[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7285-7300]
From the Federal Register Online via the Government Publishing Office 
[FR Doc No: 2016-02586]



[[Page 7285]]

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

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2014-0023]


New Performance Standards for Salmonella and Campylobacter in 
Not-Ready-to-Eat Comminuted Chicken and Turkey Products and Raw Chicken 
Parts and Changes to Related Agency Verification Procedures: Response 
to Comments and Announcement of Implementation Schedule

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: The Food Safety and Inspection Service (FSIS or ``the 
Agency'') is announcing that it will begin assessing whether 
establishments meet the pathogen reduction performance standards for 
Salmonella and Campylobacter in raw chicken parts and not-ready-to-eat 
(NRTE) comminuted chicken and turkey products. It will also begin 
posting, based on FSIS sampling results and depending on the standard 
for the particular product, whether an establishment meets the FSIS 
pathogen reduction performance standards, or what category an 
establishment is in. This notice also responds to comments received on 
the January 2015 Federal Register notice that proposed the standards 
and announced changes to FSIS's verification sampling program.

DATES: FSIS will begin assessing whether establishments meet the new 
pathogen reduction performance standards for chicken parts and 
comminuted chicken and turkey products on May 11, 2016. Also beginning 
no sooner than May 11, 2016, FSIS will begin posting on its Web site 
the category status of all eligible establishments subject to the 
existing poultry carcass pathogen reduction performance standards based 
on sample results from May 2015 (when FSIS stopped set-based, 
consecutive day testing and began routine sampling throughout the year 
of broiler and turkey carcasses) to the present. See the SUPPLEMENTARY 
INFORMATION section for more information about implementation dates.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495, or by Fax: (202) 720-2025.

SUPPLEMENTARY INFORMATION:

Background

    FSIS is responsible for verifying that the nation's commercial 
supply of meat, poultry, and egg products is safe, wholesome, and 
properly labeled and packaged.
    As FSIS explained in the January 26, 2015 (80 FR 3940), Federal 
Register notice (``January 2015 notice'') in which the Agency proposed 
the new pathogen reduction performance standards, Salmonella and 
Campylobacter bacteria are among the most frequent causes of human 
foodborne illness in the United States. Currently, events that cause 
contamination of raw carcasses cannot be eliminated through the 
commercial production and slaughter practices employed by the U.S. 
industry. Contamination can be minimized, however, with the use of 
proper sanitary dressing procedures and by the application of 
interventions during slaughter and fabrication of the carcasses into 
parts and comminuted product.
    Significantly, even though FSIS set standards for ground turkey and 
chicken in 1996 (61 FR 38806; July 25, 1996), the Agency has not set 
standards for other comminuted chicken and turkey products. These 
products have been associated with outbreaks (see 77 FR 72686; December 
6, 2012). In addition, the Agency has not set a standard for chicken 
parts even though about 80 percent of chicken product is in the form of 
raw chicken parts fabricated from broiler carcasses (80 FR at 3941; 
January 26, 2015).
    In the absence of standards, the Salmonella and Campylobacter 
present on raw poultry will survive on that product if it is not 
subjected to a full lethality treatment such as thorough cooking. In 
addition, cross contamination occurs when bacteria (such as Salmonella 
or Campylobacter) are spread from a contaminated source--a contaminated 
food or an infected food handler--to other foods or objects in the 
environment (80 FR 3940; January 26, 2015). FSIS will monitor the 
sampling results and the Centers for Disease Control and Prevention 
(CDC) illness data to evaluate the industry's progress in reducing 
product contamination and reducing illnesses.
    A reduction in illness rates should result from the implementation 
of these performance standards because a smaller proportion of raw 
chicken parts and NRTE comminuted chicken and turkey products will 
likely be contaminated with Salmonella and Campylobacter than has been 
the case without standards (80 FR at 3942; January 26, 2015).
    Recognizing the need for standards, FSIS began sampling and testing 
NRTE comminuted chicken and turkey products on June 1, 2013.\1\ The 
Agency posted the aggregate results of this testing as part of its 
quarterly Salmonella report.\2\
---------------------------------------------------------------------------

    \1\ This sampling and testing for Salmonella and Campylobacter 
did not include heat-treated NRTE comminuted chicken or turkey.
    \2\ http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/quarterly-reports-salmonella.
---------------------------------------------------------------------------

    In addition, FSIS conducted the Nationwide Microbiological Baseline 
Data Collection Programs: Raw Chicken Parts Baseline Survey, from 
January 2012 to August 2012, to estimate the percent positive of 
various raw chicken parts sampled and the levels of Salmonella, 
Campylobacter, and indicator bacteria on these products. FSIS used this 
information to estimate the national prevalence of Salmonella and 
Campylobacter in four pound portions of raw chicken parts. An overview 
of the Raw Chicken Parts Baseline Survey is available at http://www.fsis.usda.gov/wps/wcm/connect/a9837fc8-0109-4041-bd0c-729924a79201/Baseline_Data_Raw_Chicken_Parts.pdf?MOD=AJPERES.
    In the January 2015 notice, FSIS also announced and requested 
comment on proposed pathogen reduction performance standards for 
Salmonella and Campylobacter in raw chicken parts and NRTE comminuted 
chicken and turkey products (80 FR at 3946; January 26, 2015). FSIS 
developed these proposed standards using the baseline data for parts 
and the on-going sampling data for NRTE comminuted chicken and turkey 
products. It also factored in what reduction in these two pathogens 
would be necessary to meet the Healthy People 2020 (HP2020) goals. The 
Agency developed Salmonella performance standards that would achieve at 
least a 30 percent reduction in illness rates from Salmonella for 
chicken parts, comminuted chicken, and comminuted turkey. FSIS 
developed a Campylobacter standard for chicken parts and comminuted 
chicken that it estimated would achieve a 33 percent reduction in 
illness rates.
    Because FSIS found the prevalence for Campylobacter in 325 gram 
samples of comminuted turkey to be especially low, the highest 
practical reduction in illness rates for this product without 
establishing a zero-tolerance standard was estimated to be 19 percent. 
So, the reduction in illness rates estimated for the proposed standard 
for this one product-pathogen pair was less than the Healthy People 
goal of a 33-percent reduction (80 FR at 3942; January 26, 2015).
    In the same Federal Register notice, for all FSIS-regulated 
products subject

[[Page 7286]]

to Salmonella and Campylobacter verification testing, FSIS announced 
that it would begin using routine, random sampling throughout the year 
rather than the set-based consecutive day approach that it had used in 
the past (80 FR at 3945; January 26, 2015), and that it would assess 
performance using a moving window of FSIS sampling results (80 FR at 
3946). FSIS explained that it intended to collect samples on a weekly 
basis in high volume establishments and less frequently in lower volume 
establishments. In addition, FSIS announced that it would begin 
exploratory sampling of raw chicken parts (80 FR at 3945), raw pork 
products (80 FR at 3942), and imported raw poultry products (80 FR at 
3944).
    Finally, FSIS announced that it intended to post the category 
status for all eligible establishments because web-posting provides the 
public with the tools and information it needs to make informed food 
safety decisions (80 FR at 3948). Because a pathogen reduction 
performance standard already exists for young chicken (broiler) and 
turkey carcasses, FSIS announced that it would begin web-posting 
individual establishment category information for these establishments 
after it had considered the comments it received. FSIS stated that it 
would assess what category these establishments are in using combined 
historical set data and sample results beginning March 2015.
    In response to a coalition of trade associations that requested 
that FSIS extend the comment period to provide additional time to 
formulate meaningful comments, FSIS extended the comment period by an 
additional 60 days to May 26, 2015 (80 FR 12618; March 10, 2015).
    The coalition also requested that FSIS extend all implementation 
dates announced in the January 2015 notice. The Agency did not delay 
implementation of all actions announced in the January 2015 notice 
because FSIS made available much of the information in that notice in 
other Federal Register notices.\3\ Therefore, in March 2015, FSIS began 
sampling raw chicken parts to gain information on the prevalence of 
Salmonella and Campylobacter (in four pound sample units) of those 
products and to gain experience in scheduling, collecting, and 
analyzing raw chicken parts for these pathogens.\4\ In April 2015, FSIS 
began sampling raw pork products for pathogens of public health 
concern, as well as for indicator organisms.\5\ In May 2015, FSIS began 
routine sampling, rather than set-based consecutive day sampling, of 
young chicken (broiler) and turkey carcasses.\6\ FSIS began sampling 
imported poultry carcasses, imported raw chicken parts, and imported 
NRTE comminuted chicken and turkey for Salmonella and Campylobacter in 
July 2015.\7\ FSIS has begun posting aggregate results from this 
testing as part of its quarterly Salmonella report.\8\
---------------------------------------------------------------------------

    \3\ 78 FR 53017; Aug. 28, 2013, and 79 FR 32436; Jun. 5, 2014.
    \4\ FSIS Notice 16-15; http://www.fsis.usda.gov/wps/wcm/connect/5233e84c-f4a6-4959-b861-926a4d912eff/16-15.pdf?MOD=AJPERES.
    \5\ FSIS Notice 23-15; http://www.fsis.usda.gov/wps/wcm/connect/41f2bd6b-2c06-4384-935d-2ac31e3e77e9/23-15.pdf?MOD=AJPERES.
    \6\ FSIS Notice 22-15; http://www.fsis.usda.gov/wps/wcm/connect/3379df49-cc8d-47f7-83c3-d4d802668f6c/22-15.pdf?MOD=AJPERES.
    \7\ FSIS Notice 32-15; http://www.fsis.usda.gov/wps/wcm/connect/41a60d0e-060e-479c-a2c0-4096d8a542f2/32-15.pdf?MOD=AJPERES.
    \8\ http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/quarterly-reports-salmonella.
---------------------------------------------------------------------------

    Because FSIS needed additional time to fully evaluate the comments 
submitted on posting information on establishment performance under the 
standards, FSIS did delay, and has yet to web-post, individual 
establishment information for establishments subject to poultry carcass 
sampling. On August 14, 2015, FSIS announced that it was temporarily 
removing the Category 3 list from its Web site until the new moving 
window sampling procedure is fully implemented.\9\
---------------------------------------------------------------------------

    \9\ http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/constituent-updates/archive/2015/ConstUpdate081415.
---------------------------------------------------------------------------

Final Performance Standards, Follow-up Sampling, Food Safety 
Assessments, and Establishment Posting

    FSIS will begin assessing whether establishments meet the new 
pathogen reduction performance standards on May 11, 2016. The new 
standards are:

----------------------------------------------------------------------------------------------------------------
                                    Maximum acceptable percent                Performance standard *
                                             positive            -----------------------------------------------
             Product             --------------------------------
                                    Salmonella     Campylobacter        Salmonella             Campylobacter
----------------------------------------------------------------------------------------------------------------
Comminuted Chicken (325 g                   25.0             1.9  13 of 52..............  1 of 52
 sample).
Comminuted Turkey (325 g sample)            13.5             1.9  7 of 52...............  1 of 52
Chicken Parts (4 lb. sample)....            15.4             7.7  8 of 52...............  4 of 52
----------------------------------------------------------------------------------------------------------------
* FSIS intends to interpret results within a moving window comprising fewer than 52 samples (n) by establishing
  a number of positive samples (s) such that (s-1)/n < p <= s/n, where p is the maximum percent positive that
  would meet the performance standards.

    These standards are the same as what FSIS proposed in the January 
2015 notice.
    Following publication of that notice, FSIS continued sampling and 
testing comminuted poultry products for Salmonella and Campylobacter. 
Also, as noted above, FSIS implemented ongoing sampling and testing of 
chicken parts for Salmonella and Campylobacter. FSIS found no notable 
difference between the results from this testing and the earlier test 
results for comminuted product and the chicken parts baseline results. 
Therefore, FSIS has made no changes to the standards based on these 
additional test results.
    In addition, consistent with the January 2015 notice, FSIS will 
collect samples based on the volume of production at an establishment. 
FSIS will sample eligible product from the largest-volume 
establishments four or five times per month (once per week), on 
average, and will decrease incrementally the number of samples it 
collects from establishments producing less volume. FSIS may sample a 
small number of establishments up to six times per month. The frequency 
will be determined on the basis of their production volume and history 
of sampling results.\10\ Establishments likely to get six samples are 
those that produce high volumes of several products. Furthermore, FSIS 
will attempt to collect at least the minimum number of samples outlined 
in the chart below per year in order to assess process control in all 
establishments subject to performance standards.
---------------------------------------------------------------------------

    \10\ http://www.fsis.usda.gov/wps/wcm/connect/99b43489-0e14-40c0-b13e-53163d68bf1f/Sampling-Program-Plan-FY2016.pdf?MOD=AJPERES.

[[Page 7287]]



------------------------------------------------------------------------
                                           Minimum number of samples to
                                            assess process control in a
                 Product                           moving window
                                         -------------------------------
                                            Salmonella     Campylobacter
------------------------------------------------------------------------
Broiler Carcass.........................              11              10
Turkey Carcass..........................              14              19
Comminuted Chicken......................              10              52
Comminuted Turkey.......................              10              52
Chicken Parts...........................              10              13
------------------------------------------------------------------------

    Because the Salmonella performance standard for broiler carcasses 
is 9.8 percent positive or less, FSIS has changed the minimum number of 
Salmonella samples to assess process control in a moving window for 
broiler carcasses to eleven. The minimum number identified in the 
January 2015 notice (10) would have effectively allowed zero positives. 
This would have constituted a zero tolerance standard. FSIS did not 
want to create a zero tolerance standard but did want to maintain the 
level of precision that underlay the proposal. FSIS accomplished this 
by increasing the minimum number of samples collected for Salmonella on 
broiler carcasses by one.
    Consistent with what FSIS announced in the January 2015 Federal 
Register notice, the moving window for all products will be 52 weeks. 
However, the number of samples collected in the window can vary, 
depending on the volume of the product the establishment produces, and 
depending on whether FSIS collects follow up samples in response to an 
establishment not meeting the standard. Therefore, FSIS will assess 
establishment performance based on the maximum acceptable percent 
positive.
    Because the comminuted chicken and turkey pathogen reduction 
performance standards permit only one positive result for Campylobacter 
in order to pass the standard, essentially eliminating Category 2, FSIS 
will only categorize eligible establishments producing these products 
as either passing or failing. FSIS will categorize establishments 
following the criteria below:

    I. Category 1. Consistent Process Control: Establishments that 
have achieved 50 percent or less of the Salmonella or Campylobacter 
maximum allowable percent positive during all completed 52-week 
moving windows over the last three months.
    II. Category 2. Variable Process Control: Establishments that 
meet the Salmonella or Campylobacter maximum allowable percent 
positive for all completed 52-week moving windows but have results 
greater than 50 percent of the maximum allowable percent positive 
during any completed 52-week moving window over the last three 
months.
    III. Category 3. Highly Variable Process Control: Establishments 
that have exceeded the Salmonella or Campylobacter maximum allowable 
percent positive during any completed 52-week moving window over the 
last three months.
    IV. Passing. Establishments that meet the Campylobacter maximum 
allowable percent positive for NRTE comminuted chicken or turkey 
during all completed 52-week moving windows over the last three 
months.
    V. Failing. Establishments that have exceeded the Campylobacter 
maximum allowable percent positive for NRTE comminuted chicken or 
turkey during any completed 52-week moving window over the last 
three months.

Note that when FSIS collects multiple samples within a week, all those 
samples will be included in the window for that week.
    In the January 2015 notice, FSIS stated that it intended to 
determine categories based on moving windows over the last six months. 
FSIS is changing this timeframe to every three months to provide more 
timely information on the establishment's status. As FSIS explained in 
the January 2015 notice, FSIS has determined that a 6-month time 
component will have minimal impact on the categorization of 
establishments that are most likely to meet the standard (80 FR at 
3947). Similarly, the 3-month time component will have minimal effect 
on establishments that are most likely to meet the standard.
    As part of its verification sampling program, consistent with its 
exploratory sampling program for comminuted product, FSIS will collect 
finished NRTE ground chicken and turkey and other types of NRTE 
comminuted chicken and turkey products. FSIS will not sample dumplings, 
wontons, egg rolls, or other comminuted chicken or turkey products 
wrapped in dough or other similar covering at this time. However, FSIS 
will sample raw sausage in casing.
    FSIS will continue to sample mechanically separated chicken and 
turkey that is not intended to be processed into a ready-to-eat (RTE) 
product in a domestic official establishment, just as it has done 
during the on-going exploratory testing. At this time, mechanically 
separated poultry will not be subject to the pathogen reduction 
performance standard for comminuted poultry. Given that mechanically 
separated chicken and turkey are not typically added to NRTE comminuted 
poultry products, results for these products were not used in 
developing the Salmonella contamination distribution used in the risk 
assessment (80 FR at 3943; January 26, 2015).
    FSIS may consider implementing a pathogen reduction performance 
standard for mechanically separated poultry in the future, particularly 
if there is evidence that this product is being used in domestic NRTE 
product available to consumers, if the FSIS results for this product 
exhibit an unchanged or upward trend in positives, or if there is 
evidence that industry is not taking steps to reduce contamination of 
source carcass frame materials within the year following the 
publication of this notice. FSIS is concerned about the ongoing 
wholesomeness of this product if establishments do not take steps to 
reduce the high frequency of contamination of mechanically separated 
poultry,\11\ even if it is to be used in a finished product that is 
RTE. FSIS recommends that the industry at least begin implementing 
quality control procedures for ensuring that extraneous materials, 
including intestinal tract and other internal organ fragments, do not 
contaminate the source carcass frames regardless of whether or not the 
product is destined for RTE processing. These steps, at a minimum, will 
better ensure the wholesomeness of the product.
---------------------------------------------------------------------------

    \11\ From January 1, 2015, through March 31, 2015, the percent 
positive rate for Salmonella in mechanically separated chicken was 
88.52 percent and for mechanically separated turkey was 52.78 
percent. (Available at http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/quarterly-reports-salmonella/quarterly-progress-reports.)
---------------------------------------------------------------------------

    Consistent with the January 2015 notice, FSIS will sample the 
following chicken parts to assess whether they meet the standards: legs 
(comprised of the drumstick and thigh portions either

[[Page 7288]]

separately or combined), wings, and breasts.
    Also, consistent with what it announced in the January 2015 notice, 
as soon as practical after May 11, 2016, FSIS will begin sampling 3-4 
times per year product that has been excluded from Salmonella 
verification testing: chicken in poultry slaughter establishments 
operating under a religious exemption; the minor species carcasses 
under FSIS jurisdiction and inspection (species other than chicken, 
turkey, pork, and cattle, such as squab, ratites, goose and lamb); and 
product otherwise eligible for sampling that FSIS has excluded because 
it is produced in low volume establishments that produce 1,000 pounds 
or less per day. FSIS expects to eventually implement pathogen 
reduction performance standards to assess process control for these 
products. However, before FSIS begins using these sample results to 
assess whether establishments previously excluded from verification 
sampling meet performance standards, it will provide notice and request 
comment on such standards in the Federal Register. Meanwhile, FSIS will 
treat these sample results as separate populations and report the 
aggregate results quarterly, including such information as percentage 
positive at the 25th, 50th, and 75th percentile.
    No sooner than May 11, 2016, FSIS will begin web-posting the 
category status of all establishments subject to the existing poultry 
carcass pathogen reduction performance standards. At that time, FSIS 
will post these establishments' Salmonella and Campylobacter category 
status based on sample results from May 2015 (when FSIS began routine 
sampling of broiler and turkey carcasses) to the present.
    After completion of the first year of sampling (i.e., the first 52-
week moving window), for chicken parts and comminuted poultry products 
subject to sampling under the new pathogen reduction performance 
standards, FSIS will begin web-posting whether, based on FSIS results, 
the establishment is passing, or what category the establishment is in, 
depending on the standard for the particular product. However, based on 
at least the minimum number of samples to assess process control for 
that product/pathogen pair and other available information about 
establishments, such as noncompliance rates, if establishment 
performance overall does not improve or appears to be worsening before 
the completion of the first moving window, FSIS may begin web-posting 
individual establishment category information sooner.
    In the January 2015 notice, FSIS announced that it intended to web-
post the categories for all establishments subject to the Campylobacter 
pathogen reduction performance standards. However, because, as comments 
pointed out, the comminuted chicken and turkey pathogen reduction 
performance standards permit only one positive result for Campylobacter 
in order to pass the standard, essentially eliminating Category 2, FSIS 
will not, at this time, web-post the category status of individual 
establishments that do not meet the Campylobacter standard for 
comminuted chicken or turkey products (i.e., those in Category 3). 
Instead, FSIS will web-post whether the eligible establishment is 
passing or failing. Consistent with the January 2015 notice, FSIS will 
update individual establishment postings on a monthly basis.
    Starting August 9, 2016, FSIS will web-post quarterly aggregate 
information relative to categories for all establishments subject to 
sampling under the new performance standards for which FSIS has 
collected the minimum number of samples, using the most recent sample 
results. This information will be aggregated and will not single out 
any specific establishment. This information will give industry and 
other stakeholders timely information about progress being made to 
reduce contamination in NRTE poultry of all types sampled. FSIS will 
also web-post calendar year prevalence estimates in its Salmonella and 
Campylobacter annual report. Results of follow-up sampling will be 
excluded for the purposes of these prevalence estimates. FSIS will not 
include follow-up sampling in prevalence estimates because these 
samples are non-random and targeted.
    FSIS will schedule a Public Health Risk Evaluation (PHRE), and 
possibly a Food Safety Assessment (FSA), based on FSIS test results, 
for establishments that do not meet the pathogen reduction performance 
standards; for establishments that have produced products with 
repetitive Salmonella or Campylobacter serotypes of public health 
concern or repetitive antibiotic resistant Salmonella; and for 
establishments with Salmonella or Campylobacter pulsed-field gel 
electrophoresis (PFGE) (or whole-genome sequencing, as it becomes 
available) patterns matching those found in recent outbreaks or 
epidemiologically linked to illnesses. FSIS intends to do the PHRE 
because it can reasonably be inferred that establishments in these 
categories have not adequately addressed Salmonella or Campylobacter in 
their Hazard Analysis and Critical Control Point (HACCP) systems. Based 
on PHRE analysis, FSIS will determine whether to schedule a FSA \12\ at 
the establishment.
---------------------------------------------------------------------------

    \12\ The purpose of an FSA is to assess and analyze an 
establishment's food safety system to verify that the establishment 
is able to produce safe and wholesome meat or poultry products in 
accordance with FSIS statutory and regulatory requirements.
---------------------------------------------------------------------------

    FSIS will collect 16 or 8 follow-up samples (depending on the 
product volume) on a daily or per shift basis, as soon as possible 
after an establishment has not met a pathogen reduction performance 
standard. The follow-up samples will count towards the samples 
collected as part of the moving window procedure for that 
establishment. In the January 2015 notice, FSIS stated that it did not 
intend to count the follow up samples in the moving window for 
assessing whether establishments are meeting the standards. FSIS has 
decided to change its approach so that it can more quickly assess 
whether establishments have regained process control, and because, when 
establishments have regained control, FSIS believes their posted 
category status should reflect that fact. FSIS is also making this 
change in response to comments.
    As we currently do for outbreak investigations, for at least 90 
days after an establishment has not met a standard, FSIS will monitor 
CDC PulseNet database for matching food isolates to those obtained by 
FSIS in its sampling of products produced by the establishment. This 
monitoring will give FSIS early warning if an outbreak involving the 
establishment's products is developing. Moreover, as new tools such as 
whole genome sequencing become available, FSIS will also search for 
official sequencing databases matches between FSIS-regulated NRTE 
products and human illness. FSIS will alert its public health partners 
when an establishment does not meet the standard, so that they can also 
be on the lookout for an emerging outbreak. In addition, FSIS may 
collect the consignee list for product produced when an establishment 
has not met the standard so that the Agency can focus its attention on 
the area in which the product was distributed.
    Consistent with existing practices,\13\ after notifying an 
establishment that it has not met a performance standard, FSIS will 
conduct an assessment of the establishment's HACCP plan and

[[Page 7289]]

Sanitation Standard Operating Procedures, through a PHRE, focusing on 
the establishment's planned corrective actions. In addition, FSIS will 
develop a plan to verify whether the establishment implemented 
corrective actions. FSIS may also conduct a FSA, when it deems it 
appropriate. If, after 90 days, the establishment has not been able to 
gain process control, as determined from FSIS's follow-up sampling and 
from the results of the PHRE or FSA, and the establishment has not 
taken corrective actions, FSIS will likely take enforcement actions, 
such as by issuing a Notice of Intended Enforcement (NOIE) or by 
suspending inspection, under the conditions and according to the 
procedures described in 9 CFR part 500. FSIS will not issue an NOIE or 
suspend inspection based solely on the fact that an establishment did 
not meet a performance standard.
---------------------------------------------------------------------------

    \13\ FSIS stated in a Federal Register notice published April 
16, 2003 (68 FR 18593), that it was using Salmonella sample-set 
failures as an indication that there is something wrong in the 
establishment's HACCP system, and that the system needs to be 
carefully evaluated by the Agency.
---------------------------------------------------------------------------

    If the establishment produced product associated with an outbreak, 
even if the establishment is in category 1, FSIS will scrutinize its 
corrective actions with particular care, including performing an 
Incident Investigation Team review (see FSIS Directive 5500.3).
    Generally, if an establishment produces product associated with an 
outbreak or has failed to meet a pathogen reduction performance 
standard for Salmonella or Campylobacter and has not addressed those 
hazards in its HACCP plan, the establishment would need to reassess its 
HACCP plan for that product to determine whether the plan needs to be 
modified to address the hazard (9 CFR 417.3(b)). Thus, the 
establishment, to maintain an adequate HACCP system, will have to 
address the pathogen in its HACCP plan, rather than through a 
prerequisite program like the Sanitation Standard Operating Procedures.
    Finally, consistent with FSIS testing of imported beef and poultry 
products for pathogens, FSIS will begin testing imported pork for 
Salmonella later in Fiscal Year 2016 (FY2016).

Summary of Implementation Dates

    FSIS will begin assessing whether establishments meet the new 
pathogen reduction performance standards for chicken parts and 
comminuted chicken and turkey products on May 11, 2016. Also beginning 
no sooner than May 11, 2016, FSIS will begin posting on its Web site 
the category status of all eligible establishments subject to the 
existing poultry carcass pathogen reduction performance standards based 
on sample results from May 2015 (when FSIS stopped set-based, 
consecutive day testing and began routine sampling throughout the year 
of broiler and turkey carcasses) to the present. After completion of 
the first moving window of product sampled under the new pathogen 
reduction performance standards for chicken parts, comminuted chicken, 
and turkey products (approximately 1 year from publication of this 
notice), FSIS will begin web-posting whether individual establishments 
are in Category 1, 2, or 3, or whether they are passing the standards 
(in the case of NRTE comminuted chicken or turkey for Campylobacter). 
However, based on at least the minimum number of samples to assess 
process control for that product/pathogen pair and other available 
information about establishments, such as noncompliance rates, if 
establishment performance overall does not improve or appears to be 
worsening before the completion of the first moving window, FSIS may 
begin web-posting individual establishment category information sooner. 
As soon as practical after May 11, 2016, FSIS will begin sampling 3-4 
times per year the following products which have been excluded from 
Salmonella verification testing: Broilers produced in poultry slaughter 
establishments operating under a religious exemption, minor species 
carcasses (minor species are those other than classes of chicken, 
turkey, pork and beef for which FSIS has previously set pathogen 
reduction performance standards and that are produced and consumed in 
larger quantities than other classes of these species or other species 
under FSIS jurisdiction and inspection, such as squab, ratites, lamb, 
and goose), and product from low volume establishments that produce up 
to 1,000 pounds per day of poultry product subject to sampling. This 
fiscal year, FSIS will also begin sampling imported pork products for 
Salmonella.

Summary of Comments and Responses

    In the January 2015 notice, FSIS requested comment on specific 
issues: The proposed pathogen reduction performance standards for 
Salmonella and Campylobacter in raw chicken parts and NRTE comminuted 
chicken and turkey products; sampling of raw chicken parts that have 
been marinated or injected; the Agency's implementation strategy, 
including how it plans to assess process control in low volume 
establishments and the planned modifications to its categorization 
system; how it plans to web-post the category status of eligible 
establishments; and the accuracy of the information and assumptions 
used in its cost-benefit analysis. FSIS received 15 comments in 
response to these and other issues in the notice. The comments were 
from consumer advocacy groups, organizations representing the meat/
poultry industry, meat/poultry processors, a food ingredient supplier, 
and an individual.
    FSIS has summarized and responded to the relevant issues raised by 
commenters below.

A. General Comments on Actions Announced in the Notice

    Comments: Many comments from both industry and consumer groups 
supported FSIS establishing pathogen reduction performance standards 
for Salmonella and Campylobacter in NRTE chicken parts and comminuted 
chicken and turkey products because the commenters agreed that the 
standards are likely to benefit public health. In addition, many 
comments supported FSIS replacing set-based, consecutive-day sampling 
with routine sampling, including weekly sampling in high volume 
operations, and using a moving window approach for assessing process 
control to gain a better sense of ongoing establishment performance. 
Likewise, several comments supported FSIS using a more sensitive 
enrichment-based method to analyze samples for Campylobacter, sampling 
imported raw chicken products, and sampling raw chicken parts other 
than breasts, legs, and wings to better understand the incidence of 
Salmonella and Campylobacter in these products and to assess whether 
additional performance standards may be needed. Finally, several 
comments supported FSIS's planned action to web-post the individual 
category status of establishments subject to FSIS sampling to assess 
whether they meet performance standards because it will provide the 
public with specific, geographical, and process capability information 
and will provide industry with incentives for making changes to their 
operations or from whom they purchase source materials.
    Meanwhile, other commenters, mostly representing industry 
interests, generally were opposed to the issuance of new pathogen 
reduction performance standards and to web-posting individual 
establishment performance.
    Response: FSIS has determined that it is prudent to issue of new 
pathogen reduction performance standards and to web-post establishment-
specific performance as noted in detail below.

B. Proposed Performance Standards

    Comment: An organization representing the chicken industry objected 
to the method and scientific evidence used to develop the

[[Page 7290]]

performance standards. Rather than use the Healthy People 2020 (HP2020) 
goals to set the standards, the organization argued that FSIS should 
identify the most significant sources of illnesses from these pathogens 
and focus its resources on these products. In addition, the 
organization argued that chicken and turkey are not the most 
significant sources of illnesses associated with these pathogens.
    Response: The Healthy People Initiatives have served as a science-
based framework for public health activities by FSIS, CDC, the Food and 
Drug Administration, and across other sections of the public health 
community for years. Furthermore, FSIS disagrees that the proposed 
pathogen reduction performance standards were not based on sufficient 
valid scientific evidence. Using a common analytical framework,\14\ 
FSIS developed the standards based on a variety of data sources, 
including Agency sampling data, the CDC foodborne illness and outbreak 
data, and the most recent available research, as well as the HP2020 
national health objectives.
---------------------------------------------------------------------------

    \14\ http://www.fsis.usda.gov/wps/wcm/connect/afe9a946-03c6-4f0d-b024-12aba4c01aef/Effects-Performance-Standards-Chicken-Parts-Comminuted.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    Recent research supports that poultry represents the largest 
fraction of Salmonella and Campylobacter illnesses attributed to FSIS-
regulated products.\15\ \16\ \17\ Furthermore, data from the National 
Antimicrobial Resistance Monitoring System (NARMS) show that the 
incidence of Salmonella in poultry products is five to ten times higher 
than that in ground beef or pork chops.\18\ Because FSIS can only 
directly affect those food commodities that fall under its 
jurisdiction, FSIS is addressing the product it regulates that poses 
the highest public health risk.
---------------------------------------------------------------------------

    \15\ Batz, M.B., et al. 2012. ``Ranking the disease burden of 14 
pathogens in food sources in the United States using attribution 
data from outbreak investigations and expert elicitation.'' J. Food 
Prot 75(7):1278-91.
    \16\ Painter, J.A., et al. 2013. ``Attribution of foodborne 
illnesses, hospitalizations, and deaths to food commodities by using 
outbreak data, United States, 1998-2008.'' Emerg Infect Dis 19(3): 
407-15.
    \17\ Interagency Food Safety Analytics Collaboration, 2015. 
``Foodborne Illness Source Attribution Estimates for Salmonella, 
Escherichia coli O157:H7, Listeria monocytogenes, and Campylobacter 
using Outbreak Surveillance Data.''
    \18\ Table 6 in NARMS. 2013. Retail Meat Report 2011. At: http://www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/UCM334834.pdf.
---------------------------------------------------------------------------

    In addition, evidence of the connection of salmonellosis and 
contaminated NRTE comminuted poultry products can be found in the 
recent outbreaks that have been associated with these products. In 
2011, there were two outbreaks involving ground turkey product. The 
2011 Salmonella Hadar outbreak associated with turkey burgers sickened 
12 people in 10 states and led to a recall of 54,960 pounds of turkey 
burger.\19\ The 2011 Salmonella Heidelberg outbreak associated with 
ground turkey product sickened 136 people in 34 states and led to one 
death. Approximately 36 million pounds of ground turkey were ultimately 
recalled.\20\ The CDC reported a 2013-2014 Salmonella Heidelberg 
illness outbreak associated with the consumption of chicken parts that 
sickened 634 people in 29 states and Puerto Rico.\21\
---------------------------------------------------------------------------

    \19\ http://www.fsis.usda.gov/wps/wcm/connect/fsis-archives-content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archives/ct_index295a.
    \20\ http://www.cdc.gov/salmonella/2011/ground-turkey-11-10-2011.
    \21\ http://www.cdc.gov/salmonella/heidelberg-10-13/.
---------------------------------------------------------------------------

    In addition, in 2015, the CDC investigated two separate outbreaks 
of Salmonella Enteritidis infections linked to raw, frozen, stuffed 
chicken entrees associated with two separate establishments that 
produced these products. These two outbreaks stemmed from poultry 
product in which the source materials were either comminuted chicken 
breast meat or whole chicken breast parts and resulted in twelve 
illnesses and five hospitalizations. In both outbreaks, the 
establishment involved did not consider implementing effective controls 
for the source materials or for the production process to know the 
frequency of contamination of source materials with Salmonella.
    Thus, FSIS has concluded, using the available data and the public 
health science principles contained in a quantitative risk assessment, 
that adopting new pathogen reduction performance standards for 
comminuted poultry and chicken parts to reduce the Salmonella on these 
types of products would reduce consumer exposure to this pathogen and 
thus reduce the occurrence of illness.
    Comment: An organization representing the turkey industry stated 
that the industry has already made great strides in lowering illness 
that, according to the commenter, FSIS did not account for in setting 
the standards. This organization also stated that it will be very 
difficult to achieve further reduction in illness through the proposed 
NRTE comminuted turkey product standards.
    Response: FSIS agrees that the turkey industry, particularly, has 
collectively taken steps to reduce the incidence of pathogens in 
comminuted product following the Salmonella Heidelberg multistate 
outbreak in 2011 that infected more than 100 individuals. Nonetheless, 
setting pathogen reduction performance standards is an important tool 
in targeting reductions and in protecting public health, and FSIS has 
decided to proceed to do so.
    In setting the performance standards, FSIS did not explicitly 
account for the decrease in pathogen contamination observed following 
the Salmonella Heidelberg outbreak. To do this, FSIS would have needed 
to use the most up-to-date attribution data. Given that there is about 
a two year lag in the CDC outbreak data, it was not possible for the 
Agency to do so. FSIS did, however, use the most up-to-date published 
attribution data available (Painter et al., 2013). In addition, FSIS 
used the most recent contamination data available at the time it 
developed the performance standards (2013-2014). These contamination 
data reflect some of the reduction in pathogen contamination seen in 
comminuted turkey.
    Still, FSIS recognizes that the performance standard for 
Campylobacter, allowing only one positive sample in the moving window, 
is quite rigorous. Regardless, such a performance standard is necessary 
to maintain industry focus on continuous improvement. However, as 
discussed later in this document, FSIS has agreed that, because the 
comminuted chicken and turkey pathogen reduction performance standards 
permit only one positive result for Campylobacter in order to pass the 
standard, there is no Category 2. Thus, FSIS will web-post these 
establishments as either passing or failing.
    Comment: Several comments criticized the proposed pathogen 
reduction performance standards for comminuted poultry because they 
were not based on a full year of data. The commenters also stated that 
the standards were based on data from the high prevalence season for 
the pathogens.
    Response: At the time that the pathogen reduction performance 
standards for comminuted poultry were developed and subsequently 
published, the standards were based on eight months of data. Meanwhile, 
FSIS has analyzed the first twelve months of data for NRTE comminuted 
chicken and turkey and compared the results to that of the 8-month 
analysis.\22\ FSIS found

[[Page 7291]]

no notable difference between these results and earlier test results 
for comminuted product. Therefore, FSIS made no changes to the 
standards based on these additional test results.
---------------------------------------------------------------------------

    \22\ Additional data is available at http://www.fsis.usda.gov/wps/wcm/connect/25bc47ad-d59d-48d6-b90f-4865d1483f4a/Q2-CY2014-Salmonella-Testing.pdf?MOD=AJPERES (see Table 8a and 8b).
---------------------------------------------------------------------------

    However, FSIS acknowledges that setting the performance standards 
on data from a true high prevalence season (i.e., a period in which 
there was more frequent exposure of the public to pathogens of public 
health concern) could create an unintended consequence of permitting 
more exposure of the public to pathogens of public health concern 
during a true low prevalence season. FSIS's published analysis of 
seasonal patterns of Salmonella contamination in FSIS regulated 
products did not identify a significant seasonal pattern in ground 
chicken or turkey.\23\ Therefore, FSIS concludes that the performance 
standards have been appropriately designed, and that no change is 
necessary.
---------------------------------------------------------------------------

    \23\ Williams, M.S., et al. (2014). Temporal Patterns in the 
Occurrence of Salmonella in Raw Meat and Poultry Products and Their 
Relationship to Human Illnesses in the United States. Food Control 
35, 267-273.
---------------------------------------------------------------------------

    Comment: As more data become available (and regularly thereafter), 
several consumer advocacy groups requested that FSIS re-evaluate the 
performance standards. In addition, comments requested that FSIS assess 
whether the performance standards need to be updated to account for the 
actual compliance fraction and other assumptions made during initial 
calculations. The comments also requested that FSIS periodically 
measure the impact of the performance standards on public health goals.
    Response: FSIS will periodically assess the effect of the 
performance standards. This assessment will include an estimation of 
all the parameters used in the risk assessment model and their 
contribution to a potential reduction in illnesses. FSIS will assess 
each pathogen reduction performance standard on at least a five-year 
basis to determine whether the standard should be adjusted. FSIS will 
calculate ongoing pathogen prevalence for all products subject to 
standards and will determine whether the pathogen prevalence has been 
significantly reduced in deciding whether to revise the performance 
standards.
    Comment: A consumer advocacy group requested that FSIS also 
establish a performance standard for live animals entering the 
slaughter facility.
    Response: FSIS disagrees that it should establish pathogen 
reduction performance standards for live animals because FSIS does not 
have jurisdiction on the farm and has not conducted testing on live 
animals. However, FSIS does recommend that establishments develop 
pathogen prevention targets for products derived from live animals that 
an establishment would apply as early as safely possible in its 
slaughter process. Sampling at this early stage would enable an 
establishment to determine whether its food safety system is adequately 
designed to mitigate the incoming load of pathogens.
    The rehang or pre-evisceration sampling point used in the FSIS 
carcass baseline best represents the contamination on the carcass 
before there is secondary contamination from the evisceration process. 
FSIS provides information to industry on median indicator organism 
values at rehang in its compliance guide, ``Modernization of Poultry 
Slaughter Inspection--Microbiological Sampling of Raw Poultry'' (June 
2015).\24\ When an establishment compares its rehang or pre-
evisceration sample results to the ones in the table in the compliance 
guide, a sample value that is higher than the corresponding one listed 
in the table indicates that the incoming bacterial load on the bird may 
be higher than expected, and that the establishment may not be able to 
maintain process control. As a result, the establishment would be less 
likely to meet the applicable performance criteria.
---------------------------------------------------------------------------

    \24\ Available at http://www.fsis.usda.gov/wps/wcm/connect/a18d541e-77d2-40cf-a045-b2d2d13b070d/Microbiological-Testing-Raw-Poultry.pdf?MOD=AJPERES
---------------------------------------------------------------------------

    Comments: An organization representing the chicken industry urged 
FSIS to not apply the performance standard for raw chicken parts to any 
products not consistently sampled in the Raw Chicken Parts Baseline 
Survey. The organization stated that FSIS has no basis for concluding 
that the Raw Chicken Parts Baseline Survey is applicable to parts that 
were marinated with a clear solution. If the Agency has a means to 
identify which samples in the Survey were from marinated parts, the 
organization requested that FSIS remove those samples from its 
calculations.
    In addition, the organization stated that necks and giblets should 
not be subject to a pathogen reduction performance standard because 
they are typically sold to (and used by) consumers differently than 
breasts, legs, and wings. However, several consumer advocacy groups 
requested that FSIS apply the pathogen reduction performance standard 
for raw chicken parts to necks, giblets, half carcasses, quarter 
carcasses, and parts injected or marinated with a clear solution until 
the Agency has developed a pathogen reduction performance standard 
specific to those items.
    A consumer advocacy group requested that FSIS establish a sampling 
program for raw chicken livers. The group cited a CDC report detailing 
outbreaks linked to the consumption of chicken livers \25\ as support 
for its request. The group also requested that FSIS sample and develop 
pathogen reduction performance standards for raw turkey parts because 
turkey parts are commonly purchased by consumers.
---------------------------------------------------------------------------

    \25\ Available at http://www.cdc.gov/salmonella/heidelberg-chickenlivers/011112/index.html.
---------------------------------------------------------------------------

    Response: As FSIS explained in the January 2015 Federal Register 
notice, during the baseline some inspection personnel sampled parts 
that were injected with a solution or otherwise marinated (80 FR at 
3943). Because FSIS did not identify the samples as injected or 
otherwise marinated at the time of collection, FSIS is unable to remove 
these results from its calculations and will apply the performance 
standards to marinated, injected, tumbled, or tenderized parts. For its 
ongoing exploratory sampling of parts, FSIS issued instructions to 
inspection program personnel to make explicit that such parts are to be 
sampled.\26\ Based on the first 3-4 months of exploratory chicken parts 
sampling, Salmonella results for injected, tenderized, or vacuum 
tumbled parts were not significantly higher than those for intact 
parts. These products are available to the consumer and do present a 
risk of exposure. FSIS does not believe it appropriate to set a 
different pathogen reduction performance standard for these products 
than for other parts.
---------------------------------------------------------------------------

    \26\ FSIS Notice 16-15; available at http://www.fsis.usda.gov/wps/wcm/connect/5233e84c-f4a6-4959-b861-926a4d912eff/16-15.pdf?MOD=AJPERES
---------------------------------------------------------------------------

    FSIS will not, however, apply the pathogen reduction performance 
standard for raw chicken parts to necks, giblets, half carcasses, and 
quarter carcasses at this time. In FY2016, FSIS will begin exploratory 
sampling of necks, giblets (i.e., gizzards, hearts, and livers), half 
carcasses, and quarter carcasses to better understand the prevalence of 
Salmonella and Campylobacter in these parts. FSIS will post the 
aggregate results of this testing as part of its Salmonella reporting. 
In addition, FSIS plans to analyze these data to better understand the 
potential differences in contamination for gizzards, hearts, and 
livers.

[[Page 7292]]

    FSIS will use these data to determine whether further sampling is 
needed. Such information could then be used by the Agency to decide 
whether pathogen reduction performance standards for these products are 
necessary.
    Comment: An organization representing the chicken industry opposed 
FSIS using the more sensitive, enrichment-based method for 
Campylobacter testing that the Agency is using for comminuted product 
and chicken parts because, according to the commenter, the method 
increases the likelihood of establishments not meeting the performance 
standard when actual prevalence may not have changed.
    Several consumer advocacy groups requested that the performance 
standard for Campylobacter in NRTE comminuted chicken and turkey be 
based on the most sensitive enrichment-based testing method.
    Response: In 2013, FSIS began testing NRTE comminuted poultry for 
Campylobacter using a direct plating method (1 mL test portion). Later, 
in August 2015, FSIS began concurrently analyzing all NRTE comminuted 
poultry samples for Campylobacter using the direct plating method and 
an enrichment-based method (30 mL test portion).\27\ The Agency took 
this step because the enrichment-based method can detect a higher 
percent of positive samples, as determined from the results of an 
analysis comparing the direct plating method with the enrichment-based 
method.
---------------------------------------------------------------------------

    \27\ http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/constituent-updates/archive/2015/ConstUpdate032015.
---------------------------------------------------------------------------

    FSIS found that the 1 mL direct plating method identified about 3-4 
percent Campylobacter-positive samples for comminuted chicken and about 
1 percent Campylobacter-positive samples for comminuted turkey. In 
contrast, the 30 mL enrichment-based method identified about 15 percent 
of the samples Campylobacter-positive in comminuted chicken, i.e. about 
a 4-fold increase in percent positive results between the 30 mL 
enrichment-based method and the 1 mL direct plating method for 
comminuted chicken.\28\ FSIS has not completed a similar evaluation for 
comminuted turkey.
---------------------------------------------------------------------------

    \28\ Though comminuted turkey was not tested in this methods 
comparison, FSIS expects there would also be an increase in the 
Campylobacter percent positive using the enrichment-based method.
---------------------------------------------------------------------------

    Regardless, FSIS developed the pathogen reduction performance 
standards for Campylobacter using a direct plating laboratory method of 
analysis with a 1 mL test portion. Therefore, FSIS will proceed with 
assessing establishment performance relative to those standards based 
on the 1 mL portion size.
    The Agency will continue to perform the 1 mL direct plating method 
alongside the 30 mL enrichment-based method and analyze data generated 
from both analytical approaches. These analyses will show whether 
significant differences exist, and whether these differences support 
that there is a need to change the combined analytical approach, the 
pathogen reduction performance standards, and the associated method of 
analysis for Campylobacter in NRTE comminuted chicken and turkey. If 
FSIS determines that it needs to changes the standards, it will propose 
changes in the Federal Register.

C. Implementation of Final Performance Standards

    Comment: Several industry comments requested that FSIS provide at 
least a 1- or 2-year transition period after FSIS announces the final 
performance standards, and before FSIS begins assessing whether 
establishments meet the standards, to allow industry time to adjust to 
the new standards.
    Response: FSIS does not agree. FSIS notes that the poultry industry 
has been aware of the FSIS intent to develop pathogen reduction 
performance standards for chicken parts since at least 2012 when the 
baseline study got underway. Multiple recent outbreaks for both chicken 
parts and comminuted poultry heighten the need for industry to 
collectively address more optimal process control to limit exposure of 
the public to pathogens of public health concern. Thus, FSIS is 
providing a short but practical implementation period sufficient for 
establishments to adjust their food safety system. FSIS will begin 
assessing whether establishments meet the new Salmonella and 
Campylobacter performance standards for NRTE comminuted chicken and 
turkey and raw chicken parts on May 11, 2016. This 90-day delay is 
appropriate because 9 CFR 304.3 provides establishments up to 90 days 
to validate changes to their food safety system. Consequently, sample 
results affecting whether establishments meet the new standards begin 
with the first sample collected as part of a moving window on or after 
May 11, 2016. This 90-day period will effectively provide for a 
sufficient period of time for establishments to validate that their 
food safety systems can consistently control for enteric pathogens of 
public health concern, in accordance with 9 CFR 417.4.

D. Routine Verification Sampling and Testing

    Comment: An individual and several consumer advocacy groups stated 
that routine verification sampling should be unannounced, 
unpredictable, and completely random to prevent establishments from 
temporarily altering their food safety systems to ``pass'' tests.
    In addition, two consumer advocacy groups noted that antimicrobial 
agents used as interventions in poultry establishments may be masking 
the presence of Salmonella (i.e., in the neutralizing solution used by 
the Agency during sample collection) resulting in ``false negatives.''
    Response: The fact that FSIS no longer collects samples on 
consecutive days provides establishment less awareness about when a 
sample is to be collected. FSIS personnel notify establishment 
management just before collecting each sample that a routine Salmonella 
and Campylobacter sample is being collected. In addition, FSIS 
personnel use a method for randomly selecting specific product for 
sampling such that all product from all shifts, rails, chillers, 
coolers, and grinders have an equal chance of being selected for 
sampling.
    FSIS has issued instructions to inspection program personnel, 
directing them to report changes in establishment practices when FSIS 
samples are collected.\29\ FSIS has not noted any significant concern 
with changed production practices during FSIS sampling. Further, based 
on experience in-plant, FSIS does not believe that establishments can 
readily adjust their food safety systems to eliminate pathogens without 
such a change being obvious and inconsistent with their routine food 
safety system or HACCP flow chart. FSIS inspection personnel are 
present every day and are aware of the design of the food safety system 
in each establishment.
---------------------------------------------------------------------------

    \29\ See Chapter VIII, Section II of FSIS Directive 10,250.1; 
available at http://www.fsis.usda.gov/wps/wcm/connect/ebf83112-4c3b-4650-8396-24cc8d38bf6c/10250.1.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    FSIS continues to work with USDA's Agricultural Research Service to 
investigate the potential impact of carryover of antimicrobial agents 
on sampling results. The findings of this research will inform any 
actions the Agency may take. Regardless, in 2016, FSIS plans to begin 
evaluating the use of a new buffer solution to reduce the potential 
impact from carryover of antimicrobial agents. If an effective 
buffering media is identified, the buffer media will be used by 
inspection

[[Page 7293]]

program personnel when sampling poultry carcasses and parts to reduce 
carryover from the common antimicrobial interventions that may 
potentially impact sampling results.
    Comment: An organization representing the chicken industry and a 
meat and poultry processor requested that raw chicken parts only be 
eligible for sampling in the primary producing establishment.
    Response: FSIS disagrees with this comment. Establishment handling 
and processing of raw chicken parts at secondary processing facilities 
presents additional opportunity for contamination with pathogens, 
particularly when new source materials are incorporated. Thus, FSIS 
will continue sampling finished raw chicken parts at slaughter 
establishments, as well as at those that further process the product. 
By doing so, exposure of the public to pathogens of public health 
concern will be reduced at each practical step in the production 
process. FSIS has issued instructions to its inspection program 
personnel that make clear that product that is only repackaged and not 
subject to further reprocessing is not subject to sampling (see Section 
V, Part D, of FSIS Notice 16-15).\30\
---------------------------------------------------------------------------

    \30\ Available at http://www.fsis.usda.gov/wps/wcm/connect/5233e84c-f4a6-4959-b861-926a4d912eff/16-15.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    Comment: An organization representing the chicken industry 
requested that FSIS provide more detail about how each sample will be 
collected, where in the process the product will be sampled, and how 
the products will be tested.
    Response: FSIS has issued necessary notices and directives \31\ on 
this matter and will issue additional instructions as necessary.
---------------------------------------------------------------------------

    \31\ See Directive 10,250.1 and FSIS Notices 16-15, 22-15, 23-
15, 31-15 and 32-15.
---------------------------------------------------------------------------

    Comment: A consumer advocacy group requested that FSIS verification 
sampling include raw chicken parts derived from carcasses set aside for 
in-plant ``reprocessing'' and ``salvage'' activities.
    Response: Parts derived from ``reprocessing'' and ``salvage'' 
activities most commonly end up as comminuted product or as parts 
destined for further processing--both of which are subject to FSIS 
verification sampling and testing. If FSIS finds that these parts are 
being handled in a manner that consistently circumvents Agency 
verification testing, FSIS will consider sampling of this product.
    Comment: A meat and poultry processor requested that FSIS enumerate 
all of its Salmonella results and focus its resources on facilities 
with higher levels of Salmonella and not focus on presence of the 
pathogen alone.
    Response: FSIS agrees that high levels of pathogens should be 
considered in FSIS sampling considerations and is exploring options for 
enumerating more samples. However, because the occurrence of any 
Salmonella poses a potential hazard for consumers, FSIS will continue 
to primarily focus upon the presence or absence of the pathogen. In 
addition, based on sampling results from establishments linked to 
outbreaks, FSIS has found low level but frequent contamination does 
contribute to adverse public health outcomes. Furthermore, pathogen 
reduction through performance standards results in fewer contaminated 
products overall, regardless of the levels of Salmonella present. Thus, 
by setting new performance standards for these products that are based 
on presence or absence testing, FSIS anticipates establishments will 
adopt practices that will reduce all pathogens in their products, 
resulting in a greater overall impact on reducing human illnesses 
associated with FSIS-regulated products than would result from a focus 
on enumeration.
    Comment: A consumer advocacy group suggested that FSIS sample the 
neck skins of several birds in a flock (defined as one broiler house) 
immediately after the kill step, as is done in Sweden.
    Response: FSIS questions whether such a sampling program would 
derive different results than those found through other FSIS sampling. 
Sampling of the neck skins immediately after the slaughter step is one 
component of Sweden's Salmonella control program which primarily 
regulates on-farm production. The testing of the neck skins at the time 
of slaughter is done to verify the effectiveness of on-farm screening 
activities.
    FSIS encourages establishments to determine the incoming pathogen 
load on live birds to determine whether its processes can effectively 
address the pathogens. For example, these data could be used by 
establishments to determine which farms to obtain birds from for 
slaughtering, and how to schedule the order of flocks or houses of 
birds to decrease cross contamination during slaughter.
    In addition, FSIS requires that slaughter establishments sample 
most poultry pre-chill (9 CFR 381.65(g)(1))-- a valuable source of data 
about how well an establishment is minimizing contamination with 
enteric pathogens and fecal material on live birds presented for 
slaughter and on carcasses throughout the evisceration and dressing 
process.
    Comment: An organization representing the chicken industry 
requested that FSIS share reserve rinsate (the solution obtained and 
sent to FSIS laboratories for analysis after mixing/washing product) 
with establishments at the time of sample collection.
    Response: FSIS does not intend to share rinsate with 
establishments. FSIS is satisfied with the competency of its laboratory 
personnel and the procedures they implement, which are able to reliably 
detect pathogens. FSIS encourages establishments to conduct their own 
sampling rather than rely upon FSIS sampling results. In fact, FSIS 
assumes that establishments will choose to increase sampling and 
testing as a means of verifying process control, and that they are 
meeting the new pathogen reduction performance standards. FSIS included 
additional costs associated with increased sampling and testing by 
establishments in our cost-benefit analysis posted with this notice.

E. Proposed Moving Window Approach for Assessing Process Control

    Comment: In lieu of the moving window approach, an organization 
representing the meat/poultry industry suggested that FSIS consider 
other alternative approaches to evaluate process control in which 
observations are weighted; e.g., the exponentially weighted moving 
average in which observations are weighted with the highest weight 
given to the most recent data.
    Response: While an exponentially weighted moving average could move 
some establishments out of a failing status more quickly, it would also 
move some potentially passing establishments into a failing status. 
Thus, FSIS concludes the equally weighted 12-month moving average is 
the best approach.
    In the January 2015 notice, FSIS stated that 10 would be the 
minimum number of samples (over 52 weeks) required to assess process 
control (80 FR at 3947). Upon further consideration, FSIS has 
discovered that the proposed minimum number of Salmonella samples for 
broiler carcasses (10) would effectively equate to a zero tolerance 
standard. Therefore, FSIS has revised the minimum number of samples to 
11

[[Page 7294]]

for broiler carcasses only. The following table sets out what FSIS has 
determined to be the revised minimum number of samples to assess 
process control for each product class by pathogen.

----------------------------------------------------------------------------------------------------------------
                                                    Maximum acceptable percent     Minimum number of samples to
                                                             positive                 assess process control
                     Product                     ---------------------------------------------------------------
                                                    Salmonella     Campylobacter    Salmonella     Campylobacter
----------------------------------------------------------------------------------------------------------------
Broiler Carcass.................................             9.8            15.7              11              10
Turkey Carcass..................................             7.1             5.4              14              19
Comminuted Chicken (325 g sample)...............            25.0             1.9              10              52
Comminuted Turkey (325 g sample)................            13.5             1.9              10              52
Chicken Parts (4 lb. sample)....................            15.4             7.7              10              13
----------------------------------------------------------------------------------------------------------------

    Comment: Commenters opposed assessing poultry carcass performance 
categories by combining old and new samples because the results are 
inconsistent and cannot be compared. In addition, a comment noted that 
some poultry carcass data may be relatively old and not necessarily 
indicative of current establishment conditions. Rather than combining 
old and new sample results to assess performance, comments requested 
that FSIS ``reset'' the performance standards for poultry carcasses and 
begin building new datasets.
    Response: FSIS agrees that for categorization purposes of 
individual establishments, category status should be reflective of the 
most current sample results. Therefore, beginning May 11, 2016, FSIS 
will begin web-posting the category status of all establishments 
subject to the existing poultry carcass pathogen reduction performance 
standards based on sample results from May 2015 (when FSIS began 
routine sampling of broiler and turkey carcasses) to the present.
    Comment: Several commenters from industry stated that assessing 
process control in an establishment over 52 weeks, based solely on one 
FSIS verification sample per week, will not reflect current or very 
recent conditions in the establishment. These commenters also requested 
that FSIS consider supplemental establishment test results and other 
establishment measures when assessing process control before 
determining individual establishment category determinations and 
presumably posting of establishments' name and category.
    To facilitate data sharing between establishments and FSIS, several 
comments provided recommendations for ``supplemental data'' that could 
be submitted by establishments, such as Salmonella enumeration data, 
indicator organism process control monitoring, or corrective actions. 
If an establishment elects to share data to demonstrate process 
control, an organization representing the chicken industry suggested 
that FSIS incorporate those data into the establishment's dataset and 
assess the establishment based on the most recent 52 samples--whether 
they are FSIS verification samples or establishment samples. In 
addition, if FSIS proceeds with web-posting establishment-specific 
data, several industry commenters requested that the Agency allow 
establishments to review the data and to provide any comments, 
objections, or explanations, which could be included with released 
data.
    Response: The concept of data sharing between establishments and 
FSIS could have merit. This approach could provide an incentive for 
establishments to gain better process control of individual production 
lots whereby microbiological independence and improved lotting 
practices can be incorporated. For example, establishments performing 
their own robust sampling and testing of microbiologically independent 
lots of raw poultry product could use the results to assess whether 
they are maintaining ongoing process control. In addition, such lotting 
and sampling could provide valuable data for establishments when making 
final decisions on product disposition during corrective actions and 
HACCP decisions in performing pre-shipment review. FSIS intends to find 
a mechanism for ensuring that these data are available to the public if 
FSIS decides to supplement its decision making based on these data.
    However, there are a number of challenges, such as variation in 
industry sampling and testing methodologies, collection of on-going 
establishment data, and data interpretation. Mechanisms need to be 
identified and implemented to ensure that these non-FSIS data are 
reliable, and that they remain reliable over time. FSIS intends to make 
available compliance guidelines for standardizing data collection and 
reporting.
    FSIS, therefore, is considering initiating a pilot project using 
volunteer establishments to evaluate the feasibility of the concept. As 
part of the pilot project, FSIS may request establishment isolates and 
use them in the same manner as it uses FSIS isolates; data on how the 
establishment determines and controls risk; and information on 
corrective actions taken by the establishment when its risk control 
parameters are not met. If the pilot project is successful, FSIS would 
then determine how best to use non-FSIS data in Agency decision making. 
FSIS will make information available to the public on any pilot or any 
changes to posting as it moves forward.
    Comment: A consumer advocacy group requested that FSIS use data 
collected to evaluate whether establishment performance for different 
products (e.g., whole carcasses and parts) is correlated.
    Response: FSIS disagrees with the suggestion that setting 
performance standards requires such data because of how samples are 
collected, and how organisms attach to product. Attachment of the 
microorganisms, recovery from injury, and other factors impact the 
detection of pathogens throughout the production process. Consequently, 
it is appropriate to set pathogen reduction performance standards on 
different product types at all feasible points in the production 
process where control can be exerted and effective (e.g., for 
carcasses, parts, and comminuted products). Furthermore, process 
control demonstrated on carcasses may have no bearing on the level of 
process control demonstrated for parts or comminuted product.

F. Proposed Changes to Categorization System and Web-Posting

    Comment: An organization representing the chicken industry stated 
that the proposed categorization system will result in categories that 
fail to reflect current conditions in the establishment. The commenter 
stated that an establishment could remain in categories 2 or 3 up to 
eighteen months after addressing whatever conditions

[[Page 7295]]

caused the establishment to be classified in the category. Instead of 
re-categorizing establishments based on their performance over the last 
six months, as FSIS proposed, the organization requested that FSIS 
categorize establishments based on the results of a continuous moving 
window of the last 52 samples and post categories monthly based on the 
most recent 52-sample dataset. If the most recent 52-sample dataset 
indicates that the establishment should be moved into a lower category 
(Category 2 or 3), the commenter stated that FSIS should provide the 
establishment with an additional two months to provide supplemental 
data for FSIS to consider before making its final category 
determination.
    An organization representing the turkey industry and a meat/poultry 
processor stated that because the proposed standards for NRTE 
comminuted turkey product allow for so few positive results, there 
would be very little difference between a Category 1 or 3 turkey 
establishment. The organization also stated that web-posting individual 
turkey establishment category information will put turkey 
establishments at a competitive disadvantage relative to chicken 
product because the proposed performance standards allow for fewer 
positives for turkey establishments. To demonstrate this point, the 
industry comments argued that consumers may choose a Category 1 chicken 
product over a Category 2 turkey product thinking the chicken product 
is ``safer'' or ``better,'' when the turkey product may actually have 
lower numbers of Salmonella. If FSIS proceeds with web-posting 
establishment-specific data for all eligible turkey establishments, the 
comments requested that FSIS also post information on the data 
represented.
    An organization representing the turkey industry stated that 
posting individual establishments' categories has not historically been 
a substantial factor in driving industry to reduce pathogens. Rather, 
the organization stated that posting individual establishments' 
categories may be harmful to industry and confusing to consumers. 
Likewise, several industry comments supported posting aggregate data 
rather than individual establishment-specific data to minimize 
unintended consequences to industry. An organization representing the 
chicken industry recommended posting Category 3 establishments only.
    An organization representing the meat industry stated improvements 
in controlling Escherichia coli O157:H7 in beef were more the result of 
industry's implementation of new processes and interventions than to 
public accessibility of establishment-specific data. In addition, for 
consistency, the organization requested that FSIS outline its Category 
1/2/3 posting procedures in the draft Establishment-specific Data 
Release Strategic Plan.
    An organization representing the chicken industry stated that 
consumers are only able to associate web-posting with branded products. 
As a result, the organization stated that web-posting would 
disproportionately harm establishments producing branded products 
compared to establishments producing non-branded product.
    Response: FSIS has decided to re-categorize establishments monthly 
based on their performance over the last three months. For example, if 
an establishment has exceeded the Salmonella or Campylobacter maximum 
allowable percent positive during any completed 52-week moving window 
over the last three months, it will be placed in Category 3 at least 
until establishments are re-categorized a month later.
    In addition, because the comminuted chicken and turkey pathogen 
reduction performance standards permit only one positive result for 
Campylobacter in order to pass the standard, essentially eliminating 
Category 2, FSIS will categorize eligible establishments producing 
these products as either passing or failing. Thus, FSIS has revised its 
category classification system as follows:

    I. Category 1. Consistent Process Control: Establishments that 
have achieved 50 percent or less of the Salmonella or Campylobacter 
maximum allowable percent positive during all completed 52-week 
moving windows over the last three months.
    II. Category 2. Variable Process Control: Establishments that 
meet the Salmonella or Campylobacter maximum allowable percent 
positive for all completed 52-week moving windows but have results 
greater than 50 percent of the maximum allowable percent positive 
during any completed 52-week moving window over the last three 
months.
    III. Category 3. Highly Variable Process Control: Establishments 
that have exceeded the Salmonella or Campylobacter maximum allowable 
percent positive during any completed 52-week moving window over the 
last three months.
    IV. Passing. Establishments that meet the Campylobacter maximum 
allowable percent positive for NRTE comminuted chicken or turkey 
during all completed 52-week moving windows over the last three 
months.
    V. Failing. Establishments that have exceeded the Campylobacter 
maximum allowable percent positive for NRTE comminuted chicken or 
turkey during any completed 52-week moving window over the last 
three months.

    FSIS disagrees that a delay in web-posting should occur if an 
establishment's performance is trending in an adverse direction. One 
purpose of the pathogen reduction performance standards is to ensure 
that industry is taking steps to continuously improve its food safety 
system. Therefore, FSIS will begin web-posting as follows:
     No sooner than May 11, 2016, for establishments that 
produce poultry carcasses and that have the minimum number of samples, 
FSIS will begin posting individual establishment category status based 
on sample results from May 2015 (when FSIS began routine sampling of 
broiler and turkey carcasses) to the present. Thereafter, FSIS will 
update the category status for each eligible establishment monthly.
     For establishments that produce chicken parts and 
comminuted poultry products, FSIS intends to begin web-posting 
quarterly aggregate information relative to categories beginning about 
May 11, 2016. This information will give industry and other 
stakeholders timely information about progress being made to reduce 
contamination in NRTE poultry of all types sampled.
     For all establishments subject to the new pathogen 
reduction performance standards, after completion of the first 52-week 
moving window (approximately one year), FSIS will begin posting whether 
establishments meet the standards, or what category establishments are 
in, depending on the standard for the particular product, based on FSIS 
results. However, as is discussed above, based on at least the minimum 
number of samples to assess process control for that product/pathogen 
pair and other available information about establishments, such as 
noncompliance rates, if establishment performance overall does not 
improve or appears to be worsening before the completion of the first 
moving window, FSIS may begin web-posting individual establishment 
category information sooner.
    FSIS does not agree that the category approach has not been 
effective. Our experience with performance standards shows that 
industry does respond to new pathogen reduction performance standards. 
For example, the proportion of positive Salmonella carcasses fell after 
implementation of 1996 Pathogen Reduction/Hazard Analysis and Critical 
Control Point (PR/HACCP) final rule but then began to rise in the mid-
2000s. FSIS speculates that this rise was because there were rarely 
significant consequences to failing a Salmonella set. In 2006, this 
trend of rising Salmonella positive carcasses was reversed when FSIS 
instituted

[[Page 7296]]

categorization and web-posting of Category 2 and 3 establishments. In 
fact, the number of establishments not meeting the standard fell by 50 
percent in the 2-year period following the time FSIS started posting 
category information.
    On January 15, 2015, FSIS published a notice in the Federal 
Register that requested comment on the Agency's draft Establishment-
specific Data Release Strategic Plan for sharing with the public data 
on federally inspected meat and poultry establishments (80 FR 2092). 
Although outside the scope of this policy initiative, FSIS will 
consider the issue raised by the commenter as it considers other 
comments received on the draft Plan.
    Finally, FSIS disagrees that web-posting will disproportionately 
harm establishments producing branded products compared to those 
producing non-branded product. Any establishment could be potentially 
affected by the postings because consumers and wholesale buyers in the 
poultry supply chain can equally view the Web site. Therefore, it is in 
any establishment's interest, whether branded or non-branded, to put 
the processes in place to ensure that it meets or exceeds the pathogen 
reduction performance standards.
    Comment: A consumer advocacy group requested that FSIS post 
aggregate data for Campylobacter in imported poultry products and post 
aggregate reports showing the Category 1/2/3 distribution for each 
product class.
    Response: FSIS disagrees with the comment because FSIS does not 
collect enough samples from individual foreign establishments to assess 
whether they meet the standards. The foreign government conducts 
verification activities at the foreign establishment to make that type 
of determination. Through records reviews and audits, FSIS verifies 
that foreign inspection systems include these types of verification 
activities.
    FSIS plans to develop and implement a voluntary pilot project to 
explore mechanisms for reporting aggregate data specific to foreign 
countries that export NRTE poultry to the United States. FSIS will 
continue to verify whether those governments assess individual 
establishment process control as part of the equivalency process.

H. Enforcement

    Comment: Several consumer advocacy groups stated that certain 
serotypes of Salmonella should be considered adulterants. The comments 
cited other actions that FSIS should take to enforce the performance 
standards, including suspending inspection at facilities that do not 
meet a performance standard until the establishment meets the standard 
and recommending the recall of product produced during periods when the 
establishment has inadequate process control.
    Response: FSIS disagrees with the comment. The pathogen reduction 
performance standards are not lot-release standards. Product produced 
by an establishment that does not meet the standard is not necessarily 
adulterated. However, failing to meet the standard provides evidence 
that the production process is not well controlled, and FSIS will take 
steps to ensure that the establishment improves its production process 
to reduce variability and to gain more consistent process control. FSIS 
does agree that persistent failure to meet the pathogen reduction 
performance standards can be used as a rationale to progressively 
encourage the establishment to implement more effective food safety 
system controls or to discontinue production of product.
    In May 2011, the Center for Science in the Public Interest (CSPI) 
petitioned FSIS to issue an interpretive rule to declare certain 
strains of antibiotic-resistant (ABR) Salmonella to be adulterants in 
raw ground meat and raw ground poultry.\32\ On July 31, 2014, FSIS 
denied the petition without prejudice because the Agency concluded that 
the data do not support giving the four strains of ABR Salmonella 
identified in the petition a different status as an adulterant in raw 
ground meat and raw ground poultry than Salmonella strains that are 
susceptible to antibiotics.\33\ The Agency concluded that additional 
data on the characteristics of ABR Salmonella are needed to determine 
whether certain strains of ABR Salmonella could qualify as adulterants 
under the Federal Meat Inspection Act and Poultry Products Inspection 
Act. On October 14, 2014, CSPI refiled its petition to provide 
additional data and requested that FSIS declare certain strains of ABR 
Salmonella adulterants in all raw meat and raw poultry products. FSIS 
is evaluating the new request.
---------------------------------------------------------------------------

    \32\ http://www.fsis.usda.gov/wps/wcm/connect/04cb5fad-c13e-4de7-b391-acd95191a95/Petition_CSPI_052511.pdf?MOD=AJPERES.
    \33\ http://www.fsis.usda.gov/wps/wcm/connect/73037007-59d6-4b47-87b7-2748edaa1d3e/FSIS-response-CSPI-073114.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    Comment: A consumer advocacy group requested that FSIS instruct 
inspection personnel on when and how to increase enforcement at 
facilities that do not meet the performance standards. In addition, the 
commenter requested that FSIS initiate increased enforcement action 
when an establishment repeatedly fails to meet the performance 
standard.
    Response: FSIS recently revised FSIS Directive 5100.4 \34\ to 
provide instructions to its personnel on how to conduct a PHRE. 
Enforcement, Investigations, and Analysis Officers (EIAOs) will conduct 
a PHRE (in priority order) at every establishment that does not meet a 
performance standard (i.e., the establishment is in Category 3); at 
establishments that have produced products with repetitive Salmonella 
serotypes of public health concern, indicating potential higher risk 
for being identified as contributing to an outbreak; and establishments 
with Salmonella PFGE patterns matching those found in recent outbreaks 
or epidemiological evidence linking them to illness to determine the 
need for a FSA. If, during the PHRE, the EIAO determines that the 
establishment is shipping or producing adulterated product, operating 
without a HACCP plan, or engaging in any other type of non-compliance 
that supports taking a withholding or suspension action without prior 
notification (9 CFR 500.3), the EIAO will take immediate steps to stop 
the wrongful practice. Next, the EIAO will consult with the District 
Office (DO) to determine whether additional enforcement action is 
needed. For an EIAO to recommend that the DO issue a NOIE, he or she 
must support that the conditions in the establishment, or the actions 
of establishment personnel, constitute a situation that would justify 
the action under 9 CFR 500.4, and that such conditions have resulted in 
adulterated product or create insanitary conditions that could cause 
product to be adulterated.
---------------------------------------------------------------------------

    \34\ Available at http://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    As stated above, if, after 90 days, the establishment has not been 
able to gain process control, as determined from FSIS's follow-up 
sampling and from the results of the PHRE or FSA, and the establishment 
has not taken corrective actions, FSIS will likely take enforcement 
actions, such as by issuing a NOIE or by suspending inspection, under 
the conditions and according to the procedures described in 9 CFR part 
500. FSIS will not issue an NOIE or suspend inspection based solely on 
the fact that an establishment did not meet a performance standard.
    Comment: A consumer advocacy group requested that FSIS refuse entry 
of imported raw poultry product that FSIS finds positive for 
Salmonella. On

[[Page 7297]]

the other hand, an organization representing the chicken industry 
stated that denying entry of imported products (or determining foreign 
country equivalency) based on import verification sampling results may 
result in international trade ramifications.
    Response: Salmonella is not an adulterant in NRTE poultry products. 
Therefore, a positive test result for Salmonella in imported NRTE 
poultry product sampled by FSIS import inspection personnel would not 
result in regulatory control actions at port-of-entry (i.e., refused 
entry of the product). However, foreign countries that are eligible to 
export poultry products to the United States must apply inspection, 
sanitation, and other standards that are equivalent to those that FSIS 
applies to poultry products. Thus, in evaluating whether a foreign 
country maintains an equivalent inspection system to that of FSIS, FSIS 
considers whether the country's pathogen reduction performance 
standards, testing, and other verification procedures related to 
Salmonella or Campylobacter are equivalent to those that FSIS uses.

I. Other Agency Actions

    Comment: A consumer advocacy group requested that FSIS make 
detailed testing data available to public health officials (e.g., 
through PulseNet).
    Response: FSIS routinely shares subtyping data for positive samples 
with public health officials for data analysis, interpretation, and 
application. This sharing includes submission of serotype and PFGE data 
to Pulsenet and antimicrobial resistance data to the National 
Antimicrobial Resistance Monitoring System for Enteric Bacteria 
(NARMS). FSIS has also recently begun using whole genome sequencing to 
analyze positive isolates in certain cases and will continue to expand 
this testing as resources allow. FSIS is submitting this sequencing 
data to the National Center for Biotechnology Information, a publically 
accessible database.
    Comment: An organization representing the meat industry requested 
that FSIS evaluate the correlation between higher sanitary dressing 
noncompliances and the probability of positive sample results in 
poultry products, as it did for beef products.
    Response: FSIS will assess this issue and report its findings in 
FY2016. Meanwhile, outbreaks associated with Salmonella in raw poultry 
products continue. Improvement in sanitary dressing and other process 
controls can reduce the levels of Salmonella and other enteric 
bacteria, such as Campylobacter, on poultry carcasses. Therefore, FSIS 
believes that establishments should focus more closely on their 
sanitary dressing and process control procedures to prevent carcass 
contamination. Importantly, the recent final rule on poultry inspection 
modernization mandates that establishments prevent contamination of 
poultry product with feces throughout the slaughter and dressing 
operation rather than permit carcasses to be contaminated and then 
reconditioned (9 CFR 381.45(g)).
    Comment: An organization representing the meat/poultry industry 
requested that FSIS explain how the Agency intends to assess whether 
the raw beef follow-up sampling model (i.e., either 16 or eight follow-
up samples will be collected when an establishment does not meet the 
standard) is working for Salmonella and Campylobacter testing, and, if 
changes are made, how FSIS plans to communicate the changes to 
industry.
    Response: FSIS has found follow-up sampling to be effective at 
finding additional positives in raw beef samples. FSIS will analyze the 
data and information collected during follow-up sampling (which will be 
part of the moving window sampling) of poultry and make any necessary 
changes to the follow-up sampling procedures based on that analysis.
    Comment: A consumer advocacy group requested that FSIS include 
improving poultry welfare and living conditions and protecting bird 
health in its recommended pre-harvest strategies for producers for 
controlling Salmonella and Campylobacter. The group stated that 
research has shown that environmental stresses (e.g., depriving a bird 
of feed, overcrowding) can result in increased incoming poultry 
pathogen loads.
    Response: FSIS agrees with the comment. FSIS has reviewed available 
information, including the information provided by the commenter, 
regarding the impact of animal welfare and living conditions on food 
safety. FSIS has updated the Compliance Guideline for Controlling 
Salmonella and Campylobacter in Raw Poultry to include interventions 
and best practices that should assist producers in providing for animal 
welfare, living conditions, and bird health at pre-harvest, which 
should in turn minimize stress in poultry and reduce pathogens in birds 
presented at slaughter.
    Comment: An organization representing the chicken industry stated 
that a shift from Category 1 to Category 2 does not warrant a for-cause 
FSA because Category 2 establishments are technically meeting the 
standard. The organization requested that FSIS outline situations in 
which verification sampling would trigger a for-cause FSA and clarify 
what the Agency means by a ``higher number of positives.''
    The same organization also opposed FSIS conducting for-cause FSAs 
when it finds serotypes of public health significance because, 
according to the organization, doing so would effectively impose a 
zero-tolerance standard for these serotypes. The organization argued 
that using this approach would encourage establishments to focus only 
on certain serotypes rather than manage overall pathogen levels through 
a process control program.
    Response: FSIS will not typically schedule an FSA based on an 
establishment moving from Category 1 to Category 2. As mentioned above, 
during the PHRE, EIAOs use the decision-making process outlined in FSIS 
Directive 5100.4 to determine whether the DO needs to schedule an FSA.
    FSIS will focus on Salmonella serotypes of public health concern 
because the incidence rate of infection by these serotypes is higher 
than for other serotypes. Moreover, for-cause PHREs in response to 
serotypes of public health concern will in fact stimulate improvement 
in industry performance in controlling Salmonella generally.
    As for ``higher number of positives,'' FSIS intends to analyze 
results of the routine sampling to identify data trends indicative of 
an establishment moving in an adverse direction. Once identified, these 
trends may prompt FSIS to conduct a PHRE or take other appropriate 
actions, such as additional sanitary dressing verification procedures, 
at the establishment that produced the product. FSIS provides 
Salmonella serotype results to establishments to facilitate their 
efforts in identifying the appropriate intervention.
    FSIS is concerned that there is a misguided belief that new 
products do not need to be produced in a manner to reduce the presence 
of pathogens of public health concern. Since the 1996 PR/HACCP final 
rule, FSIS has stressed that properly operating food safety systems are 
designed to reduce the presence of pathogens of public health concern.

J. Cost-Benefit Analysis

    Comment: Factoring in the costs of the additional FSAs and follow-
up sampling associated with the high percentage of establishments not 
expected to initially meet the new standards, an organization 
representing

[[Page 7298]]

the meat industry questioned how FSIS does not expect to incur any 
additional costs as a result of setting new performance standards. The 
organization requested that FSIS calculate the number and cost of FSAs 
and follow-up samples the Agency expects to collect for the first three 
years after the changes are implemented. Other more general comments 
stated that the proposed changes would be overly resource intensive or 
potentially cost prohibitive for FSIS.
    Response: To account for the sampling and enforcement actions 
associated with the new performance standards, FSIS will realign 
resources, rather than allocating any additional resources beyond what 
it currently budgets. FSIS will examine the following in a 
retrospective analysis to realign resources: the allocation of sampling 
and outcome of FSAs initiated as a result of the new pathogen reduction 
performance standards.
    In addition, FSIS has updated its FSA methodology by shortening the 
timeline for completion of most FSAs from 2 to 4 weeks to 5 to 7 
production days.\35\ This change will enable FSIS personnel to perform 
a greater number of FSAs each year, thereby improving Agency 
efficiency.
---------------------------------------------------------------------------

    \35\ FSIS Directive 5100.1, Revision 4; available at: http://www.fsis.usda.gov/wps/wcm/connect/31bb8000-fb33-4b51-964b-1db9dfb488dd/5100.1.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

Cost-Benefit Analysis

    FSIS has considered the economic effects of new pathogen reduction 
performance standards for Salmonella and Campylobacter in NRTE chicken 
parts and comminuted poultry. FSIS published a preliminary cost-benefit 
analysis in support of the January 2015 Federal Register notice in 
which FSIS proposed the new performance standards and sought comment on 
the estimates and the methodology used.\36\ After reviewing the 
comments received, FSIS updated the cost benefit analysis to reflect a 
change in a cost assumption. In addition to making changes to their 
production processes in order to meet the new pathogen reduction 
performance standards, FSIS originally assumed that only 30, 40, or 50 
percent of establishments that fail to meet the performance standard 
would re-asses their HACCP plan. However, FSIS now assumes that all, or 
100 percent, of establishments that fail to meet the standard will re-
assess their HACCP plans to comply with 9 CFR 417(3)(b). A summary of 
the analysis follows. The full analysis is published on the FSIS Web 
site as supporting documentation to this notice.
---------------------------------------------------------------------------

    \36\ Chicken Parts and Not Ready-To-Eat Comminuted Poultry 
Performance Standards Preliminary Cost-Benefit Analysis; available 
at: http://www.fsis.usda.gov/wps/wcm/connect/e146ef97-c269-44ee-bea2-0c04fcc6f463/CBA-Chicken-Parts-Comminuted.pdf?MOD=AJPERES .
---------------------------------------------------------------------------

Industry Costs

    Establishments will incur costs as they make changes to their 
processes to meet the new standards. FSIS estimates that approximately 
63 percent of raw chicken parts producing establishments, 62 percent of 
NRTE comminuted chicken producing establishments, and 58 percent of 
NRTE comminuted turkey producing establishments will not meet the new 
Salmonella standards. FSIS estimates that approximately 46 percent of 
raw chicken parts producing establishments, 24 percent of NRTE 
comminuted chicken producing establishments, and 9 percent of NRTE 
comminuted turkey producing establishments will not meet the new 
Campylobacter standards.
    Establishments that initially do not meet the standard but that 
choose to do so will need to make changes to their production processes 
to lower the prevalence of Salmonella and Campylobacter in their 
products. Changes made by poultry slaughter establishments could 
include pre-harvest interventions, such as vaccination programs; well-
timed feed withdrawal; clean and dry litter and transportation; and 
supplier contract guarantees of pathogen-free flocks. During 
processing, establishments could add additional cleaning procedures, 
apply chemical antimicrobial agents to parts and source materials for 
comminuted poultry product, and provide additional sanitation training 
to employees. For the purposes of the cost-benefit analysis, FSIS used 
the cost of adding antimicrobial agents to poultry parts as a proxy for 
the costs of interventions and changes that could be implemented. FSIS 
used this approach based on information from FSAs in response to 
broiler Salmonella sets not meeting the standards and information from 
the FSIS Poultry Checklist. Through FSAs, FSIS has found that the 
majority of establishments added antimicrobial agents to the production 
process as a corrective action, suggesting that an antimicrobial 
intervention would be the most likely response should an establishment 
not meet the proposed performance standards. Also, information from the 
FSIS Poultry Checklist showed that the majority of establishments are 
not applying antimicrobial agents to raw poultry parts and source 
materials for comminuted poultry product. FSIS accounted for 
uncertainty in the proportion of establishments making changes to their 
production processes by providing a range of 30, 40, and 50 percent (of 
establishments initially falling short of but eventually meeting the 
standards in two years) for cost estimates for capital equipment, 
antimicrobial agents, and microbial sampling. For HACCP plan re-
evaluation and training costs, FSIS assumes that all establishments 
(100 percent) that do not meet the standard will re-evaluate their 
HACCP plan. These costs are summarized and annualized over 10 years at 
a discount rate of 7 percent in Table 1.

                                  Table 1--Total Industry Costs Annualized \1\
----------------------------------------------------------------------------------------------------------------
                                                                      Primary
  Compliance level of establishments         Cost component          estimate      Low estimate    High estimate
         not meeting standard                                         ($mil)          ($mil)          ($mil)
----------------------------------------------------------------------------------------------------------------
30%...................................  Capital Equipment.......            2.15  ..............  ..............
                                        Antimicrobial Agent.....            6.54            4.61            8.46
                                        Microbiological Sampling            9.27            6.18           12.36
                                        HACCP Reassessment &                   *  ..............  ..............
                                         Training.
                                                                 -----------------------------------------------
    Total Costs.......................  ........................           17.96           12.94           22.97
40%...................................  Capital Equipment.......            2.86  ..............  ..............
                                        Antimicrobial Agent.....            8.72            6.14           11.28
                                        Microbiological Sampling            9.82            6.52           13.05

[[Page 7299]]

 
                                        HACCP Reassessment &                   *  ..............  ..............
                                         Training.
                                                                 -----------------------------------------------
    Total Costs.......................  ........................           21.41           15.52           27.19
50%...................................  Capital Equipment.......            3.58  ..............  ..............
                                        Antimicrobial Agent.....           10.89            7.68           14.12
                                        Microbiological Sampling           10.40            6.91           13.81
                                        HACCP Reassessment &                   *  ..............  ..............
                                         Training.
                                                                 -----------------------------------------------
    Total Costs.......................  ........................           24.88           18.17           31.51
----------------------------------------------------------------------------------------------------------------
\1\ Costs annualized at a discount rate of 7 percent over 10 years.
* Approximately $12,216, a value too small to display in table.

Agency Costs

    FSIS will not request additional funding as a result of introducing 
new performance standards. FSIS allocates a fixed number of samples by 
product class, sampling project, and pathogen each year. The two major 
components of the pathogen reduction performance standards--product 
sampling and follow-up actions--will be implemented in such a way that 
they are resource neutral. FSIS is not expanding the number of samples 
it will analyze. Instead, it will reallocate samples from other 
programs, specifically the young chicken and turkey sampling programs 
for Salmonella and Campylobacter, as FSIS moves towards assessing 
performance using a moving window (described above) of sampling 
results. FSIS does not anticipate the need to exclude any of the other 
testing programs allocated to other product classes. FSIS intends to 
test carcasses at the level that is needed to document establishment 
performance status. Furthermore, enforcement actions taken as a result 
of the new performance standards, namely FSAs, will not require 
additional FSIS resources. FSIS has updated its FSA methodology and has 
shortened the timeline for the completion of most FSAs from 2 to 4 
weeks to 5 to 7 production days.\37\ The shortened FSA will enable FSIS 
Enforcement, Investigations and Analysis Officers to perform more FSAs 
each year. Therefore, FSIS will not expend additional resources to 
implement the proposed performance standards.
---------------------------------------------------------------------------

    \37\ FSIS Directive 5100.1, Revision 4; available at: http://www.fsis.usda.gov/wps/wcm/connect/31bb8000-fb33-4b51-964b-1db9dfb488dd/5100.1.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

Public Health Benefits

    As establishments make changes to their production processes and 
reduce the prevalence of Salmonella and Campylobacter in chicken parts 
and NRTE comminuted poultry, public health benefits will be realized in 
the form of averted illnesses. For each assumed compliance level FSIS 
estimated the cost savings associated with the percentage reduction in 
human illnesses as calculated in the 2015 Risk Assessment. The results 
of this calculation were annualized over 10 years at a discount rate of 
7 percent and are displayed in Table 2.

                                 Table 2--Public Health Benefits Annualized \1\
----------------------------------------------------------------------------------------------------------------
                                                                      Primary
  Compliance level of establishments not meeting the standard %      estimate      Low estimate    High estimate
                                                                      ($mil)          ($mil)          ($mil)
----------------------------------------------------------------------------------------------------------------
30..............................................................           50.87           31.84           79.89
40..............................................................           79.66           50.43          125.89
50..............................................................          109.10           68.80          171.24
----------------------------------------------------------------------------------------------------------------
\1\ Benefits annualized over 10 years at a discount rate of 7 percent.

Summary of Net Benefits

    Table 3 displays the total costs and benefits expected from the 
implementation of performance standards for chicken parts and 
comminuted poultry. All values have been annualized over 10 years at a 
7 percent discount rate. For all compliance levels considered, the 
performance standards result in net benefits.

                                      Table 3--Summary of Net Benefits \1\
----------------------------------------------------------------------------------------------------------------
                                                                      Primary
Compliance level of establishments not   Cost/benefit component      estimate      Low estimate    High estimate
        meeting the standard %                                        ($mil)          ($mil)          ($mil)
----------------------------------------------------------------------------------------------------------------
30....................................  Industry Costs..........          (18.0)          (12.9)          (23.0)
                                        FSIS Costs..............  ..............  ..............  ..............
                                        Public Health Benefits..            50.9            31.8            79.9
----------------------------------------------------------------------------------------------------------------
    Net Benefits......................  ........................            32.9            18.9            56.9
----------------------------------------------------------------------------------------------------------------

[[Page 7300]]

 
40....................................  Industry Costs..........          (21.4)          (15.5)          (27.2)
                                        FSIS Costs..............  ..............  ..............  ..............
                                        Public Health Benefits..            79.7            50.4           125.9
----------------------------------------------------------------------------------------------------------------
    Net Benefits......................  ........................            58.3            34.9            98.7
----------------------------------------------------------------------------------------------------------------
50....................................  Industry Costs..........          (24.9)          (18.2)          (31.5)
                                        FSIS Costs..............  ..............  ..............  ..............
                                        Public Health Benefits..           109.1            68.8           171.2
----------------------------------------------------------------------------------------------------------------
    Net Benefits......................  ........................            84.2            50.6           139.7
----------------------------------------------------------------------------------------------------------------
\1\ All costs and benefits annualized over 10 years at a 7 percent discount rate.

USDA Nondiscrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.
    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:

Mail

    U.S. Department of Agriculture, Director, Office of Adjudication, 
1400 Independence Avenue SW., Washington, DC 20250-9410.

Fax

    (202) 690-7442.

Email

    program.intake@usda.gov.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.) should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

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/subscribe. 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: February 4, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-02586 Filed 2-10-16; 8:45 am]
 BILLING CODE 3410-DM-P