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Docket No. FSIS-2008-0008

[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]


========================================================================
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.

========================================================================


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.

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

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:
    <bullet> The comment period for SIP issues has been extended to 
September 12, 2011.
    <bullet> SIP is open to all establishments.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> A SIP establishment will not be suspended or lose its 
waiver solely because of its Salmonella testing results.
    <bullet> 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.
    <bullet> FSIS is also considering reducing the required frequency 
of testing for small and very small establishments that participate in 
SIP.
    <bullet> The Agency intends to conduct its own unannounced, small-
set sampling to verify the consistent performance of all 
establishments, including those participating in SIP.
    <bullet> 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


    
Last Modified Oct 31, 2013