[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26249-26271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09043]


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  Federal Register / Vol. 88 , No. 82 / Friday, April 28, 2023 / 
Notices  

[[Page 26249]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2022-0013]


Salmonella in Not-Ready-To-Eat Breaded Stuffed Chicken Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed determination and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
declare that not-ready-to-eat (NRTE) breaded stuffed chicken products 
that contain Salmonella at levels of 1 colony forming unit (CFU) per 
gram or higher are adulterated within the meaning of the Poultry 
Products Inspection Act (PPIA). Although the labeling of these products 
has undergone significant changes over time to better inform consumers 
that they are raw and to provide instructions on how to prepare them 
safely, NRTE breaded stuffed chicken products continue to be associated 
with Salmonella illness outbreaks. Therefore, FSIS has concluded that 
public health measures that focus primarily on product labeling and 
consumer handling practices have not been effective in preventing 
additional foodborne illnesses associated with NRTE breaded stuffed 
chicken products. FSIS is also proposing to carry out verification 
procedures, including sampling and testing of the chicken component of 
these products prior to stuffing and breading, to ensure producing 
establishments control Salmonella in these products.

DATES: Comments on this proposed determination and the proposed 
verification procedures must be received on or before June 27, 2023. 
FSIS specifically requests comments on alternative bases for 
determining adulteration of breaded stuffed NRTE products.

ADDRESSES: FSIS invites interested persons to submit comments on this 
document. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, 
Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2022-0013. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 937-4272 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development, FSIS, USDA; 
Telephone: (202) 937-4272.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background
    Pathogens as Adulterants in Raw and Not-Ready-To Eat Meat and 
Poultry Products
    Shiga Toxin-Producing Escherichia Coli as Adulterants
    Petitions To Declare Certain Salmonella Serotypes as Adulterants
    Assessing a Pathogen's Status as an Adulterant in a NRTE Product
II. NRTE Breaded Stuffed Chicken Products
    Salmonella Illness Outbreak Investigations Associated With NRTE 
Breaded Stuffed Chicken Products 1998-2016 and FSIS and Industry 
Response
    2016 National Advisory Committee on Meat and Poultry Inspection 
Recommendations and National Chicken Council Petition
    Consumer Behavior Research
    2021 Salmonella Illness Outbreak, NACMPI Subcommittee 
Recommendations, and National Chicken Council Petition Supplement
III. Evaluation of the Status of Salmonella in NRTE Breaded Stuffed 
Chicken Products Under the PPIA
    Salmonella as an ``Added Substance'' in NRTE Breaded Stuffed 
Chicken Products
    Adulteration Standard for NRTE Breaded Stuffed Chicken Products
IV. Proposed Policy Implementation
    HACCP Reassessment
    Proposed Implementation and Status of Laboratory Methods
    Sampled Lot
    State Programs and Foreign Government Programs
V. Anticipated Costs and Benefits Associated With This Policy
    Agency Costs
    Industry Costs
    Benefits
    Summary of Estimated Costs and Benefits
    Potential Impact on Small Business
    USDA Nondiscrimination Statement
    Additional Public Notification

I. Background

Pathogens as Adulterants in Raw and Not-Ready-To Eat Meat and Poultry 
Products

    Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et 
seq.) and the Poultry Products Inspection Act (PPIA)(21 U.S.C 453 et 
seq.), a meat or poultry product is adulterated if, among other 
circumstances, ``it bears or contains any poisonous or deleterious 
substance which may render it injurious to health; but in case the 
substance is not an added substance, such article shall not be 
considered adulterated . . . if the quantity of such substance in or on 
such article does not ordinarily render it injurious to health'' (21 
U.S.C. 601(m)(1); 21 U.S.C. 453(g)(1)). Meat and poultry products are 
also adulterated if they are ``unsound, unhealthful, unwholesome, or 
otherwise unfit for human food'' (21 U.S.C. 601(m)(3)); 21 U.S.C. 
453(g)(3)).
    Historically, most foodborne pathogens, including Salmonella, have 
not been considered as adulterants of raw and other NRTE meat and 
poultry

[[Page 26250]]

products based on the assumption that ordinary cooking is generally 
sufficient to destroy the pathogens.1 2 The exceptions are 
Escherichia coli O157:H7 (E. coli O157:H:7) \3\ and certain non-O157 
Shiga toxin-producing Escherichia coli (STEC) in raw, non-intact beef 
products and intact cuts that are to be further processed into non-
intact products before being distributed for consumption. As discussed 
below, these pathogens are considered adulterants in these specific raw 
products because they render ``injurious to health'' what many 
consumers believe to be properly cooked non-intact beef products.\4\
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    \1\ See proposed rule ``Pathogen Reduction; Hazard Analysis and 
Critical Control Point (HACCP) Systems,'' February 4, 1993 (60 FR 
6774 at 6798-6799) and final rule ``Pathogen Reduction; Hazard 
Analysis and Critical Control Point (HACCP) Systems,'' July 25, 1996 
(61 FR 38806 at 38835.) See also Amer. Public Health Ass'n v. Butz, 
511 F.2d 331 (U.S. App. DC, 1974).
    \2\ When raw meat or poultry products are associated with an 
illness outbreak and contain pathogens that are not considered 
adulterants in those products, FSIS considers the product linked to 
the illness outbreak to be adulterated under 21 U.S.C. 601(m)(3) or 
453(g)(3) because the product is ``. . . unsound, unhealthful, 
unwholesome, or otherwise unfit for human food'' (77 FR 72681, 72689 
(Dec. 6, 2012). Products that contain an adulterant are considered 
adulterated under 21 U.S.C. 601(m)(1) or 453(g)(1) even if they are 
not linked to an illness outbreak.
    \3\ On April 16, 2021, FSIS announced that it was aligning the 
testing criteria for E. coli O157:H7 with that for non-O157 STEC. 
Under the updated method, consistent with laboratory testing for 
non-O157 STEC, an E. coli O157:H7 isolate is confirmed positive if 
it has a stx gene, an eae gene, and is identified by the laboratory 
as O157. FSIS no longer performs H7 gene testing. FSIS began using 
the updated method on samples received on or after May 17, 2021. 
(see FSIS Announces Updates to Laboratory Testing Criteria for 
Escherichia coli (E. coli) O157:H7, FSIS Constituent Update (April 
16, 2021). Available at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-april-16-2021).
    \4\ See Texas Food Industry Association v. Espy, 870 F. Supp. 
143 (1994).
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STEC as Adulterants

    When FSIS determined that certain STEC are adulterants in non-
intact raw beef products, the Agency identified characteristics 
associated with both the pathogen and the product that distinguish them 
from other raw products contaminated with other pathogens. 
Specifically, in 1994, when FSIS initially notified the public that raw 
ground beef products contaminated with E. coli O157:H7 are adulterated 
within the meaning of the FMIA, the Agency noted that exposure to E. 
coli O157:H7 organisms had been linked with serious, life-threatening 
human illnesses, such as hemorrhagic colitis and hemolytic uremic 
syndrome (HUS).\5\ In addition, FSIS noted that only small numbers of 
E. coli O157:H7 organisms may cause illness. Because of its low 
infectious dose, FSIS also noted that E. coli O157:H7 can be spread 
from person-to-person, as had been reported in child day-care settings. 
The Agency concluded that raw ground beef products present a 
significant public health risk because they are frequently consumed 
after preparation, (e.g., cooking hamburger to a rare or medium rare 
state) that does not destroy E. coli O157:H7 organisms that have been 
introduced below the product's surface by chopping or grinding.
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    \5\ Michael R. Taylor, FSIS Administrator. September 29, 1994. 
``Change and Opportunity to Improve the Safety of the Food Supply.'' 
Speech to American Meat Institute Annual Convention, San Francisco, 
CA.
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    In 1999, FSIS published a Federal Register notice to update its 
policy concerning raw beef products contaminated with E. coli O157:H7 
(64 FR 2803, Jan. 19, 1999). In the notice, FSIS stated that the public 
health risk presented by beef products contaminated with E. coli 
O157:H7 is not limited to raw ground beef products. In the notice, FSIS 
announced that ``given the low infectious dose of E. coli O157:H7 
associated with foodborne disease outbreaks and the very severe 
consequences of an E. coli O157:H7 infection, the Agency believes that 
the status under the FMIA of beef products contaminated with E. coli 
O157:H7 must depend on whether there is adequate assurance that 
subsequent handling of the product will result in food that is not 
contaminated when consumed'' (64 FR 2803). The Agency also explained 
that ``in evaluating beef products contaminated with E. coli O157:H7, 
intact cuts of muscle that are to be distributed for consumption as 
intact cuts should be distinguished from non-intact products as well as 
from intact cuts of muscle that are to be further processed into non-
intact product prior to distribution for consumption'' (64 FR 2803, 
2804). Intact beef cuts of muscle include steaks, roasts, and other 
intact cuts in which the meat interior remains protected from pathogens 
migrating below the exterior surface and are not considered adulterated 
if the outer surface is contaminated with STEC. FSIS stated that, with 
the exception of intact cuts of muscle that are to be distributed for 
consumption as intact cuts, an E. coli O157:H7-contaminated beef 
product must not be distributed until it has been processed into a RTE 
product. FSIS, therefore, deemed E. coli O157:H7 as an adulterant of 
non-intact raw beef products and intact cuts that are to be further 
processed into non-intact raw products before being distributed for 
consumption.
    In September 2011, FSIS determined that six additional STEC 
serogroups (O26, O45, O103, O111, O121, and O145) are also adulterants 
of raw non-intact beef products and product components used to 
manufacture these products (76 FR 58157, Sept. 20, 2011). In announcing 
this determination, the Agency explained that while over 50 STEC 
serogroups have been associated with human illness, U.S. Centers for 
Disease Control and Prevention (CDC) data shows that over 70 to 83 
percent of confirmed, serogrouped, non-O157 STEC illnesses are caused 
by these six STEC serogroups (76 FR 58157, 58158). Available data at 
that time, including information from outbreaks and human illnesses, 
showed that, like E. coli O157:H7, these six STEC were associated with 
serious illnesses and that they have a relatively low infectious dose. 
There is also evidence that these strains have very similar 
characteristics to E. coli O157:H7 strains in that they too can survive 
ordinary consumer cooking practices for raw, non-intact beef products. 
Thus, FSIS determined that raw, non-intact beef products and intact 
cuts to be further processed into non-intact products that are 
contaminated with E. coli O157:H7 and pathogenic STEC O26, O45, O103, 
O111, O121, and O145 are adulterated under the FMIA because they 
contain a poisonous or deleterious substance that may render them 
injurious to health (21 U.S.C. 601(m)(1)) (76 FR 31975). The Agency 
also determined that raw, non-intact beef products that are 
contaminated with these pathogens are unhealthful and unwholesome (21 
U.S.C. 601(m)(3)) (76 FR 31975).

Petitions To Declare Certain Salmonella Serotypes as Adulterants

    As noted above, FSIS historically has not considered raw meat and 
poultry products to be adulterated when they contain Salmonella, based 
on the assumption that ordinary methods of cooking and preparing these 
products kill Salmonella. In response to petitions submitted by the 
Center for Science in the Public Interest (CSPI) in 2011 and 2014, FSIS 
evaluated whether certain antibiotic-resistant (ABR) Salmonella 
serotypes could be considered as adulterants in raw meat and raw 
poultry products under the FMIA and PPIA. The 2011 petition asked FSIS 
to declare four strains of ABR Salmonella as adulterants when found in 
ground meats and poultry.\6\ FSIS denied the

[[Page 26251]]

2011 petition without prejudice on July 31, 2014. In its response, FSIS 
explained that the data available at that time ``did not support giving 
the four strains of ABR Salmonella identified in the petition a 
different status as an adulterant in raw ground beef and raw ground 
poultry than Salmonella strains that are susceptible to antibiotics.'' 
\7\ The response stated that additional data on the characteristics of 
ABR Salmonella are needed to determine whether certain strains could 
qualify as adulterants under the FMIA and PPIA. The response also noted 
that because the Agency's denial was without prejudice, the petitioner 
was not precluded from submitting a revised petition that includes 
additional information to support the requested action.
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    \6\ CSPI petition #11-06 (May 25, 2011), ``Petition for an 
Interpretive Rule Declaring Specific Strains of Antibiotic Resistant 
Salmonella to be Adulterants Withing the Meaning or 21 U.S.C. 
601(m)(1) and (2)(a) and 21 U.S.C. 453(g)(1) and (2)(a).'' FSIS 
final response July 31, 2014.
    \7\ FSIS final response to petition #11-06, p. 1.
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    The CSPI 2014 petition was a refiling of the 2011 petition and 
asked that FSIS declare certain strains of ABR Salmonella as 
adulterants in all meat and poultry products based on evidence attained 
since 2011 that, according to the petition, demonstrates both ground 
and intact poultry products are associated with outbreaks from ABR 
Salmonella.\8\ Based on the data available at the time, FSIS denied the 
2014 petition without prejudice on February 7, 2018. In its response to 
the petition, the Agency concluded that, with respect to its status as 
an adulterant, ``Salmonella does not appear to present the same issues 
as STEC, regardless of whether it is resistant or susceptible to 
antibiotics.'' \9\ The Agency noted that the consumer studies submitted 
in support of the petitions did not demonstrate that the study 
participants had expressed a specific preference or intent to prepare 
or consume a meat or poultry product in a manner that is not properly 
cooked and did not describe specific characteristics of a meat or 
poultry product that consumers might mistakenly associate with proper 
cooking, such as a rare or medium rare hamburger. Thus, based on the 
consumer studies and other information on Salmonella available at that 
time, FSIS determined that it ``had no basis to conclude that either 
ABR-Salmonella or non-ABR Salmonella would render injurious to health 
what consumers consider to be properly cooked meat or poultry.'' \10\
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    \8\ CSPI petition #14-01 (October 1, 2014), ``Request for an 
Interpretive Rule Declaring Certain Antibiotic-Resistant Strains of 
Salmonella to be Adulterants'' and FSIS final response (February 7, 
2018) at: https://www.fsis.usda.gov/federal-register/petitions/request-interpretive-rule-declaring-certain-antibiotic-resistant-strains.
    \9\ FSIS final response to petition #14-06, p. 6. Available at: 
https://www.fsis.usda.gov/federal-register/petitions/request-interpretive-rule-declaring-certain-antibiotic-resistant-strains.
    \10\ FSIS final response to petition #14-06, p. 7. Available at: 
https://www.fsis.usda.gov/federal-register/petitions/request-interpretive-rule-declaring-certain-antibiotic-resistant-strains.
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    FSIS also considered whether certain Salmonella serotypes should be 
considered as adulterants in all meat and poultry products in response 
to a petition submitted by Marler Clark LLP on behalf of several 
individuals and consumer advocacy organizations in January 2020.\11\ 
The petition asked FSIS to declare 31 Salmonella serotypes that have 
been associated with foodborne illness outbreaks to be adulterants of 
all meat and poultry products subject to the FMIA and the PPIA.
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    \11\ Marler Clark LLP petition #20-01 ``Petition for an 
Interpretive Rule Declaring `Outbreak' Serotypes of Salmonella 
enteritica subspecies to be Adulterants'' dated January 19, 2020. 
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-salmonella-serotypes.
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    In its response to the petition, FSIS explained that while the 
Agency agrees that it needs to rethink its existing Salmonella strategy 
to reduce human illnesses associated with poultry, it does not believe 
that there is sufficient data available at this time to support the 
sweeping actions requested in the petition.\12\ The response noted 
that, as announced in October 2021,\13\ FSIS is in the process of re-
evaluating its approach to controlling Salmonella in poultry and is 
considering many of the points and arguments made in the petition as 
part of its re-evaluation. The response also noted that while FSIS has 
traditionally viewed Salmonella as ``naturally occurring'' in food 
animals, the Agency is reassessing this interpretation as part of its 
Salmonella in poultry initiative and considering whether Salmonella 
should be considered an adulterant in any poultry products. The 
response stated that in this consideration, FSIS is relying on the 
factors it identified when the Agency declared certain STEC strains to 
be adulterants in raw non-intact beef products and intact source 
materials for raw ground beef.
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    \12\ FSIS Final Response to Petition #20-01, May 31, 2022. 
Available at: https://www.fsis.usda.gov/policy/petitions/petition-interpretive-rule-related-certain-salmonella-serotypes.
    \13\ United States Department of Agriculture. (October 19, 
2021). USDA Launches New Effort to Reduce Salmonella Illness Linked 
to Poultry. https://www.usda.gov/media/press-releases/2021/10/19/usda-launches-new-effort-reduce-salmonella-illnesses-linked-poultry; 
see also Food Safety and Inspection Service. (December 2, 2021). 
Pilot Projects: Salmonella Control Strategies. https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/pilot.
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    On January 25, 2021, CSPI and other consumer advocacy organizations 
and individuals petitioned FSIS to establish enforceable standards 
targeting Salmonella types of greatest public health concern and all 
Campylobacter in poultry, and to require supply chain controls.\14\ 
With respect to the request to establish enforceable performance 
standard, the petition asserts that FSIS should focus specifically on 
the types of Salmonella of greatest public health concern and declare 
the most virulent Salmonella strains to be adulterants in raw poultry 
products. The petition also requests that FSIS employ enforceable 
quantitative thresholds to ensure that any Salmonella or Campylobacter 
that is permitted on poultry products is maintained at levels low 
enough to be less likely to cause human illness. The petition asserts 
that 21 U.S.C. 453(g)(1) authorizes FSIS to deem poultry products that 
contain virulent Salmonella strains and that contain pathogens levels 
above a set threshold to be adulterated under the PPIA.
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    \14\ CSPI petition #21-01, ``Petition to Establish Enforceable 
Standards Targeting Salmonella Types of Greatest Public Health 
Concern while Reducing all Salmonella and Campylobacter in Poultry, 
and to Require Supply Chain Controls'' (January 25, 2021) at: 
https://www.fsis.usda.gov/policy/petitions/petition-submitted-center-science-public-interest.
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    FSIS is currently reviewing the 2021 CSPI petition and supporting 
information. As noted above, FSIS is in the process of reevaluating its 
approach to controlling Salmonella in poultry. Because the actions 
requested in the 2021 CSPI petition are directly related to this 
effort, FSIS is considering the petition and supporting information as 
part of its reevaluation.

Assessing a Pathogen's Status as an Adulterant in a NRTE Product

    As noted above, while certain STEC have been the only pathogens to 
date that are considered adulterants in a raw product, certain other 
pathogens may also exhibit characteristics that would meet the standard 
to be considered as adulterants in a specific raw product. Thus, if 
FSIS became aware of evidence to show that a specific pathogen and 
product pair presents a significant public health risk, the Agency 
would consider the factors it identified to distinguish certain STEC 
from other pathogens as adulterants in raw, non-intact beef products 
and intact cuts to be further processed into non-intact beef products 
to determine the pathogen's status as an adulterant. The parallel to 
STEC in beef is not intended to be a direct comparison between non-
intact raw beef products and other raw

[[Page 26252]]

products or about the specific preparation methods between non-intact 
raw beef and other raw products. The intent is to identify the criteria 
that were used to determine that certain STECs are adulterants in non-
intact beef and apply these criteria to assess whether there are other 
pathogens that should be considered as adulterants when present in a 
specific raw product. Specifically, the Agency would consider whether 
certain pathogen serogroups or types have been associated with human 
illnesses; whether the pathogen has a relatively low infectious dose; 
whether the pathogen can cause serious human illnesses; and whether 
traditional or ordinary cooking practices associated with the specific 
raw products are sufficient to destroy the pathogen.

II. NRTE Breaded Stuffed Chicken Products

    NRTE breaded stuffed chicken products contain raw, comminuted 
chicken breast meat, trim, or whole chicken breast meat, but the 
finished product is heat-treated only to set the batter or breading on 
the exterior of the product, which may impart an RTE appearance.\15\ 
The product typically is stuffed with ingredients, such as a raw 
vegetable, butter, cheese or meat such as ham, and is typically cooked 
by household consumers from a frozen state. NRTE breaded stuffed 
chicken products do not include other types of stuffed products that 
are not breaded, such as turducken or whole stuffed chickens. NRTE 
breaded products that are not also stuffed, such as chicken nuggets and 
other par-fried products are not included in this product type. Only 
NRTE products that are both breaded and stuffed are the subject of this 
policy.
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    \15\ FSIS Directive 5300.1, Revision 1. Managing the 
Establishment Profile in the Public Health Information System (Oct 
19, 2016). See attachment 2 ``NRTE Stuffed Chicken Products that 
appear RTE.'' Available at: https://www.fsis.usda.gov/policy/fsis-directives/5300.1.
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    NRTE breaded stuffed chicken products contain raw poultry and thus 
may contain pathogens, such as Salmonella. However, because the product 
may appear fully cooked, some consumers may only reheat the product for 
aesthetic or palatability purposes rather than subject it to cooking 
sufficient to kill pathogenic bacteria. NRTE breaded stuffed chicken 
products are also typically cooked from a frozen state, which increases 
the risk that they will not reach an internal temperature needed to 
destroy Salmonella organisms that may be in the product. While NRTE 
chicken nuggets and other par-fried breaded products that are not 
stuffed may also have a cooked appearance, the focus of this document 
is on NRTE breaded stuffed chicken products because these stuffed 
products are thicker in diameter and have a different composition than 
other par-fried breaded products, which can make effective cooking of 
NRTE breaded stuffed chicken products more challenging. In addition, it 
may be difficult for a consumer to determine an accurate internal 
temperature of these products because they contain multiple ingredients 
that may cook at different rates. FSIS has recommended in the past that 
consumers check the temperature at multiple locations throughout the 
product, but this is not always practical or accurate.\16\ In addition, 
NRTE breaded stuffed chicken products have been associated with a 
number of Salmonella illness outbreaks in the United States.
---------------------------------------------------------------------------

    \16\ Smith, K.E., Medus, C., Meyer, S.D., Boxrud, J.D., Leano, 
F., Hedburg, C., Elfering, K., Braymen, C., Bender, J.B., Danila, 
R.N. 2008. Outbreaks of Salmonellosis in Minnesota (1998 through 
2006) Associated with Frozen, Microwaveable, Breaded Stuffed Chicken 
Products. Journal of Food Protection. 71(10): 2153-2160.
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    Before 2006, many NRTE breaded stuffed chicken products were 
marketed as a microwaveable product, and the labeling on the product 
packaging included instructions for cooking the products in both a 
microwave and conventional oven. However, as discussed below, 
information from documented Salmonella illness outbreaks associated 
with NRTE breaded stuffed chicken products from 1998 through 2006 
showed that, based on the product's labeling, appearance, and frozen 
state, most case patients that became ill after consuming these 
products thought that the product was pre-cooked, and therefore, did 
not cook it to an internal temperature necessary to destroy pathogens. 
In response, industry producers have made numerous changes to the 
labeling of NRTE breaded stuffed chicken products over time to inform 
consumers that these products are raw and to provide instructions on 
how to prepare them safely. In addition, industry no longer markets 
NRTE breaded stuffed chicken products as microwavable products because 
cooking these products in a microwave oven decreases the chances that 
they will reach an internal temperature needed to destroy Salmonella. 
From 1998 to 2021, FSIS and public health partners have investigated 14 
Salmonella illness outbreaks associated with consumption of NRTE 
breaded stuffed chicken products, which are summarized below and listed 
in Table 1. An FSIS analysis of all chicken associated outbreaks the 
Agency identified in the CDC National Outbreak Reporting System (NORS) 
\17\ or in the scientific literature from 1998-2020 found that although 
NRTE breaded stuffed chicken products account for less than 0.15 
percent of the total domestic chicken supply (in 2021, 53.9 million 
pounds of NRTE breaded stuffed chicken were produced compared to 45.4 
billion pounds of raw chicken products overall), outbreaks linked to 
these products represented approximately five percent of all chicken-
associated outbreaks in the United States during this time. (See 
Appendix A for the list of Salmonella outbreak investigations 
associated with all chicken products from 1998-2020).
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    \17\ CDC National Outbreak Reporting System available at: 
https://www.cdc.gov/nors/index.html.
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Salmonella Illness Outbreak Investigations Associated With NRTE Breaded 
Stuffed Chicken Products 1998-2016 and FSIS and Industry Response

    1998-2006 outbreak investigations. From 1998 through 2006, four 
separate outbreaks of salmonellosis associated with consumption of NRTE 
breaded stuffed chicken products were identified in Minnesota.\18\ In 
the first outbreak in 1998, 33 Salmonella Typhimurium cases were 
associated with a single brand of raw, frozen, stuffed, breaded, pre-
browned, and microwaveable Chicken Kiev product.\19\ Of the 33 people 
who became ill, 3 were hospitalized for a range of 2-3 days. The 
outbreak duration was 5 months. Most case patients reported that they 
thought the product was pre-cooked, and most prepared the product in a 
microwave oven. No case patients reported taking an internal 
temperature of the product after cooking. In response to the outbreak, 
the company that produced the product initiated a voluntary recall of 
the implicated products and made several changes to the product label, 
such as replacing the words ``ready to cook'' on the principal display 
panel with the words ``not precooked'' and adding ``not pre-cooked--
cook thoroughly'' and ``cook to an internal temperature of 165 [deg]F'' 
to the cooking instructions on the back of the package.
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    \18\ Smith K, Medus C, Meyer S. et al. Outbreaks of 
Salmonellosis in Minnesota (1998 through 2006) Associated with 
frozen, microwavable, breaded, stuffed chicken products (2008). 
Journal of Food Protection, 71(10), 2153-2160.
    \19\ Smith, K. et al. (2008).
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    In the second outbreak in early 2005, four Salmonella Heidelberg 
human illnesses were associated with raw, frozen, stuffed, breaded, 
pre-browned, and microwaveable chicken products.\20\

[[Page 26253]]

One elderly case patient was hospitalized for 4 days. The duration of 
the outbreak was three months. A separate published report noted that 
additional Salmonella cases associated with similar products were also 
reported in Michigan.\21\ In response to the outbreak, FSIS issued a 
public health alert (PHA) to remind consumers that frozen meat and 
poultry products must be fully cooked before they are consumed. In 
addition, the manufacturer modified the labels of the products to 
include the word ``uncooked'' and verified the cooking instructions.
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    \20\ Smith, K. et al. (2008).
    \21\ Response to the Questions Posed by the Food Safety and 
Inspection Service Regarding Consumer Guidelines for the Safe 
Cooking of Poultry Products; APPENDIX I. REPORT ON SALMONELLOSIS 
LINKED TO CONSUMING PROCESSED CHICKEN PRODUCTS IN MINNESOTA AND 
MICHIGAN: SUMMARY OF A PRESENTATION GIVEN TO NACMCF ON 7 JULY 2005 
BY MR. KEVIN ELFERING OF THE MINNESOTA DEPARTMENT OF AGRICULTURE. 
Journal of Food Protection, 70(1), 251-260.
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    In the third outbreak in August 2005 through July 2006, 27 
Salmonella Enteritidis cases were associated with a variety of raw, 
frozen, stuffed, breaded, pre-browned, and microwaveable chicken 
products.\22\ The products represented eight product brands produced by 
three separate companies. Salmonella Enteritidis was isolated from 
intact samples of breaded stuffed chicken products produced in an 
establishment owned by one of the companies. Of the 27 case patients, 6 
were hospitalized. The length of hospitalization ranged from 2 to 30 
days. Two elderly case patients were hospitalized for 30 days. Another 
case patient required surgery for a perforated colon. The duration of 
the outbreak was 11 months. Nineteen of the 27 case patients used a 
microwave oven to cook the products and none of the case patients took 
the internal temperature of the product after cooking it. The 
establishment that produced the products from which Salmonella 
Enteritidis had been isolated voluntarily recalled 75,800 pounds of 
frozen, breaded stuffed NRTE chicken entrees.\23\ Because of the 
ongoing nature of this outbreak, FSIS issued a PHA in July 2006 to 
provide additional information to enable consumers to more readily 
identify the class of products implicated in the outbreak and to 
emphasize that they must be cooked to an internal temperature of 165 
[deg]F.\24\ The PHA noted that in addition to the cases in Minnesota, 
there were at least 34 other human illnesses across the United States 
associated with the consumption of undercooked chicken entrees.
---------------------------------------------------------------------------

    \22\ Smith, K. et al. (2008).
    \23\ FSIS Recall Release: Indiana Firm Recalls Frozen Stuffed 
Chicken Entrees Associated with Illnesses (March 10, 2006).
    \24\ FSIS Issues Public Health Alert for Frozen, Stuffed, Raw 
Chicken Products (July 2006).
---------------------------------------------------------------------------

    While the 2005-2006 Salmonella Enteritidis outbreak was being 
investigated, an outbreak of three Salmonella Typhimurium illnesses 
associated with breaded stuffed chicken products was identified.\25\ 
Two of the case patients were hospitalized for 2 days each. The 
duration of the outbreak was two months. All three case patients 
microwaved the product, and none used a thermometer to check the 
internal temperature of the product.
---------------------------------------------------------------------------

    \25\ Smith, K. et al. (2008).
---------------------------------------------------------------------------

    2005-2006 FSIS and industry response. In March 2006, in response to 
the 2005-2006 Salmonella Enteritidis outbreak and recall, FSIS sent a 
letter to all establishments that produced frozen NRTE breaded stuffed 
chicken products to strongly recommend that the labeling of these 
products be modified to emphasize that the products are not cooked. 
FSIS also recommended that these establishments enhance and validate 
the cooking instructions to ensure that they address the intended use 
by the consumer. FSIS posted the letter to the FSIS website.\26\ The 
letter explained that a statement on the principal display panel of the 
packaging, such as ``Uncooked: For Safety, Must be Cooked to an 
Internal Temperature of 165 degrees F as Measured by Use of a 
Thermometer'', would be appropriate to help consumers understand the 
need to safely prepare the product on their part. The letter also 
stated that in light of the concerns associated with the NRTE breaded 
stuffed chicken products subject to the recall, establishments were 
requested to submit their revised labeling to FSIS for evaluation of 
the necessary modifications and re-approval. The letter noted that if 
FSIS did not receive the modified labeling submissions by May 1, 2006, 
the labels for the subject products would be deemed to be rescinded.
---------------------------------------------------------------------------

    \26\ Letter to industry about the safe handling labeling of 
uncooked, breaded, boneless poultry products (March 2006) at: 
https://www.fsis.usda.gov/guidelines/2006-0007.
---------------------------------------------------------------------------

    In addition to the letter, in March 2006, FSIS made publicly 
available guidance contained in a March 2006 report of the Subcommittee 
on Consumer Guidelines for the Safe Cooking of Poultry Products of the 
National Advisory Committee on Microbiological Criteria for Foods 
(NACMCF) regarding consumer guidelines for the safe cooking of NRTE 
breaded stuffed chicken products.\27\ The NACMCF recommended, among 
other things, that consumers should be advised to cook these products 
to a single minimum internal temperature of 165 [deg]F and that 
microwaving raw poultry from a frozen state is not advisable unless the 
manufacturer's cooking instructions ensures that they achieve the 
recommended 165 [deg]F end point temperature. The NACMCF also 
recommended that the principal display panel on the label indicate 
whether the product is RTE or NRTE and stated that it may be necessary 
to provide a warning on the label to fully cook the product if the 
product appears RTE to the consumer. In addition, in April 2006, FSIS 
issued guidance to establishments that produce NRTE breaded stuffed 
chicken products on the necessary modifications recommended for the 
labeling of these products.\28\
---------------------------------------------------------------------------

    \27\ Response to the Questions Posed by the Food Safety and 
Inspection Service Regarding Consumer Guidelines for the Safe 
Cooking of Poultry Products. Journal of Food Protection, 70(1), 251-
260.
    \28\ Labeling Policy Guidance Uncooked, Breaded, Boneless 
Poultry Products (April 2006) at: https://www.fsis.usda.gov/guidelines/2017-0001.
---------------------------------------------------------------------------

    In November 2006, FSIS issued instructions to its inspection 
program personnel (IPP) on how to verify that establishments producing 
NRTE breaded stuffed chicken product have product labeling consistent 
with the April 2006 guidance.\29\ Specifically, FSIS IPP were 
instructed to verify that the establishments had new labeling along 
with adequate validation to support the cooking instructions to be 
included on the product label.
---------------------------------------------------------------------------

    \29\ FSIS Notice 75-06, Verification Instructions for Changes in 
Label Requirements for Uncooked and Raw Frozen, Breaded, Boneless 
Poultry Products (Nov 13, 2006). Supplemental Q's and A's to Address 
Products Affected by FSIS Notice 75-06 Verification Instructions for 
Changes in Label Requirements for Uncooked and Raw Frozen, Breaded, 
Boneless Poultry Products at: https://www.fsis.usda.gov/guidelines/2006-0008.
---------------------------------------------------------------------------

    In response to the 2005-2006 outbreaks and to FSIS guidance, 
companies that produced NRTE breaded stuffed chicken products modified 
the product labeling to emphasize that these products are raw and that 
they should not be microwaved. The companies also modified the product 
labeling to provide validated instructions for cooking the products in 
a conventional oven and instructions to cook the product to a minimum 
internal temperature of 165 [deg]F as measured by a food thermometer. 
However, even with these labeling modifications, Salmonella illnesses 
associated with these products continued to be reported.
    2008-2009 outbreak investigations. In 2008 and 2009, FSIS and 
public health partners investigated 4 separate

[[Page 26254]]

outbreaks associated with NRTE breaded stuffed chicken products. From 
February to April 2008, the Minnesota Department of Health (MDH) 
identified seven Salmonella Enteritidis illnesses associated with 
frozen, pre-browned breaded stuffed chicken products.\30\ Five of the 
seven case patients reported cooking the product in the microwave, even 
though the cooking instructions did not include microwave preparation 
and recommended against that method of cooking. In response, FSIS 
issued a PHA in March 2008 to remind consumers of the importance of 
following package instructions for NRTE breaded stuffed chicken 
products and to emphasize that it is important to cook these products 
in a conventional oven.\31\ The PHA identified the establishment that 
had produced the products associated with the illnesses, and FSIS 
conducted a Food Safety Assessment (FSA) \32\ at the establishment.
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    \30\ Minnesota Department of Health Annual Summary of Disease 
Activity: Disease Control Newsletter. Salmonella 2008 at: https://www.health.state.mn.us/diseases/reportable/dcn/sum08/salmonellosis.html.
    \31\ FSIS Public Health Alert, March 29, 2008.
    \32\ The purpose of an FSA is to conduct a risk-based, targeted 
review of establishment food safety systems to verify that the 
establishment is able to produce safe and wholesome meat or poultry 
products in accordance with FSIS statutory and regulatory 
requirements (https://www.fsis.usda.gov/policy/fsis-directives/5100.1).
---------------------------------------------------------------------------

    In a separate investigation in October 2008, the MDH reported 14 
Salmonella illness cases had been linked to raw, frozen, breaded, and 
pre-browned, stuffed Chicken Cordon Bleu and Chicken Kiev products.\33\ 
MDH reported that the outbreak strain of Salmonella was found in four 
packages of breaded stuffed chicken products recovered from the homes 
of some of the individuals that were ill and from grocery stores. The 
outbreak strain was identified as Salmonella I 4,[5],12:i:-.\34\ An 
investigation subsequently conducted by FSIS and other public health 
partners identified 47 illness cases from 17 States associated with the 
same outbreak strain with 8 reported hospitalizations.\35\ Information 
from case patients identified in Wisconsin found that 9 out of 11 
reported that they consumed frozen NRTE breaded stuffed Chicken Kiev or 
Cordon Bleu products. Four of the Wisconsin case patients reported that 
they cooked the product in a microwave, and 4 reported that they cooked 
the product in an oven.
---------------------------------------------------------------------------

    \33\ MDH News Release; Salmonella cases linked to raw, frozen 
chicken entrees (Oct 8, 2008).
    \34\ FSIS outbreak investigation case 2009-02.
    \35\ FSIS outbreak investigation case 2009-02.
---------------------------------------------------------------------------

    After the investigation was initiated, FSIS issued a PHA due to 
concerns about illnesses that may be associated with NRTE breaded 
stuffed chicken products.\36\ The PHA reminded consumers of the 
importance of following package cooking instructions for NRTE breaded 
stuffed chicken products and general food safety guidelines when 
handling raw meat or poultry products.
---------------------------------------------------------------------------

    \36\ FSIS Issues Public Health Alert, October 3, 2008.
---------------------------------------------------------------------------

    In an additional investigation in May 2009, FSIS received a report 
from the MDH that 2 Salmonella Enteritidis case patients from different 
households reported eating a NRTE breaded stuffed Chicken Cordon Bleu 
product that was produced by the same establishment.\37\ The illness 
onsets were reported in February 2009 and April 2009; both less than a 
week after last consumption of the NRTE breaded stuffed chicken 
product. The case patients were unable to provide dates of purchase or 
production. MDH also reported this product was linked to a previous 
case patient with the same strain by consumption history in September 
2008.
---------------------------------------------------------------------------

    \37\ FSIS outbreak investigation case 2009-23.
---------------------------------------------------------------------------

    In the final 2008-2009 investigation, FSIS received a report from 
the MDH of two Salmonella Enteritidis cases with an indistinguishable 
genetic pattern that reported consuming NRTE breaded stuffed chicken 
products that were produced at the same establishment.\38\ The product 
was produced in January 2009 but FSIS was unable to obtain further 
details because the packaging was partially discarded. An earlier case 
patient also reported consuming the same product but had no remaining 
product.
---------------------------------------------------------------------------

    \38\ FSIS outbreak investigation case 2009-43.
---------------------------------------------------------------------------

    2013 and 2014 outbreak investigations. In 2013 and 2014, FSIS and 
public health partners investigated 2 separate Salmonella illness 
outbreaks associated with NRTE breaded stuffed chicken product. In 
August 2013, FSIS was notified of three Salmonella Enteritidis cases 
from Minnesota.\39\ The illness onset dates were from April 2013 to 
July 2013. All three case patients reported consuming various NRTE 
chicken products produced by two separate establishments prior to 
illness onset. The Minnesota Department of Agriculture (MDA) collected 
and tested intact breaded stuffed chicken products from the case 
patients' homes. Products produced by one of the establishments tested 
positive for Salmonella Enteritidis, Salmonella Typhimurium, Salmonella 
Kentucky, and Salmonella I 4,12:i:-. A Chicken Cordon Bleu and Bacon 
and Cheddar product produced by the other establishment tested positive 
for the same Salmonella Enteritidis outbreak strain as the case 
patients. Two case patients reported cooking the product in the oven 
but one of them stated that they were not aware that the product was 
raw. Another case patient reported microwaving the product.
---------------------------------------------------------------------------

    \39\ FSIS outbreak investigation case 2013-17.
---------------------------------------------------------------------------

    In response to the information obtained from the August 2013 
outbreak investigation, FSIS issued an FSIS Notice in June 2014 
instructing FSIS Inspection Program Personnel (IPP) to perform a Hazard 
Analysis Verification (HAV) Task \40\ at establishments that produced 
NRTE breaded stuffed chicken products.\41\ The Notice stated that 
during the 2013 outbreak investigation, FSIS discovered that there are 
consumers that may be unaware that NRTE breaded stuffed chicken 
products can be produced as raw frozen products. The Notice explained 
that the frozen state, labeling, and cooked appearance of these 
products may cause consumers to falsely believe that such products are 
precooked. The Notice instructed IPP to verify that establishments 
producing NRTE breaded stuffed chicken products have appropriately 
considered the microbial hazards associated with these products and 
have documentation to support their resulting decisions.
---------------------------------------------------------------------------

    \40\ An HAV task is a verification task performed by IPP 
focusing on establishments' hazard analyses, pre-requisite programs, 
and other supporting documentation.
    \41\ FSIS Notice 31-14, Supplemental Instructions for Performing 
the Hazard Analysis Verification Task in Establishments that Produce 
NRTE Stuffed Poultry Products (June 30, 2014).
---------------------------------------------------------------------------

    In a separate investigation in August 2014, six Salmonella 
Enteritidis illnesses in Minnesota were associated with NRTE breaded 
stuffed Chicken Kiev products.\42\ The illness onsets ranged from 
August 17, 2014, to September 27, 2014, and one case patient was 
hospitalized. In October 2014, the establishment that produced the 
product initiated a voluntary recall of 28,980 pounds of the 
product.\43\ The product labeling stated in several places that the 
product was raw and included validated cooking instructions as 
recommended in the FSIS guidance for labeling NRTE breaded stuffed 
chicken products. The FSIS recall release associated with the recall 
emphasized

[[Page 26255]]

the importance of following package cooking instructions on any NRTE 
breaded chicken product and to use a thermometer to ensure that the 
product reaches an internal temperature of 165 [deg]F.
---------------------------------------------------------------------------

    \42\ Salmonella cases linked to raw, frozen chicken entrees 
(October 23, 2014). Press release by Minnesota Department of Health/
Minnesota Department of Agriculture.
    \43\ FSIS Recall Release (October 24, 2014): Illinois Firm 
Recalls Chicken Products Due To Salmonella Enteritidis Contamination 
https://www.fsis.usda.gov/recalls-alerts/illinois-firm-recalls-chicken-products-due-possible-salmonella-enteritidis.
---------------------------------------------------------------------------

    2015-2016 outbreak investigations. In 2015 and 2016, FSIS and 
public health partners investigated three Salmonella outbreaks 
associated with NRTE breaded stuffed chicken products. The MDH, 
Minnesota Department of Agriculture, CDC, and FSIS investigated two 
separate Salmonella Enteritidis outbreaks associated with NRTE breaded 
stuffed chicken products produced by different establishments from June 
2015 through October 2015.44 45 One of the outbreaks 
included five cases from Minnesota with illness onset dates from May 9, 
2015, through July 22, 2015.\46\ Two of the case patients were 
hospitalized. All case patients reported consuming various NRTE breaded 
stuffed chicken products the week before illness onset. All products 
were produced at the same establishment. In follow-up interviews, two 
case patients stated that they were aware that the product was raw, 
three stated that they cooked the product in a conventional oven as 
instructed on the label, one reported that they used a convection oven/
microwave and used a thermometer to confirm that the product reached an 
internal temperature of 165 [deg]F, and one case patient stated that 
they were not aware that the product was raw and cooked it in a 
microwave.
---------------------------------------------------------------------------

    \44\ FSIS Salmonella Enteritidis Illness Outbreaks Associated 
with Raw, Frozen, Stuffed Chicken Products, 2015 After-Action Review 
Report 2015-11/2015-12 (December 6, 2016) at: https://www.fsis.usda.gov/food-safety/foodborne-illness-and-disease/outbreaks/outbreak-investigations-response.
    \45\ Minnesota Department of Health: Salmonella cases linked to 
raw, frozen, stuffed chicken products (July 2, 2015) at: https://content.govdelivery.com/accounts/MNMDH/bulletins/10d1df0.
    \46\ CDC: Outbreak of Salmonella Enteritidis Infections Linked 
to Raw, Frozen, Stuffed Chicken Entrees Produced by Aspen Foods 
(Final Update) at: https://www.cdc.gov/salmonella/frozen-chicken-entrees-part2-07-15/index.html.
---------------------------------------------------------------------------

    In response to the outbreak, the establishment voluntarily recalled 
approximately 1,978,608 pounds of product in July 2015.\47\ In 
addition, in September 2015, FSIS issued a PHA to inform the public 
that additional NRTE breaded stuffed chicken products produced by the 
establishment subject to the July 2015 recall had tested positive for 
the same Salmonella Enteritidis strain associated with the 
outbreak.\48\ In October 2015, the establishment expanded the July 2015 
recall to include an additional 561,000 pounds of products implicated 
by Salmonella-positive results matching the outbreak strain to prevent 
additional illnesses.\49\ The labeling of most of the products subject 
to the recall stated that the product was raw, should not be cooked in 
a microwave oven, and provided validated cooking instructions. The 
label also included instructions to cook the product to a minimum 
internal temperature of 165 [deg]F as measured by a food thermometer 
and included icons and illustration that emphasized these messages.
---------------------------------------------------------------------------

    \47\ Aspen Foods Recalls Frozen, Raw, Stuffed and Breaded 
Chicken Product Due To Possible Salmonella Contamination (July 15, 
2015) at: https://www.fsis.usda.gov/recalls-alerts/aspen-foods-recalls-frozen-raw-stuffed-breaded-chicken-products-due-possible-
0#labels.
    \48\ FSIS Issues Public Health Alert for Stuffed Chicken 
Products Due to Possible Salmonella Contamination (September 17, 
2015) at: https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-stuffed-chicken-products-due-possible-salmonella.
    \49\ Aspen Foods Recalls Frozen, Raw, Stuffed and Breaded 
Chicken Product Due To Possible Salmonella Contamination (October 2, 
2015) at: https://www.fsis.usda.gov/recalls-alerts/aspen-foods-recalls-frozen-raw-stuffed-breaded-chicken-products-due-possible.
---------------------------------------------------------------------------

    A separate 2015 outbreak associated with NRTE breaded stuffed 
chicken produced by a different establishment included 15 cases from 7 
states (CT, IL, MN, NH, NY, OK, and WI) with illness onset dates from 
April 5, 2015, through July 27, 2015. Among 10 case patients with 
available information, 4 were hospitalized.\50\ Information available 
from eight case patients indicated that seven of the eight cooked the 
product in a conventional oven and one used a toaster oven.\51\ In 
response, in July 2015, the establishment that produced the implicated 
product voluntarily recalled approximately 58,320 pounds of various 
NRTE breaded stuffed chicken products, which was expanded to include 
additional product for a total of over 1,700,000 pounds of product.\52\ 
The labeling of most of the products subject to the recall clearly 
stated that the product was raw, should not be cooked in a microwave 
oven, and provided validated cooking instructions. The label also 
included instructions to cook the product to a minimum internal 
temperature of 165 [deg]F as measured by a food thermometer and 
included icons and illustration that emphasized these messages.
---------------------------------------------------------------------------

    \50\ CDC: Multi-State Outbreak of Drug-Resistant Salmonella 
Enteritidis Infections Linked to Raw, Frozen, Stuffed Chicken 
Entrees Produced by Barber Foods (Final Update; October 16, 2015) 
https://www.cdc.gov/salmonella/frozen-chicken-entrees-07-15/index.html..
    \51\ FSIS outbreak ID 2015-12.
    \52\ Barber Foods Recalls Stuffed Chicken Products Due to 
Possible Salmonella Enteritidis Contamination (July 12, 2015) at: 
https://www.fsis.usda.gov/recalls-alerts/barber-foods-recalls-stuffed-chicken-products-due-possible-salmonella-enteritidis.
---------------------------------------------------------------------------

    In 2016, 5 Salmonella Enteritidis cases associated with NRTE 
breaded stuffed chicken were reported in Minnesota.\53\ Three of the 5 
case patients reported eating NRTE breaded stuffed chicken products 
purchased at the same retail store, and 2 of those 3 purchased a 
product brand that was produced by the same establishment. An FSIS 
investigation found that the retail store had received the same brand 
of NRTE breaded stuffed chicken products produced by the same 
establishment during the time in which case patients reported shopping 
at the retail store.
---------------------------------------------------------------------------

    \53\ FSIS outbreak investigation case 2016-06.
---------------------------------------------------------------------------

    2015-2016 FSIS and industry response. In response to the 2015 
outbreaks and recalls, FSIS issued NOIEs to the two establishments that 
produced the products associated with the outbreaks to inform them that 
FSIS intended to withhold marks of inspection or issue a suspension if 
they did not respond to FSIS within 3 business days regarding how they 
have or will implement corrective actions.54 55  FSIS also 
conducted intensified sampling in these establishments for Salmonella, 
including sampling of comminuted source material, final product, and 
production environment surface sampling. Both establishments 
implemented corrective actions, such as source product testing and 
application of new interventions during processing, that were validated 
and verified by FSIS. One of the establishments also implemented 
product labeling changes.
---------------------------------------------------------------------------

    \54\ NOIE Establishment P-1358, July 10, 2015.
    \55\ NOIE Establishment P-276, July 10, 2015.
---------------------------------------------------------------------------

    In February 2016, FSIS instructed FSIS IPP at establishments that 
produce raw and heat-treated but not fully cooked, not shelf-stable 
breaded stuffed chicken products to update the establishments' Public 
Health Information System (PHIS) profile to allow FSIS to determine 
which establishments produce NRTE breaded stuffed chicken products that 
appear RTE.\56\ After IPP updated the PHIS profiles, FSIS used the 
information to schedule a Public Health Risk Evaluation (PHRE) \57\ 
and, if necessary, an FSA at these establishments. FSIS also captured 
information concerning

[[Page 26256]]

these establishments' production practices and evaluated whether 
establishments had reassessed their Hazard Analysis and Critical 
Control Point (HACCP) plans in response to the recent outbreaks 
associated with these products (9 CFR 417.4(b)). In addition, the 
Agency published industry guidance with information on developing 
validation for labeled cooking instructions for raw and partially 
cooked, breaded, boneless poultry products.\58\
---------------------------------------------------------------------------

    \56\ FSIS Notice 15-16, Profile Update In Establishments That 
Produce Not-Ready-To-Eat Stuffed Chicken Products That Appear Ready-
To Eat (February 18, 2016).
    \57\ The PHRE is an analysis of establishment performance based 
on ``For-cause'' and ``Routine risk-based'' criteria, https://www.fsis.usda.gov/policy/fsis-directives/5100.4.
    \58\ Information on Validation of Labeled Cooking Instructions 
for Products Containing Raw or Partially Cooked Poultry (February 
2017) at: https://www.fsis.usda.gov/guidelines/2017-0017.
---------------------------------------------------------------------------

    In 2015-2016, FSIS also held conference calls and worked directly 
with establishments that produced NRTE breaded stuffed chicken products 
to modify the product labeling to further emphasize that the product is 
raw and to ensure that the label included validated cooking 
instructions. Based on recommendations from FSIS, establishments re-
validated the cooking instructions on the product label to ensure that, 
when prepared as instructed, a NRTE breaded stuffed chicken product 
would reach an internal temperature needed to destroy Salmonella 
organisms on the interior of the product. FSIS also worked with 
industry to ensure that the product labels emphasized that these 
products should not be prepared in a microwave oven.

2016 National Advisory Committee on Meat and Poultry Inspection 
Recommendations and National Chicken Council Petition

    2016 National Advisory Committee on Meat and Poultry Inspection 
recommendations. In March 2016, a National Advisory Committee on Meat 
and Poultry Inspection (NACMPI) subcommittee was charged to consider 
mandatory labeling features for certain NRTE meat and poultry products 
that appear RTE.\59\ The subcommittee met on March 29, 2016, and issued 
a report that provided recommendations on labeling and other measures 
to prevent illnesses associated with these products.\60\ The report 
recommended, among other things, that the labels of NRTE meat and 
poultry products that appear RTE include statements, such as ``Raw'' 
and ``Uncooked'' to differentiate these products from RTE products, and 
that they should also include validated cooking instructions that 
include the method of cooking, the endpoint temperature for safety, and 
an instruction to use a thermometer to measure the endpoint. The report 
also recommended that the cooking instructions include a disclaimer to 
not use a microwave, if applicable. Moreover, it recommended that FSIS 
conduct consumer focus groups to understand the optimal messaging and 
design of packaging to ensure consumers properly understand that NRTE 
products need to be cooked for lethality. The report further stated 
that FSIS should consider creating a standard of identity for these 
products if illnesses continue after labeling changes are made.
---------------------------------------------------------------------------

    \59\ National Advisory Committee on Meat and Poultry Inspection, 
Subcommittee #2 Consideration of Mandatory Labeling Features for 
Certain Processed Not Ready to Eat Meat and Poultry products. March 
26, 2016. (https://www.fsis.usda.gov/news-and-events/events-meetings/2016-national-advisory-committee-meat-and-poultry-inspection-nacmpi).
    \60\ Subcommittee #2 Consideration of Mandatory Labeling 
Features for Certain Processed Not Ready to Eat Meat and Poultry 
Products (March 2016) (https://www.fsis.usda.gov/sites/default/files/media_file/2021-02/NRTE-Labeling.pdf).
---------------------------------------------------------------------------

    2016 National Chicken Council petition. In May 2016, the National 
Chicken Council (NCC) submitted a petition requesting FSIS to adopt 
regulations that would define and establish labeling requirements for 
NRTE breaded stuffed chicken products that appear RTE.\61\ The petition 
also requests that FSIS issue a guidance document for developing and 
communicating validated cooking instructions that would incorporate the 
NCC's Best Practices for Cooking Instruction Validation for Frozen NRTE 
Stuffed Chicken Breast Products.\62\ The petition requests that FSIS 
establish regulations to require, among other things, that the product 
name for NRTE breaded stuffed chicken products include the term 
``raw;'' that the principal display panel on the product packaging 
include statements and icons to signal that the product is raw and 
should not be cooked in a microwave; and that the labeling provide 
validated cooking instructions that include a ``do not microwave'' icon 
and state that the product must be cooked to a specified endpoint 
temperature as measured by a food thermometer. FSIS received two 
letters in support of the petition, one from an industry trade 
association and one from a consumer advocacy organization.\63\ The 
consumer advocacy organization expressed general support for new 
labeling requirements for NRTE breaded stuffed chicken products but 
noted that determining consumer compliance with labeling instructions 
is hard to assess and that the chicken industry should not rely on 
labeling alone as a measure to prevent human illnesses associated with 
these products. The industry trade association believed that the 
labeling requirements requested in the petition would enhance food 
safety by reinforcing proper consumer handling of these products and 
encouraged FSIS to move forward with rulemaking consistent with the 
petition.
---------------------------------------------------------------------------

    \61\ National Chicken Council petition #16-03, ``Petition to 
Establish Regulations for the Labeling and Validated Cooking 
Instructions for Not-Ready-to-Eat Stuffed Chicken Breast Products 
That Appear Ready-to-Eat'' dated May 24, 2016 available at: https://www.fsis.usda.gov/federal-register/petitions/establish-labeling-requirements-not-ready-eat-stuffed-chicken-products.
    \62\ Attachment 1, National Chicken Council petition #16-03.
    \63\ Letter from Safe Food Coalition dated September 30, 1996 
at: https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/16-03-Support-Ltr-093016.pdf and Letter from American Frozen 
Foods Institute dated August 17, 2016 at: https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/16-03-Support-Ltr-081716.pdf.
---------------------------------------------------------------------------

    To support the requested action, the petition submitted the results 
of a 2009 online study conducted by the NCC. The study included the 
results of 1,000 online interviews to assess consumers' understanding 
of the raw nature of NRTE breaded stuffed chicken products that appear 
RTE based on a 2008 ``generic old copy'' of a NRTE breaded stuffed 
chicken label that did not include the labeling features requested in 
the petition and a 2009 ``generic new copy'' of a NRTE breaded stuffed 
chicken product label that included the labeling requirements requested 
in the petition. The study found that when compared to the labeling 
features in the 2008 generic label, the mandatory labeling features in 
the 2009 generic label increased the study participants' awareness of 
the raw state of the product and increased the number of participants 
who noticed the mention of a food thermometer. As additional support, 
the petition referenced the labeling recommendations included in the 
2006 NACMCF report discussed above as well as the 2016 NACMPI report 
recommendations that FSIS require NRTE products that appear RTE to bear 
mandatory labeling statements and include validated cooking 
instructions.
    When FSIS received the 2016 NCC petition, most manufacturers of 
NRTE breaded stuffed chicken products had voluntarily incorporated the 
labeling features recommended by the 2016 NACMPI subcommittee and 
requested in the 2016 NCC petition in response to the outbreaks 
associated with these products. However, as discussed below, consumer 
behavior research results from 2020 found that even when NRTE breaded 
stuffed chicken product labels included features recommended by the 
NACMPI subcommittee and requested in the 2016 NCC petition, twenty-two

[[Page 26257]]

percent of the study participants were still confused about the raw 
nature of the product.

Consumer Behavior Research

    2020 Meal Preparation Experiment. In September 2020, FSIS published 
a final report on a consumer research study that examined consumers' 
use of a food thermometer to check doneness of raw stuffed chicken 
products prepared from a frozen state.\64\ FSIS had contracted with RTI 
International (RTI) and its subcontractor, North Carolina State 
University (NCSU), to conduct five separate iterations of a meal 
preparation study to evaluate consumer food handling behaviors in a 
test kitchen. The study examining participants' meal preparation 
related to NRTE breaded stuffed chicken products was the third 
iteration of the study. It was conducted in a test kitchen facility 
with individuals who self-reported preparing NRTE breaded stuffed 
chicken products when cooking at home. The NRTE breaded stuffed chicken 
product used in the study was packaged to resemble a commercially 
available product and included the labeling features that manufacturers 
have voluntarily incorporated into the labeling: i.e., the term ``raw'' 
was prominently displayed on the front and back of the product 
packaging; the principal display panel included statements and icons to 
signal that the product is raw and should not be cooked in a microwave; 
and the labeling provided validated cooking instructions that included 
a ``do not microwave'' icon as well as icons and instructions to cook 
the product in a conventional oven to an internal temperature of 165 
[deg]F as measured by a food thermometer.\65\
---------------------------------------------------------------------------

    \64\ Final Report: Food Safety Consumer Research Project: Meal 
Preparation Experiment on Raw Stuffed Chicken Breasts (September 23, 
2020) at: https://www.fsis.usda.gov/sites/default/files/media_file/2021-04/fscrp-yr3-nrte-final-report.pdf.
    \65\ Figure 2-2 Packaging for NRTE Chicken Product Used in Meal 
Preparation Study.
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    A short video, meant to simulate a real news segment on safely 
preparing frozen NRTE foods, was played for some of the study 
participants (referred to as ``the intervention group'') as they sat in 
the waiting room at the start of their appointment. The segment was 
included as part of a looped video containing six separate news 
segments on current news topics. The food safety news segment 
communicated that although frozen NRTE foods may appear RTE, they are 
not fully cooked, and the endpoint temperature should be checked with a 
food thermometer to ensure safety. The segment showed a variety of 
frozen NRTE foods, including NRTE breaded stuffed chicken products and 
bagged frozen corn being prepared in the meal preparation study as well 
as products not being prepared in the study. The control group was 
exposed to a similar news segment video loop that did not include the 
segment on food safety. The study had the capacity to include up to 400 
participants in each iteration of the meal preparation experiment. The 
study randomly assigned half of the participants (n=200) to the 
treatment group and the remaining 200 participants to the control 
group. Observations were conducted from April 29, 2019, to September 5, 
2019. A final report was issued on September 23, 2020.
    With respect to NRTE breaded stuffed chicken products, the study 
found that consumers may confuse NRTE frozen foods with RTE products. 
Nearly a quarter of all participants preparing frozen foods were not 
sure if the products were raw or fully cooked despite reading the 
preparation instructions on the product label. Twenty-two percent of 
participants were unaware that the NRTE frozen chicken product they 
prepared was raw. They believed it was either fully cooked, partially 
cooked, or were unsure. Eleven percent of the participants incorrectly 
believed the product was fully cooked. Nearly all study participants 
had prior experience preparing chicken nuggets. Thus, the pre-browned 
breaded appearance of the NRTE breaded stuffed chicken products may 
have also led participants to believe that these stuffed products can 
be handled the same as other breaded chicken products that are RTE. 
Seventy-six percent of participants said they would buy NRTE breaded 
stuffed chicken products for their children to prepare at home.
    Ninety-nine percent of all participants self-reported that they had 
read the manufacturer's instructions for the NRTE breaded stuffed 
chicken products, which instructed consumers to use a food thermometer 
to check that the chicken reached a safe internal temperature of 165 
[deg]F. Seventy-seven percent of participants who were not shown the 
video used a food thermometer to check that at least one chicken breast 
reached a safe internal temperature of 165 [deg]F, and 75 percent of 
those participants successfully cooked the chicken breast to 165 
[deg]F. Eight-eight percent of participants who were shown the video 
used a food thermometer to check the temperature of at least one 
chicken breast. Although the rate of thermometer use was higher among 
the intervention group compared with the control group, the difference 
was not significantly different. Participants who used other methods to 
determine doneness relied on time, visual cues, and touch. Although 
most participants reported owning a food thermometer at home, 38 
percent reported not using their food thermometer at home to check that 
NRTE breaded stuffed chicken products were properly cooked. Thus, for 
some participants, their behavior in the test kitchen differed from 
their typical practice.
    The researchers also observed participants throughout the meal 
preparation to determine whether they adhered to recommended 
handwashing practices. For purposes of the study, a handwashing attempt 
was considered successful based on CDC's criteria--wet hands with 
water; rub hands with soap for at least 20 seconds; rinse hands with 
water; and dry hands using a clean, one-use towel. The study found that 
approximately 72 percent of participants attempted to wash their hands 
before beginning meal preparation. Among handwashing attempts, 5 
percent of attempts contained all steps of correct handwashing and were 
considered successful according to the CDC's criteria. However, during 
meal preparation, handwashing was attempted only 5 percent of the time 
that it was required (e.g., after touching the NRTE chicken product), 
and there were no successful attempts. The study concluded that the 
small number of handwashing attempts during meal preparation of NRTE 
breaded stuffed chicken products is likely attributable to participants 
preparing a raw frozen breaded chicken product rather than fresh raw 
poultry. Thus, the appearance of NRTE breaded stuffed chicken products 
and the fact that they are typically cooked from a frozen state may 
contribute to Salmonella cross contamination in the home.
    2022 Study on Appliances Used to Prepare NRTE Breaded Stuffed 
Chicken Products. In December 2022, the CDC published a report on a 
study that describes the demographic characteristics of persons who 
prepare NRTE breaded stuffed chicken products and which appliances they 
use to prepare them.\66\ In the study, to assess types of cooking 
appliances used to prepare NRTE breaded stuffed chicken products, 
members of an internet research panel were asked to identify

[[Page 26258]]

which appliances they use to prepare these products. Respondents could 
choose more than one appliance. Of the 2,546 panel members that 
reported preparing NRTE breaded stuffed chicken products, approximately 
80 percent reported using an oven as one of the cooking appliances, 
while 54 percent reported that they prepared these products using 
appliances other than or in addition to ovens. Although the labeling of 
NRTE breaded stuffed chicken products typically includes instructions 
to cook the product in an oven and warns consumers not to cook them in 
a microwave, approximately 30 percent of the respondents who reported 
preparing NRTE breaded stuffed chicken products reported using air 
fryers, 20 percent reported using microwaves, approximately 14 percent 
reported using toaster ovens, and approximately 4 percent reported 
using another appliance. The study found that respondents with lower 
incomes and who live in mobile types of homes reported lower oven use 
and higher microwave use.
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    \66\ Marshall, K.E., Canning, M., Ablan, M., Crawford T.N., 
Robyn, M. Appliances Used by Consumers to Prepare Frozen Stuffed 
Chicken Products-United States, May-July 2022. Morb Mortal Wkly Rep 
Dec 2,2022; 71(48);1511-1516. Available at: http://dx.doi.org/10.15585/mmwr.mm7148a2.
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    The study noted that current measures to prevent Salmonella 
infections linked to contaminated NRTE breaded stuffed chicken products 
primarily rely on consumers' ability to identify that they are raw, 
follow and adequately cook the products according to validated cooking 
instructions, and to verify the product's internal temperature using a 
food thermometer. The researchers stated that the survey findings 
highlight some possible challenges consumers may face preparing NRTE 
breaded stuffed chicken products safely and the need for additional 
action. The study suggests that, given the percentage of respondents 
who reported using an appliance other than an oven to prepare NRTE 
breaded stuffed chicken products, and socioeconomic characteristics of 
respondents with lower oven usage, e.g., oven use was lower among 
respondents with household income <$25,000 (68.9%), and who lived in 
mobile homes or other portable types of homes (66.5%), companies that 
produce these products could consider implementing interventions that 
rely less on labeling and consumer preparation practices to ensure that 
these products are safe when consumed. The study noted that persons who 
live in mobile or other portable types of homes might have less or 
insufficient space for a conventional oven and that appliances like 
microwaves are small, often portable, and cost less to own and operate 
than an oven. According to the study, these findings suggest that 
economic and other factors might influence some groups' access to 
recommended cooking appliances.

2021 Salmonella Illness Outbreak, NACMPI Subcommittee Recommendations, 
and NCC Petition Supplement

    2021 Salmonella illness outbreak. From April through August 2021, 
state public health officials, the CDC, and FSIS investigated a 
multistate outbreak of Salmonella Enteritidis illnesses linked to NRTE 
breaded stuffed chicken products.67 68 Epidemiologic, 
laboratory, and traceback data showed that NRTE breaded stuffed chicken 
products produced by a single establishment were associated with the 
illnesses. The outbreak included 36 cases from 11 States with illness 
onset dates from February 21, 2021, to August 16, 2021. Of the 27 case 
patients interviewed, 14 (52 percent) reported preparing and eating 
NRTE frozen breaded stuffed chicken products. Of 32 case patients with 
information available (out of 36 total cases), 12 were hospitalized. No 
deaths were reported.
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    \67\ USDA, FSIS: Salmonella Enteritidis Outbreak Linked to 
Frozen, Raw, Breaded, Stuffed, Chicken Products; Outbreak 
Investigation After Action Review, Report 2021-07 at: https://www.fsis.usda.gov/sites/default/files/media_file/2022-04/FSIS-After-Action-Review-2021-07.pdf.
    \68\ CDC: Salmonella Outbreak Linked to Raw Frozen Breaded 
Stuffed Chicken Products (October 13, 2021) at: https://www.cdc.gov/salmonella/enteritidis-06-21/index.html.
---------------------------------------------------------------------------

    The labeling of the products associated with the outbreak stated: 
the product was raw on the front and back of the packaging; included 
statements and icons to signal that the product is raw and should not 
be cooked in a microwave oven; and provided validated cooking 
instructions that included a ``do not microwave'' icon as well as icons 
and instructions to cook the product in a conventional oven to an 
internal temperature of 165 [deg]F as measured by a food thermometer. 
However, some of the case patients reported that they did not follow 
the manufacturer's cooking instructions on the label. Some case 
patients reported that they cooked the product in a microwave oven, air 
fryer, or for a shorter time than instructed for a conventional oven, 
and they did not use a food thermometer to check that the product 
reached an internal temperature of 165 [deg]F, as instructed on the 
product label.
    The MDA conducted retail product sampling of these products as part 
of the investigation and isolated the outbreak strain. Based on the 
strong link between epidemiologic information and product sampling 
results, FSIS issued a Public Health Alert (PHA) on June 2, 2021, to 
inform the public that some of the ill patients in the outbreak had 
reported eating NRTE breaded stuffed chicken prior to illness 
onset.\69\ FSIS traced the product purchased by one ill patient to an 
FSIS-regulated establishment, and on August 9, 2021, the establishment 
voluntarily recalled approximately 59,251 pounds of the affected 
products.\70\
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    \69\ FSIS Issues Public Health Alert for Frozen, Raw, Breaded 
Stuffed Chicken Products Due to Possible Salmonella Contamination 
(June 2, 2021) at: https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-frozen-raw-breaded-stuffed-chicken-products-due.
    \70\ Serenade Foods Recalls Frozen, Raw, Breaded, Stuffed 
Chicken Products Due to Possible Salmonella Contamination (August 9, 
2021) at: https://www.fsis.usda.gov/recalls-alerts/serenade-foods-recalls-frozen-raw-breaded-stuffed-chicken-products-due-possible.

  Table 1--Summary of Salmonella Outbreak Investigations Associated With NRTE Breaded Stuffed Chicken Products
                                                    1998-2021
----------------------------------------------------------------------------------------------------------------
               Year                        Serotype           Illnesses    Hospitalization       Recall/PHA
----------------------------------------------------------------------------------------------------------------
1998..............................  Typhimurium..........              33                3  Recall.
2005..............................  Heidelberg...........               4                1  PHA.
2005-2006.........................  Enteritidis..........              27                6  Recall and PHA.
2006..............................  Typhimurium..........               3                2
2008..............................  Enteritidis..........               7                2  PHA.
2008-2009.........................  I 4,[5],12:i:-.......              47                8  PHA.
2009..............................  Enteritidis..........               2
2009..............................  Enteritidis..........               2
2013..............................  Enteritidis..........               3

[[Page 26259]]

 
2014..............................  Enteritidis..........               6                1  Recall and PHA.
2015..............................  Enteritidis..........               5                2  Recall.
2015..............................  Enteritidis..........              15                4  Recall and PHA.
2016..............................  Enteritidis..........               5
2021..............................  Enteritidis..........              36               12  Recall and PHA.
----------------------------------------------------------------------------------------------------------------
Note: Outbreak investigation data from FSIS at the time the investigations were closed.

    2021 NACMPI Recommendations. On August 27, 2021, FSIS announced 
that the NACMPI would hold a virtual meeting to consider, among other 
things, issues related to NRTE breaded stuffed chicken products.\71\ 
The virtual public meeting was held on September 27 and 28, 2021, and a 
subcommittee was charged to consider actions FSIS should take to 
prevent and reduce illnesses associated with the handling or 
consumption of NRTE breaded stuffed poultry products that may appear 
RTE to consumers.\72\ In presenting the charge to the subcommittee, 
FSIS noted the history of outbreak investigations associated with these 
products, including the outbreak that resulted in the August 2021 
recall, and that these products are labeled as raw and include 
validated cooking instructions. The Agency also reviewed the results of 
the consumer research discussed above and noted that FSIS had been 
petitioned by the NCC in 2016 to establish labeling requirements for 
NRTE breaded stuffed chicken products and to issue guidance for 
developing validated cooking instructions. In its charge, FSIS asked 
the subcommittee to consider several questions on possible measures to 
address human illnesses associated with NRTE breaded stuffed chicken 
products.
---------------------------------------------------------------------------

    \71\ National Advisory Committee on Meat and Poultry Inspection, 
Notification of Public Meeting (86 FR 48115, August 27, 2021) at: 
https://www.fsis.usda.gov/sites/default/files/media_file/2021-08/FSIS-2021-0019.pdf.
    \72\ 2021 National Advisory Committee on Meat and Poultry 
Inspection Public Meeting at: https://www.fsis.usda.gov/news-events/events-meetings/national-advisory-committee-meat-and-poultry-inspection-nacmpi-public.
---------------------------------------------------------------------------

    In a September 28, 2021, report, the subcommittee provided several 
recommendations that primarily focus on the labeling of NRTE breaded 
stuffed chicken products. The subcommittee recommended that FSIS re-
verify that companies continue to voluntarily label NRTE breaded 
stuffed chicken products as raw in several places on the label and that 
labels of these products include validated cooking instructions. The 
subcommittee also recommended that FSIS update the 2006 labeling 
guidance to warn consumers not to use microwaves and air fryers if 
validated instructions are not provided for these methods and to cook 
the product to a minimum of 165 [deg]F as measured using a food 
thermometer.\73\ The subcommittee further recommended that FSIS add 
label verification for these products as a recurring task for 
inspectors and review labels from the 2021 outbreak. In addition, the 
subcommittee recommended that FSIS require establishments that produce 
these products to reassess their HACCP plans in light of the outbreaks 
and encouraged FSIS to conduct targeted consumer outreach regarding 
these types of products, including creating an FSIS web page 
highlighting NRTE breaded stuffed chicken products. The subcommittee 
did not reach consensus on whether FSIS should conduct exploratory 
sampling for indicator organisms or pathogens or whether it should 
conduct sampling for Salmonella for these products. The subcommittee 
also did not recommend that FSIS require that establishments apply a 
lethality treatment to ensure that all NRTE breaded stuffed chicken 
products are RTE. The subcommittee agreed with the 2016 NCC petition's 
request for FSIS to establish requirements for the labeling of NRTE 
breaded stuffed chicken products and publish industry guidance 
explaining how to validate cooking instructions for such products and 
recommended that FSIS take such action.
---------------------------------------------------------------------------

    \73\ National Advisory Committee on Meat and Poultry Inspection: 
Subcommittee II Stuffed Not-Ready-To-Eat Poultry Products (September 
28, 2021) at: https://www.fsis.usda.gov/sites/default/files/media_file/2021-10/Subcommittee_II_Stuffed_Not_Read-to-Eat_Poultry_Products_9-28-21_final_Report.pdf.
---------------------------------------------------------------------------

    2022 NCC petition supplement. On February 25, 2022, the NCC 
submitted a supplement to update its 2016 petition to reflect updates 
in what the NCC stated was the collective understanding of NRTE breaded 
stuffed chicken products. Among the updates was a request to establish 
required specifications for color, shapes, and font sizes for certain 
labeling statements and icons; a request to require an additional ``do 
not air fry'' statement and icon to the product label; and a request to 
require a website URL, QR code, or similar mechanism on the label that 
takes the consumer to a web page that includes a video demonstrating 
proper cooking methods. The 2022 supplement also requested that the 
regulations allow statements that emphasize that the product should 
only be cooked in a conventional oven to be modified to reflect any 
additional validated cooking instructions, e.g., ``do not air fry'' 
could be modified to provide validated air fryer cooking instructions.

III. Evaluation of the Status of Salmonella in NRTE Breaded Stuffed 
Chicken Products Under the PPIA

    FSIS has carefully considered the 2021 NACMPI subcommittee 
recommendations on actions the Agency could take to prevent and reduce 
illnesses associated with NRTE breaded stuffed chicken products as well 
as the issues raised in the NCC petition and supplement. In light of 
the 2021 Salmonella outbreak and earlier outbreaks associated with 
these products, the Agency has concluded that the recommendations, 
which focus primarily on product labeling and consumer handling 
practices, are unlikely to be effective in preventing additional 
foodborne illnesses associated with NRTE breaded stuffed chicken 
products.
    Although the labeling of NRTE breaded stuffed chicken products has 
undergone significant changes over time to better inform consumers that 
the products are raw and to provide instructions on how to prepare them 
safely, these products continue to be associated with Salmonella 
illness outbreaks. Information from outbreak investigations found that 
some ill persons were not aware that the product was raw and did not 
follow the cooking instructions on the product label. In addition, one 
of the consumer behavior

[[Page 26260]]

research studies discussed above found that nearly a quarter of the 
study participants were unaware that the NRTE frozen chicken product 
they prepared was raw, and 38 percent of the participants reported not 
using their food thermometer at home to check that NRTE breaded stuffed 
chicken products were properly cooked. The other study found that 54 
percent of participants reported that they prepared NRTE breaded 
stuffed chicken products using appliances other than or in addition to 
ovens, even though the labeling of NRTE breaded stuffed chicken 
products typically states that the product should only be cooked in a 
conventional oven.
    Information from outbreak investigations also found that some case 
patients reported following the cooking instructions on the label but 
still became ill. The characteristics and composition of NRTE breaded 
stuffed chicken products may have contributed to these illnesses. As 
noted above, NRTE breaded stuffed chicken products are typically cooked 
from a frozen state, which increases the risk that they will not reach 
an internal temperature needed to destroy Salmonella that may be in the 
product. In addition, because these products contain multiple 
ingredients that may cook at different rates, consumers may face 
challenges in determining an accurate internal temperature of these 
products even when they use a thermometer as recommended on the product 
label. These findings suggest that NRTE breaded stuffed chicken 
products present a serious public health risk, regardless of the 
information provided on the label.
    Thus, because measures that have primarily focused on product 
labeling and consumer handling practices have not been effective in 
addressing the public health risk associated with Salmonella 
contaminated NRTE breaded stuffed chicken products, the Agency has 
decided to re-evaluate the status of Salmonella in these products under 
the PPIA.

Salmonella as an ``Added Substance'' in NRTE Breaded Stuffed Chicken 
Products

    As noted above, a meat or poultry product is adulterated if, among 
other circumstances, ``it bears or contains any poisonous or 
deleterious substance which may render it injurious to health; but in 
case the substance is not an added substance, such article shall not be 
considered adulterated . . . if the quantity of such substance in or on 
such article does not ordinarily render it injurious to health'' (21 
U.S.C. 601(m)(1); 21 U.S.C. 453(g)(1)). As stated in its response to 
the 2020 petition submitted by Marler Clark, LLP, FSIS has 
traditionally viewed Salmonella as ``naturally occurring'' in food 
animals. However, the Agency also stated that it was reassessing this 
interpretation as part of its Salmonella in poultry initiative and 
considering whether Salmonella should be considered an adulterant in 
any poultry products under any of the PPIA's adulteration definitions. 
As discussed below, FSIS has reassessed whether Salmonella should be 
considered as a ``naturally occurring'' substance in NRTE breaded 
stuffed chicken products. Based on this assessment, the Agency has 
tentatively concluded that for these specific products, Salmonella is 
an added substance within the meaning of 21 U.S.C. 453(g)(1) of the 
PPIA. This tentative determination is limited to Salmonella in NRTE 
breaded stuffed chicken products. FSIS will reassess its traditional 
view of Salmonella as ``naturally occurring'' in other poultry products 
in the near future as it develops a new strategy to control Salmonella 
in poultry products.\74\
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    \74\ United States Department of Agriculture. (October 19, 
2021). USDA Launches New Effort to Reduce Salmonella Illness Linked 
to Poultry. https://www.usda.gov/media/press-releases/2021/10/19/usda-launches-new-effort-reduce-salmonella-illnesses-linked-poultry. 
see also Food Safety and Inspection Service. (December 2, 2021). 
Pilot Projects: Salmonella Control Strategies. https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/pilot.
---------------------------------------------------------------------------

    Salmonella is present in the gastrointestinal tract of live birds, 
and there is evidence that extraintestinal Salmonella exist in poultry 
skin, livers, bones, and bone marrow before processing.\75\ Salmonella 
is not, however, ordinarily found in the muscle tissue of healthy 
birds. NRTE breaded stuffed chicken products contain raw, comminuted 
chicken breast meat, trim, or whole chicken breast meat (i.e., further 
processed chicken parts or comminuted chicken). FSIS sampling data show 
that further processed chicken parts (breasts, legs, and wings) and 
comminuted chicken have a higher incidence of Salmonella compared to 
carcasses.\76\ This difference is most likely because of cross 
contamination between positive and negative parts and carcasses during 
further processing.77 78
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    \75\ Rimet, C.S., et al. (2019). Salmonella Harborage Sites in 
Infected Poultry That May Contribute to Contamination of Ground 
Meat. Frontiers in Sustainable Food Systems 3(2). see also Jones-
Ibarra, A.M., et al. (2019). Salmonella recovery from chicken bone 
marrow and cecal counts differ by pathogen challenge method. Poult 
Sci 98(9): 4104-4112. see also Cox, N.A., et al. (2007). Recovery of 
Campylobacter and Salmonella Serovars From the Spleen, Liver and 
Gallbladder, and Ceca of Six-and Eight-Week-Old Commercial Broilers. 
Journal of Applied Poultry Research 16(4): 477-480.
    \76\ Sampling Results for FSIS-Regulated Products. Available at: 
https://www.fsis.usda.gov/science-data/sampling-program/sampling-results-fsis-regulated-products.
    \77\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) p. 59. Available at: https://www.fsis.usda.gov/sites/default/files/media_file/2021-07/FSIS-GD-2021-0005.pdf.
    \78\ Codex Guideline for the Control of Campylobacter and 
Salmonella in Chicken Meat at: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B78-2011%252FCXG_078e.pdf.
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    Further processing presents various opportunities in which 
Salmonella that is present in certain parts of the bird may be added to 
interior edible muscle where Salmonella is not ordinarily found. For 
example, Salmonella can be found in feather follicles in the 
skin.79 80 When the skin is cut, Salmonella can be exposed 
and spread during processing to previously uncontaminated product.\81\ 
Additionally, many NRTE breaded stuffed chicken products are made with 
comminuted chicken. Comminuted products are those that are ground, 
mechanically separated, or hand- or mechanically deboned and further 
chopped, flaked, minced, or otherwise processed to reduce particle 
size. Because of the nature of comminuted processes, Salmonella 
contamination in chicken skin and bone can spread throughout an entire 
batch or lot through cross contamination. FSIS sampling data show that 
ground and other raw comminuted chicken products that were produced 
using either bone-in or skin-on source materials were more likely to be 
contaminated with Salmonella than those fabricated from deboned, 
skinless source materials.\82\ In addition, Salmonella-negative raw 
poultry parts and comminuted poultry may become cross-contaminated by 
contact with Salmonella-contaminated equipment or when they are 
commingled with Salmonella-positive products, such as when they are 
collected in combo bins

[[Page 26261]]

for further processing.83 84 Salmonella-contaminated 
equipment used to incorporate the stuffed ingredients into the chicken 
component of NRTE breaded stuffed chicken products may also contribute 
to Salmonella contamination in these products. Thus, because Salmonella 
may be added to previously uncontaminated chicken parts and comminuted 
chicken during processing, and because the chicken component of NRTE 
breaded stuffed chicken products is made from further processed poultry 
parts or comminuted poultry, FSIS has tentatively concluded that 
Salmonella is an ``added substance'' when present in these specific 
products.
---------------------------------------------------------------------------

    \79\ Kim J-W and Slavik M.F. 1996. Cetylpyridinium Chloride 
(CPC) treatment on poultry skin to reduce attached Salmonella. J. 
Food Prot. 59: 322-326.
    \80\ Wu D., Alali W.Q., Harrison M.A., and Hofacre C.L. 2014. 
Prevalence of Salmonella in neck skin and bone of chickens. J Food 
Prot. 77(7): 1193-1197.
    \81\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) pp. 59-60. Available at: https://www.fsis.usda.gov/guidelines/2021-0005.
    \82\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) pp. 65-66, Table 4 FSIS exploratory sampling test results, raw 
comminuted chicken by source material composition (6/1/13-6/30/15, 
2,688 samples. Available at: https://www.fsis.usda.gov/guidelines/2021-0005.
    \83\ FSIS Guidance for Controlling Salmonella in Poultry (June 
2021) pp. 59. Available at: https://www.fsis.usda.gov/guidelines/2021-0005.
    \84\ Codex Guideline for the Control of Campylobacter and 
Salmonella in Chicken Meat at https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B78-2011%252FCXG_078e.pdf.
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The Adulteration Standard for NRTE Breaded Stuffed Chicken Products

    As noted above, a poultry product that bears or contains any added 
poisonous or deleterious substance which may render it injurious to 
health or that bears or contains an inherent substance in sufficient 
quantity to ordinarily render it injurious to health is adulterated 
under the PPIA (21 U.S.C. 453(g)(1)). A poultry product can also be 
found to be adulterated if it is ``unsound, unhealthful, unwholesome, 
or otherwise unfit for human food'' (21 U.S.C. 453(g)(3)).
    Consistent with its approach used to determine the status of 
certain STEC in raw non-intact beef products and intact cuts to be 
further processed into non-intact products, to assess the status of 
Salmonella in NRTE breaded stuffed chicken products under the PPIA, 
FSIS has evaluated the available information on Salmonella serotypes 
associated with human illnesses, the Salmonella infectious dose, the 
severity of human illnesses caused by Salmonella, and consumer 
preparation practices associated with NRTE breaded stuffed chicken 
products as documented in outbreak investigations associated with these 
products and as described in the consumer behavior research studies 
discussed above. Based on this evaluation, FSIS is proposing to declare 
that NRTE breaded stuffed chicken products contaminated with Salmonella 
at levels of 1 CFU/gram or higher are adulterated within the meaning of 
21 U.S.C. 453(g)(1) and 21 U.S.C. 453(g)(3) of the PPIA.
    Because FSIS has tentatively concluded that Salmonella is an added 
substance in NRTE breaded stuffed chicken products, the Agency has 
tentatively concluded that these products are adulterated when they 
contain Salmonella at levels of 1 CFU per gram or higher because 
Salmonella at these levels ``may render'' NRTE breaded stuffed chicken 
products injurious to health (21 U.S.C. 453(g)(1)).\85\ Moreover, FSIS 
is proposing to declare that NRTE breaded stuffed chicken products that 
are contaminated with Salmonella at levels of 1 CFU per gram or above 
are adulterated within the meaning of 21 U.S.C. 453(g)(3) because when 
they contain Salmonella at these levels, NRTE breaded stuffed chicken 
products present a sufficiently serious risk of causing human 
Salmonella illnesses such as to make them unhealthful, unwholesome, or 
otherwise unfit for human food. The basis for this proposed 
determination is discussed below.
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    \85\ The adulteration definition in 21 U.S.C. 453(g)(1) includes 
two separate standards for determining whether a product is 
adulterated. Under 21 U.S.C. 453(g)(1), if a substance is an ``added 
substance'' the product is adulterated if the substance ``may 
render'' the product injurious to health. If the substance is not 
added, the product is adulterated ``if the quantity of such 
substance in or on'' the product ``ordinarily'' renders it injurious 
to health. As discussed in this document, FSIS has tentatively 
concluded that when present in NRTE breaded stuffed chicken 
products, Salmonella at 1 CFU per gram or higher meets the 
definition of an ``added substance'' that ``may render'' these 
products injurious to health. Although the ``may render'' standard 
is the primary basis for FSIS' tentative determination that the 
product is adulterated, FSIS also believes that NRTE breaded stuffed 
chicken products that contain Salmonella at 1 CFU per gram or higher 
meet the more stringent ``ordinarily injurious'' standard for 
substances that are not added because ordinary consumer handling and 
preparation, as reported in outbreak investigations and consumer 
research, may not reduce Salmonella to levels that do not result in 
illness and may also contribute to cross-contamination when these 
products are prepared in the home.
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    Pathogen serogroups or types associated with human illness. With 
respect to specific Salmonella serotypes, the Salmonella outbreaks 
associated with NRTE breaded stuffed chicken products investigated by 
FSIS and public health partners have been associated with the serotypes 
Typhimurium, Heidelberg, I 4,[5], 12:i:-, and Enteritidis and tend to 
reflect the outbreak serotypes for raw chicken products in general. All 
outbreaks documented after 2009 have involved Salmonella Enteritidis. 
Additionally, from 2017 to 2021, FSIS and public health partners 
investigated 13 Salmonella outbreaks potentially associated with all 
raw chicken products.\86\ Serotypes Typhimurium, Enteritidis, Blockley, 
and Infantis account for 92 percent of the outbreak related illnesses. 
These 4 serotypes account for 77.4 percent of 1,946 illnesses reported 
in the National Outbreak Reporting System due to Salmonella from 
chicken during the years 2015-2019 (61 outbreaks).\87\ Approximately 
2,500 Salmonella serotypes have been identified,\88\ though not all 
serotypes have been isolated from chicken. Almost all strains of 
Salmonella are pathogenic as they have the ability to invade, replicate 
and survive in human host cells, resulting in potentially fatal 
disease,\89\ though not all are equally likely to cause illness. 
Additionally, according to the CDC, reported cases from outbreaks only 
represent a fraction of actual cases.\90\ Thus, because the reported 
outbreaks represent a small portion of Salmonella illnesses, the 
serotypes that have been found to be associated with Salmonella 
outbreaks do not capture all serotypes that are causing illnesses.
---------------------------------------------------------------------------

    \86\ FSIS Outbreak Reports at: https://www.fsis.usda.gov/food-safety/foodborne-illness-and-disease/outbreaks.
    \87\ Centers for Disease Control and Prevention: National 
Outbreak Reporting System at: https://wwwn.cdc.gov/norsdashboard/.
    \88\ Brenner F.W., Villar R.G., Angulo F.J., Tauxe R., 
Swaminathan B. Salmonella nomenclature. J Clin Microbiol. 2000 
Jul;38(7):2465-7. doi: 10.1128/JCM.38.7.2465-2467.2000. PMID: 
10878026; PMCID: PMC86943.
    \89\ Shu-Kee Eng, Priyia Pusparajah, Nurul-Syakima Ab Mutalib, 
Hooi-Leng Ser, Kok-Gan Chan & Learn-Han Lee (2015) Salmonella: A 
review on pathogenesis, epidemiology and antibiotic resistance, 
Frontiers in Life Science, 8:3, 284-293, DOI: 10.1080/
21553769.2015.1051243
    \90\ Scallan, E., Hoekstra, R.M., Angulo, F.J., Tauxe, R.V., 
Widdowson, M., Roy, S.L. Griffin, P.M. (2011). Foodborne Illness 
Acquired in the United States--Major Pathogens. Emerging Infectious 
Diseases, 17(1), 7-15. https://doi.org/10.3201/eid1701.p11101; Mead, 
P.S., et al., Food-related illnesses and deaths in the United 
States. Emerging Infect Dis, Oct1999. 5(5) p. 607-625.
---------------------------------------------------------------------------

    Consistent with its approach used to determine the adulterant 
status of STEC, FSIS considered declaring the Salmonella serotypes 
responsible for the largest proportion of Salmonella illness outbreaks 
associated with chicken as adulterants in NRTE breaded stuffed chicken 
products. As the pathogens and products are different, there were 
different considerations when making this determination. First, 
Salmonella virulence factors are not as well understood as those of 
STEC. With Salmonella, higher virulence is associated with enhanced 
ability to survive and grow in the gut or to attach to and invade human 
cells, which is driven by changes to several mechanisms, including 
mobile genetic elements and resident genes as well as

[[Page 26262]]

variations in gene sequence and expression. In an August 2018 report, 
the NACMCF was unable to find evidence in the literature for any 
determinant that correlated with high virulence in human foodborne 
disease.\91\ The NACMCF noted that a few Salmonella serotypes are 
consistently associated with the greatest incidence of human disease. 
However, this disparity among serotypes may be related to survival in 
animal hosts or during food harvesting and processing rather than 
serotype-specific differences in human virulence.
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    \91\ NACMCF (2019). Response to Questions Posed by the Food 
Safety and Inspection Service Regarding Salmonella Control 
Strategies in Poultry. Journal of Food Protection 82(4): 645-668.
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    FSIS seeks to better understand Salmonella characteristics, 
including virulence, and actively engages in and encourages research in 
this area. In October 2021, FSIS launched a new effort aimed at 
developing a stronger and more comprehensive framework for reducing 
Salmonella illnesses associated with poultry products.\92\ As part of 
this initiative, FSIS will leverage USDA's strong research \93\ 
capabilities and strengthen its partnership with the USDA Research 
Education and Economics \94\ mission area to address data gaps and 
develop new laboratory methods to guide future Salmonella policy. FSIS 
is also exploring more efficient methods to enumerate pathogens in 
samples, detect virulence factors in pathogens, and investigate new 
pathogen characterization methods. As science and laboratory 
technologies advance, FSIS will continue to use the most innovative and 
sensitive methods available to protect public health.
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    \92\ USDA Launches New Effort to Reduce Salmonella Linked to 
Poultry (October 19, 2021) at: https://www.usda.gov/media/press-releases/2021/10/19/usda-launches-new-effort-reduce-salmonella-illnesses-linked-poultry.
    \93\ FSIS Food Safety Research Priorities and Studies, available 
at https://www.fsis.usda.gov/science-data/research-
priorities#:~:text=FSIS%20Data%20Gaps%20%20%20%20Study%20Title,may%20
survi%20...%20%209%20more%20rows%20?msclkid=f7030eaea6c411ec9e91f63d1
dde98ff.
    \94\ USDA Research, Education, and Economics website, available 
at: https://www.ree.usda.gov/
#:~:text=The%20Research%2C%20Education%2C%20and%20Economics%20%28REE%
29%20mission%20area,and%20youth%20through%20integrated%20research%2C%
20analysis%2C%20and%20education.?msclkid=261bd671a6c411eca6c1c87daaae
90cd.
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    Therefore, after considering the current state of the science and 
laboratory technology, to address the significant public health risk 
associated with NRTE breaded stuffed chicken products contaminated with 
Salmonella, FSIS is proposing to declare, at certain levels, all 
Salmonella as adulterants in NRTE breaded stuffed chicken products at 
this time. Although certain Salmonella serotypes have been associated 
with illnesses identified in outbreak investigations associated with 
NRTE breaded stuffed chicken products, as discussed above, the basis 
for Salmonella virulence is not fully understood, all Salmonella 
serotypes have the potential to cause illness, and, as noted in the 
2018 NACMCF report, the disparity among serotypes may be related to 
factors other than serotype-specific differences in human virulence. In 
addition, FSIS' current laboratory methods typically require 
approximately 14 days from sample collection for results to be reported 
for Salmonella serotypes. Therefore, FSIS is tentatively declaring all 
Salmonella at certain levels as an adulterant in NRTE breaded stuffed 
chicken products. As noted above, FSIS is actively seeking research to 
address data gaps and develop more efficient laboratory methods to, 
among other things, enumerate and characterize pathogens and detect 
virulence factors in pathogens. FSIS will continue to evaluate and, if 
necessary, refine its proposed determination on the status of 
Salmonella as an adulterant in NRTE breaded stuffed chicken products as 
advances in science and technology related to pathogen levels, 
serotypes, and infectious dose become available. FSIS will consider 
public comments before issuing a final determination of Salmonella as 
an adulterant in NRTE breaded stuff chicken products.
    Infectious dose. Foodborne outbreaks are extraordinary events where 
conditions combine to result in illness among a group of people. It 
could be that a highly sensitive group of people, e.g., 
immunosuppressed, consumed contaminated product. It could be that a 
unique and significantly virulent strain is present in the food. It 
could be the result of a process failure where a high number of 
infectious organisms are present in the food. Outbreaks also may occur 
due to exposure of a large number of consumers to contaminated product. 
A combination of those four factors--agent virulence, dose, consumer 
susceptibility, and the extent of exposure--elevates the potential for 
foodborne outbreaks.
    In assessing the status of certain STEC as adulterants in non-
intact raw beef products and intact cuts to be further processed into 
non-intact products, FSIS considered data that indicates that the 
infectious dose for these specific serogroups is relatively low. 
Although Salmonella data are limited, international and domestic 
outbreak investigations associated with a variety of food products have 
been used to estimate the relationship between the number of organisms 
consumed and the probability of illness. Five Salmonella foodborne 
outbreaks have shown that Salmonella can cause illness from exposure of 
10 or fewer organisms per person.\95\ Additionally, several outbreaks 
from a range of Salmonella serotypes in various food products have 
shown that exposure from 11 to 420 organisms per person can result in 
illness.\96\ Thus, in these published studies, the infectious dose 
ranged from 1 to 420 Salmonella organisms per person. Using a dose-
response model approach utilizing outbreak data, and accounting for 
variation among

[[Page 26263]]

outbreaks represented by the data (predominately Enteritidis and 
Typhimurium serotypes), the average Salmonella median illness dose was 
36 colony forming units (CFU) (with 95% prediction interval of 0.69-
1.26 x 10\7\ CFU).\97\ The median illness dose refers to the dose at 
which 50% of individuals in an exposed population will experience 
symptomatic illness. The average median illness dose and its prediction 
interval reflect variability among outbreak strains and exposed 
populations and uncertainty about the dose-response relationship. A 
similar dose-response approach was developed by the World Health 
Organization Food and Agriculture Organization of the United Nations 
for risk assessments for Salmonella in eggs and broiler chickens.\98\ 
Also using outbreaks, the model estimated a 13 percent chance of 
becoming ill if ingesting 100 organisms. Even at the level of 1 
organism ingested, there was still a non-zero chance of illness (0.25 
percent). These Salmonella outbreaks as well as dose-response modeling 
of Salmonella outbreaks, suggest that exposure to a small number of 
Salmonella organisms can result in foodborne illness. Assuming a 
minimum of 0.5 log (68%) Salmonella reduction likely achieved with even 
partial cooking, the proposed level of 1 CFU per gram (assuming a 
typical 70-88 gram portion size) should significantly mitigate the risk 
of illness associated with NRTE breaded stuffed chicken products.
---------------------------------------------------------------------------

    \95\ Killalea, D., et al., International Epidemiological and 
Microbiological Study of Outbreak of Salmonella Agona Infection from 
a Ready to Eat Savoury Snack--I: England and Wales and the United 
States. 1996, British Medical Journal Publishing Group.; Shohat, T., 
et al., International Epidemiological and Microbiological Study of 
Outbreak of Salmonella Agona Infection from a Ready to Eat Savoury 
Snack--Ii: Israel. BMJ, 1996. 313(7065): p. 1107-1109.; D'aoust, 
J.Y. and J.Y.D. Aoust, Infective Dose of Salmonella Typhimurium in 
Cheddar Cheese. American Journal of Epidemiology, 1985. 122(4): p. 
717-720.; D'aoust, J.Y., D.W. Warburton, and A.M. Sewell, Salmonella 
Typhimurium Phage-Type 10 from Cheddar Cheese Implicated in a Major 
Canadian Foodborne Outbreak. Journal of Food Protection, 1985. 
48(12): p. 1062-1066.; Kapperud, G., et al., Outbreak of Salmonella 
Typhimurium Infection Traced to Contaminated Chocolate and Caused by 
a Strain Lacking the 60-Megadalton Virulence Plasmid. J Clin 
Microbiol, 1990. 28(12): p. 2597-601.; Hockin, J.C. et al., An 
International Outbreak of Salmonella Nima from Imported Chocolate. J 
Food Prot. 1989. 52(1): p. 51-54.; Lehmacher, A., Bockemuhl, J., and 
Aleksic. S. Nationwide outbreak of human salmonellosis in Germany 
due to contaminated paprika and paprika-powdered potato chips. 1995. 
Epidemiol Infect. 115: p. 501-11.
    \96\ Kasuga F. et al., Archiving of food samples from 
restaurants and caterers--Quantitative profiling of outbreaks of 
foodborne salmonella in Japan. Journal of Food Protection, 2004. 67: 
p. 2024-2032; Blaser, M.J., and Newman, L.S. A review of human 
salmonellosis: I. Infective dose. Rev Infect Dis., 1982.4: p.1096-
106; Abe, K., N. et al., Prolonged incubation period of 
Salmonellosis associated with low bacterial doses. Journal of food 
protection, 2004. 67: p. 2735-2740; Hara-Kudo, Y. and K. Takatori, 
Contamination level and ingestion dose of foodborne pathogens 
associated with infections. Epidemiology and Infection, 2011. 139: 
p. 1505-1510; Hennessy T.W., et al., A national outbreak of 
Salmonella enteritidis infections from ice cream. N Engl J Med, 
1996. 334(20): p. 1281-6; Hedberg C.W., et al., A multistate 
outbreak of Salmonella javiana and Salmonella oranienburg infections 
due to consumption of contaminated cheese. JAMA, 1992. 268(22): p. 
3203-7; Todd, E.C., et al., Outbreaks where food workers have been 
implicated in the spread of foodborne disease. Part 4. Infective 
doses and pathogen carriage. J Food Prot, 2004. 71: p. 2339-73; 
Scheil W., et al., A South Australian Mdbandaka outbreak 
investigation using a database to select controls. Aust NZ J Public 
Health, 1998. 22(5): p. 536-9; Tamber, S., E. Swist, and D. Oudit, 
Physicochemical and bacteriological characteristics of organic 
sprouted chia and flax seed powders implicated in a foodborne 
Salmonellosis outbreak. Journal of Food Protection, 2016. 79(5): p. 
703-709.
    \97\ Teunis P.F., et al., Dose-response modeling of Salmonella 
using outbreak data. Int J Food Microbiol, 2010. 144(2): p. 243-9.
    \98\ World Health Organization, Risk assessment of Salmonella in 
eggs and broiler chickens, March 25, 2002. Available at: https://www.who.int/publications/i/item/9291562293.
---------------------------------------------------------------------------

    Taking into account: (1) the range of infectious doses referenced 
above (between 1-420 CFU), in particular that a Salmonella dose-
response model based on outbreaks showed the average Salmonella median 
illness dose was 36 CFU; (2) that most consumers will cook NRTE breaded 
stuffed chicken products to some degree, resulting in mitigation of the 
exposure to the pathogen; (3) that the average chicken portion in a 
NRTE breaded stuffed chicken product is approximately 70-88 grams; \99\ 
and (4) that, at this point, technology does not exist to identify 
serotype pathogenicity factors in a timely manner, FSIS has tentatively 
concluded that Salmonella, at a concentration lower than 1 CFU per 
gram, would not ordinarily render this type of NRTE commodity injurious 
to health or make them unwholesome, unhealthful or otherwise unfit for 
human food. The Agency believes that this target is also achievable 
under industry production conditions and that laboratory analytical 
methodology is available to detect organisms at this level. FSIS 
requests comments on this tentative conclusion and whether there are 
studies that support an alternative adulteration threshold.
---------------------------------------------------------------------------

    \99\ Based on product formulation information.
---------------------------------------------------------------------------

    Severity of illnesses. When FSIS declared certain STEC as 
adulterants in raw non-intact beef products and intact cuts to be 
further processed into non-intact beef products, the Agency considered 
the severity of the consequences of an infection with these pathogens 
and noted that they had been linked with serious, life-threatening 
human illnesses, such as hemorrhagic colitis and HUS. Although the 
symptoms of Salmonella infections are typically not reported to be as 
severe as those associated with STEC, Salmonella can cause bloody 
diarrhea, fever, abdominal cramps, nausea, and vomiting. In some 
instances, Salmonella enters the blood and makes its way to other areas 
of the body including, but not limited to, the heart, lung, bone, 
joints and the central nervous system.\100\ This can result in severe 
illness requiring hospitalizations and even death, especially in 
vulnerable populations, such as very young, elderly, and 
immunocompromised individuals. Even when Salmonella is no longer 
detectable in the body, prior Salmonella illness has also been 
associated with an increased risk in colon cancer.\101\ And can cause 
debilitating, long-lasting conditions including inflammatory bowel 
disease, irritable bowel syndrome and reactive arthritis.
---------------------------------------------------------------------------

    \100\ Batz, M.B., et al., Long-Term consequences of foodborne 
illness. Infect Dis Clin North Am, Sept 2013. 28(3) p. 599-661; 
Hohmann, E.L., Nontyphoidal Salmonellosis, Clin Infect Dis, Sept 
2001. 32 p. 263-269; Heymann, D. Salmonellosis. Control of 
Communicable Disease Manual, 2021.
    \101\ Mughini-Gras, L. et al. Increased colon cancer risk after 
severe Salmonella infection. PLoS ONE, 2018. 13(1): p. 1-19. https://doi.org/10.1371/journal.pone.0189721.
---------------------------------------------------------------------------

    Furthermore, a study that allows for a comparison of case-fatality 
proportions of both Salmonella and STEC O157 demonstrates a higher 
frequency of deaths among Salmonella cases than among STEC O157 
cases.\102\ The estimated annual domestic foodborne illnesses reported 
in the study were 1,027,561 and 63,153 for Salmonella and STEC O157, 
respectively. Annual deaths from domestic foodborne illnesses are 378 
and 20 for Salmonella and STEC O157, respectively. Therefore, 
Salmonella deaths occur at a frequency of 4 per 10,000 illnesses, while 
STEC O157 deaths occur at a frequency of 3 per 10,000 illnesses.
---------------------------------------------------------------------------

    \102\ Scallan, et al., 2011.
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    When FSIS declared certain STEC as adulterants in raw non-intact 
beef products and intact cuts to be further processed into non-intact 
products, there was a limited history of documented illnesses and 
outbreaks associated with these serogroups in raw beef. In fact, when 
FSIS declared the six non-O157:H7 STEC as adulterants, the Agency noted 
that the illnesses associated with these strains had not primarily been 
due to contamination in beef (76 FR 58158). However, because these 
pathogens had been associated with severe, debilitating illnesses, 
particularly in vulnerable populations, FSIS determined that, in order 
to protect public health, it was necessary to evaluate their status as 
adulterants in certain raw beef products under the FMIA.
    In contrast, there has been a long history of documented Salmonella 
illness outbreaks associated with NRTE breaded stuffed chicken products 
produced by different establishments that included illnesses that 
required hospitalization. The most recent multi-state outbreak in 2021 
included 36 cases from 11 states, and of 32 people with information 
available, 12 were hospitalized. The actual number of cases and 
hospitalizations are likely higher because the overwhelming number of 
Salmonella illnesses are not diagnosed and reported to public health 
officials.\103\
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    \103\ Scallan, et al. 2011; Mead, P.S., et al., Food-related 
illnesses and deaths in the United States. Emerging Infect Dis, 
Oct1999. 5(5) p. 607-625.
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    In addition, because NRTE breaded stuffed chicken products are 
typically stored in the freezer and consumed over time, Salmonella 
illness outbreaks associated with these products tend to persist for 
several months, even when implicated products represent a few days of 
production. Thus, the long, recurring history and ongoing nature of 
Salmonella illness outbreaks associated with NRTE breaded stuffed 
chicken products raise significant concerns about the impact on human 
health of Salmonella contamination in these products.
    Consumer cooking practices. In addition to their relatively low 
infectious dose and potential to cause severe illness, certain STEC are 
considered as adulterants in raw non-intact beef product because there 
is evidence to show that these strains can survive what many consumers 
consider to be proper cooking of these products. Information from the 
outbreak investigations associated with NRTE

[[Page 26264]]

breaded stuffed chicken products and the 2020 consumer behavior 
research report show that with respect to consumer preparation 
practices, Salmonella in NRTE breaded stuffed chicken products presents 
similar issues to STEC-contaminated raw ground beef because both 
products are frequently consumed after preparation that may not destroy 
pathogens in the product.
    As noted earlier, NRTE breaded stuffed chicken products contain 
raw, comminuted chicken breast meat or whole chicken breast meat, but 
the finished product is heat-treated only to set the batter or breading 
on the exterior of the product, which is not sufficient to destroy 
Salmonella that may be present in the product but may impart an RTE 
appearance to the consumer. Information from Salmonella illness 
outbreak investigations associated with NRTE stuffed chicken products 
show that, even with labeling that prominently discloses that these 
products are raw, the fact that they may appear fully cooked and are 
typically prepared from a frozen state may lead some consumers to 
believe that the products are properly cooked when reheated for 
aesthetic or palatability purposes rather than to a temperature 
sufficient to kill pathogenic bacteria as instructed on the product 
labeling. On the other hand, information from some earlier Salmonella 
outbreak investigations associated with NRTE breaded stuffed chicken 
product found that some cases that became ill reported following the 
validated cooking instructions on the product label. Thus, information 
from outbreak investigations also shows that the ordinary consumer 
cooking practices for NRTE breaded stuffed chicken products may not be 
sufficient to destroy Salmonella that may be present in the product 
regardless of the information provided on the product label.
    Also, as discussed above, FSIS consumer research on preparation of 
NRTE breaded stuffed chicken product found that despite reading the 
product label, 22 percent of participants were unaware that the NRTE 
breaded stuffed chicken product they prepared was raw, and 11 percent 
incorrectly believed that the product was fully cooked. The study also 
found that while 99 percent of the participants self-reported that they 
had read the manufacturer's instructions for the NRTE breaded stuffed 
chicken products, which instructed consumers to use a food thermometer 
to check that the product reached an internal temperature of 165 
[deg]F, only 77 percent of a control group used a thermometer. With 
respect to handwashing, the study found that during preparation of NRTE 
breaded stuffed chicken products, handwashing was attempted only 5 
percent of the time it was required, e.g., after touching the NRTE 
breaded stuffed chicken product. The study concluded that this was most 
likely because the participants were preparing a NRTE frozen breaded 
product rather than fresh poultry. Thus, these findings show that 
ordinary consumer handling of NRTE breaded stuffed chicken product may 
contribute to cross contamination, which may be why some outbreak cases 
that reported following validated cooking instructions still became 
ill.
    In addition, the 2022 study on appliances used to prepare NRTE 
breaded stuffed chicken products discussed above found that although 
the labeling of NRTE breaded stuffed chicken products typically 
includes instructions to cook the product in an oven, 54 percent of 
study respondents reported preparing these products using appliances 
other than or in addition to ovens.
    Proposed determination. After careful consideration of the 
information presented above, FSIS has tentatively determined that NRTE 
breaded stuffed chicken products contaminated with Salmonella present a 
significant public health concern because data from outbreak 
investigations as well as consumer behavior research studies show that 
common consumer preparation practices associated with these products 
may not destroy organisms that may be present in the product. 
Information from consumer behavior research also shows that common 
consumer handling of NRTE breaded stuffed chicken products may also 
contribute to cross contamination. As discussed above, Salmonella has 
been associated with severe and debilitating human illness and 
available data suggest that the Salmonella infectious dose is 
relatively low. In addition, because NRTE breaded stuffed chicken 
products have been associated with several Salmonella illness 
outbreaks, and because of the recurring nature of these outbreaks, FSIS 
has tentatively determined that the status, under the PPIA, of NRTE 
breaded stuffed chicken products contaminated with Salmonella must 
depend on whether there is adequate assurance that subsequent handling 
of the product will result in a product that does not contain 
Salmonella at levels sufficient to cause human illness when consumed 
(64 FR 2803). Information from Salmonella illness outbreaks associated 
with NRTE breaded stuffed chicken products and the information on 
consumer handling practices with respect to these products show that 
labeling that informs consumers that these products are raw and how to 
prepare them safely fails to provide such assurance. Thus, because 
Salmonella can survive ordinary handling and cooking practices for NRTE 
breaded stuffed chicken products, FSIS has tentatively concluded that 
the appropriate response to protect public health is to ensure that 
products contaminated with Salmonella at levels sufficient to cause 
human illness are excluded from commerce.
    Therefore, for the reasons discussed above, FSIS is proposing to 
declare that NRTE breaded stuffed chicken products contaminated with 
Salmonella at levels of 1 CFU/gram or higher are adulterated as defined 
in 21 U.S.C. 453(g)(1)) and 21 U.S.C 453(g)(3)) of the PPIA. FSIS 
requests comments on this proposed determination and whether there are 
alternative bases for determining adulteration of these NRTE products.

IV. Proposed Policy Implementation

HACCP Reassessment

    The HACCP system regulations require that every establishment 
reassess the adequacy of its HACCP plan at least annually and whenever 
any changes occur that could affect the underlying hazard analysis or 
alter the HACCP plan (9 CFR 417.4(a)(3)). If finalized, FSIS' proposed 
determination that Salmonella at levels of 1 CFU/gram or higher is an 
adulterant in NRTE breaded stuffed chicken products would be such a 
change. Thus, if FSIS finalizes this proposed determination, all 
establishments that produce Heat Treated but Not Fully Cooked--Not 
Shelf Stable NRTE breaded stuffed chicken products would need to 
reassess their HACCP plans. Establishments that make changes to their 
production process as a result of their reassessment would also need to 
re-validate their HACCP plans. FSIS would issue instructions to 
inspection program personnel in establishments that produce NRTE 
breaded stuffed chicken products to verify that these establishments 
have completed their reassessment before the effective date of any 
final determination resulting from this proposal.

Proposed Implementation and Status of Laboratory Methods

    As noted above, FSIS is proposing a routine sampling and 
verification testing program for Salmonella in NRTE breaded stuffed 
chicken products in which the Agency would collect and analyze samples 
from the chicken component prior to breading and stuffing, for 
Salmonella at 1 CFU per gram or higher. FSIS would collect the

[[Page 26265]]

verification samples after the establishment has completed all 
processes needed to prepare the chicken component to be stuffed and 
breaded to produce a final NRTE breaded stuffed chicken product. Should 
FSIS finalize this proposed testing program, the Agency would consider 
NRTE breaded stuffed chicken products produced with a chicken component 
that tested positive for Salmonella at levels of 1CFU per gram or 
higher to be adulterated. FSIS would sample the chicken component prior 
to stuffing and breading and would perform, evaluate, determine, and 
report whole genome sequencing (WGS), serotype, levels, and 
antimicrobial resistance (AMR) profile for each Salmonella isolate 
identified in the sampling program.\104\
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    \104\ This information would be reported as with any test 
result. Inspectors would get result through PHIS. FSIS would report 
out through Laboratory Information Management System (LIMS) Direct 
for industry as well as the result would be in the new PHIS sample 
result history report. The results would also be in public release 
data sets that the agency does quarterly. The WGS data would also be 
uploaded to NCBI as are other Salmonella isolates.
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    If FSIS finalizes this proposed sampling plan, data gathered from 
the sampling plan would enable the Agency to more precisely gauge the 
level of hazard posed by Salmonella in the chicken component of these 
products prior to stuffing and breading. As noted above, FSIS intends 
to further evaluate and, if necessary, refine the proposed status of 
Salmonella as an adulterant in NRTE breaded stuffed chicken products as 
advances in science and technology related to pathogen levels, 
serotypes, and virulence genes become available.
    The detection and isolation methodology for Salmonella is described 
in MLG chapter 4.13, of the FSIS Microbiology Laboratory 
Guidebook.\105\ When sampling the chicken component of NRTE breaded 
stuffed chicken products under this proposed determination, FSIS would 
collect one pound of the chicken component prior to stuffing and 
breading from the establishment to analyze 325 grams per test for 
Salmonella. Samples would be initially screened, post-enrichment, for 
the presence or absence of Salmonella. Samples that screen negative 
would be reported as ``negative.'' For samples that screen positive, 
FSIS would use selective and differential culture-based media and 
proteomics testing to identify the presumptive positive samples. All 
presumed positive samples would be subject to confirmatory tests and 
enumeration. A sample is considered confirmed positive for Salmonella 
after completion of both cultural and confirmatory tests. Any chicken 
component ``confirmed positive'' with Salmonella levels of 1 CFU per 
gram or higher prior to stuffing and breading would need to be diverted 
to a use other than NRTE breaded stuffed chicken products. Any NRTE 
breaded stuffed chicken products that contain a chicken component 
confirmed positive with Salmonella levels of 1 CFU per gram or higher 
prior to stuffing and breading would be considered adulterated.
---------------------------------------------------------------------------

    \105\ FSIS Microbiology Laboratory Guidebook available at: 
https://www.fsis.usda.gov/news-events/publications/microbiology-laboratory-guidebook.
---------------------------------------------------------------------------

    FSIS estimates that negative results would routinely be available 
within 48 hours of shipment of the samples to the laboratory, assuming 
overnight sample transit coupled with a 24-hour sample enrichment and 
screening at the laboratory. For samples that screen positive, an 
additional 2 to 4 days may be necessary for a confirmed positive or 
negative result. Enumeration is run concurrently with confirmatory 
testing and would be reported with the confirmed positive result. 
Salmonella serotypes, WGS, and AMR profile would require at least 14 
days for result reporting. These timeframes and methods may change as 
FSIS incorporates new laboratory technologies into its sampling 
verification program.\106\
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    \106\ For example, on July 8, 2022, FSIS announced that it had 
awarded a contract to bioM[eacute]rieux to incorporate its non-
enrichment quantification system for Salmonella, `GENE-
UPTM QUANT Salmonella,' into the Agency's laboratory 
system. The Agency evaluated commercially available quantification 
systems and determined that this technology is the most appropriate 
for use in the high throughput FSIS laboratory environment. FSIS 
stated that in the future, the Agency would announce when the method 
is available and when it will be implemented in all three FSIS food 
testing laboratories. FSIS also stated that it plans to extend 
pathogen quantification technology to sample types other than raw 
poultry rinses in the future (see FSIS Constituent Update, Jul 8, 
2022, FSIS to include Salmonella Quantification in Raw Poultry Rinse 
Samples. Available at: https://www.fsis.usda.gov/news-events/news-
press-releases/constituent-update-july-8-
2022#:~:text=Salmonella%20quantification%20is%20a%20significant%20ste
p%20in%20FSIS%E2%80%99,regulatory%20sample%2C%20not%20solely%20its%20
presence%20or%20absence.
---------------------------------------------------------------------------

    To help inform FSIS verification sampling plan resulting from this 
proposal, FSIS conducted a study with the Food Emergency Response 
Network (FERN) Cooperative Agreement Laboratories to gather data at 
retail to provide information about the positive rate of Salmonella in 
NRTE breaded stuffed chicken products. Through the FERN, FSIS has 
cooperative agreements with 11 geographically dispersed state 
laboratories that participated in this study: California Department of 
Public Health Food and Drug Laboratory, Colorado Department of 
Agriculture, Florida Department of Agriculture, State Hygienic 
Laboratory of Iowa, Michigan Department of Health and Human Services, 
Minnesota Department of Agriculture, Missouri Department of Health, New 
York Department of Health Wadsworth Center, Ohio Department of 
Agriculture, Texas State Chemist Laboratory, and Virginia Division of 
Consolidated Laboratory Services. From July 1, 2022, to September 30, 
2022, these laboratories purchased locally available, NRTE breaded 
stuffed chicken products at retail and tested them for the presence of 
Salmonella and sanitary indicator aerobic organism counts using the 
current validated methods that each state laboratory employed. The 
laboratories obtained approximately 15 samples per month depending on 
availability in their local area and retail stores. Fifty-eight of the 
487 samples collected were positive for the presence of Salmonella. The 
laboratories that used Salmonella detection and sample preparation 
methods that are the same as FSIS MLG 4.12 found Salmonella in 36 (27%) 
samples. Out of 58 isolates, 18 (31%) were Salmonella Enteritidis, 22 
(38%) Salmonella Infantis, 15 (26%) Salmonella Kentucky, and 3 (5%) 
Salmonella Typhimurium (3/58). These serotypes include those serotypes 
associated with the most recent NRTE breaded stuffed chicken product 
outbreaks and the most common serotypes associated with outbreak 
related illnesses for all chicken products.107 108
---------------------------------------------------------------------------

    \107\ FSIS Outbreak Reports at: https://www.fsis.usda.gov/food-safety/foodborne-illness-and-disease/outbreaks.
    \108\ Centers for Disease Control and Prevention: National 
Outbreak Reporting System at: https://wwwn.cdc.gov/norsdashboard/.
---------------------------------------------------------------------------

    The 27 percent-positive rate for Salmonella in NRTE breaded stuffed 
chicken products detected in retail samples is comparable to the 29 
percent positive rate detected in FSIS' sampling of ground 
chicken.\109\ These rates are higher than the Salmonella-positive rates 
for other raw chicken products, which suggests that NRTE breaded 
stuffed chicken products and ground chicken have a higher risk per 
serving than other raw chicken products. However, consumer preparation 
practices are more likely to mitigate the risk associated with ground 
chicken because, unlike NRTE breaded stuffed chicken products, ground 
chicken

[[Page 26266]]

clearly appears raw and is not typically cooked from a frozen state.
---------------------------------------------------------------------------

    \109\ USDA Food Safety and Inspection Service Annual Sampling 
Report Fiscal Year 2021: https://www.fsis.usda.gov/sites/default/files/media_file/2022-02/FY2021-Sampling-Summary-Report.pdf.
---------------------------------------------------------------------------

    Thus, given the number of outbreak investigations associated with 
NRTE stuffed chicken products and the consumer handling practices 
identified in both outbreak investigations and consumer behavior 
research, the disposition of the chicken component of NRTE breaded 
stuffed chicken products prior to stuffing and breading is an important 
factor in mitigating the public health risk associated with these 
products. Therefore, FSIS is proposing a verification sampling program 
for Salmonella in NRTE breaded stuffed chicken products in which the 
Agency would test the chicken component of these products prior to 
stuffing and breading and require that chicken component lots that 
confirm positive for Salmonella at 1 CFU per gram or higher be diverted 
to a use other than NRTE breaded stuffed chicken products. Under this 
proposal, such lots could be diverted for use in a fully cooked poultry 
product or for use in another raw poultry product, such as ground 
chicken, in which consumer preparation is more likely to mitigate the 
risk. FSIS has tentatively concluded that such a program would 
effectively address the serious public health risk associated with 
Salmonella in NRTE breaded stuffed chicken products while minimizing 
the potential loss associated with product that is confirmed positive 
for Salmonella at 1 CFU per gram. FSIS requests comments on this 
proposed verification sampling plan and possible alternative sampling 
plans. FSIS specifically requests comments on whether the Agency's 
verification sampling program should collect and analyze samples from 
the final packaged NRTE breaded stuffed chicken product rather than the 
chicken component prior to stuffing and breading.

Sampled Lot

    When FSIS tests a product sample for adulterants, the Agency 
withholds its determination as to whether product is not adulterated, 
and thus eligible to enter commerce, until all test results that bear 
on the determination have been received (77 FR 73401, Dec 10, 2012). 
Under this policy, establishments must maintain control of products 
tested for adulterants to ensure that the products do not enter 
commerce while waiting for receipt of the test results. Thus, if FSIS 
finalizes its proposed routine Salmonella verification testing program 
for the chicken component in NRTE breaded stuffed chicken products 
prior to stuffing and breading, establishments that produce these NRTE 
products would need to control and maintain the integrity of the 
sampled chicken component lot pending the availability of test results.
    Under any final verification sampling plan, FSIS IPP would give 
establishments that produce NRTE breaded stuffed chicken product 
advance notice before they collect a product sample from the chicken 
component for Salmonella to give the establishment enough time to 
control the sampled lot. The sampled lot is the product represented by 
the sample collected and analyzed by FSIS. Establishments are 
responsible for providing a supportable basis for defining the sample 
lot. For sampling purposes, product lots should be defined such that 
they are microbiologically independent. Microbiological independence is 
documented by separation, e.g., physical, temporal, or by sanitation 
intervention, that clearly delineates the end of one production lot and 
the beginning of the next. The microbiological results from one test 
are independent of prior or later lots. In other words, under this 
proposed verification plan, if a chicken component sample collected 
prior to stuffing and breading tests positive for Salmonella at a level 
of 1 CFU per gram or higher, products from other chicken component lots 
should not be implicated.
    Generally, FSIS recommends that establishments develop and 
implement in-plant sampling plans that define production lots or sub-
lots that are microbiologically independent of other production lots or 
sub-lots. Production lots that are so identified may bear distinctive 
markings on the shipping cartons. FSIS has issued guidance to help 
establishments comply with the Agency's policy that does not allow 
product that FSIS has tested for adulterants to enter commerce until 
test results become available.\110\ In addition to providing guidance 
on adequate control measures establishments can implement for products 
tested for adulterants, the document also includes guidance on how 
establishments can define a product lot in order to determine the 
amount of product that must be controlled pending test results. If FSIS 
finalizes its proposed Salmonella verification sampling for NRTE 
breaded stuffed chicken product, FSIS would update the guidance to 
cover Salmonella sampling of the chicken component of NRTE breaded 
stuffed chicken products before the effective date of the sampling 
program.
---------------------------------------------------------------------------

    \110\ FSIS Compliance Guideline: Controlling Meat and Poultry 
Product Pending FSIS Test Results (2013) at: https://www.fsis.usda.gov/guidelines/2013-0003.
---------------------------------------------------------------------------

    As discussed above, under this proposed verification sampling plan, 
establishments would be required to control the chicken component 
product sampled by FSIS and not incorporate it into NRTE breaded 
stuffed chicken products pending the test results. If test results 
detect Salmonella at a level of 1 CFU per gram or higher and the 
chicken component has been incorporated into a NRTE breaded stuffed 
chicken product, FSIS would consider the NRTE breaded stuffed chicken 
product that contains the chicken component represented by the sampled 
lots to be adulterated and request that the producing establishment 
recall any product implicated by the product lot that is in commerce. 
In addition, FSIS would issue a noncompliance record (NR) and, 
depending on the circumstances, take other appropriate enforcement 
action as authorized in 9 CFR part 500 because the establishment would 
have produced and shipped adulterated product. Such actions may include 
immediately suspending inspection or issuing a Notice of Intended 
Enforcement Action.

State Programs and Foreign Government Programs

    States that have their own poultry inspection programs for poultry 
products produced and transported solely within the State are required 
to have mandatory ante-mortem and post-mortem inspection, reinspection, 
and sanitation requirements that are at least equal to those in the 
Federal Meat Inspection Act (21 U.S.C. 661(a)(1)). Therefore, if FSIS 
finalizes this proposed determination, these States would need to adopt 
sampling procedures and testing methods to detect Salmonella at 1 CFU/
gram or above in the chicken component in NRTE breaded stuffed chicken 
products that are at least equal to FSIS' procedures and testing 
methods for State-inspected establishments that produce these 
products.\111\ Any State participating in a Cooperative Interstate 
Shipment Program would need to adopt FSIS' sampling procedures and 
testing methods to detect Salmonella at 1 CFU/gram or above in NRTE 
breaded stuffed chicken products in selected establishments that 
produce these products for shipment in interstate commerce (21 U.S.C. 
472). Foreign countries that are eligible to export poultry products to 
the United States must apply inspection, sanitary, and

[[Page 26267]]

other standards that are equivalent to those that FSIS applies to those 
products (21 U.S.C. 620). Thus, if FSIS finalizes this proposed 
determination, in evaluating a foreign country's poultry products 
inspection system to determine the country's eligibility to export 
poultry products to the United States, FSIS would consider whether the 
sampling procedures and testing methods to detect Salmonella at 1 CFU/
gram in the chicken component in NRTE breaded stuffed chicken products 
prior to stuffing and breading the country uses are equivalent to those 
that FSIS uses.
---------------------------------------------------------------------------

    \111\ FSIS is not aware of any State-inspected establishments 
that produce NRTE stuffed chicken products.
---------------------------------------------------------------------------

V. Anticipated Costs and Benefits Associated With This Proposed 
Determination

    FSIS has considered the economic effects of this proposed 
determination. The full analysis is published on the FSIS website as 
supporting documentation to this Federal Register Notice ([insert 
link]). FSIS is seeking comment on the information and assumptions used 
in the cost-benefit analysis. A summary of the analysis follows.

Summary of Estimated Costs and Benefits

    If finalized, this proposed determination is expected to impact six 
domestic establishments and cost industry at least $4.33 million 
annually, assuming a 7 percent discount rate over a ten-year 
period.\112\ These costs are associated with HACCP plan reassessments, 
holding sampled chicken components in cold storage awaiting test 
results, and the costs associated with developing and implementing an 
establishment-conducted sampling program. To varying degrees, industry 
may also incur costs associated with their individual responses to this 
policy. The Agency would incur costs associated with sampling and 
testing for Salmonella and conducting FSAs. However, these costs are 
likely more than offset by consumer and industry benefits.
---------------------------------------------------------------------------

    \112\ FSIS used its Public Health Information System (PHIS) data 
accessed on 07/28/2022.
---------------------------------------------------------------------------

    The benefit from reduced outbreak-related recalls depends on the 
number of recalls this proposed determination would prevent annually. 
With a total estimated annual industry cost of $4.33 million, and the 
estimated quantified benefit of one prevented outbreak-related recall 
being $25.85 million, total benefits would exceed total costs if the 
proposed determination prevents at least 1 outbreak-related recall 
every 5.96 years ($25.85/$4.33).\113\ Although the proposed policy may 
not prevent every possible Salmonella-related outbreak or illness in 
these products, FSIS believes the benefits of the proposed policy would 
exceed the costs if the policy contributes to preventing at least 1 
outbreak-related recall every 60 months.\114\ Between 2006 and 2021 
there was one outbreak every 16.4 months average (15 years/11 
outbreaks). Also, according to the CDC, reported cases from outbreaks 
only represent a fraction of actual cases; therefore, the health 
benefits associated with this new policy is likely to be higher than 
estimated in the published CBA.\115\
---------------------------------------------------------------------------

    \113\ Numbers may not calculate due to rounding.
    \114\ Numbers rounded to the nearest month.
    \115\ Scallan, E., Hoekstra, R.M., Angulo, F.J., Tauxe, R.V., 
Widdowson, M., Roy, S.L. Griffin, P.M. (2011). Foodborne Illness 
Acquired in the United States--Major Pathogens. Emerging Infectious 
Diseases, 17(1), 7-15. https://doi.org/10.3201/eid1701.p11101.
---------------------------------------------------------------------------

Potential Impact on Small Businesses

    In the CBA, FSIS defines high-volume establishments as 
establishments that produce at least 1 million pounds of NRTE stuffed 
chicken products annually and low-volume establishments as 
establishments that produce less than 1 million pounds annually. Using 
these categories, three of the six establishments that produce NRTE 
stuffed chicken products were classified as high-volume, and three 
establishments as low-volume. All three of the low-volume 
establishments are HACCP size small or very small.\116\ FSIS expects 
the cost burden of this proposed determination on low-volume 
establishments would be small. Nearly 90 percent of production at these 
three low-volume establishments is product other than NRTE stuffed 
chicken products. These establishments would choose to incur costs 
based on their own economic rationale.
---------------------------------------------------------------------------

    \116\ Under the HACCP size definitions, large establishments 
have 500 or more employees, small establishments have between 10 and 
499 employees, and very small establishments have less than 10 
employees or less than $2.5 million in annual revenue. 61 FR 38806.
---------------------------------------------------------------------------

    In addition, if FSIS finalizes this proposed determination, FSIS 
intends to implement routine testing for Salmonella and would allow 
industry time to implement possible changes to food safety systems. A 
small business would have this time to prepare for changes, lowering 
the burden.
    FSIS also assumes establishments needing monetary assistance to 
comply with any final determination resulting from this proposal would 
take advantage of the grants and financial options available to small 
establishments. More information on these loans and grants can be found 
on the FSIS website.\117\
---------------------------------------------------------------------------

    \117\ Grants and Financial Options, USDA FSIS https://www.fsis.usda.gov/inspection/apply-grant-inspection/grants-financial-options.
---------------------------------------------------------------------------

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, USDA, its 
Mission Areas, agencies, staff offices, employees, and institutions 
participating in or administering USDA programs are prohibited from 
discriminating based on race, color, national origin, religion, sex, 
gender identity (including gender expression), sexual orientation, 
disability, age, marital status, family/parental status, income derived 
from a public assistance program, political beliefs, or reprisal or 
retaliation for prior civil rights activity, in any program or activity 
conducted or funded by USDA (not all bases apply to all programs). 
Remedies and complaint filing deadlines vary by program or incident.
    Program information may be made available in languages other than 
English. Persons with disabilities who require alternative means of 
communication to obtain program information (e.g., Braille, large 
print, audiotape, American Sign Language) should contact the 
responsible Mission Area, agency, or staff office; the USDA TARGET 
Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service 
at (800) 877-8339.
    To file a program discrimination complaint, a complainant should 
complete a Form AD-3027, USDA Program Discrimination Complaint Form, 
which can be obtained online at https://www.usda.gov/forms/electronic-forms, from any USDA office, by calling (866) 632-9992, or by writing a 
letter addressed to USDA. The letter must contain the complainant's 
name, address, telephone number, and a written description of the 
alleged discriminatory action in sufficient detail to inform the 
Assistant Secretary for Civil Rights (ASCR) about the nature and date 
of an alleged civil rights violation. The completed AD-3027 form or 
letter must be submitted to USDA by:
    (1) Mail: U.S. Department of Agriculture, Office of the Assistant 
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 
20250-9410; or
    (2) Fax: (833) 256-1665 or (202) 690-7442; or
    (3) Email: [email protected].
    USDA is an equal opportunity provider, employer, and lender.

[[Page 26268]]

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register. FSIS also will make copies 
of this 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 our constituents and stakeholders. The Constituent 
Update is available on the FSIS web page. Through the web page, FSIS is 
able to provide information to a much broader, more diverse audience. 
In addition, FSIS offers an email subscription service which provides 
automatic and customized access to selected food safety news and 
information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information, 
regulations, directives, and notices. Customers can add or delete 
subscriptions themselves and have the option to password protect their 
accounts.

Paul Kiecker,
Administrator.

Appendix A: Salmonella Outbreak Investigations Associated With All 
Chicken Products 1998-2020

----------------------------------------------------------------------------------------------------------------
   Running total         Data source          Year          Poultry type         Product            Subtype
----------------------------------------------------------------------------------------------------------------
1..................  CDC NORS..........            1998  Chicken..........  chicken,           Enteritidis.
                                                                             unspecified.
2..................  CDC NORS..........            1998  Chicken..........  chicken..........  Enteritidis.
3..................  CDC NORS..........            1998  Chicken..........  chicken..........  Enteritidis.
4..................  CDC NORS..........            1998  Chicken..........  chicken,           Group E1.
                                                                             unspecified.
5..................  CDC NORS..........            1998  Chicken..........  chicken,           Typhimurium.
                                                                             unspecified.
6..................  PubMed............            1998  Chicken..........  chicken Kiev.....  Typhimurium.
7..................  CDC NORS..........            1999  Chicken..........  chicken salad....  Enteritidis.
8..................  CDC NORS..........            1999  Chicken..........  chicken,           Enteritidis.
                                                                             unspecified.
9..................  CDC NORS..........            1999  Chicken..........  chicken,           Enteritidis.
                                                                             unspecified;
                                                                             mung bean
                                                                             sprouts.
10.................  CDC NORS..........            1999  Chicken..........  chicken,           Give.
                                                                             unspecified.
11.................  CDC NORS..........            1999  Chicken..........  chicken, baked...  Hadar.
12.................  CDC NORS..........            1999  Chicken..........  chicken,           Hadar.
                                                                             unspecified.
13.................  CDC NORS..........            1999  Chicken..........  chicken, bbq.....  Heidelberg.
14.................  CDC NORS..........            1999  Chicken..........  chicken,           Javiana.
                                                                             unspecified.
15.................  CDC NORS..........            1999  Chicken..........  chicken, other...  Muenchen.
16.................  CDC NORS..........            1999  Chicken..........  burrito, chicken;  Typhimurium.
                                                                             taco, chicken;
                                                                             chicken, nuggets/
                                                                             fingers.
17.................  CDC NORS..........            1999  Chicken..........  deli meat, sliced  Unsubtyped.
                                                                             chicken.
18.................  CDC NORS..........            1999  Chicken..........  chicken,           Unsubtyped.
                                                                             unspecified.
19.................  CDC NORS..........            2000  Chicken..........  chicken,           Group B.
                                                                             unspecified.
20.................  CDC NORS..........            2000  Chicken..........  chicken, bbq.....  Group C1.
21.................  CDC NORS..........            2000  Chicken..........  chicken, fried...  Newport.
22.................  CDC NORS..........            2000  Chicken..........  chicken,           Newport.
                                                                             unspecified.
23.................  CDC NORS..........            2000  Chicken..........  chicken,           Typhimurium.
                                                                             unspecified.
24.................  CDC NORS..........            2001  Chicken..........  chicken, grilled.  Braenderup.
25.................  CDC NORS..........            2001  Chicken..........  chicken, nuggets/  Enteritidis.
                                                                             fingers.
26.................  CDC NORS..........            2001  Chicken..........  chicken, baked...  Enteritidis.
27.................  CDC NORS..........            2001  Chicken..........  chicken, fried...  Newport.
28.................  CDC NORS..........            2001  Chicken..........  specialty salads   Typhimurium.
                                                                             unspecified.
29.................  CDC NORS..........            2001  Chicken..........  chicken, other...  Typhimurium.
30.................  CDC NORS..........            2001  Chicken..........  chicken, other...  Unsubtyped.
31.................  CDC NORS..........            2001  Chicken..........  chicken, other...  Unsubtyped.
32.................  CDC NORS..........            2002  Chicken..........  chicken..........  Enteritidis.
33.................  CDC NORS..........            2002  Chicken..........  chicken, other...  Rubislaw.
34.................  CDC NORS..........            2002  Chicken..........  chicken, baked...  Unsubtyped.
35.................  CDC NORS..........            2003  Chicken..........  sauces,            Enteritidis.
                                                                             unspecified;
                                                                             chicken,
                                                                             unspecified.
36.................  CDC NORS..........            2003  Chicken..........  chicken, baked...  Enteritidis.
37.................  CDC NORS..........            2003  Chicken..........  chicken, baked...  Newport;
                                                                                                Muenster;
                                                                                                Heidelberg.
38.................  CDC NORS..........            2003  Chicken..........  chicken,           Typhimurium.
                                                                             unspecified.
39.................  CDC NORS..........            2003  Chicken..........  chicken, other...  Unsubtyped.
40.................  CDC NORS..........            2003  Chicken..........  chicken, roasted.  Unsubtyped.
41.................  CDC NORS..........            2004  Chicken..........  chicken, raw.....  Enteritidis.
42.................  CDC NORS..........            2004  Chicken..........  chicken, roasted.  Group B.
43.................  CDC NORS..........            2004  Chicken..........  chicken, curry...  Group D1.
44.................  CDC NORS..........            2004  Chicken..........  chicken, baked...  Hadar.
45.................  CDC NORS..........            2004  Chicken..........  chicken, other...  Heidelberg.
46.................  CDC NORS..........            2004  Chicken..........  chicken,           Heidelberg.
                                                                             unspecified.
47.................  CDC NORS..........            2004  Chicken..........  chicken,           Heidelberg.
                                                                             unspecified.
48.................  CDC NORS..........            2004  Chicken..........  chicken, other...  Thompson.
49.................  CDC NORS..........            2004  Chicken..........  chicken, baked...  Typhimurium.
50.................  CDC NORS..........            2004  Chicken..........  chicken, other...  Typhimurium.
51.................  CDC NORS..........            2004  Chicken..........  chicken, grilled.  Typhimurium var
                                                                                                Cope.
52.................  CDC NORS..........            2004  Chicken..........  chicken,           Unsubtyped.
                                                                             unspecified.
53.................  CDC NORS..........            2005  Chicken..........  chicken, grilled.  Enteritidis.

[[Page 26269]]

 
54.................  CDC NORS..........            2005  Chicken..........  stuffing/          Enteritidis.
                                                                             dressing; gravy,
                                                                             chicken;
                                                                             chicken, other.
55.................  CDC NORS..........            2005  Chicken..........  chicken, grilled.  Enteritidis.
56.................  CDC NORS..........            2005  Chicken..........  stuffed chicken..  Enteritidis;
                                                                                                Typhimurium;
                                                                                                Kentucky.
57.................  CDC NORS..........            2005  Chicken..........  chicken, other...  Heidelberg.
58.................  CDC NORS..........            2005  Chicken..........  stuffed chicken    Heidelberg.
                                                                             (Chicken
                                                                             Broccoli and
                                                                             Cheese).
59.................  CDC NORS..........            2005  Chicken..........  chicken, other...  Unsubtyped.
60.................  CDC NORS..........            2006  Chicken..........  chicken..........  Agona.
61.................  CDC NORS..........            2006  Chicken..........  chicken, baked...  I 4,[5],12:i:-.
62.................  CDC NORS..........            2006  Chicken..........  chicken,           Newport.
                                                                             unspecified.
63.................  CDC NORS..........            2006  Chicken..........  chicken,           Typhimurium.
                                                                             teriyaki; sushi,
                                                                             unspecified.
64.................  PubMed............            2006  Chicken..........  Chicken Kiev,      Typhimurium.
                                                                             Chicken Broccoli
                                                                             and Cheese,
                                                                             Chicken
                                                                             Mushrooms and
                                                                             Cheddar, Chicken
                                                                             Mushrooms in
                                                                             Wine Sauce, and/
                                                                             or Chicken
                                                                             Romanov.
65.................  CDC NORS..........            2006  Chicken..........  chicken,           Typhimurium var
                                                                             unspecified.       Cope.
66.................  CDC NORS..........            2007  Chicken..........  chicken, bbq.....  Braenderup.
67.................  CDC NORS..........            2007  Chicken..........  chicken dishes,    Enteritidis.
                                                                             unspecified.
68.................  CDC NORS..........            2007  Chicken..........  ribs, bbq;         Enteritidis.
                                                                             chicken wings,
                                                                             bbq.
69.................  CDC NORS..........            2007  Chicken..........  Not RTE frozen     I 4,[5],12:i:-.
                                                                             chicken pot pie.
70.................  CDC NORS..........            2007  Chicken..........  chicken..........  Schwarzengrund.
71.................  CDC NORS..........            2007  Chicken..........  chicken, baked;    Typhimurium.
                                                                             chicken, grilled.
72.................  CDC NORS..........            2008  Chicken..........  specialty/ethnic   Enteritidis.
                                                                             dishes.
73.................  CDC NORS..........            2008  Chicken..........  chicken, roasted.  Typhimurium.
74.................  CDC NORS..........            2008  Chicken..........  chicken, other...  Typhimurium.
75.................  CDC NORS..........            2008  Chicken..........  chicken,           Typhimurium.
                                                                             unspecified.
76.................  CDC NORS..........            2009  Chicken..........  chicken..........  Heidelberg.
77.................  CDC NORS..........            2009  Chicken..........  chicken..........  Heidelberg.
78.................  FSIS/NORS.........            2009  Chicken..........  Stuffed chicken..  1 4,[5], 12:i-.
79.................  CDC NORS..........            2009  Chicken..........  chicken..........  Typhimurium.
80.................  CDC NORS..........            2010  Chicken..........  Cheesy Chicken     Chester.
                                                                             and Rice frozen
                                                                             meals (frozen
                                                                             entr[eacute]e).
81.................  CDC NORS..........            2010  Chicken..........  chicken and rice.  Enteritidis.
82.................  CDC NORS..........            2010  Chicken..........  chicken salad....  Enteritidis.
83.................  CDC NORS..........            2010  Chicken..........  chicken..........  Heidelberg.
84.................  CDC NORS..........            2010  Chicken..........  chicken, baked...  Typhimurium var
                                                                                                Cope.
85.................  CDC NORS..........            2011  Chicken..........  chicken..........  Enteritidis.
86.................  CDC NORS..........            2011  Chicken..........  chicken picata...  Enteritidis.
87.................  CDC NORS..........            2011  Chicken..........  chicken..........  Enteritidis.
88.................  CDC NORS..........            2011  Chicken..........  Kosher Broiled     Heidelberg.
                                                                             Chicken Livers.
89.................  CDC NORS..........            2011  Chicken..........  chicken, other...  Montevideo.
90.................  CDC NORS..........            2011  Chicken..........  chicken..........  Typhimurium var
                                                                                                Cope.
91.................  CDC NORS..........            2012  Chicken..........  chicken..........  Enteritidis.
92.................  CDC NORS..........            2012  Chicken..........  fajita, chicken..  Enteritidis.
93.................  CDC NORS..........            2012  Chicken..........  chicken..........  Heidelberg.
94.................  CDC NORS..........            2012  Chicken..........  chicken, baked...  Javiana.
95.................  CDC NORS..........            2012  Chicken..........  chicken..........  Newport.
96.................  CDC NORS..........            2012  Chicken..........  chicken..........  Schwarzengrund.
97.................  CDC NORS..........            2012  Chicken..........  chicken..........  Unsubtyped.
98.................  FSIS/NORS.........            2013  Chicken..........  Stuffed chicken..  Enteritidis.
99.................  CDC NORS..........            2013  Chicken..........  chicken..........  Enteritidis.
100................  CDC NORS..........            2013  Chicken..........  ground chicken...  Enteritidis.
101................  CDC SNORS.........            2013  Chicken..........  Mechanically       Heidelberg.
                                                                             Separated
                                                                             Chicken.
102................  CDC NORS..........            2013  Chicken..........  chicken..........  Heidelberg.
103................  CDC NORS..........            2013  Chicken..........  chicken mole.....  Heidelberg.
104................  CDC SNORS.........            2013  Chicken..........  chicken products.  Heidelberg.
105................  CDC NORS..........            2013  Chicken..........  chicken..........  Javiana.
106................  CDC NORS..........            2013  Chicken..........  chicken, bbq.....  Montevideo.
107................  CDC NORS..........            2014  Chicken..........  chicken..........  Carmel.
108................  CDC NORS..........            2014  Chicken..........  chicken..........  Enteritidis.
109................  CDC NORS..........            2014  Chicken..........  chicken..........  Enteritidis.
110................  CDC NORS..........            2014  Chicken..........  chicken,           Enteritidis.
                                                                             casserole.
111................  FSIS/NORS.........            2014  Chicken..........  stuffed chicken    Enteritidis.
                                                                             (chicken kiev).
112................  CDC NORS..........            2014  Chicken..........  chicken liver      Enteritidis.
                                                                             pate.
113................  CDC NORS..........            2014  Chicken..........  chicken..........  Enteritidis;
                                                                                                Enteritidis.
114................  CDC NORS..........            2014  Chicken..........  chicken, smoked..  Heidelberg.

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115................  CDC NORS..........            2014  Chicken..........  chicken, grilled.  Heidelberg.
116................  CDC NORS..........            2014  Chicken..........  chicken..........  Infantis.
117................  CDC NORS..........            2014  Chicken..........  chicken, smoked..  Thompson.
118................  CDC NORS..........            2014  Chicken..........  sandwich, chicken  Thompson.
119................  CDC NORS..........            2015  Chicken..........  chicken,           Braenderup.
                                                                             rotisserie.
120................  CDC NORS..........            2015  Chicken..........  chicken,           Derby.
                                                                             rotisserie.
121................  CDC NORS..........            2015  Chicken..........  Stuffed chicken..  Enteritidis.
122................  CDC NORS..........            2015  Chicken..........  chicken tenders..  Enteritidis.
123................  FSIS/NORS.........            2015  Chicken..........  frozen, raw,       Enteritidis.
                                                                             stuffed and
                                                                             breaded chicken.
124................  FSIS/NORS.........            2015  Chicken..........  chicken Kiev,      Enteritidis.
                                                                             cordon bleu,.
125................  CDC NORS..........            2015  Chicken..........  chicken, grilled;  Enteritidis.
                                                                             chicken,
                                                                             blackened.
126................  CDC NORS..........            2015  Chicken..........  chicken and        Enteritidis.
                                                                             waffles.
127................  CDC NORS..........            2015  Chicken..........  chicken katsu      Muenchen.
                                                                             plate; korean
                                                                             chicken.
128................  CDC NORS..........            2015  Chicken..........  chicken, roasted.  Unsubtyped.
129................  FSIS/NORS.........            2016  Chicken..........  Stuffed chicken..  Enteritidis.
130................  CDC NORS..........            2016  Chicken..........  pate, chicken      Enteritidis.
                                                                             liver.
131................  CDC NORS..........            2016  Chicken..........  chicken, baked...  Enteritidis;
                                                                                                Enteritidis;
                                                                                                Enteritidis.
132................  CDC NORS..........            2016  Chicken..........  chicken..........  Heidelberg.
133................  CDC NORS..........            2016  Chicken..........  rotisserie         I 4,[5],12:i:-.
                                                                             chicken salad
                                                                             from Costco's
                                                                             Alderwood store.
134................  CDC NORS..........            2016  Chicken..........  chicken..........  Muenchen.
135................  CDC NORS..........            2016  Chicken..........  chicken..........  Norwich.
136................  CDC NORS..........            2016  Chicken..........  chicken..........  Saintpaul.
137................  CDC NORS..........            2016  Chicken..........  chicken..........  Thompson.
138................  CDC NORS..........            2016  Chicken..........  chicken..........  Unsubtyped.
139................  CDC NORS..........            2017  Chicken..........  sandwich, chicken  Anatum.
140................  CDC NORS..........            2017  Chicken..........  chicken..........  Enteritidis.
141................  CDC NORS..........            2017  Chicken..........  chicken..........  Enteritidis.
142................  CDC NORS..........            2017  Chicken..........  chicken dishes...  Enteritidis.
143................  CDC NORS..........            2017  Chicken..........  kabobs, chicken..  Enteritidis.
144................  CDC NORS..........            2017  Chicken..........  chicken salad      Enteritidis.
                                                                             sandwich;
                                                                             grilled chicken
                                                                             salad; chicken
                                                                             caesar salad.
145................  CDC NORS..........            2017  Chicken..........  chicken..........  Enteritidis.
146................  CDC NORS..........            2017  Chicken..........  chicken..........  Enteritidis.
147................  CDC NORS..........            2017  Chicken..........  chicken, pulled..  Heidelberg.
148................  CDC NORS..........            2017  Chicken..........  chicken..........  I 4,[5],12:i:-.
149................  CDC NORS..........            2017  Chicken..........  chicken, smoked..  Infantis.
150................  CDC NORS..........            2018  Chicken..........  chicken, raw.....  Blockley.
151................  CDC NORS..........            2018  Chicken..........  chicken..........  Blockley.
152................  CDC NORS..........            2018  Chicken..........  chicken, grilled.  Braenderup.
153................  CDC NORS..........            2018  Chicken..........  chicken..........  Enteritidis.
154................  FSIS/NORS.........            2018  Chicken..........  raw breaded        Enteritidis.
                                                                             chicken.
155................  CDC NORS..........            2018  Chicken..........  chicken, smoked..  Enteritidis.
156................  CDC NORS..........            2018  Chicken..........  smoked chicken...  Enteritidis.
157................  CDC NORS..........            2018  Chicken..........  chicken, other...  Enteritidis.
158................  CDC NORS..........            2018  Chicken..........  chicken..........  Enteritidis;
                                                                                                Thompson.
159................  CDC NORS..........            2018  Chicken..........  chicken, raw.....  Heidelberg.
160................  CDC NORS..........            2018  Chicken..........  kosher chicken...  I 4,[5],12:i:-.
161................  CDC NORS..........            2018  Chicken..........  chicken..........  Paratyphi B.
162................  CDC NORS..........            2018  Chicken..........  chicken salad....  Typhimurium.
163................  CDC NORS..........            2018  Chicken..........  chicken..........  Typhimurium.
164................  CDC NORS..........            2019  Chicken..........  chicken..........  Braenderup.
165................  CDC NORS..........            2019  Chicken..........  chicken..........  Enteritidis.
166................  CDC NORS..........            2019  Chicken..........  chicken..........  Enteritidis.
167................  CDC NORS..........            2019  Chicken..........  chicken..........  Enteritidis.
168................  CDC NORS..........            2019  Chicken..........  chicken fingers..  Enteritidis.
169................  CDC NORS..........            2019  Chicken..........  chicken..........  Enteritidis.
170................  CDC NORS..........            2019  Chicken..........  chicken..........  Enteritidis.
171................  CDC NORS..........            2019  Chicken..........  mechanically       Enteritidis;
                                                                             separated          Infantis.
                                                                             chicken.
172................  CDC NORS..........            2019  Chicken..........  chicken..........  Heidelberg.
173................  CDCNORS...........            2019  Chicken..........  chicken products.  Infantis.
174................  CDC NORS..........            2019  Chicken..........  chicken..........  Infantis.
175................  CDC NORS..........            2019  Chicken..........  chicken..........  Thompson.
176................  CDC NORS..........            2020  Chicken..........  chicken..........  Enteritidis.
177................  CDC NORS..........            2020  Chicken..........  chicken..........  Enteritidis.
178................  CDC NORS..........            2020  Chicken..........  chicken..........  Enteritidis.
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[FR Doc. 2023-09043 Filed 4-27-23; 8:45 am]
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