New Performance Standards for Salmonella and Campylobacter in Young Chicken and Turkey Slaughter Establishments: Response to Comments and Announcement of Implementation Schedule, 15282-15290 [2011-6585]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15282-15290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6585]


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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.

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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 micro-organisms 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 follow-up 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 micro-
organisms 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

[[Page 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 notice-and-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 non-compliant 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

[[Page 15284]]

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 https://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 non-chicken 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) (https://wwwn.cdc.gov/foodborneoutbreaks/), 
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) (https://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 outbreak-related (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, fruits-nuts, 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 product-specific 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

[[Page 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 
second-highest 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 non-categorized 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.

[[Page 15286]]

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 dose-response 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 https://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 [deg]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 [deg]C and then a small 
amount of enriched culture is streaked to Campy-Cefex plating medium 
and incubated under microaerophilic conditions for 48 hours at 42 
[deg]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,

[[Page 15287]]

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 
https://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 cm\2\ 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 https://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

[[Page 15288]]

safety news and information. This service is available at https://www.fsis.usda.gov/news_&_events/e-mail_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).

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Estab relative      Samples HACCP  Positive HACCP  Positive HACCP   Samples base    Positive base   Positive base
       April percent to July           positive rates       ()     ()      (percent)      ()     ()      (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
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 15289]]

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 cell-specific 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 row-specific 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

[[Page 15290]]

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 w