Salmonella Verification Sampling Program

41186

Notices

Federal Register
Vol. 76, No. 134
Wednesday, July 13, 2011

This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2008–0008]

Salmonella Verification Sampling
Program: Response to Comments on
New Agency Policies and Clarification
of Timeline for the Salmonella Initiative
Program (SIP)
Food Safety and Inspection
Service, USDA.
ACTION: Notice; response to comments;
reopening of comment period.
AGENCY:

The Food Safety and
Inspection Service (FSIS) is responding
to comments on a January 28, 2008
Federal Register notice (73 FR 4767–
4774), which described upcoming
policy changes in the FSIS Salmonella
Verification Program and outlined a
new voluntary Salmonella Initiative
Program (SIP) for meat and poultry
slaughter establishments that agree to
share internal food safety data with FSIS
in order to receive waivers of regulatory
requirements. SIP benefits public health
in that it encourages slaughter
establishments to test for microbial
pathogens and to respond to the ongoing
results by taking steps when necessary
to regain process control and thus to
minimize the presence of pathogens of
public health concern. In addition, SIP
enables FSIS to use establishment data
to enhance public health protection. In
this notice, the Agency is announcing
several policy developments and
changes regarding SIP. This notice also
includes Agency responses to comments
on SIP and on other issues discussed in
the January 2008 Federal Register
notice.

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SUMMARY:

Comments are due by September
12, 2011. Policies regarding waivers for
On-Line Reprocessing (OLR), the
HAACP-based Inspection Models
Project (HIMP), or any other slaughter

DATES:

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process will be implemented by
November 10, 2011.
ADDRESSES: FSIS invites interested
persons to submit comments on the
January 2008 notice referenced in this
document with regard to SIP. 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 Regulations.Gov at http://
www.regulations.gov/ and 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–
2006–0034. 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, PhD, 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; e-mail
[email protected].
SUPPLEMENTARY INFORMATION:

Background
Details of SIP 2011
SIP, as described in the January 2008
Federal Register notice, offers
incentives to meat and poultry slaughter
establishments to control Salmonella in
their operations. SIP does this by
granting waivers of regulatory
requirements with the condition that
establishments test for Salmonella,

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Campylobacter (if applicable), and
generic E. coli or other indicator
organisms and share all sample results
with FSIS. SIP benefits public health
because it encourages establishments to
test for microbial pathogens, which is a
key feature of effective process control.
Also, under SIP establishments will
share their data with FSIS to inform
Agency policy on pathogens.
Furthermore, if the establishment’s
results show it is not meeting the
Agency’s current performance standards
for turkeys or young chickens, it is to
increase testing, determine whether its
waiver is affecting its public health
protection performance, and take steps
to regain process control in order to
minimize the presence of pathogens of
public health concern. Establishments
currently operating under regulatory
waivers will have to participate in SIP
or drop their waivers. Establishments
operating under waivers through HIMP
will continue to operate as HIMP
establishments but will have to conduct
new testing under SIP. The primary
policy decisions regarding SIP
discussed in this notice, including
recent developments and changes,
include:
• The comment period for SIP issues
has been extended to September 12,
2011.
• SIP is open to all establishments.
• Establishments that have received
waivers under SIP terms and conditions
are to begin submitting microbial testing
data to FSIS within 60 days of
publication of this notice.
• Establishments currently operating
under waivers for OLR, HIMP, or any
other slaughter process will have 120
days from publication of this notice to
participate in SIP or else drop their
waivers and return to conventional
inspection.
• SIP establishments must agree to
conditions prescribed in the January
2008 Federal Register notice, except
that enumeration of weekly postchill
samples will not be required.
• SIP establishments are not routinely
required to provide FSIS with isolates,
but, if requested, establishments must
work with FSIS on a mutually agreeable
means for doing so.
• The Agency is selecting no more
than five establishments that applied in
2008 to receive waivers of regulations
restricting line speeds. If necessary,
FSIS will re-open the application

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process until five establishments have
been selected.
• A SIP establishment will not be
suspended or lose its waiver solely
because of its Salmonella testing results.
• FSIS is considering reducing the
required frequency of testing for SIP
establishments that meet the Salmonella
performance standard for at least six
months and can maintain that level of
process control with reduced testing
frequency.
• FSIS is also considering reducing
the required frequency of testing for
small and very small establishments
that participate in SIP.
• The Agency intends to conduct its
own unannounced, small-set sampling
to verify the consistent performance of
all establishments, including those
participating in SIP.
• FSIS will begin evaluating whether
establishments operating under SIP
waivers are meeting the new Salmonella
and Campylobacter performance
standards with sample sets beginning in
and after July 2011 as announced in a
Federal Register notice of March 21,
2011 (76 FR 15282).
Events Leading Up to SIP
FSIS is the public health regulatory
agency in the U.S. Department of
Agriculture (USDA) responsible for
ensuring that the nation’s commercial
supply of meat, poultry, and processed
egg products is safe, wholesome, and
correctly labeled and packaged. FSIS
establishes performance standards for
Salmonella on carcasses and raw
products that enter commerce and
evaluates whether establishments are
meeting the standards.
After an intensive review of the
results of several years of this testing,
FSIS published a Federal Register
notice on February 27, 2006 (71 FR
9772–9777; Docket 04–026N) in which
the Agency set forth three establishment
performance categories for Salmonella
based on current standards. The new
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 included
establishments exceeding the standard.
In the 2006 Federal Register notice,
FSIS stated that it intended to track the
performance of the different product
classes it samples 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.
On January 28, 2008, FSIS published
a notice in the Federal Register (73 FR
4767–4774; Docket FSIS–2006–0034) in

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which it announced 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, which have been a
primary concern for FSIS. Publication of
Categories 2 and 3 young chicken
slaughter establishments began on
March 28, 2008. FSIS has continued to
publish the names of these
establishments on or about the 15th of
each month since then. FSIS believes
that doing so has provided a strong
incentive for improved industry
performance. After FSIS announced
performance categories in 2006, 55–60
percent of non-compliant
establishments moved to become
compliant within two years (see 75 FR
27288–27294). FSIS is also considering
publishing verification sampling results
for other product classes.
In the 2006 Federal Register notice,
the Agency stated that it intended to
update the year long Nationwide
Microbiological Baseline Data
Collection Programs to better measure
improvements in pathogen reduction in
all classes of raw product. Both young
chicken and young turkey
microbiological baselines were
completed in 2008 and 2009,
respectively, and from them, FSIS
developed updated performance
standards for Salmonella and new
performance standards for
Campylobacter.
On May 14, 2010, FSIS published a
Federal Register notice (75 FR 27288) in
which it announced the forthcoming
implementation of the new performance
standards for the pathogenic
microorganisms Salmonella and
Campylobacter for chilled carcasses in
young chicken (broiler) and turkey
slaughter establishments. The new
performance standards were developed
in response to a charge from the
President’s Food Safety Working Group
and, as stated above, the standards were
based on recent FSIS Nationwide
Microbiological Baseline Data
Collection Programs. The standards are
applied to sample sets collected and
analyzed by the Agency to evaluate
establishment performance with respect
to requirements of the Pathogen
Reduction/Hazard Analysis and Critical
Control Points (PR/HACCP) Final Rule.
The Agency received detailed comments
in response to the notice and published
a follow-up notice on March 21, 2011
(76 FR 15282) responding to the
comments. FSIS will begin evaluating
whether establishments operating under
SIP waivers are meeting the new
Salmonella and Campylobacter

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performance standards with sample sets
beginning in and after July 2011.
FSIS plans to begin focusing next on
the Salmonella controls in market hog
slaughter operations. In July 2011 the
standards for Salmonella positives in
young chicken and turkey will become
7.5 and 1.7 percent, respectively. Thus,
as of July 2011 establishments
slaughtering market hog carcasses will
have the highest remaining permissible
standard (8.7 percent) for Salmonella of
all raw carcass product classes.
Significantly, outbreaks resulting in
human illness involving pork have been
consistently identified on an annual
basis, suggesting pork as a vehicle for
salmonellosis. Between 2000 and 2007,
about four outbreaks and 82 illnesses
per year on average have been
associated with pork. A simple yearly
comparison suggests a decline from
2000 to 2002 (five, seven, and three
outbreaks, respectively), followed by a
period of stability from 2003–2006
(three, four, three, and three outbreaks,
respectively) and an increase in 2007
(seven outbreaks and 236 illnesses).
(Reference: http://wwwn.cdc.gov/
foodborneoutbreaks/.)
The FSIS Nationwide Market Hog
Microbiological Baseline Data
Collection Program, which includes
collecting carcass sponge samples at
pre-evisceration and post-chill, is
underway, and sample collection is
expected to be completed in 2011. New
performance standards for Salmonella
will be developed based on the results
from the year-long baseline survey.
FSIS has not provided any
compliance guideline information for
market hog slaughter operations. The
Agency expects to remedy this situation
by issuing guidelines within the next
120 days and to confer with the pork
industry on Salmonella controls.
In the January 2008 Federal Register
notice, FSIS also announced that it
would increase the Agency’s use of
targeted sampling and collaborative
microbial serotype and subtype data. In
addition, FSIS announced that it would
exclude from the Salmonella
verification testing program schedule
any slaughter establishment that
processes all carcasses slaughtered into
ready-to-eat (RTE) product or that sends
all of its raw products to another official
federally inspected establishment for
further processing into an RTE product.
The notice also announced that
establishments producing a low volume
of raw ground beef would be removed
from the scheduling frame for PR/
HACCP verification sample sets. These
establishments would be sampled for
Salmonella at the same time they are
sampled for E. coli O157:H7. FSIS is

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now considering removing
establishments slaughtering heifer and
steers, regardless of size, from the
scheduling frame for PR/HACCP
verification sample sets and increasing
sampling of raw ground beef and beef
trim.
FSIS received no significant
comments on these changes and
therefore began implementing them
immediately after the comment period
ended. FSIS does not schedule an
establishment for Salmonella
verification testing if all product is
processed for RTE. Such product is
excluded from sampling regardless of
whether it is processed as RTE in the
slaughter establishment or diverted
under establishment or FSIS control to
another federally inspected
establishment. A slaughter
establishment producing RTE product
subject to this exclusion and non-RTE
carcasses is sampled for the non-RTE
product classes only.
Similarly, FSIS removed
establishments producing a low volume
of raw ground beef (less than 1,000
pounds per day and fewer than 150 days
per year) from the PR/HACCP
verification sample set scheduling frame
because these establishments will be
sampled for Salmonella at the same
time and manner in which they are
sampled for E. coli O157:H7.

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Response to Comments on SIP, SIP
Policy Developments, and Comment
Period Extension
In response to requests for additional
time to comment on SIP, FSIS is reopening the comment period for SIP
issues for 60 days (see DATES) and
setting a new timeline for
establishments with existing OLR,
HIMP, or any other slaughter process
waivers to participate in SIP (see
Implementation Timelines below). After
the re-opened comment period ends, the
Agency will evaluate all comments
received on SIP and publish its response
to those comments in a notice in the
Federal Register.
Conditions for Participating in SIP
The Agency reconsidered the
potential scope of SIP and decided not
to limit the program to establishments
that are meeting the current Salmonella
standard for young chickens or turkeys
as measured by FSIS. Additionally,
establishments slaughtering classes of
poultry other than young chickens and
turkeys may participate in SIP. FSIS
will allow those establishments to
collect Salmonella data to determine an
establishment-specific baseline of
microbiological contamination that the
establishment will use to demonstrate

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continuous process control in place of
using the young chicken or turkey
Salmonella performance standard.
FSIS decided not to suspend an
establishment from the program or
revoke its waiver solely because of its
Salmonella testing results. The
Salmonella status of an establishment is
determined by FSIS sampling results.
However, when applying for SIP an
establishment agrees to take certain
actions, which are described below, if
its testing results show it is not meeting
the current Salmonella standard for
turkeys or for young chickens.
All establishments that apply to
participate in the program must agree to
certain conditions. An establishment
selected for SIP is required to take
samples for microbial analysis on each
line every day and during each shift.
The sample set of reference for
Salmonella is the same size as that used
by FSIS for verification testing of the
specific product class, but, unlike
current FSIS practice, the establishment
may take multiple samples on one day.
Each week, poultry slaughter
establishments selected for SIP collect at
least one sample at both rehang and
postchill. Establishments collect the
postchill sample at the approximate
time the carcass sampled at rehang
would move to postchill, so as to reflect
the time it takes for a carcass to pass
from rehang to postchill. Establishments
are to analyze all samples for
Salmonella, Campylobacter (if
applicable), and generic E. coli or other
indicator organisms but are not required
to enumerate these samples.
In the event of an establishment
exceeding the Salmonella standard in
its own testing, the establishment must
investigate whether the waiver
conditions in the establishment’s
process contributed to, or caused, the
lack of process control. The
establishment must document its
findings and the corrective and
preventive actions taken to return to the
current Salmonella standard of process
control. The establishment must
increase the frequency of its sampling
for Salmonella until the current
standard of process control is regained
as shown by two consecutive sample
sets with results meeting the current
standard. FSIS inspection personnel
will verify that a SIP establishment
takes these actions when appropriate.
FSIS is considering the possibility of
reducing the required frequency of
testing of samples for SIP
establishments that maintain the current
standard for at least six months and can
maintain that level of process control
with reduced testing frequency. The
Agency intends, however, to conduct its

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own unannounced, small-set sampling
to verify the consistent performance of
all establishments, including those
participating in SIP. FSIS is also
considering reducing the frequency with
which small and very small
establishments that participate in SIP
will need to sample.
SIP establishments are not routinely
required to provide FSIS with isolates,
but, if requested, establishments must
work with FSIS on a mutually agreeable
means for doing so.
Every establishment that wishes to
participate in the SIP must agree to
share its food safety data with FSIS and
make the data available for copying or
electronic transfer to the Agency.
Establishments may obtain instructions
on how to share microbial data results
with FSIS via an electronic data sharing
template by e-mailing the SIP Mailbox
at [email protected]. FSIS
understands that many meat and
poultry establishments have viewed
such data as confidential commercial
information. Pursuant to USDA’s
Freedom of Information Act (FOIA)
regulations (7 CFR 1.1 et seq.), FSIS is
responsible for making the
determination with regard to the
disclosure or nondisclosure of
information in agency records that has
been submitted by a business. When, in
the course of responding to an FOIA
request, an agency cannot readily
determine whether the information
obtained from a person is confidential
business information, the Agency will
seek to obtain and carefully consider the
views of the submitter of the
information and provide the submitter
an opportunity to object to any decision
to disclose the information. FSIS will
protect establishments’ confidential
business information from public
disclosure to the extent authorized
under FOIA and in conformity with
USDA’s FOIA regulations.
FSIS will, however, combine data
submitted by individual establishments
in SIP and publish the aggregated
results on a quarterly basis. The data
from establishments participating in SIP
will play an important role in improving
public health protection by providing
many additional sample results for
Agency evaluation in developing public
health policies related to decreasing
foodborne illness. On a quarterly basis,
FSIS will analyze the aggregated
microbial data from SIP establishments
to evaluate the overall effects of the
waivers. In developing these quarterly
evaluations, the data analysts may
consider observed patterns of the
aggregated SIP establishment microbial
data, together with an assessment of
potential associations between the

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microbial testing results and various SIP
establishment factors (e.g., location and
type of antimicrobial interventions and
selected information related to
processing procedures, etc.) recorded on
the electronic data sharing template.

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Waivers of Regulatory Requirements
Under SIP
In return for meeting the conditions of
SIP, the Agency grants establishments
appropriate waivers of certain
regulatory requirements, based upon
establishment proposals and
documentation, under FSIS regulations
at 9 CFR 303.1(h) and 381.3(b). These
regulations specifically provide for the
Administrator to waive for limited
periods any provisions of the
regulations to permit experimentation
so that new procedures, equipment, or
processing techniques may be tested to
facilitate definite improvements.
SIP establishments do not need to
repeat in-plant protocols or submit
microbial monitoring test results to
FSIS. Establishments requesting
participation in SIP need simply to
agree to the conditions of SIP regarding
pathogen testing and sharing of test
result data with FSIS as described
above.
SIP applications and requests for
waivers should be sent to
[email protected] and
should follow the guidance procedures
for waivers and notifications and
protocols posted on the FSIS Web site
at http://www.fsis.usda.gov/OPPDE/op/
technology/New_Technology_
Waiver.pdf and http://www.fsis.usda.
gov/OPPDE/op/technology/
guidance.pdf.
Waivers of Line Speed Restrictions
Under SIP
The January 2008 Federal Register
notice also stated that FSIS would select
‘‘no more than five establishments in
which any waiver of regulatory
requirements may affect inspection
whereby additional inspectors are
needed.’’ Additional inspectors would
be necessary for establishments that
receive waivers of regulatory restrictions
on line speed, which has been a subject
of interest for industry. Establishments
desiring additional FSIS inspection
personnel under SIP were asked to show
that they had (1) For all Salmonella
sample sets collected by FSIS since
February 2006, a positive rate of half the
rate required to be in Category 1 (e.g.,
5 percent for young chickens), as well
as for establishment-collected sample
sets completed within the past quarter,
and that they had (2) identified
Salmonella as a hazard reasonably
likely to occur in their HACCP plans or

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had written controls in place to address
Salmonella within the Sanitation
Standard Operating Procedures or other
HACCP prerequisite programs.
Qualifying establishments were asked to
request these waivers within 15 days of
publication of the January 2008 Federal
Register notice. The Agency is selecting
no more than five establishments from
the requests it received after the 2008
notice. Due to the time that has elapsed,
FSIS is evaluating the requests of
establishments that had previously
volunteered under the prior criteria on
completeness of application, as well as
on other considerations such as
geographic location, number of FSIS
inspectors needed, prior participation in
SIP for other regulatory waivers, and
FSIS data needs for ongoing policy
development. If additional plants are
needed to fill the five slots, FSIS will
ask for additional volunteers.
FSIS also recognizes that evaluation
of the effects of line speed on food
safety should include the effects of line
speed on establishment employee
safety. To obtain preliminary data on
this matter, FSIS has asked the National
Institute for Occupational Safety and
Health (NIOSH) to evaluate the effects of
increased line speed as part of the SIP
waiver program. NIOSH has stated its
willingness to evaluate the effects of
increased production volume on
employee health, with a focus on
musculoskeletal disorders and acute
traumatic injuries. NIOSH’s activities
may ultimately include observation of
work processes and practices; collection
of company payroll, personnel, and
injury and illness records; interviews
with plant managers, supervisors, and
employees; health surveys of
employees; and videotaping and
measurement of specific aspects of job
tasks. NIOSH will prepare a report
based on its findings of short-,
intermediate-, and long-term effects
from the process modifications. NIOSH
will make recommendations as needed.
FSIS will use any available data from
NIOSH activities to inform its decisions
as it moves forward with planned
regulatory reform. FSIS will require that
establishments granted waivers for
regulatory line speeds under SIP
cooperate with NIOSH.
Implementation Timelines
The Agency stated in its May 16, 2008
Constituent Update that it would
implement SIP as soon as possible for
establishments that do not have an
existing waiver. As stated in the January
2008 Federal Register notice, FSIS
strives to respond to requests for
waivers within 60 days. The Agency
gives priority to those establishments

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that are already meeting the most recent
young chicken or turkey standard. FSIS
will contact establishments that have
already submitted requests to
participate in SIP but have not met the
conditions for a waiver.
Because FSIS is re-opening the
comment period for SIP, FSIS is
updating the timeline announced in the
January 2008 Federal Register notice for
establishments that are operating under
waived regulations for HIMP, OLR, or
any other slaughter process.
Under the previous timeline, FSIS
stated that an establishment that
chooses to terminate its HIMP waiver or
has an HIMP waiver terminated at six
months after publication of the January
2008 Federal Register notice could
apply for a waiver under SIP after a
waiting period of nine months after
termination of the old waiver (73 FR
4772). This new timeline will also apply
to establishments operating under
waivers that affect the slaughter process.
Under this new timeline, all of these
establishments will have 120 days from
publication of this notice to decide
whether they will continue to operate
under the waiver by complying with the
provisions of SIP or else operate without
a waiver. Any establishment that
chooses not to participate in SIP and
thereby drop its waiver should give
FSIS written notice of when and how it
will return to operating without a
waiver in order for the Agency to plan
to restructure inspection responsibilities
at that establishment. If the
establishment does not provide such
written notice, FSIS will notify the
establishment of the steps necessary to
return the establishment to operating
without a waiver.
During that 120-day period,
establishments desiring to continue
these waivers under SIP will need to
apply for SIP and agree to comply with
its provisions. FSIS encourages these
establishments to begin submitting
applications to participate in SIP as
soon as possible. After the 120-day
period following this Federal Register
notice, HIMP, OLR, or any other
slaughter process waivers will only be
continued if the establishment has
agreed to participate in SIP.
Establishments that have applied for
and received other waivers under SIP
terms and conditions and have been
operating with SIP procedures are to
begin formally submitting their
microbial testing data to FSIS within 60
days of this notice.

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Response to Comments on Publication
of Salmonella Sample Set Results as
Described in the Federal Register
Notice of January 28, 2008

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Time for Comments
Several comments stated that the
comment period of 30 days provided in
the notice was too brief to allow for
proper consideration of the issues
described there.
Response: As stated above, the
Agency is re-opening the comment
period for certain issues involved with
SIP that have not yet been resolved.
FSIS notes, however, that publication
of Salmonella verification sample set
results by establishment was first
presented publicly in the Federal
Register notice of February 27, 2006,
and was extensively discussed in the
notice of January 28, 2008. The Agency
also discussed publication of
establishment Salmonella results at a
public meeting on August 7, 2007
(http://www.fsis.usda.gov/OPPDE/rdad/
FRPubs/2007–0026.htm), and presented
detailed plans for publication in its
Constituent Update of August 31, 2007
(http://www.fsis.usda.gov/News_&_
Events/Const_Update_083107/
index.asp). Given this history, FSIS
believes that the notice’s 30-day period
for comments on publication of
establishment Salmonella results was
appropriate.
Categories
Some comments asserted that the
performance Categories 1, 2, and 3 used
to determine posting are arbitrary and
not founded in public health science.
Several comments stressed that an
establishment with only one current
completed sample set that is at or below
half of the performance standard should
not be in Category 2 simply because it
lacks two completed sample sets at the
level required for Category 1. Several
comments argued that requiring two
successive sets at or below half the
performance standard for Category 1 is
inconsistent with determining Category
2 or 3 status by a single set, the most
recent one.
One comment from a public interest
group saw no need to publish results
from Category 1 establishments,
although a comment from another
public interest group stated that results
from Category 1 establishments should
be published as well as results from
establishments in Categories 2 and 3. A
similar point was made in another
comment arguing that if establishment
data are to be published at all, results
should be reported for all categories.
Two other comments stated that only
Category 3 results should be published.

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One comment asserted that no results
should be published.
Response: The Agency stated in its
February 2006 Federal Register notice
that, as would be expected,
establishments performing very well
overall do so consistently and
predictably. Establishments that
perform less well overall are much less
consistent and thus pose a greater
concern for public health protection.
Given these observed tendencies, the
Agency believes that encouraging
establishments to perform consistently
at or below half the standard is a
meaningful and practical approach to
improving public health protection.
Such encouragement is especially
pertinent when a product class has
shown a relatively high prevalence of
Salmonella. In such a case,
establishments aiming at a prevalence
rate lower than the standard will tend
to improve the performance of the
overall product class. As stated above,
this 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 presented information in the
February 2006 notice indicating that the
selection of the Category 1 and Category
2 criteria was based, in part, on longterm Agency experience showing a
statistically significant difference in the
likelihood that serotypes of Salmonella
that are common causes of human
illness are present in sample sets from
Category 2 establishments versus those
in Category 1. At that time, these
differences were particularly evident for
the young chicken class.
For any classes of raw products, a
reduction of Salmonella by half or more
based on the current performance
standard would have practical
implications for continuous
improvement in the control of this
enteric pathogen. When a new standard
is established through a new baseline
study and is published, FSIS expects to
re-set the Category designations, again
differentiating Category 1 from Category
2 by using the practical application of
the ‘‘at or below half the standard’’
criterion.
The Agency agrees with the comment
that an establishment with its last
verification sample set at or below half
the standard, but with the prior set
above half but not exceeding the
standard, should not simply be posted
as a Category 2. The Agency has been
categorizing these cases as ‘‘2T’’ with
‘‘T’’ standing for Transitional to
Category 1. Similarly, an establishment
with its last verification sample set at or

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below half the standard, but with the
prior set exceeding the standard, is also
categorized as ‘‘2T.’’ This approach
recognized that two sets needed to be at
or below half the standard for Category
1, while still recognizing progress by
transitional establishments. Beginning
with the Quarterly Progress Report for
April–June 2008, the aggregate
Quarterly Progress Reports have
presented such ‘‘2T’’ establishments
separately from Category 2
establishments.
Also beginning with the second
quarter 2008 Progress Report, FSIS
ceased counting in aggregate totals any
establishment with only one completed
set. Since 2006 the aggregate Quarterly
Progress Reports had reflected all results
and included in either Category 2 or
Category 3 any establishment that had
not attained a Category 1 classification
by having its two most recent FSIS sets
at or under half the standard. Thus, the
quarterly aggregate reports included
establishments that had completed only
one set and had not exceeded the
standard in that set in Category 2, and
included establishments that had
completed only one set but did exceed
the standard in that set in Category 3. To
clarify these matters, the Agency
determined that it would neither post an
establishment with only one completed
FSIS sample set (e.g., new
establishments) nor count that
establishment in the aggregate Category
2 or 3 totals. With the new Salmonella
and Campylobacter performance
standards going into effect in July 2011
(76 FR 15282), FSIS will transfer
existing data for establishments with
two sample sets completed for
calculation of categories.
Statistical Standards
Some comments asserted that the
number of positive samples acceptable
per Salmonella sample set is too
stringent in that an establishment
operating either at the standard, or for
Category 1 at or below half the standard,
has an approximately 25 percent chance
of exceeding the target level with any
given sample set. These comments
urged that the number of samples
acceptable be increased to provide a
lower chance of exceeding the target
level when an establishment is
operating over some period at the target
level. Another comment conversely
asserted that with product classes that
have standards with odd numbers of
acceptable positives, the Agency should
round down to determine the ‘‘at or
below half’’ criterion for inclusion in
Category 1. For instance, the maximum
number of positives acceptable out of 56
samples for the turkey carcass class has

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been 13, and the Category 1 criterion
was rounded up by the Agency to accept
seven or fewer positive results rather
than six or fewer positives.
Response: A prudent establishment
should strive to operate with more
effective process control over time at a
relatively lower level of positive
samples if it is to preclude exceeding its
target level. This is the case because
FSIS standards have been traditionally
set with a certain probability of failure
for an establishment operating in fact
precisely at the standard. For this
reason, an establishment wishing to
avoid any failures should aim its
process control efforts at achieving a
performance below the standard. The
Agency views this relative stringency as
a necessary and important incentive to
improving performance in controlling
Salmonella.
In addition, FSIS is clarifying that its
intent was not to round up the number
of acceptable positives. When this
practice of rounding up was called to its
attention, FSIS changed its practice to
rounding down. Thus, FSIS now rounds
down for standards with an odd number
of acceptable positives. For example, the
acceptable number of Salmonella
positives for turkey carcasses had been
set at six rather than seven positives out
of 56 samples. The Agency rounds
down in determining the standard for
any product class with a standard that
accepts an odd number of positive
samples.
Time Lag for Establishment Category
Change
Several comments argued that
publishing the names of establishments
in Categories 2 and 3 each month is
unfair and unrepresentative, in that
FSIS sample set results may be months
old before they are superseded by
another set, and that the establishment
has no way to demonstrate significant
improvement in the meantime. Some
comments stated that the Agency should
use establishment data to evaluate an
establishment’s significant improvement
and thus recognize movement to a
higher degree of control sooner than
would be possible with use of FSIS data
alone for this determination. These
comments noted that something like
this approach is envisioned with SIP.
One comment stated that an
establishment’s published category
standing should be updated
immediately upon movement between
categories rather than monthly.
Response: Monthly updates are
sufficiently frequent to provide current
information concerning the Salmonella
category status of establishments. The
Agency schedules verification sample

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sets for Category 3 establishments first,
followed by Category 2, and then
Category 1. Furthermore, the Agency
intends to use unannounced, small-set
sampling to verify the consistent
performance of all Category 1
establishments. In this way,
improvement in performance that
would lead to movement from Category
3 to 2 or from Category 2 to 1 is
registered as soon as possible. FSIS
notes that an establishment’s consistent
performance at half the standard or
lower would preclude any concern on
this score.
Any movement of an establishment
from Category 2 or 3 into Category 1
must be based upon FSIS testing. The
verification program is based on Agency
Salmonella testing, and at this time,
FSIS can see no reason to modify that
design. Moreover, as stated above, FSIS
tests frequently enough, particularly for
Category 3 establishments, that there is
no need for FSIS to rely on the
establishment’s testing. Under the
Salmonella and Campylobacter
standards (76 FR 15282) to be
implemented in July 2011, FSIS will not
publish names of Category 2 poultry
establishments. To date, poultry
establishments are the only classes of
raw product that have been published.
Qualitative vs. Quantitative Data
Several comments noted that FSIS
Salmonella verification sampling data
are qualitative (presence/absence) rather
than quantitative (number of
microorganisms present), thus giving no
indication of actual concentration or
dose level.
Response: The Agency’s baseline
studies have included enumeration of
microbial populations of positive
Salmonella samples. After analyzing the
two most recent year long poultry
microbiological baselines (2008 and
2009), the Agency has noted that the
number of microorganisms present in
positive samples did not vary to any
significant degree from the positive
samples analyzed in the older surveys,
despite a significant decline in
prevalence from the older surveys.
Therefore, FSIS does not believe that
there is a compelling need to enumerate
positive Salmonella samples.
Salmonella Serotypes of Human Health
Significance
Some comments stated that simply
publishing the number of positive
samples does not convey the true
potential threat to public health because
an establishment may have multiple
samples that are positive for Salmonella
serotypes that are rarely associated with
human illness.

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Response: The Agency agrees that
identifying Salmonella serotypes of
human health significance is an
important factor in public health
protection. Consequently, FSIS includes
serotype information when notifying
establishments of sample results and in
the End-of-Set Letter detailing the
overall results of a completed FSIS set.
FSIS also publishes aggregate serotype
data in an annual report (http://
www.fsis.usda.gov/Science/Q1–
4_2008_Salmonella_Serotype_Results/
index.asp).
The serotypes most commonly found
in FSIS-regulated products have all been
associated with human illness. For
example, S. Kentucky is the most
commonly reported serotype in FSISregulated young chicken products, and
the CDC reported that in 2006 this
serotype was associated with 123
illnesses, ranking it at 33 in the top 50
serotypes associated with illnesses that
year. Research has shown that when
Salmonella contamination is present in
a product sample, multiple serotypes
are not uncommon. Our current
methodology used for sample analysis
allows FSIS to determine the presence
of any Salmonella, regardless of
serotype. One bacterial colony is tested
to determine serotype and is reported to
establishments. This single colony is not
necessarily the only serotype present,
nor is it necessarily the most common
serotype in the product. The Agency
uses the Salmonella verification
program as a measure of process control,
not an indicator of the prevalence or
diversity of different Salmonella
serotypes on FSIS-regulated products.
This measure of process control is
appropriate because current
interventions and technologies for the
reduction of Salmonella target all
serotypes; so the presence of any one
serotype indicates a possible lapse in
process control, which could allow the
outgrowth of any serotype that might be
present in the product.
Domestic and International Trade
Effects
Two comments urged the Agency to
consider the possible negative effects
posting results that would have on the
international competitiveness of the
U.S. meat and poultry industry.
Commenters worried that publication
could lead to unwarranted trade barriers
on the grounds of food safety.
Response: Industry performance has
shown that meat and poultry
establishments have adequate means to
attain Category 1 status. Improved
international trade competitiveness is
likely to result from a lower incidence
of Salmonella and the production of

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fewer products positive with serotypes
of human health concern. FSIS notes
that completed sample set results have
always been available through FOIA,
but the Agency has not seen any marked
increases in foreign FOIA requests for
such data. Given these facts, FSIS does
not believe that establishments have
significant grounds for concern because
of Web publication of completed sample
set results.
Paperwork Reduction Act
FSIS has reviewed the paperwork and
recordkeeping requirements in this
notice in accordance with the
Paperwork Reduction Act (44 U.S.C.
3501, et seq.) and has determined that
the paperwork requirements constitute a
new information collection.
Title: Salmonella Initiative Program
(SIP).
Type of Collection: New.
Abstract: Currently, nine
establishments are operating under SIP.
The information collection burden
incurred by these nine establishments is
covered under the Procedures for the
Notification of New Technology
information collection currently
approved by OMB (0583–0127).
The Agency is selecting no more than
five establishments that applied in 2008
to receive waivers of regulations
restricting line speeds. If necessary,
FSIS will re-open the application
process until five establishments have
been selected. The information
collection burdens incurred by these
establishments will also be included
under 0583–0127.
This notice opens SIP to all slaughter
establishments, and all establishments
receiving a waiver must participate in
SIP. Data collected by the additional
number of establishments coming under
the expanded SIP program will
constitute a new information collection.
SIP offers incentives to meat and
poultry slaughter establishments to
control Salmonella in their operations.
SIP does this by granting waivers of
regulatory requirements with the
condition that establishments test for
Salmonella, Campylobacter (if
applicable), and generic E. coli or other
indicator organisms and share all
sample results with FSIS. If the
establishment’s results show it is not
meeting the Agency’s current
performance standards for turkeys or
young chickens, it is to increase testing,
determine whether its waiver is
affecting its public health protection
performance, and take steps to regain
process control to minimize the
presence of pathogens of public health
concern. Establishments currently
operating under regulatory waivers will

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have to participate in SIP or drop their
waivers. Establishments operating under
waivers through the HACCP-based
Inspection Models Project (HIMP) will
continue to operate as HIMP
establishments but will have to conduct
new testing under SIP.
SIP is now open to all slaughter
establishments. Establishments that
have received waivers under SIP terms
and conditions are to begin submitting
microbial testing data to FSIS within 60
days of this notice. Establishments
currently operating under waivers for
on-line reprocessing or HIMP or any
other slaughter process will have 120
days from publication of this notice to
participate in SIP or else drop their
waivers and return to conventional
inspection.
FSIS will begin evaluating young
chicken and turkey slaughter
establishments operating with SIP
waivers under new performance
standards with sample sets beginning in
or after July 2011.
Estimate of Burden: FSIS estimates
that annually it will take approximately
686.6 hours per respondent.
Respondents: Official slaughter
establishments that are under a waiver.
Estimated number of Respondents:
300
Estimated number of Responses per
Respondent: 2,081
Estimated Total Annual Burden on
Respondents: 206,000 hours.
Copies of this information collection
assessment can be obtained from John
O’Connell, Paperwork Reduction Act
Coordinator, Food Safety and Inspection
Service, USDA, 1400 Independence
Avenue, SW., Room 6065, South
Building, Washington, DC 20250, (202)
720–0345.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of FSIS’s functions, including whether
the information will have practical
utility; (b) the accuracy of FSIS’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (c) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques, or other forms of
information technology. Comments may
be sent to both FSIS, at the addresses
provided above, and the Desk Officer for
Agriculture, Office of Information and
Regulatory Affairs, Office of

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Management and Budget, Washington,
DC 20253.
Responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
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/
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, 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, 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 July 8, 2011.
Alfred V. Almanza,
Administrator.
[FR Doc. 2011–17625 Filed 7–12–11; 8:45 am]
BILLING CODE 3410–DM–P

DEPARTMENT OF AGRICULTURE
Forest Service
Mines Management Inc. Montanore
Project, Kootenai National Forest,
Lincoln County, MT
AGENCY:

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Forest Service, USDA.

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