation, these standards are met 

by half of the establishments that would 

not meet them at first. The new 

performance standards for young 

chickens and turkeys were informed by, 

among other data sources, data collected 

during the Agency’s recent Nationwide 

Microbiological Baseline Data 

Collection Programs: The Young 

Chicken Baseline Survey (YCBS), and 

the Young Turkey Baseline Survey 

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Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 15283 

(YTBS) (Baselines). The May 14, 2010 

notice detailed the baseline surveys and 

their use in developing the new 

performance standards. 

Although FSIS had planned to 

implement the new standards in July 

2010, the Agency decided to delay 

implementation until the many 

comments filed in response to the May 

14, 2010 notice had been evaluated. 

This current notice responds to those 

comments and explains the policy 

changes made by the Agency based on 

its careful evaluation of the comments. 

These policy changes are listed in the 

notice Summary above and are further 

detailed in the responses to comments 

below. 

The Agency cannot yet determine if it 

has met the FSWG goal of having 90 

percent of poultry establishments 

meeting the new Salmonella standards 

by the end of Calendar Year (CY) 2010 

as Salmonella verification set 

scheduling and sampling is an ongoing 

process and a number of establishments 

that started sets in CY 2010 were not 

completed by December 31, 2010. 

Partial sets are incommensurate, 

moreover, with the completed-set-based 

performance measures used by the 

Agency and the FSWG. Therefore, in 

preparing its CY 2010 accounting for 

this FSWG goal, FSIS plans to complete 

sample sets started in 2010 or earlier 

during the first quarter of 2011 and 

count those completed sets toward its 

final 2010 report. The Agency will cut 

off its 2010 sample set total on April 1, 

2011 and issue its final 2010 accounting 

at that point. Any 2010-started sample 

sets not completed by April 1 will be 

applied toward CY 2011 totals once 

completed. The final CY total will thus 

comprise sets started no later than 

December 31, 2010 and completed no 

later than March 31, 2011. As of March 

2011, 86.2 percent of young chicken 

slaughter establishments would have 

met the new standard for 2010. Also as 

of March 2011, 87.8 percent of young 

turkey slaughter establishments would 

have met the new standard for 2010. 

The Agency believes that the policy 

changes announced in this notice, 

which will be implemented in July 

2011, will encourage the poultry 

industry to reduce Salmonella in 

poultry and thereby further reduce the 

risk of human illnesses. 

Foreign Government Programs 

Foreign countries that are eligible to 

export poultry products to the United 

States must apply inspection, sanitary, 

and other standards that are equivalent 

to those that FSIS applies to poultry 

products. Thus, in evaluating a foreign 

country’s poultry inspection system to 

determine the country’s eligibility to 

export products to the United States, 

FSIS will consider whether Salmonella 

or Campylobacter methods and 

procedures that the country applies are 

equivalent to those that FSIS uses. 

Response to Comments on the Federal 

Register Notice of May 14, 2010 

Administrative Procedure Questions 

Some comments claimed that the 

Agency is violating the Administrative 

Procedure Act (APA) by effectively 

promulgating a ‘‘regulation’’ without 

following due notice-and-comment 

procedure. 

FSIS Response: The Agency does not 

agree that FSIS policies explained 

herein are regulations subject to noticeand-comment requirements under the 

APA or are otherwise in violation of the 

APA. The policies and performance 

standards, including the testing process 

the Agency will undertake, do not 

impose requirements on establishments. 

We would note, however, that the 

Agency has sought to engage industry 

and all interested parties in the subject 

matter of this notice, has provided 

extensive opportunity for public 

comment, delayed implementation to 

carefully consider issues that were 

raised in comments, and made various 

substantive changes to policies based on 

those comments. We would also note 

that this is not a novel approach and 

that notice establishing standards 

against which to measure establishment 

performance has been accomplished 

before through Federal Register notices 

in 2005 (70 FR 8058) and 2006 (71 FR 

9772) (referenced in the May 14, 2010 

notice). In 2008, FSIS further articulated 

how the Agency intended to evaluate 

whether industry was adequately 

controlling for Salmonella in carcasses 

(73 FR 4767). 

Salmonella Posting Rationale 

Several comments expressed 

opposition to the Agency’s decision to 

apply the new standards requiring fewer 

positives for Category 1 status than has 

been the case and that posting Category 

2 establishments unrealistically 

differentiates such establishments from 

those in Category 1. 

FSIS Response: The Agency believes 

that its policy of posting establishments 

that are not in the highest performance 

rank has stimulated improvement in 

industry performance, as was shown in 

the Agency’s experience after 

announcing performance categories in 

2006 when 55–60 percent of noncompliant establishments moved to 

become compliant within two years. 

FSIS, however, recognizes that some 

establishments that have been excluded 

from posting may now be included 

based on the same level of performance. 

While the Agency will implement 

updated Salmonella and new 

Campylobacter performance standards 

for young chickens and turkeys with 

Agency verification sample sets 

scheduled for July 2011, establishments 

that complete sample sets begun in or 

after July 2011 will be Web-posted only 

if they have failed the new standards. 

Web-posting of Category 2 and 3 

establishments that began sets under 

current standards will continue until 

these establishments have completed 

sets under the new standards. 

Effective with samples sets starting in 

or after July 2011, Salmonella 

performance Categories 1 and 2, based 

on the new performance standards, will 

be applied exclusively for Agency 

internal analysis and not for posting 

purposes. The Agency will post 

quarterly aggregate reports showing the 

Category 1/2/3 distribution for each 

relevant product class subject to FSIS 

Salmonella testing but will not identify 

individual establishments. In order to 

accomplish this, the Agency will 

determine Category 1 and 2 performance 

criteria for young turkey establishments. 

The Agency believes that this policy 

change is reasonable given the general 

progress of the poultry industry in 

reducing positive rates from the 1996 

HACCP baselines to current rates. 

Though the ‘‘pass-fail’’ approach is to be 

taken with young chickens now as well 

as turkeys, as stated in the May 14, 2010 

notice, the smaller prevalence on young 

turkey carcasses permits a less stringent 

compliance criterion that is consistent 

with the Agency’s stated objectives of 

substantially reducing pathogen 

presence. Thus, the young chicken 

standard allows an establishment 

operating at the baseline prevalence 

approximately an 80 percent chance of 

passing. The turkey standard, however, 

is based on a much lower prevalence 

and so the turkey standard’s higher 

chance of passing of 99+ percent is 

appropriate. 

Connection Between Salmonella 

Contamination of Chicken Carcasses 

and Human Illness 

Several comments doubted that there 

is a connection between Salmonella 

contamination of chicken carcasses and 

the occurrence of cases of human 

salmonellosis. 

FSIS Response: The Agency believes 

that there is a connection between 

Salmonella contamination and human 

illness, and that poultry contamination 

continues to contribute significantly to 

salmonellosis. Evidence of the 

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15284 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 

connection of salmonellosis and 

contaminated chicken products can be 

found in the outbreaks that have been 

associated with chicken (CDC food 

borne outbreaks) and a 2004 case 

control study conducted by the Centers 

for Disease Control and Prevention 

(CDC) that has linked salmonellosis 

with chicken products (A.C. Kimura et 

al.; Kimura et al. study). Furthermore, in 

a Memorandum to the Record dated 

January 18, 2011, CDC re-affirmed that 

‘‘Poultry products are an important 

vehicle for human Salmonella and 

Campylobacter infections in the United 

States’’ (posted with this notice at 

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

&_Policies/2011_Notices_Index/

index.asp). Since raw chicken products 

(ground and carcasses) continue to show 

greater Salmonella prevalence than is 

found with other product classes 

(Salmonella Testing Tables), it is likely 

that the source of the contamination was 

chicken carcasses rather than other nonchicken ingredients such as spices that 

may be used with such products. The 

Agency has concluded, using the 

available data and the best science 

available, that reducing Salmonella on 

chicken carcasses would reduce risk of 

illness and thus potentially reduce the 

occurrence of illnesses. 

The Agency further notes, however, 

that the commenter’s evidence to 

support the assertion of no connection 

was based on the human illness 

FoodNet database (see discussion 

below). Salmonellosis cases due to 

poultry are only a subset of all 

salmonellosis cases reported through 

the CDC FoodNet program. The total 

number of salmonellosis cases stem 

from all sources including cattle, swine, 

eggs, fish, fruits and vegetables. Thus an 

observed correlation (negative or 

positive) between Salmonella 

occurrence in poultry carcasses at post 

chill and salmonellosis from FoodNet 

data cannot be used to assert a causal 

relationship between poultry 

contamination and salmonellosis. 

Further, the available salmonellosis data 

cannot be stratified by food vehicle (e.g., 

poultry), given the lack of food 

attribution data within the FoodNet 

database. Given this data gap, it is 

entirely conceivable that a reduction of 

salmonellosis due to one food product 

such as poultry could be negated by an 

increase in salmonellosis due to another 

product or unrelated vehicle. In any 

case, the Agency believes that the 

available evidence leads to the 

conclusion that Salmonella occurrence 

in poultry has the potential to cause 

salmonellosis in humans. 

Efficacy of Performance Standards 

Several comments from industry 

argued that tightening Salmonella 

performance standards since 2006 has 

not resulted in fewer cases of human 

salmonellosis and thus that further 

tightening the standards would be 

pointless and punitive. They argue that 

available evidence (from CDC FoodNet 

data sets) did not support the Agency’s 

predictions that there would be benefits 

derived from decreases in Salmonella 

found on carcasses at post chill. 

FSIS Response: There are important 

reasons why it is not appropriate to 

examine CDC salmonellosis rates and 

compare these data directly to trends of 

Salmonella incidence for inferring the 

impact of reduction of Salmonella 

incidence for any particular commodity 

and salmonellosis rates. Specifically, it 

is important to distinguish the two 

surveillance datasets available from the 

CDC used to analyze outbreak trends 

and foodborne illness. First, the CDC 

National Outbreak Reporting System 

(NORS) (http://wwwn.cdc.gov/food

borneoutbreaks/), referred here as 

outbreak data, provides information on 

reported outbreaks (defined as two or 

more illnesses associated with a single 

vehicle (product) that caused the 

illness). The source of the 

contamination is investigated (the 

pathogen and food product responsible 

for the outbreak); however, about 50 

percent of confirmed Salmonella 

outbreaks do not have a known food 

vehicle. Second, the Foodborne Diseases 

Active Surveillance Network (FoodNet) 

(http://cdc.gov/foodnet/) produces 

annual case rates for several major 

foodborne pathogens, including 

Salmonella. FoodNet data tracks 

salmonellosis cases presently in 10 

states, presently covering about 1⁄7 of the 

U.S. population (46 million). The 

majority of reported FoodNet cases 

reflect sporadic cases of Salmonella (for 

example, only six percent of 2007 

reported FoodNet cases were outbreakrelated (2007 annual report). There is no 

information regarding the food product 

that was (or might have been) associated 

with the illness. Therefore, FoodNet 

data are only available as aggregated 

information from cases due to all 

sources thought to be foodborne, 

including all food products such as 

those categories of foods defined by the 

CDC—including fish, crustaceans, 

mollusks, dairy, eggs, beef, game, pork, 

poultry, grains-beans, oils-sugars, fruitsnuts, fungi, leafy vegetables, root 

vegetables, sprout, vine-stalk vegetables 

(Painter et al., 2009; Painter et al.). Thus 

an observed correlation (negative or 

positive) between Salmonella 

occurrence in chicken carcasses at post 

chill and FoodNet salmonellosis cannot 

be used, by itself, to assert a causal 

relationship between chicken 

contamination and salmonellosis. 

Unfortunately, as mentioned above, the 

FoodNet database reflecting trends of 

salmonellosis rates cannot be stratified 

by food vehicle (e.g., chicken), given the 

lack of food attribution data. However, 

for all food sources, the incidence of 

Salmonella-caused human illness 

declined approximately eight percent 

from the beginning of surveillance in 

1996 to the most recently released 

annual report case rate in 2007 (as 

opposed to the most recently released 

preliminary report in 2009), with most 

of the reductions in the earlier years. 

This trend (or lack of trend) though 

cannot be assumed true for productspecific trends: It is possible that 

reduction of salmonellosis due to one 

food product such as chicken could be 

negated by the increase in salmonellosis 

due to another product or unrelated 

vehicle, such as produce, thus causing 

the stable case rate in recent years. 

Consequently, even if there is not a 

positive correlation of salmonellosis 

rates and the incidence of 

contamination rates on young chicken 

carcasses over time, it would not be 

possible to dismiss the likelihood that 

Salmonella occurrence in chicken and 

salmonellosis are causally connected. 

The data presented above are part of 

a weight of evidence approach to refute 

the assertion that there is no connection 

between the presence of Salmonella on 

broilers and human illnesses. 

Additional evidence can be gleaned by 

performing trend analyses comparing 

either CDC outbreak data or the serotype 

data contained within FoodNet to FSIS 

verification results (FSIS Serotype Data). 

Campylobacter Performance 

Standards 

Some comments questioned the 

validity of applying Campylobacter 

performance standards, given the 

fragility of the organism and the 

relatively low risk associated with all 

but highly-contaminated servings or 

samples. 

FSIS Response: After evaluating 

comments pointing out the complexities 

of Campylobacter and considering the 

Agency’s lack of experience with 

verification sampling for this organism, 

FSIS has decided that it will track and 

report Campylobacter results to 

establishments and will not post the 

names of establishments that fail to 

meet the new Campylobacter standards. 

The Campylobacter performance 

standards and sample set criteria for 

tracking and reporting to establishments 

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Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 15285 

will be applied to results from the 

smaller of the two laboratory 

Campylobacter sample portions (1 mL) 

described in the May 14, 2010 Notice, 

which detects higher levels of 

contamination. The Campylobacter 

sample set criteria for tracking and 

reporting 1 mL results are eight positive 

samples acceptable per 51-sample set 

for young chickens and three positive 

samples acceptable per 56-sample set 

for turkeys. Campylobacter results from 

the larger of the two laboratory 

Campylobacter sample portions (30 mL 

for chickens, sponge plus 24 mL sponge 

diluent for turkeys), which detects 

lower levels of contamination, will be 

used for Agency internal analysis. 

Agency responses to Campylobacter 

sample set results will follow current 

Salmonella procedures for immediate 

follow-up testing for both organisms and 

for Food Safety Assessments (FSAs) 

when deemed necessary. 

The Agency notes that the 

implementation of Campylobacter 

standards and sampling in July 2011 

will mean that all poultry 

establishments will move to the highest 

priority in the Agency scheduling 

algorithm as ‘‘new’’ establishments. Each 

set scheduled under the new standards 

will be tested for both Campylobacter 

and Salmonella. Furthermore, any 

establishment that fails a set for either 

organism will be moved to the secondhighest priority for scheduling to 

conduct an immediate follow-up set, 

and the samples taken in the follow-up 

set will be analyzed for both organisms. 

FSIS believes that this more intensive 

sampling approach will provide a 

significant incentive for establishments 

to increase process control for both 

pathogens. 

Category 1/2/3 results will be posted 

in quarterly aggregate reports for all 

establishments producing raw products 

subject to FSIS Salmonella testing, 

including young chickens and turkeys 

under the new standards including 

Campylobacter. FSIS will evaluate 

industry performance trends with regard 

to both Salmonella and Campylobacter. 

In response to adverse trends, the 

Agency may consider actions that could 

include, among other things, posting 

young chicken and turkey Category 2 

establishments, posting all 

establishments that fail any applicable 

performance standards, or posting noncategorized individual sample set 

results from all establishments 

producing raw products subject to such 

testing. Any such actions would be 

announced in a Federal Register notice. 

Public Health Predictions 

Some comments criticized the 

Agency’s predictions of illness 

reduction, including (1) the 

assumptions used, and (2) that such 

reductions were not possible because 

the standard would primarily affect 

small volume establishments (Potential 

Public Health Impact). 

FSIS Response: FSIS notes here that 

the public health predictions made in 

the May 14, 2010 Federal Register 

notice were derived from the latest 

available illness-attribution data 

published by the CDC in 1999. Updated 

data have been published recently by 

the CDC (CDC updated data). The 

Agency has adjusted its public health 

predictions accordingly. These public 

health predictions depend on 

establishments that currently do not 

pass the new performance standards 

changing their processes to pass. 

Although FSIS has some historic 

evidence regarding industry behavior in 

response to previous measures (i.e., 

Salmonella HACCP verification program 

data and categorization of 

establishments in that program [FSIS 

2006]), the true behavior of the industry 

in response to the new performance 

standards is unknowable in advance. If 

the status quo remains and no 

establishments change their processes to 

meet the new performance standards, 

zero illnesses will be avoided. 

Alternatively, approximately 40,000 

illnesses could be avoided if all initially 

noncompliant establishments were to 

become compliant. Based on the past 

performance of the industry to the 

previous guidance where approximately 

50 percent of noncompliant 

establishments became compliant (FSIS, 

2006), FSIS now predicts that two years 

after implementing the Salmonella 

standards, human illnesses due to 

Salmonella could decrease by 

approximately 20,000 per year. 

The case of Campylobacter is 

somewhat different, in that the Agency 

will be tracking industry performance 

and will expect to see improvement 

rather than stasis or regression. If the 

Agency, as stated above, sees adverse 

trends with Campylobacter, it may take 

various mitigation actions. These public 

health predictions depend on 

establishments that currently do not 

pass the new performance standards 

changing their processes to pass. 

Although FSIS has some historic 

evidence regarding industry behavior in 

response to previous measures (i.e., 

Salmonella HACCP verification program 

data and categorization of 

establishments in that program [FSIS 

2006]), the true behavior of the industry 

in response to the new performance 

standards is unknowable in advance. If 

the status quo remains and no 

establishments change their processes to 

meet the new performance standards, 

zero illnesses will be avoided. If all 

initially noncompliant establishments 

were to become compliant, 

approximately 11,000 illnesses due to 

Campylobacter could be avoided. Based 

on the past response of the industry to 

the previous guidance where 

approximately 50 percent of 

noncompliant establishments became 

compliant (FSIS, 2006), the Agency 

predicts that, two years after 

implementation, as many as 5,000 fewer 

cases of human illness due to 

Campylobacter might occur each year. 

The Agency’s detailed response to 

comments on its approach to making 

public health predictions is contained 

in Appendix I. 

Turkey Salmonella Issues 

Comments noted that the Agency’s 

Young Turkey Baseline Survey (YTBS) 

found 0.35 percent of post-chill samples 

positive for Salmonella and asked the 

Agency to explain the discrepancy 

between the YTBS and FSIS HACCP 

verification sampling results. In light of 

the lowered performance standards and 

these other concerns, comments 

requested a ‘‘grace period’’ for turkey 

establishments failing under the new 

standards, using an average over two 

sets before posting establishments. 

FSIS Response: As an initial matter, 

FSIS notes and regrets the error in the 

report ‘‘The Nationwide Microbiological 

Baseline Data Collection Program: 

Young Turkey Survey August 2008— 

July 2009’’ where the report erroneously 

stated that 0.35 percent of the analyzed 

post chill samples were found with 

Salmonella; in the report FSIS also 

correctly stated that ‘‘The estimated 

prevalence for Salmonella was 1.73 

percent * * *’’ (pages 9 and 11). 

Reference was made to a technical 

report: ‘‘Technical Paper for 

Performance Guidance for Broilers and 

Young Turkey at Post-chill,’’ that 

explains the estimation procedure used 

(Technical Paper). In that technical 

report, FSIS addressed this issue of the 

difference of percentages of positive 

results between the two sampling 

programs. The comparison between the 

percentages of positive Salmonella 

results showed a higher percentage with 

the HACCP verification sampling, 

though the difference was not 

statistically significant. A more detailed 

response to these comments is attached 

in Appendix II. 

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Campylobacter Methodology 

Questions 

Use of Large-Portion Campylobacter 

Procedure for Performance Standards 

Comments on the proposed 

Campylobacter performance standards 

for chickens and turkeys suggest 

removing the larger sample test portion 

of the compliance criteria (30 mL for 

chickens and sponge plus 24 mL sponge 

diluent for turkeys). Remaining would 

be the test to detect relatively high 

levels based on analyses of 1 mL 

portions for chickens and turkeys. 

FSIS response: The Agency believes 

that a performance standard based on 

the 1 mL is most efficient in that it 

targets samples with higher levels of 

Campylobacter, which have a greater 

probability of inducing human illness 

by cross-contamination and surviving 

cooking compared to lower levels. The 

performance criteria (number of positive 

samples acceptable per sample set) for 

tracking and reporting to establishments 

will be eight positive samples 

acceptable per 51-sample set for young 

chickens and three positive samples 

acceptable per 56-sample set for turkeys. 

Data collected for the 30 and sponge 

plus 24 mL sponge diluent enrichment 

will be used primarily for Agency 

internal analysis but will also be 

aggregated and posted quarterly by 

performance category to show the 

progress of the chicken and turkey 

industries. If there is no improvement in 

these data over time, FSIS may consider 

implementing the performance standard 

using the larger-portion sample results 

as well. 

Dose-Response Level for Campylobacter 

Comments cited studies claiming that 

the threshold of concern for 

Campylobacter in broilers is much 

higher than the new Campylobacter 

performance standard and questioned 

the standard’s relevance to public 

health. 

FSIS Response: The threshold doseresponse concept implies that there is a 

very low probability of illness below a 

certain dose. The 500 Colony Forming 

Units/gram (CFU/g) threshold suggested 

would translate into roughly 50,000 

CFU as a minimum dose to cause illness 

assuming a serving of about 100 grams. 

This assertion is in contrast to the 

available data. Campylobacter human 

feeding trials show human illness can 

result in healthy adult males fed 500 

CFU and 800 CFU (Robinson, 1985; 

Black et al., 1988). If such low levels can 

result in human illness among healthy 

adult males, it is reasonable to assume 

that lower doses might result in human 

illness in traditionally sensitive 

populations, such as the young, the old, 

and the immuno-compromised. Given 

these concerns, the Agency believes that 

establishing a performance standard 

from baseline data is warranted. 

Campylobacter Fragility 

A comment stated that the 

Campylobacter organism is very fragile 

and is unlikely to survive regular 

processing and handling and thus 

questioned the need or usefulness of 

creating a performance standard for it. 

FSIS Response: The FSIS Young 

Chicken Baseline Survey, 2007–2008, 

found about 46 percent of sampled 

chicken carcasses at post-chill had 

Campylobacter. FSIS does not have data 

to confirm or deny the presence of 

Campylobacter on finished product or at 

retail. However, two Consumer Reports 

of retail sampling programs for leading 

national brands of young chickens, 

published in January of 2007 and 2010 

respectively, found about 81 and 62 

percent of retail young chickens 

contaminated with Campylobacter 

(Consumer Reports). Given the limited 

sampling, these results cannot be 

generalized to the retail market as a 

whole. In addition, however, the 

National Antibiotic Resistance 

Monitoring System (NARMS) annual 

retail meat survey reported that between 

2002 and 2008 the incidence of 

Campylobacter on chicken breasts was 

between approximately 40 and 60 

percent (NARMS). 

As Campylobacter does not grow at 

normal distribution temperatures, it is 

likely that Campylobacter organisms are 

able to survive the commercial 

processes and current interventions 

employed by the industry. In view of 

these facts, the Agency believes that it 

is appropriate to apply Campylobacter 

standards for tracking and reporting to 

establishments and for Agency internal 

analysis, follow-up testing, and Food 

Safety Assessments when deemed 

necessary. 

Campylobacter Methodology 

Several comments asked for 

clarification on appropriate methods for 

use by establishments to verify 

compliance with the new 

Campylobacter standards. 

FSIS Response: The Agency testing 

program to verify establishment 

performance against the new standards 

will collect young chicken rinsates and 

turkey carcass sponges to be tested for 

Campylobacter using a method 

described in the Microbiology 

Laboratory Guidebook (MLG), which is 

available on the FSIS Web site at http:// 

www.fsis.usda.gov/PDF/MLG_41_00.pdf. 

Contrary to a misleading note in the 

May 14, 2010 notice implying that the 

method was being significantly revised, 

no substantive changes to this method 

are anticipated at this time. 

The MLG 41 method for poultry 

rinsates and carcass sponges is designed 

to be selective for the Campylobacter 

species of interest. FSIS will perform 

testing for detection and enumeration of 

Campylobacter jejuni, C. coli, and 

C. lari. According to CDC data, C. jejuni 

and C. coli cause the majority of 

Campylobacter illnesses in the U.S. The 

National Advisory Committee for 

Microbiological Criteria of Foods 

(NACMCF) recommended the use of 

methodology to specifically target these 

Campylobacter species so FSIS 

encourages industry testing to include 

these species. 

The MLG method includes two 

procedures. In the first procedure (MLG 

41 Section 41.5), an aliquot of the 

rinsate or sponge/buffered peptone 

water (BPW) combination is plated 

directly to the Campy-Cefex plating 

medium and then incubated under 

microaerophilic conditions for 48 hours 

at 42 °C. 

In the second procedure (MLG 41 

Section 41.6.1 or 41.6.2), an aliquot of 

rinsate or sponge/BPW combination is 

cultured in blood free Bolton 

enrichment broth plus Bolton broth 

selective supplements under 

microaerophilic conditions for 48 hours 

at 42 °C and then a small amount of 

enriched culture is streaked to CampyCefex plating medium and incubated 

under microaerophilic conditions for 48 

hours at 42 °C. 

The theoretical limit of detection is 

considerably higher for the direct 

plating sample compared with the 

enriched sample. For both procedures, 

multiple colonies that are typical of the 

appearance of Campylobacter are picked 

from the Campy-Cefex plating medium 

and confirmed as Campylobacter jejuni, 

coli, or lari (Campylobacter j/c/l) using 

microscopy to assess cell morphology 

and motility, and a latex agglutination 

serological testing procedure that 

identifies Campylobacter specifically 

belonging to these three species. To 

determine establishment performance 

relative to the performance standards, 

samples by the direct plating procedure 

with one or more colonies confirmed as 

Campylobacter j/c/l would be 

considered positive. Samples positive 

by either or both procedures will be 

recorded by FSIS and used for internal 

Agency analysis and quarterly aggregate 

reports. 

Establishments that wish to perform 

Campylobacter testing to verify their 

process control procedures can use the 

FSIS MLG method. Alternatively, 

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establishments may rely on methods 

that have been validated to provide 

equivalent or superior sensitivity. For 

example, verification testing programs 

based solely on enriching samples could 

provide equivalent sensitivity compared 

with the FSIS method. To be 

comparable with the FSIS method, 

confirmatory methods should be 

demonstrated to be capable of detecting 

C. coli, C. jejuni, and C. lari. However, 

FSIS realizes that C. lari is rarely 

encountered in poultry samples. The 

culture and identification procedures in 

MLG 41 are not optimized for detection 

of non-Campylobacter j/c/l species. 

Questions related to specific 

Campylobacter methods used by 

establishments should be directed to the 

AskFSIS sampling queue at http:// 

www.fsis.usda.gov/Businesses/ 

index.asp. 

One comment queried why available 

Polymerase Chain Reaction (PCR) 

methodology is not used by the Agency. 

FSIS Response: For its baseline 

testing, FSIS applied standard culture 

methodology recommended by the 

NACMCF for detecting and quantifying 

levels of Campylobacter on poultry 

samples. Non-proprietary traditional 

culture methodology offers advantages 

for reliability of results, the potential for 

confirming and subtyping isolates, and 

implementation of testing in a broad 

range of laboratories that may not have 

access to equipment for PCR or similar 

testing technologies. FSIS plans to apply 

the same NACMCF-recommended 

methodology used in the baseline study 

for future Agency verification testing. 

However, FSIS is encouraging 

development and validation of 

alternative testing methodologies for 

detecting and quantifying 

Campylobacter. 

Sample Collection Methods—Turkey 

Sponge vs. Chicken Rinse 

One comment questioned the Agency 

use of different sampling methodologies 

for young chickens and turkeys, 

asserting that the turkey methodology is 

biased against finding Salmonella and 

Campylobacter. 

FSIS Response: FSIS agrees that 

sampling methodology has an impact on 

pathogen detection and enumeration. 

Because different sampling 

methodologies are used for chicken and 

turkey carcasses, FSIS has not proposed 

to compare data for these commodities. 

FSIS agrees that rinsate sampling, even 

without complete recovery of attached 

pathogens, provides a representative 

sample for internal and external carcass 

surfaces. For the first turkey carcass 

baseline in the mid-1990s, FSIS had 

attempted to use 600 mL rinsate 

sampling for turkey carcasses. However, 

because the typical turkey carcass was 

quite large and heavy, the manual rinse 

procedure posed problems for effective 

sampling and workplace safety. 

Following that initial study, FSIS 

adopted an industry recommendation to 

use a sponge to sample a 100 cm2 area 

of the turkey carcass. To compare the 

effectiveness of rinse vs. sponge 

sampling, FSIS conducted two baseline 

studies, Young Turkey Rinse Baseline 

(1996–1997) and the Young Turkey 

Sponge Baseline (1997–1998). The two 

baseline studies demonstrated a 

comparable Salmonella prevalence of 

18.6 percent and 19.6 percent, 

respectively. For the most recent turkey 

carcass baseline study in 2009, FSIS 

considered sampling skin from the neck 

flap or other areas of the carcass, but 

these sampling procedures also present 

technical and logistical challenges. FSIS 

agrees that sponge sampling likely 

under-represents the prevalence and 

levels of Salmonella and Campylobacter 

on turkey carcasses, but this approach, 

applied consistently over time to 

sampling continues to provide an 

effective means to identify 

establishments where process control 

may be less robust. 

General questions were raised about 

Agency policies regarding 

Campylobacter following 

implementation of the new performance 

standards. 

FSIS Response: The Agency will 

respond to a sample set failure for either 

organism by immediately scheduling a 

follow-up set, the samples of which will 

be analyzed for both organisms. An FSA 

will automatically be triggered under 

the current criteria for failing the 

Salmonella standard. The Agency will 

follow the Salmonella methodology for 

Campylobacter until FSIS develops 

specific methodology for a 

Campylobacter FSA. The Agency will 

not set an automatic Campylobacter 

FSA trigger until two full sample sets 

have been completed under the new 

standard for 90 percent of the eligible 

establishments in the product class, at 

which time the Agency will evaluate the 

results to determine the best food safety 

and public health policy. The Agency 

may, however, conduct an FSA for any 

establishment failing the Campylobacter 

performance standard for two sets 

straight or in the case of egregious 

failure of a single set. The concept for 

an egregious failure is based on a 

comparison of the establishment’s 

performance for the set versus 

establishments’ performances on other 

sets during some specified period of 

time. Thus, the actual criterion for 

determining an egregious failure could, 

and is expected to, change over time. 

The criterion is based on first 

determining an 80th percentile of the 

distribution of establishment-specific 

prevalences of positive results over 

some specified period, and then 

determining a cutoff threshold for the 

number of positive results in a set such 

that if exceeded for a set would be 

considered an egregious occurrence. 

Using the Young Chicken Baseline 

Survey and a statistical model using 

empirical Bayes estimation procedures 

for developing a tentative criterion, the 

Agency estimated the 80th percentile of 

the establishments’ specific estimated 

prevalence to be 18 percent. The 

compliance criterion would therefore be 

14 positive samples out of a 51 sample 

set. Fifteen or more positive results 

would be considered egregious given 

there would be more than 95 percent 

confidence that the true underlying 

establishment-specific prevalence 

during the period of sampling exceeded 

18 percent, based on an assumption that 

positive results are distributed 

randomly following the binomial 

distribution. However, as mentioned 

above, FSIS expects this threshold value 

to change over time as data from the 

HACCP verification samples are 

analyzed. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that minorities, women, and 

persons with disabilities are aware of 

this notice, FSIS will announce it online 

through the FSIS Web page located at 

http://www.fsis.usda.gov/regulations_&_

policies/Federal_Register_Notices/

index.asp. 

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. 

Through the Listserv and Web page, 

FSIS is able to provide information to a 

much broader and more diverse 

audience. In addition, FSIS offers an 

electronic mail subscription service 

which provides automatic and 

customized access to selected food 

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safety news and information. This 

service is available at http:// 

www.fsis.usda.gov/news_&_events/email_subscription/. 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 March 16, 

2011. 

Alfred V. Almanza, 

Administrator. 

Appendix I 

Comments questioned the design and 

development of the Agency’s public health 

predictions. In developing its public health 

predictions, FSIS used a ‘‘prevalence-based’’ 

approach to estimate the impact of the 

proposed performance standards. The 

approach used in this model assumes that 

contamination levels on broiler carcasses are 

independent of the frequency of 

contaminated carcasses. If the prevalence of 

Salmonella-contaminated carcasses and the 

levels of Salmonella on contaminated 

carcasses are positively correlated, then this 

assumption would likely be conservative in 

models that estimate the reduction in 

illnesses associated with a reduction in 

prevalence. Nevertheless, the available 

evidence does not reject this assumption. For 

samples that were test-positive, the average 

concentration of Salmonella per mL of 

sample rinsate was 0.16 and 0.14 CFU in the 

1995 and 2008 baseline surveys, respectively 

(FSIS 1996, FSIS 2009). Yet, the prevalence 

of positive carcasses was demonstrably 

different in those surveys, 20 percent and 7.5 

percent, respectively. 

Estimates of the reduction of Salmonella 

incidence (presence/absence) as a result of 

compliance with the proposed performance 

standards were used for estimating the 

averted number of illnesses as a consequence 

of implementing these performance 

standards. A detailed description of the 

underlying model follows. 

The true annual number of poultry-related 

illnesses is determined by only three 

components. The first is the number of 

servings, denoted as Nservings, consumed in 

the U.S. It is reasonable to assume that this 

number does not fluctuate wildly from year 

to year. The second component describes the 

frequency of exposure to contaminated 

servings, denoted by P(exp). It is reasonable 

to assume that P(exp) is proportional the 

percent of positives carcasses (i.e., it only 

differs by a simple scaling factor). The final 

component is the probability that an 

individual serving derived from a 

contaminated carcass causes illness. Let this 

be denoted by P(ill/(exp). This component 

contains all the factors that FSIS does not 

control, such as storage, handling, cooking 

practices, and pathogenicity of different 

strains that are circulating in any given year. 

Taking all three factors into account, the 

number of illnesses is 

Nill = NservingsP(ill/exp)P(exp). 

This formula summarizes all the components 

that go into any food-safety risk assessment. 

Thus, there are actually very few 

assumptions involved with the estimation. 

The source of uncertainty that was evaluated 

in the document was the uncertainty about 

the proportion of non-compliant 

establishments that would modify their 

production practices in order to meet the 

new standard. The analysis of this parameter 

does indeed demonstrate that the true effect 

of the performance standard varies directly 

with this parameter. Nevertheless, FSIS has 

provided historic evidence that suggests that 

this parameter will not be zero and may 

approach 50 percent or more. 

The comment implied that FSIS estimates 

are not correct because only small 

establishments would be affected and it 

would not be possible that such impact could 

lead to FSIS’ estimates of averted illnesses. 

FSIS disagrees with this assertion and 

believes that some larger volume 

establishments would be affected and thus 

the estimates of averted illnesses reflect this 

belief. The technical paper attached to the 

May 14, 2010 Federal Register Notice 

(Technical Paper) that explained in detail the 

derivation of the performance standard, 

explains also how the proposed standards 

would affect the prevalence. In that 

document, Equation 3 provides the formula 

that was used to compute the expected 

prevalence, which as described above FSIS 

assumed is proportional to P(exp), for 

product that would be associated with 

passing the compliance rule. Similarly, a 

formula was computed for the expected 

prevalence for product that would be 

associated with establishments that fail the 

compliance criterion. These formulas 

explicitly treat establishments as ‘‘different’’ 

depending upon their results from the 

baseline. 

Because the formula of Equation 3 

explicitly treats establishments as ‘‘different’’ 

depending upon their results from the 

baseline, it was not assumed that all large or 

medium volume establishments would pass 

the compliance criterion. The compliance 

criterion is designed such that if an 

establishment were meeting the standard 

exactly—that is, the establishment’s 

prevalence was in fact the standard of 7.5 

percent—then the establishment would fail 

the compliance criterion 20 percent of the 

time. Thus, in modeling the impact, such an 

establishment would contribute to the 

estimate of the expected number of illnesses 

prevented because it would be expected that 

20 percent of such establishments would 

make improvement. 

Though FSIS believes these assumptions 

are reasonable, only time can validate their 

appropriateness. Though it is possible that 

establishments, even if they fail, might not 

make any changes, such a possibility would 

not invalidate the model. In sum, FSIS 

believes that the model reflects a reasonable 

expectation. 

Appendix II 

Comments noted differences in FSIS 

baseline and PR/HACCP verification data. To 

explore the question in more depth, FSIS 

examined its HACCP verification and 

Baseline data since the baseline survey 

(August 2008–July 2010) for comparison 

purposes. As the Agency has discussed in 

other communications, percentages of 

positive results from HACCP verification data 

should not be interpreted as an estimate of 

prevalence because the sample and 

establishment selections are not designed for 

statistical purposes but rather for verification 

activities. Thus, the HACCP verification 

sampling program takes disproportional 

numbers of samples in some establishments 

over time. In the period being discussed, 

2362 samples were taken from 35 

establishments—82 were positive, for a 

percent positive rate of 3.47. Five 

establishments, with 8–12 positive results, 

accounted for 49 positive results. No other 

establishments had more than five positive 

results. Thus there appears a distinction 

between the performances of these five 

establishments and all other establishments. 

If results from these five establishments were 

deleted, the percentage of positive results 

from the remainder (1872 samples) is 1.76. 

This percentage is congruent with the 

Baseline estimate of prevalence. However, 

the establishment-effect was not seen in the 

Baseline in part because the numbers of 

samples per establishment were not large, 

particularly during the period from April to 

July when most of the HACCP samples were 

analyzed. The following table classifies data 

by sampling program, period of time, and 

whether or not the sample was taken from 

one of the 5 establishments referred to above. 

The column heading ‘‘Estab Relative Positive 

Rates’’ distinguishes the results from the 5 

establishments (High) from the others (Low). 

April percent to 

July 

Estab relative 

positive rates 

Samples 

HACCP 

(#) 

Positive 

HACCP 

(#) 

Positive 

HACCP 

(percent) 

Samples base 

(#) 

Positive base 

(#) 

Positive base 

(percent) 

No .......................... Low ....................... 387 2 0.52 842 7 0.83 

Yes ........................ Low ....................... 1485 31 2.09 416 11 2.64 

No .......................... High ...................... 70 6 8.57 118 3 2.54 

Yes ........................ High ...................... 420 43 10.24 66 3 4.55 

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From this table an explanation of why the 

percentage of positive samples for the 

HACCP verification sample program is 

greater than the estimated prevalence derived 

from the Baseline survey data. On a relative 

scale, by examining the table one can see 

where the large differences between cellspecific percentages occur and where small 

differences occur and identify the factors and 

their values that are associated with large 

differences. For example, consider the cells 

with data from establishments that are 

classified with ‘‘Low’’ relative positive rates 

(second column of table) thus excluding data 

from the 5 establishment identified above 

with exceptionally high percentages of 

positive results. And within those cells, 

consider the differences of the two 

percentages within each of the periods 

identified in the April–-July column (no, 

yes). These cells are in bold in the above 

table. Differences of percentages can be 

computed in two directions: (1) Differences 

of the percentages in the same rows, and (2) 

differences of percentages in the same 

columns. The first direction (in the same 

rows): For the first row, data not collected 

between April to July, the difference is 

computed as: 0.83 percent (for the Baseline) 

minus 0.52 percent (for the HACCP data), 

which is equal to 0.31 percent; for the second 

row, data collected between April–July, the 

difference is computed as: 2.64 percent¥2.09 

percent = 0.55 percent. So the two rowspecific differences are 0.31 percent and 0.55 

percent. Now compute the differences for 

results in the same columns: For the baseline 

cells, the difference is computed as: 2.64 

percent (for data collected between April– 

July) minus 0.83 percent (for data collected 

not between April–July) which is equal to 

1.81 percent; for the HACCP cells, the 

corresponding difference is computed as: 

2.09 percent¥0.52 percent = 1.57 percent. So 

the two column-specific differences are 1.81 

percent and 1.57 percent. These two 

percentages average to 1.69 percent. These 

two column-specific differences are quite a 

bit larger than the two row-specific 

differences of 0.31 percent and 0.55 percent, 

which average to 0.43 percent. In other 

words, the average of the differences of 

percentage when comparing the percentages 

in different periods is about 4 times the 

average of the differences of percentages 

when comparing the percentages in different 

sampling programs. Thus on a relative scale, 

this relationship suggests that an important 

variable or factor that ‘‘explains’’ the variation 

of percentages is the period in which the data 

were collected. 

The third and fourth rows of the table 

contain percentages of positive results for the 

5 establishments that performed poorly on 

the HACCP samples. It can be seen that for 

the Baseline samples, for these 

establishments, the percentages of them that 

were positive were larger than the 

corresponding percentages for the other 

establishments (in the first two rows). For 

example, for the samples not collected during 

April–July, the percentage of positive 

samples for these 5 establishments was 2.54 

percent versus 0.83 percent for the samples 

collected from the other establishments; and 

for the samples collected during April–July 

the two percentages are 4.55 percent and 2.64 

percent, respectively. The relationship of the 

percentages for the different periods of 

sampling is also in the same direction as seen 

for the percentages given in the first two rows 

of the table; that is, the percentages of 

positive samples for samples taken during 

April–July are larger than the corresponding 

percentages for the samples not taken during 

April–July. Thus these results, associated 

with the 3rd and 4th rows of the above table, 

support the assessment that ‘‘period of 

sample selection’’ is an important 

explanatory variable, as well as supporting 

that the ‘‘group of establishments’’ is an 

important explanatory variable. 

The difference of percentage positive 

results between the HACCP verification and 

Baseline sampling programs is, it appears, a 

result of the differences of proportions of 

samples between the two programs, 

associated with the above two explanatory 

variables. Specifically, there are large 

differences of the proportions of samples for 

the two designated groupings of 

establishments and from the two designated 

periods: (1) Close to 21 percent of the HACCP 

samples were from the 5 poorer performing 

establishments, whereas about 13 percent of 

the Baseline samples were from these 

establishments; and (2) about 80 percent of 

the HACCP samples were from the period 

April-July, whereas about 33 percent of the 

Baseline samples were from the same period. 

The above is an explanation of the 

differences between the two sampling 

programs’ percentages of positive results. 

FSIS had been aware of the possibility of 

both temporal and establishment effects in 

developing its performance standard 

approach. FSIS addressed possible temporal 

effects by using year long baseline surveys 

(with the exception of some ground 

products). The purpose of the performance 

standard is to eliminate establishment effects 

that would lead to higher than expected risk 

to the public. Thus performance standards 

are designed to bring a degree of consistency 

of performance by noting poor performance, 

relative to the rest of the industry, over time. 

For these data, the concern of a lack of 

consistency is clearly justified—there are 

many establishments with low percentages of 

positive results and there are (only) a few 

others that had what would be considered, 

relatively, a high percentage of positive 

results, suggesting that the establishments’ 

processes were not in control, as least as well 

as others in the industry. 

This observation informs the Agency’s 

response to the comment suggesting that 

FSIS provide a ‘‘grace period’’ when results 

on a sample set does not meet the 

compliance criterion of no more than four 

positive results in a sample set for turkey 

carcasses. The comment noted that because 

the number of positive results permitted is 

low, results from every set would not meet 

the criterion, thus implying that 

establishments would be failing incorrectly— 

that the failing establishment’s process was 

actually in control. In statistical quality 

control parlance, this misclassification is 

referred to as a type 1 error. However, it 

should be noted that FSIS addressed this 

issue by relaxing the criterion for failing a set 

from the approximate 80 percent confidence 

requirement for asserting a failure that had 

been, and still is, being used by FSIS for 

other products, to requiring at least having 99 

percent confidence before asserting a failure. 

In other words, because of the low expected 

incidence of Salmonella findings, FSIS 

reduced the type 1 error rate from about 20 

percent to less than 1 percent. If FSIS had 

followed its previous procedure and required 

only about 80 percent confidence before 

asserting a failure, then the compliance 

criterion would have been ‘‘no more than 1 

positive result in 56 samples (providing a 75 

percent probability of passing when the 

performance standard (of 1.73 percent) was 

being met). Originally the 80 percent 

confidence rule was used because FSIS 

wanted establishments to take action to 

reduce the incidence of pathogens in their 

products to below the performance standard 

percentage; that is, if an establishment were 

actually producing at the performance 

standard, there would be a 20 percent chance 

that it would not pass the set—a risk of 

failing which the Agency believed would be 

too high. Thus, FSIS believed that 

establishments in such a situation would 

improve their processing in order to reduce 

the risk of failing. By selecting an at least 99 

percent confidence requirement FSIS 

acknowledged that the industry has 

improved and that at the present time FSIS 

could not expect more improvement. FSIS 

believes the ‘‘at least 99 percent confidence’’ 

rule helps ensure that processing will not get 

worse, and at the same time minimizes the 

type 1 error rate, thereby addressing the 

commenter’s concern. 

The comment’s implication of using an 

average of two 56-sample sets, together with 

the at least 99 percent criterion, would mean 

that in 112 samples there should be no more 

than six positive results. Using an average 

could place an establishment in a more 

difficult situation. For example, if there were 

five or six positive results in the first set then 

only at most one or no positive results would 

be permitted for the second set in order to 

pass. An establishment in such a situation 

would fail if there were more than one or 

zero positive results—a difficult standard 

even if the establishment had the best 

control. Upon a failure (e.g., two or three 

positive results within the set), a third set 

would be needed, in the meantime, the 

establishment would have failed to meet the 

standard, when in fact the establishment’s 

process might actually be in control. Thus, 

following the comment’s suggestion actually 

would be increasing the type 1 error rate by 

resulting in listing of establishments at a time 

in which their process is most likely to be in 

control, and increasing the so-called type 2 

errors of not posting an establishment when 

its process was not performing well. Rather 

the FSIS approach is timelier: When 

sufficient evidence exists (in this case, with 

99.7 percent confidence, or a type 1 error rate 

of 0.3 percent) that the standard was not 

being met, then the establishment would be 

listed, and if on a second set, the 

establishment passes with no more than four 

positive results, the establishment’s name 

would be removed. 

FSIS believes that HACCP verification data 

examined above support the Agency’s 

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position. For the two-year period for which 

data were analyzed, five establishments had 

seven, seven, nine, nine, and 10 positive 

results (the same five establishments with the 

largest number of positive results identified 

above). Of these, three establishments had a 

second full set of 56 samples, with a total 

number of six positive results (one, two, and 

three), for a rate of 3.6 percent, still above 

average. These three establishments though 

would have met the standard and thus would 

have been taken off the list. If the proposed 

grace period option were operating, then it 

would have been invoked if there had been 

six positive results instead of seven for one 

of the sets; in such a case, any of results from 

the second sets given above would have 

resulted in the establishment not meeting the 

standard, and the establishment’s name 

would have been listed. Under FSIS’ system, 

in this case the establishments would have 

been listed after the first set when there was 

sufficient evidence for adducing that the 

establishments’ processes were not as good as 

could be relative to the rest of the industry, 

and then removed after the second set 

success, when the latest evidence would not 

be sufficient for such an adduction. 

In conclusion, FSIS believes that its system 

prevents type 1 errors from occurring often 

and is timelier regarding when poor 

performing establishments would be listed. 

FSIS believes that its policy is appropriate for 

maintaining the status quo, and inducing 

poorer performing establishments to improve 

their processes to a level consistent with the 

industry’s overall performance. By relaxing 

the required degree of confidence to 99 

percent from 80 percent confidence, FSIS 

believes that it has provided a reasonable 

policy with regard to small deviations from 

the standard for which the establishment 

could and should address without being 

listed. For the compliance guideline for the 

turkey performance standard, the actual 

degree of confidence is 99.7 percent. As a 

consequence, FSIS does not believe a ‘‘grace 

period’’ is necessary; that if an establishment 

fails to meet the standard compliance 

criterion it would indicate that the 

establishment’s process can be improved. In 

addition, (1) The discrepancy between the 

baseline and HACCP percentages of positive 

results can be ‘‘explained’’ for the most part 

by the disproportional distribution of 

samples over time and over establishments; 

(2) HACCP verification data show that over 

90 percent of the sets in the time period 

analyzed had no more than three positive 

results, and thus for the most part it seems 

that establishments have been performing 

recently at or better than the specified 

performance standard. 

[FR Doc. 2011–6585 Filed 3–18–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Sanders County Resource Advisory 

Committee Meeting 

AGENCY: Forest Service, USDA. 

ACTION: Notice of Sanders County 

Resource Advisory Committee Meeting. 

SUMMARY: Pursuant to the authorities in 

the Federal Advisory Committee Act 

(Pub. L. 92–463) and under the Secure 

Rural Schools and Community SelfDetermination Act of 2000 (Pub. L. 106– 

393) the Lolo and Kootenai National 

Forests’ Sanders County Resource 

Advisory Committee will meet on April 

21, 2011 at 7 p.m. in Thompson Falls, 

Montana for a business meeting. The 

meeting is open to the public. 

DATES: April 21, 2011. 

ADDRESSES: The meeting will be held at 

the Thompson Falls Courthouse, 1111 

Main Street, Thompson Falls, MT 

59873. 

FOR FURTHER INFORMATION CONTACT: 

Randy Hojem, Designated Federal 

Official (DFO), District Ranger, Plains 

Ranger District, Lolo National Forest at 

(406) 826–3821. 

SUPPLEMENTARY INFORMATION: Agenda 

topics include solicitation for new RAC 

project proposals, reviewing progress on 

current projects, and receiving public 

comment. If the meeting location is 

changed, notice will be posted in the 

local newspapers, including the Clark 

Fork Valley Press, and Sanders County 

Ledger. 

Dated: March 14, 2011. 

Randy R. Hojem, 

District Ranger. 

[FR Doc. 2011–6503 Filed 3–18–11; 8:45 am] 

BILLING CODE 3410–11–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

[0209IDP30910] 

Upper Rio Grande Resource Advisory 

Committee 

AGENCY: Forest Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: The Upper Rio Grande 

Resource Advisory Committee will meet 

in Monte Vista, Colorado. The 

committee is meeting as authorized 

under the Secure Rural Schools and 

Community Self-Determination Act 

(Pub. L. 110–343) and in compliance 

with the Federal Advisory Committee 

Act. The purpose is to review and 

recommend project proposals to be 

funded with Title II money. 

DATES: The meeting will be held on 

April 11, 2011 and will begin at 10 a.m. 

ADDRESSES: The meeting will be held at 

the South Fork Community Building, 

0254 Highway 149, South Fork, 

Colorado. Written comments should be 

sent to Mike Blakeman, San Luis Valley 

Public Lands Center, 1803 West U.S. 

Highway 160, Monte Vista, CO 81144. 

Comments may also be sent via e-mail 

to mblakeman@fs.fed.us, or via 

facsimile to 719–852–6250. 

All comments, including names and 

addresses when provided, are placed in 

the record and are available for public 

inspection and copying. The public may 

inspect comments received at the San 

Luis Valley Public Lands Center, 1803 

West U.S. Highway 160, Monte Vista, 

CO 81144. 

FOR FURTHER INFORMATION CONTACT: 

Mike Blakeman, RAC coordinator, 

USDA, San Luis Valley Public Lands 

Center, 1803 West U.S. Highway 160, 

Monte Vista, CO 81144; 719–852–6212; 

E-mail mblakeman@fs.fed.us. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

between 8 a.m. and 8 p.m., Eastern 

Standard Time, Monday through Friday. 

SUPPLEMENTARY INFORMATION: The 

meeting is open to the public. The 

following business will be conducted: 

(1) Introductions of all committee 

members, replacement members and 

Forest Service personnel; (2) Review 

status of approved projects; (3) Review, 

evaluate and recommend project 

proposals to be funded with Title II 

money; (4) Create a timeline to receive 

and review new project proposals and 

schedule the next meeting; and (5) 

Public Comment. Persons who wish to 

bring related matters to the attention of 

the Committee may file written 

statements with the Committee staff 

before or after the meeting. 

Dated: March 15, 2011. 

Dan S. Dallas, 

Forest Supervisor. 

[FR Doc. 2011–6531 Filed 3–18–11; 8:45 am] 

BILLING CODE 3410–11–P 

DEPARTMENT OF COMMERCE 

Foreign-Trade Zones Board 

[Docket 20–2011] 

Foreign-Trade Zone 106—Oklahoma 

City, OK Application for 

Reorganization/Expansion Under 

Alternative Site Framework 

An application has been submitted to 

the Foreign-Trade Zones (FTZ) Board 

(the Board) by the Port Authority of 

Greater Oklahoma City, grantee of FTZ 

106, requesting authority to reorganize 

and expand the zone under the 

alternative site framework (ASF) 

mstockstill on DSKH9S0YB1PROD with NOTICES