[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Notices]
[Pages 22084-22090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08952]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[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: Notice; response to comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is responding to
comments on a Federal Register notice, ``HACCP Plan Reassessment for
Not-Ready-to-Eat (NRTE) Comminuted Poultry Products and Related Agency
Verification Procedures,'' that it published on December 6, 2012. The
notice provided updated information on the Agency's sampling and
testing of these products, and on how it is verifying that
establishments are effectively addressing the possible presence of
Salmonella and Campylobacter in them.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495 or by Fax: (202) 720-2025.
SUPPLEMENTARY INFORMATION:
Background
In the December 6, 2012, Federal Register notice (77 FR 72686),
FSIS informed establishments producing NRTE ground or otherwise
comminuted chicken and turkey products that they must reassess their
Hazard Analysis and Critical Control Point (HACCP) plans for these
products. The Agency also described how it would determine whether the
association of NRTE meat or poultry product with an illness outbreak
would make subsequently-produced ``like'' product adulterated. FSIS
announced that it would expand its Salmonella sampling beyond ground
chicken and turkey to include all forms of non-breaded, non-battered
comminuted NRTE chicken or turkey product not destined for further
processing into ready-to-eat (RTE) products. Finally, FSIS announced
that it intended to use the sampling results to determine the
prevalence of Salmonella and Campylobacter in NRTE comminuted chicken
and turkey and to
[[Page 22085]]
develop pathogen reduction performance standards for these products.
In response to an industry request for more time to comment, on
March 7, 2013, FSIS extended the original comment period for the
December 2012 notice by 45 days, until April 20, 2013 (78 FR 14635).
Also on March 7, 2013, FSIS stated in the notice that establishments
that produced NRTE comminuted chicken or turkey products would have to
reassess their HACCP plans for those products by April 20, 2013,
thereby providing them an additional 45 days to conduct the
reassessment. Finally, FSIS announced that it would announce any new
standards in the Federal Register and request comment on them before
implementing them.
FSIS requested comment on the notice concerning the required
reassessment and new sampling to inform FSIS's planned sampling
procedures, to gather information on how best to establish pathogen
reduction performance standards for NRTE comminuted chicken and turkey
products, and to gather any other necessary information on how best to
move forward with addressing Salmonella and Campylobacter in comminuted
poultry products.
On May 8, 2013, FSIS issued instructions to its inspectors to begin
verifying whether establishments had reassessed their HACCP plans (FSIS
Notice 33-13; http://www.fsis.usda.gov/wps/wcm/connect/12ab8084-1641-4e9a-ba3c-c647afe7e428/33-13_447.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=12ab8084-1641-4e9a-ba3c-c647afe7e428). From the
available data concerning establishment production and inspection task
procedures from the Public Health Information System (PHIS) and from
District Offices, FSIS found that about 70 percent of inspection
personnel at establishments producing raw and not-heat-treated NRTE
ground or otherwise comminuted chicken or turkey product verified that
the establishments had reassessed their HACCP plans for these products
in light of the outbreak information provided in the December 2012
notice. Inspection personnel found that about 90 percent of the
establishments at which verification occurred had complied with the
reassessment requirements. Most of the establishments that had not
reassessed were very low volume (less than 1,000 pounds average
production of product subject to comminuted poultry sampling) and not
included in the sampling frame for this product.
FSIS found that only 30 percent of inspection personnel verified
whether establishments producing heat-treated NRTE comminuted chicken
or turkey products had reassessed their HACCP plans for these products.
Inspection personnel have had questions about whether reassessment is
required for such products and have had questions concerning whether
the poultry components of these heat-treated products have received a
full lethality treatment or are comminuted. If the products themselves,
or the comminuted poultry component of such products, receive a full
lethality, they would not be subject to the HACCP plan reassessment
requirement.
District Offices will work with inspection program personnel to
ensure that they verify whether all establishments required to reassess
HACCP plans for NRTE comminuted (including ground) chicken or turkey
product do so. In addition, FSIS intends to prioritize completion of
Food Safety Assessments (FSAs) in establishments producing NRTE
comminuted chicken or turkey product. During an FSA, if an Enforcement
Investigations and Analysis Officer (EIAO) finds that an establishment
producing such product has not reassessed its HACCP plan and should
have done so, the EIAO will inform inspection program personnel at the
establishment. Those personnel will then inform the establishment that
it needs to reassess its HACCP plan for this product. If an
establishment does not perform reassessment after it is advised to do
so, FSIS will issue a noncompliance record. FSIS will post on its Web
site an update on what it finds on the status of reassessments through
the poultry checklist, discussed below. In addition, FSIS will prepare
and post a report on what it has learned about the reassessments from
the FSAs that EIAOs have conducted.
FSIS began the new Agency sampling and testing of raw comminuted
chicken and turkey products on June 1, 2013 (FSIS Notice 35-13; http://www.fsis.usda.gov/wps/wcm/connect/366615fa-923b-4d9a-954d-c6ad30ea3242/35-13.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=366615fa-923b-4d9a-954d-c6ad30ea3242). This sampling and testing for Salmonella and
Campylobacter does not include heat-treated NRTE comminuted chicken or
turkey. FSIS is analyzing the results of the new sampling and testing.
FSIS has posted aggregate results of this testing for all finished
products as part of its quarterly report on Salmonella.\1\
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\1\ http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/quarterly-reports-salmonella/quarterly-progress-reports.
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FSIS intends to continue the current sampling program until the new
Salmonella and Campylobacter pathogen performance standards are
implemented. FSIS intends to derive the new standards based on a risk
assessment that takes into account the prevalence and distribution of
Salmonella and Campylobacter in NRTE comminuted chicken and turkey
product and the predicted illnesses averted as a consequence of
reducing the prevalence of these pathogens. FSIS will estimate
prevalence when it has collected enough data to develop standards.
Until FSIS establishes pathogen reduction performance standards for
comminuted chicken and turkey, FSIS recommends that establishments
increase their awareness of the pathogen incidence in these products
and compare the on-going incidence in their establishments against the
results made public by FSIS. In addition to the posted results, FSIS
intends to provide each establishment whose product the Agency samples
with periodic status reports comparing that establishment's results
with those industrywide. FSIS advises establishments to make necessary
changes in their procedures to control Salmonella and Campylobacter,
particularly if FSIS finds that the levels of these pathogens in their
comminuted products are higher than those in similar products of most
other establishments or higher than the standard.
If establishments implement pathogen control procedures and conduct
their own verification testing, FSIS advises them to compare their
results to FSIS results and to make necessary changes to control the
pathogens if their results are higher than the results of FSIS's
testing in most other establishments or the FSIS standard. As has been
the Agency's practice since February 2006, when it first began
encouraging establishments to gain more optimal and consistent process
control by attaining Category 1 status (i.e., half the current number
of acceptable positive samples in a sample set), FSIS continues to
encourage establishments to gain more optimal and consistent process
control by achieving test results that are better than those for most
other establishments, and that are lower than the FSIS standard.
At this time, not all establishments apply antimicrobial treatments
to the source materials used for producing comminuted poultry,
including mechanically separated product. FSIS is, therefore, revising
its FSA Tools to ensure that EIAOs verify that establishments
adequately address
[[Page 22086]]
Salmonella and Campylobacter in comminuted poultry, including
mechanically separated product, in their hazard analysis and food
safety system.
Consistent with plans announced in the December 2012 Federal
Register notice, FSIS is surveying its poultry inspection program
personnel through a PHIS profile extension questionnaire during the
first half of Fiscal Year (FY) 2014 to gather specific information on
changes made to HACCP plans in response to the required reassessment
(77 FR 72686, at 72689). FSIS will evaluate the information gathered
from the questionnaires to determine what hazards the Agency needs to
consider in establishments that produce NRTE comminuted chicken and
turkey products, and that FSIS needs to target in industry-wide FSAs of
comminuted poultry operations. Similarly, if any of the testing data
show high numbers of Salmonella positives within an establishment, or
high levels of Salmonella through enumeration, FSIS may conduct a for-
cause FSA at the establishment that produced the product or increase
verification testing or inspection procedures at the establishment,
such as sanitary dressing procedures, until the establishment controls
pathogens on the source materials and food contact equipment. For
slaughter operations, FSIS may slow down the evisceration line if
conditions, including contamination resulting from a lack of process
control, are preventing inspection personnel from adequately performing
inspection procedures within the time available (9 CFR 381.68(c)).
FSIS announced its Salmonella Action Plan on December 4, 2013.\2\
According to the plan, FSIS intends to complete a risk assessment and
develop Salmonella performance standards for comminuted poultry this
fiscal year. FSIS also intends to announce and request comment in the
Federal Register on the setting of pathogen reduction performance
standards for Salmonella and Campylobacter during this fiscal year for
poultry parts and comminuted poultry. FSIS will then analyze the
comments and announce final standards in a subsequent Federal Register
notice and would provide time for establishments to make any changes to
their procedures before assessing whether establishments meet the new
standards. FSIS is analyzing the testing data discussed above to
develop proposed new standards.
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\2\ http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/foodborne-illness-and-disease/salmonella/sap.
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Summary of Comments and Responses
FSIS received 22 comments in response to the December 2012 notice.
Of those comments, one was a joint submission signed by eight consumer
advocacy groups, and another was from a coalition of six trade
associations on behalf of their member companies. The remaining
individual comments were from private citizens, domestic poultry
processors, trade associations, industry advocacy associations, a
consumer advocacy organization, a food marketing company, a private
foreign consulting agency, and a member of academia. FSIS has
summarized and responded to the comments below.
Administrative Procedure Act
Comment: One comment claimed that the Agency is violating the
Administrative Procedure Act by effectively promulgating new regulatory
requirements without following notice and comment procedures.
Response: The notice did not establish any new requirements. The
December 2012 Federal Register notice was based on the Agency's
determination that changes had occurred that could affect
establishments' hazard analysis for comminuted poultry products because
of the outbreaks and recalls described in the December 2012 notice.
Therefore, as FSIS explained in the March 7, 2013 Federal Register, the
predicate for triggering the reassessment required under 9 CFR 417.4
(a)(3) clearly existed (78 FR 14635). FSIS provided recommendations on
issues establishments should consider during the reassessment but did
not require establishments to consider those specific issues.
Although FSIS did not set new requirements for industry, the Agency
provided a comment period. In addition, before beginning new sampling
or verifying that establishments had reassessed their HACCP plans, FSIS
delayed implementation to carefully consider issues that were raised in
comments.
Definition of NRTE Comminuted Poultry
Comment: Several comments commended FSIS for expanding its
Salmonella verification sampling program to include previously untested
forms of NRTE comminuted poultry products and for taking actions to
assess the prevalence of Salmonella and Campylobacter in these
products. However, a turkey processor remarked that the Agency's
definition for NRTE comminuted poultry is ``excessively broad.''
Instead of the term ``comminuted,'' several comments stated that FSIS
should maintain its current use of the terms ``mechanically
separated,'' as defined in 9 CFR Part 381, and ``ground'' when
implementing the new sampling.
Response: FSIS considers ``NRTE comminuted poultry'' to be 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 (77 FR 72687). FSIS
developed this definition to encompass not only ground and mechanically
separated poultry products but also other similarly produced products
across the spectrum of comminuted poultry products, including those
with ingredients added during the comminution process, because
production of any NRTE comminuted poultry involves similar processes
that make them susceptible to the same hazards. FSIS had not previously
included mechanically separated product or other comminuted product in
its ground poultry sampling frame. By expanding the sampling frame to
include all raw comminuted products, FSIS can verify that
establishments are adequately controlling hazards in products produced
by similar processes.
HACCP Plan Reassessment
Comment: Several comments supported HACCP plan reassessment for
establishments producing NRTE comminuted chicken and turkey to take
into account recent Salmonella outbreaks. Conversely, a domestic
chicken processor and several trade associations objected to the
required reassessment because FSIS failed to provide evidence in the
notice that a food safety hazard has historically occurred or is
reasonably likely to occur in the production of all NRTE comminuted
poultry products. Several comments stated that the ground turkey
products recalled in 2011, discussed in the December 2012 notice,
contained no mechanically separated turkey.
Response: Although one outbreak and a subsequent recall discussed
in the December 2012 notice involved only ground turkey products, the
2011 Salmonella Heidelberg outbreak \3\ (FSIS Recall Case 060-
2011) \4\ discussed in
[[Page 22087]]
the notice was specifically associated with mechanically separated
turkey source materials. Furthermore, all comminuted products undergo
similar processing and, for that reason, are susceptible to the same
hazards. Comminuting intact NRTE chicken or turkey spreads any surface
contamination throughout the finished product. Thus, FSIS required
reassessment of HACCP plans for all NRTE comminuted chicken and turkey
products, including ground, hand- or mechanically-deboned, and
mechanically separated product.
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\3\ A total of 79 persons infected with the outbreak strain of
Salmonella Heidelberg were reported from 26 states between March 1
and August 3, 2011.
\4\ Information on this recall and others can be found on the
FSIS Web page (http://www.fsis.usda.gov), through the ``FSIS
Recalls'' link, under the recall case number.
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Importantly, on January 10, 2014, FSIS announced a product recall
(FSIS Recall Case 001-2014) involving NRTE mechanically
separated chicken, linked to an outbreak, that was sold for
institutional use.
FSIS Salmonella Verification Sampling Program Procedures
Comment: One comment requested that FSIS exempt from sampling and
testing raw comminuted poultry and turkey source materials destined for
High Pressure Processing (HPP). If the materials were not exempted from
sampling and testing by FSIS, the commenter requested that
establishments using HPP be granted the benefit of having product
sampled in its final, packaged form, after the HPP Critical Control
Point.
Response: Any chicken or turkey product treated with an
intervention or antimicrobial treatment, including HPP, that has been
validated to achieve at least a 7-log reduction of Salmonella in
poultry product would be considered RTE and exempt from FSIS Salmonella
verification sampling. (Raw meat product would need a 5-log reduction
of Salmonella to be exempt from FSIS Salmonella testing.) The HACCP
plan reassessment requirement announced in the December 2012 Federal
Register notice did not apply to HACCP plans for RTE chicken or turkey
products. FSIS generally attempts to sample product after the product
has received all antimicrobial treatments. In the case of HPP, which
oftentimes is applied off-site at another establishment, if controls
are in place to ensure that the antimicrobial treatment is applied to
the product, FSIS would attempt to sample product at the off-site
locale after the antimicrobial treatment is applied.
Comment: An industry advocacy association stated that the shifting
to a 325-gram sample method will impair FSIS's and stakeholders'
ability to compare historical and newly-generated data. The comment
also requested that FSIS demonstrate how it validated a sampling
methodology for poultry based on the larger sample size.
Response: FSIS agrees that comparing data generated before and
after a microbiologic method change may be difficult. However, the 325-
gram analytic portion will provide FSIS and industry with a more
accurate estimate of the presence of Salmonella and Campylobacter in
the products tested. The larger analytic portion size will also likely
provide FSIS with a clearer picture of Salmonella serotype
distribution. This increased understanding will assist FSIS with
foodborne illness source attribution and outbreak traceback
investigations.
To support an increase in the sample size analyzed, FSIS conducted
studies to verify the performance characteristics (selectivity,
sensitivity, reproducibility) of the FSIS Salmonella detection method
(FSIS Microbiology Laboratory Guidebook Chapter 4.06) for poultry and
found no significant difference between 25-gram and 325-gram analytical
sample portions.
Comment: A trade association recommended that FSIS require safe
handling and cooking instructions on all domestic and exported NRTE
comminuted poultry product labels. The commenter also recommended that
FSIS require all mechanically separated poultry products to be
processed into RTE products. Other commenters recommended that FSIS
establish additional labeling requirements for NRTE comminuted products
such as, ``For Export Only,'' ``Must Be Fully Cooked to a Temperature
of 165 [deg]F (74 [deg]C),'' ``Not for Retail Sale,'' and stating the
intended use of the product (NRTE or RTE) on the label.
Response: Safe handling instructions are required to appear on the
labels of raw or partially cooked NRTE poultry products (9 CFR
381.125(b)). The remaining labeling and processing requirements
suggested by the commenters would require rulemaking and are outside
the scope of this notice. However, establishments can voluntarily
include validated cooking instructions or statements of limited use on
product labels.
This January, FSIS sought input from the National Advisory
Committee on Meat and Poultry Inspection \5\ to explore possible
changes to the safe food handling label on meat and poultry packages.
With this input, FSIS will consider whether the current safe handling
instruction requirements should be changed to meet the needs of the
consuming public (78 FR 77643; Dec. 24, 2013).
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\5\ For more information on the National Advisory Committee on
Meat and Poultry Inspection, visit http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/advisory-committees/nacmpi.
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Estimating Prevalence
Comment: Several consumer advocacy organizations asked how the
Agency intends to use its verification testing program to determine
prevalence when, in April 2012, FSIS said it was not possible to
estimate prevalence accurately by using its Salmonella verification
data.
Response: To estimate prevalence in NRTE comminuted poultry
products, FSIS has replaced its traditional sampling-set approach with
a census-type approach where each establishment is sampled
continuously. This change will allow estimation of the average
prevalence in each establishment across the sampling period. In
addition, post-hoc adjustments for production volume will allow for
national Salmonella and Campylobacter prevalence estimation.
Comment: A consumer advocacy organization stated that, to get an
accurate estimate of the national prevalence of Salmonella, FSIS must
sample from all establishments producing NRTE comminuted poultry
products, not just establishments in Category 3. Several comments
recommended that the new sampling of comminuted chicken and turkey span
at least one year to account for seasonality when estimating
prevalence. An industry advocacy organization stated that this sampling
program must have enough samples taken across the seasons to be
statistically significant.
Response: To estimate prevalence, FSIS is sampling eligible NRTE
comminuted poultry product from all establishments producing it,
regardless of category status. As stated above, FSIS is now analyzing
the results of the new sampling and testing.
To address comments received on seasonality, FSIS analyzed
Salmonella verification sampling data from 2000-2010 and found no
significant seasonal patterns for either ground chicken or ground
turkey. Accordingly, FSIS disagrees that the exploratory sampling
period must span at least one year to account for seasonality.
Furthermore, the existing pathogen reduction performance standards from
the mid-1990s for both ground chicken and ground turkey are based on
prevalence data collected over a period of approximately three to four
months.\6\
[[Page 22088]]
However, FSIS will use at least 6 months of data on comminuted chicken
and turkey to assess prevalence and developing standards.
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\6\ http://www.fsis.usda.gov/OPHS/baseline/rwgrchck.pdf and
http://www.fsis.usda.gov/OPHS/baseline/rwgrturk.pdfhttp://www.fsis.usda.gov/OPHS/baseline/rwgrturk.pdf, respectively.
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New Performance Standards
Comment: Many comments requested separate performance standards for
NRTE mechanically separated versus ground products because of the
differences in how each product category is produced, marketed, and
used. An industry advocacy association stated that a performance
standard is not necessary for mechanically separated chicken products
because mechanically separated chicken is only sold for inclusion in
items that are fully cooked before sale to consumers.
Response: FSIS will develop separate Salmonella (and possibly
Campylobacter) pathogen reduction performance standards for both
chicken and turkey. Before determining whether to develop different
pathogen reduction performance standards for different categories of
NRTE comminuted poultry product, FSIS must consider the prevalence data
for these categories that will be generated during its sampling
program. If the data support doing so, FSIS may develop separate
pathogen reduction performance standards for mechanically separated
chicken and turkey. Although FSIS agrees that products that contain
mechanically separated turkey now, after the August 3, 2011, recall,
are typically sold to consumers fully-cooked, FSIS is aware of multiple
establishments that produce NRTE products that contain mechanically
separated chicken destined for sale to consumers as raw product. As
noted earlier, the early January 2014 recall of mechanically separated
chicken was marketed as NRTE for institutional use and was associated
with numerous illnesses. Importantly, FSIS is aware that both
mechanically separated turkey and mechanically separated chicken are
marketed for export as NRTE product. FSIS is working with the poultry
industry to better ensure that this type of product is produced under
control programs that ensure consistent pathogen reduction in the
product.
Comment: A consumer advocacy organization suggested that FSIS set a
performance standard that is no greater than 12.3 percent for NRTE
comminuted turkey products to reflect recent National Antimicrobial
Resistance Monitoring System (NARMS) data. A domestic processor
requested that the new performance standard be rolled out over two
years to allow for modifications in sampling methodologies.
Response: FSIS will base its estimate of the prevalence of
Salmonella and Campylobacter in NRTE comminuted poultry products on the
data collected during the sampling program, while considering other
relevant data sources, including NARMS. As noted above, FSIS will
announce any new pathogen reduction performance standards in the
Federal Register and request comment on them before finalizing. In
addition, before implementing the standards, FSIS will provide
establishments with sufficient time to make any necessary changes to
address the standards.
Adulterated Product
Comment: Several consumer advocacy organizations asked FSIS to
declare specific strains of Salmonella adulterants. They noted the
Agency's recent determination that certain strains of pathogenic
Escherichia coli (E. coli) are adulterants. Another comment stated that
FSIS should declare as an adulterant any Salmonella serotype that
appears on the Center for Disease Control's ``top 20'' list of
Salmonella serotypes of human health concern at http://www.cdc.gov/ncezid/dfwed/PDFs/SalmonellaAnnualTable2009.pdf and that is also
antibiotic resistant.
Response: FSIS is considering a petition for rulemaking submitted
by the Center for Science in the Public Interest (CSPI) requesting that
the Agency issue an interpretive rule declaring certain antibiotic-
resistant strains of Salmonella to be adulterants when found in ground
meat and ground poultry.\7\ FSIS will address the issues raised by
these commenters when we respond to the CSPI petition.
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\7\ Available at http://www.fsis.usda.gov/wps/wcm/connect/04cb5fad-c13e-4de7-b391-2acd95191a95/Petition_CSPI_052511.pdf?MOD=AJPERES.
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Comment: A consumer advocacy organization said that the Agency
should declare as adulterated any raw product with the same pulsed
field gel electrophoresis (PFGE) pattern as the Salmonella serotype
associated with an illness outbreak, even if the product was produced
in an establishment that has no relationship to the product involved in
an illness outbreak. Conversely, an industry advocacy organization
remarked that deeming certain strains of Salmonella adulterated when
linked to an illness would penalize establishments for events beyond
their control.
Response: As is explained in the December 2012 Federal Register
notice, FSIS would likely not consider product of the same type
adulterated though it is found to have the pathogen associated with the
illness outbreak if the product were produced in other establishments
that have no relationship to product involved in the illness outbreak
(77 FR 72686, at 72689). A determination of adulteration would be
specific to the product linked to the illness outbreak, to the
conditions in the establishment where that product was produced, and
possibly to product in other establishments when there is a
relationship to the product involved in the outbreak.
Exporting NRTE Comminuted Poultry Products
Comment: Several comments questioned the Agency's sampling
eligibility policies for exported NRTE products outlined in FSIS Notice
23-13.\8\ A foreign consulting firm and several domestic processors and
trade associations argued that NRTE comminuted poultry product being
exported for further processing into RTE product should be treated the
same way as NRTE comminuted poultry product destined for processing
into RTE product within official establishments in the United States.
Therefore, these commenters stated, the product destined for export
should be exempt from FSIS sampling and testing. Multiple trade
associations asserted that the ability to export NRTE comminuted
poultry should be based on the requirements of the importing country,
not domestic requirements.
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\8\ Available at http://www.fsis.usda.gov/wps/wcm/connect/d27b07b5-f3e0-4ae1-8aff-9390c57ce132/23-13_422.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=d27b07b5-f3e0-4ae1-8aff-9390c57ce132.
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Response: FSIS stated in the Federal Register (73 FR 4767; Jan. 28,
2008) that it will exclude from the Salmonella verification testing
program any establishment that diverts all of its raw products to
another official, federally inspected establishment for further
processing into a RTE product. The instructions provided to inspection
personnel in FSIS Notice 23-13 are consistent with what we announced in
the January 2008 Federal Register.
If an establishment sends NRTE mechanically separated poultry
product to export, FSIS cannot verify that all of the product exported
will be processed into RTE product. Thus, if the product to be exported
is in a class of product that FSIS samples and tests for Salmonella and
Campylobacter, that product would be subject to FSIS verification
sampling. In any case, even if the product is subject to FSIS
Salmonella and Campylobacter testing, products otherwise eligible for
export could still be exported. Such product needs to be produced under
good
[[Page 22089]]
manufacturing practices (GMPs) to ensure wholesomeness of the product.
GMPs would include process controls to ensure pathogen reduction at
least on the source materials, and on-going verification testing to
demonstrate that the product is maintained in a wholesome manner. As is
discussed above, FSIS is providing test results to industry on the
distribution of contamination in this type of product. Establishments
desiring to export such NRTE product should strive to consistently
produce product with a pathogen positive rate below the industry
average and the FSIS standard, if one exists.
If a foreign country notifies FSIS that it will accept raw product
from the United States that is normally subject to Salmonella and
Campylobacter sampling and testing, but only if the product is labeled
``for cooking only'' or with another statement that indicates that
product is to be handled a certain way in that country, FSIS would
include that new labeling requirement in the export library. FSIS would
need to approve the special claims on the labeling. In addition,
inspectors would need to verify that the product meets the requirements
in the export library, and that the product is going to a country that
accepts the product as long as it bears the required labeling. If
inspectors can verify these facts, FSIS likely would not sample and
test the product for Salmonella and Campylobacter. However, if there is
evidence that the establishment does not have adequate on-going
controls to demonstrate that the product is maintained in a wholesome
manner, FSIS may conduct intensified verification activities at this
establishment, including testing and inspection procedures such as
verification that the establishment maintains adequate sanitary
dressing procedures, and that the establishment is effectively
addressing pathogens. If FSIS is unable to verify that the
establishment is addressing microbial contamination, FSIS may not
certify the product for export.
Economic Impact of the Notice
Comment: One comment asserted that FSIS failed to address the
negative economic impact of the 2012 Federal Register notice on the
domestic poultry industry. An industry advocacy association estimated
that it will cost some turkey producers close to $100,000 to transition
to the 325-gram analytic sample size.
Response: As is explained above, FSIS's regulations require
reassessment of HACCP plans when changes occur that could affect the
HACCP plan or hazard analysis. Therefore, any costs associated with
reassessment would not be ``new'' costs. Similarly, FSIS did not impose
any new sampling requirements on establishments. If establishments
choose to analyze their products for Salmonella or Campylobacter, they
are not required to use the same sample analysis procedures as FSIS.
The regulations require the establishment to maintain documents that
support its verification activities and their frequency as appropriate
for their intended purpose (9 CFR 417.5(a)(3)).
Comment: Several trade associations asserted that the changes
announced in the notice will negatively affect exporters of NRTE
mechanically separated poultry products \9\ because they will be unable
to obtain export certificates for the products.
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\9\ Dr. Paul Aho, Economic Impact of the Loss of the Export
Market for Mechanically Separated Poultry Meat (February 2013).
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Response: FSIS finds no evidence that the notice will jeopardize
the ability of exporters to obtain export certificates. Establishments
can continue to export comminuted product even if it subject to FSIS
testing.
Salmonella Control Strategies for Industry
Comment: Several trade associations requested that FSIS provide
small and very small establishments with specific guidance that will
assist them in reassessing their HACCP plans for NRTE comminuted
poultry and meat products.
Response: Guidance on how establishments can meet FSIS expectations
(including pre-harvest and post-harvest suggestions) for the control of
Salmonella and Campylobacter in poultry can be found in the Compliance
Guideline for Controlling Salmonella and Campylobacter in Poultry,
Third Edition, May 2010.\10\
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\10\ Available at http://www.fsis.usda.gov/PDF/Compliance_Guide_Controling_Salmonella_Campylobacter_Poultry_0510.pdf.
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In addition, Attachment 1 \11\ to FSIS Notice 17-13 \12\ details
lessons learned regarding establishment sanitation, intervention use,
and cooking instructions validation associated with two outbreaks
involving NRTE comminuted poultry products. FSIS also sent Historical
Salmonella Serotype Information (HSSI) letters to establishments that
produce raw comminuted chicken or turkey products and that have had
ground poultry samples collected between January 2005 and January 2012.
Together with any existing Salmonella End of Set Letters (EOSL), the
HSSI letters and associated spreadsheets provide each establishment
with compiled serotype information on all available positive FSIS
Salmonella results.
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\11\ Available at http://www.fsis.usda.gov/wps/wcm/connect/91c2976b-8eb4-4a7f-8390-9f7889f24709/NRTE-Comminuted-Turkey-Prod-Outbreaks.pdf?MOD=AJPERES.
\12\ Available at http://www.fsis.usda.gov/wps/wcm/connect/f1e5822e-dd07-49d1-8bf7-ecd8d345c09a/17-13_412.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=f1e5822e-dd07-49d1-8bf7-ecd8d345c09a.
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FSIS provided the information in the Attachment and in the HSSI
letters because FSIS anticipated that establishments producing NRTE
comminuted poultry products would find the information useful when they
reassessed their HACCP plans for these products.
Comment: Multiple comments stated that FSIS failed to include in
the December 2012 notice information on meaningful anti-Salmonella
interventions or other factors that affect Salmonella control.
Specifically, an industry advocacy organization stated that it is not
practical to test for pathogens in incoming flocks, that pre-harvest
information provides little useful information to set interventions,
and that focusing on serotype-specific interventions is an ineffective
approach to food safety. A member of academia said that insufficient
attention is being paid to the practices of poultry growing operations.
Response: Establishments are in the best position to assess
intervention use, including antimicrobial treatments, based on their
knowledge of their own processes. However, as FSIS explained in the
2012 Federal Register notice, establishments should ensure that their
slaughter and dressing procedures are designed to prevent contamination
to the maximum extent possible (77 FR 72686, at 72688). These
procedures should, at a minimum, be designed to limit the exterior
contamination of birds before exsanguination, as well as to minimize
digestive tract content spillage during the dressing process. In
addition, the Compliance Guideline for Controlling Salmonella and
Campylobacter in Poultry and Attachment 1 of FSIS Notice 17-13 provide
guidance on the multiple-hurdle approach to reducing pathogens.
Establishments should identify the critical operating parameters of
their antimicrobial interventions, as prescribed in their scientific
support, and ensure that they are meeting these parameters effectively.
FSIS found that the establishments associated with the outbreaks
described in the December 2012 Federal Register notice were not
consistently identifying the appropriate critical operating parameters
of their antimicrobial interventions or
[[Page 22090]]
consistently applying these interventions effectively against pathogens
of concern. Inappropriate application of antimicrobial interventions
can result in establishments not being able to reduce pathogens to
acceptable levels.
FSIS considers serotype information to be useful because
establishments may consider measures to control serotypes of human
health concern as well as measures to control all Salmonella. FSIS
provides serotype information to assist establishments in identifying
pathogen trends that may indicate one or more specific sources of
Salmonella that establishments can address. Interventions may include
serotype-specific interventions or controls that generally impact
Salmonella in poultry.
Finally, FSIS encourages establishments, in considering food safety
hazards that can occur before, during, and after entry into
establishments, to consider pre-harvest factors that influence
pathogens on incoming birds. The Compliance Guideline for Controlling
Salmonella and Campylobacter in Poultry \13\ includes pre-harvest
information.
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\13\ Available at http://www.fsis.usda.gov/wps/wcm/connect/6732c082-af40-415e-9b57-90533ea4c252/Compliance_Guide_Controling_Salmonella_Campylobacter_Poultry_0510.pdf?MOD=AJPERES.
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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 notice online through the FSIS Web page
located at http://www.fsis.usda.gov/federal-register.
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/wps/portal/fsis/programs-and-services/email-subscription-service. 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: April 15, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-08952 Filed 4-18-14; 8:45 am]
BILLING CODE 3410-DM-P