[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Pages 41186-41192]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2011-17625]
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Notices
Federal Register
________________________________________________________________________
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.
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Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 /
Notices
[[Page 41186]]
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)
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice; response to comments; reopening of comment period.
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SUMMARY: 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.
DATES: 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 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 daniel.engeljohn@fsis.usda.gov.
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, 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
[[Page 41187]]
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 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 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
[[Page 41188]]
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.
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 re-opening 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 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 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 SIP.Mailbox@fsis.usda.gov. 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
[[Page 41189]]
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.
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
isabel.arrington@fsis.usda.gov 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 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 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.
[[Page 41190]]
Response to Comments on Publication of Salmonella Sample Set Results as
Described in the Federal Register Notice of January 28, 2008
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. 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 long-term 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 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
[[Page 41191]]
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 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.
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 FSIS-regulated 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
[[Page 41192]]
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 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 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