[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