[Federal Register Volume 75, Number 93 (Friday, May 14, 2010)]
[Notices]
[Pages 27288-27294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11545]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2009-0034]


New Performance Standards for Salmonella and Campylobacter in 
Young Chicken and Turkey Slaughter Establishments; New Compliance 
Guides

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
new performance standards for the pathogenic micro-organisms Salmonella 
and Campylobacter for use in young chicken and turkey slaughter 
establishments. The new performance standards were developed in 
response to a charge from the Food Safety Working Group. The Agency 
tentatively plans to implement these new performance standards for 
chilled carcasses in July 2010. The new standards are based on recent 
FSIS Nationwide Microbiological Baseline Data Collection Programs: The 
Young Chicken Survey and the Young Turkey Survey. The Agency invites 
comments on the new performance standards.
    FSIS is also announcing that it has posted on its Web site the 
third edition of the compliance guide for controlling Salmonella and 
Campylobacter in poultry and a compliance guide on pre-harvest 
management to reduce E. coli O157:H7 contamination in cattle. FSIS 
issues guidance documents to present current Agency thinking on 
specific topics related to food safety. Though Agency guidance 
documents are recommendations rather than regulatory requirements and 
are revised as new information becomes available, FSIS encourages meat 
and poultry establishments to follow this guidance. FSIS requests 
comments on these guidance documents.

DATES: Comments are due by July 13, 2010.

ADDRESSES: Comments may be submitted by either of the following 
methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. Go to http://www.regulations.gov. 
Follow the online instructions at that site for submitting comments.
    Mail, including floppy disks or CD-ROMs, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture 
(USDA), FSIS, Room 2-2127, George Washington Carver Center, 5601 
Sunnyside Avenue, Mailstop 5474, Beltsville, MD 20705-5474.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2009-0034. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or to comments received, 
go to the FSIS Docket Room at the address listed above between 8:30 
a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D., Deputy 
Assistant Administrator for Office of Policy and Program Development, 
FSIS, U.S. Department of Agriculture, Room 349-E, Jamie Whitten 
Building, 14th and Independence, SW., Washington, DC 20250-3700; 
telephone (202) 205-0495, fax (202) 720-2025; 
<a href="/cdn-cgi/l/email-protection#1175707f78747d3f747f76747d7b7e797f51776278623f646275703f767e67"><span class="__cf_email__" data-cfemail="0d696c636468612368636a6861676265634d6b7e647e23787e696c236a627b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

Background

    FSIS is the public health regulatory agency in the U.S. Department 
of Agriculture (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 (FSWG 
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 charged FSIS with ``cutting Salmonella risk in Poultry 
Products'' by ``develop[ing] new standards to reduce

[[Page 27289]]

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 2010.'' These new Salmonella standards will 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 FSWG further charged FSIS with ``develop[ing] a new 
performance standard for Campylobacter for young chickens and 
turkeys.'' This notice announces that FSIS has developed such 
performance standards. The notice also describes the estimated public 
health impact that is likely to result if these standards are met.
    The performance standards for young chickens and turkeys set out in 
this notice are based on the Agency's recent Nationwide Microbiological 
Baseline Data Collection Programs: The Young Chicken Baseline Survey 
(YCBS), and the Young Turkey Baseline Survey (YTBS).
    From July 2007 to June 2008, the YCBS collected and analyzed 6,550 
samples at 182 establishments that slaughtered young chickens and 
produced whole carcasses under Federal inspection. Rinsate samples were 
taken both at re-hang and post-chill locations, from whole carcasses 
that were shaken in bags together with 400 mL of sample rinse solution. 
``Re-hang'' refers to the location in the process after the picker and 
prior to evisceration of the bird. ``Post-chill'' refers to the point 
in the process where the carcasses exit the immersion chiller or other 
chill media (such as ice) after all slaughter interventions have taken 
place, but before entering coolers or proceeding to further processing.
    These samples were analyzed by different methods to estimate the 
prevalence or ``qualitative'' rate and the levels or ``quantitative'' 
measures (colony forming units per milliliter or cfu/mL) of two human 
pathogens, Salmonella and Campylobacter, and four non-pathogenic 
``indicator organisms'' that track process control: Generic Escherichia 
coli, Aerobic Plate Count (APC), Enterobacteriaceae, and total 
coliforms. Re-hang sample results were compared with post-chill sample 
results, and the comparison confirmed that microbial loads are 
significantly reduced by the time the carcasses reach post-chill.
    The Agency has used the post-chill sample results from the YCBS, 
weighted by volume, to estimate the prevalence of Salmonella and 
Campylobacter on inspected and passed young chicken carcasses. These 
prevalence estimates constitute the new performance standards announced 
in this notice. These performance standards will apply to all young 
chickens, including roasters and Cornish game hens. The Agency intends 
to use the same sample collection and analysis procedures that it used 
in the baseline.
    The YTBS report is being prepared for publication. In the YTBS, 
FSIS collected and analyzed 1,442 carcass sponge samples at the re-hang 
and post-chill locations from young turkeys (including young breeder 
turkeys) slaughtered in 58 Federal establishments from August 2008 to 
July 2009. Inspection program personnel used two sponges, each 
moistened with 25 mL of solution, for each carcass sampled at the two 
locations. They swiped each sponge over 100 cm\2\ of the thigh and back 
of one half of the carcass (50 cm\2\ on each part). One of the two 
sponges used at each location was used to analyze for Salmonella and 
the other for Campylobacter. For Salmonella samples, each sponge plus 
the 25 mL of solution was enriched to determine the presence or absence 
of Salmonella. For Campylobacter samples, from each 25 mL sponge sample 
portion, 1-1.3 mL was extracted for the direct plating test, which is 
referred to as the ``1 mL'' procedure.
    The 1 mL procedure provides data on levels of organisms present but 
is relatively insensitive because of the small size of the sample 
portion analyzed and thus detects positive samples with higher levels 
of organisms. The remaining 24 mL of solution, which contains the 
sample sponge, was enriched so as to detect positive samples with low 
levels of organisms and thus to help estimate prevalence. Thus, the 
sample results were used to estimate the prevalence or ``qualitative'' 
rate and the levels or ``quantitative'' measures of the same organisms 
as for the YCBS. The Agency used the post-chill sample results from the 
YTBS, weighted by volume, to estimate the prevalence of Salmonella and 
Campylobacter at post-chill. The Agency then used those estimates of 
prevalence to develop the new performance standards announced in this 
notice. The sample collection and analysis procedures used in assessing 
compliance with the performance standard will be the same as used in 
the baseline. A technical paper on the method used to develop the 
performance standards is posted at the FSIS Web site with this notice 
at http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp.
    These performance standards are derived from the poultry baseline 
surveys and from 2008-2009 Salmonella Verification Program data. FSIS 
estimated the potential public health impacts of the proposed 
performance standards.\1\ For estimating potential public health 
impacts regarding the Salmonella standards, the Agency used both the 
baseline data and the more current verification data because of changes 
observed in the industry since the collection of the baseline data, 
which may lead to slight underestimates of prevalence relative to other 
approaches. For estimating the potential impact of the Campylobacter 
standards, only baseline data were available. Note that FSIS's 
estimates of the potential reductions in human illnesses from 
Salmonella and Campylobacter should be considered separately; it is not 
appropriate from a scientific standpoint to add them together. A 
technical paper on the method used to develop the potential public 
health impacts is posted at the FSIS Web site with this notice at 
http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp.
---------------------------------------------------------------------------

    \1\ These estimates include a variety of assumptions. An area of 
considerable uncertainty is the determination of the number of 
attributed illness because the existence of Salmonella or 
Campylobacter itself does not mean that there is a human health 
impact because the true FSIS share of Salmonella and Campylobacter 
illnesses caused from consumption of poultry is unknown.
---------------------------------------------------------------------------

    FSIS intends to conduct more frequent baseline studies, at 
intervals not greater than every four years, and to make appropriate 
adjustments to these performance standards based on the results of the 
studies. Given the performance standards discussed in this notice, the 
Agency requests comments on practical and realistic goals for reducing 
the prevalence of microbial pathogens.

Salmonella Performance Standards

    Salmonella bacteria are among the most frequently-reported causes 
of foodborne illness. The bacteria live in the intestinal tract of 
humans and other animals, including birds. Salmonella contamination of 
raw meat and poultry products occurs during slaughter operations, as 
well as during the live-animal rearing process (e.g., on-farm 
contamination can coat the exterior of the bird and remain attached to 
the skin). Currently, such events cannot be

[[Page 27290]]

eliminated, and contamination of raw carcasses will result unless a 
lethality antimicrobial treatment is applied (e.g., irradiation). These 
events, however, can be minimized. Salmonella and, to a lesser extent, 
Campylobacter may increase on pre-cooked poultry if subjected to 
temperature abuse. However, levels present on and in raw poultry 
product would only survive on the product presented for human 
consumption if it is not cooked thoroughly. Also, if poultry is 
improperly handled, Salmonella and Campylobacter can cross-contaminate 
other foods or food contact surfaces.
    Among Salmonella-contaminated poultry carcasses, the number of 
Salmonella organisms is generally low. It is thought that human cases 
of salmonellosis likely result when those small numbers of Salmonella 
bacteria are subject to conditions that allow them to grow to sizeable 
doses between production and consumption. Because the occurrence of any 
Salmonella on a carcass poses a potential hazard for consumers, 
measuring contamination, and thus setting standards, refers to 
estimated prevalence of Salmonella among samples collected from 
facilities and not to the quantitative level of individual samples. A 
different approach is needed for Campylobacter, as explained below. The 
Appendix to this notice provides a detailed history of Agency actions 
regarding Salmonella.

New Salmonella Standard for Young Chickens

    The estimated prevalence of Salmonella in young chicken carcasses 
at post-chill based on volume-weighted YCBS baseline data collected 
from July 2007 through June 2008 is 7.5%. Based upon its evaluation of 
this new baseline data, the Agency has concluded that it should revise 
its performance standard to further improve establishment control of 
Salmonella in young chickens in order to reduce illnesses attributed to 
this product. The Agency will lower the performance standard to the 
current level indicated by the new baseline data accordingly, revise 
establishment categories, and continue to publish the names of 
establishments that do not meet the new Category 1 criteria. The Agency 
will continue its qualitative approach to analyzing Salmonella samples 
for presence/absence under the new performance standard, leaving 
unchanged the current sample procedures for Salmonella requiring 51 
samples per set. Inspection program personnel will continue to collect 
400 mL of rinsate for each sample, from which a 30 mL portion is 
analyzed.
    Under the new performance standard, the Agency will:
    <bullet> Establish a new performance standard of 7.5 percent based 
on the estimated prevalence of Salmonella-positive results from the 
2007-8 YCBS data.
    <bullet> Continue collecting and analyzing a 51-sample set.
    <bullet> Set 5 out of 51 positive samples as the maximum number of 
positives allowed to achieve the new performance standard, which will 
provide an 80 percent probability of an establishment meeting the 
standard when operating at the 7.5% performance standard.
    <bullet> Continue the Category 1/2/3 approach as determined by an 
establishment's most recent sets:
     [cir] Category 1 = two consecutive sets with no more than two 
positives;
     [cir] Category 2T = two positives or fewer in last set, 3 or more 
positives in prior set;
     [cir] Category 2 = last set with 3-5 positives, any result in 
prior set;
     [cir] Category 3 = last set with six or more positives, any result 
in prior set.
    <bullet> Continue publishing Category 2 and 3 establishments based 
on the performance standard in effect when the last sample set was 
begun. FSIS will continue to follow the criteria it uses to select 
establishments for posting--Category 2 and 3 establishments are posted, 
Category 1 and 2T establishments are not posted, and establishments in 
a product class will not be published if 90 percent of its eligible 
establishments are in Category 1 and no establishment is in Category 3.
    <bullet> Prioritize the scheduling of testing of young chicken 
establishments that are not meeting the new standard.
    Under the current performance standard, approximately 82 percent of 
young chicken establishments eligible for the Salmonella Verification 
Program are in Category 1. Under the new performance standard, 
approximately 57 percent of eligible establishments would be in the new 
Category 1, representing a significant tightening beyond the current 
Category 1. Another 28 percent is in new Category 2, and 15 percent is 
in new Category 3.
    The Agency's experience after 2006 with the industry response to 
Salmonella policies implemented that year leads the Agency to estimate 
that approximately half of the 15 percent of establishments that would 
not meet the new standard will improve their food safety systems to do 
so during the first two years of implementation. Much of that 
improvement, we believe, would likely occur in the first year. This 
would result in a shift of 7-8 percent of establishments meeting the 
new standard. This improved performance, when added to the 85 percent 
of establishments that already meet the new standard, would result in 
more than 90 percent of establishments meeting the new standard and 
thus, meeting the FSWG goal to be accomplished by the end of 2010.
    The Agency has applied a model to estimate the potential public 
health impact of the proposed performance standards. The model contains 
considerable uncertainty about the relationship between the rate of 
contamination on raw carcasses and human illness as well as assumptions 
about how establishments will change their behavior as a result of the 
new guidance. Under the assumption that the 7-8 percent of 
establishments improving performance to meet the new standard would 
improve to the average of those establishments that already meet the 
new standard, the Agency estimates that after the first two years of 
implementation, it is possible that approximately 26,000 human 
illnesses would be averted annually when compared to the period prior 
to implementation of the standard. This would be a reduction of 
approximately 12 percent of human illnesses from the current 220,000 
attributed to this cause, as discussed in the public health impacts 
paper referenced above. This would be a permanent structural reduction 
of 26,000 illnesses averted for each future year as compared to before 
implementation.
    Additional public health benefits could potentially be realized as 
more establishments move into the new Category 1 status. The Agency 
will carefully analyze data on individual establishments to see if 
further public health benefits can be projected if establishments 
increasingly move into the new Category 1 status.

Campylobacter Performance Standard for Young Chickens

    Campylobacter species, including C. jejuni, C. coli, and C. lari, 
can be isolated from the intestinal tract of poultry and poultry 
products. The two most frequently occurring Campylobacter species of 
clinical significance for human consumption of food are C. jejuni and 
C. coli. These species are the ones most often isolated in poultry 
products.
    Until the recent baselines, the Agency had limited data on 
Campylobacter, in part because of difficulties with available 
methodology to account for presence and numbers of this pathogen. In 
2005, the National Advisory Committee on Microbiological Criteria for 
Foods (NACMCF) was asked to

[[Page 27291]]

address Campylobacter, particularly with regard to the analytical 
utility of methodologies for the upcoming YCBS. In its final report 
(NACMCF on Campylobacter methodology), the NACMCF recommended that FSIS 
adapt the direct plating enumeration methodology to detect and 
enumerate Campylobacter that had been developed by USDA's Agricultural 
Research Service (ARS).
    In the YCBS, accordingly, rinsate samples were analyzed using two 
distinct procedures adapted from the ARS methodology. A quantitative 
detection and enumeration procedure was used to analyze both re-hang 
and post-chill rinsate samples, and a qualitative detection method, 
which included an enrichment step, was used only with the rinsates 
obtained from post-chill samples. FSIS is revising its Microbiology 
Laboratory Guidebook, Section 41.00, to include these qualitative and 
direct plating quantitative procedures for the isolation, 
identification, and enumeration of C. jejuni/coli/lari present in 
poultry rinses and sponges. FSIS will use these procedures in the 
verification testing for Campylobacter that it intends to conduct, as 
discussed in this notice.
    With the methodology employed in the baseline and in the 
verification testing described in this notice, all 51 samples taken for 
a set are to be analyzed both for Salmonella, using the standard Agency 
method, and Campylobacter. Each portion of sample rinsate used for 
Campylobacter analysis will be subdivided into two portions, one of 1 
mL and one of 30 mL. The 1 mL and the 30 mL portions of this test are 
begun in the laboratory at the same time. The result for the 1 mL 
portion is available before the result for the 30 mL portion. The 1 mL 
portion is plated for both qualitative (presence/absence) and 
quantitative (enumeration) results. The 30 mL portion is first enriched 
and then plated for qualitative (presence/absence) results only. The 30 
mL enrichment-based test laboratory procedure increases the practical 
sensitivity of testing primarily by accommodating significantly larger 
test portions. Thus it can detect as few as 1 bacterial cell (referred 
to as Colony Forming Unit or CFU) per 30 mL portion. Therefore the 
theoretical Limit of Detection (LOD) per portion is calculated as 0.03 
CFU per mL.
    The 1 mL direct plating test procedure, on the other hand, is 
relatively less sensitive in practice because of its much smaller size 
and has a LOD of 1 CFU per mL rather than 0.03 CFU per mL, which means 
that direct plating with the 1 mL portion will tend to detect samples 
with higher contamination. Detecting samples with higher contamination 
is crucial to addressing the public health concerns with regard to 
Campylobacter contamination. If the 1 mL portion is qualitatively 
negative, then the 30 mL portion will be used to determine whether the 
sample is positive or negative for Campylobacter. As the 1 mL procedure 
is relatively less sensitive and detects samples with higher 
contamination, positive 1 mL results are considered positive for the 30 
mL procedure as well. This approach, which was used in the YCBS, will 
conserve limited laboratory resources without having a negative impact 
on the verification program.
    The 1 mL procedure offers the benefit of providing quantitative 
data by enumerating the organisms present in these higher-load samples, 
thus informing the Agency about the prevalence of high-load samples. 
The 30 mL procedure can detect lower-load samples when necessary but, 
because of the enrichment step required, cannot provide meaningful 
quantitative data on initial contamination levels.

New Performance Standard for Campylobacter in Young Chicken Carcasses

    In light of the FSWG recommendations discussed above, FSIS has 
concluded that it should foster and encourage improved establishment 
control of Campylobacter in young chickens by setting a performance 
standard based upon the YCBS prevalence. The performance standard for 
Campylobacter comprises two factors based on YCBS prevalence: One 
specifying the percentage of 1 mL portions that are positive, and the 
other specifying the percentage of total sample-specific positive 
results counting either the 1 mL or the 30 mL rinsate portions as 
positive. Accordingly, the Agency will:
    <bullet> Test each of the 51 samples in a Salmonella verification 
set for Campylobacter using the initial 1 mL quantitative portion. If 
the 1 mL procedure is negative, the 30 mL procedure will be performed.
    <bullet> Establish a performance standard for the 1 mL portion at 
10.4 percent, which is the YCBS estimated prevalence for 1 mL portions, 
with no more than 8 positive samples from the 1 mL results.
    <bullet> Establish the performance standard for the sample-specific 
positive results, which is the YCBS estimated sample-specific 
prevalence for 1 mL and 30 mL results combined, at 46.7 percent with no 
more than 27 of 51 samples positive in any combination of 30 mL and 1 
mL results. As the 1 mL procedure is relatively less sensitive and 
detects samples with higher contamination, positive 1 mL results will 
be considered positive for the 30 mL procedure as well.
    This standard will allow the Agency to gauge both overall frequency 
of contamination and the frequency of greater than expected carcass 
contamination levels. The 1 mL component of the standard was added 
based on the Agency's understanding that higher than expected numbers 
of Campylobacter on chicken carcasses present a different challenge to 
public health than with Salmonella. Campylobacter is found more 
frequently, but it is not able to grow at temperatures below 
approximately 86 degrees Fahrenheit. Thus, high levels of this pathogen 
are unlikely at the point of consumption, unless they were present at 
high levels before the product left the establishment. Conversely, 
Salmonella can grow at colder temperatures, but positive carcasses tend 
to have low initial levels of contamination. This Campylobacter 
performance standard therefore addresses the need to minimize the 
frequency of greater than expected levels of Campylobacter 
contamination on carcasses.
    After 90 percent of eligible establishments have been sampled for 
two full sets, which the Agency estimates will be accomplished by 2012, 
the Agency will consider setting establishment categories 1/2/3 for 
Campylobacter under the new performance standard (separate from 
Salmonella) and publishing Campylobacter Category 2/3 establishments.
    Based on the Agency's experience with the industry response to 
Salmonella policies implemented in 2006 (discussed above), the Agency 
estimates that 50 percent of establishments that at present would not 
meet the new Campylobacter standard would likely improve their food 
safety systems to meet the standard during the first two years of 
implementation. Assuming 75 percent of establishments meeting the new 
standard, the public health impact model for Campylobacter estimates 
that after the first two years of implementation, it is possible, not 
withstanding considerable uncertainty, that approximately 39,000 human 
illnesses would be averted annually as compared to the period before 
implementation, a reduction of approximately 10 percent from the 
current 400,000 attributed to this cause, as discussed in the potential 
public

[[Page 27292]]

health impacts paper referenced above. This result could yield a 
permanent structural reduction of 39,000 illnesses averted for each 
future year as compared to before implementation. Note however that 
past reductions in Salmonella prevalence do not necessarily imply that 
industry has the resources and the technical ability to further reduce 
pathogen levels. There is likely a lower limit to pathogen levels that 
can be achieved with current technologies.
    Additional public health benefits could potentially be realized if 
the Agency decides to implement a Category 1/2/3 approach, and 
establishments move into the new Category 1 status. As with the 
Salmonella verification program, the Agency will analyze data on 
individual establishments sampled in the YCBS to evaluate whether 
further benefits could be predicted if establishments increasingly move 
into a hypothetical Campylobacter Category 1 status.
    This Campylobacter testing program would require additional funding 
in fiscal year 2011 to implement because of its associated demand on 
laboratory resources. New employees will need to be hired and trained, 
and laboratory supplies purchased, to run the tests. The President's 
budget request for fiscal year 2011 includes a funding request for this 
testing.

Salmonella Performance Standard for Young Turkey Carcasses

    The Agency has decided to take a different approach to Salmonella 
in turkeys. Past FSIS sampling data suggest that the prevalence of 
Salmonella-positive broiler and turkey carcasses was similar (FSIS 1995 
Broiler chicken baseline study; FSIS 1998 Young turkey baseline study; 
Baseline Data). FSIS sampling data from the YTBS suggest that the 
prevalence of Salmonella-positive whole young turkey carcasses is now 
substantially less than the prevalence of Salmonella-positive young 
chicken carcasses. The prevalence estimate at post-chill for whole 
young turkey carcasses was about 1.7 percent, more than a 10-fold 
decrease from the prevalence estimated from the previous turkey 
baseline. The Agency notes, furthermore, that under the Category 1/2/3 
approach used since 2006, more than 90 percent of young turkey 
slaughter establishments have been in Category 1 and none in Category 
3. Thus, the Category 2 establishments from this class have not been 
published.
    At the very low positive rates seen in whole young turkey 
carcasses, sample sets much larger than those currently collected 
(i.e., many more than 56 samples per set) would be necessary to detect 
real differences in establishment performance. The Agency believes that 
resources that have been used in tracking category status for this 
product can be better utilized to address more pressing public health 
concerns, including pathogens found in ground turkey and turkey parts 
that have an increasing market share for the young turkey product 
class.
    For these reasons, the Agency has decided to establish an 
acceptable positive rate for whole young turkey carcasses that is lower 
than the current acceptable positive rate, but high enough that an 
establishment actually operating at the YTBS prevalence will have at 
least a 99 percent probability of meeting the new standard. The 99 
percent probability chosen for the new acceptable positive rate would 
allow fewer positive results in a set of 56 samples than under the 
current turkey carcass performance standard. This approach will permit 
the Agency to better utilize its resources, to focus its activities on 
public health issues, and, at the same time, to continue to monitor or 
evaluate industry performance. Specifically, the Agency will:
    <bullet> Establish a new performance standard of 1.7 percent for 
post-chill with no more than 4 positive samples in a 56-sample set, 
providing an approximate 99.7 percent probability of an establishment 
meeting the standard when actually operating at the performance 
standard.
    <bullet> Continue the 56-sample set under the new standard.
    <bullet> Publish the names of establishments that do not meet the 
performance standard in their last set based on that set having begun 
after implementation of this new standard.
    <bullet> Exclude young turkey slaughter establishments from posting 
if 90 percent of establishments meet the new performance standard.
    <bullet> Prioritize scheduling of testing at turkey establishments 
not meeting the new standard.
    Based on current FSIS Salmonella Verification Program data on 
establishment performance levels, 82 percent of eligible establishments 
would initially meet the new performance standard for turkeys with no 
more than 4 positive samples out of 56 in the last set. This level of 
performance would come close to meeting the FSWG goal of 90 percent of 
establishments meeting the new standard by the end of 2010. Using our 
public health impact model, the Agency estimates approximately 100 
human illnesses averted annually after the first two years of 
implementation as compared to the period before implementation, a 
reduction of approximately 1.5 percent from the current 9,000 
attributed to this cause, as discussed in the public health impacts 
paper referenced above. This public health impact could yield a 
permanent structural reduction in illnesses.
    The Agency believes that this performance standard, setting a level 
below the current standard for Category 1, will provide an incentive 
for the turkey industry to continue to improve its process control. As 
noted above, FSIS estimates that only 82 percent of turkey 
establishments will meet the new standard under their current 
performance levels. Since the Agency plans to begin publishing the 
names of establishments that do not meet the new standard, the Agency 
has concluded that a significant incentive will be established for 
immediate improvement in the turkey industry and for consistent 
maintenance of good performance. This new approach can be accomplished 
under the current sampling and testing infrastructure and current 
funding levels. The agency plans to commence publishing the names of 
establishments that do not meet the standard in sets begun after 
implementation of the new standard.

Campylobacter Performance Standard for Young Turkey Carcasses

    The estimated prevalence of Campylobacter at post-chill derived 
from the YTBS is about 1.1 percent. As it did with its approach to 
Salmonella in young turkeys discussed above, the Agency is setting a 
low performance standard for Campylobacter with an acceptable positive 
rate that provides a higher probability of meeting the standard when an 
establishment is actually operating at the standard. Unlike with 
Campylobacter in young chickens, however, the percent positive in young 
turkeys is so low, especially with the 24 mL results (as described 
above), that a single performance standard is indicated for any 
combination of 1 mL or 24 mL results. FSIS intends to:
    <bullet> Establish a new performance standard at the YTBS 
prevalence of 1.1 percent with no more than 3 positive samples in a 56-
sample set from any combination of 1 mL or 24 mL results, providing an 
approximate 99.7 percent probability of an establishment meeting the 
standard when actually operating at the performance standard.
    <bullet> Continue the 56-sample set under the new standard.
    <bullet> Prioritize scheduling of testing at young turkey 
establishments not meeting the new standard.
    <bullet> After 90 percent of establishments have been sampled for 
two full sets

[[Page 27293]]

(estimated by 2012), post names of establishments that do not meet the 
standard in the last set on the Agency Web site.
    <bullet> Exclude young turkey slaughter establishments from posting 
if 90 percent of establishments meet the new standard.
    Based on our estimates, 81 percent of eligible establishments would 
initially meet the new performance standard. Using our public health 
impact model, the Agency estimates that approximately half of the 
establishments that would not now meet the new standard will improve 
their performance to do so. This assumption provides an estimate of 
approximately 100 human illnesses averted after the first two years of 
implementation as a permanent structural reduction as compared to 
before implementation. This result would be a reduction of 
approximately five percent from the current 1,700 illnesses attributed 
to this cause, as discussed in the potential public health impacts 
paper referenced above.
    The Agency plans to begin posting the names establishments that do 
not meet the new standard in 2012. The Agency believes this plan 
provides an incentive for further improvements in process control in 
the turkey industry and for consistent maintenance of good performance.

Compliance Guides

    The agency has posted on its Significant Guidance Documents Web 
page (Significant Guidance) the third edition of a compliance guide for 
poultry slaughter. The guide includes new pre-harvest recommendations 
for controlling Salmonella and recommendations for controlling 
Campylobacter in poultry. FSIS has also posted on its Significant 
Guidance Documents Web page a compliance guide on known practices for 
pre-harvest management to reduce E. coli O157:H7 contamination in 
cattle. This guide focuses on the prevention of E. coli O157:H7 through 
reduced fecal shedding and during live animal holding before slaughter.
    These two compliance guides represent current FSIS thinking, and 
FSIS encourages establishments to begin using them. The guides present 
recommendations and not regulatory requirements.

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 
document, FSIS will announce it online through the FSIS Web page 
located at http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/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, recalls, 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 and farm groups, consumer interest groups, health 
professionals, and other individuals who have asked to be included. The 
Update is available on the FSIS Web page. Through the Listserv and the 
Web page, FSIS is able to provide information to a much broader and 
more diverse audience. In addition, FSIS offers an e-mail subscription 
service that provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range 
from recalls to export information to regulations, directives and 
notices. Customers can add or delete subscriptions themselves, and have 
the option to password-protect their accounts.

    Done, at Washington, DC, on May 10, 2010.
Alfred V. Almanza,
Administrator.

Appendix

    Salmonella has been a major concern for the Agency for many 
years. In 1996 FSIS published the final rule ``Pathogen Reduction; 
Hazard Analysis and Critical Control Point (PR/HACCP) Systems'' (61 
FR 38806; Jul. 25, 1996), which established, among other measures, 
pathogen reduction performance standards for Salmonella bacteria for 
certain slaughter establishments and for establishments producing 
certain raw ground products (9 CFR 310.25(b)(1)and 381.94(b)(1)). 
Salmonella was selected as the target organism because it was at 
that time the most common cause of foodborne illness known to be 
associated with meat and poultry products. It is present to varying 
degrees in all major species, and interventions targeted at reducing 
it may be beneficial in reducing contamination by other enteric 
pathogens.
    The pathogen reduction performance standards established for 
Salmonella in the PR/HACCP Final Rule covered raw product classes 
including carcasses of cows/bulls, steers/heifers, market hogs, 
broilers (young chickens), and ground beef, ground chicken, and 
ground turkey. The Agency later developed a performance standard for 
turkeys based on a 1997 baseline survey (2005 Turkey Performance 
Standard). In the PR/HACCP final rule, FSIS required that the 
prevalence of Salmonella contamination in each of the major species 
and in raw ground products be reduced by each establishment to a 
level below the current national baseline prevalence.
    These Salmonella performance standards reflected the estimated 
prevalence found by the Agency's nationwide microbiological baseline 
surveys, which were conducted before the PR/HACCP rule was adopted 
(Baseline Data). Each performance standard was a target prevalence 
for a given product class using the same sample portion and 
collection and analytical procedures that were used in the baseline, 
for example, 20 percent positive for whole young chicken carcasses 
from 400-mL rinse samples collected at post-chill.
    The PR/HACCP rule also established a Salmonella Verification 
Program, in which FSIS inspection personnel assess industry 
performance by collecting product samples from individual 
establishments over the course of a defined number of sequential 
days of production to complete a sample set, with product samples 
being sent to FSIS laboratories for analysis. Establishments were 
made subject to sampling if they produced sufficient product 
annually to complete a sample set, which for young chicken slaughter 
establishments means approximately 20,000 birds slaughtered per 
year. The PR/HACCP rule further specified the maximum number of 
Salmonella-positive samples acceptable per sample set consisting of 
a specified number of samples.
    The Agency selected the maximum number of positive samples 
acceptable per set so as to meet two objectives. The Agency 
determined a number that would provide a reasonable probability of 
passing the set for an establishment that in actuality is operating 
precisely at the performance standard. The Agency also wanted the 
number chosen to provide a relatively high probability of failing 
the set for an establishment that in actuality is operating 
precisely at the performance standard. This relatively high 
probability of failing the set was intended to encourage 
establishments to minimize the chance of failure by aiming at 
tighter process control and lower numbers of positives.
    The Agency chose an ``80 percent rule''--i.e., an establishment 
actually operating at the performance standard has an approximately 
80 percent chance of passing the set and therefore an approximately 
20 percent chance of failing. For young chickens, the baseline 
prevalence was estimated to be 20.0 percent of carcasses positive 
for Salmonella, and using the ``80 percent rule'' resulted in a 
requirement that there be no more than 12 positive samples out of a 
51-sample set. For turkeys, the baseline prevalence was estimated to 
be about 19.6 percent of carcasses positive for Salmonella, and 
using the ``80 percent rule'' resulted in a requirement that there 
be no more than 13 positive samples out of a 56-sample set. This 
same approach is used for the new performance standards announced in 
this notice.
    In the 1996 PR/HACCP rule, FSIS indicated that the pathogen 
reduction

[[Page 27294]]

performance standards would be changed as new data became available, 
and that the Agency would periodically repeat its baseline surveys 
to obtain updated data. FSIS intends to use the new Salmonella 
performance standard for young chickens that it is announcing in 
this Notice in the place of the performance standard codified at 9 
CFR 381.94.
    In that regulation, FSIS stated that an establishment that 
failed to meet the standard in three consecutive sample sets would 
be considered to have failed to maintain sanitary conditions and to 
maintain an adequate HACCP plan. The Agency said the failure would 
cause it to suspend inspection at the establishment. In December 
2001, the U.S. Court of Appeals for the Fifth Circuit (Supreme Beef 
Processors, Inc. v. USDA, 275 F.3d 432) affirmed a ruling by the 
U.S. District Court for the Northern District of Texas (Supreme Beef 
Processors, Inc. v. USDA, 113 F. Supp. 2d 1048) that USDA did not 
have the authority to suspend inspection at an establishment solely 
on the basis of Salmonella test results for the raw meat product 
produced at the establishment. FSIS had suspended inspection at 
Supreme Beef Processors, Inc., for failing the standard in three 
consecutive Agency sample sets. The District Court held that 21 
U.S.C. 604(m)(4) focused on a processor's plant and not on the 
condition of its meat. The Court further held that the presence of 
Salmonella in the finished product did not render the product 
``injurious to health'' within the meaning of Sec.  601(m)(4). The 
Appellate Court agreed, and further held that 21 U.S.C. 601(m)(4), 
and hence the Salmonella performance standards, cannot be used to 
regulate the characteristics of incoming raw materials used in the 
raw ground beef.
    Since the Supreme Beef case, FSIS has used results from its 
verification testing program as a measure of establishment process 
control for reducing exposure of the public to pathogens. FSIS 
expects establishments to control their processes to ensure that 
public exposure to pathogens is minimized. The Agency has found that 
using pathogen reduction performance standards in this way is 
effective in encouraging improved establishment control of 
pathogens.
    After our review and evaluation of the testing results for 
several years, in which the frequency with which Salmonella was 
found in testing at young chicken establishments rose, FSIS 
published a Federal Register Notice on February 27, 2006 (71 FR 
9772-9777; Docket 04-026N). This notice, among other things, 
announced a new Agency policy for reporting the results from the 
Agency's Salmonella testing program and established three 
performance categories for establishments. Performance Category 1 
was set at an upper limit of no more than half the standard. 
Category 2 was set at more than half but not exceeding the standard. 
Category 3 was for establishments exceeding the standard. Thus, for 
young chickens, Category 1 performance for a set was defined as no 
more than six positive samples out of a 51-sample set, Category 2 as 
more than six but no more than 12 positives, and Category 3 as more 
than 12 positives in a set. For turkeys, Category 1 was defined as 
no more than six positive samples out of a 56-sample set, Category 2 
as more than six but no more than 13 positives, and Category 3 as 
more than 13 positives in a set.
    In the 2006 Federal Register Notice, FSIS stated that it 
intended to track establishment performance with respect to the 
different product classes sampled for Salmonella over the next year 
and, after that time, publish the names of establishments in 
Categories 2 and 3 for any product class that did not have 90 
percent of its establishments in Category 1. After the 2006 Federal 
Register notice, the Agency added a second feature to its Salmonella 
testing and reporting program. In addition to having 90 percent of 
eligible establishments in Category 1, in order to be exempt from 
having any of its establishments published, a product class must not 
have any establishment in Category 3.
    In 2008, FSIS published a notice in the Federal Register (73 FR 
4767-4774; Jan. 28, 2008) explaining certain policy decisions 
relating to the Salmonella program and announcing that the Agency 
would begin publishing monthly results of completed FSIS 
verification sets for establishments in Categories 2 and 3, 
beginning with young chicken slaughter establishments. In that 
notice, the Agency clarified that Category 1 status requires two 
successive sets at no more than half the standard, but that 
Categories 2 and 3 are determined by the most recent set. Since 
publishing that notice, the Agency has created a Category 2T for 
establishments whose most recent set was at Category 1 level but 
whose prior set was above half the standard. Such establishments are 
counted in aggregate statistics but are not published individually. 
Publication of Category 2 and 3 young chicken establishments began 
in March 2008, and FSIS continues to publish the names of these 
establishments on or about the 15th of each month. The production 
class of whole young turkey carcasses has had more than 90 percent 
of establishments in Category 1 and no establishments in Category 3 
and thus has not had Category 2 establishments published. The Agency 
believes that publishing Category 2 and 3 establishments has 
provided an effective incentive for improving performance.

[FR Doc. 2010-11545 Filed 5-13-10; 8:45 am]
BILLING CODE 3410-DM-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>