[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Rules and Regulations]
[Pages 72686-72691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29510]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 417

[Docket No. FSIS-2012-0007]


HACCP Plan Reassessment for Not-Ready-To-Eat Comminuted Poultry 
Products and Related Agency Verification Procedures

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations and request for 
comments

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this notice to inform establishments producing not-ready-to-eat (NRTE) 
ground or otherwise comminuted chicken and turkey products that they 
must reassess their Hazard Analysis and Critical Control Points (HACCP) 
plans for these products to take into account several recent Salmonella 
outbreaks associated with consumption of comminuted NRTE turkey 
products. No sooner than 90 days following publication of this notice, 
Agency inspection program personnel (IPP) will begin verifying that 
establishments that manufacture comminuted NRTE turkey or chicken 
product, as a final or intermediary product for further processing as 
NRTE product, have reassessed their HACCP plans for these products.
    This notice also describes how FSIS will determine whether the 
association of NRTE meat or poultry product with an outbreak would make 
subsequently-produced like product adulterated.
    In addition, FSIS is expanding its Salmonella Verification Sampling 
Program for Raw Meat and Poultry product to include all forms of non-
breaded, non-battered comminuted NRTE poultry product that are not 
destined under company control programs for further processing into RTE 
products in official establishments.
    Finally, this notice announces that FSIS will apply its Category 1 
performance measure based on current performance standards for ground 
chicken and turkey product to comminuted poultry to mark the level of 
process control that all establishments producing such products should 
maintain. No sooner than 90 days after publication of this notice, the 
Agency will begin sampling to determine the prevalence of Salmonella in 
comminuted poultry and will use the results from this sampling to 
develop performance standards for these products. For reasons discussed 
later, FSIS has not tested NRTE comminuted poultry products, other than 
ground chicken and ground turkey, for Salmonella. In addition, FSIS is 
likely to develop Campylobacter standards for these products following 
validation of an analytic method.
    FSIS invites comments on this notice.

DATES: The Agency must receive comments by March 6, 2013.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by either of the following methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. Go to http://www.regulations.gov/
. Follow the on-line instructions at that site for submitting comments.
    Mail, including CD-ROMs: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 
Independence Avenue SW., Mailstop 3782 Room 8-163A, Washington, DC 
20250-3700.
    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 
355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2012-0007. 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 Patriots Plaza 3, 355 E Street SW., Room 
8-164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: For information: Contact Rachel 
Edelstein, Assistant Administrator, Office of Policy and Program 
Development, at (202) 205-0495, or by fax at (202) 720-2025.

SUPPLEMENTARY INFORMATION:

I. Background

    FSIS administers a regulatory program under the Federal Meat 
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products 
Inspection Act (PPIA) (21 U.S.C. 453 et seq.) to protect the health and 
welfare of consumers by preventing the distribution in commerce of meat 
or poultry products that are adulterated or misbranded. In pursuit of 
its goal of reducing the risk of foodborne illness from meat and 
poultry products to the maximum extent possible, FSIS issued final 
regulations on July 25, 1996, that mandated the development and 
implementation of Pathogen Reduction and Hazard Analysis and Critical 
Control Point (HACCP) Systems by federally inspected establishments (61 
FR 38806). These regulations require that federally inspected 
establishments take preventive and corrective measures at each stage of 
the food production process where food safety hazards are likely to 
occur. The HACCP regulations (9 CFR 417.2(a)) require establishments to 
conduct a hazard analysis to determine what food safety hazards are 
reasonably likely to occur in the production process of particular 
products and to identify the preventive measures that the establishment 
can apply to control those hazards.
    Section 417.2(a)(1) of the HACCP regulations states that a food 
safety hazard that is reasonably likely to occur is one for which a 
prudent establishment would establish control measures because the 
hazard historically has occurred, or because there is a reasonable 
possibility that it will occur in the particular type of product being 
processed, in the absence of those controls. Whenever a hazard analysis 
reveals that one or more hazards are reasonably likely to occur in the 
production process, the regulations require that the establishment 
develop and implement a written HACCP plan that includes specific 
control measures for each hazard identified (9 CFR 417.2(b)(1) and 
(c)).
    Section 417.4(a)(3) of the regulations requires that every 
establishment reassess the adequacy of its HACCP plan at least annually 
and whenever any

[[Page 72687]]

changes occur that could affect the hazard analysis or alter the HACCP 
plan. Because the recent outbreaks discussed in this notice were 
associated with many individual consumers in multiple States, the 
occurrence of these outbreaks could represent a change in the sanitary 
conditions involved in the manufacture of these products and is a 
change that could affect the hazard analysis or alter the HACCP plans 
for comminuted poultry products. Although the recalls described in this 
notice have involved NRTE comminuted turkey products, NRTE comminuted 
chicken products are produced in a similar manner. Therefore, FSIS is 
requiring that establishments reassess HACCP plans for comminuted NRTE 
chicken or turkey products, including final products or intermediary 
product for further processing as NRTE product. Such product includes 
any NRTE chicken or turkey product that has been ground, mechanically 
separated, or hand- or mechanically deboned and further chopped, 
flaked, minced or otherwise processed to reduce particle size.

II. Findings Associated With Recent Outbreaks

    In February 2011, the Wisconsin Department of Health and Family 
Services (WDHFS) notified FSIS of a case-patient hospitalized with a 
confirmed Salmonella Hadar infection who had consumed turkey burgers 
within the incubation period of illness onset. Leftover product tested 
positive for the pathogen associated with the outbreak. The clinical 
and product isolates also exhibited similar antimicrobial resistance. 
In March 2011, Colorado notified FSIS of a case-patient with multiple 
drug resistant Salmonella Hadar who had consumed the same brand of 
turkey burgers before becoming ill. Turkey burger from the case-
patient's home was positive for the pathogen associated with the 
outbreak. Shopper card information was used to determine that the case-
patient's family had purchased the same brand of turkey burgers in 
January 2011. Later that month, the Ohio Department of Health notified 
FSIS of a case-patient hospitalized with Salmonella Hadar with a 
history of consuming the same brand of turkey burgers. The three case-
patients with detailed food histories reporting these turkey burger 
exposures were all hospitalized overnight. In mid-January 2011, the 
Minnesota Department of Agriculture's retail food sampling program had 
detected the pathogen associated with the outbreak in the same brand of 
NRTE turkey meatloaf with gravy product with nationwide distribution. 
In March 2011, the New Mexico Department of Health had detected the 
outbreak strain of Salmonella Hadar in a ground turkey product from the 
same company during routine National Antimicrobial Resistance 
Monitoring System (NARMS) retail meat study testing (no illnesses 
resulted from consumption of these turkey products). The producing 
establishment voluntarily recalled approximately 54,960 pounds of 
ground turkey product. Information on this recall can be found on the 
FSIS Web page (http://www.fsis.usda.gov), through the ``FSIS Recalls'' 
link, under recall case number 028-2011.
    In response to the events, the Agency conducted a Food Safety 
Assessment (FSA) at the establishment in April-May 2011. An FSA is 
performed to assess the design and validity of food safety systems in 
an establishment. FSAs are conducted routinely and periodically and 
also ``for cause'' when prompted by a positive sample result, 
production and shipment of adulterated product, or any other high 
priority food safety related incident. FSIS issued a Notice of Intended 
Enforcement Action (NOIE) to this establishment in early May due to 
lack of validated cooking instructions, among other findings. 
Specifically, the cooking instructions prescribed a certain number of 
minutes for cooking per patty side, but the establishment's validation 
cooking study did not demonstrate that the cook time and cooking 
methods prescribed in these instructions ensured that a safe internal 
temperature is reached. In response to the NOIE, the establishment 
decreased its patty thickness, revalidated cooking instructions, and 
changed its consumer package instructions to recommend cooking to 165 
degrees Fahrenheit. The establishment also implemented antimicrobial 
treatments in product manufacture and made other changes in response to 
the NOIE. FSIS verified that the establishment was implementing 
effective Salmonella controls.
    The establishment associated with this outbreak is not a slaughter 
establishment and receives raw product for grinding and ground product 
for blending from other establishments in its corporate structure. The 
recalled product was produced at this establishment by blending turkey 
ground at slaughter establishments within its corporate structure.
    Through review of records, FSIS found that at the time of the 
outbreak, this further processing establishment had not, as cited 
above, provided validated cooking instructions for the recalled 
product, did not use interventions other than temperature control on 
raw parts for grinding, and did not prevent lots from contaminating 
each other by cleaning and sanitizing blending and grinding equipment 
between lots. FSIS also found that in the months leading up to the 
outbreak, the establishment that manufactured the product associated 
with the outbreak may not have had adequate controls to prevent or 
reduce Salmonella.
    In May 2011, FSIS became aware of a cluster of 29 Salmonella 
Heidelberg illnesses from 18 states. Additionally, three ground turkey 
samples collected as part of the NARMS retail testing program (two in 
New Mexico and one in Minnesota) were included in the cluster; the MN 
sample was resistant to ampicillin, streptomycin, tetracycline, and 
gentamycin. Interviewed case-patients who had consumed turkey mentioned 
several brands, including a number of store brands. FSIS issued a 
public health alert based upon the investigative findings on July 29, 
2011, by which time there were 77 case patients from 26 states. As part 
of the outbreak investigation, the California Department of Public 
Health collected ground turkey samples from retail stores and tested 
them for Salmonella. On August 3, 2011, the producing establishment 
voluntarily recalled approximately 36 million pounds of ground turkey. 
Information on this recall can be found on the FSIS Web page (http://www.fsis.usda.gov), through the ``FSIS Recalls'' link, under recall 
case number 060-2011. FSIS requested that the establishment recall 
product based on outbreak investigation data implicating the 
establishment as a supplier of product linked to human illness. FSIS 
suspended inspection for the NRTE grinding operations producing the 
implicated products at the establishment.
    The establishment responded with modifications to its food safety 
system to improve its interventions designed to control Salmonella. The 
establishment's stated goal had been to meet the FSIS Salmonella 
performance standard for ground turkey (49.9 percent positive or less) 
(9 CFR 381.94(b)(1)). The establishment was depending solely on non-
specific Salmonella controls to prevent further illness from its 
product. FSIS allowed the establishment to resume operations to 
validate those modifications.
    FSIS initiated an FSA and scheduled an Incident Investigation Team 
(IIT) review at the establishment. An IIT review is convened to 
investigate and provide information regarding a non-routine incident 
involving the adulteration of FSIS-regulated product

[[Page 72688]]

or a significant event or potential public health issue. This IIT was 
convened in response to the outbreak linked to poultry product and 
repetitive food safety concerns identified in the review of 
establishment microbiological sampling and testing results by the FSIS 
District Office directing the investigation. The IIT investigation at 
the establishment showed that the establishment's umbrella corporation 
was unable to substantiate that it had controlled the pathogen 
associated with the outbreak in its source products. Testing of the 
establishment environment and poultry product by FSIS found additional 
evidence of the pathogen associated with the outbreak. Further, while 
the establishment was on track to meet the performance standard of 49.9 
percent positive for generic Salmonella and validate its interventions, 
it had not correlated the standard to the effective control of the 
pathogen associated with the outbreak. The establishment was unable to 
substantiate that the non-specific Salmonella controls it had initiated 
were sufficient to prevent further illness from comminuted product.
    Establishment data indicated, furthermore, that the use of 
mechanically deboned and separated product increased the likelihood of 
Salmonella contamination. As noted below, both mechanically deboned 
product and mechanically separated product were used in the product 
associated with one of the outbreaks discussed in this notice. This 
appears to have been due to the establishment using antimicrobial 
treatments on some but not all source materials and specifically not on 
mechanically separated source materials.
    Based on information from the FSA and IIT, FSIS issued an NOIE on 
the same NRTE ground processes previously suspended to provide the 
establishment the opportunity to demonstrate compliance as directed by 
9 CFR 500.4(a). This resulted in a new suspension of inspection for the 
specified NRTE ground processes until the establishment was able to 
demonstrate effective controls. On September 11, the producing 
establishment voluntarily recalled 185,000 pounds of ground turkey. 
Information on this recall can be found on the FSIS Web page (http://www.fsis.usda.gov), through the ``FSIS Recalls'' link, under recall 
case number 071-2011.

III. Reassessment in Response to Outbreaks

    Because the recent outbreaks discussed above have been directly 
associated with illness in many unrelated individuals in multiple 
states, these outbreaks, in the Agency's view, represent evidence of a 
material change in the effectiveness of what heretofore had been 
regarded as necessary and appropriate sanitary conditions required to 
manufacture safe and wholesome product. As such, the occurrence of 
these outbreaks is a change that could affect the hazard analysis or 
alter the HACCP plans for such products and like products. Therefore, 
establishments that produce NRTE comminuted turkey or chicken poultry 
products (including ground, mechanically separated, or hand- or 
mechanically-deboned poultry that is further chopped, flaked, minced, 
or otherwise processed to reduce particle size but not battered or 
breaded) in final form or as an intermediary product must evaluate the 
information discussed above to determine whether their HACCP plans for 
these products adequately address biological hazards, particularly 
Salmonella. An establishment that produces comminuted poultry and has 
already taken these outbreaks into account in a HACCP plan reassessment 
for these products is not required to do so again, provided the 
establishment has documented its reassessment in its hazard analysis or 
HACCP plans, or a record or reassessment, and makes this evidence 
available to FSIS inspection program personnel.
    The investigations conducted at establishments associated with the 
outbreaks showed that sanitation procedures are particularly important 
in the production of ground and comminuted poultry products. When 
conducting a reassessment that takes these outbreaks into account to 
determine whether HACCP plans for NRTE comminuted poultry products 
adequately address biological hazards, Salmonella in particular, 
establishments should evaluate the adequacy of their sanitation 
procedures for processing equipment, including grinders, blenders, 
pipes, and other components and surfaces in contact with the product. 
Thus, Sanitation SOPs, other prerequisite programs, or HACCP plans 
should address procedures that ensure that all slaughter and further 
processing equipment, employee hands, tools, and clothing, and food 
contact surfaces are maintained in a sanitary manner to minimize the 
potential for cross contamination within and among lots of production. 
In addition, FSIS expects establishments to ensure that slaughter and 
dressing procedures are designed to prevent contamination to the 
maximum extent possible. Such procedures should, at a minimum, be 
designed to limit the exterior contamination of birds before 
exsanguination, as well as minimize digestive tract content spillage 
during dressing process.
    Establishments producing NRTE comminuted poultry products should 
ensure that cooking instructions are validated, especially if the 
instructions explain how to cook the product to attain an end-point 
temperature of 165 degrees Fahrenheit (e.g., when grilling patties, 
cook from the unfrozen state on each side for ``X'' minutes for a patty 
of ``Y'' thickness; bake uncovered in an oven at ``Z'' degrees for 
``A'' minutes).
    Establishments producing NRTE comminuted poultry products should 
also consider lotting practices (distinguishing one portion of 
production from another such that they are microbiologically 
independent) and ability to prevent lots from contaminating each other, 
including not carrying over production; cleaning and sanitizing between 
lots; and being able to trace back product to originating slaughter 
establishments (if applicable), grow-out houses, hatcheries, and 
breeding flocks. Such process control procedures may be instrumental in 
reducing the impact of potential future product recalls.
    Establishments producing NRTE comminuted poultry products should 
evaluate the adequacy of any Salmonella interventions applied to 
product source materials or to product during or after grinding or 
blending. These establishments should also evaluate these interventions 
for their ability to reduce Salmonella (expressed as ``log 
reduction''). When they are evaluating the effectiveness of these 
interventions, establishments should consider incoming variability of 
Salmonella levels in live birds (at establishments that slaughter) and 
on parts (at establishments that use parts in comminuted product 
manufacturing).
    If they have not already done so, establishments producing NRTE 
ground and comminuted poultry products should consider implementing 
purchase specifications that require raw materials used to produce such 
products to have been treated with an intervention shown to reduce 
Salmonella. If establishments producing NRTE comminuted poultry 
products require their suppliers (both within and outside their 
corporate structure) to meet such specifications, they should also 
ensure that their suppliers actually meet these purchase 
specifications. Establishments could incorporate such specifications in 
their HACCP plans, in their Sanitation SOPs, or in other prerequisite 
programs.

[[Page 72689]]

    Establishments producing comminuted poultry should also consider 
serotype information, focusing on presence and trends in the serotypes 
of human health concern identified by the Centers for Disease Control 
and Prevention (CDC) in the CDC top 30 serotypes list (available at 
http://www.cdc.gov/ncezid/dfwed/PDFs/SalmonellaAnnualSummaryTables2009.pdf). FSIS provides guidance, 
including data on serotype information to establishments that have had 
Salmonella HACCP verification testing performed by FSIS. This guidance 
explains that serotype information can be used to better focus food 
safety efforts to protect public health. For example, compiled serotype 
information can assist an establishment's efforts to identify 
interventions it may use and in that way help address the problem.
    Finally, establishments producing NRTE comminuted poultry products 
should consider pre-harvest factors and interventions that may 
influence Salmonella contamination in NRTE comminuted poultry products 
(including breeder flock Salmonella status, hatchery management, 
biosecurity and pest control, feed manufacturing and feed withdrawal 
practices, and sanitation of pre-harvest environments including 
transport crates).
    Although comminuted livestock products (e.g., beef and pork) are 
similarly produced, this notice is specific to poultry. Historically, 
ground chicken products have the highest Salmonella spp. percent 
positive rates of all FSIS-regulated product classes. Further, three of 
the five most common Salmonella serotypes known to cause human illness 
are consistently found more in ground chicken. As such, available data 
suggests a continued focus on poultry products will reduce 
salmonellosis. Prudent manufacturers of comminuted meat products, 
however, should be aware of the factors contributing to the recent 
ground turkey product outbreaks and consider the information in this 
notice with regard to assessing whether their food safety systems 
present similar vulnerabilities.

IV. FSIS Actions To Enforce and Facilitate Compliance With the 
Reassessment Requirement

    FSIS will instruct inspection program personnel to ensure that all 
establishments producing non-breaded, non-battered NRTE comminuted 
chicken or turkey, including small and very small establishments that 
may not belong to a trade association, are aware that the Agency has 
issued this notice.
    No sooner than 90 days following publication of this notice in the 
Federal Register, FSIS will instruct inspection program personnel to 
begin conducting a checklist survey in chicken and turkey slaughter and 
further processing establishments, including establishments that 
produce comminuted poultry. Through this checklist survey, FSIS will 
document whether establishments made changes to their HACCP plans in 
response to the required reassessment or whether changes were made 
before the mandatory reassessment, and will capture a general 
description of the type of changes made. IPP will be instructed to 
share establishment responses to the checklist with establishment 
management in order to best ensure that the information is complete. 
Establishments that disagree with the IPP checklist entries will be 
encouraged to provide supporting rationale for why the responses should 
be changed. The completed survey will enable the Agency to identify 
which establishments have reassessed HACCP plans for NRTE comminuted 
poultry products, based on the outbreak information discussed above.
    FSIS will subsequently evaluate establishments that produce NRTE 
comminuted poultry products to collect in-depth information on changes 
made. FSIS will evaluate information gathered in the survey and may 
conduct FSAs of establishments producing NRTE comminuted poultry 
products. The Agency will decide on the conditions under which it will 
conduct any other evaluations for establishments producing NRTE 
comminuted poultry products. Consistent with current Agency practices, 
FSIS may conduct a ``for cause'' FSA in response to production and 
shipment of adulterated product. In response to the survey results 
discussed above, FSIS may consider conducting a ``for cause'' FSA, if 
FSIS has any concerns regarding that establishment's food safety 
system.
    Once FSIS has evaluated such establishments, it intends to publish 
guidance for industry on best practices to reduce Salmonella in 
comminuted poultry. In addition, the Agency expects to use the results 
in designing targeted verification activities.
    FSIS recommends that manufacturers of comminuted products derived 
from cattle, hogs, and sheep or comminuted poultry products derived 
from poultry other than chicken or turkeys also take note of the 
factors contributing to the recent comminuted turkey product outbreaks. 
These manufacturers should consider the instructions in this notice 
with regard to assessing whether their food safety systems present 
similar vulnerabilities.

Adulteration of Product Associated With Outbreaks

    When NRTE poultry or meat products are associated with an illness 
outbreak and contain pathogens that are not considered adulterants, 
FSIS likely will consider the product linked to the illness outbreak to 
be adulterated under 21 U.S.C. 453(g)(3) or 21 U.S.C. 601(m)(3) because 
the product is ``* * * unsound, unhealthful, unwholesome, or otherwise 
unfit for human food.'' In such cases, the Agency would request that 
the establishment recall the product if it is still in commerce.
    FSIS will also evaluate whether the particular product associated 
with the illness outbreak may also be adulterated because it was ``* * 
*prepared, packed, or held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been 
rendered injurious to health'' (21 U.S.C. 453(g)(4) or 21 U.S.C. 
601(m)(4)). FSIS would likely find that such product is adulterated 
because it was produced under insanitary conditions where the 
establishment produced the product of concern under conditions that did 
not adequately address control of the pathogen in the product 
associated with the illness.
    The Agency would also likely determine the insanitary conditions to 
be continuing in the establishment until the establishment demonstrates 
that it has regained control of its production processes and re-
established sanitary conditions under which the product is produced so 
that the establishment is able to produce unadulterated product.
    FSIS would also have to evaluate whether the type of product 
produced at other establishments, when demonstrably linked to product 
associated with the outbreak, is adulterated because it was produced 
under substantially similar processes and insanitary conditions. For 
example, associated product at another establishment produced from 
birds that came from the same grow-out house as the birds that were the 
source of the product associated with the illness outbreak, and that 
were subject to substantially similar processing conditions, may also 
be determined to be adulterated by the Agency.
    FSIS would not be likely, however, to consider product of the same 
type adulterated though it is found to have the pathogen associated 
with the illness outbreak, provided it was produced in other 
establishments that have no relationship to product involved in the 
illness outbreak. A determination of

[[Page 72690]]

adulteration would be specific to the product linked to the illness 
outbreak and to the conditions in the establishment where that product 
was produced.

Agency Verification Sampling and Testing

    The Agency is expanding its Salmonella Verification Sampling 
Program to include all non-breaded, non-battered ``NRTE comminuted'' 
chicken or turkey products in addition to the currently sampled NRTE 
ground chicken and turkey. In a way similar to the process of grinding 
product, the process of producing comminuted product, whether 
mechanically deboned or mechanically separated, leads to the 
distribution of pathogens throughout the product. These techniques 
differ mainly in the equipment used and the source materials (i.e., 
boneless meat versus meat with bone attached). Both mechanically 
deboned product and mechanically separated product were used in the 
product associated with one of the outbreaks discussed in this notice. 
The product involved in the outbreak was likely not subject to FSIS 
sampling. In the past, mechanically separated product was not typically 
used in poultry product sold to consumers in an NRTE product. At this 
time, however, mechanically separated product may be included in such 
product, especially for export. For all these reasons, FSIS will begin 
sampling non-breaded, non-battered comminuted product for Salmonella. 
In addition, FSIS expects to use the verification testing program as 
the mechanism to obtain samples to determine the prevalence of 
Salmonella in comminuted poultry and will use the results from this 
sampling to develop performance standards for these products. FSIS also 
expects to analyze the samples for Campylobacter, as well as for other 
microorganisms that could serve as indicators of inadequate process 
control.
    As explained above, ``NRTE comminuted poultry'' products to be 
sampled include any non-breaded, non-battered raw or otherwise NRTE 
product that has been ground, mechanically separated, or hand- or 
mechanically-deboned and further chopped, flaked, minced, or otherwise 
processed to reduce particle size. The Agency will also include in its 
sampling non-breaded, non-battered NRTE comminuted poultry product 
after other ingredients such as spices have been added, since the 
Agency expects establishments to control pathogens in final product 
regardless of the source of the pathogens. Consistent with FSIS's 
current Salmonella sampling procedures for NRTE product, when the 
establishment either processes all comminuted product into RTE product 
or moves all such product to another official federally-inspected 
domestic establishment for further processing into RTE product, such 
product will not be subject to Agency sampling. The Agency will collect 
comminuted NRTE samples in establishments with an average daily 
production of greater than 1,000 pounds over the past month, but this 
may change as the program progresses.
    A sampling change will be initiated to allow for a more accurate 
measurement of the incidence of Salmonella. Beginning 90 days after 
publication of this notice, the sampling for these comminuted poultry 
products will begin with a new larger standard size for its 
verification samples as the Agency completes validation studies on 
moving its microbiological testing from a 25 gram sample size to 325 
grams. This larger sample size will provide consistency as the Agency 
moves toward analyzing each sample for two pathogens.
    Meanwhile, based on analysis of data from three consecutive years, 
Fiscal Year (FY) 2009 to FY2011, FSIS is considering reducing the 
number of samples in a set from 53 to 26 samples. FY2009-2011 data 
analysis showed that reducing samples from 53 to 26 will not compromise 
the ability to detect non-compliant establishments. With this change, 
based on current standards, FSIS is considering accepting a maximum of 
15 positive samples in a 26-sample ground turkey set to meet the 
performance standard and a maximum of seven positive samples for such a 
set to count toward Category 1 status. For ground chicken, based on 
current standards, FSIS is considering accepting a maximum of 13 
positive samples in a 26-sample set to meet the performance standard 
and a maximum of six positive samples for such a set to count toward 
Category 1 status. Because a reduction in sample set size could 
increase the number of sets that can be performed in a given period of 
time, the possibility exists that this modification may result in a 
greater number of non-compliant establishments detected in that time 
period, providing a better reflection of current production practices 
and increasing the efficiency of FSIS resource utilization.
    The original Salmonella performance standards were established 
based on industry averages (percent positive samples) estimated from 
baseline surveys conducted more than a decade ago. The current 
standards were designed such that establishments with sampling results 
above an average (or expected) result would be considered non-compliant 
with the standard. Recently, FSIS has explored designing performance 
standards to achieve a public health objective. For example, the 
Healthy People 2020 goal for human salmonellosis is a 25 percent 
reduction. FSIS intends to apply its Category 1 ranking for ground 
chicken and turkey product to comminuted product to mark the level of 
performance at which all establishments producing such products should 
maintain process control. The Agency's Category 1 approach for the 
current performance standard includes establishments with sample 
results at 50 percent or less of the relevant performance standard, as 
detailed in a February 2006 Federal Register notice (http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/04-026N.htm;http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2010-0029.htm). For ground chicken 
the performance standard is 44.6 percent and the acceptable number of 
positive samples per set is 26 of 53. For ground turkey the performance 
standard is 49.9 percent and the acceptable number of positive samples 
per set is 29 of 53.
    FSIS intends to conduct a risk assessment based on at least three 
months of these new sampling and testing results and issue a new 
performance standard for these products for Salmonella and likely 
Campylobacter as well. With publication of this notice, FSIS will 
discontinue sampling sets for ground poultry product, except for 
establishments in category 3. When FSIS stops testing sets at 
establishments, FSIS recommends that they assess whether they meet the 
category 1 standard. Establishments in category 3 are those that have 
not been able to maintain consistent process control over the previous 
two Salmonella verification testing sets and have shown highly variable 
process control over the most recent set (i.e., the most recent set 
does not meet the performance standard and any result in prior set). 
For these establishments, FSIS will continue to schedule sets for 
ground chicken or turkey and would also sample other comminuted chicken 
or turkey products. The Agency requests comment on whether, given the 
relatively high prevalence of Salmonella in comminuted chicken and 
turkey product, it should apply to these product classes a more 
stringent measure of 25 percent of the national

[[Page 72691]]

prevalence for defining Category 1 rather than the traditional measure 
of 50 percent of the national prevalence for defining Category 1. That 
is, the traditional 50 percent reduction applied to the current 
standard of 44.6 for ground chicken and 49.9 percent for ground turkey 
would give a Category 1 standard of approximately 22 and 24 percent, 
respectively. Applying a more stringent measure of 25 percent of the 
national prevalence to these product classes would give a Category 1 
standard of approximately 11 and 12 percent, respectively. FSIS 
believes that establishments would seek to improve process control so 
as to remain compliant with a revised performance standard and that, as 
a result, a substantial number of illnesses would be averted. In 
addition, a reduction of Category 1 to 25 percent of the performance 
standard would be consistent with the goals of the Healthy People 2020 
initiative.
    Except for category 3 establishments, FSIS will discontinue the 
concept of set testing for ground and comminuted chicken or turkey at 
least until it establishes new performance standards for these 
products. For samples that are not collected as part of sets, FSIS 
field service laboratories will perform qualitative testing for the 
presence or absence of Salmonella using the same methodology, discard 
criteria, and reporting as those currently in place. Samples that 
screen positive will be analyzed, i.e., the Salmonella organisms 
present will be enumerated, using the MPN (Most Probable Number) 
procedure.

Paperwork Reduction Act

    FSIS has reviewed the paperwork and recordkeeping requirements in 
this notice in accordance with the Paperwork Reduction Act and has 
determined that the paperwork requirements for this notice, which 
informs establishments that produce not ready-to-eat comminuted poultry 
products that they need to reassess their HACCP Plans, have already 
been accounted for in the Pathogen Reduction/HACCP Systems information 
collection approved by the Office of Management and Budget (OMB). The 
OMB approval number for the Pathogen Reduction/HACCP Systems 
information collection is 0583-0103.

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.)
    Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, audiotape, 
etc.) should contact USDA's Target Center at (202) 720-2600 (voice and 
TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

Additional Public Notification

    FSIS will announce this document online through the FSIS Web page 
located at http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. In addition, FSIS offers an electronic mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range 
from recalls to export information to regulations, directives and 
notices. Customers can add or delete subscriptions themselves, and have 
the option to password protect their accounts.

    Done at Washington, DC, on November 30, 2012.
Alfred V. Almanza,
Administrator, FSIS.
[FR Doc. 2012-29510 Filed 12-5-12; 8:45 am]
BILLING CODE 3410-DM-P