[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Rules and Regulations]
[Pages 72686-72691]
From the Federal Register Online via the Government Printing 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]
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