[Federal Register Volume 76, Number 54 (Monday, March 21, 2011)]
[Notices]
[Pages 15282-15290]
From the Federal Register Online via the Government Publishing 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; [email protected].
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 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 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) (http://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) (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 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 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 [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
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 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 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
[[Page 15288]]
safety news and information. This service is available at http://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 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]
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